4–23–96 tuesday vol. 61 no. 79 april 23, 1996 pages 17823 ... · manufacturer reporting...

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TuesdayApril 23, 1996Vol. 61 No. 79

Pages 17823–18046

4–23–96

Briefings on How To Use the Federal RegisterFor information on briefings in Washington, DC, seeannouncement on the inside cover of this issue.

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Federal Register / Vol. 61, No. 79 / Tuesday, April 23, 1996

WASHINGTON, DC[Two Sessions]

WHEN: May 14, 1996 at 9:00 amMay 21, 1996 at 9:00 am

WHERE: Office of the Federal Register ConferenceRoom, 800 North Capitol Street, NW.,Washington, DC (3 blocks north of UnionStation Metro)

RESERVATIONS: 202–523–4538

Contents Federal Register

III

Vol. 61, No. 79

Tuesday, April 23, 1996

Agriculture DepartmentSee Forest ServiceRULESAgricultural Trade Development and Assistance Act:

Agricultural commodities; commercial sales financing,17823–17824

PROPOSED RULESNondiscrimination in USDA conducted programs and

activities, 17851–17853

Air Force DepartmentRULESAircraft:

DOD commercial air carrier quality and safety reviewprogram, 17840–17841

Antitrust DivisionNOTICESNational cooperative research notifications:

Cullen Engineering Research Foundation CooperativeResearch Venture, 17912

Joint Industry Program, 17913

Census BureauNOTICESAgency information collection activities:

Proposed collection; comment request, 17872–17874

Centers for Disease Control and PreventionNOTICESGrants and cooperative agreements; availability, etc.:

Hemophilia; surveillance of complications, 17896–17900

Coast GuardRULESRegattas and marine parades:

River Race Augusta, GA, 17841–17842PROPOSED RULESAnchorage regulations:

South Carolina, 17861–17863

Commerce DepartmentSee Census BureauSee Foreign-Trade Zones BoardSee National Institute of Standards and TechnologySee National Oceanic and Atmospheric Administration

Commodity Futures Trading CommissionNOTICESMeetings:

Agricultural Advisory Committee, 17881–17882

Customs ServiceNOTICESMerchandise, special classes:

China; importation of convict, forced, or indentured labormade goods—

Tianjin Malleable Iron Factory, 17956–17957

Defense DepartmentSee Air Force Department

Drug Enforcement AdministrationRULESDomestic Chemical Diversion Control Act of 1993;

implementation:List 1 chemicals; manufacturers, distributors, importers,

and exporters; registration—Manufacturer reporting requirements; correction, 17958

NOTICESApplications, hearings, determinations, etc.:

Phillips, Ronald, D.O.; correction, 17958Siddiqui, Shahid Musud, M.D.; correction, 17958

Energy DepartmentSee Energy Efficiency and Renewable Energy OfficeSee Federal Energy Regulatory CommissionNOTICESGrant and cooperative agreement awards:

Low-Level Radioactive Waste Forum, 17882Meetings:

Environmental Management Site-Specific AdvisoryBoard—

Hanford Site, 17883–17884Idaho National Engineering Library, 17882–17883Savannah River Site, 17883

National Coal Council, 17884Patent licenses; non-exclusive, exclusive, or partially

exclusive:PLD Advanced Automation Systems, Inc., 17884–17885

Energy Efficiency and Renewable Energy OfficeNOTICESConsumer product test procedures; waiver petitions:

Superior Fireplace Co., 17885–17887Thermo Products Inc., 17887–17888

Energy-efficient product commercialization study, 17888–17889

Environmental Protection AgencyPROPOSED RULESHazardous waste:

Treatment, storage, and disposal facilities—Tanks, surface impoundments, and containers; organic

air emission standards, 17863–17864NOTICESCommittees; establishment, renewal, termination, etc.:

National Environmental Education and TrainingFoundation, Inc.; appointment to Board of Directors,17891–17892

Drinking water:Public water supply supervision program—

Hawaii, 17892Meetings:

Analysis of pollutants in the environment; conferenceand training workshop, 17892–17893

Climate change; issues analysis; workshop, 17893–17894Reports; availability, etc.:

Cancer risk assessment guidelines, 17960–18011

Executive Office of the PresidentSee Management and Budget OfficeSee Presidential Documents

IV Federal Register / Vol. 61, No. 79 / Tuesday, April 23, 1996 / Contents

Federal Aviation AdministrationRULESAirworthiness directives:

Boeing, 17824–17825Saab, 17825–17826

Class D airspace, 17826–17828PROPOSED RULESAirworthiness directives:

de Havilland, 17855–17857Empressa Brasileira de Aeronautica, S.A., 17853–17855

NOTICESCivil penalty actions; Administrator’s decisions and orders;

index availability, 17937–17949Exemption petitions; summary and disposition, 17949–

17950

Federal Communications CommissionPROPOSED RULESRadio and television broadcasting:

Telecommunications Act of 1996; implementation—Broadcast facilities; license term extension to 8 years,

17864–17866NOTICESAgency information collection activities under OMB

review, 17894

Federal Energy Regulatory CommissionNOTICESNatural gas certificate filings

Williams Natural Gas Co., 17891Applications, hearings, determinations, etc.:

CNG Transmission Corp., 17889–17890National Fuel Gas Supply Corp., 17890Transcontinental Gas Pipe Line Corp., 17890

Federal Highway AdministrationPROPOSED RULESMotor carrier safety regulations:

Parts and accessories necessary for safe operation—Manufactured homes transportation; overloading of

tires by up to 18 percent, 18014–18024

Federal Maritime CommissionRULESMaritime carriers in foreign commerce:

Agreements among ocean common carriers; informationform and post-effective reporting requirements;reconsideration petitions, extension of filing time,17849

NOTICESComplaints filed:

Southern Pacific Transportation Co. et al., 17894–17895Freight forwarder licenses:

RMG International Inc. et al., 17895Investigations, hearings, petitions, etc.:

Longrow Shipping Ltd., 17895–17896

Federal Reserve SystemNOTICESBanks and bank holding companies:

Permissible nonbanking activities, 17896

Food and Drug AdministrationRULESAnimal drugs, feeds, and related products:

Sponsor name and address changes—Anthony Products Co., 17829–17830

Food for human consumption:Food additives—

Sodium chlorite; use in poultry processing, 17828–17829

NOTICESAgency information collection activities:

Proposed collection; comment request, 17900–17901Food additive petitions:

Dainippon Ink & Chemicals, Inc., 17901Human drugs:

Export applications—Differin (Adapalene) 0.1% topical gel, 17902–17903Migramist (dihydroergotamine mesylate, USP) 4 mg/mL

nasal spray, 17901–17902

Foreign Claims Settlement CommissionNOTICESPrivacy Act:

Systems of records, 17913–17914

Foreign-Trade Zones BoardNOTICESApplications, hearings, determinations, etc.:

KansasTexaco, Inc.; oil refinery complex, 17874–17875

OhioAbbott Manufacturing, Inc.; infant formula, adult

nutritional products plant, 17875Texas, 17875

Basis Petroleum, Inc.; oil refinery complex, 17875–17876

Forest ServiceNOTICESLand and jurisdiction transfers, etc.:

Sam Rayburn Dam and Reservoir Project, 17872

Health and Human Services DepartmentSee Centers for Disease Control and PreventionSee Food and Drug AdministrationSee Indian Health ServiceSee National Institutes of HealthSee Substance Abuse and Mental Health Services

Administration

Housing and Urban Development DepartmentPROPOSED RULESFederal regulatory review:

Hearing procedures; streamlining, 18026–18037Manufactured home construction and safety standards:

Transportation of manufactured homes; overloading oftires by up to 18 percent, 18014–18024


Submission for OMB review; comment request, 17906Grants and cooperative agreements; availability, etc.:

Youthbuild program; historically black colleges anduniversities program; early childhood developmentprogram; continuum of care homeless assistance,17906–17908

Indian Affairs BureauPROPOSED RULESFederal regulatory reform:

Regulations rewriting in ‘‘plain English;’’ obsoleteregulations removal, 17857–17859

VFederal Register / Vol. 61, No. 79 / Tuesday, April 23, 1996 / Contents

Indian Health ServiceNOTICESAgency information collection activities:

Proposed collection; comment request, 17903–17904

Interior DepartmentSee Indian Affairs BureauSee Land Management BureauSee National Park ServiceSee Surface Mining Reclamation and Enforcement OfficeRULESTribal government:

Self-governance program; awarding negotiation andplanning grants; procedure establishment, 17830–17833

NOTICESGrants and cooperative agreements; availability, etc.:

Tribal self-governance program—Negotiation and advance planning, 17908

Justice DepartmentSee Antitrust DivisionSee Drug Enforcement AdministrationSee Foreign Claims Settlement Commission

Land Management BureauNOTICESClosure of public lands:

Utah, 17908–17909Environmental statements; notice of intent:

COE Mosquito Creek Lake Project, OH, 17909–17910Oil and gas leases:

Arkansas, 17910Public land orders:

Washington, 17910–17911

Management and Budget OfficeNOTICESBudget rescissions and deferrals, 17915–17926

National Archives and Records AdministrationRULESNixon administration presidential historical materials;

preservation, protection, and access procedures, 17842–17849

National Highway Traffic Safety AdministrationNOTICESMotor vehicle safety standards:

Nonconforming vehicles—Importation eligibility; determinations, 17950–17951

National Institute of Standards and TechnologyNOTICESInformation processing standards, Federal:

Initial graphics exchange specification, 17876–17879

National Institutes of HealthNOTICESMeetings:

National Heart, Lung, and Blood Institute, 17904National Institute of Dental Research, 17904–17905Research Grants Division Advisory Committee, 17905

National Oceanic and Atmospheric AdministrationRULESFishery conservation and management:

Bering Sea and Aleutian Islands groundfish, 17849–17850

PROPOSED RULESFishery conservation and management:

Atlantic swordfish, 17866Shrimp fishery off Southern Atlantic states, 17866–17871

NOTICESMeetings:

Monterey Bay National Marine Sanctuary AdvisoryCouncil, 17879

West Coast salmon fisheries; northwest emergencyassistance plan, 17879–17881

National Park ServiceNOTICESEnvironmental statements; availability, etc.:

Olympic National Park, WA, 17911–17912National Register of Historic Places:

Pending nominations, 17912

National Transportation Safety BoardNOTICESMeetings; Sunshine Act, 17914

Nuclear Regulatory CommissionNOTICESMeetings:

Nuclear Safety Research Review Committee, 17914Meetings; Sunshine Act, 17915Regulatory guides; issuance, availability, and withdrawal,

17915

Office of Management and BudgetSee Management and Budget Office

Presidential DocumentsPROCLAMATIONSSpecial observances:

Crime Victims’ Rights Week, National (Proc. 6888),18045–18046

Jewish Heritage Week (Proc. 6887), 18043Organ and Tissue Donor Awareness Week, National

(Proc. 6886), 18041

Public Health ServiceSee Centers for Disease Control and PreventionSee Food and Drug AdministrationSee Indian Health ServiceSee National Institutes of HealthSee Substance Abuse and Mental Health Services

Administration

Research and Special Programs AdministrationNOTICESAgency information collection activities:

Submission for OMB review; comment request, 17951–17952

Securities and Exchange CommissionNOTICESSelf-regulatory organizations; proposed rule changes:

American Stock Exchange, Inc., 17931–17932Chicago Stock Exchange, Inc., 17932–17936

Applications, hearings, determinations, etc.:Emerging Markets Growth Fund, Inc., et al., 17927–17929Glickenhaus & Co. et al., 17929–17931

Small Business AdministrationNOTICESInterest rates; quarterly determinations, 17936

VI Federal Register / Vol. 61, No. 79 / Tuesday, April 23, 1996 / Contents

Substance Abuse and Mental Health ServicesAdministration



Surface Mining Reclamation and Enforcement OfficeRULESIndian lands program:

Abandoned mine land reclamation plan—Hopi Tribe, 17833–17840

PROPOSED RULESPermanent program and abandoned mine land reclamation

plan submissions:West Virginia, 17859–17861

Surface Transportation BoardNOTICESMeetings; Sunshine Act, 17954Railroad operation, acquisition, construction, etc.:

Central Railroad Co. of Indiana, 17952Longhorn Railway Co., 17952–17953

Railroad services abandonment:Burlington Northern Railroad Co., 17953Jacksonville Port Authority, 17953–17954

Thrift Supervision OfficeNOTICESApplications, hearings, determinations, etc.:

First Federal Savings & Loan Association of Bloomington,17957

First Federal Savings & Loan Association of Ironton,17957

First Lancaster Federal Savings Bank, 17957

Transportation DepartmentSee Coast GuardSee Federal Aviation AdministrationSee Federal Highway AdministrationSee National Highway Traffic Safety AdministrationSee Research and Special Programs AdministrationSee Surface Transportation Board

NOTICESAviation proceedings:

Agreements filed; weekly receipts, 17936–17937Certificates of public convenience and necessity and

foreign air carrier permits; weekly applications,17937

Treasury DepartmentSee Customs ServiceSee Thrift Supervision OfficeNOTICESAgency information collection activities:


Separate Parts In This Issue

Part IIEnvironmental Protection Agency, 17960–18011

Part IIIDepartment of Transportation, Federal Highway

Administration; Housing and Urban DevelopmentDepartment, 18014–18024

Part IVHousing and Urban Development Department, 18026–18037

Part VThe President, 18041–18046

Reader AidsAdditional information, including a list of public laws,telephone numbers, reminders, and finding aids, appears inthe Reader Aids section at the end of this issue.

Electronic Bulletin BoardFree Electronic Bulletin Board service for Public Lawnumbers, Federal Register finding aids, and a list ofdocuments on public inspection is available on 202–275–1538 or 275–0920.

CFR PARTS AFFECTED IN THIS ISSUE

A cumulative list of the parts affected this month can be found in theReader Aids section at the end of this issue.

VIIFederal Register / Vol. 61, No. 79 / Tuesday, April 23, 1996 / Contents

3 CFRProclamations:6886.................................180416887.................................180436888.................................18045

7 CFR17.....................................17823Proposed Rules:15.....................................1785115d...................................17851

14 CFR39 (2 documents) ...........17824,

1782571.....................................17826Proposed Rules:39 (2 documents) ...........17853,

17855

21 CFR173...................................17828529...................................178291310.................................17958

24 CFRProposed Rules:26.....................................1802628.....................................1802630.....................................1802681.....................................18026200...................................18026950...................................18026965...................................180263280.................................180143500.................................18026

25 CFR1001.................................17830Proposed Rules:Ch. I .................................17857

30 CFR756...................................17833Proposed Rules:948...................................17859

32 CFR861...................................17840

33 CFR100...................................17841Proposed Rules:110...................................17842

36 CFR1275.................................17842

40 CFRProposed Rules:262...................................17863264...................................17863265...................................17863270...................................17863

46 CFR572...................................17849

47 CFRProposed Rules:73.....................................1786474.....................................17864

49 CFRProposed Rules:393...................................18014

50 CFR675...................................17849Proposed Rules:630...................................17866659...................................17866

This section of the FEDERAL REGISTERcontains regulatory documents having generalapplicability and legal effect, most of whichare keyed to and codified in the Code ofFederal Regulations, which is published under50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold bythe Superintendent of Documents. Prices ofnew books are listed in the first FEDERALREGISTER issue of each week.

Rules and Regulations Federal Register

17823

Vol. 61, No. 79


DEPARTMENT OF AGRICULTURE

Office of the Secretary

7 CFR Part 17

Regulations Governing the Financingof Commercial Sales of AgriculturalCommodities

AGENCY: Foreign Agricultural Service,USDA.ACTION: Final rule.

SUMMARY: This rule amends regulationsapplicable to the financing of the saleand exportation of agriculturalcommodities pursuant to title I of theAgricultural Trade Development andAssistance Act of 1954, as amended(Pub. L. 480).

The amendment deletes onedocument from the list of thosedocuments currently required to besubmitted by the commodity supplier tothe banking institution to support arequest for payment; and deletes thecontracting and documentaryrequirements for commodities whichhave not been shipped under theprogram for a number of years.

The purpose of these changes is toreduce the documentation required forpayment to commodity suppliers and tosimplify and shorten the regulations.EFFECTIVE DATE: May 23, 1996. SeeSUPPLEMENTARY INFORMATION forcompliance requirements.FOR FURTHER INFORMATION CONTACT:Connie B. Delaplane, Director, PublicLaw 480 Operations Division, ExportCredits, Foreign Agricultural Service,U.S. Department of Agriculture, Room4549, South Building, 14th andIndependence, SW., Washington, DC20250–1033. Telephone: (202) 720–3664.SUPPLEMENTARY INFORMATION: This finalrule is issued in conformance withExecutive Order 12866. It has beendetermined to be significant for the

purposes of E.O. 12866 and, therefore,has been reviewed by the Office ofManagement and Budget (OMB).

Regulatory Flexibility ActThis final rule has been reviewed

with regard to the requirements of theRegulatory Flexibility Act. The GeneralSales Manager has certified that thisrule will not have a significanteconomic impact on a substantialnumber of small entities. There will beno significant economic impact fromthis final rule on small or large entities.A copy of this final rule has beensubmitted to the General Counsel, SmallBusiness Administration.

Executive Order 12372This program is not subject to the

provisions of Executive Order 12372which requires intergovernmentalconsultation with state and localofficials. See the Notice related to 7 CFRPart 3015, Subpart V, published at 48FR 29115 (June 24, 1983).

Executive Order 12778This final rule has been reviewed

under the Executive Order 12778, CivilJustice Reform. The final rule wouldhave preemptive effect with respect toany state or local laws, regulations, orpolicies which conflict with suchprovisions or which otherwise impedetheir full implementation. The final rulewould not have retroactive effect. Therule does not require that administrativeremedies be exhausted before suit maybe filed.

BackgroundThe Secretary of Agriculture

implements title I of the AgriculturalTrade Development and Assistance Actof 1954, as amended (Pub. L. 480). Thisfunction is delegated to the GeneralSales Manager, Foreign AgriculturalService. On August 22, 1995, theForeign Agricultural Service (FAS)published a proposed rule (60 FR43566) to amend the regulationsgoverning the financing of the sale andexportation of agricultural commoditiesmade available under title I, Public Law480.

Discussion of CommentsOnly one comment was received,

fully supporting the proposed changesto the regulations: (1) Removing fromthe regulations information regarding anumber of inactive commodities and (2)

Eliminating one document currentlyrequired to be submitted by commoditysuppliers seeking payment.

Effective Date

The provisions of this rule shall applyto contracts entered into under purchaseauthorizations issued on or after May23, 1996.

Paperwork Reduction Act

This final rule does not contain anyinformation collection requirements thatrequire OMB approval under theprovisions of the Paperwork ReductionAct.

List of Subjects in 7 CFR Part 17

Agricultural commodities, Exports,Finance; Maritime carriers.

Accordingly, 7 CFR Part 17, SubpartA, is amended as follows:

1. The authority citation for Part 17continues to read as follows:

Authority: 7 U.S.C. 1701–1705, 1736a,1736c, 5676; E.O. 12220, 45 FR 44245.

§ 17.2 [Amended]

2. Section 17.2 is amended byremoving the last sentence of thedefinition of ‘‘Form CCC–106’’ inparagraph (b).

3. Section 17.14 is amended byremoving the word ‘‘(white)’’ from thefirst sentence of paragraph (d)(1);revising the last sentence of paragraph(d)(1) and all of paragraph (d)(2)(i) toread as follows; and removing the word‘‘(yellow)’’ from paragraph (d)(2)(ii), asfollows:

§ 17.14 Ocean transportation.

* * * * *(d) Advice of vessel approval. * * *(1) For cotton. * * * If CCC finances

any part of the ocean freight whencotton is shipped on an f.a.s. basis, asigned original copy of this form will beissued to the ocean carrier.

(2) For commodities other thancotton. * * *

(i) For shipments to be made on anf.o.b. or f.a.s. basis, when CCC financesany part of the cost of ocean freight, theoriginal of Form CCC–106–2 will beissued to the ocean carrier.* * * * *

§ 17.18 [Amended]

4. Section 17.18 is amended byadding the phrase ‘‘for c. & f. or c.i.f.sales’’ at the end of paragraph (c)(8)(ii).

17824 Federal Register / Vol. 61, No. 79 / Tuesday, April 23, 1996 / Rules and Regulations

§ 17.20 [Amended]5. Section 17.20 is amended by

changing the reference to ‘‘sections (V)and (W)’’ to read ‘‘sections (D) and (E)’’in paragraph (a)(9)(i).

Appendices A and B [Amended]6. Appendix A and Appendix B are

amended by removing existing sections(D), (E), (G), (I), (J), (L), (M), (N), (O), (P),(Q), (R), (S), (T), and (U); redesignatingexisting section ((K) as (G);redesignating existing section (V) as (D);and redesignating existing section (W)as (E).

7. Appendix B is amended bychanging the reference to ‘‘section(K)(7)(b)’’ to read ‘‘section (G)(7)(b)’’ innewly redesignated paragraph (G)(1)(j)and by adding the phrase ‘‘for c. & f. orc.i.f. sales’’ at the end of the followingparagraphs: (A)(1)(d) and (2)(d); (B)(4);(C)(1)(d) and (2)(d); newly redesignated(D)(4) and (E)(4); (F)(1)(d) and (2)(d);newly redesignated (G)(1)(d) and (2)(d);and (H)(1)(d) and (2)(d).

Signed at Washington, D.C. on February22, 1996.Christopher E. Goldthwait,General Sales Manager, Foreign AgriculturalService and Vice President, Commodity CreditCorporation.[FR Doc. 96–9899 Filed 4–22–96; 8:45 am]BILLING CODE 3410–10–M

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 95–NM–98–AD; Amendment39–9571; AD 96–08–05]

Airworthiness Directives; BoeingModel 747–400 Series AirplanesPowered by General Electric CF6–80C2or Pratt & Whitney PW4000 SeriesEngines

AGENCY: Federal AviationAdministration, DOT.ACTION: Final rule.

SUMMARY: This amendment adopts anew airworthiness directive (AD),applicable to certain Boeing Model 747–400 series airplanes, that requiresmodification of the engine fuel feedsystem. This amendment is promptedby reports indicating that the couplingnut on the fuel tube on the outboardstrut (engine position 1) fractured. Theactions specified by this AD areintended to prevent such fracturing ofthe coupling nut, which could result inrelease of fuel onto the engine cowlingand a subsequent fire.DATES: Effective May 23, 1996.

The incorporation by reference ofcertain publications listed in theregulations is approved by the Directorof the Federal Register as of May 23,1996.ADDRESSES: The service informationreferenced in this AD may be obtainedfrom Boeing Commercial AirplaneGroup, P.O. Box 3707, Seattle,Washington 98124–2207. Thisinformation may be examined at theFederal Aviation Administration (FAA),Transport Airplane Directorate, RulesDocket, 1601 Lind Avenue SW., Renton,Washington; or at the Office of theFederal Register, 800 North CapitolStreet NW., suite 700, Washington, DC.FOR FURTHER INFORMATION CONTACT:Tamra J. Elkins, Aerospace Engineer,Propulsion Branch, ANM–140S, FAA,Seattle Aircraft Certification Office,1601 Lind Avenue SW., Renton,Washington; telephone (206) 227–2669;fax (206) 227–1181.SUPPLEMENTARY INFORMATION: Aproposal to amend part 39 of the FederalAviation Regulations (14 CFR part 39) toinclude an airworthiness directive (AD)that is applicable to certain BoeingModel 747–400 series airplanes waspublished in the Federal Register onDecember 12, 1995 (60 FR 63663). Thataction proposed to require modificationof the engine fuel feed system.

Interested persons have been affordedan opportunity to participate in themaking of this amendment. Dueconsideration has been given to thecomments received.

One commenter supports theproposed rule.

The Air Transport Association (ATA)of America, on behalf of one of itsmembers, requests that the proposedcompliance time be extended from 18months to 24 months to provide time foroperators to procure replacement kitsand to accomplish the proposed actionsduring a regularly scheduledmaintenance (‘‘C’’) check. The FAAconcurs with the commenter’s request.The FAA finds that extending thecompliance time to 24 months will notcompromise safety; will allow operatorssufficient time to procure the necessaryreplacement kits (estimated by themanufacturer to take approximatelynine months); and will allow themodification to be accomplished duringa ‘‘C’’ check interval (15 months formost operators) at a main maintenancebase where special equipment andtrained personnel will be available ifnecessary.

After careful review of the availabledata, including the comments notedabove, the FAA has determined that airsafety and the public interest require the

adoption of the rule with the changepreviously described. The FAA hasdetermined that this change will neitherincrease the economic burden on anyoperator nor increase the scope of theAD.

There are approximately 226 Model747–400 series airplanes of the affecteddesign in the worldwide fleet.

The FAA estimates that 34 airplanesof U.S. registry will be required by thisAD to replace the strut fuel tubes andcouplings at engine positions 1 and 4 inaccordance with Boeing Alert ServiceBulletin 747–28A2185. Thatreplacement will take approximately 74work hours per airplane to accomplish,at an average labor rate of $60 per workhour. Required parts will costapproximately $9,582 per airplane.Based on these figures, the cost impactof this required replacement on U.S.operators is estimated to be $476,748, or$14,022 per airplane.

The cost impact figure discussedabove is based on assumptions that nooperator has yet accomplished any ofthe requirements of this AD action, andthat no operator would accomplishthose actions in the future if this ADwere not adopted.

Currently, there are no Model 747–400 series airplanes on the U.S. Registerthat would be required by this AD toaccomplish the installation specified inBoeing Service Bulletin 747–28–2146[and required by paragraph (a)(2) of thefinal rule]. However, should an affectedairplane be imported and placed on theU.S. Register in the future, it wouldrequire approximately 162 work hoursper airplane (81 work hours per engine;2 engines per airplane) to accomplishthe installation, at an average labor rateof $60 per work hour. Required partswould cost approximately $9,582 perairplane. Based on these figures, the costimpact of this installation would be$19,302 per airplane.

The regulations adopted herein willnot have substantial direct effects on theStates, on the relationship between thenational government and the States, oron the distribution of power andresponsibilities among the variouslevels of government. Therefore, inaccordance with Executive Order 12612,it is determined that this final rule doesnot have sufficient federalismimplications to warrant the preparationof a Federalism Assessment.

For the reasons discussed above, Icertify that this action (1) is not a‘‘significant regulatory action’’ underExecutive Order 12866; (2) is not a‘‘significant rule’’ under DOTRegulatory Policies and Procedures (44FR 11034, February 26, 1979); and (3)will not have a significant economic

17825Federal Register / Vol. 61, No. 79 / Tuesday, April 23, 1996 / Rules and Regulations

impact, positive or negative, on asubstantial number of small entitiesunder the criteria of the RegulatoryFlexibility Act. A final evaluation hasbeen prepared for this action and it iscontained in the Rules Docket. A copyof it may be obtained from the RulesDocket at the location provided underthe caption ADDRESSES.

List of Subjects in 14 CFR Part 39Air transportation, Aircraft, Aviation

safety, Incorporation by reference,Safety.

Adoption of the AmendmentAccordingly, pursuant to the

authority delegated to me by theAdministrator, the Federal AviationAdministration amends part 39 of theFederal Aviation Regulations (14 CFRpart 39) as follows:

PART 39—AIRWORTHINESSDIRECTIVES

1. The authority citation for part 39continues to read as follows:

Authority: 49 USC 106(g), 40113, 44701.


adding the following new airworthinessdirective:96–08–05 Boeing: Amendment 39–9571.

Docket 95–NM–98–AD.Applicability: Model 747–400 series

airplanes powered by General Electric CF6–80C2 or Pratt & Whitney PW4000 seriesengines; as identified in Boeing Alert ServiceBulletin 747–28A2185, Revision 1, datedSeptember 21, 1995, and Boeing ServiceBulletin 747–28–2146, dated August 13,1992; certificated in any category.

Note 1: This AD applies to each airplaneidentified in the preceding applicabilityprovision, regardless of whether it has beenotherwise modified, altered, or repaired inthe area subject to the requirements of thisAD. For airplanes that have been modified,altered, or repaired so that the performanceof the requirements of this AD is affected, theowner/operator must request approval for analternative method of compliance inaccordance with paragraph (b) of this AD.The request should include an assessment ofthe effect of the modification, alteration, orrepair on the unsafe condition addressed bythis AD; and, if the unsafe condition has notbeen eliminated, the request should includespecific proposed actions to address it.

Compliance: Required as indicated, unlessaccomplished previously.

To prevent fracturing of the coupling nut,which could result in release of fuel onto theengine cowling and a subsequent fire,accomplish the following:

(a) Within 24 months after the effectivedate of this AD, accomplish the requirementsof paragraph (a)(1) or (a)(2), as applicable.

(1) For Model 747–400 series airplanesidentified in Boeing Alert Service Bulletin

747–28A2185, Revision 1, dated September21, 1995: Replace the strut fuel tubes andcouplings at engine numbers 1 and 4 withnew redesigned (shrouded) couplings, inaccordance with that alert service bulletin.

(2) For Model 747–400 series airplaneshaving variable numbers RT641 throughRT650 inclusive, identified in Boeing ServiceBulletin 747–28–2146, dated August 13,1992: On engine positions 1 and 4 only,install new fuel lines, shrouded fuel linecouplings (between the strut mid bulkheadand the wing front spar), and drain lines inaccordance with that service bulletin.

(b) An alternative method of compliance oradjustment of the compliance time thatprovides an acceptable level of safety may beused if approved by the Manager, SeattleAircraft Certification Office (ACO), FAA,Transport Airplane Directorate. Operatorsshall submit their requests through anappropriate FAA Principal MaintenanceInspector, who may add comments and thensend it to the Manager, Seattle ACO.

Note 2: Information concerning theexistence of approved alternative methods ofcompliance with this AD, if any, may beobtained from the Seattle ACO.

(c) Special flight permits may be issued inaccordance with sections 21.197 and 21.199of the Federal Aviation Regulations (14 CFR21.197 and 21.199) to operate the airplane toa location where the requirements of this ADcan be accomplished.

(d) The actions shall be done in accordancewith Boeing Alert Service Bulletin 747–28A2185, Revision 1, dated September 21,1995, and Boeing Service Bulletin 747–28–2146, dated August 13, 1992. Thisincorporation by reference was approved bythe Director of the Federal Register inaccordance with 5 U.S.C. 552(a) and 1 CFRpart 51. Copies may be obtained from BoeingCommercial Airplane Group, P.O. Box 3707,Seattle, Washington 98124–2207. Copies maybe inspected at the FAA, Transport AirplaneDirectorate, 1601 Lind Avenue, SW., Renton,Washington; or at the Office of the FederalRegister, 800 North Capitol Street, NW., suite700, Washington, DC.

(e) This amendment becomes effective onMay 23, 1996.

Issued in Renton, Washington, on April 10,1996.Darrell M. Pederson,Acting Manager, Transport AirplaneDirectorate, Aircraft Certification Service.[FR Doc. 96–9338 Filed 4–22–96; 8:45 am]BILLING CODE 4910–13–U

14 CFR Part 39

[Docket No. 95–NM–121–AD; Amendment39–9572; AD 96–08–06]

Airworthiness Directives; Saab ModelSAAB SF340A and SAAB 340B SeriesAirplanes

AGENCY: Federal AviationAdministration, DOT.ACTION: Final rule.

SUMMARY: This amendment adopts anew airworthiness directive (AD),applicable to certain Saab Model SAABSF340A and SAAB 340B seriesairplanes, that requires visual and dyepenetrant inspection(s) to detect cracksof the nose rib of the rudder, and stopdrilling and blending of minor cracks.This amendment also requiresreplacement of the nose rib with a newnose rib and reinforcement of the noserib, if extensive cracking is detected orif an operator elects to terminate therepetitive inspections. This amendmentis prompted by the result of aninspection that revealed a cracked noserib on the front spar of the rudder dueto vibration-related stress. The actionsspecified by this AD are intended toprevent such stress and cracking, whichcould result in the deformation of thenose rib; this condition may lead tofriction and jamming between the finand the rudder and subsequent reducedcontrollability of the airplane.DATES: Effective May 23, 1996.

The incorporation by reference ofcertain publications listed in theregulations is approved by the Directorof the Federal Register as of May 23,1996.ADDRESSES: The service informationreferenced in this AD may be obtainedfrom SAAB Aircraft AB, SAAB AircraftProduct Support, S–581.88, Linkoping,Sweden. This information may beexamined at the Federal AviationAdministration (FAA), TransportAirplane Directorate, Rules Docket,1601 Lind Avenue SW., Renton,Washington; or at the Office of theFederal Register, 800 North CapitolStreet, NW., suite 700, Washington, DC.FOR FURTHER INFORMATION CONTACT:Ruth Harder, Aerospace Engineer,Standardization Branch, ANM–113,FAA, Transport Airplane Directorate,1601 Lind Avenue, SW., Renton,Washington 98055–4056; telephone(206) 227–1721; fax (206) 227–1149.SUPPLEMENTARY INFORMATION: Aproposal to amend part 39 of the FederalAviation Regulations (14 CFR part 39) toinclude an airworthiness directive (AD)that is applicable to certain Saab ModelSAAB SF340A and SAAB 340B seriesairplanes was published in the FederalRegister on January 9, 1996 (61 FR 640).That action proposed to require visualand dye penetrant inspection(s) todetect cracks of the nose rib of therudder, and stop drilling and blendingof minor cracks. That action alsoproposed to require replacement of thenose rib with a new nose rib andreinforcement of the nose rib, if anyextensive crack is detected or if an


operator elects to terminate therepetitive inspections.

Interested persons have been affordedan opportunity to participate in themaking of this amendment. Dueconsideration has been given to thesingle comment received.

The commenter supports theproposed rule.

After careful review of the availabledata, including the comment notedabove, the FAA has determined that airsafety and the public interest require theadoption of the rule as proposed.

The FAA estimates that 221 SaabModel SAAB SF340A and SAAB 340Bseries airplanes of U.S. registry will beaffected by this AD, that it will takeapproximately 4 work hours perairplane to accomplish the requiredactions, and that the average labor rateis $60 per work hour. Based on thesefigures, the cost impact of the inspectionrequirement of this AD on U.S.operators is estimated to be $53,040, or$240 per airplane.

The cost impact figure discussedabove is based on assumptions that nooperator has yet accomplished any ofthe requirements of this AD action, andthat no operator would accomplishthose actions in the future if this ADwere not adopted.

The regulations adopted herein willnot have substantial direct effects on theStates, on the relationship between thenational government and the States, oron the distribution of power andresponsibilities among the variouslevels of government. Therefore, inaccordance with Executive Order 12612,it is determined that this final rule doesnot have sufficient federalismimplications to warrant the preparationof a Federalism Assessment.

For the reasons discussed above, Icertify that this action (1) is not a‘‘significant regulatory action’’ underExecutive Order 12866; (2) is not a‘‘significant rule’’ under DOTRegulatory Policies and Procedures (44FR 11034, February 26, 1979); and (3)will not have a significant economicimpact, positive or negative, on asubstantial number of small entitiesunder the criteria of the RegulatoryFlexibility Act. A final evaluation hasbeen prepared for this action and it iscontained in the Rules Docket. A copyof it may be obtained from the RulesDocket at the location provided underthe caption ADDRESSES.


Air transportation, Aircraft, Aviationsafety, Incorporation by reference,Safety.

Adoption of the AmendmentAccordingly, pursuant to the

authority delegated to me by theAdministrator, the Federal AviationAdministration amends part 39 of theFederal Aviation Regulations (14 CFRpart 39) as follows:



Authority: 49 USC 106(g), 40113, 44701.


adding the following new airworthinessdirective:96–08–06 Saab Aircraft AB: Amendment 39–

9572. Docket 95–NM–121–AD.Applicability: Model SAAB. SF340A series

airplanes having serial numbers (S/N) 004through 159 inclusive, and Model SAAB340B having S/N’s 160 through 369inclusive; certificated in any category.

Note 1: This AD applies to each airplaneidentified in the preceding applicabilityprovision, regardless of whether it has beenmodified, altered, or repaired in the areasubject to the requirements of this AD. Forairplanes that have been modified, altered, orrepaired so that the performance of therequirements of this AD is affected, theowner/operator must request approval for analternative method of compliance inaccordance with paragraph (b) of this AD.The request should include an assessment ofthe effect of the modification, alteration, orrepair on the unsafe condition addressed bythis AD; and, if the unsafe condition has notbeen eliminated, the request should includespecific proposed actions to address it.


To prevent vibration-related stress andcracking and consequent deformation of thenose rib, which could result in friction andjamming between the fin and the rudder andsubsequent reduced controllability of theairplane, accomplish the following:

(a) Prior to the accumulation of 2,400 totalflight hours, or within 800 flight hours afterthe effective date of this AD, whicheveroccurs later, perform a visual and dyepenetrant inspection to detect cracks of thenose rib of the rudder, in accordance withSaab Service Bulletin 340–55–032, datedMay 22, 1995.

(1) If no cracks are detected, repeat theinspection thereafter at intervals not toexceed 800 flight hours, or replace the noserib with a new nose rib and reinforce it, inaccordance with the service bulletin.Accomplishment of the replacement andreinforcement constitutes terminating actionfor this AD.

(2) If any minor crack [less than 25.4 mm(1.0 inch) long] is detected, prior to furtherflight, stop drill and blend the crack inaccordance with the service bulletin. Repeatthe inspection thereafter at intervals not toexceed 800 flight hours, or replace the nose

rib with a new nose rib and reinforce it, inaccordance with the service bulletin.Accomplishment of the replacement andreinforcement constitutes terminating actionfor this AD.

(3) If any extensive crack [greater than orequal to 25.4 mm (1.0 inch) long] is detected,prior to further flight, replace the nose ribwith a new nose rib and reinforce it, inaccordance with the service bulletin.Accomplishment of this replacement andreinforcement constitutes terminating actionfor this AD.

(b) An alternative method of compliance oradjustment of the compliance time thatprovides an acceptable level of safety may beused if approved by the Manager,Standardization Branch, ANM–113, FAA,Transport Airplane Directorate. Operatorsshall submit their requests through anappropriate FAA Principal MaintenanceInspector, who may add comments and thensend it to the Manager, StandardizationBranch, ANM–113.

Note 2: Information concerning theexistence of approved alternative methods ofcompliance with this AD, if any, may beobtained from the Standardization Branch,ANM–113.

(c) Special flight permits may be issued inaccordance with sections 21.197 and 21.199of the Federal Aviation Regulations (14 CFR21.197 and 21.199) to operate the airplane toa location where the requirements of this ADcan be accomplished.

(d) The actions shall be done in accordancewith Saab Service Bulletin 340–55–032,dated May 22, 1995. This incorporation byreference was approved by the Director of theFederal Register in accordance with 5 U.S.C.552(a) and 1 CFR part 51. Copies may beobtained from SAAB Aircraft AB, SAABAircraft Product Support, S–581.88,Linkoping, Sweden. Copies may be inspectedat the FAA, Transport Airplane Directorate,1601 Lind Avenue, SW., Renton,Washington; or at the Office of the FederalRegister, 800 North Capitol Street NW., suite700, Washington, DC.

(e) This amendment becomes effective onMay 23, 1996.


14 CFR Part 71

[Airspace Docket No. 95–ANM–19]

Establishment of Class D Airspace;Vancouver, Washington

AGENCY: Federal AviationAdministration (FAA), DOT.ACTION: Final rule.

SUMMARY: This action establishes ClassD airspace at Pearson Field, Vancouver,Washington. This action is necessary to


enhance safety within the area whichwas previously excluded from thePortland International Airport (PDX)Class C airspace and commonly referredto as the Pearson Cutout. A minorchange is also being made to the airportname, formerly called Pearson Airpark,and to the geographic coordinates ofPearson Field, Vancouver, Washington.EFFECTIVE DATE: June 20, 1996.FOR FURTHER INFORMATION CONTACT:James C. Frala, Operations Branch,ANM–532.4, Federal AviationAdministration, Docket No. 95–ANM–19, 1601 Lind Avenue SW., Renton,Washington 98055–4056; telephonenumber: (206) 227–2535.

SUPPLEMENTARY INFORMATION:

HistoryOn November 9, 1995, the FAA

proposed to amend part 71 of theFederal Aviation Regulations (14 CFRpart 71) to establish Class D airspace atPearson Field, Vancouver, Washington(60 FR 56539). This proposal was theproduct of an airspace and proceduralreview of new instrument approachprocedures to PDX and an analysis ofthe Pearson Field/Portland Internationalutilization of airspace west of PDX. Thisrule was proposed to minimize potentialconflicts and mitigate wake turbulenceconcerns. The proposed establishmentof Class D airspace at Pearson Fieldrequires pilots operating in the airspaceto be in communication with thecontrolling Air traffic facility so thattraffic information and wake turbulenceadvisories can be issued. Interestedparties were invited to participate in therulemaking proceeding by submittingwritten comments on the proposal. Thisaction is the same as the proposalexcept the airport name and coordinateshave been changed in this document toreflect information published in theNational Flight Data Digest Number 226,dated November 24, 1995. Additionally,a change is made to reflect the dates andtimes the Class D airspace area iseffective.

Discussion of CommentsA total of 17 individuals submitted

written comments to FR Doc. 95–27830,Notice of Proposed Rulemaking (NPRM)95–ANM–19. Additionally, verbalcomments were expressed by some ofthe approximately 350 personsattending informal aviation gatherings.The FAA considered these comments inthe adoption of this rule. Commentssubmitted on NPRM 95–ANM–19 reflectthe views of a broad spectrum of theaviation public including individualsand organizations representingcommercial and general aviation pilots.

Organizations that commented includeAir Line Pilots Association (ALPA);Delta Air Lines, Inc.; Port of Portland;Experimental Aircraft Association; TheCity of Vancouver, Washington; ClarkCounty Airport Owners and ManagersAssociation; and the Washington PilotsAssociation.

Of the 17 who submitted writtencomments to the docket, 6 commenterssupported and 11 commenters opposedthe establishment of Class D airspace. Ofthe 6 supporting comments, 5commenters agreed that this actionwould promote safety for users at bothPDX and Pearson Field.

One commenter (ALPA) wouldsupport the establishment of Class Dairspace if additional restrictions, suchas requiring an operating transponder,segregating Pearson Field traffic fromPDX traffic, and lowering the PearsonField traffic pattern altitude to 700 feetmean sea level, were included in theproposed action. These suggestedrestrictions were evaluated anddetermined to be excessive and notnecessary for safety. Lowering thePearson Field pattern altitude to 700feet would place pilots in closerproximity to terrain and to people andproperty on the ground. This option wasrejected because it contradicts thepurpose of the rule which is to enhancesafety.

Of the 11 commenters opposing therule, one commenter felt that theproposed action was an attempt to closePearson Field. The FAA did notconsider closing Pearson Field as anoption. Rather, the FAA is committed tomitigating airspace management issueswhen airports are in close proximity toeach other. The purpose of thisrulemaking is to allow Pearson Field tocontinue to operate safely in closeproximity to its larger neighbor. Threecommenters felt that the proposedaction would introduce jet traffic to anew route over Pearson Field and inclose proximity to downtownVancouver, Washington. Fourcommenters expressed concern forincreased jet noise. The establishment ofClass D airspace introduces acommunication requirement only. Nonew jet routes will result from thisaction and this airspace action does notalter existing flight tracks. Jet noise willnot be altered by this rule. Twocommenters suggested that theapproaches to PDX should be offset tothe south to avoid conflicts in trafficflows. This option is not viable for tworeasons. First, the rising terrain andobstructions southwest of the airportcreate serious safety obstacles to safeinstrument approaches. Second, if itwas feasible to offset the approaches to

the south, the approach minimumswould be very high due to the terrainand the fact that the approach wouldnot be aligned with the runway. As aresult, offsetting the approaches wouldhave an adverse effect on airportcapacity. Three commenters expressedconcerns for wake turbulence generatedby aircraft landing and departing PDX.The FAA shares these concerns asdemonstrated by this rule that isintended to facilitate the transfer ofwake turbulence information to PearsonField users. In addition to the traffic andwake turbulence advisories resultingfrom this rule, the FAA has agreed toassist in presentation of waketurbulence training for Pearson Fieldoperators and to publish cautionaryadvisories where appropriate.

Two commenters were opposed to theaction due to the additional cockpitworkload of radio communications andthe financial burden of acquiring aradio. The FAA recognizes that therequirement for radio communicationswill have some impact on users atPearson Field, particularly those who donot have radio-equipped aircraft.However, due to the proximity of thetwo airports and the need to minimizepotential conflicts and mitigate waketurbulence concerns, some airspacesafety change is necessary. Prior to thisrulemaking, FAA Air Traffic and FlightStandards personnel met with customerrepresentatives for Pearson Field andPDX to seek solutions and minimizeimpacts on users at the airports. It wasgenerally agreed that establishing ClassD airspace at Pearson Field wouldsatisfy safety concerns while imposingthe least restrictions on users.Furthermore, the FAA and Pearsonpilots are developing procedures for no-radio aircraft operations at PearsonField.

The Clark County Airport Owners andManagers Association objects to thisproposed action suggesting it violatestheir constitutional rights. They claimGrandfather Rights to the airspace inand around their airports because thoseairports were in existence many yearsprior to PDX. Title 49 United StatesCode, section 40103 charges the FAAwith the responsibility to regulate theuse of airspace for efficiency and safety.As mentioned previously, the purposeof this rule is to preserve safe operationsat Pearson. This rule does not addressthe operation of PDX or the effects ofthat airport’s operations on surroundingairports other than Pearson.

One commenter provided commentsthat were unrelated to the proposal.

During the comment period, verbalresponses relating to this proposedairspace action were heard at several


aviation gatherings. Instructions and theappropriate address for submittingwritten comments were disseminated tothe approximately 360 pilots at thosegatherings who expressed an interest inthis rulemaking. Verbal comments fromthose gatherings were noted. In general,most pilots of aircraft equipped withelectrical systems expressed agreementwith the rule. There was a suggestionthat a control tower may be necessary atPearson. However, others felt a controltower was neither needed nor wanted.In fact, the activity level at Pearson doesnot approach the level established bythe FAA to support a control tower.Some expressed concern that traffic atPearson would be delayed for PDXtraffic either by denying access to theClass D airspace for aircraft arriving atPearson, or by requiring aircraftdeparting Pearson Field to hold on theground until separation from PDX trafficcould be achieved. Separation servicesare not provided for aircraft operatingunder visual flight rules in Class Dairspace. Air Traffic will not becontrolling the flow of aircraft arrivingat or departing from Pearson.

The Rule

This amendment to part 71 of FederalAviation Regulations establishes Class Dairspace at Pearson Field, Vancouver,Washington. The FAA has determinedthat this regulation only involves anestablished body of technicalregulations for which frequent androutine amendments are necessary tokeep them operationally current. It,therefore, (1) is not a ‘‘significantregulatory action’’ under ExecutiveOrder 12866; (2) is not a ‘‘significantrule’’ under DOT Regulatory Policiesand Procedures (44 FR 11034; February26, 1979); and (3) does not warrantpreparation of a regulatory evaluation asthe anticipated impact is so minimal.Since this is a routine matter that willonly affect air traffic procedures and airnavigation, it is certified that this rulewill not have a significant economicimpact on a substantial number of smallentities under the criteria of theRegulatory Flexibility Act.


Airspace, Incorporation by reference,Navigation (air).

The Proposed Amendment

In consideration of the foregoing, theFederal Aviation Administrationamends 14 CFR part 71 as follows:

PART 71—[AMENDED]

1. The authority citation for 14 CFRpart 71 continues to read as follows:

Authority: 49 U.S.C. 106(g), 40103, 40113,40120; E.O. 10854, 24 FR 9565, 3 CFR 1959–1963 Comp., p. 389; 14 CFR 11.69.

§ 71.1 [Amended]2. The incorporation by reference in

14 CFR 71.1 of the Federal AviationAdministration Order 7400.9C, AirspaceDesignations and Reporting Points,dated August 17, 1995, and effectiveSeptember 16, 1995, is amended asfollows:

Paragraph 5000 Class D Airspace* * * * *ANM WA D Vancouver, WAVancouver, Pearson Field, WA

(lat. 45°37′14′′N, long. 122°39′23′′W)Portland International Airport, OR

(lat. 45°35′19′′N, long 122°35′51′′W)That airspace extending upward from the

surface to but not including 1,100 feet MSLin an area bounded by a line beginning at thepoint where the 019° bearing from PearsonField intersects the 5-mile arc from PortlandInternational Airport extending southeast toa point 11⁄2 miles east of Pearson Field on theextended centerline of Runway 8/26, andthence south to the north shore of theColumbia River, thence west via the northshore of the Columbia River to the 5-mile arcfrom Portland International Airport andthence clockwise via the 5-mile arc to pointof beginning. This Class D airspace area iseffective during the specific dates and timesestablished in advance by a Notice toAirmen. The effective date and time willthereafter be continuously published in theAirport/Facility Directory.* * * * *

Issued in Seattle, Washington, on April 8,1996.Richard E. Prang,Acting Assistant Manager, Air TrafficDivision, Northwest Mountain Region.[FR Doc. 96–9992 Filed 4–22–96; 8:45 am]BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH ANDHUMAN SERVICES

Food and Drug Administration

21 CFR Part 173

[Docket No. 94F–0358]

Secondary Direct Food AdditivesPermitted in Food for HumanConsumption

AGENCY: Food and Drug Administration,HHS.ACTION: Final rule.

SUMMARY: The Food and DrugAdministration (FDA) is amending thefood additive regulations to provide forthe safe use of acidified solutions ofsodium chlorite in poultry processingwater. This action is in response to apetition filed by Alcide Corp.

DATES: Effective April 23, 1996; writtenobjections and requests for a hearing byMay 23, 1996. The Director of the Officeof the Federal Register approves theincorporation by reference inaccordance with 5 U.S.C. 552(a) and 1CFR part 51 of certain publicationslisted in new § 173.325, effective April23, 1996.ADDRESSES: Submit written objections tothe Dockets Management Branch (HFA–305), Food and Drug Administration,12420 Parklawn Dr., rm. 1–23,Rockville, MD 20857.FOR FURTHER INFORMATION CONTACT:Robert L. Martin, Center for Food Safetyand Applied Nutrition (HFS–217), Foodand Drug Administration, 200 C St. SW.,Washington, DC 20204–0001, 202–418–3074.SUPPLEMENTARY INFORMATION: In a noticepublished in the Federal Register ofNovember 1, 1994 (59 FR 54609), FDAannounced that a food additive petition(FAP 4A4433) had been filed by AlcideCorp., Inc., 8561 154th Ave. NE.,Redmond, WA 98052, proposing thatthe food additive regulations beamended to provide for the safe use ofacidified solutions of sodium chlorite/chlorous acid in poultry processingwater.

FDA has evaluated data in thepetition and other relevant material andhas consulted with scientists in theFood Safety and Inspection Service inthe U.S. Department of Agricultureconcerning the technological andpractical aspects of the proposed use ofacidified solutions of sodium chlorite.The agency concludes that the proposeduse of the additive is safe and will havethe intended technical effect of reducingmicrobial contamination on poultry.The agency also concludes that theregulation approving the additiveshould be entitled ‘‘acidified sodiumchlorite solutions.’’ Acidification ofsodium chlorite results in partialconversion of chlorite to chlorous acid.Also, in the notice of filing, FDAannounced that the petition proposed toallow the use of any of the followingacids to prepare acidified sodiumchlorite solutions: Phosphoric acid,citric acid, hydrochloric acid, lacticacid, malic acid, or sulfuric acid. Theseacids are all generally recognized as safe(GRAS) acids. The agency hasconcluded that the use of any GRASacid is appropriate, and is codifying thisconclusion in the regulation. Therefore,21 CFR part 173 is amended as set forthbelow.

In accordance with § 171.1(h) (21 CFR171.1(h)), the petition and thedocuments that FDA considered andrelied upon in reaching its decision to


approve the petition are available forinspection at the Center for Food Safetyand Applied Nutrition by appointmentwith the information contact personlisted above. As provided in § 171.1(h),the agency will delete from thedocuments any materials that are notavailable for public disclosure beforemaking the documents available forinspection.

In the notice of filing for this petitionFDA gave interested parties anopportunity to submit comments on thepetitioner’s environmental assessment.FDA received no comments in responseto that notice.

The agency has carefully consideredthe potential environmental effects ofthis action. FDA has concluded that theaction will not have a significant impacton the human environment, and that anenvironmental impact statement is notrequired. The agency’s finding of nosignificant impact and the evidencesupporting that finding, contained in anenvironmental assessment, may be seenin the Dockets Management Branch(address above) between 9 a.m. and 4p.m., Monday through Friday.

Any person who will be adverselyaffected by this regulation may at anytime on or before May 23, 1996, filewith the Dockets Management Branch(address above) written objectionsthereto. Each objection shall beseparately numbered, and eachnumbered objection shall specify withparticularity the provisions of theregulation to which objection is madeand the grounds for the objection. Eachnumbered objection on which a hearingis requested shall specifically so state.Failure to request a hearing for anyparticular objection shall constitute awaiver of the right to a hearing on thatobjection. Each numbered objection forwhich a hearing is requested shallinclude a detailed description andanalysis of the specific factualinformation intended to be presented insupport of the objection in the eventthat a hearing is held. Failure to includesuch a description and analysis for anyparticular objection shall constitute awaiver of the right to a hearing on theobjection. Three copies of all documentsshall be submitted and shall beidentified with the docket numberfound in brackets in the heading of thisdocument. Any objections received inresponse to the regulation may be seenin the Dockets Management Branchbetween 9 a.m. and 4 p.m., Mondaythrough Friday.


Food additives, Incorporation byreference.

Therefore, under the Federal Food,Drug, and Cosmetic Act and underauthority delegated to the Commissionerof Food and Drugs, 21 CFR part 173 isamended as follows:

PART 173—SECONDARY DIRECTFOOD ADDITIVES PERMITTED INFOOD FOR HUMAN CONSUMPTION


Authority: Secs. 201, 402, 409 of theFederal Food, Drug, and Cosmetic Act (21U.S.C. 321, 342, 348).

2. New § 173.325 is added to subpartD to read as follows:

§ 173.325 Acidified sodium chloritesolutions.

Acidified sodium chlorite solutionsmay be safely used in accordance withthe following prescribed conditions:

(a) The additive is produced bymixing an aqueous solution of sodiumchlorite (CAS Reg. No. 7758–19–2) withany generally recognized as safe (GRAS)acid.

(b) The additive is used as anantimicrobial agent in poultryprocessing water as a component of acarcass spray or dip solution prior toimmersion of the carcass in a prechilleror chiller tank, or in a prechiller orchiller solution in accordance withcurrent industry practice for use ofpoultry processing water.

(1) When used in a carcass spray ordip solution, the additive is used atlevels that result in sodium chloriteconcentrations between 500 and 1,200parts per million (ppm), in combinationwith any GRAS acid at levels sufficientto achieve a solution pH of 2.5 to 2.9.The concentration of sodium chlorite isdetermined by a method entitled‘‘Determination of Sodium Chlorite: 50ppm to 1500 ppm Concentration,’’which is incorporated by reference inaccordance with 5 U.S.C. 552(a) and 1CFR part 51. Copies are available fromthe Division of Petition Control (HFS–215), Center for Food Safety andApplied Nutrition, Food and DrugAdministration, 200 C St. SW.,Washington, DC 20204–0001, or may beexamined at the Center for Food Safetyand Applied Nutrition’s Library, Foodand Drug Administration, 200 C St. SW.,rm. 3321, Washington, DC, or at theOffice of the Federal Register, 800 NorthCapitol St. NW., suite 700, Washington,DC.

(2) When used in a prechiller orchiller tank, the additive is used atlevels that result in sodium chloriteconcentrations between 50 and 150ppm, in combination with any GRASacid at levels sufficient to achieve a

solution pH of 2.8 to 3.2. Theconcentration of sodium chlorite isdetermined by a method entitled‘‘Determination of Sodium Chlorite: 50ppm to 1500 ppm Concentration,’’which is incorporated by reference inaccordance with 5 U.S.C. 552(a) and 1CFR part 51. The availability of thismethod is listed in paragraph (b)(1) ofthis section.

Dated: April 11, 1996.William K. Hubbard,Associate Commissioner for PolicyCoordination.[FR Doc. 96–9783 Filed 4–22–96; 8:45 am]BILLING CODE 4160–01–F

21 CFR Part 529

Animal Drugs, Feeds, and RelatedProducts; Change of Sponsor

AGENCY: Food and Drug Administration,HHS.ACTION: Final rule.

SUMMARY: The Food and DrugAdministration (FDA) is amending theanimal drug regulations to reflect thechange of sponsor for an approvedabbreviated new animal drugapplication (ANADA) from MacleodPharmaceuticals, Inc., to AnthonyProducts Co.EFFECTIVE DATE: April 23, 1996.FOR FURTHER INFORMATION CONTACT:Thomas J. McKay, Center for VeterinaryMedicine (HFV–102), Food and DrugAdministration, 7500 Standish Pl.,Rockville, MD 20855, 301–827–0213.SUPPLEMENTARY INFORMATION: MacleodPharmaceuticals, Inc., 2600 Canton Ct.,Fort Collins, CO 80525, has informedFDA that it has transferred theownership of, and all rights andinterests in, approved ANADA 200–115(Gentamicin Sulfate) to AnthonyProducts Co., 5600 Peck Rd., Arcadia,CA 91006. Accordingly, FDA isamending the regulations in 21 CFR529.1044a to reflect the change ofsponsor.

List of Subjects in 21 CFR Part 529Animal drugs.Therefore, under the Federal Food,

Drug, and Cosmetic Act and underauthority delegated to the Commissionerof Food and Drugs and redelegated tothe Center for Veterinary Medicine, 21CFR part 529 is amended as follows:

PART 529—CERTAIN OTHER DOSAGEFORM NEW ANIMAL DRUGS NOTSUBJECT TO CERTIFICATION



Authority: Sec. 512 of the Federal Food,Drug, and Cosmetic Act (21 U.S.C. 360b).

§ 529.1044a [Amended]2. Section 529.1044a Gentamicin

sulfate intrauterine solution is amendedin paragraph (b) by removing ‘‘000061,000856, 054273, 057561, and 058711’’and adding in its place, ‘‘000061,000856, 000864, 054273, and 057561’’.

Dated: April 4, 1996.Robert C. Livingston,Director, Office of New Animal DrugEvaluation, Center for Veterinary Medicine.[FR Doc. 96–9870 Filed 4–22–96; 8:45 am]BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR


25 CFR Part 1001

RIN 1076–AD26

Tribal Self-Governance ProgramInterim Rule Establishing Proceduresfor Awarding Negotiation/PlanningGrants

AGENCY: Office of Self-Governance,Office of the Secretary, Interior.ACTION: Interim rule.

SUMMARY: In this interim rule, the Officeof Self-Governance (OSG) establishesprocedures for awarding negotiationgrants; advance planning grants; andnegotiation/planning grants to negotiatefor Department of the Interior (DOI)non-Bureau of Indian Affairs (BIA)programs, pursuant to the Tribal Self-Governance Act.DATES: The effective date of this interimrule is April 19, 1996. OSG willconsider Written comments on theinterim rule when revising this rule. Tobe considered, comments must bereceived on or before May 31, 1996.ADDRESSES: Written comments on theinterim rule should be sent to theDirector, Office of Self-Governance, U.S.Department of the Interior, Mail Stop2548, 1849 C Street NW., WashingtonDC 20240.FOR FURTHER INFORMATION CONTACT:Dr. Kenneth D. Reinfeld, U.S.Department of the Interior, Office ofSelf-Governance, 1849 C Street NW.,Mail Stop 2548, Washington DC 20240,202–219–0240.


Justification for Interim RuleThis rule is not a rulemaking subject

to the provisions of section 553 of theAdministrative Procedure Act (5 U.S.C.551, et seq.) (APA). Section 553(a)(2)

excepts from the scope of rulemakingrules ‘‘relating to agency management orpersonnel or to public property, loans,grants, benefits, or contracts.’’

Even if this rule were consideredrulemaking subject to the provisions ofsection 553 of the APA, good causeexists to publish this interim rulewithout prior opportunity for publiccomment.

Section 553 outlines the followingrulemaking steps: (1) Publication of anotice of proposed rulemaking, (2)solicitation of public comment on theproposed rule, (3) review of commentsreceived prior to developing the finalrule, and (4) publication of the final rule30 days prior to the effective date. Usingthis process at this time would not servethe goal of the Tribal Self-GovernanceAct of 1994, which is to expand tribalparticipation in the tribal self-governance program, because theprocess would diminish the ability ofsome selected tribes/consortia toeffectively negotiate agreements forfiscal year 1997 or calendar year 1997.The process would also diminish theability of other tribes/consortia in thenear term to plan for and possibly delaytheir participation in tribal self-governance.

The Tribal Self-Governance Act of1994 (Pub. L. 103–413) was enacted andbecame effective on October 25, 1994.While the interim rule may be changedby later rulemaking, the Act stipulatesthat the lack of promulgated regulationswill not limit the Act’s effect.

Under section 402(b) of the Act, theDirector, Office of Self-Governance mayselect up to 20 additional participatingtribes/consortia per year for the tribalself-governance program, and negotiateand enter into an annual writtenfunding agreement with eachparticipating tribe. In order to completethe negotiation process for 1997 fundingagreements, it is necessary to makeavailable negotiation grants to the newtribes by May 15, 1996. The Actmandates that the Secretary submitcopies of the funding agreements at least90 days before the proposed effectivedate to the appropriate committees ofthe Congress and to each tribe that isserved by the BIA agency that is servingthe tribe that is a party to the fundingagreement. Initial negotiations with atribe/consortium located in an area and/or agency which has not previouslybeen involved with self-governancenegotiations, will take approximatelytwo months from start to finish.

Publication of this interim rulewithout prior opportunity for publiccomment is necessary to complete theabove procedures in a timely fashion.Therefore, applying the criteria at 5

U.S.C. 553(b)(3)(B) and 553(d), goodcause exists to make the rule effectiveless than thirty days from today’s date.

BackgroundThe tribal self-governance program is

designed to promote self determinationby allowing tribes to assume morecontrol through negotiated agreementsof programs operated by the Departmentof the Interior. The new law allows fornegotiations to be conducted forprograms operated by BIA and forprograms operated by other bureaus andoffices within the Department that areavailable to Indians or when there is anhistorical, cultural, or geographicconnection to an Indian tribe.

The Tribal Self-Governance Act of1994 requires the Secretary, uponrequest of a majority of self-governancetribes, to initiate procedures under theNegotiated Rulemaking Act, 5 U.S.C.561 et seq., to negotiate and promulgateregulations necessary to carry out thetribal self-governance program. The Actcalls for a negotiated rulemakingcommittee to be established pursuant to5 U.S.C. 565 comprised of Federal andtribal representatives, with a majority ofthe tribal representatives representingself-governance tribes. The Act alsoauthorizes the Secretary to adaptnegotiated rulemaking procedures to theunique context of self-governance andthe government-to-governmentrelationship between the United Statesand the Indian tribes. On November 1,1994, a majority of self-governancetribes wrote the Secretary requesting theimmediate initiation of negotiatedrulemaking. On February 15, 1995, theself-governance negotiated rulemakingcommittee was established.

On the same day, an interim rule waspublished in the Federal Register at 60FR 8553 announcing the criteria fortribes to be included in an applicantpool and the establishment of theselection process for tribes to negotiateagreements pursuant to the Tribal Self-Governance Act of 1994. This interimrule allowed an additional 20 newtribes/consortia to negotiate compactsand annual funding agreements forfiscal year 1996 and calendar year 1996as authorized by the Act. Using thesame interim rule, a notice of deadlinefor submitting completed applicationsto begin participation in tribal self-governance in fiscal year 1997 orcalendar year 1997 was published in theFederal Register on February 1, 1996.To date, a total of 54 compacts andannual funding agreements have beennegotiated.

Since publication of the interim rule,the self-governance negotiatedrulemaking committee has reached


tentative agreement on draft provisionsrelating to the procedures for awardingnegotiation grants; advance planninggrants; and negotiation/planning grantsto negotiate for DOI non-BIA programs.These provisions along with othersections of the negotiated rules aresubject to notice and public commentprocedures as part of the rulemakingprocess. Given the fact that more timeis needed to reach agreement on othersections of the negotiated rules, it is notpossible to provide notice and obtainpublic comment on the rule so as toaward the grants in a timely fashionusing fiscal year 1996 funds.

Purpose of Rule

This interim rule establishesprocedures which are consistent withthe self-governance negotiatedrulemaking committee’s negotiations forawarding negotiation and planninggrants. The interim rule is intended toallow the grants to be awarded usingfiscal year 1996 funds.

This interim rule will take immediateeffect to allow the grant selectionprocess for the upcoming year to beginunder an interim rule that has beententatively agreed upon by the self-governance negotiated rulemakingcommittee.

The Department is adopting this rulebefore the self-governance negotiatedrulemaking process is completed. Thisinterim rule will be subject tonegotiation and amendment by thenegotiated rulemaking process. The self-governance negotiated rulemakingcommittee will use any commentsreceived following the publication ofthis interim rule in negotiating the finalrule. Furthermore, the portion of theinterim rule governing the awarding ofthe grants will be subject to additionalcomment once the proposed regulationsrecommended by the self-governancerulemaking committee are published inthe Federal Register. The finalpublished rule will supersede thisinterim rule.

A. E.O. 12612

The Department has determined thatthis interim rule does not havesignificant federalism effects.

B. E.O. 12630

In accordance with Executive Order12630, the Department has determinedthat this interim rule does not havesignificant takings implications.

C. E.O. 2778

The Department has certified to theOffice of Management and Budget thatthis interim rule meets the applicable

standards provided in sections 2(a) and2(b)(2) of Executive Order 12778.

D. E.O. 12886

This interim rule is not a significantregulatory action under Executive Order12866, and therefore will not bereviewed by the Office of Managementand Budget.

E. Regulatory Flexibility Act Statement

This interim rule will not have asignificant economic impact on asubstantial number of small entitiesunder the Regulatory Flexibility Act (5U.S.C. 601 et seq.).

F. NEPA Statement

The Department has determined thatthis interim rule does not constitute amajor Federal action significantlyaffecting the quality of the humanenvironment and that no detailedstatement is required pursuant to theNational Environmental Policy Act of1969.

G. Information Collection Statement

The information collectionrequirements contained in this interimrule are included in current collections1076–0090, 0091, 0096, 1030 and OMBCirculars A–102, A–110, and SF–424.

H. Authorship Statement

The primary author of this documentis Dr. Kenneth Reinfield, Office of Self-Governance.


Indians, Native Americans.For the reasons given in the preamble,

title 25, part 1001 is amended asfollows:

PART 1001—SELF-GOVERNANCEPROGRAM


Authority: 26 U.S.C. 450 note, 458aa–458gg.

2. Sections 1001.7 through 1001.10are added to read as follows:

§ 1001.7 Availability, amount, and numberof planning and negotiation grants.

(a) What is the purpose of thissection? This section describes how toapply for planning and negotiationgrants authorized by section 402(d) ofthe Act to help meet tribal costsincurred:

(1) In meeting the planning phaserequirement of Pub. L. 103–413,including planning to negotiate non-BIAprograms, services, functions andactivities; and

(2) In conducting negotiations.

(b) What types of grants are available?Three categories of grants may beavailable:

(1) Negotiation grants for tribes/consortia selected from the applicantpool as described in § 1001.5 of theseregulations;

(2) Planning grants for tribes/consortiarequiring advance funding to meet theplanning phase requirement of Pub. L.103–413; and

(3) Financial assistance for tribes/consortia to plan for negotiating for non-BIA programs, services, functions andactivities, as described in § 1001.10.

(c) Will grants always be madeavailable to meet the planning phaserequirement as described in section402(d) of Pub. L. 103–413? No. Grantsto cover some or all of the planningcosts that a tribe/consortium may incurmay be made available depending uponthe availability of funds appropriated byCongress. We will publish notice ofavailability of grants in the FederalRegister as described in this section.

(d) May a tribe use its own resourcesto meet its planning and negotiationexpenses in preparation for enteringinto self-governance? Yes. A tribe/consortium may use its own resourcesto meet these costs. Receiving a grant isnot necessary to meet the planningphase requirement of the Act or tonegotiate a compact and annual fundingagreement.

(e) What happens if there areinsufficient funds to meet theanticipated tribal requests for planningand negotiation grants in any givenyear? If appropriated funds are availablebut insufficient to meet the totalrequests from tribes/consortia, we willgive first priority to those that have beenselected from the applicant pool tonegotiate an annual funding agreement.We will give second priority to tribes/consortia that require advance funds tomeet the planning requirement for entryinto the self-governance program. Wewill give third priority to tribes/consortia that require negotiation/planning funds to negotiate for DOI non-BIA programs.

(f) How many grants will theDepartment make each year and whatfunding will be available? The numberand size of grants awarded each yearwill depend on Congressionalappropriations and tribal interest. Eachyear, we will publish a notice in theFederal Register which providesrelevant details about the applicationprocess, including: The funds available,timeframes, and requirements fornegotiation and advance planningspecified in this part.


§ 1001.8 Selection criteria for tribes/consortia to receive a negotiation grant.

(a) Who may be selected to receive anegotiation grant? Any tribe/consortiumthat has been accepted into theapplicant pool in accordance with§ 1001.5 and has been selected tonegotiate a self-governance annualfunding agreement is eligible to applyfor a negotiation grant. Each year, wewill publish a notice in the FederalRegister with all relevant details as tohow tribes/consortia which have beenselected can apply for negotiationgrants.

(b) What must a tribe/consortium doto receive a negotiation grant?

(1) To receive a negotiation grant, atribe/consortium must:

(i) Be selected from the applicant poolto negotiate an annual fundingagreement;

(ii) Be identified as eligible to receivea negotiation grant; and

(iii) Not have received a negotiationgrant within the 3 years preceding thedate of the latest Federal Registerannouncement described in § 1001.7.

(2) The tribe/consortium must submita letter affirming its readiness tonegotiate and formally request anegotiation grant to prepare for andnegotiate a self-governance agreement.These grants are not competitive.

(c) May a selected tribe negotiatewithout applying for a negotiationgrant? Yes. In this case, the tribe shouldnotify us in writing so that funds can bereallocated for other grants.

§ 1001.9 Selection criteria for tribes/consortia seeking advance planning grantfunding.

(a) Who is eligible to apply for aplanning grant that will be awardedbefore a tribe/consortium is admittedinto the applicant pool? Any tribe/consortium that is not a self-governancetribe and needs advance funding inorder to complete the planning phaserequirement may apply. Tribes/consortia that have received a planninggrant within 3 years preceding the dateof the latest Federal Registerannouncement described in § 1001.7 arenot eligible.

(b) What must a tribe/consortiumseeking a planning grant submit in orderto meet the planning phaserequirements? A tribe/consortium mustsubmit the following material:

(1) a tribal resolution or other finalaction of the tribal governing bodyindicating a desire to plan for tribal self-governance;

(2) audits from the last 3 years whichdocument that the tribe meets therequirement of being free from anymaterial audit exception;

(3) a proposal that describes thetribe’s/consortium’s plans to conduct:

(i) legal and budgetary research, and(ii) internal tribal government and

organization planning;(4) a timeline indicating when

planning will start and end; and(5) evidence that the tribe/consortium

can perform the tasks associated with itsproposal (i.e., submit resumes andposition descriptions of key staff orconsultants to be used).

(c) How will tribes/consortia knowwhen and how to apply for planninggrants? Each year, we will publish in theFederal Register a notice of theavailability of planning grants foradditional tribes as described in§ 1001.7. This notice will identify thespecific details for applying.

(d) What criteria will be used toaward planning grants to those tribes/consortia requiring advance funding tomeet the planning phase requirement ofPublic Law 103–413? Advance planninggrants are discretionary and based onneed. The following criteria will be usedto determine whether to award aplanning grant to a tribe/consortiumbefore the tribe is being selected into theapplicant pool:

(1) A complete application asdescribed in §§ 1001.9(b) and 1001.9(c);

(2) A demonstration of financial need.We will rank applications according tothe percentage of tribal resources to totalresources as indicated in the latest A–128 audit. We will give priority toapplications that demonstrate financialneed by having a lower level of tribalresources as a percent of total resources;and

(3) Other factors that demonstrate thereadiness of the tribe/consortium toenter into a self-governance agreement,including previous efforts of the tribe/consortium to participate in self-governance.

(e) Can tribes/consortia that receiveadvance planning grants also apply fora negotiation grant? Yes. Tribes/consortia that receive advance planninggrants may submit a completedapplication to be included in theapplicant pool. Once approved forinclusion in the applicant pool, thetribe/consortium may apply for anegotiation grant according to theprocess identified in § 1001.7 above.

(f) When and how will a tribe/consortium know whether it has beenselected to receive an advance planninggrant? Within 30 days of the deadlinefor submitting applications we willnotify the tribe/consortium by letterwhether it has been selected to receivean advance planning grant.

§ 1001.10 Selection criteria for otherplanning and negotiating financialassistance.

(a) What is the purpose of thissection? This section describes how toapply for other financial assistance forplanning and negotiating of a DOI non-BIA program, service, function oractivity that may be available, as well asthe selection process.

(b) Are there other funds that may beavailable to self-governance tribes/consortia for planning and negotiatingwith DOI non-BIA bureaus? Yes.Tribes/consortia may contact the Director,Office of Self-Governance to determineif funds are available for the purpose ofplanning and negotiating with DOI non-BIA bureaus under this section. A tribe/consortium may also requestinformation from a DOI non-BIA bureauon any funds which may be availablefrom that bureau.

(c) Who is eligible to apply forfinancial assistance to plan andnegotiate for a DOI non-BIA program?Any existing self-governance tribe/consortium is eligible.

(d) Under what circumstances mayplanning and negotiation financialassistance be made available to tribes/consortia? At the discretion of theDirector, grants may be awarded whenrequested by the tribe and coordinatedwith the DOI non-BIA agency involved.

(e) How does the tribe/consortiumapply for a grant to plan and negotiatefor a DOI non-BIA program? When suchfunds are available, we will publish anotice of their availability and adeadline for submitting applications forsuch grants in the Federal Register asindicated in § 1001.7.

(f) What must be included in theapplication? The application mustinclude the following:

(1) the tribal resolution or other finalaction of the tribal governing bodyindicating that the tribe/consortiumintends to negotiate for a DOI non-BIAprogram;

(2) a copy of the proposal or summarythat was submitted to the DOI non-BIAbureau;

(3) a time line indicating whenplanning will begin and end;

(4) the planning resources from allother sources that are approved and/oranticipated for the planning activity;and

(5) the amount requested and ajustification of why it is needed by thetribe/consortium.

(g) What criteria will we use to awardgrants to those tribes/consortiarequesting financial assistance to planand negotiate for a DOI non-BIAprogram? The award of such grants isdiscretionary. After consulting with the


requesting tribe/consortium and theappropriate DOI non-BIA bureau, theDirector will determine whether toaward a grant to plan and negotiate fora DOI non-BIA program. Thedetermination will be based upon thecomplexity of the project, theavailability of resources from all othersources, and the relative need of thetribe/consortium to receive such fundsfor the successful completion of theplanning and negotiating activity, asdetermined by the percentage of tribalresources to total resources as indicatedin the latest A–128 audit. All decisionsto award or not to award grants asdescribed in paragraphs (e) and (f) ofthis section are final for the Department.

Dated: April 4, 1996.Ada E. Deer,Assistant Secretary—Indian Affairs.[FR Doc. 96–9740 Filed 4–22–96; 8:45 am]BILLING CODE 4310–02–M

Office of Surface Mining Reclamationand Enforcement

30 CFR Part 756

[HO–OO3–FOR]

Hopi Tribe Abandoned Mine LandReclamation Plan

AGENCY: Office of Surface MiningReclamation and Enforcement, Interior.ACTION: Final rule; approval ofamendment.

SUMMARY: The Office of Surface MiningReclamation and Enforcement (OSM) isapproving, with certain exceptions andadditional requirements, a proposedamendment to the Hopi TribeAbandoned Mine Land Reclamation(AMLR) plan (hereinafter, the ‘‘HopiTribe plan’’) under the Surface MiningControl and Reclamation Act of 1977(SMCRA). The Hopi Tribe proposedrevisions of and additions to planprovisions pertaining to the purpose ofthe plan; eligible lands and watersubsequent to certification; coordinationwith other programs; land acquisition,management, and disposal; reclamationon private land and rights of entry;public participation; organization of theHopi Tribe; personnel staffing policies;purchasing policies, procurementprocedures, and accounting systems;economic conditions on the HopiReservation; a description of flora andfauna at abandoned mine sites; the HopiTribe’s authority to administer its plan,as amended, in the absence of a specificstatute; changing the name of thedesignated agency; and affirmation thatthe manual for purchasing policies and

procedures is in accordance with theOffice of Management and Budget’s(OMB) Common Rule. Additionally, theHopi Tribe is proposing numerouseditorial and recodification changes.The amendment revised the Hopi Tribeplan to meet the requirements of andincorporate the additional flexibilityafforded by the revised Federalregulations and SMCRA, as amended,and improve operational efficiency.EFFECTIVE DATE: April 23, 1996.FOR FURTHER INFORMATION CONTACT:Guy Padgett, Telephone: (505) 248–5070.


I. Background on the Hopi Tribe PlanOn June 28, 1988, the Secretary of the

Interior approved the Hopi Tribe plan.General background information on theHopi Tribe plan, including theSecretary’s findings and the dispositionof comments, can be found in the June28, 1988, Federal Register (53 FR24262). Subsequent actions concerningthe Hopi Tribe plan and planamendments can be found at 30 CFR756.16, 756.17, and 756.18.

II. Proposed AmendmentBy letter dated November 2, 1995, the

Hopi Tribe submitted a proposedamendment to its plan (administrativerecord No. HO–148) pursuant toSMCRA (30 U.S.C. 1201 et seq.). TheHopi Tribe submitted the proposedamendment in response to a September26, 1994, letter (administrative recordNo. HO–145.1) that OSM sent to theHopi Tribe in accordance with 30 CFR884.15(b), and at its own initiative.

The provisions of the Hopi Tribe planthat the Hopi Tribe proposed to reviseor add were: the table of contents,including a list of appendices; a prefaceto the amended reclamation plan; a listof addenda and errata, including a listof figures; the Chairman’s letter ofdesignation and Hopi Tribe resolution;the General Counsel’s opinion on theauthority of the Hopi Tribe to conductan AMLR program; Part I, purpose of theHopi Tribe plan; Part II, eligible landsand water subsequent to certification;Part III, coordination of the Hopi AMLRProgram with other programs; Part IV,land acquisition, management, anddisposal; Part V, reclamation on privateland; Part VI, rights of entry; Part VII,Hopi Department of Natural Resources(DNR) policy on public participation;Part VIII, organization of the Hopi Tribe;Part IX, personnel staffing policies; PartX, purchasing policies and procurementprocedures; Part XI, accounting systemsand management accounting; Part XII,economic conditions on the Hopi

Reservation; and Part XIII, a descriptionof flora and fauna at abandoned minesites. The Hopi Tribe also proposednumerous minor editorial andgrammatical revisions andrecodification changes. Finally, theHopi Tribe proposed changes to theappendices included in its plan asfollows: (a) provided as ‘‘Appendix 1,’’the ‘‘Constitution and By-Laws of theHopi Tribe,’’ which was approvedDecember 19, 1936, and amended onAugust 1, 1969, February 14, 1980, andDecember 7, 1993, (b) provided coverpages for Appendices 2 through 12, and(c) changed the title of Appendix 7 from‘‘Hopi Tribe Resolution H–93–80’’ to‘‘Hopi Tribe Resolution H–93–80 andSubsequent Correspondence to theBureau of Census.’’

In addition, the Hopi Tribe proposedthe deletion of the following sections intheir entirety: (a) Section 884.13(e)(1),which is replaced by specific criteria foreligible lands and waters subsequent tocertification at Part II of the Hopi Tribeplan; (b) Sections 884.13(e)(2) and884.13(e)(3), which are replaced by adescription of current problems andneeds and current proposals at Part II,section H of the Hopi Tribe plan; and (c)Section 884.13(f)(2), Description ofAesthetic, Cultural and RecreationalConditions of the Hopi Reservation.

The Hopi Tribe also proposed addingthe following items to its plan: (1) Amemorandum dated May 18, 1995, fromthe Hopi Tribe’s Assistant GeneralCounsel affirming the authority of theTribe’s AMLR Program to administer theHopi Tribe plan as amended in theabsence of any AMLR statute; (2) HopiTribal Resolution H–134–89 thatprovides documentation of the Tribe’saction changing the name of the Officeof Natural Resources to the Departmentof Natural Resources; and (3) amemorandum dated August 31, 1995,from the Tribe’s Office of FinancialManagement that affirms that the HopiTribe ‘‘Purchasing Policies andProcedures Manual’’ is in accordancewith OMB’s Common Rule.

OSM announced receipt of theproposed amendment in the December7, 1995, Federal Register (60 FR 62786),provided an opportunity for a publichearing or meeting on its substantiveadequacy, and invited public commenton its adequacy (administrative recordNo. HO–150). Because no one requesteda public hearing or meeting, none washeld. The public comment period endedon January 8, 1996.

III. Director’s FindingsAs discussed below, the Director, in

accordance with SMCRA and 30 CFR884.14 and 884.15, finds, with certain


exceptions and additional requirements,that the proposed plan amendmentsubmitted by the Hopi Tribe onNovember 2, 1995, meets therequirements of the correspondingFederal regulations and is consistentwith SMCRA. Thus, the Directorapproves the proposed amendment.

1. Nonsubstantive Revisions to the HopiTribe Plan Provisions

The Hopi Tribe proposed revisions tothe following previously-approved planprovisions that are nonsubstantive innature and consist of minor editorial,punctuation, grammatical, andrecodification changes (correspondingFederal regulation or SMCRA provisionsare listed in parentheses):

Table of Contents (there are nocounterpart Federal regulations orSMCRA provisions), title of Part II,‘‘Eligible Lands and Waters Subsequentto Certification;’’

Table of Contents, (there are nocounterpart Federal regulations orSMCRA provisions), List of Appendices;

List of Addenda and Errata, (there areno counterpart Federal regulations orSMCRA provisions), title for this part;

List of Figures, (there are nocounterpart Federal regulations orSMCRA provisions), title of Figure 4and deletion of Figure 5;

Chairman’s Letter of Designation andHopi Tribe Resolution, (30 CFR884.13(a)), designation of agencyauthorized to administer approved plan;

Opinion of Legal Counsel, (30 CFR884.13(b)), authority of designatedagency to conduct the AMLR program inaccordance with the requirements ofTitle IV of SMCRA;

Part III, (30 CFR 884.13(c)),coordination of Tribal AML programswith other programs;

Sections IV, A(2) (c), (d), (e), B(2), andC (30 CFR Part 879), land acquisition,management, and disposal;

Part V and Figures 1 and 2, (30 CFRPart 882), reclamation on private land;

Sections VI, A, B, and C, (30 CFR Part877), rights of entry;

Part VII, (30 CFR 884.13(c)(7)), HopiDNR policy on public participation;

Part VIII and Figure 4, (30 CFR884.13(d)(1)), organization of the HopiTribe;

Part IX, (30 CFR 884.13(d)(2)),personnel staffing policies;

Part X, (30 CFR 884.13(d)(3)),purchasing and procurement;

Part XI, (30 CFR 884.13(d)(4)),management accounting;

Deletion of section 884.13(e)(1)[replaced by Part II] and deletion ofsections 884.13(e) (2) and (3) [replacedby section II, H], (30 CFR 884.13 (c) (1)and (2)), purpose of Hopi Tribe

reclamation plan and criteria for rankingand identifying projects;

Part XIII, (30 CFR 884.13(f)(2), floraand fauna;

Appendices 1 through 12, (there areno counterpart Federal regulations orSMCRA provisions), addition of coverpages; and

Appendix 7, (there is no counterpartFederal regulation or SMCRAprovision), change of title of appendix.

Because the proposed revisions tothese previously-approved Hopi Tribeplan provisions are nonsubstantive innature, the Director finds that they meetthe requirements of the Federalregulations and are consistent with thecorresponding provisions of SMCRA.Therefore, the Director approves theproposed revisions to these planprovisions.

In addition, the Director is acceptingthe following supporting documents forinclusion to the Hopi Tribe AMLR plan:

Memorandum from Assistant GeneralCounsel/Legislative Counsel to DNRdated May 18, 1995, concerningelimination of Title IV from the draftHopi Code Mining Ordinance;

Hopi Tribal Council Resolution H–134–89, adopted August 29, 1989; and

Memorandum from the Hopi TribeOffice of Financial Management to DNRdated September 7, 1995, concerningpurchasing procedures.

2. Substantive Revisions to the HopiTribe Plan Provisions That AreSubstantially Identical to theCorresponding Provisions of the FederalRegulations and SMCRA

The Hopi Tribe proposed revisions tothe following plan provisions that aresubstantive in nature and containlanguage that is substantively identicalto the requirements of thecorresponding Federal regulations andSMCRA provisions (listed inparentheses):

Preface to Amended ReclamationPlan, (section 411 of SMCRA and 30CFR Part 875), program goals andobjectives and eligible projects;

Section I, B, (30 CFR 884.13(a)),designation of administrative authority;

Section I, C, (section 403(a) ofSMCRA), introductory paragraph forreclamation priorities;

Section I, C (4) and (5), (section 403(a)(4) and (5) of SMCRA), deletion ofexisting C (4) and recodification of C(5)and (6) and C(4) and (5);

Section I, C, (deleted section 402(g)(2)of SMCRA), deletion of provisionsconcerning allocation of funds;

Sections II, A(1) (a) through (f), (30CFR 874.12 (a) through (h)), eligible coallands and water;

Section II, A(1)(g), (30 CFR 874.16),contractor responsibility;

Sections II, B(1) (a) and (b), (30 CFR875.14(a) (1) and (2)), eligible lands andwater subsequent to certification;

Sections II, B(1)(c), (d)(i) and (iii), (e),and (g), (30 CFR 875.15(a), (b)(1) and (3),(c), and (e)), reclamation priorities fornoncoal program;

Sections II, C through F, (30 CFR875.16, 875.17, 875.19, and 875.20),exclusion of certain noncoalreclamation sites, noncoal landacquisition authority, limited liability,and contractor responsibility;

Section II, H and [deletion of] rankingand selection of noncoal reclamationprojects and Table I, Comprehensive/Problem Evaluation Matrix, (30 CFR884.13 (c) and (e)), description of needs,proposed construction and activities;

Section IV, A(2)(b), (30 CFR 879.11),lands eligible for acquisition;

Part XII, (30 CFR 884.13(f)(1)),economic conditions of the HopiReservation; and

Appendix 1, (there is no counterpartFederal regulation or SMCRAprovision), Constitution and By-Laws ofthe Hopi Tribe, as amended.

Because these proposed revisions tothe Hopi Tribe plan provisions aresubstantively identical to thecorresponding provisions of the Federalregulations and SMCRA or concernproposed deletions of provisionsdeleted from Title IV of SMCRA, theDirector finds that they meet therequirements of the Federal regulationsand are consistent with SMCRA. TheDirector approves these proposedrevisions to the Hopi Tribe planprovisions.

3. Preface to Amended ReclamationPlan

The Hopi Tribe proposed the additionof a preface to the Hopi Tribe plan,which provides, in part, a discussion inthe introductory paragraph of thereasons for the amended reclamationplan. The preface discusses theAbandoned Mine Reclamation Act of1990 (Pub. L. 101–508), but there is nomention of the Energy Policy Act of1992. (Pub. L. 102–486, EPACT), whichwas enacted October 24, 1992. EPACTamended Title IV of SMCRA in severalways. The Hopi Tribe incorporated inthe proposed revisions to the Hopi Tribeplan provisions addressing some of theamended Federal requirements. TheDirector finds that the preface isconsistent with title IV of SMCRA andis in compliance with the implementingFederal regulations, but suggests thatthe introductory paragraph be revised toalso reference the Energy Policy Act of1992 and provide that the planamendment has been prepared to be inconformance with it.


The introductory paragraph alsoprovides that the amendment has beenprepared to meet the requirements of 30CFR Parts 870 (Abandoned MineReclamation Fund-Fee Collection andCoal Production Reporting), 872(Abandoned Mine Reclamation Funds),873 (Future Reclamation Set-AsideProgram), 874 (General ReclamationRequirements), 875 (NoncoalReclamation), 876 (Acid Mine DrainageTreatment and Abatement Program),and 886 (State and Tribal ReclamationGrants). However, the amendmentcontains no provisions concerning afuture reclamation set-aside program oran acid mine drainage treatment andabatement program. The Directorrecommends that the references to theprovisions concerning a futurereclamation set-aside program and anacid mine drainage treatment andabatement program should be deleted.

4. Section I, A, Purpose of the HopiTribe AMLR Plan

a. Section I, A.—The Hopi Tribeproposed to revise Part I to provide ageneral description of funding prioritiessimilar to those at sections 403 (a) and(b)(1) of SMCRA, which pertain only tocoal, and to include reclamationactivities pertaining to the adverseeffects and impacts of mineral miningand processing practices [noncoal]similar to those provided at sections 411(c) and (e) of SMCRA.

However, the Hopi Tribe did notretain the distinctions between coal andnoncoal by setting out separateprovisions for each. Title IV of SMCRAand the Federal regulations distinctlyand separately provide requirementsconcerning coal reclamation at section403 and 30 CFR Part 874 and noncoalreclamation at section 411 and 30 CFRPart 875. The Director finds that theHopi Tribe’s proposed replacement ofthe word ‘‘coal’’ with the phrase‘‘mining and processing practices’’ atsection I, A inappropriately combinescoal and noncoal reclamation activities,and is, therefore, inconsistent withSMCRA and not in compliance with theFederal regulations. The Director isrequiring, in order to properly reflectthe objectives and priorities forexpenditures of moneys from theabandoned mine land fund, the HopiTribe to revise Part I by creatingseparate provisions for coal and noncoalreclamation activities in order to beconsistent with sections 403 and 411 ofSMCRA and in compliance with theFederal regulations at 30 CFR Parts 874and 875.

b. Section I, A(1).—Section I, A(1)provides, in part, that one purpose ofthe Hopi AMLR plan is to ‘‘protect the

health, safety, and general welfare ofmembers of the Hopi Tribe * * *.’’ Thelanguage contained in this section issimilar to sections 403(a) (1) and (2) and411(c) (1) and (2) of SMCRA, except thatsections 403 and 411 distinguishbetween the ‘‘protection of publichealth, safety, general welfare, andproperty from extreme danger of adverseeffects’’ of mining (emphasis added) andthe ‘‘protection of public health, safety,and general welfare from adverseeffects’’ of mining. Section I, A of theHopi Tribe plan is a general descriptionof the purpose the plan itself. As such,the Director finds that, even thoughsection I, A(1) does not distinguishbetween the ‘‘extreme danger of adverseeffects’’ and the ‘‘adverse effects’’ ofmining and processing practices, theplan at sections I, C (1) and (2) andproposed II, B(1)(d) (i) and (ii) providefor coal and noncoal reclamationpriorities, which specifically addressthe ‘‘extreme danger of the adverseeffects’’ and the ‘‘adverse effects’’consistent with sections 403(a) and411(c) of SMCRA. Therefore, theDirector approves the proposedlanguage of section I, A(1).

c. Section I, A(2).—The proposedrevisions at section I, A(2) provide thatanother purpose of the Hopi AMLR planis to ‘‘restore land and water resourcesdegraded by the adverse effects ofmining and processing practices forboth aesthetic and conservationreasons.’’ This language is similar tosections 403(a)(3) and 411(c)(3) ofSMCRA, except that sections 403 and411 also provide for the restoration ofthe environment previously degraded bymining practices; and section 403(a)(3),which concerns coal reclamation only,includes restoration measures forconservation and development of soil,water (excluding channelization),woodland, fish and wildlife, recreationresources, and agricultural productivity.The specific priorities for coal andnoncoal reclamation concerningrestoration of land and water resourcesand the environment previouslydegraded by mining practices areprovided for in the Hopi Tribe plan atsection I, C(3) and proposed section II,B(1)(d)(iii). These provisions aresubstantively identical to sections403(a)(3) and 411(c)(3) of SMCRA.Therefore, the Director finds that thegeneral description concerningrestoration of land and water resourcesprovided in the purpose of the HopiTribe plan at section I, A(2) is consistentwith sections 403 and 411 of SMCRA.The Director approves the revisions tothis plan provision.

d. Section I, A(3).—The Hopi Tribeproposed to revise section I, A of the

Hopi Tribe plan by adding newlanguage at paragraph (3) ‘‘to provide forprotecting, repairing, replacing,constructing, or enhancing facilitiesrelated to water supply, including waterdistribution facilities and treatmentplants, to replace water suppliesadversely affected by mining andprocessing practices.’’ The Directorfinds that proposed section I, A(3),which is similar to section 403(b)(1) ofSMCRA, is inconsistent with SMCRAfor two reasons. First of all, the HopiTribe is proposing to extend theprovisions of section I, A(3) to noncoalreclamation activities by proposing tochange the word ‘‘coal’’ to ‘‘mining andprocessing practices.’’ The provisions ofsection 403 of SMCRA apply only tocoal, and as proposed at I, A(3) in theHopi Tribe plan, the water replacementprovision includes all mining andprocessing practices, and is not limitedto only coal mining practices. Secondly,section 403(b)(1) of SMCRA also onlyapplies in those States or Indian tribesthat have not certified to the completionof coal reclamation. The Hopi Tribeprovided certification of completion ofcoal reclamation in a letter from theChairman and Chief Executive Officer ofthe Hopi Tribe dated February 2, 1994(59 FR 29719, June 9, 1994). TheDirector requires the Hopi Tribe torevise its AMLR plan by deleting sectionI, A(3) and recodifying the subsequentparagraphs accordingly.

e. Section I, A(4).—The Hopi Tribeproposed to add new language at sectionI, A(4) ‘‘to provide for the protection,repair, replacement, construction, orenhancement of public facilities such asutilities, roads, recreation, andconservation facilities adversely affectedby mining and processing practices.’’This provision is similar to section403(a)(4) of SMCRA, except that I, A(4)applies to ‘‘mining and processingpractices’’ while section 403(a)(4)pertains only to public facilitiesadversely affected by coal miningpractices (emphasis added). Also,subsequent to certification, reclamationprojects involving the protection, repair,replacement, construction, orenhancement of utilities, such as thoserelating to water supply, roads, andother facilities that have been adverselyaffected by mining and processingpractices, and the construction of publicfacilities in communities impacted bycoal or other mineral mining andprocessing practices, are provided for atsection 411(e) of SMCRA. Therefore, theDirector finds that section I, A(4) isinconsistent with sections 403(a)(4) and411(e) of SMCRA. The Director isrequiring the Hopi Tribe to revise


section I, A(4) to reflect the objectivesand priorities concerning publicfacilities set forth at section 411(e) ofSMCRA.

5. Sections II, A(1), (f) and (h), CoalReclamation After Certification

a. Section II, A.—Section II, A doesnot contain provisions concerninglimited liability for coal reclamationactivities similar to the Federalregulations at 30 CFR 874.15. This planamendment does provide at proposedsection II, E limited liability provisions,which are viewed by OSM, consistentwith the Federal regulations at 30 CFRParts 874 and 875, which provideseparate and distinct provisions for coaland noncoal reclamation, includinglimited liability provisions, as onlyapplying to noncoal reclamationactivities. As provided in OSM’sSeptember 26, 1994, 30 CFR Part 884issue letter (administrative record No.HO–145.1), the Hopi Tribe was giventhe option to adopt limited liabilityprovisions for coal reclamationactivities similar to the counterpartFederal regulations at 30 CFR 874.15.Because the Hopi Tribe was given thediscretion to determine whether toinclude in its plan limited liabilityprovisions for coal reclamationactivities, the Director finds that sectionII, A is in compliance with 30 CFR Part875 and approves section II, A withouta specific limited liability provision forcoal. The Director cautions the HopiTribe, however, that should any coalprojects occur subsequent to the HopiTribe’s certification of completion ofcoal reclamation, the Hopi Tribe AMLRprogram may be held liable underFederal law for any costs or damages asa result of any action or omitted actionwhile carrying out its approvedabandoned mine reclamation plan. TheHopi Tribe may wish to revise sectionII, A to extend its limited liabilitycoverage to coal reclamation projects.

b. Section II, A(1).—Proposed sectionII, A(1) of the Hopi Tribe AMLR planprovides that February 2, 1994, is theeffective date of the Hopi Tribe’scertification that all known abandonedcoal mine problems had been addressed.This date is actually the date that theHopi Tribe submitted to OSM itscertification of completion of coalreclamation with a request forconcurrence by the Secretary of theInterior. OSM approved the Hopi Tribe’scertification effective June 9, 1994 (see59 FR 29721). The Director is notrequiring the Hopi Tribe to revisesection II, (A)(1) to reflect the correcteffective date because between February2, 1994, which is the date of the HopiTribe’s submittal, and June 9, 1994,

which is the effective date of thecertification, no new coal problemswere identified as evidenced by the lackof public response to the proposed ruleFederal Register notice seeking publicparticipation in the certification process(see 59 FR 29720). Therefore, theDirector is taking this opportunity toclarify that the effective date of the HopiTribe’s certification of completion ofcoal reclamation is June 9, 1994.

Also, proposed section II, A(1)requires the Hopi Tribe to abate coalproblems found after the effective dateof certification of completion of coalreclamation in the first grant cyclefollowing discovery of any coal problemsubject to the availability of fundsdistributed to the Hopi Tribe in thatcycle. The Director finds that thisrequirement is consistent with therequirements at 30 CFR 875.14(b) of theFederal regulations, except that§ 875.14(b) also provides that ‘‘[t]he coalproject would be subject to the coalprovisions specified in sections 401through 410 of SMCRA.’’ This languageensures that should a coal problemoccur, a State or Indian tribe that hascertified to the completion of coalreclamation, would carry outsubsequent coal reclamation activitiesunder the State of Indian tribeauthorities relating to coal and notpursuant to noncoal authority containedin section 411 of SMCRA. Therefore, theDirector approves section II, A(1) to theextent that it requires the Hopi Tribe toabate any new coal problems that ariseafter the effective date of thecertification of completion of coalreclamation and requires the Hopi Tribeto modify section II, A(1) to require thatany coal project would be subject to theprovisions of sections 401 through 410of SMCRA or otherwise amend itsAMLR plan to provide that new coalprojects identified after the effectivedate of certification would be subject tothe coal provisions of SMCRA.

c. Section II, A(1)(h).—The Hopi Tribeproposed at section II, A(1)(h) to requirethat Form OSM–76 be submitted toOSM upon coal project completion toreport accomplishments achievedthrough the project. This provision is incompliance with the Federal regulationsat 30 CFR 886.23 to the extent that theHopi Tribe is required to submit FormOSM–76 to OSM upon projectcompletion. However, 30 CFR 886.23also requires the submission of otherforms as specified by OSM, includingreporting forms for each grant and anyother closeout reports. The grantdocument awarding AML funds to aState or Indian tribe includes acondition requiring the grantee tosubmit financial status reports,

performance reports, and other suchreports according to the timing, content,and format as required by OSM. Suchdocuments are signed, not only by theOSM Field Office Director, but also byan officer of the grantee authorized toaccept the award with all its conditions.Because the grant reportingrequirements are attached to the grantdocument, the Hopi Tribe AMLR planappropriately does not need to providefor reports concerning the grant itself.Therefore, the Director finds section II,A(1)(h) is in compliance with theFederal regulations at 30 CFR 886.23and is not requiring the Hopi Tribe toadd requirements at section II, A(1)(h)concerning reporting information onother forms specified by OSM. TheDirector approves section II, A(1)(h).

6. Sections II, B(1)(d)(ii), (f), and G,Noncoal Reclamation After Certification

a. Section II, B(1)(d)(ii).—The HopiTribe proposed to add language atsection II, B(1)(d)(i) through (iii) toprovide criteria for determining thepriority of noncoal reclamation projectsand construction of facilities. Theproposed criteria are similar to thecriteria provided in the Federalregulations at 30 CFR 875.15(b)(1)through (3), except that section II,B(1)(d)(ii) of the Hopi Tribe AMLR planincludes, as priority 2, the protection ofproperty from the adverse effects ofmineral mining and processingpractices. 30 CFR 875.15(b)(2) provides,as priority 2, for the protection of publichealth, safety, and general welfare fromthe adverse effect of mineral mining andprocessing practices. The Director findsthat section II, B(1)(d)(ii) of the HopiTribe AMLR plan, by including theprotection of property from the adverseeffects of noncoal mining as a secondlevel priority, is not in compliance withthe Federal regulations, which providefor the protection of property from theextreme danger of the adverse effects ofnoncoal mining as a level one priority.Therefore, the Director requires theHopi Tribe to revise section II,B(1)(d)(ii) by deleting the word‘‘property’’ or otherwise modify its planto provide the same criteria as that at 30CFR 875.15(b)(2) for priority 2 noncoalreclamation.

b. Section II, B(1)(f).—The Hopi Tribeproposed at section II, B(1)(f) to providethat where the Chairman of the HopiTribe determines there is a need foractivities or construction of specificpublic facilities related to the coal ormineral industry on Tribal landsimpacted by coal or mineraldevelopment, the Tribe may submit agrant application to OSM requestingfunds to carry out such activities or


construction. This provision is incompliance with the Federal regulationsat 30 CFR 875.15(d), which allow a Stateor Indian Tribe to request funding for apublic facility if the Governor of a Stateor head of a governing body of an Indiantribe determines there is a need for theconstruction of a public facility relatedto the coal or minerals industry. 30 CFR875.15(d) also requires that where aState or Tribe determines there is a needfor activities or construction, theDirector of OSM must concur in thatneed. As discussed in the preamble ofthe final rule Federal Register notice(see 59 FR 28136, 28162–3, May 31,1994), OSM, concerned that the AMLprogram not be sidetracked from itsprimary mission to reclaim lands andwaters damaged by coal and noncoalmining processes, must determinewhether a need exists for projectsinvolving the construction of facilitiespursuant to section 411(f) SMCRA. Thisdetermination is an action carried outsolely by OSM, and the State or Tribeis not involved in the determinationmade by OSM. Therefore, the HopiTribe plan does not need to provide forthis action. The Director approvessection II, B(1)(f), and is taking thisopportunity to reiterate that, prior togranting AML funds for public facilityprojects proposed under section 411(f)of SMCRA and the Federal regulationsat 30 CFR 875.15(d), OSM’s Directorwill concur with the Hopi TribeChairman’s statement of need for suchprojects.

c. Section II, G.—The Hopi Tribeproposed at section II, G that FormOSM–76 be submitted to OSM uponnoncoal project completion to reportaccomplishments achieved through theproject. The Director finds that thisprovision is in compliance with theFederal regulations at 30 CFR 886.23(b).The Director also notes that thedocuments awarding grants require, as acondition of acceptance, certaininformation to be reported by thegrantee, which complies with thereporting requirements of 30 CFR886.23(a). Therefore, the Directorapproves proposed section II, G (seefinding No. 5(c)).

7. Sections IV, A(1), 2(a)(i), and B(1),Land Acquisition, Management, andDisposal

a. Section IV, A(1).—The Hopi Tribeproposed to revise section IV, A(1) toprovide, in part, that land adverselyaffected by coal and noncoal miningpractices, including refuse piles and allcoal refuse piles thereon, may beacquired by the Hopi Tribe for thepurposes of the reclamation programwhen the acquisition of the lands meets

the requirements of section 407 ofSMCRA (emphasis added). Thisprovision is in compliance with theFederal regulations at 30 CFR 879.11(a)and (c), concerning lands eligible foracquisition. However, the Federalregulations at 30 CFR 875.17 extend theland acquisition authority to noncoal.At section IV, A(1), the Hopi Tribeproposed changing the phrase ‘‘coalmining practices’’ to the phrase ‘‘coaland noncoal mining practices’’ in oneinstance, but did not change ‘‘coalrefuse’’ to a term that ensures that refuseon lands adversely affected by noncoalmining practices may also be acquiredunder this provision. The Directorapproves section IV, A(1), but requiresthe Hopi Tribe to revise it by deletingthe word ‘‘coal’’ from the phrase ‘‘coalrefuse thereon’’ to ensure that thisprovision extends to refuse on landadversely affected by past noncoalpractices.

b. Section IV, A(2)(a)(i).—The HopiTribe proposed revisions at section IV,A(2)(a)(i) concerning appraisals toprovide for a ‘‘valuation of the fairmarket value * * *’’ and ‘‘principle ofbest and highest use * * *.’’ Theprovisions of section IV, A(2)(a)(i) are incompliance with the Federal regulationsat 30 CFR 879.12 (a) and (d), except thatthe language proposed by the HopiTribe concerning fair market value anduse is not the same language as thatused in the recognized standards foracquisitions. 30 CFR 879.12(d) requiresOSM or an Indian tribe which acquiresland to comply with the UniformRelocation Assistance and Real PropertyAcquisition Policies Act of 1970 (URA),42 U.S.C. 4601, et seq., and 41 CFR Part114–50. URA applies to all Federal orfederally-assisted activities that involvethe acquisition of real property. Theregulations implementing URA are at 49CFR Part 24. 49 CFR 24.103 requiresthat a detailed appraisal shall reflectnationally recognized standards,including the Uniform AppraisalStandards for Federal Land Acquisition(see 54 FR 8912, 8934, March 2, 1989).The ‘‘Uniform Appraisal Standards forFederal Acquisitions’’ handbook, whichby reference is the standard required bythe Federal regulations at 30 CFR879.12, provides for a ‘‘determination ofthe fair market value’’ and ‘‘theprinciple of highest and best use.’’

Even though the language proposedby the Hopi Tribe at section IV,A(2)(a)(i) does not use the standardizedlanguage for appraisals, the Directorinterprets the terms ‘‘valuation of fairmarket value’’ and ‘‘the principle of bestand highest use’’ as having the samemeaning as the recognized standards fora ‘‘determination of fair market value’’

and the ‘‘principle of highest and bestuse.’’ Therefore, the Director findssection IV, A(2)(a)(i) to be in compliancewith the Federal regulations at 30 CFR879.12 and approves the proposedrevisions.

c. Section IV, B(1).—As proposed,section IV, B(1) provides that ‘‘[l]andacquired under rules of section A of thispart Hopi AML Program and TribalCouncil concurrence, for any lawfulpurpose that is not inconsistent with thereclamation activities and post-reclamation uses for which it wasacquired.’’ The proposed deletion of thephrase ‘‘may be used, pending’’ betweenthe phrases ‘‘section A of this part’’ and‘‘Hopi AML Program and Tribalconcurrence’’ causes the sentence tobecome unclear. The counterpartFederal regulations at 30 CFR 879.14provide the missing language as follows:‘‘ ‘‘[l]and acquired under this part maybe used for any lawful purpose.’’ TheDirector finds that section IV, B(1) is incompliance with 30 CFR 879.14, andapproves the proposed revisionsconcerning the references to ‘‘section A’’and ‘‘this part.’’ The Director, however,requires the Hopi Tribe to remove thedeletion of the phrase ‘‘may be used,pending.’’

8. Section VI, C, Rights of Entry forEmergency Reclamation

The Hopi Tribe proposed to deleteexisting section VI, C concerning entryfor emergency reclamation. The Federalregulation at 30 CFR 877.14(a) providesfor entry by OSM, its agents, employees,or contractors upon land where anemergency exists and on any other landto have access to the land where theemergency exists to restore, reclaim,abate, control, or prevent the adverseeffects of coal [and noncoal as providedby 30 CFR 875.17] mining practices andto do all things necessary to protect thepublic health, safety, or general welfare.The preamble of the final rule for 30CFR Part 877 (see 47 FR 28574, 28583,June 30, 1982) states that final rule 30CFR 877.14 concerning emergencyreclamation activities appliesexclusively to OSM, its agents,employees, and contractors. In the caseof emergency reclamation on HopiIndian lands, OSM is the authoritybecause the Hopi Tribe did not requestauthority to conduct emergencyresponse reclamation under the originalplan approval (see 53 FR 24262, June28, 1988) and has not subsequentlysought emergency power through theamendment process. Because theemergency program on Hopi Indianlands rests exclusively with OSM, theDirector finds the deletion of existingsection VI, C of the Hopi Tribe plan to


be in compliance with the Federalregulations at 30 CFR Part 877.Therefore, the Director approves thedeletion.

9. Section 884.13(f)(2), Description ofAesthetic, Cultural and RecreationalConditions of the Hopi Reservation

The Hopi Tribe proposed deletion of§ 884.13(f)(2), which provided adescription of aesthetic, cultural andrecreational conditions of the HopiReservation. The counterpart Federalregulation at 30 CFR 884.13(f)(2)requires that the reclamation planinclude a general description of theconditions prevailing in differentgeographic areas of the Indian landswhere reclamation is planned, includingsignificant esthetic, historic or cultural,and recreational values. The Hopi Tribedid not provide, in this amendment, ajustification for the proposed deletion.Because 30 CFR 884.13(f) is a specificrequirement for information that shallbe included in a State or Tribereclamation plan, the Director finds thatthe proposed deletion of § 884.13(f)(2) ofthe Hopi Tribe plan is not incompliance with the Federal regulationat 30 CFR 884.13(f)(2). The Director,therefore, requires the Hopi Tribe toremove its proposed deletion of§ 884.13(f)(2) or otherwise provide theinformation required by 30 CFR884.13(f)(2) in its reclamation plan.

IV. Summary and Disposition ofComments

Following are summaries of allsubstantive written comments on theproposed amendment that werereceived by OSM, and OSM’s responsesto them.

1. Public comments

OSM invited public comments on theproposed amendment, but none werereceived.

2. Federal agency comments

Pursuant to 30 CFR 884.15(a) and884.14(a)(2), OSM solicited commentson the proposed amendment fromvarious Federal agencies with an actualor potential interest in the Hopi Tribeplan (administrative record Nos. HO–149 and 152).

The State Historic Preservation Officefor the State of Arizona responded onJanuary 9, 1996, that the amendmenthad been reviewed and stated that theproposed changes did not pertain tocultural resource preservation(administrative record No. HO–151).

V. Director’s DecisionBased on the above findings, the

Director approves, with certain

exceptions and additional requirements,the Hopi Tribe’s proposed planamendment as submitted on November2, 1995.

With the requirement that the HopiTribe further revise its plan provisions,the Director does not approve, asdiscussed in:

(1) finding No. 4(a), Part I, concerningthe purpose of the Hopi Tribe plan;finding No. 4(d), section I, A(3),concerning facilities related to watersupplies; and finding No. 4(e), section I,A(4), concerning public facilitiesprojects;

(2) finding No. 6(a), section II,B(1)(d)(ii), concerning the priority 2noncoal reclamation activities; and

(3) finding No. 9, § 884.13(f)(2),concerning proposed deletion ofprovisions related to a description ofaesthetic, cultural and recreationalconditions of the Hopi Reservation.

The Director approves, as discussedin:

(1) finding No. 1, the Table ofContents, concerning the title of Part IIand List of Appendices; List of Addendaand Errata, concerning the title; List ofFigures, concerning the title of Figure 4and deletion of Figure 5; Chairman’sLetter of Designation and Hopi TribeResolution, concerning the designationof the Tribal agency authorized toadminister the approved plan; Opinionof Legal Counsel, concerning theauthority of the designated agency toconduct the AMLR program inaccordance with the requirements ofTitle IV of SMCRA; Part III, concerningcoordination of Tribal AML programswith other programs; sections IV, A(2)(c), (d), (e), B(2), and C, concerning landacquisition, management, and disposal;Part V and Figures 1 and 2, concerningreclamation on private land; sections VI,A, B, and C, concerning rights of entry;Part VII, concerning the Hopi DNRpolicy on public participation; Part VIIIand Figure 4, concerning organization ofthe Hopi Tribe; Part IX, concerningpersonnel staffing policies; Part X,concerning purchasing andprocurement; Part XI, concerningmanagement accounting; deletion ofsections 884.13(e) (1), (2), and (3),concerning the purpose of Hopi Tribereclamation plan and criteria for rankingand identifying projects; Part XIII,concerning flora and fauna; Appendices1 through 12, concerning the addition ofcover pages; Appendix 7, concerningthe title of the appendix; amemorandum from the AssistantGeneral Counsel/Legislative Counsel toDNR dated May 18, 1995, concerningthe elimination of Title IV from the draftHopi Code Mining Ordinance; HopiTribal Council Resolution H–134–89,

adopted August 29, 1989; and amemorandum from the Hopi TribeOffice of Financial Management to DNRdated September 7, 1995, concerningpurchasing procedures;

(2) finding No. 2, preface to theamended reclamation plan, concerningprogram goals and objectives andeligible projects; section I, B, concerningthe designation of administrativeauthority; section I, C, concerningreclamation priorities; sections I, C (4)and (5), concerning deletion of existingC(4) and recodification of C (5) and (6)as C (4) and (5); section I, C, concerningdeletion of allocation of fundsprovisions; sections II, A(1) (a) through(f), concerning eligible coal lands andwater; section II, A(1)(g), concerningcontractor responsibility; sections II,B(1) (a) and (b), concerning eligiblelands and water subsequent tocertification; sections II, B(1)(c), (d) (i)and (iii), (e), and (g), concerningreclamation priorities for noncoalprogram; sections II, C through F,concerning exclusion of certain noncoalreclamation sites, noncoal landacquisition authority, limited liability,and contractor responsibility; section II,H, concerning description of needs,proposed construction and activities,and deletion of ranking and selection ofnoncoal reclamation projects and TableI, Comprehensive/Problem EvaluationMatrix; section IV, 2(b), concerninglands eligible for acquisition; Part XII,concerning economic conditions of theHopi Reservation; and Appendix 1,concerning the amended constitutionand by-laws of the Hopi Tribe;

(3) finding No. 3, preface to theamended reclamation plan, concerningthe introductory paragraph;

(4) finding No. 4(b), section I, A(1),concerning the protection of the health,safety, and general welfare of membersof the Hopi Tribe and finding No. 4(c),concerning the restoration of land andwater resources;

(5) finding No. 5(a), section II, A,concerning limited liability provisionsfor coal reclamation activities andfinding No. 5(c), section II, A(1)(h),concerning reports;

(6) finding No. 6(b), section II, B(1)(f),concerning the need for activities orconstruction of specific public facilitiesrelated to the coal or mineral industryon Tribal lands impacted by coal ormineral development and finding No.6(c), section II, G, concerning reports;

(7) finding No. 7(b), section IV,A(2)(a)(i) concerning appraisals; and

(8) finding No. 8, section VI, C,concerning entry for emergencyreclamation.


With the requirement that the HopiTribe further revise its plan provisions,the Director approves, as discussed in:

(1) finding No. 5(b), section II, A(1),concerning the abatement of any newcoal problems that arise after theeffective date of the certification ofcompletion of coal reclamation;

(2) finding No. 7(a), section IV, A(1),concerning the acquisition of lands bythe Hopi Tribe; and

(3) finding No. 7(c), section IV, B(1),concerning management of acquiredlands.

The Director approves the planprovisions as proposed by the HopiTribe with the provision that they befully promulgated in identical form tothe plan provisions submitted to andreviewed by OSM and the public.

The Federal regulations at 30 CFRPart 756.17, codifying decisionsconcerning the Hopi Tribe plan, arebeing amended to implement thisdecision. This final rule is being madeeffective immediately to expedite theTribe plan amendment process and toencourage Tribes to bring their plansinto conformity with the Federalstandards without undue delay.Consistency of Tribe and Federalstandards is required by SMCRA

VI. Procedural Determinations

1. Executive Order 12866

This rule is exempted from review bythe Office of Management and Budget(OMB) under Executive Order 12866(Regulatory Planning and Review).

2. Executive Order 12778

The Department of the Interior hasconducted the reviews required bysection 2 of Executive Order 12778(Civil Justice Reform) and hasdetermined that this rule meets theapplicable standards of subsections (a)and (b) of that section. However, thesestandards are not applicable to theactual language of Tribe or State AMLRplans and revisions thereof since eachsuch plan is drafted and promulgated bya specific Tribe or State, not by OSM.Decisions on proposed Tribe or StateAMLR plans and revisions thereofsubmitted by a Tribe or State are basedon a determination of whether thesubmittal meets the requirements of titleIV of SMCRA (30 U.S.C. 1231–1243) andthe applicable Federal regulations at 30CFR Parts 884 and 888.

3. National Environmental Policy Act

No environmental impact statement isrequired for this rule since agencydecisions on proposed Tribe or StateAMLR plans and revisions thereof arecategorically excluded from compliance

with the National Environmental PolicyAct (42 U.S.C. 4332) by the Manual ofthe Department of the Interior (516 DM6, appendix 8, paragraph 8.4B(29)).

4. Paperwork Reduction Act

This rule does not containinformation collection requirements thatrequire approval by OMB under thePaperwork Reduction Act (44 U.S.C.3507 et seq.).

5. Regulatory Flexibility Act

The Department of the Interior hasdetermined that this rule will not havea significant economic impact on asubstantial number of small entitiesunder the Regulatory Flexibility Act (5U.S.C. 601 et seq.). The Tribe or Statesubmittal which is the subject of thisrule is based upon Federal regulationsfor which an economic analysis wasprepared and certification made thatsuch regulations would not have asignificant economic effect upon asubstantial number of small entities.Accordingly, this rule will ensure thatexisting requirements established bySMCRA or previously promulgated byOSM will be implemented by the Tribeor State. In making the determination asto whether this rule would have asignificant economic impact, theDepartment relied upon the data andassumptions in the analyses for thecorresponding Federal regulations.


Abandoned mine reclamationprograms, Indian lands, Surface mining,Underground mining.

Dated: April 16, 1996.Russell F. Price,Acting Regional Director, Western RegionalCoordinating Center.

For the reasons set out in thepreamble, Title 30, Chapter VII,Subchapter E of the Code of FederalRegulations is amended as set forthbelow:

PART 756—‘‘INDIAN TRIBEABANDONED MINE LANDRECLAMATION PROGRAMS’’


Authority: 30 U.S.C. 1201 et seq. and Pub.L. 100–71.

2. Section 756.17 is revised to read asfollows:

§ 756.17 Approval of the Hopi Tribe’sAbandoned Mine Land Reclamation PlanAmendments.

The following amendments to theHopi Tribe’s abandoned mine landreclamation plan are approved.

(a) The Hopi Tribe certification ofcompletion of coal reclamation, assubmitted on February 2, 1994, isapproved effective June 9, 1994.

(b) With the exceptions of Part I,concerning the purpose of the Hopi tribeplan; section I, A(3) concerning facilitiesrelated to water supplies; section I, A(4),concerning public facilities projects;section II, B(1)(d)(ii), concerning theprotection of property; and section884.13(f)(2), concerning a description ofaesthetic, cultural and recreationalconditions of the Hopi Reservation,revisions to and additions of thefollowing plan provisions, as submittedto OSM on November 2, 1995, areapproved effective April 23, 1996.

Table of Contents—Title of Part II and Listof Appendices;

List of Addenda and Errata—Title for thispart;

List of Figures—Title of Figure 4 anddeletion of Figure 5;

Preface to Amended Reclamation Plan—Introductory paragraph, program goals andobjectives, and eligible projects;

Chairman’s Letter of Designation and HopiTribe Resolution—Designation of Tribalagency authorized to administer approvedplan;

Opinion of Legal Counsel—Authority ofdesignated agency to conduct the AMLRprogram in accordance with the requirementsof Title IV of SMCRA;

Section I, A(1)—Protection of the health,safety, and general welfare of members of theHopi Tribe;

Section I, A(2)—Restoration of land andwater resources;

Section I, B—Designation of administrativeauthority;

Section I, C—Reclamation priorities;Sections I, C (4) and (5)—Deletion of

existing C(4) and recodification of C(5) and(6) as C(4) and (5);

Section I, C—Deletion of allocation offunds provisions;

Section II, A—[Lack of] Limited liabilityprovision for coal;

Section II, A(1)—Abatement of any newcoal problems that arise after the effectivedate of the certification of completion of coalreclamation;

Sections II, A(1) (a) through (f)—Eligiblecoal lands and water;

Section II, (A)(1)(g)—Contractorresponsibility;

Section II, A(1)(h)—Reports;Sections II, B(1) (a) and (b)—Eligible lands

and water subsequent to certification;Sections II, B(1)(c), (d) (i) and (iii), (e), and

(g)—Reclamation priorities for noncoalprogram;

Section II, B(1)(f)—Need for activities orconstruction of specific public facilitiesrelated to the coal or mineral industry onTribal lands impacted by coal or mineraldevelopment;

Section II, G—Reports;Sections II, C through F—Exclusion of

certain noncoal reclamation sites, noncoalland acquisition authority, limited liability,and contractor responsibility;


Section II, H and [deletion of] ranking andselection of noncoal reclamation projects andTable I, Comprehensive/Problem EvaluationMatrix—Description of needs, proposedconstruction and activities;

Part III—Coordination of Tribal AMLprograms with other programs;

Section IV, A(1)—Acquisition of lands bythe Hopi Tribe;

Section IV, A(2)(a)(i)—Appraisals;Section IV, A(2)(b)—Lands eligible for

acquisition;Sections IV, A(2) (c), (d), (e), B(2), and C—

Land acquisition, management, and disposal;Section IV, B(1)—Management of acquired

lands;Part V and Figures 1 and 2—Reclamation

on private land;Section VI, A, B, and C—Rights of entry;Deletion of section VI, C—Entry for

emergency reclamation;Part VII—Hopi Department of Natural

Resources (DNR) policy on publicparticipation;

Part VIII and Figure 4—Organization of theHopi Tribe;

Part IX—Personnel staffing policies;Part X—Purchasing and procurement;Part XI—Management accounting;[Deletion of] sections 884.13(e) (1), (2), and

(3)—Purpose of Hopi Tribe plan and criteriafor ranking and identifying projects;

Part XII—Economic conditions of the HopiReservation;

Part XIII—Flora and fauna;Appendices 1 through 12—Addition of

cover pages;Appendix 1—Constitution and By-Laws of

the Hopi Tribe, as amended;Appendix 7—Title of the appendix;Memorandum from the Assistant General

Counsel/Legislation Counsel to DNR datedMay 18, 1995—Elimination of Title IV fromthe draft Hopi Code Mining Ordinance;

Hopi Tribal Council Resolution H–134–89,adopted August 29, 1989; and

Memorandum from the Hopi Tribe Officeof Financial Management to DNR datedSeptember 7, 1995—Purchasing procedures.

3. Section 756.18 is amended byadding paragraphs (a) through (h) toread as follows:

§ 756.18 Required amendments to theHopi Tribe’s Abandoned Mine LandReclamation Plan.

* * * * *(a) By June 24, 1996, the Hopi Tribe

shall revise the introductory paragraphat Part I, or otherwise revise the purposeof the Hopi Tribe plan, to provideseparate and distinct provisions for coaland noncoal reclamation activities to beconsistent with sections 403 and 411 ofSMCRA and in compliance with theFederal regulations at 30 CFR Parts 874and 875 in order to properly reflect theobjectives and priorities forexpenditures of monies from theabandoned mine land fund.

(b) By June 24, 1996, the Hopi Tribeshall delete section I, A(3) and recodifyany subsequent paragraphs accordingly,or otherwise revise the Hopi Tribe plan,

to provide appropriate provisionssubsequent to the certification ofcompletion of coal reclamation.

(c) By June 24, 1996, the Hopi Tribeshall revise Section I, A(4), or otherwiserevise the Hopi Tribe plan, to requirethe same objectives and prioritiesconcerning public facilities as set forthat section 411(e) of SMCRA.

(d) By June 24, 1996, the Hopi Tribeshall revise Section II, A(1), orotherwise revise the Hopi Tribe plan, torequire that any coal reclamationactivities subsequent to certification ofcompletion of coal reclamation aresubject to the provisions of sections 401through 410 of SMCRA.

(e) By June 24, 1996, the Hopi Tribeshall revise Section II, B(1)(d)(ii) bydeleting the word ‘‘property’’ forpriority 2 noncoal reclamation, orotherwise revise the Hopi Tribe plan toprovide for the protection of publichealth, safety, and general welfare fromthe adverse effects of mineral miningand processing practices.

(f) By June 24, 1996, the Hopi Tribeshall revise Section IV, A(1) by deletingthe word ‘‘coal’’ from the phrase ‘‘coalrefuse thereon,’’ or otherwise revise theHopi Tribe plan to ensure that landseligible for acquisition include those onwhich refuse from both coal andnoncoal mining practices are located.

(g) By June 24, 1996, the Hopi Tribeshall revise Section IV, B(1) byreinstating the phrase ‘‘may be used,pending.’’

(h) By June 24, 1996, the Hopi Tribeshall revise the Hopi Tribe plan byreinstating Section 884.13(f)(2), orotherwise modify its plan to includeinformation concerning significantesthetic, historic or cultural, andrecreational values.[FR Doc. 96–9938 Filed 4–22–96; 8:45 am]BILLING CODE 4310–05–M

DEPARTMENT OF DEFENSE

Department of the Air Force

32 CFR Part 861

Department of Defense Commercial AirCarrier Quality and Safety ReviewProgram

AGENCY: Department of the Air Force,DoD.ACTION: Final rule.

SUMMARY: The Department of the AirForce revises its regulation on DoDquality and safety criteria for air carriersproviding or seeking to provide airliftservices to the DoD. The revisionclarifies air carrier prerequisites before

an air carrier can solicit DoD businessand be used by DoD agencies.Specifically, the change clarifies thatcargo carriers must have previouslyperformed cargo business in the 12continuous months immediately prior toapplying for DoD business. The revisionalso changes the Commercial AirliftReview Board (CARB) membership fromsix voting members to four.

This revision serves to notify theaviation industry of the above changes.The changes are necessary for the DoDCommercial Airlift Review Board toeffectively and legally carry out itsaviation safety responsibilities asspecified in the National DefenseAuthorizations Act for fiscal year 1987.EFFECTIVE DATE: April 23, 1996.FOR FURTHER INFORMATION CONTACT: Mr.Dennis D. Emmons, Chief, DoD AirCarrier Survey and Analysis Division,Directorate of Operations, HeadquartersAir Mobility Command (HQ AMC/DOB), Scott AFB IL 62225–5302,telephone (618) 256–4801/4806.SUPPLEMENTARY INFORMATION: This partis published as a final rule because itimplements Public Law 99–661 (FY87National Defense Authorization Act,§ 1204, Requirements ConcerningTransportation of Members of theArmed Forces by Chartered Aircraft)and DoD Directive 4500.53 (CommercialPassenger Airlift Management andQuality Control). Additionally, and aspart of the final rule determination, thispart is related to public contracts and toprovisions for agency management.

The Department of the Air Force hasdetermined that this regulation is not amajor rule as defined by ExecutiveOrder 12866, is not subject to therelevant provisions of the RegulatoryFlexibility Act of 1980 (5 U.S.C. 601–661), does not contain reporting orrecordkeeping requirements under thecriteria of the Paperwork Reduction Actof 1980 (44 U.S.C. 35), and poses nonegative environmental impact asdefined in the National EnvironmentalPolicy Act of 1969 (42 U.S.C. 4321 etseq).


Air carriers, Aviation safety.Therefore, 32 CFR Part 861 is

amended as follows:

PART 861—DEPARTMENT OFDEFENSE COMMERCIAL AIRCARRIER QUALITY AND SAFETYREVIEW PROGRAM


Authority: 10 U.S.C. 8013; 10 U.S.C. 2640.


2. Section 861.3 is amended byrevising paragraph (d)(1) to read asfollows:

§ 861.3 DOD commercial air carrier qualityand safety requirements.

* * * * *(d) * * *(1) Quality and Safety Requirements—

prior experience. Commercial aircarriers or operators applying toconduct passenger or cargo business forthe United States Department of Defenseare required to possess 12 months ofcontinuous service equivalent to theservice sought by DoD. The service musthave been performed for the 12continuous months immediately prior toapplying for DoD business. Priorexperience must be equivalent indifficulty and complexity in regard todistance, weather systems, internationalor national procedures, similar aircraft,schedule demands, aircrew experience,and management required.* * * * *

3. Section 861.4 is amended byrevising paragraph (g)(1) and (2) to readas follows:

§ 861.4 DOD Commercial Airlift ReviewBoard procedures.

* * * * *(g) * * *(1) Four voting members will

constitute the CARB; two senior,knowledgeable individuals appointedby Commander, AMC; one similarlyknowledgeable individual appointed byUSCINCTRANS; and one appointed byCommander, MTMC. At least one of thevoting HQ AMC members and theMTMC member will be of general/flagofficer or civilian equivalent rank. Othernon-voting CARB members will beappointed as necessary to facilitate theCARB deliberative process. A non-voting recorder will also be appointed.

(2) The HQ AMC senior member willact as the CARB chairperson. A votingmember who will not be present at anymeeting of the CARB, may berepresented by a knowledgeablealternate empowered with the votingresponsibilities of the voting member.Three voting members (or theiralternate) shall constitute a quorum.Decisions shall be by majority vote. Inthe case of a tie vote, the chairpersonwill have the deciding vote.* * * * *Patsy J. Conner,Air Force Federal Register Liaison Officer.[FR Doc. 96–9928 Filed 4–22–96; 8:45 am]BILLING CODE 3910–01–W


Coast Guard

33 CFR Part 100

[CGD07–96–028]

RIN 2115–AE46

Special Local Regulations: River RaceAugusta; Augusta, GA

AGENCY: Coast Guard, DOT.ACTION: Temporary final rule.

SUMMARY: The Coast Guard isestablishing temporary Special LocalRegulations for the River Race Augusta.This event will be held from 7 a.m. to5 p.m. est (eastern standard time) onMay 17, 18, and 19, 1996. There will beapproximately seventy-five participantsracing 16 to 18 foot outboard powerboats on that portion of the SavannahRiver at Augusta, Georgia, between U.S.Highway 1 (Fifth St) Bridge at milemarker 199.45 and Eliot’s Fish Camp atmile marker 197. The boats will becompeting at high speeds and at closerange on a prescribed course. The natureof the event and the closure of theSavannah River creates an extra orunusual hazard in the navigable waters.These temporary regulations arenecessary to provide for the safety of lifeon navigable waters during the event.EFFECTIVE DATES: This rule is effectivefrom 7 a.m. to 5 p.m. eastern standardtime on May 17, 18, and 19, 1996.FOR FURTHER INFORMATION CONTACT:ENS M.J. DaPonte, Coast Guard GroupCharleston at (803) 724–7621.SUPPLEMENTARY INFORMATION: Inaccordance with 5 U.S.C. 553, a noticeof proposed rulemaking has not beenpublished for these regulations andgood cause exists for making themeffective in less than 30 days from thedate of publication. Following normalrulemaking procedures would havebeen impractical. The information tohold the event was not received untilApril 4, 1996, and there was notsufficient time remaining to publishproposed rules in advance of the eventor to provide for a delayed effectivedate.

Discussion of Regulations

The temporary regulations are neededto provide for the safety of life duringRiver Race Augusta. These regulationsare intended to promote safe navigationon the waters off Augusta on theSavannah River during the races bycontrolling the traffic entering, exiting,and traveling within these waters. Theanticipated concentration of spectatorand participant vessels associated with

the River Race poses a safety concern,which is addressed in these speciallocal regulations. The temporaryregulations will not permit the entry ormovement of spectator vessels and othernonparticipating vessel traffic betweenthe U.S. Highway Route 1 (Fifth Street)Bridge at mile marker 199.45 and Eliot’sFish Camp at mile marker 197 from 7a.m. to 5 p.m. est, on May 17, 18 and19, 1996. The temporary regulationswill permit the movement of spectatorvessels and other non-participants afterthe termination of race each day, andduring intervals between scheduledevents at the discretion of the CoastGuard Patrol Commander.

Regulatory EvaluationThis rulemaking is not a significant

regulatory action under Section 3(f) ofthe Executive Order 12866 and does notrequire an assessment of the potentialcosts and benefits under Section 6(a)(3)of that Order. It has been exempted fromreview by the Office of Management andBudget under that order. It is notsignificant under the regulatory policiesand procedures of the Department ofTransportation (DOT) (44 FR 11040;February 26, 1979). The Coast Guardexpects the economic impact of thisproposed rule to be so minimal that afull Regulatory Evaluation underparagraph 10e of the regulatory policiesand procedures of DOT is unnecessary.These temporary regulations will last foronly 10 hours each day of the event.

Small EntitiesUnder the Regulatory Flexibility Act

(5 U.S.C. 601 et seq.), the Coast Guardmust consider whether this action willhave a significant economic impact ona substantial number of small entities.‘‘Small entities’’ include independentlyowned and operated small businessesthat are not dominant in their field andthat otherwise qualify as ‘‘smallbusiness concerns’’ under Section 3 ofthe Small Business Act (15 U.S.C. 632).

For reasons set forth in the aboveRegulatory Evaluation, the Coast Guardcertifies under 5 U.S.C. 605(b) that thisaction will not have a significanteconomic impact on a substantialnumber of small entities.

Collection of InformationThese temporary regulations contain

no collection of informationrequirements under the PaperworkReduction Act (44 U.S.C. 3501 et seq.).

FederalismThis action has been analyzed in

accordance with the principles andcriteria contained in Executive Order12612, and it has been determined that


the rulemaking does not have sufficientFederalism implications to warrant thepreparation of a Federalism Assessment.

Environmental AssessmentThe Coast Guard has considered the

environmental impact of this actionconsistent with section 2.B.2. ofCommandant Instruction M16475.1B. Inaccordance with that section, this actionhas been environmentally assessed (EAcompleted), and the Coast Guard hasconcluded that it will not significantlyaffect the quality of the humanenvironment. An environmentalassessment and a finding of nosignificant impact have been preparedand are available in the docket forinspection or copying.List of Subjects in 33 CFR Part 100

Marine safety, Navigation (water),Reporting and recordkeepingrequirements, Waterways.Temporary Final Regulations

In consideration of the foregoing, Part100 of Title 33, Code of FederalRegulations, is amended as follows:

PART 100—[AMENDED]1. The authority citation for Part 100

continues to read as follows:Authority: 33 U.S.C. 1233; 49 CFR 1.46 and

33 CFR 100.35.

2. A temporary § 100.35–T96–028 isadded to read as follows:

§ 100.35–T96–028 River Race Augusta;Savannah River, Augusta GA.

(a) Definitions:(1) Regulated Area. The regulated area

is formed by a line drawn directlyacross the Savannah River at the U.S.Highway 1 (Fifth Street) Bridge at milemarker 199.45 and directly across theSavannah River at Eliot’s Fish Camp atmile marker 197. The regulated areaencompasses the width of the SavannahRiver between these two lines.

(2) Coast Guard Patrol Commander.The Coast Guard Patrol Commander isa commissioned, warrant or petty officerof the Coast Guard who has beendesignated by the Commander, CoastGuard Group Charleston, SouthCarolina.

(b) Special Local Regulations.(1) Entry into the regulated area is

prohibited to all non participants.(2) After termination of the River Race

Augusta each day, and during intervalsbetween scheduled events, at thediscretion of the Coast Guard PatrolCommander, all vessels may resumenormal operations.

(c) Effective Dates: This section iseffective at 7 a.m. and terminates at 5p.m. EST on May 17, 18 and 19, 1996,unless otherwise specified in the

Seventh Coast Guard District LocalNotice to Mariners.

Dated: April 10, 1996.P.J. Cardaci,Captain U.S. Coast Guard, Commander,Seventh Coast Guard District, Acting.[FR Doc. 96–9880 Filed 4–22–96; 8:45 am]BILLING CODE 4910–14–M

NATIONAL ARCHIVES AND RECORDSADMINISTRATION

36 CFR Part 1275

RIN 3095–AA59

Preservation and Protection of andAccess to the Presidential HistoricalMaterials of the Nixon Administration;Amendment of Public AccessRegulations

AGENCY: National Archives and RecordsAdministration.ACTION: Final rule and interim final rule.

SUMMARY: This rule revises theprocedures to be followed by theNational Archives and RecordsAdministration (‘‘NARA’’) forpreserving and protecting thePresidential historical materials of theNixon Administration, for providingpublic access to these materials, and forproviding for the reproduction of theNixon White House tape recordings,based on a Settlement Agreementreached through mediation amongPublic Citizen and Stanley I. Kutler, theNational Archives and RecordsAdministration, and William E. Griffinand John H. Taylor, co-executors of theEstate of Richard M. Nixon, parties toStanley I. Kutler and Public Citizen v.John W. Carlin, Archivist of the UnitedStates, and William E. Griffin and JohnH. Taylor, Co-executors of Richard M.Nixon’s Estate, Civ. A. No. 92–0662–NHJ (D.D.C.) (Johnson, J.). Furthermore,the final rule clarifies various terms thatappear in 36 CFR Part 1275. This finalrule and interim final rule will affect theheirs of former President Nixon andother individuals whose names appearin the materials, as well as members ofthe general public interested inconducting research regarding thosematerials.DATES: The effective date for this finalrule and interim final rule is May 23,1996.

Comments on the amendments to§§ 1275.42, 1275.48, and 1275.64 mustbe received by close of business June 24,1996. NARA will issue a final ruleconfirming or further amending theseamendments after this comment periodcloses.

ADDRESSES: All comments must besubmitted in writing to the RegulationComment Desk, Policy and PlanningDivision (PIRM-POL), Room 3200,National Archives and RecordsAdministration, 8601 Adelphi Road,College Park, MD 20740–6001.FOR FURTHER INFORMATION CONTACT:Nancy Allard at (301) 713–6730.SUPPLEMENTARY INFORMATION: ProfessorStanley Kutler and Public Citizencommenced an action against theArchivist of the United States on March19, 1992, by filing a complaint underthe Administrative Procedure Act, 5U.S.C. 701, et seq. The complaintalleged that the Archivist had failed tocarry out his obligations under thePresidential Recordings and MaterialsPreservation Act of 1974 (‘‘PRMPA’’), 44U.S.C. 2111 note, concerning the releaseof approximately 3,700 hours of taperecordings made during the Presidencyof Richard M. Nixon. Thereafter, formerPresident Nixon intervened and filedcross-claims; after his death in 1994, hisco-executors were substituted in hisplace.

During the course of the litigation,which entailed substantial discoveryand motions, the principal disputesrevolved around the issue of how toreconcile the disclosure requirements ofthe PRMPA and the privacy interests ofMr. Nixon and his family, as well as theother interests legally protected by thePRMPA. A major portion of thecontroversy centered on the issue of thetiming of releases of the tapes (all atonce or in segments), and whether thereleases could be made before some orall of the tape segments found to beprivate or personal were returned to Mr.Nixon or his estate as required by law.

Following the release ofapproximately 60 hours of taperecordings subpoenaed by the WatergateSpecial Prosecution Force (‘‘WSPF’’)during its investigation, NARA haddecided that the best way to proceedwith the release of the body of theapproximately 3,700 hours of NixonWhite House tape recordings was torelease Watergate-related segments ofthe tape recordings in small monthlygroupings on an ongoing basis. The firstof these releases was noticed in theFederal Register on April 2, 1993, 58 FR17433, and took place on May 17, 1993,without any objections from affectedparties.

The second and third releases werenoticed in the Federal Register on June3, 1993, and July 2, 1993, to take placeon July 15, 1993 (later extended toAugust 13, 1993), and August 26, 1993,respectively. 58 FR 31548 (June 3,1993); 58 FR 35983 (July 2, 1993).


Former President Nixon raised certainobjections to these proposed releases.When NARA rejected former PresidentNixon’s contention that those releasesshould not go forward, he sought reliefin the district court. On August 9, 1993,Judge Royce Lamberth of the UnitedStates District Court for the District ofColumbia issued an order in the Kutlercase preliminarily enjoining NARA fromcarrying out the releases of Watergate-related tape segments scheduled forrelease on August 13 and 26, 1993,pending (1) segregation and return toformer President Nixon of all private orpersonal conversations on the taperecordings; and (2) processing of thetape recordings as a single ‘‘integral filesegment’’ before release to the public.

On March 25, 1994, the proposedamendments to the current PRMPAregulations were published for publiccomment at 59 FR 14128. At that time,NARA believed that the proposedamendments were required to clarifyvarious terms that appear in 36 CFR Part1275; clarify the nature of the archivalprocessing being conducted on theNixon Presidential historical materials;and provide for the reproduction of theavailable Nixon White House taperecordings.

During the comment period,originally 60 days but extended by anadditional 30 days, 59 FR 27257 (May26, 1994), NARA received commentsfrom eight individuals andorganizations in response to theseproposed regulations. The commentsconsisted of both objections to andsupport for the proposed amendments,although many of the comments weregenerally supportive of the proposedregulatory changes. The Nixon estatesubmitted extensive comments objectingto the proposed amendments.

The Kutler case was referred to acourt-appointed mediator, and most ofthe issues were resolved by the partiesin a Settlement Agreement, which isattached hereto as Appendix A to 36CFR Part 1275. As a result of themediation, NARA is amending certainof its regulations as set forth below.Other comments have been incorporatedinto this final and interim final rule.Although NARA does not take aposition as to whether it is necessary toresubmit the proposed changes to theregulations as a result of the SettlementAgreement, NARA nevertheless ispublishing as an interim final rule for a60-day comment period those sectionsof Part 1275 which have been revised inaccordance with the provisions of theSettlement Agreement reached amongthe parties. Those sections of theproposed rule published on March 25,1994, that have not been further revised

due to the Settlement Agreement areissued as a final rule. No additionalcomments will be considered on thesesections, which include 36 CFR1275.16(e) and (g), 1275.20, 1275.46,1275.56, 1275.66 and 1275.70. NARAhad previously proposed to amend§ 1275.16(b), but now has decided thatan amendment to this section is notnecessary. NARA is amending thecurrent regulations in accordance withthe terms of the Settlement Agreement.

Interim Final Rule Provisions (SectionsAffected by the Settlement Agreement)

The following amended sections of 36CFR Part 1275 are being issued as aninterim final rule to allow publiccomment.

NARA had previously proposed toamend § 1275.42(a) to clarify themanner in which NARA intends toproceed with the archival processingand release of the tape recordings andall other textual Nixon Presidentialhistorical materials. To address theseconcerns, the proposed amendments to§ 1275.42(a) would have allowed therelease of the tape recordings ingroupings that would not necessarilyhave constituted ‘‘integral filesegments,’’ but which would havepermitted the opening of portions of thetape recordings without the need for theapproximately 3,700 hours to bereleased at once. The current regulationsprovide that Nixon White Housematerials will be disclosed to the publicin ‘‘integral file segments.’’

As a result of the SettlementAgreement in the Kutler case, NARA isnow amending § 1275.42(a) to describespecifically the schedule for the openingof the approximately 3,700 hours of taperecordings, as well as the procedures forallowing interested and affectedparties—including the Nixon estate—the opportunity to review (and object asappropriate to) a particular segment oftape recordings being proposed foropening. The Settlement Agreement alsotakes into account the fact that due tothe extensive nature of the taperecordings collection, it would beimpossible for the Nixon estate toreview all portions of the taperecordings proposed for opening withinthe allotted 30-day period. As a result,the current revised amendments to§ 1275.42(a) incorporate a procedurewhereby the Nixon estate will be givensufficient lead time to review eachsegment of tape recordings NARAproposes for opening.

In addition, the previously proposedamendments to § 1275.42(a) providedthat the Archivist was free to releasesegments of the tape recordings prior totransferring private or personal material

in accordance with current § 1275.48,thereby allowing NARA to continueprocessing and opening Watergate-related segments of the tape recordingsat the earliest reasonable date, inaccordance with its statutory andregulatory responsibility. Based on theSettlement Agreement in the Kutlercase, however, NARA is now amending§ 1275.42(a)(2) to allow foridentification of additional private orpersonal materials located during therereview of the tape recordings andreturn to the Nixon estate atapproximately the time that NARAproposes each segment for publicrelease.

In accordance with the SettlementAgreement in the Kutler case, NARA isamending § 1275.44 by adding a newsubsection (e) which sets forth theprecise procedures for the Nixon estateto raise any objections to those taperecordings that NARA has designated asrelating to abuses of governmentalpower, as well as the standard to beapplied by the specially appointedreview panel in reviewing thoseobjections. For those segmentsdesignated abuses of governmentalpower, the Nixon estate has agreed toaccept the review panel’s decisions asbinding, thereby foregoing its right toappeal decisions regarding its objectionsin the normal course pursuant to§ 1275.46. In addition, although theNixon estate has not waived its appealrights available for any objections withrespect to the remaining tape segments,subsection (e) provides that the Nixonestate may, at any time, elect to use theprocedures used for raising objections tothe abuses of governmental power tapesegments. Subsection (e) also specifiesthe standard that will be applied by thespecially appointed review panel inreviewing the objections to theremaining tape recordings should theNixon estate elect to use the alternativeprocedure.

NARA is amending § 1275.48(a) tomake clear that no portion of theoriginal tape recordings or masterpreservation copy is to be returned tothe heirs of former President Nixon.NARA’s position is that it is complyingwith the PRMPA by retaining the entireoriginal tape recordings and a masterpreservation copy containing thesematerials. This is one of the issues inthe Kutler case and the parties to theSettlement Agreement have agreed toresolve this issue, including the validityof this particular section and of§ 1275.64(e), in the courts. NARA is alsoamending this section to make clear thatit restricts access to all private orpersonal material on the original tape


recordings and master preservation copythat NARA maintains.

NARA had previously proposed toamend § 1275.64 to include a provisionallowing for the reproduction of taperecordings opened to the public. Theissue of whether to provide copies oftape recordings has been considered byNARA on several occasions. At the timethe current regulations were written,NARA decided to maintain its priorposition of not allowing copies of taperecordings, although it specificallystated that this position would bereviewed periodically. 51 FR 7228 (Feb.28, 1986). In accordance with theSettlement Agreement in the Kutlercase, § 1275.64 is being amended tostate that copies of the tapes will bemade available following the publicrelease of the last of the tape segmentscontemplated in § 1275.42(a). However,if the last tape segment is not releasedby December 31, 1999, NARA will allowmembers of the public to obtain copiesonly of the abuses of governmentalpower tapes, together with any othertapes publicly released as of theeffective date of the SettlementAgreement, beginning January 1, 2000.If the releases contemplated in§ 1275.42(a) are not completed byDecember 31, 2002, NARA will,beginning January 1, 2003, allowmembers of the public to obtain copiesof all tapes that have been madeavailable to the public by that date andtapes that subsequently becomeavailable, as they are released. NARA isalso adding § 1275.64(e) to make clearthat the Archivist will produce andmaintain a master preservation copy ofthe original tape recordings forpreservation purposes.

Final Rule ProvisionsThe following amendments to 36 CFR

Part 1275 are being adopted as a finalrule. No comments will be accepted onthese provisions.

Section 1275.16(e) clarifies thenomenclature used throughout theregulations and distinguishes between‘‘Archivist,’’ defined as the Archivist ofthe United States or his or herdesignated agent, and ‘‘archivist,’’ asdefined in the current subsection, i.e., asan employee of NARA, who, byeducation or experience, is speciallytrained in archival science.

Section 1275.16(g) clarifies thedefinition of ‘‘archival processing’’ toensure that nothing in the subsectioncreates any obligation on the part of theArchivist to perform any one particulararchival processing task listed in thesubsection. In so doing, NARA intendsto make clear that transcripts of the taperecordings need not be made. Although

the current regulations indicate that theprocessing of the Nixon White Housematerials may undergo one or more ofseveral archival processing phases,including the preparation of transcripts,NARA does not believe that theregulations intended to obligate theprocessing archivists to transcribe all ofthe approximately 3,700 hours of taperecordings before releasing them to thepublic. NARA does not believe this is anobligation because the tapes are theoriginal record. NARA has created tapelogs to serve as a subject guide to thetape recordings. NARA chose to createtape logs instead of transcriptionsbecause NARA has estimated that itwould take at least 400,000 hours ofstaff time to accomplish suchtranscriptions. In addition, because ofthe sound quality of the tape recordings,NARA could not guarantee the accuracyof the transcriptions. Furthermore, thedefinition of ‘‘archival processing’’ in§ 1275.16(g) has been expanded toreflect the archival processing of theNixon Presidential historical materialsthat actually has been taking place.

Section 1275.20 is amended to beconsistent with the amended definitionof ‘‘Archivist’’ set forth in amended§ 1275.16(e).

Sections 1275.46(d) and 1275.46(f) areamended to be consistent with theamended definition of ‘‘Archivist’’ setforth in amended § 1275.16(e).

Section 1275.64(b) is also amended tobe consistent with the nomenclaturedistinction between ‘‘Archivist’’ and‘‘archivist’’ as set forth in § 1275.16(e).

Section 1275.66(a) is amended toaccommodate two different possibilitieswith respect to the reproduction ofreleased Nixon materials other than taperecordings: copying by researchers onself-service government copiers; andcopying by contract vendors at therequest of NARA. This change reflectsnot only current practice at the NixonPresidential Materials Staff, butcommon practice at other Presidentiallibraries within the NARA system aswell as NARA regulations regardingcopying of archival documents.

Sections 1275.70(a) and 1275.70(b)are amended to be consistent with thenomenclature distinction between‘‘Archivist’’ and ‘‘archivist’’ as set forthin § 1275.16(e).

Typographical corrections are made to§ 1275.46(i) and § 1275.56.

OtherNARA has issued these regulations as

an interim final rule under the goodcause exception to the AdministrativeProcedures Act. NARA believes that theproper execution of the agency’sfunction—in this case, the release of the

Nixon Presidential historical materialsat the earliest reasonable date—requiresprompt implementation of theamendments to Part 1275, including theprovisions that have been modified bythe Settlement Agreement. Therefore,NARA finds it in the public interest toissue these regulations as an interimfinal rule.

The amendments to 36 CFR Part 1275are not a significant regulatory action forpurposes of Executive Order 12866 ofSeptember 30, 1993. As required by theRegulatory Flexibility Act, it is herebycertified that these regulatoryamendments will not have a significantimpact on small business entities. Forpurposes of Title II, Subtitle E of PublicLaw 104–121, this rule is not a majorrule as defined in section 804 of the act.


Archives and RecordsFor the reasons set forth in the

preamble above, Part 1275 of Title 36 ofthe Code of Federal Regulations isamended as follows:

PART 1275—PRESERVATION ANDPROTECTION OF AND ACCESS TOTHE PRESIDENTIAL HISTORICALMATERIALS OF THE NIXONADMINISTRATION


Authority: Sec. 102(a) of the NationalArchives and Records Administration Act of1984, Pub. L. 98–497; 44 U.S.C. 2104; andsections 103 and 104 of the PresidentialRecordings and Materials Preservation Act,88 Stat. 1695; 44 U.S.C. 2111 note.

2. Section 1275.16 is amended byrevising paragraphs (e) and (g) to read asfollows:

§ 1275.16 Definitions.* * * * *

(e) Archivist. The term ‘‘Archivist’’shall mean the Archivist of the UnitedStates or his designated agent. The term‘‘archivist’’ shall mean an employee ofthe National Archives and RecordsAdministration who, by education orexperience, is specially trained inarchival science.* * * * *

(g) Archival processing. The term‘‘archival processing’’ may include thefollowing general acts performed byarchivists with respect to thePresidential historical materials:Shelving boxes of documents inchronological, alphabetical, numericalor other sequence; surveying anddeveloping a location register and cross-index of the boxes; arranging materials;refoldering and reboxing the documentsand affixing labels; producing finding


aids such as folder title lists, scope andcontent notes, biographical data, andseries descriptions; rewinding,duplicating and preserving the originaltape recordings; enhancing the taperecordings on which the conversationsare wholly or partially unintelligible sothat extraneous noises may be filteredout; producing general subject matterlogs of the tape recordings; reproducingand transcribing tape recordings;reviewing the materials to identify itemsthat appear subject to restriction;identifying items in poor physicalcondition and assuring theirpreservation; identifying materialsrequiring further processing; andpreparation for public access of allmaterials which are not subject torestriction.* * * * *

3. Section 1275.20 is revised to readas follows:

§ 1275.20 Responsibility.The Archivist is responsible for the

preservation and protection of theNixon Presidential historical materials.

4. Section 1275.42 is amended byrevising paragraph (a) to read as follows:

§ 1275.42 Processing period; notice ofproposed opening.

(a) (1) The archivists will conductarchival processing of those materialsother than tape recordings to preparethem for public access. In processing thematerials, the archivists will givepriority to segregating private orpersonal materials and transferring themto their proprietary or commemorativeowner in accordance with § 1275.48. Inconducting such archival processing,the archivists will restrict portions ofthe materials pursuant to §§ 1275.50 and1275.52. All materials other than taperecordings to which reference is madein § 1275.64 will be prepared for publicaccess and released subject torestrictions or outstanding claims orpetitions seeking such restrictions. TheArchivist will open for public accesseach integral file segment of materialsupon completion of archival processingof that segment.

(2) The archivists will conductarchival processing of the taperecordings to prepare them for publicaccess in accordance with theprovisions set forth in the SettlementAgreement (see Appendix A to thispart). In conducting the archivalprocessing of the tape recordings, thearchivists will restrict segments of thetape recordings pursuant to §§ 1275.50and 1275.52. The tape segments whichconsist of abuses of governmental powerinformation, as defined in § 1275.16(c),will be given priority processing by the

archivists and will be prepared forpublic access and released followingreview and resolution of objections fromthe Nixon estate and other interestedparties as set forth in the SettlementAgreement (see Appendix A to thisPart). After the tape segments whichconsist of abuses of governmental powerinformation have been released, thearchivists will conduct archivalprocessing of those tape recordingswhich were taped in the Cabinet Room,as set forth in the SettlementAgreement, Appendix A to this Part.Following release of the Cabinet Roomtape recordings, the remaining taperecordings will be prepared for publicaccess and released in five segments inaccordance with the schedule set forthin the Settlement Agreement. Inaddition, NARA will identify and returnany additional private or personalsegments to the Nixon estate, atapproximately the time that NARAproposes each segment for publicrelease.* * * * *

5. Section 1275.44 is amended byadding new paragraph (e) to read asfollows:

§ 1275.44 Rights and privileges; right to afair trial.* * * * *

(e)(1) In place of the right to make allother objections with respect to the tapesegments that NARA has designated asabuses of governmental powermaterials, the Nixon estate may object totheir release only on the ground thatsuch designation by NARA is clearlyinconsistent with the term ‘‘abuses ofgovernmental power’’ as used in§ 104(a)(1) of the PresidentialRecordings and Materials PreservationAct (PRMPA) and defined in§ 1275.16(c), as qualified by§ 1275.50(b). Any such objection maynot be based on isolated instances ofalleged failure by NARA to apply theappropriate review standard, but onlyon a pattern of misapplication of therequirements of the PRMPA and itsimplementing regulations. Further, anysuch objection must be accompanied byspecific examples of alleged reviewerrors and contain sufficientinformation to enable the review panelof three Presidential Library archivistsappointed by the Archivist, as describedin the Settlement Agreement, AppendixA to this Part, to locate those examplesreadily.

(2) If an objection is made by theNixon estate to the abuses ofgovernmental power tape segments, thematter shall be immediately referred toa panel of three Presidential Libraryarchivists appointed by the Archivist as

set forth in the Settlement Agreement,Appendix A to this Part. The decisionof the panel shall be either that theNixon estate’s objection is sustained orthat it is rejected. The decision shallinclude a brief statement of the panel’sreasons, but it need not include an item-by-item determination. In decidingwhether the designation by NARA of thematerial proposed to be released isclearly inconsistent with the definitionof ‘‘abuses of governmental power’’, thepanel shall consider whether the releasewould seriously injure legitimateinterests of identifiable individuals,whether the errors suggest a pattern ofmisinterpretation, and any other factorthat bears on the issue of whetherNARA’s designation of material asrelating to ‘‘abuses of governmentalpower’’ was reasonable, considered as awhole. The panel’s decision shall befinal and binding on all parties to theKutler litigation, and no party mayexercise any right to appeal to anyperson, board, or court that mightotherwise be available.

(3) The Nixon estate may, at any time,elect to use the procedures outlined inparagraphs (e)(1) and (e)(2) of thissection for the tape recordings otherthan the abuses of governmental powersegments, except that the standardunder which objections shall be madeby the Nixon estate, and under whichthe review panel shall decide theirmerits, is whether the release taken asa whole is plainly inconsistent with therequirements of the PresidentialRecordings and Materials PreservationAct of 1974 and these regulations. If theNixon estate elects to use theprocedures in paragraph 1 of theSettlement Agreement (Appendix A tothis Part) in place of the provisions inparagraphs 4 (b) and (d) and 5(c) of theSettlement Agreement for a tapesegment, the estate cannot subsequentlyrevert back to the formal objectionprocess set forth in this section for thattape segment.


removing in paragraph (d) andparagraph (f), wherever it appears, theterm ‘‘Archivist of the United States’’and adding in its place the term‘‘Archivist,’’ and by removing inparagraph (i)(2) the term ‘‘reasonbly’’and adding in its place the term‘‘reasonably.’’


§ 1275.48 Transfer of materials.(a) The Archivist will transfer sole

custody and use of those materialsdetermined to be private or personal, or


to be neither related to abuses ofgovernmental power nor otherwise ofgeneral historical significance, to formerPresident Nixon’s estate, or, whenappropriate and after notifying theNixon estate, to the former staff memberhaving primary proprietary orcommemorative interest in thematerials; however, no physical part ofany original tape recording or a masterpreservation copy to which reference ismade in § 1275.64 shall be transferred tothe heirs of former President. NARAwill maintain the original taperecordings and a master preservationcopy, including the private and personalsegments, in a manner consistent withthe PRMPA and these regulations andwill restrict access to all private orpersonal material on the originals andthe master preservation copy.* * * * *


removing the term ‘‘adminsitrative’’ andreplacing it with the term‘‘administrative.’’

9. Section 1275.64 is amended byremoving in paragraph (b) the term‘‘Archivists’’ and replacing it with theterm ‘‘archivists’’ and adding newparagraphs (d) and (e) to read as follows:

§ 1275.64 Reproductions of taperecordings of Presidential conversations.* * * * *

(d) The reproduction for members ofthe public of the reference copies of theavailable tape recordings described inparagraph (a) of this section will bepermitted as follows: Copies of taperecordings will be made availablefollowing the public release of the lastof the tape segments contemplated in§ 1275.42(a). If the releasescontemplated in § 1275.42(a) are notcompleted by December 31, 1999,NARA will, beginning January 1, 2000,allow members of the public to obtaincopies only of the abuses ofgovernmental power tapes, togetherwith any other tapes publicly releasedas of the effective date of the SettlementAgreement. If the releases contemplatedin § 1275.42(a) are not completed byDecember 31, 2002, NARA will,beginning January 1, 2003, allowmembers of the public to obtain copiesof all tapes that have been madeavailable to the public by that date andtapes that subsequently becomeavailable as they are released. Suchcopying will be controlled by NARA orits designated contractor. The fees forthe reproduction of the tape recordingsunder this section shall be thoseprescribed in the schedule set forth inpart 1258 of this chapter or pertinent

successor regulation, as that schedule isamended from time to time.

(e) The Archivist shall produce andmaintain a master preservation copy ofthe original tape recordings forpreservation purposes.


§ 1275.66 Reproduction and authenticationof other materials.

(a) Copying of materials other thantape recordings described in § 1275.64may be done by NARA, by a contractordesignated by NARA, or by researchersusing self-service copiers. Such self-service copying shall be done inaccordance with the NARA policy onself-service copying set forth at 36 CFR1254.71, to ensure that such copyingwill not harm the materials or disruptreference activities.* * * * *


removing in paragraph (a) the term ‘‘anArchivist’’ and adding in its place theterm ‘‘an archivist’’ and by removing inparagraph (b) the term ‘‘NARAArchivists’’ and adding in its place theterm ‘‘NARA archivists.’’* * * * * *

12. Appendix A to Part 1275 is addedto read as follows:

Appenidx A—Settlement Agreement

Settlement Agreement filed April 12, 1996,in Stanley I. Kutler and Public Citizen v. JohnW. Carlin, Archivist of the United States, andWilliam E. Griffin and John H. Taylor, Co-executors of Richard M. Nixon’s Estate, CivilAction No. 92–0662–NHJ (D.D.C.) (Johnson,J.)

Settlement AgreementThis Settlement Agreement (‘‘Agreement’’)

is made by and entered into among plaintiffsStanley I. Kutler and Public Citizen;defendant/cross-claim defendant John W.Carlin, in his official capacity as Archivist ofthe United States; and defendant-intervenors/cross-claimants John H. Taylor and WilliamE. Griffin, co-executors of the estate ofRichard M. Nixon (‘‘the Nixon estate’’), in theabove-entitled action by and through theparties’ undersigned attorneys.

It is hereby agreed, by and among theparties, appearing through their undersignedattorneys, that this action is partially settledon the following terms:Terms of Agreement

1(a). As soon as practicable, the NationalArchives and Records Administration (‘‘theArchives’’) will publicly release the segmentsof tape recordings made during thePresidency of Richard M. Nixon (‘‘taperecordings’’ or ‘‘tapes’’) identified by theArchives as relating to ‘‘abuses ofgovernmental power,’’ as defined by 36C.F.R. Part 1275, along with thecorresponding portions of the tape log and

any other finding aid. The date of thatrelease, which is expected to be on or aboutNovember 15, 1996, shall be determined inthe following manner.

(b). No later than April 15, 1996, theArchives shall deliver to an agent of theNixon estate a copy of the approximately 201hours of abuses of governmental power tapesegments that it proposes to release, togetherwith the corresponding portions of the tapelog and any other finding aid, for review bythe Nixon estate to determine whether itintends to object to the release. The Archivesagrees to provide a period of orientation tothe designated Nixon estate agent withrespect to the review of the abuses ofgovernmental power tape segments and to beavailable to respond to questions thereafter.

(c). In place of the right to make all otherobjections with respect to the tape recordingsthat the Archives has designated as abuses ofgovernmental power materials, the Nixonestate agrees that it may object to their releaseonly on the ground that such designation bythe Archives is clearly inconsistent with theterm ‘‘abuses of governmental power’’ asused in section 104(a)(1) of the PresidentialRecordings and Materials Preservation Act of1974 (‘‘the Act’’), 44 U.S.C. § 2111 note, anddefined in 36 C.F.R. 1275.16(c), as qualifiedby 36 C.F.R. 1275.50(b). Any such objectionshall be in writing and may not be based onisolated instances of alleged failure by theArchives to apply the appropriate reviewstandard, but only on a pattern ofmisapplication of the requirements of the Actand its implementing regulations. Further,any such objection must be accompanied byspecific examples of alleged review errorsand contain sufficient information to enablethe review panel described in subparagraph1(e) below to locate those examples readily.Nothing in this paragraph shall preclude theNixon estate and the Archives from havinginformal discussions regarding theappropriate treatment of any of the abuses ofgovernmental power tape segments.

(d). The Nixon estate shall have untilOctober 1, 1996, to submit any objection inaccordance with subparagraph 1(c) above. Ifno such objection is filed, the Archives shallproceed to issue a notice of proposed releasepursuant to 36 C.F.R. 1275.42 as soon aspossible, but no later than October 15, 1996.

(e). If an objection is made, the matter shallbe immediately referred to a panel of thefollowing three Presidential Libraryarchivists: David Alsobrook, Frances Seeber,and Claudia Anderson. If any of these threepersons is unable to serve, the Archivist shallappoint a substitute who is acceptable to theother parties.

(f). The panel shall have such access to thetapes as it deems necessary to make itsdecision. The decision of the panel shall beeither that the Nixon estate’s objection issustained or that it is rejected. The decisionshall include a brief statement of the panel’sreasons, but it need not include an item-by-item determination. In deciding whether thedesignation by the Archives of the materialproposed to be released is clearlyinconsistent with the definition of ‘‘abuses ofgovernmental power,’’ the panel shallconsider whether the release would seriouslyinjure legitimate interests of identifiable


individuals, whether the errors suggest apattern of misinterpretation, and any otherfactor that bears on the issue of whether theArchives’ designation of material as relatingto abuses of governmental power wasreasonable, considered as a whole. Thedecision of the panel shall be made withinsixty (60) days of the date of the objection.However, if the panel determines thatexceptional circumstances interfere with itsability to meet this deadline, the panel shallhave up to an additional sixty (60) days tomake its decision. The Archives shall notifythe other parties of the need for an extensionand briefly describe the reasons therefor. Thepanel’s decision shall be final and binding onall parties, and no party may exercise anyright to appeal to any person, board, or courtthat might otherwise be available. Nothingcontained in this Agreement shall precludethe panel from advising the Archives of anyparticular processing errors that it believesmay have been made, but the Archivist shallmake the final determination as to whetherto accept such advice.

(g). If the objection of the Nixon estate issustained, the Archives shall re-review thetapes sufficiently to address the concernsraised by whatever aspect of the objection issustained. At the conclusion of such re-review, the same process of review, first bythe Nixon estate and then by the panel in theevent of further objection, shall be repeatedfor those tape segments concerning thesubject matter of the sustained objectionprior to any release of tape recordingsdesignated as relating to abuses ofgovernmental power.

(h). The Nixon estate agrees to inform theArchives and plaintiffs whether it intends tofile objections as soon as it has made itsdecision. If there is an objection by the Nixonestate and it is overruled, the FederalRegister notice shall be published within ten(10) days of the date of the panel’s decision.

(i). If, following the Federal Registernotice, no objection by other individuals toa release is received within the time providedby law, the Archives shall release the taperecordings within ten (10) days after suchtime has expired. If objections are received,they shall be promptly considered by theArchives and shall be decided as soonthereafter as practical. Any materials as towhich an objection to release has been timelyfiled shall not be released until suchobjection has been resolved pursuant to 36C.F.R. 1275.44. All materials not objected toshall be released no later than thirty (30) daysafter the time for objections has expired,provided that the Archives may withhold anyadditional conversation to which noobjection has been made, pending finalresolution of an objection to anotherconversation, if (i) such additionalconversation is in close proximity on thetapes to the objected-to conversation and itwould be burdensome for the Archives toseparate out the releasable and objected-toportions, or (ii) the subjects of the releasableand the objected-to conversations are closelyrelated to one another and the Archivesdetermines that it might be misleading ormight unfairly prejudice a living individualto release only one conversation. Any releaseunder this Agreement shall include the

corresponding portions of the tape log andany other finding aid.

(j). The Archives shall send to plaintiffKutler, to arrive no later than the day that therelease of the tapes occurs, a copy of theportions of the tape log and any other findingaid that correspond to the tapes beingreleased. The Archives shall also makesuitable arrangements for plaintiff Kutler tolisten to such tapes on the date of theirrelease, and/or on such other subsequentbusiness days as plaintiff Kutler shalldesignate.

2(a). Although the Agreement provides thatthe Archives will identify and return to theNixon estate a copy of any private orpersonal materials identified on the tapes,the parties have been unable to reachagreement regarding the Archivist’s retentionand maintenance of the original taperecordings in their entirety, including thosesegments deemed to be private or personal,along with a master preservation copy. Thegovernment’s position is that it is complyingwith the Act by retaining the original tapesand a master preservation copy, includingthose portions containing private or personalconversations. The Nixon estate’s position,with which plaintiffs agree, is that the familyhas statutory, constitutional, and other rightsthat prevent the Archives from retainingprivate or personal materials, on both theoriginal tapes and all copies.

(b). The parties have agreed to litigate theissue described in subparagraph 2(a) above,including the validity of 36 C.F.R. 1275.48(a)and 1275.64(e) as proposed for amendment.The parties further agree that the Court shallretain jurisdiction of that issue, as providedin paragraph 14 below, and that the right tolitigate this issue includes the right to seekreview in the United States Court of Appealsfor the District of Columbia Circuit and theUnited States Supreme Court. If there islitigation between the Nixon estate and theArchivist over the issue described insubparagraph 2(a) above, the plaintiffs shallsupport the Nixon estate in any suchlitigation by filing a brief supporting theestate’s position in District Court. The partiesagree to make all reasonable efforts toexpedite resolution of this issue.

(c). This Agreement and all discussions,negotiations and exchanges of informationleading to it shall be entirely withoutprejudice to any positions the parties maytake in the event of such litigation. Nothingin this Agreement, in any discussions leadingto it, or in any information or materialsexchanged by the parties as part of themediation may be relied on or disclosed byany party to support or rebut the position ofany party with respect to the treatment ofprivate or personal materials on the originaltapes. Nothing in this subparagraph preventsany party from expressing its understandingas to the meaning and effect of the legalposition of another party.

3. The Archives will provide to the Nixonestate any additional private or personalmaterials at approximately the time that theArchives proposes each segment identified inparagraphs 4 and 5 below for public release.Any additional copies of that material (otherthan on a master preservation copy, thestatus of which will be determined in

accordance with the resolution of the issueas described in subparagraph 2(a) above),will be destroyed by appropriate method,with appropriate means of verification.

4(a). The second group of tapes to beprocessed for release is the approximately278 hours recorded in the Cabinet Room. Theprojected date for publishing a notice ofproposed opening of tapes in that group isAugust 1, 1997. The Archives will make theCabinet Room tapes proposed for releaseavailable to the Nixon estate in no fewer thanfour (4) segments. The process by whichthose tapes will be reviewed by the Nixonestate, and the objections handled by theArchives, is set forth in the followingsubparagraphs of this paragraph 4.

(b). The Nixon estate agrees to review eachsegment as it is received and promptly to callto the attention of the Archives any concernsthat it may have. The Archives and the Nixonestate agree to attempt to work out theirdifferences informally in order to minimizeany objections to a proposed release. Tofacilitate informal consultation between theNixon estate and the Archives concerning thetape review, the Archivist shall designate apanel member identified in subparagraph1(e) above who will serve as a contact withthe Nixon estate and assure access toinformation relating to Presidential librariespractices and procedures that may arise inthe course of the tape review. The designatedindividual will be responsible for assuringthat the Nixon estate has access to theappropriate person to answer its concerns.The Nixon estate may communicate with thedesignated individual orally or in writing. Ifthe Archives agrees with the Nixon estatethat any portion of a segment that has beensent to the Nixon estate as a proposed releaseshould not be released, the Archives shallassure that there is appropriatedocumentation to reflect that change.

(c). The Nixon estate will have a period ofat least six (6) months in which to review allof the Cabinet Room tapes, beginning on thedate the Archives makes the first installmentof such tapes available to the estate forreview (but in no event will the six (6)months begin earlier than November 15,1996). During the review of the Cabinet Roomtapes, the Nixon estate will employ an agentor agents who will spend an average of atleast thirty two (32) hours a week (total) inactual review of the tapes. The Nixon estatemay request from the Archives an extensionof the six-month review period, which theArchives shall grant if good cause is shown.

(d). If, during its review, the Nixon estatebecomes aware that there are materialsproposed for release that it believes shouldnot be heard even by individuals on theregistry list, it will promptly advise theArchives of any such materials so that theycan be reviewed and/or segregated by theArchives before any other individual ispermitted to listen to them. The Nixon estatewill cooperate with the Archives so that therequired Federal Register notice is publishedas soon as possible, but in no event shallsuch notice be provided later than ten (10)days after the time the Nixon estatecompletes its review. Final objections fromthe Nixon estate to the release of portions ofthe tapes shall be filed in accordance with 36


C.F.R. Part 1275 no later than the date forfiling objections by other persons. Thereafter,subject to paragraph 7 below, the provisionsof subparagraphs 1(i) and 1(j) above willapply.

5(a). The remaining tapes, consisting ofapproximately 2338 hours, shall be processedfor release in five (5) segments. Because theprecise number of hours of tapes for eachmonth cannot readily be determined, theparties have agreed to divide the releases intothe segments set forth below. The Archiveswill begin processing (which includes, but isnot limited to, tape review, preparing tapesfor declassification review, tape editing andproduction of finding aids) each segmentbefore processing of the preceding segment isconcluded. Processing of the tapes in eachsegment is projected to take from aboutfifteen (15) to about twenty three (23)months. The approximate number of hours oftapes to be reviewed in each segment is setforth in parentheses in the following listingof the segments. The projected number ofmonths between the completion of theArchives’ processing of the immediatelypreceding segment and the completion of theArchives’ processing of each listed segmentis set forth in brackets.1. February 1971–July 1971 (437 hours) [8

months]2. August 1971–December 1971 (405 hours)

[7 months]3. January 1972–June 1972 (440 hours) [7

months]4. July 1972–October 1972 (410 hours) [6

months]5. November 1972–July 1973 (646 hours) [10

months](b). The time estimates in this Agreement

are not enforceable as such, but the partiesagree to have the Court retain jurisdiction toconsider requests that it enter a binding ordersetting a schedule for the Archives tocomplete the processing of the tapes. Noparty may seek such an order unless thatparty first provides twenty (20) days’ writtennotice to the other parties of that party’sintention to seek such an order. Further, noparty may seek such an order except on theground that the Archives has unreasonablyfailed to meet the estimates contained hereinby a substantial amount. The type of proofthat will demonstrate reasonableness on thepart of the Archives in this regard mayinclude, but will not necessarily be limitedto, a showing that the Archives is reasonablyallocating its resources among its variousprograms and activities in the event that itexperiences a shortage of resources,including any occasioned by court order.

(c). Portions of each segment processed bythe Archives shall be provided to the Nixonestate when the processing of each month oftape recorded material is completed, unlessthere are a very few hours for two (2) or moremonths, which may then be combined intoa single unit. During its review of thechronological tape segments, the Nixon estatewill employ an agent or agents who willspend an average of at least thirty two (32)hours a week (total) in actual review of thetapes, forty eight (48) weeks of the year. Asits review of the tapes proceeds, the Nixonestate shall provide a written report of itsprogress to the Archives and the plaintiffs on

a bimonthly basis. The report shall includethe number of hours worked in each week,the number of hours of tapes reviewed ineach week, and the Nixon estate’s projectedcompletion date for review of the segmentcurrently under review. The provisions ofsubparagraphs 4(b) and 4(d) above shallapply to the review, objections, and releaseswith respect to the chronological tapesegments, subject to paragraph 7 below.

(d). If one of the other parties to thisAgreement determines that the Nixon estate’sreview is not being conducted diligently orin good faith, or that the estate’s estimatedcompletion date(s) of one or more segmentsis unreasonable, that party may petition theArchivist to establish an earlier date(s) for thecompletion of the review of that segmentand/or of future segments. Any such date(s)established by the Archivist shall provide theNixon estate with a reasonable opportunity toprotect and assert its interests withoutunduly delaying the release of the tapes, andshall be based upon consideration of theprogress of the Archives’ review and itsscheduled completion date(s); the progress todate of the estate’s review; and the timereasonably necessary to complete the estate’sreview and to formulate and present anyobjections. The Archives may also proposeearlier dates for the completion of the reviewby the Nixon estate on the basis provided forin this subparagraph. If a proposal for anearlier date is made, the Nixon estate willhave a reasonable opportunity to respond.

6. Once the Archives has completedprocessing the approximately 2338 hours oftapes discussed in paragraph 5 above, andhas made corresponding releases, theArchives shall identify any additional copiesof partial tape segments in its possession. Ifthe Archives determines that some or all ofsuch additional partial tape segments areduplicative of any tape recordings that it hasalready processed, the Archives may disposeof the duplicative tape segments, followingnotification to the parties, subject toparagraph 3 above. To the extent that suchpartial tape segments are not duplicative ofthe tape recordings already processed, theArchives shall promptly process such non-duplicative portions and shall treat anyportions determined to be private or personalconsistently with the resolution of the issueto be litigated as described in paragraph 2above.

7(a). After completion of the proceduresdescribed in paragraph 4 above, the CabinetRoom tapes that are found to be releasableunder paragraph 4 above may be released ifeither there has been a final decision by thedistrict court on the issue to be litigated asdescribed in subparagraph 2(a) above, or therelease is scheduled after April 1, 1998,whichever of these two events happenssooner.

(b). After completion of the proceduresdescribed in paragraph 5 above, the tapesdescribed in paragraph 5(a) above that arefound to be releasable may be released ifeither there has been a final judgment by thedistrict court, which is not subject to furtherreview by appeal or certiorari, with regard tothe issue to be litigated as described insubparagraph 2(a) above, or there has been afinal decision by the United States Court of

Appeals for the District of Columbia Circuiton this issue, or the release is scheduled totake place after November 1, 1999, whicheverof these three events happens sooner.

(c). As used in subparagraphs 7(a) and (b)above, the term ‘‘final decision’’ means adecision not subject to reconsideration underRule 59 of the Federal Rules of CivilProcedure, or Rules 35 or 40 of the FederalRules of Appellate Procedure, respectively.

8. The Nixon estate may, at any time, electto use the procedures in paragraph 1 abovewith respect to any tape segment in place ofthe provisions of paragraphs 4(b) and (d) and5(c) above, with the following substitution:The standard under which objections shall bemade, and under which the panel shalldecide their merits, is whether the releasetaken as a whole is plainly inconsistent withthe requirements of the Act and itsimplementing regulations. Provided,however, that once the Nixon estate elects touse the procedures in paragraph 1 above inplace of the provisions in paragraphs 4(b)and (d) and 5(c) above, it cannotsubsequently revert back to the formalobjection process set forth in 36 C.F.R. Part1275 for that tape segment.

9. Within thirty (30) days of the Court’sentry of an order as described in paragraph14 below, the Archivist shall designate aparticular person who shall be responsiblefor responding to reasonable inquiries fromthe plaintiffs on the status of the releases andobjections. Such designation may be changedat any time at the Archivist’s discretion bya notice to plaintiffs through their counsel.

10. If the Archives appoints a SeniorArchival Panel as defined in 36 C.F.R.1275.46(d) and (e), no party to the Agreementmay object to the appointment of such apanel on the ground that the suggestion toappoint such a panel was originated by anindividual other than the processingarchivists assigned to the Archives’ NixonPresidential Materials Staff.

11. The Archives will allow members ofthe public to obtain copies of publiclyaccessible portions of the tapes after thereleases described in paragraph 5 above, arecompleted; provided, however, that if thereleases described in paragraph 5 above arenot completed by December 31, 1999, theArchives will allow members of the public toobtain copies only of the abuses ofgovernmental power tapes, together with anyother tapes publicly released as of the dateof the filing of this Agreement with the Court,beginning January 1, 2000. Further provided,that if the releases described in paragraph 5above are not completed by December 31,2002, the Archives will, beginning January 1,2003, allow members of the public to obtaincopies of all tapes that have been madeavailable to the public by that date and tapesthat subsequently become available, as theyare released.

12(a). Promptly after the Court enters theOrder provided for in paragraph 14 below,plaintiff Kutler will withdraw his requestunder the Freedom of Information Act, 5U.S.C. 552, for any and all tape logs andother finding aids, which is pending inKutler v. Carlin, et al., Civ. A. No. 92–0661–NHJ (D.D.C.). In all other respects, plaintiffKutler’s request in that action shall beunaffected by this Agreement.


(b). Nothing in this Agreement shall affectthe processing by the Archives of anydictabelts, which are a collection ofrecordings of former President Nixon andother White House staff members dictatingmemoranda, correspondence and speechdrafts, that are included in the materials thatare subject to the Act.

13. Pursuant to Rule 315 of this Court, theplaintiffs and the defendant shall attempt toresolve the plaintiffs’ claim for attorneys’ feesand expenses and shall advise the Court nolater than forty-five (45) days after this Courthas entered the Order provided for inparagraph 14 below on whether they havebeen able to resolve the issue of attorneys’fees and expenses. If no resolution has beenreached, they will, at that time, recommenda schedule to the Court to resolve such claim.

14. The parties agree to the dissolution ofthe preliminary injunction entered on August9, 1993, and dismissal with prejudice of thisaction, including all claims and cross-claims,except for the issue to be litigated asdescribed in subparagraph 2(a) above, andany fees and expenses claimed pursuant toparagraph 13 above, by filing the attachedJoint Motion to Vacate PreliminaryInjunction and to Dismiss Claims, and theattached Consent Order. The parties agreethat the Court shall retain jurisdiction to: (a)Consider the entry of an order in accordancewith the terms of paragraph 5 above; (b)resolve the issue to be litigated as describedin subparagraph 2(a) above; (c) determine anyfees and expenses claimed pursuant toparagraph 13 above; and (d) for the purposeof enforcing the terms of this Agreement. Theparties further agree that such jurisdiction,except with respect to the issue described inparagraph 2 above, will be retained only untilthe later of the implementation of paragraph11 above or the completion of the releasescalled for in paragraph 5 above. Plaintiffs andthe Nixon estate further agree that they willnot challenge any regulations issued by theArchives which implement and areconsistent with this Agreement.

15. The terms of this Agreement may notbe altered except with the written consent ofthe parties. Nothing in this Agreementconstitutes an admission of liability orwrongdoing on the part of any party.

Executed this 12th day of April, 1996.For Plaintiffs Stanley I. Kutler and Public

Citizen:Alan B. Morrison,(D.C. Bar No. 073114), Public CitizenLitigation Group, 1600 20th Street NW.,Washington, DC 20009, (202) 588–1000.

For Defendant John W. Carlin:Anne L. Weismann,(D.C. Bar No. 298190)Judry L. Subar,(D.C. Bar No. 347518)

Alina S. Kofsky,

(D.C. Bar No. 419093), Department of Justice,Federal Programs Branch, Civil Division, 901E Street NW., Room 1010, Washington, DC20530, (202) 514–4523.

For Defendant-Intervenors John H. Taylorand William E. Griffin:Herbert J. Miller,(D.C. Bar No. 026120)R. Stan Mortenson,(D.C. Bar No. 114678)Scott L. Nelson,(D.C. Bar No. 413548)Ellen Fels Berkman,(D.C. Bar No. 433310)Miller, Cassidy, Larroca & Lewin,2555 M Street, NW., Washington, DC 20037,(202) 293–6400.

Dated: April 18, 1996.John W. Carlin,Archivist of the United States.[FR Doc. 96–9974 Filed 4–22–96; 8:45 am]BILLING CODE 7515–01–P

FEDERAL MARITIME COMMISSION

46 CFR Part 572

[Docket No. 94–31]

Information Form and Post-EffectiveReporting Requirements forAgreements Among Ocean CommonCarriers Subject to the Shipping Act of1984

AGENCY: Federal Maritime Commission.

ACTION: Final Rule; Extension of time forfiling Petition for Reconsideration.

SUMMARY: On March 21, 1996, (61 FR11564), the Federal MaritimeCommission published a final ruleamending its regulations governing theinformation submission requirementsfor agreements among ocean carrierssubject to the Shipping Act of 1984.Extension of time for filing a petition forreconsideration has been requested bythe Asia North America Eastbound RateAgreement, Japan-United StatesEastbound Freight Conference,Transpacific Westbound RateAgreement and their members. Therequest is granted; this extension doesnot affect the effective date of the finalrule.

DATES: Petition for Reconsideration dueMay 19, 1996.

FOR FURTHER INFORMATION CONTACT:Joseph C. Polking, Secretary, FederalMaritime Commission, 800 North

Capitol St., NW., Washington, D.C.20573, (202) 523–5725.Joseph C. Polking,Secretary.[FR Doc. 96–9872 Filed 4–22–96; 8:45 am]BILLING CODE 6730–01–M

DEPARTMENT OF COMMERCE

National Oceanic and AtmosphericAdministration

50 CFR Part 675

[Docket No. 960129019–6019–01; I.D.041796A]

Groundfish of the Bering Sea andAleutian Islands Area; Pacific OceanPerch in the Western Aleutian District

AGENCY: National Marine FisheriesService (NMFS), National Oceanic andAtmospheric Administration (NOAA),Commerce.ACTION: Closure.

SUMMARY: NMFS is closing the directedfishery for Pacific ocean perch in theWestern Aleutian District of the BeringSea and Aleutian Islands managementarea (BSAI). This action is necessary toprevent exceeding the total allowablecatch of Pacific ocean perch in this area.EFFECTIVE DATE: 12 noon, Alaska localtime (A.l.t.), April 18, 1996, until 12midnight, A.l.t., December 31, 1996.FOR FURTHER INFORMATION CONTACT:Mary Furuness, 907–586-7228.SUPPLEMENTARY INFORMATION: Thegroundfish fishery in the BSAI exclusiveeconomic zone is managed by NMFSaccording to the Fishery ManagementPlan for the Groundfish Fishery of theBering Sea and Aleutian Islands Area(FMP) prepared by the North PacificFishery Management Council underauthority of the Magnuson FisheryConservation and Management Act.Fishing by U.S. vessels is governed byregulations implementing the FMP at 50CFR parts 620 and 675.

In accordance with § 675.20(a)(7)(ii),the initial total allowable catch ofPacific ocean perch for the WesternAleutian District was established by theFinal 1996 Harvest Specifications ofGroundfish (61 FR 4311, February 5,1996) for the BSAI as 5,143 metric tons(mt). As of March 30, 1996, 1,465 mtremains. The directed fishery for Pacificocean perch in the Western AleutianDistrict was closed under § 675.20(a)(8)on March 20, 1996 (58 FR 12041, March25, 1996) and reopened on April 15,1996 (Action filed by the Office of theFederal Register on April 15, 1996, andscheduled for publication in the FederalRegister on April 19, 1996.).


The Director, Alaska Region, NMFS(Regional Director), has determined, inaccordance with § 675.20(a)(8), that thePacific ocean perch initial totalallowable catch in the Western AleutianDistrict subarea soon will be reached.Therefore, the Regional Director hasestablished a directed fishing allowanceof 5,093 mt after determining that 50 mtwill be taken as incidental catch indirected fishing for other species in theWestern Aleutian District.Consequently, NMFS is prohibitingdirected fishing for Pacific ocean perchin the Western Aleutian District.

Maximum retainable bycatch amountsfor applicable gear types may be foundin the regulations at § 675.20(h).

Classification

This action is taken under § 675.20and is exempt from review under E.O.12866.

Authority: 16 U.S.C. 1801 et seq.Dated: April 17, 1996.

Richard W. Surdi,Acting Director, Office of FisheriesConservation and Management, NationalMarine Fisheries Service.[FR Doc. 96–9971 Filed 4–18–96; 3:09 pm]BILLING CODE 3510–22–F

This section of the FEDERAL REGISTERcontains notices to the public of the proposedissuance of rules and regulations. Thepurpose of these notices is to give interestedpersons an opportunity to participate in therule making prior to the adoption of the finalrules.

Proposed Rules Federal Register

17851

Vol. 61, No. 79


1 The Office of Civil Rights Enforcement has beenreorganized into two entities within DepartmentalAdministration, i.e., Civil Rights and Civil RightsAdjudication and Enforcement.



7 CFR Parts 15 and 15d

Nondiscrimination in USDA ConductedPrograms and Activities

AGENCY: Department of Agriculture.ACTION: Proposed rule.

SUMMARY: The United States Departmentof Agriculture (USDA or theDepartment) is proposing to revise itsregulations governingnondiscrimination in programs andactivities conducted by the Department.The proposal would remove the currentregulation on this subject found at 7CFR part 15, subpart B (Subpart B), andplace it in a new part 15d; clarify thatthe regulation applies to all Department-conducted programs and activities, notjust to direct assistance programs; addfamilial status and marital status to theprotected classes contained in theregulation; add a provision onDepartment agencies’ complianceefforts; reflect that the AssistantSecretary for Administration has beendelegated the authority to make finaldeterminations as to whether prohibiteddiscrimination occurred and thecorrection action required to resolvecomplaints; remove the Appendix to theregulation that lists the Departmentprograms subject to these provisions;and make other clarifications to theregulation.DATES: Comments must be received byMay 23, 1996.ADDRESSES: Send comments to Directorof Civil Rights, Department ofAgriculture, Washington, DC 20250.Comments will be available for publicinspection at Room 1322, SouthBuilding, Department of Agriculture,Washington, DC 20250.FOR FURTHER INFORMATION CONTACT:Andrew Johnson, Director, Policy andPlanning, Civil Rights, 202–720–1130;or Ron Walkow, Attorney-Advisor,Office of General Counsel, 202–720–6056.

SUPPLEMENTARY INFORMATION: TheDepartment in 1964 first adoptedregulations to cover nondiscriminationin all programs and activities directlyadministered by USDA (29 FR 16966).At that time, the regulations wereintended to complement the newlyenacted Title VI of the Civil Rights Actof 1964 (42 U.S.C. 2000d et seq.) bycovering those programs and activitiesnot subject to Title VI; that is, programsand activities in which USDA or anagency thereof made available a benefitdirectly to persons rather than througha recipient. However, these regulationswere made a part of the Department’sTitle VI regulations; specially, they wereissued at Subpart B where they haveremained to this day. Since then,subpart B has been amended on severaloccasions to include a variety ofprotected classes in addition to race,color, and national origin. (38 FR 22465;42 FR 65202; 47 FR 25458). Subpart Balso was amended to provide thatindividuals who believe they weresubject to discrimination under theregulations may file a complaint withthe Department (50 FR 25687; 54 FR31164).

Since Title VI is not the authority forthe regulations, having these regulationscodified as part of the Department’sTitle VI regulations has resulted in someconfusion over the years. Accordingly,the Department is proposing to removethe regulations from subpart B of part 15and reissue them in a new regulation,part 15f of Title 7. Along these samelines, the authority provision of theregulation would be revised to clarifythat the authority for the regulation is 5U.S.C. 301, not Title VI.

In addition to removing and reissuingthe regulation, the Department isproposing to make some minorsubstantive changes to the regulation.First, the regulation will be reworded toclarify that it applies to discriminationin all Department-conducted programsand activities; that is, to any allegationthat a USDA employee discriminatedagainst a member of the public—whether in a direct assistance programor in any other manner.

Second, the Department is alsoproposing to add familial status andmarital status to the protected classescovered by the regulation. Over theyears, the Department has addedprotected classes to the regulation inorder to reflect those classes protected

by the various Federal civil rights laws.Two of those classes not currentlyincluded are familial status (which isincluded in the Fair Housing Act (42U.S.C. 3601 et seq.)) and marital status(which is included in the Equal CreditOpportunity Act (15 U.S.C. 1691 etseq.). Accordingly, the proposed rulewould include these classes.

The proposed regulation would deletethe provision now contained in subpartB at § 15.51(b). The Department believesthat the broad language used inproposed § 15d.2 is sufficient to makeclear that the Department will notdiscriminate in any of its conductedprograms, without having to providespecific examples, of prohibiteddiscriminatory acts. By this action, theDepartment does not intend tosubstantively affect the scope of theprotections currently covered by§ 15.51(b).

The Department is also proposing toadd a new section on the efforts of theDepartment to ensure compliance withthis part since it is as crucial to have anongoing evaluation of Departmentagencies’ compliance with this sectionas it is to have a complaint process.Therefore, the enforcement sections, i.e.proposed §§ 15d.3 and 15d.4, providefor the Department engaging incompliance activities and in complaintresolution. Specific provisions notinghow these efforts will be implementedwithin the Department will be set forthin internal regulations and guidelines.

The proposed regulation would reflectthat the authority to make finaldeterminations for the Department as to(1) whether discrimination occurred andthe corrective action required by theDepartment to resolve complaints and(2) whether Department agencies’ effortsto comply with nondiscriminationrequirements are sufficient will nolonger be delegated to the Director,Office of Civil Rights Enforcement,1 butinstead has been delegated to AssistantSecretary for Administration (ASA).This delegation already has beeneffectuated in 7 CFR part 2, and thatchange would be reflected in theproposed regulation. The Departmentbelieves that determinations of thismagnitude should be elevated to thesub-cabinet level. In addition, this

17852 Federal Register / Vol. 61, No. 79 / Tuesday, April 23, 1996 / Proposed Rules

change would make the determiningofficial in program discriminationcomplaints the same official, i.e. theASA, who makes final determinationson employment discriminationcomplaints within the Department. CivilRights Adjudication and Enforcement(AE) will be responsible for conductingthe investigations on complaints andevaluating agencies’ efforts to complywith the discrimination prohibitionprovisions of this new Part.

The Department is also proposing toremove the provisions in § 15.52(a) thatrequire covered agencies of theDepartment to provide notice of thepublic’s right to file a complaint underthat Subpart. Under the proposed newPart 15d, this requirement will betransferred to the Department’s internalregulations. The Department nowbelieves that internal instructions suchas the notice requirement now in§ 15.52(a) are more appropriate in sucha regulatory setting. However, until suchinternal regulations are issued, agenciesof the Department will continue tofollow the procedures currentlyrequired in § 15.52(a).

The Department is next proposing toremove the appendix to the regulation(currently ‘‘Appendix to Subpart B’’),which purports to list the programs andactivities conducted by the Department.The Department has found that it isdifficult to maintain the accuracy of thislist on a regular basis when it iscontained in the Code of FederalRegulations. Additionally, having theAppendix in the Code of FederalRegulations does not contribute to theeffectiveness of the regulation.Accordingly, the Department wouldremove the Appendix and maintainsuch a list of programs and activities ininternal guidelines to be maintained byCivil Rights (CR).

The proposed regulation wouldcontain a new provision that wouldstate that nothing in the regulation shallbe construed as making unlawful anyprogram or activity conducted by theDepartment that is otherwise lawful.The purpose of this provision is to makeclear the intent of the regulation. Thatis, this regulation is not intended toprohibit the Department from doinganything that it is not already prohibitedfrom doing by the Constitution andvarious Federal statutes. The regulationmerely states the nondiscriminationpolicy of the Department; it does notcreate any additional rights forindividuals and entities that deal withthe Department. The proposed languagewould make clear this intention as wellas the legal effect of the regulation.

Finally, the Department proposes toadd a provision stating that complaints

filed under the regulation that aresubject to a Department complaintprocess that is implemented underspecific statutory authority will beprocessed under the statutory complaintprocess. Thus, for example, a complaintalleging that the Departmentdiscriminated on the basis of disabilityin a conducted program will beprocessed under 7 CFR part 15e, whichimplements the Rehabilitation Act.

In conclusion, the proposedregulation would set forth thenondiscrimination policy of theDepartment, provide for complianceefforts by the Department, notify thepublic that it may file complaints withthe Department alleging discrimination,and provide that complainants will benotified of the final determinations ontheir complaints. The Departmentbelieves that the detailed internalprocedures on the processing of thesecomplaints should be contained ininternal regulations rather than in theCode of Federal Regulations. Theseinternal regulations will address suchmatters as the duties of Departmentagencies under the regulation,guidelines on what constitutes a properinvestigation, and the standards for‘‘good-cause’’ extension of the 180-dayfiling period. The Department will issuethese internal regulations as soon as ispracticable after this proposed rule hasbeen made final. Once completed, theinternal regulations will be available forpublic inspection.

This proposed rule has beendetermined to be ‘‘not-significant’’ forpurposes of Executive Order 12866, andtherefore has not been reviewed by theOffice of Management and Budget.USDA certifies that this proposed rulewould not have a significant economicimpact on a substantial number of smallentities under the Regulatory FlexibilityAct of 1980 (5 U.S.C. 601 et seq.). USDAalso certifies that this proposed rulewould not impose any reporting orrecordkeeping requirements under thePaperwork Reduction Act of 1995, 44U.S.C. Chapter 35.

USDA is providing a 30-day commentperiod for this rule. Comment is invitedon all aspects of the proposal, includingthe appropriateness and effect of theproposed changes, and any additional oralternative measures that would servethe goals of USDA as outlined in theproposal.

List of Subjects in 7 CFR Parts 15 and15d

Nondiscrimination.In consideration of the foregoing, the

Department proposes to amend Title 7of the Code of Federal Regulations,Subtitle A, as follows:

PART 15—[AMENDED]


Authority: 5 U.S.C. 301; 29 U.S.C. 794.

2. Part 15, subpart B (§§ 15.50–15.52)and the appendix thereto would beremoved; and

3. A new Part 15d would be added asfollows:

PART 15d—NONDISCRIMINATION INPROGRAMS OR ACTIVITIESCONDUCTED BY THE UNITED STATESDEPARTMENT OF AGRICULTURE

Sec.15d.1 Purpose.15d.2 Discrimination prohibited.15d.3 Compliance.15d.4 Complaints.15d.5 Effect of regulation.

Authority: 5 U.S.C. 301.

§ 15d.1 Purpose.The purpose of this part is to set forth

the nondiscrimination policy of theUnited States Department of Agriculturein programs or activities conducted bythe Department, including suchprograms and activities in which theDepartment or any agency thereof makesavailable any benefit directly to personsunder such programs and activities.

§ 15d.2 Discrimination prohibited.No agency, officer, or employee of the

United States Department of Agricultureshall exclude from participation in,deny the benefits of, or subject todiscrimination any person in the UnitedStates on the ground of race, color,religion, sex, age, national origin,marital status, familial status, ordisability under any program or activityconducted by such agency, officer, oremployee.

§ 15d.3 Compliance.The Office of the Director of Civil

Rights shall evaluate each agency’sefforts to comply with this part andreport to the Assist Secretary forAdministration the results of suchevaluations, includingrecommendations for improving suchefforts. The Assistant Secretary shallmake a final determination as to themerits of such recommendations andthe actions to be taken to improve suchefforts.

§ 15d.4 Complaints.(a) Any person who believes that he

or she (or any specific class ofindividuals) has been, or is being,subjected to practices prohibited by thispart may file on his or her own, orthrough an authorized representative, awritten complaint alleging such

17853Federal Register / Vol. 61, No. 79 / Tuesday, April 23, 1996 / Proposed Rules

discrimination. No particular form ofcomplaint is required. The complaintmust be filed within 180 calendar daysfrom the date the person knew orreasonably should have known of thealleged discrimination, unless the timeis extended for good cause by theAssistant Secretary for Administrationor his designee. Any person whocomplains of discrimination under thispart in any fashion shall be advised ofhis or her right to file a complaint asherein provided.

(b) All complaints under this partshould be filed with the Director of CivilRights Adjudication and Enforcement,United States Department ofAgriculture, Washington, DC 20250,who will investigate the complaints.The Assistant Secretary forAdministration will make finaldeterminations as to the merits ofcomplaints under this part and as to thecorrective actions required to resolvethe complaints. The complainant will benotified of the final determination onhis or her complaint.

(c) Any complaint filed under thispart that is subject to a Departmentcomplaint process that is implementedunder specific statutory authority willbe processed under the statutorycomplaint process.

§ 15d.5 Effect of regulation.

Nothing in this part shall beconstrued as making unlawful anyprogram or activity conducted by theDepartment that is otherwise lawful.

Dated: April 16, 1996.Dan Glickman,Secretary of Agriculture.[FR Doc. 96–9900 Filed 4–22–96; 8:45 am]BILLING CODE 3410–01–M



14 CFR Part 39

[Docket No. 95–NM–192–AD]

Airworthiness Directives; EmpresaBrasileira de Aeronautica, S.A.(EMBRAER) Model EMB–120 SeriesAirplanes

AGENCY: Federal AviationAdministration, DOT.ACTION: Notice of proposed rulemaking(NPRM).

SUMMARY: This document proposes theadoption of a new airworthinessdirective (AD) that is applicable tocertain EMBRAER Model EMB–120series airplanes. This proposal would

require repetitive inspections to detectcracks in the wing rib-to-skin supportbrackets (shear clips), and replacementof cracked brackets with new orserviceable brackets. This proposal alsowould require the eventual replacementof certain brackets with new brackets,which would terminate the requirementfor the inspections. This proposal isprompted by reports of cracks in thewing rib-to-skin support brackets inboth the lower and upper skin of thewings. The actions specified by theproposed AD are intended to preventcracking of those support brackets,which can subsequently lead to theloosening of the rivets in the wing skin,leakage of fuel through the rivet holes,and, ultimately, the reduction of thestructural integrity of the wing.DATES: Comments must be received byJune 3, 1996.ADDRESSES: Submit comments intriplicate to the Federal AviationAdministration (FAA), TransportAirplane Directorate, ANM–103,Attention: Rules Docket No. 95–NM–192–AD, 1601 Lind Avenue SW.,Renton, Washington 98055–4056.Comments may be inspected at thislocation between 9:00 a.m. and 3:00p.m., Monday through Friday, exceptFederal holidays.

The service information referenced inthe proposed rule may be obtained fromEMBRAER, Empresa Brasileira DeAeronautica S/A, Sao Jose dos Campos- SP, Brazil. This information may beexamined at the FAA, TransportAirplane Directorate, 1601 Lind AvenueSW., Renton, Washington.FOR FURTHER INFORMATION CONTACT:Curtis Jackson, Aerospace Engineer,Airframe and Propulsion Branch, ACE–117A, FAA, Atlanta AircraftCertification Office, Small AirplaneDirectorate, Campus Building, 1701Columbia Avenue, Suite 2–160, CollegePark, Georgia 30337–2748; telephone(404) 305–7358; fax (404) 305–7348.


Comments Invited

Interested persons are invited toparticipate in the making of theproposed rule by submitting suchwritten data, views, or arguments asthey may desire. Communications shallidentify the Rules Docket number andbe submitted in triplicate to the addressspecified above. All communicationsreceived on or before the closing datefor comments, specified above, will beconsidered before taking action on theproposed rule. The proposals containedin this notice may be changed in lightof the comments received.

Comments are specifically invited onthe overall regulatory, economic,environmental, and energy aspects ofthe proposed rule. All commentssubmitted will be available, both beforeand after the closing date for comments,in the Rules Docket for examination byinterested persons. A reportsummarizing each FAA-public contactconcerned with the substance of thisproposal will be filed in the RulesDocket.

Commenters wishing the FAA toacknowledge receipt of their commentssubmitted in response to this noticemust submit a self-addressed, stampedpostcard on which the followingstatement is made: ‘‘Comments toDocket Number 95–NM–192–AD.’’ Thepostcard will be date stamped andreturned to the commenter.

Availability of NPRMsAny person may obtain a copy of this

NPRM by submitting a request to theFAA, Transport Airplane Directorate,ANM–103, Attention: Rules Docket No.95–NM–192–AD, 1601 Lind AvenueSW., Renton, Washington 98055–4056.

DiscussionThe Departamento de AviaCao Civil

(DAC), which is the airworthinessauthority for Brazil, recently notified theFAA that an unsafe condition may existon certain EMBRAER Model EMB–120series airplanes. The DAC advises thatit has received reports of cracks in therib-to-skin fitting brackets (shear clips)both in the lower and upper skin of thewings on Model EMB–120 seriesairplanes. The development of crackingof the shear clips can occur in the wingskin riveting line and can cause thecomplete failure of the ledge of theshear clips, resulting in separation ofthe skin from the shear clip on theaffected area. Although there are severalshear clips per rib, the simultaneousoccurrence of cracking in several shearclips will affect the wing’s structuralintegrity. The cause of the cracking isattributed to fatigue. Cracking of thosesupport brackets can cause rivets in thewing skin to loosen and, consequently,permit fuel to leak into the wingthrough the rivet holes. Propagation ofsuch cracking, if not corrected, couldreduce the structural integrity of thewing and permit fuel leakage into thewing.

EMBRAER has issued Service Bulletin(SB) 120–57–0031, dated July 6, 1995,which describes procedures forrepetitive internal visual inspections todetect cracks in the wing rib-to-skinsupport brackets (shear clips), andreplacement of cracked brackets withnew or serviceable parts. The service


bulletin also describes procedures for aterminating action for the repetitiveinspections. That action involvesreplacement of all wing rib-to-skinsupport brackets of ribs 15 and 16 withbrackets having a new part number;inspection to detect cracking of the wingskin support brackets of ribs 18, 19, 20,21, and 22; and replacement of crackedbrackets with new or serviceablebrackets having the same part number.The DAC classified this service bulletinas mandatory and issued Brazilianairworthiness directive (DA) 95–05–01R1, dated August 25, 1995, in order toassure the continued airworthiness ofthese airplanes in Brazil .

This airplane model is manufacturedin Brazil and is type certificated foroperation in the United States under theprovisions of section 21.29 of theFederal Aviation Regulations (14 CFR21.29) and the applicable bilateralairworthiness agreement. Pursuant tothis bilateral airworthiness agreement,the DAC has kept the FAA informed ofthe situation described above. The FAAhas examined the findings of the DAC,reviewed all available information, anddetermined that AD action is necessaryfor products of this type design that arecertificated for operation in the UnitedStates.

Since an unsafe condition has beenidentified that is likely to exist ordevelop on other airplanes of the sametype design, the proposed AD wouldrequire repetitive internal visualinspections to detect cracks in the wingrib-to-skin support brackets (shearclips). If cracks are found that are withincertain limits (in length), this proposedAD would permit flights to continue,but the inspections would be required tobe conducted more often. If cracks arefound that are outside certain limits, thebracket would be required to bereplaced prior to further flight, andadditional inspection of other adjacentsupport brackets would be required tobe accomplished. This proposed ADalso would require that all wing rib toskin support brackets of ribs 15 and 16be replaced with new brackets. Thisreplacement would constituteterminating action for the requiredinspections. The actions would berequired to be accomplished inaccordance with the service bulletindescribed previously.

Operators should note that, inaddition to the inspection for crackingof the wing skin brackets recommendedin the referenced Embraer servicebulletin, this proposed AD wouldrequire that a repetitive visualinspection of the wing skin for fuelleakage be accomplished within every50 flight hours until the terminating

action has been accomplished. The FAAfinds that inspections for such fuelleakage [fuel leakage as defined andclassified in the Airplane MaintenanceManual (AMM)] are necessary toprovide an indication of the urgency ofneed to inspect for cracking of the wingskin brackets.

The FAA estimates that 169 airplanesof U.S. registry would be affected by thisproposed AD.

It would take approximately 6 workhours per airplane to accomplish theproposed visual inspection for cracking,at an average labor rate of $60 per workhour. Based on these figures, the costimpact of this proposed inspectionaction on U.S. operators is estimated tobe $60,840, or $360 per airplane, perinspection cycle.

It would take approximately 56 workhours to accomplish the proposedreplacement of support brackets, at anaverage labor rate of $60 per work hour.Required parts would costapproximately $1,000 per airplane.Based on these figures, the cost impactof the proposed replacement on U.S.operators is estimated to be $736,840, or$4,360 per airplane.

The cost impact figures discussedabove are based on assumptions that nooperator has yet accomplished any ofthe requirements of this proposed AD,and that no operator would accomplishthose actions in the future if thisproposal were not adopted. However,the FAA has been advised that theterminating modification already hasbeen installed on a number of airlinesthat are subject to this AD. Therefore,the future economic cost impact of thisrule on U.S. operators is expected to beless than the cost impact figuresindicated above.

The regulations proposed hereinwould not have substantial direct effectson the States, on the relationshipbetween the national government andthe States, or on the distribution ofpower and responsibilities among thevarious levels of government. Therefore,in accordance with Executive Order12612, it is determined that thisproposal would not have sufficientfederalism implications to warrant thepreparation of a Federalism Assessment.

For the reasons discussed above, Icertify that this proposed regulation (1)is not a ‘‘significant regulatory action’’under Executive Order 12866; (2) is nota ‘‘significant rule’’ under the DOTRegulatory Policies and Procedures (44FR 11034, February 26, 1979); and (3) ifpromulgated, will not have a significanteconomic impact, positive or negative,on a substantial number of small entitiesunder the criteria of the RegulatoryFlexibility Act. A copy of the draft

regulatory evaluation prepared for thisaction is contained in the Rules Docket.A copy of it may be obtained bycontacting the Rules Docket at thelocation provided under the captionADDRESSES.


safety, Safety.

The Proposed AmendmentAccordingly, pursuant to the

authority delegated to me by theAdministrator, the Federal AviationAdministration proposes to amend part39 of the Federal Aviation Regulations(14 CFR part 39) as follows:



Authority: 49 USC 106(g), 40113, 44701.


adding the following new airworthinessdirective:EMBRAER: Docket 95–NM–192–AD.

Applicability: Model EMB–120 airplanes,serial numbers 120001, 120003, 120004, and120006 through 120304 inclusive;certificated in any category.

Note 1: This AD applies to each airplaneidentified in the preceding applicabilityprovision, regardless of whether it has beenotherwise modified, altered, or repaired inthe area subject to the requirements of thisAD. For airplanes that have been modified,altered, or repaired so that the performanceof the requirements of this AD is affected, theowner/operator must request approval for analternative method of compliance inaccordance with paragraph (e) of this AD.The request should include an assessment ofthe effect of the modification, alteration, orrepair on the unsafe condition addressed bythis AD; and, if the unsafe condition has notbeen eliminated, the request should includespecific proposed actions to address it.


To prevent reduced wing structuralintegrity and fuel leakage of the wing due tocracking of wing rib-to-skin support brackets,accomplish the following:

Note 2: The term ‘‘fuel leakage’’ and‘‘stain,’’ as used throughout this AD, are usedas they are defined and classified in Chapter28, Fuel, of the Airplane MaintenanceManual (AMM).

(a) Within 10 days after the effective dateof this AD: Perform a visual inspection of thewing skin along rib lines 15 and 16 to detectany fuel leakage other than a stain.Thereafter, repeat this inspection every 50flight hours until the requirements ofparagraph (d) of this AD have beenaccomplished.

(b) For airplanes on which fuel leakage isdetected during any inspection required by


paragraph (a) of this AD: Within 50 flightsafter detection of fuel leakage; perform aninternal visual inspection to detect crackingof the wing rib-to-skin support brackets(shear clips) that connect the lower andupper wing skins to ribs 15 and 16, inaccordance with the AccomplishmentInstructions of EMBRAER Service Bulletin120–57–0031, dated July 6, 1995, at the timespecified in paragraph (b)(1), (b)(2), or (b)(3)of this AD, as applicable.

(1) If no cracking is detected: Repeat theinternal visual inspection required byparagraph (b) of this AD thereafter atintervals not to exceed 1,200 flight cyclesuntil the requirements of paragraph (d) ofthis AD have been accomplished.

(2) If any cracking is detected in only onewing skin support bracket and that crackingis more than half the length of the bracket;and if any cracking also is detected in up totwo additional wing skin support bracketsand that cracking is less than half the lengthof the bracket: Repeat the internal visualinspection required by paragraph (b) of thisAD thereafter at intervals not to exceed 400flight cycles, until the requirements ofparagraph (d) of this AD have beenaccomplished.

(3) If any cracking is detected other thanthat specified in paragraph (b)(2) of this AD:Prior to further flight, replace any supportbracket that is cracked beyond the limitsspecified in paragraph (b)(2) of this AD witha new bracket, in accordance with theAccomplishment Instructions of the servicebulletin. Following any replacement, prior tofurther flight, perform an additional internalvisual inspection to detect cracking of thesupport brackets that connect the wing skinsto ribs 18, 19, 20, 21, and 22 in accordancewith the service bulletin.

(i) If no cracking is found, repeat theinternal visual inspection required byparagraph (b) of this AD thereafter atintervals not to exceed 1,200 flight cyclesuntil the requirements of paragraph (d) ofthis AD are accomplished.

(ii) If any cracking is found, prior to furtherflight, replace any cracked bracket with aserviceable part, in accordance with theservice bulletin.

(c) For airplanes on which no wing fuelleakage is detected during any inspectionrequired by paragraph (a) of this AD: Performan internal visual inspection to detectcracking of the wing rib-to-skin supportbrackets (shear clips) that connect the lowerand upper wing skins to ribs 15 and 16, inaccordance with the AccomplishmentInstructions of EMBRAER Service Bulletin120–57–0031, dated July 6, 1995, at the timespecified in paragraph (c)(1), (c)(2), (c)(3), or(c)(4) of this AD, as applicable. Thereafter,repeat this inspection as intervals not toexceed 1,200 flight cycles until therequirements of paragraph (d) of this AD areaccomplished.

(1) For airplanes that have accumulatedless than 4,000 total flight cycles as of theeffective date of this AD: Inspect prior to theaccumulation of 5,200 total flight cycles, orwithin 1,200 flight cycles after the effectivedate of this AD, whichever occurs later.

(2) For airplanes that have accumulated4,000 or more total flight cycles, but less than

8,000 total flight cycles as of the effectivedate of this AD: Inspect within 1,200 flightcycles after the effective date of this AD.

(3) For airplanes that have accumulated8,000 or more total flight cycles, but less than12,000 total flight cycles as of the effectivedate of this AD: Inspect within 800 flightcycles after the effective date of this AD.

(4) For airplanes that have accumulated12,000 or more total flight cycles as of theeffective date of this AD: Inspect within 400flight cycles after the effective date of thisAD.

(d) Within 2 years after the effective dateof this AD: Replace all wing rib-to-skinsupport brackets of ribs 15, 16, and 18 withnew brackets in accordance with EMBRAERService Bulletin 120–57–0031, dated July 6,1995. Prior to further flight following thereplacement, perform a visual inspection todetect cracking of the wing skin supportbrackets of ribs 19, 20, 21, and 22. If anycracking is found, prior to further flight,replace cracked brackets with serviceablebrackets in accordance with the servicebulletin. Accomplishment of theserequirements constitutes terminating actionfor the requirements of this AD.

(e) An alternative method of compliance oradjustment of the compliance time thatprovides an acceptable level of safety may beused if approved by the Manager, AtlantaAircraft Certification Office (ACO), FAA,Small Airplane Directorate. Operators shallsubmit their requests through an appropriateFAA Principal Maintenance Inspector, whomay add comments and then send it to theManager, Atlanta ACO.

Note 3: Information concerning theexistence of approved alternative methods ofcompliance with this AD, if any, may beobtained from the Atlanta ACO.

(f) Special flight permits may be issued inaccordance with sections 21.197 and 21.199of the Federal Aviation Regulations (14 CFR21.197 and 21.199) to operate the airplane toa location where the requirements of this ADcan be accomplished.


14 CFR Part 39

[Docket No. 95–NM–268–AD]

Airworthiness Directives; de HavillandModel DHC–8–301, –311, and –315Series Airplanes

AGENCY: Federal AviationAdministration, DOT.ACTION: Notice of proposed rulemaking(NPRM).

SUMMARY: This document proposes thesupersedure of an existing airworthinessdirective (AD), applicable to certain deHavilland Model DHC–8–301, –311, and

–315 series airplanes, that currentlyrequires modification of the airspeedlimitations placard and revision of theAirplane Flight Manual to specifyoperating at lower airspeeds when theairplane is operating at full flaps. Thataction also provides for the optionaltermination of the requirements of theAD for certain airplanes. That actionwas prompted by a report that incorrectrivets were installed on the outboardflaps assemblies of these airplanes. Theactions specified in that AD areintended to prevent structural failure ofthe outboard flaps of the wings due tothe installation of incorrect rivets in theflap assemblies, which could result inreduced controllability of the airplane.This action would require installation ofthe terminating modification on certainairplanes.DATES: Comments must be received byJune 3, 1996.ADDRESSES: Submit comments intriplicate to the Federal AviationAdministration (FAA), TransportAirplane Directorate, ANM–103,Attention: Rules Docket No. 95–NM–268–AD, 1601 Lind Avenue SW.,Renton, Washington 98055–4056.Comments may be inspected at thislocation between 9:00 a.m. and 3:00p.m., Monday through Friday, exceptFederal holidays.

The service information referenced inthe proposed rule may be obtained fromBombardier, Inc., Bombardier RegionalAircraft Division, Garratt Boulevard,Downsview, Ontario M3K 1Y5, Canada.This information may be examined atthe FAA, Transport AirplaneDirectorate, 1601 Lind Avenue, SW.,Renton, Washington; or at the FAA,New York Aircraft Certification Office,Engine and Propeller Directorate, 10Fifth Street, Third Floor, Valley Stream,New York.FOR FURTHER INFORMATION CONTACT:Franco Pieri, Aerospace Engineer,Airframe Branch (ANE–171), FAA, NewYork Aircraft Certification Office,Engine and Propeller Directorate, 10Fifth Street, Third Floor, Valley Stream,New York 11581; telephone (516) 256–7526; fax (516) 568–2716.


Comments InvitedInterested persons are invited to

participate in the making of theproposed rule by submitting suchwritten data, views, or arguments asthey may desire. Communications shallidentify the Rules Docket number andbe submitted in triplicate to the addressspecified above. All communicationsreceived on or before the closing datefor comments, specified above, will be


considered before taking action on theproposed rule. The proposals containedin this notice may be changed in lightof the comments received.

Comments are specifically invited onthe overall regulatory, economic,environmental, and energy aspects ofthe proposed rule. All commentssubmitted will be available, both beforeand after the closing date for comments,in the Rules Docket for examination byinterested persons. A reportsummarizing each FAA-public contactconcerned with the substance of thisproposal will be filed in the RulesDocket.

Commenters wishing the FAA toacknowledge receipt of their commentssubmitted in response to this noticemust submit a self-addressed, stampedpostcard on which the followingstatement is made: ‘‘Comments toDocket Number 95–NM–268–AD.’’ Thepostcard will be date stamped andreturned to the commenter.

Availability of NPRMsAny person may obtain a copy of this

NPRM by submitting a request to theFAA, Transport Airplane Directorate,ANM–103, Attention: Rules Docket No.95–NM–268–AD, 1601 Lind Avenue,SW., Renton, Washington 98055–4056.

DiscussionOn December 22, 1995, the FAA

issued AD 95–26–17, amendment 39–9475 (61 FR 5277, February 12, 1996),applicable to certain de HavillandModel DCH–8–301, –311, and –315series airplanes, to require modificationof the airspeed limitations placard toindicate that the airplane must be flownat reduced airspeed when flying at 35degrees flaps. Additionally, that ADrequires a revision to the FAA-approvedAirplane Flight Manual (AFM) for allairplanes to include information relativeto reducing airspeed at 35 degrees flaps.For Model DHC–8–311 and –315 seriesairplanes, that AD also provides for anoptional termination action for therequirements of the AD by modifyingthe outboard flaps (installation ofModification 8/2066).

That action was prompted by a reportthat incorrect rivets were installed onthe outboard flaps assemblies of theseairplanes. The actions specified in thatAD are intended to prevent structuralfailure of the outboard flaps of the wingsdue to the installation of incorrect rivetsin the flap assemblies, which couldresult in reduced controllability of theairplane.

In the preamble to AD 95–26–17, theFAA indicated that it regarded therequirements of that AD to be interimaction, and that it was considering

additional rulemaking to mandate theoptional terminating action that wasprovided in that AD. This notice followsfrom the FAA’s decision to mandate thatterminating action.

Description of Pertinent ServiceInformation

De Havilland has issued ServiceBulletin S.B. 8–57–24, Revision ‘A,’dated September 26, 1995, whichdescribes installation of Modification 8/2066 at the outboard flaps. Thatmodification entails drilling out thesuspect rivets and installing new DDrivets. The modification positivelyaddresses the previously identifiedunsafe condition associated with thesuspect rivets, and accomplishment of iteliminates the need for the airspeedlimitations placard (which was thesubject of AD 95–26–17). Thismodification, however, is applicableonly to Model DHC–8–311 and –315series airplanes; a correctivemodification has not yet been developedfor Model DHC–8–301 series airplanes.

Transport Canada classified the deHavilland service bulletin as mandatoryand issued Canadian airworthinessdirective CF–95–05R1, dated October19, 1995, in order to assure thecontinued airworthiness of theseairplanes in Canada.

Description of the ProposedRequirements

This airplane model is manufacturedin Canada and is type certificated foroperation in the United States under theprovisions of section 21.29 of theFederal Aviation Regulations (14 CFR21.29) and the applicable bilateralairworthiness agreement. Pursuant tothis bilateral airworthiness agreement,Transport Canada Aviation has kept theFAA informed of the situation describedabove. The FAA has examined thefindings of Transport Canada Aviation,reviewed all available information, anddetermined that AD action is necessaryfor products of this type design that arecertificated for operation in the UnitedStates.

Since an unsafe condition has beenidentified that is likely to exist ordevelop on other airplanes of the sametype design registered in the UnitedStates, the proposed AD wouldsupersede AD 95–26–17.

For Model DHC–8–301 seriesairplanes, it would continue to requiremodification of the airspeed limitationsplacard and revision of the AFM tospecify operating at lower airspeedswhen the airplane is operating at fullflaps.

For Model DHC–8–311 and –315series airplanes, it would require that

the terminating modification(Modification 8/2066) be installed onwithin two years. The modificationwould be required to be accomplishedin accordance with the service bulletindescribed previously. Once themodification is installed, the currently-required placard and AFM revision maybe removed. Additionally, this proposalwould require that Modification 8/2066be installed on certain outboard flapassemblies prior to their installation onthese airplanes.

The FAA has determined that longterm continued operational safety willbe better assured by design changes toremove the source of the problem, ratherthan by special operating procedures.Long term special operating proceduresmay not be providing the degree ofsafety assurance necessary for thetransport airplane fleet. This, coupledwith a better understanding of thehuman factors associated withnumerous continual special procedures,has led the FAA to consider placing lessemphasis on special procedures andmore emphasis on designimprovements. The proposedmodification requirement of this ADaction is in consonance with theseconsiderations.

Cost ImpactThere are approximately 18 de

Havilland Model DHC–8–301, –311, and–315 series airplanes of U.S. registrywould be affected by this proposed AD.

The actions that are currentlyrequired by AD 95–26–17 (modificationof the airspeed limitations placard andrevision of the Airplane Flight Manual)affect all 18 U.S.-registered airplanes.Those actions take approximately .5work hour per airplane to accomplish,at an average labor rate of $60 per workhour. The cost of required parts isnegligible. Based on these figures, thecost impact on U.S. operators of theactions currently required is estimatedto be $540, or $30 per airplane.

The new actions that are proposed inthis AD action (installation of theterminating modification) would affect14 U.S.-registered Model DHC–8–311and –315 series airplanes. The proposedactions would take approximately 60work hours per airplane to accomplish,at an average labor rate of $60 per workhour. Required parts would be providedby the manufacturer at no cost tooperators. Based on these figures, thecost impact on U.S. operators of theproposed requirements of this AD isestimated to be $50,400, or $3,600 perairplane.

The cost impact figures discussedabove are based on assumptions that nooperator has yet accomplished any of


the current or proposed requirements ofthis AD action, and that no operatorwould accomplish those actions in thefuture if this AD were not adopted.

Regulatory ImpactThe regulations proposed herein

would not have substantial direct effectson the States, on the relationshipbetween the national government andthe States, or on the distribution ofpower and responsibilities among thevarious levels of government. Therefore,in accordance with Executive Order12612, it is determined that thisproposal would not have sufficientfederalism implications to warrant thepreparation of a Federalism Assessment.

For the reasons discussed above, Icertify that this proposed regulation (1)is not a ‘‘significant regulatory action’’under Executive Order 12866; (2) is nota ‘‘significant rule’’ under the DOTRegulatory Policies and Procedures (44FR 11034, February 26, 1979); and (3) ifpromulgated, will not have a significanteconomic impact, positive or negative,on a substantial number of small entitiesunder the criteria of the RegulatoryFlexibility Act. A copy of the draftregulatory evaluation prepared for thisaction is contained in the Rules Docket.A copy of it may be obtained bycontacting the Rules Docket at thelocation provided under the captionADDRESSES.


safety, Safety.

The Proposed AmendmentAccordingly, pursuant to the

authority delegated to me by theAdministrator, the Federal AviationAdministration proposes to amend part39 of the Federal Aviation Regulations(14 CFR part 39) as follows:



Authority: 49 U.S.C. 106(g), 40113, 44701.


removing amendment 39–9475 (61 FR5277, February 12, 1996), and by addinga new airworthiness directive (AD), toread as follows:

De Havilland, Inc.: Docket 95–NM–268–AD. Supersedes AD 95–26–17, amendment39–9475.

Applicability: Model DHC–8–301, –311,and –315 series airplanes; as listed in deHavilland Service Bulletin S.B. 8–57–24,Revision ‘A’, dated September 26, 1995;certificated in any category.

Note 1: This AD applies to each airplaneidentified in the preceding applicabilityprovision, regardless of whether it has beenotherwise modified, altered, or repaired inthe area subject to the requirements of thisAD. For airplanes that have been modified,altered, or repaired so that the performanceof the requirements of this AD is affected, theowner/operator must request approval for analternative method of compliance inaccordance with paragraph (f) of this AD. Therequest should include an assessment of theeffect of the modification, alteration, or repairon the unsafe condition addressed by thisAD; and, if the unsafe condition has not beeneliminated, the request should includespecific proposed actions to address it.


(a) Within 30 days after February 27, 1996(the effective date of AD 95–26–17,amendment 39–9475, accomplish themodification of the airspeed limitationplacards (Modification 8/2498) in accordancewith de Havilland Service Bulletin S.B. 8–57–24, Revision ‘A’, dated September 26,1995.

(b) Prior to further flight followingaccomplishment of the modification requiredby paragraph (a) of this AD, revise theLimitations Section of the FAA-approvedAirplane Flight Manual (AFM) byaccomplishing either paragraph (b)(1) or(b)(2) of this AD, as applicable; and operatethe airplane in accordance with thoselimitations.

(1) For Model DHC–8–301 series airplanes:Include the information specified in DHC–8Model 301 Flight Manual, PSM 1–83–1A,Flight Manual Revision 57, dated September26, 1995, which specifies a lower airspeedlimitation at full flaps. This may beaccomplished by inserting a copy of FlightManual Revision 57 into the AFM.

(2) For Model DHC–8–311 and –315 seriesairplanes: Include the following statement insection 2, paragraph 2.4.1.2., of the AFM.This may be accomplished by inserting acopy of this AD in the AFM.

‘‘Flap extended speed (VFE): Flaps 35degrees 130 knots IAS’’

(c) For Model DHC–8–311 and –315 seriesairplanes: Within 2 years after the effectivedate of this AD, install Modification 8/2066in accordance with de Havilland ServiceBulletin S.B. 8–57–24, Revision ‘A’, datedSeptember 26, 1995. Such installationconstitutes terminating action for therequirements of paragraphs (a) and (b) of thisAD.

Following accomplishment of Modification8/2066, the airspeed limitations placard(Modification 8/2498) required by paragraph(a) of this AD and the AFM limitationrequired by paragraph (b) of this AD may beremoved.

(d) Except as required by paragraph (e) ofthis AD: As of February 27, 1996 (theeffective date of AD 95–26–17, amendment39–9475), Modification 8/2498 must beaccomplished in accordance with deHavilland Service Bulletin S.B. 8–57–24,Revision ‘A’, dated September 26, 1995, priorto installation of any outboard flap assemblyhaving a part number and serial number thatis listed in de Havilland Service Bulletin S.B.

8–57–24, Revision ‘A’, dated September 26,1995.

(e) For Model DHC–8–311 and –315 seriesairplanes: As of two years after the effectivedate of this AD, prior to the installation ofany outboard flap assembly having a partnumber and serial number that is listed in deHavilland Service Bulletin S.B. 8–57–24,Revision ‘A’, dated September 26, 1995,install Modification 8/2066 on the affectedflap assembly in accordance with that servicebulletin. Installation of this modificationterminates the requirements specified inparagraphs (a), (b), and (d) of this AD.

(f) An alternative method of compliance oradjustment of the compliance time thatprovides an acceptable level of safety may beused if approved by the Manager, New YorkAircraft Certification Office (ACO), FAA,Engine and Propeller Directorate. Operatorsshall submit their requests through anappropriate FAA Principal MaintenanceInspector, who may add comments and thensend it to the Manager, New York ACO.

Note 3: Information concerning theexistence of approved alternative methods ofcompliance with this AD, if any, may beobtained from the New York ACO.

(g) Special flight permits may be issued inaccordance with §§ 21.197 and 21.199 of theFederal Aviation Regulations (14 CFR 21.197and 21.199) to operate the airplane to alocation where the requirements of this ADcan be accomplished.



Bureau of Indian Affairs

25 CFR Ch. I

Federal Regulatory Review; Notice ofIntent

AGENCY: Bureau of Indian Affairs,InteriorACTION: Notice of intent.

SUMMARY: The President’s RegulatoryReform Initiative requires Federalagencies to streamline the regulatoryprocess, to remove obsolete regulations,and to reduce the regulatory burden onthe general public. The Bureau of IndianAffairs (BIA) is committed to a goal ofeliminating or improving over 500 pagesof regulations by June 1, 1996. We willremove obsolete or unnecessary rulesand rewrite existing regulations in theclearer, more precise andunderstandable format of ‘‘PlainEnglish.’’ This approach to regulationwriting is intended to make rules easierto understand without changing theirmeaning.


FOR FURTHER INFORMATION CONTACT:Hilda Manuel, Deputy Commissioner ofIndian Affairs, Bureau of Indian Affairs,Mail Stop 4145–MIB, 1849 C StreetNW., Washington, DC 20240, ortelephone (202) 208–5116. Calls will bereferred to the Deputy Commissioner’sregulation reform team members forfurther coordination.

SUPPLEMENTARY INFORMATION: By June 1,1996, the BIA will publish rules forpublic and tribal review. The rules

included in this notice were identifiedin the Joint Tribal/BIA/DOI AdvisoryTask Force on Bureau of Indian AffairsReorganization report and by tribes andBIA program staff. Additional rules theJoint Tribal/BIA/DOI Advisory TaskForce on Bureau of Indian AffairsReorganization recommended forrevision will be considered separately(25 CFR Part 61, Preparation of Rolls ofIndians, 25 CFR Part 89, AttorneyContracts with Indian Tribes, 25 CFRPart 144, American Indian Trust Funds

Management Reform Act, and 25 CFRPart 287, Buy Indian Act).

This effort does not preclude anyconsultation currently planned orunderway. Tribal consultation onregulations with substantive rulemakingwill continue as planned. For the rulesinvolving only ‘‘Plain English’’ revision,consultation will be scheduled if thecomments received followingpublication of the proposed rulesindicate a need for further consultation.

LIST OF RULES THE BIA WILL REWRITE PLAIN ENGLISH AND PUBLISH AS PROPOSED RULES

25CFRpart

Title of rule

1 Applicability of Rules of the Bureau of Indian Affairs.2 Appeals from Administrative Actions.

26 Employment Assistance for Adult Indians.27 Vocational Training for Adult Indians.31 Federal Schools for Indians.33 Transfer of Indian Education Functions.43 Maintenance and Control of Student Records in Bureau Schools.

152 Issuance of Patents in Fee, Certificates of Competency, Removal of Restrictions, and Sale of Certain Indian Lands.154 Osage Roll, Certificate of Competency.169 Rights-of-Way over Indian Lands.175 Indian Electric Power Utilities.273 Education Contracts under Johnson O’Malley Act.

LIST OF RULES CURRENTLY IN THE RULEMAKING PROCESS—BIA WILL MAKE SUBSTANTIVE REVISIONS, REMOVE OBSO-LETE OR UNNECESSARY REQUIREMENTS, REWRITE IN ‘‘PLAIN ENGLISH,’’ AND PUBLISH AS PROPOSED OR FINALRULES

25CFRpart

Title of rule

5 Preference in Employment.10 Adult and Juvenile Detention Standards for Facilities and Programs.12 The Indian Police.36 Minimum Academic Standards for the Basic Education of Indian Children and National Criteria for Dormitory Situations.39 The Indian School Equalization Program.40 Administration of Educational Loans, Grants and Other Assistance for Higher Education.41 Grants to Tribally Controlled Community Colleges and Navajo Community College.46 Administration of the Adult Education Program—NEW RULE.81 Tribal Reorganization Under a Federal Statute.82 Petitioning Procedures for Tribes Reorganized Under Federal Statute and Other Organized Tribes.

101 Loans to Indians from the Revolving Loan Fund.103 Loan Guaranty, Insurance and Interest Subsidy.150 Land Records and Title Documents.162 Leasing and Permitting.166 General Grazing Regulations.170 Roads of the Bureau of Indian Affairs.171 Operation and Maintenance.211 Leasing of Tribal Lands for Mining.212 Leasing of Allotted Lands for Mining.213 Leasing of Restricted Lands of Members of Five Civilized Tribes, Oklahoma for Mining, Except Oil and Gas.214 Leasing of Osage Reservation Lands, Oklahoma, for Mining, Except Oil and Gas.215 Lead and Zinc Mining Operations and Leases, Quapaw Agency.216 Surface Exploration, Mining, and Reclamation of Lands.217 Management of Tribal Assets of Ute Indian Tribe, Uintah and Ouray Reservation, Utah, by the Tribe and the Ute Distribution Corp.227 Leasing of Certain Lands in Wind River Indian Reservation, Wyoming, for Oil and Gas Mining.256 Housing Improvement Program.286 Indian Business Development Program.


LIST OF RULES THAT ARE OBSOLETE OR REPLACED BY NEW RULES—BIA WILL REMOVE THESE RULES

25CFRpart

Title of rule

45 Special Education.65 Preparation of a Membership Roll of Delaware Indians of Western Oklahoma.66 Preparation of Rolls of Delaware Indians.76 Enrollment of Indian of the San Pasqual Band of Mission Indians in California.

142 Operation of U.S.M.S. ‘‘North Star’’ between Seattle, Washington and Stations of the Bureau of Indian Affairs and other GovernmentAgencies, Alaska.

250 Indian Fishing—Hoopa Valley Indian Reservation.271 Contracts under Indian Self-determination Act—Replaced with new Part 900.272 Grants under Indian Self-determination Act—Replaced with new Part 900.274 School Construction Contracts or Services for Tribally Operated Previously Private Schools.276 Uniform Administrative Requirements for Grants—Replaced with new Part 900.278 Special Grants for Economic Development and Core Management Grants to Small Tribes—Replaced with new Part 900.

Dated: April 12, 1996.Ada E. Deer,Assistant Secretary—Indian Affairs.[FR Doc. 96–9745 Filed 4–22–96; 8:45 am]BILLING CODE 4310–02–P

Office of Surface Mining Reclamationand Enforcement

30 CFR Part 948

[WV–075–FOR]

West Virginia Permanent RegulatoryProgram

AGENCY: Office of Surface MiningReclamation and Enforcement (OSM),Interior.ACTION: Proposed rule.

SUMMARY: OSM is announcing thereceipt of proposed amendments to theWest Virginia permanent regulatoryprogram (hereinafter referred to as theWest Virginia program) under theSurface Mining Control andReclamation Act of 1977 (SMCRA). Theamendments concern revisions to theWest Virginia Surface MiningReclamation Regulations. Theamendments are intended to improvethe clarity and effectiveness of the WestVirginia program, and to revise the Stateprogram to be consistent with thecorresponding Federal regulations.DATES: Written comments must bereceived on or before 4:00 p.m. on May23, 1996. If requested, a public hearingon the proposed amendments will beheld at 1:00 p.m. on May 20, 1996.Requests to present oral testimony at thehearing must be received on or before4:00 p.m. on May 8, 1996.ADDRESSES: Written comments andrequests to speak at the hearing shouldbe mailed or hand delivered to Mr.James C. Blankenship, Jr., Director,Charleston Field Office at the addresslisted below.

Copies of the proposed amendment,the West Virginia program, and theadministrative record on the WestVirginia program are available for publicreview and copying at the addressesbelow, during normal business hours,Monday through Friday, excludingholidays. Each requester may receiveone free copy of the proposedamendment by contacting the OSMCharleston Field Office.Mr. James C. Blankenship, Jr., Director,

Charleston Field Office, Office ofSurface Mining Reclamation andEnforcement, 1027 Virginia Street,East, Charleston, West Virginia 25301,Telephone: (304) 347–7158

West Virginia Division ofEnvironmental Protection, 10McJunkin Road, Nitro, West Virginia25143, Telephone: (304) 759–0515.In addition, copies of the proposed

amendments are available for inspectionduring regular business hours at thefollowing locations:Office of Surface Mining Reclamation

and Enforcement, Morgantown AreaOffice, 75 High Street, Room 229, P.O.Box 886, Morgantown, West Virginia26507, Telephone (304) 291–4004

Office of Surface Mining Reclamationand Enforcement, Beckley AreaOffice, 323 Harper Park Drive, Suite 3,Beckley, West Virginia 25801,Telephone (304) 255–5265.

FOR FURTHER INFORMATION CONTACT: Mr.James C. Blankenship, Jr., Director,Charleston Field Office; Telephone:(304) 347–7158.


I. Background on the West VirginiaProgram

On January 21, 1981, the Secretary ofthe Interior conditionally approved theWest Virginia program. Backgroundinformation on the West Virginiaprogram, including the Secretary’sfindings, the disposition of comments,

and the conditions of the approval canbe found in the January 21, 1981,Federal Register (46 FR 5915–5956).Subsequent actions concerning the WestVirginia program and previousamendments are codified at 30 CFR948.10, 948.12, 948.13, 948.15, and948.16.

II. Discussion of the ProposedAmendment

By letter dated April 2, 1996(Administrative Record Number WV–1024), the West Virginia Division ofEnvironmental Protection (WVDEP)submitted an amendment to itsapproved permanent regulatory programpursuant to 30b CFR 732.17. Theamendment contains revisions to theWest Virginia Surface MiningReclamation Regulations (CSR section38–2–1 et seq.).

The last time the State regulationswere significantly revised was onFebruary 21, 1996. The Directorpartially approved the revisions in theFebruary 21, 1996, Federal Register (61FR 6511–6537). See 30 CFR 948.15 forthe provisions partially approved. See30 CFR 948.16 for requiredamendments.

Proposed Amendments

1. Section 38–2–2–106 Definition of‘‘Safety factor.’’ This definition isrevised to mean the ratio of the sum ofthe resisting forces to the sum of theloading or driving forces as determinedby acceptable engineering practices.Prior to this change, the term wasdefined as the ratio of the sum of theresisting forces to the sum of the loadingforces.

2. Section 38–2–3.2(e)Readvertisement of permit applications.This provision is amended by addingthe phrase, ‘‘that do not significantlyaffect the health, safety or welfare of thepublic and,’’ to the first sentence. Withthis change, a limited number of minor


changes may be grouped and advertisedin one additional notice if the changesdo not significantly affect the health,safety or welfare of the public.

3. Section 38–2–2.6(h)(5) Certificationof drainage/sediment control structuredesigns. This provision is amended bychanging a cited reference concerningdams. ‘‘Article 5D of Chapter 20’’ isdeleted and replaced by ‘‘Article 14 ofChapter 22.’’

4. Section 38–2–3.8(c) Revision orreconstruction of existing structures andsupport facilities. This provision isamended by adding the followinglanguage: ‘‘Provided, that thosestructures and facilities, where it can bedemonstrated that reconstruction orrevision would result in greaterenvironmental harm and theperformance standards set forth in theAct and these regulations can otherwisebe met, may be exempt from revision orreconstruction.’’ This amendment, ineffect, provides an alternative torequiring revision or reconstruction ofstructures or support facilities in caseswhere greater environmental harmwould result from the revisions orreconstruction.

5. Section 38–2–3.27 Permit renewalsand extensions. The introductoryparagraph of this provision is amendedby deleting the work ‘‘may’’ and addingin its place the word ‘‘shall.’’ Inaddition, language has been deleted thatrequired all backfilling and grading becompleted within 60 days prior to theexpiration date of the permit, and thatan application for Phase I bond releasebe filed prior to the expiration date ofthe permit. As amended, the provisionprovides that the Director of theDivision of Environmental Protection(DEP) shall waive the requirements forrenewal if the permittee certifies inwriting that all coal extraction iscompleted, that all backfilling andregrading will be completed andreclamation activities are ongoing.

6. Section 38–2–4.4 Infrequently usedaccess road. This provision is revised bydeleting and adding rule citations. asamended, infrequently used accessroads may not be exempt from therequirements of §§ 38–2–4.2, 4.7(a), 4.8,4.9, and 5.3.

7. Section 38–2–4.12 Certification ofprimary roads. This provision isamended by deleting the requirementthat changes documented in the as-builtplans be submitted to the Director ofDEP as a permit revision. In its place,the following language is added: ‘‘If as-built plans are submitted, thecertification shall describe how and towhat extent the construction deviatesfrom the proposed design, and shallexplain how and certify that the road

will meet performance standards. Ineffect, this amendments replaces arequirement that all changesdocumented as-built plans be submittedas a permit revision, with a requirementthat when changes are certified, thecertification shall include anexplanation and certification that thechanges will meet performancestandards.

8. Section 38–2–5.4(c) Safetystandards for embankment typestructures. The first paragraph of thisprovision is amended by deleting thephrase ‘‘which may include slurryimpoundments.’’ With this amendment,the provision’s safety standards apply toall embankment type sediment controlor other water retention structures.

9. Section 38–2–11.6(a) Review ofpermits for adequacy of bond. Thisprovision is amended to add arequirement that permits will not berenewed until the appropriate amountof bond has been posted.

Also, subparagraphs (a) (2), (3), and(4) are deleted. These subparagraphsprovided that existing permits (forunderground mines, preparation plants,and coal refuse sites) shall be subject tothe site-specific bond criteria of § 38–2–11.6 at the time of application forrenewal or mid-term review, shall notbe renewed by the Director of DEP untilthe appropriate amount of bond isposted. See the first paragraph in 11.6(a)for language similar to that which isbeing deleted.

10. Section 38–2–11.6( c)(6), (d)(6),(e)(5), (f)(5) Bond reduction credits.These provisions are being amended todelete, in various places, the phrase‘‘within five (5) years of the date of SMAapproval.’’ In effect, the amount of bondreduction credits assigned is no longercontingent upon the ‘‘five years from thedate of SMA approval’’ criterion.

11. Section 38–2–12.2(e) Bondrelease—chemical treatment. Theexisting language of this provision isdeleted and replaced by the following:

Notwithstanding any other provisions ofthis rule, no bond release or reduction willbe granted if, at the time, water dischargedfrom or affected by the operation requireschemical treatment in order to comply withapplicable effluent limitations or waterquality standards; Provided, That theDirector may approve a request for Phase Ibut not Phase II or III, release if the applicantdemonstrates to the satisfaction of theDirector that either:

(A) The remaining bond is adequate toassure long term treatment of the drainage; or

(B) The operator has irrevocably committedother financial resources which are adequateto assure long term treatment of the drainage;Provided, That the alternate financialresources must be in acceptable form, andmeet the standards set forth in Section 11 of

the Act and Section 11 of these regulations;Provided, however, That alternate financialarrangements shall provide a mechanismwhereby the Director can assumemanagement of the resources and treatmentwork in the event that the operator defaultsfor any reason; And provided further, Thatdefault on a treatment obligation under thisparagraph shall be considered equivalent toa bond forfeiture, and the operator will besubject to penalties and sanctions, includingpermit blocking, as if a bond forfeiture hadoccurred.

In order to make such demonstration asreferenced above, the applicant shall address,at a minimum, the current and projectedquantity and quality of drainage to be treated,the anticipated duration of treatment, theestimated capital and operating cost of thetreatment facility, and the calculations whichdemonstrate the adequacy of the remainingbond or of the alternate financial resources.

In effect, the added language wouldallow, under the specifiedcircumstances, Phase I bond release onoperations which require chemicaltreatment in order to comply withapplicable effluent limitations or waterquality standards.

The Director notes that the State’sdefinition of ‘‘chemical treatment’’ at§ 38–2–2.20 has only been partiallyapproved by OSM. Specifically, thelanguage of the definition that excludespassive treatment systems from beingconsidered ‘‘chemical treatment’’ wasnot approved to the extent that suchpassive treatment systems would beapplied in the context of § 38–2–12.2(e)to authorize bond release for sites withdischarges that require passivetreatment to meet discharge standards.For a complete explanation of thepartial disapproval of the State’sdefinition of ‘‘chemical treatment,’’ seeFinding B–2, in the February 21, 1996,Federal Register (61 FR 6511) page6517.

12. Section 38–2–14.14(e)(4) Valleyfills—rock core chimney drains. Thisprovision is being amended by deletingthe third sentence, which concerns thecontrol of surface water runoff, andreplacing that language with thefollowing:

Surface water runoff from areas above andadjacent to the fill shall be diverted intoproperly designed and constructed stabilizeddiversion channels which have beendesigned using best current technology tosafely pass the peak runoff from a 1.0 year,24-hour precipitation event. The channelshall be designed and constructed to ensurestability of the fill, control erosion, andminimize water infiltration into the fill.

13. Section 38–2–14.15(m) Coalprocessing waste disposal. Thisprovision is being amended by deletingthe prohibition at 14.15(m)(1) that coalprocessing waste ‘‘will not contain acidproducing or toxic forming material.’’ A


new provision at 14.15(m)(2) is added toprovide as follows:

(2) The coal processing waste will not beplaced in the backfill unless it has beendemonstrated to the satisfaction of theDirector that: (A) the coal processing wasteto be placed based upon laboratory testing tobe non-toxic and/or non-acid producing; or(B) an adequate handling plan includingalkaline additives has been developed andthe material after alkaline addition is non-toxic and/or non-acid producing.

III. Public Comment ProceduresIn accordance with the provisions of

30 CFR 732.17(h), OSM is now seekingcomments on the proposed amendmentssubmitted by the State of West Virginiato its permanent regulatory program.Specifically, OSM is seeking commentson the revisions to the State’sregulations that were submitted onApril 2, 1996 (Administrative RecordNo. WV–1024). Comments shouldaddress whether the proposedamendments satisfy the applicableprogram approval criteria of 30 CFR732.15. If the amendments are deemedadequate, they will become part of theWest Virginia program.

Written CommentsWritten comments should be specific,

pertain only to the issues proposed inthis rulemaking and includeexplanations in support of thecommenter’s recommendations.Comments received after the timeindicated under DATES or at locationsother than the OSM Charleston FieldOffice will not necessarily beconsidered in the final rulemaking orincluded in the Administrative Record.

Public HearingPersons wishing to testify at the

public hearing should contact theperson listed under FOR FURTHERINFORMATION CONTACT by the close ofbusiness on May 8, 1996. If no onerequests an opportunity to testify at thepublic hearing by that date, the hearingwill not be held.

Filing of a written statement at thetime of the hearing is requested as itwill greatly assist the transcriber.Submission of written statements inadvance of the hearing will allow OSMofficials to prepare adequate remarksand appropriate questions.

The public hearing will continue onthe specified date until all personsscheduled to testify have been heard.Persons in the audience who have notbeen scheduled to testify, and who wishto do so, will be heard following thosescheduled. The hearing will end after allpersons scheduled to testify and personspresent in the audience who wish totestify have been heard.

Public MeetingIf only one person or group requests

to testify at a hearing, a public meeting,rather than a public hearing, may beheld, and the results of the meetingincluded in the Administrative Record.

Persons wishing to meet with OSMrepresentatives to discuss the proposedamendments may request a meeting atthe OSM Charleston Field Office listedunder ADDRESSES by contacting theperson listed under FOR FURTHERINFORMATION CONTACT.

All such meetings will be open to thepublic and, if possible, notices ofmeetings will be posted in advance atthe locations listed under ADDRESSES. Awritten summary of each public meetingwill be made a part of theAdministrative Record.

IV. Procedural Determinations

Executive Order 12291On July 12, 1984, the Office of

Management and Budget (OMB) grantedOSM an exemption from sections 3, 4,7 and 8 of Executive Order 12291(Reduction of Regulatory Burden) foractions related to approval orconditional approval of State regulatoryprograms, actions and programamendments. Therefore, preparation ofa regulatory impact analysis is notnecessary, and OMB regulatory reviewis not required.

Executive Order 12778The Department of the Interior has

conducted the reviews required bysection 2 of Executive Order 12778(Civil Justice Reform) and hasdetermined that, to the extent allowedby law, this rule meets the applicablestandards of subsections (a) and (b) ofthat section. However, these standardsare not applicable to the actual languageof State regulatory programs andprogram amendments since each suchprogram is drafted and promulgated bya specific state, not by OSM. Undersections 503 and 505 of the SurfaceMining Control and Reclamation Act(SMCRA) (30 U.S.C. 1253 and 1255) and30 CFR 730.11, 732.15 and732.17(h)(10), decisions on proposedState regulatory programs and programamendments submitted by the Statesmust be based solely on a determinationof whether the submittal is consistentwith SMCRA and its implementingFederal regulations and whether theother requirements of 30 CFR parts 730,731 and 732 have been met.

National Environmental Policy ActNo environmental impact statement is

required for this rule since section702(d) of SMCRA [30 U.S.C. 1292(d)]

provides that agency decisions onproposed State regulatory programprovisions do not constitute majorFederal actions within the meaning ofsection 102(2)(C) of the NationalEnvironmental Policy Act, 42 U.S.C.4332(2)(C).


This rule does not containinformation collection requirements thatrequire approval by the Office ofManagement and Budget under thePaperwork Reduction Act, 44 U.S.C.3507 et seq.

Regulatory Flexibility Act

The Department of the Interior hasdetermined that this rule will not havea significant economic impact on asubstantial number of small entitiesunder the Regulatory Flexibility Act (5U.S.C. 601 et seq.). The State submittalwhich is the subject of this rule is basedupon counterpart Federal regulations forwhich an economic analysis wasprepared and certification made thatsuch regulations would not have asignificant economic effect upon asubstantial number of small entities.Accordingly, this rule will ensure thatexisting requirements previouslypromulgated by OSM will beimplemented by the State. In making thedetermination as to whether this rulewould have a significant economicimpact, the Department relied upon thedata and assumptions for thecounterpart Federal regulations.


Intergovernmental relations, Surfacemining, Underground mining.

Dated: April 12, 1996.Allen D. Klein,Regional Director, Appalachian RegionalCoordinating Center.[FR Doc. 96–9937 Filed 4–22–96; 8:45 am]BILLING CODE 4310–05–M


Coast Guard

33 CFR Part 110

[CGD07–96–017]

RIN 2115–AA98

Special Anchorage Areas; AshleyRiver, Charleston, SC

AGENCY: Coast Guard, DOT.ACTION: Notice of proposed rulemaking.

SUMMARY: The Coast Guard is proposingto establish two new anchorage areas inthe Ashley River, Charleston, South


Carolina to replace an existinganchorage. Due to pending constructionof two 1000 ft piers at the George M.Lockwood Municipal Marina, inCharleston, the current anchorage willnot be available for anchoringrecreational vessels. The MunicipalMarina has received a constructionpermit to build the piers from the U.S.Army Corps of Engineers. The newanchorages will be necessary to replacethe one described in 33 CFR 110.72d.The proposed anchorages are across theAshley River from the current anchorageand though not designated as Federalanchorages, they are already widelyused by recreational vessels as overflowfrom the current anchorage.DATES: Comments must be received onor before June 24, 1996.ADDRESSES: Comments should bemailed to the Captain of the PortCharleston, Marine Safety OfficeCharleston, South Carolina 29401–1899.The comments will be available forinspection and copying at 196 TraddStreet, Charleston, SC between 9 a.m.and 3 p.m., Monday through Friday,except Federal holidays. Comments mayalso be hand delivered to this address.FOR FURTHER INFORMATION CONTACT:CW04 R.M. Webber, Project Officer, Tel:(803) 724–7690.SUPPLEMENTARY INFORMATION: Interestedpersons are invited to participate in thisrulemaking by submitting written views,data or arguments. Persons submittingcomments should include their namesand addresses, identify this notice(CGD07–96–017) and the specificsection of this proposal to which theircomments apply, and give reasons foreach comment. The regulations may bechanged in the light of commentsreceived. All comments received beforethe expiration of the comment periodwill be considered before final action istaken on this proposal.

No public hearing is planned, but onemay be held if written requests for ahearing are received, and it isdetermined that the opportunity tomake oral presentations will aid therulemaking process.

Discussion of Proposed RegulationsThe City Marina Company and the

City of Charleston have been granted, bythe U.S. Army Corps of Engineers, apermit to build two 1000 foot piers onthe south side of the Municipal Marina.These piers will cross an existinganchorage eliminating most of theanchorages within that area that haveover six feet of water at mean low water.As the anchorage is extensively used byrecreational vessels, two new anchorageareas are being proposed to

accommodate vessels that will bedisplaced when the new piers are built.The new anchorages are already beingused by recreational vessels as overflowfrom the existing anchorage. To date, noproblems have arisen from recreationalvessels anchoring in these areas. Sincethe marina plans were published in thelocal newspaper, there has beenconsiderable public interest inestablishing new anchorages to replacethe existing anchorage.

Proposed Ashley River AnchorageNumber One would be located on thewaters lying within an area across theAshley River Channel from the GeorgeM. Lockwood Municipal Marinabounded by the southwest side of thechannel beginning at latitude32°46′43.7′′N, longitude 079°57′19.3′′W;thence to latitude 32°46′38.0′′N,longitude 079°57′24.0′′W; thence tolatitude 32°46′32.0′′N, longitude079°57′15.5′′W; thence to latitude32°46′29.0′′N, longitude 079°57′00.9′′W;thence back to the beginning followingthe southwest boundary of the AshleyRiver Channel. All coordinatesreferenced use Datum: NAD 1983.

Proposed Ashley River AnchorageNumber Two would be located on thewaters lying within an area across theAshley River Channel from the AshleyMarina bounded by the southwest sideof the channel beginning latitude32°46′53.0′′N, longitude 079°57′34.5′′W;thence to latitude 32°46′50.5′′N,longitude 079°57′40.5′′W; thence tolatitude 32°46′46.0′′N, longitude079°57′34.5′′W; thence to latitude32°46′49.0′′N, longitude 079°57′28.7′′W;thence back to the beginning followingthe southwest boundary of the AshleyRiver Channel. All referencedcoordinates use Datum: NAD 1983.

These proposed anchorage areas willprovide that vessels no more than sixty-five feet in length, when anchored in theanchorage areas, shall not be required tocarry or exhibit the white anchor lightsrequired by the Navigation Rules.

Regulatory EvaluationThis proposal is not a significant

regulatory action under section 3(f) ofExecutive Order 12866 and does notrequire an assessment of potential costsand benefits under section 6(a)(3) of thatorder. It has been exempted from reviewby the Office of Management andBudget under that order. It is notsignificant under the regulatory policiesand procedures of the Department ofTransportation (DOT) (44 FR 11040;February 26, 1979). The Coast Guardexpects the economic impact of thisproposal to be so minimal that a fullRegulatory Evaluation under paragraph10e of the regulatory policies and

procedures of DOT is unnecessary. Theproposed anchorage areas described inthis notice are currently being used byrecreational vessels as over flow fromthe existing anchorage.

Since the impact of this proposal isexpected to be minimal, the Coast Guardcertifies that, if adopted, it will not havea significant economic impact on asubstantial number of small entities.

Collection of InformationThis proposed rule contains no

collection-of-information requirementsunder the Paperwork Reduction Act (44U.S.C. 3501 et seq.).

FederalismThis action has been analyzed in

accordance with the principles andcriteria contained in Executive Order12612, and it has been determined thatthe proposed rulemaking does not havesufficient federalism implications towarrant the preparation of a FederalismAssessment.

Environmental AssessmentThe Coast Guard has considered the

environmental impact of this proposaland has determined pursuant to Section2.B.2. of Commandant InstructionM16475.1B, hat this action iscategorically excluded from furtherenvironmental documentation. ACategorical Exclusion Determinationand Environmental Analysis Checklistare available in the docket forinspection or copying at the locationlisted in ADDRESSES.

List of Subjects in 33 CFR Part 110Anchorage grounds.

Proposed RegulationsIn consideration of the foregoing, the

Coast Guard proposes to revise Part 110of Title 33, Code of Federal Regulations,as follows:

PART 110—[AMENDED]


Authority: 33 U.S.C. 471, 2030, 2035 and2071; 49 CFR 1.46 and 33 CFR 1.05–1(g).Section 110.1a and each section listed in110.1a are also issued under 33 U.S.C. 1223and 1231.

2. Section 110.72d is revised to readas follows:

§ 110.72d Ashley River Anchorage Areas,SC.

The following locations are specialanchorage areas:

(a) Ashley River Anchorage 1. Thewaters lying within an area across theAshley River Channel from the GeorgeM. Lockwood Municipal Marinabounded by the southwest side of thechannel beginning at latitude


33°46′43.7′′ N, longitude 079°57′19.3′′W; thence to latitude 32°46′38.0′′ N,longitude 079°57′24.0′′ W; thence tolatitude 32°46′32.0′′ N, longitude079°57′15.5′′ W; thence to latitude32°46′29.0′′ N, longitude 079°57′00.9′′W; thence back to the beginningfollowing the southwest boundary of theAshley River Channel. All coordinatesreferenced use Datum: NAD 1983.

(b) Ashley River Anchorage 2. Thewaters lying within an area across theAshley River Channel from the AshleyMarina bounded by the southwest sideof the channel beginning at latitude33°46′53.0′′ N, longitude 079°57′34.5′′W; thence to latitude 32°46′50.5′′ N,longitude 079°57′40.5′′ W; thence tolatitude 32°46′46.0′′ N, longitude079°57′34.5′′ W; thence to latitude32°46′49.0′′ N, longitude 079°57′28.7′′W; thence back to the beginningfollowing the southwest boundary of theAshley River Channel. All coordinatesreferenced use Datum: NAD 1983.

Dated: April 10, 1996.P.J. Cardaci,Captain, U.S. Coast Guard, ActingCommander, Seventh Coast Guard District.[FR Doc. 96–9879 Filed 4–22–96; 8:45 am]BILLING CODE 4910–14–P

ENVIRONMENTAL PROTECTIONAGENCY

40 CFR Parts 262, 264, 265, and 270

[IL–64–2–5807; FRL–5459–9]

Hazardous Waste Treatment, Storage,and Disposal Facilities and HazardousWaste Generators; Organic AirEmission Standards for Tanks, SurfaceImpoundments, and Containers

AGENCY: Environmental ProtectionAgency (EPA).ACTION: Notice of data availability.

SUMMARY: This notice announces theavailability of additional data that arebeing considered by the EPA inamending the air emission standards forhazardous waste treatment, storage, anddisposal facilities (TSDF) that werepublished December 6, 1994 under theauthority of the Resource Conservationand Recovery Act (RCRA), as amended(59 FR 62896). This notice addresses thenarrow issue of an Other ThermalTreatment Facility subject to regulationunder subpart P of Part 265 (40 CFR265.370 through 265.383) being eligibleto receive spent activated carbon whichis a hazardous waste. The additionaldata are available for public inspectionat the EPA RCRA Docket Office.

DATES: Comments on these additionaldata will be accepted through May 7,1996.DOCKET: The information referenced bytoday’s notice is available for publicinspection and copying in the RCRAdocket. The RCRA docket numberspertaining to this rulemaking are F–91–CESP–FFFFF, F–92–CESA–FFFFF, F–94–CESF–FFFFF, F–94–CE2A–FFFFF,and F–95–CE3A–FFFFF. The RCRAdocket is located at Crystal Gateway,1235 Jefferson Davis Highway, FirstFloor, Arlington, Virginia. Handdelivery of items and review of docketmaterials are made at the Virginiaaddress. The public must have anappointment to review docket materials.Appointments can be scheduled bycalling the Docket Office at (703) 603–9230. The mailing address for the RCRAdocket office is RCRA InformationCenter (5305W), U. S. EnvironmentalProtection Agency, 401 M Street SW.,Washington, DC 20460.COMMENTS: Written comments regardingthese data may be mailed to the DocketClerk at the above-mentionedWashington, DC mailing address. Pleasesend an original and two copies of allcomments, and refer to Docket NumberF–96–CE4A–FFFFF. The EPA willconsider comments on the additionaldata that are received through May 7,1996.FOR FURTHER INFORMATION CONTACT: Forinformation about this notice and theassociated rulemaking contact the RCRAHotline at (703) 412–9877 or toll-free at1–800–424–9346.SUPPLEMENTARY INFORMATION: Thisnotice is available on the EPA’s Clean-up Information Bulletin Board (CLU–IN). To access CLU–IN with a modem ofup to 28,800 baud, dial (301) 589–8366.First time users will be asked to inputsome initial registration information.Next, select ‘‘D’’ (download) from themain menu. Input the file name‘‘RCRA–NDA.496’’ to download thisnotice. Follow the on-line instructionsto complete the download. Moreinformation about the downloadprocedure is located in Bulletin 104; toread this type ‘‘B 104’’ from the mainmenu. For additional help with theseinstructions, telephone the CLU–IN helpline at (301) 589–8368.

On December 6, 1994, the EPApublished in the Federal Register (59FR 62896) under authority of the RCRAstandards requiring the use of airemission controls on certain tanks,surface impoundments, and containersat hazardous waste TSDF. Thesestandards are codified in 40 CFR parts264 and 265 under subpart CC (referredto as the ‘‘subpart CC standards’’).

This Notice of Data Availabilityaddresses the appropriateness of anOther Thermal Treatment Facilitysubject to regulation under subpart P ofPart 265 (40 CFR 265.370 through265.383) being eligible to receive spentactivated carbon which is a hazardouswaste. In the December 6, 1994 finalsubpart CC standards (59 FR 62896), theEPA established a requirement thatspent activated carbon removed from acontrol device had to be managed atparticular types of facilities, namelyregulated incinerators, regulated boilersor industrial furnaces, or ‘‘thermaltreatment units that [are] permittedunder subpart X of 40 CFR part 264 orsubpart P of [Part 265]’’. See 40 CFR265.1033(l)(1) as promulgated at 59 FRat 62935 (Dec. 6, 1994). A parallelrequirement was contained in 40 CFR264.1033(m), but no reference to subpartP was included (59 FR at 62927). In theFebruary 9, 1996 technical correctionnotice, the EPA amended theseprovisions to clarify that they applyonly to activated carbon which is ahazardous waste, and that interim statusincinerators and boilers and industrialfurnaces which had certifiedcompliance could receive such activatedcarbon. See 61 FR at 4910, 4911, and4913. In so doing, the EPA removed thereference to subpart P facilities in265.1033(l)(1), thus removing suchfacilities from eligibility to receivehazardous waste spent activated carbonfrom interim status facilities, but did notprovide any explanation for thisomission.

The Response to CommentBackground Information Document tothe Final Rule does not completelyclarify the EPA’s intent. At one pointthe EPA mentioned subpart P facilitiesas potentially eligible to receivehazardous waste spent activated carbon(BID page 6–113 and 114), but at otherpoints indicated that only other thermaltreatment units permitted under subpartX would be eligible (BID at 6–116 and117).

After publication of the February 9notice, the EPA received a letter from asubpart P facility which reactivatesspent activated carbon questioning theomission of subpart P facilities fromamended 265.1033(l). The EPA isnoticing this letter, along withmemoranda documenting EPA’s furthercontacts with the facility, for comment.The EPA is also seeking comment on thefollowing issues. The subpart CCstandards specify the types of facilitiesthat can manage hazardous waste spentactivated carbon so that EPA can ensurethat any adsorbed hazardous organic


constituents released from the carbonare adequately controlled or destroyed,rather than emitted to the atmosphere(BID page 6–115). It is not clear that thesubpart P standards, taken bythemselves, provide this assurance,since subpart P standards do not containsubstantive air emission controls. Thus,in addition to soliciting comment on theinformation in the docket, the EPAsolicits comment on whether somefurther limitation should be necessary ifsubpart P facilities are to be eligible. Forexample, should eligibility be limited tofacilities whose regeneration unitsprovide adequate protection from theemission of desorbed organics? If so, isit appropriate to require compliancewith subpart CC, or comparable controlsto ensure such protection? The EPA willconsider all comments on the new datareceived by the close of the commentperiod when making a final regulatorydetermination on the regulatoryrequirements for this regulation.

This notice does not represent theonly provision of the final subpart CCstandards which the EPA is consideringrevising. The EPA is planning to publishtechnical amendments to the rulewithin the next two months which willinclude revisions described in theAugust 14, 1995 Federal Registerdocument entitled, ‘‘Proposed rule; dataavailability’’ (60 FR 41870), as well asa finding on the issue discussed intoday’s notice.

Dated: April 11, 1996.Richard Wilson,Acting Assistant Administrator for Air andRadiation.[FR Doc. 96–9973 Filed 4–22–96; 8:45 am]BILLING CODE 6560–50–P

FEDERAL COMMUNICATIONSCOMMISSION

47 CFR Parts 73 and 74

[MM Docket No. 96–90, FCC 96–169]

Telecommunications Act of 1996;Broadcast License Terms

AGENCY: Federal CommunicationsCommission.ACTION: Proposed rule.

SUMMARY: We issue this Notice ofProposed Rule Making (‘‘NPRM’’) toimplement Section 203 of theTelecommunications Act of 1996(‘‘Telecom Act’’) (Broadcast LicenseTerms). Section 203 eliminates thestatutory distinction between themaximum allowable license terms fortelevision stations and radio stations,and provides that such licenses may be

for terms ‘‘not to exceed 8 years.’’Amendment of the Commission’s Rulesis necessary to conform them to Section203 of the Telecom Act. We seekcomment on our proposal to amend ourrules to extend broadcast license termsto 8 years, as well as on our proposal forimplementing this change within theframework of existing license renewalcycles.DATES: Comments are due on or beforeMay 20, 1996, and reply comments aredue on or before June 4, 1996. Writtencomments by the public on theproposed and/or modified informationcollections are due on or before May 20,1996.ADDRESSES: Federal CommunicationsCommission, Washington, D.C. 20554.FOR FURTHER INFORMATION CONTACT:Robert Somers (202–418–2130), MassMedia Bureau.SUPPLEMENTARY INFORMATION: This is asynopsis of the Notice of Proposed RuleMaking in MM Docket No. 96–90, FCC96–169, adopted April 11, 1996 andreleased April 12, 1996. The completetext of this Notice of Proposed RuleMaking is available for inspection andcopying during normal business hoursin the FCC Reference Center (Room239), 1919 M Street NW., Washington,D.C., and also may be purchased fromthe Commission’s copy contractor,International Transcription Service,(202) 857–3800, 2100 M Street, N.W.,Suite 140, Washington, DC 20037.

Synopsis of Notice of Proposed RuleMaking Extending License Terms forBroadcast Facilities

1. Section 307(c) of theCommunications Act of 1934, asamended, 47 U.S.C. § 307(c), authorizesthe Commission to establish the periodor periods for which licenses shall begranted or renewed. Prior to theenactment of the Telecom Act, Section307(c) provided that the licenses oftelevision stations, including low powerTV stations, could be issued for a termof no longer than 5 years. It furtherprovided that license terms for radiostations, including auxiliary facilities,could be for a period not to exceed 7years. These were the maximumallowable license terms and theCommission had the discretion to grantor renew a broadcast license for ashorter period if the public interest,convenience, and necessity would beserved by such action. Consistent withthese statutory provisions, Section73.1020 of the Commission’s Rulescurrently states that ‘‘[r]adiobroadcasting stations will ordinarily berenewed for 7 years and TV broadcaststations will be renewed for 5 years.

However, if the FCC finds that thepublic interest, convenience andnecessity will be served thereby, it mayissue either an initial license or arenewal thereof for a lesser term.’’Section 73.1020 also sets forth a renewalschedule for broadcast stations based onthe geographical region of the country inwhich each station is located.

2. Section 203 of the Telecom Actamends Section 307(c) of theCommunications Act to read as follows:

Each license granted for the operation of abroadcasting station shall be for a term of notto exceed 8 years. Upon application therefor,a renewal of such license may be grantedfrom time to time for a term of not to exceed8 years from the date of expiration of thepreceding license, if the Commission findsthat public interest, convenience, andnecessity would be served thereby.Consistent with the foregoing provisions ofthis subsection, the Commission may by ruleprescribe the period or periods for whichlicenses shall be granted and renewed forparticular classes of stations, but theCommission may not adopt or follow anyrule which would preclude it, in any caseinvolving a station of a particular class, fromgranting or renewing a license for a shorterperiod than that prescribed for stations ofsuch class if, in its judgment, the publicinterest, convenience, or necessity would beserved by such action.

3. Length of License Terms. Althoughthe language of Section 203 of theTelecom Act lengthens the maximumpermissible broadcast license term to 8years for both television and radiostations, the statute does not require theCommission to extend license terms to8 years as a matter of course. Thestatutory language provides that licensesare to have terms ‘‘not to exceed 8years’’ and expressly states that theCommission ‘‘may’’ grant renewals forterms not to exceed 8 years if the publicinterest would be served thereby.Moreover, the language indicates thatthe Commission may, by rule, adoptdifferent license terms for differentclasses of stations. Given this discretionunder the statute regarding how wemight amend our rules, we believe it isappropriate to determine through noticeand comment rulemaking the properlength of broadcast license terms as ageneral matter.

4. For several reasons, we propose toamend our Rules to provide thatbroadcast licenses ordinarily have themaximum 8-year term authorized underthe statute. First, the practice ofordinarily granting television and radiolicenses for the maximum terms willreduce the burden to broadcasters ofseeking the periodic renewal of theirlicenses and the associated burdens onthe Commission. Second, it is consistentwith past Commission practice; our


current rules provide for the maximumlicense terms in accordance withprevious statutory maximum terms of 5years for television stations and 7 yearsfor radio stations. Finally, this approachis consistent with the legislative historyof the Telecom Act. While the statutorylanguage provides the Commissiondiscretion in this area, the ConferenceReport indicates that Congress intendedthe Commission to adopt the maximumterm, stating that Section 203 of theTelecom Act ‘‘extends the license termfor broadcast licenses to eight years forboth television and radio.’’

5. We seek comment on this proposalto amend Sections 73.1020 and 74.15 ofour Rules to provide that theCommission will ordinarily grantlicenses for the 8-year terms allowed bySection 203 of the Telecom Act.Irrespective of what the Commissionultimately determines to be anappropriate standard license term, wenote that Section 203 of the TelecomAct explicitly reserves theCommission’s authority to grantindividual licenses for less than thestatutory maximum if the publicinterest, convenience, and necessitywould be served by such action.

6. Classes of Stations. Section 203 ofthe Telecom Act states in part:

‘‘the Commission may by rule prescribe theperiod or periods for which licenses shall begranted and renewed for particular classes ofstations. * * *’’ While this provision provides usauthority to designate different license termsfor particular classes of stations (provided thatthey do not exceed 8 years), we propose totreat all but experimental broadcast stationsuniformly.

7. With respect to television and radiostations the statute eliminates thecurrent distinction between theseservices for purposes of establishing themaximum allowable license terms. Inthis regard, the legislative history states:‘‘By applying a uniform license term* * * for all broadcast station licenses,the Committee simply recognizes thatthere is no reason for longer radiolicense terms than for televisionlicenses. The Committee intends thatapplying a uniform license term * * *for radio and television licenses willenable the Commission to operate moreefficiently in the awarding of new orrenewed licenses for all broadcastlicenses.’’ H.R. Rep. No. 104–204,Section 304, 104th Cong., 1st Sess. 122(1995).

8. Similarly, we propose to track theapproach we take with full-servicestations and adopt an 8-year licenseterm for FM and TV translator facilitiesand low power TV stations, as well asfor international broadcasting stations.This approach is consistent with our

previous decision to treat these differentclasses of stations uniformly. See Reportand Order in MM Docket No. 92–168, 59FR 63049, December 7, 1994. We furtherpropose to continue our practice, setforth in Sections 74.15(b) and (c) of ourRules, of tying the license terms forauxiliary and booster facilities to thelicense terms of the broadcast stationswith which they are associated. We seekcomment on these proposals.

9. Finally, we propose to continue ourpractice, set forth in Section 74.15(a) ofour Rules, of issuing licenses forexperimental broadcast stations for aterm of 1 year. We believe that a longerlicense term would not be warranted forthis class of station and seek commenton this proposal.

10. Implementation of AmendedLicense Term Provisions. Section 203 ofthe Telecom Act and the legislativehistory are silent as to whether existingbroadcast station licenses may bemodified immediately to conform to anynew license terms that may be adopted.

11. The implementation issue isimportant because of the logisticsinvolved in renewing broadcastlicenses. Under Sections 73.1020 and74.15 of the Commission’s Rules, all ofthe licenses for a particular class ofbroadcast stations expire at fixedintervals over a 3-year period. To staggerthe processing of renewal applicationsand thus perform this task moreefficiently, the country is divided into18 different regions containing 1 ormore states for purposes of establishingsynchronized schedules for radio andtelevision license renewals. The radiorenewal schedule and the televisionrenewal schedule operate on separateand distinct cycles that do not runconcurrently. Accordingly, once allradio licenses have been renewed asscheduled, there is a 50-month hiatusbefore the radio renewal cycle beginsagain. Similarly, once all televisionlicenses have been renewed asscheduled, there is also a 26-monthhiatus before the television renewalcycle begins again.

12. Because of the cyclical nature ofthis process, any change in the length ofthe license term implemented in themiddle of a renewal cycle couldadversely affect the synchronization ofthe whole process.

13. By the time the Telecom Act of1996 was enacted in February 1996, therenewal cycle had already begun forradio stations in several regions of thecountry. The practical effect of thissituation is that radio licenses that havealready been renewed for the currentmaximum allowable 7-year term willhave shorter terms than radio licensesrenewed later in the renewal cycle, if we

adopt the 8-year term we now propose.When these previously granted licensesexpire the radio renewal process will nolonger be synchronized. We wish tomaintain the efficiencies inherent in theexisting synchronized schedule ofrenewal cycles. Should we ultimatelyadopt an 8-year license term, wetherefore propose to implement it asfollows. For broadcast renewalapplications that are granted after theeffective date of a decision in thisproceeding, we propose to ordinarilygrant the renewed license for themaximum proposed term of 8 years. Forrenewal applications that have beenfiled as part of the current renewal cycle(i.e., the cycle beginning October 1,1995 for radio stations) and that havebeen granted only the maximum 7-yearlicense term provided under our currentrules because they were processed priorto a decision in this proceeding, wepropose to extend by rule the alreadyrenewed 7-year license term for suchstations to the proposed 8-year term.These licenses will thus be modified byrule to have the new maximum termand will come up for renewal insynchronization with future radiorenewal cycles. The Commissionadopted a similar approach in 1983when it extended existing commoncarrier and satellite licenses from 5 to 10years. As noted in that decision, theCommission’s authority to modify theprovisions of existing licenses byrulemaking has been upheld on severaloccasions. This type of approach is alsoconsistent with the discretion we aregiven by the Telecom Act to prescriberules governing the period or periods forwhich licenses are granted for particularclasses of stations. We solicit commenton this proposed approach forimplementing the new maximumbroadcast license terms authorized bythe Telecom Act.

14. By this Notice of Proposed RuleMaking we request comments on how tobest implement the provisions ofSection 203 of the Telecom Act.Specifically, we seek comment onwhether we should amend Sections73.1020, 73.733, and 74.15 of theCommission’s Rules to provide thatbroadcast licenses ordinarily shouldhave 8-year terms, the maximumprovided under the Telecom Act. Wealso seek comment on the treatment ofdifferent classes of broadcast stationsand how best to implement thetransition to any amended license termin an equitable manner given that therenewal cycle has already begun.

15. This action is taken pursuant toauthority found in Sections 4(i), 303(r),and 307(c) of the Communications Actof 1934, as amended, 47 U.S.C. 154(i),


303(r), and 307(c), and Sections0.204(b), 0.283 and 1.45 of theCommission’s Rules, 47 CFR 0.204(b),0.283 and 1.45.

List of Subjects

47 CFR Part 73

Radio broadcasting, Televisionbroadcasting.

47 CFR Part 74

Radio broadcasting, Televisionbroadcasting.Federal Communications Commission.William F. Caton,Acting Secretary.[FR Doc. 96–10051 Filed 4–22–96; 8:45 am]BILLING CODE 6712–01–P



[I.D. 040896C]

50 CFR Part 630

Atlantic Swordfish Fisheries; PublicHearings

AGENCY: National Marine FisheriesService (NMFS), National Oceanic andAtmospheric Administration (NOAA),Commerce.ACTION: Additional public hearing;request for comments.

SUMMARY: On April 12, 1996, NMFSannounced four public hearings toreceive comments from fisheryparticipants and other members of thepublic regarding proposed amendmentsto regulations governing the Atlanticswordfish fisheries. NMFS nowannounces one additional publichearing.DATES: Comments on the proposed rulemust be received on or before May 2,1996. The hearing is scheduled for April25, 1996, from 7–10 p.m.ADDRESSES: Written comments shouldbe sent to William Hogarth, ActingChief, Highly Migratory SpeciesManagement Division, Office ofFisheries Conservation and Management(F/CM), National Marine FisheriesService, 1315 East-West Highway, SilverSpring, MD 20910. Clearly mark theoutside of the envelope ‘‘AtlanticSwordfish Comments.’’ The additionalhearing will be held at the followinglocation:

Pompano Beach Civic Center1801 NE 6th StreetPompano Beach, FL 32060

FOR FURTHER INFORMATION CONTACT:William Hogarth at 301–713–2339;Kevin Foster at 508–281–9260.SUPPLEMENTARY INFORMATION: NMFSannounces an additional public hearingon the Atlantic swordfish proposed rule(61 FR 15212, April 5, 1996). Theannouncement of the four originalmeetings was published April 12, 1996(61 FR 16236) and included backgroundinformation that is not repeated here.

Authority: 16 U.S.C. 1801 et seq. and 16U.S.C. 971 et seq.

Dated: April 16, 1996.Richard W. Surdi,Acting Director, Office of FisheriesConservation and Management, NationalMarine Fisheries Service.[FR Doc. 96–9868 Filed 4–22–96; 8:45 am]BILLING CODE 3510–22–F

50 CFR Part 659

[Docket No. 960409106–6106–01; I.D.031196A]

RIN 0648–AG26

Shrimp Fishery Off the SouthernAtlantic States; Amendment 1

AGENCY: National Marine FisheriesService (NMFS), National Oceanic andAtmospheric Administration (NOAA),Commerce.ACTION: Proposed rule; request forcomments.

SUMMARY: NMFS issues this proposedrule to implement Amendment 1 to theFishery Management Plan for theShrimp Fishery of the South AtlanticRegion (FMP). Amendment 1 would:add rock shrimp to the FMP’smanagement unit; prohibit trawling forrock shrimp in an area off the Floridaeast coast; require permits for dealers,vessels, and vessel operators involved inthe rock shrimp fishery; require dealersto report information needed to monitorthe fishery; and require that the initialsale, trade, barter, or transfer of rockshrimp harvested from the exclusiveeconomic zone (EEZ) occur onlybetween permitted dealers andpermitted vessels. Based on apreliminary evaluation of Amendment1, NMFS disapproved the measurerequiring a vessel operator permit. Theproposed rule would implement theremaining measures in Amendment 1.The intended effect is to protect criticalhabitat and conserve and manage therock shrimp fishery.DATES: Written comments must bereceived on or before June 7, 1996.ADDRESSES: Comments on the proposedrule must be sent to the Southeast

Regional Office, NMFS, 9721 ExecutiveCenter Drive N., St. Petersburg, FL33702.

Requests for copies of Amendment 1,which includes a regulatory impactreview, an initial regulatory flexibilityanalysis (IRFA), a social impactanalysis, and an environmentalassessment, should be sent to the SouthAtlantic Fishery Management Council,(South Atlantic Council) One SouthparkCircle, Suite 306, Charleston, SC 29407–4699, telephone: 803–571–4366, FAX:803–769–4520.

Comments regarding the collection-of-information requirements contained inthis proposed rule should be sent toEdward E. Burgess, Southeast RegionalOffice, NMFS, 9721 Executive CenterDrive N., St. Petersburg, FL 33702, andto the Office of Information andRegulatory Affairs, Office ofManagement and Budget (OMB),Washington, DC 20503 (Attention:NOAA Desk Officer).FOR FURTHER INFORMATION CONTACT:Peter J. Eldridge, 813–570–5305.SUPPLEMENTARY INFORMATION: The FMPwas prepared by the South AtlanticCouncil and is implemented throughregulations at 50 CFR part 659 under theauthority of the Magnuson Act. AddRock Shrimp to the Management Unit

In the FMP, rock shrimp are includedas part of the fishery, but they are notincluded in the management unit,because there are no managementmeasures specific to rock shrimp.Amendment 1 contains managementmeasures applicable to rock shrimp,including closing one area to trawling,and permitting and reportingrequirements; therefore, rock shrimpwould be included in the managementunit.

Area Closed to Rock Shrimp Trawling

Amendment 1 proposes to prohibittrawling for rock shrimp between 27°30′N. lat. and 28°30′ N. lat. in the areaextending shoreward of the 100-fathom(183-m) depth contour (as shown on thelatest edition of NOAA chart 11460) to80°00′ W. long. The Council isproposing this measure to minimize theimpacts of rock shrimp trawling onimportant live-bottom habitat, includingthe slow-growing, fragile Oculina coralspecies in and adjacent to the OculinaBank Habitat Area of Particular Concern(HAPC).

Oculina coral is fragile andparticularly vulnerable to damage due tobottom trawling. The largest knownconcentrations of Oculina occur in anarrow band extending from CapeCanaveral, FL south through the HAPC.The Oculina formations provide


important habitat for rock shrimp, fishesin the snapper-grouper fishery, andnumerous other species.

Testimony at public hearingsindicated that some rock shrimp trawlactivity has shifted south of CapeCanaveral since 1991, exposing theOculina to trawl damage. Prohibition ofrock shrimp trawling in the designatedarea would extend protection of thevaluable Oculina habitat to the northand east of the existing HAPC, therebypreventing trawl damage to habitat thatis currently unprotected and alsoenhancing the integrity of the existingHAPC.

Dealer Permit Requirement

Amendment 1 would require a dealerinvolved in the rock shrimp fishery toobtain an annual dealer permit. A dealerwould be defined as the person whofirst receives rock shrimp harvestedfrom the EEZ. To be eligible for a dealerpermit, an applicant would be requiredto have a valid state wholesaler’s licensein the state where he or she operates ifa license is required by that state, andhave a physical facility for the receipt ofrock shrimp at a fixed location in thatstate. A fee would be charged to coverthe administrative cost of issuing thepermit. A dealer permit would not betransferable and would expire uponchange of ownership of the business.

Dealer permits are proposed toidentify the universe of dealers involvedin the rock shrimp fishery and tofacilitate collection of data necessary tomanage the fishery. The Councilbelieves that this permit requirementwould help ensure accurate dealerreporting, improve enforcement of theregulations by increasing dealeraccountability, provide a means toimprove communications amongparticipants in the fishery managementprocess, and improve understanding ofthe economic characteristics of thefishery.

Vessel Permit Requirement

For a person aboard a vessel to fish foror possess rock shrimp from the EEZ, anannual vessel permit would be required.A fee would be charged to cover theadministrative costs associated withissuing the permit. The vessel permitrequirement would identify the universeof participants in the harvesting sectorof the fishery. The Council believes thatthe permit requirement would also helpprovide information necessary to assessimpacts of fishing on the resource andassociated habitats.

Vessel Operator Permit Requirement—Disapproved Measure

One measure in Amendment 1 wouldhave required a vessel operator fishingfor rock shrimp in the EEZ to obtain avessel operator permit. An operatorwould have been defined as the masteror other individual aboard who is incharge of the vessel. No performance orcompetency testing would be requiredto obtain a permit. A fee would havebeen charged to cover the administrativecosts associated with issuing the permit.

The vessel operator permitrequirement was proposed initially bythe Council’s Ad Hoc Rock ShrimpAdvisory Panel and was subsequentlyadopted by the Council for inclusion inAmendment 1. The permit requirementwas intended to instill vessel operatorswith greater responsibility andaccountability regarding compliancewith fishery regulations. The Councilbelieves that revocation of an operator’spermit would be more effective thanexisting penalties in deterring fisheryviolations.

NMFS has determined that therequirement for a vessel operator permitwould not minimize costs and isinconsistent with the Magnuson Act’snational standard 7 that requiresconservation and management measuresto minimize costs and avoidunnecessary duplication wherepracticable. NMFS believes thatadequate regulatory compliance can beachieved via the existing penaltyschedule without incurring theadditional costs and public paperworkburden that would be associated withimplementing a new class of permits.Accordingly, the Director, SoutheastRegion, NMFS (Regional Director) hasdisapproved this provision ofAmendment 1, and it is not included inthis proposed rule. The RegionalDirector has determined that thisprovision is not a matter of sufficientscope and substance warranting reviewunder section 304(a)(1)(A) of theMagnuson Act.

Dealer Reporting

Permitted dealers would be requiredto maintain and submit basicinformation essential for propermanagement of the fishery. Additionaldata may be collected by authorizedstatistical reporting agents or authorizedofficers as necessary to address specificissues.

A permitted dealer who is selected bythe Science and Research Director,Southeast Fisheries Center, NMFS(Science and Research Director) wouldbe required to provide information onreceipts and prices paid for rock shrimp

to the Science and Research Director inaccordance with instructions providedon the reporting form. Such informationwould be submitted at monthlyintervals, or more frequently ifrequested, postmarked not later than 5days after the end of each month. TheCouncil intends that, to the extentpossible, the required information beprovided through existing state/Federalcooperative agreements for datacollection. To minimize duplication, theScience and Research Director wouldselect a dealer to report only if theessential information were nototherwise available through the state/Federal cooperative data collectionsystem.

Restrictions on SaleRestrictions on sale of rock shrimp are

proposed to ensure that the fishery isconducted only by properly permittedindividuals and to assure that alllandings are documented through theproposed data collection system. Theproposed rule would require that rockshrimp harvested in the EEZ by apermitted vessel be sold, traded,bartered, or transferred only to apermitted dealer. Similarly, a permitteddealer would be allowed to purchase,barter, trade, or transfer rock shrimpharvested from the EEZ only from apermitted vessel.

Availability of Amendment 1Additional background and rationale

for the measures discussed above arecontained in Amendment 1, theavailability of which was announced inthe Federal Register on March 19, 1996(61 FR 11181).

ClassificationSection 304(a)(1)(D) of the Magnuson

Act requires publication of regulationsproposed by a regional fisherymanagement council within 15 days ofreceipt of an amendment andregulations. At this time, NMFS has notdetermined that Amendment 1 isconsistent with the national standards,other provisions of the Magnuson Act,and other applicable laws, except for theprovision of Amendment 1 specificallydisapproved, as discussed above.NMFS, in making that determinationwith respect to the remaining parts ofAmendment 1, will take into accountthe data, views, and comments receivedduring the comment period.

This proposed rule has beendetermined to be not significant forpurposes of E.O. 12866.

The Council prepared an IRFA whichdescribes the impacts this proposed rulewould have on small entities, ifadopted. The Council concluded that


the proposed measures in Amendment 1would have a significant economicimpact on a substantial number of smallentities. These impacts, as assessed inthe IRFA, may be summarized asfollows. All of the commercial rockshrimp vessel owners and dealers aresmall entities that would be affected byone or more actions in the proposedrule. The south Atlantic rock shrimpfishery may have as many as 108 activevessels according to Florida’s landingsdata, although industry representativesindicate that the number of vesselsparticipating throughout the season maybe closer to 65. The Council estimatesthat currently there are about 12 dealersactively buying rock shrimp fromfishing vessels. It is noted that over 95percent of rock shrimp harvested in thesouth Atlantic region occur in the EEZoff the east coast of Florida.

The IRFA identified the followingimpacts on small entities in terms ofcosts and revenues: (1) The addition ofrock shrimp to the FMP managementunit should not result in any changes inoperating revenues or costs forindividual vessels in the commercialfishery; (2) the prohibition of trawlingfor rock shrimp in the closed area off theFlorida east coast may cause a reductionin annual gross revenues of current rockshrimp fishery participants by morethan 5 percent. Although total annualrock shrimp catches by area are notavailable from NMFS or State sources,34 participants in the fishery reportedtheir 1994 landings by area fishedduring the public hearings process.These participants reported a catch of1,128,624 pounds of rock shrimp fromthe area to be closed. This represents 25percent of their total 1994 catch of rockshrimp from the South Atlantic and is17 percent of the total 1994 catch ofrock shrimp of all harvesters as reportedin NMFS data. Using an average ex-vessel price of $1.25 per pound, thevalue of the harvest by the 34participants reporting catch by area isexpected to decline $1.41 million in thefirst year. These data do not indicate thetotal estimated catch or revenue effectfrom closing the area since, as indicatedabove, reliable data on catch locationsfor all fishery participants are notavailable. The IRFA indicates that manyof the freezer-trawler vesselsparticipating in the fishery in 1994 mayshow a reduction in harvest incomesomewhat in excess of $40,000 pervessel during the first year of the areaclosure. Rock shrimp are known tomove throughout the area off the eastcoast of Florida. Thus, it is likely thatsome of the shrimp initially locatedwithin the closed area may move to

other areas where they may beharvested. The impacted rock shrimpvessels are expected to shift fishingeffort away from the closed area to openareas. The extent to which they cansuccessfully shift effort will determinehow well they can minimize adverseimpacts. If vessels have to travel extradistances to the open fishing areas, theywould incur additional operating costs.This may not result in a reduction in netrevenue for vessels that can catch largersize shrimp yielding higher exvesselprices. Also, many vessels participate inother fisheries when they are not fishingfor rock shrimp; it is likely that theymay switch effort to these other fisheriesduring the time they would have beentrawling for shrimp in the closed area.For these reasons, the above estimates ofadverse economic impacts on smallentities from the closed area should beconsidered maximum levels.Nevertheless, it is reasonable to assumethat the 5 percent criterion forsignificant effects will be met for thesmall entities participating in the rockshrimp fishery in the U.S. SouthAtlantic. Finally, no small entities areexpected to be forced to ceaseoperations; (3) permit requirements forvessel owners, vessel operators, anddealers would increase costs for thosesectors; (4) dealer reportingrequirements would increase dealercosts marginally; and (5) restrictions onthe sale of rock shrimp (i.e., permittedvessels may sell rock shrimp only topermitted dealers) would decreaserevenues and increase costs marginally.

In deciding on its preferredmanagement measures for this rule, theCouncil attempted to balance thecompeting objectives of providingprotection for important habitat areasknown to support importantpopulations of juvenile rock shrimp andother valuable species, such assnappers, with the possible adverseeconomic effects on current fisheryparticipants. The Council believes thatAmendment 1 will reduce fisheryrelated habitat damage and ensuresuccessful recruitment of rock shrimp tothe fishery over the long run as well asprotecting the biological productivity ofthe snapper-grouper complex. TheCouncil believes that without theseconservation measures, the potentiallong-term, adverse economic effects onsmall entities would outweigh the short-term effects. A copy of the IRFA isavailable from the Council (seeADDRESSES).

Notwithstanding any other provisionof law, no person is required to respondto nor shall a person be subject to apenalty for failure to comply with acollection of information subject to the

requirements of the PaperworkReduction Act (PRA) unless thatcollection of information displays acurrently valid OMB control number.

This rule contains new collection-of-information requirements subject to thePRA—namely, vessel permitapplications, dealer permit applications,dealer reports regarding rock shrimpreceipts, and vessel identificationrequirements. These requirements havebeen submitted to OMB for approval.The public reporting burdens for thesecollections of information are estimatedto average 20, 5, 10, and 45 minutes perresponse, respectively, including thetime for reviewing instructions,searching existing data sources,gathering and maintaining the dataneeded, and completing and reviewingthe collection of information. Sendcomments regarding these reportingburden estimates or any other aspect ofthe collections of information, includingsuggestions for reducing the burdens, toNMFS and OMB (see ADDRESSES).


Fisheries, Fishing, Reporting andrecordkeeping requirements.

Dated: April 16, 1996.Gary Matlock,Program Management Officer, NationalMarine Fisheries Service.

For the reasons set out in thepreamble, 50 CFR part 659 is proposedto be amended as follows:

PART 659—SHRIMP FISHERY OFFTHE SOUTHERN ATLANTIC STATES


Authority: 16 U.S.C. 1801 et seq.

§ 659.1 [Amended]

2. In § 659.1, paragraph (b) isamended by adding the phrase ‘‘rockshrimp,’’ after ‘‘pink shrimp,’’.

3. In § 659.2, definitions for‘‘Authorized statistical reporting agent’’,‘‘Dealer’’, ‘‘Regional Director’’, ‘‘Rockshrimp’’, and ‘‘Science and ResearchDirector’’ are added, in alphabeticalorder, to read as follows:

§ 659.2 Definitions.

* * * * *Authorized statistical reporting agent

means:(1) Any person so designated by the

Science and Research Director; or(2) Any person so designated by the

head of any Federal or state agency thathas entered into an agreement with theAssistant Administrator to collectfishery data.* * * * *


Dealer, for the purposes of this part659, means the person who first receivesrock shrimp harvested from the EEZupon transfer ashore.* * * * *

Regional Director means the Director,Southeast Region, NMFS, or a designee.

Rock shrimp means the speciesSicyonia brevirostris.

Science and Research Director meansthe Science and Research Director,Southeast Fisheries Science Center,NMFS, or a designee.* * * * *

4. Section 659.3 is revised to read asfollows:

§ 659.3 Relation to other laws.(a) The relation of this part to other

laws is set forth in § 620.3 of thischapter and paragraph (b) of thissection.

(b) Regulations governing the takingof endangered and threatened marinemammals and sea turtles appear at 50CFR parts 222 and 227.

§§ 659.4, 659.5, 659.6 [Redesignated as§§ 659.7, 659.8, 659.9]

5. In subpart A, §§ 659.4, 659.5, and659.6 are redesignated as §§ 659.7,659.8, and 659.9, respectively; new§§ 659.4, 659.5, and 659.6 are added;and newly redesignated § 659.7 isrevised to read as follows:

§ 659.4 Permits and fees.(a) Applicability—(1) Annual vessel

permit for rock shrimp. For a personaboard a fishing vessel to fish for rockshrimp in the EEZ or possess rockshrimp in or from the EEZ, a vesselpermit for rock shrimp must be issuedfor the vessel and be on board.

(2) Annual dealer permit for rockshrimp. A dealer who receives rockshrimp harvested from the EEZ mustobtain an annual dealer permit for rockshrimp. To be eligible for such permit,an applicant must have a valid statewholesaler’s license, if required in thestate where the applicant operates, andmust have a physical facility for receiptof rock shrimp at a fixed location in thatstate.

(b) Application for an annual vesselpermit for rock shrimp. (1) Applicationsare available from the Regional Director.An application must be signed andsubmitted by the owner (in the case ofa corporation, an officer or shareholder;in the case of a partnership, a generalpartner) or operator of the vessel. Theapplication should be submitted to theRegional Director at least 30 days priorto the date the applicant desires thepermit to be effective.

(2) A permit applicant must providethe following information:

(i) A copy of the vessel’s valid U.S.Coast Guard certificate ofdocumentation or, if not documented, acopy of its valid state registrationcertificate.

(ii) Vessel name and official number.(iii) Name, address, telephone

number, and other identifyinginformation of the vessel owner and ofthe applicant, if other than the owner.

(iv) Any other information concerningthe vessel, gear characteristics, principalfisheries engaged in, or fishing areasrequested by the Regional Director.

(v) Any other information that may benecessary for the issuance oradministration of the permit, asrequested by the Regional Director andincluded on the application form.

(c) Application for an annual dealerpermit for rock shrimp. (1) Applicationsare available from the Regional Director.An application for a dealer permit mustbe submitted and signed by the dealeror an officer of a corporation acting asa dealer. The application should besubmitted to the Regional Director atleast 30 days prior to the date theapplicant desires the permit to beeffective.

(2) A permit applicant must providethe following information:

(i) A copy of each state seafoodwholesaler’s license held by the dealer.

(ii) Business name; mailing address,including zip code, of the principaloffice of the business; telephonenumber; employer identificationnumber, if one has been assigned by theInternal Revenue Service; and date thebusiness was formed.

(iii) The address of each physicalfacility at a fixed location where thebusiness receives rock shrimp.

(iv) Applicant’s name; officialcapacity in the business; address;including zip code; telephone number;and identifying information specified onthe application form.

(v) Any other information that may benecessary for the issuance oradministration of the permit, asrequested by the Regional Director andincluded on the application form.

(d) Fees. A fee is charged for eachpermit application submitted pursuantto this section. The amount of the fee iscalculated in accordance with theprocedures of the NOAA FinanceHandbook for determining theadministrative costs of each specialproduct or service. The fee may notexceed such costs and is specified witheach application form. The appropriatefee must accompany each application.

(e) Initial issuance. (1) The RegionalDirector will issue an initial permit atany time to an applicant if theapplication is complete and the specific

requirements for the requested permithave been met. An application iscomplete when all required forms,information, documentation, and feeshave been received.

(2) Upon receipt of an incompleteapplication, the Regional Director willnotify the applicant of the deficiency. Ifthe applicant fails to correct thedeficiency within 30 days of the date ofthe Regional Director’s letter ofnotification, the application will beconsidered abandoned.

(f) Duration. A permit remains validfor the period for which it is issuedunless revoked, suspended, or modifiedpursuant to subpart D of 15 CFR part904.

(g) Renewal. (1) A permit required bythis section will be effective for 1 year.Application for permit renewal isrequired only every 2 years. In theinterim year, a permit will be renewedautomatically (without application) if avessel owner or a dealer has met therenewal requirements under paragraph(g)(2) of this section. The owner of apermitted vessel or a permitted dealerwho does not meet the renewalrequirements will be notified by theRegional Director approximately 2months prior to the expiration of thecurrent permit. The notification willspecify the reasons the permit is noteligible for renewal and will provide anopportunity for correction of anydeficiencies. For a year in which permitrenewal application is required, theRegional Director will mail anapplication form to each owner of apermitted vessel or permitted dealerapproximately 2 months prior toexpiration of the current permit. Avessel owner or dealer who does notreceive a renewal application in thattime frame must contact the RegionalDirector to obtain a renewal application.

(2) The permit renewal requirementsare:

(i) All reports required of an owner ofa vessel or a dealer under the MagnusonAct have been submitted.

(ii) The permit has not been revoked,suspended, or denied under paragraph(j) of this section.

(h) Transfer. A vessel or dealer permitissued pursuant to this section is nottransferable or assignable. A personobtaining a permitted vessel ordealership who desires to conductactivities for which a permit is requiredmust apply for a permit in accordancewith the provisions of paragraph (b) or(c) of this section, as appropriate.

(i) Display. A vessel permit issuedpursuant to this section must be carriedon board the vessel and such vesselmust be identified as provided for in§ 659.6. A dealer permit issued pursuant


to this section must be available on thedealer’s premises. The operator of avessel or a dealer must present thepermit for inspection upon request of anauthorized officer.

(j) Sanctions and denials. A permitissued pursuant to this section may berevoked, suspended, or modified, and apermit application may be denied, inaccordance with the proceduresgoverning enforcement-related permitsanctions and denials found at subpartD of 15 CFR part 904.

(k) Alteration. A permit that is altered,erased, or mutilated is invalid.

(l) Replacement. The RegionalDirector may issue a replacementpermit. An application for areplacement permit will not beconsidered a new application. A fee, theamount of which is stated with theapplication form, must accompany eachrequest for a replacement permit.

(m) Change in applicationinformation. The owner or operator of avessel with a permit for rock shrimp ora dealer with a permit for rock shrimpmust notify the Regional Director within15 days after any change in theapplication information required byparagraph (b) or (c) of this section,respectively. The permit is void if anychange in the information is notreported within 15 days.

§ 659.5 Recordkeeping and reporting.(a) Dealers. A dealer who has been

issued a permit required by § 659.4(a)(2)and who is selected by the Science andResearch Director must provideinformation on receipts of rock shrimpand prices paid, to the Science andResearch Director in accordance withinstructions on the reporting form. Therequired information must be submittedat monthly intervals, or more frequentlyif requested, postmarked not later than5 days after the end of each month.

(b) Additional data and inspection.(1) Additional data will be collected byauthorized statistical reporting agents orby authorized officers. A dealer isrequired, upon request, to make rockshrimp, or parts thereof, available forinspection by the Science and ResearchDirector or an authorized officer.

(2) On demand, a dealer must makeavailable to an authorized officer allrecords of off-loadings, purchases,barters, or sales of rock shrimp.

§ 659.6 Vessel identification.(a) Official number. The owner and

operator of a vessel with a valid permit,as required under § 659.4(a)(1) mustensure that the vessel’s official numberis displayed—

(1) On the port and starboard sides ofthe deckhouse or hull and on a weather

deck so as to be clearly visible from anenforcement vessel or aircraft;

(2) In block arabic numerals incontrasting color to the background;

(3) At least 18 inches (45.7 cm) inheight for fishing vessels over 65 feet(19.8 m) in length and at least 10 inches(25.4 cm) in height for all other vessels;and

(4) Permanently affixed to or paintedon the vessel.

(b) Duties of operator. The operator ofeach fishing vessel specified inparagraph (a) of this section must—

(1) Keep the official number clearlylegible and in good repair; and

(2) Ensure that no part of the fishingvessel, its rigging, fishing gear, or anyother material on board obstructs theview of the official number from anenforcement vessel or aircraft.

§ 659.7 Prohibitions.In addition to the general prohibitions

specified in § 620.7 of this chapter, it isunlawful for any person to do any of thefollowing:

(a) Fish for rock shrimp in the EEZ orpossess rock shrimp in or from the EEZ,on board a vessel that does not have avessel permit for rock shrimp, asspecified in § 659.4(a)(1).

(b) As a dealer, receive rock shrimpharvested from the EEZ without a dealerpermit, as specified in § 659.4(a)(2).

(c) Falsify information specified in§ 659.4(b)(2), or (c)(2) on an applicationfor a permit.

(d) Fail to display a permit, asspecified in § 659.4(h).

(e) Falsify or fail to maintain, submit,or provide information required to bemaintained, submitted, or provided, asspecified in § 659.5(a) or (b), or as maybe required as a condition of anauthorized activity under § 659.22.

(f) Fail to make rock shrimp, or partsthereof, available for inspection, asspecified in § 659.5(b)(1).

(g) Falsify or fail to display andmaintain vessel identification, asspecified in § 659.6(a) and (b).

(h) Trawl for white shrimp, pinkshrimp, or brown shrimp in a closedarea or possess such shrimp in or froma closed area, as specified in§ 659.20(a)(2)(i)(A), except possessionauthorized under § 659.20(a)(2)(ii).

(i) Use or have on board a vesseltrawling in that part of a closed areaspecified under § 659.20(a)(1) that iswithin 25 nautical miles (46.30 km) ofthe baseline from which the territorialsea is measured, a trawl net with a meshsize less than 4 inches (10.2 cm), asspecified in § 659.20(a)(2)(i)(B).

(j) Trawl for rock shrimp in the closedarea specified in § 659.20(b) or possesson board a fishing vessel rock shrimp inor from that closed area.

(k) Transfer, receive, sell, purchase,barter, or trade, or attempt to transfer,receive, sell, purchase, barter, or trade arock shrimp harvested from the EEZfrom a vessel that does not have a validpermit, as specified in § 659.21(a).

(l) Transfer, sell, trade, or barter orattempt to transfer, sell, trade, or barterfrom a vessel rock shrimp harvestedfrom the EEZ to a dealer who does nothave a permit, as specified in§ 659.21(b).

(m) As a permitted dealer, receive,purchase, barter, or trade or attempt toreceive, purchase, barter, or trade rockshrimp harvested from the EEZ from avessel that does not have a valid permit,as specified in § 659.21(c).

(n) Interfere with, obstruct, delay, orprevent by any means an investigation,search, seizure, or disposition of seizedproperty in connection withenforcement of the Magnuson Act.

(o) Make any false statement, oral orwritten, to an authorized officerconcerning the taking, catching,harvesting, landing, purchase, sale,possession, or transfer of brown shrimp,pink shrimp, rock shrimp, or whiteshrimp.

6. In § 659.20, paragraphs (a), (b),(b)(1), (b)(1)(i), (b)(1)(ii), and (b)(2) areredesignated as paragraphs (a)(1), (a)(2),(a)(2)(i), (a)(2)(i)(A), (a)(2)(i)(B), and(a)(2)(ii), respectively; in newlyredesignated paragraph (a)(2)(i),introductory text, the reference‘‘paragraph (a)’’ is removed and‘‘paragraph (a)(1)’’ is added in its place;in newly redesignated paragraphs(a)(2)(i)(A) and (a)(2)(ii), the reference‘‘paragraph (b)(2)’’ is removed and thereference ‘‘paragraph (a)(2)(ii)’’ is addedin its place; and a new paragraph (a)heading and new paragraph (b) areadded to read as follows:

§ 659.20 Closures.(a) Seasonal closures for brown, pink,

and white shrimp.* * * * *

(b) Area closure for rock shrimp. Noperson may trawl for rock shrimp in theclosed area east of 80°00′ W. long.between 27°30′ N. lat. and 28°30′ N. lat.shoreward of the 100-fathom (183-m)contour, as shown on the latest editionof NOAA chart 11460; and no personmay possess rock shrimp in or from thisclosed area on board a fishing vessel.

7. Section 659.21 is redesignated as§ 659.22 and a new § 659.21 is added toread as follows:

§ 659.21 Restrictions on sale/purchase ofrock shrimp.

(a) No person may transfer, receive,purchase, barter, trade, or sell, orattempt to transfer, receive, purchase,


barter, trade, or sell, rock shrimpharvested in the EEZ by a vessel forwhich a valid permit has not beenissued under § 659.4(a)(1).

(b) No person may transfer, sell, trade,or barter or attempt to transfer, sell,trade, or barter, rock shrimp harvestedin the EEZ by a vessel permitted under§ 659.4(a)(1) to a dealer who does nothave a valid permit issued under§ 659.4(a)(2).

(c) No dealer who has a valid permitissued under § 659.4(a)(2) may receive,purchase, trade, or barter or attempt toreceive, purchase, trade, or barter rockshrimp harvested in the EEZ from avessel for which a valid permit has notbeen issued under § 659.4(a)(1).

[FR Doc. 96–9882 Filed 4–22–96; 8:45 am]BILLING CODE 3510–22–P

This section of the FEDERAL REGISTERcontains documents other than rules orproposed rules that are applicable to thepublic. Notices of hearings and investigations,committee meetings, agency decisions andrulings, delegations of authority, filing ofpetitions and applications and agencystatements of organization and functions areexamples of documents appearing in thissection.

Notices Federal Register

17872

Vol. 61, No. 79



Forest Service

Transfer of AdministrativeJurisdiction; Sam Rayburn Dam andReservoir Project

AGENCY: Forest Service, USDA.ACTION: Notice of joint interchange oflands.

SUMMARY: On October 10, 1995, andJanuary 11, 1996, the Secretary of theArmy and the Secretary of Agriculturerespectively signed a joint interchangeorder agreeing to the transfer ofadministrative jurisdiction from theDepartment of Agriculture to theDepartment of the Army of 36.286 acres,more or less, lying within the AngelinaNational Forest in Jasper County, Texas,and from the Department of the Army tothe department of Agriculture of 48.29acres, more or less lying, within theexterior boundaries of the SabineNational Forest in Sabine County,Texas. As required by the Act of July 26,1956, Congress has received 47 daysadvance notice of this action. A copy ofthe Joint Order, as signed, appears at theend of this notice.EFFECTIVE DATE: The order is effectiveApril 23, 1996.FOR FURTHER INFORMATION CONTACT:David M. Sherman, Lands Staff, ForestService, USDA, Telephone: (202) 205–1362.

Dated: April 12, 1996.Jerry A. Sesco,Acting Chief.

Department of the Army

Department of Agriculture

Sam Rayburn Reservoir, Texas

Joint Order Interchanging AdministrativeJurisdiction of Department of the ArmyLands and National Forest Lands

By Virtue of the authority vested in theSecretary of Agriculture and the Secretary ofthe Army by Public Law 804 dated July 26,

1956 (70 Stat. 656; 16 U.S.C. 505a, 505b) itis ordered as follows:

(1) The jurisdiction now held by theSecretary of the Army over the Army landsdescribed in Exhibits A and A–1, attachedhereto and made a part hereof, which landsare within the boundaries of the SabineNational Forest, Texas, is hereby transferredfrom the Secretary of the Army to theSecretary of Agriculture, subject to the Corpsof Engineers’ full, complete and perpetualright, power, privilege and easementoccasionally to overflow, flood and submergethe land described in Exhibits A and A–1lying below elevation 179′ National GeodeticVertical Datum (NGVD), and its right tomaintain mosquito control as may berequired in connection with the construction,operation and maintenance of the SamRayburn Reservoir Project, Texas, providedthat no structures for human habitation shallbe constructed or maintained on said land,and that no other structures shall beconstructed or maintained on said landexcept as may be approved in writing by therepresentatives of the United States in chargeof the Project, and that no excavation shallbe conducted and no landfill placed on theland without such approval as to the locationand method of excavation and/or placementof landfill, provided further that any use ofthe land shall be subject to Federal and Statelaws with respect to pollution.

(2) The jurisdiction now held by theSecretary of Agriculture over the NationalForest lands described in Exhibits B and B–1, attached hereto and made a part hereof,which are a part of the Angelina NationalForest, Texas, is hereby transferred from theSecretary of Agriculture to the Secretary ofthe Army, subject to continued accessthereover by the Forest Service as may benecessary for National Forest purposes.

(3) Pursuant to Section 2 of the aforesaidAct of July 26, 1956, the National Forestlands transferred to the Secretary of the Armyby this order are hereafter subject only to thelaws applicable to the Department of theArmy lands comprising the Sam RayburnReservoir Project, Texas. The Department ofthe Army lands transferred to the Secretaryof Agriculture by this order are herebysubject to the laws applicable to landsacquired under the Act of March 1, 1911 (38Stat. 961), as amended, in addition to thelaws applicable to the Department of Armynecessary to provide for flood control asspecified in paragraph 1 of this Order.Pursuant to authority contained in section 11of the Act of March 1, 1911, the Secretary ofAgriculture hereby orders that those landstransferred to the Secretary of Agricultureshall be administered as a part of the SabineNational Forest, Texas.

This order will be effective as of date ofpublication in the Federal Register.

Dated: October 10, 1995.Togo D. West, Jr.,Secretary of the Army.

Dated: January 11, 1996.Dan Glickman,Secretary of Agriculture.[FR Doc. 96–9865 Filed 4–22–96; 8:45 am]BILLING CODE 3410–11–M


Bureau of the Census

Current Population Survey (CPS)School Enrollment Supplement;Proposed Agency InformationCollection Activity; Comment Request

SUMMARY: The Department ofCommerce, as part of its continuingeffort to reduce paperwork andrespondent burden, invites the generalpublic and other Federal agencies totake this opportunity to comment onproposed and/or continuing informationcollections, as required by thePaperwork Reduction Act of 1995,Public Law 104–13 (44 U.S.C. 3506 (2)(A)).DATES: Submit written comments on orbefore June 24, 1996.ADDRESSES: Direct all written commentsto Linda Engelmeier, ActingDepartmental Forms Clearance Officer,Department of Commerce, Room 5327,14th and Constitution Avenue, NW.,Washington, DC 20230.FOR FURTHER INFORMATION CONTACT:Requests for additional information orcopies of the information collectioninstrument(s) and instructions shouldbe directed to Bonnie Tarsia, Bureau ofthe Census, FOB 3, Room 3340,Washington, DC 20233–8400, (301) 457–3806.


I. Abstract

The Census Bureau is requestingclearance for the collection of dataconcerning the School EnrollmentSupplement to be conducted inconjunction with the October 1996 CPS.Title 13, United States Code, Section182; and Title 29 United States Code,Sections 1–9, authorize the collection ofCPS information. The Bureau of theCensus and the Bureau of LaborStatistics (BLS) sponsor the basic annualschool enrollment questions, which

17873Federal Register / Vol. 61, No. 79 / Tuesday, April 23, 1996 / Notices

have been collected annually in the CPSfor over 25 years. The National Centerfor Education Statistics (NCES) sponsorsthe inclusion of the additional questionson summer school enrollment.

This survey provides information onpublic/private elementary andsecondary school enrollment, andcharacteristics of private schoolstudents and their families, which isused for tracking historical trends andfor policy planning and support. Thisyear we will also ask questions aboutsummer school enrollment and otherorganized activities in which the childparticipated during the previoussummer. This survey is the only sourceof national data on the age distributionand family characteristics of collegestudents, and the only source ofdemographic data on preprimary schoolenrollment. As part of the FederalGovernment’s efforts to collect data andprovide timely information to localgovernments for policymakingdecisions, the survey provides nationaltrends in employment and progress inschool.

II. Method of CollectionThe school enrollment information

will be collected by both personal visitand telephone interviews in conjunctionwith the regular October CPSinterviewing. All interviews areconducted using computer-assistedinterviewing.

III. DataOMB Number: 0607–0464.Form Number: There are no forms.

We conduct all interviewing oncomputers.

Type of Review: Regular.Affected Public: Individuals or

households.Estimated Number of Respondents:

48,000 per month.Estimated Time Per Response: 8

minutes.Estimated Total Annual Burden

Hours: 6,400.Estimated Total Annual Cost:

$360,000.

IV. Request for CommentsComments are invited on: (a) Whether

the proposed collection of informationis necessary for the proper performanceof the functions of the agency, includingwhether the information shall havepractical utility; (b) the accuracy of theagency’s estimate of the burden(including hours and cost) of theproposed collection of information; (c)ways to enhance the quality, utility, andclarity of the information to becollected; and (d) ways to minimize theburden of the collection of information

on respondents, including through theuse of automated collection techniquesor other forms of informationtechnology.

Comments submitted in response tothis notice will be summarized and/orincluded in the request for OMBapproval of this information collection;they also will become a matter of publicrecord.

Dated: April 18, 1996.Linda Engelmeier,Acting Department Forms Clearance Officer,Office of Management and Organization.[FR Doc. 96–9981 Filed 4–22–96; 8:45 am]BILLING CODE 3510–07–P

1997 Economic Census CoveringTrucks, Automobiles, and Buses;Proposed Agency InformationCollection Activity, Comment Request

SUMMARY: The Department ofCommerce, as part of its continuingeffort to reduce paperwork andrespondent burden, invites the generalpublic and other Federal agencies totake this opportunity to comment onproposed and/or continuing informationcollections, as required by thePaperwork Reduction Act of 1995,Public Law 104–13 (44 U.S.C.3506(c)(2)(A)).DATES: Written comments must besubmitted on or before June 24, 1996.ADDRESSES: Direct all written commentsto Linda Engelmeier, ActingDepartmental Forms Clearance Officer,Department of Commerce, Room 5327,14th and Constitution Avenue, NW.,Washington, DC 20230.FOR FURTHER INFORMATION CONTACT:Requests for additional information orcopies of the information collectioninstrument(s) and instructions shouldbe directed to Robert Crowther, Bureauof the Census, Room 2754, Building 3,Washington, DC 20233, (301) 457–2797.


I. AbstractThe Census Bureau is the preeminent

collector and provider of timely,relevant, and quality data about thepeople and economy of the UnitedStates. Economic data are the CensusBureau’s primary program commitmentduring nondecennial census years. Theeconomic census, conducted underauthority of Title 13 U.S.C., is theprimary source of facts about thestructure and functioning of theNation’s economy and features uniqueindustry and geographic detail.Economic census statistics serve as partof the framework for the nationalaccounts and provide essential

information for government, businessand the general public. The 1997Economic Census will cover virtuallyevery sector of the U.S. economy.

The 1997 Vehicle Inventory and UseSurvey, a component of the EconomicCensus, will produce basic statistics onthe physical and operationalcharacteristics of the nation’s trucks,automobiles, and buses. It also willyield a variety of subject statistics,including vehicles by annual miles,major use, fuel type, miles per gallon,and products carried. The CensusBureau will publish truck estimates atthe state and national level, andautomobile and bus estimates at thenational level.

Primary strategies for reducing burdenin the Vehicle Inventory and Use Surveydata collections include employing astratified random sample to use the leastnumber of sampling units required toproduce reliable statistics, separatevehicle-type specific questionnaires,check boxes with ranges in lieu ofspecific responses, accepting estimates,and utilizing a short form for lighttrucks with homogeneouscharacteristics.

II. Method of CollectionThe Vehicle Inventory and Use

Survey will survey a sample of privateand commercial trucks, automobiles,and buses registered in the 50 States andthe District of Columbia. Governmentvehicles will not be sampled. Truckswill be divided into 5 different groups:‘‘pick-up,’’ ‘‘van,’’ ‘‘single-unit light,’’‘‘single-unit heavy,’’ and ‘‘trucktractors.’’ Automobiles will be dividedinto 2 different groups: ‘‘station wagon’’and ‘‘other automobiles.’’ Buses will bedivided into 4 different groups: ‘‘buses,’’‘‘transit buses,’’ ‘‘school buses,’’ and‘‘large van-type buses.’’ All vehicles willbe selected at random with equalprobabilities of selection within a group.For each selected vehicle, aquestionnaire will be mailed to theowner identified in the vehicleregistration records. The owner will beasked to respond only for the vehicleidentified by the registrationinformation imprinted on thequestionnaires, regardless of whether ornot he still owns the vehicle.

Mail selection procedures willdistinguish the following groups ofvehicles:

A. Light TrucksA sample of ‘‘pickups’’ and ‘‘vans’’

(including panel trucks, minivans, sportutility vehicles, and station wagonsbuilt on truck chassis) will be selected.We estimate that the census mailcanvass for 1997 will include

17874 Federal Register / Vol. 61, No. 79 / Tuesday, April 23, 1996 / Notices

approximately 35,000 light trucks of theestimated over 55 million privately andcommercially registered light trucks.

B. Medium and Heavy Trucks

Selection procedures will assign allsingle-unit trucks (excluding those inthe pickup and van strata) with a grossvehicle weight (GVW) of 26,000 poundsor less to the ‘‘single-unit light’’ stratum,the remaining single unit trucks to the‘‘single-unit heavy’’ stratum, and trucktractors to the ‘‘truck tractor’’ stratum.We estimate that the census mailcanvass for 1997 will includeapproximately 93,000 medium andheavy trucks of the estimated over 4million privately and commerciallyregistered medium and heavy trucks.

C. Automobiles

Selection procedures will assignautomobiles to either the ‘‘stationwagon’’ or ‘‘other automobiles’’ stratabased on the vehicle’s identificationnumber (VIN). We estimate that thecensus mail canvass for 1997 willinclude approximately 3,100automobiles of the estimated over 132million automobiles.

D. Buses

Selection procedures will assign allnon-government buses to one of thefollowing groups: ‘‘intercity buses’’consisting of tour/charter buses, ‘‘transitbuses’’ consisting of publictransportation buses, ‘‘school buses’’consisting of privately-owned schoolbuses, and ‘‘large van-type buses’’consisting of all remaining buses. Weestimate that the census mail canvassfor 1997 will include approximately 710of the estimated over 250,000 non-government buses.

III. Data

OMB Number: Not Available.Form Number:

TC–9501: Light TrucksTC–9502: Medium and Heavy TrucksTC–9503: AutomobilesTC–9504: Buses

Type of Review: Regular Review.Affected Public: Individuals, Farms,

Businesses and Other For-profit,Non-profit Institutions, SmallBusinesses or Organizations.

Estimated Number of Respondents:TC–9501: (Light Trucks): 35,190TC–9502: (Medium and Heavy

Trucks): 92,797TC–9503: (Automobiles): 3,100TC–9504: (Buses): 710Total Number of Respondents—

131,797Estimated Time Per Response:

TC–9501: (Light Trucks): .5 hoursTC–9502: (Medium and Heavy

Trucks): .83 hoursTC–9503: (Automobiles): .5 hoursTC–9504: (Buses): .83 hours

Estimated Total Annual Burden Hours:TC–9501: (Light Trucks): 17,595TC–9502: (Medium and Heavy

Trucks): 77,022TC–9503: (Automobiles): 1,550TC–9504: (Buses): 589Total Annual Burden Hours—96,756

Estimated Total Annual Cost: The costto the government for this work isincluded in the total cost of the1997 Economic Census, estimatedto be $218 million.

IV. Request for Comments

Comments are invited on: (a) Whetherthe proposed collection of informationis necessary for the proper performanceof the functions of the agency, includingwhether the information shall havepractical utility; (b) the accuracy of theagency’s estimate of the burden(including hours and cost) of theproposed collection of information; (c)ways to enhance the quality, utility, andclarity of the information to becollected; and (d) ways to minimize theburden of the collection of informationon respondents, including through theuse of automated collection techniquesor other forms of informationtechnology.

Comments submitted in response tothis notice will be summarized and/orincluded in the request for OMBapproval of this information collection;they also will become a matter of publicrecord.

Dated: April 18, 1996.Linda Engelmeier,Acting Departmental Forms Clearance OfficerOffice of Management and Organization.[FR Doc. 96–9982 Filed 4–22–96; 8:45 am]BILLING CODE 3510–07–P

Foreign-Trade Zones Board

[Docket 26–96]

Foreign-Trade Zone 161—SedgwickCounty, KS, Application for SubzoneStatus; Texaco Inc., (Oil RefineryComplex) Butler County, KS

An application has been submitted tothe Foreign-Trade Zones Board (theBoard) by the Board of Commissionersof Sedgwick County, Kansas, grantee ofFTZ 161, requesting special-purposesubzone status for the oil refinerycomplex of Texaco Inc., located inButler County, Kansas. The applicationwas submitted pursuant to theprovisions of the Foreign-Trade ZonesAct, as amended (19 U.S.C. 81a-81u),and the regulations of the Board (15 CFR

part 400). It was formally filed on April2, 1996.

The refinery complex (578 acres, 517employees) consists of 2 sites andconnecting pipelines in Butler County,35 east of Wichita, Kansas: Site 1 (460acres)—main refinery complex (110,000BPD) located at 1401 Douglas Road, justsouth of El Dorado; Site 2 (118 acres)—crude oil storage facility (1.2 mil. barrelcapacity) located at 3913 SW 10thStreet, 3 miles west of the refinery.

The refinery complex is used toproduce fuels and petrochemicalfeedstocks. Fuels produced includegasoline, jet fuel, distillates, diesel, andresidual fuels. Petrochemical feedstocksand refinery by-products includemethane, ethane, propane, butane,butylene, toluene, propylene, cumene,sulfur, carbon black and petroleumcoke. About 46 percent of the crude oil(90 percent of inputs), and somefeedstocks and motor fuel blendstocksused in producing fuel products aresourced abroad.

Zone procedures would exempt theoperations involved from Customs dutypayments on the foreign products usedin its exports. On domestic sales, thecompany would be able to choose thefinished product duty rate(nonprivileged foreign status—NPF) oncertain petrochemical feedstocks andrefinery by-products (duty-free) insteadof the duty rates that would otherwiseapply to the foreign-sourced inputs (e.g.,crude oil). The duty rates on crude oilrange from 5.25¢/barrel to 10.5¢/barrel.The application indicates that thesavings from zone procedures wouldhelp improve the refinery’sinternational competitiveness.

In accordance with the Board’sregulations, a member of the FTZ Staffhas been designated examiner toinvestigate the application and report tothe Board.

Public comment is invited frominterested parties. Submissions (originaland 3 copies) shall be addressed to theBoard’s Executive Secretary at theaddress below. The closing period fortheir receipt is June 24, 1996. Rebuttalcomments in response to materialsubmitted during the foregoing periodmay be submitted during the subsequent15-day period (to July 8, 1996).

A copy of the application andaccompanying exhibits will be availablefor public inspection at each of thefollowing locations:U.S. Department of Commerce District

Office, 151 N. Volutsia, Wichita,Kansas 67214

Office of the Executive Secretary,Foreign-Trade Zones Board, Room3716, U.S. Department of Commerce,


14th and Pennsylvania Avenue, NW.,Washington, DC 20230.Dated: April 9, 1996.

John J. Da Ponte, Jr.,Executive Secretary.[FR Doc. 96–9983 Filed 4–22–96; 8:45 am]BILLING CODE 3510–DS–P

[Docket 28–96]

Foreign-Trade Zone 138—Columbus,OH, Application for Subzone Status;Abbott Manufacturing, Inc./RossProducts, Plant (Infant Formula, AdultNutritional Products), Columbus, OH

An application has been submitted tothe Foreign-Trade Zones Board (theBoard) by the Rickenbacker PortAuthority, grantee of FTZ 138,requesting special-purpose subzonestatus for export activity at the infantformula and adult nutritional productsmanufacturing plant of AbbottManufacturing, Inc. (AMI) (a subsidiaryof Abbott Laboratories, Inc.), located inColumbus, Ohio. The application wassubmitted pursuant to the provisions ofthe Foreign-Trade Zones Act, asamended (19 U.S.C. 81a–81u), and theregulations of the Board (15 CFR Part400). It was formally filed on April 9,1996.

The plant (642,000 sq. ft. on 56 acres),known as the Ross Products facility, islocated at 585 Cleveland Avenue in theCity of Columbus (Franklin County),Ohio. The facility (560 employees) isused to produce milk and sugar-basedinfant formula and adult nutritionalproducts for export and the domesticmarket; however, zone procedureswould be used only for production forexport. The production process involvesblending foreign, ex-quota milk powderand foreign, ex-quota sugar withdomestically-sourced oils, soy isolates,vitamins and minerals, and EZO ends.Other foreign-sourced items that may beused in the export-blending activityinclude: cocoa powder, pharmaceuticalgrade fat emulsions, vitamins andminerals, and caseinates (up to 14% offinished product value). All foreign-origin milk and sugar would be re-exported as finished blended products.

Zone procedures would exempt AMIfrom quota requirements and Customsduty payments on the foreign milk andsugar products used in the exportactivity and from Customs dutypayments on the other foreigningredients involved. The applicationindicates that subzone status wouldhelp improve the plant’s internationalcompetitiveness.

In accordance with the Board’sregulations, a member of the FTZ Staff

has been designated examiner toinvestigate the application and report tothe Board.

Public comment on the application isinvited from interested parties.Submissions (original and three copies)shall be addressed to the Board’sExecutive Secretary at the addressbelow. The closing period for theirreceipt is June 24, 1996. Rebuttalcomments in response to materialsubmitted during the foregoing periodmay be submitted during the subsequent15-day period (to July 8, 1996).

A copy of the application and theaccompanying exhibits will be availablefor public inspection at each of thefollowing locations:U.S. Department of Commerce, District

Office, 4th Floor, 37 North HighStreet, Columbus, OH 43215.

Office of the Executive Secretary,Foreign-Trade Zones Board, U.S.Department of Commerce, Room3716, 14th Street & PennsylvaniaAvenue, NW., Washington, DC20230–0002.Dated: April 12, 1996.


[Docket 27–96]

Foreign-Trade Zone 168—Dallas/FortWorth, TX; Application for Expansion

An application has been submitted tothe Foreign-Trade Zones Board (theBoard) by the Dallas/Fort WorthMaquila Trade DevelopmentCorporation (MTDC), grantee of FTZ168, requesting authority to expand itszone in the Fort Worth, Texas, area,within the Dallas/Fort Worth Customsport of entry. The application wassubmitted pursuant to the provisions ofthe Foreign-Trade Zones Act, asamended (19 U.S.C. 81a-81u), and theregulations of the Board (15 CFR Part400). It was formally filed on April 3,1996.

FTZ 168 was approved on November1, 1990 (Board Order 491, 55 FR 46974,11/8/90) and reorganized in 1992 and1994. The zone currently consists ofthree sites in the Fort Worth, Texas,area:Site 1 (24 acres)—an industrial area at

Alta Mesa and Will RogersBoulevards, Fort Worth;

Site 2 (263 acres)—within theCentreport industrial development,south of DFW International Airport,Fort Worth;

Site 3 (195 acres)—within the FossilCreek Business Park, I–35W andI–820, Fort Worth.An application is currently pending

(Doc. 77–95, 60 FR 61528, 11/30/95) fora fourth site located at the RegencyBusiness Park, Post & Paddock Road,Grand Prairie, Texas, west of the City ofDallas.

The applicant is now applying for afifth site (630 acres) within the 1,200-acre Mercantile Center, located at I–35and Meacham Boulevard, Fort Worth,Texas. The site is owned by MercantilePartners, L.P., a Texas LimitedPartnership. Zone services will beprovided by the FTZ OperatingCompany of Texas.

No specific manufacturing requestsare being made at this time. Suchrequests would be made to the Board ona case-by-case basis.


Public comment on the application isinvited from interested parties.Submissions (original and 3 copies)shall be addressed to the Board’sExecutive Secretary at the addressbelow. The closing period for theirreceipt is June 24, 1996. Rebuttalcomments in response to materialsubmitted during the foregoing periodmay be submitted during the subsequent15-day period (to July 8, 1996).

A copy of the application andaccompanying exhibits will be availablefor public inspection at each of thefollowing locations:U.S. Department of Commerce, District

Office, 2050 N. Stemmons Fwy., Suite170, Dallas, Texas 75258

Office of the Executive Secretary,Foreign-Trade Zones Board, U.S.Department of Commerce, Room3716, 14th and Pennsylvania Avenue,NW., Washington, DC 20230Dated: April 9, 1996.


[Docket 29–96]

Foreign-Trade Zone 199—Texas City,TX, Application for Subzone Status,Basis Petroleum, Inc. (Oil RefineryComplex), Texas City, TX

An application has been submitted tothe Foreign-Trade Zones Board (theBoard) by the Texas City Foreign TradeZone Corporation, grantee of FTZ 199,requesting special-purpose subzone


status for the oil refinery complex ofBasis Petroleum, Inc. (Basis) (formerlyPhibro Energy USA, Inc.), located inTexas City, Texas. The application wassubmitted pursuant to the provisions ofthe Foreign-Trade Zones Act, asamended (19 U.S.C. 81a-81u), and theregulations of the Board (15 CFR part400). It was formally filed on April 11,1996.

The refinery complex (130,000 BPD,310 acres) is located at 1301 Loop 197South, Texas City (Galveston County),Texas, some 40 miles southeast ofHouston. The refinery (400 employees)is used to produce fuels andpetrochemical feedstocks. Fuelsproduced include gasoline, jet fuel,distillates, naphthas, and residual fuels.Petrochemical feedstocks and refineryby-products include methane, ethane,propane, butane, propylene and sulfur.About 85 percent of the crude oil (95percent of inputs), and some feedstocksand motor fuel blendstocks used inproducing fuel products are sourcedabroad.

Zone procedures would exempt theoperations involved from Customs dutypayments on the foreign products usedin its exports. On domestic sales, thecompany would be able to choose thefinished product duty rate(nonprivileged foreign status—NPF) oncertain petrochemical feedstocks andrefinery by-products (duty-free). Theduty on crude oil ranges from 5.25¢/barrel to 10.5¢/barrel. The applicationindicates that the savings from zoneprocedures would help improve therefinery’s international competitiveness.


Public comment is invited frominterested parties. Submissions (originaland 3 copies) shall be addressed to theBoard’s Executive Secretary at theaddress below. The closing period fortheir receipt is June 24, 1996. Rebuttalcomments in response to materialsubmitted during the foregoing periodmay be submitted during the subsequent15-day period (to July 8, 1996).

A copy of the application andaccompanying exhibits will be availablefor public inspection at each of thefollowing locations:U.S. Department of Commerce District

Office, #1 Allen Center, Suite 1160,500 Dallas, Houston, Texas 77002.

Office of the Executive Secretary,Foreign-Trade Zones Board, Room3716, U.S. Department of Commerce,14th & Pennsylvania Avenue, NW.,Washington, DC 20230.

Dated: April 12, 1996.John J. Da Ponte, Jr.,Executive Secretary.[FR Doc. 96–9986 Filed 4–22–96; 8:45 am]BILLING CODE 3510–DS–P

National Institute of Standards andTechnology

[Docket No. 960212025–6025–01]

RIN 0693–XX14

Approval of Federal InformationProcessing Standards Publication177–1, Initial Graphics ExchangeSpecification (IGES)

AGENCY: National Institute of Standardsand Technology (NIST), Commerce.ACTION: Notice.

SUMMARY: The purpose of this notice isto announce that the Secretary ofCommerce has approved a revision ofFederal Information ProcessingStandard (FIPS) 177, Initial GraphicsExchange Specification (IGES), whichwill be published as FIPS Publication177–1. This revision adopts theAmerican National Standard DigitalRepresentation for Communication ofProduct Definition Data, ANSI/US PRO/IPO (United States Product DataAssociation/IGES PDES Organization)–100–1993, Version 5.2, and the specifiedapplication protocols. FIPS PUB 177–1addresses IGES implementation anddata file acquisition, interpretation, andconformance.

On April 12, 1995, notice waspublished in the Federal Register (60FR 18583–18586) that a revision ofFederal Information ProcessingStandard (FIPS) 177, Initial GraphicsExchange Specification (IGES), wasbeing proposed for Federal use.

The written comments submitted byinterested parties and other materialavailable to the Department relevant tothis standard were reviewed by NIST.On the basis of this review, NISTrecommended that the Secretaryapprove the revised standard as FederalInformation Processing StandardsPublication (FIPS PUB) 177–1, andprepared a detailed justificationdocument for the Secretary’s review insupport of that recommendation.

The detailed justification documentwhich was presented to the Secretary,and which includes an analysis of thewritten comments received, is part ofthe public record and is available forinspection and copying in theDepartment’s Central Reference andRecords Inspection Facility, Room 6020,Herbert C. Hoover Building, 14th Street

between Pennsylvania and ConstitutionAvenues, NW, Washington, DC 20230.

This FIPS contains two sections: (1)an announcement section, whichprovides information concerning theapplicability, implementation, andmaintenance of the standard; and (2) aspecifications section, which deals withthe technical requirements of thestandard. Only the announcementsection of the standard is provided inthis notice.EFFECTIVE DATE: This revised standardbecomes effective November 1, 1996.ADDRESSES: Interested parties maypurchase copies of this revisedstandard, including the technicalspecifications section, from the NationalTechnical Information Service (NTIS).Specific ordering information fromNTIS for this standard is set out in theWhere to Obtain Copies Section of theannouncement section of the standard.FOR FURTHER INFORMATION CONTACT: MsLynne Rosenthal, telephone (301) 975–3353, National Institute of Standardsand Technology, Gaithersburg, MD20899.

Dated: April 16, 1996.Samuel Kramer,Associate Director.

Federal Information ProcessingStandards Publication 177–1

Announcing the Standard for InitialGraphics Exchange Specification(IGES)

Federal Information ProcessingStandards Publications (FIPS PUBS) areissued by the National Institute ofStandards and Technology (NIST) afterapproval by the Secretary of Commercepursuant to Section 5131 of theInformation Technology ManagementReform Act of 1996 and the ComputerSecurity Act of 1987, Public Law 104–106.

1. Name of Standard. Initial GraphicsExchange Specification (IGES) (FIPSPUB 177–1).

2. Category of Standard. SoftwareStandard; Graphics and InformationInterchange.

3. Explanation. This publication is arevision of the FIPS PUB 177 andsupersedes FIPS PUB 177 in its entirety.It provides a substantial, upward-compatible enhancement of IGESVersion 4.0. FIPS PUB 177–1 specifiesnew conformance requirements, theaddition and use of applicationprotocols (APs), and increasedenhancement, correction, andclarification of the existingspecification. It does not contain anynew requirements that would make an


existing conforming implementationnonconforming.

FIPS PUB 177–1 adopts the AmericanNational Standard DigitalRepresentation for Communication ofProduct Definition Data, ANSI/US PRO/IPO (United States Product DataAssociation/IGES PDES Organization)–100–1993, Version 5.2, and the specifiedapplication protocols. FIPS PUB 177–1addresses IGES implementation anddata file acquisition, interpretation, andconformance.

The purpose of the FIPS for IGES isto enable the compatible exchange ofproduct definition data used bydissimilar computer-aided design andcomputer-aided manufacturing (CAD/CAM) systems. Utilizing a neutraldatabase format the IGES processor cancreate or translate two-dimensional (2–D) or three-dimensional (3–D) vector-based digital product model data. Thestandard specifies file structure andsyntactical definition, and defines therepresentation of geometric, topological,and nongeometric product definitiondata. The exact specification is inSection 10 of this standard.

4. Approving Authority. Secretary ofCommerce.

5. Maintenance Agency. U.S.Department of Commerce, NationalInstitute of Standards and Technology(NIST), Computer Systems Laboratory(CSL).

6. Cross Index.a. American National Standard Digital

Representation for Communication ofProduct Definition Data, ANSI/US PRO/IPO–100–1993, Version 5.2.

b. American Society of MechanicalEngineers/American National StandardsInstitute (ASME/ANSI) Y14.26M–1989,Digital Representation forCommunication of Product DefinitionData, IGES Version 4.0.

c. MIL–D–28000A, ContinuousAcquisition and Life-Cycle SupportSpecification, Digital Representation forCommunication of Product DefinitionData: IGES Application Subsets andIGES Application Protocols, February10, 1992.

d. American National Standard, 3–DPiping IGES Application Protocol,ANSI/US PRO/IPO–110–1994.

e. IGES Layered Electrical ProductApplication Protocol, Committee DraftSAND94–2375, December 1, 1994.

7. Related Documents.a. Federal Information Resources

Management Regulations (FIRMR)subpart 201.20.303, Standards, andsubpart 201.39.1002, Federal Standards.

b. Federal ADP andTelecommunications Standards Index,U.S. General Services Administration,Information Technology Management

Service, October 1994 (updatedperiodically).

c. FIPS PUB 29–3, InterpretationProcedures for Federal InformationProcessing Standards for Software.

d. NISTIR 4379, IGES TechnicalIllustrations Application Guide.

e. NISTIR 4600, IGES 5.0Recommended Practices Guide.

f. NISTIR 5541, Initial GraphicsExchange Specification (IGES):Procedures for the NIST IGESValidation Test Service.

g. MIL–T–31000, GeneralSpecification for Technical DataPackages.

8. Objectives. Federal standards forelectronic interchange permit Federaldepartments and agencies to exercisemore effective control over theproduction, management, and use of thegovernment’s information resources.The primary objectives specific to IGESare to:—Reduce the overall life-cycle cost for

digital systems by establishing acommon exchange format that allowsfor the transfer of product definitiondata across organizational boundariesand independent of any particularCAD/CAM system.

—Exchange digital representations ofproduct definition data in variousforms: illustrations, 2–D drawings, 3–D edge-vertex models, surface models,solid models, and complete productmodels.

—Provide CAD/CAM implementationmanufacturers with a guideline foridentifying useful combinations ofproduct definition data capabilities inany CAD/CAM system.

—Specify APs that can be used byFederal departments and agencies tosupport the exchange of product datawhen applicable.9. Applicability.9.1 This FIPS for IGES is intended for

the computer-interpretablerepresentation and exchange of CAD/CAM product definition data amongapplications and programs that areeither developed or acquired ordeveloped by a Federal agency shallinclude an IGES preprocessor and IGESpostprocessor capability. FIPS for IGESis designed to support the exchange of2–D or 3–D product definition data withrich attributable information. It providesa data format for describing productdesign and manufacturing informationthat has been created and stored in acomputer-readable, device independentform.

9.2. The FIPS for IGES shall be usedwhen one or more of the followingsituations exist:

—The product definition application orprogram is under constant review,and changes may result frequently.

—It is anticipated that the life of thedata files will be longer than the lifeof the presently utilized CAD/CAMsystem.

—The application is being designedcentrally for a decentralized systemthat may employ computers ofdifferent makes and models anddifferent CAD/CAM devices.

—The product definition applicationmay run on equipment other than thaton which it was developed.

—The product definition data is to beused and maintained by other thanthe original designer.

—The product definition data is or islikely to be used by organizationsoutside the Federal Government.

—It is desired to have the designunderstood by multiple people,groups, or organizations.For layered electrical product

technology, three dimensional piping,and engineering drawing applications,the use of the appropriate AP or subset(as described below) is required forimplementation of this FIPS IGES.

An AP or subset provides a means toimprove the fidelity of the product dataexchanged. APs are developed bydomain experts for the purpose ofdefining the processes, informationflows, and functional requirements of anapplication. An AP defines the scope,context, information requirements,representation of the applicationinformation, and conformancerequirements. Initial release of this FIPSfor IGES publication includes two APsand one application subset.—Layered Electrical Product (LEP)

Application Protocol: The LEP AP isused for the transference of 2-Delectrical and electro-mechanicalproduct models. This AP is requiredfor layered electrical productstechnology applications, includingspecification control drawings,circuitry, fabrication and finalassembly of a layered product system.

—3-D Piping Application Protocol: The3-D Piping AP is used for theexchange of models from one pipingmodeling application to another. ThisAP is required for 3-D piping andrelated equipment models, includingthe fabrication and assembly of pipingsystems (e.g. pipe, pipe fittings,attached equipment, piping supports,and insulation).

—Engineering Drawing (Class II) Subset(MIL–D–28000A): The Class II subsetis used for the exchange of thedrawing model; including geometricand annotation entities, attributes


such as color and line fonts, andorganization information such aslevels and subfigures. This subset isrequired for the exchange ofengineering drawings and productdata following MIL–T–31000 (GeneralSpecification for Technical DataPackages).10. Specifications. This FIPS adopts

ANSI/US PRO/IPO–100–1993 and thespecified APs: Layered ElectricalProduct (LEP) Application Protocol; 3-DPiping Application Protocol; andEngineering Drawing (Class II) Subset(MIL–D–28000A). The ANSI/US PRO/IPO–100–1993 standard for IGES,defines the communications filestructure and format (i.e., a file ofentitles), language format, and therepresentation of product definitiondata.

New entities and constructs are addedwith each revision and are upwardlycompatible. Thus, processor conformingto IGES Version 5.2 would be able toread and process an IGES Version 4.0file, but the converse may not be true.The capabilities brought to the IGESuser implementing the IGES Version 5.2standard are:—A new character set for the European

Community;—additional properties to the attribute

table for Architecture/Engineering/Construction (AEC);

—the addition of a new form of thedrawing entity; and

—the addition of a new class of entityuse, termed construction information.Conformance Requirements.

Conformance is mandatory for thisstandard and is applicable to all Federaldepartment and agency procurements.Conforming data files and processorsmush adhere to all the rules appropriateto specific features, such as entities,defines within ANSI/US PRO/IPO–100–1993 and when applicable, one of theAPs or subset identified in thisstandard. Vendors of processorsclaiming conformance to this standardshall complete documentation whichaccurately indicates the processor’ssupport of, and mapping between,native and IGES entities.

A conforming preprocessor shallcreate conforming IGES data files whichrepresent the native database which wasinput to the preprocessor. File contentshall represent the native entitiesaccording to the vendor’s completeddocumentation. Unsupported nativeentities shall be reported.

A conforming postprocessor shall becapable of reading any complying datafile without halting or aborting,including data files containingunprocessible entitles. All

unprocessible entities shall be ignored.A conforming postprocessor shalltranslate conforming IGES data files intothe native database form of a specificCAD/CAM system. It shall convert eachsupported entity into native constructs,which preserve the functionality andmatch the geometry, attributes, andrelationships of the IGES entity in thefile. The postprocessor shall report onany IGES entities or features which havebeen discarded.

Any visual presentation of supported,displayable entities that is produced bythe processor, shall represent a visualappearance equivalent to the examplesappearing in ANSI/US PRO/IPO–100–1993 and, if applicable, the AP orsubset. The visual appearance shalldepict the functional intent of thedatabase.

Conformance Rules for ApplicationProtocols and Subsets. An applicationprotocol or subset which claimsconformance to this standard, mustsatisfy the following rule:—An implementation conforming to an

AP shall satisfy the conformancerequirements specified in the AP aswell as the conformance requirementsin the ANSI/US PRO/IPO–100–1993specification.11. Implementation. The

implementation of this standardinvolves four areas of consideration:effective date, acquisition,interpretation, and validation.

11.1 Effective Date. This publicationis effective November 1, 1996. Atransition period of twelve (12) months,beginning on the effective date, allowsindustry to produce IGESimplementations and data filesconforming to this standard. Agenciesare encouraged to use this standard forsolicitation proposals during thetransition period. This standard ismandatory for use in all solicitationproposals for IGES data files andimplementations (i.e., computer-aideddesign and manufacturing systems)acquired twelve (12) months after theeffective date.

11.2 Acquisition of IGESImplementations and Data Files.Conformance to this standard should beconsidered whether the CAD/CAMsystems are developed internally,acquired as part of a systemprocurement, acquired by separateprocurement, used under a leasingagreement, or specified for use incontracts for programming services.Recommended terminology forprocurement of FIPS IGES is containedin the U.S. General ServicesAdministration publication FederalADP and TelecommunicationsStandards Index, Chapter 5, Part 1.

11.3 Interpretation of FIPS IGES.Resolutions of questions regarding thisstandard will be provided by NIST.Procedures for interpretations arespecified in FIPS PUB 29–3. Allquestions concerning the specificationsand content should be addressed to:Director, Computer Systems Laboratory,ATTN: FIPS IGES Interpretation,Building 820, Room 562, NationalInstitute of Standards and Technology,Gaithersburg, MD 20899.

11.4 Validation of IGESImplementations. Validation of IGESimplementations is not mandatory atthis time. Testing of animplementation’s conformance to thisFIPS IGES will be optional by theagency. Government agencies acquiringimplementations in accordance withthis standard may wish to requiretesting for conformance,interoperability, and performance. Thetests to be administered and the testingorganization are at the discretion of theagency Acquisition Authority.

12. Waivers. Under certainexceptional circumstances, the heads ofFederal departments and agencies mayapprove waivers to Federal InformationProcessing Standards (FIPS). The headof such agency may redelegate suchauthority only to a senior officialdesignated pursuant to section 3506(b)of Title 44, U.S. Code. Waivers shall begranted only when:

a. Compliance with a standard wouldadversely affect the accomplishment ofthe mission of an operator of a Federalcomputer system, or

b. Cause a major adverse financialimpact on the operator which is notoffset by Governmentwide savings.

Agency heads may act upon a writtenwaiver request containing theinformation detailed above. Agencyheads may also act without a writtenwaiver request when they determinethat conditions for meeting the standardcannot be met. Agency heads mayapprove waivers only by a writtendecision which explains the basis onwhich the agency head made therequired finding(s). A copy of each suchdecision, with procurement sensitive orclassified portions clearly identified,shall be sent to: National Institute ofStandards and Technology; ATTN: FIPSWaiver Decisions, Building 820, Room509; Gaithersburg, MD 20899.

In addition, notice of each waivergranted and each delegation of authorityto approve waivers shall be sentpromptly to the Committee onGovernment Operations of the House ofRepresentatives and the Committee onGovernmental Affairs of the Senate andshall be published promptly in theFederal Register.


When the determination on a waiverapplies to the procurement ofequipment and/or services, a notice ofthe waiver determination must bepublished in the Commerce BusinessDaily as a part of the notice ofsolicitation for offers of an acquisitionor, if the waiver determination is madeafter that notice is published, byamendment to such notice.

A copy of the waiver, any supportingdocuments, the document approving thewaiver and any supporting andaccompanying documents, with suchdeletions as the agency is authorizedand decides to make under 5 U.S.C. Sec.552(b), shall be part of the procurementdocumentation and retained by theagency.

13. Where to Obtain Copies. Copies ofthis publication are for sale by theNational Technical Information Service,U.S. Department of Commerce,Springfield, VA 22161. (Sale of theincluded specifications document is byarrangement with the NationalComputer Graphics Association and theAmerican National Standards Institute.)When ordering, refer to FederalInformation Processing StandardsPublication 177–1 (FIPSPUB177–1), andtitle. Payment may be made by check,money order, or NTIS deposit account.

[FR Doc. 96– 9941 Filed 4–22–96; 8:45 am]BILLING CODE 3510–CN–M


Monterey Bay National MarineSanctuary Advisory Council; Meeting

AGENCY: Sanctuaries and ReservesDivision (SRD), Office of Ocean andCoastal Resource Management (OCRM),National Ocean Service (NOS), NationalOceanic and AtmosphericAdministration (NOAA), Department ofCommerce.ACTION: Monterey Bay National MarineSanctuary Advisory Council OpenMeeting.

SUMMARY: The Advisory Council wasestablished in December 1993 to adviseNOAA’s Sanctuaries and ReservesDivision regarding the management ofthe Monterey Bay National MarineSanctuary. The Advisory Council wasconvened under the National MarineSanctuaries Act.TIME AND PLACE: Friday, April 26, 1996,from 10:00 until 3:00. The meeting willbe held at the Montaro PointLighthouse, Highway #1, Montaro,California.AGENDA: General issues related to theMonterey Bay National Marine

Sanctuary are expected to be discussed,including an update from the SanctuaryManager, reports from the workinggroups, a discussion of Sanctuarymanagement options, a report on theelephant seal population at PiedrasBlancas, and a discussion of kelpharvesting in the Sanctuary.PUBLIC PARTICIPATION: The meeting willbe open to the public. Seats will beavailable on a first-come, first-servedbasis.FOR FURTHER INFORMATION CONTACT: JaneDelay at (408) 647–4246 or ElizabethMoore at (301) 713–3141.Federal Domestic Assistance Catalog Number11.429Marine Sanctuary Program

Dated: April 17, 1996.David L. Evans,Acting Deputy Assistant Administrator forOcean Services and Coastal ZoneManagement.[FR Doc. 96–9987 Filed 4–22–96; 8:45 am]BILLING CODE 3510–08–M

[Docket No. 960412111–6111–01; I.D.040596B]

RIN 0648–ZA20

West Coast Salmon Fisheries;Northwest Emergency Assistance Plan(NEAP)

AGENCY: National Marine FisheriesService (NMFS), National Oceanic andAtmospheric Administration (NOAA),Commerce.ACTION: Notice; request for comments.

SUMMARY: On August 2, 1995, theSecretary of Commerce (Secretary)declared that a fishery resource disasterstill persists in the Pacific States ofCalifornia (north of San Francisco),Oregon, and Washington (excludingPuget Sound). Pursuant to thisdeclaration, the Secretary has providedan additional $13 million in assistanceto the affected fishermen in the PacificNorthwest. The additional funds will beused to continue funding the NorthwestEmergency Assistance Plan (NEAP). Thepurpose of this action is to notify thepublic of new aspects of the NEAP andto solicit comments on proposedchanges to the NEAP.DATES: Written comments must bereceived by May 23,1996.ADDRESSES: Comments should be sent toStephen P. Freese, NorthwestEmergency Assistance Plan, Trade andIndustry Services Division, NorthwestRegional Office, National MarineFisheries Service, BIN C15700, 7600Sand Point Way NE, Seattle, WA 98115.

FOR FURTHER INFORMATION CONTACT:Stephen Freese, (206) 526–6113.SUPPLEMENTARY INFORMATION:

BackgroundOn May 26, 1994, the Secretary

declared a fishery resource disaster, andauthorized the expenditure of $12million in financial assistance for theNEAP, under the authority of section308(d) of the InterjurisdictionalFisheries Act (IFA); (16 U.S.C. 1407(d)).Pursuant to the Secretary’s declaration,NMFS established three NEAPprograms: (1) A habitat restoration jobsprogram ($6 million), administered bythe U.S. Department of Agriculture’sNatural Resources Conservation Service(USDA/NRCS); (2) a salmon fishinglicense buy out program ($4 million),which has been completed by theWashington Department of Fish andWildlife (WDFW); and (3) a datacollection jobs program ($2 million),administered by the Pacific StatesMarine Fisheries Commission (PSMFC).These programs provided financialassistance to the fishermen who sufferedlosses due to the fishery resourcedisaster that arose from factors thatincluded drought, flooding, minimalsnowpack, and an extreme El Ninoocean warming event.

On August 2, 1995, the Secretarydeclared that the fishery resourcedisaster continued in 1995 for thesalmon fisheries of the Pacific States ofCalifornia (north of San Francisco),Oregon, and Washington, excludingPuget Sound. In extending the disasterand determining its impacts, theSecretary considered the magnitude ofthe disaster in economic and socialterms, in addition to the various naturalfactors causing the fishery resourcedisaster. Salmon stocks along the WestCoast remain extremely depressed, andthe fishery disaster has caused highlevels of economic damage and socialdisruption. Therefore, NMFS willcontinue the NEAP to encompass thedisaster period that extends fromJanuary 1, 1991 through December 31,1995, and will continue to providefunding pursuant to the FederalRegister notice that established theNEAP, published on October 11, 1994(59 FR 51419), with subsequent minoramendments published on January 31,1995, and June 22, 1995 (60 FR 3908, 60FR 32507). The original NEAP termsand conditions will be in effect until theproposed revisions to the NEAP that arecontained in this notice are finalizedand implemented.

Of the $13 million in additionalNEAP funding, NMFS will transfer $4.8million to USDA/NRCS to continue itsrole as administrative intermediary for


the Habitat Restoration Jobs Program,and award $2.65 million to the PSMFCfor the 1996 phase of the Data CollectionJobs Program. Both the USDA/NRCSand the PSMFC will use the samecriteria as those established in the NEAPand set forth in October 11, 1994,Federal Register notice (59 FR 51419).If the revised criteria proposed in thisnotice are adopted, NMFS will amendthe agreement with USDA and the grantto PSMFC accordingly, and the revisedcriteria will be effective from the date ofpublication of the final Federal Registernotice announcing this program. NMFShas also allocated $5.25 million for theLicense Buy Out Program to continue topurchase licenses from fisheries thatdepend on chinook and coho salmon.NMFS proposes to implement thisprogram through WDFW by June 1,1996. NMFS proposes to maintain thesame limitations in determiningmaximum bid amounts as currentlyemployed in the NEAP. Reasons forusing the same limitations includefairness to previous successfulparticipants, reduced administrativecosts, and reduced paperwork burdenupon fishermen. NMFS is retaining$300,000 for administrative costs.

Congress is currently consideringamendments to the IFA. If suchamendments are passed and can beapplied retroactively, or if suchamendments become law prior topublication of a final Federal Registernotice announcing this program, theeligibility criteria may be subject tofurther change. Although NMFS maychoose to maintain the currenteligibility criteria to minimizedisruption to the existing programs, orfor other reasons, NMFS may changesome or all of the eligibility limitationsfor certain programs. Such changes maymean that participation in the programwould no longer be restricted toapplicants with gross incomes under $2million, financial assistance would nolonger be limited to $100,000, and nocalculation of uninsured loss would benecessary.

New Aspects to the NEAP ProgramsNMFS has determined that changes

are required to certain aspects of theNEAP programs in order to ensureeffective implementation. This noticeserves to notify the public of thosechanges.

The calculation of uninsured loss willchange due to the expansion of thedisaster period pursuant to theSecretary’s 1995 disaster declarationand to new biological information onthe state of the fishery in 1991. NMFSis extending the disaster period from1992–1994 to 1991–1995 based on a

review of biological studies and onlandings and ex-vessel revenue trendsin ocean (Northern California, Oregon,and Washington) and Columbia Rivercoho and chinook fisheries. Many, if notall, of the factors underlying the declinein the 1992–94 fisheries were present in1991. The disaster period includes theyear 1995 pursuant to the Secretary’s1995 disaster declaration.

Furthermore, as a result of theSecretary’s expansion of the disasterand NMFS’s efforts to improve theprogram, the term ‘‘loss’’, as defined inthe NEAP published on January 31,1994 (60 FR 5908), is redefined as a lossof income not subject to Federal or statecompensation and determined by thefollowing multi-step procedure. In Step1, the applicant can select a base yearfrom the years 1986 through 1991. InStep 2, the applicant can select acomparison year from the years 1991through 1995. Step 3 will remain thesame, i.e., the comparison year must beless than the base year in order to showa loss. Step 4 of this procedure is nowdifferent from the procedure set forth inthe January 31, 1994, Federal Registernotice due to the expansion of thedisaster period to the years 1991through 1995. The amount of annualloss is now multiplied by five, asopposed to three, to account for thisexpansion.

Finally, applicants can now use eithertheir 1993, 1994, or 1995 gross incometo determine whether they meet the$25,000 or $50,000 gross income cap.

Proposed Revisions to the NEAPPrograms

NMFS proposes to revise some of thelimitations, terms, and conditions toaddress the new disaster declaration forthe continuation of the NEAP. Theintent of these revisions is to increasethe number of fishermen eligible toreceive assistance under the NEAP, aswell as continue the conservation workalready begun. Section 308(d) of the IFArequires the Secretary to solicit publiccomment on the limitations, terms, andconditions that the Secretary hasdetermined are necessary to administerthe NEAP. Accordingly, the public isrequested to comment on the itemsbelow.

(1) Proposed Change to MinimumAmount of Commercial Fishing IncomeEarning Requirement

An applicant must have earned atleast $2,500 in commercial fishingincome in the base year selected indetermining loss. The decrease to$2,500 from $5,000 would provide crewmembers with greater accessibility to

the program. The rest of the eligibilitycriteria would remain the same.

(2) Ability to Participate in All NEAPPrograms

Participants in the License Buy OutProgram would not be excluded fromparticipation in the Habitat Restorationand Data Collection Jobs Program.Therefore, a fisherman who sold alicense under the License Buy OutProgram could be employed undereither of the Jobs Programs, as long asthe total compensation did not exceed75 percent of the fisherman’s uninsuredloss. Compensation includes allcompensation earned from NEAP.

(3) Requirement for Fishermen toPossess Same Licenses in 1995 as WerePossessed in 1994

NMFS proposes to exclude applicantsfrom the License Buy Out Program whobought licenses in 1995. Such exclusionwould limit applicants who speculatedon the licenses in 1995 in anticipationof the revised License Buy Out program.Therefore, applicants to the License BuyOut Program who possessed one of theWashington State salmon licenses listedbelow in 1995 must also have possessedthe same license(s) in 1994:

(a) Salmon troll license(b) Salmon delivery license(c) Salmon gill net—Grays Harbor-

Columbia River(d) Salmon gill net— Willapa Bay-

Columbia River(e) Salmon charter

(4) Alternative Bidding Options for theLicense Buy Out Program

Option 1— According to gear group,all eligible fishermen would submit newbids or verify that they wish to maintaintheir previous bids. Offer packageswould be ranked. Starting with thelowest offers in each license type,licenses would be accepted and retiredby WDFW.

Option 2 —WDFW would purchaselicenses from the pool of applicants forthe NEAP License Buy Out Program,beginning with the lowest unsuccessful1995 offer. The WDFW would purchaselicenses until the remaining funds areinsufficient for the entire next offeramount.

Option 3—WDFW would purchaselicenses beginning with the pool ofapplicants for the NEAP License BuyOut Program. Licensees who offeredlicenses in the NEAP, but wereunsuccessful, would have anopportunity to sell their licenses for thelast price paid per gear group. Theseamounts are: Salmon troll anddelivery—$24,984, Salmon gill net—$38,000, and Salmon charter—$21,300.


If any funds remain after purchase oflicenses from the 1995 programapplicants, 1996 program applicationswould be accepted as provided for inthis section from persons who areeligible to participate, starting with thelowest offer. The WDFW wouldpurchase licenses until the remainingfunds are insufficient for the entire nextoffer amount.

Option 4—This option is modeledconceptually on NMFS’s FishingCapacity Reduction DemonstrationProgram (FCRDP) for Northeastgroundfish vessels, published in theFederal Register, June 22, 1995 (60 FR32504). Under the FCRDP, NMFSbought out both vessels and licenses,and bids were ranked by taking intoconsideration vessel performance.Under Option 4, WDFW would continueto buy out only licenses, but wouldestablish a ranking system similar tothat of the FCRDP. Bids would beranked by license score, and the licensescore would be determined by dividingthe bid by the applicant’s uninsuredloss, since the calculation of uninsuredloss reflects vessel performance.

Using the same limitations employedin the 1995 NEAP buy out program, theapplicant would submit a bid that canrange from $1.00 up to the maximumamount that the applicant can bid. Themaximum amount that an applicant canbid is 2.25 times the difference betweenthe highest gross income derived fromsalmon fishing during any calendar year1986 through 1991 (which becomes theapplicant’s ‘‘base year’’), and the leastamount of gross income derived fromsalmon fishing activities during anycalendar year from 1992 through 1994(which becomes the applicant’s‘‘comparison year’’). No bid can exceed$100,000 minus any Federalunemployment or NEAP related incomealready received.

Using the definition of uninsured lossas defined by this notice, the applicantwould also submit the amount ofuninsured loss suffered as a result of thefishery disaster. Uninsured loss is 5times the difference between the highestgross income derived from salmonfishing during any calendar year 1986through 1991 (base year), and the leastamount of gross income derived fromsalmon fishing activities during anycalendar year from 1991 through 1995(comparison year). The comparison yearmust be less than the base year. Theapplicant’s bid amount would then bedivided by the applicant’s uninsuredloss to determine the applicant’s licensescore. The scores of all the applicantswould be ranked from low to high withthe lowest scores being purchased first.

Provided below are three examples ofthis scoring process:

Example 1Step A. Applicant A submits a bid for

$18,500.Step B. Applicant A has an uninsured

loss of $29,670.Step C. The score for Applicant A is

.6235 ($18,500 divided by $29,670).

Example 2Applicant B submits the same bid as

Applicant A ($18,500). However, theuninsured loss for Applicant B is$42,680.

Step A. Applicant B submits a bid for$18,500.

Step B. Applicant B has an uninsuredloss of $42,680.

Step C. The score for Applicant B is.4335 ($18,500 divided by $42,680).

Example 3Applicant C submits a bid for

$35,000. Applicant C’s uninsured loss is$81,860.

Step A. Applicant C submits a bid for$35,000.

Step B. Applicant C has an uninsuredloss of $81,860.

Step C. The score for Applicant C is.4276 ($35,000 divided by $81,860).

Even though Applicant C’s bid ishigher than that of Applicants A and B,Applicant C’s score is lower because ofthe greater uninsured loss.Consequently, Applicant C would beselected over Applicants A or B, andApplicant B would be selected beforeApplicant A. In the instances where achoice must be made between two ormore equally scored bids, applicantswith the lowest bid (Step A) will begiven preference.

Catalogue of Federal DomesticAssistance

The NEAP is listed in the ‘‘Catalogueof Federal Domestic Assistance’’ underNo.11.452, Unallied Industry Projects.

ClassificationThis action has been determined to be

not significant for purposes of E.O.12866.

Some of the activities mentioned inthis notice are subject to the PaperworkReduction Act (PRA). They have beenapproved by the Office of Managementand Budget (OMB) under controlnumber 0648–0288.

Notwithstanding any other provisionof law, no person is required to respondto, nor shall a person be subject to, apenalty for failure to comply with acollection of information subject to therequirements of the PRA unless thatcollection of information displays acurrently valid OMB control number.

Dated: April 17, 1996.Gary Matlock,Program Management Officer, NationalMarine Fisheries Service.[FR Doc. 96–9906 Filed 4–18–96; 3:09 pm]BILLING CODE 3510–22–F

COMMODITY FUTURES TRADINGCOMMISSION

Agricultural Advisory CommitteeMeeting

This is to give notice, pursuant toSection 10(a) of the Federal AdvisoryCommittee Act, 5 U.S.C. App. 2, Section10(a) and 41 CFR 101–6.1015(b), thatthe Commodity Futures TradingCommission’s Agricultural AdvisoryCommittee will conduct a publicmeeting on May 8, 1996 from 1:00 p.m.to 5:00 p.m. in the first floor hearingroom of the Commodity Futures TradingCommission (Room 1000), ThreeLafayette Centre, 1155 21st Street, N.W.,Washington, D.C. 20581. The agendawill consist of:

AgendaI. Opening Remarks by Acting Chairman John

E. Tull;II. Report from Dr. Wayne Purcell, of Virginia

Tech, on ‘‘Needed Changes in TaxTreatment of Cattle Feeders’ Activities inCattle Futures;’’

III. Report on the FAIR Act Provisions for aUSDA Office of Risk Management;

IV. Report from the CBOT Regular GrainStorage Capacity Task Force;

V. Report from the National Grain and FeedAssociation’s Risk Evaluation TaskForce;

VI. Presentation by CBOT on the Project ATrading System;

VII. Update on the CFTC–DEA Staff WhitePaper on the Agricultural Trade OptionProhibition;

VIII. Report on the CME Proposal to Increasethe Spot Month Speculative PositionLimit on the Live Cattle Contract;

IX. Other Committee Business;X. Closing Remarks by Commissioner Joseph

Dial.

The purpose of this meeting is tosolicit the views of the Committee onthe above-listed agenda matters. TheAdvisory Committee was created by theCommodity Futures TradingCommission for the purpose of receivingadvice and recommendations onagricultural issues. The purposes andobjectives of the Advisory Committeeare more fully set forth in the sixthrenewal charter of the AdvisoryCommittee.

The meeting is open to the public.The Chairman of the AdvisoryCommittee, Commissioner Joseph B.Dial, is empowered to conduct themeeting in a fashion that will, in his


judgment, facilitate the orderly conductof business. Any member of the publicwho wishes to file a written statementwith the Advisory Committee shouldmail a copy of the statement to theattention of: the Commodity FuturesTrading Commission AgriculturalAdvisory Committee c/o KimberlyHarter, Commodity Futures TradingCommission, Three Lafayette Centre,1155 21st Street, N.W., Washington,D.C. 20581, before the meeting.Members of the public who wish tomake oral statements should also informMs. Harter in writing at the foregoingaddress at least three business daysbefore the meeting. Reasonableprovision will be made, if time permits,for an oral presentation of no more thanfive minutes each in duration.

Issued by the Commission in Washington,D.C. on April 17, 1996.Jean A. Webb,Secretary of the Commission.[FR Doc. 96–9931 Filed 4–22–96; 8:45 am]BILLING CODE 6351–01–M

DEPARTMENT OF ENERGY

Low-Level Radioactive Waste Program,Idaho Operations Office; Notice ofIntent

SUMMARY: The U.S. Department ofEnergy’s (DOE) Office of EnvironmentalManagement through the IdahoOperations Office and pursuant to 10CFR 600.6(c), intends to negotiate andaward on a noncompetitive basis, arenewal of Grant No. DE–FG07–90ID13039 to the state of Washington’sDepartment of Ecology (Washington) onbehalf of the Low-Level RadioactiveWaste Forum (Forum). The totalestimated cost of the three year 100%DOE funded renewal award is$1,972,002 or $657,334 per year. Thetechnical assistance proposed is theresult of an unsolicited request fromWashington for continued support ofthe Forum in maintaining anindependent self-directed organizationto promote an effective and efficientnational system for the management anddisposal of commercially generated low-level radioactive waste.FOR FURTHER INFORMATION CONTACT:Dallas L. Hoffer, Contract Specialist,(208) 526–0014; U.S. Department ofEnergy, Idaho Operations Office, 850Energy Drive, Mail Stop 1221, IdahoFalls, Idaho 83401–1563.SUPPLEMENTARY INFORMATION: Theanticipated award is justified inaccordance with 10 CFR 600.6(c), asfollows: The activity to be funded isnecessary to the satisfactory completion

of an activity (a) that is presently beingfunded by DOE and (b) for whichcompetition for support would have asignificant adverse effect on continuityor completion of the activity.

The Statutory Authority for therenewal award can be found in Section7(a) of the Low-Level Radioactive WastePolicy Amendments Act of 1985 (Pub.L. 99–240). In the Act, Congress hasdirected DOE to provide continuingtechnical assistance to states andcompact commissions.

Procurement Request Number: 07–96ID13420.000.

Dated: April 10, 1996.R. Jeffrey Hoyles,Director, Procurement Services Division.[FR Doc. 96–9939 Filed 4–22–96; 8:45 am]BILLING CODE 6450–01–M

Environmental Management Site-Specific Advisory Board, IdahoNational Engineering Laboratory

AGENCY: Department of Energy.ACTION: Notice of open meeting.

SUMMARY: Pursuant to the provisions ofthe Federal Advisory Committee Act(Pub. L. 92–463, 86 Stat. 770) notice ishereby given of the following AdvisoryCommittee meeting: EnvironmentalManagement Site-Specific AdvisoryBoard (EM SSAB), Idaho NationalEngineering Laboratory (INEL)

DATES:

Site Tour: Monday, May 20, 1996 from7:30 a.m. until 5:30 p.m. MountainSavings Time (MST)

Meeting: Tuesday, May, 21, 1996 from8:00 a.m. until 6:00 p.m. MST. Therewill be a public comment availabilitysession Tuesday, May 21, 1996 from5:00 p.m. until 6:00 p.m. MST.

ADDRESSES: Holiday Inn Westbank, 475Park Way, Idaho Falls, Idaho 83402.FOR FURTHER INFORMATION CONTACT:Idaho National Engineering LaboratoryInformation 1–800–708–2680 or MarshaHardy, Jason Associates CorporationStaff Support 1–208–522–1662.


Purpose of the BoardThe purpose of the Board is to make

recommendations to DOE and itsregulators in the areas of environmentalrestoration, waste management, andrelated activities.

Meeting PurposeThe EM SSAB, INEL will tour the

Naval Reactors Facility, RadioactiveWaste Management Complex, and somearcheological sites at INEL. The Board

meeting features consensus training, apanel discussion on Health Effectsissues, and presentations oninformational topics includingIntegration of Federal Regulations andthe Federal Facilities Compliance Act/Site Treatment Plan. Study issues forfuture recommendations include theAlternative Disposal Sites for Low-LevelWaste and the INEL Spent Nuclear FuelStrategic Plan.

Tentative Agenda

Tuesday, May 21, 19967:30 a.m.—Sign-in and Registration8:00 a.m.—Miscellaneous Business:

Old Business• Jerry Bowman—Deputy Designated

Federal Official Report• Chuck Rice (acting)—Chair Report

Standing Committee Reports• Member Selection Committee—

Dean Mahoney (chair), Chuck Rice, E.J.Smith

Member Reports

9:00 a.m.—Health Effects PanelDiscussion (speakers to beannounced)

10:15 a.m.—Break10:30 a.m.—Health Effects Panel

Discussion (continued)12:00 p.m.—Lunch1:00 p.m.—Consensus Training

• Peter Woodrow, CDR Associates2:30 p.m.—Break2:45 p.m.—Consensus Training

(continued)5:00 p.m.—Public Comment Availability6:00 p.m.—Adjourn

Wednesday, May 22, 19967:30 a.m.—Sign-in and Registration8:00 a.m.—Miscellaneous Business8:45 a.m.—Alternate Disposal Sites for

Low-Level Waste• Committee members—Terry Perez,

Chuck Rice, Clarence Bellem; Speaker tobe announced; Presentation andDiscussion10:30 a.m.—Break10:45 a.m.—DOE Presentation:

Integration of Regulations• Speaker to be announced;

Presentation and Discussion12:00 p.m.—Lunch1:00 p.m.—INEL Spent Nuclear Fuel

Strategic Plan• Committee members—Ben Collins,

Clarence Bellem, E.J. Smith; Speaker tobe announced; Presentation andDiscussion3:00 p.m.—Break3:15 p.m.—Federal Facilities

Compliance Act/Site TreatmentPlan Update


4:00 p.m.—Board Work4:30 p.m.—Meeting Evaluation5:00 p.m.—Adjourn

This agenda is subject to change asthe Board meeting nears. For a mostcurrent copy of the agenda, contactWoody Russell, DOE-Idaho, (208) 526–0561, or Marsha Hardy, JasonAssociates, (208) 522–1662. The finalagenda will be available at the meeting.

Public Comment AvailabilityThe two-day meeting is open to the

public, with a Public CommentAvailability session scheduled forTuesday, September 19, 1995 from 5:00p.m. to 6:00 p.m. MST. The Board willbe available during this time period tohear verbal public comments or toreview any written public comments. Ifthere are no members of the publicwishing to comment or no writtencomments to review, the board willcontinue with it’s current discussion.Written statements may be filed withthe Committee either before or after themeeting. Individuals who wish to makeoral statements pertaining to agendaitems should contact the Idaho NationalEngineering Laboratory Information lineor Marsha Hardy, Jason Associates, atthe addresses or telephone numberslisted above. Requests must be received5 days prior to the meeting andreasonable provision will be made toinclude the presentation in the agenda.The Designated Federal Official isempowered to conduct the meeting in afashion that will facilitate the orderlyconduct of business. Each individualwishing to make public comment willbe provided a maximum of 5 minutes topresent their comments.

MinutesThe minutes of this meeting will be

available for public review and copyingat the Freedom of Information PublicReading Room, 1E–190, ForrestalBuilding, 1000 Independence Avenue,SW, Washington, DC 20585 between9:00 a.m. and 4 p.m., Monday-Friday,except Federal holidays.

Issued at Washington, DC on April 15,1996.Gail Cephas,Acting Deputy Advisory CommitteeManagement Officer.[FR Doc. 96–9944 Filed 4–22–96; 8:45 am]BILLING CODE 6450–01–P

Environmental Management Site-Specific Advisory Board, SavannahRiver Site


SUMMARY: Pursuant to the provisions ofthe Federal Advisory Committee Act(Pub. L. 92–463, 86 Stat. 770) notice ishereby given of the following AdvisoryCommittee meeting: EnvironmentalManagement Site-Specific AdvisoryBoard (EM SSAB), Savannah River Site.DATES AND TIMES: Monday, May 13,1996: 6:00 p.m.–7:00 p.m. (publiccomment session); Tuesday, May 14,1996: 8:30 a.m.–4:00 p.m.ADDRESSES: Hyatt Regency Savannah,Two West Bay Street, Savannah,Georgia.FOR FURTHER INFORMATION CONTACT: TomHeenan, Manager, EnvironmentalRestoration and Solid Waste,Department of Energy Savannah RiverOperations Office, P.O. Box A, Aiken,S.C. 29802 (803) 725–8074.



recommendations to DOE and itsregulators in the areas of environmentalrestoration, waste management andrelated activities.

Tentative Agenda

Monday, May 13, 1996

6:00 p.m.—Public Comment Session (5-minute rule)

7:00 p.m.—AdjournSubcommittee meetings will follow

the public comment session.

Tuesday, May 14, 1996

8:30 a.m.—Approval of Minutes,Agency Updates (∼ 15 minutes);Public Comment Session (5-minuterule) (∼ 30 minutes); NuclearMaterials ManagementSubcommittee Report (∼ 2 hours);Recommendation on plutoniumdisposition; OutreachSubcommittee Report (∼ 15minutes)

12:00 p.m.—Lunch1:00 p.m.—Environmental Remediation

& Waste ManagementSubcommittee Report (∼ 1.5 hours)Risk Management & Future UseSubcommittee Report (∼ 30minutes) SubcommitteeParticipation (∼ 15 minutes)

4:00 p.m.—AdjournIf needed, time will be allotted after

public comments for items added to theagenda, and administrative details. Afinal agenda will be available at themeeting Monday, May 13, 1996.

Public Participation

The meeting is open to the public.Written statements may be filed withthe Committee either before or after the

meeting. Individuals who wish to makeoral statements pertaining to agendaitems should contact Tom Heenan’soffice at the address or telephonenumber listed above. Requests must bereceived 5 days prior to the meeting andreasonable provision will be made toinclude the presentation in the agenda.The Designated Federal Official isempowered to conduct the meeting in afashion that will facilitate the orderlyconduct of business. Each individualwishing to make public comment willbe provided a maximum of 5 minutes topresent their comments.

MinutesThe minutes of this meeting will be

available for public review and copyingat the Freedom of Information PublicReading Room, 1E–190, ForrestalBuilding, 1000 Independence AvenueSW., Washington, DC 20585 between9:00 a.m. and 4 p.m., Monday–Fridayexcept Federal holidays. Minutes willalso be available by writing to TomHeenan, Department of EnergySavannah River Operations Office, P.O.Box A, Aiken, S.C. 29802, or by callinghim at (803) 725–8074.


Environmental Management Site-Specific Advisory Board, Hanford Site


SUMMARY: Pursuant to the provisions ofthe Federal Advisory Committee Act(Pub. L. 92–463, 86 Stat. 770) notice ishereby given of the following AdvisoryCommittee meeting: EnvironmentalManagement Site-Specific AdvisoryBoard (EM SSAB), Hanford Site.DATES: Thursday, May 2, 1996: 9:00a.m.–5:15 p.m.; Friday, May 3, 1996:8:30 a.m.–4:00 p.m.ADDRESSES: Shilo Inn, 50 Comstock,Richland, Washington.FOR FURTHER INFORMATION CONTACT: JonYerxa, Public Participation Coordinator,Department of Energy RichlandOperations Office, P.O. Box 550,Richland, WA 99352.



recommendations to DOE and itsregulators in the areas of environmental


restoration, waste management, andrelated activities.

Tentative Agenda.

May Meeting Topics

The Hanford Advisory Board willreceive information on and discussissues related to: the Tri-PartyAgreement (TPA) Community RelationsPlan, DOE budget issues, the status ofM–33 negotiations, strategic planning,the Tank Waste Remediation System(TWRS) Draft Environmental ImpactStatement, the status of TWRSprivatization, TWRS TPA changepacket, and the TWRS request forproposal.

Public Participation

The meeting is open to the public.Written statements may be filed withthe Committee either before or after themeeting. Individuals who wish to makeoral statements pertaining to agendaitems should contact Jon Yerxa’s officeat the address or telephone numberlisted above. Requests must be received5 days prior to the meeting andreasonable provision will be made toinclude the presentation in the agenda.The Designated Federal Official isempowered to conduct the meeting in afashion that will facilitate the orderlyconduct of business. Each individualwishing to make public comment willbe provided a maximum of 5 minutes topresent their comments. Due toprogrammatic issues that had to beresolved, the Federal Register notice isbeing published less than fifteen daysbefore the date of the meeting.

Minutes

The minutes of this meeting will beavailable for public review and copyingat the Freedom of Information PublicReading Room, 1E–190, ForrestalBuilding, 1000 Independence AvenueSW., Washington, DC 20585 between9:00 a.m. and 4 p.m., Monday–Friday,except Federal holidays. Minutes willalso be available by writing to JonYerxa, Department of Energy RichlandOperations Office, P.O. Box 550,Richland, WA 99352, or by calling himat (509) 376–9628.


Office of Fossil Energy

National Coal Council; Notice of OpenMeeting

Pursuant to the provisions of theFederal Advisory Committee Act (Pub.L. 92–463, 86 Stat. 770), notice is herebygiven of the following meeting:

Name: National Coal Council.Date and Time: Thursday, May 16, 1996,

9:00 a.m.Place: Ritz-Carlton Washington, 2100

Massachusetts Avenue, N.W., Washington,D.C.

Contact: Margie D. Biggerstaff, U.S.Department of Energy, Office of Fossil Energy(FE–5), Washington, D.C. 20585; Telephone:202/586–3867.

Purpose of the Council: To provide advice,information, and recommendations to theSecretary of Energy on matters relating tocoal and coal industry issues.

Tentative Agenda—Call to order and opening remarks by

Joseph Craft III, Chairman of the NationalCoal Council.

—Approval of final agenda.—Remarks by the Honorable Hazel R.

O’Leary, Secretary of Energy.—Remarks by the Honorable Elizabeth Ann

Moler, Chairman, Federal EnergyRegulatory Commission. (Invited)

—Remarks by the Honorable Bob Armstrong,Assistant Secretary for Land and MineralsManagement, Department of the Interior.(Invited)

—Remarks by the Honorable Fred J. Hansen,Deputy Administrator, EnvironmentalProtection Agency. (Invited)

—Report of the Coal Policy Committee.—Administrative matters.—Election of 1996–97 Officers.—Discussion of any other business properly

brought before the Council.—Public comment—10-minute rule.—Adjournment.

Public Participation: The meeting isopen to the public. The Chairman of theCouncil is empowered to conduct themeeting in a fashion that will facilitatethe orderly conduct of business. Anymember of the public who wishes to filea written statement with the Councilwill be permitted to do so, either beforeor after the meeting. Members of thepublic who wish to make oralstatements pertaining to agenda itemsshould contact Margie D. Biggerstaff atthe address or telephone number listedabove. Requests must be received atleast five days prior to the meeting andreasonable provisions will be made toinclude the presentation on the agenda.

Transcript: Available for publicreview and copying at the PublicReading Room, Room 1E–190, ForrestalBuilding, 1000 Independence Avenue,S.W., Washington, D.C., between 9:00a.m. and 4:00 p.m., Monday throughFriday, except Federal holidays.

Issued at Washington, D.C., on April 17,1996.Gail Cephas,Acting Deputy Advisory CommitteeManagement Officer.[FR Doc. 96–9942 Filed 4–22–96; 8:45 am]BILLING CODE 6450–01–P

PLD Advanced Automatic Systems,Inc.

AGENCY: Department of Energy, Office ofthe General Counsel.ACTION: Notice of Intent to GrantExclusive Patent License.

SUMMARY: Notice is hereby given of anintent to grant to PLD AdvancedAutomation Systems, Inc., of Rockledge,Florida, an exclusive license to practicethe invention described in U.S. PatentNo.. 4,942,339, entitled ‘‘Intense, SteadyState, Electron Beam Generator.’’ Theinvention is owned by the United Statesof America, as represented by theDepartment of Energy (DOE). Theproposed license will be exclusive for aspecified duration, subject to a licenseand other rights retained by the U.S.Government, and other terms andconditions to be negotiated. DOEintends to grant the license, upon a finaldetermination in accordance with 35U.S.C. § 209(c), unless within 60 days ofthis notice the Assistant GeneralCounsel for Technology Transfer andIntellectual Property, Department ofEnergy, Washington, D.C. 20585,receives in writing any of the following,together with supporting documents:

(i) A statement from any personsetting forth reasons why it would notbe in the best interests of the UnitedStates to grant the proposed license; or

(ii) An application for a nonexclusivelicense to the invention, in whichapplicant states that he has alreadybrought the invention to practicalapplication or is likely to bring theinvention to practical applicationexpeditiously.DATES: Written comments ornonexclusive license applications are tobe received at the address listed belowno later than June 24, 1996.ADDRESSES: Office of Assistant GeneralCounsel for Technology Transfer andIntellectual Property, U.S. Departmentof Energy, 1000 Independence Avenue,S.W., Washington, D.C. 20585.FOR FURTHER INFORMATION: Robert J.Marchick, Office of the AssistantGeneral Counsel for TechnologyTransfer and Intellectual Property, U.S.Department of Energy, ForrestalBuilding, Room 6F–067, 1000Independence Avenue, Washington,D.C. 20585; Telephone (202) 586–4792.


SUPPLEMENTARY INFORMATION: 35 U.S.C.309(c) provides the Department withauthority to grant exclusive or partiallyexclusive licenses in Department-ownedinventions, where a determination canbe made, among other things, that thedesired practical application of theinvention has not been achieved, or isnot likely expeditiously to be achieved,under a nonexclusive license. Thestatute and implementing regulations(37 C.F.R. 404) require that thenecessary determinations be made afterpublic notice and opportunity for filingwritten objections.

PLD Advanced Automation Systems,Inc., of Rockledge, Florida, has appliedfor an exclusive license to practice theinvention embodied in U.S. Patent No.4,942,339, and has a plan forcommercialization of the invention.

The proposed license will beexclusive as defined above, subject to alicense and other rights retained by theU.S. Government, and subject to anegotiated royalty. The Department willreview all timely written responses tothis notice, and will grant the license if,after expiration of the 60-day noticeperiod, and after consideration ofwritten responses to this notice, adetermination is made, in accordancewith 35 U.S.C. 209(c), that the licensegrant is in the public interest.

Issued in Washington, D.C., on April 16,1996.Agnes P. Dover,Deputy General Counsel for TechnologyTransfer and Procurement.[FR Doc. 96–9943 Filed 4–22–96; 8:45 am]BILLING CODE 6450–01–P

Office of Energy Efficiency andRenewable Energy

[Case No. DH–005]

Energy Conservation Program forConsumer Products: Decision andOrder Granting a Waiver From theVented Home Heating Equipment TestProcedure to Superior FireplaceCompany

AGENCY: Office of Energy Efficiency andRenewable Energy, Department ofEnergy.ACTION: Decision and order.

SUMMARY: Notice is given of theDecision and Order (Case No. DH–005)granting a Waiver to Superior FireplaceCompany (Superior) from the existingDepartment of Energy (DOE orDepartment) test procedure for ventedhome heating equipment. TheDepartment is granting Superior’sPetition for Waiver regarding pilot light

energy consumption for manuallycontrolled heaters in the calculation ofAnnual Fuel Utilization Efficiency(AFUE), and calculation procedure forweighted average steady state efficiencyfor manually controlled heaters withvarious input rates for its models GI–3821, DSH–36T, DVH–33R, DVH–33T,DVA–33R, and DVA–33T manuallycontrolled vented heaters.

FOR FURTHER INFORMATION CONTACT:

William W. Hui, U.S. Department ofEnergy, Office of Energy Efficiencyand Renewable Energy, Mail StationEE–431, Forrestal Building, 1000Independence Avenue SW.,Washington, DC 20585–0121, (202)586–9145

Eugene Margolis, Esq., U.S. Departmentof Energy, Office of General Counsel,Mail Station GC–72, ForrestalBuilding, 1000 Independence AvenueSW., Washington, DC 20585–0103,(202) 586–9507.

SUPPLEMENTARY INFORMATION: Inaccordance with Title 10 CFR 430.27(j),notice is hereby given of the issuance ofthe Decision and Order as set out below.In the Decision and Order, Superior hasbeen granted a Waiver for its models GI–3821, DSH–36T, DVH–33R, DVH–33T,DVA–33R, and DVA–33T manuallycontrolled vented heaters, permittingthe company to use an alternate testmethod in determining AFUE.

Issued in Washington, DC, on April 4,1996.Christine A. Ervin,Assistant Secretary, Energy Efficiency andRenewable Energy.

Decision and Order, Department ofEnergy, Office of Energy Efficiency andRenewable Energy

In the Matter of: Superior FireplaceCompany (Case No. DH–005)

Background

The Energy Conservation Program forConsumer Products (other thanautomobiles) was established pursuantto the Energy Policy and ConservationAct, Public Law 94–163, 89 Stat. 917, asamended (EPCA), which requires DOEto prescribe standardized testprocedures to measure the energyconsumption of certain consumerproducts, including vented homeheating equipment. The intent of thetest procedures is to provide acomparable measure of energyconsumption that will assist consumersin making purchasing decisions. Thesetest procedures appear at Title 10 CFRPart 430, Subpart B.

The Department amended theprescribed test procedures by adding

Title 10 CFR 430.27 to create a waiverprocess. 45 FR 64108, September 26,1980. Thereafter, DOE further amendedits appliance test procedure waiverprocess to allow the Assistant Secretaryfor Energy Efficiency and RenewableEnergy (Assistant Secretary) to grant anInterim Waiver from test procedurerequirements to manufacturers that havepetitioned DOE for a waiver of suchprescribed test procedures. 51 FR 42823,November 26, 1986.

The waiver process allows theAssistant Secretary to waive temporarilytest procedures for a particular basicmodel when a petitioner shows that thebasic model contains one or moredesign characteristics which preventtesting according to the prescribed testprocedures or when the prescribed testprocedures may evaluate the basicmodel in a manner so unrepresentativeof its true energy consumption as toprovide materially inaccuratecomparative data. Waivers generallyremain in effect until final testprocedure amendments becomeeffective, resolving the problem that isthe subject of the waiver.

Superior filed a ‘‘Petition for Waiver’’dated August 30, 1995, a second letter,dated November 30, 1995, whichrequested modification to the minimumfuel input rate of the vented heaterspreviously submitted for consideration,and a third letter dated January 12,1996, which provided a list ofcompanies that make similar products,confidential product performance data,and amending the list of modelssubmitted for consideration in theAugust 30, 1995, Waiver request, inaccordance with section 430.27 of Title10 CFR Part 430. The Departmentpublished in the Federal Register onFebruary 14, 1996, Superior’s Petitionand solicited comments, data andinformation respecting the Petition. 61FR 5755, February 14, 1996. Superioralso filed an ‘‘Application for InterimWaiver’’ under section 430.27(b)(2),which DOE granted on February 1,1996. 61 FR 5755, February 14, 1996.

No comments were receivedconcerning either the ‘‘Petition forWaiver’’ or the ‘‘Interim Waiver.’’ TheDepartment consulted with The FederalTrade Commission (FTC) concerning theSuperior Petition. The FTC did not haveany objections to the issuance of thewaiver to Superior.

Assertions and DeterminationsSuperior’s Petition seeks a waiver

from the DOE test provisions regarding(a) pilot light energy consumption formanually controlled heaters in thecalculation of AFUE and (b) calculationprocedure for weighted average steady


state efficiency for manually controlledheaters with various input rates. TheDOE test provisions in section 3.5 ofTitle 10 CFR Part 430, Subpart B,Appendix O requires measurement ofenergy input rate to the pilot light (QP)with an error no greater than 3 percentfor vented heaters, and use of this datain section 4.2.6 for the calculation ofAFUE using the formula: AFUE =[4400ηSSηuQin-max] / [4400ηSSQin-max +2.5(4600)ηu QP]. Superior requests theallowance to delete the [2.5(4600)ηu QP]term in the denominator in thecalculation of AFUE when testing itsmodels GI–3821, DSH–36T, DVH–33R,DVH–33T, DVA–33R, and DVA–33Tmanually controlled vented heaters.Superior states that its models GI–3821,DSH–36T, DVH–33R, DVH–33T, DVA–33R, and DVA–33T manually controlledvented heaters are designed with atransient pilot which is to be turned offby the user when the heater is not inuse. The control knob on thecombination gas control in these heatershas three positions: ‘‘OFF,’’ ‘‘PILOT’’and ‘‘ON’’. Gas flow to the pilot isobtained by rotating the control knobfrom ‘‘OFF’’ to ‘‘PILOT,’’ depressing theknob, holding in, pressing the piezoigniter. When the pilot heats athermocouple element, sufficientvoltage is supplied to the combinationgas control for the pilot to remain litwhen the knob is released and turned tothe ‘‘ON’’ position. The main burner canthen be ignited by moving an ON/OFFswitch to the ‘‘ON’’ position.Instructions to instruct users to turn thegas control knob to the ‘‘OFF’’ positionwhen the heater is not in use, whichautomatically turns off the pilot, areprovided in the User’s InstructionManual and on a label adjacent to thegas control knob. If the manufacturer’sinstructions are observed by the user,the pilot light will not be left on. Thiswill result in a lower energyconsumption, and in turn a higherefficiency than calculated by the currentDOE test procedure. Since the currentDOE test procedure does not addressthis issue, Superior asks that the Waiverbe granted.

Based on DOE’s review of howSuperior’s models GI–3821, DSH–36T,DVH–33R, DVH–33T, DVA–33R, andDVA–33T manually controlled ventedheaters operate and the fact that if themanufacturer’s instructions arefollowed, the pilot light will not be lefton, DOE grants Superior a Petition forWaiver to exclude the assumed pilotlight energy input term in thecalculation of AFUE.

This decision is subject to thecondition that the heaters shall have aneasily read label near the gas control

knob instructing the user to turn thevalve to the off-position when theheaters are not in use be maintained.

Superior also seeks a Waiver from theDOE test provisions in section 3.1.1 ofTitle 10 CFR Part 430, Subpart B,Appendix O that require steady stateefficiency for manually controlledheaters with various flow rates to bedetermined at a fuel input rate that iswithin ±5 percent of 50 percent of themaximum fuel input rate, and the use ofthis data in section 4.2.4 to determinethe weighted average steady stateefficiency in the calculation of AFUE.

Superior states that its manuallycontrolled heaters utilize a gas controlwith a variable pressure regulatorcontrol that allows the user to selectvarious fuel input rates by varying therange of pressures of the heaters, andrequest that it be allowed to determinesteady state efficiency and weightedaverage steady state efficiency in thecalculation of AFUE at a minimum fuelinput rate of no greater than two-thirdsof the maximum fuel input rate insteadof the specified ±5 percent of 50 percentof the maximum fuel input rate. Also,previous Petitions for Waiver to excludethe pilot light energy input term in thecalculation of AFUE for home heatingequipment with a manual transient pilotcontrol and allowance to determinesteady state efficiency and weightedaverage steady state efficiency used inthe calculation of AFUE at a minimumfuel input rate of 65.3 percent of themaximum fuel input rate have beengranted by DOE to Appalachian Stoveand Fabricators, Inc., 56 FR 51711,October 15, 1991, and Valor Inc., 56 FR51714, October 15, 1991.

Based on DOE having granted similarwaivers in the past to heaters utilizinga variable pressure regulator control thatallows a user to set various fuel inputrates, DOE agrees that a waiver shouldbe granted to allow the determination ofsteady state efficiency and weightedaverage steady state efficiency used inthe calculation of AFUE at a minimumfuel input rate of no greater than two-thirds of the maximum fuel input rateinstead of the specified ±5 percent of 50percent of the maximum fuel input ratefor Superior models GI–3821, DSH–36T,DVH–33R, DVH–33T, DVA–33R, andDVA–33T manually controlled ventedheaters.

It is therefore, ordered that:(1) The ‘‘Petition for Waiver’’ filed by

Superior Fireplace Company (Case No.DH–005) is hereby granted as set forthin paragraph (2) below, subject to theprovisions of paragraphs (3), (4), and (5).

(2) Notwithstanding any contraryprovisions of Appendix O of Title 10CFR Part 430, Subpart B, Superior

Fireplace Company shall be permittedto test its models GI–3821, DSH–36T,DVH–33R, DVH–33T, DVA–33R, andDVA–33T manually controlled ventedheaters on the basis of the testprocedure specified in Title 10 CFR Part430, with modifications set forth below:

(i) Delete paragraph 3.5 of AppendixO.

(ii) The last paragraph of 3.1.1 ofAppendix O is revised to read asfollows:

3.1.1 (a) For manually controlled gasfueled vented heaters, with variousinput rates determine the steady-stateefficiency at:

(1) A fuel input rate within ±5 percentof 50 percent of the maximum fuel inputrate or,

(2) The minimum fuel input rate if thedesign of the heater is such that ±5percent of 50 percent of the maximumfuel input rate can not be set, providedthis minimum input rate is no greaterthan two-thirds of the maximum inputrate of the heater.

(b) If the heater is designed to use acontrol that precludes operation at otherthan maximum output (single firingrate) determine the steady stateefficiency at the maximum input rateonly.

(iii) Delete paragraph 4.2.4 ofAppendix O and replace with thefollowing paragraph:

4.2.4 Weighted Average Steady-StateEfficiency. (a) For manually controlledheaters with various input rates, theweighted average steady-state efficiency(ηSS–WT) is:

(1) At ±5 percent of 50 percent of themaximum fuel input rate as measured ineither section 3.1.1 to this appendix formanually controlled gas vented heatersor section 3.1.2 to this appendix formanually controlled oil vented heaters,or

(2) At the minimum fuel input rate asmeasured in either section 3.1.1 to thisappendix for manually controlled gasvented heaters or section 3.1.2 to thisappendix for manually controlled oilvented heaters if the design of the heateris such that ±5 percent of 50 percent ofthe maximum fuel input rate can not beset, provided the tested input rate is nogreater than two-thirds of maximuminput rate of the heater.

(b) For manually controlled heaterwith one single firing rate, the weightedaverage steady-state efficiency is thesteady-state efficiency measured at thesingle firing rate.

(iv) Delete paragraph 4.2.6 ofAppendix O and replace with thefollowing paragraph:

4.2.6 Annual Fuel UtilizationEfficiency. For manually controlledvented heaters, calculate the Annual


Fuel Utilization Efficiency (AFUE) as apercent and defined as:AFUE=ηu

where:ηu=as defined in section 4.2.5 of this

appendix.(v) With the exception of the

modification set forth above, SuperiorFireplace Company shall comply in allrespects with the test proceduresspecified in Appendix O of Title 10 CFRPart 430, Subpart B.

(3) The Waiver shall remain in effectfrom the date of issuance of this Orderuntil DOE prescribes final testprocedures appropriate to models GI–3821, DSH–36T, DVH–33R, DVH–33T,DVA–33R, and DVA–33T manuallycontrolled vented heaters manufacturedby Superior Fireplace Company.

(4) This Waiver is based upon thepresumed validity of statements,allegations, and documentary materialssubmitted by the petitioner. This Waivermay be revoked or modified at any timeupon a determination that a factualbasis underlying the Petition isincorrect.

(5) Effective April 14, 1996, thisWaiver supersedes the Interim Waivergranted Superior Fireplace Company onFebruary 1, 1996. 61 FR 5755, February14, 1996. (Case No. DH–005).

Issued in Washington, D.C., on April 4,1996.Christine A. Ervin,Assistant Secretary, Energy Efficiency andRenewable Energy.[FR Doc. 96–9948 Filed 4–22–96; 8:45 am]BILLING CODE 6450–01–P

[Case No. F–083]

Energy Conservation Program forConsumer Products: Decision andOrder Granting a Waiver From theFurnace Test Procedure to ThermoProducts Inc.

AGENCY: Office of Energy Efficiency andRenewable Energy, Department ofEnergy.ACTION: Decision and order.

SUMMARY: Notice is given of theDecision and Order (Case No. F–083)granting a Waiver to Thermo ProductsInc. (Thermo) from the existingDepartment of Energy (DOE orDepartment) test procedure for furnaces.The Department is granting Thermo’sPetition for Waiver regarding blowertime delay in calculation of Annual FuelUtilization Efficiency (AFUE) for itsCHA-upflow and CGA-downflow seriesof condensing gas furnaces.

FOR FURTHER INFORMATION CONTACT:

Cyrus H. Nasseri, U.S. Department ofEnergy, Office of Energy Efficiencyand Renewable Energy, Mail StationEE–431, Forrestal Building, 1000Independence Avenue SW.,Washington, DC 20585–0121 (202)586–9138

Eugene Margolis, Esq., U.S. Departmentof Energy, Office of General Counsel,Mail Station GC–72, ForrestalBuilding, 1000 Independence AvenueSW., Washington, DC 20585–0103,(202) 586–9507.

SUPPLEMENTARY INFORMATION: Inaccordance with 10 CFR 430.27(j),notice is hereby given of the issuance ofthe Decision and Order as set out below.In the Decision and Order, Thermo hasbeen granted a Waiver for its CHA-upflow and CGA-downflow series ofcondensing gas furnaces permitting thecompany to use an alternate test methodin determining AFUE.

Issued in Washington, DC, on April 4,1996.Christine A. Ervin,Assistant Secretary, Energy Efficiency andRenewable Energy.

Decision and Order, Department ofEnergy, Office of Energy Efficiency andRenewable Energy

In the matter of: Thermo Products Inc.(Case No. F–083).

Background

The Energy Conservation Program forConsumer Products (other thanautomobiles) was established pursuantto the Energy Policy and ConservationAct, Public Law 94–163, 89 Stat. 917, asamended (EPCA), which requires DOEto prescribe standardized testprocedures to measure the energyconsumption of certain consumerproducts, including furnaces. The intentof the test procedures is to provide acomparable measure of energyconsumption that will assist consumersin making purchasing decisions. Thesetest procedures appear at 10 CFR Part430, Subpart B.

The Department amended theprescribed test procedures by adding 10CFR 430.27 to create a waiver process.45 FR 64108, September 26, 1980.Thereafter, DOE further amended itsappliance test procedure waiver processto allow the Assistant Secretary forEnergy Efficiency and RenewableEnergy (Assistant Secretary) to grant anInterim Waiver from test procedurerequirements to manufacturers that havepetitioned DOE for a waiver of suchprescribed test procedures. 51 FR 42823,November 26, 1986.

The waiver process allows theAssistant Secretary to waive temporarilytest procedures for a particular basicmodel when a petitioner shows that thebasic model contains one or moredesign characteristics which preventtesting according to the prescribed testprocedures or when the prescribed testprocedures may evaluate the basicmodel in a manner so unrepresentativeof its true energy consumption as toprovide materially inaccuratecomparative data. Waivers generallyremain in effect until test procedureamendments become effective, resolvingthe problem that is the subject of thewaiver.

Thermo filed a ‘‘Petition for Waiver,’’dated November 29, 1995, in accordancewith section 430.27 of 10 CFR Part 430.The Department published in theFederal Register on January 30, 1996.Thermo’s Petition and solicitedcomments, data and informationrespecting the Petition. 61 FR 3023,January 30, 1996. Thermo also filed an‘‘Application for Interim Waiver’’ undersection 430.27(b)(2), which DOE grantedon January 24, 1996. 61 FR 3023,January 30, 1996.

No Comments were receivedconcerning either the ‘‘Petition forWaiver’’ or the ‘‘Application for InterimWaiver.’’ The Department consultedwith The Federal Trade Commission(FTC) concerning the Thermo Petition.The FTC did not have any objections tothe issuance of the waiver to Thermo.

Assertions and DeterminationsThermo’s Petition seeks a waiver from

the DOE test provisions that require a1.5-minute time delay between theignition of the burner and the starting ofthe circulating air blower. Thermorequests the allowance to test using a45-second blower time delay whentesting its CHA-upflow and CGA-downflow series of condensing gasfurnaces. Thermo states that since the45-second delay is indicative of howthese models actually operate, and sincesuch a delay results in an increase inAFUE improvement of up to 2.0percent, the Petition should be granted.

Under specific circumstances, theDOE test procedure contains exceptionswhich allow testing with blower delaytimes of less than the prescribed 1.5-minute delay. Thermo indicates that itis unable to take advantage of any ofthese exceptions for its CHA-upflow andCGA-downflow series of condensing gasfurnaces.

Since the blower controlsincorporated on the Thermo furnacesare designed to impose a 45-secondblower delay in every instance of startup, and since the current test procedure


provisions do not specifically addressthis type of control, DOE agrees that awaiver should be granted to allow the45-second blower time delay whentesting the Thermo CHA-upflow andCGA-downflow series of condensing gasfurnaces. Accordingly, with regard totesting the CHA-upflow and CGA-downflow series of condensing gasfurnaces, today’s Decision and Orderexempts Thermo from the existing testprocedure provisions regarding blowercontrol and allows testing with the 45-second delay.

It is, therefore, ordered that:(1) The ‘‘Petition for Waiver’’ filed by

Thermo Products Inc. (Case No. F–083)is hereby granted as set forth inparagraph (2) below, subject to theprovisions of paragraph (3), (4), and (5).

(2) Notwithstanding any contraryprovisions of Appendix N of 10 CFRPart 430, Subpart B, Thermo ProductsInc., shall be permitted to test its CHA-upflow and CGA-downflow series ofcondensing gas furnaces on the basis ofthe test procedure specified in 10 CFRPart 430, with modifications set forthbelow.

(I) Section 3.0 of Appendix N isdeleted and replaced with the followingparagraph:

3.0 Test Procedure. Testing andmeasurements shall be as specified insection 9 in ANSI/ASHRAE Standard103-82 with the exception of section9.2.2, 9.3.1, and 9.3.2, and the inclusionof the following additional procedures:

(ii) Add a new paragraph 3.10 toAppendix N as follows:

3.10 Gas- and Oil-Fueled CentralFurnaces. The following paragraph is inlieu of the requirement specified insection 9.3.1. of ANSI/ASHRAEStandard 103–82. After equilibriumconditions are achieved following thecool-down test and the requiredmeasurements performed, turn on thefurnace and measure the flue gastemperature, using the thermocouplegrid described above, at 0.5 and 2.5minutes after the main burner(s) comeson. After the burner start-up, delay theblower start-up by 1.5 minutes (t¥),unless: (1) the furnace employs a singlemotor to drive the power burner and theindoor air circulating blower, in whichcase the burner and blower shall bestarted together; or (2) the furnace isdesigned to operate using an unvaryingdelay time that is other than 1.5minutes, in which case the fan controlshall be permitted to start the blower; or(3) the delay time results in theactivation of a temperature safety devicewhich shuts off the burner, in whichcase the fan control shall be permittedto start the blower. In the latter case, ifthe fan control is adjustable, set it to

start the blower at the highesttemperature. If the fan control ispermitted to start the blower, measuretime delay, (t-), using a stopwatch.Record the measured temperatures.During the heat-up test for oil-fueledfurnaces, maintain the draft in the fluepipe within ±0.01 inch of water columnof the manufacturer’s recommended on-period draft.

(iii) With the exception of themodifications set forth above, ThermoProducts Inc. shall comply in allrespects with the test proceduresspecified in Appendix N of 10 CFR Part430, Subpart B.

(3) The Waiver shall remain in effectfrom the date of issuance of this Orderuntil DOE prescribes final testprocedures appropriate to the CHA-upflow and CGA-downflow series ofcondensing gas furnaces manufacturedby Thermo Products Inc.

(4) This Waiver is based upon thepresumed validity of statements,allegations, and documentary materialssubmitted by the petitioner. This Waivermay be revoked or modified at any timeupon a determination that the factualbasis underlying the Petition isincorrect.

(5) Effective April 14, 1996, thisWaiver supersedes the Interim Waivergranted Thermo Products Inc. onJanuary 24, 1996. 61 FR 3023, January30, 1996 (Case No. F–083).

Issued In Washington, DC, on April 4,1996.Christine A. Ervin,Assistant Secretary, Energy Efficiency andRenewable Energy.[FR Doc. 96–9949 Filed 4–22–96; 8:45 am]BILLING CODE 6450–01–M

Energy-Efficiency and RenewableEnergy Office

Energy-Efficient ProductCommercialization Study

AGENCY: Office of Energy Efficiency andRenewable Energy, DOE.ACTION: Notice.

SUMMARY: The Department of Energy(DOE) is investigating the potential useof the purchasing power of the Federalgovernment to promote thecommercialization of energy-efficientproducts that incorporate new, value-added technologies for federal buyers.The Energy Policy Act directs theSecretary of Energy to conduct a studyto identify energy-efficient, renewableenergy, and water conserving productsfor which there is a high potential forfederal purchasing power tosubstantially promote their

development and commercialization,and to identify barriers to federalprocurement of such products. Theprincipal product focus of the study ison those which are beyond theprototype stage, but are notcommercially available or inwidespread use. These products mustalso be potentially cost-effective tofederal and non-federal buyers, withincreased production and sales volume.DOE is soliciting information frominterested parties concerning productswhich offer this potential,recommendations on how federalprocurement actions could facilitateproduct commercialization, and existingbarriers to such procurement actions.DATES: Written information on productswhich meet the criteria listed below,barriers to federal procurement of suchproducts, and recommended federalprocurement actions and programs topromote commercialization of suchproducts (1 copy) must be received onor before May 13, 1996, to be includedfor consideration in this study. A publicmeeting will be held on June 5, 1996;requests to present information at thispublic meeting on recommended federalactions and programs must be receivedby May 13, 1996.ADDRESSES: All written comments (1copy), as well as requests to speak at thepublic meeting, are to be submitted to:U.S. Department of Energy, Office ofEnergy Efficiency and RenewableEnergy, EE–90, Energy-Efficient ProductCommercialization Study, 1000Independence Avenue SW.,Washington, DC 20585–0121, 202–586–8287. FAXed comments may be sent to202–586–3000. The public meeting willbe held at the U.S. Department ofEnergy, Main Auditorium, 1000Independence Avenue, SW.,Washington, DC.FOR FURTHER INFORMATION CONTACT: RickKlimkos, EE–90, U.S. Department ofEnergy, 1000 Independence AvenueSW., Washington, DC 20585–0121, 202–586–8287.SUPPLEMENTARY INFORMATION: TheFederal government is the largestcustomer in the world for many energy-related products. The Department ofEnergy (DOE) is investigating thepotential use of the purchasing power ofthe Federal government to promote thedevelopment and commercialization ofenergy-efficient products thatincorporate new, value-addedtechnologies for federal buyers. Theobjective of this study is to identifyenergy-efficient, renewable energy, andwater conserving products for whichthere is a high potential for federalpurchasing power to substantially


1 CNG filed its request pursuant to Sections157.205 and 157.211 of the Commission’sRegulations under the Natural Gas Act (18 CFR157.205, 157.211), however, CNG’s request is beingtreated as a Section 7(c) application.

promote their commercialization, and toidentify barriers to federal procurementof such products. It is anticipated thatGovernment procurement of energyefficient products will stimulateindustry to introduce energy-efficientproducts which enhance nationalcompetitiveness both domestically andinternationally, to achieve a productionscale which improves the cost-effectiveness of new technologies togovernment and non-governmentpurchasers, and create new jobopportunities throughout theseindustries. This notice requestsinformation from interested parties onhow the government can mosteffectively use its buying power tocreate or expand the market for energy-efficient products.

Section 152(h) of the Energy PolicyAct of 1992 (Pub. L. 102–486) amendsthe National Energy Conservation PolicyAct (NECPA) by inserting section 549,subsection (e). This section directs theSecretary of Energy to conduct thisstudy, which is the responsibility of theFederal Energy Management ProgramsOffice within the DOE Office of EnergyEfficiency and Renewable Energy. DOEis soliciting information from interestedparties to identify and recommendenergy-saving, renewable energy, andwater-conserving products which offerhigh potential for federal purchasingpower to substantially promote theircommercialization.

The product component of this studyis focused on products which meetcertain criteria for technical andcommercial viability and which are, orcould be, purchased in significantquantities by federal agencies. Thesecriteria include products:

• Which meet applicableperformance, safety, and reliabilityrequirements;

• For which the prototypedevelopment stage has been completedor is near completion;

• Which offer the potential forminimizing life-cycle cost for theapplication;

• For which commercial productionis practical and economically feasible;

• For which initial market analysishas demonstrated a sufficiently largepotential market to warrant commercialproduction and sales; and

• Which are not yet in production atcommercial levels or which have justreached commercial availability.

These criteria do not include productsat earlier stages of development—ranging from concept developmentthrough engineering prototype testingand field demonstrations—for which thetechnical and economic feasibility ofcommercial production have not yet

been established. For products,technologies, or concepts in theseearlier stages, programs such as theDOE/National Institute for Standardsand Technology (NIST) Energy-RelatedInventions Program (ERIP) and the DOEInnovative Concepts Program (InnCon)are available. For informationconcerning the ERIP program, contactthe Office of Technology Evaluation andAssessment, National Institute ofStandards and Technology,Gaithersburg, MD 20899. Forinformation concerning the InnConprogram contact Mr. E. Levine, U.S.,Department of Energy, ForrestalBuilding, EE–521, 1000 IndependenceAve., SW, Washington, DC 20585–0121,202–586–1605.

Interested parties are requested tosubmit information to DOE on productswhich meet the above criteria forcommercial viability and relevance tothe federal market, on federalprocurement actions which couldpromote commercialization of theseproducts, and on potential barriers tosuch procurement actions, including:

• The product’s energy efficiency andother performance characteristics;

• The product’s current state ofcommercial development, includingmanufacturing capacity and sales;

• Results of market analyses whichindicate the potential market—bothwithin the federal government and thenon-federal market, domestically andinternationally;

• The potential for energy and dollarsavings, both per unit and for potentialtotal sales to federal and non-federalcustomers;

• Assessment of the life-cycle cost ofthe product, including projected capitalcost and operating and maintenancecosts, based upon projected costs atcommercially viable levels ofproduction,

• The total level of sales, includingfederal and non-federal sectors,considered necessary to justifyundertaking commercial production;

• Concepts for federal policies andprograms which would facilitatecommercialization of energy-efficientproducts;

• Concepts for federal procurementactions which, combined with othermarket opportunities, could be used toimplement these policies and programs;

• Barriers to the rapid penetration ofproducts in federal, other governmental,and commercial markets (e.g. sole-source, lowest first-cost, no history ofperformance); and

• Recommendations for actionswhich DOE, other federal agencies, orCongress could take to reduce oreliminate these barriers.

An information packet whichprovides further definition of the typesof information desired, outlinespreliminary concepts being consideredfor such federal policies and programs,and provides information on the Marchpublic meeting will be sent to thoseresponding to this Notice.

Only non-proprietary technical ormarket information should be submittedin response to this request. DOEreserves the right to publish or use anyinformation submitted.

The Federal Energy ManagementPrograms Office will conduct the publicmeeting on June 5, 1996, to solicitpublic comment on how federalprocurement actions and relatedinformation programs, technologydemonstrations, or other actions couldfacilitate commercialization of productsmeeting the criteria of this study.Responses may be in written form and/or may be presented verbally at themeeting. Verbal presentations must belimited to no more than five minutes.Verbal presentations will be limited tocomments on barriers, opportunities,and recommended policies andprograms; information on specificproducts will not be accepted in verbalcomments at the hearings but should besubmitted in writing.

Issued in Washington, DC on April 16,1996.Christine A. Ervin,Assistant Secretary, Energy Efficiency andRenewable Energy.[FR Doc. 96–9947 Filed 4–22–96; 8:45 am]BILLING CODE 6450–01–P

Federal Energy RegulatoryCommission

[Docket No. CP96–298–000]

CNG Transmission Corporation; Noticeof Application

April 17, 1996.Take notice that on April 4, 1996,

CNG Transmission Corporation (CNG),445 West Main Street, Clarksburg, WestVirginia 26301, filed in Docket No.CP96–298–000 an application pursuantto Section 7(c) 1 of the Natural Gas Actfor authorization to amend an existingservice agreement applicable to thestorage of natural gas under RateSchedule GSS between CNG and LongIsland Lighting Company (LILCO) toadd, on a secondary basis, a new storagereceipt point, all as more fully set forth


in the application on file with theCommission and open to publicinspection.

CNG states that LILCO, a localdistribution company, has requested,and CNG has agreed to add, on asecondary basis, a new storage injectionreceipt point at an existinginterconnection between CNG andIroquois Pipeline Company, known asCanajoharie, to the existing GSS ServiceAgreement between CNG and LILCOdated January 1, 1996.

CNG states that the utilization of theCanajoharie receipt point as a storageinjection receipt point will only be usedas operating conditions permit, and thatsince the interconnect already exists, nonew facilities are required.

CNG states that the addition of thissecondary receipt point will notdisadvantage any existing CNGcustomer and does not change LILCO’sGSS Storage injection quantities.

Any person desiring to be heard or tomake any protest with reference to saidapplication should on or before April29, 1996, file with the Federal EnergyRegulatory Commission, Washington,D.C. 20426, a motion to intervene or aprotest in accordance with therequirements of the Commission’s Rulesof Practice and Procedure (18 CFR385.214 or 385.211) and the Regulationsunder the Natural Gas Act (18 CFR157.10). All protests filed with theCommission will be considered by it indetermining the appropriate action to betaken but will not serve to make theprotestants parties to the proceeding.Any person wishing to become a partyto a proceeding or to participate as aparty in any hearing therein must file amotion to intervene in accordance withthe Commission’s Rules.

Take further notice that, pursuant tothe authority contained in and subject tothe jurisdiction conferred upon theFederal Energy Regulatory Commissionby Sections 7 and 15 of the Natural GasAct and the Commission’s Rules ofPractice and Procedure, a hearing willbe held without further notice before theCommission or its designee on thisapplication if no motion to intervene isfiled within the time required herein, ifthe Commission on its own review ofthe matter finds that a grant of thecertificate is required by the publicconvenience and necessity. If a motionfor leave to intervene is timely filed, orif the Commission on its own motionbelieves that a formal hearing isrequired, further notice of such hearingwill be duly given.

Under the procedure herein providedfor, unless otherwise advised, it will be

unnecessary for CNG to appear or berepresented at the hearing.Lois D. Cashell,Secretary.[FR Doc. 96–9886 Filed 4–22–96; 8:45 am]BILLING CODE 6717–01–M

[Docket Nos. RP94–367–007 and RP95–31–014]

National Fuel Gas Supply Corporation;Notice of Tariff Filing

April 17, 1996.

Take notice that on April 12, 1996,National Fuel Gas Supply Corporation(National) tendered for filing as part ofits FERC Gas Tariff, Third RevisedVolume No. 1, the following tariff sheetsproposed to be effective April 1, 1996:

2nd Sub. Sixth Revised Sheet No. 2Fourth Revised Sheet No. 17Second Revised Sheet No. 17AThird Revised Sheet No. 1593rd Sub. Fifth Revised Sheet Nos. 236 and

237

National states that on March 22,1996, National submitted its complianceFiling in the above-captionedproceedings. On April 1, 1996 and April5, 1996, National submitted correctionsto the Compliance Filing. The above-listed sheets correct pagination andtypographical errors in National’sprevious filings.

National further states that copies ofthis filing were served upon thecompany’s jurisdictional customers andupon the Regulatory Commissions of theStates of New York, Ohio, Pennsylvania,Delaware, Massachusetts, and NewJersey.

Any person desiring to protest saidfiling should file a protest with theFederal Energy Regulatory Commission,888 First Street, N.E., Washington, D.C.,20426, in accordance with Rule 211 ofthe Commission’s Rules of Practice andProcedure (18 CFR 385.211). All suchprotests must be filed as provided inSection 154.210 of the Commission’sRegulations. Protests will be consideredby the Commission in determining theappropriate action to be taken but willnot serve to make protestants parties tothe proceeding. Copies of this filing areon file with the Commission and areavailable for public inspection.Lois D. Cashell,Secretary.[FR Doc. 96–9888 Filed 4–22–96; 8:45 am]BILLING CODE 6717–01–M

[Docket No. TM96–13–29–000]

Transcontinental Gas Pipe LineCorporation; Notice of ProposedChanges in FERC Gas Tariff

April 17, 1996.Take notice that on April 12, 1996

Transcontinental Gas Pipe LineCorporation (Transco) tendered forfiling certain revised tariff sheets to itsFERC Gas Tariff, Third Revised VolumeNo. 1 which tariff sheets are enumeratedin Appendix A attached to the filing.

Transco states that the purpose of theinstant filing is to track rate changesattributable to a) storage servicepurchased from CNG TransmissionCorporation (CNG) under its RateSchedule GSS the costs of which areincluded in the rates and chargespayable under Transco’s Rate SchedulesLSS and GSS and b) transportationservice purchased from Texas GasTransmission Corporation (Texas Gas)under its rate schedule FT the costs ofwhich are included in the rates andcharges payable under Transco’s RateSchedule FT–NT. This tracking filing isbeing made pursuant to Section 4 ofTransco’s Rate Schedule LSS, Section 3of Transco’s Rate Schedule GSS andSection 4 of Transco’s Rate ScheduleFT–NT.

Transco states that included inAppendices B and C attached to thefiling are explanations of the ratechanges and details regarding thecomputation of the revised RateSchedule LSS, GSS and FT–NT rates.

Transco states that copies of the filingare being mailed to each of its LSS, GSSand FT–NT customers and interestedState Commissions.

Any person desiring to be heard or toprotest said filing should file a motionto intervene or protest with the FederalEnergy Regulatory Commission, 888First Street, Washington, D.C. 20426, inaccordance with Sections 385.214 and385.211 of the Commission’s Rules andRegulations. All such motions orprotests must be file as provided inSection 154.210 of the Commission’sRegulations. Protests will be consideredby the Commission in determining theappropriate action to be taken, but willnot serve to make protestants parties tothe proceeding. Any person wishing tobecome a party must file a motion tointervene. Copies of this filing are onfile with the Commission and areavailable for public inspection in thePublic Reference Room.Lois D. Cashell,Secretary.[FR Doc. 96–9889 Filed 4–22–96; 8:45 am]BILLING CODE 6717–01–M


[Docket No. CP96–311–000]

Williams Natural Gas Company; Noticeof Application To Amend Certificate

April 17, 1996.Take notice that, on April 11, 1996,

Williams Natural Gas Company(Williams), P.O. Box 3288, Tulsa,Oklahoma 74101, filed an abbreviatedapplication, pursuant to section 7 of theNatural Gas Act, to amend the certificateissued on September 24, 1958, in DocketNo. G–10956 (20 FPC 390) by expandingthe storage area of its Elk City StorageField, all as more fully set forth in theapplication, which is on file with theCommission and open to publicinspection.

The certificate issued in Docket No.G–10956 authorized Williams (formerly:Cities Service Gas Company) toconstruct and operate the Elk CityStorage Field, in Elk, Chautauqua, andMontgomery Counties, Kansas, as anunderground gas storage field. Williamsnow requests the Commission toauthorize it to extend the Elk CityStorage Field’s buffer zone north andwest of its current location, by acquiringgas storage rights under approximately2,740 acres of land in Elk andMontgomery Counties, Kansas. Asproposed, the extension would add thefollowing parcels of land to the storagearea:

Montgomery County, Kansas

The west half of Section 2 in T31S, R13E.

Elk County, Kansas

All of Section 3 in T31S, R13E.The east half of Section 4 in T31S, R13E.The east half of Section 9 in T31S, R13E.All of Section 10 in T31S, R13E.The north half of the north half of Section 15

in T31S, R13E.The south half of the southwest quarter of the

northwest quarter of Section 15 in T31S,R13E.

The east half of Section 16 in T31S, R13E.

Williams would acquire the subjectacreage by lease, purchase, or throughthe exercise of eminent domain underthe Natural Gas Act. Williams states thatthe gas wells located on the property tobe acquired will be converted intoobservation wells. Williams also statesthat it believes the extension willincrease the effectiveness of the storagearea, enhance the overall efficiency ofits storage operations, and reduce therisk of storage gas migrating toproducing wells outside the presentstorage area boundary. Williams furtherasserts that extending the storage areaboundary, as proposed, is bothreasonable and required by the presentand future public convenience andnecessity.

Any person desiring to be heard, or tomake any protest with reference to saidapplication should, on or before May 8,1996, file with the Federal EnergyRegulatory Commission, Washington,D.C., 20426, a motion to intervene orprotest in accordance with therequirements of the Commission’s Rulesof Practice and Procedure (18 CFR385.214 or 385.211) and the regulationsunder the Natural Gas Act (18 CFR157.10). All protests filed with theCommission will be considered by it indetermining the appropriate action to betaken, but will not serve to make theprotestants parties to the proceeding.Any person wishing to become a partyto the proceeding, or to participate as aparty in any hearing therein, must filea motion to intervene in accordancewith the Commission’s Rules.

Take further notice that, pursuant tothe authority contained in and subject tothe jurisdiction conferred upon theFederal Energy Regulatory Commissionby Sections 7 and 15 of the Natural GasAct and the Commission’s Rules ofPractice and Procedure, a hearing willbe held without further notice before theCommission or its designee on thisapplication, if no motion to intervene isfiled within the same required herein, orif the Commission on its own review ofthe matter finds that a grant of thecertificate is required by the publicconvenience and necessity. If a motionfor leave to intervene is timely filed, orthe Commission on its own motionbelieves that a formal hearing isrequired, further notice of such hearingwill be duly given.

Under the procedure herein providedfor, unless otherwise advised, it will beunnecessary for Williams to appear orbe represented at the hearing.Lois D. Cashell,Secretary.[FR Doc. 96–9887 Filed 4–22–96; 8:45 am]BILLING CODE 6717–01–M


[FRL–5460–6]

National Environmental Education andTraining Foundation, Inc.;Announcement of a New Appointmentto the Board of Directors

The National EnvironmentalEducation and Training Foundation(NEETF) was created by Public Law101–619, the National EnvironmentalEducation Act of 1990. It is a private501(c)(3) non-profit organizationestablished to promote and supporteducation and training as necessary

tools to further environmentalprotection and sustainable,environmentally sound development.NEETF provides the common groundupon which leaders from business andindustry, all levels of government,public interest groups, and others canwork cooperatively to expand the reachof environmental education and trainingprograms beyond the traditionalclassroom. The Foundation operates agrant program that promotes innovativeenvironmental education and trainingprograms; it also develops partnershipswith government and otherorganizations to administer projects thatpromote the development of anenvironmentally literate public.

The Administrator of the U.S.Environmental Protection Agency, asrequired by the terms of the Act,announces the appointment of WalterM. Higgins to the NEETF Board ofDirectors. Walter Higgins is Presidentand Chief Executive Officer of SierraPacific Power Company and SierraPacific Resources, a diversified utilityholding company in Reno, Nevada.Prior to 1993 when he joined SierraPacific Resources, Mr. Higgins was thePresident of the Louisville Gas andElectric Company in Kentucky, andprior to that he was with the PortlandGeneral Electric Company (PGE) inOregon for 14 years. In the mid-1980’she was President of PGE’s first non-utility subsidiary, an energyconservation and cogenerationcompany.

Education: Mr. Higgins graduatedwith distinction from the U.S. NavalAcademy with a degree in NuclearScience; two years of Navy postgraduatenuclear engineering training; GeorgeWashington University graduatebusiness studies; Public UtilityExecutive Course at the University ofIdaho; and Stanford University GraduateSchool of Business Executive Program.

Organizations: Mr. Higgins has a greatdeal of experience with a number oforganization including the following—Board of Trustees of the NatureConservancy of Nevada; Board ofDirectors of the Reno United Way;Edison Electric Institute Board ofDirectors; Pacific Coast Gas AssociationBoard of Directors; Western Energy andCommunication Association Board ofDirectors and Executive Board ofNevada Area Council Boy Scouts ofAmerica.

Mr. Higgins appointment to theNEETF Board of Directors will be for a4-year term. Great care is taken to assurethat each new appointee to the thirteen-member NEETF Board has the highestdegree of expertise and commitment,and also brings to the Board diverse


points of view relating to environmentaleducation and training.

Dated: April 15, 1996.Carol M. Browner,Administrator.[FR Doc. 96–9977 Filed 4–22–96; 8:45 am]BILLING CODE 6560–50–M

[FRL–5460–8]

Public Water System SupervisionProgram Revisions for the State ofHawaii Lead and Copper Rule

AGENCY: U.S. Environmental ProtectionAgency (EPA).ACTION: Notice of decision andopportunity for hearing.

SUMMARY: Notice is hereby given thatthe State of Hawaii is revising itsapproved State Public Water SystemSupervision Program. Hawaii hasadopted regulations for controlling leadand copper in drinking water. TheHawaii State regulations correspond tothe National Primary Drinking WaterRegulations promulgated by EPA onJune 7, 1991 [56 FR 26460], also knownas the Lead and Copper Rule; andcorrecting amendments appearing onJuly 15, 1991 [56 FR 32112]; June 29,1992 [57 FR 28785]; and June 30, 1994[59 FR 33860]. EPA has determined thatthe State program revisions are no lessstringent than the corresponding federalregulations. Therefore, EPA hastentatively decided to approve the Stateprogram revision.

All interested parties are invited torequest a public hearing on EPA’sdecision to approve the State programrevisions. A request for a public hearingmust be submitted by May 23, 1996, tothe Regional Administrator at theaddress shown below. Insubstantialrequests for a hearing may be denied bythe Regional Administrator. If no timelyand appropriate request for a hearing isreceived and the Regional Administratordoes not elect to hold a hearing on his/her own motion, this determinationshall become effective May 23, 1996.

Any request for a public hearing shallinclude the following: [1] the name,address, and telephone number of theindividual, organization, or other entityrequesting a hearing; [2] a briefstatement of the requesting person’sinterest in the Regional Administrator’sdetermination and of information thatthe requesting person intends to submitat such hearing; and [3] the signature ofthe individual making the request, or, ifthe request is made on behalf of anorganization or other entity, thesignature of a responsible official of theorganization or other entity.

ADDRESSES: All documents relating tothis determination are available forinspection between the hours of 8:30a.m. and 4:00 p.m., Monday throughFriday, at the following offices: HawaiiDepartment of Health, Five WaterfrontPlaza, Suite 250, 500 Ala Moana Blvd.,Honolulu, Hawaii 96813; and EPA,Region IX, Water Management Division,Drinking Water Section (W–6–1), 75Hawthorne Street, San Francisco,California 94105.FOR FURTHER INFORMATION CONTACT:Barry Pollock, EPA, Region IX, at theSan Francisco address given above or bytelephone at (415) 744–1854.(Sec. 1413 of the Safe Drinking Water Act asamended [1986]; and 40 CFR 142.10 of theNational Primary Drinking WaterRegulations)

Dated: April 10, 1996.Felicia Marcus,Regional Administrator.[FR Doc. 96–9847 Filed 4–22–96; 8:45 am]BILLING CODE 6560–50–P

[FRL–5462–3]

Annual Conference on Analysis ofPollutants in the Environment

AGENCY: United States EnvironmentalProtection Agency (EPA).ACTION: Notice of conference.

SUMMARY: The Office of Science andTechnology and the Water EnvironmentFederation, co-sponsors, will hold the‘‘19th Annual Conference on Analysis ofPollutants in the Environment’’ todiscuss all aspects of environmentalmeasurement. The conference is open tothe public. The Water EnvironmentFederation is sponsoring aPreconference Workshop on QualityBased Laboratory Performance.DATES: The conference will be held onMay 15–16, 1996. On May 15, 1996, theconference will begin at 8:30 am andlast until 5:30 pm. On May 16, 1996, theconference will begin at 8:30 am andadjourn at 5:30 pm. The PreconferenceWorkshop on Quality Based LaboratoryPerformance will be held on May 14,1996, from 9:00 am to 5:00 pm.ADDRESSES: The conference will be heldat the Omni Waterside Hotel, Norfolk,Virginia. The Preconference Workshopon Quality Based LaboratoryPerformance will be held at the NorfolkWaterside Marriott.FOR FURTHER INFORMATION CONTACT:Conference and workshop arrangementsare being conducted by the WaterEnvironment Federation. Forinformation on registration, hotel rates,transportation, social events, and

reservations call the Water EnvironmentFederation at (800) 666–0206. If youhave technical questions regarding theconference program, please contactWilliam Telliard, Office of Science andTechnology (Mail Code 4303), telephone(202) 260–7120, fax (202) 260–7185.SUPPLEMENTARY INFORMATION: EPA’s19th Annual Conference on Analysis ofPollutants in the Environment isdesigned to bring togetherrepresentatives of regulated industries,commercial environmental laboratories,state and Federal regulators, andenvironmental consultants andcontractors to discuss all aspects ofenvironmental measurement with aparticular focus on analytical methodsand related issues.

A Preconference Workshop onQuality Based Laboratory Performancewill be presented by the WaterEnvironment Federation’s LaboratoryPractices Committee on Tuesday, May14, 1996, at the Norfolk WatersideMarriott, Norfolk, Virginia.

The program for the conferencefollows:

19th Annual Conference on Analysis ofPollutants in the Environment

Wednesday, May 15, 1996

8:30 a.m.—Opening RemarksWilliam Telliard, Director,

Engineering and Analysis Division,Analytical Methods Staff, Office ofScience and Technology, Office ofWater, USEPA

8:40 a.m.—Introductory RemarksLenore Clesceri, Water Environment

Federation8:50 a.m.—Welcome

James Hanlon, Deputy Office Director,Office of Science and Technology,USEPA

Regulatory Initiatives

9:00 a.m.—Streamlining Promulgationof Methods at 40 CFR Parts 136 and141 Under Section 304(h) of theClean Water Act and Section1401(1)(D) of the Safe DrinkingWater Act

William Telliard, Director,Engineering and Analysis Division,Analytical Methods Staff, Office ofScience and Technology, Office ofWater, USEPA

Toxicity Testing

9:30 a.m.—The Acute Whole EffluentToxicity of Storm Water From anInternational Airport

Daniel Fisher, University of MarylandWREC

10:00 a.m.—Break10:15 a.m.—West Coast WET Tests—

Different Strokes for Different Folks


Gary Chapman, Paladin WaterQuality Consulting

Microwave Assisted Solvent Extraction

10:45 a.m.—Abbreviated MicrowaveAssisted Extraction of Pesticidesand PCBs in Soils

Rick McMillan, USEPA Region 6Laboratory

Solid Phase Extraction

11:15 a.m.—Optimizing Solid PhaseExtraction for Oil and Grease andParticulate Laden Samples

Margaret Raisglid, University ofArizona

11:45 a.m.—Lunch

Method Detection Limit Issues

1:00 p.m.—Alternative Minimum Level(AML): A Scientifically Sound andPractical Approach to ComplianceLimits

Ray Maddalone, TRW1:30 p.m.—Application of an

Alternative Minimum LevelDetermination for Volatile WaterSoluble Compounds in Pulp MillEffluent using Microdistillation(SW–846 Method 5031)

Alex Gholson, NCASI2:00 p.m.—Evaluation of Alternative

Detection Limit Concepts Using aCommon Database

Barry Eynon, SRI International

Field Studies

2.30 p.m.—Field Analysis: EffectiveApproach to Site Assessment andRemediation

Ileana Rhodes, Shell DevelopmentCompany

3:00 p.m.—Break

Biomarkers

3:15 p.m.—Use of a Human Cell LineBiomarker to Assess the Risk ofDioxin-like Compounds

Jack Anderson, Columbia AnalyticalServices, Inc.

3:45 p.m.—Biomarkers ofEnvironmental Contamination

Scott Steinert, Computer SciencesCorporation

Cyanide

4:15 p.m.—A Method Comparison andEvaluation for the Analysis of WeakAcid Dissociable Cyanide

John Sebroski, Bayer Corporation

Great Lakes

4:45 p.m.—The Lake Michigan MassBalance Study: Amalgam, Resin andDramamine

Marcia Kuehl, Grace Analytical5:15 p.m.—Adjourn

Thursday, May 16, 1996

Organics

8:30 a.m.—The SemipermeableMembrane Device (SPMD)—Sampling Dissolved OrganicContaminants

Carl Orazio, National BiologicalService

9:00 a.m.—Determination of CDDs andCDFs at Part-per-quintillion LevelsUsing a Cubic Meter Sample

Dale Rushneck, Interface, Inc.9:30 a.m.—A Quantitative Immunoassay

for Triazine Herbicides in DrinkingWater

Harry McCarty, SAIC10:00 a.m.—Break10:15 a.m.—Equilibrium Headspace: An

Alternative to Purge and Trap forIndustrial Wastewater Analyses

Elaine Lemoine, The Perkin ElmerCorporation

10:45 a.m.—Toxaphene, and ItsOccurrence in Large Lakes

John Kucklick, National MarineFisheries Service

11:15 a.m.—Initial Validation of Method1668: Toxic PCBs by HRGC/HRMS

Bruce Colby, Pacific Analytical, Inc.11:45 a.m.—Lunch1:00 p.m.—Analysis of Phenolic Acid

Compounds in Calcareous Soils bySW–846 Method 8270

Cary Jackson, Support Systems, Inc./Global Environmental Services

Trace Metals

1:30 p.m.—Expedited Delineation ofElemental Mercury (Hg) in Soils atan Industrial Facility in SouthAmerica

Thomas Lusardi, KeatingEnvironmental Management, Inc.

2:00 p.m.—Analysis of Trace Metals inComplex Matrices

Howard Weinberg, University of NorthCarolina

2:30 p.m.—Applying Clean MetalTechniques to Real WorldSituations

Paul Boothe, Albion Environmentaland TERL at Texas A&M University

3:00 p.m.—Break3:15 p.m.—How Dirty Can an Acid Bath

be and Still Meet ‘‘Clean Metal’’Requirements

Eric Crecelius, Battelle MarineSciences Laboratory

3:45 p.m.—Application of Clean MetalsTechniques to WastewaterMonitoring

Paula Hogg, Hampton RoadsSanitation District

4:15 p.m.—A Practical Approach toPermit-based Trace MetalsMonitoring

Roger Stewart, Virginia DEQ4:45 p.m.—A Common Sense Approach

to Turning Your Metals Laboratory

into an Environment Where CleanMetals Analysis Can be PerformedReliably

Jim Anderson, Commonwealth ofVirginia/Division of ConsolidatedLaboratories

5:15 p.m.—Adjourn.Dated: April 17, 1996.

Tudor Davies,Director, Office of Science and Technology.[FR Doc. 96–9978 Filed 4–22–96; 8:45 am]BILLING CODE 6560–50–P

[FRL–5462–4]

Workshop Announcement; Call forPapers: Analysis of Issues Related toNext Steps on Climate Change

AGENCY: Environmental ProtectionAgency (EPA).ACTION: Notice.

SUMMARY: Negotiations under theFramework Convention on ClimateChange (FCCC) are underway to addresspossible actions under the BerlinMandate. These discussions arescheduled to reach a conclusion at theThird Meeting of the Parties which isplanned for Fall of 1997. To provideinput on a wide range of analyticalissues related to these negotiations, theDepartments of Agriculture, Commerce,Energy, and State, and theEnvironmental Protection Agency arehosting a workshop on June 6–7 in theWashington, D.C. area.

The purpose of the workshop is toprovide a forum to share and discussinformation on analytical issues to helpinform U.S. policymakers and theinterested public as we move forward innegotiations concerning possible nextsteps under the Berlin Mandate.

The workshop will focus on analysisof the key issues identified in the BerlinMandate. These issues are:

• the elaboration of policies andmeasures,

• the setting of quantified emissionslimitation and reduction objectives, and

• actions to advance theimplementation of existingcommitments under Article 4.1 forParties not included in Annex 1.

This workshop provides anopportunity for federal agencies topresent the interim results of theirongoing analyses related to theeconomic and environmental impacts ofissues arising in the context of thesenegotiations.

The workshop also offers anopportunity for other interestedindividuals and organizations to presentanalytical studies that contribute to animproved understanding of the issuesdescribed above.


People interested in presenting papersat the workshop should submit anabstract of no more than one page to theconference organizer identified below.Abstracts should be received by April29th and submitters will be notified iftheir paper has been accepted forpresentation by May 6th. All papersshould focus on analytical issues relatedto the issues described above. Paperswill be selected on the basis of theirrelevance to the workshop topics, theavailability of time, and the need forpresentations in each of the three areasidentified in the mandate.

For information about attending theworkshop or submitting an abstract of apaper for the meeting, please call (703)934–3870.DATES: The conference will be held June6–7, 1996.FOR FURTHER INFORMATION CONTACT:Jeremy Symons, U.S. EnvironmentalProtection Agency, 401 M Street, NW,Mail Code 6202J, Washington, DC20460.

Dated: April 17, 1996.Mary D. Nichols,Assistant Administrator for Air andRadiation.[FR Doc. 96–10088 Filed 4–22–96; 8:45 am]BILLING CODE 6560–50–P

FEDERAL COMMUNICATIONSCOMMISSION

Public Information CollectionApproved by Office of Managementand Budget

April 17, 1996.The Federal Communications

Commission (FCC) has received Officeof Management and Budget (OMB)approval for the following publicinformation collection pursuant to thePaperwork Reduction Act of 1995, Pub.L. 96–511. An agency may not conductor sponsor a collection of informationunless it displays a currently validcontrol number. Not withstanding anyother provisions of law, no person shallbe subject to any penalty for failing tocomply with a collection of informationsubject to the Paperwork Reduction Act(PRA) that does not display a validcontrol number. Questions concerningthe OMB control numbers andexpiration dates should be directed toDorothy Conway, FederalCommunications Commission, (202)418–0217.

Federal Communications Commission

OMB Control No.: 3060–0054.Expiration Date: 2/28/99.

Title: Application for Exemption fromShip Radio Station Requirements FCCForm 820.

Estimated Annual Burden: 233 hoursannual burden; average 1 hour and 10minutes per respondent; 200respondents.

Description: FCC Rules require thiscollection of information whenexemptions from radio provisions ofstatute; treaty or international agreementare requested. The data is used by theexaminers to determine the applicantsqualifications for the requestedexemption.OMB Control No.: 3060–0541.

Expiration Date: 2/28/99.Title: Transmittal Sheet for Phase 2

Cellular Applications for UnservedAreas.

Form: FCC Form 464–A.Estimated Annual Burden: 1,660 total

annual hours; average 10 minutes perrespondent; 10,000 respondents.

Description: The information is usedby the Commission to determinewhether the applicant is qualifiedlegally, technically, and financially tobe licensed as a cellular operator.Without the information theCommission could not determinewhether to issue licenses to theapplicants that providetelecommunications services to thepublic. The transmittal sheet facilitatesapplication intake and other processingfunctions. The applicant must certify onthe form that the application iscomplete in every respect and containsall the required information.OMB Control No.: 3060–0321.

Expiration Date: 2/28/99.Title: Sampling systems for Antenna

Monitors - Section 73.68.Estimated Annual Burden: 200 total

annual hours; average 2 hours perrespondent; 100 respondents.

Description: Section 73.68(b) requiresthat licensees of existing AM broadcaststations with antenna monitor samplingsystems, meeting the performancestandards specified in the rules may fileinformal request for approval of theirsampling systems. Section 73.68(d)requires that a request for modificationof the station license be submitted bythe FCC when the antenna samplingsystem is modified or components of thethe sampling system are replaced. Thedata is used by staff to maintaincomplete technical informationregarding licensees to insure that thesampling system is in full compliancewith the rules and will not causeinterference to other facilities.OMB Control No.: 3060–0175.

Expiration Date: 2/28/99.Title: Station Main Studio Location

Section 73.1125.

Estimated Annual Burden: 68 totalannual hours; average 30 minutes perrespondent; 135 respondents.

Description: Section 73.1125 requiresAM, FM or TV licensees to locate theirmain studio at any point within thestation’s principal community contours.If the station relocates its main studiothe licensee is required to notify theCommission. This notice assures thatthe station is located within theprincipal community contours andnotifies FCC of the change in mailingaddress.OMB Control No.: 3060–0160.

Expiration Date: 2/28/99.Title: Directional Antenna Monitoring

Points - Section 73.158.Form: N/A.Estimated Annual Burden: 320 total

annual hours; average 4 hours perrespondent; 80 respondents.

Description: Section 73.158 requireslicensees of AM radio stations using adirectional antenna system to file aninformal application to modify theirstation license for changes in fieldmonitoring point and for routingdescription to each. It also requireslicensees to file a request for a correctedstation license when the descriptiverouting to reach any of the monitoringpoints is no longer correct. The data isused by FCC staff to alleviate electromagnetic interference and issue a newlicense.Federal Communications Commission.William F. Caton,Acting Secretary.[FR Doc. 96–9930 Filed 4–22–96; 8:45 am]BILLING CODE 6712–01–F

FEDERAL MARITIME COMMISSION


Southern Pacific Transportation Co.and the Atchison, Topeka & Santa FeRailway Co. v. Port of Long Beach;Filing of Complaint and Assignment

Notice is given that a complaint filedby Southern Pacific TransportationCompany and The Atchison, Topekaand Santa Fe Railway Company(‘‘Complainants’’) against Port of LongBeach (‘‘Respondent’’) was served April17, 1996. Complainants allege thatRespondent has violated section10(d)(1) of the Shipping Act of 1984, 46U.S.C. app 1709(d)(1), in connectionwith a new item in Respondent’s tariffthat imposes an access charge for use ofPort owned rail tracks, contrary toprovisions of existing agreementsbetween Complainants and the City ofLong Beach.


This proceeding has been assigned tothe office of Administrative Law Judges.Hearing in this matter, if any is held,shall commence within the timelimitations prescribed in 46 CFR 502.61,and only after consideration has beengiven by the parties and the presidingofficer to the use of alternative forms ofdispute resolution. The hearing shallinclude oral testimony and cross-examination in the discretion of thepresiding officer only upon propershowing that there are genuine issues ofmaterial fact that cannot be resolved onthe basis of sworn statements, affidavits,depositions, or other documents or thatthe nature of the matter in issue is suchthat an oral hearing and cross-examination are necessary for thedevelopment of an adequate record.Pursuant to the further terms of 46 CFR502.61, the initial decision of thepresiding officer in this proceeding shallbe issued by April 17, 1997, and thefinal decision of the Commission shallbe issued by August 15, 1997.Joseph C. Polking,Secretary.[FR Doc. 96–9885 Filed 4–22–96; 8:45 am]BILLING CODE 6730–01–M

Ocean Freight Forwarder LicenseApplicants

Notice is hereby given that thefollowing applicants have filed with theFederal Maritime Commissionapplications for licenses as ocean freightforwarders pursuant to section 19 of theShipping Act of 1984 (46 U.S.C. app.1718 and 46 CFR 510).

Persons knowing of any reason whyany of the following applicants shouldnot receive a license are requested tocontact the Office of Freight Forwarders,Federal Maritime Commission,Washington, D.C. 20573.

RMG International Inc., 755 Bradfield,Houston, TX 77060, Officers: RobertM. Goodsir, President, Michael K.Freeman, Vice President

Smile Enterprises Co., 500 Carson PlazaDrive, #125, Carson, CA 90746, Se IlCha, Sole Proprietor

Dated: April 18, 1996.Joseph C. Polking,Secretary.[FR Doc. 96–9956 Filed 4–22–96; 8:45 am]BILLING CODE 67301–01–M


Longrow Shipping Limited; PossibleViolations of Sections 8 and 10(b)(1) ofthe Shipping Act of 1984 andCommission Rule 514.1(e)(1); Order ofInvestigation and Hearing

This proceeding is instituted pursuantto sections 3, 8, 10, 11 and 13 of theShipping Act of 1984 (‘‘1984 Act’’), 46USC app. 1702, 1707, 1709, 1710 and1712, and the Federal MaritimeCommission’s (‘‘Commission’’)regulations governing the tariffing ofnon-vessel-operating common carriers,46 CFR Part 514.

Longrow Shipping Limited(‘‘Longrow’’) is a non-vessel-operatingcommon carrier (‘‘NVOCC’’)incorporated in Hong Kong in 1991. Itsreceiving agent in the United States andagent for service of process is Pan-Pacific Express Corporation inCalifornia. Longrow currently maintainsa tariff, effective July 17, 1994, in theCommission’s Automated Tariff Filingand Information System. It holds anNVOCC surety bond, issued on May 26,1994, in the amount of $50,000.

It appears that between May 30 andJuly 16, 1994, Longrow may haveoperated as a NVOCC without aneffective tariff. During this time,Longrow held itself out as a NVOCCproviding ocean transportation fromHong Kong to the United States in itsdealings with at least five shippers andone ocean common carrier. Section 8 ofthe 1984 Act, 46 USC app. 1707,provides that no common carrier mayprovide service in the United Statesforeign trade unless the carrier first hasfiled a tariff with the Commissionshowing all of its rates, charges andpractices. Section 8 also states that nonew rates may become effective earlierthan 30 days after filing at theCommission. In promulgating thisstatutory provision, Commission rule514.9(b)(9)(i)(A), 46 CFR514.9(b)(9)(i)(A), explains that ‘‘[n]ewtariffs * * * shall * * * be filed tobecome effective not earlier than 30days after the date of filing.’’ Accordingto the records maintained by theCommission’s Bureau of Tariffs,Certification and Licensing, Longrowdid not have an effective tariff until July17, 1994. Commission rule 514.1(e)(1),46 CFR 514.1(e)(1), provides that‘‘[o]perating without an effective tariffon file with the Commission * * * isunlawful.’’ Therefore, it would appearand Longrow, by providing and holdingout to the public to providetransportation by water of cargo forcompensation and by contracting as ashipper in relation to a common carrier

for the transportation of cargo of otherpersons, may have acted as a NVOCCwithout an effective tariff, in violationof section 8 of the 1984 Act andCommission rule 514.1(e)(1).

After Longrow’s tariff becameeffective, Longrow transported betweenJuly 17, 1994 and February 21, 1995, atleast twenty (20) shipments from HongKong to the United States. For thoseshipments, Longrow appears to havecharged rates other than those shown inLongrow’s tariff. Pursuant to section10(b)(1), 46 USC app. 1709(b)(1), the1984 Act maintains that a commoncarrier is prohibited from charging,demanding, collecting or receivinggreater, less or different compensationfor transportation of property than therates shown in its tariffs or servicecontracts. This prohibition is reiteratedin Commission rule 514.1(e)(1) whichstates that ‘‘charging rates not inconformance with such a tariff islawful.’’ Therefore, Longrow may haveviolated section 10(b)(1) of the 1984 Actand Commission rule 514.1(e)(1) bycharging rates other than those shown inits tariff between July 17, 1994 andFebruary 21, 1995.

Section 11 of the 1984 Act, 46 USCapp. 1710, sets forth the Commission’sauthority to investigate any conduct thatmay be in violation of the 1984 Act. Inthe event violations are found, section13 of the 1984 Act, 46 USC app. 1712,provides that the Commission mayassess civil penalties for violations ofthe 1984 Act and the regulations issuedthereunder.

Now therefore it is ordered, Thatpursuant to sections 3, 8, 10, 11, and 13of the 1984 Act, 46 USC app. 1702,1707, 1709, 1710, and 1712, aninvestigation is hereby instituted todetermine:

(1) Whether Longrow ShippingLimited violated section 8 of the 1984Act and Commission rule 514.1(e)(1), byproviding common carrier serviceswithout an effective tariff filed at theCommission between May 30, 1994 andJuly 16, 1994;

(2) Whether Longrow ShippingLimited violated section 10(b) of the1984 Act and Commission rule514.1(e)(1), by failing to charge the ratesshown in its tariff between July 17, 1994and February 21, 1995;

(3) Whether, in the event LongrowShipping Limited violated sections 8and 10(b) of the 1984 Act andCommission rule 514.1(e)(1), civilpenalties should be assessed and, if so,the amount of such penalties;

It is further ordered, That a publichearing be held in this proceeding andthat this matter be assigned for hearingbefore an Administrative Law Judge of


the Commission’s Office ofAdministrative Law Judges incompliance with Rule 61 of theCommission’s Rules of Practice andProcedure, 46 CFR 502.61. The hearingshall include oral testimony and cross-examination in the discretion of thePresiding Administrative Law Judgeonly upon a proper showing that thereare genuine issues of material fact thatcannot be resolved on the basis of swornstatements, affidavits, depositions, orother documents or that the nature ofthe matters in issue is such that an oralhearing and cross-examination arenecessary for the development of anadequate record;

It is further ordered, That LongrowShipping Limited is designatedRespondent in this proceeding;

It is further ordered, That theCommission’s Bureau of Enforcement isdesignated a party to this proceeding;

It is further ordered, That notice ofthis Order be published in the FederalRegister, and a copy be served on partiesof record;

It is further ordered, That otherpersons having an interest inparticipating in this proceeding may filepetitions for leave to intervene inaccordance with Rule 72 of theCommission’s Rules of Practice andProcedure, 46 CFR 502.72;

It is further ordered, That all furthernotices, orders, and/or decisions issuedby or on behalf of the Commission inthis proceeding, including notice of thetime and place of hearing or prehearingconference, shall be served on parties ofrecord;

It is further ordered, That alldocuments submitted by any party ofrecord in this proceeding shall bedirected to the Secretary, FederalMaritime Commission, Washington,D.C. 20573, in accordance with Rule 118of the Commission’s Rules of Practiceand Procedure, 46 CFR 502.118, andshall be served on parties of record;

It is further ordered, That inaccordance with Rule 61 of theCommission’s Rules of Practice andProcedure, the initial decision of theAdministrative Law Judge shall beissued by April 16, 1997, and the finaldecision of the Commission shall beissued by August 14, 1997.

By the Commission.Joseph C. Polking,Secretary.[FR Doc. 96–9873 Filed 4–22–96; 8:45 am]BILLING CODE 6730–01–M

FEDERAL RESERVE SYSTEM

Notice of Proposals to Engage inPermissible Nonbanking Activities orto Acquire Companies That areEngaged in Permissible NonbankingActivities

The companies listed in this noticehave given notice under section 4 of theBank Holding Company Act (12 U.S.C.1843) (BHC Act) and RegulationY, (12 CFR part 225) to engage de novo,or to acquire or control voting securitiesor assets of a company that engageseither directly or through a subsidiary orother company, in a nonbanking activitythat is listed in § 225.25 of RegulationY (12 CFR 225.25) or that the Board hasdetermined by Order to be closelyrelated to banking and permissible forbank holding companies. Unlessotherwise noted, these activities will beconducted throughout the United States.

Each notice is available for inspectionat the Federal Reserve Bank indicated.Once the notice has been accepted forprocessing, it will also be available forinspection at the offices of the Board ofGovernors. Interested persons mayexpress their views in writing on thequestion whether the proposal complieswith the standards of section 4 of theBHC Act, including whetherconsummation of the proposal can‘‘reasonably be expected to producebenefits to the public, such as greaterconvenience, increased competition, orgains in efficiency, that outweighpossible adverse effects, such as undueconcentration of resources, decreased orunfair competition, conflicts ofinterests, or unsound banking practices’’(12 U.S.C. 1843). Any request for ahearing on this question must beaccompanied by a statement of thereasons a written presentation wouldnot suffice in lieu of a hearing,identifying specifically any questions offact that are in dispute, summarizing theevidence that would be presented at ahearing, and indicating how the partycommenting would be aggrieved byapproval of the proposal.

Unless otherwise noted, commentsregarding the applications must bereceived at the Reserve Bank indicatedor the offices of the Board of Governorsnot later than May 14, 1996.

A. Federal Reserve Bank of Chicago(James A. Bluemle, Vice President) 230South LaSalle Street, Chicago, Illinois60690:

1. Boscobel Bancorp, Inc., Boscobel,Wisconsin; to engage de novo in makingand servicing loans, pursuant to §225.25(b)(1) of the Board’s Regulation Y.

Board of Governors of the Federal ReserveSystem, April 17, 1996.Jennifer J. Johnson,Deputy Secretary of the Board.[FR Doc. 96–9920 Filed 4–22–96; 8:45 am]BILLING CODE 6210–01–F

DEPARTMENT OF HEALTH ANDHUMAN SERVICES

Centers for Disease Control andPrevention

[Announcement Number 614]

Surveillance of the Complications ofHemophilia

Introduction

The Centers for Disease Control andPrevention (CDC) announces theavailability of fiscal year (FY) 1996funds to continue a cooperativeagreement program to conduct activesurveillance for hemophilia A and B(henceforth referred to as hemophilia)and their complications. Theinternational classification of diseases(ICD) code definition of hemophilia A iscongenital factor VIII disorder andhemophilia B is congenital factor IXdisorder. Applicant’s programs must betargeted to individuals with hemophiliawho receive their care both within andoutside hemophilia treatment centersand comprehensive care centers. Suchindividuals should include: personswho do not access traditionalhemophilia treatment services and mayreceive inadequate care (and arepossibly over-represented by personswho are economically disadvantaged),persons who live in rural areas or innercities; or, persons who are members ofone of four federally recognizedminority groups: (1) Black; African-American or Caribbean; (2) Hispanic;Central American, South American,Mexican American, Dominican, Cuban,or Puerto Rican; (3) Asian/PacificIslander, or (4) American Indian orAlaskan Native.

CDC is committed to achieving thehealth promotion and diseaseprevention objectives of Healthy People2000, a national activity to reducemorbidity and mortality and improvethe quality of life. This announcementis related to the priority area of Diabetesand Chronic Disabling Conditions. (Forordering a copy of Healthy People 2000,see the Section Where to ObtainAdditional Information.)

Authority

This program is authorized underSections 301(a) and 317(k)(2) of thePublic Health Service Act, as amended


[42 U.S.C. 241(a) and 247b(k)(2)].Applicable program regulations arefound in 42 CFR Part 51b - ProjectGrants for Preventive Health Services.

Smoke-Free WorkplaceCDC strongly encourages all grant

recipients to provide a smoke-freeworkplace and to promote non-use of alltobacco products, and Public Law 103–227, the Pro-Children Act of 1994,prohibits smoking in certain facilitiesthat receive Federal funds in whicheducation, library, day care, health care,and early childhood developmentservices are provided to children.

Eligible ApplicantsAssistance will be provided only to

the official public health agencies ofStates or their bona fide agents. Thisincludes the District of Columbia,American Samoa, the Commonwealth ofPuerto Rico, the Virgin Islands, theFederated States of Micronesia, Guam,the Northern Mariana Islands, theRepublic of the Marshall Islands, theRepublic of Palau, and federallyrecognized Indian tribal governments.

The low prevalence of hemophilialimits competition to the official publichealth agencies of States. This projectrequires experience in conductingstatewide, active surveillance programsfor hemophilia, and experience incollaboration with organizations havingthe ability to reach a wide variety ofdemographically distinct populations,including traditionally under servedpopulations. Since only State healthagencies can perform the requiredproject activities, competition is limitedaccordingly.

Funding preference will be given tocompetitive continuation applicationsof States who have currently establishedstatewide hemophilia surveillancesystems (HSS); and, who havedemonstrated collaboration betweenhealth departments, hemophiliatreatment centers, and/or universityschools of public health, in hemophiliasurveillance activities.

Availability of FundsApproximately $2,500,000 is available

in FY 1996 to fund approximately 6awards. The average award will be$350,000, ranging from $250,000 to$450,000. It is expected that the fundswill be awarded on or about September30, 1996, and will be made for a 12-month budget period within a projectperiod of up to 3 years. Fundingestimates may vary and are subject tochange. Continuation awards within theproject period will be made on the basisof satisfactory programmatic progressand the availability of funds.

PurposeThe purpose of the hemophilia

cooperative agreement program is toassist recipients in characterizing thestatewide epidemiology of hemophiliaand its complications, and determiningits impact among three populations: (1)Those who access traditionalhemophilia treatment andcomprehensive care services, (2) thosewho receive care outside traditionalhemophilia care centers, and (3) thosewho receive inadequate care. The latterpopulation category may be over-represented by persons who areeconomically disadvantaged, or wholive in rural areas, or inner cities.Inadequate care would include less thanprompt treatment, treatment fromimproperly trained personnel, or pooraccess to comprehensive care. The datacollected through a HemophiliaSurveillance System (HSS) can assisthemophilia treatment providers andStates in developing, implementing, andevaluating education and preventionprograms to reduce the morbidity,mortality, and costs of hemophilia andits complications.

Program RequirementsIn conducting activities to achieve the

purpose of this program, the recipientwill be responsible for the activitiesunder A. below, and CDC will beresponsible for conducting the activitiesunder B. below:

A. Recipient ActivitiesAll recipients must conduct activities

in collaboration and coordination withthe CDC.

Required Activities for All Recipients1. Meet with representatives from

CDC to: (a) Assure continuation ofoptimal surveillance methods, such asthe use of standardized HSS protocolsand data collection form, and (b) amendprevious HSS protocols with any newactivities or procedures.

2. Use standard surveillance protocolsas a basis to design, implement, andevaluate statewide surveillanceprograms for adult, adolescent, andpediatric cases of hemophilia and itscomplications.

3. Update data abstractors, asnecessary, in methods of activesurveillance, use of the HSS dataabstraction form, techniques ofreviewing medical records, and othermethods of surveillance as appropriateand provided for in the HSS Manual.

4. Maintain appropriate managementand evaluation systems that ensure dataabstractors conduct active surveillance,and use data collection methodsaccording to the HSS Manual.

5. Maintain secure databases of allreported cases of hemophilia and itscomplications.

6. Maintain strict policies onprotecting the confidentiality of personswith hemophilia, and ensure thesecurity of databases and other recordsthrough controlled access to areas withconfidential information, databasepassword protection, locking filecabinets, and other security features.

7. Using the standardized format,prepare and submit progress reports ona quarterly basis that address theachievements of HSS activities, programgoals and objectives for the previousquarter.

8. Upon request, assist State orregional programs in the use of data todevelop or improve hemophilia careprograms.

Surveillance of Hemophilia: SpecificRequired Activities

1. Promote and maintain liaison withpotential reporting sources both withinand outside of the traditionalhemophilia treatment system. Thesepotential reporting sources include, butare not limited to, State or regionalhemophilia chapters or associations,hospitals, emergency care centers,hematology clinics, private physicians,organizations that provide home-infusion therapy, distributors of home-infusion factor concentrates, and others.

2. In accordance with HSS protocols,implement active hemophiliasurveillance among reporting sourcesoutside of the traditional hemophiliacare system, and in the collaborativenetwork of hemophilia treatmentcenters to determine the statewideprevalence of hemophilia.

3. In accordance with standard HSSprotocols, redirect current surveillanceactivities as indicated through criticalreview of data and evaluation of yieldfrom various surveillance activities.Initiate additional methods ofsurveillance for hemophilia, asappropriate.

4. Augment surveillance through theuse of at least one alternate database(e.g., death certificates, State hospital-discharge summaries, Statereimbursement programs). Documentthese methods, results, and ifappropriate, the redirection ofsurveillance activities in the quarterlyprogress report.

5. Through death certificate reviewand active surveillance, collect data ondeaths attributed to hemophilia tocalculate State hemophilia-specificmortality rates. Collect epidemiologicdata that could be used to determine thesensitivity of death certificates in


documenting deaths attributed tohemophilia.

6. Collect Universal Data Collection(UDC) forms from designatedhemophilia treatment centers, and enterinto the CDC-provided UDC software fortransmission to the CDC on a regularbasis. Document this activity in thequarterly progress report.

Surveillance of Hemophilia-RelatedComplications: Specific RequiredActivities

1. Through medical record review orother methods proposed by theapplicant, describe the source,frequency, and type of preventive andmedical care among persons withhemophilia, and determine theprevalence of the following hemophilia-related complications:Joint diseaseLiver diseaseInhibitorsHIV/AIDSBlood-borne infections

Sampling methods, if used, will bedeveloped in collaboration with CDC toinsure sufficient representation ofpersons of different race/ethnicity, age,HIV status, severity of hemophilia, andsource of care.

2. Conduct longitudinal follow-up ofpersons with hemophilia-related jointdisease to relate the source, frequency,and type of preventive and medical careto health outcome (e.g., severity of jointdisease, degree of disability). In additionto joint disease, applicants areencouraged to propose and conductlongitudinal follow-up of persons withother hemophilia-related complications.

B. CDC Activities

1. Provide programmatic consultation,scientific and technical assistance inplanning, implementing, and evaluatinghemophilia surveillance activities.Assistance includes the implementationof standardized HSS protocols, and theuse of the HSS data abstraction form,progress report forms, and HSS databasesoftware.

2. Plan, coordinate, and facilitateperiodic meetings with recipients toexchange operational experiences, andto provide consultation and assistancein the modification of standardsurveillance protocols as needed.

3. Provide programmatic coordinationof surveillance initiatives among therecipients.

4. Assist with the analysis andreporting of aggregate surveillance datacollected from funded initiatives bycoordinating and consolidating thetransfer of tabulated data, analyses, andconclusions from the recipients.

5. Assist National, State, or regionalprograms in the use of data to developor improve hemophilia care programs.

Evaluation CriteriaApplications will be reviewed and

evaluated according to the followingcriteria: (Total 100 points)

A. Capacity1. The capacity of the applicant to

access the medical records ofhemophilia patients who receive careboth within and outside of thetraditional hemophilia treatmentsystem. The capacity to access theserecords is measured by (a) the extentthat the applicant incorporates sharedresponsibility between hemophiliatreatment centers and State healthdepartments as delineated in letters ofagreement, and (b) the extent ofcollaboration among these entities andwith other organizations involved in thedelivery of care to persons withhemophilia. (25 points)

2. The scope and magnitude ofprevious cooperative efforts betweenregional or State hemophilia treatmentcenters and State or local healthdepartments that propose to collaboratein this application. (5 points)

3. The allocation of time, number, andqualifications of proposed staff to meetstated objectives and goals, and theavailability of facilities to be usedduring the project period. (5 points)

B. Goals and ObjectivesThe extent to which the applicant’s

proposed goals and objectives meet therequired activities specified underProgram Requirements section A.Recipient Activities of thisannouncement, and that are measurable,specific, time-phased, and realistic. (20points)

C. Methods and Activities

1. The quality of the applicant’s planfor conducting program activities andthe extent to which surveillancemethods proposed are: (a) Appropriateto accomplish stated goals andobjectives; (b) adaptable to a variety ofhealth care settings, multiplecomplications of hemophilia, and thecollection of longitudinal data; (c)accurate to produce valid and reliabledata, and (d) feasible withinprogrammatic and fiscal restrictions. (25points)

2. The applicant’s documented abilityto (a) identify optimal surveillancemethods, (b) develop standardized HSSprotocols, HSS data collectioninstruments, progress report forms, andHSS database software, (c) modifyproposed methods and activities to

conform to standardized protocols, and(d) ensure that women and racial andethnic minority populations areappropriately represented inapplications for research involvinghuman subjects. (10 points)

D. Program Management andEvaluation

The extent to which the proposedmanagement system, including the type,frequency, and methods of evaluation,will be used to assure valid and reliabledata. (10 points)

E. BudgetThe extent to which the budget is

reasonable and consistent with theintended use of the cooperativeagreement funds. (not scored)

F. Human Subjects ResearchWhether or not exempt from DHHS

regulations, are the procedures adequatefor the protection of human subjects?Recommendations on the adequacy ofprotections include: (1) Protectionsappear adequate and there are nocomments to make or concerns to raise,or (2) protections appear adequate, butthere are comments regarding theprotocol, or (3) protections appearinadequate and the objective reviewgroup (ORG) has concerns related tohuman subjects; or (4) disapproval ofthe application is recommendedbecause the research risks aresufficiently serious and protectionagainst the risks are inadequate as tomake the entire applicationunacceptable. (not scored)

Executive Order 12372 ReviewApplications are subject to

Intergovernmental Review of FederalPrograms as governed by ExecutiveOrder (E.O.) 12372, which sets up asystem for State and local governmentreview of proposed Federal assistanceapplications. Applicants (other thanfederally recognized Indian tribalgovernments) should contact their stateSingle Point of Contact (SPOC) early aspossible to alert them to the prospectiveapplications and receive any necessaryinstructions on the State process. Indiantribes are strongly encouraged to requesttribal government review of theapproved application. A current list ofSPOCs is included in the applicationkit. If SPOCs (or tribal governments)have any State (or tribal) processrecommendations on applicationssubmitted to CDC, they should referencethis announcement number (614) andforward recommendations to SharronOrum, Grants Management Officer,Grants Management Branch,Procurement and Grants Office, Centers


for Disease Control and Prevention(CDC), 255 East Paces Ferry Road, NE.,Room 300, Mailstop E–18, Atlanta,Georgia 30305, no later than 60 daysafter the application deadline date. CDCdoes not guarantee to ‘‘accommodate orexplain’’ State processrecommendations it receives after thatdate.

Public Health System ReportingRequirement

This program is not subject to thePublic Health System ReportingRequirement.

Catalog of Federal Domestic AssistanceNumber

The Catalog of Federal DomesticAssistance number is 93.283, Centers forDisease Control and Prevention (CDC)—Investigations and Technical Assistance.

Other Requirements

Paperwork Reduction ActProjects that involve collection of

information from 10 or more individualsand funded by cooperative agreementswill be subject to review by the Officeof Management and Budget (OMB)under the Paperwork Reduction Act.

Human SubjectsIf the proposed project involves

research on human subjects, theapplicant must comply with theDepartment of Health and HumanServices Regulations, 45 CFR Part 46,regarding the protection of humansubjects. Assurance must be provided todemonstrate that the project will besubject to initial and continuing reviewby an appropriate institutional reviewcommittee. In addition to otherapplicable committees, Indian HealthService (IHS) institutional reviewcommittees must review the project ifany component of IHS will be involvedor will support the research. If anyAmerican Indian community isinvolved, its tribal government mustalso approve that portion of the projectapplicable to it. The applicant will beresponsible for providing evidence ofthis assurance in accordance with theappropriate guidelines and formsprovided in the application kit.

ConfidentialityAll information obtained in

connection with this surveillanceprogram shall not, without suchindividual’s consent, be disclosedexcept as may be necessary to provideservices to him or her or as may berequired by a law of a State or politicalsubdivision of a State. Informationderived from any such program may bedisclosed: (1) in summary, statistical, or

other form, or (2) for clinical or researchpurposes, but only if the identity of theindividual under such program is notdisclosed.

HIV/AIDS RequirementRecipients must comply with the

document entitled ‘‘Content of AIDS-Related Written Materials, Pictorials,Audiovisuals, Questionnaires, SurveyInstruments, and Educational Sessions’’(June 1992), a copy of which is includedin the application kit. To meet therequirements for a program reviewpanel, recipients are encouraged to usean existing program review panel suchas the one created by the State healthdepartment’s HIV/AIDS preventionprogram. If the recipient forms its ownprogram review panel, at least onemember must be an employee (or adesignated representative) of agovernment health departmentconsistent with the content guidelines.The names of the review panel membersmust be listed on the Assurance ofCompliance form CDC 0.1113, which isalso included in the application kit. Therecipient must submit the programreview panel’s report that indicates allmaterials have been reviewed andapproved, including conferenceagendas.

Women, Racial and Ethnic MinoritiesIt is the policy of the Centers for

Disease Control and Prevention (CDC)and the Agency for Toxic Substancesand Disease Registry (ATSDR) to ensurethat individuals of both sexes and thevarious racial and ethnic groups will beincluded in CDC/ATSDR-supportedresearch projects involving humansubjects, whenever feasible andappropriate. Racial and ethnic groupsare those defined in OMB Directive No.15 and include American Indian,Alaskan Native, Asian, Pacific Islander,Black and Hispanic. Applicants shallensure that women, racial and ethnicminority populations are appropriatelyrepresented in applications for researchinvolving human subjects. Where clearand compelling rationale exist thatinclusion is inappropriate or notfeasible, this situation must beexplained as part of the application.This policy does not apply to researchstudies when the investigator cannotcontrol the race, ethnicity and/or sex ofsubjects. Further guidance to this policyis contained in the Federal Register,Vol. 60, No. 179, Friday, September 15,1995, pages 47947–47951.

Application Submission and DeadlineThe original and two copies of the

application PHS Form 5161–1 (Revised7/92, OMB number 0937–0189) must be

submitted to Sharron Orum, GrantsManagement Officer, GrantsManagement Branch, Procurement andGrants Office, Centers for DiseaseControl and Prevention (CDC), 255 EastPaces Ferry Road, NE., Room 300,Mailstop E–18, Atlanta, Georgia 30305,on or before June 24, 1996.

1. Deadline: Applications shall beconsidered as meeting the deadline ifthey are either: a. Received on or beforethe deadline date; or b. Sent on or beforethe deadline date and received in timefor submission to the objective reviewgroup. (Applicants must request alegibly dated U.S. Postal Servicepostmark or obtain a legibly datedreceipt from a commercial carrier orU.S. Postal Service. Private meteredpostmarks shall not be acceptable asproof of timely mailing.)

2. Late Applications: Applicationswhich do not meet the criteria in 1.a. or1.b. above are considered lateapplications. Late applications will notbe considered in the currentcompetition and will be returned to theapplicant.

Where To Obtain AdditionalInformation

A complete program description andinformation on application proceduresare contained in the applicationpackage. Business managementassistance may be obtained from LockeThompson, Grants ManagementSpecialist, Grants Management Branch,Procurement and Grants Office, Centersfor Disease Control and Prevention(CDC), 255 East Paces Ferry Road, NE.,Room 300, Mailstop E–18, Atlanta,Georgia 30305, telephone (404) 842–6595, or by Internet or CDC WONDERelectronic mail [email protected] technical assistance maybe obtained from Robert Cicatello,Public Health Advisor, telephone (404)639–4034, or by Internet or CDCWONDER electronic mail [email protected],Hematologic Diseases Branch, NationalCenter for Infectious Diseases, Centersfor Disease Control and Prevention(CDC), 1600 Clifton Road, NE., MailstopD–02, Atlanta, Georgia 30333.

Please refer to AnnouncementNumber 614 when requestinginformation and submitting anapplication.

Potential applicants may obtain acopy of Healthy People 2000 (FullReport, Stock No. 017–001–00474–0) orHealthy People 2000 (Summary Report,Stock No. 017–001–00473–1) referencedin the ‘‘Introduction’’ through theSuperintendent of Documents,Government Printing Office,


Washington, DC 20402–9325, telephone(202) 512–1800.

Dated: April 17, 1996.Joseph R. Carter,Acting Associate Director for Managementand Operations, Centers for Disease Controland Prevention (CDC).[FR Doc. 96–9936 Filed 4–22–96; 8:45 am]BILLING CODE 4163–18–P

Food and Drug Administration

[Docket No. 96N–0066]

Agency Information CollectionActivities: Proposed Collection;Comment Request; Extension

AGENCY: Food and Drug Administration,HHS.ACTION: Notice.

SUMMARY: The Food and DrugAdministration (FDA) is announcing anopportunity for public comment on theproposed collection of certaininformation by the agency. Under thePaperwork Reduction Act of 1995,Federal agencies are required to publisha notice in the Federal Registerconcerning each proposed collection ofinformation, including each proposedextension of an existing collection ofinformation, and allow 60 days forpublic comment in response to thenotice. This notice solicits comments onreporting and recordkeepingrequirements implementing the FederalImport Milk Act.DATES: Submit written comments on thecollections of information by June 24,1996.

ADDRESSES: Submit written commentson the collections of information to theDockets Management Branch (HFA–305), Food and Drug Administration,12420 Parklawn Dr., rm. 1–23,Rockville, MD 20857. All commentsshould be identified with the docketnumber found in brackets in theheading of this document.FOR FURTHER INFORMATION CONTACT:Charity B. Smith, Office of InformationResources Management (HFA–250),Food and Drug Administration, 5600Fishers Lane, rm. 16B–19, Rockville,MD 20857, 301–827–1686.SUPPLEMENTARY INFORMATION: Section3506(c)(2)(A) of the PaperworkReduction Act of 1995 (44 U.S.C.3506(c)(2)(A)) requires Federal agenciesto provide a 60-day notice in theFederal Register concerning eachproposed collection of information,including each proposed extension of anexisting collection of information.‘‘Collection of information’’ is definedin 44 U.S.C. 3502(3) and 5 CFR1320.3(c). To comply with thisrequirement, FDA is publishing noticeof the proposed collection ofinformation listed below.

With respect to the followingcollection of information, FDA invitescomments on: (1) Whether the proposedcollection of information is necessaryfor the proper performance of FDA’sfunctions, including whether theinformation will have practical utility;(2) the accuracy of FDA’s estimate of theburden of the proposed collection ofinformation, including the validity ofthe methodology and assumptions used;(3) ways to enhance the quality, utility,and clarity of the information to be

collected; and (4) ways to minimize theburden of the collection of informationon respondents, including through theuse of automated collection techniques,when appropriate, and other forms ofinformation technology.

Part 1210 Regulations Under the FederalImport Milk Act (21 CFR Part 1210)(OMB Control Number 0910–0212—Extension)

Under the regulations implementingthe Federal Import Milk Act (21 U.S.C.141–149), milk or cream may beimported into the United States only bythe holder of a valid import milk permit.Before such permit is issued: (1) Allcows from which import milk or creamis produced must be physicallyexamined and found healthy; (2) if themilk or cream is imported raw, all suchcows must pass a tuberculin test; (3) thedairy farm and each plant in which themilk or cream is processed or handledmust be inspected and found to meetcertain sanitary requirements; (4)bacterial counts of the milk at the timeof importation must not exceedspecified limits; and (5) the temperatureof the milk or cream at time ofimportation must not exceed 50 °F. Inaddition, the regulations require thatdairy farmers and plants maintainpasteurization records (§ 1210.15) andthat each container of milk or creamimported into the United States bear atag with the product type, permitnumber, and shipper’s name andaddress (§ 1210.22).

FDA estimates the burden ofcomplying with the informationcollection provisions of theseregulations as follows:

Estimated Annual Reporting Burden

Form No. 21 CFR Sec-tion

No. of Re-spondents

Annual Fre-quency perResponse

Total AnnualResponses

Hours perResponse Total Hours

FDA 1815/Permits granted on certificates 1210.23 1 1 1 0.5 0.5FDA 1993/Application of permit 1210.20 1 1 1 0.5 0.5FDA 1994/Tuberculin test 1210.13 0 0 0 N/A 0FDA 1995/Physical examination of cows 1210.12 0 0 0 N/A 0FDA 1996/Sanitary inspection of dairy farms 1210.11 1 300 300 1.5 450FDA 1997/Sanitary inspections of plants 1210.14 1 1 1 2.0 2.0Total 453

Estimated Annual Recordkeeping Burden

21 CFR Section No. of Recordkeepers Annual Frequency per RecordkeepingTotal An-

nualRecords

Hours perRecord-keeper

TotalHours

21 CFR 1210.15 1 1 1 .05 0.05

There are no capital or operating and maintenance costs associated with this collection.


No burden has been estimated for thetagging requirement in § 1210.22because the information on the tag iseither supplied by FDA (permit number)or is disclosed to third parties as a usualand customary part of the shipper’snormal business activities (type ofproduct, shipper’s name and address).Under 5 CFR 1320.3(c)(2), the publicdisclosure of information originallysupplied by the Federal government tothe recipient for the purpose ofdisclosure to the public is not acollection of information. Under 5 CFR1320.3(b)(2)), the time, effort, andfinancial resources necessary to complywith a collection of information areexcluded from the burden estimate ifthe reporting, recordkeeping, ordisclosure activities needed to complyare usual and customary because theywould occur in the normal course ofactivities. No burden has been estimatedfor Forms FD 1994 and 1995 becausethey are not currently being used. TheSecretary of Health and Human Serviceshas the discretion to allow Form FD1815, a duly certified statement signedby an accredited official of a foreigngovernment, to be submitted in lieu ofForms FD 1994 and 1995. To date, FormFD–1815 has been submitted in lieu ofthese forms.

Dated: April 11, 1996.William K. Hubbard,Associate Commissioner for PolicyCoordination.[FR Doc. 96–9869 Filed 4–22–96; 8:45 am]BILLING CODE 4160–01–F

[Docket No. 96F–0107]

Dainippon Ink and Chemicals, Inc.;Filing of Food Additive Petition


SUMMARY: The Food and DrugAdministration (FDA) is announcingthat Dainippon Ink and Chemicals, Inc.,has filed a petition proposing that thefood additive regulations be amended toprovide for the safe use of aliphaticpolyester-polyurethane resin-aciddianhydride adhesive in retortablepouches intended for use in contactwith food.DATES: Written comments on thepetitioner’s environmental assessmentby May 23, 1996.ADDRESSES: Submit written commentsto the Dockets Management Branch(HFA–305), Food and DrugAdministration, 12420 Parklawn Dr.,rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:Mark A. Hepp, Center for Food Safetyand Applied Nutrition (HFS–216), Foodand Drug Administration, 200 C St. SW.,Washington, DC 20204, 202–418–3098.

SUPPLEMENTARY INFORMATION: Under theFederal Food, Drug and Cosmetic Act(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),notice is given that a food additivepetition (FAP 6B4496) has been filed byDainippon Ink and Chemicals, Inc., c/oCenter for Regulatory Services, 2347Paddock Lane, Reston, VA 22091. Thepetition proposes to amend the foodadditive regulations in § 177.1390Laminate structures for use attemperatures of 250° F and above (21CFR 177.1390) to permit the safe use ofaliphatic polyester-polyurethane resin-acid dianhydride adhesive in retortablepouches intended for use in contactwith food.

The potential environmental impactof this action is being reviewed. Toencourage public participationconsistent with regulations promulgatedunder the National EnvironmentalPolicy Act (40 CFR 1501.4(b)), theagency is placing the environmentalassessment submitted with the petitionthat is the subject of this notice onpublic display at the DocketsManagement Branch (address above) forpublic review and comment. Interestedpersons may, on or before May 23, 1996,submit to the Dockets ManagementBranch (address above) writtencomments. Two copies of any commentsare to be submitted, except thatindividuals may submit one copy.Comments are to be identified with thedocket number found in brackets in theheading of this document. Receivedcomments may be seen in the officeabove between 9 a.m. and 4 p.m.,Monday through Friday. FDA will alsoplace on public display anyamendments to, or comments on, thepetitioner’s environmental assessmentwithout further announcement in theFederal Register. If, based on its review,the agency finds that an environmentalimpact statement is not required andthis petition results in a regulation, thenotice of availability of the agency’sfinding of no significant impact and theevidence supporting that finding will bepublished with the regulation in theFederal Register in accordance with 21CFR 25.40(c).

Dated: April 4, 1996.George H. Pauli,Acting Director, Office of PremarketApproval, Center for Food Safety and AppliedNutrition.[FR Doc. 96–9915 Filed 4–22–96; 8:45 am]BILLING CODE 4160–01–F


Drug Export; MigramistTM

(dihydroergotamine mesylate, USP) 4Milligrams(mg)/Milliliters(mL) NasalSpray


SUMMARY: The Food and DrugAdministration (FDA) is announcingthat Sandoz Pharmaceuticals Corp. hasfiled an application requestingconditional approval for the export ofthe human drug MigramistTM

(dihydroergotamine mesylate, USP) 4mg/mL Nasal Spray to Canada.ADDRESSES: Relevant information onthis application may be directed to theDockets Management Branch (HFA–305), Food and Drug Administration,12420 Parklawn Dr., rm. 1–23,Rockville, MD 20857, and to the contactperson identified below. Any futureinquiries concerning the export ofhuman drugs under the Drug ExportAmendments Act of 1986 should also bedirected to the contact person.FOR FURTHER INFORMATION CONTACT:James E. Hamilton, Center for DrugEvaluation and Research (HFD–310),Food and Drug Administration, 7520Standish Pl., Rockville, MD 20855, 301–594–3150.SUPPLEMENTARY INFORMATION: The drugexport provisions in section 802 of theFederal Food, Drug, and Cosmetic Act(the act) (21 U.S.C. 382) provide thatFDA may approve applications for theexport of drugs that are not currentlyapproved in the United States. Section802(b)(3)(B) of the act sets forth therequirements that must be met in anapplication for approval. Section802(b)(3)(C) of the act requires that theagency review the application within 30days of its filing to determine whetherthe requirements of section 802(b)(3)(B)have been satisfied. Section 802(b)(3)(A)of the act requires that the agencypublish a notice in the Federal Registerwithin 10 days of the filing of anapplication for export to facilitate publicparticipation in its review of theapplication. To meet this requirement,the agency is providing notice thatSandoz Pharmaceuticals Corp., 59 Rt.10, East Hanover, NJ 07936–1080, hasfiled an application requestingconditional approval for the export ofthe human drug MigramistTM

(dihydroergotamine mesylate, USP) 4mg/mL Nasal Spray to Canada. Thisproduct is indicated for the treatment ofmigraine headaches. The applicationwas received and filed in the Center forDrug Evaluation and Research on


October 19, 1995, which shall beconsidered the filing date for purposesof the act.

Interested persons may submitrelevant information on the applicationto the Dockets Management Branch(address above) in two copies (exceptthat individuals may submit singlecopies) and identified with the docketnumber found in brackets in theheading of this document. Thesesubmissions may be seen in the DocketsManagement Branch between 9 a.m. and4 p.m., Monday through Friday.

The agency encourages any personwho submits relevant information onthe application to do so by May 3, 1996,and to provide an additional copy of thesubmission directly to the contactperson identified above, to facilitateconsideration of the information duringthe 30-day review period.

This notice is issued under theFederal Food, Drug, and Cosmetic Act(sec. 802 (21 U.S.C. 382)) and underauthority delegated to the Commissionerof Food and Drugs (21 CFR 5.10) andredelegated to the Center for DrugEvaluation and Research (21 CFR 5.44).

Dated: April 5, 1996.Betty L. Jones,Deputy Director, Office of Compliance, Centerfor Drug Evaluation and Research.[FR Doc. 96–9896 Filed 4–22–96; 8:45 am]BILLING CODE 4160–01–F


Drug Export; DifferinTM (Adapalene)0.1% Topical Gel


SUMMARY: The Food and DrugAdministration (FDA) is announcingthat Galderma Laboratories, Inc., hasfiled an application requesting approvalfor the export of the human drugDifferinTM (Adapalene) 0.1% TopicalGel to Canada.ADDRESSES: Relevant information onthis application may be directed to theDockets Management Branch (HFA–305), Food and Drug Administration,12420 Parklawn Dr., rm. 1–23,Rockville, MD 20857, and to the contactperson identified below. Any futureinquiries concerning the export ofhuman drugs under the Drug ExportAmendments Act of 1986 should also bedirected to the contact person.FOR FURTHER INFORMATION CONTACT:James E. Hamilton, Center for DrugEvaluation and Research (HFD–310),Food and Drug Administration, 7520

Standish Pl., Rockville, MD 20855, 301–594–3150.SUPPLEMENTARY INFORMATION: The drugexport provisions in section 802 of theFederal Food, Drug, and Cosmetic Act(the act) (21 U.S.C. 382) provide thatFDA may approve applications for theexport of drugs that are not currentlyapproved in the United States. Section802(b)(3)(B) of the act sets forth therequirements that must be met in anapplication for approval. Section802(b)(3)(C) of the act requires that theagency review the application within 30days of its filing to determine whetherthe requirements of section 802(b)(3)(B)have been satisfied. Section 802(b)(3)(A)of the act requires that the agencypublish a notice in the Federal Registerwithin 10 days of the filing of anapplication for export to facilitate publicparticipation in its review of theapplication. To meet this requirement,the agency is providing notice thatGalderma Laboratories, Inc., 3000 AltaMesa Blvd., Forth Worth, TX 76133, hasfiled an application requesting approvalfor the export of the human drugDifferinTM (Adapalene) 0.1% TopicalGel to Canada. This product is indicatedfor the topical treatment of acnevulgaris. The application was receivedand filed in the Center for DrugEvaluation and Research on October 16,1995, which shall be considered thefiling date for purposes of the act.

Interested persons may submitrelevant information on the applicationto the Dockets Management Branch(address above) in two copies (exceptthat individuals may submit singlecopies) and identified with the docketnumber found in brackets in theheading of this document. Thesesubmissions may be seen in the DocketsManagement Branch between 9 a.m. and4 p.m., Monday through Friday.

The agency encourages any personwho submits relevant information onthe application to do so by May 3, 1996,and to provide an additional copy of thesubmission directly to the contactperson identified above, to facilitateconsideration of the information duringthe 30-day review period.




Drug Export; DifferinTM (Adapalene)0.1% Topical Gel


SUMMARY: The Food and DrugAdministration (FDA) is announcingthat Galderma Laboratories, Inc., hasfiled an application requesting approvalfor the export of the human drugDifferinTM (Adapalene) 0.1% TopicalGel to Canada.ADDRESSES: Relevant information onthis application may be directed to theDockets Management Branch (HFA–305), Food and Drug Administration,12420 Parklawn Dr., rm. 1–23,Rockville, MD 20857, and to the contactperson identified below. Any futureinquiries concerning the export ofhuman drugs under the Drug ExportAmendments Act of 1986 should also bedirected to the contract person.FOR FURTHER INFORMATION CONTACT:James E. Hamilton, Center for DrugEvaluation and Research (HFD–310),Food and Drug Administration, 7520Standish Pl., Rockville, MD 20855, 301–594–3150.SUPPLEMENTARY INFORMATION: The drugexport provisions in section 802 of theFederal Food, Drug, and Cosmetic Act(the act) (21 U.S.C. 382) provide thatFDA may approve applications for theexport of drugs that are not currentlyapproved in the United States. Section802(b)(3)(B) of the act sets forth therequirements that must be met in anapplication for approval. Section802(b)(3)(C) of the act requires that theagency review the application within 30days of its filing to determine whetherthe requirements of section 802(b)(3)(B)have been satisfied. Section 802(b)(3)(A)of the act requires that the agencypublish a notice in the Federal Registerwithin 10 days of the filing of anapplication for export to facilitate publicparticipation in its review of theapplication. To meet this requirement,the agency is providing notice thatGalderma Laboratories, Inc., 3000 AltaMesa Blvd., Forth Worth, TX 76133, hasfiled an application requesting approvalfor the export of the human drugDifferinTM (Adapalene) 0.1% TopicalGel to Canada. This product is indicatedfor the topical treatment of acnevulgaris. The application was receivedand filed in the Center for DrugEvaluation and Research on October 16,1995, which shall be considered thefiling date for purposes of the act.

Interested persons may submitrelevant information on the application


to the Dockets Management Branch(address above) in two copies (exceptthat individuals may submit singlecopies) and identified with the docketnumber found in brackets in theheading of this document. Thesesubmissions may be seen in the DocketsManagement Branch between 9 a.m. and4 p.m., Monday through Friday.

The agency encourages any personwho submits relevant information onthe application to do so by May 3, 1996,and to provide an additional copy of thesubmission directly to the contractperson identified above, to facilitateconsideration of the information duringthe 30-day review period.



Indian Health Service

Proposed Information CollectionActivities Available for PublicComment and Recommendations

In accordance with Section3506(c)(2)(A) of the Paperwork

Reduction Act of 1995, the IndianHealth Service (IHS) is requestingpublic comment on the followingproposed agency information collectionactivities. Your comments are invitedon: (a) Whether the informationcollection activity is necessary to carryout an agency function and whether theIHS processes the information collectedin a useful and timely fashion; (b) theaccuracy of the public burden estimate(this is the amount of time needed forindividual respondents to provide therequested information) and themethodology and assumptions used todetermine the estimate; (c) ways toenhance the quality, utility, and clarityof the information being collected; and(d) ways to minimize the public burdenthrough the use of automated,electronic, mechanical, or othertechnological collection techniques orother forms of information technology.

Proposed Activity #1: The IHSContract Health Service (CHS) seeks (A)approval for a 1 year reinstatement withno change of previously approvedinformation collection activity, 0917–0002, ‘‘Indian Health Service, Hospital,Dental and Other Contract HealthService Reports’’; and (B) a 1 yearapproval for a new CHS form (IHS–843–1A, ‘‘Purchase-Delivery Order for HealthServices’’) which is currently being pilottested and is expected to be completedby September 1996.

The 1 year reinstatement of thecurrent CHS forms and the 1 yearapproval of the new form will provide

for a transition and implementationperiod for the new form and will allowthe IHS to provide education andtraining in the use of the new singleform; make any necessary adjustmentsin the protocol for the use of the newsingle form; and, make computerprogramming corrections as may beneeded during the implementationperiod. The IHS-wide implementationof the new form is expected to becompleted by the end of fiscal year1997.

The new streamlined, user friendlyCHS form IHS–843–1A combines thethree current CHS forms (the IHS 43–1Aused for hospital inpatient services, theIHS–57–1A used for dental services,and, the IHS–64–1A used for health careservices other than hospital inpatient ordental) into one single form whichreduces public response burden. TheCHS forms are completed by CHSProviders and used to certify that thehealth care services request andauthorized by the IHS have beenperformed by the CHS provider(s);process payments for health careservices performed by such providers;and serve as a legal document for healthand medical care authorized by the IHSand rendered by health care providersunder contract with the IHS. Theburden estimate for this informationcollection activity follows:

Information collection activity Number ofrespondents

Responsesper

respondent

Average burdenper response

(hours)*

IHS–43–1A .................................................................................................................................... 580 148 0.17 (10 mins).IHS–57–1A .................................................................................................................................... 532 22 0.42 (25 mins).IHS–64–1A .................................................................................................................................... 7,688 32 0.17 (10 mins).New form: IHS–843–1A ................................................................................................................ 13.215 41 0.05 (3 mins).Inpatient Discharge Summary ...................................................................................................... 85,988 1 1.37 (82 mins).

* Burden estimate is based on data provided by the IHS Fiscal Intermediary (FI) contractor and feedback from CHS Providers (respondents)who have completed the forms (current or new) for at least one year. For FY–1994, the FI processed approximately 360,000 forms for some8,800 respondents; and, the IHS CHS staff processed approximately 180,000 forms for some 4,400 respondents. The number of responses perrespondent is based on the average number of forms processed for each Provider.

The inpatient discharge summary was overlooked as an information collection activity in prior approval requests and is added accordingly.

Proposed Activity #2: The IHS LoanRepayment Program (LRP) seeks a 3 yearapproval for reinstatement with minorchange of previously approvedinformation collection activity, 0917–0014, ‘‘Indian Health Service LoanRepayment Program’’. The IHS LRPrecruits highly qualified health careprofessionals to meet agency health carestaffing needs. The informationcollection forms used for this activityare contained in the IHS LRPInformation and Application Booklet.

The booklet provides an overview of theLRP, instructions regarding applicationprocedures and potential employmentopportunities, and tear-out applicationforms. The application form collects thefollowing data from each applicant:Name, address, work and hometelephone numbers, education anddegree(s) obtained, work experience,and an accounting of financial (tuition)loans to be considered for payback. Theinstructions and forms contained in theLRP information and application

booklet were updated, revised andclarified to improve applicantunderstanding and ease the responseburden. The information collected isused to verify and evaluate applicationsto determine eligibility for the IHS LRP;award and authorize applicantpayments; and, provide statisticalprogram data. The burden estimate forthis information collection activityfollows:


Information collection activity Number ofrespondents

Responsesper

respondent

Average burden/re-sponse (hours)*

Section I ........................................................................................................................................ 350 1 0.25 (15 mins).Section II ....................................................................................................................................... 350 1 0.50 (30 mins).Section III ...................................................................................................................................... 350 4 0.25 (15 mins).Contract ........................................................................................................................................ 350 1 0.34 (20 mins).Affidavit ......................................................................................................................................... 350 1 0.17 (10 mins).Lender Cert ................................................................................................................................... 1400 1 0.25 (15 mins).

* Burden estimate is based on feedback from applicants or lenders who have completed these forms over the past year.

To request more information on anyof the proposed information collectionactivities or to obtain a copy of thecollection of information form(s) and/orinstructions, you may call the IHSReports Clearance Officer on (301) 443–0461. This is not a toll free number.Please send your written commentsregarding any or all of the proposedinformation collection activities to Mr.Lance Hodahkwen, Sr., IHS ReportsClearance Officer, 12300 TwinbrookParkway, Suite 450, Rockville, MD20857. Comments may also be sent viafacsimile to: (301) 443–1522, or Internet:[email protected]. Writtencomments should be received within 60days of this notice.

Dated: April 16, 1996,Michael H. Trujillo,Assistant Surgeon General, Director.[FR Doc. 96–9871 Filed 4–22–96; 8:45 am]BILLING CODE 4160–16–M

National Institutes of Health

National Heart, Lung, and BloodInstitute; Notice of a Closed Meeting

Pursuant to Section 10(d) of theFederal Advisory Committee Act, asamended (5 U.S.C. Appendix 2), noticeis hereby given of the following Heart,Lung, and Blood Special EmphasisPanel (SEP) meeting:

Name of SEP: Growth and Differentiationof Smooth Muscle Cells.

Date: May 22–23, 1996.Time: 8:30 p.m.Place: Holiday Inn Bethesda, 8120

Wisconsin Avenue, Bethesda, Maryland.Contact Person: Louis M. Ouellette, Ph.D.,

Two Rockledge Center, Room 7216, 6701Rockledge Drive, Bethesda, MD 20892–7924(301) 435–0310.

Purpose/Agenda: To review and evaluategrant applications.

The meeting will be closed in accordancewith the provisions set forth in sections552b(c)(4) and 552b(c)(6), Title 5, U.S.C.Applications and/or proposals and thediscussions could reveal confidential tradesecrets or commercial property such aspatentable material and personal informationconcerning individuals associated with theapplications and/or proposals, the disclosure

of which would constitute a clearlyunwarranted invasion of personal privacy.(Catalog of Federal Domestic AssistancePrograms Nos. 93.837, Heart and VascularDiseases Research; 93.838, Lung DiseasesResearch; and 93.839, Blood Diseases andResources Research, National Institutes ofHealth)

Dated: April 17, 1996.Susan K. Feldman,Committee Management Officer, NIH.[FR Doc. 96–9952 Filed 4–22–96; 8:45 am]BILLING CODE 4140–01–M

National Heart, Lung, and BloodInstitute; Notice of Meetings

Pursuant to Public Law 92–463,notice is hereby given of the meetings ofthe following Heart, Lung, and BloodSpecial Emphasis Panels.

These meetings will be open to thepublic to provide concept review ofproposed contract or grant solicitations.

Individuals who plan to attend andneed special assistance, such as signlanguage interpretation or otherreasonable accommodations, shouldinform the Contact Person listed belowin advance of the meeting.

Name of Panel: Cardiovascular DiseaseCommunity Surveillance.

Dates of Meeting: May 7, 1996.Time of Meeting: 8:00 a.m.Place of Meeting: Two Rockledge Center,

Room 7111 6701 Rockledge Drive, Bethesda,MD.

Agenda: To provide concept review forcardiovascular disease communitysurveillance.

Contact Person: Lawton S. Cooper, M.D.,M.P.H., NIH/NHLBI/DECA, Rockledge CenterTwo, Room 8166, 6701 Rockledge Drive,Bethesda, Maryland 20892–7934, (301) 435–0444.

Name of Panel: Heart Failure Research.Dates of Meeting: May 20, 1996.Time of Meeting: 8:00 a.m.Place of Meeting: Two Rockledge Center,

Conference Room 9B1 6701 Rockledge Drive,Bethesda, MD.

Agenda: Prioritize needs and futuredirections for research to advanceunderstanding, prevention, and treatment ofheart failure.

Contact Person: Leslie Reinlib, Ph.D., NIH/NHLBI/DHVD, Rockledge Center Two, Rm.9188, 6701 Rockledge Drive, Bethesda,Maryland 20892–7940, (301) 435–0504.

(Catalog of Federal Domestic AssistancePrograms Nos. 93.837, Heart and VascularDiseases Research; 93.838, Lung DiseasesResearch; and 93.839, Blood Diseases andResources Research, National Institute ofHealth)


National Institute of Dental Research;Notice of Closed Meetings

Pursuant to Section 10(d) of theFederal Advisory Committee Act, asamended (5 U.S.C. Appendix 2), noticeis hereby given of the followingNational Institute of Dental ResearchSpecial Emphasis Panel (SEP) meetings:

Name of SEP: National Institute of DentalResearch Special Emphasis Panel-Review ofRO3 grants 96–22.

Dates: May 16, 1996.Time: 12:00 pm.Place: Natcher Building, Rm. 4AN–44F,

National Institutes of Health, Bethesda, MD20892, (teleconference).

Contact person: Dr. George Hausch, Chief,Grants Review Section, 4500 Center Drive,Natcher Building, Room 4AN–44F, Bethesda,MD 20892, (301) 594–2372.

Purpose/Agenda: To evaluate and reviewgrant applications and/or contract proposals.

Name of SEP: National Institute of DentalResearch Special Emphasis Panel-Review ofRO3 grants 96–23.

Dates: May 17, 1996.Time: 3:00 pm.Place: Natcher Building, Rm. 4AN–44F,

National Institutes of Health, Bethesda, MD20892, (teleconference).

Contact person: Dr. George Hausch, Chief,Grants Review Section, 4500 Center Drive,Natcher Building, Room 4AN–44F, Bethesda,MD 20892, (301) 594–2372.

Purpose/Agenda: To evaluate and reviewgrant applications and/or contract proposals.

The meetings will be closed in accordancewith the provisions set forth in secs.552b(c)(4) and 552b(c)(6), Title 5, U.S.C.Applications and/or proposals and thediscussions could reveal confidential tradesecrets or commercial property such aspatentable material and personal informationconcerning individuals associated with theapplications and/or proposals, the disclosure


of which would constitute a clearlyunwarranted invasion of personal privacy.(Catalog of Federal Domestic AssistanceProgram No. 93.121, Oral Diseases andDisorders Research)


Division of Research Grants; Notice ofMeeting of the Division of ResearchGrants Advisory Committee

Pursuant to Public Law 92–463,notice is hereby given of the meeting ofthe Division of Research GrantsAdvisory Committee, May 20–21, 1996,Natcher Building (Building 45)Conference Room F, National Institutesof Health, Bethesda, Maryland 20892.

The entire meeting will be open to thepublic from 8:30 a.m. on May 20 toadjournment on May 21. The meetingwill include, among other topics, adiscussion of some recent experiencesand experiments in streamlining the

peer review system. Attendance by thepublic will be limited to space available.

The Office of CommitteeManagement, Division of ResearchGrants, Rockledge 2 Building, Suite3016, National Institutes of Health,Bethesda, Maryland 20892–7778,telephone (301) 435–1124, will furnisha summary of the meeting and a rosterof the committee members.

Dr. Samuel Joseloff, ExecutiveSecretary of the Committee, Rockledge 2Building, Suite 3176, National Institutesof Health, Bethesda, Maryland 20892–7762, phone (301) 435–0691, willprovide substantive programinformation upon request.

Individuals who plan to attend andneed special assistance, such as signlanguage interpretation or otherreasonable accommodations, shouldcontact the Executive Secretary at leasttwo weeks in advance of the meeting.


Substance Abuse and Mental HealthServices Administration

Agency Information CollectionActivities; Submission for OMBReview, Comment Request

Periodically, the Substance Abuse andMental Health Services Administration(SAMHSA) will publish a list ofinformation collection requests underOMB review, in compliance with thePaperwork Reduction Act (44 U.S.C.Chapter 35). To request a copy of thesedocuments, call the SAMHSA ReportsClearance Officer on (301) 443–0525.

Substance Abuse Prevention andTreatment Block Grant—45 CFR Part96—Extension of a currently approvedcollection—This interim final ruleprovides guidance to States regardingthe Substance Abuse Prevention andTreatment Block Grant legislation. Therule implements the reporting andrecordkeeping requirements of 42 U.S.C.300x 21–35 & 51–64 by specifying thecontent of the The annual reporting andrecordkeeping burden estimate is shownbelow:

REPORTING BURDEN

Section Number ofrespondents

Number ofresponsesper year

Numberhours perresponse

Total hours

Standard Form and Content:96.122(c)

Annual Report:96.122(f) .................................................................................................................... 60 1 152 9,12096.134(d) ................................................................................................................... 60 1 16 960

State Plan:96.122(g) ................................................................................................................... 60 1 162 9,72096.124(c)(1) ............................................................................................................... 60 1 40 2,40096.127(b) ................................................................................................................... 60 1 8 48096.131(f) .................................................................................................................... 60 .................... 8 48096.133(a) ................................................................................................................... 60 1 80 4,800

Waivers:96.132(d)* .................................................................................................................. 60 1 16 96096.134(b)* .................................................................................................................. 60 1 40 2,40096.135(d)* .................................................................................................................. 60 1 8 480

Total ....................................................................................................................... 60 1 530 ** 31,800

* For the purpose of calculating burden in this OMB submission, it is assumed that all States would apply for each waiver. In reality it expectedthat only a small number would apply.

** This is the burden for the annual application for the Substance Abuse Prevention and Treatment Block Grant, not including the reporting bur-den associated with the Tobacco Regulation for the Substance Abuse and Treatment Block Grants Final Rule. OMB approval for the actual ap-plication is under control number 0930–0080.

RECORDKEEPING BURDEN—45 CFR 96

SectionNumber of

record-keepers

Numberhours per

respondentTotal hours

96.129(a)(13) ............................................................................................................................................ 60 16 960

Total ............................................................................................................................................... 60 16 960


TOTAL COMBINED BURDEN—45 CFR 96

No. hoursper re-

spondenttotal hours

546 32,760

Written comments andrecommendations concerning theproposed information collection shouldbe sent within 30 days of this notice to:Virginia Huth, Human Resources andHousing Branch, Office of Managementand Budget, New Executive OfficeBuilding, Room 10236, Washington,D.C. 20503.

Dated: April 15, 1996.Richard Kopanda,Executive Officer, SAMHSA.[FR Doc. 96–9935 Filed 4–22–96; 8:45 am]BILLING CODE 4162–20–P

DEPARTMENT OF HOUSING ANDURBAN DEVELOPMENT

[Docket No. FR–4049–N–02]

Office of Lead-Based Paint Abatementand Poisoning Prevention; Notice ofProposed Information Collection forPublic Comment Submission for OMBReview: Comment Request

AGENCY: Office of Lead-Based PaintAbatement and Poisoning Prevention,HUD.ACTION: Notice for emergencyprocessing.

SUMMARY: The proposed informationcollection requirement described belowhas been submitted to the Office ofManagement and Budget (OMB) foremergency processing, as required bythe Paperwork Reduction Act. TheDepartment is soliciting publiccomments on the subject proposal.

DATES: Comments due date: April 30,1996.ADDRESSES: Interested persons areinvited to submit comments regardingthis proposal. Comments must bereceived within seven days from thedate of this Notice. Comments shouldrefer to the proposal by name and/orOMB Control Number (2539–0005) andshould be sent to: Joseph F. Lackey, Jr.,OMB Desk Officer, Office ofManagement and Budget, Room 10235,New Executive Office Building,Washington, D.C., 20503.FOR FURTHER INFORMATION CONTACT:Kay Weaver, Reports ManagementOfficer, Department of Housing andUrban Development, 451 7th St., SW.,Washington, DC 20410, Tel. (202) 708–0050.

This is not a toll-free number. Copiesof the proposed forms and/or otheravailable documents submitted to OMBmay be obtained from Ms. Weaver.SUPPLEMENTARY INFORMATION: TheDepartment is submitting the proposedinformation collection to OMB foremergency processing, as required bythe Paperwork Reduction Act of 1995(44 U.S.C., Chapter 35, as amended.)April 25, 1996 is the requested date forOMB approval.

This Notice is soliciting commentsfrom members of the public and affectedagencies concerning the proposedcollection of information to:

(1) evaluate whether the proposedcollection of information is necessaryfor the proper performance of thefunctions of the agency, including

whether the information will havepractical utility;

(2) evaluate the accuracy of theagency’s estimate of the burden of theproposed collection of information;

(3) enhance the quality, utility, andclarity of the information to becollected; and

(4) minimize the burden of thecollection of information on those whoare to respond, including through theuse of appropriate automated collectiontechniques or other forms of informationtechnology, e.g., permitting electronicsubmission of responses.

This Notice also lists the followinginformation:

Title of Proposal: Notice of FundingAvailability for 1996—HUD’s GrantProgram for Lead-Based Paint HazardReduction in Priority Housing (FR–4049).

Description of the Need for theInformation and Proposed Use: Thisinformation collection is required inconnection with the anticipatedissuance of a Notice of FundingAvailability that will announce theavailability of $50 million for grants forlead-based paint hazard reduction inprivate priority housing, pursuant toTitle X of the Housing and CommunityDevelopment Act of 1992.

Form Number: None.Members of Affected Public: State and

local governments.Estimation of the Total Number of

Hours Needed to Prepare theInformation Collection includingNumber of Respondents, Frequency ofResponse, and Hours of Response:

Number ofrespondents × Frequency of

responses = Hours perresponse = Burden

hours

Application Development ....................................................................... 75 1 120 9,000

Total Estimated Burden Hours: 9,000.Status of the Proposed Information

Collection: Emergency Processing.

Authority: Section 3506 of the PaperworkReduction Act of 1995, 44 U.S.C., Chapter 35,as amended.

Dated: April 17, 1996.David S. Cristy,Director, IRM Policy and ManagementDivision.[FR Doc. 96–9968 Filed 4–22–96; 8:45 am]BILLING CODE 4210–01–M

[Docket Nos. FR–4005–N–02; FR–4014–N–02; FR–3961–N–04; FR–4042–N–02]

Office of the Assistant Secretary forCommunity Planning andDevelopment; Supplemental NoticeConcerning Notices of FundingAvailability

AGENCY: Office of the AssistantSecretary for Community Planning andDevelopment, HUD.


ACTION: Supplemental and AmendatoryNotice Concerning Notices of FundingAvailability (NOFAs) of the Office ofCommunity Planning and Development:NOFA for the Youthbuild Program,NOFA for the Historically BlackColleges and Universities Program,NOFA for the Early ChildhoodDevelopment Program, and NOFA forContinuum of Care HomelessAssistance.

SUMMARY: This notice advises ofadditional information and amendmentsconcerning the Department’s NOFAsissued to date by the Office ofCommunity Planning and Development.The additional information andamendments relate to the submission ofapplications in response to the NOFAs;the review, rating, and selection of theseapplications; and the funding availableunder the NOFAs.DATES: For the Historically BlackColleges and Universities (HBCU)NOFA: For the HBCU NOFA, publishedin the Federal Register on March 7,1996 (61 FR 9258), completedapplications are due before midnighteastern time on July 11, 1996.

For the Continuum of Care HomelessAssistance NOFA: For the Continuum ofCare Homeless Assistance NOFA,published in the Federal Register onMarch 15, 1996 (61 FR 10866),applications that are mailed before June12, 1996, but received within ten (10)days after that date, will be deemed tohave been received by that date ifpostmarked by the United States PostalService by no later than June 11, 1996.

All other application due dates andany other dates, if applicable, remain asset forth in the individual NOFAs, or asset forth in any extension notices, thatthe Department has published.FOR FURTHER INFORMATION CONTACT:Applicants should contact theindividual or office listed in the ‘‘ForFurther Information Contact’’ section ofthe individual NOFAs for which theapplicant has a question. Hearing- orspeech-impaired persons may access thetelephone numbers via TTY by callingthe Federal Information Relay Service at1–800–877–8339.


NOFA for the Youthbuild ProgramThe Department published the Notice

of Funding Availability (NOFA) for theYouthbuild Program in the FederalRegister on March 4, 1996 (61 FR 8442).This notice advises the public that theNOFA for the Youthbuild Program isamended in the following ways:

1. The Department is amending theNOFA for the Youthbuild Program to

include the following language: ‘‘TheDepartment may establish panelsincluding persons not currentlyemployed by the Department to obtaincertain expertise and outside points ofview, including views from otherFederal agencies.’’

2. The Department is amending theNOFA for the Youthbuild Programregarding the estimated amount of fundsavailable. The March 4, 1996 NOFAannounced the expected availability of$37.5 million for Fiscal Year (FY) 1996.However, this notice amends that NOFAto announce the availability ofapproximately $20 million for FY 1996under the Youthbuild Program.

NOFA for the Historically BlackColleges and Universities Program

The Department published the NOFAfor the Historically Black Colleges andUniversities (HBCU) Program in theFederal Register on March 7, 1996 (61FR 9258). This notice advises the publicthat the NOFA for the HBCU Program isamended in the following ways:

1. The Department is amending theNOFA for the Historically BlackColleges and Universities Program toinclude the following language: ‘‘TheDepartment may establish panelsincluding persons not currentlyemployed by the Department to obtaincertain expertise and outside points ofview, including views from otherFederal agencies.’’

2. The Department is changing thesubmission deadline for applicationsunder the Historically Black Collegesand Universities Program. The March 7,1996 NOFA announced an applicationsubmission deadline of May 23, 1996.However, this notice extends thedeadline for applications under thisNOFA to be July 11, 1996.

NOFA for the Early ChildhoodDevelopment Program

The Department published the NOFAfor the Early Childhood DevelopmentProgram in the Federal Register onMarch 28, 1996 (61 FR 13950). Thisnotice advises the public that the NOFAfor the Early Childhood DevelopmentProgram is amended to include thefollowing language: ‘‘The Departmentmay establish panels including personsnot currently employed by theDepartment to obtain certain expertiseand outside points of view, includingviews from other Federal agencies.’’

NOFA for Continuum of Care HomelessAssistance

The Department published the NOFAfor Continuum of Care HomelessAssistance in the Federal Register onMarch 15, 1996 (61 FR 10866). This

notice advises the public that the NOFAfor Continuum of Care HomelessAssistance is amended in the followingways:

1. The Department is changing theapplication submission information forthe Continuum of Care HomelessAssistance NOFA in order to make thedeadline for using the Postal Service thesame as the deadline for using anovernight delivery service.

On page 10873 of the NOFA, in thefirst column, this notice amends the firstsentence of the paragraph under theheading ‘‘Submissions’’ to provide that:‘‘Applications that are mailed beforeJune 12, 1996, but received within ten(10) days after that date will be deemedto have been received by that date ifpostmarked by the United States PostalService by no later than June 11, 1996.’’

2. This notice also providesinformation on additional selectionconsiderations under the NOFA forContinuum of Care Homeless Assistance(61 FR 10866). These considerations arebased on statutorily required fundinglimitations, and are described in sectionIII.(a)(7) of the NOFA (61 FR 10870).

On page 10871, in the first column, insection III.(a)(7), under the heading‘‘Additional selection considerations’’,the first two paragraphs are corrected toread as follows:

In accordance with section 455(b) of theMcKinney Act, no more than 10 percent ofthe assistance made available for Shelter PlusCare in any fiscal year may be used forprograms located within any one unit ofgeneral local government.

In accordance with section 441(c) of theMcKinney Act, no city or urban county mayhave Section 8 SRO projects receiving a totalof more than 10 percent of the assistancemade available under this program.

On page 10871, in the first column, insection III.(a)(7), under the heading‘‘Additional selection consideration’’,new paragraph is added after the secondparagraph, to read as follows:

This year’s NOFA does not set-asidespecific amounts to be awarded under theShelter Plus Care, Supportive Housing or theSection 8/SRO Moderate Rehabilitationprograms. Instead, the distribution will bedemand-driven. However, potentialapplicants need to be able to plan for theirproject proposals. Therefore, in accordancewith the requirements of section 455(b) andsection 441(c) of the McKinney Act,restricting awards to any one unit of generallocal government (for purposes of Shelterplus Care) or city or urban county (forpurposes of the SRO program) in any fiscalyear to no more than 10 percent of theassistance made available under each of thesetwo programs, HUD is defining 10 percentthis fiscal year as $10 million for each ofthese two programs. This $10 million numberis based on past experience of thedistribution of the total funds made available


for HUD homeless assistance programs.However, if the amount awarded under eitherof these two programs exceeds $100 million,then the amount awarded to any one unit ofgeneral local government (for purposes of theShelter Plus Care program) and or city orurban county (for the purposes of the SROprogram) may not exceed 10 percent of theactual total amount awarded for thatprogram.

In addition, if the Administration budgetrequest is enacted as the final appropriationas referred to earlier in the NOFA, the 10%number for each of the 2 programs wouldincrease proportionately.

Dated: April 18, 1996.Mark C. Gordon,General Deputy Assistant Secretary forCommunity Planning and Development.[FR Doc. 96–9969 Filed 4–18–96; 3:03 pm]BILLING CODE 4210–29–P



Tribal Self-Governance Notice ofAvailability of Self-GovernanceNegotiation/Planning Grants

AGENCY: Office of Self-Governance,Office of the Secretary, Interior.ACTION: Notice.

SUMMARY: In this notice, the Office ofSelf-Governance (OSG) announces theavailability of fiscal year 1996 (1)negotiation grants (up to 20 grants of$40,000 each); (2) advance planninggrants (up to 10 grants of $50,000 each);and (3) negotiation/planning grants tonegotiate for DOI non-BIA programs (upto 10 grants of no more than $40,000each). The timeframes for applicationand selection vary with each type ofgrant and are specified in thisannouncement.DATES: Applications must be submittedin accordance with the table below:

Type of grantDeadline forsubmittingapplication

Negotiation ........................... May 10, 1996.Advance Planning ................ July 31, 1996.Negotiation/Planning ............ May 15. 1996.

ADDRESSES: Completed applications forgrants should be sent to the Director,Office of Self-Governance, U.S.Department of the Interior, Mail Stop2548, 1849 C Street NW, Washington DC20240.FOR FURTHER INFORMATION CONTACT:Dr. Kenneth D. Reinfeld, U.S.Department of the Interior, Office ofSelf-Governance, 1849 C Street NW,Mail Stop 2548, Washington DC 20240,202–219–0240.

SUPPLEMENTARY INFORMATION: The tribalself-governance program is designed topromote self determination by allowingtribes to assume more control throughnegotiated agreements of programsoperated by the Department of theInterior. The new law allows fornegotiations to be conducted forprograms operated by BIA and forprograms operated by other bureaus andoffices within the Department that areavailable to Indians or when there is anhistorical cultural, or geographicconnection to an Indian tribe.

One of the criteria for entry into self-governance negotiations is thecompletion of a self-governanceplanning activity. For this purpose, theCongress has provided funding forplanning and negotiation grants.

The purpose of this notice is toannounce the availability of planningand negotiation grants in accordancewith the self-governance interim rulepublished elsewhere in today’s FederalRegister.

The following types of grants areavailable to tribes in 1996 with thedeadlines as stated below:

(1) Negotiation Grants: Up to 20grants of $40,000 are available. Asannounced in the Federal Register onFebruary 1, 1996, the closing date forsubmitting completed applications tobegin participation in tribal self-governance in fiscal year 1996 orcalendar year 1996 is April 29, 1996.Applications requesting to be includedin the applicant pool to beginparticipation in tribal self-governancemay be submitted at any time. Subjectto the availability of funds, all tribes/consortia selected from the applicantpool to begin participation in tribal self-governance in fiscal year 1996 orcalendar year 1997, will be eligible toreceive a negotiation grant. Selectedtribes/consortia will be notified by May3, 1996, an must submit writtenapplications for a negotiation grant nolater than May 10, 1996, by indicatingtheir intention to negotiate and annualfunding agreement with any bureauwithin DOI for 1997.

(2) Advance Planning Grants: Up to10 grants of $50,000 are available. Theclosing date for submitting applicationsto receive a grant to plan for futureparticipation in the tribal self-governance program is July 31, 1996.

(3) Negotiation/Planning Grants toNegotiate Non-BIA Programs: Up to 10grants of no more than $40,000 areavailable. The closing date forsubmitting applications to receive anegotiation/planning grant for existingself-governance tribes to negotiate forDOI non-BIA programs is May 15, 1996.

In order to provide sufficient time fortribes to effectively use the planningand negotiation grants, the followingdates have been identified for theawarding of grants:

(1) Negotiation Grants: Sinceagreements for the 1997 fiscal year needto be signed and submitted by July 1,1996, to allow sufficient time to preparefor negotiations, new participating tribeswill be selected and awardednegotiation grants by May 15, 1996.

(2) Advance Planning Grants: In orderto avoid delays in planning activity andfuture participation in tribal self-governance, advance planning grantsmust be awarded to tribes/consortia byAugust 30, 1996.

(3) Negotiation/Planning Grants toNegotiate Non-BIA Programs: Sinceagreements for the 1997 fiscal year needto be signed and submitted by July 1,1996, to allow sufficient time to preparefor negotiation of DOI non-BIAprograms, negotiation/planning grantsfor existing self-governance tribes tonegotiate non-BIA programs must beawarded by May 22, 1996.

Submitting Applications(1) Applications must be submitted in

accordance with the interim rulepublished elsewhere today in theFederal Register and by the deadlinesidentified in this announcement.

(2) Applications may be mailed orhand-delivered.

(3) Applications which are mailedmust be postmarked no later than thedate given in this notice for theparticular type of grant being appliedfor.

Dated: April 4, 1996.Ada E. Deer,Assistant Secretary—Indian Affairs.[FR Doc. 96–9739 Filed 4–22–96; 8:45 am]BILLING CODE 4310–02–M

Bureau of Land Management

[UT–020–03–1430–01; U–72442]

Salt Lake District, Temporary Closureof Lands

AGENCY: Bureau of Land Management,Interior.ACTION: Temporary closure of lands tomotorized vehicles in Tooele County,Utah.

SUMMARY: Notice is hereby given thatunder the provisions of 43 CFR 8364.1the public lands listed below are herebyclosed to motorized vehicles for aperiod not to exceed 5 years from thedate this notice is published. Thistemporary closure affects all publiclands within the following description:


Salt Lake MeridianT. 2 S., R. 3 W.,

Sections 5, 7, 8, 16, 17, 20, 21, 28–34inclusive;

T. 2 S., R. 4 W.,Section 1, E1⁄2SE1⁄4;Section 12, E1⁄2E1⁄2;Tract 37;

T. 3 S., R. 3 W.,Sections 4–9 inclusive.

T. 3 S., R. 4 W.,Section 1;Section 11, 12.Containing 15,553 acres more or less.

T. 2 S., R. 6 W.,Sections 19, 20, 21, 29, 30;

T. 2 S., R. 7 W.,Sections 24, 25, 26.Containing 1,235 acres more or less.

T. 9 S., R. 3 W.,Sections 5, 8, 9.Containing 987 acres more or less.

This closure order does not restrictuse by the Bureau of Land Managementand their grazing permittees ormaintenance crews from the followingorganizations:Utah Power and Light CompanyLincoln Water Users Association

The Bureau of Land Management hasrecently acquired the above describedlands through land exchange withprivate parties. Detailed land useplanning for these lands are not coveredunder the existing Pony ExpressResource Management Plan of 1990. Thelands contain important wildlife habitat,watershed, and safety hazards relatingto historic mining activity. The closureis necessary to protect the public andthe resources that exist on these landsuntil the BLM Salt Lake District hasdeveloped and implemented land useplanning for these areas and hasmitigated the safety concerns that exist.FOR FURTHER INFORMATION CONTACT:Michael Nelson, BLM Salt Lake DistrictOffice, (801) 977–4300.

Dated: April 10, 1996.Joseph L. Jewkes,Acting Salt Lake District Manager.[FR Doc. 96–9878 Filed 4–22–96; 8:45 am]BILLING CODE 4310–DQ–M

[ES–030–06–1310–01]

Notice of Intent To Prepare a PlanningAnalysis/Environmental Assessmentfor the Leasing of Federal Minerals

AGENCY: Bureau of Land Management,Interior.ACTION: Notice of intent.

SUMMARY: The Milwaukee DistrictOffice, Eastern States, in cooperationwith the U.S. Army Corps of Engineers(COE), Pittsburgh District, will prepare

a Planning Analysis/EnvironmentalAssessment (PA/EA) to assist in thedecision-making process related to theleasing of Federal oil and gas resourcesadministered by the Bureau of LandManagement (BLM) at the COEMosquito Creek Lake (MCL) Project,Trumbull County, Ohio. In addition tothose Federal oil and gas resourcesfound within the COE administrativeboundary, 32.46 acres of Federal oil andgas rights are located under one non-COE tract located in the southwesterncorner adjacent to the MCL Project. Thistract is owned by the Lakeview LocalSchool District.

This notice is issued pursuant to Title43 CFR 1610.8(b) and 1610.2(c). ThePA/EA will follow the procedures setforth in 43 CFR 1610.5–5.

The public is invited to review andprovide comments on issues, concernsand related agency resource objectivesas outlined in this notice, or identifyadditional issues or concerns, ifappropriate.DATES: Comments relating to issues,concerns, and agency resourceobjectives will be accepted through May23, 1996.ADDRESSES: Comments and requests tobe included on the mailing list for thisproject should be sent to: Bureau ofLand Management, Milwaukee District,P.O. Box 631, Milwaukee, WI 53201–0631.FOR FURTHER INFORMATION CONTACT: Ms.Terry Saarela, PA/EA Team Leader,Milwaukee District, (414) 297–4437.SUPPLEMENTARY INFORMATION: MosquitoCreek Lake is located on Mosquito Creekin Trumbull County, northeastern Ohioabout 4.5 miles north-northeast of theCity of Warren and 14 miles north-northwest of the City of Youngstown.The majority of the COE administeredproperty is either leased or licensed tothe Ohio Department of NaturalResources (ODNR) and managed forparks/recreation and wildlife purposes(of the 11,180.62 acres owned in fee,5,635 acres are leased to the ODNRDivision of Parks and Recreation and5,370 acres are licensed to the ODNRDivision of Wildife).

There are public-use sites scatteredaround the lake.

The PA/EA will aid in makingdecisions related to the leasing of theFederal oil and gas resources in thevicinity of the MCL Project. Decisionsrelating to Federal oil and gas leasingwill be made within the context ofexisting land use planning documentsdeveloped by the COE and the ODNR.Existing management decisions will notbe changed or modified by the PA/EA.

The leasing of the Federal oil and gasresources and subsequent developmentwill be carried out in accordance withFederal and State laws, regulations, andorders. The PA/EA will assess theimpacts of foreseeable Federal oil andgas development on these lands. Mostoil and gas drilling would occur on thesouthern two-thirds of the MCL Projectand vicinity, because this area has thehighest development potential. BLM’spreliminary estimate indicates thatapproximately 84 wells could be drilledto develop the Federal oil and gasresources. Drilling would occur over a 9to 12 year period with 7 to 9 wellsdrilled per year. The primary drillingtarget would be the Clinton sandstone.Natural gas with some oil and brinewould be produced.

Mosquito Creek Lake, developedareas, sensitive biological habitats, andother special uses greatly reduce theavailable surface for locating oil and gasoperations within the MCL Project andschool district property boundaries.This would require the use ofdirectional drilling technology todevelop Federal oil and gas beneathareas where the surface cannot beoccupied. Therefore, most of the surfacedisturbance associated with drillingwells to develop the Federal leaseswould be shifted to private landadjacent to the MCL Project and schooldistrict property. However, surfacelocations for some vertical anddirectional wells would be on the MCLProject, and one surface location mightbe on the school district property.

The BLM, COE and ODNR haveidentified the following preliminaryissues in relation to oil and gasdevelopment: (1) Potential impacts tothe aesthetic qualities for residents andusers; (2) Potential impacts to surfaceand ground water quality in thewatersheds of Mosquito Creek Lake; (3)Potential impacts to wetlands andassociated resources; (4) Potentialimpacts to historic, archaeological andtraditional cultural properties; (5)Potential impacts to Special StatusSpecies and habitat; (6) Potentialimpacts to cooperative (ODNR and localfarmers) farming leasees; (7) Potentialimpacts to outdoor recreationopportunities; (8) Effect of fluctuatingpool elevation of Mosquito Creek Lakeon location of oil and gas operations; (9)Safety concerns for recreational usersand residents; and (10) Potential impactto current and future uses of LakeviewLocal School District property. Twoissues were identified as being beyondthe scope of the document. Theseincluded: (1) Oil and gas leasing andsubsequent operations may affectproperty values in the Mosquito Creek


Lake area; and (2) traffic associated withoil and gas operations may impact roadconditions in the Mosquito Creek Lakevicinity. These issues will be addressedin the analysis process, but no decisionsresulting from the PA/EA will bespecific to these two issues.

Resource objectives were developedto address specific issues or concerns.Management actions developed throughthe planning process will strive to meetthe outlined resource objectives. Thespecific objectives, as they relate to oiland gas leasing and development, are:—Maintain or minimize the impacts to

the aesthetic values present at theMosquito Creek Lake area.

—Sustain and/or improve current safetylevels for recreational users andresidents.

—Maintain or enhance wetland valuesin the Mosquito Creek Lakewatersheds.

—Maintain existing surface and groundwater quality in the Mosquito CreekLake watersheds.

—Maintain or enhance the historical,archaeological, and traditionalcultural resource values.

—Maintain and enhance special statusspecies populations and suitablehabitat.

—Minimize impact to farm cooperativeleasees and associated forage area.

—Maintain current outdoor recreationalopportunities and facilities andminimize impacts to futureopportunities and facilities.

—Maintain the assigned visual resourcemanagement class as determinedthrough the planning process.

—Maintain the integrity of the reservoirpool zones.

—Maintain and/or enhance current andfuture uses of the Lakeview LocalSchool District property.Additional issues and resource

objectives may be identified as a resultof public input.

The PA/EA will be developed by aninterdisciplinary team (IDT) composedof specialists in air quality, archaeology,forestry, geographic informationsystems, hazardous and solid waste,minerals, paleontology, recreation,socio-economics, soils, visual resources,water resources, and wildlife andspecial status species. Additionaltechnical support will be provided byother specialists as needed.

Public participation will be animportant part of the PA/EA process. Itis intended that all interested or affectedparties be involved. The IDT will seekinput by direct mailings, mediacoverage, person to person contacts, andcoordination with local, State, and otherFederal agencies throughout the

process. Written and oral comments willbe accepted at an open house and publicmeeting to be held in the multi purposeroom of the Cortland ElementarySchool, 264 Park Avenue in Cortland,Ohio on May 8, 1996. An informal openhouse will be held from 3:30 p.m. to5:30 p.m. Resource specialists will beavailable to discuss specific areas ofinterest with the public. A formalmeeting will be held from 7:00 p.m. to9:00 p.m. with registration beginning at6:30 p.m. Agency personnel will acceptoral or written comments on thepreliminary issues and resourceobjectives.

Complete records of all phases of theplanning process will be available forpublic review at the Milwaukee DistrictOffice. The draft, proposed, and thefinal PA/EA will be available uponrequest.

Dated: April 17, 1996.James W. Dryden,District Manager.[FR Doc. 96–9908 Filed 4–22–96; 8:45 am]BILLING CODE 4310–GJ–P

[ES–020–1310–00]

Notice of Intent for Planning Analyses

AGENCY: Bureau of Land Management(BLM), Interior.SUMMARY: The Jackson District Office,Eastern States, will prepare PlanningAnalyses (PA) for consideration ofleasing ten scattered tracts of Federalmineral estate for oil and gasexploration and development. The PAswill be prepared in concert withEnvironmental Analyses (EA).

This notice is issued pursuant to Title40 Code of Federal Regulations (CFR)1501.7 and Title 43 CFR 1610.2(c). Theplanning effort will follow theprocedures set forth in 43 CFR Part1600.

The public is invited to participate inthis planning process, beginning withthe identification of planning issues andcriteria.DATES: Comments relating to theidentification of planning issues andcriteria will be accepted through May30, 1996.ADDRESSES: Send comments to Bureauof Land Management, Jackson District,411 Briarwood Drive, Suite 404,Jackson, Mississippi 39206.FOR FURTHER INFORMATION CONTACT:Sid Vogelpohl, Assistant DistrictManager for Mineral Resources, JacksonDistrict, (601) 977–5400.SUPPLEMENTARY INFORMATION: The BLMhas responsibility to considerapplications to lease Federal mineral

estate for oil and gas exploration anddevelopment. An interdisciplinary teamwill be used in the preparation of thePA/EAs. Preliminary issues, subject tochange as a result of public input, are(1) potential impacts of oil and gasexploration and development on thesurface resources and (2) considerationof restrictions on lease rights to protectsurface resources.

Due to the scattered nature of the tentracts proposed for leasing, a separateanalysis will be prepared for each tract.Tract locations, along with acreages, arelisted below.

Arkansas; Sebastian County, Fifth MeridianT 7 N, R 31 W, Sec. 36;T 7 N, R 30 W, Sec. 31 & 32; 970 acres.

Arkansas, Yell County, Fifth MeridianT 5 N, R 25 W, Sec. 10; 511 acres.

Louisiana, Bienville Parish, LA MeridianT 16 N, R 7 W, Sec. 15; 40 acres.

Louisiana, Livingston Parish, LA MeridianT 5 S, R 4 E, Sec. 39; 636 acres.

Louisiana, Vermillion Parish, LA MeridianT 12 S, R 1 E, Sec. 26 & 27; 295 acres.

Mississippi, Covington County, St. StephensMeridianT 6 N, R 14 W, Sec. 21; 88 acres.

Mississippi, Hancock County, St. StephensMeridianT 7 S, R 16 W, Sec 31;T 8 S, R 16 W, Sec. 8 & 17; 1,404 acres.

Mississippi, Jones County, St. StephensMeridianT 7 N, R 13 W, Sec. 33; 29 acres.

Mississippi, Monroe County, HuntsvilleMeridianT 15 S, R 17 W, Sec. 1; 120 acres.

Mississippi, Pearl River, St. StephensMeridianT 4 S, R 18 W, Sec. 37; 26 acres.

Due to the limited scope of this PA/EA process, public meetings are notscheduled.Bruce E. Dawson,District Manager, Jackson.[FR Doc. 96–9970 Filed 4–22–96; 8:45 am]BILLING CODE 4310–GJ–M

[OR–958–1430–01; GP6–0072; OR–48432(WASH)]

Public Land Order No. 7193;Withdrawal of Public Lands andReserved Minerals for Protection ofYakima Firing Center Expansion;Washington

AGENCY: Bureau of Land Management,Interior.ACTION: Public land order.


SUMMARY: This order withdraws6,640.02 acres of public lands fromsurface entry and mining, and 3,090.80acres of reserved mineral interests frommining for a period of 5 years. This willprotect the expansion of the YakimaFiring Center for the Department of theArmy, Corps of Engineers, pending theprocessing of an Engle Act withdrawalapplication. The lands have been andwill remain open to mineral leasing.EFFECTIVE DATE: April 23, 1996.FOR FURTHER INFORMATION CONTACT:Betty McCarthy, BLM Oregon/Washington State Office, P.O. Box 2965,Portland, Oregon 97208–2965, 503–952–6155.

By virtue of the authority vested inthe Secretary of the Interior by Section204 of the Federal Land Policy andManagement Act of 1976, 43 U.S.C.1714 (1988), it is ordered as follows:

1. Subject to valid existing rights, thefollowing described public lands arehereby withdrawn from settlement, sale,location, and entry under the generalland laws, including the United Statesmining laws (30 U.S.C. Ch. 2 (1988)),but not the mineral leasing laws, toprotect lands pending action on anEngle Act withdrawal application:

Willamette Meridian

Surface and Mineral EstatesT. 17 N., R. 20 E.,

Sec. 22, S1⁄2;Sec. 24, S1⁄2SW1⁄4 and that portion of the

E1⁄2 lying south of the Interstate Highway90 right-of-way;

Sec. 26.T. 16 N., R. 21 E.,

Sec. 4, SW1⁄4SW1⁄4;Sec. 12, SE1⁄4;Sec. 18, lots 1, 2, 3, and 4, E1⁄2, and

E1⁄2W1⁄2.T. 17 N., R. 21 E.,

Sec. 30, lots 3 and 4;Sec. 32, NE1⁄4SE1⁄4.

T. 16 N., R. 22 E.,Sec. 2, lots 1, 2, 3, and 4, S1⁄2N1⁄2, and S1⁄2;Sec. 4, lots 1, 2, 3, and 4, S1⁄2N1⁄2, and S1⁄2;Secs. 10 and 14;Sec. 20, SE1⁄4SW1⁄4;Sec. 22;Sec. 26, N1⁄2;Sec. 28, N1⁄2.

T. 16 N., R. 23 E.,Sec. 18, lots 3 and 4, E1⁄2SW1⁄4, W1⁄2SE1⁄4,

and that portion of the E1⁄2SE1⁄4 lyingwesterly of the westerly right-of-way lineof Huntzinger Road;

Sec. 20, that portion of the SW1⁄4 lyingwesterly of the easterly right-of-way lineof the railroad;

Sec. 30, lots 1 and 2, NE1⁄4, and E1⁄2NW1⁄4.The areas described aggregate

approximately 6,640.02 acres of public landsin Kittitas County.

2. Subject to valid existing rights, thereserved mineral interests in thefollowing described lands are hereby

withdrawn from the United Statesmining laws (30 U.S.C. Ch. 2 (1988)),but not from the mineral leasing laws:

Willamette Meridian

Mineral EstateT. 16 N., R. 20 E.,

Sec. 12;Sec. 18, lot 4 and SE1⁄4;Sec. 20, S1⁄2.

T. 16 N., R. 21 E.,Sec. 4, lots 1, 2, 3, and 4, and S1⁄2NE1⁄4;Sec. 8.

T. 17 N., R. 21 E.,Sec. 32, S1⁄2SE1⁄4;Sec. 34, W1⁄2.

T. 16 N., R. 22 E.,Sec. 12.The areas described aggregate 3,090.80

acres of reserved minerals in Kittitas County.

3. The withdrawal made by this orderdoes not alter the applicability of thosepublic land laws governing the use ofthe lands under lease, license, or permitor governing the disposal of theirmineral or vegetative resources otherthan under the mining laws.

4. This withdrawal will expire 5 yearsfrom the effective date of this orderunless, as a result of a review conductedbefore the expiration date pursuant toSection 204(f) of the Federal LandPolicy and Management Act of 1976, 43U.S.C. 1714(f) (1988), the Secretarydetermines the withdrawal shall beextended.

Dated: April 15, 1996.Bob Armstrong,Assistant Secretary of the Interior.[FR Doc. 96–9898 Filed 4–22–96; 8:45 am]BILLING CODE 4310–33–P

National Park Service

Draft Environmental Impact Statement,Elwha River Ecosystem RestorationImplementation, Olympic NationalPark, WA

ACTION: Notice of Availability of DraftEnvironmental Impact Statement.

SUMMARY: This notice announces theavailability of a draft environmentalimpact statement (DEIS) for therestoration of the Elwha RiverEcosystem in Olympic National Park,Washington. This notice also announcespublic meetings for the purpose ofreceiving comments on the draftdocument.DATES: There will be a 60-day publicreview period for comment on thisdocument. Comments on the DEISshould be received no later than June26, 1996. Public meetings will be heldin Seattle, Washington, on Tuesday,May 21, 1996, from 5:30 to 9:00 p.m. atThe Mountaineer’s Building, Olympus

Room, 300 3rd Ave. West; and in PortAngeles, Washington, on Wednesday,May 22, 1996, from 1:30 to 4:00 p.m.and from 5:30 to 9:00 p.m. at the VernBurton Community Center, 308 E. 4thStreet.ADDRESSES: Comments on the DEISshould be submitted to: Sarah Bransom,National Park Service—RP, P.O. Box25287, Denver, CO 80225–0287.

Public reading copies of the DEIS willbe available for review at the followinglocations:Office of Public Affairs, National Park

Service, Department of the Interior,18th & C Streets, NW, Washington, DC20240, Telephone: (202) 208–6843

Columbia/Cascades System SupportOffice, National Park Service, Rm.650, 909 First Ave., Seattle, WA98104–1060, Telephone: (206) 220–4154

Olympic National Park, National ParkService, 600 E. Park Ave., PortAngeles, WA 98362, Telephone: (360)452–4501

North Olympic Library System, PortAngeles Branch, 207 S. Lincoln St.,Port Angeles, WA, Telephone: (360)452–9253

Government Documents, Seattle PublicLibrary, 1000 4th Ave., Seattle, WA98104–1193, Telephone (206) 386–4686

Government Publications, SuzzalloLibrary, University of Washington,Seattle, WA 98195, Telephone: (206)543–1937

FOR FURTHER INFORMATION CONTACT:Brian Winter, Elwha River RestorationCoordinator, Olympic National Park,600 E. Park Ave., Port Angeles, WA98362, Telephone: (360) 452–0302. Alimited number of copies of the DEIS areavailable on request.SUPPLEMENTARY INFORMATION: In 1994and 1995, draft and final EISs werereleased which determined theDepartment of the Interior’s policy onElwha River Restoration. The Record ofDecision on that EIS process,documenting the decision to purseremoval of the dams, is available fromthe Superintendent, Olympic NationalPark at the above address.

This document and analysis hasresulted from the passage of Public Law102–495, the Elwha River Ecosystemand Fisheries Restoration Act of 1992.The DEIS has been completed by theNational Park Service in cooperationwith the US Fish and Wildlife Service,Bureau of Reclamation, Bureau ofIndian Affairs, and the Lower ElwhaKlallam Tribe.

This draft environmental impactstatement on implementing ecosystemrestoration describes and analyzes a


proposed action and two alternatives.Under the proposed action, theSecretary of the Interior would removeboth the Elwha and Glines Canyondams, and allow natural river erosion totransport accumulated reservoirsediments to the ocean. The otheralternatives are: remove both dams anddredge accumulated sediments into aslurry pipeline for transport to theocean; and no action—continue tooperate the dams without anadromousfish mitigation.

Impacts are analyzed on the followingtopics: fluvial processes and sedimenttransport, flooding, groundwater,surface water, native anadromous andresident fisheries, vegetation, wildlife,species of special concern, living marineresources, air quality and noise, culturalresources, socioeconomics, publichealth and safety, traffic, Indian trustresources, recreation, land use, andaesthetics.

All review comments received willbecome part of the public record andcopies of comments, including names,addresses and telephone numbersprovided by respondents, may bereleased for public inspection.

Dated: April 8, 1996William C. Walters,Deputy Field Director, Pacific West Area,National Park Service.[FR Doc. 96–9979 Filed 4–22–96; 8:45 am]BILLING CODE 4310–70–M

National Register of Historic Places;Notification of Pending Nominations

Nominations for the followingproperties being considered for listingin the National Register were receivedby the National Park Service beforeApril 13, 1996. Pursuant to section60.13 of 36 CFR Part 60 writtencomments concerning the significanceof these properties under the NationalRegister criteria for evaluation may beforwarded to the National Register,National Park Service, P.O. Box 37127,Washington, D.C. 20013–7127. Writtencomments should be submitted by May8, 1996.Carol D. Shull,Keeper of the National Register.

ARIZONA

Maricopa CountyNohlechek, Rhoda, House, Jct. of 2nd St. and

Date Ave., NW corner, Wenden, 96000529

ARKANSAS

Benton CountyStroud House (Benton County MPS), Jct. of

SE F St. and E. Central Ave., SE corner,Bentonville, 96000527

Garland CountyHot Springs Railroad Warehouse Historic

District, 401–439 Broadway, Hot Springs,96000526

Lonoke CountyLonoke Downtown Historic District, Jct. of

Front and Center Sts., Lonoke, 96000528

FLORIDA

Lee CountyGalt Island Archeological District

(Archeological Resources of theCaloosahatchee Region MPS), AddressRestricted, St. James City vicinity,96000531

Pardo, Mark Shellworks Site (ArcheologicalResources of the Caloosahatchee RegionMPS), Address Restricted, Bokeeliavicinity, 96000533

Useppa Island Site (Archeological Resourcesof the Caloosahatchee Region MPS),Address Restricted, Bokeelia vicinity,96000532

Leon CountyFlorida Agricultural and Mechanical College

Historic District, Roughly, Martin LutherKing Blvd. from S. Adams St. to WahnishWay, Tallahassee, 96000530

GEORGIA

Oconee CountyBishop Historic District, Roughly along Price

Mill, Old Bishop Rds., and US 441 withinthe Bishop city limits, Bishop, 96000534

MARYLAND

Wicomico CountyWhitehaven Hotel, Whitehaven Rd., jct. of

Whitehaven Rd. and River St., Whitehaven,96000535

NEW JERSEY

Morris CountyPalace Theatre, 7 Ledgewood Ave., Netcong,

96000536

Warren CountyBowerstown Historic District, Roughly

bounded by Bowerstown, Plane Hill,Lanning and Mine Hill Rds., WashingtonTownship, Belvidere vicinity, 96000537

TEXAS

Galveston CountySilk Stocking Residential Historic District,

Roughly bounded by Ave. K, 23rd St., Ave.P, and 26th St., Galveston, 96000539

VIRGINIA

Albemarle CountyEast Belmont, W side of VA 22, jct. of VA 22

and Co. Rt. 616, Keswick vicinity,96000540

WISCONSIN

Oconto CountyWeber Lake Picnic Ground Shelter, Jct. of WI

32 and NFS 2308, Mountain, 96000541

Vilas CountyAnvil Lake Campground Shelter, Jct. of Anvil

Lake Rd. and WI 70, Eagle River, 96000542

In order to assist in the preservation of thefollowing property, the comment period hasbeen waived:

NORTH CAROLINA

Macon CountyGlen Choga Lodge, 50 Lodge Rd., Aquone

vicinity, 96000538[FR Doc. 96–9929 Filed 4–22–96; 8:45 am]BILLING CODE 4310–70–P

DEPARTMENT OF JUSTICE

Antitrust Division

Notice Pursuant to the NationalCooperative Research and ProductionAct of 1993; Cullen EngineeringResearch Foundation CooperativeResearch Venture

Notice is hereby given that, on June 6,1995, pursuant to Section 6(a) of theNational Cooperative Research andProduction Act of 1993, 15 U.S.C. 4301et seq. (‘‘the Act’’), Cullen EngineeringResearch Foundation filed notificationssimultaneously with the AttorneyGeneral and the Federal TradeCommission disclosing (1) Theidentities of the parties and (2) thenature and objectives of a researchventure. The notifications were filed forthe purpose of invoking the Act’sprovisions limiting the recovery ofantitrust plaintiffs to actual damagesunder specified circumstances. Pursuantto Section 6(b) of the Act, the identitiesof the parties are Amoco Corporation,Naperville, IL; Elf Aquitaine, Inc.,Washington, DC, a subsidiary of SocieteNationale Elf Aquitaine, Paris, France;Hydril Company, Houston, TX; PhillipsPetroleum Company, Bartlesville, OK;Exploration and Production TechnologyCompany, a division of ShellExploration and Production Company,Houston, TX, a subsidiary of RoyalDutch/Shell Group of Companies, TheHague, Netherlands; University ofHouston—CEAC, Houston, TX; andCullen Engineering ResearchFoundation, Houston, TX. The purposeof the venture is to develop thetechnology to overcome the barriers tothe design, manufacture, and utilizationof a broad range of long continuouslengths of high performance, spoolablecomposite tubing. The activities of theproject will be partially funded by anaward from the Advanced TechnologyProgram, National Institute of Standardsand Technology, Department ofCommerce.Constance K. Robinson,Director of Operations, Antitrust Division.[FR Doc. 96–9884 Filed 4–22–96; 8:45 am]BILLING CODE 4410–01–M


Notice Pursuant to the NationalCooperative Research and ProductionAct of 1993; Joint Industry Program

Notice is hereby given that, on March15, 1996, pursuant to Section 6(a) of theNational Cooperative Research andProduction Act of 1993, 15 U.S.C. 4301et seq. (‘‘the Act’’), Southwest ResearchInstitute (SwRI) has filed writtennotifications simultaneously with theAttorney General and the Federal TradeCommission disclosing changes in itsmembership and restating the natureand objectives of the venture. Thenotifications were filed for the purposeof extending the Act’s provisionslimiting the recovery of antitrustplaintiffs to actual damages underspecified circumstances. Pursuant toSection 6(b) of the Act, the newparticipant who has been added to theventure known as the Joint IndustryProgram is: Chevron Research andTechnology Company, a division ofChevron U.S.A., Inc., Richmond, CA.SwRI wishes to restate the plannedactivities of JIP because the originallypublished notice was abbreviated anddid not sufficiently state these activities.The planned research activities are todevelop a cost effective nondestructiveevaluation technique whose capabilitiesinclude the nonintrusive inspection ofthe entire cross section of pipe and todetect both OD and ID defects withoutthe removal of insulating material at ahigh inspection speed with a short setup time and to develop a fielddeployable production modelmagnetostrictive sensor (MsS) forinspecting and detecting corrosion ininsulated piping systems found in theoil, gas, chemical and petrochemicalindustries by evaluating the operatingrange of the MsS technique taking intoconsideration pipe diameter, grade,configuration, wall thickness,temperature and operating pressure ofthe line and by developing instrumentspecifications suitable for in-planttesting.

No other changes have been made ineither the membership or plannedactivity of the group research project.Membership in this group researchproject remains open, and SwRI intendsto file additional written notificationdisclosing all changes in membership.

On October 25, 1995, SouthwestResearch Institute, (Joint IndustryProgram, JIP) filed its originalnotification pursuant to Section 6(a) ofthe Act. The Department of Justicepublished a notice in the Federal

Register pursuant to Section 6(b) of theAct on February 23, 1996 (61 FR 7020).Constance K. Robinson,Director of Operations, Antitrust Division.[FR Doc. 96–9883 Filed 4–22–96; 8:45 am]BILLING CODE 4410–01–M

Foreign Claims SettlementCommission

Privacy Act of 1974; New System ofRecords Notice; Albanian ClaimsProgram

AGENCY: Foreign Claims SettlementCommission; Justice.ACTION: Notice of new system of records.

SUMMARY: The Foreign ClaimsSettlement Commission (FCSC) herebypublishes notice of the establishment ofan additional records system to beeffective as of May 24, 1996, anddesignated ‘‘FCSC–36, Albania, ClaimsAgainst.’’ This records system will beadded to the Commission’s currentPrivacy Act Systems of Records.DATES: The system of records designated‘‘FCSC–36, Albania, Claims Against’’shall be established and becomeeffective on May 24, 1996, as publishedherein unless amended by noticepublished prior to that date. Theexisting systems of records continue ineffect. Comments must be submitted onor before May 24, 1996.ADDRESSES: Any person interested incommenting on this system may do soby submitting comments in writing tothe Administrative Office of the ForeignClaims Settlement Commission, 600 EStreet, NW, Washington, DC 20579.FOR FURTHER INFORMATION CONTACT:David E. Bradley, Chief Counsel,Foreign Claims Settlement Commission,600 E Street NW, Room 6002,Washington, DC 20579, telephone (202)616–6975, fax (202) 616–6993.

FCSC–36

SYSTEM NAME:Albania, Claims Against.

SYSTEM LOCATION:Foreign Claims Settlement

Commission, 600 E Street NW, Room6002, Washington, DC 20579.

CATEGORIES OF INDIVIDUALS COVERED BY THESYSTEM:

Natural and juridical persons whoassert claims for losses of propertyresulting from expropriation or othertaking by the Government of Albania.

CATEGORIES OF RECORDS IN THE SYSTEM:Claim information, including name

and address of claimant and

representative, if any; date and place ofbirth or naturalization; nature andvaluation of claim; description,ownership, and value of property; otherevidence establishing entitlement tocompensation for claim.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

Title I, International ClaimsSettlement Act of 1949, as amended,and the Agreement Between theGovernment of the United States ofAmerica and the Government of Albaniaon the Settlement of CertainOutstanding Claims of March 10, 1995(entered into force April 18, 1995).

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF THE USES:

Records are used for the purpose ofdetermining the validity and amount ofclaims; issuance of decisions concerningeligibility to receive compensationunder the Act and Agreement;notifications to claimants of rights toappeal; and preparation of certificationsof awards, if any, to the TreasuryDepartment for payment. Names andother information furnished byclaimants may be used for verifyingcitizenship status with the Immigrationand Naturalization Service. Theinformation contained in this system ofrecords is considered by theCommission to be public informationwhich may be disclosed as a routine useto interested persons who makeinquiries about the claims program orindividual claims therein, including butnot limited to Members of Congress orCongressional staff, staff of the Office ofManagement and Budget, other personsinterested in the work of theCommission, and members of the newsmedia.

Law Enforcement: In the event that asystem of records maintained by theFCSC to carry out its functions indicatesa violation or potential violation of law,whether civil or criminal or regulatoryin nature and whether arising by generalstatute or particular program statute ororder issued pursuant thereto, therelevant records in the system of recordsmay be referred, as a routine use, to theappropriate agency, whether FederalState, local or foreign, charged withenforcing or implementing the statute,rule, regulation or order issued pursuantthereto.

A record, or any facts derivedtherefrom, may be disclosed in aproceeding before a court oradjudicative body before which theFCSC is authorized to appear or to the


Department of Justice for use in suchproceeding when:

i. The FCSC, or any subdivisionthereof, or

ii. Any employee of the FCSC in hisor her official capacity, or

iii. Any employee of the FCSC in hisor her official capacity where theDepartment of Justice has agreed torepresent the employee, or

iv. The United States, where the FCSCdetermines that the litigation is likely toaffect it or any of its subdivisions, is aparty to litigation or has an interest inlitigation and such records aredetermined by the FCSC to be arguablyrelevant and necessary to the litigationand such disclosure is determined bythe FCSC to be a use compatible withthe purpose for which the records werecollected.

POLICIES AND PRACTICES FOR STORING,RETRIEVING, ACCESSING, RETAINING, ANDDISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Paper records maintained in filefolders.

RETRIEVABILITY:

Filed numerically by claim number.Alphabetical index used foridentification of claim.

SAFEGUARDS:

At FCSC: Building employs securityguards.

Records are maintained in a lockedroom accessible to authorized FCSCpersonnel and other persons whenaccompanied by such personnel.

RETENTION AND DISPOSAL:

Records are maintained in accordancewith 5 U.S.C. 301. Disposal of recordswill be in accordance with 44 U.S.C.3301–3314 when such records aredetermined no longer useful.

SYSTEM MANAGER(S) AND ADDRESS:

Administrative Office, Foreign ClaimsSettlement Commission, 600 E Street,NW, Room 6002, Washington, DC20579; telephone 202–616–6975, fax202–616–6993.

NOTIFICATION PROCEDURE:

Same as above.

CONTESTING RECORD PROCEDURES:

Same as above.

RECORD SOURCE CATEGORIES:

Claimant on whom the record ismaintained.David E. Bradley,Chief Counsel.[FR Doc. 96–9881 Filed 4–22–96; 8:45 am]BILLING CODE 4410–01–P

NATIONAL TRANSPORTATIONSAFETY BOARD

Sunshine Act Meeting

TIME AND DATES: 9:30 a.m., Tuesday,April 30, 1996.PLACE: The Board Room, 5th Floor, 490L’Enfant Plaza, S.W., Washington, D.C.20594.STATUS: The first item is open to thepublic. The second item is closed to thepublic under Exemption 10 of theGovernment in Sunshine Act.

MATTERS TO BE CONSIDERED:

5745D—‘‘Most Wanted’’ SafetyRecommendations Program: Status Reportand Suggested Modifications.

6661—Opinion and Order: Petersen v.Administrator, Docket SE–14007;disposition of Administrator’s appeal.

NEWS MEDIA CONTACT: Telephone: (202)382–0660.FOR MORE INFORMATION CONTACT: BeaHardesty, (202) 382–6525.

Dated: March 19, 1996.Bea Hardesty,Federal Register Liaison Officer.[FR Doc. 96–10081 Filed 4–19–96; 2:53 pm]BILLING CODE 7533–01–P

NUCLEAR REGULATORYCOMMISSION

Nuclear Safety Research ReviewCommittee; Subcommittees Meetings

AGENCY: Nuclear RegulatoryCommission.ACTION: Notice of meetings.

The PRA Subcommittee will hold ameeting on May 13–14, 1996, the I&Cand Human Factors Subcommittee onMay 14–15, 1996, and the AccidentAnalysis Subcommittee on May 16–17,1996. The meetings will take place,starting at 8:00 am, in room T–2B1, TwoWhite Flint North (TWFN) Building,11545 Rockville Pike, Rockville, MDand will be open to public attendance.

I. The PRA Subcommittee will reviewthe following topics:

(a) The accident sequence precursorprogram,

(b) research supporting risk informedregulation, and

(c) reactor related methodsdevelopment.

II. The I&C and Human FactorsSubcommittee will review the status ofthe issues and methods currently beingaddressed in the RES program onHuman Factors and Instrumentation andControl Systems including:

(a) Staffing levels,(b) root-cause analysis,

(c) hybrid control rooms,(d) organizational factors,(e) human-system interfaces,(f) NAS study and workshop,(g) total systems,(h) numerical reliability of software(i) programming languages and CASE

tools, and(j) digital hardware qualification.III. The Accident Analysis

Subcommittee’s will review thefollowing topics:

(a) Assessment of RELAP adequacyfor AP–600 analysis,

(b) plans for other advanced reactorthermal hydraulic work,

(c) status of high burnup fuel work(d) status of severe accident research

program, and(e) future plans beyond ALWR work.Detailed agendas will be made

available at the meetings.Oral statements may be presented by

members of the public with theconcurrence of the presidingSubcommittee Chairman; writtenstatements will be accepted and madeavailable to the Subcommittee.Questions may be asked only bymembers of the NSRRC Committee andthe staff. Persons desiring to make oralstatements should notify the NuclearRegulatory Commission staff membernamed below as far in advance as ispracticable so that appropriatearrangements can be made.

During the initial portions of themeetings, the Subcommittees mayexchange preliminary views regardingmatters to be considered during thebalance of the meeting. TheSubcommittees will then hearpresentations by and hold discussionswith representatives of the NRC staffregarding the topics to be discussed.

Further information regarding topicsto be covered, the rescheduling and/orcancellation of meeting sessions, andthe Chairmen’s ruling on requests forthe opportunity to present oralstatements and the time allotted fordiscussion can be obtained by atelephone call to Dr. Jose Luis M. Cortez(telephone 301/415–6596) between 9:00a.m. and 4:30 p.m. (EST). Personsplanning to attend these meetings areurged to contact the above namedindividual one or two business daysbefore the scheduled meeting to beadvised of any changes in schedule, etc.,that may have occurred.

Dated: April 16, 1996.Jose Luis M. Cortez,Senior Research Program Coordinator, Officeof Nuclear Regulatory Research.[FR Doc. 96–9924 Filed 4–22–96; 8:45 am]BILLING CODE 7590–01–P


Guidelines for Preparing andReviewing Applications for theLicensing of Non-Power Reactors:Availability

The U.S. Nuclear RegulatoryCommission (NRC) has publishedNUREG–1537, ‘‘Guidelines forPreparing and Reviewing Applicationsfor the Licensing of Non-PowerReactors.’’ Part 1 of NUREG–1537contains format and content guidancefor non-power reactor applicants andlicensees and Part 2 contains a standardreview plan and acceptance criteria forNRC non-power reactor reviewers.

The format and content guide suggestsa uniform format for presentinginformation in non-power reactorapplications, helps ensure completenessof information provided, assists theCommission staff and others in locatinginformation, and aids in increasing theefficiency of the review process. Theformat and content guide represents aformat for non-power reactorapplications that is acceptable to theNRC staff. Conformance with the formatand content, however, is not required.

The standard review plan ensures thequality and uniformity of the staffreviews, makes information aboutregulatory matters concerning NPRswidely available, and improves theunderstanding of the staff reviewprocess by interested members of thenon-power reactor community and thepublic.

The document covers all aspects ofnon-power reactor licensing. Thedocument can be used for theconstruction permit and the initialoperating license, license renewal,license amendment, decommissioningand license termination, and highlyenriched to low-enriched uranium coreconversions. There is also an appendixto the format and content guide that listsselected regulations that are applicableto non-power reactors.

NUREG–1537 is available forinspection and copying for a fee at theNRC Public Document Room, theGelman Building, 2120 L Street, NW,Washington, DC 20555. Copies of thisdocument can also be purchased fromthe Superintendent of Documents, U.S.Government Printing Office, P.O. Box37082, Washington, DC 20402–9828 orthe National Technical InformationService, 5285 Port Royal Road,Springfield, VA 22161–0002.

Dated at Rockville, Maryland, this 16th dayof April, 1996.

For the Nuclear Regulatory Commission.Seymour H. Weiss, DirectorNon-Power Reactors and DecommissioningProject Directorate, Division of ReactorProgram Management, Office of NuclearReactor Regulation.[FR Doc. 96–9923 Filed 4–22–96; 8:45 am]BILLING CODE 7590–01–P

Sunshine Act Meeting

AGENCY HOLDING THE MEETING: NuclearRegulatory Commission.DATE: Weeks of April 22, 29, May 6, and13, 1996.PLACE: Commissioners’ ConferenceRoom, 11555 Rockville Pike, Rockville,Maryland.STATUS: Public and Closed.

MATTERS TO BE CONSIDERED:

Week of April 22There are no meetings scheduled for the

week of April 22.

Week of April 29—Tentative

Friday, May 311:30 a.m.

Affirmation Session (Public Meeting) (ifneeded)

2:00 p.m.Meeting with ACMUI and Dr. Robert Adler

on Recommendations of NAS Report onReview of Medical Use Program (PublicMeeting)

(Contact: Larry Camper, 301–415–7231)

Week of May 6—Tentative

Friday, May 10

10:00 a.m.Briefing on Severe Accident Master

Integration Plan (Public Meeting)(Contact: Themis Speis, 301–415–6802)

11:30 a.m.Affirmation Session (Public Meeting) (if

needed)

Week of May 13—Tentative

Monday, May 13

2:00 p.m.Briefing by Commonwealth Edison (Public

Meeting)

Wednesday, May 15

2:00 p.m.Briefing on Performance Assessment

Program in HLW, LLW, and SDMP(Public Meeting)

(Contact: Norman Eisenberg, 301–415–7285)

3:30 p.m.

Affirmation Session (Public Meeting) (ifneeded)

The schedule for Commissionmeetings is subject to change on shortnotice. To verify the status of meetingscall (recording)—(301) 415–1292.CONTACT PERSON FOR MORE INFORMATION:Bill Hill, (301) 415–1661.

This notice is distributed by mail to severalhundred subscribers; if you no longer wishto receive it, or would like to be added to it,please contact the Office of the Secretary,Attn: Operations Branch, Washington, D.C.20555 (301–415–1963).

In addition, distribution of this meetingnotice over the internet system is available.If you are interested in receiving thisCommission meeting schedule electronically,please send an electronic message [email protected] or [email protected].

Dated: April 18, 1996.William M. Hill, Jr.,SECY Tracking Officer, Office of theSecretary.[FR Doc. 96–10117 Filed 4–19–96; 2:53 pm]BILLING CODE 7590–01–M

OFFICE OF MANAGEMENT ANDBUDGET

Budget Rescissions and Deferrals

April 12, 1996.Dear Mr. President: In accordance

with the Congressional Budget andImpoundment Control Act of 1974, Iherewith report 10 proposed rescissionsof budgetary resources, totaling $400.4million. These rescission proposalsaffect the Department of Defense.

Sincerely,William J. Clinton

The Honorable Albert Gore, Jr., President ofthe Senate, Washington, DC 20510.

April 12, 1996.Dear Mr. Speaker: In accordance with

the Congressional Budget andImpoundment Control Act of 1974, Iherewith report 10 proposed rescissionsof budgetary resources, totaling $400.4million. These rescission proposalsaffect the Department of Defense.

Sincerely,William J. ClintonThe Honorable Newt Gingrich, Speaker of theHouse of Representatives, Washington, DC20515.

BILLING CODE 3110–01–P


R96–11


PROCUREMENT

Aircraft Procurement, Army

Of the funds made available under this heading in Public Law 104–61, $140,000,000 are rescinded.


R96–12


PROCUREMENT

Procurement of Ammunition, Army



R96–13


PROCUREMENT

Other Procurement, Army



R96–15


PROCUREMENT

Procurement of Ammunition, Navy and Marine Corps



R96–14


PROCUREMENT

Shipbuilding and Conversion, Navy



R96–16


PROCUREMENT

National Guard and Reserve Equipment



R96–17


RESEARCH, DEVELOPMENT, TEST, AND EVALUATION

Research, Development, Test, and Evaluation, Army



R96–18



Research, Development, Test, and Evaluation, Navy



R96–19



Research, Development, Test, and Evaluation, Air Force



R96–20



Research, Development, Test, and Evaluation, Defense-Wide


[FR Doc. 96–9902 Filed 4–22–96; 8:45 am]BILLING CODE 3110–01–C


1 The Commission also granted exemptive reliefto permit the Fund to invest in the New Europe EastInvestment Fund, an affiliated closed-endLuxembourg investment company that invests inequity securities in Eastern Europe and the formerSoviet republics. See Investment Company ActRelease Nos. 20236 (Apr. 20, 1994) (notice) and20305 (May 17, 1994) (order).

SECURITIES AND EXCHANGECOMMISSION

[Investment Company Act Release No.21900; International Series Release No. 970;812–9868]

Emerging Markets Growth Fund, Inc.,et al.; Notice of Application

April 17, 1996.AGENCY: Securities and ExchangeCommission (‘‘SEC’’).ACTION: Notice of Application for anOrder under the Investment CompanyAct of 1940 (the ‘‘Act’’).

APPLICANTS: Emerging Markets GrowthFund, Inc. (the ‘‘Fund’’), New Asia EastInvestment Fund Ltd. (the ‘‘New AsiaFund’’), Capital International EmergingMarkets Fund (‘‘CIEMF’’), CapitalInternational, Inc. (the ‘‘Manager’’) andThe Capital Group Companies, Inc. (the‘‘Capital Group’’).RELEVANT ACT SECTIONS: Order ofexemption requested pursuant tosection 6(c) of the Act from section12(d)(1) of the Act, pursuant to sections6(c) and 17(b) of the Act from section17(a) of the Act, and pursuant to rule17d–1 under the Act permitting certainjoint transactions in accordance withsection 17(d) of the Act and rule 17d–1 thereunder.SUMMARY OF APPLICATION: The requestedorder would permit the Fund to investup to 1% of its assets in the New AsiaFund, an affiliated closed-end Singaporeinvestment company that invests insecurities of companies in East andSoutheast Asia.FILING DATES: The application was filedon November 30, 1995 and amended onFebruary 14, 1996 and on March 25,1996.HEARING OR NOTIFICATION OF HEARING: Anorder granting the application will beissued unless the SEC orders a hearing.

Interested persons may request ahearing by writing to the SEC’sSecretary and serving applicants with acopy of the request, personally or bymail. Hearing requests should bereceived by the SEC by 5:30 p.m. onMay 13, 1996 and should beaccompanied by proof of service onapplicants, in the form of an affidavit,or, for lawyers, a certificate of service.Hearing requests should state the natureof the writer’s interest, the reason for therequest, and the issues contested.Persons may request notification of ahearing by writing to the SEC’sSecretary.ADDRESSES: Secretary, SEC, 450 FifthStreet, N.W., Washington, D.C. 20549.Applicants, c/o Capital International,Inc., 11100 Santa Monica Boulevard,

Los Angeles, California 90025, Attn.:Roberta A. Conroy, Esq.FOR FURTHER INFORMATION CONTACT:Sarah A. Buescher, Staff Attorney, at(202) 942–0573, or Alison E. Baur,Branch Chief, at (202) 942–0564(Division of Investment Management,Office of Investment CompanyRegulation).SUPPLEMENTARY INFORMATION: Thefollowing is a summary of theapplication. The complete applicationmay be obtained for a fee from the SEC’sPublic Reference Branch.

Applicants’ Representations1. The Fund, a Maryland corporation,

registered under the Act as a closed-enddiversified management investmentcompany on June 2, 1986. The Fund’sinvestment objective is to seek long-term capital growth through investmentin equity securities of issuers indeveloping countries.1 The Fund investsprimarily in securities that are listed ona securities exchange or are activelytraded in an over-the-counter market indeveloping countries. Under afundamental investment policy, theFund may not acquire any security if theacquisition would result in the Fundowning more than 10% of theoutstanding voting securities of any oneissuer.

2. Of the Fund’s fifteen directors,eleven are not ‘‘interested persons’’ ofthe Fund (‘‘Independent Directors’’).Seven of the Independent Directorsrepresent institutional shareholders ofthe Fund and three IndependentDirectors represent former shareholdersof the Fund. All but one of theIndependent Directors are full-timeinvestment professionals who act in thatcapacity for their respective employers.

3. The Fund’s suitability standardsrequire each institutional investor in theFund that is a ‘‘company,’’ as defined inthe Act, to have total assets in excess of$5 million. An investor who is a naturalperson must be an ‘‘accredited investor’’as defined in Regulation D under theSecurities Act of 1933 (‘‘SecuritiesAct’’). The minimum initial investmentin the Fund is $100,000, and $25,000 forsubsequent investments.

4. The Fund proposes to invest up to1% of its assets in the New Asia Fund.The New Asia Fund is a closed-endinvestment company incorporated inSingapore. The New Asia Fund’s

investment objective is to seek long-term capital appreciation throughinvestment in companies doing themajority of their business in thecountries of East and Southeast Asiathat are member countries of the AsianDevelopment Bank.

5. The New Asia Fund is privatelyoffering two classes of securities inseveral tranches: (i) Voting preferredshares (‘‘A Shares’’) and (ii) non-votingpreferred shares (‘‘B Shares’’)(collectively, the ‘‘Shares’’). The parvalue per Share and subscription priceper Share are $0.01 and $10.00,respectively. All subscriptions must befor A Shares, unless legal, tax orcontractual restrictions limit asubscriber’s ownership of votingsecurities. In that case, an investor mustsubscribe for the maximum number of AShares it is able to hold and thereaftersubscribe for B Shares.

6. The New Asia Fund offers and sellsShares only to a limited number ofinvestors. The Shares are not listed onany stock exchange and they may not beoffered or sold in the United States orto any United States person, unless theperson is an ‘‘accredited investor’’ asdefined in Regulation D underSecurities Act. The Shares are notredeemable, and the New Asia Fundpresently does not intend to repurchasethe Shares.

7. Applicants represent that the NewAsia Fund is currently not subject toregistration under section 7(d) of theAct. Section 7(d) prohibits aninvestment company organized outsidethe United States from using the mailsor any means or instrumentality ofinterstate commerce to offer, sell, ordeliver after sale, in connection with apublic offering, any security of whichthe company is the issuer.

8. The Fund proposes to invest $43million, approximately 1% of its assets,to acquire the New Asia Fund’ssecurities. To comply with itsfundamental investment policy, theFund would invest in a combination ofA Shares and B Shares so that it wouldhold between 3% and 10% of the totalvoting power, but approximately30.71% of the economic power, of theNew Asia Fund (‘‘ProposedInvestment’’).

9. CIEMF, an investment companyorganized and operated outside theUnited States, has invested $5 million toacquire approximately 3.57% of theNew Asia Fund’s securities andapproximately 3% of its voting stock.CIEMF anticipates acquiring both A andB Shares.

10. The Capital Group, the indirectparent company of the Manager, hasinvested approximately $3 million to


acquire the New Aisa Fund’s A Shares,which will represent approximately2.14% of the New Asia Fund’s securitiesand 2.76% of its voting securities.

11. The Manager, an investmentadviser registered under the InvestmentAdvisers Act of 1940 (‘‘Advisers Act’’),advises the Fund, the New Asia Fundand CIEMF. Under an investmentadvisory and service agreementcurrently in force between the Fund andthe Manager, the Fund pays theManager a fee. To avoid the possibilitythat the Manager would receiveduplicate fees from the Fund and theNew Asia Fund, the Manager will waiveits management fee, includingadministrative fees, with respect to theFund’s net assets represented by theProposed Investment. Specifically, theFund’s aggregate net assets will beadjusted downward by the amountinvested in the New Asia Fund prior todetermining the Manager’s fee. Whilethe Fund does not have an expense caparrangement with the Manager, theFund is subject to mandatory expensecap limitations imposed by stateregulatory authorities. Any applicableexpense cap limitation or fee waiverwill not limit the Manager’s fee waiverwith respect to the Fund’s investment inthe New Asia Fund.

12. As investment adviser to the NewAsia Fund, the Manager will receive anadvisory fee at the rate of 2% per annumof net asset value, as determined on thelast business day of each quarter.However, until the Manager invests90% of the proceeds raised by alltranches of the offering, the advisory feefor the uninvested portion shall be .90%per annum. The New Asia Fund will notpay an advisory fee on the value ofsecurities held in any investmentvehicle that pays management andadvisory fees to an affiliate of theCapital Group.

13. The New Asia Fund will also paythe Manager an inventive fee equal to20% of any amount available fordistribution to the New Asia Fundshareholders, to be calculated andaccrued immediately prior to anydistribution. However, no incentive feewill be charged unless and until theNew Asia Fund shareholders haverecovered through distributions theentire amount of their originalsubscriptions for Shares, plus a return atthe rate of 9% per annum(compounded) on the originalsubscription. Applicants represent thatthe incentive fee arrangement complieswith the safe harbor of rule 205–3 underthe Advisers Act.

14. Section 18(i) of the Act providesthat each share of stock issued by aregistered management investment

company shall be voting stock and shallhave equal voting rights, except asprovided in section 18(a) of the Act.Although the New Asia Fund is notsubject to section 18(i), applicantsrepresent that the New Asia Fund’scapital structure does not present any ofthe potential harms that section 18(i)was intended to address. The New AsiaFund tailored the voting rights of theShares to satisfy the needs of certainprospective investors, all of whom aresophisticated, institutional investors.Applicants represent that such investorswill understand a capital structure thatwas created to suit their needs.

Applicants’ Legal Analysis

Section 12(d)(1)

1. Section 12(d)(1)(A)(i) provides thatno registered investment company mayacquire securities of another investmentcompany if such securities representmore than 3% of the acquiredcompany’s outstanding voting stock.The New Asia Fund may be consideredan investment company for purposes ofsection 12(d)(1), and therefore, theProposed Investment may be subject tosection 12(d)(1).

2. Section 6(c) provides that the SECmay exempt persons or transactions if,and to the extent that, such exemptionis necessary or appropriate in the publicinterest and consistent with theprotection of investors and the purposesfairly intended by the policy andprovisions of the Act. Applicantsrequest an order under section 6(c)exempting them from section12(d)(1)(A)(i) to permit the Fund topurchase more than 3% but less than10% of the outstanding voting securitiesof the New Asia Fund.

3. Section 12(d)(1) was intended tomitigate or eliminate actual or potentialabuses that might arise when oneinvestment company acquires shares oranother investment company. Theseabuses include the acquiring fundimposing undue influence over themanagement of the acquired fundthrough the threat of large scaleredemptions, the acquisition by theacquiring company of voting control ofthe acquiring company, the layer ofsales charges, expenses, and fees, andthe creation of a complex structure thatmay prevent shareholders fromascertaining the true value of theirinvestments.

4. Applicants believe that theProposed Investments creates none ofthe perceived abuses addressed bysection 12(d)(1). The Fund would notexercise any influence over themanagement of the New Asia Fund bythe threat of redemptions. Because the

New Asia Fund is a closed-end fund, itsShares are not redeemable and it doesnot need to have cash on hand to coverredemptions by shareholders. Inaddition, because the Fund is also aclosed-end fund, its liquidity needs arenot significant.

5. To minimize the risk that the Fundwould exercise voting control over theNew Asia Fund to the detriment of theNew Asia Fund or its shareholders, theFund will have its A Shares voted by anindependent director designated to actin such capacity.

6. The Proposed Investment wouldcontain no improper layering of salescharges or advisory fees. Shareholdersof the Fund and the New Asia Fund donot pay any sales charge, redemption feeor distribution fee. In addition, theManager will exclude the assets withrespect to the Proposed Investment incalculating the Fund’s management fees.

7. Applicants believe that theProposed Investment will not result ina complex structure that could not beunderstood by the Fund or itsshareholders. The New Asia Fund’soffering of A and B Shares is designedto accommodate the needs of itssophisticated, institutionalshareholders. In addition, the New AsiaFund has created procedures toaccurately determine the net assetsvalue of its Shares, which will allow thevalue of the Fund’s investment in theNew Asia Fund to be easily andaccurately determinable.

Section 17(a)8. Section 17(a) makes it unlawful for

an affiliated person of a registeredinvestment company to sell securitiesto, or purchase securities from, thecompany. Section 2(a)(3)(C) of the Actdefines an ‘‘affiliated person’’ to include‘‘any person directly or indirectlycontrolling, controlled by, or undercommon control with, such otherperson.’’ In addition, under section2(a)(3)(E), an investment adviser to aninvestment company is an ‘‘affiliatedperson’’ of such company. The Fund,the New Asia Fund, and CIEMF may bedeemed to be under common controlbecause the Manager is the investmentadviser to each of them. Therefore, theNew Asia Fund may be affiliated withthe Fund, and section 17(a) mayprohibit the New Asia Fund from sellingits Shares to the Fund.

9. Section 17(b) provides that the SECshall exempt a proposed transactionfrom section 17(a) if evidenceestablishes that: (a) the terms of theproposed transaction are reasonable andfair and do not involve overreaching; (b)the proposed transaction is consistentwith the policies of the registered


2 Section 17(b) applies to specific proposedtransactions and not to an ongoing series of futuretransactions. See Keystone Custodian Funds, 21S.E.C. 295, 298–299 (1945). Section 6(c) can be usedto grant relief from section 17(a) for an ongoingseries of future transactions.

investment company involved; and (c)the proposed transaction is consistentwith the general provisions of the Act.Applicants request an exemption undersections 6(c) and 17(b) to permit theNew Asia Fund to sell its Shares to theFund.2

10. Applicants believe that theProposed Investment satisfies thestandards of sections 6(c) and 17(b). TheFund will purchase Shares of the NewAsia Fund at the same purchase priceand on the same basis as all otherpurchasers of Shares. In addition, theProposed Investment is consistent withthe Fund’s investment objectives andpolicies as set forth in the Fund’sregistration statement. Applicants alsobelieve that the Proposed Investment isconsistent with the general purposes ofthe Act.

Section 17(d) and Rule 17d–111. Section 17(d) prohibits an

affiliated person of a registeredinvestment company, or an affiliatedperson of such person, acting asprincipal, from effecting any transactionin which such investment company is ajoint, or joint and several, participantwith such person in contravention ofSEC rules and regulations. Rule 17d–1provides that an affiliated person of aregistered investment company or anaffiliated person of such person, actingas principal, shall not participate in, oreffect any transaction in connectionwith, any joint enterprise or other jointarrangement in which the registeredinvestment company is a participantunless the SEC has issued an orderapproving the arrangement. TheProposed Investment may constitute ajoint enterprise or other jointarrangement within the meaning of rule17d–1.

12. Applicants believe that theProposed Investment satisfies the rule17d–1 standards. Applicants representthat the Fund’s board approved theinvestment by the Fund after carefullyconsidering all relevant factors. Allpurchasers of the New Asia Fund Shareswill receive equal treatment, and no oneparticipant will be favored over anyother in any respect.

Applicants’ ConditionsApplicants agree that the order

granting the requested relief shall besubject to the following conditions:

1. The Manager will waive itsmanagement fee (which includes

administrative fees) with respect to theFund’s net assets represented by theFund’s Proposed Investment in the NewAsia Fund. To effectuate this waiver,Fund assets represented by the Sharespurchased by the Fund under theProposed Investment will be excludedfrom the net assets of the Fund in thecalculation of the Manager’s fee. Assuch waiver relates to the Manager’s feeschedule, any Fund assets invested inthe New Asia Fund will be excludedfrom the Fund’s assets before any feecalculation is made; thus, the Fund’saggregate net assets will be adjusted bythe amount invested in the New AsiaFund prior to determining the fee basedon the Manager’s fee schedule (theamount waived pursuant to thisprocedure shall be defined as the‘‘Reduction Amount’’ for purposes ofcondition 4 below).

2. Any fees payable by the Fund to theManager so excluded in connectionwith the Proposed Investment, asdescribed herein, will be excluded forall time, and will not be subject torecoupment by the Manager or by anyother investment adviser at any othertime.

3. The Fund’s Proposed Investment inthe Shares will be limited to 1% of theFund’s total assets, taken at the time ofthe Fund’s subscription.

4. If the Manager waives any portionof its fees or bears any portion of itsexpenses in respect of the Fund (an‘‘Expense Waiver’’), the adjusted fees forthe Fund (gross fees minus ExpenseWaiver) will be calculated withoutreference to the Reduction Amount.Adjusted fees then will be reduced bythe Reduction Amount. If the ReductionAmount exceeds adjusted fees, theManager will reimburse the Fund in anamount equal to such excess.

5. The Shares owned by the Fund willbe voted by an independent directordesignated to act in such capacity.

6. Capital Group, CIEMF, and anyother Capital Group affiliates that maypurchase Shares of the New Asia Fundin the future will vote their Shares inproportion to the vote of all othershareholders of the New Asia Fund.

7. Shares of the New Asia Fund willnot be subject to a sales load,redemption fee, or a distribution fee.

8. Investment in Shares will be inaccordance with the Fund’s investmentrestrictions and will be consistent withits policies as recited in its registrationstatement and prospectus.

For the Commission, by the Division ofInvestment Management, pursuant todelegated authority.Margaret H. McFarland,Deputy Secretarys.[FR Doc. 96–9940 Filed 4–22–96; 8:45 am]BILLING CODE 8010–01–M

[Rel. No. IC–21899; 812–9948]

Glickenhaus & Co., et al.; Notice ofApplication

April 16, 1996.AGENCY: Securities and ExchangeCommission (‘‘SEC’’).ACTION: Notice of application forexemption under the InvestmentCompany Act of 1940 (the ‘‘Act’’).

APPLICANTS: Glickenhaus & Co.(‘‘Glickenhaus’’) and Lebenthal & Co.,Inc. (‘‘Lebenthal’’) (collectively, the‘’Sponsors’’); Empire State MunicipalExempt Trust (‘‘Empire Trust’’) andGlickenhaus Value Portfolios (‘‘EquityTrust’’).RELEVANT ACT SECTIONS: Order requestedunder sections 11(a) and 11(c).SUMMARY OF APPLICATION: Applicantsrequest an order to permit certain offersof exchange between unit investmenttrusts.FILING DATES: The application was filedon January 4, 1996 and amended onMarch 21, 1996.HEARING OR NOTIFICATION OF HEARING: Anorder granting the application will beissued unless the SEC orders a hearing.Interested persons may request ahearing by writing to the SEC’sSecretary and serving applicants with acopy of the request, personally or bymail. Hearing requests should bereceived by the SEC by 5:30 p.m. onMay 13, 1996, and should beaccompanied by proof of service onapplicants, in the form of an affidavit or,for lawyers, a certificate of service.Hearing requests should state the natureof the writer’s interest, the reason for therequest, and the issues contested.Persons who wish to be notified of ahearing may request notification bywriting to the SEC’s Secretary.ADDRESSES: Secretary: SEC, 450 5thStreet NW, Washington, DC 20549.Applicants: Glickenhaus, 6 East 43rdStreet, New York, New York 10017;Lebenthal, 120 Broadway, New York,New York 10271.FOR FURTHER INFORMATION CONTACT:David W. Grim Staff Attorney (202)942–0571, or David M. Goldberg,Branch Chief, at (202) 942–0564(Division of Investment Management,Office of Investment CompanyRegulation).


SUPPLEMENTARY INFORMATION: Thefollowing is a summary of theapplication. The complete application isavailable for a fee at the SEC’s PublicReference Branch.

Applicants’ Representations1. Glickenhaus and Lebenthal are the

sponsors for successive series of theEmpire Trust, and Glickenhaus is thesponsor for successive series of theEquity Trust, each series being aseparate unit investment trust registeredunder the Securities Act of 1933 and theAct. Applicants request that any reliefgranted pursuant to the application alsoapply to future series of the EmpireTrust and the Equity Trust andsubsequently issued unit investmenttrusts sponsored by either or both of theSponsors or a sponsor controlled by orunder common control with theSponsors and registered (or to beregistered) under the Securities Act of1933 and the Act (collectively with theEmpire Trust and the Equity Trust, the‘‘Trusts’’).

2. The sales charge for initialinvestment in the Empire Trust is 4.9%of the public offering price, and thesales charge for initial investment in theEquity Trust is 3.9% of the publicoffering price. Both sales charges aresubject to discounts for certain volumetransactions. The Sponsors intend tomaintain a secondary market for theunits of each series of the Empire Trustand the Equity Trust, although they arenot obligated to do so. The maximumsales charge upon units sold in thesecondary market is 5.9% for theEmpire Trust and 3.9% for the EquityTrust.

3. Applicants propose to offer topurchasers of units of any of the Trusts(‘‘Unitholders’’) the ability to exchangeany or all of their units for units in oneor more available series of the Trusts(the ‘‘Exchange Trusts’’) at a reducedsales charge (the ‘‘Exchange Privilege’’).Applicants also propose to offer toUnitholders the ability to roll over anyor all of their units in a series which isterminating for units of one or more newseries of the Trusts (the ‘‘RolloverTrusts’’) at a reduced sales charge (the‘‘Rollover Privilege’’).

4. A Unitholder must notify theSponsors of his or her desire to exercisehis or her Exchange Privilege. Exerciseof the Exchange Privilege is subject tothe following conditions: (a) theSponsors must be maintaining asecondary market in units of the Trustheld by the Unitholder and units of theavailable Exchange Trust, (b) at the timeof the Unitholder’s election toparticipate in the Exchange Privilege,there must be units of the Exchange

Trust available for sale, either under theinitial primary distribution or in theSponsors’ secondary market, and (c)exchanges will be effected in wholeunits only. Any excess proceeds fromthe units surrendered for exchange willbe remitted to the Unitholder; theUnitholder will not be permitted toadvance any new funds in order topurchase units of any of the ExchangeTrusts.

5. Except for Unitholders who wish toexercise the Exchange Privilege withinthe first five months of their purchase ofunits of the Trust, an investor whopurchases units under the ExchangePrivilege will pay a lower aggregatesales charge than that which would bepaid for the units by a new investor. ForUnitholders who wish to exercise theExchange Privilege within the first fivemonths of their purchase of units of anExchange Trust will be greater of (a) thereduced sales charge or (b) an amountwhich, when coupled with the salescharge paid by the Unitholder upon hisoriginal purchase of units of the Trust,would equal the sales charge applicableto the direct purchase of units of anExchange Trust, determined as of thedate of the exchange.

6. A Unitholder must notify theSponsors of his or her desire to exercisehis or her Rollover Privilege. Exercise ofthe Rollover Privilege is subject to thefollowing conditions: (a) the Sponsorsmust be maintaining a secondary marketin units of the available Rollover Trust,and (b) at the time of the Unitholders’election to participate in the RolloverPrivilege there must be units of theRollover Trust available for sale, eitherunder the initial primary distribution orin the Sponsors’ secondary market. Anyexcess proceeds from the unitssurrendered for exchange will beremitted to the Unitholder.

Applicants’ Legal Analysis1. Section 11(a) requires SEC approval

of an offer to exchange securities by aregistered open-end investmentcompany to the holder of a security ofsuch company or of any other open-endinvestment company if the exchangeoccurs on any basis other than therelative net asset values of the securitiesto be exchanged. Section 11(c) makessection 11(a) applicable to any type ofexchange offer of securities of registeredunit investment trusts for the securitiesof any other investment company,irrespective of the basis of exchange.

2. Applicants represent thatUnitholders will not be induced orencouraged to participate in theExchange or rollover Privilege throughan active advertising or sales campaign.The Sponsors state that they recognize

their responsibility to their customersnot to generate excessive commissionsthrough churning and represent that thesales charge collected will not be asignificant economic incentive tosalesmen to promote inappropriately theExchange or Rollover Privilege.Applicants further believe that theExchange and Rollover Privileges areappropriate in the public interest andconsistent with the protection ofinvestors and the purposes fairlyintended by the policy and provisions ofthe Act.

Applicants’ Conditions

If the requested order is granted,applicants agree to the followingconditions:

1. The prospectus for each series andany sales literature or advertisementthat mentions the existence of theExchange Privilege or the RolloverPrivilege will disclose that the Exchangeand the Rollover Privilege are subject totermination and that their terms aresubject to change.

2. Whenever the Exchange Privilegeor the Rollover Privilege is to beterminated or its terms are to beamended materially, any holder of asecurity subject to that privilege will begiven prominent notice of theimpending termination or amendmentat least 60 days prior to the date oftermination or the effective date of theamendment, provided that:

a. No such notice need be given if theonly material effect of an amendment isto reduce or eliminate the sales chargepayable at the time of an exchange, toadd one or more new series eligible forthe Exchange Privilege or the RolloverPrivilege, or to delete a series which hasterminated; and

b. No notice need be given if, underextraordinary circumstances, either

i. There is a suspension of theredemption of units of an ExchangeTrust or a Rollover Trust under section22(e) of the Act and the rules andregulations thereunder, or

ii. An Exchange Trust or a RolloverTrust temporarily delays or ceases thesale of its units because it is unable toinvest amounts effectively inaccordance with applicable investmentobjectives, policies and restrictions.

3. An investor who purchases unitsunder the Exchange or RolloverPrivilege will pay a lower aggregatesales charge than that which would bepaid for the units by a new investor.


1 15 U.S.C. 78s(b)(1) (1988).2 17 CFR 240.19b–4 (1994).

3 The Commission notes that a list of thecomponent securities and their respective weightsin the Index were attached to the proposed rulefiling as Exhibit A, and are available forexamination at the Amex or at the Commission asspecified in Item IV.

For the Commission, by the Division ofInvestment Management, pursuant todelegated authority.Margaret H. McFarland,Deputy Secretary.[FR Doc. 96–9865 Filed 4–22–96; 8:45 am]BILLING CODE 8010–01–M

[Release No. 34–37122; File No. SR–Amex–96–12]

Self-Regulatory Organizations; Noticeof Filing of Proposed Rule Change bythe American Stock Exchange, Inc.,Relating to Listing and Trading ofWarrants Based on the Selected TechStock Index

April 17, 1996.Pursuant to Section 19(b)(1) of the

Securities Exchange Act of 1934(‘‘Act’’) 1 and Rule 19b–4 thereunder,2notice is hereby given that on April 9,1996, the American Stock Exchange,Inc. (‘‘Amex’’ or ‘‘Exchange’’) filed withthe Securities and ExchangeCommission (‘‘Commission’’) theproposed rule change as described inItems I, II, and III below, which Itemshave been prepared by the Amex. TheCommission is publishing this notice tosolicit comments on the proposed rulechange from interested persons.

I. Self-Regulatory Organization’sStatement of the Terms of Substance ofthe Proposed Rule Change

The Amex, pursuant to Rule 19b–4 ofthe Act, proposes to approve for listingand trading, under Section 106 of theAmex Company Guide, index warrantsbased on the Selected Tech Stock Index(‘‘Index’’), a price-weighted, narrow-based index developed by an issuer andcomprised of 24 technology stockswhich are traded on the Amex, the NewYork Stock Exchange, Inc. (‘‘NYSE’’), orthrough the facilities of the NationalAssociation of Securities DealersAutomated Quotation system and arereported national market systemsecurities (‘‘Nasdaq/NMS’’).

II. Self-Regulatory Organization’sStatement of the Purpose of, andStatutory Basis for, the Proposed RuleChange

In its filing with the Commission, theAmex included statements concerningthe purpose of and basis for theproposed rule change, and discussedany comments it received on theproposed rule change. The text of thesestatements may be examined at theplaces specified in Item IV below. TheAmex has prepared summaries, set forth

in Sections A, B, and C below, of themost significant aspects of suchstatements.

A. Self-Regulatory Organization’sStatement of the Purpose of, andStatutory Basis for, the Proposed RuleChange

1. Purpose

Under Section 106 (Currency andIndex Warrants) of the Amex CompanyGuide, the Exchange may approve forlisting index warrants based on foreignand domestic market indices. While theExchange currently lists and tradeswarrants on a number of foreign marketindices and broad-based domesticmarket indices, it now proposes to listand trade a warrant based on a narrow-based domestic market index. Thelisting and trading of warrants on theSelected Tech Stock Index will complyin all respects with Exchange Rules1100 through 1110 for the trading ofstock index and currency warrants.

Warrant issues on the Index willconform to the listing guidelines underSection 106, which provide, amongother things, that: (1) The issuer shallhave tangible net worth in excess of$250,000,000 and otherwisesubstantially exceed size and earningsrequirements in Section 101(A) of theCompany Guide or meet the alternateguideline in paragraph (a); (2) the termof the warrants shall be for a periodranging from one to three years from thedate of issuance; and (3) the minimumpublic distribution of such issues shallbe 1,000,000 warrants, together with aminimum of 400 public holders, andhave an aggregate market value of$4,000,000.

Index warrants will be directobligations of their issuer subject tocash-settlement during their term, andeither exercisable throughout their life(i.e., American style) or exercisable onlyon their expiration date (i.e., Europeanstyle). Upon exercise, or at the warrantexpiration date (if not exercisable priorto such date), the holder of a warrantstructured as a ‘‘put’’ would receivepayment in U.S. dollars to the extentthat the Index has declined below a pre-stated cash settlement value.Conversely, holders of a warrantstructured as a ‘‘call’’ would, uponexercise or at expiration, receivepayment in U.S. dollars to the extentthat the Index has increased above thepre-stated cash settlement value. If ‘‘out-of-the-money’’ at the time of expiration,the warrants would expire worthless. Inaddition, the Amex, prior to thecommencement of trading, willdistribute a circular to its membership

calling attention to specific risksassociated with warrants on the Index.

The Amex is proposing to list indexwarrants based on the Selected TechStock Index, a price-weighted indexdeveloped by an issuer and representinga narrow-based portfolio of large,actively-traded technology stocks.3 Thetotal market capitalization of the Indexwas $329,094,000,000 on April 3, 1996.The median capitalization of thecomponents in the Index on that datewas $3.8 billion, and the average marketcapitalization of these companies was$13.71 billion. The individual marketcapitalization of the companies rangedfrom $594 million to $68.1 billion.Average monthly trading volume in theIndex stocks ranged from approximately4.4 million shares to approximately229.6 million shares during the six-month period from October 1995through March 1996. The Exchange willmonitor the components in the basketon a monthly basis and will advise theCommission whenever less than 75% ofthose components are eligible forstandardized options trading. Currently,100% of the components are eligible forstandardized options trading. TheSelected Tech Stock Index shall be usedas the basis for only one index warrantto be listed and traded on the Exchange.If the Exchange wishes to list and tradeother products based on the SelectedTech Stock Index, including other indexwarrants, the Exchange shall advise theCommission to determine whether anadditional filing pursuant to Rule 19b–4 of the Act is necessary or appropriate.

The Index is price-weighted; its valuecorresponds to the sum of the prices ofone share of each of the componentstocks, reduced by a divisor. The Indexdivisor will be determined to yield thebenchmark value of 100.00 on the datethe warrant is priced for initial offeringto the public. Similar to other stockindex values published by theExchange, the value of the Index will becalculated continuously anddisseminated every 15 seconds over theConsolidated Tape Association’sNetwork B.

The Index will be monitored daily forcertain types of corporate actions suchas the payment of a dividend other thanan ordinary cash dividend, stockdistribution, stock split, reverse stocksplit, rights offering, distribution,reorganization, recapitalization, orsimilar event which may require adivisor adjustment to maintain


4 15 U.S.C. 78f(b)(5) (1988).

5 17 CFR 200.30–3(a)(12) (1994).1 Amendment No. 1 serves to supersede entirely

the Exchange’s initial rule filing. Therefore, thisnotice incorporates Amendment No. 1 in itsentirety. Letter from Charles R. Haywood, Foley &Lardner, to Francois Mazur, Attorney, Division of

Market Regulation, Commission, dated April 11,1996 (‘‘Amendment No. 1’’).

2 Telephone Conversation between David T.Rusoff, Foley & Lardner, and Francois Mazur, Officeof Market Supervision, Division of MarketRegulation, on April 12, 1996.

continuity of the index’s value. In theevent of a merger, consolidation,dissolution, or liquidation of an issuer,or in certain other events such as thedistribution of property by an issuer toshareholders, components in the indexmay be deleted or replaced. Shares of acomponent stock may be replaced (orsupplemented) with other securitiesunder certain other circumstances, suchas the conversion of a component stockinto another class of security or thespin-off of a subsidiary. If the stockremains in the index, the divisor may beadjusted to maintain the continuity ofthe Index’s value. In the event that asecurity in the index is removed due toa corporate consolidation and theholders of such security receive cash,the cash value of such security will beincluded in the Index and will accrueinterest at LIBOR to term.

2. Statutory Basis

The Amex believes that the proposedrule change is consistent with Section6(b) of the Act in general, and withSection 6(b)(5) in particular,4 in that itis designed to prevent fraudulent andmanipulative acts and practices, topromote just and equitable principles oftrade, and is not designed to permitunfair discrimination betweencustomers, issuers, brokers, or dealers.

B. Self-Regulatory Organization’sStatement on Burden on Competition

The Amex does not believe that theproposed rule change will impose anyinappropriate burden on competition.

C. Self-Regulatory Organization’sStatement on Comments on theProposed Rule Change Received FromMembers, Participants, or Others

No written comments were solicitedor received with respect to the proposedrule change.

III. Date of Effectiveness of theProposed Rule Change and Timing forCommission Action

Within 35 days of the publication ofthis notice in the Federal Register orwithin such longer period (i) as theCommission may designate up to 90days of such date if it finds such longerperiod to be appropriate and publishesits reasons for so finding, or (ii) as towhich the Amex consents, theCommission will:

A. By order approve the proposed rulechange, or

B. Institute proceedings to determinewhether the proposed rule changeshould be disapproved.

IV. Solicitation of CommentsInterested persons are invited to

submit written data, views, andarguments concerning the foregoing.Persons making written submissionsshould file six copies thereof with theSecretary, Securities and ExchangeCommission, 450 Fifth Street, NW.,Washington, DC 20549. Copies of thesubmission, all subsequentamendments, all written statementswith respect to the proposed rulechange that are filed with theCommission, and all writtencommunications relating to theproposed rule change between theCommission and any person, other thanthose that may be withheld from thepublic in accordance with theprovisions of 5 U.S.C. 552, will beavailable for inspection and copying atthe Commission’s Public ReferenceSection, 450 Fifth Street, N.W.,Washington, DC 20549. Copies of suchfiling also will be available forinspection and copying at the principaloffice of the Amex. All submissionsshould refer to File No. SR–Amex–96–12 and should be submitted by May 14,1996.

For the Commission, by the Division ofMarket Regulation, pursuant to delegatedauthority.5

Margaret H. McFarland,Deputy Secretary.[FR Doc. 96–9894 Filed 4–22–96; 8:45 am]BILLING CODE 8010–01–M

[Release No. 34–37121; International SeriesRelease No. 969; File No. SR–CHX–96–12]

Self-Regulatory Organizations; Noticeof Filing of Proposed Rule Change andAmendment No. 1 Thereto by theChicago Stock Exchange, Inc. Relatingto Listing Standards for InvestmentCompany Units

April 17, 1996.Pursuant to Section 19(b)(1) of the

Securities Exchange Act of 1934, 15U.S.C. 78s(b)(1) (‘‘Act’’), notice is herebygiven that on March 27, 1996, theChicago Stock Exchange, Inc. (‘‘CHX’’ or‘‘Exchange’’) filed with the Securitiesand Exchange Commission the proposedrule change as described in Items I, II,and III below, which Items have beenprepared by the self-regulatoryorganization. On April 12, 1996, theExchange filed Amendment No. 1 to itsproposal.1 The Commission is

publishing this notice to solicitcomments on the proposed rule changefrom interested persons.

I. Self-Regulatory Organization’sStatement of the Terms of Substance ofthe Proposed Rule Change

The Exchange proposes to amendArticle XXVIII of its Rules governing thelisting requirements of securities on theCHX, as well as Article XXX of theCHX’s Rules governing specialists.

II. Self-Regulatory Organization’sStatement of the Purpose of, andStatutory Basis for, the Proposed RuleChange

In its filing with the Commission, theself-regulatory organization includedstatements concerning the purpose ofand basis for the proposed rule changeand discussed any comments it receivedon the proposed rule change. The textof these statements may be examined atthe places specified in Item IV below.The self-regulatory organization hasprepared summaries, set forth insections A, B and C below, of the mostsignificant aspects of such statements.

A. Self-Regulatory Organization’sStatement of the Purpose of, andStatutory Basis for, the Proposed RuleChange

The Exchange is proposing listingstandards for units of trading (‘‘Units’’)that represent an interest in a registeredinvestment company (‘‘InvestmentCompany’’) that could be organized as aunit investment trust (‘‘UIT’’), an open-end management investment company,or a similar entity. The investmentcompany would hold securitiescomprising, or otherwise based on orrepresenting an investment in, an indexor portfolio of securities. Theinvestment company could either holdthe securities directly or could holdanother security representing the indexor portfolio of securities (such as sharesof a UIT that holds shares of an open-end investment company).

Under the proposed rules, theInvestment Company would be requiredeither to: (i) hold securities comprisingor otherwise based on or representingand interest in an index or portfolio ofsecurities, or (ii) hold securities inanother registered investmentcompany.2 The Investment Companywould then issue Units in a specifiedaggregate number in return for a depositof either: (i) shares of securities


3 Id.4 Id.

5 Interpretation and Policy .01 of Article XXX,Rule 23 defines ‘‘exclusive issue’’ as the stock ofany company traded on the Exchange no otherwisetraded on the NYSE, American Stock Exchange, orNASDAQ/NMS, and, where there exists anothermarket for such issue, the Exchange has executed15% or more of the volume in the issue during thethree previous months.

6 CHX understands that ‘‘CountryBaskets’’ and‘‘The CountryBaskets Index Fund’’ are servicemarks of Deutsche Morgan Grenfell/C.J. Lawrence,Inc. (‘‘DMG’’), the investment advisor to the fund.

7 Securities Exchange Act Release No. 36923(March 5, 1996), 61 FR 10410.

8 17 CFR 240.12f–5 (1995).

comprising or otherwise based on therelevant index or portfolio, or (ii) sharesof a registered investment company. Inaddition or instead of the ‘‘in-kind’’deposit, the Investment Company mightrequire a cash deposit. Thus, Unitscould be structured as series of an open-end management investment companyinvesting in a portfolio of securities(‘‘Fund-only structure’’). Alternatively,Units could be structured as UITs thathave as their assets shares of an open-end investment company holding aportfolio of securities (‘‘Fund/UITstructure’’). Unit holders would receiveperiodic cash payments correspondingto the regular cash dividends ordistributions declared with respect tothe securities held by the InvestmentCompany (after subtracting applicableexpenses and charges).

Units would be distributed in‘‘Creation Transactions.’’ To effect aCreation Transaction in a Fund-onlystructure, an entity would buy sharesfrom the investment company (‘‘Fund’’)in ‘‘Creation Unit’’ size aggregations inexchange for a deposit of a basket ofsecurities reflecting the securitiesunderlying the Fund and/or cashdeposit. To effect a Creation Transactionin a Fund/UIT structure, an entitywould buy a Fund share with a similardeposit and exchange it for a CreationUnit.3 The owner of a Creation Unitcould then subdivide the Creation Unitinto a specific number of identicalfractional non-redeemable sub-units, theUnits, that would constitute securitiestraded. Units could be recombined intoCreation Unit aggregations, andredeemed for the securities underlyingthe Fund and/or an amount of cash,either directly, or indirectly, dependingon the structure chosen. The securitieswould not be redeemable other than inCreation Unit aggregations.4

Dealing in Units on the Exchange willbe conducted pursuant to theExchange’s general agency-auctiontrading rules. The Exchange’s generaldealing and settlement rules wouldapply, including its rules on clearanceand settlement of securities transactionsand its equity margin rules. Othergenerally applicable Exchange equityrules and procedures also would apply.Unless the prospectus for a specificsecurity states otherwise, the Unitstrading on the Exchange will have onevote per share; however, as with othersecurities issued by registeredinvestment companies, there will not bea ‘‘pass-through’’ of the voting rights onthe actual index securities held by afund or directly or indirectly by a trust.

With respect to specialist dealings,Article XXX, Rule 23(a) of theExchange’s Rules precludes certainbusiness relationships between anissuer of an ‘‘exclusive issue’’ and thespecialist in that exclusive issue.5 Rule23(a) could be interpreted when listingcertain types of Units to prevent aspecialist from engaging in CreationTransactions with the issuer. TheExchange believes, however, that suchmarket activities could enhanceliquidity in the Units and facilitate thespecialist’s market-makingresponsibilities. In addition, since thespecialist will be able to engage inCreation Transactions and redemptionsonly according to the same terms andconditions as every other investor (andonly at net asset value), the Exchangebelieves that there is no potential forabuse.

Therfore, the Exchange proposesamending Article XXX, Rule 23(a) topermit specialists to engage in thesetypes of transactions if such transactionswould facilitate the maintenance of afair and orderly market in the Security.Any Creation Transactions in which thespecialist engages, however, will have tobe effected through the Distributor (asdefined herein), and not directly withthe issuer. This requirement will makeclear that the specialist is purchasingUnits in Creation Unit-size aggregationsonly to facilitate normal specialisttrading activity.

With respect to investor disclosure,the Exchange notes that, pursuant to therequirements of the Securities Act of1933 (‘‘1933 Act’’), all investors in Unitswill receive a prospectus regarding theUnits. Because the Units will be incontinuous distribution, the prospectusdelivery requirements of the 1933 Actwill apply to all investors in Units. It ispossible, however, that an exemptionfrom the prospectus deliveryrequirement may be obtained at somepoint in the future with respect to Unitslisted or traded on the Exchange. In theevent of such an exemption, theExchange will discuss with Commissionstaff the appropriate level of disclosurethat should be required with respect tothe Units being listed or traded, asappropriate, and will file any necessaryrule change to provide for suchdisclosure.

Upon the initial listing of any class ofUnits or trading of such Units pursuant

to unlisted trading privileges, theExchange will issue a circular to itsmembership explaining the uniquecharacteristics and risks of this type ofsecurity. The circular will, among otherthings, inform member organizations oftheir responsibility to deliver aprospectus to investors.

With respect to trading halts, thetrading of Units would be halted, alongwith the trading of all other listedstocks, in the event the ‘‘circuit breaker’’thresholds of Article IX, Rule 10A of theExchange’s Rules are reached.

The Exchange proposes that Unitstrade either in certificated form or solelythrough the use of a global certificate.Permitting the use of global certificateswould be consistent with expediting theprocessing of transactions in Units andwould minimize the costs of engaging intransactions in these securities.

One existing form of Units areCountryBasket securities(‘‘Securities’’),6 Which are createdpursuant to a Fund-only structure. TheNew York Stock Exchange (‘‘NYSE’’)has received permission to list and tradeCountryBaskets.7 CHX is not askingpermission to list CountryBaskets at thistime, but rather will tradeCountryBaskets pursuant to unlistedtrading privileges (‘‘UTP’’) once thegeneric listing standards set forth hereinare approved.

Pursuant to Rule 12f–5 under theAct,8 prior to trading a particular classor type of security pursuant to UTP,CHX must have listing standardscomparable to those of the primaryexchange on which the security islisted. The NYSE has adopted listingstandards for investment companyunits, and CHX’s proposed rule changeis designed to create similar standardsfor investment company unit listingand/or trading on CHX. As stated above,CHX propose to trade CountryBasketspursuant to UTP upon approval of thisrule filing.

The remainder of this section of thefiling merely provides backgroundinformation on CountryBaskets. Theinformation, taken from File No. SR–NYSE–95–23, describes the structureand mechanics of CountryBaskets.

CountryBasket securities are issued asseries of an open-end managementinvestment company that will invest ina portfolio of securities (‘‘IndexSecurities’’) included in acorresponding index. Each series of the


9 According to Amendment No. 1 to SR–NYSE–95–23, the Indices are a continuation of the FT–Actuaries World Indices, which were jointlyfounded by The Financial Times Limited (‘‘FT’’),Goldman, Sachs & Co. (‘‘Goldman’’), and NatWestSecurities Limited (‘‘NatWest,’’ and each a‘‘Founding Member’’). In May 1995, Standard &Poor’s (‘‘S&P’’), a division of The McGraw-HillCompanies, Inc., joined FT and Goldman as co-publishers of the predecessor to the Indices. As partof the new arrangement, NatWest withdrew fromthe management of those indices, but continues tobe recognized as a Founding Member. The Indicesare now jointly owned by S&P, FT and Goldman.Following a transition period, FT and S&P willjointly calculate the Indices. In November 1995, FTtransferred its ownership rights in the Indices toFT–SE International, a new company jointly ownedby the FT and the London Stock Exchange. By theend of 1996, it is expected that FT–SE Internationalwill assume responsibility for calculating theEuropean and Asia-Pacific Indices and S&P willcalculate the U.S. Index.

10 If a Fund/UIT structure instead had been used,a ‘‘Redeemable Unit’’ would represent thefunctional equivalent of the Creation Unit. Theowner of a Redeemable Unit could separate it intoa specific number of identical fractional non-redeemable sub-units that would constitute theSecurities traded on the Exchange. In the case of theGermany CountryBasket series, for example, therewould be 100,000 Securities per Redeemable Unit.These Securities could be recombined intoRedeemable Units and then redeemed, at NAV, forthe appropriate number of Fund shares. In turn, theFund shares could be redeemed for the IndexSecurities and cash. The Securities would not beredeemable other than in the Creation Unitaggregations.

11 In Amendment No. 1 to SR–NYSE–95–23, theNYSE stated that certain modifications hadoccurred to the indices. The Chicago StockExchange’s filing has incorporated the additionalinformation, and operates under the assumptionthat the original information detailed in SR–NYSE–95–23 continues to be accurate to the extent notmodified by the NYSE’s amendment.

investment company is designed toprovide investment results thatsubstantially correspond to the priceand yield performance of acorresponding FT/S&P–Actuaries WorldIndex (‘‘Index’’ or ‘‘FT/S&P’’).9 Theinitial nine series of Funds will be basedon the following Indices: Australia,France, Germany, Hong Kong, Italy,Japan, South Africa, United Kingdom,and the United States.

Distribution of the SecuritiesThe Securities are distributed in

transactions with the Fund throughCreation Transactions. To effect aCreation Transaction, a person wouldbuy Fund shares from the Fund at theirnet asset value (‘‘NAV’’) next computed.The sales will be in Creation Unit-sizeaggregations in exchange for a deposit(‘‘Deposit’’) of Index Securities (a ‘‘FundBasket’’) and a specified amount of cashsufficient to equal the NAV of suchshares.

Securites in Creation Unit-sizeaggregations may be redeemed, at NAV,generally for an in-kind distribution ofIndex Securities comprising the Fundshares, plus a cash payment. A CreationUnit-size of Fund shares will representsecurities with approximately $2 to $9.5million in market value. The CreationUnit would be disaggregated into theindividual Securities that would tradeon the Exchange.10 For the nine initial

CountryBasket securities, there wouldbe the following number of Securitiesper Creation Unit:Australia—100,000France—100,000Germany—100,000Hong Kong—100,000Italy—100,000Japan—250,000South Africa—100,000United Kingdom—100,000United States—100,000

There may be an initial distributionperiod of Fund shares lasting from oneto a few weeks. During this period, theprincipal underwriter or distributor(‘‘Distributor’’) directly or throughsoliciting dealers would acceptsubscriptions to purchase Fund shares.

Exchange Trading of UnitsThe proposed listing criteria provide

flexible standards for the listing ofUnits. Before commencing trading, theExchange will require that there be atleast 300,000 tradeable Unitsoutstanding, representing, for the nineseries encompassed by this filing, atleast three Creation Units (except for theJapan CountryBasket). The Exchangewill consider the suspension of tradingand the delisting of a series of Units if:

• After the first year of trading, there arefewer than 50 record or beneficial holders ofthe Units for 30 or more consecutive tradingdays;

• The value of the underlying index orportfolio of securities is no longer calculatedor available; or

• There occurs another event that makesfurther dealings in the Units on the Exchangeinadvisable.

The FT/S&P-Actuaries World IndicesDeutsche Bank Securities

Corporation, formerly investmentadviser to the Funds, provided theNYSE with certain informationdescribing the FT/S&P-Actuaries WorldIndices, contained within NYSE filingSR–NYSE–95–23, as amended. Thefollowing combines information fromthe initial filing and Amendment Nos. 1and 2 to that filing.

Establishing an IndexThe FT/S&P are jointly compiled by

the Financial Times Limited, Goldman,Sachs & Co., and Standard & Poor’s, adivision of The McGraw-HillCompanies, Inc., in conjunction withthe Institute of Actuaries (together, the‘‘consortium’’).11 The aim of the

Consortium is to create and maintain aseries of high quality equity indices foruse by the global investmentcommunity. Specifically, theConsortium seeks to establish andmaintain the FT/S&P so that the respectto their corresponding markets, they arecomprehensive, consistent, flexible,accurate, investible, and representative.

The World Index Policy Committee(‘‘WIPC’’) makes all policy decisionsconcerning the FT/S&P, includingobjectives, selection criteria, liquidityrequirements, calculationmethodologies, and the timing anddisclosure of additions and deletions.The WIPC makes those decisions in amanner that is consistent with the statedaims and objectives of the Consortium.In general, the WIPC aims for aminimum of 70 percent coverage of theaggregate value of all domesticexchange-listed stocks in every country,region and sector in which it maintainsan index.

The WIPC consists of onerepresentative of each Consortiummember, one member nominated byeach of the parties as representing anactual or prospective main user group ofthe World Indices, a Chairman andadditional member who are members ofthe Institute of Actuaries of the Facilityof Actuaries.

A country must satisfy the followingcriteria for the WIPC to include it in theFT/S&P-Actuaries World Indices: (1)Direct equity investment by non-nationals must be permitted, (2)accurate and timely data must beavailable; (3) no significant exchangecontrols should exist that would preventthe timely repatriation of capital ordividends; (4) significant internationalinvestor interest in the local equitymarket must have been demonstrated;and (5) adequate liquidity must exist.

Securities in the FT/S&P are subject tothe following ‘‘investibility screens’’: (1)Securities comprising the bottom fivepercent of any market’s capitalizationare excluded; (2) securities must beeligible to be owned by foreigninvestors; (3) 25 percent or more of thefull capitalization of eligible securitiesmust be publicly available forinvestment and not in the hands of asingle party or parties ‘‘acting inconcert’’; and (4) securities that fail totrade for more than 15 business dayswithin each of two consecutive quartersare excluded.

The WIPC seeks to select constituentstocks that capture 85 percent of theequity that remains in any market(known as the ‘‘investible universe’’)after applying the investibility screens.Securities are selected with regard toeconomic sector and market


capitalization to make a given FT/S&Phighly representative of the overalleconomic sector make-up and marketcapitalization distribution of theinvestible universe of a market.

Maintaining an IndexThe WIPC may add securities to the

FT/S&P for any of the following reasons:(1) The addition would make theeconomic sector make-up and marketcapitalization distribution of the FT/S&P component more representative ofits investible universe; (2) a non-constituent security has gained inimportance and replaces an existingconstituent security under the rules ofreview established by the WIPC; (3) theFT/S&P component represents less thanits targeted percentage of thecapitalization of its investible universe(usually in cases where the investibleuniverse has grown faster than thecorresponding FT/S&P); (4) a new,eligible security becomes availablewhose total capitalization is one percentor more of the current capitalization ofthe relevant FT/S&P; (5) an existingconstituent ‘‘spins off’’ a part of itsbusiness and issues new equity to theexisting shareholders; or (6) changes ininvestibility factors lead to a stockbecoming eligible for inclusion and thatstock now qualifies on other grounds.

The WIPC may adjust the FT/S&P forany of the following reasons: (1) Thecomponent comprises too high apercentage of its representativeuniverse; (2) a review by the WIPCshows that a constituent security hasdeclined in importance and should bereplaced by a non-constituent security;(3) the deletion of a security that hasdeclined in importance would make theFT/S&P more representative of theeconomic make-up of its investibleuniverse; (4) circumstances regardinginvestibility and free float change,causing the constituent security to failthe FT/S&P screening criteria; (5) andexisting constituent security is acquiredby another entity; or (6) the stock hasbeen suspended from trading for aperiod of more than ten working days.Generally, but not in all cases, changesresulting from review by the WIPCoccur at the end of a calendar quarter.Changes resulting from merger or ‘‘spin-off’’ activity will be effectuated as soonas practicable.

Dissemination of Changes to theConstituent Stocks in the Indices

Changes to an Index made during acalendar quarter are noted at the foot ofthe tables containing the Indices that arepublished daily in the ET. Consistentwith the FT publication policy, thesechanges also are shown prior to the

actual day of implementation (unless forreasons beyond the control of FT this isnot possible). Decisions regarding theaddition of new eligible constituentstocks that are unrelated to existingstocks in an Index, or weighting changesto existing constituent stocks, areannounced in the FT at least fourworking days before they areimplemented. Monday editions of theFT also show all constituent changesmade during the previous week,together with base values for eachIndex. Changes to be made in an Indexat the end of a calendar quarter arepublished as soon as is practicablefollowing the quarterly meeting of theWorld Indices Policy Committee, butbefore the quarter-end.

Calculation and Dissemination of anIndex

The FT/S&P are calculated throughwidely accepted mathematical formulae,with the effect that the Indices areweighted arithmetic averages of theprice relatives of the constituents—asproduced solely by changes in themarketplace—adjusted for interveningcapital changes. The FT/S&P are base-weighted aggregates of the initial marketcapitalization, the price of each issuebeing weighted by the number of sharesoutstanding, modified to reflect onlythose shares outstanding that areeligible to be owned by foreigninvestors.

For each constituent security, theimplied annual dividend is divided by260 (an accepted approximation for thenumber of business days in a calendaryear). This dividend is then reinvesteddaily according to standard actuarialcalculations. Distributions affectadjustments to the base capital or theprice per share in accordance withprescribed FT/S&P standards. Theindices’ values and related performancefigures for various periods of time arecalculated daily and are disseminated tothe public.

The FT/S&P are valued in terms oflocal currency, U.S. dollars, and U.K.pounds sterling, thereby allowing theeffect of currency value on the Indexvalue to be measured. Changes to theindices are announced as soon aspossible, and on Mondays the FinancialTimes publishes a list of changes toeach index implemented during theprevious week, if any. The FT/S&P arecalculated once a day on weekdayswhen one or more of the constituentmarkets are open; the indices aresyndicated and published in thefinancial sections of several newspapersworldwide. FT/S&P data also may bepurchased electronically.

Recognizing the importance of havingcurrent information on the value of theIndices, DMG has arranged forTelesphere Corporation (formerlyTelekurs (North America) Inc.)(‘‘Telesphere’’) to calculate ‘‘indicativevalues’’ for the nine Indices on whichCountryBaskets are based on a morefrequent basis. CHX understands thatthe NYSE will provide for thedissemination of these indicative valuesthrough the facilities of theConsolidated Tape Association(‘‘CTA’’).

In calculating ‘‘indicative values,’’Telesphere will use the most currentlyavailable stock price information for theconstituent stocks in an Index (based onhome currency prices) and prevailingcurrency exchange rates to translate theIndex value into U.S. dollars.Telesphere will also use the samepricing algorithm and methodology asthe Index calculators in calculating theindicative values. These values will bedisseminated every 30 seconds by theNYSE during regular trading hours of9:30 A.M. to 4:00 P.M. Eastern time. Dueto the differences in trading hours in themarkets for the stocks underlying theIndices, the calculation of the indicativevalues will be implemented as follows:

• Pacific Rim. Australia, Hong Kong, andJapan. There is no overlap between the NYSEtrading hours and the home-country tradinghours. Thus, the indicative values willalways reflect the closing prices of theunderlying securities on the most recentlycompleted trading day, but will be updatedevery 30 seconds to reflect changes inexchange rates.

• Europe. France, Germany, Italy, and theUnited Kingdom. There is some overlapbetween NYSE trading hours and home-country trading hours. Thus, the 30-secondupdates for these Indices will reflect changesin both current stock price information andcurrency exchange rates while the relevantmarket is open; it will reflect only changesin exchange rates once the home-marketcloses.

• United States. Each 30-second updatewill reflect the current price of U.S.component stocks.

• South Africa. During Eastern StandardTime there is no overlap between NYSE andSouth African trading hours. During EasternDaylight Savings Time there is a half-houroverlap. Thus, during Standard Time, thedisseminated Index values will reflect theclosing South African prices. During DaylightSavings Time, there will be a real-time feedof stock prices from the Johannesburg StockExchange and there will be a real-timecalculation of the indicative value of theIndex at 30-second intervals during the half-hour overlap.

While these indicative values will notbe the official values of the Indices(which will continue to be calculatedand disseminated once each day), the


12 In the unlikely event that Telespheredetermines that it no longer will calculate theindicative values of the Indices, according to theNYSE DMG will seek to find another entity toprovide such values on substantially the same basisas Telesphere. if this were to occur, the NYSE hasrepresented that it will consult with the staff of theDivision of Market Regulation to ensure that thestaff finds any proposed new arrangementsacceptable, including the possibility of endingtrading in the securities. 13 17 CFR 200.30–3(a)(12) (1994).

Exchange believes that these values willprovide investors with accurate, timelyinformation on the values of the Indices.Of course, it cannot be guaranteed thatthe indicative value will at all times bea completely accurate reflection of thevalue of the underlying index. This alsowill provide all investors with equalaccess to information concerning thevalues of the Indices. While somemarket participants may be able toperform these calculations for their owntrading purposes during the businessday, many participants lack sufficientresources to do so. Providingstandardized information through CTAfacilities will help ensure that allinvestors have equal access to thismarket information.12

Although the Chicago Stock Exchangeoperates under Central Time, its tradinghours are timed to coincide with thoseof the NYSE. Therefore, the time zonedifference will not affect the ability totrade CountryBaskets on the CHX withfull price information.

Telesphere is providing the indicativevalues subject to substantially thefollowing terms regarding its liability:

The values are representative, unofficial,and indicative estimates of the FT/S&P-Actuaries World Indices (‘‘FT/S&P’’)calculated by Telesphere Corporation(‘‘Telesphere’’). Although they are providedwith permission under a licensing agreementwith Deutsche Morgan Grenfell/C.J.Lawrence Inc. (‘‘Subscriber’’), they are not,and should not be considered as, official FT/S&P index values. They are provided as aninformation service to benefit the investmentcommunity. Neither Telesphere norSubscriber, The Financial Times Ltd.,Standard & Poor’s, Goldman, Sachs & Co., ortheir partners, affiliates employees andAgents, shall have any liability contingent orotherwise, to third parties for thecompleteness, or interruption in the deliveryof the indicative indices. In no event will anysuch party be liable for any special, indirect,incidental, or consequential damages.

The Exchange believes that itsproposal is consistent with Section6(b)(5) of the Act in that the proposalfosters cooperation and coordinationwith persons engaged in regulating,clearing, settling, processinginformation with respect to, andfacilitating transactions in securities,removes impediments to and perfectsthe mechanism of a free and open

market and a national market systemand protects investors and the publicinterest.

B. Self-Regulatory Organization’sStatement on Burden on Competition

The proposed rule change does notimpose any burden on competition thatis not necessary or appropriate infurtherance of the purposes of the 1934Act.

C. Self-Regulatory Organization’sStatement on Comments on theProposed Rule Change Received FromMembers, Participants or Others

The Exchange has not solicited, anddoes not intend to solicit, comments onthis proposed rule change. TheExchange has not received anyunsolicited written comments frommembers or other interested parties.

III. Date of Effectiveness of theProposed Rule Change and Timing forCommission Action

Within 35 days of the date ofpublication of this notice in the FederalRegister or within such longer period (i)as the Commission may designate up to90 days of such date if it finds suchlonger period to be appropriate andpublishes its reasons for so finding or(ii) as to which the self-regulatoryorganization consents, the Commissionwill:

(a) By order approve such proposedrule change, or

(b) Institute proceedings to determinewhether the proposed rule changeshould be disapproved.

IV. Solicitation of CommentsInterested persons are invited to

submit written data, views andarguments concerning the foregoing.Persons making written submissionsshould file six copies thereof with theSecretary, Securities and ExchangeCommission, 450 Fifth Street, NW.,Washington, DC 20549. Copies of thesubmission, all subsequentamendments, all written statementswith respect to the proposed rulechange that are filed with theCommission, and all writtencommunications relating to theproposed rule change between theCommission and any person, other thanthose that may be withheld from thepublic in accordance with theprovisions of 5 U.S.C. 552, will beavailable for inspection and copying inthe Commission’s Public ReferenceSection, 450 Fifth Street, NW.,Washington, DC 20549. Copies of suchfiling will also be available forinspection and copying at the principaloffice of the above-mentioned self-

regulatory organization. All submissionsshould refer to File No. SR–CHX–96–12and should be submitted by May 14,1996.

For the Commission, by the Division ofMarket Regulation, pursuant to delegatedauthority.13

Margaret H. McFarland,Deputy Secretary.[FR Doc. 96–9893 Filed 4–22–96; 8:45 am]BILLING CODE 8010–01–M

SMALL BUSINESS ADMINISTRATION

Interest Rates

The Small Business Administrationpublishes an interest rate called theoptional ‘‘peg’’ rate (13 CFR 122.8–4(d))on a quarterly basis. This rate is aweighted average cost of money to thegovernment for maturities similar to theaverage SBA direct loan. This rate maybe used as a base rate for guaranteedfluctuating interest rate SBA loans. Thisrate will be 53⁄4 percent for the April-June quarter of FY 96.

Pursuant to 13 CFR 108.503–8(b)(4),the maximum legal interest rate for acommercial loan which funds anyportion of the cost of a project (see 13CFR 108.503–4) shall be the greater of6% over the New York prime rate or thelimitation established by theconstitution or laws of a given State.The initial rate for a fixed rate loan shallbe the legal rate for the term of the loan.John R. Cox,Associate Administrator for FinancialAssistance.[FR Doc. 96–9876 Filed 4–22–96; 8:45 am]BILLING CODE 8025–01–M


Aviation Proceedings; AgreementsFiled During the Week Ending April 12,1996

The following Agreements were filedwith the Department of Transportationunder the provisions of 49 U.S.C 412and 414. Answers may be filed within21 days of date of filing.Docket Number: OST–96–1251Date filed: April 11, 1996Parties: Members of the International

Air Transport AssociationSubject:

COMP Telex Mail Vote 798Fares from SudanIntended effective date: May 1, 1996

Docket Number: OST–96–1252Date filed: April 11, 1996


Parties: Members of the InternationalAir Transport Association

Subject:TC Telex Mail Vote 796Hong Kong-Japan faresr–1–053i r–2–043i r–3–070tTC2 Telex Mail Vote 797Iran-Europe faresr–4–003jIntended effective date: May 1, 1996

Paulette V. Twine,Chief, Documentary Services Division.[FR Doc. 96–9904 Filed 4–22–96; 8:45 am]BILLING CODE 4910–62–P

Notice of Applications for Certificatesof Public Convenience and Necessityand Foreign Air Carrier Permits FiledUnder Subpart Q During the WeekEnding April 12, 1996

The following Applications forCertificates of Public Convenience andNecessity and Foreign Air CarrierPermits were filed under Subpart Q ofthe Department of Transportation’sProcedural Regulations (See 14 CFR302.1701 et seq.). The due date forAnswers, Conforming Applications, orMotions to modify Scope are set forthbelow for each application. Followingthe Answer period DOT may process theapplication by expedited procedures.Such procedures may consist of theadoption of a show-cause order, atentative order, or in appropriate casesa final order without furtherproceedings.Docket Number: OST–96–1248Date filed: April 9, 1996Due Date for Answers, Conforming

Applications, or Motion to ModifyScope: May 7, 1996

Description: Application of United AirLines, Inc., pursuant to 49 U.S.C.Section 41101 and Subpart Q of theRegulations, requests an amendmentof its certificate of public convenienceand necessity for Route 130 forauthority to offer scheduled foreignair transportation of property andmail between all points in the U.S., onthe one hand, and a point or points inJapan and points beyond Japan, on theother hand. United also requestsauthority to integrate its new servicesdescribed above with other servicesconsistent with outstanding bilateralagreements.

Paulette V. Twine,Chief, Documentary Services Division.[FR Doc. 96–9905 Filed 4–22–96; 8:45 am]BILLING CODE 4910–62–P


Index of Administrator’s Decisions andOrders in Civil Penalty Actions;Publication

AGENCY: Federal AviationAdministration (FAA), DOT.ACTION: Notice of publication.

SUMMARY: This notice constitutes therequired quarterly publication of anindex of the Administrator’s decisionsand orders in civil penalty cases. TheFAA is publishing an index by ordernumber, an index by subject matter, andcase digests that contain identifyinginformation about the final decisionsand orders issued by the Administrator.Publication of these indexes and digestsis intended to increase the public’sawareness of the Administrator’sdecisions and orders. Also, thepublication of these indexes and digestsshould assist litigants and practitionersin their research and review of decisionsand orders that may have precedentialvalue in a particular civil penaltyaction. Publication of the index by ordernumber, as supplemented by the indexby subject matter, ensures that theagency is in compliance with statutoryindexing requirements.FOR FURTHER INFORMATION CONTACT:James S. Dillman, Assistant ChiefCounsel for Litigation (AGC–400),Federal Aviation Administration, 701Pennsylvania Avenue NW, Suite 925,Washington, DC 20004: telephone (202)376–6441.SUPPLEMENTARY INFORMATION: TheAdministrative Procedure Act requiresFederal agencies to maintain and makeavailable for public inspection andcopying current indexes containingidentifying information regardingmaterials required to be made availableor published. 5 U.S.C. 552(a)(2). In anotice issued on July 11, 1990, andpublished in the Federal Register (55FR 29148; July 17, 1990), the FAAannounced the public availability ofseveral indexes and summaries thatprovide identifying information aboutthe decisions and orders issued by theAdministrator under the FAA’s civilpenalty assessment authority and therules of practice governing hearings andappeals of civil penalty actions. 14 CFRPart 13, Subpart G.

The FAA maintains an index of theAdministrator’s decisions and orders incivil penalty actions organized by ordernumber and containing identifyinginformation about each decision ororder. The FAA also maintains asubject-matter index, and digestsorganized by order number.

In a notice issued on October 26,1990, the FAA published these indexesand digests for all decisions and ordersissued by the Administrator throughSeptember 30, 1990. 55 FR 45984;October 31, 1990. The FAA announcedin that notice that it would publishsupplements to these indexes anddigests on a quarterly basis (i.e., inJanuary, April, July, and October of eachyear). The FAA announced further inthat notice that only the subject-matterindex would be published cumulatively,and that both the order number indexand the digests would be non-cumulative.

Since that first index was issued onOctober 26, 1990 (55 FR 45984; October31, 1990), the FAA has issuedsupplementary notices containing thequarterly indexes of the Administrator’scivil penalty decisions as follows:

Dates of quarter Federal Registerpublication

10/1/90–12/31/90 ........ 56 FR 44886; 2/6/91.

1/1/91–3/31/91 ............ 56 FR 20250; 5/2/91.

4/1/91–6/30/91 ............ 56 FR 31984; 7/12/91.

7/1/91–9/30/91 ............ 56 FR 51735; 10/15/91.

10/1/91–12/31/91 ........ 57 FR 2299; 1/21/92.

1/1/92–3/31/92 ............ 57 FR 12359; 4/9/92.

4/1/92–6/30/92 ............ 57 FR 32825; 7/23/92.

7/1/92–9/30/92 ............ 57 FR 48255; 10/22/92.

10/1/92–12/31/92 ........ 58 FR 5044; 1/19/93.

1/1/93–3/31/93 ............ 58 FR 21199; 4/19/93.

4/1/93–6/30/93 ............ 58 FR 42120; 8/6/93.

7/1/93–9/30/93 ............ 58 FR 58218; 10/29/93.

10/1/93–12/31/93 ........ 59 FR 5466; 2/4/94.1/1/94–3/31/94 ............ 59 FR 22196; 4/29/

94.4/1/94–6/30/94 ............ 59 FR 39618; 8/3/

94.7/1/94–12/31/94* ......... 60 FR 4454; 1/23/

95*.1/1/95–3/31/95 ............ 60 FR 19318; 4/17/

95.4/1/95–6/30/95 ............ 60 FR 36854; 7/18/

95.7/1/95–9/30/95 ............ 60 FR 53228; 10/12/

95.


Dates of quarter Federal Registerpublication

10/1/95–12/31/95 ........ 61 FR 1972; 1/24/96.

*Due to administrative oversight, the indexfor the third quarter of 1994, including informa-tion pertaining to the decisions and orders is-sued by the Administrator between July 1 andSeptember 30, 1994, was not published ontime. The information regarding the third quar-ter’s decisions and orders, as well as thefourth quarter’s decisions and orders in 1994,were included in the index published on Janu-ary 23, 1995.

In the notice published on January 19,1993, the Administrator announced thatfor the convenience of the users of theseindexes, the order number indexpublished at the end of the year wouldreflect all of the civil penalty decisionsfor that year. 58 FR 5044; 1/19/93. Theorder number indexes for the first,

second, and third quarters would benon-cumulative.

The Administrator’s final decisionsand orders, indexes, and digests areavailable for public inspection andcopying at all FAA legal offices. (Theaddresses of the FAA legal offices arelisted at the end of this notice.)

Also, the Administrator’s decisionsand orders have been published bycommercial publishers and are availableon computer databases. (Informationabout three commercial publicationsand computer databases is provided atthe end of this notice.)

Civil Penalty Actions—Orders Issuedby the Administrator

Order Number Index

(This index includes all decisions andorder issued by the Administrator fromJanuary 1, 1996, to March 31, 1996.)

96–1 ............. [Airport Operator]1/4/96 .......... CP94**008996–2 ............. Skydiving Center of D.C.1/5/96 .......... CP94EA026196–3 ............. America West Airlines2/13/96 ........ CP93WP0172, CP93WP0173,

CP93WP017496–4 ............. South Aero2/13/96 ........ CP94SW002396–5 ............. Alphin Aircraft2/13/96 ........ CP93EA033496–6 ............. Evgeniy V. Ignatov2/13/96 ........ CP94GL007696–7 ............. Delta Air Lines2/15/96 ........ CP94SO000396–8 ............. Empire Airlines2/29/96 ........ CP95NM003496–9 ............. [Airport Operator]3/5/96 .......... CP94**008996–10 ........... USAir3/11/96 ........ CP95EA010096–11 ........... USAir3/19/96 ........ CP94GL019096–12 ........... USAir3/19/96 ........ CP94EA0126

Civil Penalty Actions—Orders Issued by the Administrator

Subject Matter Index

(Current as of March 31, 1996)Administrative Law Judges—Power and Authority:

Authority to extend deadlines ......................................................... 95–28 Atlantic.Continuance of hearing .................................................................... 91–11 Continental Airlines; 92–29 Haggland.Credibility findings .......................................................................... 90–21 Carroll; 92–3 Park; 93–17 Metcaft; 94–3 Valley Air; 94–4

Northwest Aircraft Rental; 95–25 Conquest; 95–26 Hereth.Default Judgment .............................................................................. 91–11 Continental Airlines; 92–47 Cornwall; 94–8 Nunez; 94–22

Harkins; 94–28 Toyota; 95–10 Diamond.Discovery ........................................................................................... 89–6 American Airlines; 91–17 KDS Aviation; 91–54 Alaska Air-

lines; 92–46 Sutton-Sautter; 93–10 Costello.Expert Testimony ............................................................................. 94–21 Sweeney.Granting extensions of time ............................................................. 90–27 Gabbert.Hearing location ............................................................................... 92–50 Cullop.Hearing request ................................................................................. 93–12 Langton; 94–6 Strohl; 94–27 Larsen; 94–37 Houston; 95–19

Rayner.Initial Decision ................................................................................. 92–1 Costello; 92–32 Barnhill.Jurisdiction ........................................................................................ 90–20 Degenhardt; 90–33 Cato; 92–1 Costello; 92–32 Barnhill.

After order assessing civil penalty ........................................... 94–37 Houston; 95–19 Rayner.After complaint withdrawn ...................................................... 94–39 Kirola.

Motion for Decision .......................................................................... 92–73 Wyatt; 92–75 Beck; 92–76 Safety Equipment; 93–11 Merkley.Notice of Hearing .............................................................................. 92–31 Eaddy.Sanction ............................................................................................ 90–37 Northwest Airlines; 91–54 Alaska Airlines; 94–22 Harkins;

94–28 Toyota.Vacating initial decision .................................................................. 90–20 Degenhardt; 92–32 Barnhill; 95–6 Sutton.

Aerial Photography .................................................................................. 95–25 Conquest Helicopters.Agency Attorney ...................................................................................... 93–13 Medel.Air Carrier:

Agent/independent contractor of .................................................... 92–70 USAir.Careless or Reckless ......................................................................... 92–48 & 92–70 USAir; 93–18 Westair Commuter.

Employee ................................................................................... 93–18 Westair Commuter.Aircraft Maintenance (see Airworthiness, Maintenance Mannual) ...... 90–11 Thunderbird Accessories; 91–8 Watts Agricultural Aviation;

93–36 & 94–3 Valley Air; 94–38 Bohan; 95–11 Horizon; 96–3America West Airlines.

Acceptable methods, techniques, and practices ............................. 96–3 America West Airlines.After certificate revocation .............................................................. 92–73 Wyatt.Major/minor repairs ......................................................................... 96–3 America West Airlines.Minimum Equipment List (MEL) .................................................... 94–38 Bohan; 95–11 Horizon.

Aircraft Records:Aircraft Operation ............................................................................ 91–8 Watts Agricultural Aviation.Flight and Duty Time ....................................................................... 96–4 South Aero.Maintenance Records ....................................................................... 91–8 Watts Agricultural Aviation; 94–2 Woodhouse.‘‘Yellow tags’’ .................................................................................... 91–8 Watts Agricultural Aviation.

Aircraft-Weight and Balance (See Weight and Balance)Airmen:


Pilots .................................................................................................. 91–12 & 91–31 Terry & Menne; 92–8 Watkins; 92–49 Richardson &Shimp; 93–17 Metcalf.

Altitude deviation ............................................................................ 92–49 Richardson & Shimp.Careless or Reckless ......................................................................... 91–12 & 91–31 Terry & Menne; 92–8 Watkins; 92–49 Richardson &

Shimp; 92–47 Cornwall; 93–17 Metcalf; 93–29 Sweeney.Flight time limitations ..................................................................... 93–11 Merkley.Follow ATC Instruction ................................................................... 91–12 & 91–31 Terry & Menne; 92–8 Watkins; 92–49 Richardson &

Shimp.Low Flight ......................................................................................... 92–47 Cornwall; 93–17 Metcalf.See and Avoid .................................................................................. 93–29 Sweeney.

Air Operations Area (AOA):Air Carrier Responsibilities ............................................................. 90–19 Continental Airlines; 91–33 Delta Air Lines; 94–1 Delta Air

Lines.Airport Operator Responsibilities ................................................... 90–19 Continental Airlines; 91–4 [Airport Operator]; 91–18 [Airport

Operator]; 91–40 [Airport Operator]; 91–41 [Airport Operator];91–58 [Airport Operator]; 96–1 [Airport Operator].

Badge Display ................................................................................... 91–4 [Airport Operator]; 91–33 Delta Air Lines.Definition of ...................................................................................... 90–19 Continental Airlines; 91–4 [Airport Operator]; 91–58 [Airport

Operator].Exclusive Areas ................................................................................ 90–19 Continental Airlines; 91–4 [Airport Operator]; 91–58 [Airport

Operator].Airport Security Program (ASP):

Compliance with .............................................................................. 91–4 [Airport Operator]; 91–18 [Airport Operator]; 91–40 [AirportOperator]; 91–41 [Airport Operator]; 91–58 [Airport Operator];94–1 Delta Air Lines; 96–1 [Airport Operator].

Airports:Airport Operator Responsibilities ................................................... 90–12 Continental Airlines; 91–4 [Airport Operator]; 91–18 [Airport

Operator]; 91–40 [Airport Operator]; 91–41 [Airport Operator];91–58 [Airport Operator]; 96–1 [Airport Operator].

Air Traffic Control (ATC):Error as mitigating factor ................................................................. 91–12 & 91–31 Terry & Menne.Error as exonerating factor ............................................................... 91–12 & 91–31 Terry & Menne; 92–40 Wendt.Ground Control ................................................................................. 91–12 Terry & Menne; 93–18 Westair Commuter.Local Control .................................................................................... 91–12 Terry & Menne.Tapes & Transcripts .......................................................................... 91–12 Terry & Menne; 92–49 Richardson & Shimp.

Airworthiness ........................................................................................... 91–8 Watts Agricultural Aviation; 92–10 Flight Unlimited; 92–48 &92–70 USAir; 94–2 Woodhouse; 95–11 Horizon; 96–3 AmericaWest Airlines.

Amicus Curiae Briefs ............................................................................... 90–25 Gabbert.Answer:

Timeliness of answer ....................................................................... 90–3 Metz; 90–15 Playter; 92–32 Barnhill; 92–47 Cornwall; 92–75Beck; 92–76 Safety Equipment; 94–5 Grant; 94–29 Sutton; 94–30Columna; 94–43 Perez; 95–10 Diamond; 95–28 Atlantic.

What constitutes ............................................................................... 92–32 Barnhill; 92–75 Beck.Appeals (See also Timeliness; Mailing Rule)

Briefs, Generally ............................................................................... 89–4 Metz; 91–45 Park; 92–17 Giuffrida; 92–19 Cornwall; 92–39Beck; 93–24 Steel City Aviation; 93–28 Strohl; 94–23 Perez; 95–13Kilrain.

Additional Appeal Brief ................................................................... 92–3 Park; 93–5 Wendt; 93–6 Westair Commuter; 93–28 Strohl; 94–4 Northwest Aircraft; 94–18 Luxemburg; 94–29 Sutton.

Appeal dismissed as premature ...................................................... 95–19 Rayner.Appeal dismissed as moot after complaint withdrawn ................. 92–9 Griffin.Appellate arguments ........................................................................ 92–70 USAir.Court of Appeals, appeal to (See Federal Courts)‘‘Good Cause’’ for Late-Filed Brief or Notice of Appeal ................ 90–3 Metz; 90–27 Gabbert; 90–39 Hart; 91–10 Graham; 91–24 Esau;

91–48 Wendt; 91–50 & 92–1 Costello; 92–3 Park; 92–17 Giuffrida;92–39 Beck; 92–41 Moore & Sabre Associates; 92–52 Beck; 92–57Detroit Metro Wayne Co. Airport; 92–69 McCabe; 93–23 Allen;93–27 Simmons; 93–31 Allen; 95–2 Meronek; 95–9 Woodhouse;95–25 Conquest.

Motion to Vacate construed as a brief ............................................ 91–11 Continental Airlines.Perfecting an Appeal ........................................................................ 92–17 Giuffrida; 92–19 Cornwall; 92–39 Beck; 94–23 Perez; 95–13

Kilrain; 96–5 Alphin Aircraft.Extension of Time for (good cause for) .................................... 89–8 Thunderbird Accessories; 91–26 Britt Airways; 91–32 Bargen;

91–50 Costello; 93–2 & 93–3 Wendt; 93–24 Steel City Aviation;93–32 Nunez.


Failure to .................................................................................... 89–1 Gressani; 89–7 Zenkner; 90–11 Thunderbird Accessories; 90–35 P. Adams; 90–39 Hart; 91–7 Pardue; 91–10 Graham; 91–20Bargen; 91–43, 91–44, 91–46 & 91–47 Delta Air Lines; 92–11Alilin; 92–15 Dillman; 92–18 Bargen; 92–34 Carrell; 92–35 BayLand Aviation; 92–36 Southwest Airlines; 92–45 O’Brien; 92–56Montauk Caribbean Airways; 92–67 USAir; 92–68 Weintraub; 92–78 TWA; 93–7 Dunn; 93–8 Nunez; 93–20 Smith; 93–23 & 93–31Allen; 93–34 Castle Aviation; 93–35 Steel City Aviation; 94–12Bartusiak; 94–24 Page; 94–26 French Aircraft; 94–34 AmericanInternational Airways; 94–35 American International Airways;94–36 American International Airways; 95–4 Hanson; 95–22 &96–5 Alphin Aircraft; 96–2 Skydiving Center.

What Constitutes ....................................................................... 90–4 Metz; 90–27 Gabbert; 91–45 Park; 92–7 West; 92–17 Giuffrida;92–39 Beck; 93–7 Dunn; 94–15 Columna; 94–23 Perez; 94–30Columna; 95–9 Woodhouse; 95–23 Atlantic World Airways.

Service of brief:Failure to serve other party ...................................................... 92–17 Giuffrida; 92–19 Cornwall.

Timeliness of Notice of Appeal ....................................................... 90–3 Metz; 90–39 Hart; 91–50 Costello; 92–7 West; 92–69 McCabe;93–27 Simmons; 95–2 Meronek; 95–9 Woodhouse; 95–15 AlphinAviation.

Withdrawal of appeal ....................................................................... 89–2 Lincoln-Walker; 89–3 Sittko; 90–4 Nordrum; 90–5 Sussman;90–6 Dabaghian; 90–7 Steele; 90–8 Jenkins; 90–9 Van Zandt; 90–13 O’Dell; 90–14 Miller; 90–28 Puleo; 90–29 Sealander; 90–30Steidinger; 90–34 D. Adams; 90–40 & 90–41 Westair CommuterAirlines; 91–1 Nestor; 91–5 Jones; 91–6 Lowery; 91–13 Kreamer;91–14 Swanton; 91–15 Knipe; 91–16 Lopez; 91–19 Bayer; 91–21Britt Airways; 91–22 Omega Silicone Co.; 91–23 Continental Air-lines; 91–25 Sanders; 91–27 Delta Air Lines; 91–28 ContinentalAirlines; 91–29 Smith; 91–34 GASPRO; 91–35 M. Graham; 91–36;Howard; 91–37 Vereen; 91–39 America West; 91–42 Pony Ex-press; 91–49 Shields; 91–56 Mayhan; 91–57 Britt Airways; 91–59Griffin; 91–60 Brinton; 92–2 Koller; 92–4 Delta Air Lines; 92–6Rothgeb; 92–12 Bertetto; 92–20 Delta Air Lines; 92–21 Cronberg;92–22, 92–23, 92–24, 92–25, 92–26 & 92–28 Delta Air Lines; 92–33 Port Authority of NY & NJ; 92–42 Jayson; 92–43 Delta AirLines; 92–44 Owens; 92–53 Humble; 92–54 & 92–55 NorthwestAirlines; 92–60 Costello; 92–61 Romerdahl; 92–62 USAir; 92–63Schaefer; 92–64 & 92–65 Delta Air Lines; 92–66 Sabre Associates& Moore; 92–79 Delta Air Lines; 93–1 Powell & Co.; 93–4 Harrah;93–14 Fenske; 93–15 Brown; 93–21 Delta Air Lines; 93–22Yannotone; 93–26 Delta Air Lines; 93–33 HPH Aviation; 94–9 B &G Instruments; 94–10 Boyle; 94–11 Pan American Airways; 94–13Boyle; 94–14 B & G Instruments; 94–16 Ford; 94–33 Trans WorldAirlines; 94–41 Dewey Towner; 94–42 Taylor; 95–1 DiamondAviation; 95–3 Delta Air Lines; 95–5 Araya; 95–6 Sutton; 95–7Empire Airlines; 95–20 USAir; 95–21 Faisca; 95–24 Delta AirLines; 96–7 Delta Air Lines; 96–8 Empire Airlines; 96–10 USAir,96–11 USAir, 96–12 USAir.

Assault. (see also Passenger Misconduct) .............................................. 96–6 Ignatov.‘‘Attempt’’ ................................................................................................. 89–5 Schultz.Attorney Conduct:

Obstreperous or Disruptive .......................................................... 94–39 Kirola.Attorney Fees (See EAJA)Aviation Safety Reporting System .......................................................... 90–39 Hart; 91–12 Terry & Menne; 92–49 Richardson & Shimp.Balloon (Hot Air) ..................................................................................... 94–2 Woodhouse.Bankruptcy ............................................................................................... 91–2 Continental Airlines.Battery ...................................................................................................... 96–6 Ignatov.Certificates and Authorizations:

Surrender when revoked .................................................................. 92–73 Wyatt.Civil Air Security National Airport:

Inspection Program (CASNAIP) ....................................................... 91–4 [Airport Operator]; 91–18 [Airport Operator]; 91–40 [AirportOperator]; 91–41 [Airport Operator], 91–58 [Airport Operator].

Civil Penalty Amount (See Sanction)Closing Argument (See Final Oral Argument)Collateral Estoppel ................................................................................... 91–8 Watts Agricultural Aviation.Complaint:

Complainant Bound By .................................................................... 90–10 Webb; 91–53 Koller.No Timely Answer to. (See Answer)Partial Dismissal/Full Sanction ....................................................... 94–19 Pony Express; 94–40 Polynesian Airways.Timeliness of complaint .................................................................. 91–51 Hagwood; 93–13 Medel; 94–7 Hereth; 94–5 Grant.Withdrawal of ................................................................................... 94–39 Kirola; 95–6 Sutton.

Compliance & Enforcement Program:(FAA Order No. 2150.3A) ................................................................ 89–5 Schultz; 89–6 American Airlines; 91–38 Esau; 92–5 Delta Air

Lines.Sanction Guidance Table ................................................................. 89–5 Schultz; 90–23 Broyles; 90–33 Cato; 90–37 Northwest Airlines;

91–3 Lewis; 92–5 Delta Air Lines.


Concealment of Weapons ........................................................................ 89–5 Schultz; 92–46 Sutton-Sautter; 92–51 Koblick.Consolidation of Cases ............................................................................ 90–12, 90–18 & 90–19 Continental Airlines.Constitutionality of Regulations ............................................................. 96–1 [Airport Operator].Continuance of Hearing ........................................................................... 90–25 Gabbert; 92–29 Haggland.Corrective Action (See Sanction)Credibility of Witnesses:

Generally ........................................................................................... 95–25 Conquest Helicopters; 95–26 Hereth.Deference to ALJ ............................................................................... 90–21 Carroll; 92–3 Park; 93–17 Metcalf; 95–26 Hereth.Expert witnesses (See also Witnesses) ............................................ 90–27 Gabbert; 93–17 Metcalf; 96–3 American West Airlines.Impeachment .................................................................................... 94–4 Northwest Aircraft Rental.

De facto answer ........................................................................................ 92–32 Barnhill.Deliberative Process Privilege ................................................................. 89–6 American Airlines; 90–12, 90–18 & 90–19 Continental Air-

lines.Deterrence ................................................................................................ 89–5 Schultz; 92–10 Flight Unlimited; 95–16 Mulhall; 95–17 Larry’s

Flying Service.Discovery:

Deliberative Process Privilege .......................................................... 89–6 American Airlines; 90–12, 90–18 & 90–19 Continental Air-lines.

Depositions ....................................................................................... 91–54 Alaska Airlines.Notice of ..................................................................................... 91–54 Alaska Airlines.

Failure to Produce ............................................................................ 90–18 & 90–19 Continental Airlines; 91–17 KDS Aviation; 93–10Costello.

Of Investigative File in Unrelated Case .......................................... 92–46 Sutton-Sautter.Sanctions for ..................................................................................... 91–17 KDS Aviation; 91–54 Alaska Airlines.

Double Jeopardy ....................................................................................... 95–8 Charter Airlines.Due Process:

Before finding a violation ................................................................ 90–27 Gabbert.Violation of ....................................................................................... 89–6 American Airlines; 90–12 Continental Airlines; 90–37 North-

west Airlines; 96–1 [Airport Operator].EAJA:

Adversary Adjudication ................................................................... 90–17 Wilson; 91–17 & 91–52 KDS Aviation; 94–17 TCI; 95–12 Toy-ota.

Amount of award .............................................................................. 95–27 Valley Air.Appeal from ALJ Decision ............................................................... 95–9 Woodhouse.Expert witness fees ........................................................................... 95–27 Valley Air.Further proceedings ......................................................................... 91–52 KDS Aviation.Jurisdiction over appeal ................................................................... 92–74 Wendt.Other expenses ................................................................................. 93–29 Sweeney.Position of agency ............................................................................ 95–27 Valley Air.Prevailing party ................................................................................ 91–52 KDS Aviation.Special circumstances ...................................................................... 95–18 Pacific Sky.Substantial justification ................................................................... 91–52 & 92–71 KDS Aviation; 93–9 Wendt; 95–18 Pacific Sky; 95–

27 Valley Air.Supplementation of application ...................................................... 95–27 Valley Air.

Evidence (See Proof & Evidence)Ex Parte Communications ....................................................................... 93–10 Costello; 95–16 Mulhall; 95–19 Rayner.Expert Witnesses (See Witness)Extension of Time:

By Agreement of Parties ................................................................... 89–6 American Airlines; 92–41 Moore & Sabre Associates.Dismissal by Decisionmaker ............................................................ 89–7 Zenkner; 90–39 Hart.Good Cause for ................................................................................. 89–8 Thunderbird Accessories.Objection to ....................................................................................... 89–8 Thunderbird Accessories; 93–3 Wendt.Who may grant ................................................................................. 90–27 Gabbert.

Federal Courts .......................................................................................... 92–7 West.Federal Rules of Civil Procedure ............................................................ 91–17 KDS Aviation.Federal Rules of Evidence (See also Proof & Evidence).

Settlement Offers .............................................................................. 95–16 Mulhall.Final Oral Argument ............................................................................... 92–3 Park.Firearms (See Weapons)Ferry Flights ............................................................................................. 95–8 Charter Airlines.Flight & Duty Time:

Circumstances beyond control of the crew .................................... 95–8 Charter Airlines.Foreseeability ............................................................................. 95–8 Charter Airlines.Late freight ................................................................................. 95–8 Charter Airlines.Weather ...................................................................................... 95–8 Charter Airlines.

Competency check flights ................................................................ 96–4 South Aero.Limitation of Duty Time .................................................................. 95–8 Charter Airlines; 96–4 South Aero.Limitation of Flight Time ................................................................ 95–8 Charter Airlines.

‘‘Other commercial flying’’ ....................................................... 95–8 Charter Airlines.Flights ....................................................................................................... 94–20 Conquest Helicopters.Freedom of Information Act ................................................................... 93–10 Costello.Fuel Exhaustion ....................................................................................... 95–26 Hereth.Guns (See Weapons)Hazardous Materials Transp. Act ........................................................... 90–37 Northwest Airlines; 92–76 Safety Equipment; 92–77 TCI; 94–

19 Pony Express; 94–28 Toyota; 94–31 Smalling; 95–12 Toyota;95–16 Mulhall.


Ability to Pay .................................................................................... 95–16 Mulhall.Installment payments ................................................................ 95–16 Mulhall.

Civil Penalty ..................................................................................... 92–77 TCI; 94–28 Toyota; 94–31 Smalling; 95–16 Mulhall.Financial hardship and inability to pay .................................. 95–16 Mulhall.Minimum penalty ...................................................................... 95–16 Mulhall.

Corrective Action .............................................................................. 92–77 TCI; 94–28 Toyota.Criminal Penalty ............................................................................... 92–77 TCI; 94–31 Smalling.Culpability ........................................................................................ 92–77 TCI; 94–28 Toyota; 94–31 Smalling.EAJA, applicability of ...................................................................... 94–17 TCI; 95–12 Toyota.First-time violation ........................................................................... 92–77 TCI; 94–28 Toyota; 94–31 Smalling.Gravity of violation .......................................................................... 92–77 TCI; 94–28 Toyota; 94–31 Smalling.Individual violations ........................................................................ 95–16 Mulhall.Knowingly ......................................................................................... 92–77 TCI; 94–19 Pony Express; 94–31 Smalling.

Informal Conference ................................................................................ 94–4 Northwest Aircraft Rental.Initial Decision:

What constitutes ............................................................................... 92–32 Barnhill.Interference with crewmembers (see also Passenger Misconduct; As-

sault).92–3 Park; 96–6 Ignatov.

Interlocutory Appeal ............................................................................... 89–6 American Airlines; 91–54 Alaska Airlines; 93–37 Airspect; 94–32 Detroit Metropolitan.

Internal FAA Policy and/or Procedures ................................................. 89–6 American Airlines; 90–12 Continental Airlines; 92–73 Wyatt.Jurisdiction:

After initial decision ........................................................................ 90–20 Degenhardt; 90–33 Cato; 92–32 Barnhill; 93–28 Strohl.After Order Assessing Civil Penalty ................................................ 94–37 Houston; 95–19 Rayner.After withdrawal of complaint ........................................................ 94–39.$50,000 Limit .................................................................................... 90–12 Continental Airlines.EAJA cases ........................................................................................ 92–74 Wendt.HazMat cases .................................................................................... 92–76 Safety Equipment.NTSB ................................................................................................. 90–11 Thunderbird Accessories.

Knowledge (See also Weapons Violations):Of concealed weapon ....................................................................... 89–5 Schultz; 90–20 Degenhardt.

Laches (See Unreasonable Delay)Mailing Rule ............................................................................................. 89–7 Zenkner; 90–3 Metz; 90–11 Thunderbird Accessories; 90–39

Hart.Overnight express delivery .............................................................. 89–6 American Airlines.

Maintenance (See Aircraft Maintenance)Maintenance Instruction ......................................................................... 93–36 Valley Air.Maintenance Manual ............................................................................... 90–11 Thunderbird Accessories.

Air carrier maintenance manual ...................................................... 96–3 America West Airlines.Approved/accepted repair methods ................................................ 96–3 America West Airlines.Manufacturer’s maintenance manual .............................................. 96–3 America West Airlines.

Minimum Equipment List (MEL) (See Aircraft Maintenance)Mootness:

Appeal dismissed as moot ............................................................... 92–9 Griffin; 94–17 TCI.National Aviation Safety Inspection Program (NASIP) ......................... 90–16 Rocky Mountain.National Transportation Safety Board:

Administrator not bound by NTSB case law .................................. 91–12 Terry & Menne: 92–49 Richardson & Shimp; 93–18 WestairCommuter.

Lack of Jurisdiction .......................................................................... 90–11 Thunderbird Accessories; 90–17 Wilson; 92–74 Wendt.Notice of Hearing:

Receipt ............................................................................................... 92–31 Eaddy.Notice of Proposed Civil Penalty:

Initiates Action ................................................................................. 91–9 Continental Airlines.Signature of agency attorney ........................................................... 93–12 Langton.Withdrawal of ................................................................................... 90–17 Wilson.

Operate ..................................................................................................... 91–12 & 91–31 Terry & Menne; 93–18 Westair Commuter.Oral Argument:

Decision to hold ............................................................................... 92–16 Wendt.Instructions for ................................................................................. 92–27 Wendt.

Order Assessing Civil Penalty:Appeal from ...................................................................................... 92–1 Costello; 95–19 Rayner.Timeliness of request for hearing .................................................... 95–19 Rayner.Withdrawal of ................................................................................... 89–4 Metz; 90–16 Rocky Mountain; 90–22 USAir; 95–19 Rayner.

Parts Manufacturer Approval:Failure to obtain ............................................................................... 93–19 Pacific Sky Supply.

Passenger Misconduct ............................................................................. 92–3 Park.Assault ............................................................................................... 96–6 Ignatov.Interference with a crewmember ..................................................... 96–6 Ignatov.Smoking ............................................................................................ 92–37 Giuffrida.

Penalty (See Sanction)Person ....................................................................................................... 93–18 Westair Commuter.Proof & Evidence (See also Federal Rules of Evidence):

Affirmative Defense .......................................................................... 92–13 Delta Air Lines; 92–72 Giuffrida.Burden of Proof ................................................................................ 90–26 & 90–43 Waddell; 91–3 Lewis; 91–30 Trujillo; 92–13 Delta

Air Lines; 92–72 Giuffrida; 93–29 Sweeney.Circumstantial Evidence .................................................................. 90–12, 90–19 & 91–9 Continental Airlines; 93–29 Sweeney; 96–3

America West Airlines.


Credibility (See Administrative Law Judges; Credibility of Wit-nesses)

Closing Arguments ........................................................................... 94–20 Conquest Helicopters.Criminal standard rejected ............................................................... 91–12 Terry & Menne.Extra-record material ........................................................................ 95–26 Hereth.Hearsay .............................................................................................. 92–72 Giuffrida.Preponderance of evidence .............................................................. 90–11 Thunderbird Accessories; 90–12 Continental Airlines; 91–12

& 91–31 Terry & Menne; 92–72 Giuffrida.Presumption that message on ATC tape is received as transmit-

ted.91–12 Terry & Menne; 92–49 Richardson & Shimp.

Presumption that a gun is deadly or dangerous ............................. 90–26 Waddell; 91–30 Trujillo.Prima facie case ................................................................................ 95–26 Hereth.Settlement offer ................................................................................ 95–16 Mulhall.Substantial evidence ........................................................................ 92–72 Giuffrida.

Prima Facie Case. (See also Proof & Evidence) ..................................... 95–26 Hereth; 96–3 America West Airlines.Pro Se Parties:

Special Considerations ..................................................................... 90–11 Thunderbird Accessories; 90–3 Metz; 95–25 Conquest.Prosecutorial Discretion .......................................................................... 89–6 American Airlines; 90–23 Broyles; 90–38 Continental Airlines;

91–41 (Airport Operator); 92–46 Sutton-Sautter; 92–73 Wyatt; 95–17 Larry’s Flying Service.

Reconsideration:Denied by ALJ ................................................................................... 89–4 & 90–2 Metz.Granted by ALJ ................................................................................. 92–32 Barnhill.Repetitious petitions ........................................................................ 96–9 (Airport Operator).Stay of Order Pending ...................................................................... 90–31 Carroll; 90–32 Continental Airlines.

Remand ..................................................................................................... 86–6 American Airlines; 90–16 Rocky Mountain; 90–24 Bayer; 91–51 Hagwood; 91–54 Alaska Airlines; 92–1 Costello; 92–76 SafetyEquipment; 94–37 Houston.

Repair Station .......................................................................................... 90–11 Thunderbird Accessories; 92–10 Flight Unlimited; 94–2Woodhouse.

Request for Hearing ................................................................................. 94–37 Houston; 95–19 Rayner.Rules of Practice (14 CFR Part 13, Subpart G)

Applicability of ................................................................................. 90–12, 90–18 & 90–19 Continental Airlines; 91–17 KDS Aviation.Challenges to ..................................................................................... 90–12, 90–18 & 90–19 Continental Airlines, 90–21 Carroll; 90–37

Northwest Airlines.Effect of Changes in .......................................................................... 90–21 Carroll; 90–22 USAir; 90–38 Continental Airlines.Initiation of Action ........................................................................... 91–9 Continental Airlines.

Runway incursions .................................................................................. 92–40 Wendt; 93–18 Westair Commuter.Sanction:

Ability to Pay .................................................................................... 89–5 Schultz; 90–10 Webb; 91–3 Lewis; 91–38 Essau; 92–10 FlightUnlimited; 92–32 Barnhill; 92–37 & 92–72 Giuffrida; 92–38Cronberg; 92–46 Sutton-Sautter; 92–51 Koblick; 93–10 Costello;94–4 Northwest Aircraft Rental; 94–20 Conquest Helicopters; 95–16 Mulhall; 95–17 Larry’s Flying Service.

Agency policy:ALJ Bound by ............................................................................ 90–37 Northwest Airlines; 92–46 Sutton-Sautter.Statements of (e.g., FAA Order 2150.3A, Sanction Guidance

Table, memoranda pertaining to).90–19 Continental Airlines; 90–23 Broyles; 90–33 Cato; 90–37

Northwest Airlines; 92–46 Sutton-Sautter; 96–4 South Aero.Consistency with Precedent ............................................................. 96–6 Ignatov.Corrective Action .............................................................................. 91–18 [Airport Operator]; 91–40 [Airport Operator]; 91–41 [Airport

Operator]; 92–5 Delta Air Lines; 93–18 Westair Commuter; 94–28Toyota; 96–4 South Aero.

Discovery (See Discovery)Factors to consider ........................................................................... 89–5 Schultz; 90–23 Broyles; 90–37 Northwest Airlines; 91–3 Lewis;

91–18 [Airport Operator]; 91–40 [Airport Operator]; 91–41 [Air-port Operator]; 92–10 Flight Unlimited; 92–46 Sutton-Sautter; 92–51 Koblick; 94–28 Toyota; 95–11 Horizon.

First-Time Offenders ........................................................................ 89–5 Schultz; 92–5 Delta Air Lines; 92–51 Koblick.HazMat (See Hazardous Materials Transp. Act)Inexperience ...................................................................................... 92–10 Flight Unlimited.Installment Payments ....................................................................... 95–16 Mulhall; 95–17 Larry’s Flying Service.Maintenance ...................................................................................... 95–11 Horizon; 96–3 America West Airlines.Maximum .......................................................................................... 90–10 Webb; 91–53 Koller.Minimum (HazMat) .......................................................................... 95–16 Mulhall.Modified ............................................................................................ 89–5 Schulta; 90–11 Thunderbird Accessories; 91–38 Esau; 92–10

Flight Unlimited; 92–13 Delta Air Lines; 92–32 Barnhill.Partial Dismissal of Compalint/Full Sanction (See also Com-

plaint).94–19 Pony Express; 94–40 Polynesian Airways.

Sanctions in specific cases:Pilot Deviation ........................................................................... 92–8 Watkins.Test object detection ................................................................. 90–18 & 90–19 Continental Airlines.Unauthorized access ................................................................. 90–19 Continental Airlines; 90–37 Northwest Airlines; 94–1 Delta

Air Lines.Weapons cases ........................................................................... 90–23 Broyles; 90–33 Cato; 91–3 Lewis; 91–38 Esau; 92–32 Barnhill;

92–46 Sutton-Sautter; 92–51 Koblick; 94–5 Grant.Screening of Persons:


Air Carrier failure to detect weapon.Sanction ..................................................................................... 94–44 American Airlines.

Entering Sterile Areas ...................................................................... 90–24 Bayer; 92–58 Hoedl.Security (See Screening of Persons, Standard Security Program, Test

Object Detection, Unauthorized Access, Weapons Violations)Separation of Functions .......................................................................... 90–12 Continental Airlines; 90–18 Continental Airlines; 90–19 Con-

tinental Airlines; 90–21 Carroll; 90–38 Continental Airlines; 93–13 Medel.

Service (See also Mailing Rule):Of NPCP ............................................................................................ 90–22 USAir.Of FNPCP .......................................................................................... 93–13 Medel.Valid Service ..................................................................................... 92–18 Bargen.

Settlement ................................................................................................ 91–50 & 92–1 Costello; 95–16 Mulhall.Smoking .................................................................................................... 92–37 Giuffrida; 94–18 Luxemburg.Standard Security Program (SSP):

Compliance with .............................................................................. 90–12, 90–18 & 90–19 Continental Airlines; 91–33 Delta Air Lines;91–55 Continental Airlines; 92–13 & 94–1 Delta Air Lines.

Stay of Orders .......................................................................................... 90–31 Carroll; 90–32 Continental Airlines.Pending judicial review ................................................................... 95–14 Charter Airlines.

Strict Liability .......................................................................................... 89–5 Schultz; 90–27 Gabbert; 91–18 [Airport Operator]; 91–40 [Air-port Operator]; 91–58 [Airport Operator].

Test Object Detection .............................................................................. 90–12, 90–18, 90–19, 91–9 & 91–55 Continental Airlines; 92–13Delta Air Lines.

Proof of violation .............................................................................. 90–18, 90–19 & 91–9 Continental Airlines; 92–13 Delta Air Lines.Sanction ............................................................................................ 90–18 & 90–19 Continental Airlines.

Timeliness (See also Complaint; Mailing Rule; and Appeals):Of response to NPCP ........................................................................ 90–22 USAir.Of complaint ..................................................................................... 91–51 Hagwood; 93–13 Medel; 94–7 Hereth.Of NPCP ............................................................................................ 92–73 Wyatt.Of request for hearing ...................................................................... 93–12 Langton; 95–19 Rayner.

Unapproved Parts (See also Parts Manufacturer Approval) ................. 93–19 Pacific Sky Supply.Unauthorized Access:

To Aircraft ......................................................................................... 90–12 & 90–19 Continental Airlines; 94–1 Delta Air Lines.To Air Operations Area (AOA) ........................................................ 90–37 Northwest Airlines; 91–18 [Airport Operator]; 91–40 [Airport

Operator]; 91–58 [Airport Operator]; 94–1 Delta Air Lines.Unreasonable Delay:

In Initiating Action ........................................................................... 90–21 Carroll.Visual Cues Indicating Runway, Adequacy of ...................................... 92–40 Wendt.Weapons Violations:

Generally ........................................................................................... 89–5 Schultz; 90–10 Webb; 90–20 Degenhardt; 90–23 Broyles; 90–33Cato; 90–26 & 90–43 Waddell; 91–3 Lewis; 91–30 Trujillo; 91–38Esau; 91–53 Koller; 92–32 Barnhill; 92–46 Sutton-Sautter; 92–51Koblick; 92–59 Petek-Jackson; 94–5 Grant; 94–44 American Air-lines.

Concealment (See Concealment)‘‘Deadly or Dangerous’’ .................................................................... 90–26 & 90–43 Waddell; 91–30 Trujillo; 91–38 Esau.First-time Offenders ......................................................................... 89–5 Schultz.Intent to commit violation ............................................................... 89–5 Schultz; 90–20 Degenhardt; 90–23 Broyles; 90–26 Waddell;

91–3 Lewis; 91–53 Koller.Knowledge:

Of Weapon Concealment (See also Knowledge) ..................... 89–5 Schultz; 90–20 Degenhardt.Sanction (See ‘‘Sanction’’)

Weight and Balance ................................................................................. 94–40 Polynesian Airways.Witnesses:

Absence of, Failure to subpoena ..................................................... 92–3 Park.Expert testimony (See also Credibility)

Evaluation of .............................................................................. 93–17 Metcalf; 94–3 Valley Air; 94–21 Sweeney; 96–3 AmericaWest Airlines.

Expert witness fees (See EAJA).Regulations (Title 14 CFR, unless otherwise noted):

1.1 (maintenance) ............................................................................. 94–38 Bohan.1.1 (major repair) .............................................................................. 96–3 America West Airlines.1.1 (minor repair) ............................................................................. 96–3 America West Airlines.1.1 (operate) ...................................................................................... 91–12 & 91–31 Terry & Menne; 93–18 Westair Commuter.1.1 (person) ....................................................................................... 93–18 Westair Commuter.13.16 .................................................................................................. 90–16 Rocky Mountain; 90–22 USAir; 90–37 Northwest Airlines;

90–38 & 91–9 Continental Airlines; 91–18 [Airport Operator]; 91–51 Hagwood; 92–1 Costello; 92–46 Sutton-Sautter; 93–13 Medel;93–28 Strohl; 94–27 Larsen; 94–37 Houston; 94–31 Smalling; 95–1 Rayner.

13.201 ................................................................................................ 90–12 Continental Airlines.13.202 ................................................................................................ 90–6 American Airlines; 92–76 Safety Equipment.13.203 ................................................................................................ 90–12 Continental Airlines; 90–21 Carroll; 90–38 Continental Air-

lines.13.204 ................................................................................................


13.205 ................................................................................................ 90–20 Degenhardt; 91–17 KDS Aviation; 91–54 Alaska Airlines; 92–32 Barnhill; 94–32 Detroit Metropolitan; 94–39 Kirola; 95–16Mulhall.

13.206 ................................................................................................13.207 ................................................................................................ 94–39 Kirola.13.208 ................................................................................................ 90–21 Carroll; 91–51 Hagwood; 92–73 Wyatt; 92–76 Safety Equip-

ment; 93–13 Medel; 93–28 Strohl; 94–7 Hereth.13.209 ................................................................................................ 90–3 Metz; 90–15 Playter; 91–18 [Airport Operator]; 92–32 Barnhill;

92–47 Cornwall; 92–75 Beck; 92–76 Safety Equipment; 94–8Nunez; 94–5 Grant; 94–22 Harkins; 94–29 Sutton; 94–30Columna; 95–10 Diamond; 95–28 Valley Air.

13.210 ................................................................................................ 92–19 Cornwall; 92–75 Beck; 92–76 Safety Equipment; 93–7 Dunn;93–28 Strohl; 94–5 Grant; 94–30 Columna; 95–28 Valley Air.

13.211 ................................................................................................ 89–6 American Airlines; 89–7 Zenkner; 90–3 Metz; 90–11 Thunder-bird Accessories; 90–39 Hart; 91–24 Esau; 92–1 Costello; 92–9Griffin; 92–18 Bargen; 92–19 Cornwall; 92–57 Detroit Metro.Wayne County Airport; 92–74 Wendt; 92–76 Safety Equipment;93–2 Wendt; 94–5 Grant; 94–18 Luxenburg; 94–29 Sutton; 95–12Toyota; 95–28 Valley Air.

13.212 ................................................................................................ 90–11 Thunderbird Accessories; 91–2 Continental Airlines.13.213 ................................................................................................13.214 ................................................................................................ 91–3 Lewis.13.215 ................................................................................................ 93–28 Strohl; 94–39 Kirola.13.216 ................................................................................................13.217 ................................................................................................ 91–17 KDS Aviation.13.218 ................................................................................................ 89–6 American Airlines; 90–11 Thunderbird Accessories; 90–39

Hart; 92–9 Griffin; 92–73 Wyatt; 93–19 Pacific Sky Supply; 94–6Strohl; 94–27 Larsen; 94–37 Houston; 95–18 Rayner.

13.219 ................................................................................................ 89–6 American Airlines; 91–2 Continental Airlines; 91–54 AlaskaAirlines; 93–37 Airspect; 94–32 Detroit Metro. Wayne Airport.

13.220 ................................................................................................ 89–6 American Airlines; 90–20 Carroll; 91–8 Watts AgriculturalAviation; 91–17 KDS Aviation; 91–54 Alaska Airlines; 92–46 Sut-ton-Sautter.

13.221 ................................................................................................ 92–29 Haggland; 92–31 Eaddy; 92–52 Cullop.13.222 ................................................................................................ 92–72 Giuffrida.13.223 ................................................................................................ 91–12 & 91–31 Terry & Menne; 92–72 Giuffrida; 95–26 Hereth.13.224 ................................................................................................ 90–26 Waddell; 91–4 [Airport Operator]; 92–72 Giuffrida; 94–18

Luxemburg; 94–28 Toyota; 95–25 Conquest.13.22513.22613.227 ................................................................................................ 90–21 Carroll; 95–26 Hereth.13.228 ................................................................................................ 92–3 Park.13.229.13.230 ................................................................................................ 92–19 Cornwall; 95–26 Hereth.13.231 ................................................................................................ 92–3 Park.13.232 ................................................................................................ 89–5 Schultz; 90–20 Degenhardt; 92–1 Costello 92–18 Bargen; 92–32

Barnhill; 93–28 Strohl; 94–28 Toyota 95–12 Toyota; 95–16Mulhall 96–6 Ignatov.

13.233 ................................................................................................ 89–1 Gressani; 89–4 Metz; 89–5 Schultz; 89–7 Zenkner; 89–8 Thun-derbird Accessories; 90–3 Metz; 90–11 Thunderbird Accessories;90–19 Continental Airlines 90–20 Degenhardt; 90–25 & 90–27Gabbert; 90–35 P. Adams; 90–19 Continental Airlines; 90–39 Hart;91–2 Continental Airlines; 91–3 Lewis; 91–7 Pardue; 91–8 WattsAgricultural Aviation; 91–10 Graham; 91–11 Continental Airlines;91–12 Bargen; 91–24 Esau; 91–26 Britt Airways; 91–31 Terry &Menne; 91–32 Bargen; 91–43 & 91–44 Delta; 91–45 Park; 91–46Delta; 91–47 Delta; 91–48 Wendt; 91–52 KDS Aviation; 91–53Koller; 92–1 Costello; 92–3 Park; 92–7 West; 92–11 Alilin; 92–15Dillman; 92–16 Wendt; 92–18 Bargen; 92–19 Cornwall; 92–27Wendt; 92–32 Barnhill; 92–34 Carrell; 92–35 Bay Land Aviation;92–36 Southwest Airlines; 92–39 Beck; 92–45 O’Brien; 92–52Beck; 92–56 Montauk Caribbean Airways; 92–57 Detroit Metro.Wayne Co. Airport; 92–67 USAir; 92–69 McCabe; 92–72 Giuffrida;92–74 Wendt; 92–78 TWA; 93–5 Wendt; 93–6 Westair Commuter;93–7 Dunn; 93–8 Nunez; 93–19 Pacific Sky Supply; 93–23 Allen;93–27 Simmons; 93–28 Strohl; 93–31 Allen; 93–32 Nunez; 94–9 B& G Instruments; 94–10 Boyle; 94–12 Bartusiak; 94–15 Columna;94–18 Luxemburg; 94–23 Perez; 94–24 Page; 94–26 French Air-craft; 94–28 Toyota; 95–2 Meronek; 95–9 Woodhouse; 95–13Kilrain; 95–23 Atlantic World Airways; 95–25 Conquest; 95–26Hereth; 96–1 [Airport Operator]; 96–2 Skydiving Center.

13.234 ................................................................................................ 90–19 Continental Airlines; 90–31 Carroll; 90–32 & 90–38 Continen-tal Airlines; 91–4 [Airport Operator]; 95–12 Toyota; 96–9 [AirportOperator].

13.235 ................................................................................................ 90–11 Thunderbird Accessories; 90–12 Continental Airlines; 90–15Playter; 90–17 Wilson; 92–7 West.


Part 14 ............................................................................................... 92–74 & 93–2 Wendt; 95–18 Pacific Sky Supply.14.01 .................................................................................................. 91–17 & 92–71 KDS Aviation.14.04 .................................................................................................. 91–17, 91–52 & 92–71 KDS Aviation; 93–10 Costello; 95–27 Valley

Air.14.05 .................................................................................................. 90–17 Wilson.14.12 .................................................................................................. 95–27 Valley Air.14.20 .................................................................................................. 91–52 KDS Aviation.14.22 .................................................................................................. 93–29 Sweeney.14.26 .................................................................................................. 91–52 KDS Aviation; 95–27 Valley Air.14.28 .................................................................................................. 95–9 Woodhouse.21.303 ................................................................................................ 93–19 Pacific Sky Supply; 95–18 Pacific Sky Supply.25.855 ................................................................................................ 92–37 Giuffrida.39.3 .................................................................................................... 92–10 Flight Unlimited; 94–4 Northwest Aircraft Rental.43.3 .................................................................................................... 92–73 Wyatt.43.9 .................................................................................................... 91-8 Watts Agricultural Aviation.43.13 .................................................................................................. 90-11 Thunderbird Accessories; 94-3 Valley Air; 94-38 Bohan;

America West Airlines.43.15 .................................................................................................. 90-25 & 90-27 Gabbert; 91-8 Watts Agricultural Aviation; 94-2

Woodhouse.65.15 .................................................................................................. 92-73 Wyatt.65.92 .................................................................................................. 92-73 Wyatt.91.8 (91.11 as of 8/18/90) ................................................................ 92-3 Park.91.9 (91.13 as of 8/18/90) ................................................................ 90-15 Playter, 91-12 & 91-31 Terry & Menne; 92-8 Watkins; 92-40

Wendt; 92-48 USAir; 92-49 Richardson & Shimp; 92-47 Cornwall;92-70 USAir; 93-9 Wendt; 93-17 Metcalf; 93-18 Westair Com-muter; 93-29 Sweeney; 94-29 Sutton; 95-26 Hereth.

91.11 .................................................................................................. 96-6 Ignatov.91-29 (91.7 as of 8/18/90) ................................................................ 91-8 Watts Agricultural Aviation; 92-10 Flight Unlimited; 94-4

Northwest Aircraft Rental.91.65 (91.111 as of 8/18/90) ............................................................ 91-29 Sweeney; 94-21 Sweeney.91.67 (91.113 as of 8/18/90) ............................................................ 91-29 Sweeney.91.75 (91.123 as of 8/18/90) ............................................................ 91-12 & 91.31 Terry & Menne; 92-8 Watkins; 92-40 Wendt; 92-49

Richardson & Shimp; 93-9 Wendt.91.79 (91.119 as of 8/18/90) ............................................................ 90-15 Playter; 92-47 Cornwall; 93-17 Metcalf.91.87 (91.129 as of 8/18/90) ............................................................ 91-12 & 91-31 Terry & Menne; 92-8 Watkins.91.103 ................................................................................................ 95-26 Hereth.91.151 ................................................................................................ 95-26 Hereth.91.173 (91.417 as of 8/18/90) .......................................................... 91-8 Watts Agricultural Aviation.91.703 ................................................................................................ 94-29 Sutton.107.1 .................................................................................................. 90-19 Continental Airlines; 90-20 Degenhardt; 91-4 [Airport Opera-

tor]; 91-58 [Airport Operator].107.13 ................................................................................................ 90-12 & 90-19 Continental Airlines; 91-4 [Airport Operator]; 91-18

[Airport Operator]; 91-40 [Airport Operator]; 91-41 [Airport Oper-ator]; 91-58 [Airport Operator]; 96-1 [Airport Operator].

107.20 ................................................................................................ 90-24 Bayer; 92-58 Hoedl.107.21 ................................................................................................ 89-5 Schultz; 90-10 Webb; 90-22 Degenhardt; 90-23 Broyles; 90-26 &

90-43 Waddell; 90-33 Cato; 90-39 Hart; 91-3 Lewis; 91-10 Graham;91-30 Trujillo; 91-38 Esau; 91-53 Koller; 92-32 Barnhill; 92-38Cronberg; 92-46 Sutton-Sautter; 92-51 Koblick; 92-59 Petek-Jack-son; 94-5 Grant; 94-31 Smalling.

107.25 ................................................................................................ 94-30 Columna.108.5 .................................................................................................. 90-12, 90-18, 90-19, 91-2, & 91-9 Continental Airlines; 91-33 Delta

Air Lines; 91-54 Alaska Airlines; 91-55 Continental Airlines; 92-13 & 94-1 Delta Air Lines; 94-44 American Airlines.

108.7 .................................................................................................. 90–18 & 90–19 Continental Airlines.108.11 ................................................................................................ 90–23 Broyles; 90–26 Waddell; 91–3 Lewis; 92–46 Sutton-Sautter;

94–44 American Airlines.108.13 ................................................................................................ 90-12 & 90-19 Continental Airlines; 90-37 Northwest Airlines.121.133 .............................................................................................. 90-18 Continental Airlines.121.153 .............................................................................................. 92-48 & 92-70 USAir; 95-11 Horizon; 96-3 America West Airlines.121.317 .............................................................................................. 92-37 Giuffrida; 94-18 Luxemburg.121.318 .............................................................................................. 92-37 Giuffrida.121.367 .............................................................................................. 90-12 Continental Airlines.121.571 .............................................................................................. 92-37 Giuffrida.121.628 .............................................................................................. 95-11 Horizon.135.1 .................................................................................................. 95-8 Charter Airlines; 95-25 Conquest.135.5 .................................................................................................. 94-3 Valley Air; 94-20 Conquest Helicopters; 95-25 Conquest; 95-27

Valley Air.135.25 ................................................................................................ 92-10 Flight Unlimited; 94-3 Valley Air; 95-27 Valley Air.135.63 ................................................................................................ 94-40 Polynesian Airways; 95-17 Larry’s Flying Service; 95-28 At-

lantic; 96-4 South Aero.135.87 ................................................................................................ 90-21 Carroll.135.95 ................................................................................................ 95-17 Larry’s Flying Service.135.185 .............................................................................................. 94–40 Polynesian Airways.135.263 .............................................................................................. 95–9 Charter Airlines; 96–4 South Aero.135.267 .............................................................................................. 95–8 Charter Airlines; 95–17 Larry’s Flying Service; 96–4 South

Aero.


135.293 .............................................................................................. 195–17 Larry’s Flying Service; 96–4 South Aero.135.343 .............................................................................................. 95–17 Larry’s Flying Service.135.413 .............................................................................................. 94–3 Valley Air.135.421 .............................................................................................. 93–36 Valley Air; 94–3 Valley Air.135.437 .............................................................................................. 94–3 Valley Air.145.53 ................................................................................................ 90–11 Thunderbird Accessories.145.57 ................................................................................................ 94–2 Woodhouse.145.61 ................................................................................................ 90–11 Thunderbird Accessories.191 ..................................................................................................... 90–12 & 90–19 Continental Airlines; 90–37 Northwest Airlines.298.1 .................................................................................................. 92–10 Flight Unlimited.302.8 .................................................................................................. 90–22 USAir.

49 CFR:1.47 .................................................................................................... 92–76 Safety Equipment.171 et seq .......................................................................................... 95–10 Diamond.171.2 .................................................................................................. 92–77 TCI; 94–28 Toyota; 94–31 Smalling; 95–16 Mulhall.171.8 .................................................................................................. 92–77 TCI.172.101. ............................................................................................. 92–77 TCI; 94–28 Toyota; 94–31 Smalling.172.200 .............................................................................................. 92–77 TCI; 94–28 Toyota; 95–16 Mulhall.172.202 .............................................................................................. 92–77 TCI; 94–28 Toyota; 94–31 Smalling; 95–16 Mulhall.172.203 .............................................................................................. 94–28 Toyota.172.204 .............................................................................................. 92–77 TCI; 94–28 Toyota; 94–31 Smalling; 95–16 Mulhall.172.300 .............................................................................................. 94–31 Smalling; 95–16 Mulhall.172.301 .............................................................................................. 94–31 Smalling; 95–16 Mulhall.172.304 .............................................................................................. 92–77 TCI; 94–31 Smalling; 95–16 Mulhall.172.400 .............................................................................................. 92–77 TCI; 94–28 Toyota; 94–31 Smalling; 95–16 Mulhall.172.402 .............................................................................................. 94–28 Toyota.172.406 .............................................................................................. 92–77 TCI.173.1 .................................................................................................. 92–77 TCI; 94–28 Toyota; 94–31 Smalling; 95–16 Mulhall.173.3 .................................................................................................. 94–28 Toyota; 94–31 Smalling.173.6 .................................................................................................. 94–28 Toyota.173.22(a) ............................................................................................ 94–28 Toyota; 94–31 Smalling.173.24 ................................................................................................ 94–28 Toyota; 95–16 Mulhall.173.25 ................................................................................................ 94–28 Toyota.173.27 ................................................................................................ 92–77 TCI.173.115 .............................................................................................. 92–77 TCI.173.240 .............................................................................................. 92–77 TCI.173.243 .............................................................................................. 94–28 Toyota.173.260 .............................................................................................. 94–28 Toyota.173.266 .............................................................................................. 94–28 Toyota; 94–31 Smalling.175.25 ................................................................................................ 94–31 Smalling.821.30 ................................................................................................ 92–73 Wyatt.821.33 ................................................................................................ 90–21 Carroll.

Statutes5 U.S.C.:

504 ..................................................................................................... 90–17 Wilson; 91–17 & 92–71 KDS Aviation; 92–74, 93–2 & 93–9Wendt; 93–29 Sweeney; 94–17 TCI; 95–27 Valley Air.

552 ..................................................................................................... 90–12, 90–18 & 90–19 Continental Airlines; 93–10 Costello.554 ..................................................................................................... 90–18 Continental Airlines; 90–21 Carroll; 95–12 Toyota.556 ..................................................................................................... 90–21 Carroll; 91–54 Alaska Airlines.557 ..................................................................................................... 90–20 Degenhardt; 90–21 Carroll; 90–37 Northwest Airlines; 94–28

Toyota.705 ..................................................................................................... 95–14 Charter Airlines.5332 ................................................................................................... 95–27 Valley Air.

11 U.S.C.:362 ..................................................................................................... 91–2 Continental Airlines.

28 U.S.C.:2412 ................................................................................................... 93–10 Costello.2462 ................................................................................................... 90–21 Carroll.

49 U.S.C.:5123 ................................................................................................... 95–16 Mulhall.44701 ................................................................................................. 96–6 Ignatov.44704 ................................................................................................. 96–3 America West Airlines.

49 U.S.C. App.:1301(31) (operate) ............................................................................. 93–18 Westair Commuter.

(32) (person) ............................................................................... 93–18 Westair Commuter.1356 ................................................................................................... 90–18 & 90–19, 91–2 Continental Airlines.1357 ................................................................................................... 90–18, 90–19 & 91–2 Continental Airlines; 91–41 [Airport Operator];

91–58 [Airport Operator].1421 ................................................................................................... 92–10 Flight Unlimited; 92–48 USAir; 92–70 USAir; 93–9 Wendt.1429 ................................................................................................... 92–73 Wyatt.


1471 ................................................................................................... 89–5 Schultz; 90–10 Webb; 90–20 Degenhardt; 90–12, 90–18 & 90–19 Continental Airlines; 90–23 Broyles; 90–26 & 90–43 Waddell;90–33 Cato; 90–37 Northwest Airlines; 90–39 Hart; 91–2 Con-tinental Airlines; 91–3 Lewis; 91–18 [Airport Operator]; 90–53Koller; 92–5 Delta Air Lines; 92–10 Flight Unlimited; 92–46 Sut-ton-Sautter; 92–51 Koblick; 92–74 Wendt; 92–76 Safety Equip-ment; 94–20 Conquest Helicopters; 94–40 Polynesian Airways;96–6 Ignatov.

1472 ................................................................................................... 96–6 Ignatov.1475 ................................................................................................... 90–20 Degenhardt; 90–12 Continental Airlines; 90–18, 90–19 & 91–1

Continental Airlines; 91–3 Lewis; 91–18 [Airport Operator]; 94–40Polynesian Airways.

1486 ................................................................................................... 90–21 Carroll.1809 ................................................................................................... 92–77 TCI; 94–19 Pony Express; 94–28 Toyota; 94–31 Smalling; 95–

12 Toyota.

Civil Penalty Actions—Orders Issuedby the Administrator Digests

(Current as of March 31, 1996)The digests of the Administrator’s

final decisions and orders are arrangedby order number, and briefly summarizekey points of the decision. Thefollowing compilation of digestsincludes all final decisions and ordersissued by the Administrator fromJanuary 1, 1996, to March 31, 1996. TheFAA will publish noncumulativesupplements to this compilation on aquarterly basis (e.g., April, July,October, and January of each year).

These digests do not constitute legalauthority, and should not be cited orrelied upon as such. The digests are notintended to serve as a substitute forproper legal research. Parties, attorneys,and other interested persons shouldalways consult the full text of theAdministrator’s decision before citingthem in any context.

In the Matter of: [Airport Operator]

Order No. 96–1 (1/4/96)

Vehicle Gates Must ControlPedestrian Access. This case arose whenFAA security inspectors found gaps,under or near two vehicle gates at theairport, that were large enough to permitunauthorized individuals to slipthrough into the air operations area.Despite repeated and warnings from theinspectors, the airport operator failed tocorrect the problem. The airportoperator argued that it did not violate 14CFR 107.13(a)(1), the regulationrequiring it to control access to the airoperations area, because the gates werevehicles gates. Contrary to the airportoperator’s arguments, the vehicle gatesmust control pedestrian access.

Regulation Not Unconstitutional.Section 107.13(a)(1) is notunconstitutionally vague or overbroad.

Penalty. The law judge’s imposition ofa $1,000 civil penalty is affirmed.

In the Matter of: Skydiving Center ofWashington, D.C.

Order No. 96–2 (1/5/96)Appeal Dismissed. Complainant has

failed to prefect its appeal by filing anappeal brief, as required by the Rules ofPractice. Therefore, its appeal isdismissed.

In the Matter of: America West Airlines

Order No. 96–3 (2/13/96)Failure to use methods acceptable to

the Administrator. America Westviolated 14 CFR 43.13(a) when itrepaired three Boeing 737s with speedtape. It employed methods that were notin the Boeing Structural Repair Manualand had not been accepted or approvedby the Administrator for this type andextent of damage to these aircraft.America West failed to prove that it hadused practices that were in keeping withthose employed in the industry for thistype of damage to these aircraft. Aircarriers must use repair methods thathave been approved or accepted by theAdministrator even if the actual minorrepair on a particular aircraft does nothave to be inspected by a FAArepresentative before putting the aircraftback into service.

Airworthiness. There is a two-prongtest for airworthiness: (1) the aircraftmust conform to its type design orsupplemental type design and to anyapplicable airworthiness directives, and(2) it must be in a condition for safeoperation. In this case, the partiesstipulated that the aircraft with theminor damage and temporary speedtape repairs did not present a safetyproblem. However, the aircraft with theminor damage (engine fan cowlpuncture of a Boeing 737–300, and flaptrailing edge delamination of a Boeing737–200 and a Boeing 737–300) and thespeed tape were not in conformity withtheir type designs. Although the typedesigns were not introduced intoevidence, there was still sufficientcircumstantial evidence to prove thatthe aircraft did not conform to their typedesigns. Consequently, America West

violated 14 CFR 121.153 when itoperated these aircraft in anunairworthy condition.

Sanction. The civil penalties totalling$44,750, for these operational andmaintenance violations are affirmed.

In the Matter of: South Aero

Order No. 96–4 (2/13/96)

Competency Check Flights.Competency check flights administeredby a company check pilot in a companyplane occurred on duty time rather thanrest time and therefore needed to berecorded on the company’s flight andduty time records, even though the aircarrier did not pay the pilotsspecifically for the time the pilots spenttaking their competency checks.

In the Matter of: Alphin Aircraft, Inc.

Order No. 96–5 (2/13/96)

Petition for Modification Granted.FAA Order No. 95–22 is modified inpart to allow Alphin Aircraft to file anappeal brief within 30 days of service ofFAA Order No. 96–5.

In the Matter of: Evgeniy V. Ignatov

Order No. 96–6 (2/13/96)

Assault and Interference withCrewmember. Willful intent to injureneed not be present to show assaultunder 14 CFR 91.11, which prohibitsassaulting, intimidating, threatening, orinterfering with a crewmember in theperformance of the crewmember’sduties. Under Section 91.11, assaultincludes the concept of battery. In theinstant case, Respondent committed twoseparate violations of Section 91.11. Thefirst violation, which consisted ofinterfering with a crewmember,occurred when Respondent refused tosit down in compliance with the seatbelt light and the flight attendant’srequest, and when he blocked the flightattendant’s passage as she wasattempting to serve the passengers. Thesecond violation, which consisted ofassault, occurred when Respondentpushed past the flight attendant whenthere was not enough room to get by


safely, grabbed the flight attendant’sshoulders, and stepped on the flightattendant’s foot, causing her sharp painand a bruise.

Section. The civil penalty the lawjudge imposed, of $750 for one violationand $1,000 for the other, is not toosevere. Although Respondent points outthat in another case involving the sameregulation, the civil penalty assessedwas only $1,000, that case involved onlyone violation of Section 91.11, while theinstant case involves two separateviolations.

In the Matter of: Delta Air Lines, Inc.

Order No. 96–7 (2/15/96)

Appeals Dismissed. The parties havewithdrawn their respective notices ofappeal in this matter. Therefore, thecross-appeals are dismissed.

In the Matter of: Empire Airlines, Inc.

Order No. 96–8 (2/29/96)

Appeals Dismissed. The parties havewithdrawn their respective notices ofappeal in this matter. Therefore, thecross-appeals are dismissed.

In the Matter of: [Airport Operator]

Order No. 96–9 (3/5/96)

Reconsideration Denied. Nothing inthe airport operator’s petition forreconsideration warrants modificationor reversal of Order No. 96–1. Notablyabsent from the petition is any case lawor other legal authority to support theairport operator’s contention that OrderNo. 96–1 was in error. Moreover, theprincipal arguments contained in thepetition are not new. They have alreadybeen considered and rejected by theAdministrator. Section 13.234(d) of theRules of Practice, 14 CFR 13.234(d),permits the Administrator to dismisssummarily petitions to reconsider thatare repetitious.

In the Matter of: U.S. Air, Inc.

Order No. 96–10 (3/11/96)

Appeal dismissed. Complainantwithdrew its appeal from the lawjudge’s initial decision. Complainant’sappeal is dismissed.

In the Matter of: US Air, Inc.

Order No. 96–11 (3/19/96)

Appeal dismissed. Respondentwithdrew its appeal from the lawjudge’s initial decision. Respondent’sappeal is dismissed.

In the Matter of: U.S. Air, Inc.

Order No. 96–12 (3/19/96)

Appeal dismissed. Respondentwithdrew its appeal from the lawjudge’s initial decision. Respondent’sappeal is dismissed.

Commercial Reporting Services of theAdministrator’s Civil Penalty Decisionsand Orders

In June 1991, as a public service, theFAA began releasing to commercialpublishers the Administrator’s decisionsand orders in civil penalty cases. Thegoal was to make these decisions andorders more accessible to the public.The Administrator’s decisions andorders in civil penalty cases are nowavailable in the following commercialpublications:

AvLex, published by Aviation Daily,1156 15th Street, NW, Washington, DC20005, (202) 822–4669;

Civil Penalty Cases Digest Service,published by Hawkins PublishingCompany, Inc., P.O. Box 480, Mayo, MD21106, (410) 798–1677;

Federal Aviation Decisions, ClarkBoardman Callaghan, 50 Broad StreetEast, Rochester, NY 14694, (716) 546–1490.

The decisions and orders may beobtained on disk from Aviation Records,Inc., P.O. Box 172, Battle Ground, WA98604, (206) 896–0376. AeroflightPublications, P.O. Box 854, 433 MainStreet, Gruver, TX 79040, (806) 733–2483, is placing the decisions on CD–ROM. Finally, the Administrator’sdecisions and orders in civil penaltycases are available on Compuserve andFedWorld.

The FAA has stated previously thatpublication of the subject-matter indexand the digests may be discontinuedonce a commercial reporting servicepublishes similar information in atimely and accurate manner. Nodecision has been made yet on thismatter, and for the time being, the FAAwill continue to prepare and publish thesubject-matter index and digests.

FAA Offices

The Administrator’s decisions andorders, indexes, and digests areavailable for public inspection andcopying at the following location inFAA headquarters:

FAA Hearing Docket, Federal AviationAdministration; 800 Independence Avenue,SW., Room 924A, Washington, DC 20591;(202) 267–3641.

These materials are also available atall FAA regional and center legal officesat the following locations:

Office of the Assistant Chief Counsel forthe Aeronautical Center (AMC–7), MikeMonroney Aeronautical Center, 6500 SouthMacArthur Blvd., Oklahoma City, OK 73125;(405) 954–3296.

Office of the Assistant Chief Counsel forthe Alaskan Region (AAL–7), Alaskan RegionHeadquarters, 222 West 7th Avenue,Anchorage, AK 99513; (907) 271–5269.

Office of the Assistant Chief Counsel forthe Central Region (ACE–7), Central RegionHeadquarters, 601 East 12th Street, FederalBuilding, Kansas City, MO 64106; (816) 426–5446.

Office of the Assistant Chief Counsel forthe Eastern Region (AEA–7), Eastern RegionHeadquarters, JFK International Airport,Federal Building, Jamaica, NY 11430; (718)553–3285.

Office of the Assistant Chief Counsel forthe Great Lakes Region (AGL–7), 2300 EastDevon Avenue, Suite 419, Des Plaines, IL60018; (708) 294–7108.

Office of the Assistant Chief Counsel forthe New England Region (ANE–7), NewEngland Region Headquarters, 12 NewEngland Executive Park, Room 401,Burlington, MA 01803–5299; (617) 238–7050.

Office of the Assistant Chief Counsel forthe Northwest Mountain Region (ANM–7),Northwest Mountain Region Headquarters,1601 Lind Avenue, SW, Renton, WA 98055–4056; (206) 227–2007.

Office of the Assistant Chief Counsel forthe Southern Region (ASO–7), SouthernRegion Headquarters, 1701 ColumbiaAvenue, College Park, GA 30337; (404) 305–5200.

Office of the Assistant Chief Counsel forthe Southwest Region (ASW–7), SouthwestRegion Headquarters, 2601 Meacham Blvd.,Fort Worth, TX 76137–4298; (817) 222–5087.

Office of the Assistant Chief Counsel forthe Technical Center (ACT–7), FederalAviation Administration Technical Center,Atlantic City International Airport, AtlanticCity, NJ 08405; (609) 485–7087.

Office of the Assistant Chief Counsel forthe Western-Pacific Region (AWP–7),Western-Pacific Region Headquarters, 15000Aviation Boulevard, Lawndale, CA 90261;(310) 725–7100.

Issued in Washington, DC on April 11,1996.James S. Dillman,Assistant Chief Counsel for Litigation.[FR Doc. 96–9962 Filed 4–22–96; 8:45 am]BILLING CODE 4910–13–M

[Summary Notice No. PE–96–21]

Petitions for Exemption; Summary ofPetitions Received, Dispositions ofPetitions Issued

AGENCY: Federal AviationAdministration (FAA), DOT.ACTION: Notice of petitions forexemption received and of dispositionsof prior petitions.

SUMMARY: Pursuant to FAA’s rulemakingprovisions governing the application,processing, and disposition of petitionsfor exemption (14 CFR Part 11), thisnotice contains a summary of certainpetitions seeking relief from specifiedrequirements of the Federal AviationRegulations (14 CFR Chapter I),dispositions of certain petitionspreviously received, and corrections.The purpose of this notice is to improve


the public’s awareness of, andparticipation in, this aspect of FAA’sregulatory activities. Neither publicationof this notice nor the inclusion oromission of information in the summaryis intended to affect the legal status ofany petition or its final disposition.DATES: Comments on petitions receivedmust identify the petition docketnumber involved and must be receivedon or before May 13, 1996.ADDRESSES: Send comments on anypetition in triplicate to: FederalAviation Administration, Office of theChief Counsel, Attn: Rule Docket (AGC–200), Petition Docket No. llllll,800 Independence Avenue, SW.,Washington, D.C. 20591.

Comments may also be sentelectronically to the following Internetaddress: [email protected].

The petition, any comments received,and a copy of any final disposition arefiled in the assigned regulatory docketand are available for examination in theRules Docket (AGC–200), Room 915G,FAA Headquarters Building (FOB 10A),800 Independence Avenue, SW.,Washington, D.C. 20591; telephone(202) 267–3132.FOR FURTHER INFORMATION CONTACT: Mr.D. Michael Smith, Office of Rulemaking(ARM–1), Federal AviationAdministration, 800 IndependenceAvenue, SW., Washington, DC 20591;telephone (202) 267–7470.

This notice is published pursuant toparagraphs (c), (e), and (g) of § 11.27 ofPart 11 of the Federal AviationRegulation (14 CFR Part 11).Donald P. Byrne,Assistant Chief Counsel for Regulations.

Petitions for Exemption

Docket No.: 28502.Petitioner: Cape Smythe Air Service,

Inc.Sections of the FAR Affected: 14 CFR

121.1 and 135.1.Description of Relief Sought: To

permit Cape Smythe Air Service, Inc., tocontinue to operate its Beechcraft 99aircraft with up to 15 passenger seats, inpart 135 scheduled passenger service.

Docket No.: 28504.Petitioner: Renown Aviation, Inc.Sections of the FAR Affected: 14 CFR

121.356(a).Description of Relief Sought: To

permit Renown Aviation, Inc., tooperate one Convair 330 non-turbine-powered aircraft (Registration No.N3HH, Serial No. 173), and two Convair440 non-turbine-powered aircraft(Registration Nos. N202RA andN204RA; Serial Nos. 497 and 504,respectively) without traffic alert and

collision avoidance system (TCAS) IIequipment installed.

Docket No.: 28513.Petitioner: Evergreen Helicopters of

Alaska, Inc.Sections of the FAR Affected: 14 CFR

135.153 and 135.180.Description of Relief Sought: To

permit Evergreen Helicopters of Alaska,Inc., to operate five CASA C–212–200–CC aircraft in Angola, Africa, in supportof the United Nations AngolanVerification and Enforcement Mission,without these aircraft being equippedwith an FAA-approved groundproximity warning system or a trafficalert and collision avoidance system.

Docket No.: 28543.Petitioner: Bombardier, Inc.Sections of the FAR Affected: 14 CFR

25.562.Description of Relief Sought: To allow

U.S. certification of the Canadair newmodel Global Express airplane withoutbeing required to meet the dynamic seattest requirements of the FAR.

Dispositions of Petitions

Docket No.: 25493.Petitioner: Corporate Air.Sections of the FAR Affected: 14 CFR

21.197(c)(2).Description of Relief Sought/

Disposition: To allow the issuance of aspecial flight permit with continuingauthorization to the petitioner foraircraft that are operated andmaintained in accordance with§§ 135.411(a)(1) and 135.419,‘‘Approved aircraft inspectionprogram.’’

Denial, March 18, 1996, ExemptionNo. 6416.

[FR Doc. 96–9963 Filed 4–22–96; 8:45 am]BILLING CODE 4910–13–M

National Highway Traffic SafetyAdministration

[Docket No. 94–93; Notice 2]

Decision That Nonconforming 1995Chevrolet 400 SS Pickup Trucks AreEligible for Importation

AGENCY: National Highway TrafficSafety Administration (NHTSA), DOT.ACTION: Notice of decision by NHTSAthat nonconforming 1995 Chevrolet 400SS pickup trucks manufactured for theMexican market are eligible forimportation.

SUMMARY: This notice announces thedecision by NHTSA that 1995 Chevrolet400 SS pickup trucks manufactured forthe Mexican market and not originallymanufactured to comply with all

applicable Federal motor vehicle safetystandards are eligible for importationinto the United States because they aresubstantially similar to a vehicleoriginally manufactured for sale in theUnited States and certified by itsmanufacturer as complying with thesafety standards (the 1995 ChevroletC1500), and they are capable of beingreadily altered to conform to thestandards.DATES: The decision is effective on orbefore April 23, 1996.FOR FURTHER INFORMATION CONTACT:George Entwistle, Office of VehicleSafety Compliance, NHTSA (202–366–5306).


BackgroundUnder 49 U.S.C. 30141(a)(1)(A)

(formerly section 108(c)(3)(A)(i) of theNational Traffic and Motor VehicleSafety Act (the Act)), a motor vehiclethat was not originally manufactured toconform to all applicable Federal motorvehicle safety standards shall be refusedadmission into the United States unlessNHTSA has decided that the motorvehicle is substantially similar to amotor vehicle originally manufacturedfor importation into and sale in theUnited States, certified under 49 U.S.C.30115 (formerly section 114 of the Act),and of the same model year as themodel of the motor vehicle to becompared, and is capable of beingreadily altered to conform to allapplicable Federal motor vehicle safetystandards.

Petitions for eligibility decisions maybe submitted by either manufacturers orimporters who have registered withNHTSA pursuant to 49 CFR part 592. Asspecified in 49 CFR 593.7, NHTSApublishes notice in the Federal Registerof each petition that it receives, andaffords interested persons anopportunity to comment on the petition.At the close of the comment period,NHTSA decides, on the basis of thepetition and any comments that it hasreceived, whether the vehicle is eligiblefor importation. The agency thenpublishes this decision in the FederalRegister.

Wallace Environmental TestingLaboratories, Inc, of Houston, Texas(Registered Importer No. R–90–005)petitioned NHTSA to decide whether1995 Chevrolet 400 SS pickup trucksmanufactured for the Mexican marketare eligible for importation into theUnited States. NHTSA published noticeof the petition on February 22, 1966 (61FR 6889) to afford an opportunity forpublic comment. The reader is referredto that notice for a thorough description


of the petition. No comments werereceived in response to the notice.Based on its review of the informationsubmitted by the petitioner, NHTSA hasdecided to grant the petition.

Vehicle Eligibility Number for SubjectVehicles

The importer of a vehicle admissibleunder any final decision must indicateon the form HS-7 accompanying entrythe appropriate vehicle eligibilitynumber indicating that the vehicle iseligible for entry. VSP–150 is thevehicle eligibility number assigned tovehicles admissible under this notice offinal decision.

Final Decision

Accordingly, on the basis of theforegoing, NHTSA hereby decides that a1995 Chevrolet 400 SS pickup truckmanufactured for the Mexican market issubstantially similar to a 1995 ChevroletC1500 originally manufactured for salein the United States and certified under49 U.S.C. 30115, and is capable of beingreadily altered to conform to allapplicable Federal motor vehicle safetystandards.

Authority: 49 U.S.C. 30141(a)(1)(A) and(b)(1); 49 CFR 593.8; delegations of authorityat 49 CFR 1.50 and 501.8.

Issued on: April 17, 1996.Marilynne Jacobs,Director, Office of Vehicle Safety Compliance.[FR Doc. 96–9901 Filed 4–22–96; 8:45 am]BILLING CODE 4910–59–M

[Docket No. 96–13; Notice 2]

Decision That Nonconforming 1972Ford Mustang Passenger Cars AreEligible for Importation

AGENCY: National Highway TrafficSafety Administration, (NHTSA), DOT.ACTION: Notice of decision by NHTSAthat nonconforming 1972 Ford Mustangpassenger care manufactured for theMexican market are eligible forimportation.

SUMMARY: This notice announces thedecision by NHTSA that 1972 FordMustang passenger cars manufacturedfor the Mexican market that were notoriginally manufactured to comply withall applicable Federal motor vehiclesafety standards are eligible forimportation into the United Statesbecause they are substantially similar toa vehicle originally manufactured forimportation into and sale in the UnitedStates and certified by its manufactureras complying with the safety standards(the U.S.-certified version of the 1972Ford Mustang), and they are capable of

being readily altered to conform to thestandards.

DATES: This decision is effective on orbefore April 23, 1996.

FOR FURTHER INFORMATION CONTACT:George Entwistle, Office of VehicleSafety Compliance, NHTS (202–366–5306).


Background

Under 49 U.S.C. 30141(a)(1)(A)(formerly section 108(c)(3)(A)(i) of theNational Traffic and Motor VehicleSafety Act (the Act)), a motor vehiclethat was not originally manufactured toconform to all applicable Federal motorvehicle safety standards shall be refusedadmission into the United Sates unlessNHTSA has decided that the motorvehicle is substantially similar to amotor vehicle originally manufacturedfor importation into and sale in theUnited States, certified under 49 U.S.C.30115 (formerly section 114 of the Act),and of the same model year as themodel of the motor vehicle to becompared, and is capable of beingreadily altered to conform to allapplicable Federal motor vehicle safetystandards.

Petitions for eligibility decisions maybe submitted by either manufactures orimporters who have registered withNHTSA pursuant to 49 CFR part 592. Asspecified in 49 CFR 593.7, NHTSApublishes notice in the Federal Registerof each petition that it receives, andaffords interested persons anopportunity to comment on the petition.At the close of the comment period,NHTSA decides, on the basis of thepetition and any comments that it hasreceived, whether the vehicle is eligiblefor importation. The agency thenpublishes this decision in the FederalRegister.

Wallace Environmental TestingLaboratories, Inc. of Houston, Texas(Registered Importer R–90–005)petitioned NHTSA to decide whether1972 Ford Mustang passenger carsmanufactured for the Mexican marketare eligible for importation into theUnited States. NHTSA published noticeof the petition on February 21, 1996 (61FR 6685) to afford an opportunity forpublic comment. The reader is referredto that notice for a thorough descriptionof the petition. No comments werereceived in response to the notice.Based on its review of the informationsubmitted by the petitioner, NHTSA hasdecided to grant the petition.

Vehicle Eligibility Number for SubjectVehicles

The importer of a vehicle admissibleunder any7 final decision must indicateon the form HS–7 accompanying entrythe appropriate vehicle eligibility underindicating that the vehicle is eligible forentry. VSP–151 is the vehicle eligibilitynumber assigned to vehicles admissibleunder this decision.

Final DecisionAccordingly, on the basis of the

foregoing, NHTSA hereby decides that a1972 Ford Mustang manufactured forthe Mexican market that was notoriginally manufactured to comply withall applicable Federal motor vehiclesafety standards is substantially similarto a 1972 Ford Mustang originallymanufactured for sale in the UnitedStates and certified under 49 U.S.C.30115, and is capable of being readilyaltered to conform to all applicableFederal motor vehicle safety standards.

Authority: 49 U.S.C. 30141(a)(1)(A) and(b)(1); 49 CFR 593.8; delegations of authorityat 49 CFR 1.50 and 501.8.

Issued on: April 17, 1996.Marilynne JacobsDirector, Office of Vehicle Safety Compliance.[FR Doc. 96–9903 Filed 4–22–96; 8:45 am]BILLING CODE 4910–59–M

Research and Special ProgramsAdministration

Submission for OMB Review;Comment Request

ACTION: Notice of request to extend anexisting OMB approved informationcollection (2137–0584).

SUMMARY: As required by the PaperworkReduction Act of 1995, a notice waspublished in the Federal Register onFebruary 1, 1996 stating the Researchand Special Programs Administration’s(RSPA) intention to request OMBapproval to extend this informationcollection. The notice allowed 60 daysfor public comments; none werereceived. The information collection hasbeen submitted to OMB for review andapproval, and the purpose of this noticeis to allow 30 days from the date of thisnotice for public comment. Interestedpersons are invited to send commentsregarding the burden estimate or anyother aspect of this collection ofinformation, including any of thefollowing: (1) The necessity and utilityof the proposed information collectionfor the proper performance of theagency’s functions; (2) the accuracy ofthe estimated burden; (3) ways toenhance the quality, utility, and clarity


1 The ICC Termination Act of 1995, Pub. L. 104–88, 109 Stat. 803, which was enacted on December29, 1995, and took effect on January 1, 1996,

abolished the Interstate Commerce Commission andtransferred certain functions to the SurfaceTransportation Board (Board). This notice relates tofunctions that are subject to Board jurisdictionpursuant to 49 U.S.C. 11323.

1 The ICC Termination Act of 1995, Pub. L. No.104–88, 109 Stat. 803, which was enacted onDecember 29, 1995, and took effect on January 1,1996, abolished the Interstate CommerceCommission and transferred certain functions to theSurface Transportation Board (Board). This noticerelates to functions that are subject to Boardjurisdiction pursuant to 49 U.S.C. 10902.

2 Before 1986, the Southern PacificTransportation Company (SP) owned and operatedthe line from Giddings to Austin (the GiddingsBranch) and the connecting line from Austin toLlano, TX (the Llano Branch). SP also owned andoperated a line extending off of the Llano Branchat Fairland, TX, to Marble Falls, TX (the MarbleFalls Branch). In 1986, the City purchased theGiddings, Llano and Marble Falls Branches fromSP. See Austin Railroad Co.—OperationExemption—City of Austin, TX, Finance Docket No.30861(B) (ICC served Nov. 4, 1986) (51 FR 40084).Subsequently, the City was exempted from therequirements of 49 U.S.C. Subtitle IV, with respectto the acquisition which, among other things,relieved the City of any common carrier obligationthat it would incur upon consummation of thetransaction. See City of Austin, TX—Exemption—From 49 U.S.C. Subtitle IV, Finance Docket No.30861(A) (Sub-No. 1) (ICC served Apr. 23, 1987).

of the information to be collected; and(4) the use of automated collectiontechniques or other forms of informationtechnology to minimize the informationcollection burden.

Type of Information CollectionRequest: Renewal of Existing Collection.

Title of Information Collection:Certification and Agreement Forms forthe Gas and Hazardous Liquid PipelineSafety Program.

OMB Approval Number: 2137–0584.Frequency: Annually.Use: This collection is used by RSPA

to ensure that state agencies attestingthey have regulatory jurisdiction overpipeline safety have adopted and arecomplying with minimum Federalsafety standards. This information isused to calculate grants to states.

Estimated Number of Respondents:61.

Respondents: State Agencies.Total Annual Hours Requested: 3,649.Copies of this information collection

can be reviewed at the Dockets Unit(Docket PS–146; Notice 2), Room 8421,Research and Special ProgramsAdministration, U.S. Department ofTransportation, 400 Seventh St. SW.,Washington, D.C.ADDRESSES: Written comments andrecommendations concerning theproposed information collection shouldbe sent within 30 days of this noticedirectly to the Office of Information andRegulatory Affairs, Office ofManagement and Budget, 726 JacksonPlace NW., Washington, DC 20503,ATTN: Desk Officer for Department ofTransportation, RSPA.FOR FURTHER INFORMATION CONTACT:Marvin Fell, Office of Pipeline Safety,Research and Special ProgramsAdministration, Department ofTransportation, 400 Seventh Street SW.,Washington, DC 20590 (202) 366–1640.

Dated: April 17, 1996.Michael T. Horkan,Clearance Officer, United States Departmentof Transportation.[FR Doc. 96–9957 Filed 4–22–96; 8:45 am]BILLING CODE 4910–60–P

Surface Transportation Board 1

[STB Finance Docket No. 32902]

Central Railroad Company of Indiana—Trackage Rights Exemption—CSXTransportation, Inc.

Central Railroad Company of Indiana(CIND) has filed a verified notice under

49 CFR 1180.2(d)(7) to acquire trackagerights from the CSX Transportation, Inc.(CSXT) from connection with CIND onCSXT’s connection track T–1415 (D)(1)at Ownership Point (O.P.) 1+53 at NorthBend, OH, near CSXT’s milepost B.C.15and CSXT’s connection with CIND onCSXT’s connection track T–2 at O.P.1144+96.2 at Lawrenceburg, IN nearCSXT’s milepost 22, a distance ofapproximately 7 miles.

The purpose of the transaction is toreroute overhead traffic for CIND’sLawrenceburg, IN customers via CSXT,in order that CIND may abandon its own2.3 miles of right-of-way from railroadmilepost 22.4 near LawrenceburgJunction (about 0.4 miles north of theintersection of Route 50 and Route 1 inGreendale) to railroad milepost 24.7near Dearborn Junction (at the CIND/CSXT connection south of the formerPierson-Hollowell site inLawrenceburg), in Dearborn County, IN.See Central Railroad Company ofIndiana—Abandonment Exemption—inDearborn Country, IN, STB Docket No.AB–459 (Sub-No. 1X) (ICC served Mar.11, 1996). By Board decision servedApril 5, 1996, the effective date of theabandonment exemption was postponeduntil April 30, 1996.

The trackage rights transaction isexpected to be consummatedimmediately after conveyance of theabandoned right of way for constructionof a public highway.

As a condition to this exemption, anyemployees affected by the trackagerights will be protected by theconditions imposed in Norfolk andWestern Ry. Co.—Trackage Rights—BN,354 I.C.C. 605 (1978), as modified inMendocino Coast Ry., Inc.—Lease andOperate, 354 I.C.C. 732 (1978) and 360I.C.C. 653 (1980).

If the notice contains false ormisleading information, the exemptionis void ab initio. Petitions to revoke theexemption under 49 U.S.C. 10502(d)may be filed at any time. The filing ofa petition to revoke will notautomatically stay the transaction.

An original and 10 copies of allpleadings, referring to STB FinanceDocket No. 32902, must be filed withthe Surface Transportation Board, Officeof the Secretary, Case Control Branch,1201 Constitution Avenue NW.,Washington, DC 20423 and served on: JoA. DeRoche, Weiner, Brodsky, Sidman &Kider, P.C., 1350 New York AvenueNW., Suite 800, Washington, DC 20005–4797.

Decided: April 16, 1996.By the Board, David M. Konschnik,

Director, Office of Proceedings.Vernon A. Williams,Secretary.[FR Doc. 96–9967 Filed 4–22 –96; 8:45 am]BILLING CODE 4915–00–P


[STB Finance Docket No. 32885 (Sub- No.1)]

Central of Tennessee Railway &Navigation Company Incorporated d/b/a The Longhorn Railway Company—Change of Operator Exemption—TheCity of Austin, TX

AGENCY: Surface Transportation Board.ACTION: Notice of exemption.

SUMMARY: The Board, under 49 U.S.C.10502, exempts from the prior approvalrequirements of 49 U.S.C. 10902 theoperation by Central of TennesseeRailway & Navigation CompanyIncorporated doing business as TheLonghorn Railway Company (CTRN) ofa rail line owned by the City of Austin,TX (the City) 2 and currently operatedby Austin Railroad Company d/b/aAustin & Northwestern Railroad(AUNW). The line extends betweenAUNW milepost 00.00, west ofGiddings, and AUNW milepost 154.07,at Llano, including the Marble FallsBranch (6.43 miles), the Scobee Spur(3.3 miles), and the Burnet Spur (0.93mile), for approximately 162 miles, inBastrop, Burnet, Lee, Llano, Travis andWilliamson Counties, TX.DATES: This exemption is effective onMay 3, 1996. Petitions to stay must be


1 The ICC Termination Act of 1995, Pub. L. No.104–88, 109 Stat. 803, which was enacted onDecember 29, 1995, and took effect on January 1,1996, abolished the Interstate CommerceCommission and transferred certain functions to theSurface Transportation Board (Board). This noticerelates to functions that are subject to the Board’sjurisdiction pursuant to 49 U.S.C. 10903.

2 BN has proposed a consummation date for theabandonment that is four months from the date offiling of its verified notice. This proposedconsummation date is based on BN’s reading of 49U.S.C. 10904. The first sentence of 10904(c)provides, ‘‘Within 4 months after an application isfiled under section 10903, any person may offer tosubsidize or purchase the railroad line that is thesubject of such application.’’

The Board recently addressed this provision inproposing revised abandonment regulations toimplement 49 U.S.C. 10903–04, as established bythe ICC Termination Act. In Abandonment and

Discontinuance of Rail Lines and RailTransportation Under 49 U.S.C. 10903, STB ExParte No. 537 (STB served Mar. 15, 1996) slip op.at 10 [61 FR 11174, 11176 (Mar. 19, 1996)], theBoard said, ‘‘We see the 4-month statutory deadlineas an outer limit, which does not require us to delayresolution of proceedings where the entire time isnot needed.’’

Based on the Board’s statement, the exemption inthis proceeding will be scheduled to becomeeffective on May 23, 1996, or 50 days after BN’sfiling of its verified notice of exemption. This isconsistent with the existing rules at 49 CFR1152.50. Offers of financial assistance will be dueaccording to deadlines established in this notice.Potential offerors will not have until 4 months afterthe notice was filed by BN with the Board to makean offer of financial assistance.

While the exemption is scheduled to take effecton May 23, 1996, BN may of course delayconsummation until a later date.

3 The Board will grant a stay if an informeddecision on environmental issues (whether raisedby a party or by the Board’s Section ofEnvironmental Analysis in its independentinvestigation) cannot be made before theexemption’s effective date. See Exemption of Out-of-Service Rail Lines, 5 I.C.C.2d 377 (1989). Anyrequest for a stay should be filed as soon as possibleso that the Board may take appropriate action beforethe exemption’s effective date.

4 See Exempt. of Rail Abandonment—Offers ofFinan. Assist., 4 I.C.C.2d 164 (1987).

5 The Board will accept late-filed trail userequests so long as the abandonment has not been

consummated and the abandoning railroad iswilling to negotiate an agreement.

1 The ICC Termination Act of 1995, Pub. L. 104–88, 109 Stat. 803 (the Act), which was enacted onDecember 29, 1995, and took effect on January 1,1996, abolished the Interstate CommerceCommission and transferred certain functions to theSurface Transportation Board (Board). This noticerelates to functions that are subject to Boardjurisdiction pursuant to 49 U.S.C. 10903.

filed by April 29, 1996, and petitions toreopen must be filed by May 16, 1996.ADDRESSES: Send pleadings, referring toSTB Finance Docket No. 32885 (Sub-No.1) to: (1) Surface Transportation Board,Office of the Secretary, Case ControlBranch, 1201 Constitution Avenue,N.W., Washington, DC 20423; and (2)Donald T. Cheatham, 150 FourthAvenue, North, Suite 1210, Nashville,TN 37219.FOR FURTHER INFORMATION CONTACT:Beryl Gordon, (202) 927–5610. [TDD forthe hearing impaired: (202) 927–5721.]SUPPLEMENTARY INFORMATION:Additional information is contained inthe Board’s decision. To purchase acopy of the full decision, write to, call,or pick up in person from: DC Data &News, Inc., Room 2229, 1201Constitution Avenue, N.W.,Washington, DC 20423. Telephone:(202) 289–4357/4359. [Assistance forthe hearing impaired is availablethrough TDD services, (202) 927–5721.]

Decided: April 16, 1996.By the Board, Chairman Morgan, Vice

Chairman Simmons, and CommissionerOwen.Vernon A. Williams,Secretary.[FR Doc. 96–9964 Filed 4–22–96; 8:45 am]BILLING CODE 4915–00–P


[STB Docket No. AB–6 (Sub-No. 377X)]

Burlington Northern RailroadCompany—Abandonment Exemption—in Thayer County, NE

Burlington Northern RailroadCompany (BN) filed a notice ofexemption under 49 CFR Part 1152Subpart F—Exempt Abandonments toabandon 12.15 miles of its line ofrailroad between milepost 24.00 nearBruning and milepost 32.20 nearHebron, including the station of Hebronat milepost 26.2, in Thayer County, NE.2

BN has certified that: (1) No localtraffic has moved over the line for atleast 2 years; (2) there is no overheadtraffic to be rerouted from the line; (3)no formal complaint filed by a user ofrail service on the line (or by a state orlocal government entity acting on behalfof such user) regarding cessation ofservice over the line either is pendingwith the Board or with any U.S. DistrictCourt or has been decided in favor ofcomplainant within the 2-year period;and (4) the requirements at 49 CFR1105.7 (environmental reports), 49 CFR1105.8 (historic reports), 49 CFR1105.11 (transmittal letter), 49 CFR1105.12 (newspaper publication), and49 CFR 1152.50(d)(1) (notice togovernmental agencies) have been met.

As a condition to use of thisexemption, any employee adverselyaffected by the abandonment shall beprotected under Oregon Short Line R.Co.—Abandonment—Goshen, 360 I.C.C.91 (1979). To address whether thiscondition adequately protects affectedemployees, a petition for partialrevocation under 49 U.S.C. 10502(d)must be filed. Provided no formalexpression of intent to file an offer offinancial assistance (OFA) has beenreceived, this exemption will beeffective on May 23, 1996, unless stayedpending reconsideration. Petitions tostay that do not involve environmentalissues,3 formal expressions of intent tofile an OFA under 49 CFR1152.27(c)(2),4 and trail use/rail bankingrequests under 49 CFR 1152.29 5 must

be filed by May 3, 1996. Petitions toreopen or requests for public useconditions under 49 CFR 1152.28 mustbe filed by May 13, 1996, with: Officeof the Secretary, Case Control Branch,Surface Transportation Board, 1201Constitution Avenue, N.W.,Washington, DC 20423.

A copy of any petition filed with theBoard should be sent to applicant’srepresentative: Sarah J. Whitley, GeneralAttorney, Burlington Northern RailroadCompany, 3800 Continental Plaza, 777Main Street, Fort Worth, TX 76102–5384.

If the verified notice contains false ormisleading information, the exemptionis void ab initio.

BN has filed an environmental reportwhich addresses the abandonment’seffects, if any, on the environment andhistoric resources. The Section ofEnvironmental Analysis (SEA) willissue an environmental assessment (EA)by April 26, 1996. Interested personsmay obtain a copy of the EA by writingto SEA (Room 3219, SurfaceTransportation Board, Washington, DC20423) or by calling Elaine Kaiser, Chiefof SEA, at (202) 927–6248. Commentson environmental and historicpreservation matters must be filedwithin 15 days after the EA becomesavailable to the public.

Environmental, historic preservation,public use, or trail use/rail bankingconditions will be imposed, whereappropriate, in a subsequent decision.

Decided: April 12, 1996.By the Board, David M. Konschnik,

Director, Office of Proceedings.Vernon A. Williams,Secretary.[FR Doc. 96–9966 Filed 4–22–96; 8:45 am]BILLING CODE 4915–00–P


[STB Docket No. AB–469]

Jacksonville Port Authority; AdverseDiscontinuance; In Duval County, FLAGENCY: Surface Transportation Board.ACTION: Exemption from statutoryprovisions concerning giving of noticeof an application and filing of a systemdiagram map.

SUMMARY: Under 49 U.S.C. 10502, theBoard is exempting the Jacksonville Port


Authority from the requirements that itpost and publish notice of itsapplication and certify that it has doneso, and that it file with the Board asystem diagram map identifying anddescribing the subject line. The Board isgranting an exemption because theapplication is being filed by a partyother than the carrier whose operationsare the object of the discontinuance.DATES: The exemption will take effecton April 23, 1996. Petitions to reopenmust be filed by May 3, 1996.ADDRESSES: Send pleadings referring toSTB Docket No. AB–469 to: (1) Office ofthe Secretary, Case Control Branch,Surface Transportation Board, 1201Constitution Avenue, N.W.,Washington, DC 20423; and (2)petitioner’s representatives: Ernst D.Mueller, 220 East Bay Street,Jacksonville, FL 32202; and Kelvin J.Dowd, 1224 Seventeenth Street, NW.,Washington, DC 20036.FOR FURTHER INFORMATION CONTACT:Joseph H. Dettmar, (202) 927–5660.[TDD for the hearing impaired: (202)927–5721.]SUPPLEMENTARY INFORMATION: TheJacksonville Port Authority (JPA) hasfiled an application seeking adetermination by the Board that thepublic convenience and necessityrequire or permit the discontinuance ofservice by Jaxport Terminal RailwayCompany (JTRC) over approximately 10miles of terminal switching tracks thatJPA owns and that connect itsTalleyrand Marine Dock and TerminalFacilities in Jacksonville, FL, with thetracks of line-haul carriers. The fact thatthe application has been filed by a partyother than the carrier whose operationsare the subject of the discontinuance hasled JPA to seek a waiver of therequirement that it post and publishnotice of its application. Also, JPA isunable to require JTRC to file a systemdiagram map (SDM). Accordingly, JPAseeks exemption from the provisions of49 U.S.C. 10903(a)(3) (B), (C), and (E),which require, respectively posting of acopy of a notice of the application interminals and stations, publishing acopy of the notice in newspapers forspecified periods, and certifying that ithas satisfied these requirements. JPAalso seeks exemption from theprovisions of 49 U.S.C. 10903(c), whichrequire carriers to submit to the Boardan SDM identifying each line for whichthe carrier plans to file a discontinuanceapplication.

The Board is granting the exemption,finding that compliance with the statuteis not required to carry out the railtransportation policy of 49 U.S.C.10101, the matter is of limited scope,

and strict adherence to the statutoryrequirements is not needed to protectshippers from the abuse of marketpower. The Board is also granting JPAa waiver of certain regulatoryrequirements relating to (1) thesubmission of service, financial andenvironmental information and (2) thenotice and SDM matters discussedabove.

Additional information is containedin the Board’s decision, in which theBoard also declined to institute aninvestigation into the proposeddiscontinuance. To purchase a copy ofthe full decision, write to, call, or pickup in person from: DC News & Data,Inc., 1201 Constitution Avenue, NW.,Room 2229, Washington, DC 20423.Telephone: (202) 289–4357/4359.[Assistance for the hearing impaired isavailable through TDD services (202)927–5721.]

Decided: April 16, 1996.By the Board, Chairman Morgan, Vice

Chairman Simmons, and CommissionerOwen.Vernon A. Williams,Secretary.[FR Doc. 96–9965 Filed 4–22–96; 8:45 am]BILLING CODE 4915–00–P

Board Conference; Sunshine ActMeeting

TIME & DATES: 10:00 a.m., April 30, 1996.PLACE: Hearing Room A, SurfaceTransportation Board, 1201 ConstitutionAvenue, N.W., Washington, D.C. 20423.STATUS: The Board will meet to discussamong themselves the following agendaitems. Although the conference is openfor the public observation, no publicparticipation is permitted.

MATTERS TO BE DISCUSSED:

STB Ex Parte No. 528, Disclosure,Publication, and Notice of Change of Ratesand Other Service Terms for Rail CommonCarriage.

Ex Parte No. 392 (Sub-No. 2), ClassExemption for the Construction ofConnection Track Under 49 U.S.C. 10901 andEx Parte No. 392 (Sub-No. 3), ClassExemption for Rail Construction Under 49U.S.C. 10901.

Finance Docket No. 32830, AlamedaCorridor Construction Application.

STB Finance Docket No. 32858, IllinoisCentral Corporation and Illinois CentralRailroad Company—Control—CCP Holdings,Inc., Chicago, Central & Pacific RailroadCompany and Cedar River RailroadCompany.

No. MC–F–20783, Capitol Bus Company-Pooling-Greyhound Lines, Inc.

CONTACT PERSON FOR MORE INFORMATION:Dennis Watson, Office of Congressional

and Press Service, Telephone: (202)927–5350, TDD: (202) 927–5721.Vernon A. Williams,Secretary.[FR Doc. 96–10064 Filed 4–19–96; 2:53 pm]BILLING CODE 4915–00–P

DEPARTMENT OF THE TREASURY


April 15, 1996.The Department of the Treasury has

submitted the following publicinformation collection requirement(s) toOMB for review and clearance under thePaperwork Reduction Act of 1995,Public Law 104–13. Copies of thesubmission(s) may be obtained bycalling the Treasury Bureau ClearanceOfficer listed. Comments regarding thisinformation collection should beaddressed to the OMB reviewer listedand to the Treasury DepartmentClearance Officer, Department of theTreasury, Room 2110, 1425 New YorkAvenue, NW., Washington, DC 20220.

Bureau of the Public Debt (BPD)

OMB Number: 1535–0001.Form Number: SB–60 and SB–60a.Type of Review: Extension.Title: Payroll Savings Report.Description: These forms are used to

determine the total number ofparticipants purchasing U.S. SavingsBonds through the Payroll Savings Plan.

Respondents: Business or other for-profit.

Estimated Number of Respondents:25,910.

Estimated Burden Hours PerResponse: 41 minutes.

Frequency of Response: Semi-annually.

Estimated Total Reporting Burden:17,871 hours.

OMB Number: 1535–0059.Form Number: PD F 1832.Type of Review: Extension.Title: Special Form of Assignment for

U.S. Registered Definitive Securities.Description: PD F 1832 is used to

certify assignments of U.S. RegisteredDefinitive Securities.

Respondents: Individuals orhouseholds, business or other for-profit,not-for-profit institutions, FederalGovernment, State, Local or TribalGovernment.



Frequency of Response: On occasion.


Estimated Total Reporting Burden:2,500 hours.

OMB Number: 1535–0070.Form Number: PD F 5192.Type of Review: Extension.Title: Stop Payment/Replacement

Check Request.Description: PD F 5192 is used by the

payee to report loss, stolen, destroyed ornonreceipt of fiscal agency check and torequest a replacement check.

Respondents: Individuals orhouseholds, Business or other for-profit,not-for-profit institutions, State, Local orTribal Government.



Frequency of Response: On occasion.Estimated Total Reporting Burden:

125 hours.OMB Number: 1535–0113.Form Number: PD F 1849.Type of Review: Extension.Title: Disclaimer and Consent With

Respect to United States Savings Bonds/Notes.

Description: PD F 1849 is used toobtain a disclaimer and consent as theresult of an error in registration orotherwise the payment, refund of thepurchase price, or reissue as requestedby one person would appear to affectthe right, title or interest of some otherperson.

Respondents: Individuals orhouseholds.




700 hours.OMB Number: 1535–0114.Form Number: PD F 2001.Type of Review: Extension.Title: Release.Description: PD F 2001 is used by the

owner, coowner, or other personentitled to ratify payment of savingsbonds/notes and release the UnitedStates of America from any liability.




Frequency of Response: On occasion.Estimated Total Reporting Burden: 20

hours.Clearance Officer: Vicki S. Ott (304)

480–6553, Bureau of the Public Debt,200 Third Street, Parkersburg, West VA26106–1328.

OMB Reviewer: Milo Sunderhauf(202) 395–7340, Office of Management

and Budget, Room 10226, NewExecutive Office Building, Washington,DC 20503.Lois K. Holland,Departmental Reports Management Officer.[FR Doc. 96–9890 Filed 4–22–96; 8:45 am]BILLING CODE 4810–40–P


April 10, 1996.

The Department of Treasury hassubmitted the following publicinformation collection requirement(s) toOMB for review and clearance under thePaperwork Reduction Act of 1995,Public Law 104–13. Copies of thesubmission(s) may be obtained bycalling the Treasury Bureau ClearanceOfficer listed. Comments regarding thisinformation collection should beaddressed to the OMB reviewer listedand to the Treasury DepartmentClearance Officer, Department of theTreasury, Room 2110, 1425 New YorkAvenue, NW., Washington, DC 20220.SPECIAL REQUEST: In order toimplement the process described belowby the June 1996 start-up date, theDepartment of Treasury is requestingOffice of Management and Budget(OMB) review and approve thisinformation collection by April 23,1996. To obtain a copy of this survey,please contact the IRS Clearance Officerat the address listed below.

Internal Revenue Service (IRS)

OMB Number: 1545–1432.Project Number: M:SP:V 96–011–G.Type of Review: Revision.Title: EP/EO Determination

Centralization Customer SatisfactionSurvey.

Description: In order to ascertainwhether the centralized determinationprocess is of value, IRS will administerthis survey twice for each key districtoffice.



Estimated Burden Hours PerRespondent: 3 minutes.

Frequency of Response: Other.Estimated Total Reporting Burden:

849 hours.Clearance Officer: Garrick Shear (202)

622–3869, Internal Revenue Service,Room 5571, 1111 Constitution Avenue,N.W., Washington, DC 20224.

OMB Reviewer: Milo Sunderhauf(202) 395–7340,Office of Managementand Budget, Room 10226, New

Executive Office Building, Washington,DC 20503.Lois K. Holland,Departmental Reports Management Officer.[FR Doc. 96–9891 Filed 4–22–96; 8:45 am]BILLING CODE 4830–01–P

Submission to OMB for Review;Comment Request

April 16, 1996.The Department of Treasury has

submitted the following publicinformation collection requirement(s) toOMB for review and clearance under thePaperwork Reduction Act of 1995,Public Law 104–13. Copies of thesubmission(s) may be obtained bycalling the Treasury Bureau ClearanceOfficer listed. Comments regarding thisinformation collection should beaddressed to the OMB reviewer listedand to the Treasury DepartmentClearance Officer, Department of theTreasury, Room 2110, 1425 New YorkAvenue, NW., Washington, DC 20220.

Internal Revenue Service (IRS)

OMB Number: 1545–0863.Regulation ID Number: LR–218–78

Final.Type of Review: Extension.Title: Product Liability Losses and

Accumulations for Product LiabilityLosses.

Description: Generally, a taxpayerwho sustains a product liability lossmust carry the loss back 10 years.However, a taxpayer may elect to havesuch loss treated as a regular netoperating loss under section 172. Ifdesired, such election is made byattaching a statement to the tax return.This statement will enable the IRS tomonitor compliance with the statutoryrequirements.



Estimated Burden Hours PerRespondent: 30 minutes.


2,500 hours.OMB Number: 1545–1100.Regulation ID Number: EE–84–89

NPRM.Type of Review: Extension.Title: Changes with Respect to Prizes

and Awards and EmployeeAchievement Awards.

Description: This regulation requiresrecipients of prizes and awards tomaintain records to determine whethera qualifying designation has been made.The affected public are prize and award


recipients who seek to exclude the costof a qualifying prize or award.


Estimated Number of Respondents: 1.Estimated Burden Hours Per

Respondent: 1.Frequency of Response: On occasion.Estimated Total Reporting Burden: 1

hour.OMB Number: 1545–1126.Regulation ID Number: INTL–121–90

NPRM, INTL–292–90 Final, INTL–361–89 Final, INTL–103–89 Temporary

Type of Review: Extension.Title: Treaty-Based Return Positions.Description: Section 301.6114 sets

forth the reporting requirements under§ 6114. Persons or entities subject to thisreporting requirement must make therequired disclosure on a statementattached to their return, in the mannerset forth, or be subject to a penalty.Section 301.7701(b)–7(a)(4)(iv)(C) setsforth the reporting requirement for dualresident S corporation shareholders whoclaim treaty benefits as nonresidents ofthe United States.

Respondents: Individuals orhouseholds, business or other for-profit.


Estimated Burden Hours PerRespondent: 1 hour.

Frequency of Response: Annually.Estimated Total Reporting Burden:

5,000 hours.OMB Number: 1545–1385.Regulation ID Number: GL–238–88

Final.Type of Review: Extension.Title: Preparer Penalties—Manual

Signature Requirement.Description: The reporting

requirements affect returns preparers offiduciary returns. They will be requiredto submit a list of the names andidentifying numbers of all fiduciaryreturns which are being filed withfacsimile signature of the returnspreparer.


Estimated Number of Respondents/Recordkeepers: 20,000.

Estimated Burden Hours PerRespondent/Recordkeeper: 1 hour, 17minutes.

Frequency of Response: Annually.Estimated Total Reporting/

Recordkeeping Burden: 25,825 hours.OMB Number: 1545–1435.Regulation ID Number: EE–45–93

NPRM and TemporaryType of Review: Extension.Title: Electronic Filing of Form W–4.Description: Information is required

by the Internal Revenue Service to

verify compliance with section31.3402(f)(2)–1(g)(1), which requiressubmission to the Service of certainwithholding exemption certificates. Theaffected respondents are employers thatchoose to make electronic filing ofForms W–4 available to theiremployees.

Respondents: Business or other for-profit, not-for profit institutions, FederalGovernment, State, Local or TribalGovernment.


Estimated Burden Hours PerRespondent: 20 hours.


40,000 hours.Clearance Officer: Garrick Shear (202)

622–3869, Internal Revenue Service,Room 5571, 1111 Constitution Avenue,N.W., Washington, DC 20224.

OMB Reviewer: Milo Sunderhauf(202) 395–7340, Office of Managementand Budget, Room 10226, NewExecutive Office Building, Washington,DC 20503.Lois K. Holland,Departmental Reports Management Officer.[FR Doc. 96–9892 Filed 4–22–96; 8:45 am]BILLING CODE 4830–01–P

Customs Service

[T.D. 96–34]

Determination That MerchandiseImported From the People’s Republicof China Is Produced Using Convict,Forced, or Indentured Labor by theTianjin Malleable Iron Factory

AGENCY: U.S. Customs Service,Department of the Treasury.ACTION: Determination that SubjectMerchandise is Prohibited by 19 U.S.C.1307 From Importation into the UnitedStates.

SUMMARY: This document advises thatthe Commissioner of Customs, with theapproval of the Secretary of theTreasury, has determined that certainiron pipe fittings, which are being, orare likely to be imported into the UnitedStates from the People’s Republic ofChina (PRC), are being manufacturedwith the use of convict, forced, orindentured labor by the TianjinMalleable Iron Factory, TianjinMunicipality, People’s Republic ofChina. This facility may also be knownas the Tianjin Tongbao FittingsCompany, the Tianjin NO. 2 MalleableIron Plant, the Tianjin SecondaryMugging Factory, or the Tianjin NO. 2Prison. The Commissioner of Customs,pursuant to 19 CFR 12.42(f), has

determined, on the basis of a Customsinvestigation, that such merchandise isbeing, or is likely to be, imported intothe United States in violation of Section307 of the Tariff Act of 1930 as amended(19 U.S.C. 1307), unless, pursuant to 19CFR 12.42(g), 12.43, and 12.44, theimporter establishes by satisfactoryevidence that the merchandise was notmined, produced,or manufactured inany part with the use of a class of laborspecified herein.EFFECTIVE DATE: This determinationshall take effect on or before April 29,1996.FOR FURTHER INFORMATION CONTACT:Buford E. Gates, Senior Special Agent,Office of Investigations, FraudInvestigations Division, Headquarters,U.S. Customs Service, 1301 ConstitutionAvenue, Washington, D.C. 20229, 202–927–2195.


Background

Section 307, Tariff Act of 1930 asamended, (19 U.S.C. 1307) provides inpertinent part that:

All goods, wares, articles, andmerchandise, mined, produced, ormanufactured wholly, or in part, in anyforeign country by convict labor or/andforced labor or/and indentured labor underpenal sanctions, shall not be entitled to entryat any of the ports of the United States, andthe importation thereof is hereby prohibited,and the Secretary of the Treasury isauthorized and directed to prescribe suchregulations as may be necessary for theenforcement of this provision.

Forced labor is defined as ‘‘All work orservice which is exacted from any personunder the menace of any penalty for itsnonperformance and for which the workerdoes not offer himself voluntarily.’’

Pursuant to section 307, the Secretaryof the Treasury promulgatedimplementing regulations found at 19CFR 12.42, et seq. These regulations setforth the procedure for theCommissioner of Customs to make afinding that an article being produced,whether by mining, manufacture, orother means, in any foreign locality withthe use of convict labor, forced labor, orindentured labor under penal sanctionsso as to come under the purview of 19U.S.C. 1307 is being, or is likely to be,imported into the United States.Paragraph (f) of section 12.42, CustomsRegulations (19 CFR 12.42(f), providesthat if the Commissioner of Customsfinds that merchandise within thepurview of 19 U.S.C. 1307 is being, oris likely to be, imported into the UnitedStates, {s}he will, with the approval ofthe Secretary of the Treasury, publish afinding to that effect in a weekly issue


of the Customs Bulletin and in theFederal Register.

Finding

Pursuant to section 12.42(f), CustomsRegulations (19 CFR 12.42(f)), it ishereby determined that certain articlesof the People’s Republic of China whichare produced, whether by mining,manufacture, or other means, with theuse of convict, forced, or indenturedlabor, are being, or are likely to be,imported into the United States.

Accordingly, based upon this finding,Customs officers shall withhold releaseof any of these articles from the People’sRepublic of China. Such discoveredarticles may be only exported by theCustoms Service.

Articles Covered by This Finding

Malleable Iron Pipe Fittings manufacturedby the Tianjin Malleable Iron Factory, alsoknown as the Tianjin Tongbao FittingsCompany, also known as the Tianjin NO. 2Malleable Iron Plant, also known as theTianjin Secondary Mugging Factory, alsoknown as the Tianjin NO.2 Prison.

Subject Harmonized Tariff ScheduleNumbers

7307.1930, 7307.1990, 7307.911000,7307.915010, 7307.915050, 7307.923010,7307.929000, 7307.933000, 7307.939030,7307.991000, 7307.995015, and 7307.995045.

Dated: March 6, 1996.Michael H. Lane,Acting Commissioner of Customs.

Dated: March 20, 1996.John P. Simpson,Deputy Assistant Secretary Regulatory, Tariffand Trade Enforcement.[FR Doc. 96–9875 Filed 4–22–96; 8:45 am]BILLING CODE 4820–02–P

Office of Thrift Supervision

[AC–26; OTS No. 03497]

First Federal Savings and LoanAssociation of Ironton, Ironton, OH;Approval of Conversion Application

Notice is hereby given that on April15, 1996, the Director, CorporateActivities, Office of Thrift Supervision,or her designee, acting pursuant todelegated authority, approved theapplication of First Federal Savings andLoan Association of Ironton, Ironton,Ohio, to convert to the stock form oforganization. Copies of the applicationare available for inspection at theDissemination Branch, Office of ThriftSupervision, 1700 G Street, N.W.,Washington, D.C. 20552, and the CentralRegional Office, Office of ThriftSupervision, 200 West Madison Street,Suite 1300, Chicago, Illinois 60606.

Dated: April 17, 1996.By the Office of Thrift Supervision,

Nadine Y. Washington,Corporate Secretary.[FR Doc. 96–9917 Filed 4–22–96; 8:45 am]BILLING CODE 6720–01–P

[AC–27; OTS No. 02100]

First Federal Savings and LoanAssociation of Bloomington,Bloomington, IL; Approval ofConversion Application

Notice is hereby given that on April16, 1996, the Director, CorporateActivities, Office of Thrift Supervision,or her designee, acting pursuant todelegated authority, approved theapplication of First Federal Savings andLoan Association of Bloomington,Bloomington, Illinois, to convert to the

stock form of organization. Copies of theapplication are available for inspectionat the Dissemination Branch, Office ofThrift Supervision, 1700 G Street, N.W.,Washington, D.C. 20552, and the CentralRegional Office, Office of ThriftSupervision, 200 West Madison Street,Suite 1300, Chicago, Illinois 60606.

Dated: April 17, 1996.By the Office of Thrift Supervision.


[AC–25; OTS No. 07058]

First Lancaster Federal Savings Bank,Lancaster, KY; Approval of ConversionApplication

Notice is hereby given that on April10, 1996, the Director, CorporateActivities, Office of Thrift Supervision,or her designee, acting pursuant todelegated authority, approved theapplication of First Lancaster FederalSavings Bank, Lancaster, Kentucky, toconvert to the stock form oforganization. Copies of the applicationare available for inspection at theDissemination Branch, Office of ThriftSupervision, 1700 G Street, N.W.,Washington, D.C. 20552, and the CentralRegional Office, Office of ThriftSupervision, 200 West Madison Street,Suite 1300, Chicago, Illinois 60606.

Dated: April 17, 1996.By the Office of Thrift Supervision.


This section of the FEDERAL REGISTERcontains editorial corrections of previouslypublished Presidential, Rule, Proposed Rule,and Notice documents. These corrections areprepared by the Office of the FederalRegister. Agency prepared corrections areissued as signed documents and appear inthe appropriate document categorieselsewhere in the issue.

Corrections Federal Register

17958

Vol. 61, No. 79



Drug Enforcement Administration

21 CFR Part 1310

[DEA-135F]

RIN 1117-AA30

Correction

In rule document 96–7739, beginningon page 14022, in the issue of Friday,March 29, 1996, make the followingcorrection:

On page 14024, in the first column, inthe last sentence, ‘‘manufacture of drug

dosage from,’’ should read‘‘manufacture of drug dosage form.’’BILLING CODE 1505–01–D



Ronald Phillips, D.O.; Revocation ofRegistration

CorrectionIn notice document 96–8387

beginning on page 15304 in the issue ofFriday, April 5, 1996, make thefollowing corrections:

1. On page 15304, in the thirdcolumn, in the first paragraph, the tenthline is corrected to read ‘‘Certificate ofRegistration, AP9171048’’.

2. On page 15305, in the first column,in the second complete paragraph,‘‘Vicondin’’ should read ‘‘Vicodin’’wherever it appears. And on the samepage, in the third column, in theseventh line, ‘‘and’’ the second time itappears should read ‘‘any’’.BILLING CODE 1505–01–D



[Docket No. 94-81]

Shahid Musud Siddiqui, M.D.;Revocation of Registration

Correction

In notice document 96–8043beginning on page 14818 in the issue ofWednesday, April 3, 1996, make thefollowing corrections:

1. On page 14818, in the secondcolumn, in the first paragraph, the lastline should read ‘‘42 U.S.C. 1320a-7(a)’’.In the same column, third paragraph, inthe second line ‘‘field’’ should read‘‘filed’’. And on the same page, in thethird column, in the second fullparagraph, in the sixth line ‘‘deputy’’should read ‘‘Deputy’’.

2. On page 14819, in the first column,in the ninth line ‘‘Kir’’ should read‘‘Kirk’’.

BILLING CODE 1505–01–D

fede

ral r

egiste

r

17959

TuesdayApril 23, 1996

Part II

EnvironmentalProtection AgencyProposed Guidelines for Carcinogen RiskAssessment; Notice



[FRL–5460–3]

Proposed Guidelines for CarcinogenRisk Assessment

AGENCY: Environmental ProtectionAgency (EPA).ACTION: Notice of Availability andOpportunity to Comment on ProposedGuidelines for Carcinogen RiskAssessment.

SUMMARY: The U.S. EnvironmentalProtection Agency (EPA) is todaypublishing a document entitledProposed Guidelines for CarcinogenRisk Assessment (hereafter ‘‘ProposedGuidelines’’). These ProposedGuidelines were developed as part of aninteroffice guidelines developmentprogram by a Technical Panel of theRisk Assessment Forum within EPA’sOffice of Research and Development.These Proposed Guidelines are arevision of EPA’s 1986 Guidelines forCarcinogen Risk Assessment (hereafter‘‘1986 cancer guidelines’’) published onSeptember 24, 1986 (51 FR 33992).When final, these guidelines willreplace the 1986 guidelines.

In a future Federal Register notice,the Agency intends to publish forcomment how it will implement theProposed Guidelines once they arefinalized. The plans will propose andseek comment on how the Guidelineswill be used for Agency carcinogen riskassessment and, in particular, willaddress the impact of the Guidelines onthe Agency’s existing assessments, andany mechanisms for handlingreassessments under finalizedGuidelines.DATES: The Proposed Guidelines arebeing made available for a 120-daypublic review and comment period.Comments must be in writing and mustbe postmarked by August 21, 1996. SeeADDRESSES section for guidance onsubmitting comments.ADDRESSES: The Proposed Guidelineswill be made available in the followingways:

(1) The electronic version will beaccessible on EPA’s Office of Researchand Development home page on theInternet at http://www.epa.gov/ORD

(2) 31⁄2′′ high-density computerdiskettes in Wordperfect 5.1 format willbe available from ORD Publications,Technology Transfer and SupportDivision, National Risk ManagementResearch Laboratory, Cincinnati, OH;telephone: 513–569–7562; fax: 513–569–7566. Please provide the EPA No.(EPA/600/P–92/003Ca) when ordering.

(3) This notice contains the full draftdocument. In addition, copies of thedraft will be available for inspection atEPA headquarters and regional libraries,through the U.S. GovernmentDepository Library program, and forpurchase from the National TechnicalInformation Service (NTIS), Springfield,VA; telephone: 703–487–4650, fax: 703–321–8547. Please provide the NTIS PBNo. (PB96–157599) ($35.00) whenordering.SUBMITTING COMMENTS: Comments on theProposed Guidelines may be mailed ordelivered to the Technical InformationStaff (8623), NCEA-WA/OSG, U.S.Environmental Protection Agency, 401M Street, S.W., Washington, DC 20460.Comments should be in writing andmust be postmarked by the dateindicated. Please submit one unboundoriginal with pages numberedconsecutively, and three copies. Forattachments, provide an index, numberpages consecutively with the comment,and submit an unbound original andthree copies.

Please note that all technicalcomments received in response to thisnotice will be placed in a public record.For that reason, commenters should notsubmit personal information (such asmedical data or home address),Confidential Business Information, orinformation protected by copyright. Dueto limited resources, acknowledgmentswill not be sent.FOR FURTHER INFORMATION CONTACT:Technical Information Staff, Operationsand Support Group, National Center forEnvironmental Assessment—Washington Office, telephone: 202–260–7345. Email inquiries may be sent [email protected] INFORMATION: In 1983,the National Academy of Sciences(NAS)/National Research Council (NRC)published its report entitled RiskAssessment in the Federal Government:Managing the Process (NRC, 1983). Inthat report, the NRC recommended thatFederal regulatory agencies establish‘‘inference guidelines’’ to ensureconsistency and technical quality in riskassessments and to ensure that the riskassessment process was maintained as ascientific effort separate from riskmanagement. The 1986 cancerguidelines were issued on September24, 1986 (51 FR 33992). The ProposedGuidelines published today continuethe guidelines development process.These guidelines set forth principlesand procedures to guide EPA scientistsin the conduct of Agency cancer riskassessments and to inform Agencydecisionmakers and the public aboutthese procedures.

Both the 1986 guidelines and thecurrent proposal contain inferenceguidance in the form of defaultinferences to bridge gaps in knowledgeand data. Research conducted in thepast decade has elucidated much aboutthe nature of carcinogenic processes andcontinues to provide new information.The intent of this proposal is to takeaccount of knowledge available nowand to provide flexibility for the futurein assessing data and employing defaultinferences, recognizing that theguidelines cannot always anticipatefuture research findings. Becausemethods and knowledge are expected tochange more rapidly than guidelinescan practicably be revised, the Agencywill update specific assessmentprocedures with peer-reviewedsupplementary, technical documents asneeded. Further revision of theguidelines themselves will take placewhen extensive changes are necessary.

Since 1986, the EPA has sponsoredseveral workshops about revising thecancer guidelines (U.S. EPA, 1989b,1989c, 1994a). The Society for RiskAnalysis conducted a workshop on thesubject in connection with its 1992annual meeting (Anderson et al., 1993).Participants in the most recentworkshop in 1994 reviewed an earlierversion of the guidelines proposed hereand made numerous recommendationsabout individual issues as well as broadrecommendations about explanationsand perspectives that should be added.Most recently, the Committee on theEnvironment and Natural Resources ofthe Office of Science and TechnologyPolicy reviewed the guidelines at ameeting held on August 15, 1995. TheEPA appreciates the efforts of allparticipants in the process and has triedto address their recommendations inthis proposal.

In addition, the recommendations ofthe NRC (1994) in Science andJudgment in Risk Assessment have beenaddressed. Responses to theserecommendations are given generally inAppendix B as well as being embodiedin the Proposed Guidelines. Responsesthat explain the major defaultassumptions adopted under theseguidelines and the policy for using anddeparting from these defaultassumptions appear in Section 1.3.

The Science Advisory Board also willreview these Proposed Guidelines at ameeting to be announced in a futureFederal Register notice. Following thesereviews Agency staff will preparesummaries of the public and SABcomments. Appropriate comments willbe incorporated, and the revisedGuidelines will be submitted to the RiskAssessment Forum for review. The


Agency will consider comments fromthe public, the SAB, and the RiskAssessment Forum in itsrecommendations to the EPAAdministrator.

Major Changes From the 1986Guidelines

Characterizations

Increased emphasis on providingcharacterization discussions for thehazard, dose response, and exposuresections is part of the proposal. Thesediscussions will summarize theassessments to explain the extent andweight of evidence, major points ofinterpretation and rationale, andstrengths and weaknesses of theevidence and the analysis, and todiscuss alternative conclusions anduncertainties that deserve seriousconsideration (U.S. EPA, 1995). Theyserve as starting materials for the riskcharacterization process whichcompletes the risk assessment.

Weighing Evidence of Hazard

A major change is in the way hazardevidence is weighed in reachingconclusions about the humancarcinogenic potential of agents. In the1986 cancer guidelines, tumor findingsin animals or humans were thedominant components of decisions.Other information about an agent’sproperties, its structure-activityrelationships to other carcinogenicagents, and its activities in studies ofcarcinogenic processes was oftenlimited and played only a modulatingrole as compared with tumor findings.In this proposal, decisions come fromconsidering all of the evidence. Thischange recognizes the growingsophistication of research methods,particularly in their ability to reveal themodes of action of carcinogenic agentsat cellular and subcellular levels as wellas toxicokinetic and metabolicprocesses. The effect of the change onthe assessment of individual agents willdepend greatly on the availability ofnew kinds of data on them in keepingwith the state of the art. If these newkinds of data are not forthcoming frompublic and private research on agents,assessments under these guidelines willnot differ significantly from assessmentsunder former guidelines.

Weighing of the evidence includesaddressing the likelihood of humancarcinogenic effects of the agent and theconditions under which such effectsmay be expressed, as these are revealedin the toxicological and otherbiologically important features of theagent. (Consideration of actual humanexposure and risk implications are done

separately; they are not parts of thehazard characterization). In this respect,the guidelines incorporaterecommendations of the NRC (1994). Inthat report, the NRC recommendsexpansion of the former concept ofhazard identification, which rests onsimply a finding of carcinogenicpotential, to a concept ofcharacterization that includesdimensions of the expression of thispotential. For example, an agent mightbe observed to be carcinogenic viainhalation exposure and not via oralexposure, or its carcinogenic activitymight be secondary to another toxiceffect. In addition, the consideration ofevidence includes the mode(s) of actionof the agent apparent from the availabledata as a basis for approaching doseresponse assessment.

Classification Descriptors

To express the weight of evidence forcarcinogenic hazard potential, the 1986cancer guidelines provided summaryrankings for human and animal cancerstudies. These summary rankings wereintegrated to place the overall evidencein classification groups A through E,Group A being associated with thegreatest probability of humancarcinogenicity and Group E withevidence of noncarcinogenicity inhumans. Data other than tumor findingsplayed a modifying role after initialplacement of an agent into a group.

These Proposed Guidelines take adifferent approach, consistent with thechange in the basic approach toweighing evidence. No interimclassification of tumor findings followedby modifications with other data takesplace. Instead, the conclusion reflectsthe weighing of evidence in one step.Moreover, standard descriptors ofconclusions are employed rather thanletter designations, and these areincorporated into a brief narrativedescription of their informational basis.The narrative with descriptors replacesthe previous letter designation. Thedescriptors are in three categories:‘‘known/likely,’’ ‘‘cannot bedetermined,’’ or ‘‘not likely.’’ Forinstance, using a descriptor in context,a narrative could say that an agent islikely to be carcinogenic by inhalationexposure and not likely to becarcinogenic by oral exposure. Thenarrative explains the kinds of evidenceavailable and how they fit together indrawing conclusions, and points outsignificant issues/strengths/limitationsof the data and conclusions.Subdescriptors are used to further refinethe conclusion. The narrative alsosummarizes the mode of action

information underlying a recommendedapproach to dose response assessment.

In considering revision of the formerclassification method, the Agency hasexamined other possibilities that wouldretain the use of letter and numberdesignation of weights of evidence. Theuse of standard descriptors within anarrative presentation is proposed forthree primary reasons. First, theproposed method permits inclusion ofexplanations of data and of theirstrengths and limitations. This is moreconsistent with current policy emphasison risk characterization. Second, itwould take a large set of individualnumber or letter codes to coverdifferences in the nature of contributinginformation (animal, human, other),route of exposure, mode of action, andrelative overall weight. When such a setbecomes large—10 to 30 codes—it is toolarge to be a good communicationdevice, because people cannotremember the definitions of the codes sothey have to be explained in narrative.Third, it is impossible to predefine thecourse of cancer research and the kindsof data that may become available. Aflexible system is needed toaccommodate change in the underlyingdata and inferences, and a system ofcodes might become out of date, as hasthe one in the 1986 cancer guidelines.

Dose Response AssessmentThe approach to dose response

assessment calls for analysis thatfollows the conclusions reached in thehazard assessment as to potentialmode(s) of action. The assessmentbegins by analyzing the empirical datain the range of observation. Whenanimal studies are the basis of theanalysis, the estimation of a humanequivalent dose utilizes toxicokineticdata, if appropriate and adequate dataare available. Otherwise, defaultprocedures are applied. For oral dose,the default is to scale daily applieddoses experienced for a lifetime inproportion to body weight raised to the0.75 power. For inhalation dose, thedefault methodology estimatesrespiratory deposition of particles andgases and estimates internal doses ofgases with different absorptioncharacteristics. These two defaults are achange from the 1986 cancer guidelineswhich provided a single scaling factor ofbody weight raised to the 0.66 power.Another change from the 1986guidelines is that response data oneffects of the agent on carcinogenicprocesses are analyzed (nontumor data)in addition to data on tumor incidence.If appropriate, the analyses of data ontumor incidence and on precursoreffects may be combined, using


precursor data to extend the doseresponse curve below the tumor data.Even if combining data is notappropriate, study of the dose responsefor effects believed to be part of thecarcinogenic influence of the agent mayassist in thinking about the relationshipof exposure and response in the rangeof observation and at exposure levelsbelow the range of observation.

Whenever data are sufficient, abiologically based or case-specific doseresponse model is developed to relatedose and response data in the range ofempirical observation. Otherwise, as astandard, default procedure, a model isused to curve-fit the data. The lower95% confidence limit on a doseassociated with an estimated 10%increased tumor or relevant nontumorresponse (LED10) is identified. Thisgenerally serves as the point ofdeparture for extrapolating therelationship to environmental exposurelevels of interest when the latter areoutside the range of observed data. Theenvironmental exposures of interestmay be measured ones or levels of riskmanagement interest in consideringpotential exposure control options.Other points of departure may be moreappropriate for certain data sets; asdescribed in the guidance, these may beused instead of the LED10. Additionally,the LED10 is available for comparisonwith parallel analyses of othercarcinogenic agents or of noncancereffects of agents and for gauging andexplaining the magnitude of subsequentextrapolation to low-dose levels. TheLED10, rather than the ED10 (the estimateof a 10% increased response), is theproposed standard point of departurefor two reasons. One is to permit easiercomparison with the benchmark doseprocedure for noncancer healthassessment—also based on the lowerlimit on dose. Another is that the lowerlimit, as opposed to the central estimate,accounts for uncertainty in theexperimental data. The issue of using alower limit or central estimate wasdiscussed at a workshop held on thebenchmark procedure for noncancerassessment (Barnes et al., 1995) and ata workshop on a previous version of thisproposal (U.S. EPA, 1994b). The latterworkshop recommended a centralestimate; the benchmark workshoprecommended a lower limit.

The second step of dose responseassessment is extrapolation to lowerdose levels, if needed. This is based ona biologically based or case-specificmodel if supportable by substantialdata. Otherwise, default approaches areapplied that accord with the view ofmode(s) of action of the agent. Theseinclude approaches that assume

linearity or nonlinearity of the doseresponse relationship or both. Thedefault approach for linearity is toextend a straight line to zero dose, zeroresponse. The default approach fornonlinearity is to use a margin ofexposure analysis rather than estimatingthe probability of effects at low doses.A margin of exposure analysis explainsthe biological considerations forcomparing the observed data with theenvironmental exposure levels ofinterest and helps in deciding on anacceptable level of exposure inaccordance with applicablemanagement factors.

The use of straight line extrapolationfor a linear default is a change from the1986 guidelines which used the‘‘linearized multistage’’ (LMS)procedure. This change is made becausethe former modeling procedure gave anappearance of specific knowledge andsophistication unwarranted for adefault. The proposed approach is alsomore like that employed by the Foodand Drug Administration (U.S. FDA,1987). The numerical results of thestraight line and LMS procedures arenot significantly different (Krewski etal., 1984). The use of a margin ofexposure approach is included as a newdefault procedure to accommodate casesin which there is sufficient evidence ofa nonlinear dose response, but notenough evidence to construct amathematical model for therelationship. (The Agency will continueto seek a modeling method to apply inthese cases. If a modeling approach isdeveloped, it will be subject to peerreview and public notice in the contextof a supplementary document for theseguidelines.)

The public is invited to providecomments to be considered in EPAdecisions about the content of the finalguidelines. After the public commentperiod, the EPA Science Advisory Boardwill be asked to review and provideadvice on the guidelines and issuesraised in comments. EPA asks thosewho respond to this notice to includetheir views on the following:

(1) The proposed guidance forcharacterization of hazard, including theweight of evidence descriptors andweight of evidence narrative which aremajor features of the proposal. There arethree categories of descriptors: ‘‘known/likely,’’ ‘‘cannot be determined,’’ and‘‘not likely’’ which are further refinedby subdescriptors. It is felt that thesethree descriptors will satisfactorilydelineate the types of evidence bearingon carcinogenicity as they are used withsubdescriptors in the context of anarrative of data and rationale.However, an issue that has been

discussed by external peer reviewersand by EPA staff is whether thedescriptor-subdescriptor called ‘‘cannotbe determined—suggestive evidence’’should become a separate, fourthcategory called ‘‘suggestive.’’ The EPAmay choose this course in the finalguidelines and requests comment. Inconsidering this issue, commenters maywish to refer not only to Sections 2.6.2.and 2.7.2. which cover the descriptorsand narrative, but also to case studyexample #6 in Section 2.6.3. andexample narrative #2 in Appendix A ofthe proposal. EPA asks commenters onthis question to address the rationale(science as well as policy) for leavingthe categories of descriptors as proposedor making the fourth category. Howmight the coverage of a ‘‘suggestive’’category be defined in order to be mostuseful?

(2) The use of mode of actioninformation in hazard characterizationand to guide dose response assessmentis a central part of the proposedapproach to bringing new research oncarcinogenic processes to bear inassessments of environmental agents(Sections 1.3.2., 2.3.2., 2.5., 3.1.). Theappropriate use of this information nowand in the future is important. EPArequests comment on the treatment ofsuch information in the proposal,including reliance on peer review as apart of the judgmental process on itsapplication.

(3) Uses of nontumor data in the doseresponse assessment and themethodological and science policyissues posed are new to these guidelines(Sections 1.3.2., 3.1.2.). EPA requestscomment on both issues.

(4) Dose response assessment isproposed to be considered in twoparts—range of observed data and rangeof extrapolation (Section 3.1.). Thelower 95% confidence limit on a doseassociated with a 10% response (tumoror nontumor response) is proposed as adefault point of departure, marking thebeginning of extrapolation. This is aparallel to the benchmark procedure forevaluating dose-response of noncancerhealth endpoints (Barnes et al., 1995).An alternative is to use the centralestimate of a 10% response. Anotheralternative is to use a 1%, instead of a10%, response when the observed dataare tumor incidence data. Does thegenerally larger sample size of tumoreffect studies support using a 1%response as compared with using 10%for smaller studies? Are there otherapproaches for the point of departurethat might be considered?

(5) Discussions of default assumptionsand other responses to the 1994 NRCreport Science and Judgment in Risk


1 The term ‘‘agent’’ refers generally to anychemical substance, mixture, or physical orbiological entity being assessed, unless otherwisenoted.

Assessment appear in Section 1.3.1. andAppendix B of the proposal,respectively. Comments are requestedon responses to the NRCrecommendations and how theguidelines as a whole address them.

Dated: April 10, 1996.Carol M. Browner,Administrator.

ContentsList of Figures1. Introduction

1.1. Purpose and Scope of the Guidelines1.2. Organization and Application of the

Guidelines1.2.1. Organization1.2.2. Application1.3. Use of Default Assumptions1.3.1. Default Assumptions1.3.2. Major Defaults1.3.2.1. Is the Presence or Absence of

Effects Observed in a Human PopulationPredictive of Effects in Another ExposedHuman Population?

1.3.2.2. Is the Presence or Absence ofEffects Observed in an AnimalPopulation Predictive of Effects inExposed Humans?

1.3.2.3. How Do Metabolic Pathways RelateAcross Species?

1.3.2.4. How Do Toxicokinetic ProcessesRelate Across Species?

1.3.2.5. What Is the Correlation of theObserved Dose Response Relationship tothe Relationship at Lower Doses?

1.4. Characterizations2. Hazard Assessment

2.1. Overview of Hazard Assessment andCharacterization

2.1.1. Analyses of Data2.1.2. Cross-Cutting Topics for Data

Integration2.1.2.1. Conditions of Expression2.1.2.2. Mode of Action2.1.3. Presentation of Results2.2. Analysis of Tumor Data2.2.1. Human Data2.2.1.1. Types of Studies2.2.1.2. Criteria for Assessing Adequacy of

Epidemiologic Studies2.2.1.3. Criteria for Causality2.2.1.4. Assessment of Evidence of

Carcinogenicity from Human Data2.2.2. Animal Data2.2.2.1. Long-Term Carcinogenicity Studies2.2.2.2. Other Studies2.2.3. Structural Analogue Data2.3. Analysis of Other Key Data2.3.1. Physicochemical Properties2.3.2. Structure-Activity Relationships2.3.3. Comparative Metabolism and

Toxicokinetics2.3.4. Toxicological and Clinical Findings2.3.5. Mode of Action-Related Endpoints

and Short-Term Tests2.3.5.1. Direct DNA Effects2.3.5.2. Secondary DNA Effects2.3.5.3. Nonmutagenic and Other Effects2.3.5.4. Criteria for Judging Mode of Action2.4. Biomarker Information2.5. Mode of Action—Implications for

Hazard Characterization and DoseResponse

2.6. Weight of Evidence Evaluation forPotential Human Carcinogenicity

2.6.1. Weight of Evidence Analysis2.6.2. Descriptors for Classifying Weight of

Evidence2.6.3. Case Study Examples2.7. Presentation of Results2.7.1. Technical Hazard Characterization2.7.2. Weight of Evidence Narrative

3. Dose Response Assessment3.1. Dose Response Relationship3.1.1. Analysis in the Range of Observation3.1.2. Analysis in the Range of

Extrapolation3.1.3. Use of Toxicity Equivalence Factors

and Relative Potency Estimates3.2. Response Data3.3. Dose Data3.3.1. Interspecies Adjustment of Dose3.3.2. Toxicokinetic Analyses3.3.3. Route-to-Route Extrapolation3.3.4. Dose Averaging3.4. Discussion of Uncertainties3.5. Technical Dose Response

Characterization4. Technical Exposure Characterization5. Risk Characterization

5.1. Purpose5.2. Application5.3. Presentation of Risk Characterization

Summary5.4. Content of Risk Characterization

SummaryAppendix AAppendix BAppendix CReferences

List of FiguresFigure 1–1. Decisions on Dose Response

Assessment Approaches for the Range ofExtrapolation

Figure 1–2. Risk CharacterizationFigure 2–1. Factors for Weighing Human

EvidenceFigure 2–2. Factors for Weighing Animal

EvidenceFigure 2–3. Factors for Weighing Other Key

EvidenceFigure 2–4. Factors for Weighing Totality of

EvidenceFigure 3–1. Graphical Presentation of Data

and Extrapolations

1. Introduction

1.1. Purpose and Scope of theGuidelines

These guidelines revise and replaceUnited States Environmental ProtectionAgency (EPA) Guidelines for CarcinogenRisk Assessment published in 51 FR33992, September 24, 1986. Theguidelines provide EPA staff anddecisionmakers with guidance andperspectives to develop and use riskassessments. They also provide basicinformation to the public about theAgency’s risk assessment methods.

The guidelines encourage bothregularity in procedures to supportconsistency in scientific components ofAgency decisionmaking and innovationto remain up-to-date in scientificthinking. In balancing these goals, theAgency relies on input from the general

scientific community throughestablished scientific peer reviewprocesses. The guidelines incorporatebasic principles and science policiesbased on evaluation of the currentlyavailable information. As more isdiscovered about carcinogenesis, theneed will arise to make appropriatechanges in risk assessment guidance.The Agency will revise these guidelineswhen extensive changes are due. In theinterim, the Agency will issue specialreports, after appropriate peer review, tosupplement and update guidance onsingle topics, (e.g., U.S. EPA, 1991b)

1.2. Organization and Application of theGuidelines

1.2.1. OrganizationPublications of the Office of Science

and Technology Policy (OSTP, 1985)and the National Research Council(NRC, 1983, 1994) provide informationand general principles about riskassessment. Risk assessment usesavailable scientific information on theproperties of an agent 1 and its effects inbiological systems to provide anevaluation of the potential for harm asa consequence of environmentalexposure to the agent. Risk assessmentis one of the scientific analyses availablefor consideration, with other analyses,in decisionmaking on environmentalprotection. The 1983 and 1994 NRCdocuments organize risk assessmentinformation into four areas: hazardidentification, dose responseassessment, exposure assessment, andrisk characterization. This structureappears in these guidelines, whichadditionally emphasize characterizationof evidence and conclusions in eachpart of the assessment. In particular, theguidelines adopt the approach of theNRC’s 1994 report in adding adimension of characterization to thehazard identification step. Added to theidentification of hazard is an evaluationof the conditions under which itsexpression is anticipated. The riskassessment questions addressed in theseguidelines are:

• For hazard—Can the agent presenta carcinogenic hazard to humans, and ifso, under what circumstances?

• For dose response—At what levelsof exposure might effects occur?

• For exposure—What are theconditions of human exposure?

• For risk—What is the character ofthe risk? How well do data supportconclusions about the nature and extentof the risk?


1.2.2. Application

The guidelines apply within theframework of policies provided byapplicable EPA statutes and do not altersuch policies. The guidelines coverassessment of available data. They donot imply that one kind of data oranother is prerequisite for regulatoryaction concerning any agent. Riskmanagement applies directives ofregulatory legislation, which mayrequire consideration of potential risk,or solely hazard or exposure potential,along with social, economic, technical,and other factors in decisionmaking.Risk assessments support decisions, butto maintain their integrity asdecisionmaking tools, they are notinfluenced by consideration of thesocial or economic consequences ofregulatory action.

Not every EPA assessment has thesame scope or depth. Agency staff oftenconduct screening-level assessments forpriority-setting or separate assessmentsof hazard or exposure for rankingpurposes or to decide whether to investresources in collecting data for a fullassessment. Moreover, a givenassessment of hazard and dose responsemay be used with more than oneexposure assessment that may beconducted separately and at differenttimes as the need arises in studyingenvironmental problems in variousmedia. The guidelines apply to thesevarious situations in appropriate detailgiven the scope and depth of theparticular assessment. For example, ascreening assessment may be basedalmost entirely on structure-activityrelationships and default assumptions.As more data become available,assessments can replace or modifydefault assumptions accordingly. Theseguidelines do not require that all of thekinds of data covered here be availablefor either assessment or decisionmaking.The level of detail of an assessment isa matter of Agency management policyregarding the applicable decisionmakingframework.

1.3. Use of Default Assumptions

The National Research Council, in its1983 report on the science of riskassessment (NRC, 1983), recognized thatdefault assumptions are necessarilymade in risk assessments where gapsexist in general knowledge or inavailable data for a particular agent.These default assumptions areinferences based on general scientificknowledge of the phenomena inquestion and are also matters of policyconcerning the appropriate way tobridge uncertainties that concernpotential risk to human health (or, more

generally, to environmental systems)from the agent under assessment.

EPA’s 1986 guidelines for cancer riskassessment (EPA, 1986) were developedin response to the 1983 NRC report. Theguidelines contained a number ofdefault assumptions. They alsoencouraged research and analysis thatwould lead to new risk assessmentmethods and data and anticipated thatthese would replace defaults. The 1986guidelines did not explicitly discusshow to depart from defaults. In practice,the agency’s assessments routinely haveemployed defaults and, until recently,only occasionally departed from them.

In its 1994 report on risk assessment,the NRC supported continued use ofdefault assumptions (NRC, 1994). TheNRC report thus validated a centralpremise of the approach to riskassessment that EPA had evolved inpreceding years—the making of sciencepolicy inferences to bridge gaps inknowledge—while at the same timerecommending that EPA develop moresystematic and transparent guidelines toinform the public of the defaultinferences EPA uses in practice. Itrecommended that the EPA review andupdate the 1986 guidelines in light ofevolving scientific information andexperience in practice in applying thoseguidelines, and that the EPA explain thescience and policy considerationsunderlying current views as to theappropriate defaults and providegeneral criteria to guide preparers andreviewers of risks assessments indeciding when to depart from a default.Pursuant to this recommendation, thefollowing discussion presentsdescriptions of the major defaults andtheir rationales. In addition, it presentsgeneral policy guidance on using anddeparting from defaults in specific riskassessments.

1.3.1. Default AssumptionsThe 1994 NRC report contains several

recommendations regarding flexibilityand the use of default options:

• EPA should continue to regard theuse of default options as a reasonableway to deal with uncertainty aboutunderlying mechanisms in selectingmethods and models for use in riskassessment.

• EPA should explicitly identify eachuse of a default option in riskassessments.

• EPA should clearly state thescientific and policy basis for eachdefault option.

• The Agency should considerattempting to give greater formality toits criteria for a departure from defaultoptions in order to give greater guidanceto the public and to lessen the

possibility of ad hoc, undocumenteddepartures from default options thatwould undercut the scientific credibilityof the Agency’s risk assessments. At thesame time, the Agency should be awareof the undesirability of having itsguidelines evolve into inflexible rules.

• EPA should continue to use theScience Advisory Board and otherexpert bodies. In particular, the Agencyshould continue to make the greatestpossible use of peer review, workshops,and other devices to ensure broad peerand scientific participation to guaranteethat its risk assessment decisions will bebased on the best science availablethrough a process that allows full publicdiscussion and peer participation by thescientific community.

In the 1983 report (p. 28), NASdefined the use of ‘‘inference options’’(default options) as a means to bridgeinherent uncertainties in riskassessment. These options exist whenthe assessment encounters either‘‘missing or ambiguous information on aparticular substance’’ or ‘‘gaps incurrent scientific theory.’’ Since there isno instance in which a set of data on anagent or exposure is complete, all riskassessments must use generalknowledge and policy guidance tobridge data gaps. Animal toxicity dataare used, for example, to substitute forhuman data because we do not testhuman beings. The report described thecomponents of risk assessment in termsof questions encountered duringanalysis for which inferences must bemade. The report noted (p. 36) thatmany components ‘‘* * * lackdefinitive scientific answers, that thedegree of scientific consensusconcerning the best answer varies (someare more controversial than others), andthat the inference options available foreach component differ in their degree ofconservatism. The choices encounteredin risk assessment rest, to variousdegrees, on a mixture of scientific factand consensus, on informed scientificjudgment, and on policy determinations(the appropriate degree ofconservatism)* * *.’’ The report didnot note that the mix varies significantlyfrom case to case. For instance, aquestion that arises in hazardidentification is how to useexperimental animal data when theroutes of exposure differ betweenanimals and humans. A spectrum ofinferences could be made, ranging fromthe most conservative, or risk adverseone that effects in animals from oneroute may be seen in humans by anotherroute, to an intermediate, conditionalinference that such translation of effectswill be assumed if the agent is absorbedby humans through the second route, to


a nonconservative view that noinference is possible and the agent’seffects in animals must be tested by thesecond route. The choice of aninference, as the report observed, comesfrom more than scientific thinkingalone. While the report focused mainlyon the idea of conservatism of publichealth as a science policy rationale formaking the choice, it did not evaluateother considerations. These includesuch things as the matters of time andresources and whether the analysis isfor an important decision required to bemade soon or is simply a screening orranking effort. For a screening analysis,one might make several ‘‘worst case’’inferences to determine if, even underthose conditions, risk is low enough thata problem can be eliminated fromfurther consideration. In the abovediscussion concerning inferences aboutroute-to-route extrapolation, one mightuse the most conservative one forscreening.

These revised guidelines retain theuse of default assumptions asrecommended in the 1994 report.Generally, these defaults remain publichealth conservative, but in someinstances, they have been modified toreflect the evolution of scientificknowledge since 1986.

In addition, the guidelines reflectevaluation of experience in practice inapplying defaults and departing fromthem in individual risk assessmentsconducted under the 1986 guidelines.The application and departure fromdefaults and the principles to be used inthese judgments have been matters ofdebate among practitioners andreviewers of risk assessments. Someobservers believe that in practice EPArisk assessors have been too resistant toconsidering departures; others questionwhether proposed departures have beenadequately supported. Some cases inwhich departures have been consideredhave been generally accepted, whileothers have been controversial. Theguidelines here are intended to be bothexplicit and more flexible than in thepast concerning the basis for makingdepartures from defaults, recognizingthat expert judgment and peer revieware essential elements of the process.

In response to the recommendationsof the 1994 report, these guidelines callfor identification of the defaultassumptions used within assessmentsand for highlighting significant issuesabout defaults within characterizationsummaries of component analyses inassessment documents. As to the use ofpeer review to aid in making judgmentsabout applying or departing fromdefaults, we agree with the NRCrecommendation. The Agency has long

made use of workshops, peer review ofdocuments and guidelines, andconsultations as well as formal peerreview by the Science Advisory Board(SAB). In 1994, the Administrator ofEPA published formal guidance for peerreview of EPA scientific work productsthat increases the amount of peer reviewfor risk assessments as well as otherwork, as a response to the NRC reportand to SAB recommendations (U.S.EPA, 1994b).

The 1994 NRC report recommendedthat EPA should consider adoptingprinciples or criteria that would givegreater formality and transparency todecisions to depart from defaults. Thereport named several possible criteriafor such principles (p. 7): ‘‘* * *[P]rotecting the public health, ensuringscientific validity, minimizing seriouserrors in estimating risks, maximizingincentives for research, creating anorderly and predictable process, andfostering openness and trustworthiness.There might be additional relevantcriteria* * *.’’ The report indicated,however, that the committee membershad not reached consensus on a singlecriterion to address the key issue of howmuch certainty or proof a risk assessormust have in order to justify departingfrom a default. Appendix N of the reportcontains two presentations of alternativeviews held by some committee memberson this issue. One view, known as‘‘plausible conservatism,’’ suggestedthat departures from defaults should notbe made unless new informationimproves the understanding of abiological process to the point thatrelevant experts reach consensus thatthe conservative default assumptionconcerning that process is no longerplausible. The same criterion wasrecommended where the underlyingscientific mechanism is wellunderstood, but where a default is usedto address missing data. In this case, thedefault should not be replaced withcase-specific data unless it is theconsensus of relevant experts that theproffered data make the defaultassumption no longer plausible.Another view, known as the ‘‘maximumuse of scientific information’’ approach,acknowledged that the initial choice ofdefaults should be conservative butargued that conservatism should not bea factor in determining whether todepart from the default in favor of analternate biological theory or alternatedata. According to this view, it shouldnot be necessary to reach expertconsensus that the default assumptionhad been rendered implausible; itshould be sufficient that risk assessors

find the alternate approach moreplausible than the default.

The EPA is not adopting a list offormal decision criteria in the sense ofa checklist based on either view. Itwould not be helpful to generate achecklist of uniform criteria for severalreasons. First, risk assessments arehighly variable in content and purpose.Screening assessments may bepurposely ‘‘worst case’’ in their defaultassumptions to eliminate problems fromfurther investigation. Subsequent riskassessments based on a fuller data setcan discard worst-case defaultassumptions in favor of plausiblyconservative assumptions andprogressively replace or modify thelatter with data. No uniform checklistwill fit all cases. Second, a checklistwould likely become more a source ofrote discussion than of enlightenmentabout the process.

Instead, these guidelines use acombination of principles and processin the application of and departure fromdefault assumptions. The guidelinesprovide a framework of defaultassumptions to allow risk assessment toproceed when current scientific theoryor available case-specific data do notprovide firm answers in a particularcase, as the 1983 report outlined. Someof the default assumptions bridge largegaps in fundamental knowledge whichwill be filled by basic research on thecauses of cancer and on other biologicalprocesses, rather than by agent-specifictesting. Other default assumptionsbridge smaller data gaps that canfeasibly be filled for a single agent, suchas whether a metabolic pathway in testanimals is like (default) or unlike that inhumans.

The decision to use a default, or not,is a choice considering availableinformation on an underlying scientificprocess and agent-specific data,depending on which kind of default itis. Generally, if a gap in basicunderstanding exists, or if agent-specificdata are missing, the default is usedwithout pause. If data are present, theirevaluation may reveal inadequacies thatalso lead to use of the default. If datasupport a plausible alternative to thedefault, but no more strongly than theysupport the default, both the default andits alternative are carried through theassessment and characterized for therisk manager. If data support analternative to the default as the morereasonable judgment, the data are used.(This framework of choices is notwholly applicable to screeningassessments. As mentioned above,screening assessments mayappropriately use ‘‘worst case’’inferences to determine if, even under


those conditions, risk is low enough thata problem can be eliminated fromfurther consideration.)

Scientific peer review, peerconsultative workshops and similarprocesses are the principal waysdetermining the strength of thinking andgenerally accepted views within thescientific community about theapplication of and departure fromdefaults and about judgmentsconcerning the plausibility andpersuasiveness of data in a particularcase. The choices made are explicitlydiscussed in the assessment, and if aparticular choice raises a significantissue, it is highlighted in the riskcharacterization.

The discussion of major defaults inthese guidelines together with theexplicit discussion of the choice ofinferences within the assessment andthe processes of peer review and peerconsultation will serve the several goalsstated in the 1994 report. One is toencourage research, since results ofresearch efforts will be considered.Another is to allow timelydecisionmaking, when time is aconstraint, by supporting completion ofthe risk assessment using defaults asneeded. Another is to be flexible, usingnew science as it develops. Finally, theuse of public processes of peerconsultation and peer review willensure that discipline of thought ismaintained to support trust inassessment results.

Experience has shown that the mostdifficult part of the framework ofchoices is the judgment of whether adata analysis is both biologicallyplausible and persuasive as applied tothe case at hand. There is no set of rulesfor making this judgment in all cases.Two criteria that apply in theseguidelines are that the underlyingscientific principle has been generallyaccepted within the scientificcommunity and that supportiveexperiments are available that test theapplication of the principle to the agentunder review. For example,mutagenicity through reactivity withDNA has been generally accepted as acarcinogenic influence for many years.This acceptance, together with evidenceof such mutagenicity in experiments onan agent, provides plausible andpersuasive support for the inference thatmutagenicity is a mode of action for theagent.

Judgments about plausibility andpersuasiveness of analyses varyaccording to the scientific nature of thedefault. An analysis of data may replacea default or modify it. An illustration ofthe former is development of EPAscience policy on the issue of the

relevance for humans of male rat kidneyneoplasia involving alpha 2u globulin(U.S. EPA, 1991b). The 1991 EPA policygives guidance on the kind ofexperimental findings that demonstratewhether the alpha 2u globulinmechanism is present and responsiblefor carcinogenicity in a particular case.Before this policy guidance was issued,the default assumption was thatneoplasia in question was relevant tohumans and indicated the potential forhazard to humans. A substantial body ofdata was developed by public andprivate research groups as a foundationfor the view that the alpha 2u globulin-induced response was not relevant tohumans. These studies first addressedthe alpha 2u globulin mechanism in therat and whether this mechanism has acounterpart in the human being, bothwere large research efforts. The resultingdata presented difficulties; somereviewers were concerned that themechanism in the rat appeared to beunderstood only in outline, not indetail, and felt that the data wereinsufficient to show the lack of acounterpart mechanism in humans. Itwas particularly difficult to support anegative such as the nonexistence of amechanism in humans because so littleis known about what the mechanismsare in humans. Despite these concerns,in its 1991 policy guidance, EPAconcluded that the alpha 2u globulin-induced response in rats should beregarded as not relevant to humans (i.e.,as not indicating human hazard).

One lesson in the development andpeer review of this policy is that if thedefault concerns an inherently complexbiological question, large amounts ofwork will be required to replace thedefault. A second is that addressing anegative is difficult. A third is that‘‘proof’’ in the strict sense of having laidall reasonable doubt to rest is notrequired. Instead, an alternative maydisplace a default when it is generallyaccepted in peer review as the mostreasonable judgment. The issue ofrelevance may not always be sodifficult. It would be an experimentallyeasier task, for example, to determinewhether carcinogenesis in an animalspecies is due to a metabolite of theagent in question that is not producedin humans.

When scientific processes areunderstood but case-specific data aremissing, defaults can be constructed tobe modified by experimental data, evenif data do not suffice to replace thementirely. For example, the approachesadopted in these guidelines for scalingdose from experimental animals tohumans are constructed to be eithermodified or replaced as data become

available on toxicokinetic parametersfor the particular agent being assessed.Similarly, the selection of an approachor approaches for dose responseassessment is based on a series ofdecisions that consider the nature andadequacy of available data in choosingamong alternative modeling and defaultapproaches.

The 1994 NRC report notes (p. 6) that‘‘[a]s scientific knowledge increases, thescience policy choices made by theAgency and Congress should have lessimpact on regulatory decisionmaking.Better data and increased understandingof biological mechanisms should enablerisk assessments that are less dependenton conservative default assumptionsand more accurate as predictions ofhuman risk.’’ Undoubtedly, this is thetrend as scientific understandingincreases. However, some gaps inknowledge and data will doubtlesscontinue to be encountered inassessment of even data-rich cases, andit will remain necessary for riskassessments to continue using defaultswithin the framework set forth here.

1.3.2. Major Defaults

This discussion covers the majordefault assumptions commonlyemployed in a cancer risk assessmentand adopted in these guidelines. Theyare predominantly inferences necessaryto use data observed under empiricalconditions to estimate events andoutcomes under environmentalconditions. Several inferential issuesarise when effects seen in asubpopulation of humans or animals areused to qualitatively infer potentialeffects in the population ofenvironmentally exposed humans.Several more inferential issues arise inextrapolating the exposure-effectrelationship observed empirically tolower-exposure environmentalconditions. The following issues coverthe major default areas. Typically, anissue has some subissues; they areintroduced here, but are discussed ingreater detail in subsequent sections.

• Is the presence or absence of effectsobserved in a human populationpredictive of effects in another exposedhuman population?

• Is the presence or absence of effectsobserved in an animal populationpredictive of effects in exposedhumans?

• How do metabolic pathways relateacross species?

• How do toxicokinetic processesrelate across species?

• What is the correlation of theobserved dose response relationship tothe relationship at lower doses?


1.3.2.1. Is the Presence or Absence ofEffects Observed in a HumanPopulation Predictive of Effects inAnother Exposed Human Population?When cancer effects in exposed humansare attributed to exposure to anexogenous agent, the default assumptionis that such data are predictive of cancerin any other exposed humanpopulation. Studies either attributingcancer effects in humans to exogenousagents or reporting no effects are oftenstudies of occupationally exposedhumans. By sex, age, and general health,workers are not representative of thegeneral population exposedenvironmentally to the same agents. Insuch studies there is no opportunity toobserve whether infants and children,males, or females who are underrepresented in the study, or peoplewhose health is not good, wouldrespond differently. Therefore, it isunderstood that this assumption couldstill underestimate the response ofcertain sensitive human subpopulations,i.e. biologically vulnerable parts of thepopulation may be left out of riskassessments (NRC, 1993a, 1994).Consequently, this is a default that doesnot err on the side of public healthconservatism, as the 1994 NRC reportalso recognizes.

On the one hand, if effects are seen ina worker population, this may be in factindicative of heightened effects insensitive subpopulations. There is notenough knowledge yet to form a basisfor any generally applicable, qualitativeinference to compensate for thisknowledge gap. In these guidelines, thisproblem is left to case-by-case analysis,to be attended to as future research andinformation on particular agents allow.When information on a sensitivesubpopulation exists, it will be used.The topic of variability is addressedfurther in the discussion of quantitativedefault assumptions about doseresponse relationships below. On theother hand, when cancer effects are notfound in an exposed human population,this information by itself is notgenerally sufficient to conclude that theagent poses no carcinogenic hazard tothis or other populations of potentiallyexposed humans. This is becauseepidemiologic studies usually have lowpower to detect and attribute responses(section 2.2.1.). This may be particularlytrue when extrapolating null resultsfrom a healthy, worker population toother potentially sensitive exposedhumans. Again, the problem is left tocase-by-case analysis.

1.3.2.2. Is the Presence or Absence ofEffects Observed in an AnimalPopulation Predictive of Effects inExposed Humans? The default

assumption is that positive effects inanimal cancer studies indicate that theagent under study can havecarcinogenic potential in humans. Thus,if no adequate human data are present,positive effects in animal cancer studiesare a basis for assessing the carcinogenichazard to humans. This assumption is apublic health conservative policy, and itis both appropriate and necessary giventhat we do not test for carcinogenicityin humans. The assumption issupported by the fact that nearly all ofthe agents known to cause cancer inhumans are carcinogenic in animals intests with adequate protocols (IARC,1994; Tomatis et al., 1989; Huff, 1994).Moreover, almost one-third of humancarcinogens were identified subsequentto animal testing (Huff, 1993). Furthersupport is provided by research on themolecular biology of cancer processes,which has shown that the mechanismsof control of cell growth anddifferentiation are remarkablyhomologous among species and highlyconserved in evolution. Nevertheless,the same research tools that haveenabled recognition of the nature andcommonality of cancer processes at themolecular level also have the power toreveal differences and instances inwhich animal responses are not relevantto humans (Linjinsky, 1993; U.S. EPA,1991b). Under these guidelines,available mode of action information isstudied for its implications in bothhazard and dose response assessmentand its effect on default assumptions.

There may be instances in which theuse of an animal model would identifya hazard in animals that is not truly ahazard in humans (e.g., the alpha-2u-globulin association with renalneoplasia in male rats (U.S. EPA,1991b)). The extent to which animalstudies may yield false positiveindications for humans is a matter ofscientific debate. To demonstrate that aresponse in animals is not relevant toany human situation, adequate data toassess the relevancy issue must beavailable.

Animal studies are conducted at highdoses in order to provide statisticalpower, the highest dose being one thatis minimally toxic (maximum tolerateddose). Consequently, the question oftenarises whether a carcinogenic effect atthe highest dose may be a consequenceof cell killing with compensatory cellreplication or of general physiologicaldisruption, rather than inherentcarcinogenicity of the tested agent.There is little doubt that this mayhappen in some cases, but skepticismexists among some scientists that it is apervasive problem (Ames and Gold,1990; Melnick et al., 1993a; Melnick et

al., 1993b; Barrett, 1993). In light of thisquestion, the default assumption is thateffects seen at the highest dose testedare appropriate for assessment, but it isnecessary that the experimentalconditions be scrutinized. If adequatedata demonstrate that the effects aresolely the result of excessive toxicityrather than carcinogenicity of the testedagent per se, then the effects may beregarded as not appropriate to includein assessment of the potential for humancarcinogenicity of the agent. This is amatter of expert judgment, consideringall of the data available about the agentincluding effects in other toxicitystudies, structure-activity relationships,and effects on growth control anddifferentiation.

When cancer effects are not found inwell-conducted animal cancer studies intwo or more appropriate species andother information does not support thecarcinogenic potential of the agent,these data provide a basis forconcluding that the agent is not likelyto possess human carcinogenicpotential, in the absence of human datato the contrary. This default assumptionabout lack of cancer effects is not publichealth conservative. For instance, thetested animal species may not bepredictive of effects in humans; arsenicshows only minimal or no effect inanimals, while it is clearly positive inhumans. (Other information, such asabsence of mutagenic activity or absenceof carcinogenic activity amongstructural analogues, can increase theconfidence that negative results inanimal studies indicate a lack of humanhazard.) Also, it is recognized thatanimal studies (and epidemiologicstudies as well) have very low power todetect cancer effects. Detection of a 10%tumor incidence is generally the limit ofpower with currently conducted animalstudies (with the exception of raretumors that are virtually markers for aparticular agent, e.g., angiosarcomacaused by vinyl chloride).

Target organs of carcinogenesis foragents that cause cancer in both animalsand humans are most often concordantat one or more sites (Tomatis et al.,1989; Huff, 1994). However,concordance by site is not uniform. Thedefault assumption is that target organconcordance is not a prerequisite forevaluating the implications of animalstudy results for humans. This is apublic health conservative sciencepolicy. The mechanisms of control ofcell growth and differentiation areconcordant among species, but there aremarked differences among species in theway control is managed in varioustissues. For example, in humans,mutation of the tumor suppressor gene


p53 is one of the most frequentlyobserved genetic changes in tumors.This tumor suppressor is also observedto be operating in some rodent tissues,but other growth control mechanismspredominate in rodents. Thus, ananimal response may be due to changesin a control that are relevant to humans,but appear in animals in a different way.However, it is appropriate under theseguidelines to consider the influences ofroute of exposure, metabolism, and,particularly, hormonal modes of actionthat may either support or not supporttarget organ concordance betweenanimals and humans. When data allow,these influences are considered indeciding whether the default remainsappropriate in individual instances(NRC, 1994, p. 121). An exception to thebasic default of not assuming siteconcordance exists in the context oftoxicokinetic modeling. Siteconcordance is inherently assumedwhen these models are used to estimatedelivered dose in humans based onanimal data.

As in the approach of the NationalToxicology Program and theInternational Agency for Research onCancer, the default is to include benigntumors observed in animal studies inthe assessment of animal tumorincidence if they have the capacity toprogress to the malignancies with whichthey are associated. This treats thebenign and malignant tumors asrepresentative of related responses tothe test agent, which is scientificallyappropriate. This is a science policydecision that is somewhat moreconservative of public health than notincluding benign tumors in theassessment. Nonetheless, in assessingfindings from animal studies, a greaterproportion of malignancy is weighedmore heavily than a response with agreater proportion of benign tumors.Greater frequency of malignancy of aparticular tumor type in comparisonwith other tumor responses observed inan animal study is also a factor to beconsidered in selecting the response tobe used in dose response assessment.

Benign tumors that are not observedto progress to malignancy are assessedon a case-by-case basis. There is a rangeof possibilities for their overallsignificance. They may deserveattention because they are serious healthproblems even though they are notmalignant; for instance, benign tumorsmay be a health risk because of theireffect on the function of a target tissuesuch as the brain. They may besignificant indicators of the need forfurther testing of an agent if they areobserved in a short term test protocol,or such an observation may add to the

overall weight of evidence if the sameagent causes malignancies in a longterm study. Knowledge of the mode ofaction associated with a benign tumorresponse may aid in the interpretationof other tumor responses associatedwith the same agent. In other cases,observation of a benign tumor responsealone may have no significant healthhazard implications when other sourcesof evidence show no suggestion ofcarcinogenicity.

1.3.2.3. How Do Metabolic PathwaysRelate Across Species? The defaultassumption is that there is a similarityof the basic pathways of metabolism andthe occurrence of metabolites in tissuesin regard to the species-to-speciesextrapolation of cancer hazard and risk.If comparative metabolism studies wereto show no similarity between the testedspecies and humans and a metabolite(s)were the active form, there would beless support for an inference that theanimal response(s) relates to humans. Inother cases, parameters of metabolismmay vary quantitatively betweenspecies; this becomes part of decidingon an appropriate human equivalentdose based on animal studies, optimallyin the context of a toxicokinetic model.

1.3.2.4. How Do ToxicokineticProcesses Relate Across Species? Amajor issue is how to estimate humanequivalent doses in extrapolating fromanimal studies. As a default for oralexposure, a human equivalent dose isestimated from data on another speciesby an adjustment of animal oral dose bya scaling factor of body weight to the0.75 power. This adjustment factor isused because it represents scaling ofmetabolic rate across animals ofdifferent size. Because the factor adjustsfor a parameter that can be improved onand brought into more sophisticatedtoxicokinetic modeling, when such databecome available, the defaultassumption of 0.75 power can be refinedor replaced.

For inhalation exposure, a humanequivalent dose is estimated by defaultmethodologies that provide estimates oflung deposition and of internal dose.The methodologies can be refined tomore sophisticated forms with data ontoxicokinetic and metabolic parametersof the specific agent. This defaultassumption, like the one with oralexposure, is selected in part because itlays a foundation for incorporatingbetter data. The use of information toimprove dose estimation from applied,to internal, to delivered dose isencouraged, including use oftoxicokinetic modeling instead of anydefault, where data are available. Healthconservatism is not an element inchoosing the default.

For a route-to-route of exposureextrapolation, the default assumption isthat an agent that causes internal tumorsby one route of exposure will becarcinogenic by another route if it isabsorbed by the second route to give aninternal dose. This is a qualitativeassumption and is considered to bepublic health conservative. Therationale is that for internal tumors aninternal dose is significant no matterwhat the route of exposure.Additionally, the metabolism of theagent will be qualitatively the same foran internal dose. The issue ofquantitative extrapolation of the dose-response relationship from one route toanother is addressed case by case.Quantitative extrapolation iscomplicated by considerations such asfirst-pass metabolism, but isapproachable with empirical data.Adequate data are necessary todemonstrate that an agent will actdifferently by one route versus anotherroute of exposure.

1.3.2.5. What Is the Correlation of theObserved Dose Response Relationship tothe Relationship at Lower Doses? Theoverriding preferred approach is to usea biologically based or case-specificmodel for both the observed range andextrapolation below that range whenthere are sufficient data. Whilebiologically based models are still underdevelopment, it is likely that they willbe used more frequently in the future.The default procedure for the observedrange of data, when the preferredapproach cannot be used, is to use acurve-fitting model.

In the absence of data supporting abiologically based or case-specificmodel for extrapolation outside of theobserved range, the choice of approachis based on the view of mode of actionof the agent arrived at in the hazardassessment. A linear default approach isused when the mode of actioninformation is supportive of linearity or,alternatively, is insufficient to support anonlinear mode of action. The linearapproach is used when a view of themode of action indicates a linearresponse, for example, when aconclusion is made that an agentdirectly causes alterations in DNA, akind of interaction that not onlytheoretically requires one reaction, butalso is likely to be additive to ongoing,spontaneous gene mutation. Other kindsof activity may have linear implications,e.g., linear rate-limiting steps, thatsupport a linear procedure also. Thelinear approach is to draw a straight linebetween a point of departure fromobserved data, generally, as a default,the LED10, and the origin (zero dose,zero response). Other points of


departure may be more appropriate forcertain data sets; these may be usedinstead of the LED10. This approach isgenerally considered to be public healthconservative. The LED10 is the lower95% limit on a dose that is estimated tocause a 10% response. This level ischosen to account (conservatively) forexperimental variability. Additionally,it is chosen because it rewardsexperiments with better designs inregard to number of doses and dosespacing, since these generally will havenarrower confidence limits. It is also anappropriate representative of the lowerend of the observed range because thelimit of detection of studies of tumoreffect is about 10%.

The linear default is thought togenerally produce an upper bound onpotential risk at low doses, e.g., a 1/100,000 to 1/1,000,000 risk; the straightline approach gives numerical resultsabout the same as a linearizedmultistage procedure (Krewski et al.,1984). This upper bound is thought tocover the range of human variabilityalthough, in some cases, it may notcompletely do so (Bois et al., 1995). TheEPA considers the linear default to beinherently conservative of public health,without addition of another factor forhuman variability. In any case, the sizeof such a factor would be hard todetermine since a good empirical basison which to construct an estimate doesnot currently exist. The question ofwhat may be the actual variability inhuman sensitivity is one that the 1994NRC report discussed as did the 1993NRC report on pesticides in childrenand infants. The NRC has recommendedresearch on the question, and the EPAand other agencies have begun suchresearch.

When adequate data on mode ofaction show that linearity is not themost reasonable working judgment andprovide sufficient evidence to support anonlinear mode of action, the defaultchanges to a different approach—amargin of exposure analysis—whichassumes that nonlinearity is morereasonable. The departure point is again

generally the LED10. A margin ofexposure analysis compares the LED10

with the dose associated with theenvironmental exposure(s) of interest bycomputing the ratio between the two.

The purpose of a margin of exposureanalysis is to provide the risk managerwith all available information on howmuch reduction in risk may beassociated with reduction in exposurefrom the point of departure. This is tosupport the risk manager’s decision asto what constitutes an acceptablemargin of exposure, given requirementsof the statute under which the decisionis being made. There are several factorsto be considered. (For perspective, keepin mind that a sufficient basis to supportthis nonlinear procedure often willinclude data on responses that areprecursors to tumor effects. This meansthat the point of departure may well befrom these biological response datarather than tumor incidence data, e.g.,hormone levels, mitogenic effects.) Onefactor to consider is the slope of thedose response curve at the point ofdeparture. A steeper slope implies anapparent greater reduction in risk asexposure decreases. This may support asmaller margin of exposure. Conversely,a shallow slope may support use of agreater margin of exposure. A secondfactor is the nature of the response usedin the assessment—A precursor effect orfrank toxicity or tumor response. Thelatter two may support a greater marginof exposure. A third factor is the natureand extent of human variability insensitivity to the phenomenon. A fourthfactor is the agent’s persistence in thebody. Greater variability or persistenceargue for greater margins of exposure. Afifth factor is human sensitivity to thephenomenon as compared withexperimental animals. The size of themargin of exposure that is acceptablewould increase or decrease as this factorincreases or decreases. If humanvariability cannot be estimated based ondata, it should be considered to be atleast 10-fold. Similarly, if comparison ofspecies sensitivities cannot be estimatedfrom available data, humans can be

considered to be 10-fold more sensitive.If it is found that humans are lesssensitive than animals a factor that is afraction no smaller than 1⁄10 may beassumed. The 10-fold factors aremoderately conservative, traditionalones used for decades in the assessmentof toxicological effects. It should not beassumed that the numerical factors arethe sole components for determinationof an acceptable margin of exposure.Each case calls for individual judgment.It should be noted that for cancerassessment the margin of exposureanalysis begins from a point ofdeparture that is adjusted fortoxicokinetic differences betweenspecies to give a human equivalentdose. Since the traditional factor forinterspecies difference is thought tocontain a measure for toxicokinetics aswell as sensitivity to effect, the result ofbeginning with a human equivalentdose is to add some conservatism. Theultimate judgment whether a particularmargin of exposure is acceptable is arisk management decision underapplicable law, rather than beinginherent in the risk assessment.Nonetheless, the risk assessor isresponsible for providing scientificrationale to support the the decision.

When the mode of action informationindicates that the dose response may beadequately described by both a linearand a nonlinear approach, then thedefault is to present both the linear andmargin of exposure analyses. Anassessment may use both linear andnonlinear approaches either forresponses that are thought to result fromdifferent modes of action or forpresenting considerations for a responsethat appears to be very different at highand low doses due to influence ofseparate modes of action. Also, separateapproaches may be used for differentinduced responses (i.e. tumor types)from the same agent. These would alsobe carried forward and presented in theassessment. Figure 1–1 presents thedecision points in deciding on a doseresponse approach or approaches.BILLING CODE 6560–50–P


BILLING CODE 6560–50–C

A default assumption is made thatcumulative dose received over alifetime, expressed as a lifetime averagedaily dose, is an appropriate measure ofdose. This assumes that a high dose ofsuch an agent received over a shorterperiod of time is equivalent to a lowdose spread over a lifetime. This isthought to be a relatively public healthconservative assumption and hasempirical support (Monro, 1992). Anexample of effects of short-term, highexposure that results in subsequentcancer development is treatment ofcancer patients with certainchemotherapeutic agents. An exampleof cancer from long-term exposure to anagent of relatively low potency issmoking. Whether the cumulative dosemeasure is exactly the correct measurein both such instances is not certain andshould be assessed case by case andaltered when data are available tosupport another approach. Othermeasures of dose that consider dose rateand duration are appropriate, e.g., when

an agent acts by causing cell toxicity orhormone disruption. In these cases bothagent concentration and duration arelikely to be important, because sucheffects are generally observed to bereversible at cessation of short-termexposure.

1.4. Characterizations

The risk characterization process firstsummarizes findings on hazard, doseresponse, and exposurecharacterizations, then develops anintegrative analysis of the whole riskcase. It ends in a nontechnical RiskCharacterization Summary. The RiskCharacterization Summary is apresentation for risk managers who mayor may not be familiar with thescientific details of cancer assessment. Italso provides information for otherinterested readers. The initial steps inthe risk characterization process are tomake building blocks in the form ofcharacterizations of the assessments ofhazard, dose response, and exposure.The individual assessments andcharacterizations are then integrated to

arrive at risk estimates for exposurescenarios of interest. There are tworeasons for individually characterizingthe hazard, dose response, and exposureassessments. One is that they are oftendone by different people than those whodo the integrative analyses. The secondis that there is very often a lapse of timebetween the conduct of hazard and doseresponse analyses and the conduct ofexposure assessment and integrativeanalysis. Thus, it is necessary to capturecharacterizations of assessments as theassessments are done to avoid the needto go back and reconstruct them. Figure1–2 shows the relationships of analyses.The figure does not necessarilycorrespond to the number of documentsinvolved; there may be one or several.‘‘Integrative analysis’’ is a generic term.At EPA, the documents of variousprograms that contain integrativeanalyses have other names such as the‘‘Staff Paper’’ that discusses air qualitycriteria issues. In the following sections,the elements of this figure are discussed.



2. Hazard Assessment

2.1. Overview of Hazard Assessmentand Characterization

2.1.1. Analyses of Data

The purpose of hazard assessment isto review and evaluate data pertinent totwo questions: (1) whether an agent maypose a carcinogenic hazard to humanbeings and (2) under whatcircumstances an identified hazard maybe expressed (NRC, 1994, p. 142).Hazard assessment is composed ofanalyses of a variety of data that mayrange from observations of tumorresponses to analysis of structure-activity relationships. The purpose ofthe assessment is not simply toassemble these separate evaluations; itspurpose is to construct a total caseanalysis examining the biological storythe data reveal as a whole aboutcarcinogenic effects, mode of action,and implications of these for humanhazard and dose response evaluation.Weight of evidence conclusions comefrom the combined strength andcoherence of inferences appropriatelydrawn from all of the availableevidence. To the extent that data permit,hazard assessment addresses the modeof action question as both an initial stepin considering appropriate approachesto dose response assessment and as apart of identifying human hazardpotential.

The topics in this section includeanalysis of tumor data, both animal andhuman, and analysis of other keyinformation about properties and effectsthat relate to carcinogenic potential. Thesection addresses how information canbe used to evaluate potential modes ofaction. It also provides guidance onperforming a weight of evidenceevaluation.

2.1.2. Cross-Cutting Topics for DataIntegration

Two topics are included in theanalysis of each kind of available data:first, gathering information fromavailable data about the conditions ofexpression of hazard and second,gathering perspectives on the agent’spotential mode of action.

2.1.2.1. Conditions of Expression.Information on the significance of theroute of exposure may be available fromhuman or animal studies on the agentitself or on structural analogues. Thisinformation may be found in studies ofthe agent or analogue for toxicologicalendpoints other than cancer under acuteor subchronic or chronic exposureregimens. Studies of metabolism ortoxicokinetics of the agent similarly mayprovide pertinent data.

Each kind of data is also examined forinformation on conditions that affectexpression of carcinogenic effect such aspresence or absence of metabolicpathways. If carcinogenicity issecondary to another toxic effect, thephysiological or tissue changes thatmark the other toxicity are examined.Comparison of metabolic processes andtoxicity processes in humans andanimals also bears on the relevance ofanimal responses to human hazard.Included in the examination are thequestions of the potential range ofhuman variability and whether anyspecial sensitivity may occur because ofage, sex, preexisting disease, or othercondition.

2.1.2.2. Mode of Action. Informationon an agent’s potential mode(s) of actionis important in considering therelevance of animal effects toassessment of human hazard. It alsoplays an important role in selecting doseresponse approach(es), which aregenerally either biologically basedmodels or case-specific modelsincorporating mode of action data ordefault procedures based on morelimited data that support inferencesabout the likely shape of the doseresponse curve.

Each kind of data may provide someinsight about mode of action andinsights are gathered from each to beconsidered together as discussed insection 2.4. In Appendix C, is abackground discussion of some of thedevelopment of views aboutcarcinogenic processes.

2.1.3. Presentation of Results.Presentation of the results of hazardassessment follows Agency guidance asdiscussed in section 2.7. The results arepresented in a technical hazardcharacterization that serves as a supportto later risk characterization. It includes:

• a summary of the evaluations ofhazard data,

• the rationales for its conclusions,and

• an explanation of the significantstrengths or limitations of theconclusions.

Another presentation feature is theuse of a weight of evidence narrativethat includes both a conclusion aboutthe weight of evidence of carcinogenicpotential and a summary of the data onwhich the conclusion rests. Thisnarrative is a brief summary thatreplaces the alphanumericalclassification system used in EPA’sprevious guidelines.

2.2. Analysis of Tumor DataEvidence of carcinogenicity comes

from finding tumor increases in humansor laboratory animals exposed to a given

agent, or from finding tumors followingexposure to structural analogues to thecompound under review. Thesignificance of observed or anticipatedtumor effects is evaluated in reference toall of the other key data on the agent.This section contains guidance foranalyzing human and animal studies todecide whether there is an associationbetween exposure to an agent or astructural analogue and occurrence oftumors. Note that the use of the term‘‘tumor’’ here is generic, meaningmalignant neoplasms or a combinationof malignant and corresponding benignneoplasms.

Observation of only benign neoplasiasmay or may not have significance.Benign tumors that are not observed toprogress to malignancy are assessed ona case-by-case basis. There is a range ofpossibilities for their overallsignificance. They may deserveattention because they are serious healthproblems even though they are notmalignant; for instance, benign tumorsmay be a health risk because of theireffect on the function of a target tissuesuch as the brain. They may besignificant indicators of the need forfurther testing of an agent if they areobserved in a short term test protocol,or such an observation may add to theoverall weight of evidence if the sameagent causes malignancies in a longterm study. Knowledge of the mode ofaction associated with a benign tumorresponse may aid in the interpretationof other tumor responses associatedwith the same agent. In other cases,observation of a benign tumor responsealone may have no significant healthhazard implications when other sourcesof evidence show no suggestion ofcarcinogenicity.

2.2.1. Human DataHuman data may come from

epidemiologic studies or case reports.Epidemiology is the study of thedistributions and causes of diseasewithin human populations. The goals ofcancer epidemiology are to identifydifferences in cancer risk betweendifferent groups in a population orbetween different populations, and thento determine the extent to which thesedifferences in risk can be attributedcausally to specific exposures toexogenous or endogenous factors.Epidemiologic data are extremely usefulin risk assessment because they providedirect evidence that a substanceproduces cancer in humans, therebyavoiding the problem of species tospecies inference. Thus, when availablehuman data are extensive and of goodquality, they are generally preferableover animal data and should be given


greater weight in hazardcharacterization and dose responseassessment, although both are utilized.

Null results from a singleepidemiologic study cannot prove theabsence of carcinogenic effects becausethey can arise either from being trulynegative or from inadequate statisticalpower, inadequate design, impreciseestimates, or confounding factors.However, null results from a well-designed and well-conductedepidemiologic study that containsusable exposure data can help to defineupper limits for the estimated dose ofconcern for human exposure if theoverall weight of the evidence indicatesthat the agent is potentially carcinogenicin humans.

Epidemiology can also complementexperimental evidence in corroboratingor clarifying the carcinogenic potentialof the agent in question. For example,observations from epidemiologic studiesthat elevated cancer incidence occurs atsites corresponding to those at whichlaboratory animals experience increasedtumor incidence can strengthen theweight of evidence of humancarcinogenicity. On the other hand,strong nonpositive epidemiologic dataalone or in conjunction with compellingmechanistic information can lendsupport to a conclusion that animalresponses may not be predictive of ahuman response. Furthermore, theadvent of biochemical or molecularepidemiology may help improveunderstanding of the mechanisms ofhuman carcinogenesis.

2.2.1.1. Types of Studies. The majortypes of cancer epidemiologic studiesare analytical epidemiologic studies anddescriptive or correlation epidemiologicstudies. Each study type has well-known strengths and weaknesses thataffect interpretation of study results assummarized below (Kelsey et al., 1986;Lilienfeld and Lilienfeld, 1979; Mausnerand Kramer, 1985; Rothman, 1986).

Analytical epidemiologic studies aremost useful for identifying anassociation between human exposureand adverse health effects. Analyticalstudy designs include case-controlstudies and cohort studies. In case-control studies, groups of individualswith (cases) and without (controls) aparticular disease are identified andcompared to determine differences inexposure. In cohort studies, a group of‘‘exposed’’ and ‘‘nonexposed’’individuals are identified and studiedover time to determine differences indisease occurrence. Cohort studies caneither be performed prospectively orretrospectively from historical records.

Descriptive or correlationepidemiologic studies (sometimes called

ecological studies) examine differencesin disease rates among populations inrelation to age, gender, race, anddifferences in temporal orenvironmental conditions. In general,these studies can only identify patternsor trends in disease occurrence overtime or in different geographicallocations but cannot ascertain the causalagent or degree of exposure. Thesestudies, however, are often very usefulfor generating hypotheses for furtherresearch.

Biochemical or molecularepidemiologic studies are studies inwhich laboratory methods areincorporated in analyticalinvestigations. The application oftechniques for measuring cellular andmolecular alterations due to exposure tospecific environmental agents mayallow conclusions to be drawn about themechanisms of carcinogenesis. The useof biological biomarkers inepidemiology may improve assessmentof exposure and internal dose.

Case reports describe a particulareffect in an individual or group ofindividuals who were exposed to asubstance. These reports are oftenanecdotal or highly selected in natureand are of limited use for hazardassessment. However, reports of cancercases can identify associationsparticularly when there are uniquefeatures such as an association with anuncommon tumor (e.g., vinyl chlorideand angiosarcoma or diethylstilbestroland clear-cell carcinoma of the vagina).

2.2.1.2. Criteria for AssessingAdequacy of Epidemiologic Studies.Criteria for assessing the adequacy ofepidemiologic studies are wellrecognized. Characteristics that aredesirable in these studies include (1)clear articulation of study objectives orhypothesis, (2) proper selection andcharacterization of the exposed andcontrol groups, (3) adequatecharacterization of exposure, (4)sufficient length of follow-up for diseaseoccurrence, (5) valid ascertainment ofthe causes of cancer morbidity andmortality, (6) proper consideration ofbias and confounding factors, (7)adequate sample size to detect an effect,(8) clear, well-documented, andappropriate methodology for datacollection and analysis, (9) adequateresponse rate and methodology forhandling missing data, and (10)complete and clear documentation ofresults. Ideally, these conditions shouldbe satisfied, where appropriate, butrarely can a study meet all of them. Nosingle criterion determines the overalladequacy of a study. The followingdiscussions highlight the major factors

included in an analysis ofepidemiologic studies.

Population Issues. The idealcomparison would be between twopopulations that differ only in exposureto the agent in question. Because this isseldom the case, it is important toidentify sources of bias inherent in astudy’s design or data collectionmethods. Bias can arise from severalsources, including noncomparabilitybetween populations of factors such asgeneral health (McMichael, 1976), diet,lifestyle, or geographic location;differences in the way case and controlindividuals recall past events;differences in data collection that resultin unequal ascertainment of healtheffects in the populations; and unequalfollow-up of individuals. Bothacceptance of studies for assessmentand judgment of their strengths orweaknesses depend on identifying theirsources of bias and the effects on studyresults.

Exposure Issues. For epidemiologicdata to be useful in determiningwhether there is an association betweenhealth effects and exposure to an agent,there must be adequate characterizationof exposure information. In general,greater weight should be given tostudies with more precise and specificexposure estimates.

Questions to address about exposureare: What can one reliably concludeabout the level, duration, route, andfrequency of exposure of individuals inone population as compared withanother? How sensitive are study resultsto uncertainties in these parameters?

Actual exposure measurements arenot available for many retrospectivestudies. Therefore, surrogates are oftenused to reconstruct exposure parameterswhen historical measurements are notavailable. These may involve attributingexposures to job classifications in aworkplace or to broader occupational orgeographic groupings. Use of surrogatescarries a potential for misclassificationin that individuals may be placed in theincorrect exposure group.Misclassification generally leads toreduced ability of a study to detectdifferences between study and referentpopulations.

When either current or historicalmonitoring data are available, theexposure evaluation includesconsideration of the error bounds of themonitoring and analytic methods andwhether the data are from routine oraccidental exposures. The potentials formisclassification and measurementerrors are amenable to both qualitativeand quantitative analysis. These areessential analyses for judging a study’sresults because exposure estimation is


the most critical part of a retrospectivestudy.

Biological markers potentially offerexcellent measures of exposure (Hulkaand Margolin, 1992; Peto and Darby,1994). Validated markers of exposuresuch as alkylated hemoglobin fromexposure to ethylene oxide (van Sittertet al., 1985) or urinary arsenic (Enterlineet al., 1987) can greatly improveestimates of dose. Markers closelyidentified with effects promise to greatlyincrease the ability of studies todistinguish real effects from bias at lowlevels of relative risk betweenpopulations (Taylor et al., 1994; Biggs etal., 1993) and to resolve problems ofconfounding risk factors.

Confounding Factors. Becauseepidemiologic studies are mostlyobservational, it is not possible toguarantee the control of confoundingvariables, which may affect the studyoutcome. A confounding variable is arisk factor, independent of the putativeagent, that is distributed unequallyamong the exposed and unexposedpopulations (e.g., smoking habits,lifestyle). Adjustment for possibleconfounding factors can occur either inthe design of the study (e.g., matchingon critical factors) or in the statisticalanalysis of the results. The influence ofa potential confounding factor is limitedby the effect of the exposure of interest.For example, a twofold effect of anexposure requires that the confoundereffect be at least as big. The latter maynot be possible due to the presentationof the data or because neededinformation was not collected duringthe study. In this case, indirectcomparisons may be possible. Forexample, in the absence of data onsmoking status among individuals in thestudy population, an examination of thepossible contribution of cigarettesmoking to increased lung cancer riskmay be based on information from othersources such as the American CancerSociety’s longitudinal studies(Hammand, 1966; Garfinkel andSilverberg, 1991). The effectiveness ofadjustments contributes to the ability todraw inferences from a study.

Different studies involving exposureto an agent may have differentconfounding factors. If consistentincreases in cancer risk are observedacross a collection of studies withdifferent confounding factors, theinference that the agent underinvestigation was the etiologic factor isstrengthened, even though completeadjustment for confounding factorscannot be made and no single studysupports a strong inference.

It also may be the case that the agentof interest is a risk factor in conjunction

with another agent. This relationshipmay be revealed in a collection ofstudies such as in the case of asbestosexposure and smoking.

Sensitivity. Sensitivity, or the abilityof a study to detect real effects, is afunction of several factors. Greater sizeof the study population(s) (sample size)increases sensitivity, as does greaterexposure (levels and duration) of thepopulation members. Because of theoften long latency period in cancerdevelopment, sensitivity also dependson whether adequate time has elapsedsince exposure began for effects tooccur. A unique feature that can beascribed to the effects of a particularagent (such as a tumor type that is seenonly rarely in the absence of the agent)can increase sensitivity by permittingseparation of bias and confoundingfactors from real effects. Similarly, abiomarker particular to the agent canpermit these distinctions. Statisticalreanalyses of data, particularly anexamination of different exposureindices, can give insight on potentialexposure-response relationships. Theseare all factors to explore in statisticalanalysis of the data.

Statistical Considerations. Theanalysis applies appropriate statisticalmethods to ascertain whether or notthere is any significant associationbetween exposure and effects. Adescription of the method or methodsshould include the reasons for theirselection. Statistical analyses of thepotential effects of bias or confoundingfactors are part of addressing thesignificance of an association, or lack ofone, and whether a study is able todetect any effect.

The analysis augments examination ofthe results for the whole populationwith exploration of the results forgroups with comparatively greaterexposure or time since first exposure.This may support identifying anassociation or establishing a doseresponse trend. When studies show noassociation, such exploration may applyto determining an upper limit onpotential human risk for considerationalongside results of animal tumor effectsstudies.

Combining Statistical EvidenceAcross Studies. Meta-analysis is ameans of comparing and synthesizingstudies dealing with similar healtheffects and risk factors. It is intended tointroduce consistency andcomprehensiveness into what otherwisemight be a more subjective review of theliterature. When utilized appropriately,meta-analysis can enhanceunderstanding of associations betweensources and their effects that may not beapparent from examination of

epidemiologic studies individually.Whether to conduct a meta-analysisdepends on several issues. Theseinclude the importance of formallyexamining sources of heterogeneity, therefinement of the estimate of themagnitude of an effect, and the need forinformation beyond that provided byindividual studies or a narrative review.Meta-analysis may not be useful in somecircumstances. These include when therelationship between exposure anddisease is obvious without a moreformal analysis, when there are only afew studies of the key health outcomes,when there is insufficient informationfrom available studies related to disease,risk estimate, or exposure classification,or when there are substantialconfounding or other biases that cannotbe adjusted for in the analysis (Blair etal., 1995; Greenland, 1987; Peto, 1992).

2.2.1.3. Criteria for Causality. Acausal interpretation is enhanced forstudies to the extent that they meet thecriteria described below. None of thecriteria is conclusive by itself, and theonly criterion that is essential is thetemporal relationship. These criteria aremodeled after those developed byBradford Hill in the examination ofcigarette smoking and lung cancer(Rothman, 1986) and they need to beinterpreted in the light of all otherinformation on the agent being assessed.

• Temporal relationship: Thedevelopment of cancers require certainlatency periods, and while latencyperiods vary, existence of such periodsis generally acknowledged. Thus, thedisease has to occur within abiologically reasonable time after initialexposure. This feature must be presentif causality is to be considered.

• Consistency: Associations occur inseveral independent studies of a similarexposure in different populations, orassociations occur consistently fordifferent subgroups in the same study.This feature usually constitutes strongevidence for a causal interpretationwhen the same bias or confounding isnot also duplicated across studies.

• Magnitude of the association: Acausal relationship is more crediblewhen the risk estimate is large andprecise (narrow confidence intervals).

• Biological gradient: The risk ratio(i.e., the ratio of the risk of disease ordeath among the exposed to the risk ofthe unexposed) increases withincreasing exposure or dose. A strongdose response relationship acrossseveral categories of exposure, latency,and duration is supportive for causalitygiven that confounding is unlikely to becorrelated with exposure. The absenceof a dose response relationship,


however, is not by itself evidenceagainst a causal relationship.

• Specificity of the association: Thelikelihood of a causal interpretation isincreased if an exposure produces aspecific effect (one or more tumor typesalso found in other studies) or if a giveneffect has a unique exposure.

• Biological plausibility: Theassociation makes sense in terms ofbiological knowledge. Information isconsidered from animal toxicology,toxicokinetics, structure-activityrelationship analysis, and short-termstudies of the agent’s influence onevents in the carcinogenic processconsidered.

• Coherence: The cause-and-effectinterpretation is in logical agreementwith what is known about the naturalhistory and biology of the disease, i.e.,the entire body of knowledge about theagent.

2.2.1.4. Assessment of Evidence ofCarcinogenicity from Human Data. Inthe evaluation of carcinogenicity basedon epidemiologic studies, it is necessaryto critically evaluate each study for theconfidence in findings and conclusionsas discussed under section 2.2.1.2. Allstudies that are properly conducted,whether yielding positive or nullresults, or even suggesting protectivecarcinogenic effects, should beconsidered in assessing the totality ofthe human evidence. Although a singlestudy may be indicative of a cause-effectrelationship, confidence in inferring acausal relationship is increased whenseveral independent studies areconcordant in showing the association,when the association is strong, andwhen other criteria for causality are alsomet. Conclusions about the overallevidence for carcinogenicity fromavailable studies in humans should besummarized along with a discussion ofstrengths or limitations of theconclusions.

2.2.2. Animal DataVarious kinds of whole animal test

systems are currently used or are underdevelopment for evaluating potentialcarcinogenicity. Cancer studiesinvolving chronic exposure for most ofthe life span of an animal are generallyaccepted for evaluation of tumor effects(Tomatis et al., 1989; Rall, 1991; Allenet al., 1988; but see Ames and Gold,1990). Other studies of special designare useful for observing formation ofpreneoplastic lesions or tumors orinvestigating specific modes of action.

2.2.2.1. Long-Term CarcinogenicityStudies. The objective of long-termcarcinogenesis bioassays is to determinethe carcinogenic potential and doseresponse relationships of the test agent.

Long-term rodent studies are designedto examine the production of tumors aswell as preneoplastic lesions and otherindications of chronic toxicity that mayprovide evidence of treatment-relatedeffects and insights into the way the testagent produces tumors. Currentstandardized long-term studies inrodents test at least 50 animals per sexper dose group in each of threetreatment groups and in a concurrentcontrol group, usually for 18 to 24months, depending on the rodentspecies tested (OECD, 1981; U.S. EPA,1983a; U.S. EPA, 1983b; U.S. EPA,1983c). The high dose in long-termstudies is generally selected to providethe maximum ability to detecttreatment-related carcinogenic effectswhile not compromising the outcome ofthe study due to excessive toxicity orinducing inappropriate toxicokinetics(e.g., overwhelming detoxification orabsorption mechanisms). The purposeof two or more lower doses is to providesome information on the shape of thedose response curve. Similar protocolshave been and continue to be used bymany laboratories worldwide.

All available studies of tumor effectsin whole animals are considered, atleast preliminarily. The analysisdiscards studies judged to be whollyinadequate in protocol, conduct, orresults. Criteria for the technicaladequacy of animal carcinogenicitystudies have been published and shouldbe used as guidance to judge theacceptability of individual studies (NTP,1984; OSTP, 1985). Care is taken toinclude studies that provide someevidence bearing on carcinogenicity orhelp interpret effects noted in otherstudies even if they have somelimitations of protocol or conduct. Suchlimited, but not wholly inadequate,studies can contribute as theirdeficiencies permit. The findings oflong-term rodent bioassays are alwaysinterpreted in conjunction with resultsof prechronic studies along withtoxicokinetic and metabolism studiesand other pertinent information, ifavailable. Evaluation of tumor effectsrequires consideration of both biologicaland statistical significance of thefindings (Haseman, 1984, 1985, 1990,1995). The following sections highlightthe major issues in the evaluation oflong-term carcinogenicity studies.

Dosing issues. In order to obtain themost relevant information from a long-term carcinogenicity study, it isimportant to require maximization ofexposure to the test material. At thesame time, there is a need for caution inusing excessive high dose levels thatwould confound the interpretation ofstudy results to humans. The high dose

is conventionally defined as a dose thatproduces some toxic effects withouteither unduly affecting mortality fromeffects other than cancer or producingsignificant adverse effects on thenutrition and health of the test animals(OECD, 1981; NRC, 1993b). It should benoted that practical upper limits havebeen established to avoid the use ofexcessive high doses in long-termcarcinogenicity studies (e.g., 5% of thetest substance in the feed for dietarystudies [OECD, 1981]).

Evaluating the appropriateness of thehigh dose in carcinogenicity studies isbased on scientific judgment using allavailable relevant information. Ingeneral, if the test agent does not appearto cause any specific target organtoxicity or perturbation of physiologicalfunction, an adequate high dose wouldbe a dose that causes no more than 10%reduction of body weight gain over thelife span of the animals. On the otherhand, significant increases in mortalityfrom effects other than cancer isaccepted as clear evidence of franktoxicity, which indicates that anadequate high dose may have beenexceeded. Other signs of treatment-related toxicity that may indicate that anadequate high dose has been exceededinclude the following: (a) Reduction ofbody weight gain of 10% or greater, (b)significant increases in abnormalbehavioral and clinical signs, (c)significant changes in hematology orclinical chemistry, (d) saturation ofabsorption and detoxificationmechanisms, or (e) marked changes inorgan weight, morphology, andhistopathology.

For dietary studies, weight gainreductions should be evaluated as towhether there is a palatability problemor an issue with food efficiency;certainly, the latter is a toxicmanifestation. In the case of inhalationstudies with respirable particles,evidence of impairment of normalclearance of particles from the lungshould be considered along with othersigns of toxicity to the respiratoryairways to determine whether the highexposure concentration has beenappropriately selected. For dermalstudies, evidence of skin irritation mayindicate that an adequate high dose hasbeen reached.

Interpretation of carcinogenicity studyresults is profoundly affected byexposure conditions, especially byinappropriate dose selection. This isparticularly important in studies thatare nonpositive for carcinogenicity,since failure to reach a sufficient dosereduces the sensitivity of a study. A lackof tumorigenic responses at exposurelevels that cause significant impairment


of animal survival may also not beacceptable as negative findings becauseof the reduced sensitivity of the study.On the other hand, overt toxicity orinappropriate toxicokinetics due toexcessive high doses may result intumor effects that are secondary to thetoxicity rather than directly attributableto the agent.

There are several possible outcomesregarding the study interpretation of thesignificance and relevance oftumorigenic effects associated withexposure or dose levels below, at, orabove an adequate high dose. Generalguidance is given here that should notbe taken as prescriptive; for each case,the information at hand is evaluated anda rationale should be given for theposition taken.

• Adequate high dose: If an adequatehigh dose has been utilized, tumoreffects are judged positive or negativedepending on the presence or absence ofsignificant tumor incidence increases,respectively.

• Excessive high dose: If toxicity ormortality is excessive at the high dose,interpretation depends on the finding oftumors or not.

(a) Studies that show tumor effectsonly at excessive doses may becompromised and may or may not carryweight, depending on the interpretationin the context of other study results andother lines of evidence. Results of suchstudies, however, are generally notconsidered suitable for riskextrapolation.

(b) Studies that show tumors at lowerdoses, even though the high dose isexcessive and may be discounted,should be evaluated on their ownmerits.

(c) If a study does not show anincrease in tumor incidence at a toxichigh dose and appropriately spacedlower doses are used without suchtoxicity or tumors, the study is generallyjudged as negative for carcinogenicity.

• Inadequate high dose: Studies ofinadequate sensitivity where anadequate high dose has not beenreached may be used to bound the doserange where carcinogenic effects mightbe expected.

Statistical Considerations. The mainaim of statistical evaluation is todetermine whether exposure to the testagent is associated with an increase oftumor development. Statistical analysisof a long-term study should beperformed for each tumor typeseparately. The incidence of benign andmalignant lesions of the same cell type,usually within a single tissue or organ,are considered separately and arecombined when scientifically defensible(McConnell et al., 1986).

Trend tests and pairwise comparisontests are the recommended tests fordetermining whether chance, ratherthan a treatment-related effect, is aplausible explanation for an apparentincrease in tumor incidence. A trendtest such as the Cochran-Armitage test(Snedecor and Cochran, 1967) askswhether the results in all dose groupstogether increase as dose increases. Apairwise comparison test such as theFisher exact test (Fisher, 1932) askswhether an incidence in one dose groupis increased over the control group. Byconvention, for both tests a statisticallysignificant comparison is one for whichp <0.05 that the increased incidence isdue to chance. Significance in eitherkind of test is sufficient to reject thehypothesis that chance accounts for theresult. A statistically significantresponse may or may not be biologicallysignificant and vice versa. The selectionof a significance level is a policy choicebased on a trade-off between the risks offalse positives and false negatives. Asignificance level of greater or less than5% is examined to see if it confirmsother scientific information. When theassessment departs from a simple 5%level, this should be highlighted in therisk characterization. A two-tailed testor a one-tailed test can be used. In eithercase a rationale is provided.

Considerations of multiplecomparisons should also be taken intoaccount. Haseman (1983) analyzestypical animal bioassays testing bothsexes of two species and concludes that,because of multiple comparisons, asingle tumor increase for a species-sex-site combination that is statisticallysignificant at the 1% level for commontumors or 5% for rare tumorscorresponds to a 7–8% significancelevel for the study as a whole.Therefore, animal bioassays presentingonly one significant result that fallsshort of the 1% level for a commontumor may be treated with caution.

Concurrent and Historical Controls.The standard for determining statisticalsignificance of tumor incidence comesfrom a comparison of tumors in dosedanimals as compared with concurrentcontrol animals. Additional insightsabout both statistical and biologicalsignificance can come from anexamination of historical control data(Tarone, 1982; Haseman, 1995).Historical control data can add to theanalysis particularly by enablingidentification of uncommon tumor typesor high spontaneous incidence of atumor in a given animal strain.Identification of common or uncommonsituations prompts further thoughtabout the meaning of the response in thecurrent study in context with other

observations in animal studies and withother evidence about the carcinogenicpotential of the agent. These othersources of information may reinforce orweaken the significance given to theresponse in the hazard assessment.Caution should be exercised in simplylooking at the ranges of historicalresponses because the range ignoresdifferences in survival of animals amongstudies and is related to the number ofstudies in the database.

In analyzing results for uncommontumors in a treated group that are notstatistically significant in comparison toconcurrent controls, the analyst can usethe experience of historical controls toconclude that the result is in factunlikely to be due to chance. Inanalyzing results for common tumors, adifferent set of considerations comesinto play. Generally speaking,statistically significant increases intumors should not be discounted simplybecause incidence rates in the treatedgroups are within the range of historicalcontrols or because incidence rates inthe concurrent controls are somewhatlower than average. Random assignmentof animals to groups and properstatistical procedures provide assurancethat statistically significant results areunlikely to be due to chance alone.However, caution should be used ininterpreting results that are barelystatistically significant or in whichincidence rates in concurrent controlsare unusually low in comparison withhistorical controls.

In cases where there may be reason todiscount the biological relevance tohumans of increases in common animaltumors, such considerations should beweighed on their own merits and clearlydistinguished from statistical concerns.

When historical control data are used,the discussion needs to address severalissues that affect comparability ofhistorical and concurrent control data.Among these issues are the following:genetic drift in the laboratory strains;differences in pathology examination atdifferent times and in differentlaboratories (e.g., in criteria forevaluating lesions; variations in thetechniques for preparation or reading oftissue samples among laboratories);comparability of animals from differentsuppliers. The most relevant historicaldata come from the same laboratory andsame supplier, gathered within 2 or 3years one way or the other of the studyunder review; other data should be usedonly with extreme caution.

Assessment of Evidence ofCarcinogenicity from Long-TermAnimal Studies. In general, observationof tumor effects under differentcircumstances lends support to the


significance of the findings for animalcarcinogenicity. Significance is afunction of the number of factorspresent, and for a factor such asmalignancy, the severity of the observedpathology. The following observationsadd significance to the tumor findings:

• uncommon tumor types• tumors at multiple sites• tumors by more than one route of

administration• tumors in multiple species, strains,

or both sexes• progression of lesions from

preneoplastic to benign to malignant• reduced latency of neoplastic

lesions• metastases• unusual magnitude of tumor

response• proportion of malignant tumors• dose-related increasesThese guidelines adopt the science

policy position that tumor findings inanimals indicate that an agent mayproduce such effects in humans.Moreover, the absence of tumor findingsin well-conducted, long-term animalstudies in at least two species providesreasonable assurance that an agent maynot be a carcinogenic concern forhumans. Each of these is a defaultassumption that may be adopted, whenappropriate, after evaluation of tumordata and other key evidence.

Site concordance of tumor effectsbetween animals and humans is anissue to be considered in each case.Thus far, there is evidence that growthcontrol mechanisms at the level of thecell are homologous among mammals,but there is no evidence that thesemechanisms are site concordant.Moreover, agents observed to producetumors in both humans and animalshave produced tumors either at thesame (e.g., vinyl chloride) or differentsites (e.g., benzene) (NRC, 1994). Hence,site concordance is not assumed apriori. On the other hand, certainprocesses with consequences forparticular tissue sites (e.g., disruption ofthyroid function) may lead to ananticipation of site concordance.

2.2.2.2. Other Studies. Variousintermediate-term studies often useprotocols that screen for carcinogenic orpreneoplastic effects, sometimes in asingle tissue. Some involve thedevelopment of various proliferativelesions, like foci of alteration in the liver(Goldsworthy et al., 1986). Others usetumor endpoints, like the induction oflung adenomas in the sensitive strain Amouse (Maronpot et al., 1986) or tumorinduction in initiation-promotionstudies using various organs such as thebladder, intestine, liver, lung, mammarygland, and thyroid (Ito et al., 1992). In

these tests, the selected tissue is, in asense, the test system rather than thewhole animal. Important informationconcerning the steps in the carcinogenicprocess and mode of action can beobtained from ‘‘start/stop’’ experiments.In these protocols, an agent is given fora period of time to induce particularlesions or effects, then stopped toevaluate the progression or reversibilityof processes (Todd, 1986; Marsman andPopp, 1994).

Assays in genetically engineeredrodents may provide insight into thechemical and gene interactions involvedin carcinogenesis (Tennant et al.,1995a). These mechanistically basedapproaches involve activated oncogenesthat are introduced (transgenic) ortumor suppressor genes that are deleted(knocked-out). If appropriate genes areselected, not only may these systemsprovide information on mechanisms,but the rodents typically show tumordevelopment earlier than the standardbioassay. Transgenic mutagenesis assaysalso represent a mechanistic approachfor assessing the mutagenic properties ofagents as well as developingquantitative linkages between exposure,internal dose, and mutation related totumor induction (Morrison and Ashby,1994; Sisk et al., 1994; Hayward et al.,1995). These systems use a stablegenomic integration of a lambda shuttlevector that carries a lacI target gene anda lacZ reporter gene.

The support that these studies give toa determination of carcinogenicity restson their contribution to the consistencyof other evidence about an agent. Forinstance, benzoyl peroxide has promoteractivity on the skin, but the overallevidence may be less supportive (Krauset al., 1995). These studies also maycontribute information about mode ofaction. One needs to recognize thelimitations of these experimentalprotocols such as short duration, limitedhistology, lack of complete developmentof tumors, or experimentalmanipulation of the carcinogenicprocess that may limit their contributionto the overall assessment. Generally,their results are appropriate as aids inthe assessment for interpreting othertoxicological evidence (e.g., rodentchronic bioassays), especially regardingpotential modes of action. Withsufficient validation, these studies maypartially or wholly replace chronicbioassays in the future (Tennant et al.,1995).

2.2.3. Structural Analogue DataFor some chemical classes, there is

significant information available on thecarcinogenicity of analogues, largely inrodent bioassays. Analogue effects are

instructive in investigating carcinogenicpotential of an agent as well asidentifying potential target organs,exposures associated with effects, andpotential functional class effects ormodes of action. All appropriate studiesare included and analyzed, whetherindicative of a positive effect or not.Evaluation includes tests in variousanimal species, strains, and sexes; withdifferent routes of administration; and atvarious doses, as data are available.Confidence in conclusions is a functionof how similar the analogues are to theagent under review in structure,metabolism, and biological activity.This confidence needs to be consideredto ensure a balanced position.

2.3. Analysis of Other Key DataThe physical, chemical, and structural

properties of an agent, as well as data onendpoints that are thought to be criticalelements of the carcinogenic process,provide valuable insights into thelikelihood of human cancer risk. Thefollowing sections provide guidance foranalyses of these data.

2.3.1. Physicochemical PropertiesPhysicochemical properties affect an

agent’s absorption, tissue distribution(bioavailability), biotransformation, anddegradation in the body and areimportant determinants of hazardpotential (and dose response analysis).Properties to analyze include, but arenot limited to, the following: molecularweight, size, and shape; valence state;physical state (gas, liquid, solid); wateror lipid solubility, which can influenceretention and tissue distribution; andpotential for chemical degradation orstabilization in the body.

An agent’s potential for chemicalreaction with cellular components,particularly with DNA and proteins, isalso important. The agent’s molecularsize and shape, electrophilicity, andcharge distribution are considered inorder to decide whether they wouldfacilitate such reactions.

2.3.2. Structure-Activity RelationshipsStructure-activity relationship (SAR)

analyses and models can be used topredict molecular properties, surrogatebiological endpoints, andcarcinogenicity. Overall, these analysesprovide valuable initial information onagents, which may strengthen or weakenthe concern for an agent’s carcinogenicpotential.

Currently, SAR analysis is useful forchemicals and metabolites that arebelieved to initiate carcinogenesisthrough covalent interaction with DNA(i.e., DNA-reactive, mutagenic,electrophilic, or proelectrophilic


chemicals) (Ashby and Tennant, 1991).For organic chemicals, the predictivecapability of SAR analysis combinedwith other toxicity information has beendemonstrated (Ashby and Tennant,1994). The following parameters areuseful in comparing an agent to itsstructural analogues and congeners thatproduce tumors and affect relatedbiological processes such as receptorbinding and activation, mutagenicity,and general toxicity (Woo and Arcos,1989):

• nature and reactivity of theelectrophilic moiety or moieties present,

• potential to form electrophilicreactive intermediate(s) throughchemical, photochemical, or metabolicactivation,

• contribution of the carrier moleculeto which the electrophilic moiety(ies) isattached,

• physicochemical properties (e.g.,physical state, solubility, octanol-waterpartition coefficient, half-life in aqueoussolution),

• structural and substructural features(e.g., electronic, stearic, moleculargeometric),

• metabolic pattern (e.g., metabolicpathways and activation anddetoxification ratio), and

• possible exposure route(s) of theagent.

Suitable SAR analysis of non-DNA-reactive chemicals and of DNA-reactivechemicals that do not appear to bindcovalently to DNA requires knowledgeor postulation of the probable mode(s)of action of closely related carcinogenicstructural analogues (e.g., receptor-mediated, cytotoxicity-related).Examination of the physicochemicaland biochemical properties of the agentmay then provide the rest of theinformation needed in order to make anassessment of the likelihood of theagent’s activity by that mode of action.

2.3.3. Comparative Metabolism andToxicokinetics

Studies of the absorption,distribution, biotransformation, andexcretion of agents permit comparisonsamong species to assist in determiningthe implications of animal responses forhuman hazard assessment, supportingidentification of active metabolites,identifying changes in distribution andmetabolic pathway or pathways over adose range, and making comparisonsamong different routes of exposure.

If extensive data are available (e.g.,blood/tissue partition coefficients andpertinent physiological parameters ofthe species of interest), physiologicallybased pharmacokinetic models can beconstructed to assist in a determinationof tissue dosimetry, species-to-species

extrapolation of dose, and route-to-routeextrapolation (Connolly and Andersen,1991; see section 3.2.2). If it is notcontrary to available data, it is assumedas a default that toxicokinetic andmetabolic processes are qualitativelycomparable between species. Discussionof the defaults regarding quantitativecomparison and their modificationsappears in section 3.

The qualitative question of whetheran agent is absorbed by a particularroute of exposure is important forweight of evidence classificationdiscussed in section 2.7.1. Decisionswhether route of exposure is a limitingfactor on expression of any hazard, inthat absorption does not occur by aroute, are based on studies in whicheffects of the agent, or its structuralanalogues, have been observed bydifferent routes, on physical-chemicalproperties, or on toxicokinetics studies.

Adequate metabolism andpharmacokinetic data can be appliedtoward the following as data permit.Confidence in conclusions is enhancedwhen in vivo data are available.

• Identifying metabolites and reactiveintermediates of metabolism anddetermining whether one or more ofthese intermediates are likely to beresponsible for the observed effects.This information on the reactiveintermediates will appropriately focusSAR analysis, analysis of potentialmodes of action, and estimation ofinternal dose in dose responseassessment (D’Souza et al., 1987;Krewski et al., 1987).

• Identifying and comparing therelative activities of metabolic pathwaysin animals with those in humans. Thisanalysis can provide insights forextrapolating results of animal studiesto humans.

• Describing anticipated distributionwithin the body and possiblyidentifying target organs. Use of watersolubility, molecular weight, andstructure analysis can supportqualitative inferences about anticipateddistribution and excretion. In addition,describing whether the agent ormetabolite of concern will be excretedrapidly or slowly or will be stored in aparticular tissue or tissues to bemobilized later can identify issues incomparing species and formulating doseresponse assessment approaches.

• Identifying changes intoxicokinetics and metabolic pathwayswith increases in dose. These changesmay result in important differences indisposition of the agent or its generationof active forms of the agent betweenhigh and low dose levels. These studiesplay an important role in providing a

rationale for dose selection incarcinogenicity studies.

• Determining bioavailability viadifferent routes of exposure byanalyzing uptake processes undervarious exposure conditions. Thisanalysis supports identification ofhazards for untested routes. In addition,use of physicochemical data (e.g.,octanol-water partition coefficientinformation) can support an inferenceabout the likelihood of dermalabsorption (Flynn, 1990).

In all of these areas, attempts aremade to clarify and describe as much aspossible the variability to be expectedbecause of differences in species, sex,age, and route of exposure. The analysistakes into account the presence ofsubpopulations of individuals who areparticularly vulnerable to the effects ofan agent because of toxicokinetic ormetabolic differences (genetically orenvironmentally determined) (Bois etal., 1995).

2.3.4. Toxicological and ClinicalFindings

Toxicological findings inexperimental animals and clinicalobservations in humans are animportant resource to the cancer hazardassessment. Such findings provideinformation on physiological effects,effects on enzymes, hormones, andother important macromolecules as wellas on target organs for toxicity. Giventhat the cancer process representsdefects in terminal differentiation,growth control, and cell death,developmental studies of agents mayprovide an understanding of the activityof an agent that carries over to cancerassessment. Toxicity studies in animalsby different routes of administrationsupport comparison of absorption andmetabolism by those routes. Data onhuman variability in standard clinicaltests may provide insight into the rangeof human sensitivity and commonmechanisms to agents that affect thetested parameters.

2.3.5. Mode of Action-RelatedEndpoints and Short-Term Tests

A myriad of biochemical andbiological endpoints relevant to thecarcinogenic process provide importantinformation in determining whether acancer hazard exists and include, butare not limited to, mutagenesis,inhibition of gap junctional intercellularcommunication, increased cellproliferation, inhibition of programmedcell death, receptor activation, andimmunosuppression. These precursoreffects are discussed below.

2.3.5.1. Direct DNA Effects. Becausecancer is the result of multiple genetic


defects in genes controlling proliferationand tissue homeostasis (Vogelstein etal., 1988), the ability of an agent to affectDNA is of obvious importance. It is wellknown that many carcinogens areelectrophiles that interact directly withDNA, resulting in DNA damage andadducts, and subsequent mutations(referred to in these guidelines as directDNA effects) that are thought tocontribute to the carcinogenic process(Shelby and Zeiger, 1990; Tinwell andAshby, 1991). Thus, studies of thesephenomena continue to be important inthe assessment of cancer hazard. TheEPA has published testing guidelines fordetecting the ability of agents to affectDNA or chromosomes (EPA, 1991a).Information on agents that inducemutations in animal germ cells alsodeserves attention; several humancarcinogens have been shown to bepositive in rodent tests for the inductionof genetic damage in both somatic andgerm cells (Shelby, 1995).

2.3.5.2. Secondary DNA Effects.Similarly of interest are secondarymechanisms that either increasemutation rates or the number ofdividing cells. An increase in mutationsmight be due to cytotoxic exposurescausing regenerative proliferation ormitogenic influences, either of whichcould result in clonal expansion ofinitiated cells (Cohen and Ellwein,1990). An agent might interfere with theenzymes involved in DNA repair andrecombination (Barrett and Lee, 1992).Also, programmed cell death (apoptosis)can potentially be blocked by an agent,thereby permitting replication ofdamaged cells. For example, peroxisomeproliferators may act by suppressingapoptosis pathways (Shulte-Hermann etal., 1993; Bayly et al., 1994). An agentmay also generate reactive oxygenspecies that produce oxidative damageto DNA and other importantmacromolecules that become importantelements of the carcinogenic process(Kehrer, 1993; Clayson et al., 1994;Chang et al., 1988). Damage to certaincritical DNA repair genes or other genes(e.g., the p53 gene) may result ingenomic instability, which predisposescells to further genetic alterations andincreases the probability of neoplasticprogression independent of anyexogenous agent (Harris and Hollstein,1993; Levine, 1994).

The loss or gain of chromosomes (i.e.,aneuploidy) is an effect that can resultin genomic instability (Fearon andVogelstein, 1990; Cavenee et al., 1986).Although the relationship betweeninduced aneuploidy and carcinogenesisis not completely established, severalcarcinogens have been shown to induceaneuploidy (Gibson et al., 1995; Barrett,

1992). Agents that cause aneuploidyinterfere with the normal process ofchromosome segregation and lead tochromosomal losses, gains, oraberrations by interacting with theproteins (e.g., microtubules) needed forchromosome movement.

2.3.5.3. Nonmutagenic and OtherEffects. A failure to detect DNA damageand mutation induction in several testsystems suggests that a carcinogenicagent may act by another mode ofaction.

It is possible for an agent to alter geneexpression (transcriptional,translational, or post-translationalmodifications) by means not involvingmutations (Barrett, 1995). For example,perturbation of DNA methylationpatterns may cause effects thatcontribute to carcinogenesis (Jones,1986; Goodman and Counts, 1993;Holliday, 1987). Overexpression ofgenes by amplification has beenobserved in certain tumors (Vainio etal., 1992). Other mechanisms mayinvolve cellular reprogramming throughhormonal mechanisms or receptor-mediated mechanisms (Ashby et al.,1994; Barrett, 1992).

Gap-junctional intercellularcommunication is widely believed toplay a role in tissue and organdevelopment and in the maintenance ofa normal cellular phenotype withintissues. A growing body of evidencesuggests that chemical interference withgap-junctional intercellularcommunication is a contributing factorin tumor development; manycarcinogens have been shown to inhibitthis communication. Thus, suchinformation may provide usefulmechanistic data in evaluating cancerhazard (Swierenga and Yamasaki, 1992;Yamasaki, 1995).

Both cell death and cell proliferationare mandatory for the maintenance ofhomeostasis in normal tissue. Thebalance between the two directly affectsthe survival and growth of initiatedcells, as well as preneoplastic and tumorcell populations (i.e., increase in cellproliferation or decrease in cell death)(Bellamy et al., 1995; Cohen andEllwein, 1990, 1991; Cohen et al., 1991).In studies of proliferative effects,distinctions should be made betweenmitogenesis and regenerativeproliferation (Cohen and Ellwein, 1990,1991; Cohen et al., 1991). In applyinginformation from studies on cellproliferation and apoptosis to riskassessment, it is important to identifythe tissues and target cells involved, tomeasure effects in both normal andneoplastic tissue, to distinguish betweenapoptosis and necrosis, and to

determine the dose that affects theseprocesses.

2.3.5.4. Criteria for Judging Mode ofAction. Criteria that are applicable forjudging the adequacy of mechanisticallybased data include the following:

• mechanistic relevance of the data tocarcinogenicity,

• number of studies of each endpoint,• consistency of results in different

test systems and different species,• similar dose response relationships

for tumor and mode of action-relatedeffects,

• tests conducted in accordance withgenerally accepted protocols, and

• degree of consensus and generalacceptance among scientists regardinginterpretation of the significance andspecificity of the tests.

Although important information canbe gained from in vitro test systems, ahigher level of confidence is generallygiven to data that are derived from invivo systems, particularly those resultsthat show a site concordance with thetumor data.

2.4. Biomarker Information

Various endpoints can serve asbiological markers of events inbiological systems or samples. In somecases, these molecular or cellular effects(e.g., DNA or protein adducts, mutation,chromosomal aberrations, levels ofthyroid stimulating hormone) can bemeasured in blood, body fluids, cellsand tissues to serve as biomarkers ofexposure in both animals and humans(Callemen et al., 1978; Birner et al.,1990). As such, they can do thefollowing:

• act as an internal surrogate measureof chemical dose, representing asappropriate, either recent (e.g., serumconcentration) or accumulated (e.g.,hemoglobin adducts) exposure,

• help identify doses at whichelements of the carcinogenic process areoperating,

• aid in interspecies extrapolationswhen data are available from bothexperimental animal and human cells,and

• under certain circumstances,provide insights into the possible shapeof the dose response curve below levelswhere tumor incidences are observed(e.g., Choy, 1993).

Genetic and other findings (likechanges in proto-oncogenes and tumorsuppressor genes in preneoplastic andneoplastic tissue or possibly measuresof endocrine disruption) can indicatethe potential for disease and as suchserve as biomarkers of effect. They, too,can be used in different ways:

• The spectrum of genetic changes inproliferative lesions and tumors


following chemical administration toexperimental animals can bedetermined and compared with those inspontaneous tumors in control animals,in animals exposed to other agents ofvarying structural and functionalactivities, and in persons exposed to theagent under study.

• They may provide a linkage totumor response.

• They may help to identifysubpopulations of individuals who maybe at an elevated risk for cancer, e.g.,cytochrome P450 2D6/debrisoquinesensitivity for lung cancer (Caporaso etal., 1989) or inherited colon cancersyndromes (Kinzler et al., 1991;Peltomaki et al., 1993).

• As with biomarkers of exposure, itmay be justified in some cases to usethese endpoints for dose responseassessment or to provide insight into thepotential shape of the dose responsecurve at doses below those at whichtumors are induced experimentally.

In applying biomarker data to cancerassessment (particularly assessmentsbased on epidemiologic data), oneshould consider the following:

• routes of exposure• exposure to mixtures• time after exposure• sensitivity and specificity of

biomarkers• dose response relationships.

2.5. Mode of Action—Implications forHazard Characterization and DoseResponse

The interaction of the biology of theorganism and the chemical properties ofthe agent determine whether there is anadverse effect. Thus, mode of actionanalysis is based on physical, chemical,and biological information that helps toexplain critical events in an agent’sinfluence on development of tumors.The entire range of informationdeveloped in the assessment is reviewedto arrive at a reasoned judgment. Anagent may work by more than one modeof action both at different sites and atthe same tumor site. It is felt that at leastsome information bearing on mode ofaction (e.g., SAR, screening tests formutagenicity) is present for most agentsundergoing assessment ofcarcinogenicity, even though certaintyabout exact molecular mechanisms maybe rare.

Inputs to mode of action analysisinclude tumor data in humans, animals,and among structural analogues as wellas the other key data. The morecomplete the data package and genericknowledge about a given mode ofaction, the more confidence one has andthe more one can replace or refinedefault science policy positions with

relevant information. Making reasonedjudgments is generally based on a data-rich source of chemical, chemical class,and tumor type-specific information.Many times there will be conflictingdata and gaps in the information base;one must carefully evaluate theseuncertainties before reaching anyconclusion.

Some of the questions that need to beaddressed include the following:

• Has a body of data been developedon the agent that fits with a generallyaccepted mode of action?

• Has the mode of action beenpublished and gained general scientificacceptance through peer-reviewedresearch or is it still speculative?

• Is the mode of action consistentwith generally agreed-upon principlesand understanding of carcinogenesis?

• Is the mode of action reasonablyanticipated or assumed, in the absenceof specific data, to operate in humans?How is this question influenced byinformation on comparative uptake,metabolism, and excretion patternsacross animals and humans?

• Do humans appear to be more orless sensitive to the mode of action thanare animals?

• Does the agent affect DNA, directlyor indirectly?

• Are there important determinants incarcinogenicity other than effects onDNA, such as changes in cellproliferation, apoptosis, geneexpression, immune surveillance, orother influences?

In making decisions about potentialmodes of action and the relevance ofanimal tumor findings to humans(Ashby et al., 1990), very often theresults of chronic animal studies maygive important clues. Some of theimportant factors to review include thefollowing:

• tumor types, e.g., those responsiveto endocrine influence, those producedby reactive carcinogens (Ashby andTennant, 1991),

• number of tumor sites, sexes,studies, and species affected orunaffected (Tennant, 1993),

• influence of route of exposure;spectrum of tumors; local or systemicsites,

• target organ or system toxicity, e.g.,urinary chemical changes associatedwith stone formation, effects on immunesurveillance,

• presence of proliferative lesions,e.g., hepatic foci, hyperplasias,

• progression of lesions frompreneoplastic to benign to malignantwith dose and time,

• ratio of malignant to benign tumorsas a function of dose and time,

• time of appearance of tumors aftercommencing exposure,

• tumors invading locally,metastasizing, producing death,

• tumors at sites in laboratoryanimals with high or low spontaneoushistorical incidence,

• biomarkers in tumor cells, bothinduced and spontaneous, e.g., DNA orprotein adducts, mutation spectra,chromosome changes, oncogeneactivation, and

• shape of the dose response in therange of tumor observation, e.g., linearvs. profound change in slope.

Some of the myriad of ways thatinformation from chronic animal studiesinfluences mode of action judgmentsinclude the following. Multisite andmultispecies tumor effects are oftenassociated with mutagenic agents.Tumors restricted to one sex/speciesmay suggest an influence restricted togender, strain, or species. Late onset oftumors that are primarily benign or areat sites with a high historicalbackground incidence or show reversalof lesions on cessation of exposure maypoint to a growth-promoting mode ofaction. The possibility that an agent mayact differently in different tissues orhave more than one mode of action ina single tissue must also be kept inmind.

Simple knowledge of sites of tumorincrease in rodent studies can givepreliminary clues as to mode of action.Experience at the National ToxicologyProgram (NTP) indicates that substancesthat are DNA reactive and produce genemutations may be unique in producingtumors in certain anatomical sites,while tumors at other sites may arisefrom both mutagenic or nonmutagenicinfluences (Ashby and Tennant, 1991;Huff et al., 1991).

Effects on tumor sites in rodents andother mode of action information hasbeen explored for certain agents (Alisonet al., 1994; Clayson, 1989; ECETOC,1991; MacDonald et al., 1994; McClain,1994; Tischer et al., 1991; ILSI, 1995;Cohen and Ellwein, 1991; FASEB, 1994;Havu et al., 1990; U.S. EPA, 1991; Li etal., 1987; Grasso and Hinton, 1991;Larson et al., 1994; IARC, 1990; Jack etal., 1983; Stitzel et al., 1989; Ingram andGrasso, 1991; Bus and Popp, 1987;Prahalada et al., 1994; Yamada et al.,1994; Hill et al., 1989; Burek et al.,1988).

The selection of a dose responseextrapolation procedure for cancer riskestimation considers mode of actioninformation. When information isextensive and there is considerablecertainty in a given mode of action, abiologically based or case-specificmodel that incorporates data onprocesses involved is preferred.Obviously, use of such a model requires


the existence of substantial data oncomponent parameters of the mode ofaction, and judgments on itsapplicability must be made on a case-by-case basis.

In the absence of information todevelop a biologically based or case-specific model, understanding of modeof action should be employed to theextent possible in deciding upon one ofthree science policy defaults: Low-doselinear extrapolation, nonlinear, and bothprocedures. The overall choice of thedefault(s) depends upon weighing thevarious inputs and deciding which bestreflect the mode of actionunderstanding. A rationale accompanieswhichever default or defaults arechosen.

A default assumption of linearity isappropriate when the evidence supportsa mode of action of gene mutation dueto DNA reactivity or supports anothermode of action that is anticipated to belinear. Other elements of empirical datamay also support an inference oflinearity, e.g., the background of humanexposure to an agent might be such thatadded human exposure is on the linearpart of a dose response curve that issublinear overall. The defaultassumption of linearity is alsoappropriate as the ultimate defaultwhen evidence shows no DNAreactivity or other support for linearity,but neither is it sufficient evidence of anonlinear mode of action to support anonlinear procedure.

A default assumption of nonlinearityis appropriate when there is noevidence for linearity and sufficientevidence to support an assumption ofnonlinearity and a nonlinear procedure.The mode of action may lead to a doseresponse relationship that is nonlinear,with response falling much morequickly than linearly with dose, or beingmost influenced by individualdifferences in sensitivity. Alternatively,the mode of action may theoreticallyhave a threshold, e.g., thecarcinogenicity may be a secondary

effect of toxicity that is itself a thresholdphenomenon.

Both linear and nonlinear proceduresmay be used in particular cases. If amode of action analysis findssubstantial support for differing modesof action for different tumor sites, anappropriate procedure is used for each.Both procedures may also beappropriate to discuss implications ofcomplex dose response relationships.For example, if it is apparent that anagent is both DNA reactive and is highlyactive as a promotor at high doses, andthere are insufficient data for modeling,both linear and nonlinear defaultprocedures may be needed to decoupleand consider the contribution of bothphenomena.

2.6. Weight of Evidence Evaluation forPotential Human Carcinogenicity

A weight of evidence evaluation is acollective evaluation of all pertinentinformation so that the full impact ofbiological plausibility and coherence areadequately considered. Identificationand characterization of humancarcinogenicity is based on human andexperimental data, the nature,advantages and limitations of whichhave been discussed in the precedingsections.

The subsequent sections outline: (1)the basics of weighing individual linesof evidence and combining the entirebody of evidence to make an informedjudgment, (2) classification descriptorsof cancer hazard, and (3) some casestudy examples to illustrate how theprinciples of guidance can be applied toarrive at a classification.

2.6.1. Weight of Evidence Analysis

Judgment about the weight ofevidence involves considerations of thequality and adequacy of data andconsistency of responses induced by theagent in question. The weight ofevidence judgment requires combinedinput of relevant disciplines. Initialviews of one kind of evidence may

change significantly when otherinformation is brought to theinterpretation. For example, a positiveanimal carcinogenicity finding may bediminished by other key data; a weakassociation in epidemiologic studiesmay be bolstered by consideration ofother key data and animal findings.Factors typically considered areillustrated in figures below. Generally,no single weighing factor on either sidedetermines the overall weight. Thefactors are not scored mechanically byadding pluses and minuses; they arejudged in combination.

Human Evidence. Analyzing thecontribution of evidence from a body ofhuman data requires examiningavailable studies and weighing them inthe context of well-accepted criteria forcausation (see section 2.2.1). Ajudgment is made about how closelythey satisfy these criteria, individuallyand jointly, and how far they deviatefrom them. Existence of temporalrelationships, consistent results inindependent studies, strong association,reliable exposure data, presence of dose-related responses, freedom from biasesand confounding factors, and high levelof statistical significance are among thefactors leading to increased confidencein a conclusion of causality.

Generally, the weight of humanevidence increases with the number ofadequate studies that show comparableresults on populations exposed to thesame agent under different conditions.The analysis takes into account allstudies of high quality, whethershowing positive associations or nullresults, or even protective effects. Inweighing positive studies against nullstudies, possible reasons forinconsistent results should be sought,and results of studies that are judged tobe of high quality are given more weightthan those from studies judged to bemethodologically less sound. See figure2–1.BILLING CODE 6560–50–P


Generally, no single factor isdeterminative. For example, the strengthof association is one of the causalcriteria. A strong association (i.e., a largerelatively risk) is more likely to indicatecausality than a weak association.However, finding of a large excess riskin a single study must be balancedagainst the lack of consistency asreflected by null results from otherequally well designed and wellconducted studies. In this situation, thepositive association of a single study

may either suggest the presence ofchance, bias or confounding, or reflectdifferent exposure conditions. On theother hand, evidence of weak butconsistent associations across severalstudies suggests either causality or thesame confounder may be operating inall of these studies.

Animal Evidence. Evidence fromlong-term or other carcinogenicitystudies in laboratory animals constitutesthe second major class of informationbearing on carcinogenicity. See figure 2–

2. As discussed in section 2.2.2., eachrelevant study must be reviewed andevaluated as to its adequacy of designand conduct as well as the statisticalsignificance and biological relevance ofits findings. Factors that usuallyincrease confidence in the predictivityof animal findings are those of (1)multiplicity of observations inindependent studies; (2) severity oflesions, latency, and lesion progression;(3) consistency in observations.


Other Key Evidence. Additionalinformation bearing on the qualitativeassessment of carcinogenic potentialmay be gained from comparativepharmacokinetic and metabolismstudies, genetic toxicity studies, SAR

analysis, and other studies of an agent’sproperties. See figure 2–3. Informationfrom these studies helps to elucidatepotential modes of action and biologicalfate and disposition. The knowledgegained supports interpretation of cancer

studies in humans and animals andprovides a separate source ofinformation about carcinogenicpotential.


Totality of Evidence. In reaching aview of the entire weight of evidence,all data and inferences are merged.Figure 2–4 indicates the generalities. In

fact, possible weights of evidence spana broad continuum that cannot becapsulized. Most of the time the data invarious lines of evidence fall in the

middle of the weights represented in thefour figures in this section.



The following section and the weightof evidence narrative discussed in 2.7.2.provide a way to state a conclusion andcapture this complexity in a consistentway.

2.6.2. Descriptors for Classifying Weightof Evidence

Hazard classification uses threecategories of descriptors for humancarcinogenic potential: ‘‘known/likely,’’‘‘cannot be determined,’’ and ‘‘notlikely.’’ Each category has associatedsubdescriptors to further define theconclusion. The descriptors are notmeant to replace an explanation of thenuances of the biological evidence, butrather to summarize it. Each categoryspans a wide variety of potential datasets and weights of evidence. There willalways be gray areas, gradations, andborderline cases. That is why thedescriptors are presented only in thecontext of a weight of evidence narrativewhose format is given in section 2.7.2.Using them within a narrative preservesand presents the complexity that is anessential part of the hazardclassification. Applying a descriptor is amatter of judgment and cannot bereduced to a formula. Risk managersshould consider the entire range ofinformation included in the narrativerather than focusing simply on thedescriptor.

A single agent may be categorized inmore than one way if, for instance, theagent is likely to be carcinogenic by oneroute of exposure but not by another(section 2.3.3).

The descriptors and subdescriptorsare standardized and are to be usedconsistently from case to case. Thediscussions below explain descriptorsand subdescriptors which appear initalics, and along with Appendix A andsection 2.6.3, illustrate their use.

‘‘Known/Likely’’

This category of descriptors isappropriate when the available tumoreffects and other key data are adequateto convincingly demonstratecarcinogenic potential for humans; itincludes:

• Agents known to be carcinogenic inhumans based on either epidemiologicevidence or a combination ofepidemiologic and experimentalevidence, demonstrating causalitybetween human exposure and cancer,

• Agents that should be treated as ifthey were known human carcinogens,based on a combination ofepidemiologic data showing a plausiblecausal association (not demonstrating itdefinitively) and strong experimentalevidence.

• Agents that are likely to producecancer in humans due to the productionor anticipated production of tumors bymodes of action that are relevant orassumed to be relevant to humancarcinogenicity.

Modifying descriptors for particularlyhigh or low ranking in the ‘‘known/likely’’ group can be applied based onscientific judgment and experience andare as follows:

• Agents that are likely to producecancer in humans based on data that are

at the high end of the weights ofevidence typical of this group,

• Agents that are likely to producecancer in humans based on data that areat the low end of the weights ofevidence typical of this group.

‘‘Cannot Be Determined’’

This category of descriptors isappropriate when available tumoreffects or other key data are suggestiveor conflicting or limited in quantity and,thus, are not adequate to convincinglydemonstrate carcinogenic potential forhumans. In general, further agentspecific and generic research and testingare needed to be able to describe humancarcinogenic potential. The descriptorcannot be determined is used with asubdescriptor that captures therationale:

• Agents whose carcinogenicpotential cannot be determined, but forwhich there is suggestive evidence thatraises concern for carcinogenic effects,

• Agents whose carcinogenicpotential cannot be determined becausethe existing evidence is composed ofconflicting data (e.g., some evidence issuggestive of carcinogenic effects, butother equally pertinent evidence doesnot confirm any concern),

• Agents whose carcinogenicpotential cannot be determined becausethere are inadequate data to perform anassessment,

• Agents whose carcinogenicpotential cannot be determined becauseno data are available to perform anassessment.


‘‘Not Likely’’

This is the appropriate descriptorwhen experimental evidence issatisfactory for deciding that there is nobasis for human hazard concern, asfollows (in the absence of human datasuggesting a potential for cancer effects):

• Agents not likely to be carcinogenicto humans because they have beenevaluated in at least two well conductedstudies in two appropriate animalspecies without demonstratingcarcinogenic effects,

• Agents not likely to be carcinogenicto humans because they have beenappropriately evaluated in animals andshow only carcinogenic effects that havebeen shown not to be relevant tohumans (e.g., showing only effects inthe male rat kidney due to accumulationof alpha2u-globulin),

• Agents not likely to be carcinogenicto humans when carcinogenicity is doseor route dependent. For instance, notlikely below a certain dose range(categorized as likely above that range)or not likely by a certain route ofexposure (may be categorized as likelyby another route of exposure). Toqualify, agents will have beenappropriately evaluated in animalstudies and the only effects show a doserange or route limitation or a routelimitation is otherwise shown byempirical data.

• Agents not likely to be carcinogenicto humans based on extensive humanexperience that demonstrates lack ofeffect (e.g., phenobarbital).

2.6.3. Case Study Examples

This section provides examples ofsubstances that fit the three broadcategories described above. Theseexamples are based on availableinformation about real substances andare selected to illustrate the principlesfor weight-of-evidence evaluation andthe application of the classificationscheme.

These case studies show the interplayof differing lines of evidence in makinga conclusion. Some particularlyillustrate the role that ‘‘other key data’’can play in conclusions.Example 1: ‘‘Known Human Carcinogen’’—Route-Dependent/Linear Extrapolation

Human Data

Substance 1 is an aluminosilicate mineralthat exists in nature with a fibrous habit.Several descriptive epidemiologic studieshave demonstrated very high mortality frommalignant mesothelioma, mainly of thepleura, in three villages in Turkey, wherethere was a contamination of this mineraland where exposure had occurred from birth.Both sexes were equally affected and at anunusually young age.

Animal DataSubstance 1 has been studied in a single

long-term inhalation study in rats at oneexposure concentration that showed anextremely high incidence of pleuralmesothelioma (98% in treated animals versus0% in concurrent controls). This is a raremalignant tumor in the rat and the onset oftumors occurred at a very early age (as earlyas 1 year of age). Several studies involvinginjection into the body cavities of rats ormice (i.e., pleural or peritoneal cavities) alsoproduced high incidences of pleural orperitoneal mesotheliomas. No information isavailable on the carcinogenic potential ofsubstance 1 in laboratory animals via oraland dermal exposures.

Other Key DataInformation on the physical and chemical

properties of substance 1 indicates that it ishighly respirable to humans and laboratoryrodents. It is highly insoluble and is notlikely to be readily degraded in biologicalfluid.

No information is available on thedeposition, translocation, retention, lungclearance, and excretion of the substanceafter inhalation exposure or ingestion. Lungburden studies have shown the presence ofelevated levels of the substance in lung tissuesamples of human cases of pleuralmesotheliomas from contaminated villagescompared with control villages.

No data are available on genetic or relatedeffects in humans. The substance has beenshown to induce unscheduled DNA synthesisin human cells in vitro and transformationand unscheduled DNA synthesis in mousecells.

The mechanisms by which this substancecauses cancer in humans and animals are notunderstood, but appear to be related to itsunique physical, chemical, and surfaceproperties. Its fiber morphology is similar toa known group of naturally occurring silicateminerals that have been known to causerespiratory cancers (including pleuralmesothelioma) from inhalation exposure andgenetic changes in humans.

Evaluation

Human evidence is judged to establish acausal link between exposure to substance 1and human cancer. Even though the humanevidence does not satisfy all criteria forcausality, this judgment is based on a numberof unusual observations: large magnitude ofthe association, specificity of the association,demonstration of environmental exposure,biological plausibility, and coherence basedon the entire body of knowledge of theetiology of mesothelioma.

Animal evidence demonstrates a causalrelationship between exposure and cancer inlaboratory animals. Although available dataare not optimal in terms of design (e.g., theuse of single dose, one sex only), thejudgment is based on the unusual findingsfrom the only inhalation experiment in rats(i.e., induction of an uncommon tumor, anextremely high incidence of malignantneoplasms, and onset of tumors at an earlyage). Additional evidence is provided byconsistent results from several injectionstudies showing an induction of the same

tumors by different modes of administrationin more than one species.

Other key data, while limited, support thehuman and animal evidence ofcarcinogenicity. It can be inferred fromhuman and animal data that this substanceis readily deposited in the respiratoryairways and deep lung and is retained forextended periods of time since first exposure.Information on related fibrous substancesindicates that the modes of action are likelymediated by the physical and chemicalcharacteristics of the substance (e.g., fibershape, high aspect ratio, a high degree ofinsolubility in lung tissues).

Insufficient data are available to evaluatethe human carcinogenic potential ofsubstance 1 by oral exposure. Even thoughthere is no information on its carcinogenicpotential via dermal uptake, it is notexpected to pose a carcinogenic hazard tohumans by that route because it is veryinsoluble and is not likely to penetrate theskin.

Conclusion

It is concluded that substance 1 is a knownhuman carcinogen by inhalation exposure.The weight of evidence of humancarcinogenicity is based on (a) exceptionallyincreased incidence of malignantmesothelioma in epidemiologic studies ofenvironmentally exposed humanpopulations; (b) significantly increasedincidence of malignant mesothelioma in asingle inhalation study in rats and in severalinjection studies in rats and mice; and (c)supporting information on related fibroussubstances that are known to cause cancervia inhalation and genetic damage in exposedmammalian and human mesothelial cells.The human carcinogenic potential ofsubstance 1 via oral exposure cannot bedetermined on the basis of insufficient data.It is not likely to pose a carcinogenic hazardto humans via dermal uptake because it isnot anticipated to penetrate the skin.

The mode of action of this substance is notunderstood. In addition to this uncertainty,dose response information is lacking for bothhuman and animal data. Epidemiologicstudies contain observations of significantexcess cancer risks at relatively low levels ofenvironmental exposure. The use of linearextrapolation in a dose response relationshipassessment is appropriate as a default sincemode of action data are not available.

Example 2: ‘‘As If Known HumanCarcinogen’’—Any Exposure Conditions/Linear Extrapolation

Human Data

Substance 2 is an alkene oxide. Severalcohort studies of workers using substance 2as a sterilant have been conducted. In thelargest and most informative study, mortalityfrom lymphatic and hematopoietic cancerwas marginally elevated, but a significanttrend was found, especially for lymphaticleukemia and non-Hodgkin’s lymphoma, inrelation to estimated cumulative exposure tothe substance. Nonsignificant excesses oflymphatic and hematopoietic cancer were


found in three other smaller studies ofsterilization personnel.

In one cohort study of chemical workersexposed to substance 2 and other agents,mortality rate from lymphatic andhematopoietic cancer was elevated, but theexcess was confined to a small subgroup withonly occasional low-level exposure tosubstance 2. Six other studies of chemicalworkers are considered more limited due toa smaller number of deaths. Four studiesfound an excess of lymphatic andhematopoietic cancer (which were significantin two); no increase in mortality rate wasobserved in the other two studies.

Animal DataSubstance 2 was studied in an oral gavage

study in rats. Treatment of substance 2resulted in a dose-dependent increasedincidence in forestomach tumors that weremainly squamous-cell carcinomas.

Substance 2 was also studied in twoinhalation studies in mice and two inhalationstudies in rats. In the first mouse study, dose-dependent increases in combined benign andmalignant tumors at several tissue sites wereinduced in mice of both sexes (lung tumorsand tumors of the Harderian gland in eachsex, and uterine adenocarcinomas, mammarycarcinomas, and malignant lymphomas infemales). In a second study—a screeningstudy for pulmonary tumors in mice—inhalation exposure to substance 2 resultedin a dose-dependent increase in lung tumors.In the two inhalation studies in rats,increased incidences of mononuclear-cellleukemia and brain tumors were induced inexposed animals of each sex; increasedincidences of peritoneal tumors in the regionof the testis and subcutaneous fibromas wereinduced in exposed male rats.

Substance 2 induced local sarcomas inmice following subcutaneous injection. Notumors were found in a limited skin paintingstudy in mice.

Other Key Data

Substance 2 is a flammable gas at roomtemperature. The gaseous form is readilytaken up in humans and rats, and in aqueoussolution it can penetrate human skin. Studiesin rats indicate that, once absorbed,substance 2 is uniformly distributedthroughout the body. It is eliminatedmetabolically by hydrolysis and byconjugation with glutathione. The ability toform glutathione conjugate varies acrossanimal species, with the rat being mostactive, followed by mice and rabbits.

Substance 2 is a directly acting alkylatingagent. It has been shown to form adductswith hemoglobin in both humans andanimals and with DNA in animals. Theincreased frequency of hemoglobin adducts,which have been used as markers of internaldose, has been found to correlate with thelevel and cumulative exposure to substance2. Significant increases in chromosomalaberrations and sister chromatid exchangesin peripheral lymphocytes and induction ofmicronuclei in the bone marrow cells havebeen observed in exposed workers.

Substance 2 also induced chromosomalaberrations and sister chromatid exchangesin peripheral lymphocytes of monkeys

exposed in vivo. It also induced genemutation, specific locus mutation, sisterchromatid exchanges, chromosomalaberrations, micronuclei, dominant lethalmutations, and heritable translocation inrodents exposed in vivo. In human cells invitro, it induced sister chromatid exchanges,chromosomal aberrations, and unscheduledDNA synthesis. Similar genetic and relatedeffects were observed in rodent cells in vitroand in nonmammalian systems.

Evaluation

Available epidemiologic studies, takentogether, suggest that a causal associationbetween exposure to substance 2 andelevated risk of cancer is plausible. Thisjudgment is based on small but consistentexcesses of lymphatic and hematopoieticcancer in the studies of sterilization workers.Interpretation of studies of chemical workersis difficult because of possible confoundingexposures. Nevertheless, findings of elevatedrisks of cancer at similar sites in chemicalworkers support the findings in studies ofsterilization workers. Additional support isprovided by observations of DNA damage inthe same tissue in which elevated cancer wasseen in exposed workers.

Extensive evidence indicates thatsubstance 2 is carcinogenic to laboratoryanimals. Positive results were consistentlyobserved in all well-designed and well-conducted studies. Substance 2 causes dose-related increased incidences of tumors atmultiple tissue sites in rats and mice of bothsexes by two routes of exposure (oral andinhalation). The only dermal study thatyielded a nonpositive finding is consideredof limited quality.

Other key data significantly add support tothe potential carcinogenicity of substance 2.There is strong evidence of heritablemutations of exposed rodents andmutagenicity and clastogenicity both in vivoand in vitro. These findings are reinforced byobservations of similar genetic damage inexposed workers. Additional support isbased on SAR analysis that indicates thatsubstance 2 is a highly DNA-reactive agent.Structurally related chemicals, i.e., low-molecular-weight epoxides, also exhibitcarcinogenic effects in laboratory animals.

Conclusion

Substance 2 should be considered as if itwere a known human carcinogen by allroutes of exposure. The weight of evidenceof human carcinogenicity is based on (a)consistent evidence of carcinogenicity in ratsand mice by oral and inhalation exposure; (b)epidemiologic evidence suggestive of acausal association between exposure andelevated risk of lymphatic and hematopoieticcancer; (c) evidence of genetic damage inblood lymphocytes and bone marrow cells ofexposed workers; (d) mutagenic effects innumerous in vivo and in vitro test systems;(e) membership in a class of DNA-reactivecompounds that have been shown to causecarcinogenic and mutagenic effects inanimals; and (f) ability to be absorbed by allroutes of exposure, followed by rapiddistribution throughout the body.

Although the exact mechanisms ofcarcinogenic action of substance 2 are not

completely understood, available datastrongly indicate a mutagenic mode of action.Linear extrapolation should be assumed indose response assessment.Example 3: ‘‘Likely Human Carcinogen’’—Any Exposure Conditions/LinearExtrapolation

Human DataSubstance 3 is a brominated alkane. Three

studies have investigated the cancermortality of workers exposed to thissubstance. No statistically significantincrease in cancer at any site was found ina study of production workers exposed tosubstance 3 and several other chemicals.Elevated cancer mortality was reported in amuch smaller study of production workers.An excess of lymphoma was reported ingrain workers who may have had exposure tosubstance 3 and other chemical compounds.These studies are considered inadequate dueto their small cohort size; lack of, or poorlycharacterized, exposure concentrations; orconcurrent exposure of the cohort to otherpotential or known carcinogens.

Animal DataThe potential carcinogenicity of substance

3 has been extensively studied in an oralgavage study in rats and mice of both sexes,two inhalation studies of rats of differentstrains of both sexes, an inhalation study inmice of both sexes, and a skin painting studyin female mice.

In the oral study, increased incidences ofsquamous-cell carcinoma of the forestomachwere found in rats and mice of both sexes.Additionally, there were increasedincidences of liver carcinomas in female rats,hemangiosarcomas in male rats, and alveolar/bronchiolar adenoma of the lung of male andfemale mice. Excessive toxicity and mortalitywere observed in the rat study, especially inthe high-dose groups, which resulted in earlytermination of study, and similar time-weighted average doses for the high- andlow-treatment groups.

In the first inhalation study in rats andmice, increased incidences of carcinomasand adenocarcinomas of the nasal cavity andhemangiosarcoma of the spleen were foundin exposed animals of each species of bothsexes. Treated female rats also showedincreased incidences of alveolar/bronchiolarcarcinoma of the lung and mammary glandfibroadenomas. Treated male rats showed anincreased incidence of peritonealmesothelioma. In the second inhalation studyin rats (single exposure only), significantlyincreased incidences of hemangiosarcoma ofthe spleen and adrenal gland tumors wereseen in exposed animals of both sexes.Additionally, increased incidences ofsubcutaneous mesenchymal tumors andmammary gland tumors were induced inexposed male and female rats, respectively.

Lifetime dermal application of substance 3to female mice resulted in significantlyincreased incidences of skin papillomas andlung tumors.

Several chemicals structurally related tosubstance 3 are also carcinogenic in rodents.The spectrum of tumor responses induced byrelated substances was similar to those seenwith substance 3 (e.g., forestomach,mammary gland, lung tumors).


Other Key DataSubstance 3 exists as a liquid at room

temperature and is readily absorbed byingestion, inhalation, and dermal contact. Itis widely distributed in the body and iseliminated in the urine mainly as metabolites(e.g., glutathione conjugate).

Substance 3 is not itself DNA-reactive, butis biotransformed to reactive metabolites asinferred by findings of its covalent binding toDNA and induction of DNA strand breaks,both in vivo and in vitro. Substance 3 hasbeen shown to induce sister chromatidexchanges, mutations, and unscheduled DNAsynthesis in human and rodent cells in vitro.Reverse and forward mutations have beenconsistently produced in bacterial assays andin vitro assays using eukaryotic cells.Substance 3, however, did not inducedominant lethal mutations in mice or rats, orchromosomal aberrations or micronuclei inbone marrow cells of mice treated in vivo.

EvaluationAvailable epidemiologic data are

considered inadequate for an evaluation of acausal association of exposure to thesubstance and excess of cancer mortality dueto major study limitations.

There is extensive evidence that substance3 is carcinogenic in laboratory animals.Increased incidences of tumors at multiplesites have been observed in multiple studiesin two species of both sexes with differentroutes of exposure. It induces tumors both atthe site of entry (e.g., nasal tumors viainhalation, forestomach tumors by ingestion,skin tumor with dermal exposure) and atdistal sites (e.g., mammary gland tumors).Additionally, it induced tumors at the samesites in both species and sexes via differentroutes of exposure (e.g., lung tumors). Withthe exception of the oral study in which theemployed doses caused excessive toxicityand mortality, the other studies areconsidered adequately designed and wellconducted. Overall, given the magnitude andextent of animal carcinogenic responses tosubstance 3, coupled with similar responsesto structurally related substances, theseanimal findings are judged to be highlyrelevant and predictive of human responses.

Other key data, while not very extensive,are judged to be supportive of carcinogenicpotential. Substance 3 has consistently beenshown to be mutagenic in mammalian cells,including human cells, and nonmammaliancells; thus, mutation is likely a mode ofaction for its carcinogenic activity. However,the possible involvement of other modes ofaction has not been fully investigated.Furthermore, induction of genetic changesfrom in vivo exposure to substance 3 has notbeen demonstrated.

Conclusion

Substance 3 is likely to be a humancarcinogen by any route of exposure. Incomparison with other agents designated aslikely human carcinogens, the overall weightof evidence for substance 3 puts it at the highend of the grouping.

The weight of evidence of humancarcinogenicity is based on animal evidenceand other key evidence. Human data areinadequate for an evaluation of human

carcinogenicity. The overall weight ofevidence is based on (a) extensive animalevidence showing induction of increases oftumors at multiple sites in both sexes of tworodent species via three routes ofadministration relevant to human exposure;(b) tumor data of structural analoguesexhibiting similar patterns of tumors intreated rodents; (c) in vitro evidence formutagenic effects in mammalian cells andnonmammalian systems; and (d) its ability tobe absorbed by all routes of exposurefollowed by rapid distribution throughout thebody.

Some uncertainties are associated with themechanisms of carcinogenicity of substance3. Although there is considerable evidenceindicating that mutagenic events couldaccount for carcinogenic effects, there is stilla lack of adequate information on themutagenicity of substance 3 in vivo inanimals or humans. Moreover, alternativemodes of action have not been explored.Nonetheless, available data indicate a likelymutagenic mode of action. Linearextrapolation should be assumed in doseresponse assessment.Example 4: ‘‘Likely Human Carcinogen’’—AllRoutes/Linear and Nonlinear Extrapolation

Human DataSubstance 4 is a chlorinated alkene

solvent. Several cohort studies of drycleaning and laundry workers exposed tosubstance 4 and other solvents reportedsignificant excesses of mortality due tocancers of the lung, cervix, esophagus,kidney, bladder, lymphatic andhematopoietic system, colon, or skin. Nosignificant cancer risks were observed in asubcohort of one these investigations of drycleaning workers exposed mainly tosubstance 4. Possible confounding factorssuch as smoking, alcohol consumption, orlow socioeconomic status were notconsidered in the analyses of these studies.

A large case-control study of bladdercancer did not show any clear associationwith dry cleaning. Several case-controlstudies of liver cancer identified an increasedrisk of liver cancer with occupationalexposure to organic solvents. The specificsolvents to which workers were exposed andexposure levels were not identified.

Animal Data

The potential carcinogenicity of substance4 has been investigated in two long-termstudies in rats and mice of both sexes by oraladministration and inhalation.

Significant increases in hepatocellularcarcinomas were induced in mice of bothsexes treated with substance 4 by oral gavage.No increases in tumor incidence wereobserved in treated rats. Limitations in bothexperiments included control groups smallerthan treated groups, numerous doseadjustments during the study, and earlymortality due to treatment-relatednephropathy.

In the inhalation study, there weresignificantly increased incidences ofhepatocellular adenoma and carcinoma inexposed mice of both sexes. In rats of bothsexes, there were marginally significantincreased incidences of mononuclear cell

leukemia (MCL) when compared withconcurrent controls. The incidences of MCLin control animals, however, were higherthan historical controls from the conductinglaboratory. The tumor finding was alsojudged to be biologically significant becausethe time to onset of tumor was decreased andthe disease was more severe in treated thanin control animals. Low incidences of renaltubular cell adenomas or adenocarcinomaswere also observed in exposed male rats. Thetumor incidences were not statisticallysignificant but there was a significant trend.

Other Key Data

Substance 4 has been shown to be readilyand rapidly absorbed by inhalation andingestion in humans and laboratory animals.Absorption by dermal exposure is slow andlimited. Once absorbed, substance 4 isprimarily distributed to and accumulated inadipose tissue and the brain, kidney, andliver. A large percentage of substance 4 iseliminated unchanged in exhaled air, withurinary excretion of metabolites comprising amuch smaller percentage. The absorption anddistribution profiles of substance 4 aresimilar across species including humans.

Two major metabolites (trichloroacetic acid(TCA), and trichloroethanol), which areformed by a P–450-dependent mixed-function oxidase enzyme system, have beenidentified in all studied species, includinghumans. There is suggestive evidence for theformation of an epoxide intermediate basedon the detection of two other metabolites(oxalic acid and trichloroacetyl amide). Inaddition to oxidative metabolism, substance4 also undergoes conjugation withglutathione. Further metabolism by renalbeta-lyases could lead to two minor activemetabolites (trichlorovinyl thiol anddichlorothiokente).

Toxicokinetic studies have shown that theenzymes responsible for the metabolism ofsubstance 4 can be saturated at highexposures. The glutathione pathway wasfound to be a minor pathway at low doses,but more prevalent following saturation ofthe cytochrome P–450 pathway. Comparativein vitro studies indicate that mice have thegreater capacity to metabolize to TCA thanrats and humans. Inhalation studies alsoindicate saturation of oxidative metabolismof substance 4, which occurs at higher doselevels in mice than in rats and humans.Based on these findings, it has beenpostulated that the species differences in thecarcinogenicity of substance 4 between ratsand mice may be related to the differences inthe metabolism to TCA and glutathioneconjugates.

Substance 4 is a member of the class ofchlorinated organics that often cause liverand kidney toxicity and carcinogenesis inrodents. Like many chlorinated organics,substance 4 itself does not appear to bemutagenic. Substance 4 was generallynegative in in vitro bacterial systems and invivo mammalian systems. However, a minormetabolite formed in the kidney by theglutathione conjugation pathway has beenfound to be a strong mutagen.

The mechanisms of induced carcinogeniceffects of substance 4 in rats and mice are notcompletely understood. It has been


postulated that mouse liver carcinogenesis isrelated to liver peroxisomal proliferation andtoxicity of the metabolite TCA. Informationon whether or not TCA induces peroxisomalproliferation in humans is not definitive. Theinduced renal tumors in male rats may berelated either to kidney toxicity or theactivity of a mutagenic metabolite. Themechanisms of increases in MCL in rats arenot known.

Evaluation

Available epidemiologic studies, takentogether, provide suggestive evidence of apossible causal association between exposureto substance 4 and cancer incidence in thelaundry and dry cleaning industries. This isbased on consistent findings of elevatedcancer risks in several studies of differentpopulations of dry cleaning and laundryworkers. However, each individual study iscompromised by a number of studydeficiencies including small numbers ofcancers, confounding exposure to othersolvents, and poor exposure characterization.Others may interpret these findingscollectively as inconclusive.

There is considerable evidence thatsubstance 4 is carcinogenic to laboratoryanimals. It induces tumors in mice of bothsexes by oral and inhalation exposure and inrats of both sexes via inhalation. However,due to incomplete understanding of the modeof mechanism of action, the predictivity ofanimal responses to humans is uncertain.

Animal data of structurally relatedcompounds showing common target organsof toxicity and carcinogenic effects (but lackof mutagenic effects) provide additionalsupport for the carcinogenicity of substance4. Comparative toxicokinetic and metabolisminformation indicates that the mouse may bemore susceptible to liver carcinogenesis thanrats and humans. This may indicatedifferences of the degree and extent ofcarcinogenic responses, but does not detractfrom the qualitative weight of evidence ofhuman carcinogenicity. The toxicokineticinformation also indicates that oral andinhalation are the major routes of humanexposure.

Conclusion

Substance 4 is likely to be carcinogenic tohumans by all routes of exposure. The weightof evidence of human carcinogenicity isbased on: (a) Demonstrated evidence ofcarcinogenicity in two rodent species of bothsexes via two relevant routes of humanexposure; (b) the substance’s similarity instructure to other chlorinated organics thatare known to cause liver and kidney toxicityand carcinogenesis in rodents; (c) suggestiveevidence of a possible association betweenexposure to the substance in the laundry anddry cleaning industries and increased cancerincidence; and (d) human and animal dataindicating that the substance is absorbed byall routes of exposure.

In comparison with other agentsdesignated as likely carcinogens, the overallweight of evidence places it the lower end ofthe grouping. This is because there is a lackof good evidence that observed excess cancerrisk in exposed workers is due solely tosubstance 4. Moreover, there is considerable

scientific uncertainty about the humansignificance of certain rodent tumorsassociated with substance 4 and relatedcompounds. In this case, the humanrelevance of the animal evidence ofcarcinogenicity relies on the defaultassumption.

Overall, there is not enough evidence togive high confidence in a conclusion aboutany single mode of action; it appears thatmore than one is plausible in different rodenttissues. Nevertheless, the lack ofmutagenicity of substance 4 and its generalgrowth-promoting effect on high backgroundtumors as well as its toxicity toward mouseliver and rat kidney tissue support the viewthat the predominant mode is growth-promoting rather than mutagenic. Amutagenic contribution to carcinogenicitydue to a metabolite cannot be ruled out. Thedose response assessment should, therefore,adopt both default approaches, nonlinear andlinear extrapolations. The latter approach isvery conservative since it likelyoverestimates risk at low doses in this case,and is primarily useful for screeninganalyses.Example 5: ‘‘Likely/Not Likely HumanCarcinogen’’—Range of Dose Limited,Margin-of-Exposure Extrapolation

Human Data

Substance 5 is a metal-conjugatedphosphonate. No human tumor or toxicitydata exist on this chemical.

Animal Data

Substance 5 caused a statisticallysignificant increase in the incidence ofurinary bladder tumors in male, but notfemale, rats at 30,000 ppm (3%) in the dietin a long-term study. Some of these animalshad accompanying urinary tract stones andtoxicity. No bladder tumors or adverseurinary tract effects were seen in two lowerdose groups (2,000 and 8,000 ppm) in thesame study. A chronic dietary study in miceat doses comparable to those in the rat studyshowed no tumor response or urinary tracteffects. A 2-year study in dogs at doses upto 40,000 ppm showed no adverse urinarytract effects.

Other Key Data

Subchronic dosing of rats confirmed thatthere was profound development of stones inthe male bladder at doses comparable tothose causing cancer in the chronic study,but not at lower doses. Sloughing of theepithelium of the urinary tract accompaniedthe stones.

There was a lack of mutagenicity relevantto carcinogenicity. In addition, there isnothing about the chemical structure ofsubstance 5 to indicate DNA-reactivity orcarcinogenicity.

Substance 5 is composed of a metal,ethanol, and a simple phosphorus-oxygen-containing component. The metal is notabsorbed from the gut, whereas the other twocomponents are absorbed. At high doses,ethanol is metabolized to carbon dioxide,which makes the urine more acidic; thephosphorus level in the blood is increasedand calcium in the urine is increased.Chronic testing of the phosphorus-oxygen-

containing component alone in rats did notshow any tumors or adverse effects on theurinary tract.

Because substance 5 is a metal complex, itis not likely to be readily absorbed from theskin.

Evaluation

Substance 5 produced cancer of thebladder and urinary tract toxicity in male,but not female rats and mice, and dogs failedto show the toxicity noted in male rats. Themode of action developed from the other keydata to account for the toxicity and tumorsin the male rats is the production of bladderstones. At high but not lower subchronicdoses in the male rat, substance 5 leads toelevated blood phosphorus levels; the bodyresponds by releasing excess calcium into theurine. The calcium and phosphorus combinein the urine and precipitate into multiplestones in the bladder. The stones are veryirritating to the bladder; the bladder lining iseroded, and cell proliferation occurs tocompensate for the loss of the lining. Celllayers pile up, and finally, tumors develop.Stone formation does not involve thechemical per se but is secondary to theeffects of its constituents on the blood and,ultimately, the urine. Bladder stones,regardless of their cause, commonly producebladder tumors in rodents, especially themale rat.

Conclusion

Substance 5, a metal aliphaticphosphonate, is likely to be carcinogenic tohumans only under high-exposure conditionsfollowing oral and inhalation exposure thatlead to bladder stone formation, but is notlikely to be carcinogenic under low-exposureconditions. It is not likely to be a humancarcinogen via the dermal route, given thatthe compound is a metal conjugate that isreadily ionized and its dermal absorption isnot anticipated. The weight of evidence isbased on (a) bladder tumors only in malerats; (b) the absence of tumors at any othersite in rats or mice; (c) the formation ofcalcium-phosphorus-containing bladderstones in male rats at high, but not low,exposures that erode bladder epithelium andresult in profound increases in cellproliferation and cancer; and (d) the absenceof structural alerts or mutagenic activity.

There is a strong mode of action basis forthe requirements of (a) high doses ofsubstance 5, (b) which lead to excess calciumand increased acidity in the urine, (c) whichresult in the precipitation of stones and (d)the necessity of stones for toxic effects andtumor hazard potential. Lower doses fail toperturb urinary constituents, lead to stones,produce toxicity, or give rise to tumors.Therefore, dose response assessment shouldassume nonlinearity.

A major uncertainty is whether theprofound effects of substance 5 may beunique to the rat. Even if substance 5produced stones in humans, there is onlylimited evidence that humans with bladderstones develop cancer. Most often humanbladder stones are either passed in the urineor lead to symptoms resulting in theirremoval. However, since one cannot totallydismiss the male rat findings, some hazard


potential may exist in humans followingintense exposures. Only fundamentalresearch could illuminate this uncertainty.Example 6: ‘‘Cannot Be Determined’’—Suggestive Evidence

Human DataSubstance 6 is an unsaturated aldehyde. In

a cohort study of workers in a chemical plantexposed to a mixture of chemicals withsubstance 6 as a minor component, anelevated risk of cancer than was expectedwas reported. This study is consideredinadequate because of multiple exposures,small cohort, and poor exposurecharacterization.

Animal DataSubstance 6 was tested for potential

carcinogenicity in a drinking water study inrats, an inhalation study in hamsters, and askin painting study in mice. No significantincreases in tumors were observed in malerats treated with substance 6 at three doselevels in drinking water. However, asignificant increase of adrenal corticaladenomas was found in the only treatedfemale dose group administered a doseequivalent to the high dose of males. Thisstudy used a small number of animals (20 perdose group).

No significant finding was detected in theinhalation study in hamsters. This study isinadequate due to the use of too few animals,short duration of exposure, and inappropriatedose selection (use of a single exposure thatwas excessively toxic as reflected by highmortality).

No increase in tumors was induced in theskin painting study in mice. This study is ofinadequate design for carcinogenicityevaluation because of several deficiencies:small number of animals, short duration ofexposure, lack of reporting about the sex andage of animals, and purity of test material.

Substance 6 is structurally related tolowmolecularweight aldehydes that generallyexhibit carcinogenic effects in the respiratorytracts of laboratory animals via inhalationexposure. Three skin painting studies in miceand two subcutaneous injection studies ofrats and mice were conducted to evaluate thecarcinogenic potential of a possiblemetabolite of substance 6 (identified in vitro).Increased incidences of either benign orcombined benign and malignant skin tumorswere found in the dermal studies. In theinjection studies of rats and mice, increasedincidences of local sarcomas or squamouscell carcinoma were found at the sites ofinjection. All of these studies are limited bythe small number of test animals, the lack ofcharacterization of test material, and the useof single doses.

Other Key Data

Substance 6 is a flammable liquid at roomtemperature. Limited information on itstoxicokinetics indicates that it can beabsorbed by all routes of exposure. It iseliminated in the urine mainly as glutathioneconjugates. Substance 6 is metabolized invitro by rat liver and lung microsomalpreparations to a dihydroxylated aldehyde.

No data were available on the genetic andrelated effects of substance 6 in humans. It

did not induce dominant lethal mutations inmice. It induced sister chromatid exchangesin rodent cells in vitro. The mutagenicity ofsubstance 6 is equivocal in bacteria. It didnot induce DNA damage or mutations infungi.

EvaluationAvailable human data are judged

inadequate for an evaluation of any causalrelationship between exposure to substance 6and human cancer.

The carcinogenic potential of substance 6has not been adequately studied in laboratoryanimals due to serious deficiencies in studydesign, especially the inhalation and dermalstudies. There is some evidence ofcarcinogenicity in the drinking water studyin female rats. However, the significance andpredictivity of that study to human responseare uncertain since the finding is limited tooccurrence of benign tumors, one sex, and atthe high dose only. Additional suggestion foranimal carcinogenicity comes fromobservation that a possible metabolite iscarcinogenic at the site of administration.This metabolite, however, has not beenstudied in vivo. Overall, the animal evidenceis judged to be suggestive for humancarcinogenicity.

Other key data, taken together, do not addsignificantly to the overall weight of evidenceof carcinogenicity. SAR analysis indicatesthat substance 6 would be DNA-reactive.However, mutagenicity data are inconclusive.Limited in vivo data do not support amutagenic effect. While there is someevidence of DNA damage in rodent cells invitro, there is either equivocal or no evidenceof mutagenicity in nonmammalian systems.

Conclusion

The human carcinogenicity potential ofsubstance 6 cannot be determined on thebasis of available information. Both humanand animal data are judged inadequate for anevaluation. There is evidence suggestive ofpotential carcinogenicity on the basis oflimited animal findings and SARconsiderations. Data are not sufficient tojudge whether there is a mode ofcarcinogenic action. Additional studies areneeded for a full evaluation of the potentialcarcinogenicity of substance 6. Hence, doseresponse assessment is not appropriate.Example 7: ‘‘Not Likely HumanCarcinogen’’—Appropriately StudiedChemical in Animals Without Tumor Effects

Human Data

Substance 7, a plant extract, has not beenstudied for its toxic or carcinogenic potentialin humans.

Animal Data

Substance 7 has been studied in fourchronic studies in three rodent species. In afeeding study in rats, males showed anonsignificant increase in benign tumors ofthe parathyroid gland in the high-dose group,where the incidence in concurrent controlsgreatly exceeded the historical control range.Females demonstrated a significant increasein various subcutaneous tumors in the low-dose group, but findings were not confirmedin the high-dose group, and there was no

dose response relationship. These effectswere considered as not adding to theevidence of carcinogenicity. No tumorincreases were noted in a second adequatefeeding study in male and female rats. In amouse feeding study, no tumor increaseswere noted in dosed animals. There wassome question as to the adequacy of thedosing; however it was noted that in themouse 90-d subchronic study, a dose of twicethe high dose in the chronic study led tosignificant decrements in body weight. In ahamster study there were no significantincreases in tumors at any site. No structuralanalogues of substance 7 have been tested forcancer.

Other Key Data

There are no structural alerts that wouldsuggest that substance 7 is a DNA-reactivecompound. It is negative for gene mutationsin bacteria and yeast, but positive in culturedmouse cells. Tests for structural chromosomeaberrations in cultured mammalian cells andin rats are negative; however, the animalswere not tested at sufficiently high doses.Substance 7 binds to proteins of the celldivision spindle; therefore, there is somelikelihood for producing numericalchromosome aberrations, an endpoint that issometimes noted in cancers. In sum, there islimited and conflicting informationconcerning the mutagenic potential of theagent.

The compound is absorbed via oral andinhalation exposure but only poorly via theskin.

Evaluation

The only indication of a carcinogenic effectcomes from the finding of benign tumors inmale rats in a single study. There is noconfirmation of a carcinogenic potential fromdosed females in that study, in males andfemales in a second rat study, or from mouseand hamster studies.

There is no structural indication thatsubstance 7 is DNA-reactive, there isinconsistent evidence of gene mutations, andchromosome aberration testing is negative.The agent binds to cell division spindleproteins and may have the capacity to inducenumerical chromosome anomalies. Furtherinformation on gene mutations and in vivostructural and numerical chromosomeaberrations may be warranted.

Conclusion

Substance 7 is not likely to be carcinogenicto humans via all relevant routes of exposure.This weight of evidence judgment is largelybased on the absence of significant tumorincreases in chronic rodent studies. Adequatecancer studies in rats, mice, and hamsters failto show any carcinogenic effect; a second ratstudy showed an increase in benign tumorsat a site in dosed males, but not females.

2.7. Presentation of Results

The results of the hazard assessmentare presented in the form of an overalltechnical hazard characterization.Additionally, a weight of evidencenarrative is used when the conclusionas to carcinogenic potential needs to be


presented separately from the overallcharacterization.

2.7.1. Technical HazardCharacterization

The hazard characterization has twofunctions. First, it presents results of thehazard assessment and an explanationof how the weight of evidenceconclusion was reached. It explains thepotential for human hazard, anticipatedattributes of its expression, and mode ofaction considerations for dose response.Second, it contains the informationneeded for eventual incorporation into arisk characterization consistent withEPA guidance on risk characterization(U.S. EPA, 1995).

The characterization qualitativelydescribes the conditions under whichthe agent’s effects may be expressed inhuman beings. These qualitative hazardconditions are ones that are observablein the toxicity data without having doneeither quantitative dose response orexposure assessment. The descriptionincludes how expression is afffected byroute of exposure and dose levels anddurations of exposure.

The discussion of limitations of doseas a qualitative aspect of hazardaddresses the question of whetherreaching a certain dose range appears tobe a precondition for a hazard to beexpressed; for example, whencarcinogenic effects are secondary toanother toxic effect that appears onlywhen a certain dose level is reached.The assumption is made that an agentthat causes internal tumors by one routeof exposure will be carcinogenic byanother route, if it is absorbed by thesecond route to give an internal dose.Conversely, if there is a route ofexposure by which the agent is notabsorbed (does not cross an absorptionbarrier; e.g., the exchange boundaries ofskin, lung, and digestive tract throughuptake processes) to any significantdegree, hazard is not anticipated by thatroute. An exception to the latterstatement would be when the site ofcontact is also the target tissue ofcarcinogenicity. Duration of exposuremay be a precondition for hazard if, forexample, the mode of action requirescytotoxicity or a physiologic change, oris mitogenicity, for which exposuremust be sustained for a period of timebefore effects occur. Thecharacterization could note that onewould not anticipate a hazard fromisolated, acute exposures. The aboveconditions are qualitative onesregarding preconditions for effects, notissues of relative absorption or potencyat different dose levels. The latter aredealt with under dose responseassessment (section 3), and their

implications can only be assessed afterhuman exposure data are applied in thecharacterization of risk.

The characterization describesconclusions about mode of actioninformation and its support forrecommending dose responseapproaches.

The hazard characterization routinelyincludes the following in support of riskcharacterization:

• a summary of results of theassessment,

• identification of the kinds of dataavailable to support conclusions andexplanation of how the data fit together,highlighting the quality of the data ineach line of evidence, e.g., tumor effects,short-term studies, structure-activityrelationships), and highlighting thecoherence of inferences from thedifferent kinds of data,

• strengths and limitations(uncertainties) of the data andassessment, including identification ofdefault assumptions invoked in the faceof missing or inadequate data,

• identification of alternativeinterpretations of data that areconsidered equally plausible,

• identification of anysubpopulations believed to be moresusceptible to the hazard than thegeneral population,

• conclusions about the agent’s modeof action and recommended doseresponse approaches,

• significant issues regardinginterpretation of data that arose in theassessment. Typical ones may include:—determining causality in human

studies,—dosing (MTD), background tumor

rates, relevance of animal tumors tohumans,

—weighing studies with positive andnull results, considering the influenceof other available kinds of evidence,

—drawing conclusions based on modeof action data versus using a defaultassumption about the mode of action.

2.7.2. Weight of Evidence NarrativeThe weight of evidence narrative

summarizes the results of hazardassessment employing the descriptorsdefined in section 2.6.1. The narrative(about two pages in length) explains anagent’s human carcinogenic potentialand the conditions of its expression. Ifdata do not allow a conclusion as tocarcinogenicity, the narrative explainsthe basis of this determination. Anexample narrative appears below. Moreexamples appear in Appendix A.

The items regularly included in anarrative are:

• name of agent and ChemicalAbstracts Services number, if available,

• conclusions (by route of exposure)about human carcinogenicity, using astandard descriptor from section 2.6.1,

• summary of human and animaltumor data on the agent or its structuralanalogues, their relevance, andbiological plausibility,

• other key data (e.g., structure-activity data, toxicokinetics andmetabolism, short-term studies, otherrelevant toxicity or clinical data),

• discussion of possible mode(s) ofaction and appropriate dose responseapproach(es),

• conditions of expression ofcarcinogenicity, including route,duration, and magnitude of exposure.

Example Narrative

Aromatic Compound

CAS# XXX

CANCER HAZARD SUMMARYAromatic compound (AR) is known to be

carcinogenic to humans by all routes ofexposure.

The weight of evidence of humancarcinogenicity is based on (a) consistentevidence of elevated leukemia incidence instudies of exposed workers and significantincreases of genetic damage in bone marrowcells and blood lymphocytes of exposedworkers; (b) significantly increased incidenceof cancer in both sexes of several strains ofrats and mice; (c) genetic damage in bonemarrow cells of exposed rodents and effectson intracellular signals that control cellgrowth.

AR is readily absorbed by all routes ofexposure and rapidly distributed throughoutthe body. The mode of action of AR is notunderstood. A dose response assessment thatassumes linearity of the relationship isrecommended as a default.SUPPORTING INFORMATION

Data include numerous humanepidemiologic and biomonitoring studies,long-term bioassays, and other data on effectsof AR on genetic material and cell growthprocesses. The key epidemiologic studies andanimal studies are well conducted andreliable. The other data are generally of goodquality also.Human Effects

Numerous epidemiologic and case studieshave reported an increased incidence or acausal relationship associating exposure toAR and leukemia. Among the studies are fivefor which the design and performance as wellas follow-up are considered adequate todemonstrate the causal relationship.Biomonitoring studies of exposed workershave found dose-related increases inchromosomal aberrations in bone marrowcells and blood lymphocytes.Animal Effects

AR caused increased incidence of tumorsin various tissues in both sexes of several ratand mouse strains. AR also causedchromosomal aberrations in rabbits, mice,and rats—as it does in humans.


2 For this discussion, ‘‘exposure’’ means contactof an agent with the outer boundary of an organism.‘‘Applied dose’’ means the amount of an agentpresented to an absorption barrier and available forabsorption. ‘‘Internal dose’’ means the amountcrossing an absorption barrier (e.g., the exchangeboundaries of skin, lung, and digestive tract)through uptake processes. ‘‘Delivered dose’’ for anorgan or cell means the amount available forinteraction with that organ or cell (U.S. EPA,1992a).

3 It is appropriate to report the central estimate ofthe ED10, the upper and lower 95% confidencelimits, and a graphical representation of model fit.

Other Key Data

AR itself is not DNA-reactive and is notmutagenic in an array of test systems both invitro and in vivo. Metabolism of AR yieldsseveral metabolites that have been separatelystudied for effects on carcinogenic processes.Some have mutagenic activity in test systemsand some have other effects on cell growthcontrols inside cells.

MODE OF ACTION

No rodent tumor precisely matches humanleukemia in pathology. The closest parallel isa mouse cancer of blood-forming tissue.Studies of the effects of AR at the cell levelin this model system are ongoing. As yet, themode of action of AR is unclear, but mostlikely the carcinogenic activity is associatedwith one or a combination of its metabolites.It is appropriate to apply a linear approachto the dose response assessment pending abetter understanding because: (a) geneticdamage is a typical effect of AR exposure inmammals and (b) metabolites of AR producemutagenic effects in addition to their othereffects on cell growth controls; AR is amultitissue carcinogen in mammalssuggesting that it is affecting a commoncontrolling mechanism of cell growth.

3. Dose Response Assessment

Dose response assessment firstaddresses the relationship of dose 2 tothe degree of response observed in anexperiment or human study. Whenenvironmental exposures are outside ofthe range of observation, extrapolationsare necessary in order to estimate orcharacterize the dose relationship (ILSI,1995). In general, three extrapolationsmay be made: from high to low doses,from animal to human responses, andfrom one route of exposure to another.

The dose response assessmentproceeds in two parts. The first isassessment of the data in the range ofempirical observation. This is followedby extrapolations either by modeling, ifthere are sufficient data to support amodel, or by a default procedure basedas much as possible on informationabout the agent’s mode of action. Thefollowing discussion covers theassessment of observed data andextrapolation procedures, followed bysections on analysis of response dataand analysis of dose data. The finalsection discusses dose responsecharacterization.

3.1. Dose Response Relationship

In the discussion that follows,reference to ‘‘response’’ data includesmeasures of tumorigenicity as well asother responses related tocarcinogenicity. The other responsesmay include effects such as changes inDNA, chromosomes, or other keymacromolecules, effects on growthsignal transduction, induction ofphysiological or hormonal changes,effects on cell proliferation, or othereffects that play a role in the process.Responses other than tumorigenicitymay be considered part of the observedrange in order either to extend thetumor dose response analysis or toinform it. The nontumor response orresponses also may be used in lieu oftumor data if they are considered to bea more informative representation of thecarcinogenic process for an agent (seesection 3.2).

3.1.1. Analysis in the Range ofObservation

Biologically Based and Case-SpecificModels. A biologically based model isone whose parameters are calculatedindependently of curve-fitting of tumordata. If data are sufficient to support abiologically based model specific to theagent and the purpose of the assessmentis such as to justify investing resourcessupporting use, this is the first choicefor both the observed tumor and relatedresponse data and for extrapolationbelow the range of observed data ineither animal or human studies.Examples are the two-stage models ofinitiation plus clonal expansion andprogression developed by Moolgavkarand Knudson (1981) and Chen andFarland (1991). Such models requireextensive data to build the form of themodel as well as to estimate how wellit conforms with the observedcarcinogenicity data. Theoreticalestimates of process parameters, such ascell proliferation rates, are not used toenable application of such a model(Portier, 1987).

Similarly preferred as a first choiceare dose response models based ongeneral concepts of mode of action anddata on the agent. For a case-specificmodel, model parameters and data areobtained from studies on the agent.

In most cases, a biologically based orcase-specific model will not bepracticable, either because the necessarydata do not exist or the decisions thatthe assessment are to support do notjustify or permit, the time and resourcesrequired. In these cases, the analysisproceeds using curve-fitting modelsfollowed by default procedures forextrapolation, based, to the extent

possible, on mode of action and otherbiological information about the agent.These methods and assumptions aredescribed below.

Curve-Fitting and Point of Departurefor Extrapolation. Curve-fitting modelsare used that are appropriate to the kindof response data in the observed range.Any of several models can be used; e.g.,the models developed for benchmarkdose estimation for noncancerendpoints may be applied (Barnes et al.,1995).

For some data sets, particularly thosewith extreme curvature, the impact ofmodel selection can be significant. Inthese cases, the choice is rationalized onbiological grounds as possible. In othercases, the nature of the data or the wayit is reported will suggest other types ofmodels; for instance, when longitudinaldata on tumor development areavailable, time to tumor or survivalmodels may be necessary andappropriate to fit the data.

A point of departure for extrapolationis estimated. This is a point that iseither a data point or an estimated pointthat can be considered to be in the rangeof observation, without any significantextrapolation. The LED10—the lower95% confidence limit on a doseassociated with 10% extra risk—is sucha point and is the standard point ofdeparture, adopted as a matter ofscience policy to remain as consistentand comparable from case to case aspossible.3 It is also a comparison pointfor noncancer endpoints (U.S. EPA,1991f). The central estimate of the ED10

also may be appropriate for use inrelative hazard and potency ranking.

For some data sets, a choice of pointof departure other than the LED10 maybe appropriate. For example, if theobserved response is below the LED10,then a lower point may be a betterchoice. Moreover, some forms of datamay not be amenable to curve-fittingestimation, but to estimation of a‘‘low-’’ or ‘‘no-observable-adverse-effectlevel’’ (LOAEL, NOAEL) instead, e.g.,certain continuous data.

The rationale supporting the use ofthe LED10 is that a 10% response is ator just below the limit of sensitivity ofdiscerning a significant difference inmost long-term rodent studies. Thelower confidence limit on dose is usedto appropriately account forexperimental uncertainty (Barnes et al.,1995) and for consistency with the‘‘benchmark dose’’ approach fornoncancer assessment; it does notprovide information about human


4 An RfD or RfC is an estimate with uncertaintyspanning perhaps an order of magnitude of dailyexposure to the human population (includingsensitive subgroups) that is anticipated to bewithout appreciable deleterious effects during alifetime. It is arrived at by dividing empirical dataon effects by uncertainty factors that consider inter-and intraspecies variability, extent of data on allimportant chronic exposure toxicity endpoints, andavailability of chronic as opposed to subchronicdata.

variability. In laboratory studies ofcancer or noncancer endpoints, the levelof dose at which increased incidence ofeffects can be detected, as compared tocontrols, is a function of the size of thesample (e.g., number of animals), dosespacing, and other design aspects. Innoncancer assessment, the dose atwhich significant effects are notobserved is traditionally termed theNOAEL. This is not, in fact, a level ofzero effect. The NOAEL in most studyprotocols is about the same as an LED5

or LED10—the lower 95% confidencelimit on a dose associated with a 5% or10% increased effect (Faustman et al.,1994; Haseman, 1983). Adoptingparallel points of departure for cancerand noncancer assessment is intendedto make discussion and comparison ofthe two kinds of assessment morecomparable because of their similarscience and science policy bases andsimilar analytic approaches.

Analysis of human studies in theobserved range is designed case by case,depending on the type of study and howdose and response are measured in thestudy. In some cases the agent may havediscernible interactive effects withanother agent (e.g., asbestos andsmoking), making possible estimation ofcontribution of the agent and others asrisk factors. Also, in some cases,estimation of population risk inaddition, or in lieu of, individual riskmay be appropriate.

3.1.2. Analysis in the Range ofExtrapolation

Extrapolation to lower doses isusually necessary, and in the absence ofa biologically based or case-specificmodel, is based on one of the threedefault procedures described below.The Agency has adopted these threeprocedures as a matter of science policybased on current hypotheses of thelikely shapes of dose response curvesfor differing modes of action. The choiceof the procedure to be used in anindividual case is a judgment based onthe agent’s modes of action.

Linear. A default assumption oflinearity is appropriate when theevidence supports a mode of action ofgene mutation due to DNA reactivity orsupports another mode of action that isanticipated to be linear. Other elementsof empirical support may also supportan inference of linearity, e.g., thebackground of human exposure to anagent might be such that added humanexposure is on the linear part of a doseresponse curve that is sublinear overall.The default assumption of linearity isalso appropriate as the ultimate sciencepolicy default when evidence shows noDNA reactivity or other support for

linearity, but neither does it showsufficient evidence of a nonlinear modeof action to support a nonlinearprocedure.

For linear extrapolation, a straightline is drawn from the point ofdeparture to the origin—zero dose, zeroresponse (Flamm and Winbush, 1984;Gaylor and Kodell, 1980; Krewski et al.,1984). This approach is generallyconservative of public health, in theabsence of information about the extentof human variability in sensitivity toeffects. When a linear extrapolationprocedure is used, the riskcharacterization summary displays thedegree of extrapolation that is beingmade from empirical data and discussesits implications for the interpretation ofthe resulting quantitative risk estimates.

Nonlinear. A default assumption ofnonlinearity is appropriate when thereis no evidence for linearity andsufficient evidence to support anassumption of nonlinearity. The modeof action may lead to a dose responserelationship that is nonlinear, withresponse falling much more quicklythan linearly with dose, or being mostinfluenced by individual differences insensitivity. Alternatively, the mode ofaction may theoretically have athreshold, e.g., the carcinogenicity maybe a secondary effect of toxicity or of aninduced physiological change (seeexample 5, section 2.6.3) that is itself athreshold phenomenon.

As a matter of science policy underthis analysis, nonlinear probabilityfunctions are not fitted to the responsedata to extrapolate quantitative low-dose risk estimates because differentmodels can lead to a very wide range ofresults, and there is currently no basis,generally, to choose among them.Sufficient information to choose leads toa biologically based or case-specificmodel. In cases of nonlinearity, the riskis not extrapolated as a probability of aneffect at low doses. A margin ofexposure analysis is used, as describedbelow, to evaluate concern for levels ofexposure. The margin of exposure is theLED10 or other point of departuredivided by the environmental exposureof interest. The EPA does not generallytry to distinguish between modes ofaction that might imply a ‘‘truethreshold’’ from others with a nonlineardose response relationship. Except inunusual cases where extensiveinformation is available, it is notpossible to distinguish between theseempirically.

The environmental exposures ofinterest, for which margins of exposureare estimated, may be actual orprojected future levels. The riskmanager decides whether a given

margin of exposure is acceptable underapplicable management policy criteria.The risk assessment providessupporting information to assist thedecisionmaker.

The EPA often conducts margin ofexposure analyses to accompanyestimates of reference doses orconcentrations (RfD, RfC) for noncancerendpoints.4 The procedure for a marginof exposure analysis for a responserelated to carcinogenicity isoperationally analogous, the differencebeing that a threshold of cancerresponse is not necessarily presumed. If,in a particular case, the evidenceindicates a threshold, as in the case ofcarcinogenicity being secondary toanother toxicity that has a threshold, themargin of exposure analysis for thetoxicity is the same as is done for anoncancer endpoint, and an RfD or RfCfor that toxicity also may be estimatedand considered in cancer assessment.

The analogy between margin ofexposure analysis for noncancer andcancer responses begins with theanalogy of points of departure; for bothit is an effect level, either LED10 or otherpoint (presented as a human equivalentdose or concentration), as data support.For cancer responses, when animal dataare used, the point of departure is ahuman equivalent dose or concentrationarrived at by interspecies doseadjustment or toxicokinetic analysis. Itis likely that many of the margin ofexposure analyses for cancer will be forresponses other than tumor incidence.This is because the impetus forconsidering a carcinogenic agent to havea nonlinear dose response will be aconclusion that there is sufficientevidence to support that view, and thisevidence will often be informationabout a response that is a precursor totumors.

To support a risk manager’sconsideration of the margin of exposure,information is provided in a riskassessment about current understandingof the phenomena that may be occurringas dose (exposure) decreasessubstantially below the observed data.The goal is to provide as muchinformation as possible about the riskreduction that accompanies lowering ofexposure. To this end, some importantpoints to address include:


• The slope of the observed doseresponse relationship at the point ofdeparture and its uncertainties andimplications for risk reductionassociated with exposure reduction (ashallow slope suggests less reductionthan a steep slope),

• The nature of the response used forthe dose response assessment,

• The nature and extent of humanvariability in sensitivity to thephenomena involved,

• Persistence of the agent in the body,• Human sensitivity to the

phenomena as compared withexperimental animals.

As a default assumption for two ofthese points, a factor of no less than 10-fold each may be employed to accountfor human variability and forinterspecies differences in sensitivitywhen humans may be more sensitive

than animals. When humans are foundto be less sensitive than animals, adefault factor of no smaller than a 1/10fraction may be employed to account forthis. If any information about humanvariability or interspecies differences isavailable, it is used instead of thedefault or to modify it as appropriate. Inthe case of analysis based on humanstudies, obviously, interspeciesdifferences are not a factor. It should benoted that the dose responserelationship and inter- or intraspeciesvariability in sensitivity areindependent. That is, reduction of dosereduces risk; it does not changevariability. To support consideration ofacceptability of a margin of exposure bythe risk manager, the assessmentconsiders all of the hazard and doseresponse factors together; hence, thefactors for inter- and intraspecies

differences alone are not to beconsidered a default number for anacceptable margin of exposure. (SeeSection 1.3.2.5.)

It is appropriate to provide a graphicalrepresentation of the data and doseresponse modeling in the observedrange, also showing exposure levels ofinterest to the decisionmaker. (Seefigure 3–1.) In order to provide a frameof reference, by way of comparison, astraight line extrapolation may bedisplayed to show what risk levelswould be associated with decreasingdose, if the dose response were linear.If this is done, the clear accompanyingmessage is that, in this case ofnonlinearity, the response fallsdisproportionately with decreasingdose.



Linear and Nonlinear. Both linear andnonlinear procedures may be used inparticular cases. If a mode of actionanalysis finds substantial support fordiffering modes of action for differenttumor sites, an appropriate procedure isused for each. Both procedures may alsobe appropriate to discuss implicationsof complex dose response relationships.For example, if it is apparent that anagent is both DNA reactive and is highlyactive as a promotor at high doses, andthere are insufficient data for modeling,both linear and nonlinear defaultprocedures may be needed to decoupleand consider the contribution of bothphenomena.

3.1.3. Use of Toxicity EquivalenceFactors and Relative Potency Estimates

A toxicity equivalence factor (TEF)procedure is one used to derivequantitative dose response estimates foragents that are members of a category orclass of agents. TEFs are based onshared characteristics that can be usedto order the class members bycarcinogenic potency when cancerbioassay data are inadequate for thispurpose (U.S. EPA, 1991c). The orderingis by reference to the characteristics andpotency of a well-studied member ormembers of the class. Other classmembers are indexed to the referenceagent(s) by one or more sharedcharacteristics to generate their TEFs.The TEFs are usually indexed atincrements of a factor of 10. Very gooddata may permit a smaller increment tobe used. Shared characteristics that maybe used are, for example, receptor-binding characteristics, results of assaysof biological activity related tocarcinogenicity, or structure-activityrelationships.

TEFs are generated and used for thelimited purpose of assessment of agentsor mixtures of agents in environmentalmedia when better data are notavailable. When better data becomeavailable for an agent, its TEF should bereplaced or revised. Criteria forconstructing TEFs are given in U.S. EPA(1991b). The criteria call for data thatare adequate to support summing dosesof the agents in mixtures. To date,adequate data to support use of TEF’shas been found in only one class ofcompounds (dioxins) (U.S. EPA, 1989a).

Relative potencies can be similarlyderived and used for agents withcarcinogenicity or other supportingdata. These are conceptually similar toTEFs, but they are less firmly based inscience and do not have the same levelof data to support them. They are usedonly when there is no better alternative.

The uncertainties associated withboth TEFs and relative potencies areexplained whenever they are used.

3.2. Response DataResponse data for analysis include

tumor incidence data from human oranimal studies as well as data on otherresponses as they relate to an agent’scarcinogenicity, such as effects ongrowth control processes or cellmacromolecules or other toxic effects.Tumor incidence data are ordinarily thebasis of dose response assessment, butother response data can augment suchassessment or provide separateassessments of carcinogenicity or otherimportant effects.

Data on carcinogenic processesunderlying tumor effects may be used tosupport biologically based or case-specific models. Other options for suchdata exist. If confidence is high in thelinkage of a precursor effect and thetumor effect, the assessment of tumorincidence may be extended to lowerdose levels by linking it to theassessment of the precursor effect(Swenberg et al., 1987). Even if aquantitative link is not appropriate, theassessment for a precursor effect mayprovide a view of the likely shape of thedose response curve for tumor incidencebelow the range of tumor observation(Cohen and Ellwein, 1990; Choy, 1993).If responses other than tumor incidenceare regarded as better representations ofthe carcinogenicity of the agent, theymay be used in lieu of tumor responses.For example, if it is concluded that thecarcinogenic effect is secondary toanother toxic effect, the dose responsefor the other effect will likely be morepertinent for risk assessment. Asanother example, if disruption ofhormone activity is the key mode ofaction of an agent, data on hormoneactivity may be used in lieu of tumorincidence data.

If adequate positive humanepidemiologic response data areavailable, they provide an advantageousbasis for analysis since concerns aboutinterspecies extrapolation do not arise.Adequacy of human exposure data forquantification is an importantconsideration in deciding whetherepidemiologic data are the best basis foranalysis in a particular case. If adequateexposure data exist in a well-designedand well-conducted epidemiologicstudy that detects no effects, it may bepossible to obtain an upper-boundestimate of the potential human risk toprovide a check on plausibility ofavailable estimates based on animaltumor or other responses, e.g., doconfidence limits on one overlap thepoint estimate of the other?

When animal studies are used,response data from a species thatresponds most like humans should beused if information to this effect exists.If this is unknown and an agent hasbeen tested in several experimentsinvolving different animal species,strains, and sexes at several doses anddifferent routes of exposure, all of thedata sets are considered and compared,and a judgment is made as to the datato be used to best represent the observeddata and important biological featuressuch as mode of action. Appropriateoptions for presenting results include:

• Use of a single data set,• Combining data from different

experiments (Stiteler et al., 1993; Vateret al., 1993),

• Showing a range of results frommore than one data set,

• Showing results from analysis ofmore than one statistically significanttumor response based on differingmodes of action,

• Representing total response in asingle experiment by combining animalswith statistically significant tumors atmore than one site, or

• A combination of these options.The approach judged to best represent

the data is presented with the rationalefor the judgment, including thebiological and statistical considerationsinvolved. The following are some pointsto consider:

• Quality of study protocol andexecution,

• Proportion of malignant neoplasms,• Latency of onset of neoplasia,• Number of data points to define the

relationship of dose and response,• Background incidence in test

animal,• Differences in range of response

among species, sexes, strains,• Most sensitive responding species,

and• Availability of data on related

precursor events to tumor development.Analyses of carcinogenic effects other

than tumor incidence are similarlypresented and evaluated for theircontribution to a best judgment on howto represent the biological data for doseresponse assessment.

3.3. Dose Data

Whether animal experiments orepidemiologic studies are the sources ofdata, questions need to be addressed inarriving at an appropriate measure ofdose for the anticipated environmentalexposure. Among these are:

• Whether the dose is expressed as anenvironmental concentration, applieddose, or delivered dose to the targetorgan,


• Whether the dose is expressed interms of a parent compound, one ormore metabolites, or both,

• The impact of dose patterns andtiming where significant,

• Conversion from animal to humandoses, where animal data are used, and

• The conversion metric betweenroutes of exposure where necessary andappropriate.

In practice, there may be little or noinformation on the concentration oridentity of the active form at a target;being able to compare the applied anddelivered doses between routes andspecies is the ideal, but is rarelyattained. Even so, the objective is to useavailable data to obtain as close to ameasure of internal or delivered dose aspossible.

The following discussion assumesthat the analyst will have data ofvarying detail in different cases abouttoxicokinetics and metabolism.Discussed below are approaches to basicdata that are most frequently available,as well as approaches and judgments forimproving the analysis based onadditional data. The estimation of dosein human studies is tailored to the formof dose data available.

3.3.1. Interspecies Adjustment of DoseWhen adequate data are available, the

doses used in animal studies can beadjusted to equivalent human dosesusing toxicokinetic information on theparticular agent. The methods usedshould be tailored to the nature of thedata on a case-by-case basis. In rarecases, it may also be possible to makeadjustments based on toxicodynamicconsiderations. In most cases, however,there are insufficient data available tocompare dose between species. In thesecases, the estimate of human equivalentdose is based on science policy defaultassumptions. The defaults describedbelow are modified or replacedwhenever better comparative data ontoxicokinetic or metabolic relationshipsare available. The availability anddiscussion of the latter also may permitreduction or discussion of uncertaintyin the analysis.

For oral exposure, the defaultassumption is that delivered doses arerelated to applied dose by a power ofbody weight. This assumption rests onthe similarities of mammalian anatomy,physiology, and biochemistry generallyobserved across species. Thisassumption is more appropriate at lowapplied dose concentrations wheresources of nonlinearity, such assaturation or induction of enzymeactivity, are less likely to occur. Toderive an equivalent human oral dosefrom animal data, the default procedure

is to scale daily applied dosesexperienced for a lifetime in proportionto body weight raised to the 0.75 power(W0.75). Equating exposureconcentrations in parts per million unitsfor food or water is an alternativeversion of the same default procedurebecause daily intakes of these are inproportion to W0.75. The rationale forthis factor rests on the empiricalobservation that rates of physiologicalprocesses consistently tend to maintainproportionality with W0.75. A moreextensive discussion of the rationaleand data supporting the Agency’sadoption of this scaling factor is in U.S.EPA, 1992b. Information such as bloodlevels or exposure biomarkers or otherdata that are available for interspeciescomparison are used to improve theanalysis when possible.

The default procedure to derive anhuman equivalent concentration ofinhaled particles and gases is describedin U.S. EPA (1994) and Jarabek(1995a,b). The methodology estimatesrespiratory deposition of inhaledparticles and gases and providesmethods for estimating internal doses ofgases with different absorptioncharacteristics. The method is able toincorporate additional toxicokineticsand metabolism to improve the analysisif such data are available.

3.3.2. Toxicokinetic AnalysesPhysiologically based mathematical

models are potentially the mostcomprehensive way to account fortoxicokinetic processes affecting dose.Models build on physiologicalcompartmental modeling and attempt toincorporate the dynamics of tissueperfusion and the kinetics of enzymesinvolved in metabolism of anadministered compound.

A comprehensive model requires theavailability of empirical data on thecarcinogenic activity contributed byparent compound and metabolite ormetabolites and data by which tocompare kinetics of metabolism andelimination between species. Adiscussion of issues of confidenceaccompanies presentation of modelresults (Monro, 1992). This includesconsiderations of model validation andsensitivity analysis that stress thepredictive performance of the model.When a delivered dose measure is usedin animal to human extrapolation ofdose response data, the assessmentshould discuss the confidence in theassumption that the toxicodynamics ofthe target tissue(s) will be the same inboth species. Toxicokinetic data canimprove dose response assessment byaccounting for sources of change inproportionality of applied to internal or

delivered dose at various levels ofapplied dose. Many of the sources ofpotential nonlinearity involve saturationor induction of enzymatic processes athigh doses. An analysis that accountsfor nonlinearity (for instance, due toenzyme saturation kinetics) can assist inavoiding overestimation orunderestimation of low dose responseotherwise resulting from extrapolationfrom a sublinear or supralinear part ofthe experimental dose response curve(Gillette, 1983). Toxicokinetic processestend to become linear at low doses, anexpectation that is more robust thanlow-dose linearity of response (Hattis,1990). Accounting for toxicokineticnonlinearities allows better descriptionof the shape of the curve at relativelyhigh levels of dose in the range ofobservation, but cannot determinelinearity or nonlinearity of response atlow dose levels (Lutz, 1990a; Swenberget al., 1987).

Toxicokinetic modeling results maybe presented as the preferred method ofestimating human equivalent dose or inparallel discussion with defaultassumptions depending on relativeconfidence in the modeling.

3.3.3. Route-to-Route ExtrapolationJudgments frequently need to be made

about the carcinogenicity of an agentthrough a route of exposure differentthan the one in the underlying studies.For example, exposures of interest maybe through inhalation of an agent testedprimarily through animal feedingstudies or through ingestion of an agentthat showed positive results in humanoccupational studies from inhalationexposure.

Route-to-route extrapolation has bothqualitative and quantitative aspects. Forthe qualitative aspect, the assessorweighs the degree to which positiveresults through one route of exposure inhuman or animal studies support ajudgment that similar results wouldhave been observed in appropriatestudies using the route of exposure ofinterest. In general, confidence inmaking such a judgment is strengthenedwhen the tumor effects are observed ata site distant from the portal of entryand when absorption through the routeof exposure of interest is similar toabsorption via the tested routes. In theabsence of contrary data, the qualitativedefault assumption is that, if the agentis absorbed by a route to give an internaldose, it may be carcinogenic by thatroute. (See section 2.7.1.)

When a qualitative extrapolation canbe supported, quantitative extrapolationmay still be problematic in the absenceof adequate data. The differences inbiological processes among routes of


exposure (oral, inhalation, dermal) canbe great because of, for example, first-pass effects and differing results fromdifferent exposure patterns. There is nogenerally applicable method foraccounting for these differences inuptake processes in quantitative route-to-route extrapolation of dose responsedata in the absence of good data on theagent of interest. Therefore, route-to-route extrapolation of dose data relieson a case-by-case analysis of availabledata. When good data on the agent itselfare limited, an extrapolation analysiscan be based on expectations fromphysical and chemical properties of theagent, properties and route-specific dataon structurally analogous compounds,or in vitro or in vivo uptake data on theagent. Route-to-route uptake modelsmay be applied if model parameters aresuitable for the compound of interest.Such models are currently consideredinterim methods; further modeldevelopment and validation is awaitingthe development of more extensive data(see generally, Gerrity and Henry, 1990).For screening or hazard ranking, route-to-route extrapolation may be based onassumed quantitative comparability as adefault, as long as it is reasonable toassume absorption by compared routes.When route-to-route extrapolation isused, the assessor’s degree of confidencein both the qualitative and quantitativeextrapolation should be discussed in theassessment and highlighted in the doseresponse characterization.

3.3.4. Dose AveragingThe cumulative dose received over a

lifetime, expressed as lifetime averagedaily dose, is generally considered anappropriate default measure of exposureto a carcinogen (Monro, 1992). Theassumption is made that a high dose ofa carcinogen received over a shortperiod of time is equivalent to acorresponding low dose spread over alifetime. While this is a reasonabledefault assumption based on theoreticalconsiderations, departures from it areexpected. Another approach is neededin some cases, such as when dose-rateeffects are noted (e.g., formaldehyde).Cumulative dose may be replaced, asappropriate and justified by the data,with other dose measures. In such cases,modifications to the default assumptionare made to take account of theseeffects; the rationale for the selectedapproach is explained.

In cases where a mode of action orother feature of the biology has beenidentified that has special doseimplications for sensitivesubpopulations (e.g., differential effectsby sex or disproportionate impacts ofearly-life exposure), these are explained

and are recorded to guide exposureassessment and risk characterization.Special problems arise when the humanexposure situation of concern suggestsexposure regimens (e.g., route anddosing schedule) that are substantiallydifferent from those used in the relevantanimal studies. These issues areexplored and pointed out for attentionin the exposure assessment and riskcharacterization.

3.4. Discussion of UncertaintiesThe exploration of significant

uncertainties in data for dose andresponse and in extrapolationprocedures is part of the assessment.The presentation distinguishes betweenmodel uncertainty and parameteruncertainty. Model uncertainty is anuncertainty about a basic biologicalquestion. For example, a default, lineardose response extrapolation may havebeen made based on tumor and otherkey evidence supporting the view thatthe model for an agent’s mode of actionis a DNA-reactive process. Discussion ofthe confidence in the extrapolation isappropriately done qualitatively or byshowing results for alternatives that areequally plausible. It is not useful, forexample, to conduct quantitativeuncertainty analysis running multipleforms of linear models. This wouldobviate the function of the policydefault.

Parameter uncertainties deal withnumbers representing statistical oranalytical measures of variance or errorin data or estimates. Uncertainties inparameters are described quantitatively,if practicable, through sensitivityanalysis and statistical uncertaintyanalysis. With the recent expansion ofreadily available computing capacity,computer methods are being adapted tocreate simulated biological data that arecomparable with observed information.These simulations can be used forsensitivity analysis, for example, toanalyze how small, plausible variationsin the observed data could affect doseresponse estimates. These simulationscan also provide information aboutexperimental uncertainty in doseresponse estimates, including adistribution of estimates that arecompatible with the observed data.Because these simulations are based onthe observed data, they cannot assist inevaluating the extent to which theobserved data as a whole areidiosyncratic rather than typical of thetrue situation. If quantitative analysis isnot possible, significant parameteruncertainties are describedqualitatively. In either case, thediscussion highlights uncertainties thatare specific to the agent being assessed,

as distinct from those that are generic tomost assessments.

Estimation of the applied dose in ahuman study has numerousuncertainties such as the exposurefluctuations that humans experiencecompared with the controlled exposuresreceived by animals on test. In aprospective cohort study, there isopportunity to monitor exposure andhuman activity patterns for a period oftime that supports estimation of applieddose (U.S. EPA, 1992a). In aretrospective study, exposure may bebased on monitoring data but is oftenbased on human activity patterns andlevels reconstructed from historicaldata, contemporary data, or acombination of the two. Suchreconstruction is accompanied byanalysis of uncertainties consideredwith sensitivity analysis in theestimation of dose (Wyzga, 1988; U.S.EPA, 1986a). These uncertainties canalso be assessed for any confoundingfactor for which a quantitativeadjustment of dose response data ismade (U.S. EPA, 1984).

3.5. Technical Dose ResponseCharacterization

As with hazard characterization, thedose response characterization servesthe dual purposes of presenting atechnical characterization of theassessment results and supporting therisk characterization.

The characterization presents theresults of analyses of dose data, ofresponse data, and of dose response.When alternative approaches areplausible and persuasive in selectingdose data, response data, orextrapolation procedures, thecharacterization follows the alternativepaths of analysis and presents theresults. The discussion covers thequestion of whether any should bepreferred over others because it (or they)better represents the available data orcorresponds to the view of themechanism of action developed in thehazard assessment. The results fordifferent tumor types by sex and speciesare provided along with the one(s)preferred. Similarly, results forresponses other than tumor incidenceare shown if appropriate.

Numerical dose response estimatesare presented to one significant figure.Numbers are qualified as to whetherthey represent central tendency orupper bounds and whether the methodused is inherently more likely tooverestimate or underestimate (Krewskiet al., 1984).

In cases where a mode of action orother feature of the biology has beenidentified that has special implications


for early-life exposure, differentialeffects by sex, or other concerns forsensitive subpopulations, these areexplained. Similarly, any expectationsthat high dose-rate exposures may alterthe risk picture for some portion of thepopulation are described. These andother perspectives are recorded to guideexposure assessment and riskcharacterization. Whether the lifetimeaverage daily dose or another measureof dose should be considered fordiffering exposure scenarios isdiscussed.

Uncertainty analyses, qualitative orquantitative if possible, are highlightedin the characterization.

The dose response characterizationroutinely includes the following, asappropriate for the data available:

• Identification of the kinds of dataavailable for analysis of dose andresponse and for dose responseassessment,

• Results of assessment as above,• Explanation of analyses in terms of

quality of data available,• Selection of study/response and

dose metric for assessment,• Discussion of implications of

variability in human susceptibility,including for susceptible subpopulation,

• Applicability of results to varyingexposure scenarios—issues of route ofexposure, dose rate, frequency, andduration,

• Discussion of strengths andlimitations (uncertainties) of the dataand analyses that are quantitative aswell as qualitative, and

• Special issues of interpretation ofdata, such as:—Selecting dose data, response data,

and dose response approach(es),—Use of meta-analysis,—Uncertainty and quantitative

uncertainty analysis.

4. Technical Exposure CharacterizationGuidelines for exposure assessment of

carcinogenic and other agents arepublished (U.S. EPA, 1992a) and areused in conjunction with these cancerrisk assessment guidelines. Presentationof exposure descriptors is a subject ofdiscussion in EPA risk characterizationguidance (U.S. EPA, 1995). Theexposure characterization is a technicalcharacterization that presents theassessment results and supports riskcharacterization.

The characterization provides astatement of purpose, scope, level ofdetail, and approach used in theassessment, identifying the exposurescenario(s) covered. It estimates thedistribution of exposures amongmembers of the exposed population asthe data permit. It identifies and

compares the contribution of differentsources and routes and pathways ofexposure. Estimates of the magnitude,duration, and frequency of exposure areincluded as available monitoring ormodeling results or other reasonablemethods permit. The strengths andlimitations (uncertainties) of the dataand methods of estimation are madeclear.

The exposure characterizationroutinely includes the following, asappropriate and possible for the dataavailable:

• Identification of the kinds of dataavailable,

• Results of assessment as above,• Explanation of analyses in terms of

quality of data available,• Uncertainty analyses as discussed

in Exposure Assessment Guidelines,distinguishing uncertainty fromvariability, and

• Explanation of derivation ofestimators of ‘‘high end’’ or centraltendency of exposure and theirappropriate use.

5. Risk Characterization

5.1. Purpose

The risk characterization processincludes an integrative analysisfollowed by a presentation in a RiskCharacterization Summary, of the majorresults of the risk assessment. The RiskCharacterization Summary is anontechnical discussion that minimizesthe use of technical terms. It is anappraisal of the science that supportsthe risk manager in making publichealth decisions, as do otherdecisionmaking analyses of economic,social, or technology issues. It alsoserves the needs of other interestedreaders. The summary is an informationresource for preparation of riskcommunication information, but beingsomewhat technical, is not itself theusual vehicle for communication withevery audience.

The integrative analysis bringstogether the assessments andcharacterizations of hazard, doseresponse, and exposure to make riskestimates for the exposure scenarios ofinterest. This analysis is generally muchmore extensive than the RiskCharacterization Summary. It may bepeer-reviewed or subject to publiccomment along with the summary inpreparation for an Agency decision. Theintegrative analysis may be titleddifferently by different EPA programs(e.g., ‘‘Staff Paper’’ for criteria airpollutants), but it typically will identifyexposure scenarios of interest in adecisionmaking and present riskanalyses associated with them. Some of

the analyses may concern scenarios inseveral media, others may examine, forexample, only drinking water risks. Italso may be the document that containsquantitative analyses of uncertainty.

The values supported by a riskcharacterization throughout the processare transparency in environmentaldecisionmaking, clarity incommunication, consistency in coreassumptions and science policies fromcase to case, and reasonableness. Whileit is appropriate to err on the side ofprotection of health and theenvironment in the face of scientificuncertainty, common sense andreasonable application of assumptionsand policies are essential to avoidunrealistic estimates of risk (U.S. EPA,1995). Both integrative analyses and theRisk Characterization Summary presentan integrated and balanced picture ofthe analysis of the hazard, doseresponse, and exposure. The risk analystshould provide summaries of theevidence and results and describe thequality of available data and the degreeof confidence to be placed in the riskestimates. Important features includethe constraints of available data and thestate of knowledge, significant scientificissues, and significant science andscience policy choices that were madewhen alternative interpretations of dataexisted (U.S. EPA, 1995). Choices madeabout using default assumptions or datain the assessment are explicitlydiscussed in the course of analysis, andif a choice is a significant issue, it ishighlighted in the summary.

5.2. ApplicationRisk characterization is a necessary

part of generating any Agency report onrisk, whether the report is preliminaryto support allocation of resourcestoward further study or comprehensiveto support regulatory decisions. In theformer case, the detail andsophistication of the characterizationare appropriately small in scale; in thelatter case, appropriately extensive.Even if a document covers only parts ofa risk assessment (hazard and doseresponse analyses for instance), theresults of these are characterized.

Risk assessment is an iterative processthat grows in depth and scope in stagesfrom screening for priority-making, topreliminary estimation, to fullerexamination in support of complexregulatory decisionmaking. Defaultassumptions are used at every stagebecause no database is ever complete,but they are predominant at screeningstages and are used less as more data aregathered and incorporated at laterstages. Various provisions in EPA-administered statutes require decisions


based on findings that represent allstages of iteration. There are close to 30provisions within the major statutes thatrequire decisions based on risk, hazard,or exposure assessment. For example,Agency review of premanufacturenotices under section 5 of the ToxicSubstances Control Act relies onscreening analyses, while requirementsfor industry testing under section 4 ofthat Act rely on preliminary analyses ofrisk or simply of exposure. At the otherextreme, air quality criteria under theClean Air Act rest on a rich datacollection required by statute to undergoreassessment every few years. There areprovisions that require ranking ofhazards of numerous pollutants—by itsnature a screening level of analysis—and other provisions that require a fullassessment of risk. Given this range inthe scope and depth of analyses, not allrisk characterizations can or should beequal in coverage or depth. The riskassessor must carefully decide whichissues in a particular assessment areimportant to present, choosing thosethat are noteworthy in their impact onresults. For example, health effectassessments typically rely on animaldata since human data are rarelyavailable. The objective ofcharacterization of the use of animaldata is not to recount generic issuesabout interpreting and using animaldata. Agency guidance documents coverthese. Instead, the objective is to call outany significant issues that arose withinthe particular assessment beingcharacterized and inform the readerabout significant uncertainties thataffect conclusions.

5.3. Presentation of RiskCharacterization Summary

The presentation is a nontechnicaldiscussion of important conclusions,issues, and uncertainties that uses thehazard, dose-response, exposure, andintegrative analyses for technicalsupport. The primary technical supportswithin the risk assessment are thehazard characterization, dose responsecharacterization, and exposurecharacterization described in thisguideline. The risk characterization isderived from these. The presentationshould fulfill the aims outlined in thepurpose section above.

5.4. Content of Risk CharacterizationSummary

Specific guidance on hazard, doseresponse, and exposure characterizationappears in previous sections. Overall,the risk characterization routinelyincludes the following, capturing theimportant items covered in hazard, dose

response, and exposurecharacterization.

• Primary conclusions about hazard,dose response, and exposure, includingequally plausible alternatives,

• Nature of key supportinginformation and analytic methods,

• Risk estimates and their attendantuncertainties, including key uses ofdefault assumptions when data aremissing or uncertain,

• Statement of the extent ofextrapolation of risk estimates fromobserved data to exposure levels ofinterest (i.e., margin of exposure) and itsimplications for certainty or uncertaintyin qualtifying risk,

• Significant strengths andlimitations of the data and analyses,including any major peer reviewers’issues,

• Appropriate comparison withsimilar EPA risk analyses or commonrisks with which people may befamiliar, and

• Comparison with assessment of thesame problem by another organization.

Appendix A

This appendix contains several generalillustrations of weight of evidence narratives.In addition, after narrative #5 is an exampleof a briefing summary format.

NARRATIVE #1 Chlorinated Alkene

CAS# XXX

CANCER HAZARD SUMMARY

Chlorinated alkene (cl-alkene) is likely tobe carcinogenic to humans by all routes ofexposure. The weight of evidence of humancarcinogenicity of cl-alkene is based on (a)findings of carcinogenicity in rats and miceof both sexes by oral and inhalationexposures; (b) its similarity in structure toother chlorinated organics that are known tocause liver and kidney damage, and liver andkidney tumors in rats and mice; (c)suggestive evidence of a possible associationbetween cl-alkene exposure of workers in thelaundry and dry cleaning industries andincreased cancer risk in a number of organsystems; and (d) human and animal dataindicating that cl-alkene is absorbed by allroutes of exposure.

In comparison with other agentsdesignated as likely carcinogens, the overallweight of evidence for cl-alkene places it atthe low end of the grouping. This is becauseone cannot attribute observed excess cancerrisk in exposed workers solely to cl-alkene.Moreover, there is considerable scientificuncertainty about the human significanceand relevance of certain rodent tumorsassociated with exposure to cl-alkene andother chlorinated organics, but insufficientevidence about mode of action for the animaltumors. Hence, the human relevance of theanimal evidence of carcinogenicity relies ona default assumption of relevance.

There is no clear evidence about the modeof action for each tumor type induced in ratsand mice. Available evidence suggests that

cl-alkene induces cancer mainly bypromoting cell growth rather than via directmutagenic action, although a mutagenicmode of action for rat kidney tumors cannotbe ruled out. The dose response assessmentshould, therefore, adopt both defaultapproaches, nonlinear and linear. It isrecognized that the latter approach likelyoverestimates risk at low doses if the modeof action is primarily growth-promoting. Thisapproach, however, may be useful forscreening analyses.SUPPORTING INFORMATION

Human DataA number of epidemiologic studies of dry

cleaning and laundry workers that havereported elevated incidences of lung, cervix,esophagus, kidney, blood and lymphoidcancers. Many of these studies areconfounded by co-exposure to otherpetroleum solvents, making them limited fordetermining whether the observed increasedcancer risks are causally related to cl-alkene.The only investigation of dry cleaningworkers with no known exposure to otherchemicals did not evaluate otherconfounding factors such as smoking, alcoholconsumption, and low socioeconomic statusto exclude the possible contribution of thesefactors to cancer risks.Animal Data

The carcinogenic potential of cl-alkene hasbeen adequately investigated in two chronicstudies in two rodent species, the first studyby gavage and the second study byinhalation. Cl-alkene is carcinogenic in theliver in both sexes of mice when tested byeither route of exposure. It causes marginallyincreased incidences of mononuclear cellleukemia (MCL) in both sexes of rats and lowincidences of a rare kidney tumor in malerats by inhalation. No increases in tumorincidence were found in rats treated with cl-alkene by gavage. This rat study wasconsidered limited because of high mortalityof the animals.

Although cl-alkene causes increasedincidences of tumors at multiple sites in tworodent species, controversy surrounds eachof the tumor endpoints concerning theirrelevance and/or significance to humans (seediscussion under Mode of Action).Other Key Data

Cl-alkene is a member of a class ofchlorinated organics that often cause liverand kidney toxicity and carcinogenesis inrodents. Like many chlorinatedhydrocarbons, cl-alkene itself is testednegative in a battery of standard genotoxicitytests using bacterial and mammalian cellssystems including human lymphocytes andfibroblast cells. There is evidence, however,that a minor metabolite generated by anenzyme found in rat kidney tissue ismutagenic. This kidney metabolite has beenhypothesized to be related to thedevelopment of kidney tumors in the malerat. This metabolic pathway appears to beoperative in the human kidney.

Human data indicate that cl-alkene isreadily absorbed via inhalation but to a muchlesser extent by skin contact. Animal datashow that cl-alkene is absorbed well by theoral route.


MODE OF ACTIONThe mechanisms of cl-alkene-induced

mouse liver tumors are not completelyunderstood. One mechanism has beenhypothesized to be mediated by a genotoxicepoxide metabolite generated by enzymesfound in the mouse liver, but there is a lackof direct evidence in support of thismechanism. A more plausible mechanismthat still needs to be further defined is relatedto liver peroxisomal proliferation andtoxicity by TCA (trichloroacetic acid), amajor metabolite of cl-alkene. However, thereare no definitive data indicating that TCAinduces peroxisomal proliferation inhumans.

The mechanisms by which cl-alkeneinduces kidney tumors in male rats are evenless well understood. The rat kidneyresponse may be related to either kidneytoxicity or the activity of a mutagenicmetabolite of the parent compound.

The human relevance of cl-alkene-inducedMCL in rats is unclear. The biologicalsignificance of marginally increasedincidences of MCL has been questioned bysome, since this tumor occurs spontaneouslyin the tested rat strain at very highbackground rates. On the other hand, it hasbeen considered by others to be a true findingbecause there was a decreased time to onsetof the disease and the disease was moresevere in treated as compared with untreatedcontrol animals. The exact mechanism bywhich cl-alkene increases incidences of MCLin rats is not known.

Overall, there is not enough evidence togive high confidence in a conclusion aboutany single mode of action; it would appearthat more than a single mode operates indifferent rodent tissues. The apparent lack ofmutagenicity of cl-alkene itself and itsgeneral growth-promoting effect on highbackground tumors as well as its toxicitytoward mouse liver and rat kidney tissuesupport the view that its predominant modeof action is cell growth promoting rather thanmutagenic. A mutagenic contribution to therenal carcinogenicity due to a metabolitecannot be entirely ruled out.

NARRATIVE #2

Unsaturated AldehydeCAS# XXX

CANCER HAZARD SUMMARYThe potential human hazard of unsaturated

aldehyde (UA) cannot be determined, butthere are suggestive data for carcinogenicity.

The evidence on carcinogenicity consistsof (a) data from an oral animal study showinga response only at the highest dose in femalerats, with no response in males and (b) thefact that other low-molecular-weightaldehydes have shown tumorigenicity in therespiratory tract after inhalation. The onestudy of UA effects by the inhalation routewas not adequately performed. The availableevidence is too limited to describe humancarcinogenicity potential or support doseresponse assessment.SUPPORTING INFORMATION

Human DataAn elevated incidence of cancer was

reported in a cohort of workers in a chemical

plant who were exposed to a mixture ofchemicals including UA as a minorcomponent. The study is consideredinadequate because of the small size of thecohort studied and the lack of adequateexposure data.Animal Data

In a long-term drinking water study in rats,an increased incidence of adrenal corticaladenomas was found in the highest-dosedfemales. No other significant finding wasmade. The oral rat study was well conductedby a standard protocol. In a 1-year study inhamsters at one inhalation dose, no tumorswere seen. This study was inadequate due tohigh mortality and consequent shortduration. The chemical is very irritating andis a respiratory toxicant in mammals. Theanimal data are too limited for conclusionsto be drawn.Structural Analogue Data

UA’s structural analogues, formaldehydeand acetaldehyde, both have carcinogeniceffects on the rat respiratory tract.Other Key Data

The weight of results of mutagenicity testsin bacteria, fungi, fruit flies, and mice resultin an overall conclusion of not mutagenic;UA is lethal to bacteria to a degree that makestesting difficult and test results difficult tointerpret. The chemical is readily absorbedby all routes.MODE OF ACTION

Data are not sufficient to judge whetherthere is a carcinogenic mode of action.

NARRATIVE #3

Alkene Oxide

CAS# XXX

CANCER HAZARD SUMMARYAlkene oxide (AO) should be dealt with as

if it were a known human carcinogen by allroutes of exposure. Several studies inworkers, when considered together, suggestan elevated risk of leukemia and lymphomaafter long-term exposure to AO, even thoughno single study conclusively demonstratesthat AO caused the cancer. In addition,animal cancer and mutagenicity studies aswell as short-term tests of mutagenicity havestrongly consistent results that support alevel of concern equal to having conclusivehuman studies.

The weight of evidence of humancarcinogenicity is based on (a) consistentevidence of carcinogenicity of AO in rats andmice by both oral and inhalation exposure;(b) studies in workers that taken togethersuggest elevated risk of leukemia andlymphoma to workers exposed to AO andshow genetic damage in blood lymphocytesin exposed workers; (c) mutagenic effects innumerous test systems and heritable genemutations in animals; and (d) membership ina class of DNA-reactive compounds that areregularly observed to cause cancer inanimals.

Due to its ready absorption by all routes ofexposure and rapid distribution throughoutthe body, AO is expected to pose a risk byany route of exposure. The strong evidenceof a mutagenic mode of action supports dose

response assessment that assumes linearity ofthe relationship.SUPPORTING INFORMATION

Human DataElevated risks of lymphatic cancer and

cancer of blood-forming tissue have beenreported in exposed workers in severalstudies. The interpretation of the studiesseparately is complicated by exposures toother agents in each so there is no singlestudy that demonstrates that AO caused theeffects; nevertheless, several of the studiestogether are considered suggestive of AOcarcinogenicity because they consistentlyshow cancer elevation in the same tissues.Biomonitoring studies of exposed workersfind DNA damage in blood lymphocytes andthe degree of DNA damage correlates withthe level and duration of AO exposure.Finding this damage in the same tissue inwhich elevated cancer was seen in workersadds further weight to the positive suggestionfrom the worker cancer studies. The humandata are from well-conducted studies.Animal Data

AO causes cancer in multiple tissue sitesin rats and mice of both sexes by oral andinhalation exposure. The database is moreextensive than usual and the studies aregood. The observation of multisite,multispecies carcinogenic activity by anagent is considered to be very strongevidence and is often the case with highlymutagenic agents. There are also good studiesshowing that AO causes heritable germ cellmutations in mice after inhalationexposure—a property that is very highlycorrelated with carcinogenicity.Structural Analogue Data

Organic epoxides are commonly found tohave carcinogenic effects in animals,particularly the low-molecular-weight ones.Other Key Data

The structure and DNA reactivity of AOsupport potential carcinogenicity. Bothproperties are highly correlated withcarcinogenicity. Positive mutagenicity testsin vitro and in vivo add to this support andare reinforced by observation of similargenetic damage in exposed workers.

AO is experimentally observed to bereadily absorbed by all routes and rapidlydistributed through the body.MODE OF ACTION

All of the available data are stronglysupportive of a mutagenic mode of action,with a particular human target in lymphaticand blood-forming tissue. The currentscientific consensus is that there is virtuallycomplete correspondence between ability ofan agent to cause heritable germ cellmutations, as AO does, and carcinogenicity.All of this points to a mutagenic mode ofaction and supports assuming linearity of thedose response relationship.

NARRATIVE #4

Bis-benzenamineCAS# XXX

CANCER HAZARD SUMMARYThis chemical is likely to be carcinogenic

to humans by all routes of exposure. Its


carcinogenic potential is indicated by (a)tumor and toxicity studies on structuralanalogues, which demonstrate the ability ofthe chemical to produce thyroid follicularcell tumors in rats and hepatocellular tumorsin mice following ingestion and (b)metabolism and hormonal information on thechemical and its analogues, whichcontributes to a working mode of action andassociates findings in animals with those inexposed humans. In comparison with otheragents designated as likely carcinogens, theoverall weight of evidence for this chemicalplaces it at the lower end of the grouping.This is because there is a lack of tumorresponse data on this agent itself.

Biological information on the compound iscontradictory in terms of how to quantitatepotential cancer risks. The information ondisruption on thyroid-pituitary status arguesfor using a margin of exposure evaluation.However, the chemical is an aromatic amine,a class of agents that are DNA-reactive andinduce gene mutation and chromosomeaberrations, which argues for low-doselinearity. Additionally, there is a lack ofmode of action information on the mouseliver tumors produced by the structuralanalogues, also pointing toward a low-doselinear default approach. In recognition ofthese uncertainties, it is recommended toquantitate tumors using both nonlinear (toplace a lower bound on the risks) and linear(to place an upper bound on the risks) defaultapproaches. Given the absence of tumorresponse data on the chemical per se, it isrecommended that tumor data on closeanalogues be used to possibly developtoxicity equivalent factors or relativepotencies.

Overall, this chemical is an inferential casefor potential human carcinogenicity. Theuncertainties associated with this assessmentinclude (1) the lack of carcinogenicity studieson the chemical, (2) the use of tumor data onstructural analogues, (3) the lack of definitiveinformation on the relevance of thyroid-pituitary imbalance for humancarcinogenicity, and (4) the differentpotential mechanisms that may influencetumor development and potential risks.SUPPORTING INFORMATION

Human DataWorker exposure has not been well

characterized or quantified, but recentmedical monitoring of workers exposed overa period of several years has uncoveredalterations in thyroid-pituitary hormones (adecrease in T3 and T4 and an increase inTSH) and symptoms of hypothyroidism. Aurinary metabolite of the chemical has beenmonitored in workers, with changes inthyroid and pituitary hormones noted, andthe changes were similar to those seen in ananimal study.Animal Data

The concentration of the urinarymetabolite in rats receiving the chemical for28 days was within twofold of that inexposed workers, a finding associated withcomparable changes in thyroid hormones andTSH levels. In addition, the dose of thechemical given to rats in this study wasessentially the same as that of an analogue

that had produced thyroid and pituitarytumors in rats. The human thyroid respondsin the same way as the rodent thyroidfollowing short-term, limited exposure.Although it is not well established thatthyroid-pituitary imbalance leads to cancerin humans as it does in rodents, informationin animals and in exposed humans suggestssimilar mechanisms of disrupting thyroid-pituitary function and the potential role ofaltered TSH levels in leading to thyroidcarcinogenesis.Structural Analogue Data

This chemical is an aromatic amine, amember of a class of chemicals that hasregularly produced carcinogenic effects inrodents and gene and structural chromosomeaberrations in short-term tests. Somearomatic amines have produced cancer inhumans.

Close structural analogues produce thyroidfollicular cell tumors in rats andhepatocellular tumors in mice followingingestion. The thyroid tumors are associatedwith known perturbations in thyroid-pituitary functioning. These compoundsinhibit the use of iodide by the thyroid gland,apparently due to inhibition of the enzymethat synthesizes the thyroid hormones (T3,T4). Accordingly, blood levels of thyroidhormones decrease, which induce thepituitary gland to produce more TSH, ahormone that stimulates the thyroid toproduce more of its hormones. The thyroidgland becomes larger due to increases in thesize of individual cells and their proliferationand upon chronic administration, tumorsdevelop. Thus, thyroid tumor development issignificantly influenced by disruption in thethyroid-pituitary axis.Other Key Data

The chemical can be absorbed by the oral,inhalation, and dermal routes of exposure.MODE OF ACTION

Data on the chemical and on structuralanalogues indicate the potential associationof carcinogenesis with perturbation ofthyroid-pituitary homeostasis. Structuralanalogues are genotoxic, thus raising thepossibility of different mechanisms by whichthis chemical may influence tumordevelopment.

NARRATIVE #5

Brominated Alkane (BA)

CAS# XXX

CANCER HAZARD SUMMARYBrominated alkane (BA) is likely to be a

human carcinogen by all routes of exposure.The weight of evidence for humancarcinogenicity is at the high end of agentsin the ‘‘likely’’ group. Findings are based onvery extensive and significant experimentalfindings that include (a) tumors at multiplesites in both sexes of two rodent species viathree routes of administration relevant tohuman exposure, (b) close structuralanalogues that produce a spectrum of tumorslike BA, (c) significant evidence for theproduction of reactive BA metabolites thatreadily bind to DNA and produce genemutations in many systems includingcultured mammalian and human cells, and

(d) two null and one positive epidemiologicstudy; in the positive study, there may havebeen exposure to BA. These findings supporta decision that BA might produce cancer inexposed humans. In comparison to otheragents considered likely human carcinogens,the overall weight of evidence for BA puts itnear the top of the grouping. Given theagent’s mutagenicity, which can influencethe carcinogenic process, a linear dose-response extrapolation is recommended.

Uncertainties include the lack of adequateinformation on the mutagenicity of BA inmammals or humans in vivo, although sucheffects would be expected.SUPPORTING INFORMATION

Human DataThe information on the carcinogenicity of

BA from human studies is inadequate. Twostudies of production workers have notshown significant increases in cancer fromexposure to BA and other chemicals. Anincrease in lymphatic cancer was reported ina mortality study of grain elevator workerswho may have been exposed to BA (andother chemicals).Animal Data

BA produced tumors in four chronicrodents studies. Tumor increases were notedin males and females of rats and micefollowing oral dermal and inhalationexposure (rat—oral and two inhalation,mouse—oral and dermal). It produces tumorsboth at the site of application (e.g., skin withdermal exposure) and at sites distal to theportal of entry into the body (e.g., mammarygland) following exposure from each route.Tumors at the same site were noted in bothsexes of a species (blood vessel), both species(forestomach) and via different routes ofadministration (lung). Some tumorsdeveloped after very short latency,metastasized extensively, and produceddeath, an uncommon findings in rodents.The rodent studies were well designed andconducted except for the oral studies, inwhich the doses employed caused excessivetoxicity and mortality. However, given theother rodent findings, lower doses wouldalso be anticipated to be carcinogenic.Structural Analogue Data

Several chemicals structurally related toBA are also carcinogenic in rodents. Amongfour that are closest in structure, tumors likethose seen for BA were often noted (e.g.,forestomach, mammary, lung), which helpsto confirm the findings for BA itself. In sum,all of the tumor findings help to establishanimal carcinogenicity and support potentialhuman carcinogenicity for BA.Other Key Data

BA itself is not reactive, but from itsstructure it was expected to be metabolizedto reactive forms. Extensive metabolismstudies have confined this presumption andhave demonstrated metabolites that bind toDNA and cause breaks in the DNA chain.These lesions are readily converted to genemutations in bacteria, fungi, higher plants,insects and mammalian and human cells inculture. There are only a limited number ofreports on the induction of chromosomeaberrations in mammals and humans; thusfar they are negative.


MODE OF ACTIONHuman carcinogens often produce cancer

in multiple sites of multiple animal speciesand both sexes and are mutagenic in multipletest systems. BA satisfies these findings. Itproduces cancer in males and females of ratsand mice. It produces gene mutations in cellsacross all life forms—plants, bacteria andanimals—including mammals and humans.Given the mutagenicity of BA exposure andthe multiplicity and short latency of BAtumor induction, it is reasonable to use alinear approach for cancer dose-responseextrapolation.BRIEFING SUMMARY

Route(s) ClassDesigna-

tion orrationale

Dose re-sponse

All .............. Likely .... High end Default-linear.

Basis for classification/dose response1. Human data: Two studies of production

workers show no increase in cancer (one hada small sample size; the other had mixedchemical exposures). An increase inlymphatic cancer is seen among grainelevator workers who may have beenexposed to other chemicals.

2. Animal data: BA produces tumors atmultiple sites in male and female rats andmice following oral, dermal, and inhalationexposure. Tumors are seen at the site ofadministration and distally and are oftenconsistent across sex, species, and route ofadministration; some develop early,metastasize, and cause death.

3. Structural analogue data: Closeanalogues produce some of the same tumorsas are seen with BA.

4. Other key data: BA is metabolized to areactive chemical that binds DNA andproduces gene mutations in essentially everytest system including cultured human cells.

5. Mode of action: Like most known humancarcinogens, BA is mutagenic in most testsystems.

6. Hazard classification/uncertainties:There is a rich database on BA demonstratingits potential ability to cause tumors inhumans, including (a) multiple animaltumors, (b) by appropriate routes of exposure,(c) a mode of action relevant to humancarcinogenicity, and (d) some information inhumans. Together they lead to a designationnear the high end of the likely humancarcinogen class.

7. Dose response: Given the anticipatedmode of action, a linear default doseresponse relationship should be assumed.

Appendix BThis appendix contains responses to

the National Academy of SciencesNational Research Council reportScience and Judgment in RiskAssessment (NRC, 1994).

Recommendations of the National Academyof Sciences National Research Council

In 1994, the National Academy of Sciencespublished a report Science and Judgment inRisk Assessment. The 1994 report was

written by a Committee on Risk Assessmentof Hazardous Air Pollutants formed underthe Academy’s Board on EnvironmentalStudies and Toxicology, Commission on LifeSciences, National Research Council. Thereport was called for under Section112(o)(1)(A,B) of the Clean Air ActAmendments of 1990, which provided for theEPA to arrange for the Academy to review:

• risk assessment methodology used by theEPA to determine the carcinogenic riskassociated with exposure to hazardous airpollutants from source categories andsubcategories subject to the requirements ofthis section and

• improvements in such methodology.Under Section 112(o)(2)(A,B), the Academy

was to consider the following in its review:• the techniques used for estimating and

describing the carcinogenic potency tohumans of hazardous air pollutants and

• the techniques used for estimatingexposure to hazardous air pollutants (forhypothetical and actual maximally exposedindividuals as well as other exposedindividuals).

To the extent practicable, the Academywas also to review methods of assessingadverse human health effects other thancancer for which safe thresholds of exposuremay not exist [Section 112(o)(3)]. TheCongress further provided that the EPAAdministrator should consider, but need notadopt, the recommendations in the reportand the views of the EPA Science AdvisoryBoard with respect to the report. Prior to thepromulgation of any standards under Section112(f), the Administrator is to publishrevised guidelines for carcinogenic riskassessment or a detailed explanation of thereasons that any recommendations containedin the report will not be implemented[Section 112(o)(6)].

The following discussion addresses therecommendations of the 1994 report that arepertinent to the EPA cancer risk assessmentguidelines. Guidelines for assessment ofexposure, of mixtures, and of other healtheffects are separate EPA publications. Manyof the recommendations were related topractices specific to the exposure assessmentof hazardous air pollutants, which are notcovered in cancer assessment guidelines.Recommendations about these otherguidelines or practices are not addressedhere.

Hazard ClassificationThe 1994 report contains the following

recommendation about classifying cancerhazard:

• The EPA should develop a two-partscheme for classifying evidence oncarcinogenicity that would incorporate botha simple classification and a narrativeevaluation. At a minimum, both parts shouldinclude the strength (quality) of the evidence,the relevance of the animal model and resultsto humans, and the relevance of theexperimental exposures (route, dose, timing,and duration) to those likely to beencountered by humans.

The report also presented a possible matrixof 24 boxes that would array weights ofevidence against low, medium, or highrelevance, resulting in 24 codes forexpressing the weight and relevance.

These guidelines adopt a set of descriptorsand subdescriptors of weight of evidence inthree categories: ‘‘known/likely,’’ ‘‘cannot bedetermined,’’ and ‘‘not likely,’’ and anarrative for presentation of the weight ofevidence findings. The descriptors are usedwithin the narrative. There is no matrix ofalphanumerical weight of evidence boxes.

The issue of an animal model that is notrelevant to humans has been dealt with bynot including an irrelevant response in theweighing of evidence, rather than by creatinga weight of evidence then appending adiscounting factor as the NRC scheme woulddo. The issue is more complex than the NRCmatrix makes apparent. Often the question ofrelevance of the animal model applies to asingle tumor response, but one encounterssituations in which there are more tumorresponses in animals than the questionedone. Dealing with this complexity is morestraightforward if it is done during theweighing of evidence rather than after as inthe NRC scheme. Moreover, the sameexperimental data are involved in decidingon the weight of evidence and the relevanceof a response. It would be awkward to goover the same data twice.

In recommending that the relevance ofcircumstances of human exposure also betaken into account, the NRC appears toassume that all of the actual conditions ofhuman exposure will be known when theclassification is done. This is not the case.More often than not, the hazard assessmentis applied to assessment of risks associatedwith exposure to different media orenvironments at different times. In somecases, there is no priority to obtainingexposure data until the hazard assessmenthas been done. The approach of theseguidelines is to characterize hazards as towhether their expression is intrinsicallylimited by route of exposure or by reachinga particular dose range based strictly ontoxicological and other biological features ofthe agent. Both the use of descriptors and thenarrative specifically capture thisinformation. Other aspects of appropriateapplication of the hazard and dose responseassessment to particular human exposurescenarios are dealt with in thecharacterization of the dose responseassessment, e.g., the applicability of the doseresponse assessment to scenarios withdiffering frequencies and durations.

The NRC scheme apparently intended thatthe evidence would be weighed, then givena low, medium, or high code for somecombination of relevance of the animalresponse, route of exposure, timing, duration,or frequency. The 24 codes contain none ofthis specific information, and in fact, do notcommunicate what the conclusion is about.To make the codes communicate theinformation apparently intended wouldrequire some multiple of the 24 in the NRCscheme. As the number of codes increases,their utility for communication decreases.

Another reason for declining to use codesis that they tend to become outdated asresearch reveals new information that wasnot contemplated when they were adopted.This has been the case with the classificationsystem under the EPA, 1986 guidelines.

Even though these guidelines do not adopta matrix of codes, the method they provide


of using descriptors and narratives capturesthe information the NRC recommended asthe most important, and in the EPA’s view,in a more transparent manner.

Dose Response• The 1994 report contains the following

recommendations about dose responseissues:

• EPA should continue to explore, andwhen scientifically appropriate, incorporatetoxicokinetic models of the link betweenexposure and biologically effective dose (i.e.,dose reaching the target tissue).

• Despite the advantages of developingconsistent risk assessments between agenciesby using common assumptions (e.g.,replacing surface area with body weight tothe 0.75 power), EPA should indicate othermethods, if any, that would be more accurate.

• EPA should continue to use thelinearized multistage model as a defaultoption but should develop criteria fordetermining when information is sufficient touse an alternative extrapolation model.

• EPA should continue to use as one of itsrisk characterization metrics upper-boundpotency estimates of the probability ofdeveloping cancer due to lifetime exposure.Whenever possible, this metric should besupplemented with other descriptions ofcancer potency that might more adequatelyreflect the uncertainty associated with theestimates.

• EPA should adopt a default assumptionfor differences in susceptibility amonghumans in estimating individual risks.

• In the analysis of animal bioassay dataon the occurrence of multiple tumor types,the cancer potencies should be estimated foreach relevant tumor type that is related toexposure and the individual potenciesshould be summed for those tumors.

The use of toxicokinetic models isencouraged in these guidelines withdiscussion of appropriate considerations fortheir use. When there are questions as towhether such a model is more accurate in aparticular case than the default method forestimating the human equivalent dose, bothalternatives may be used. It should be notedthat the default method for inhalationexposure is a toxicokinetic model.

The rationale for adopting the oral scalingfactor of body weight to the 0.75 power hasbeen discussed above in the explanation ofmajor defaults. The empirical basis is furtherexplored in U.S. EPA, 1992b. The moreaccurate approach is to use a toxicokineticmodel when data become available or tomodify the default when data are available asencouraged under these guidelines. As theU.S. EPA, 1992b discussion explores indepth, data on the differences among animalsin response to toxic agents are basicallyconsistent with using a power of 1.0, 0.75, or0.66. The Federal agencies chose the powerof 0.75 for the scientific reasons given in theprevious discussion of major defaults; thesewere not addressed specifically in the NRCreport. It was also considered appropriate, asa matter of policy, for the agencies to agreeon one factor. Again, the default forinhalation exposure is a model that isconstructed to become better as more agent-specific data become available.

The EPA proposes not to use a computermodel such as the linearized multistagemodel as a default for extrapolation belowthe observed range. The reason is that thebasis for default extrapolation is a theoreticalprojection of the likely shape of the curveconsidering mode of action. For this purpose,a computer model looks more sophisticatedthan a straight line extrapolation, but is not.The extrapolation will be by straight line asexplained in the explanation of majordefaults. This was also recommended byworkshop reviewers of a previous draft ofthese guidelines (U.S. EPA, 1994b). Inaddition, a margin of exposure analysis isproposed to be used in cases in which thecurve is thought to be nonlinear, based onmode of action. In both cases, the observedrange of data will be modeled by curve fittingin the absence of supporting data for abiologically based or case-specific model.

The result of using straight lineextrapolation is thought to be an upperbound on low-dose potency to the humanpopulation in most cases, but as discussed inthe major defaults section, it may not alwaysbe. Exploration and discussion of uncertaintyof parameters in curve-fitting a model of theobserved data or in using a biologically basedor case-specific model is called for in thedose response assessment andcharacterization sections of these guidelines.

The issue of a default assumption forhuman differences in susceptibility has beenaddressed under the major defaultsdiscussion in section 1.3 with respect tomargin of exposure analysis. The EPA hasconsidered but decided not to adopt aquantitative default factor for humandifferences in susceptibility when a linearextrapolation is used. In general, the EPAbelieves that the linear extrapolation issufficiently conservative to protect publichealth. Linear approaches (both LMS andstraight line extrapolation) from animal dataare consistent with linear extrapolation onthe same agents from human data (Goodmanand Wilson, 1991; Hoel and Portier, 1994). Ifactual data on human variability insensitivity are available they will, of course,be used.

In analyzing animal bioassay data on theoccurrence of multiple tumor types, theseguidelines outline a number of biological andother factors to consider. The objective is touse these factors to select response data(including nontumor data as appropriate)that best represent the biology observed. Asstated in section 3 of the guidelines,appropriate options include use of a singledata set, combining data from differentexperiments, showing a range of results frommore than one data set, showing results fromanalysis of more than one tumor responsebased on differing modes of action,representing total response in a singleexperiment by combining animals withtumors, or a combination of these options.The approach judged to best represent thedata is presented with the rationale for thejudgment, including the biological andstatistical considerations involved. The EPAhas considered the approach of summingtumor incidences and decided not to adoptit. While multiple tumors may beindependent, in the sense of not arising from

metastases of a single malignancy, it is notclear that they can be assumed to representdifferent effects of the agent on cancerprocesses. In this connection, it is not clearthat summing incidences provides a betterrepresentation of the underlying mode(s) ofaction of the agent than combining animalswith tumors or using another of the severaloptions noted above. Summing incidenceswould result in a higher risk estimate, a stepthat appears unnecessary without morereason.

Risk Characterization• When EPA reports estimates of risk to

decisionmakers and the public, it shouldpresent not only point estimates of risk, butalso the sources and magnitudes ofuncertainty associated with these estimates.

• Risk managers should be givencharacterizations of risk that are bothqualitative and quantitative, i.e., bothdescriptive and mathematical.

• EPA should consider in its riskassessments the limits of scientificknowledge, the remaining uncertainties, andthe desire to identify errors of eitheroverestimation or underestimation.

In part as a response to theserecommendations, the Administrator of EPAissued guidelines for risk characterizationand required implementation plans from allprograms in EPA (U.S. EPA, 1995). TheAdministrator’s guidance is followed in thesecancer guidelines. The assessments ofhazard, dose response, and exposure will allhave accompanying technicalcharacterizations covering issues of strengthsand limitations of data and current scientificunderstanding, identification of defaultsutilized in the face of gaps in the former,discussions of controversial issues, anddiscussions of uncertainties in both theirqualitative, and as practicable, theirquantitative aspects.

Appendix C

Overview of Cancer ProcessesThe following picture is changing as

research reveals more about carcinogenicprocesses. Nevertheless, it is apparent thatseveral general modes of action are beingelucidated from direct reaction with DNA tohormonal or other growth-signalingprocesses. While the exact mechanism ofaction of an agent at the molecular level maynot be clear from existing data, the availabledata will often provide support for deducingthe general mode of action. Under theseguidelines, using all of the available data toarrive at a view of the mode of actionsupports both characterization of humanhazard potential and assessment of doseresponse relationships.

Cancers are diseases of somatic mutationaffecting cell growth and differentiation. Thegenes that control cell growth, programmedcell death, and cell differentiation are criticalto normal development of tissues fromembryo to adult metazoan organisms. Thesegenes continue to be critical to maintenanceof form and function of tissues in the adult(e.g., Meyn, 1993) and changes in them areessential elements of carcinogenesis (Hsu etal., 1991; Kakizuka et al., 1991; Bottaro et al.,1991; Sidransky et al., 1991; Salomon et al.,


1990; Srivastava et al., 1990). The genesinvolved are among the most highlyconserved in evolution as evidenced by thegreat homology of many of them in DNAsequence and function in organisms asphylogenetically distant as worms, insects,and mammals (Auger et al., 1989a, b;Hollstein et al., 1991; Herschman, 1991;Strausfeld et al., 1991; Forsburg and Nurse,1991).

Mutations affecting three general categoriesof genes have been implicated incarcinogenesis. Over 100 oncogenes havebeen found in human and animal tumors thatact as dominant alleles, whereas there areabout 10 known tumor suppressor genes thatare recessive in action. The normal alleles ofthese genes are involved with control of celldivision and differentiation; mutated alleleslead to a disruption in these functions. Thethird class are mutator genes that predisposethe genome to enhanced mutagenic eventsthat contribute further to the carcinogenicprocess.

Adult tissues, even those that arecomposed of rapidly replicating cells,maintain a constant size and cell number(Nunez et al., 1991) by balancing three cellfates: (1) continued replication, (2)differentiation to take on specializedfunctions, or (3) programmed cell death(apoptosis) (Raff, 1992; Maller, 1991; Naeveet al., 1991; Schneider et al., 1991; Harris,1990). Neoplastic growth through clonalexpansion can result from somatic mutationsthat inactivate control over cell fate(Kakizuka et al., 1991; deThe et al., 1991;Sidransky et al., 1992; Nowell, 1976).

Cancers may also be thought of as diseasesof the cell cycle. For example, geneticdiseases that cause failure of cells to repairDNA damage prior to cell replicationpredispose people to cancer. These changesare also frequently found in tumor cells insporadic cancers. These changes appear to beparticularly involved at points in cellreplication called ‘‘checkpoints’’ where DNAsynthesis or mitosis is normally stoppeduntil DNA damage is repaired or cell deathinduced (Tobey, 1975). A cell that bypassesa checkpoint may acquire a heritable growthadvantage. Similar effects on the cell cycleoccur when mitogens such as hormones orgrowth factors stimulate cell growth. Rapidreplication in response to tissue injury mayalso lead to unrepaired DNA damage that isa risk factor for carcinogenesis.

Normally a cell’s fate is determined by atimed sequence of biochemical signals.Signal transduction in the cell involveschemical signals that bind to receptors,generating further signals in a pathwaywhose target in many cases is control oftranscription of a specific set of genes(Hunter, 1991; Cantley et al., 1991; Collumand Alt, 1990). Cells are subject to growthsignals from the same and distant tissues,e.g., endocrine tissues (Schuller, 1991). Inaddition to hormones produced by endocrinetissues, numerous soluble polypeptidegrowth factors have been identified thatcontrol normal growth and differentiation(Cross and Dexter, 1991; Wellstein et al.,1990). The cells responsive to a particulargrowth factor are those that expresstransmembrane receptors that specificallybind the growth factor.

Solid tumors develop in stagesoperationally defined as initiation,promotion, and progression (see, forexample, Pitot and Dragan, 1991). Theseterms, which were coined in the context ofspecific experimental designs, are used forconvenience in discussing concepts, but theyrefer to complex events that are notcompletely understood. During initiation, thecell acquires a genetic change that confers apotential growth advantage. Duringpromotion, clonal expansion of this alteredcell occurs. Later, during progression, a seriesof genetic and other biological events bothenhance the growth advantage of the cellsand enlist normal host processes to supporttumor development and cells develop theability to invade locally and metastasizedistally, taking on the characteristics ofmalignancy. Many endogenous andexogenous factors are known to participate inthe process as a whole. These includespecific genetic predispositions or variationsin ability to detoxify agents, medical history(Harris, 1989; Nebreda et al., 1991),infections, exposure to chemicals or ionizingradiation, hormones and growth factors, andimmune suppression. Several such riskfactors likely work together to causeindividual human cancers.

A cell that has been transformed, acquiringthe potential to establish a line of cells thatgrow to a tumor, will probably realize thatpotential only rarely. The process oftumorigenesis in animals and humans is amultistep one (Bouk, 1990; Fearon andVogelstein, 1990; Hunter, 1991; Kumar et al.,1990; Sukumar, 1989; Sukumar, 1990) andnormal physiological processes appear to bearrayed against uncontrolled growth of atransformed cell (Weinberg, 1989). Powerfulinhibition by signals from contact withneighboring normal cells is one knownbarrier (Zhang et al., 1992). Another is theimmune system (at least for viral infection).How a cell with tumorigenic potentialacquires additional properties that arenecessary to enable it to overcome these andother inhibitory processes is a subject ofongoing research. For known humancarcinogens studied thus far, there is an oftendecades-long latency between exposure tocarcinogenic agents and development oftumors (Fidler and Radinsky, 1990; Tanaka etal., 1991; Thompson et al., 1989). Thislatency is also typical of tumor developmentin individuals with genetic diseases thatmake them prone to cancer (Meyn, 1993;Srivastava et al., 1990).

The importance of genetic mutation in thecarcinogenic process calls for specialattention to assessing agents that cause suchmutations. Heritable genetic defects thatpredispose humans to cancer are well knownand the number of identified defects isgrowing. Examples include xerodermapigmentosum (DNA repair defect) and LiFraumeni and retinoblastoma (both are tumorsuppressor gene mutations). Much of thescreening and testing of agents forcarcinogenic potential has been driven by theidea of identifying this mode of action.Cognizance of and emphasis on other modesof action such as ones that act at the level ofgrowth signalling within or between cells,through cell receptors, or that indirectly

cause genetic change, comes from morerecent research. There are not yetstandardized tests for many modes of action,but pertinent information may be available inindividual cases.

Agents of differing characteristicsinfluence cancer development: inorganic andorganic, naturally occurring and synthetic, ofinanimate or animate origin, endogenous orexogenous, dietary and nondietary. Themeans by which these agents act to influencecarcinogenesis are variable, and reasonedhazard assessment requires consideration ofthe multiple ways that chemicals influencecells in experimental systems and in humans.Agents exert mutagenic effects either byinteracting directly with DNA or by indirectmeans through intermediary substances (e.g.,reactive oxygen species) or processes. MostDNA-reactive chemicals are electrophilic orcan become electrophilic when metabolicallyactivated. Electrophilic molecules may bindcovalently to DNA to form adducts, and thismay lead to depurination, depyrimidation, orproduce DNA strand breaks; such lesions canbe converted to mutations with a round ofDNA synthesis and cell division. Other DNA-interactive chemicals may cause the sameresult by intercalation into the DNA helix.Still other chemicals may methylate DNA,changing gene expression. Non-DNA-reactivechemicals produce genotoxic effects by manydifferent processes. They may affect spindleformation or chromosome proteins, interferewith normal growth control mechanisms, oraffect enzymes involved with ensuring thefidelity of DNA synthesis (e.g.,topoisomerase), recombination, or repair.

The ‘‘classical’’ chemical carcinogens inlaboratory rodent studies are agents thatconsistently produce gene mutations andstructural chromosome aberrations in short-term tests. A large database reveals that thesemutagenic substances commonly producetumors at multiple sites and in multiplespecies (Ashby and Tennant, 1991). Most ofthe carcinogens identified in human studies,aside from hormones, are also gene orstructural chromosome mutagens (Tennantand Ashby, 1991). Most of these compoundsor their metabolites contain electrophilicmoieties that react with DNA.

Numerical chromosome aberrations, geneamplification, and the loss of geneheterozygosity are also found in animal andhuman tumor cells and may arise frominitiating events or during progression. Thereis reason to believe that accumulation ofadditional genetic changes is favored byselection in the evolution of tumor cellsbecause they confer additional growthadvantages (Hartwell and Kastan, 1994).Exogenous agents may function at any stageof carcinogenesis (Barrett, 1993). Someaberrations may arise as a consequence ofgenomic instability arising from tumorsuppressor gene mutation, e.g., p53 (Harrisand Hollstein, 1993). The frequentobservation in tumor cells that both of a pairof homologous chromosomes have identicalmutation spectra in tumor suppressor genessuggests an ongoing, endogenous process ofgene conversion. Currently, there is a paucityof routine test methods to screen for eventssuch as gene conversion or geneamplification and knowledge regarding the


ability of particular agents of environmentalinterest to induce them is, for the most part,wanting. Work is under way to characterize,measure, and evaluate their significance(Travis et al., 1991).

Several kinds of mechanistic studies aid inrisk assessment. Comparison of DNA lesionsin tumor cells taken from humans with thelesions that a tumorigenic agent causes inexperimental systems can permit inferencesabout the association of exposure to the agentand an observed human effect (Vahakangas etal., 1992; Hollstein et al., 1991; Hayward etal., 1991). An agent that is observed to causemutations experimentally may be inferred tohave potential for carcinogenic activity (U.S.EPA, 1991a). If such an agent is shown to becarcinogenic in animals, the inference that itsmode of action is through mutagenicity isstrong. A carcinogenic agent that is notmutagenic in experimental systems but ismitogenic or affects hormonal levels orcauses toxic injury followed bycompensatory growth may be inferred tohave effects on growth signal transduction orto have secondary carcinogenic effects. Thestrength of these inferences depends in eachcase on the nature and extent of all theavailable data.

Differing modes of action at the molecularlevel have different dose responseimplications for the activity of agents. Thecarcinogenic activity of a direct-actingmutagen should be a function of theprobability of its reaching and reacting withDNA. The carcinogenic activity of an agentthat interferes at the level of signal pathwayswith many potential receptor targets shouldbe a function of multiple reactions. Thecarcinogenic activity of an agent that acts bycausing cell toxicity followed bycompensatory growth should be a function ofthe toxicity.

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[FR Doc. 96–9711 Filed 4–22–96; 8:45 am]BILLING CODE 6560–50–P

fede

ral r

egiste

r

18013


Part III

Department ofTransportationFederal Highway Administration49 CFR Part 393

Department ofHousing and UrbanDevelopment24 CFR Part 3280

Manufactured Home Tires, Parts andAccessories Necessary for SafeOperation; and Manufactured HomeConstruction and Safety Standards;Proposed Rule



Federal Highway Administration

49 CFR Part 393

[FHWA Docket No. MC–95–1]

RIN 2125–AD41


24 CFR Part 3280

[Docket No. FR–3943]

RIN 2502–AG54

Manufactured Home Tires, Parts andAccessories Necessary for SafeOperation; and Manufactured HomeConstruction and Safety Standards

AGENCIES: Federal HighwayAdministration (FHWA), DOT; Office ofthe Assistant Secretary for Housing,Federal Housing Commissioner,Department of Housing and UrbanDevelopment (HUD).ACTION: Notice of proposed rulemaking;proposed change in HUD interpretativebulletin.

SUMMARY: The FHWA and HUD areproposing amendments to the FederalMotor Carrier Safety Regulations and aninterpretation of the ManufacturedHome Construction and SafetyStandards concerning the transportationof manufactured homes. The FHWA andHUD propose to adopt mutuallyconsistent and readily enforceableregulations and interpretations thatpromote the safe and effectivetransportation of manufactured homes.The FHWA and HUD are proposing topermit the overloading of manufacturedhome tires by not more than 18 percentfor a period of two years from theeffective date of the final rule. Duringthat two year period, both agencieswould review test and other technicaldata concerning the relativeperformance of tires which areoverloaded by 18 percent versus no tireoverloading. Unless both agencies arepersuaded that the 18 percentoverloading does not pose a risk to thetraveling public or have an adverseimpact on the safety or transportabilityof manufactured homes, anyoverloading of tires beyond their designcapacity would be prohibited after twoyears from the effective date of the finalrule. These proposed changes areintended to clarify the regulations of theFHWA and the interpretation of itsregulations by HUD and to resolvedifferences between Federal regulationsfor the overloading of tires used in thetransportation of manufactured homes.

DATES: Comment Due Date: Commentsmust be received on or before June 24,1996.ADDRESSES: To file responses on thisproposed rule submit written, signedcomments to FHWA Docket No. MC–95–1, Room 4232, HCC–10, Office of theChief Counsel, Federal HighwayAdministration, 400 Seventh Street,SW., Washington, D.C. 20590. Allcomments received will be available forexamination at the above address from8:30 a.m. to 3:30 p.m., Eastern Time,Monday through Friday, except Federalholidays. Those desiring notification ofreceipt of comments must include a self-addressed, stamped postcard.FOR FURTHER INFORMATION CONTACT: ForFHWA: Mr. Larry W. Minor, Office ofMotor Carrier Research and Standards,HCS–10, (202) 366–4009; or Mr. CharlesE. Medalen, Office of the Chief Counsel,HCC–20, (202) 366–1354, FederalHighway Administration, 400 SeventhStreet, SW., Washington, D.C. 20590.Office hours are from 7:45 a.m. to 4:15p.m., (eastern standard time), Mondaythrough Friday, except Federal holidays.

For HUD: Mr. Philip W. Schulte,Acting Director, Manufactured Homeand Construction Standards Division,Office of Manufactured Housing andRegulatory Functions, Department ofHousing and Urban Development,L’Enfant Plaza North, Suite 3214,Washington, D.C. (mailing address:Room B–133, HUD Building,Washington, D.C. 20410–8000).Telephones: (voice) (202) 755–7420;(TDD) (202) 708–4594. (These are nottoll-free numbers.)


BackgroundThe Department of Housing and

Urban Development (HUD) and theFederal Highway Administration(FHWA) have regulations applicable tothe transportation of manufacturedhousing which are mutuallyinconsistent. In this joint NPRM, thetwo agencies are proposing to adoptidentical rules to correct theinconsistency.

On March 4, 1995, President Clintondirected all agencies to remove obsoleteand unnecessary regulations, and reviseand improve necessary regulations. Aspart of HUD’s and FHWA’s review oftheir respective regulations, each agencyidentified its regulations applicable tothe transportation of manufacturedhousing as inconsistent with oneanother. In accordance with thePresident’s directive to improveregulations, and in accordance with theprinciples of Executive Order 12866,which directs agencies to avoid

regulations that are inconsistent withregulations of other agencies, this ruleproposes to make HUD’s and FHWA’sregulations consistent on this subject.Additionally, at the final rule stage theformat of this rule may be revised toconform to the President’s regulatoryreinvention principles.

I. Department of Housing and UrbanDevelopment

A. Manufactured Home Constructionand Safety Standards

The National Manufactured HousingConstruction and Safety Standards Actof 1974 (Act), 42 U.S.C. 5401 et seq.,authorizes the Secretary of Housing andUrban Development (HUD) to establishand amend the Federal ManufacturedHome Construction and SafetyStandards (FMHCSS), 24 CFR Part 3280(Standards). The stated purposes of theAct are to reduce the number ofpersonal injuries and deaths and theamount of insurance costs and propertydamage resulting from manufacturedhome accidents and to improve thequality and durability of manufacturedhomes.

B. Transportation Systems forManufactured Homes

Subpart J of the Standards covers thegeneral requirement for designing themanufactured home to fully withstandthe adverse effects of transportationshock and vibration without damagingthe integrated structure or itscomponent parts. One of its componentsis the running gear assembly which isdefined in 24 CFR 3280.902 to includethe subsystem consisting of suspensionsprings, axles, bearings, wheels, hubs,tires, and brakes, with their relatedhardware.

Under 24 CFR 3280.904(a), the entiretransportation ‘‘system (frame, drawbarand coupling mechanism, running gearassembly, and lights) shall be designedand constructed as an integrated,balanced and durable unit which is safeand suitable for its specified use duringthe intended life of the manufacturedhome.’’ The running gear assembly,including the tires, must be able tosustain the designed loads set forth in24 CFR 3280.904(b)(3) and ‘‘to providefor durable dependable safe mobility ofthe manufactured home’’ (emphasisadded) (24 CFR 3280.904(b)(4)(i)).

The design load consists of the deadload plus a minimum of 3 pounds persquare foot floor load (for example, free-standing range, refrigerator, and loosefurniture), and the superimposeddynamic load resulting from highwaymovement but shall not be required toexceed twice the dead load. The


integrated design shall be capable ofinsuring rigidity and structural integrityof the complete manufactured homestructure and to insure againstdeformation of structural or finishmembers during the intended life of thehome.

C. Interpretative Bulletin J–1–76HUD interpreted the transportation

requirements for subpart J in theStandards by an Interpretative Bulletinpublished on December 7, 1976 (41 FR53626). Sections C and D of theInterpretative Bulletin provide asfollows:

Section C—AxlesUnless substantiated in the design to the

satisfaction of the approval agency [DesignApproval Primary Inspection Agency](DAPIA) by either engineering analysis, loadtests or documented evidence of actualtransportation experience, there shall be noless than the following minimum number of6,000 lb. rated axles with not less than themobile (manufactured) home rated tiresindicated in Table 1 or Table 2 on eachmobile home or floor section of the multipleunit mobile home:

TABLE 1

Length of the mobile(manufactured) home

Numberof 6,000lb. axlesequippedwith 7–14.5,

mobilehome 8ply tires

1. 12 foot wide:A. To 60 ft. maximum ................. 2B. Greater than 60 ft.–80 ft. max 3

2. 14 foot wide:A. To 52 ft. maximum ................. 2B. To 76 ft. maximum ................. 3C. To 80 ft. maximum ................ 4

TABLE 2

Length of the mobile(manufactured) home

Numberof 6,000lb. axlesequippedwith 8–14.5,

mobilehome 8and 10ply tires



Length of a mobile home is the length asdefined in § 3280.902(b).

Determination of the number of axlesrequired by use of the above tables does not

eliminate the requirement for each axle to becapable of withstanding the actual imposeddead load without exceeding the maximumallowable stresses for design axle life asrecommended by the axle manufacturer, orthe maximum tire load rating in§ 280.904(b)(8) [now § 3280.904(b)(8)]. If amanufacturer has submitted documentedevidence of transportation experience to meetthe requirements of § 280.903(c)(2) [now§ 3280.903(c)(2)], the minimum number ofaxles required by the experience record maynot be reduced by use of the above tables.(The number of axles must be consistent withand no less than the number and rating of theaxles indicated in the experience record.)

Section D—Tires, Wheels and RimsTires shall be sized and fitted to axles in

accordance with the gross axle weight ratingdetermined by the mobile homemanufacturer. The permissible tire loadingmay be increased by utilizing a service loadfactor not to exceed 50 percent of the mobilehome tire load limits specified in MH–1 ofthe Tire and Rim Association Handbook(1975 edition), but the individual permissibletire loading may not exceed 3,000 pounds.For example, the maximum tire loading fora 7×14.5 mobile home 8 ply tire at 70 PSIcold inflation pressure would be 2805 lbs.(1,870 lbs. (MH–1 rating)×1.5(service loadfactor)=2,805 lbs.). The tire load limitspecified in MH–I shall be determined by thetire manufacturer in accordance withprocedures described in 49 CFR 571.119.

Used tires may also be sized in accordancewith the above criteria whenever the treaddepth is at least 2⁄32 of an inch as determinedby a tread wear indicator. The determinationas to whether a particular used tire isacceptable shall also include a visualinspection of thermal and structural defects(e.g., dry rotting, excessive tire sidewallsplitting, etc.).

Wheels and rims shall be sized inaccordance with the tire manufacturer’srecommendations as suitable for use with thetires selected.

II. Department of Transportation

A. Federal Motor Carrier SafetyRegulations

The FHWA’s Federal Motor CarrierSafety Regulations (FMCSRs) are basedon a series of statutes starting with theMotor Carrier Act of 1935. The FMCSRsare codified at Subchapter B of ChapterIII, Title 49 of the Code of FederalRegulations. The FMCSRs providerequirements for the operation ofcommercial motor vehicles in interstatecommerce. The FMCSRs define acommercial motor vehicle as any self-propelled or towed vehicle used onpublic highways in interstate commerceto transport passengers or propertywhen: the vehicle has a gross vehicleweight rating or gross combinationweight of 10,001 or more pounds; or thevehicle is designed to transport morethan 15 passengers, including thedriver; or, the vehicle is used in the

transportation of hazardous materials ina quantity requiring a placard. Underthis definition, a manufactured hometransported in interstate commerce isconsidered a commercial motor vehicleand is subject to the FMCSRs.

Part 393 of the FMCSRs covers partsand accessories necessary for safeoperation. Among the safety regulationsapplicable to manufactured homes arethe requirements for lamps andreflective devices, brake systems,coupling devices, tires, and suspensionsystems.

Under the Motor Carrier SafetyAssistance Program (MCSAP), theFHWA provides financial assistance toStates to enforce the FMCSRs orcompatible State regulations pertainingto commercial motor vehicle safety (see49 CFR part 350). State enforcementofficials have expressed concerns aboutthe safety of certain practices of carrierstransporting manufactured homes. Theirprincipal concern is the movement ofmanufactured homes on overloadedtires. In certain cases, vehicles with tiresloaded to 150 percent of their capacityare operated at highway speeds. Thesepractices are inconsistent with theFMCSRs.

B. FHWA Requirements for TiresSection 393.75(f) prohibits the

operation of commercial motor vehicleson tires that carry a greater weight thanthat specified in publications of certainstandard-setting organizations listed bythe National Highway Traffic SafetyAdministration in 49 CFR 571.119(S5.1(b)) unless (1) the vehicle is beingoperated under the terms of a specialpermit issued by the State, and (2) thevehicle is being operated at a reducedspeed that is appropriate to compensatefor tire loading in excess of themanufacturer’s normal rated capacity.The FHWA first proposed restrictionson the use of overloaded tires on April17, 1974 (39 FR 13785). The proposalwas in response to two petitions fromthe Professional Drivers Council(PROD), a non-profit association ofprofessional interstate truck and busdrivers, and investigations of front tirefailures by the FHWA. The PRODpetitions addressed front tireoverloading in general, and specificallyfront tire overloading resulting from thefifth wheel position on the towingvehicle.

The investigations performed by theFHWA revealed that a significantnumber of vehicles operate withoverloaded or under-inflated tires. A tirewas considered under-inflated if itcarried a load greater than it wasdesigned to carry at the pressure towhich it was inflated, and overloaded if


it carried a load greater than it couldsafely carry at any pressure. The agencycited a growing body of evidence thatboth under-inflation and overloadingcreate identifiable dangers. Among thesewere the impairment of vehiclehandling and the loss of control fromsudden tire failures. On July 11, 1975,the FHWA published the final ruleprohibiting the operation of motorvehicles on overloaded tires (40 FR29292). Several industry groups andnumerous tire manufacturersimmediately petitioned forreconsideration. The FHWA amendedthe final rule a few months later(September 29, 1975, 40 FR 44555). Thepetitioners asked the FHWA to allowtire pressures greater than those labeledon the tire’s sidewalls; and to allowincreased loading for reduced speedoperations.

The available information from tiremanufacturers supported allowingincreased tire loadings if vehicles wereoperated at reduced speeds.Accordingly, the FHWA amended thefinal rule to that effect, provided thevehicle was operated in compliancewith a special permit which specified aspeed limitation.

The Heavy Specialized CarriersConference (now the SpecializedCarriers and Rigging Association) of theAmerican Trucking Associations (ATA)subsequently submitted a petition forrulemaking. According to the petitioner,only a few States specified speed limitsfor vehicles operating under specialpermits. The wording of the September29, 1975, final rule therefore had theeffect of limiting the exemption foroverloaded tires to motor carriersoperating in those States. The petitionerrequested that the FHWA rescind therequirement that the State-issued permitmust include a specific reduced speed.

On June 17, 1976 (41 FR 24608), theFHWA proposed to modify theconditions under which tires on axlesother than the front axle could beoverloaded. Based upon user experienceand information obtained fromcommercial vehicle tire manufacturers,the agency acknowledged that tires maybe safely overloaded if vehicle speed isreduced sufficiently to prevent heatbuildup. The FHWA concluded that ifthe reference to reduced speed specifiedon State-issued permits were deleted,the agency should impose its own speedrestriction on motor vehicles whichoperate on overloaded tires. An upperspeed limit of 72 kilometers per hour(km/hr) (45 miles per hour (mph)) wasproposed for inclusion in theexemption. This value was selected toprevent conflicts between § 393.75(f)and the posted minimum speeds on

many Primary and Interstate highways.Since the minimum speed limits help toensure safety by regulating themaximum allowable speed differentialbetween motor vehicles, the agency’sproposal addressed both the need forreduced speed to compensate foroverloading and the need for limitingspeed differentials between the affectedcommercial motor vehicles and othertraffic.

On August 31, 1976 (41 FR 36656),the FHWA published a final ruleamending § 393.75(f) to permit theoverloading of tires if (1) the vehicle isbeing operated under the terms of aspecial overweight permit issued by theState and (2) the vehicle is beingoperated at a reduced speed which isappropriate to compensate for tireloading in excess of the manufacturer’snormal rated capacity. The exemptiononly applied to tires on axles other thanthe front axle and included a maximumspeed limit of 72 km/hr (45 mph). Theeffective date for the final rule wasOctober 1, 1976.

HUD requested that the FHWApostpone the effective date of theAugust 1976 final rule with regard tothe interstate transportation ofmanufactured homes. The FHWA issuedNotice N 7510.1 on September 27, 1976,which instructed motor carrier safetypersonnel to refrain from citing mobilehome transporters for operating onoverloaded tires until further notice.This temporary relief was conditionedupon observing a speed limitation of 72km/hr (45 mph). States which hadadopted the FMCSRs were encouragedto adopt this policy. The noticeindicated that HUD’s request was basedon statistical data relating to accidentsresulting from tire failures on newmobile homes. The data indicated an‘‘insignificant accident incident ratiorelated to tire failure and an adverseeconomic impact on the mobile homeindustry and on consumers.’’ A copy ofthe September 1976 notice is includedin the FHWA and HUD docket files.

On October 10, 1978, in response toa petition from the ATA concerning tiremarking and the HUD request, theFHWA published another notice ofproposed rulemaking (43 FR 46555).The notice discussed HUD’s tireoverloading standards for manufacturedhomes: 150 percent of rated capacityprovided the total tire load does notexceed 3,000 pounds. HUD had theNational Highway Traffic SafetyAdministration (NHTSA) conduct twoseries of tests on mobile home tires. Thefirst results were summarized in aSeptember 1976 report entitled ‘‘ASafety Performance Test for MobileHome Tires, Phase I: New Tires.’’ The

second report (April 1978) was entitled‘‘A Safety Performance Test for MobileHome Tires, Phase II: Used Tires.’’ Acopy of both reports is included in theFHWA and HUD docket files. The testsindicated that new tires on mobilehomes were capable of operatingsatisfactorily under 150 percent loading,although used tires did not perform aswell. In view of this research, theFHWA proposed replacing the term‘‘special overweight permit’’ with‘‘special permit.’’ The FHWA believedthe proposal would address HUD’sconcerns. Because manufactured homesgenerally did not exceed the normalaxle or gross weight limits, they rarelyqualified for overweight permits. TheFHWA therefore proposed to allow theuse of overloaded tires if the transporterwas operating under any ‘‘specialpermit,’’ typically a permit for over-width vehicles.

The final rule amending § 393.75(f)was published on May 1, 1979 (44 FR25455). The preamble includedreference to the mobile home tireresearch studies and HUD’s request thatthe FHWA amend § 393.75. With thisamendment, tires on axles other thanthe front axle could be overloaded if (1)the vehicle was operated under theterms of a special permit (as opposed toa special overweight permit) issued bythe state and (2) the vehicle wasoperated at a reduced speed not toexceed 72 km/hr (45 mph).

On October 29, 1980, the FHWAissued FHWA Notice N 7510.2 whichrescinded Notice N 7510.1. Since the1979 final rule allowed all vehiclessubject to the FMCSRs to be operated onoverloaded tires provided the vehiclesadhered to the terms of a special permitand did not exceed speeds of 72 km/hr(45 mph), Notice N 7510.1 was nolonger necessary. A copy of the 1980notice is included in the FHWA andHUD docket files.

The current wording of § 393.75(f) isthe outcome of a 1988 final rule on partsand accessories necessary for safeoperation (53 FR 49380, December 7,1988). Under the final rule, the 72 km/hr (45 mph) maximum speed forvehicles operating on overloaded tireswas removed, and any speed below theposted speed limit is thus considered areduced speed. The effective date of theamendment was March 7, 1989.

The removal of the 72 km/hr (45 mph)maximum speed limit combined withthe fact that the FMCSRs do not includerestrictions on the extent to which a tiremay be overloaded have createdproblems for State officials responsiblefor enforcing motor carrier safety laws.


III. Differences Between the HUD andthe FHWA Regulations

Under 42 U.S.C. 5401 et seq., HUDwas required to issue construction andsafety standards for manufacturedhomes. Congress provided thatwhenever a Federal ManufacturedHome Construction and Safety Standardis in effect, no State or politicalsubdivision of a State shall have theauthority to establish or permit tocontinue in effect with respect to anymanufactured home covered, anystandard ‘‘regarding construction orsafety applicable to the same aspect ofperformance of such manufacturedhome which is not identical to theFederal manufactured homeconstruction and safety standard’’ (42U.S.C. 5403(d)). HUD issued 24 CFR3280, subpart J and InterpretativeBulletin J–1–76 which establishstandards for the running gear andwhich permit the overloading of thetires.

Furthermore, HUD has indicated in 24CFR 3282.11(c) that the Federal systemestablishes the exclusive system forenforcement of the Federalmanufactured housing standards. NoState may establish or keep in effectthrough a building code enforcementsystem or otherwise, ‘‘procedures orrequirements which constitute systemsfor enforcement of the Federal standardsor of identical State standards which areoutside the system established in theseregulations or which go beyond thissystem to require remedial actionswhich are not required by the Act andthese regulations.’’

In contrast, the Motor Carrier SafetyAct of 1984 (49 U.S.C. 31131 et seq.,formerly 49 U.S.C. app. 2501 et seq.) has

a different purpose and scope than theManufactured Housing Constructionand Safety Standards Act. It ratified theregulations adopted on the authority ofthe Motor Carrier Act of 1935, anddirected the Department ofTransportation to establish minimumFederal standards to ensure thatcommercial motor vehicles (CMVs) aresafely equipped, maintained, loaded,and operated; that the duties imposedon CMV drivers do not impair theirability to drive safely; that the physicalcondition of CMV drivers does not havean adverse impact on safety; and thatdriving CMVs does not harm thedrivers’ physical condition [49 U.S.C.31136]. The FHWA’s regulation ofvehicle components and systems,including tires, axles, brakes, etc., isconsistent with this purpose andnecessary for the protection of motoristswho share the roads with CMVs,including manufactured homes.

Most State motor carrier safety laws ineffect today are essentially required byFederal law. Congress directed theDepartment of Transportation topreempt State safety regulations that arenot compatible with the FMCSRs [49U.S.C. 31141 (formerly 49 U.S.C. App.2507), 49 CFR 355]. The MCSAP hasalso induced States to model their safetylaws on the FMCSRs. The FMCSRs asadopted by the States are State laws.The Federal Courts have not hadoccasion to consider the relationshipbetween the Manufactured HomeConstruction and Safety Standards andthe FMCSRs (or compatible Stateregulations) with regard tomanufactured home tire overloading.

Both the FHWA and HUD recognizethat the current inconsistency betweentheir regulations and interpretations

requires clarification through theissuance of joint rulemaking to establishuniform requirements for motor carrierswho are transporting manufacturedhomes. The proposed changes to theFHWA’s and HUD’s respectiverequirements for motor carrierstransporting manufactured homes arecovered under Sections X, XI, and XII ofthis notice.

IV. Analysis of Tire Loading and theTires Used in the Transporting ofManufactured Homes

A. Typical Tires Used in ManufacturedHousing

To consider whether there should bechanges in its interpretation of thestandards for transporting manufacturedhomes (Interpretative Bulletin J–1–76),HUD has gathered information fromvarious sources about the types of tiresand axles used by the manufacturedhousing industry. Some of thisinformation was submitted to HUD bythe Manufactured Housing Institute(MHI) which had established aTransportation Task Force. Informationwas also obtained from suppliers, andfrom materials provided by theDepartment of Transportation.

The MHI wrote HUD on August 5,1994, and supplied certain informationconcerning the types of tires typicallyused in manufactured homes, thetypical transport distance and thenumber of tire failures noted by majortransporters. The average transportdistance was reported to beapproximately 225 miles; the dataconcerning the types of tires, therelative usage of 7–14.5 vis-a-vis 8–14.5tires, etc., is shown in Table A.

TABLE A

Tire size and type Percent use in manufac-tured houses Tire capacity Tire capacity at max. over-

load/percent overload

7–14.5, 8 PLY, SERIES D .............................................................. 80% .................................... 1,870 lbs ........... 2,805 lbs., >50% Over.8–14.5, 8 PLY, SERIES D .............................................................. 20% are 8 and 10 ply ........ 2,270 lbs ........... 3,000 lbs., 32% Over.8–14.5, 10 PLY, SERIES E ............................................................ See above .......................... 2,540 lbs ........... 3,000 lbs., 18% Over.8–14.5, 12 PLY, SERIES F ............................................................. Not Available ...................... 2,790 lbs ........... 3,000 lbs., 8% Over.9–14.5, 8 PLY, SERIES D .............................................................. Not Available ...................... 2,620 lbs ........... 3,000 lbs., 15% Over.9–14.5, 10 PLY, SERIES E ............................................................ Not Available ...................... 2,940 lbs ........... 3,000 lbs., 2% Over.9–14.5, 12 PLY, SERIES F ............................................................. Not Available ...................... 3,240 ................ NO OVER-LOADING.

The maximum load ratings for the 9–14.5 tires are obtained from the 1994 Tire and Rim Association Yearbook.

It is apparent from a review of severalDAPIA-approved designs andinformation received from the MHI thatmost manufacturers are using 7–14.5, 8ply (Series D) tires. Under theprovisions of Section D of InterpretativeBulletin (IB) J–1–76, the tire capacity atmaximum overload is limited to 2,805

lbs. (1.5 × 1870 lbs.). However, theabove-mentioned review of designsindicated that manufacturers andDAPIAs have misinterpreted anotherprovision of the IB to permit 7–14.5, 8ply (Series D) tires to be loaded up to3,000 lbs. or 160 percent of their ratedcapacity.

Anecdotal accounts from somemanufacturers indicated that the larger8–14.5 tires are used for longer transportdistances or where the road surfaces areless smooth than those on the Interstatehighways. Presumably, manufacturershave discovered by experience that theuse of 8–14.5 Series D or E tires may


reduce the possibility of tire failureunder these circumstances.

B. The Number of Reported Failures ofNew and Used Tires During Transport

HUD has obtained information fromthree companies which transport largenumbers of manufactured homes. Thesethree companies collectively transportmore than 30 percent of themanufactured homes produced in theUnited States and in the case of thelargest transporter, nearly 50,000manufactured homes per year.

The three companies differed in thereported overall rate of tire failure forshipment of manufactured homes. Thefailure rate for new tires ranged from 4percent to 7 percent. The used tirefailure rate was 9 percent. According tothe MHI, roughly 55 percent of the tiressold to manufactured housing producersin 1994 were used tires.

Since the data from one companyrepresented a large share of the marketand transportation experience in a largenumber of States, HUD believes that thecompany’s failure rate of 7 percent isthe most representative of actualconditions. Therefore, HUD has used afailure rate of 7 percent for new tiresand 9 percent for used tires with anoverall average failure rate of 8 percent.Since each section of a manufacturedhome usually contains 6 tires, a tire willfail on about 40 percent of the sectionsshipped each year. Multiple failures oftires are less common but are known tooccur.

There was also substantial variabilityamong these three companiesconcerning the causes of tire failure.One company indicated that foreign

objects were the cause of 99 percent oftire failures, while the other companiesindicated that substandard tires and tireoverloading were the chief causes of tirefailure. The other companies also notedthat operating at excessive speed andother causes were less significant factorsin tire failure.

There are no separate data as to therate of failure due to tire overloading inrelation to other factors, such assubstandard tires, improper inflation,excessive heat, etc. The risk of tirefailure due to overloading can beincreased by operating the tire atreduced inflation, by the heat of thepavement, high speeds, mountingprocedures and other practices which, ifcombined, may virtually assure tirefailure. Hence, determining thepercentage of failures attributable solelyto tire overloading is difficult.

Data from one tire recycler, however,indicated that up to 70 percent of tireswhich are damaged can be recycled andreused after repair. This would suggestthat foreign objects may have been theprincipal cause of tire failure rather thanblow-outs due to overloading or othercauses. The damage associated withblow-outs or causes other than foreignobjects is generally too extensive to berepaired.

Based on the available information,HUD’s best estimate is that 25 percentof reported failures can be attributedpartly to tire overloading. HUD hasreduced this estimate by half to accountfor failures due in part to aggravatingfactors, such as improper inflation ormounting. Therefore, assuming that450,000 sections of manufactured

homes are shipped this year (450,000shipments × 0.40 (factor for shipmentswith at least one tire failure) × 0.125(percentage attributable to tireoverloading), tire overloading would beresponsible for at least 22,500 tireblowouts.

C. The Average Number of Times Thatthe Tire Is Used

There is no reporting mechanism orauthoritative data on the number oftimes a tire is used. However,incomplete data from transportersindicate that tires are used an average often times before they are unable to passthe tread depth requirement.

V. Cost Estimates of Possible Optionsfor the Protection of the Public and ToEnsure the Safe Transport ofManufactured Homes

Based on the available information,there are four approaches which wouldsubstantially alleviate or eliminate theproblem of overloading of tires. Thesefour options are discussed below:

A. Option No. 1: Reduction of thePermissible Tire Overloading to 18Percent

HUD has obtained data from supplierson the cost to upgrade from the 7–14.5tires to tires with a rated capacity of2,540 lbs. Assuming that the designcalls for 3,000 lbs. per tire, the degreeof tire overloading would be reducedfrom 50 to 60 percent to 18 percent. Thewholesale incremental cost estimateswere determined by assuming that eachtransportable section uses six tires. Theresults are shown in Table B:

TABLE B

Type of tire

Wholesalecost of 8–

14.5 10 ply(series E)

Wholesalecost of 7–14.5 8 ply(series D)

Increase inwholesale

cost

Total incre-mental costper section

NEW ................................................................................................................................. $40 $30 $10 $60USED ................................................................................................................................ 30 26 4 24AVERAGE COST FOR UPGRADED TIRES MAN. HOME ............................................. .................... .................... .................... 59

As shown in Table B, the cost for upgraded tires is relatively modest and this results in an average wholesale

cost increase of nearly $60 per home. The average cost per home is based on the usage patterns of new versus used

tires and the relative percentage of single (53 percent) and multi-section (47 percent) homes.

B. Option No. 2: Reduction of the Permissible Tire Overloading to 8 Percent

HUD has obtained data from suppliers on the cost to upgrade from the 7–14.5 tires to tires with a rated capacity

of 2,790 lbs. Assuming that the design calls for 3,000 lbs. per tire, the degree of tire overloading would be reduced

from 50 to 60 percent to 8 percent. The same assumptions concerning the number of tires per section, new and

used tires, etc. have been made to permit comparison of the various options. The results are shown in Table C:


TABLE C

Type of tire Wholesale cost of 8–14.512 ply (series F)

Wholesalecost of 7–14.5 8 ply(series D)


cost

Total incre-mental costper section

NEW ........................................................................................................ $44 ..................................... $30 $14 $84USED ....................................................................................................... Not available in sufficient

quantities.26 .................... ....................

AVERAGE COST PER MAN. HOME ..................................................... ............................................ .................... .................... 123.5

C. Elimination of Tire Overloading

1. Option No. 3: Addition of Another Axle and the Use of 8–14.5, 10 Ply Tires (Series E)Another option is to require that the tires’ rated capacity meet or exceed the live and dead load which will be

applied to them. The manufacturer would probably have to use an additional axle to carry some of this load. Thecost of this increased axle along with the upgraded tires is shown in Table D as follows:

TABLE D

Average cost of tires

Wholesalecost of newnon-braking

axles

Wholesalecost of usednon-braking

axles

$59 ............................................................................................................................................................ $174 $139 ....................Total wholesale cost of tires and axles .................................................................................................... .................... .................... $287

According to one source, the cost of the additional wheels and axles would be greater because half of the axleswould be braking axles which are 25 percent more expensive than non-braking axles. However, discussions with suppliersand analysis of manufactured home designs indicated that the changes in the degree of tire overloading have no impacton the number of braking versus non-braking axles as this is a function of the vehicle’s weight, not the strengthof the tires. Therefore, HUD believes that the additional cost of nearly $287 is closer to the expected cost of theaxle and tires.

2. Option No. 4: The Use of 9–14.5 12 Ply Series E and F TiresAnother alternative would be to upgrade the tires to 9–14.5, Series E and F tires which would involve little or

no overloading with the use of a 6,000 lb. axle. Suppliers reported that because the 9–14.5 tires are being madeonly in small quantities, current prices would not be reliable indicators of unit costs at higher production levels.Therefore, it will be assumed that the cost of the 9–14.5 tires are double the cost of the 7–14.5 tires for these costcomparisons. The cost of these tires is shown in Table E:

TABLE E

Type of tire Est. wholesale cost of 9–14.5 12 ply tires (series F)

Wholesalecost of 7–14.5 8 ply

tires(series D)


cost

Total aver-age cost

per section

New .......................................................................................................... $60 ..................................... $30 $30 $180Used ........................................................................................................ Not available ...................... 26 .................... ....................Average cost per man. home .................................................................. ............................................ .................... .................... 265

D. Adjustment to Cost Increases Due to Multiple UsagesIn estimating the useful life of the 8–14.5 and 9–14.5 tires, it is conservative to assume that these tires would

be able to be used for at least the same number of trips as the current 7–14.5 tires. Therefore, the FHWA and HUDhave assumed that the upgraded tires can also be used a total of ten times. Based on ten trips per tire and shipmentsof 450,000 transportable sections of manufactured homes each year, the estimated wholesale cost per transportationunit and the annual wholesale cost of each option is shown in Table F.

TABLE F.—COST PER TRANSPORTATION UNIT AND ANNUAL COSTS

OPTION NO. 1 (UPGRADE TO 8–14.5 SERIES E TIRES) ........................................................................................................... $6TOTAL ANNUAL COST (WHOLESALE) FOR ALL HOMES ................................................................................................... $2,700,000

OPTION NO. 2 (UPGRADE TO 8–14.5 SERIES F TIRES) ........................................................................................................... $12TOTAL ANNUAL COST (WHOLESALE) FOR ALL HOMES ................................................................................................... $5,400,000

OPTION NO. 3 (ADDITIONAL AXLE AND UPGRADED TIRES) ................................................................................................... $29TOTAL ANNUAL COST (WHOLESALE) FOR ALL HOMES ................................................................................................... $13,050,000

OPTION NO. 4 (UPGRADE TO 9–14.5 SERIES F TIRES) ........................................................................................................... $27TOTAL ANNUAL COST (WHOLESALE) FOR ALL HOMES ................................................................................................... $12,150,000


VI. Discussion Concerning theOverloading of Tires and the OtherRequirements of the InterpretativeBulletin

In addition to an examination of thevarious options, HUD has reviewed thebasis of the 1976 decision to permit theoverloading of manufactured home tires.The overloading of manufactured hometires was based on certain assumptionsand conditions existing at the time therule was promulgated. Theseassumptions are discussed below:

A. Single or Very Limited Use of Tires;Short Travel Distances

In 1976, it was a common practice tolimit the use of the tires to one, orperhaps a few more trips so that thetotal distance traveled would be onlyabout 500 miles. Based on such limitedusage, it may be permissible to exceedthe normal supplier recommendations.

However, the markets formanufactured homes have broadenedbeyond the 2- to 3-hour driving distanceso that some companies are shippingunits for distances in excess of 500miles. This long distance shipping issubstantially greater than the limitedrange which the original InterpretativeBulletin was based on.

In order to determine common traveldistances for homes, HUD has analyzeddata to determine the total distancetraveled from factories in severalSouthern States to the retailers whoreceived the homes. The data issummarized in Table G:

TABLE G

Numberof ship-ments

analyzed

Percentshipped1–250miles

Percentshipped251–500

miles

Percentshipped

morethan 500

miles

30,000 50 40 10

In 50 percent of the cases, the homewas shipped more than 250 miles andin 10 percent of the cases, the distanceshipped was more than 500 miles.Therefore, the typical transportationpatterns at the time the InterpretativeBulletin was issued have changedsignificantly. Secondly, these dataunderstate the total travel distance sincethey are calculated on the distance fromthe factory to the retailer, not to thehomeowner’s site. More significantly,the data supplied by the transportersindicate that the average tire is used tentimes before it is unable to be usedfurther.

B. Increased Weight of ManufacturedHomes

At the time the Interpretative Bulletinwas issued, the typical weight ofmanufactured homes per square footwas in the range of 16 to 17 lbs. Overthe years, the average weight of thehomes has increased due to the use ofheavier exterior roofing materials,heavier exterior and interior wallcoverings, and the addition of roof andwall sheathing materials. According toinformation provided by the NationalConference of States on Building Codesand Standards, Inc. (NCSBCS), theaverage weight of these homes is now 19to 23 lbs. per square foot, or an averageincrease of over 25 percent.

Furthermore, the increase in thedesign standards for homes shipped intohigh wind areas (Federal Register Vol.59, No. 10, published January 14, 1994)will further increase the weight ofhomes due to the strengthening of theroof and wall construction. In this newwind standard, the wind designpressure for homes placed in High WindZone 2 has been increased to 39 psfwith a 47 psf design pressure in HighWind Zone 3. Therefore, in high windareas, the increase in weight from 1976to the present could be as much as 30percent.

C. Increased Speed on the Highways

Tire research undertaken by HUDindicated that tire overloading wouldnot degrade tire life and performancewhen homes were transported at 50mph. During the mid-1970’s, the speedof travel in the United States waslimited to 55 mph. Accordingly, HUDconcluded that the likely travel speedswould be consistent with the researchresults and that the overloading of tireswould not result in a high percentage oftire failure.

In large areas of the southern andwestern United States, the speed limithas been increased to 65 mph. The 1994Tire and Rim Association Yearbook hasindicated that tires can be overloaded by9 percent if the tires are operated atspeeds less than 50 mph. Speeds of 65mph impose substantially greater loadson tires and industry standards wouldnot permit the overloading of the tiresat high speeds.

VII. The Use of Products in Excess ofthe Manufacturer’s RecommendationsIs Contrary to Accepted Practice inOther Sections of the Standards

In many sections of the ManufacturedHome Construction and SafetyStandards, HUD has indicated thatproducts included in manufacturedhomes should be used in accordance

with the requirements of their listingand the supplier’s installationinstructions. While Subpart J does notspecifically include requirements thatthe components be listed and certified,there are a number of other sections ofthe Standards (e.g. § 3280.304 etc.)where HUD has indicated that thecomponent should be used inaccordance with the manufacturer’sdesign limitations for safe and effectiveoperation.

HUD believes that the transportationsystem should be modeled after theseother sections of the Standards thatacknowledge the limitations establishedfor listed products or the limitationsdetermined by the supplier of theproduct. For this reason, HUD believesthat significant overloading of the tiresis a practice which is contrary to thecollective judgement of the producers ofthese products and sound engineeringpractices because it permits the use ofa product well beyond its designcapacity. Such a direct violation of thelisting or the supplier’s usageinstructions is not permitted in othersections of the Standards. Also,suppliers indicated that tire overloadingof this magnitude is not permitted forany other commercial tire.

VIII. Conclusions and the ProposedSchedule for Modifying the CurrentInterpretative Bulletin

Based on the high rate of tire failure,the impact of tire failure on thestructural integrity of the home andconcerns about the safety of thetravelling public on increasinglycrowded public highways, HUD hasconcluded that the current overloadingof manufactured home tires is no longerdefensible. Secondly, HUD believes thatthe reasons for previously permittingthe overloading do not reflect thecurrent weights of manufactured homes,the multiple reuse of running gearequipment, and the experience of thetransporters.

In addition, HUD is persuaded thatthe use of products substantially inexcess of their design capacity isunsound and that the current degree oftire overloading and failure ratesassociated with increased travel speeds,less-than-ideal highway conditions, andheavier manufactured homes is notacceptable. Given today’s conditions,the Interpretative Bulletin may bepermitting practices which do notassure ‘‘that the running gear assembly,as part of the chassis, shall be designedto perform, as a balanced system, inorder to effectively sustain the designedloads set forth in § 3280.904(b)(3) and toprovide for durable dependable safe


mobility of the manufactured home’’(emphasis added).

Therefore, HUD has concluded thatelimination or substantial mitigation oftire overloading is needed. While theuse of 9–14.5 Series F tires would be apossible option, these tires are notcurrently being produced. Therefore, aproposed rule which imposes such arequirement would require a longphase-in period. Also, the use of 9–14.5Series F tires would be the mostexpensive option.

The 8–14.5 Series F tires can beproduced with the same molds as 8–14.5 Series E tires which would shortenthe necessary lead time. Series F tires,though, have not been produced in anyquantity over the last several years andtherefore, there are relatively few usedtires that are available. Since most of thetires used to transport homes are used,this would further exacerbate a potentialtire shortage and delay theimplementation of a proposed rule.Hence, the available options have beennarrowed to the acceptance of 18percent overloading versus theelimination of tire overloading throughthe use of 8–14.5 Series E tires and anadditional axle.

Absence of Authoritative InformationConcerning This Subject

Definitive data on the effect ofreducing the number of tire failuresthrough the use of 8–14.5 Series E tiresis not available. Evaluating the risk ofallowing tire overloading by 18 percentversus no tire overloading iscomplicated by inadequate informationon the causes of tire failure, the safetymargins built into various tires, and therelative performance of new and usedtires.

The Administration’s policy inExecutive Order 12866, RegulatoryPlanning and Review, requires that‘‘Agencies should assess costs andbenefits, both quantifiable and non-quantifiable and choose the approachwith the maximum net benefits.’’ Basedon the information included in Table F,18 percent tire overloading wouldimpose one-half of the cost of theelimination of tire overloading andmight therefore be the best alternative atthis time, since it provides the greatestbenefits for the least added cost.

While Options 1 and 3 will entailsome additional cost to homemanufacturers, the use of slightlyoverloaded and properly inflated 8–14.5Series E tires should substantiallyreduce the number of tire failures. Thecost avoided by eliminating tire failureswill be considerable since there areservice calls, lost productivity due tothe time it takes to change the tire, and

even in some cases damage to the home.Knowledgeable sources indicated thatthe added cost for upgraded tires may besubstantially or wholly offset byreduced service calls, longer tire life,and other benefits.

Therefore, FHWA and HUD areproposing to permit the overloading ofmanufactured home tires by not morethan 18 percent for a period of two yearsfrom the effective date of the final ruleand amended interpretative bulletin.During that two year period, bothagencies would review any test andother technical data submitted by themanufactured housing industry and tiremanufacturers concerning the relativeperformance of tires which areoverloaded by 18 percent versus no tireoverloading.

Unless both agencies are persuadedthat the 18 percent overloading does notpose a risk to the traveling public andto the stability of the manufacturedhome, any overloading of tires beyondtheir design capacity would beprohibited after two years from theeffective date of the final rule. FHWAand HUD encourage tire manufacturersand suppliers to submit all test andrelevant information concerning the useof 8–14.5 Series E tires with an effectiveoverloading of 18 percent.

Implementation Schedule for Changesin the Standards

Manufactured home production islikely to exceed 450,000 sections thisyear which will be a 20-year high for theindustry. Since there are insufficient 8–14.5, Series E tires being produced, asudden change in the tire requirementscould result in shortages and disruptionof manufactured housing shipments.

In a letter to Mr. Frank Williams,Director of the Florida ManufacturedHousing Association, dated February 7,1994, Goodyear Tire and Rubberindicated that the tire demand for 1994would be 2,400,000 tires. Goodyear alsoindicated that should HUD eliminatethe overloading of tires, thus prohibitingthe use of the 7–14.5 tires, Goodyearcould meet only 20 percent of thedemand for 8–14.5 Series E tires.

Discussions with other tire industryofficials indicated that producers wouldrequire a number of months to increaseproduction to 90 percent of the expected8–14.5 Series E tire demand. Othersources believed that adequate suppliesof 8–14.5 Series E tires could be madeavailable within 9 months. HUD hasconcluded that it is in the publicinterest to modify Interpretative BulletinJ–1–76 as soon as an adequate supply of8–14.5 Series E tires is available.Therefore, these changes are proposedto be made effective nine months after

the publication of the amendedinterpretative bulletin.

Upon the effective date, tireoverloading would be reduced to a levelnot greater than 18 percent and thenumber of axles necessary to supportthe transportation of the home would bebased on engineering analysis or testingas required by 24 CFR 3280.904. HUDwould welcome comments from tiresuppliers and producers as to thefeasibility of this implementationschedule.

IX. Proposed Changes to InterpretativeBulletin J–1–76 of the ManufacturedHousing Standards

HUD has determined that thefollowing changes should be made toInterpretative Bulletin J–1–76:

1. Section C—‘‘Axles’’ would bedeleted in its entirety because theTables in that Section were based onhigher service load factors of up to 50%for tires. In addition, there has been anincrease of approximately 25% indesign weights for currently producedmanufactured homes than wasoriginally assumed to develop theTables.

Axles would be required to withstandthe actual imposed dead load includingall of the design loads outlined in§ 3280.904(b)(3) without exceedingmaximum allowable stresses for designaxle life as recommended by the axlemanufacturer. The manufacturer woulddetermine the number of axles byengineering analysis or by testing aspermitted in Section 3280.903(c).

Alternatively, if the manufacturer hassubmitted documented evidence oftransportation experience, the minimumnumber of axles permitted by theexperience record (weight slips, etc.)may not be less than the number ofaxles required to meet the above criteria.Also, the transportation experiencemust reflect the number of axles andtires that would be required underSubpart D of the Interpretative Bulletinas amended by this proposed rule.

2. Section D—‘‘Tires, Wheels, andRims’’ would be revised as follows:

Tires shall be sized and fitted to axlesin accordance with the gross axle weightrating determined by the manufacturedhome manufacturer. The permissibletire loading may be increased up to amaximum of 18 percent over the ratedload capacity of the manufactured hometire as determined by the manufacturerof the tire. Used tires may also be sizedin accordance with the above criteriawhenever the tread depth is at least 2⁄32

of an inch as determined by a tread wearindicator. The determination as towhether a particular used tire isacceptable shall also include a visual


inspection for thermal and structuraldefects (e.g., dry rotting, excessive tiresidewall splitting, etc.). Wheels andrims shall be sized in accordance withthe tire manufacturer’srecommendations as suitable for usewith the tires selected.

X. Proposed Amendments to theFMCSRs

The FHWA is proposing to amend 49CFR 393.75 to make the FMCSRsconsistent with the HUD’s proposedamendments to Interpretative BulletinJ–1–76. Section 393.75(f)(1)(i) and (ii)would be redesignated as § 393.75(f)(1)and (2). The redesignated paragraphswould address all CMVs with theexception of manufactured homes.Section 393.75(f)(2) would also reinstatespeed restrictions on CMVs operated onoverloaded tires. The FHWA isproposing that vehicles with overloadedtires be prohibited from operating atspeeds above 80 km/hr (50 mph). Thisspeed ensures the safe operation of thevehicle while preventing conflicts withminimum speed limits in certain States.The 80 km/hr (50 mph) speed isconsistent with the previous speedrestriction which was rescinded in1988.

The FHWA is not proposinglimitations on the amount of tireoverloading allowed for vehicles otherthan manufactured homes. The FHWAwill examine that issue separately fromthis rulemaking and, if necessary,propose amendments in a futureproceeding.

To address the issue of overloadedtires on manufactured homes, theFHWA is proposing a new paragraph.Section 393.75(g) would allow 18percent overloading of manufacturedhome tires for a period of two years afterthe effective date of the final rule.Manufactured homes operating on tiresoverloaded by more than 9 percentwould be restricted to a maximumspeed of 80 km/hr (50 mph). This speedrestriction is consistent withinformation contained in the 1994 Tireand Rim Association Handbook.

The FHWA notes that HUD is notproposing to include a speed restrictionin the Interpretative Bulletin. While thiswould result in a difference between therevised Interpretative Bulletin and theamended FMCSRs, the FHWA and HUDdo not believe this minor difference willcreate enforcement problems for theStates. Since speed limits are not relatedto the HUD standards for components orelements of the manufactured housingunits, the reinstatement of a speedrestriction under § 393.75, andsubsequent adoption by the States,

would not be in conflict with therevised Interpretative Bulletin.

With regard to the tire pressure andinflation requirements currently foundat § 393.75(f)(2) and (3), the FHWAproposes to include these provisions ina new paragraph, § 393.75(h). TheFHWA is not proposing substantivechanges to the requirements concerningtire pressure and inflation at this time.

XI. Proposed Effective Date for FHWAand HUD Amendments

The FHWA and HUD propose thatthese revisions to the Regulations andthe Interpretative bulletin be madeeffective nine months after thepublication of the final rule.

XII. Rulemaking Analysis and NoticesAll comments received before the

close of business on the commentclosing date indicated above will beconsidered and will be available forexamination in the dockets at the aboveaddress. Comments received after thecomment closing date will be filed inthe docket and will be considered to theextent practicable, but the FHWA andHUD may issue a final rule at any timeafter the close of the comment period.In addition to late comments, the FHWAwill also continue to file in the docketFHWA MC–95–1 relevant informationthat becomes available after thecomment closing date, and interestedpersons should continue to examine thedocket for new material.

Executive Order 12866 (RegulatoryPlanning and Review) and DOTRegulatory Policies and Procedures

The FHWA and HUD havedetermined that this action is not asignificant regulatory action within themeaning of Executive Order 12866. Inaddition, the FHWA has determinedthat this action is not significant withinthe meaning of Department ofTransportation regulatory policies andprocedures. This rule would, if adopted,establish tire loading limitations formanufactured homes transported ininterstate commerce. This action wouldeliminate inconsistency between theFHWA and HUD requirements formanufactured homes. The FHWA andHUD have evaluated the economicimpact of potential changes to theregulatory requirements concerning thesafe transportation of manufacturedhomes and determined that theproposed standard is reasonable,appropriate, and the least costly andintrusive approach for the resolution ofthis issue.

Nevertheless, based on theinformation received in response to thisnotice, the FHWA and HUD intend to

carefully consider the costs and benefitsassociated with various alternativerequirements. Comments, information,and data are solicited on the economicimpact of the potential changes.

Regulatory Flexibility Act

In compliance with the RegulatoryFlexibility Act (5 U.S.C. 601–612), theFHWA and HUD have evaluated thepotential effects of this rulemakingproposal on small entities anddetermined that the proposed standardis reasonable, appropriate, and the leastcostly and intrusive approach for theresolution of this issue. The FHWA andHUD certify that this rulemaking doesnot have a significant economic impacton a substantial number of smallentities. The FHWA and HUD solicitcomments, information, and data onthese impacts.

Executive Order 12612 (FederalismAssessment)

The FHWA has analyzed thisrulemaking in accordance with theprinciples and criteria contained inExecutive Order 12612, Federalism, anddetermined that this action does nothave sufficient federalism implicationsto warrant the preparation of aFederalism Assessment.

The General Counsel of HUD, as theDesignated Official under Section 6(a) ofExecutive Order 12612, has determinedthat the policies contained in this rulewill not have substantial direct effectson States or their political subdivisions,or the relationship between the Federalgovernment and the States, or on thedistribution of power andresponsibilities among the variouslevels of government. As a result, therule is not subject to review under theOrder.

Specifically, the requirements of thisrule are directed to manufacturers anddo not impinge upon the relationshipbetween the Federal government andState and local governments.

Executive Order 12372(Intergovernmental Review)

Catalog of Federal DomesticAssistance Program Number 20.217,Motor Carrier Safety. The regulationsimplementing Executive Order 12372regarding intergovernmentalconsultation on Federal programs andactivities apply to this program.


The proposal in this document doesnot contain information collectionrequirements [44 U.S.C. 3501 et seq.].


National Environmental Policy ActThe FHWA has analyzed this action

for the purpose of the NationalEnvironmental Policy Act of 1969 (42U.S.C. 4321 et seq.) and determined thatthis action would not have any effect onthe quality of the environment.

A Finding of No Significant Impactwith respect to the environment hasbeen made in accordance with HUDregulations at 24 CFR Part 50, whichimplement section 102(2)(c) of theNational Environmental Policy Act of1969. The Finding of No SignificantImpact is available for public inspectionbetween 7:30 a.m. and 5:30 p.m.weekdays in the Office of the RulesDocket Clerk at the above address.

Regulation Identification NumbersA regulation identification number

(RIN) is assigned to each regulatoryaction listed in the Unified Agenda ofFederal Regulations. The RegulatoryInformation Service Center publishesthe Unified Agenda in April andOctober of each year. The RINscontained in the heading of thisdocument can be used to cross referencethis action with the Unified Agenda.

Executive Order 12606, The FamilyThe General Counsel of HUD, as the

Designated Official under ExecutiveOrder 12606, The Family, hasdetermined that this rule does not havepotential for significant impact onformation, maintenance, and generalwell-being of families, and thus, is notsubject to review under the Order. Therule involves requirements fortransportation safety standards formanufactured homes. Any effect on thefamily would likely be indirect andinsignificant.

List of Subjects in 24 CFR Part 3280Fire prevention, Housing standards,

Manufactured homes.

List of Subjects in 49 CFR Part 393Highway safety, Highways and roads,

Motor carriers, and Motor vehicle safety.In consideration of the foregoing, the

Department of Housing and UrbanDevelopment proposes to amend 24 CFRpart 3280 and Interpretative Bulletin J–1–76, and the Department ofTransportation, Federal HighwayAdministration proposes to amend 49CFR part 393 as set forth below.

24 CFR Chapter XX

PART 3280—MANUFACTURED HOMECONSTRUCTION AND SAFETYSTANDARDS

1. The authority citation for Part 3280is revised to read as follows:

Authority: 42 U.S.C. 3535(d), 5301, and5401.

2. Interpretative Bulletin J–1–76published at 41 FR 53627 (December 7,1976) would be amended as follows.(The Interpretative Bulletin is availablefrom the Rules Docket Clerk, Room10276, Department of Housing andUrban Development, 451 7th St. SW.,Washington, DC 20410).

Section C. of the interpretativebulletin would be removed. Section D.would be redesignated as Section C. andwould be revised to read as set forthbelow. Sections E. and F. would beredesignated as Sections D. and E.* * * * *

C. Tires shall be sized and fitted to axlesin accordance with the gross axle weightrating determined by the mobile homemanufacturer. The permissible tire loadingmay be increased up to a maximum of 18percent beyond the rated load capacity of themanufactured home tire as determined by themanufacturer of the tire. Used tires may alsobe sized in accordance with the above criteriawhenever the tread depth is at least 2⁄32 of aninch as determined by a tread wear indicator.The determination as to whether a particularused tire is acceptable shall also include avisual inspection of thermal and structuraldefects (e.g., dry rotting, excessive tiresidewall splitting, etc.). Wheels and rimsshall be sized in accordance with the tiremanufacturer’s recommendations as suitablefor use with the tires selected. This provisionwill become effective nine months after thepublication date of the final rule (insertpublication date). This provision will expire(INSERT DATE TWO YEARS AFTER THEEFFECTIVE DATE OF THE AMENDEDINTERPRETATIVE BULLETIN) unlessextended by mutual consent of FHWA andHUD.* * * * *

49 CFR Chapter III

PART 393—PARTS ANDACCESSORIES NECESSARY FORSAFE OPERATION

4. The authority citation at the end of§ 393.75 would be removed and theauthority citation for 49 CFR part 393would be revised to read as follows:

Authority: Section 1041(b) of Pub. L. 102–240, 105 Stat. 1914, 1993; 49 U.S.C. 31136and 31502; 49 CFR 1.48.

5. Section 393.5 would be amendedby adding the definitions ofmanufactured home, length of amanufactured home, and width of amanufactured home, placing them inalphabetical order, as follows:* * * * *

Length of a manufactured home. Thelargest exterior length in the travelingmode, including any projections whichcontain interior space. Length does notinclude bay windows, roof projections,

overhangs, or eaves under which thereis no interior space, nor does it includedrawbars, couplings or hitches.* * * * *

Manufactured home. A structure,transportable in one or more sections,which in the traveling mode, is eightfeet or more in width or forty feet ormore in length or, when erected on site,is three hundred and twenty or moresquare feet, and which is built on apermanent chassis and designed to beused as a dwelling with or without apermanent foundation when connectedto the required utilities, and includesthe plumbing, heating, air-conditioning,and electrical systems containedtherein. Calculations used to determinethe number of square feet in a structurewill be based on the structure’s exteriordimensions measured at the largesthorizontal projections when erected onsite. These dimensions will include allexpandable rooms, cabinets, and otherprojections containing interior space,but do not include bay windows. Thisterm includes all structures which meetthe above requirements except the sizerequirements and with respect to whichthe manufacturer files a certificationpursuant to 24 CFR 3282.13 andcomplies with the standards set forth inpart 24 CFR 3280.* * * * *

Width of a manufactured home. Thelargest exterior width in the travelingmode, including any projections whichcontain interior space. Width does notinclude bay windows, roof projections,overhangs, or eaves under which thereis no interior space.

6. Section 393.75 would be amendedby revising paragraph (f), and by addingparagraphs (g) and (h) to read as follows:

§ 393.75 Tires.* * * * *

(f) Tire loading restrictions. With theexception of manufactured homes, nomotor vehicle shall be operated withtires that carry a weight greater than thatmarked on the sidewall of the tire or, inthe absence of a marking on the sidewallof the tire, a weight greater than thatspecified for the tires in any of thepublications of any of the organizationslisted in FMVSS No. 119 (49 CFR571.119, S5.1(b)) unless:

(1) The vehicle is being operatedunder the terms of a special permitissued by the State; and

(2) The vehicle is being operated at areduced speed to compensate for the tireloading in excess of the manufacturer’srated capacity for the tire. In no caseshall the speed exceed 80 km/hr (50mph).

(g) Tire loading restrictions formanufactured homes. Effective (INSERT


DATE NINE MONTHS AFTER THEPUBLICATION DATE OF THE FINALRULE), tires used for the transportationof manufactured homes (i.e., tiresmarked or labeled 7–14.5MH and 8–14.5MH) may be loaded up to 18percent over the load rating marked onthe sidewall of the tire or, in the absenceof a marking on the sidewall of the tire,18 percent over the load rating specifiedin any of the publications of any of the

organizations listed in FMVSS No. 119(49 CFR 571.119, S5.1(b)). Manufacturedhomes transported on tires overloadedby 9 percent or more must not beoperated at speeds exceeding 80 km/hr(50 mph). This provision will expire(INSERT DATE TWO YEARS AFTERTHE EFFECTIVE DATE OF THE FINALRULE) unless extended by mutualconsent of FHWA and HUD.

(h) Tire inflation pressure.

(1) No motor vehicle shall be operatedon a tire which has a cold inflationpressure less than that specified for theload being carried.

(2) If the inflation pressure of the tirehas been increased by heat because ofthe recent operation of the vehicle, thecold inflation pressure shall beestimated by subtracting the inflationbuildup factor shown in Table 1 fromthe measured inflation pressure.

TABLE 1.—INFLATION PRESSURE MEASUREMENT CORRECTION FOR HEAT

Average speed of vehicle in the previous hour

Minimum inflation pressure buildup

Tires with 1,814 kg (4,000 lbs.)maximum load rating or less

Tires with over 1,814kg (4,000 lbs.) load

rating

66–88.5 km/hr (41–55 mph) .......................................................................................... 34.5 kPa (5 psi) ........................... 103.4 kpa (15 psi).

Issued on: March 15, 1996.Nicolas P. Retsinas,Assistant Secretary for Housing-FederalHousing Commissioner.

Rodney E. Slater,Federal Highway Administrator.[FR Doc. 96–9717 Filed 4–22–96; 8:45 am]BILLING CODE 4210–27–P

fede

ral r

egiste

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18025


Part IV

Department ofHousing and UrbanDevelopmentOffice of the Secretary

24 CFR Parts 26, 28, 30, et al.Streamlining Hearing Procedures;Proposed Rule




24 CFR Parts 26, 28, 30, 81, 200, 950,965, and 3500

[Docket No. FR–4022–P–01]

RIN 2501–AC19

Streamlining Hearing Procedures;Proposed Rule

AGENCY: Office of the Secretary, HUD.ACTION: Proposed rule.

SUMMARY: In response to the President’sregulatory reform initiatives, thisproposed rule would streamline andconsolidate many of HUD’s regulationscontaining hearing procedures. Thisrule also proposes several substantivechanges to these regulations in order toimprove the hearing process and tomake the regulations more closelyfollow applicable statutes. Thisproposed rule would make theregulations easier for the public to useand understand.DATES: Comments due: June 24, 1996.ADDRESSES: Interested persons areinvited to submit comments regardingthis proposed rule to the Rules DocketClerk, Office of General Counsel, Room10276, Department of Housing andUrban Development, 451 Seventh Street,SW, Washington, DC 20410–0500.Communications should refer to theabove docket number and title.Facsimile (FAX) comments are notacceptable. A copy of eachcommunication submitted will beavailable for public inspection andcopying between 7:30 a.m. and 5:30p.m. weekdays at the above address.FOR FURTHER INFORMATION CONTACT:Emmett N. Roden, Assistant GeneralCounsel for Administrative Proceedings,Office of General Counsel, Departmentof Housing and Urban Development,451 7th Street, S.W., Room 10251,Washington, D.C. 20410, telephone(202) 708–2350. (This is not a toll-freenumber.) Hearing- and speech-impairedpersons may access this number viaTTY by calling the Federal InformationRelay Service at (800) 877–8339.


I. Regulatory ReinventionOn March 4, 1995, President Clinton

issued a memorandum to all Federaldepartments and agencies regardingregulatory reinvention. In response tothis memorandum, the Department ofHousing and Urban Developmentconducted a page-by-page review of itsregulations to determine which can be

eliminated, consolidated, or otherwiseimproved. HUD has determined thatthis proposed rule is necessary toconsolidate and streamline HUD’svarious sets of regulations containinghearing procedures. Therefore, thisproposed rule would consolidate severalsets of hearing procedures into one part,thereby eliminating approximately 20pages of unnecessary regulations fromthe Code of Federal Regulations (CFR).

II. Background

A. Hearings According to theAdministrative Procedure Act

In this rule, HUD proposes to use 24CFR part 26 to contain two sets ofhearing regulations. The first set ofregulations would contain all theprocedures that currently appear in part26. These procedures apply in HUDproceedings before a hearing officer,including administrative sanctionhearings under part 24 and hearingswith respect to actions by the MortgageeReview Board under part 25. Thisproposed rule would not change thesubstance of any of these provisions, butit would set them apart so that they allappear within a new subpart A of part26.

This proposed rule would add thesecond set of regulations to form a newsubpart B. The regulations in subpart Bwould contain a relatively uniform setof hearing procedures for formalhearings according to theAdministrative Procedure Act (5 U.S.C.551 et seq.) (APA). By adding theseuniform procedures to subpart B of part26, HUD intends to consolidate as manyof its hearing procedures as possibleinto one part. This should make HUD’shearing procedures easier to use andunderstand.

The hearing procedures in subpart Bwould apply to hearings under theProgram Fraud Civil Remedies Act of1986, the procedures for whichcurrently appear in part 28. Subpart Bwould also apply to hearings in whichHUD seeks civil money penalties, theprocedures for which currently appearin part 30, and to hearings pursuant tothe Interstate Land Sales Full DisclosureAct, the procedures for which currentlyappear in part 1720. HUD intends thatsubpart B will be used in hearingsconducted pursuant to the APA, unlessother statutory or regulatory provisionsapply.

In addition to consolidating thesehearing procedures into one part andmaking them uniform, this proposedrule would also make a number ofchanges in order to streamline pleadingsand reduce administrative overhead.This proposed rule contains specific

time limits to ensure rapid dispositionof cases (see, e.g., §§ 26.39, 26.42, 26.44,26.50). The proposed rule also wouldclarify that parties must seek Secretarialreview in order to exhaust theiradministrative remedies before seekingjudicial review, thereby addressing theSupreme Court’s decision in Darby v.Cisneros, 113 S.Ct. 2539 (1993). Thisproposed rule also incorporates theFederal Rules of Civil Procedure forcertain aspects of discovery (see§§ 26.41(a), (c); § 26.43(b)).

HUD specifically invites the public tocomment on these procedural changesthat would be incorporated into part 26subpart B, as well as ways in whichHUD could further streamline itshearing procedures.

B. Program Fraud Civil Remedies Act of1986

Part 28 of HUD’s regulations containsthe procedures for imposing civilpenalties and assessments, pursuant tothe Program Fraud Civil Remedies Actof 1986 (PFCRA), upon persons whomake false or fraudulent claims orstatements to Federal authorities. HUDestablished the regulations in part 28 onJune 24, 1988 (53 FR 24000). TheDepartment of Health and HumanServices led a task force to draft a modelregulation to implement PFCRA, andpart 28 follows the model closely withonly minor variations to accommodateHUD’s organizational and programstructure.

This proposed rule would streamlinethe provisions in part 28 by removingthe hearing procedures, and by retainingin their place a cross-reference to theuniform hearing procedures in part 26subpart B (see, e.g., § 28.40 of thisproposed rule). This proposed rulewould also streamline the substantiveprovisions of the PFCRA regulations byeliminating unnecessary language andby clarifying the remaining language,making these regulations easier to useand understand. In addition to thesestreamlining changes, HUD alsoproposes to shorten the decision processby removing the reconsideration ofinitial determinations.

C. Civil Money Penalties

HUD established the civil moneypenalties regulations in part 30 on May22, 1991 (56 FR 23622). Theseregulations implemented severalsections of the Department of Housingand Urban Development Reform Act of1989 (Pub. L. 101–235; approvedDecember 15, 1989), which authorizedHUD to impose civil money penaltiesfor unlawful conduct in connectionwith a broad array of programs.


In this rule, HUD proposes tostreamline the regulations in part 30. Aswith the regulations in part 28 forPFCRA, this proposed rule wouldremove the hearing procedures frompart 30, maintaining a cross-reference tothe uniform hearing procedures in part26 subpart B. In addition, this proposedrule would eliminate three of the civilmoney penalty panels that exist in thecurrent regulations: the Housing CivilPenalties Panel (HCPP), the GovernmentNational Mortgage Association CivilPenalties Panel (GCPP), and theDepartmental Civil Penalties Panel(DCPP) (see § 30.205 of the currentregulations). HUD created these panelsto review recommendations for and topropose civil money penalties.However, this proposed rule wouldprovide that certain appropriate HUDofficials would replace the panels intheir authority to initiate actions forcivil money penalties. For instance, in§ 30.20 of this proposed rule, theGeneral Counsel or his or her designee,rather than the DCPP, may initiate acivil money penalty action against HUDemployees who improperly discloseinformation. See also §§ 30.25 through30.60 of this proposed rule.

In addition to the streamliningchanges contained in this proposed rule,HUD proposes to revise and clarify thelist of violations for GovernmentNational Mortgage Association (GNMA)issuers and custodians (§ 30.45 of thisproposed rule). HUD also proposes torevise the list of violations applicable tomortgagees and lenders to include themisuse of loan proceeds and the failureto comply with settlement agreementswith HUD (§ 30.35(a)(11) and (a)(15) ofthis proposed rule), and to expand theviolation for failure to service Section235 mortgages to include other housingprograms (§ 30.35(a)(10) of thisproposed rule).

This proposed rule would also revisepart 30 to include the civil moneypenalties that were enacted as part ofthe Housing and CommunityDevelopment Act of 1992 (Pub. L. 102–550; approved October 28, 1992).Specifically, the proposed rule wouldadd provisions concerning failure todisclose lead-based paint (§ 30.60 of thisproposed rule) and violations bymortgagees and lenders concerning loanguarantees for Indian Housing(§ 30.35(a)(14) of this proposed rule).

D. Conforming Changes

This proposed rule would also makenecessary conforming changes, whichare merely technical andnonsubstantive, to the following HUDregulations:

1. Government Sponsored Enterprises,24 CFR part 81;

2. Participation and ComplianceRequirements for Federal HousingAdministration programs, 24 CFR200.243;

3. Insurance Entities under the IndianHousing Programs, 24 CFR 950.190, andthe Public Housing Programs, 24 CFR965.205;

4. The Real Estate SettlementProcedures Act, 24 CFR part 3500.

III. Other Matters

National Environmental Policy ActIn accordance with 40 CFR 1508.4 of

the regulations of the Council onEnvironmental Quality and 24 CFR50.20(k) of HUD regulations, thepolicies and procedures contained inthis proposed rule relate only to hearingprocedures and administrativedecisions, which do not constitutedevelopment decisions and do not affectthe physical condition of a project areaor building site. Therefore, thisproposed rule is categorically excludedfrom the requirements of the NationalEnvironmental Policy Act.

Regulatory Flexibility ActIn accordance with the Regulatory

Flexibility Act (5 U.S.C. 605(b)), theSecretary hereby certifies that thisproposed rule would not have asignificant economic impact on asubstantial number of small entities.This proposed rule implementsstatutory authority intended to protectHUD’s programs from abusive practices,but it will have no adverse ordisproportionate economic impact onsmall businesses.

Executive Order 12606, The FamilyThe General Counsel, as the

Designated Official under ExecutiveOrder 12606, The Family, hasdetermined that this proposed rule doesnot have potential for significant impacton family formation, maintenance, andgeneral well-being. No significantchange in existing HUD policies orprograms will result from promulgationof this proposed rule, as those policiesand programs relate to family concerns.Therefore, the proposed rule is notsubject to review under the Order.

Executive Order 12612, FederalismThe General Counsel, as the

Designated Official under Section 6(a) ofExecutive Order 12612, Federalism, hasdetermined that the policies containedin this proposed rule will not havesubstantial direct effects on States ortheir political subdivisions, or therelationship between the FederalGovernment and the States, or on the

distribution of power andresponsibilities among the variouslevels of government. As a result, theproposed rule is not subject to reviewunder the Order.

List of Subjects

24 CFR Part 26Administrative practice and

procedure, Claims, Fraud, Grantprograms—housing and communitydevelopment, Loan programs—housingand community development,Mortgages, Penalties.


procedure, Claims, Fraud, Penalties.


procedure, Grant programs—housingand community development, Loanprograms—housing and communitydevelopment, Mortgages, Penalties.

24 CFR Part 81Accounting, Federal Reserve System,

Mortgagees, Reporting andrecordkeeping requirements, Securities.


procedure, Claims, Equal employmentopportunity, Fair housing, Homeimprovement, Housing standards,Incorporation by reference, Leadpoisoning, Loan programs—housing andcommunity development, Minimumproperty standards, Mortgage insurance,Organization and functions(Government agencies), Penalties,Reporting and recordkeepingrequirements, Social security,Unemployment compensation, Wages.

24 CFR Part 950Aged, Grant programs—housing and

community development, Grantprograms—Indians, Indians, Individualswith disabilities, Low and moderateincome housing, Public housing,Reporting and recordkeepingrequirements.

24 CFR Part 965Energy conservation, Government

procurement, Grant programs—housingand community development, Leadpoisoning, Loan programs—housing andcommunity development, Publichousing, Reporting and recordkeepingrequirements, Utilities.

24 CFR Part 3500Consumer protection, Condominiums,

Housing, Mortgages, Mortgage servicing,Reporting and recordkeepingrequirements.


Accordingly, parts 26, 28, 30, 81, 200,950, 965, and 3500 of title 24 of theCode of Federal Regulations areproposed to be amended as follows:

PART 26—HEARING PROCEDURES

1. The part heading for part 26 isrevised to read as set forth above.


Authority: 42 U.S.C. 3535(d).

3. The heading of subpart A is revisedto read, ‘‘Subpart A—Hearings BeforeHearing Officers’’.

Subparts B, C, D, E, F, and G[Redesignated]

4. The headings for subparts B, C, D,E, F, and G are redesignated asundesignated center headings; and§§ 26.2 through 26.26 of subparts B, C,D, E, F, and G are redesignated as§§ 26.2 through 26.26 of subpart A.

5. A new subpart B is added to readas follows:

Subpart B—Hearings Pursuant to theAdministrative Procedure Act

General

Sec.26.27 Purpose and scope.26.28 Definitions.26.29 Powers and duties of the

Administrative Law Judge (ALJ).26.30 Ex parte contacts.26.31 Disqualification of ALJ.26.32 Parties to the hearing.26.33 Separation of functions.26.34 Time computations.26.35 Service and filing.26.36 Sanctions.

Prehearing Procedures

26.37 Commencement of action.26.38 Motions.26.39 Default.26.40 Prehearing conferences.26.41 Discovery.26.42 Subpoenas.26.43 Protective order.

Hearings

26.44 General.26.45 Witnesses.26.46 Evidence.26.47 The record.26.48 Posthearing briefs.26.49 Initial decision.26.50 Appeal to the Secretary.26.51 Exhaustion of administrative

remedies.26.52 Judicial review.26.53 Collection of civil penalties and

assessments.26.54 Right to administrative offset.

Subpart B—Hearings Pursuant to theAdministrative Procedure Act

General

§ 26.27 Purpose and scope.Unless otherwise specified in this

part, the rules in this subpart B apply tohearings that HUD is required by statuteto conduct pursuant to theAdministrative Procedure Act (5 U.S.C.554 et seq.).

§ 26.28 Definitions.The following definitions apply to

subpart B of this part:Chief Docket Clerk means the Chief

Docket Clerk of the Office ofAdministrative Law Judges at thefollowing address: 409 3rd Street, S.W.,Suite 320, Washington, D.C. 20024.

Complaint means the notice fromHUD alleging violations of a HUDstatute and/or regulation, citing the legalauthority upon which it is issued,stating the relief HUD seeks, andinforming a respondent of his or herright to file a response and to request anopportunity for a hearing before anAdministrative Law Judge.

Response means the written responseto a complaint, admitting or denying theallegations in the complaint and settingforth any affirmative defense and/or anymitigating factors or extenuatingcircumstances. A response is deemed arequest for a hearing.

§ 26.29 Powers and duties of theAdministrative Law Judge (ALJ).

Authority of the Administrative LawJudge (ALJ). The ALJ shall conduct a fairand impartial hearing, avoid delay,maintain order, and assure that a recordof the proceeding is made. The ALJ isauthorized to:

(a) Set and change the date, time, andplace of the hearing upon reasonablenotice to the parties;

(b) Continue or recess the hearing inwhole or in part for a reasonable periodof time;

(c) Hold conferences to identify orsimplify the issues, or to consider othermatters that may aid in the expeditiousdisposition of the proceeding;

(d) Administer oaths and affirmations;(e) Issue subpoenas requiring the

attendance of witnesses and theproduction of documents at depositionsor at hearings;

(f) Rule on motions and otherprocedural matters;

(g) Regulate the scope and timing ofdiscovery;

(h) Regulate the course of the hearingand the conduct of representatives andparties;

(i) Examine witnesses;(j) Receive, rule on, exclude, or limit

evidence;

(k) Upon motion of a party, takeofficial notice of facts;

(l) Upon motion of a party, decidecases, in whole or in part, by summaryjudgment where there is no disputedissue of material fact;

(m) Conduct any conference,argument, or hearing on motions inperson or by telephone; and

(n) Exercise such other authority as isnecessary to carry out theresponsibilities of the ALJ under thispart.

§ 26.30 Ex parte contacts.

No party or person (except employeesof the ALJ’s office) shall communicatein any way with the ALJ on any matterat issue in a case, unless on notice andopportunity for all parties to participate.This provision does not prohibit aperson or party from inquiring about thestatus of a case or asking routinequestions concerning administrativefunctions or procedures.

§ 26.31 Disqualification of ALJ.

(a) An ALJ in a particular case maydisqualify himself or herself.

(b) A party may file with the ALJ amotion for the ALJ’s disqualification.The motion shall be accompanied by anaffidavit alleging the grounds fordisqualification.

(c) Upon the filing of a motion andaffidavit, the ALJ shall proceed nofurther in the case until the matter ofdisqualification is resolved.

§ 26.32 Parties to the hearing.

(a) General. The parties to the hearingshall be the respondent and HUD.

(b) Rights of parties. Except asotherwise limited by subpart B of thispart, all parties may:

(1) Be accompanied, represented, andadvised by a representative;

(2) Participate in any conference heldby the ALJ;

(3) Conduct discovery;(4) Agree to stipulations of fact or law,

which shall be made part of the record;(5) Present evidence relevant to the

issues at the hearing;(6) Present and cross-examine

witnesses;(7) Present oral arguments at the

hearing as permitted by the ALJ; and(8) Submit written briefs and

proposed findings of fact andconclusions of law after the hearing.

§ 26.33 Separation of functions.

No officer, employee, or agent of theFederal Government engaged in theperformance of investigative,conciliatory, or prosecutorial functionsin connection with the proceeding shall,in that proceeding or any factually


related proceeding under subpart B ofthis part, participate or advise in thedecision of the administrative lawjudge, except as a witness or counselduring the proceeding, or in itsappellate review.

§ 26.34 Time computations.(a) In computing any period of time

under subpart B of this part, the timeperiod begins the day following the act,event, or default and includes the lastday of the period, unless the last day isa Saturday, Sunday, or legal holidayobserved by the Federal Government, inwhich case the time period includes thenext business day. When the prescribedtime period is seven days or less,intermediate Saturdays, Sundays, andlegal holidays shall be excluded fromthe computation.

(b) Entry of orders. In computing anytime period involving the date of theissuance of an order or decision by anadministrative law judge, the date ofissuance is the date the order ordecision is served by the Chief DocketClerk.

(c) Service by mail. If a document isserved by mail, five days shall be addedto the time permitted for a response.

§ 26.35 Service and filing.(a) Filing. All documents shall be filed

with the Chief Docket Clerk, at theaddress listed in § 26.28. Filing may beby first class mail, delivery, facsimiletransmission, or electronic means;however, the ALJ may place appropriatelimits on filing by facsimiletransmission or electronic means. Alldocuments shall clearly designate thedocket number and title of theproceeding.

(b) Service. One copy of alldocuments filed with the Chief DocketClerk shall be served upon each party bythe persons filing them and shall beaccompanied by a certificate of servicestating how and when such service hasbeen made. Service may be made bydelivery, first class mail, facsimiletransmission, or electronic means;however, the ALJ may place appropriatelimits on service by facsimiletransmission or electronic means.Documents shall be served upon aparty’s address of residence or principalplace of business, or, if the party isrepresented by counsel, upon counsel ofrecord at the address of counsel. Serviceis complete when handed to the personor delivered to the person’s office orresidence and deposited in aconspicuous place. If service is by first-class mail, facsimile transmission orelectronic means, service is completeupon deposit in the mail or uponelectronic transmission.

§ 26.36 Sanctions.

(a) The ALJ may sanction a person,including any party or representative,for failing to comply with an order, rule,or procedure governing the proceeding;failing to prosecute or defend an action;or engaging in other misconduct thatinterferes with the speedy, orderly, orfair conduct of the hearing.

(b) Any sanction, including but notlimited to those listed in paragraphs (c),(d), and (e) of this section, shallreasonably relate to the severity andnature of the failure or misconduct.

(c) Failure to comply with an order.When a party fails to comply with anorder, including an order compellingdiscovery, the ALJ may:

(1) Draw an inference in favor of therequesting party with regard to theinformation sought;

(2) In the case of requests foradmission, regard each matter aboutwhich an admission is requested to beadmitted;

(3) Prohibit the party failing tocomply with the order from introducingevidence concerning, or otherwiserelying upon, testimony relating to theinformation sought; or

(4) Strike any part of the pleadings orother submissions of the party failing tocomply with the order.

(d) If a party fails to prosecute ordefend an action under this part, theALJ may dismiss the action or may issuean initial decision against therespondent.

(e) The ALJ may refuse to considerany motion, request, response, brief orother document that is not filed in atimely fashion.

Prehearing Procedures

§ 26.37 Commencement of action.

An action under subpart B of this partshall commence with the Government’sfiling of a complaint, and a responsethereto, as those terms are defined in§ 26.28, with the Chief Docket Clerk. Ifthe respondent fails to file a response,then the Government may file a motionfor a default judgment, together with acopy of the complaint, in accordancewith § 26.39.

§ 26.38 Motions.

(a) General. All motions shall state thespecific relief requested and the basistherefor and, except during a conferenceor the hearing, shall be in writing.Written motions shall be filed andserved in accordance with § 26.35.

(b) Response to motions. Unlessotherwise ordered by the ALJ, aresponse to a written motion may befiled within 7 days after service of themotion. A party failing timely to

respond to a motion shall be deemed tohave waived any objection to thegranting of the motion.

§ 26.39 Default.(a) General. The respondent may be

found in default, upon motion, forfailure to file a timely response to theGovernment’s complaint. The motionshall include a copy of the complaintand a proposed default order, and shallbe served upon all parties. Therespondent shall have 7 days from suchservice to respond to the motion.

(b) Default order. The ALJ shall issuea decision on the motion within 15 daysafter the expiration of the time for filinga response to the default motion. If adefault order is issued, it shallconstitute the final agency action.

(c) Effect of default. A default shallconstitute an admission of all factsalleged in the Government’s complaintand a waiver of respondent’s right to ahearing on such allegations. The penaltyproposed in the complaint shall be setforth in the default order and shall beimmediately due and payable byrespondent without further proceedings.

§ 26.40 Prehearing conferences.(a) The ALJ may schedule prehearing

conferences as appropriate.(b) Upon the motion of any party, the

ALJ shall schedule at least oneprehearing conference at a reasonabletime in advance of the hearing.

(c) Prehearing conferences mayconsider the following:

(1) Simplification of the issues;(2) Stipulations of fact and of the

authenticity, accuracy, andadmissibility of documents;

(3) Submission of the case on briefs inlieu of an oral hearing;

(4) Limitation of the number ofwitnesses;

(5) The exchange of witness lists andof proposed exhibits;

(6) Discovery;(7) The time and place for the hearing;

and(8) Such other matters as may tend to

expedite the fair and just disposition ofthe proceedings.

§ 26.41 Discovery.

(a) Unless otherwise stated in subpartB of this part, discovery shall beconducted in accordance with theFederal Rules of Civil Procedure, exceptfor Rule 26(a), (d) and (f).

(b) Discovery in Program Fraud CivilRemedies actions (24 CFR part 28),unless agreed to by the parties, shall beavailable only as ordered by the ALJ.The party opposing discovery shall have10 days to respond to a motion fordiscovery. The ALJ shall grant a motion


for discovery only if he or she finds thatdiscovery is necessary for theexpeditious, fair, and reasonableconsideration of the issues, is notunduly costly or burdensome, will notunduly delay the proceeding, and doesnot seek privileged information. TheALJ may grant discovery subject to aprotective order under § 26.43. Therequest for approval sent to the AttorneyGeneral from the General Counsel ordesignee, as described in § 28.20 of thistitle, is not discoverable under anycircumstances.

(c) The following types of discoveryare authorized:

(1) Requests for production ofdocuments for inspection and copying.Nothing contained herein shall beinterpreted to require the creation of adocument.

(2) Requests for admissions.(3) Written interrogatories. Such

interrogatories shall be limited innumber in accordance with Rule 33 ofthe Federal Rules of Civil Procedure.

(4) Depositions.(d) Motions to compel. A party may

file a motion to compel discovery. Themotion shall describe the informationsought, cite the opposing party’sobjection, and provide argumentssupporting the motion. The opposingparty may file a response to the motion,including a request for a protectiveorder. The ALJ may issue an ordercompelling a response, issue sanctionspursuant to § 26.36, or issue a protectiveorder. For purposes of paragraph (d) ofthis section, an evasive or incompleteanswer to a request for discovery istreated as a failure to answer.

(e) Each party shall bear its own costsof discovery.

§ 26.42 Subpoenas.(a) General. Upon written request of a

party, the ALJ may issue a subpoenarequiring the attendance of a witness ata deposition or hearing, and/or theproduction of documents. The requestshall specify any documents to beproduced and shall list the names andaddresses of the witnesses.

(b) Time of request. A request for asubpoena in aid of discovery shall befiled in time to permit the conclusion ofdiscovery 15 days before the date fixedfor the hearing. A request for a subpoenato testify at the hearing shall be filed atleast three days prior to the hearing,unless otherwise allowed by the ALJ forgood cause shown.

(c) The subpoena shall specify thetime and place at which the witness isto appear and any documents thewitness is to produce.

(d) Service and fees. Subpoenas shallbe served, and fees and costs paid to

subpoenaed witnesses, in accordancewith Rule 45(b)(1) of the Federal Rulesof Civil Procedure.

(e) Motion to quash. The individual towhom the subpoena is directed or aparty may file a motion to quash thesubpoena within 10 days after service,or on or before the time specified in thesubpoena for compliance if it is lessthan 10 days after service.

§ 26.43 Protective order.(a) A party or a prospective witness or

deponent may file a motion for aprotective order with respect todiscovery sought by an opposing partyor with respect to the hearing, seekingto limit the availability or disclosure ofevidence.

(b) In issuing a protective order, theALJ may issue any order that justicerequires to protect a party or personfrom annoyance, embarrassment,oppression, or undue burden orexpense, as provided for in Rule 26(c)of the Federal Rules of Civil Procedure.

Hearings

§ 26.44 General.(a) Time of hearing. The hearing shall

commence not later than 60 daysfollowing the filing of the complaint andresponse under § 26.37, unless the timeis extended for good cause. The ALJshall provide written notice to allparties of the reasons for any extensionof time.

(b) Location of hearing. The hearingshall be held where the respondentresides or transacts business, or in suchother place as may be agreed upon bythe parties and the ALJ. Hearings forProgram Fraud Civil Remedies Act casesshall be located in accordance with 31U.S.C. 3803(g)(4).

(c) Notice of hearing. The ALJ shallissue a notice of hearing to all partiesspecifying the time and location of thehearing, the matters of fact and law tobe heard, the legal authority underwhich the hearing is to be held, adescription of the procedures for theconduct of the hearing, and such othermatters as the ALJ determines to beappropriate.

(d) Limitations for Program FraudCivil Remedies Act cases. The notice ofhearing must be served upon therespondent within 6 years after the dateon which the claim or statement ismade. If the respondent fails to file atimely response to the Government’scomplaint, service of a default judgmentunder § 26.39 shall be regarded as anotice of hearing for purposes of thissection. The statute of limitations maybe extended by agreement of the parties.

(e) Burden and standard of proof.HUD shall prove the respondent’s

liability and any aggravating factors bya preponderance of the evidence.Respondent shall prove any affirmativedefenses and any mitigating factors by apreponderance of the evidence.

(f) Public hearings. Unless otherwiseordered by the ALJ for good causeshown, the hearing shall be open to thepublic.

§ 26.45 Witnesses.(a) Except as provided in paragraph

(b) of this section, testimony at thehearing shall be given orally bywitnesses under oath or affirmation.

(b) At the discretion of the ALJ,testimony may be admitted in the formof a written statement or deposition. Inorder to be admissible, any writtenstatement must be provided to all otherparties along with the last knownaddress of the witness, in a manner thatallows sufficient time for other partiesto subpoena the witness for cross-examination at the hearing.

§ 26.46 Evidence.(a) The ALJ shall admit any relevant

oral or documentary evidence that is notprivileged. The ALJ may, however,exclude evidence if its probative valueis substantially outweighed by thedanger of unfair prejudice, by confusionof the issues, or by considerations ofundue delay, waste of time, or needlesspresentation of cumulative evidence.

(b) Evidence concerning offers ofcompromise or settlement shall beinadmissible to the extent provided inRule 408 of the Federal Rules ofEvidence.

(c) All documents and other evidenceoffered or taken for the record shall beopen to examination by all parties,unless otherwise ordered by the ALJ inaccordance with § 26.43.

§ 26.47 The record.(a) The hearing will be recorded and

transcribed. The transcript of testimony,exhibits, and other evidence admitted atthe hearing and all papers and requestsfiled in the proceeding constitute therecord for the decision by the ALJ andthe Secretary or designee.

(b) The record may be inspected andcopied (upon payment of a reasonablefee) by anyone, unless otherwiseordered by the ALJ in accordance with§ 26.43.

§ 26.48 Posthearing briefs.Posthearing briefs shall be filed only

upon order by the ALJ.

§ 26.49 Initial decision.(a) The ALJ shall issue an initial

decision based only on the record,which shall contain findings of fact,conclusions of law, and the relief


granted. The ALJ shall consider suchfactors as may be set forth in applicablestatutes and regulations.

(b) The ALJ shall serve the initialdecision on all parties within 45 daysafter either the close of the record, or theexpiration of time permitted forsubmission of posthearing briefs,whichever is later. The initial decisionshall include a statement of each party’sright to file a request for Secretarialreview. The ALJ may extend the 45-dayperiod for serving the initial decision inwriting for good cause.

(c) If no appeal is timely filed with theSecretary or designee, the initialdecision shall become the final agencyaction.

§ 26.50 Appeal to the Secretary.

(a) Except as otherwise set forth inparagraph (b) of this section, eitherparty may file with the Secretary apetition for review within 30 days afterthe ALJ issues an initial decision. TheSecretary or designee may extend the30-day period for good cause. If theSecretary or designee does not act uponthe petition for review within 90 daysof its service, then the initial decisionshall become final.

(b) Appeals of Program Fraud CivilRemedies Act decisions (24 CFR part28). Only the respondent may file apetition for Secretarial review. Thepetition must be filed within 30 daysafter the ALJ issues the initial decision.The Secretary or designee may extendthe 30-day period for good cause. If theSecretary or designee does not act uponthe petition for review within 30 daysof its service, then the initial decisionshall become final.

(c) Brief in support of petition. Thepetition for review shall beaccompanied by a written brief, not toexceed 10 pages, specifying exceptionsto the initial decision and reasonssupporting the exceptions.

(d) Service. The party submitting thepetition for review shall serve a copy ofthe petition and brief in support on theother parties and on the Chief DocketClerk.

(e) Forwarding of the record. Upon thefiling of a petition for review, the ALJshall forward the record of theproceeding to the Secretary or designee.

(f) Brief in opposition. Any opposingparty may file a brief opposing review,not to exceed 10 pages, within 20 daysof receiving the petition for review andaccompanying brief. The brief inopposition shall be served on all parties.

(g) Additional briefs. If the petition isgranted, then the Secretary or designeemay order the filing of additional briefs.

(h) There is no right to appearpersonally before the Secretary ordesignee.

(i) There is no right to appeal anyinterlocutory ruling by the ALJ.

(j) In reviewing the initial decision,the Secretary or designee shall notconsider any objection that was notraised before the ALJ unless ademonstration is made of extraordinarycircumstances causing the failure toraise the objection.

(k) The Secretary or designee shallconsider only evidence contained in therecord forwarded by the ALJ. However,if any party demonstrates to thesatisfaction of the Secretary or designeethat additional evidence not presentedat the hearing is material and that therewere reasonable grounds for the failureto present such evidence at suchhearing, the Secretary or designee shallremand the matter to the ALJ forconsideration of such additionalevidence.

(l) The prohibitions of ex partecontacts in § 26.30 shall apply tocontacts with the Secretary or designee.

(m) The Secretary or designee mayaffirm, reduce, reverse, compromise,remand, or settle any relief granted inthe initial decision. The Secretary ordesignee shall consider, and include inany final determination, such factors asmay be set forth in applicable statutesor regulations.

(n) The Secretary or designee shallpromptly serve each party to the appealwith a copy of his or her decision anda statement describing the right to seekjudicial review.

(o) Judicial review. Generally, a partymust file a petition for judicial reviewwithin 20 days of service of theSecretary’s determination, or theSecretary’s determination shall becomefinal and not subject to judicial review.In Program Fraud Civil Remedies Actmatters (24 CFR part 28), the respondentshall have 60 days from the date that thedetermination is sent to the respondentin which to file a petition.

§ 26.51 Exhaustion of administrativeremedies.

In order to fulfill the requirement ofexhausting administrative remedies, aparty must seek Secretarial reviewunder § 26.50 prior to seeking judicialreview of any initial decision issuedunder subpart B of this part.

§ 26.52 Judicial review.Judicial review shall be in accordance

with applicable statutory proceduresand the procedures of the appropriateFederal court. The Government may notseek judicial review of an adversedetermination of a Program Fraud CivilRemedies Act matter.

§ 26.53 Collection of civil penalties andassessments.

Collection of civil penalties andassessments shall be in accordance withapplicable statutory provisions.

§ 26.54 Right to administrative offset.The amount of any penalty or

assessment that has become final, or forwhich a judgment has been enteredunder §§ 26.52 or 26.53, or agreed uponin a compromise or settlement amongthe parties, may be collected byadministrative offset under 31 U.S.C.3716 or other applicable law. InProgram Fraud Civil Remedies Actmatters, an administrative offset maynot be collected against a refund of anoverpayment of Federal taxes then orlater owing by the United States to therespondent.

6–8. Part 28 is revised to read asfollows:

PART 28—IMPLEMENTATION OF THEPROGRAM FRAUD CIVIL REMEDIESACT OF 1986

Sec.28.1 Purpose.28.5 Definitions.28.10 Basis for civil penalties and

assessments.28.15 Investigation.28.20 Request for approval by the Justice

Department.28.25 Notice of civil penalty (and

assessment).28.30 Response.28.35 Disclosure of documents.28.40 Hearings.28.45 Settlements.

Authority: 31 U.S.C. 3801; 42 U.S.C.3535(d).

§ 28.1 Purpose.This part:(a) Establishes administrative

procedures for imposing civil penaltiesand assessments against persons whomake, submit, or present, or cause to bemade, submitted, or presented, false,fictitious, or fraudulent claims orwritten statements to Federal authoritiesor to their agents; and

(b) Specifies the hearing and appealrights of persons subject to allegations ofliability for such penalties andassessments. Hearings under this partshall be conducted pursuant to 24 CFRpart 26, subpart B.

§ 28.5 Definitions.The terms ALJ and HUD are defined

in 24 CFR part 5.Benefit means anything of value,

including, but not limited to, anyadvantage, preference, privilege, license,permit, favorable decision, ruling,status, or loan insurance or guarantee.

Claim means any request, demand, orsubmission:


(1) Made to HUD for property,services, or money (including moneyrepresenting grants, loans, insurance, orbenefits);

(2) Made to a recipient of property,services, or money from HUD or to aparty to a contract with HUD; or

(3) Made to HUD which has the effectof decreasing an obligation to pay oraccount for property, services, ormoney.

Knows or has reason to know meansthat a person has actual knowledge thata claim or statement is false, fictitious,or fraudulent; acts in deliberateignorance of the truth or falsity of theclaim or statement; or acts in recklessdisregard of the truth or falsity of theclaim or statement.

Person means any individual,partnership, corporation, association,private organization or entity.

Respondent means any person allegedto be liable for a civil penalty orassessment under § 28.25.

Statement means any representation,certification, affirmation, document,record, or accounting or bookkeepingentry made:

(1) With respect to a claim, to obtainapproval or payment of a claim, orrelating to eligibility to make a claim; or

(2) With respect to or relating toeligibility for a contract, bid, or proposalfor a contract with; or a grant orcooperative agreement, loan, or benefitfrom; HUD, any State, any politicalsubdivision of a State, or other party, ifthe United States Government providesany portion of the money or propertyunder the contract or the grant orcooperative agreement, loan, or benefit,or if the Government will reimburse theState, political subdivision, or party forany portion of the money or propertyunder the contract or for the grant orcooperative agreement, loan, or benefit.

§ 28.10 Basis for civil penalties andassessments.

(a) Claims. (1) A civil penalty of notmore than $5,000 may be imposed upona person who makes a claim that theperson knows or has reason to know:

(i) Is false, fictitious, or fraudulent;(ii) Includes or is supported by a

written statement that either contains amaterial fact which is false, fictitious, orfraudulent; or omits a material factwhich the person has a duty to includeand is false, fictitious, or fraudulent asa result of the omission; or

(iii) Is for payment for the provisionof property or services that the personhas not provided as claimed.

(2) Each voucher, invoice, claim form,or other individual request or demandfor property, services, or moneyconstitutes a separate claim.

(3) A claim shall be considered madeto HUD, to a recipient, or to a partywhen the claim actually is made to anagent, fiscal intermediary, or otherentity, including any State or politicalsubdivision of a State, acting for or onbehalf of HUD, the recipient, or theparty.

(4) Each claim for property, services,or money is subject to a civil penaltywithout regard to whether the property,services, or money actually is deliveredor paid.

(5) Limit on amount of claim. Liabilityunder this part shall not lie if theamount of money or value of propertyor services claimed exceeds $150,000 asto each claim that a person submits. Forpurposes of paragraph (a) of this section,a group of claims submittedsimultaneously as part of a singletransaction shall be considered a singleclaim.

(6) Assessment. If the Government hasmade any payment, transferred propertyor provided services on a claim, thenthe Government may assess a personfound liable up to twice the amount ofthe claim or portion of the claim that isdetermined to be in violation ofparagraph (a)(1) of this section.

(b) Statements. (1) A civil penalty ofup to $5,000 may be imposed upon aperson who makes a written statementthat:

(i) The person knows, or has reason toknow, contains a material fact which isfalse, fictitious, or fraudulent; or omitsa material fact that the person has a dutyto include and is false, fictitious, orfraudulent because of that omission; and

(ii) Contains or is accompanied by anexpress certification or affirmation ofthe truthfulness and accuracy of thecontents of the statement.

(2) Each written representation,certification, or affirmation constitutes aseparate statement.

(3) A statement shall be consideredmade to HUD when the statement isactually made to an agent, fiscalintermediary, or other entity, includingany State or political subdivision of aState, acting for or on behalf of HUD.

(c) Limit on liability. If the claim orstatement relates to low-income housingbenefits or housing benefits for theelderly or handicapped, then a personmay be held liable only if he or she hasmade the claim or statement in thecourse of applying for such benefits,with respect to his or her eligibility, orfamily’s eligibility, to receive suchbenefits. For purposes of paragraph (c)of this section, housing benefits meansany instance wherein fundsadministered by the Secretary directlyor indirectly permit low-incomefamilies or elderly or handicapped

persons to reside in housing whichotherwise would not be available tothem.

(d) No proof of specific intent todefraud is required to establish liabilityunder this section.

(e) Joint and several liability. A civilpenalty or assessment may be imposedjointly and severally where more thanone person is determined to be liable.

§ 28.15 Investigation.(a) General. HUD may initiate a

Program Fraud Civil Remedies Act (31U.S.C. 3801) case against a respondentonly upon an investigation by theInspector General or his or her designee.

(b) Subpoena. Pursuant to 31 U.S.C.3804(a), the Inspector General ordesignee may require by subpoena theproduction of records and otherdocuments. The subpoena shall state theauthority under which it is issued,identify the records sought, and namethe person designated to receive therecords. The recipient of the subpoenashall provide a certification that thedocuments sought have been produced,that the documents are not available andthe reasons they are not available, orthat the documents, suitably identified,have been withheld based upon theassertion of an identified privilege.

(c) Investigation report. If theInspector General or designee concludesthat an action under the Program FraudCivil Remedies Act may be warranted,her or she shall submit a reportcontaining the findings and conclusionsof the investigation to the GeneralCounsel or his or her designee.

(d) The Inspector General may referallegations directly to the Department ofJustice for suit under the False ClaimsAct (31 U.S.C. 3730) or for other civilrelief, or may postpone submitting areport to the General Counsel to avoidinterference with a criminalinvestigation or prosecution. TheInspector General shall report violationsof criminal law to the Attorney General.

§ 28.20 Request for approval by theJustice Department.

(a) If the General Counsel or designeedetermines that the investigation reportsupports an action under this part, he orshe must submit a written request to theDepartment of Justice for approval toissue a notice under § 28.25.

(b) The request shall include adescription of the claims or statementsat issue; the evidence supporting thenotice; an estimate of the amount ofmoney or the value of property,services, or other benefits requested ordemanded in violation of § 28.10; anyexculpatory or mitigating circumstancesthat may relate to the claims or


statements; and a statement that there isa reasonable prospect of collecting anappropriate amount of penalties andassessments.

§ 28.25 Notice of civil penalty (andassessment).

(a) General. Upon obtaining approvalfrom the Department of Justice, theGeneral Counsel or designee may issuea notice of civil penalty (andassessment, if appropriate) to therespondent. The notice shall be sent bycertified mail, return receipt requested,or shall be personally served.

(b) Notice. The notice shall include:(1) The allegations of liability against

the respondent, including the statutorybasis for liability, the claims orstatements at issue, and the reasons whyliability arises from those claims orstatements;

(2) The amount of penalties andassessments for which the respondentmay be held liable;

(3) That the respondent may requesta hearing by submitting a writtenresponse to the notice;

(4) The address to which a responsemust be sent; and

(5) That failure to submit an answerwithin 30 days of receipt of the noticemay result in the imposition of themaximum amount of penalties andassessments sought without right ofappeal.

(c) A copy of this part 28 and of 24CFR part 26, subpart B shall be includedwith the notice.

§ 28.30 Response.(a) The respondent may submit a

written response to HUD within 30 daysof service of the notice of civil penalty.The response shall be deemed to be arequest for hearing. The responseshould include the admission or denialof each allegation of liability made inthe notice; any defense on which therespondent intends to rely; any reasonswhy the penalties and assessmentsshould be less than the amount set forthin the notice; and the name, address,and telephone number of the personwho will act as the respondent’srepresentative, if any.

(b) Filing with the Administrative LawJudges. The Department shall file thenotice and response with the ChiefDocket Clerk, Office of AdministrativeLaw Judges. If no response is submitted,then the Department may file a motionfor default judgment, together with acopy of the notice, in accordance with24 CFR 26.39.

§ 28.35 Disclosure of documents.

Upon receipt of a notice of penalty,the respondent may, upon written

request to the General Counsel ordesignee, review any relevant andmaterial nonprivileged documents,including any exculpatory documents,that relate to the allegations set out inthe notice. Exculpatory information thatis contained in a privileged documentmust be disclosed.

§ 28.40 Hearings.

(a) General. Hearings under this partshall be conducted in accordance withthe procedures in 24 CFR part 26,subpart B.

(b) Factors to consider in determiningamount of penalties and assessments. Indetermining an appropriate amount ofcivil penalties and assessments, theadministrative law judge (ALJ) and,upon appeal, the Secretary shallconsider and state in their opinions anymitigating or aggravating circumstances.Because of the intangible costs of fraud,the expense of investigating fraudulentconduct, and the need for deterrence,ordinarily double damages and asignificant civil penalty should beimposed. The ALJ and the Secretaryshall consider the following factors indetermining the amount of penaltiesand assessments to be imposed:

(1) The number of false, fictitious, orfraudulent claims or statements;

(2) The time period over which suchclaims or statements were made;

(3) The degree of the respondent’sculpability with respect to themisconduct;

(4) The amount of money or the valueof the property, services, or benefitfalsely claimed;

(5) The value of the Government’sactual loss as a result of the misconduct,including foreseeable consequentialdamages and the cost of investigation;

(6) The relationship of the civilpenalties to the amount of theGovernment’s loss;

(7) The potential or actual impact ofthe misconduct upon national defense,public health or safety, or publicconfidence in the management ofGovernment programs and operations,including particularly the impact on theintended beneficiaries of such programs;

(8) Whether the respondent hasengaged in a pattern of the same orsimilar misconduct;

(9) Whether the respondent attemptedto conceal the misconduct;

(10) The degree to which therespondent has involved others in themisconduct or in concealing it;

(11) Where the misconduct ofemployees or agents is imputed to therespondent, the extent to which therespondent’s practices fostered orattempted to preclude the misconduct;

(12) Whether the respondentcooperated in or obstructed aninvestigation of the misconduct;

(13) Whether the respondent assistedin identifying and prosecuting otherwrongdoers;

(14) The complexity of the program ortransaction, and the degree of therespondent’s sophistication with respectto it, including the extent of therespondent’s prior participation in theprogram or in similar transactions;

(15) Whether the respondent has beenfound, in any criminal, civil, oradministrative proceeding, to haveengaged in similar misconduct or tohave dealt dishonestly with theGovernment of the United States or ofa State, directly or indirectly;

(16) The need to deter the respondentand others from engaging in the same orsimilar misconduct; and

(17) Any other factors that in anygiven case may mitigate or aggravate theoffense for which penalties andassessments are imposed.

(c) Stays ordered by the Departmentof Justice. If at any time the AttorneyGeneral of the United States or anAssistant Attorney General designatedby the Attorney General notifies theSecretary in writing that continuation ofthe Department’s case may adverselyaffect any pending or potential criminalor civil action related to the claim orstatement at issue, the ALJ or theSecretary shall stay the processimmediately. The case may be resumedonly upon receipt of the writtenauthorization of the Attorney General.

§ 28.45 Settlements.(a) The Department and the

respondent may enter into a settlementagreement at any time prior to theissuing of a notice of final determinationunder 24 CFR 26.50.

(b) Failure of the respondent tocomply with a settlement agreementshall be sufficient cause for resuming anaction under this part, or for any otherjudicial or administrative action.

9–11. Part 30 is revised to read asfollows:

PART 30—CIVIL MONEY PENALTIES:CERTAIN PROHIBITED CONDUCT

Subpart A—General

Sec.30.1 Purpose and scope.30.5 Effective dates.30.10 Definitions.30.15 Application of other remedies.

Subpart B—Violations

30.20 Ethical violations by HUD employees.30.25 Violations by applicants for

assistance.30.30 Urban Homestead violations.


30.35 Mortgagees and lenders.30.40 Multifamily and Section 202

mortgagors.30.45 GNMA issuers and custodians.30.50 Interstate Land Sales violations.30.55 Dealers or loan correspondents.30.60 Failure to disclose lead-based paint

hazards.

Subpart C—Procedures

30.65 Prepenalty notice.30.70 Response to prepenalty notice.30.75 Factors in determining

appropriateness and amount of civilmoney penalty.

30.80 Notice of civil money penalty.30.85 Response to the penalty notice.30.90 Hearings.30.95 Settlements.

Authority: 12 U.S.C. 1701q–1, 1703, 1723i,1735f–14, 1735f–15; 15 U.S.C. 1717a; 42U.S.C. 3535(d).

Subpart A—General

§ 30.1 Purpose and scope.Unless provided for elsewhere in this

title or under separate authority, thispart implements HUD’s civil moneypenalty provisions. The proceduralrules for hearings under this part are setforth in 24 CFR part 26, subpart B.

§ 30.5 Effective dates.(a) Under § 30.20, a civil money

penalty may be imposed for violationsoccurring on or after May 22, 1991.

(b) Under §§ 30.25, 30.35, 30.40,30.45, 30.50, and 30.55, but not§ 30.35(a)(14), a civil money penaltymay be imposed for any violations thatoccur on or after December 15, 1989.

(c) Under § 30.30, a civil moneypenalty may be imposed with respect toany property transferred for use undersection 810 of the Housing andCommunity Development Act of 1974,as amended (12 U.S.C. 1706e), afterJanuary 1, 1981, to a state, a unit ofgeneral local government, or a publicagency or qualified communityorganization designated by a unit ofgeneral local government, or a transfereeof any such entity.

(d) Under § 30.35(a)(14), concerningloan guarantees for Indian housing, acivil money penalty may be imposed forviolations occurring on or after October28, 1992.

(e) Under § 30.60, a civil moneypenalty may be imposed for violationsoccurring on or after the followingdates:

(1) September 6, 1996, for owners ofmore than four residential dwellings; or

(2) December 6, 1996, for owners ofone to four residential dwellings.

§ 30.10 Definitions.Since this part is primarily

procedural, terms not defined in thissection shall have the meanings given

them in relevant program regulations.Comprehensive definitions are in 24CFR part 4 (Prohibition of AdvanceDisclosure of Funding Decisions) and 24CFR part 12 (Accountability in theProvision of HUD Assistance). Theterms ALJ, Department, HUD, andSecretary are defined in 24 CFR part 5.

Agent. Any person who acts on behalfof another person and includes officers,directors, partners and trustees.

Dealer. A seller, contractor or supplierof goods or services having a direct orindirect financial interest in thetransaction between the borrower andthe lender, and who assists the borrowerin preparing the credit application orotherwise assists the borrower inobtaining the loan from the lender.

Knowing or Knowingly. Having actualknowledge of or acting with deliberateignorance of or reckless disregard for theprohibitions under subpart B of this partor under 24 CFR parts 4 or 12.

Loan correspondent. A lender or loancorrespondent as defined at § 202.2 ofthis title.

Material or Materially. In somesignificant respect or to some significantdegree.

Person. An individual, corporation,company, association, authority, firm,partnership, society, state, localgovernment or agency thereof, or anyother organization or group of people.

Respondent. A person against whoma civil money penalty action is initiated.

§ 30.15 Application of other remedies.

A civil money penalty may beimposed in addition to otheradministrative sanctions or any othercivil remedy or criminal penalty.

Subpart B—Violations

§ 30.20 Ethical violations by HUDemployees.

(a) General. The General Counsel, orhis or her designee, may initiate a civilmoney penalty action against HUDemployees who improperly discloseinformation pursuant to § 4.110 of thistitle.

(b) Maximum penalty. The maximumpenalty is $10,000 for each violation.

§ 30.25 Violations by applicants forassistance.

(a) General. The General Counsel, orhis or her designee, may initiate a civilmoney penalty action against applicantsfor assistance, as defined in 24 CFR part12, who knowingly and materiallyviolate the provisions of § 12.32 (a), (b),or (c) of this title.

(b) Maximum penalty. The maximumpenalty for each violation is $10,000.

§ 30.30 Urban Homestead violations.(a) General. The Assistant Secretary

for Community Planning andDevelopment, or his or her designee, orthe Director of the Office of TechnicalAssistance and Management mayinitiate a civil money penalty actionagainst persons who knowingly andmaterially violate section 810 of theHousing and Community DevelopmentAct of 1974, as amended (12 U.S.C.1706e), or the provisions of 24 CFR part590, in the use or conveyance ofproperty made available under theUrban Homestead Program.

(b) Maximum penalty. The maximumpenalty is either twice the amount of thegross profit realized from anyimpermissible use or conveyance of theproperty, or the amount of section 810funds used to reimburse HUD, theDepartment of Veterans Affairs, theResolution Trust Corporation, or theFarmers Home Administration (or itssuccessor agency under Public Law103–354) for the property, whichever isgreater. If the property is still held bythe violator, the gross profit shallinclude any appreciation between theamount the violator paid for theproperty and its current value asdetermined by an independent, HUD-qualified appraiser.

§ 30.35 Mortgagees and lenders.(a) General. The Mortgagee Review

Board may initiate a civil moneypenalty action against any mortgagee orlender who knowingly and materially:

(1) Violates the provisions listed in 12U.S.C. 1735f–14(b);

(2) Fails to comply with therequirements of § 201.27(a) of this titleregarding approval and supervision ofdealers;

(3) Approves a dealer that has beensuspended, debarred, or otherwisedenied participation in HUD’sprograms;

(4) Makes a payment that isprohibited under § 202.12(p) of thistitle;

(5) Fails to remit, or timely remit,mortgage insurance premiums, loaninsurance charges, or late charges orinterest penalties;

(6) Permits loan documents for anFHA insured loan to be signed in blankby its agents or any other party to theloan transaction unless expresslyapproved by the Secretary;

(7) Fails to follow the mortgageassignment procedures set forth in§§ 203.650 through 203.664 of this titleor in §§ 207.255 through 207.258b ofthis title.

(8) Fails to timely submit documentsthat are complete and accurate inconnection with a conveyance of


property or a claim for insurancebenefits, in accordance with §§ 203.365,203.366, or 203.368 of this title;

(9) Fails to:(i) Process requests for formal release

of liability under an FHA insuredmortgage;

(ii) Obtain a credit report, issued notmore than 90 days prior to approval ofa person as a borrower, as to theperson’s creditworthiness to assume anFHA insured mortgage;

(iii) Timely submit proper notificationof a change in mortgagor or mortgageeas required by § 203.431 of this title;

(iv) Timely submit proper notificationof mortgage insurance termination asrequired by § 203.318 of this title;

(v) Timely submit proper notificationof a change in mortgage servicing asrequired by § 203.502 of this title; or

(vi) Report all delinquent mortgages toHUD, as required by § 203.332 of thistitle;

(10) Fails to service FHA insuredmortgages, in accordance with therequirements of 24 CFR parts 201, 203,and 235;

(11) Fails to fund loans that itoriginated, or otherwise misuses loanproceeds;

(12) Fails to comply with theconditions relating to the assignment orpledge of mortgages as required by§ 207.261 of this title;

(13) Fails to comply with theprovisions of the Real Estate SettlementProcedures Act (12 U.S.C. 2601 et seq.),the Equal Credit Opportunity Act (15U.S.C. 1691 et seq.), or the Fair HousingAct (42 U.S.C. 3601 et seq.);

(14) Violates the provisions of 12U.S.C. 1715z–13a(g)(2) concerning loanguarantees for Indian housing;

(15) Fails to comply with the terms ofa settlement agreement with HUD.

(b) Continuing violation. Each daythat a violation continues shallconstitute a separate violation.

(c) Amount of penalty. The maximumpenalty is $5,000 for each violation, upto a limit of $1,000,000 for all violationscommitted during any one-year period.Each violation shall constitute aseparate violation as to each mortgage orloan application.

§ 30.40 Multifamily and Section 202mortgagors.

(a) General. The Assistant Secretaryfor Housing-Federal HousingCommissioner, or his or her designee,may initiate a civil money penaltyaction against any mortgagor of propertythat includes five or more living unitsand is subject to a mortgage insured,coinsured, or held by the Secretary, whoknowingly and materially commits aviolation listed at 12 U.S.C. 1735f–15(b)or (c), or 12 U.S.C. 1701q–1(b) or (c).

(b) Maximum penalty. The maximumpenalty for each violation of 12 U.S.C.1735f–15(b) and 12 U.S.C. 1701q–1(b) isthe amount of loss that the Secretaryincurs at a foreclosure sale, or a saleafter foreclosure, with respect to theproperty involved. The maximumpenalty for each violation of 12 U.S.C.1735f–15(c) and 12 U.S.C. 1701q–1(c) is$25,000.

§ 30.45 GNMA issuers and custodians.(a) General. The President of GNMA,

or his or her designee, may initiate acivil money penalty action against aGNMA issuer or custodian thatknowingly and materially violates anyprovision of 12 U.S.C. 1723i(b), title IIIof the National Housing Act, or anyimplementing regulation, handbook,guaranty agreement, or contractualagreement, or participant letter issuedby GNMA, or fails to comply with theterms of a settlement agreement withGNMA.


(c) Amount of penalty. The maximumpenalty is $5,000 for each violation, upto a limit of $1 million during any one-year period. Each violation shallconstitute a separate violation withrespect to each pool of mortgages.

§ 30.50 Interstate Land Sales violations.(a) General. The Assistant Secretary

for Housing-Federal HousingCommissioner, or his or her designee,may initiate a civil money penaltyaction against any person whoknowingly and materially violates anyprovision of the Interstate Land SalesFull Disclosure Act (15 U.S.C. 1701 etseq.); the rules and regulations set forthat 24 CFR parts 1710, 1715, and 1720,or any order issued thereunder.


(c) Maximum penalty. The maximumpenalty is $1,000, up to a limit for anyparticular person of $1 million duringany one-year period. Each violationshall constitute a separate violation as toeach sale or lease or offer to sell or lease.

§ 30.55 Dealers or loan correspondents.(a) General. The Assistant Secretary

for Housing-Federal HousingCommissioner, or his or her designee,may initiate a civil money penaltyaction against any dealer or loancorrespondent who violates section2(b)(7) of the National Housing Act (12U.S.C. 1703). Such violations include,but are not limited to:

(1) Falsifying information on anapplication for dealer approval orreapproval submitted to a lender;

(2) Falsifying statements on a HUDcredit application, improvementcontract, note, security instrument,completion certificate or other loandocument;

(3) Failing to sign a credit applicationif the dealer or loan correspondentassisted the borrower in completing theapplication;

(4) Falsely certifying to a lender thatthe loan proceeds have been or will bespent on eligible improvements;

(5) Falsely certifying to a lender thatthe property improvements have beencompleted;

(6) Falsely certifying that a borrowerhas not been given or promised any cashpayment, rebate, cash bonus, oranything of more than nominal value asan inducement to enter into a loantransaction;

(7) Making a false representation to alender with respect to thecreditworthiness of a borrower or theeligibility of the improvements forwhich a loan is sought.


(c) Amount of penalty. The maximumpenalty is $5,000 for each violation, upto a limit of $1 million during any one-year period.

§ 30.60 Failure to disclose lead-basedpaint hazards.

(a) General. The Director of the Officeof Lead-Based Paint Abatement andPoisoning Prevention, or his or herdesignee, may initiate a civil moneypenalty action against any person whoknowingly violates 42 U.S.C.4852d(b)(1) or any provision of 24 CFRpart 35, subpart H.

(b) Amount of penalty. The maximumpenalty is $10,000 for each violation.

Subpart C—Procedures

§ 30.65 Prepenalty notice.Whenever HUD intends to seek a civil

money penalty, the official designatedin subpart B of this part, or his or herdesignee (or the chairperson of theMortgagee Review Board, or his or herdesignee, in actions under § 30.35), shallissue a written notice to the respondent.This prepenalty notice shall include thefollowing:

(a) That HUD is considering seeking acivil money penalty;

(b) The specific violations alleged;(c) The maximum civil money penalty

that may be imposed;(d) The opportunity to reply in

writing to the designated programofficial within 30 days after receipt ofthe notice; and

(e) That failure to respond within the30-day period may result in issuance of


a notice of civil money penalty under§ 30.80 without consideration of anyinformation that the respondent maywish to provide.

§ 30.70 Response to prepenalty notice.

The response shall be in a formatprescribed in the prepenalty notice. Theresponse shall include any argumentsopposing the imposition of a civilmoney penalty that the respondent maywish to present.

§ 30.75 Factors in determiningappropriateness and amount of civil moneypenalty.

In determining whether to seek apenalty, and the amount of suchpenalty, the officials designated insubpart B of this part shall consider thefollowing factors:

(a) The gravity of the offense;(b) Any history of prior offenses. For

violations under §§ 30.25, 30.35, 30.40,30.45, 30.50, and 30.55, but notviolations under § 30.35(a)(14), offensesthat occurred prior to December 15,1989 may be considered;

(1) The ability to pay the penalty;(2) The injury to the public;(3) Any benefits received by the

violator;(4) The extent of potential benefit to

other persons;(5) Deterrence of future violations;(6) The degree of the violator’s

culpability;(7) With respect to Urban Homestead

violations under § 30.30, theexpenditures made by the violator inconnection with any gross profitderived; and

(8) Such other matters as justice mayrequire.

(c) In addition to the above factors,with respect to violations under§§ 30.40, 30.50, and 30.55, the AssistantSecretary for Housing-Federal HousingCommissioner, or his or her designee,shall also consider:

(1) Any injury to tenants; and/or(2) Any injury to lot owners.

§ 30.80 Notice of civil money penalty.

(a) General. Upon the expiration ofthe period for the respondent to submita response to the prepenalty notice, theofficial designated in subpart B of thispart, or his or her designee (or theMortgagee Review Board in actionsunder § 30.35) shall determine whetherto seek a civil money penalty. Suchdetermination shall be based upon areview of the prepenalty notice, theresponse, if any, and the factors listedat § 30.75. A determination by theMortgagee Review Board to seek a civilmoney penalty shall be by a majorityvote of the Board.

(b) Notice. If a determination is madeto seek a civil money penalty, theofficial or his or her designee, or theMortgagee Review Board, shall so notifythe respondent, in writing. The noticeshall state the following:

(1) The factual basis for the decisionto seek a penalty;

(2) The applicable civil moneypenalty statute;

(3) The amount of penalty sought;(4) The right to submit a response in

writing, within 15 days of receipt of thenotice, requesting a hearing on anymaterial fact in the notice, or on theappropriateness of the penalty sought;

(5) The address to which a responsemust be sent;

(6) That the notice shall serve asHUD’s complaint if a hearing isrequested; and

(7) That the failure to submit aresponse may result in the imposition ofthe penalty in the amount sought.

(c) A copy of this part and of 24 CFRpart 26, subpart B shall be includedwith the notice.

(d) Service of the notice. The noticeshall be served on the respondent byfirst class mail, personal delivery, orother means. In cases of violations bymortgagees and lenders of 12 U.S.C.1735f–14(b)(1)(D) or (1)(F), or by GNMAissuers or custodians of 12 U.S.C.1723i(b)(1)(G) or (1)(I), a copy of thenotice shall be provided to the AttorneyGeneral.

§ 30.85 Response to the penalty notice.

(a) General. The respondent maysubmit to HUD a written response to thepenalty notice within 15 days of itsreceipt. The response shall beconsidered a request for a hearing. Theresponse should include the admissionor denial of each allegation of liabilitymade in the notice; any defense onwhich the respondent intends to rely;any reasons why the civil moneypenalty is not warranted or should beless than the amount sought in thenotice; and the name, address, andtelephone number of the person whowill act as the respondent’srepresentative, if any.

(b) Filing with the Administrative LawJudges. HUD shall file the notice andresponse with the Chief Docket Clerk,Office of Administrative Law Judges. Ifno response is submitted, then HUDmay file a motion for default judgment,together with a copy of the notice, inaccordance with § 26.39 of this title.

§ 30.90 Hearings.

Hearings under this part shall beconducted in accordance with theprocedures at 24 CFR part 26, subpart B.

§ 30.95 Settlements.The officials listed at subpart B of this

part, or their designees (or theMortgagee Review Board for violationsunder § 30.35), are authorized to enterinto settlement agreements of civilmoney penalty claims. Settlementagreements may be executed at any timeprior to the issuing of a notice of finaldetermination under § 26.50 of this title,and may include sanctions for failure tocomply with the terms of the agreement.

PART 81—REGULATIONSIMPLEMENTING THE AUTHORITY OFTHE SECRETARY OF THEDEPARTMENT OF HOUSING ANDURBAN DEVELOPMENT OVER THECONDUCT OF THE SECONDARYMARKET OPERATIONS OF THEFEDERAL NATIONAL MORTGAGEASSOCIATION (FNMA)


Authority: 12 U.S.C. 1451 et seq., 1716–1723h, and 4501–4641; 42 U.S.C. 3535(d) and3601–3619.

13. Section 81.46 is amended byrevising the first sentence of paragraph(e)(1) to read as follows:

§ 81.46 Remedial actions.

* * * * *(e) * * * (1) Where a lender timely

requests a hearing on a remedial action,a hearing shall be conducted before aHUD Administrative Law Judge (ALJ)and a final decision rendered inaccordance with the procedures setforth in 24 CFR part 26, subpart B, to theextent such provisions are notinconsistent with subpart C of this partor FHEFSSA. * * ** * * * *

14. Section 81.82 is amended byrevising the second sentence ofparagraph (b)(2) to read as follows:

§ 81.82 Cease-and-desist proceedings.

* * * * *(b) * * *(2) Administrative Law Judge. * * *

The hearing shall be conducted inaccordance with § 81.84 and, to theextent the provisions are notinconsistent with any of the proceduresin this part or FHEFSSA, with 24 CFRpart 26, subpart B.* * * * *

15. Section 81.83 is amended byrevising paragraph (d)(3) to read asfollows:

§ 81.83 Civil money penalties.

* * * * *(d) * * *(3) Administrative Law Judge. A HUD

ALJ shall preside over any hearing


conducted under this section, inaccordance with § 81.84 and, to theextent the provisions are notinconsistent with any of the proceduresin this part or FHEFSSA, with 24 CFRpart 26, subpart B.* * * * *

16. Section 81.84 is amended by:a. Revising paragraph (b)(2);b. Revising paragraph (d);c. Amending the third sentence of

paragraph (h)(1) by removing thereference to ‘‘§ 30.515’’, and by addingin its place a reference to ‘‘§ 26.38’’;

d. Amending the first sentence ofparagraph (j)(2) by removing thereference to ‘‘§ 30.910’’, and by addingin its place a reference to ‘‘§ 26.51 (c)’’;and amending the second sentence ofparagraph (j)(2) by removing thereference to ‘‘§ 30.910 (c) and (d)’’, andby adding in its place a reference to‘‘§ 26.51(f)’’; to read as follows:

§ 81.84 Hearings.

* * * * *(b) * * *(2) Hearings shall be conducted by a

HUD ALJ authorized to conductproceedings under 24 CFR part 26,subpart B.* * * * *

(d) Procedure. Hearings shall beconducted in accordance with theprocedures set forth in 24 CFR part 26,

subpart B to the extent that suchprovisions are not inconsistent with anyof the procedures in this part orFHEFSSA.* * * * *

§ 81.85 [Amended]17. In section 81.85(c)(1), the third

sentence is amended by removing thereference to ‘‘§ 30.515’’, and by addingin its place a reference to ‘‘§ 26.38’’.

PART 200—INTRODUCTION


Authority: 12 U.S.C. 1701–1715z–18; 42U.S.C. 3535(d).

§ 200.243 [Amended]19. In § 200.243, the second sentence

of the introductory text of paragraph (a)is amended by adding the phrase ‘‘,subpart A,’’ after the phrase ‘‘24 CFRpart 26’’.

PART 950—INDIAN HOUSINGPROGRAMS


Authority: 25 U.S.C. 450e(b); 42 U.S.C.1437aa–1437ee, and 3535(d).

§ 950.190 [Amended]21. In § 950.190, the last sentence of

paragraph (e) is amended by adding the

phrase ‘‘, subpart A’’ after the phrase‘‘24 CFR part 26’’.

PART 965—PHA-OWNED OR LEASEDPROJECTS—MAINTENANCE ANDOPERATION


Authority: 42 U.S.C. 1437, 1437a, 1437d,1437g, and 3535(d). Subpart H is also issuedunder 42 U.S.C. 4821–4846.

§ 965.205 [Amended]

23. In § 965.205, the last sentence ofparagraph (e) is amended by adding thephrase ‘‘, subpart A’’ after the phrase‘‘24 CFR part 26’’.

PART 3500—REAL ESTATESETTLEMENT PROCEDURES ACT


Authority: 12 U.S.C. 2601 et seq.

§ 3500.17 [Amended]

25. In § 3500.17, paragraphs (n)(1) and(n)(4)(iii) are amended by removing thephrase ‘‘, subpart E,’’.

Dated: March 12, 1996.Henry G. Cisneros,Secretary.[FR Doc. 96–9877 Filed 4–22–96; 8:45 am]BILLING CODE 4210–32–P

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Part V

The PresidentProclamation 6886—National Organ andTissue Donor Awareness Week, 1996

Proclamation 6887—Jewish HeritageWeek, 1996

Proclamation 6888—National CrimeVictims’ Rights Week, 1996

Presidential Documents

18041

Federal Register

Vol. 61, No. 79


Title 3—

The President

Proclamation 6886 of April 19, 1996

National Organ and Tissue Donor Awareness Week, 1996

By the President of the United States of America

A Proclamation

Thousands of lives have been saved by the miracle of organ and tissuetransplantation, a medical procedure made possible only by the extraordinarygenerosity of those who agree to donate and the profound compassion oftheir loved ones. Recipients are often able to resume normal lives aftertheir transplants, working and caring for their families, and many childrenare in school today due to a donated liver or bone marrow. Still, theneed for organs far exceeds the number donated, and many Americanswait—and some will die waiting—for suitable organs or tissues to becomeavailable.

Although our Nation has a potentially adequate supply of organs and tissues,there are more than 45,000 patients on the national transplant waiting list,and some 2,000 new names are added each month. We must educate allAmericans about transplantation and its successes and raise public awarenessof the urgent need for increased donation. All of our citizens should knowthat by completing a donor card and carrying it, and particularly by makingfamily members aware of the wish to donate, they may save the health,or even the life, of someone in need.

Americans are a caring people, and our Nation’s citizens have always reachedout to one another in times of trouble. Organ donation is a unique exampleof that spirit of giving, and many who have lost loved ones have foundcomfort in knowing that their loss means the promise of life for others.This week and throughout the year, let us recognize the advances madein organ and tissue transplant techniques, honor those who have alreadypledged their organs, and encourage people to make the life-giving decisionto donate.

NOW, THEREFORE, I, WILLIAM J. CLINTON, President of the United Statesof America, by virtue of the authority vested in me by the Constitutionand laws of the United States, do hereby proclaim April 21 through April27, 1996, as National Organ and Tissue Donor Awareness Week. I callupon health care professionals, educators, the media, public and privateorganizations concerned with organ donation and transplantation, and allthe people of the United States to observe this week with appropriate activi-ties and programs that promote organ donation and invite new donors toget involved.

IN WITNESS WHEREOF, I have hereunto set my hand this nineteenth dayof April, in the year of our Lord nineteen hundred and ninety-six, andof the Independence of the United States of America the two hundredand twentieth.

œ–[FR Doc. 96–10174

Filed 4–22–96; 11:20 am]

Billing code 3195–01–P


18043Federal Register / Vol. 61, No. 79 / Tuesday, April 23, 1996 / Presidential Documents


Jewish Heritage Week, 1996


A Proclamation

The Jewish experience in America has been a mutually rewarding one forthis country and for the Jewish people. Jewish Americans have made greatcontributions in such fields as the arts and sciences, business, government,law and medicine, enriching America’s heritage with the resonant traditionof an ancient people. And America, for its part, has been a land of opportunityfor its Jewish citizens.

In many ways, the Jewish experience is unique, freighted with the anguishof frequent persecution, but ennobled by an unyielding spirit that has alwaysfound a way to turn darkness into light. In the crucible of sorrow, theJewish people have reaffirmed, time and again, the basic human valuesof faith, community, justice, and hope.

On the tolerant soil of American democracy, the Jewish people have flour-ished. We will be forever grateful for the remarkable contributions of ourJewish citizens, and it is fitting that we set aside a week to give thanksfor their inestimable gifts and to honor the traditions of their remarkablereligion and heritage.

NOW, THEREFORE, I, WILLIAM J. CLINTON, President of the United Statesof America, by virtue of the authority vested in me by the Constitutionand laws of the United States, do hereby proclaim April 21 through April28, 1996, as Jewish Heritage Week. I call upon the people of the UnitedStates to observe this week with appropriate programs, ceremonies, andactivities.


œ–[FR Doc. 96–10175

Filed 4–22–96; 11:21 am]



18045Federal Register / Vol. 61, No. 79 / Tuesday, April 23, 1996 / Presidential Documents


National Crime Victims’ Rights Week, 1996


A Proclamation

On April 19, 1995, millions of Americans witnessed the chaos and anguishwrought by a single bomb blast in Oklahoma City that took 168 lives andinjured scores of others. For days afterwards, our Nation joined the survivorsin a grim vigil as somber work crews entered the wreckage again andagain to locate victims.

That bomb blast in Oklahoma City was a devastating reminder that toomany Americans have become victims of crime. Although violent crimehas decreased every year for the last 3 years, 83 percent of our citizens12 years of age and above will experience violent or attempted violentcrime in their lifetimes. And worse, 52 percent will be victimized morethan once. Added to these grim statistics is the reality that violent crimeis increasingly a problem of our youth. For 12- to 19-year-olds, the chanceof being assaulted, robbed, or raped is two to three times higher thanfor adults, and perpetrators of crime are both younger and more violent.In 1994, for example, about 33 percent of all violent crimes were committedby those under 21 years of age.

There is another, more positive, dimension to the aftermath of crime: themultitude of dedicated professionals and volunteers who support and assistcrime victims. They are emergency medical technicians and firefighters,law enforcement officers and rescue teams, victim assistance providers andshelter workers. At the darkest of moments, these selfless men and womenrenew our Nation’s faith in humanity, and their advocacy embodies thetime-honored American traditions of compassion and service. They constitutea community of caring whose healing work helps victims to become survi-vors. As a Nation, we owe these generous individuals our deepest gratitudefor making our communities better and safer places in which to live andwork.

While 1995 brought tragedy, it also brought the implementation of oneof the most comprehensive crime laws ever enacted. The Violent CrimeControl and Law Enforcement Act of 1994 furthered the rights of victimsin the Federal justice system and targeted resources for criminal justiceimprovements. The Crime Act’s provisions include truth-in-sentencing provi-sions that ensure longer sentences for violent offenders and allocution rightsfor victims that give them the right to speak in court before the impositionof a sentence. The Crime Act also provides hundreds of communities aroundthe Nation with increased law enforcement personnel, and its ViolenceAgainst Women Act is the first comprehensive Federal effort to combatviolence against women.

The Crime Act is just one landmark in a crime victims’ movement thathas spanned 20 years and brought many hard-won reforms. A victims’bill of rights—once a novel idea—is now a reality in virtually every State.Victim assistance programs, which were few in the 1960s, now numberin the thousands. Every State has a compensation program to help reimbursevictims for mental health, medical, and other expenses resulting from thecrimes committed against them. And in 1995, the Crime Victims Fund

18046 Federal Register / Vol. 61, No. 79 / Tuesday, April 23, 1996 / Presidential Documents

in the U.S. Treasury, which supports many of these programs, surpassedthe one-billion-dollar mark in funds collected and distributed to the States.

As we reflect on the events of 1995, let us remember both the horrorand the compassion we felt last April. Let us not slip into complacencywhen we hear or read about another crime victim. Whether we are businessowners or teachers, clergy or physicians, neighbors or colleagues, we mustjoin the community of caring and lessen the burdens on our Nation’s crimevictims. Let us join together to build safe and responsive communitiesand to promote justice and healing for all who have suffered from violentcrime.

NOW, THEREFORE, I, WILLIAM J. CLINTON, President of the United Statesof America, by virtue of the authority vested in me by the Constitutionand laws of the United States, do hereby proclaim April 21 through April27, 1996, as National Crime Victims’ Rights Week. I urge all Americansto pause and remember crime victims and their families by working toreduce violence, to assist those harmed by crime, and to make our homesand communities safer places in which to live and raise our families.


œ–[FR Doc. 96–10176

Filed 4–22–96; 11:22 am]


i

Reader Aids Federal Register

Vol. 61, No. 79


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Federal Register/Code of Federal RegulationsGeneral Information, indexes and other finding

aids202–523–5227

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LawsPublic Laws Update Services (numbers, dates, etc.) 523–6641For additional information 523–5227

Presidential DocumentsExecutive orders and proclamations 523–5227The United States Government Manual 523–5227

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FEDERAL REGISTER PAGES AND DATES, APRIL

14233–14464......................... 114465–14606......................... 214607–14948......................... 314949–15176......................... 415177–15362......................... 515363–15694......................... 815695–15874......................... 915875–16042.........................1016043–16202.........................1116203–16374.........................1216375–16614.........................1516615–16702.........................1616703–16872.........................1716873–17226.........................1817227–17546.........................1917547–17822.........................2217823–18046.........................23

CFR PARTS AFFECTED DURING APRIL

At the end of each month, the Office of the Federal Registerpublishes separately a List of CFR Sections Affected (LSA), whichlists parts and sections affected by documents published sincethe revision date of each title.

3 CFRProclamations:6874.................................142336875.................................146036876.................................146056877.................................151776878.................................153636879.................................158716880.................................160356881.................................160376882.................................166116883.................................166136885.................................175456886.................................180416887.................................180436888.................................18045Executive Orders:11880 (Amended by

EO 12998)....................1587312821 (Superseded by

EO 12999)....................1722712997...............................1494912998...............................1587312999...............................17227Administrative Orders:Memorandum:April 8, 1996 ....................16039Presidential Determinations:No. 96–19 of March

19, 1996 .......................14235

5 CFR

Ch. XIV ............................16043890...................................15177

7 CFR

17.....................................1782358.........................15875, 17547301...................................17550353...................................15365354...................................15365911...................................17551915...................................17551927...................................17553932...................................17555982...................................17556985...................................156951131.................................175611208.................................149511435.................................15881Proposed Rules:1.......................................1623115.....................................1785115d...................................1785151.....................................17580330...................................15201929...................................17586946...................................17587999...................................157341002.................................145141004.................................145141106.................................17588

3550.................................15395

9 CFR

78.........................14237, 1588192.........................14239, 1723198.........................15180, 17231Proposed Rules:77.....................................1498291.....................................1498292.........................14268, 1697893.....................................1697894 ............14999, 15201, 1697895.....................................1697896.....................................1697898.....................................16978

10 CFR

170...................................16203171...................................16203Proposed Rules:50.....................................1542773.....................................16067430...................................17589437...................................157361021.................................17257

12 CFR

219...................................14382226...................................14952Proposed Rules:614...................................16403619...................................16403932...................................17603

13 CFR

301...................................15371

14 CFR

25.........................14607, 1537233.....................................1637539 ...........14240, 14242, 14608,

14960, 14961, 15184, 15882,16226, 16377, 16379, 16382,16384, 16703, 16873, 17562,

17824, 1782571.....................................1782691.....................................16287311...................................17564399...................................17565Proposed Rules:25.....................................1468439 ...........14269, 14271, 14273,

14275, 14515, 15000, 15002,15430, 15738, 15903, 15904,15906, 15908, 16412, 16413,16414, 16416, 16418, 16420,17257, 17259, 17261, 17853,

1785571 ...........15432, 15434, 15740,

15742, 16287, 17606, 1760773.....................................17608

ii Federal Register / Vol. 61, No. 79 / Tuesday, April 23, 1996 / Reader Aids

15 CFR

30.....................................15697769...................................14243902.......................14465, 15884922...................................14963

16 CFR

303...................................16385Proposed Rules:239...................................14688254...................................14685406...................................14686700...................................14688701...................................14688702...................................14688

17 CFR

200...................................15338Proposed Rules:228...................................17108229...................................17108240...................................17108242...................................17108

18 CFR

Proposed Rules:35.....................................17263

20 CFR

Proposed Rules:348...................................16067416...................................17609656...................................17610

21 CFR

Ch. I.....................14478, 164221.......................................142442.......................................156995.......................................14375101...................................16423172...................................14481173.......................14481, 17828175...................................14481176...................................14481177.......................14481, 14964178...................................14481180...................................14481181...................................14481189...................................14481201...................................17798331...................................17798341...................................15700510.......................15703, 17565520...................................15185522...................................14482529...................................17829558.......................14483, 17566573...................................15703803...................................16043807...................................16043814...................................151861310.................................179581313.................................175661316.................................17566Proposed Rules:25.....................................1492271.....................................14690170...................................14690171...................................14690201...................................17807331...................................17807510...................................15003886...................................14277900 .........14856, 14870, 14884,

14898, 14908

22 CFR

92.....................................14375514...................................15372

23 CFR

230...................................14615625...................................17566635...................................17243Proposed Rules:230...................................172641325.................................167291327.................................16729

24 CFR

0.......................................153504.......................................1444812.....................................14448100...................................14378103...................................14378109...................................14378200.......................14396, 14410207...................................14396213...................................14396215.......................14396, 16172219...................................14396220...................................14396221...................................14396222...................................14396231...................................14396232.......................14396, 14410233...................................14396234...................................14396236.......................14396, 16172237...................................14396241.......................14396, 14410242...................................14396244...................................14396248...................................14396265...................................14396267...................................14396583...................................17245811.......................14456, 16045813...................................16172913...................................16172950...................................16172990...................................175383500.................................14617Proposed Rules:26.....................................1802628.....................................1802630.....................................1802650.....................................1534081.....................................18026200...................................18026950...................................18026965...................................180263280.................................180143500.................................18026

25 CFR

1001.................................17830Proposed Rules:Ch. I .................................17857

26 CFR

1 .............14247, 14248, 15891,17572

31.....................................17572602.......................14248, 17572Proposed Rules:1 .............14517, 15204, 15743,

1761431.....................................1761435a...................................17614301.......................17265, 17614

502...................................17614503...................................17614509...................................17614513...................................17614514...................................17614516...................................17614517...................................17614520...................................17614521...................................17614

28 CFR

25.....................................17575547...................................16374Proposed Rules:36.........................16232, 1623374.....................................17667553...................................14440

29 CFR

1614.................................175761625.................................15374Proposed Rules:1904.................................154351910.................................152051915.................................152051926.................................152051952.................................154352509.................................146902520.................................146902550.................................146902610.................................163872619.................................163882622.................................163872644.................................163912676.................................16388

30 CFR

756...................................17833914.......................15378, 15891943...................................15380Proposed Rules:Ch. II ................................172666.......................................1574318.....................................1574319.....................................1574320.....................................1574321.....................................1574322.....................................1574323.....................................1574326.....................................1574327.....................................1574329.....................................1574333.....................................1574335.....................................15743218...................................17266745...................................15005900...................................15005901...................................15005906...................................15005913...................................15005914...................................15435925...................................14517926.......................15005, 15910931...................................15005934...................................15005935.......................15005, 16731936.......................15005, 15435944...................................15005946...................................15005948.......................15005, 17859950...................................15005

31 CFR

103 .........14248, 14382, 14383,14386

535...................................15382

Proposed Rules:321...................................14444

32 CFR

40a...................................16704706 .........14966, 14967, 14968,

14969861...................................17840865...................................16046Proposed Rules:117...................................15437619...................................15010

33 CFR

100 .........14249, 16709, 16711,17246, 17841

110...................................16711117 ..........14970, 17247, 17248165 .........16714, 16716, 16717,

17249175...................................15162179...................................15162181...................................15162Proposed Rules:100 .........16732, 16885, 17269,

17270110...................................17861117...................................16736165.......................14518, 16886

34 CFR

76.....................................1448381.....................................14483682...................................16718

35 CFR

70.....................................16718

36 CFR

7.......................................14617223...................................14618292...................................146211253.................................149711275.................................17842Proposed Rules:242...................................150141190.................................172711191 ........16232, 16233, 17271

38 CFR

1.......................................1459621.....................................15190

39 CFR

111.......................17190, 17206Proposed Rules:111...................................15205

40 CFR

9.......................................1629051.....................................1605052 ...........14484, 14487, 14489,

14491, 14493, 14634, 14972,14974, 14975, 15704, 15706,15709, 15713, 15715, 15717,15719, 16050, 16229, 17576

60 ............14634, 15721, 1735863.....................................1735870.....................................1606380.....................................1639181.....................................14496148.......................15566, 15660167...................................14497180 .........14637, 15192, 15895,

15896, 15900

iiiFederal Register / Vol. 61, No. 79 / Tuesday, April 23, 1996 / Reader Aids

185...................................15893186.......................15192, 15900260.......................16290, 17358261.......................16290, 17358262...................................16290263...................................16290264.......................16290, 17358265.......................16290, 17358266.......................16290, 17358268.......................15566, 15660270...................................17358271.......................15566, 17358273...................................16290300...................................15902403.......................15566, 15660716...................................14596Proposed Rules:51.....................................1606852 ...........14520, 14521, 14522,

14694, 15020, 15744, 15745,15751, 15752, 16050, 16738,

17669, 1767559.....................................1453160.....................................1735863.....................................1735868.........................16598, 1660680.....................................1643281.........................14522, 1673885.....................................16738141...................................16348142...................................16348180 .........14694, 15911, 15913,

16740, 16742, 16745, 16747260...................................17358261.......................14696, 17358262...................................17842264.......................17358, 17863265.......................17358, 17863266...................................17358270.......................17358, 17863271...................................17358300 ..........14280, 16068, 16229440...................................15917721...................................17272

41 CFR

101–25.............................14978

42 CFR

405...................................14640491...................................14640Proposed Rules:413...................................17677

43 CFR

Group 8400......................1572210010...............................16719Proposed Rules8000.................................157538300.................................15753

44 CFR

64.........................14497, 1572365 ...........14658, 14661, 16874,

17251

67.........................14665, 16875Proposed Rules:62.....................................1470967.........................14715, 16887

45 CFR

74.....................................155641633.................................142501634.................................142521635.................................14261Proposed Rules:1301.................................177541303.................................177541304.................................177541305.................................177541306.................................177541308.................................17754

46 CFR

2.......................................1516267.....................................17814159.......................15162, 15868160.......................15162, 15868514...................................14979572...................................17849Proposed Rules:10.........................15438, 1674912.........................15438, 1674913.....................................1674915.....................................15438

47 CFR

Ch. I .................................146720...........................14499, 162291.......................................157242...........................14500, 1538215.....................................1450021...................................11538761.....................................1572463.....................................1572464.....................................1497973 ...........14503, 14676, 14981,

16878, 1687976 ............15387, 15388, 1639697.....................................15382Proposed Rules:Ch. I.........14717, 16432, 168900.......................................164241.......................................154392.......................................1520615.....................................1520620.....................................1575336.....................................1520864.....................................1502068.....................................1544169.....................................1520873 ...........14733, 15022, 15439,

15442, 15443, 1786474.........................15439, 1786476.....................................16447

48 CFR

207...................................16879225...................................16880231...................................16881

242...................................16881252...................................168801425.................................153891452.................................153891516.................................145041523.................................145061535.................................142641552 ........14264, 14504, 145061604.................................151961652.................................15196Proposed Rules:9.......................................1494615.....................................1494417.....................................1494431.....................................1494435.....................................1494637.....................................1494652.....................................14944

49 CFR

3.......................................1757779.....................................17578382...................................14677383...................................14677390...................................14677391.......................14677, 17253392...................................14677395...................................14677533...................................14680538...................................14507541...................................15390583...................................17253800...................................145121154.................................16066Proposed Rules:37.........................16232, 16234393.......................14733, 18014544...................................15443571 .........15446, 15449, 15917,

16073574...................................159171002.................................152081100.................................147351101.................................147351102.................................147351103.................................147351104.................................147351105.................................147351106.................................147351107.................................147351108.................................147351109.................................147351110.................................147351111.................................147351112.................................147351113.................................147351114.................................147351115.................................147351116.................................147351117.................................147351118.................................147351119.................................147351120.................................147351121.................................147351122.................................14735

1123.................................147351124.................................147351125.................................147351126.................................147351127.................................147351128.................................147351129.................................147351130.................................147351131.................................147351132.................................147351133.................................147351134.................................147351135.................................147351136.................................147351137.................................147351138.................................147351139.................................147351140.................................147351141.................................147351142.................................147351143.................................147351144.................................147351145.................................147351146.................................147351147.................................147351148.................................147351149.................................147351169.................................175791313.................................17682

50 CFR

216...................................15884228...................................15884251...................................14682611...................................14465620...................................16401625...................................15199641...................................14683649...................................16882650...................................15733655...................................14465663.......................14512, 16402672...................................17256675 ..........16883, 17256, 17849Proposed Rules:17.....................................1545223.....................................14543100...................................15014230...................................15754625...................................17682630 ..........15212, 16236, 17866646.......................14735, 16076650...................................16237651 ..........14284, 16237, 16892659...................................17866671...................................16456672...................................16456674...................................16456675.......................16085, 16456676...................................14547681...................................15452686...................................16076

iv Federal Register / Vol. 61, No. 79 / Tuesday, April 23, 1996 / Reader Aids

REMINDERSThe rules and proposed rulesin this list were editoriallycompiled as an aid to FederalRegister users. Inclusion orexclusion from this list has nolegal significance.

RULES GOING INTOEFFECT TODAY

DEFENSE DEPARTMENTAir Force DepartmentAircraft:

DOD commercial air carrierquality and safety reviewprogram; published 4-23-96

ENVIRONMENTALPROTECTION AGENCYAir pollution control; new

motor vehicles and engines:Heavy-duty vehicles and

engines; 1996 and 1998model year emissionstandards;nonconformance penalties;published 2-23-96

HEALTH AND HUMANSERVICES DEPARTMENTFood and DrugAdministrationAnimal drugs, feeds, and

related products:Sponsor name and address

changes--Anthony Products Co.;

published 4-23-96Food for human consumption:

Food additives--Sodium chlorite; use in

poultry processing;published 4-23-96

INTERIOR DEPARTMENTSurface Mining Reclamationand Enforcement OfficeIndian lands program:

Abandoned mine landreclamation plan--Hopi Tribe; published 4-

23-96TRANSPORTATIONDEPARTMENTFederal AviationAdministrationAirworthiness directives:

Enstrom Helicopter Corp.;published 3-19-96

COMMENTS DUE NEXTWEEK

AGRICULTUREDEPARTMENTOperations OfficeAcquisition regulations:

Review and revision;comments due by 4-29-96; published 2-28-96

COMMERCE DEPARTMENTInternational TradeAdministrationUruguay Round Agreements

Act (URAA); conformance:Antidumping and

countervailing duties;comments due by 4-29-96; published 2-27-96

COMMERCE DEPARTMENTNational Oceanic andAtmospheric AdministrationFishery conservation and

management:Atlantic striped bass and

weakfish; comments dueby 4-29-96; published 3-28-96

Atlantic swordfish;comments due by 5-2-96;published 4-12-96

North Pacific fisheriesresearch plan;implementation; commentsdue by 4-29-96; published3-28-96

DEFENSE DEPARTMENTPrivacy Act; implementation;

comments due by 4-30-96;published 3-1-96

EDUCATION DEPARTMENTPostsecondary education:

Foreign language and areastudies fellowshipsprogram; comments dueby 4-29-96; published 3-28-96

Modern foreign languagetraining and area studies,etc.; comments due by 4-29-96; published 3-28-96

ENVIRONMENTALPROTECTION AGENCYAir quality implementation

plans; approval andpromulgation; variousStates:California; comments due by

5-2-96; published 3-18-96Illinois; comments due by 5-

2-96; published 4-2-96Indiana; comments due by

5-2-96; published 4-2-96Kentucky; comments due by

5-2-96; published 4-2-96Pennsylvania; comments

due by 5-2-96; published4-2-96

Tennessee; comments dueby 5-2-96; published 4-2-96

Air quality implementationplans; √A√approval andpromulgation; variousStates; air quality planningpurposes; designation ofareas:Michigan; comments due by

5-2-96; published 4-2-96Superfund program:

National oil and hazardoussubstances contingencyplan--National priorities list

update; comments dueby 4-30-96; published3-28-96

National priorities listupdate; comments dueby 5-1-96; published 4-1-96

Water pollution control:Ocean dumping; bioassay

testing requirements;comments due by 5-1-96;published 3-28-96

FEDERALCOMMUNICATIONSCOMMISSIONPractice and procedure:

Regulatory fees (FY 1996);assessment andcollection; comments dueby 4-29-96; published 4-15-96

Radio and televisionbroadcasting:Equal employment

opportunity rule andpolicies; revision;comments due by 4-30-96; published 3-12-96

Radio stations; table ofassignments:Colorado; comments due by

5-2-96; published 3-18-96Illinois et al.; comments due

by 4-29-96; published 3-13-96

Louisiana; comments due by5-2-96; published 3-18-96

New York; comments dueby 5-2-96; published 3-18-96

Virginia; comments due by4-29-96; published 3-13-96

Television stations; table ofassignments:Wisconsin; comments due

by 4-29-96; published 3-13-96

HEALTH AND HUMANSERVICES DEPARTMENTFood and DrugAdministrationBiological products:

Well-characterizedbiotechnology products--Approved application

changes reporting;comments due by 4-29-96; published 1-29-96

Approved applicationchanges reporting;guidance availability;comments due by 4-29-96; published 1-29-96

Approved applicationchanges reporting;guidance availability;

comments due by 4-29-96; published 1-29-96

Clinical investigators; financialdisclosure; comments dueby 4-29-96; published 3-5-96

Food for human consumption:Federal regulatory review

and comment request;comments due by 4-29-96; published 12-29-95

Food labeling--Nutrient content claims;

definition of term,healthy; comments dueby 4-29-96; published2-12-96

HOUSING AND URBANDEVELOPMENTDEPARTMENTFederal regulatory review:

Fair housing; certificationand funding of State andlocal enforcementagencies; comments dueby 4-29-96; published 2-28-96

INTERIOR DEPARTMENTFish and Wildlife ServiceMeetings:

Endangered Species of WildFauna and FloraInternational TradeConvention; commentsdue by 4-30-96; published3-1-96

INTERIOR DEPARTMENTSurface Mining Reclamationand Enforcement OfficePermanent program and

abandoned mine landreclamation plansubmissions:Illinois; comments due by 4-

29-96; published 3-29-96Missouri; comments due by

5-2-96; published 4-2-96LABOR DEPARTMENTOccupational Safety andHealth AdministrationOccupational injury and

illness; recording andreporting requirements;comments due by 5-2-96;published 2-2-96Preliminary economic

analysis; executivesummary; comments dueby 5-2-96; published 2-29-96

TRANSPORTATIONDEPARTMENTFederal AviationAdministrationAirworthiness directives:

AlliedSignal Inc.; commentsdue by 4-29-96; published2-29-96

Michelin Aircraft Tire Corp.;comments due by 4-30-96; published 1-29-96

vFederal Register / Vol. 61, No. 79 / Tuesday, April 23, 1996 / Reader Aids

Class E airspace; commentsdue by 4-29-96; published3-18-96

TREASURY DEPARTMENTCustoms ServiceOrganization and functions;

field organization, ports ofentry, etc.:Columbus, OH; port limits

extension; comments dueby 4-30-96; published 3-1-96

TREASURY DEPARTMENTFiscal ServiceBonds and notes, U.S.

Treasury:Payments by banks and

other financial institutionsof United States savingsbonds and notes(Freedom Shares);comments due by 5-1-96;published 4-1-96

VETERANS AFFAIRSDEPARTMENTLoan guaranty:

Discount points financed inconnection with interestrate reduction refinancingloans; limitation;comments due by 4-29-96; published 2-28-96