received clerk united states environmental · 2017-09-12 · dated: september 1, 2017 respectfully...

%i 4FOH P!IT 9 fl Uii InGulT

IN THE UNITED STATES COURT OF AP

REcEIvEDFOR THE DISTRICT OF COLUMBIA CII

)))))) No. 17—1201)

UNITED STATES ENVIRONMENTAL )PROTECTION AGENCY, and SCOTT )PRUITT, Administrator, United States )Environmental Protection Agency, )

)Respondents. )

)

FO 1JM

CUlT CLERK

ENVIRONMENTAL DEFENSE FUND,

Petitioner.

V

PETITION FOR REVIEW

Pursuant to the Toxic Substances Control Act (TSCA) § 1 9(a)(1)(A), 15

U.S.C. § 2618(a)(1)(A), the Administrative Procedure Act, 5 U.S.C. § 70 1-706,

Rule 15 of the Federal Rules of Appellate Procedure, and D.C. Circuit Rule 15, the

Environmental Defense Fund hereby petitions this Court for review of the final

rule of the U.S. Environmental Protection Agency entitled “TSCA Inventory

Notification (Active-Inactive) Requirements,” which is published at 82 Fed. Reg.

37,520 (Aug. 11, 2017), and was issued for purposes ofjudicial review on August

25, 2017. See 40 C.F.R. § 23.5(a), see also 15 U.S.C. § 2618(a)(2) (citing 28

U.S.C. § 2112). A copy of the final rule is attached to this Petition.

1

USCA Case #17-1201 Document #1691492 Filed: 09/01/2017 of 31

DATED: September 1, 2017 Respectfully submitted,

R4k PRobert P. StockmanEnvironmental Defense fund1875 Connecticut Ave. NW,Suite 600Washington, DC 20009(202) 572-3398rstockmanedf.org

Attorneyfor PetitionerEnvironmental Defense fund

2


37520 Federal Register / Vol.17—1201

82, No. 154/Friday, August 11, 2017/Rules and Regulations

(b) Regulations:(1) In the RNAs under paragraph (a)

of this section, the District Commanderor respective COTP may issue orders tocontrol vessel traffic for reasons whichinclude but are not limited to: Channelobstructions, winter navigation, unusualweather conditions, or unusual waterlevels. Prior to issuing these orders, theDistrict Commander or respective COTPwill provide advance notice asreasonably practicable under thecircumstances. The respective COTPmay close and open these regulatednavigation areas as ice conditionsdictate.

(2) Prior to the closing or opening ofthe regulated navigation areas, theCOTP will give interested parties,including both shipping interests andisland residents, not less than 72 hoursnotice of the action. This notice will begiven through Broadcast Notice toMariners, Local Notice to Mariners, andpress releases to the media (radio, printand television), local COTP will ensurewidest dissemination. No vessel maynavigate in a regulated navigation areawhich has been closed by the COTP.The general regulations in 33 CFR165.13 apply. The District Commanderor respective COTP retains thediscretion to authorize vessels tooperate outside of issued orders.

(c) The following are safety zones:(1) Lake Erie. The area known as the

Lake Erie Islands which is defined asthe U.S. waters of Lake Erie at theintersection of the International Borderat 082°55’OO” W., following theInternational Border eastward to theintersection of the International Borderat 082°35’OO” W., moving straight southto position 41°25’OO” N., 082°35’OO” W.,continuing west to position 41°25’OO”N., 082°55’OO” W., and ending north atthe International Border and 082°55’OO”w.

(2) Lake Huron. The waters of LakeHuron known as Saginaw Bay,Michigan; bounded by a line from PortAustin Reef Light (LL—10275) at44°04’55” N., 082°58’57” W.; to TawasLight (LL—11240) at 44°15’13” N.,083°26’58” W.; to Saginaw Bay RangeFront Light (LL—10550) at 43°38’54” N.,083°51’06” W.; then to the point ofbeginning.

(d) Enforcement:(1) The District Commander or

respective Captain of the Port (COTP)will enforce these safety zones as iceconditions dictate. Under normalseasonal conditions, only one closingeach winter and one opening eachspring are anticipated.

(2) Prior to closing or opening thesesafety zones, the District Commander orrespective COTP will give the public

advance notice, not less than 72 hoursprior to the closure. This notice will begiven through Broadcast Notice toMariners, Local Notice to Mariners, andpress releases to the media (radio, printand television), and the local COTP willensure widest dissemination. Thegeneral regulations in 33 CFR 165.23apply. The District Commander orrespective COTP retains the discretionto permit vessels to enter/transit aclosed safety zone under certaincircumstances.

Dated: June 12, 2017.

J.E. Ryan,Commander, RADM, U.S. Coast Guard, NinthCoast Guard District.[FR Doe. 2017—16997 filed 8—10—17; 8:45 am]

BILLING CODE 9110—04—P

DEPARTMENT OF HOMELANDSECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG—2017—0259]

Safety Zone; Cleveland National AirShow, Cleveland, OH

AGENCY: Coast Guard, DHS.ACTION: Notice of enforcement ofregulation.

SUMMARY: The Coast Guard will enforcea safety zone for the Cleveland NationalAir Show, Lake Erie and the ClevelandHarbor, Cleveland, OH from 8:00 am.until 6:00 p.m. each day from August31, 2017 through September 4, 2017.This action is necessary to provide forthe safety of life and property onnavigable waters during this event.During the enforcement period, noperson or vessel may enter therespective safety zone without thepermission of the Captain of the PortBuffalo.

DATES: The regulation in 33 CFR165.939(a](35) will be enforced from8:00 am. through 6:00 p.m., each dayfrom August 31, 2017, throughSeptember 4, 2017.

FOR FURTHER INFORMATION CONTACT: Ifyou have questions on this notice ofenforcement, call or email LT RyanJunod, Chief of Waterways Management,U.S. Coast Guard; telephone 216—937—0124, email [email protected] INFORMATION: The CoastGuard will enforce the Safety Zones;Annual Events in the Captain of the PortBuffalo Zone listed in 33 CFR165.939(a)(35) for the ClevelandNational Air Show, Cleveland, OH from8:00 am. to 6:00 p.m. each day from

August 31, 2017 through September 4,2017. This action is being taken toprovide for the safety of life andproperty on navigable waters during thisevent. Pursuant to 33 CFR 165.23, entryinto, transiting, or anchoring withinthese safety zones during anenforcement period is prohibited unlessauthorized by the Captain of the PortBuffalo or his designated representative.Those seeking permission to enter oneof these safety zones may requestpermission from the Captain of PortBuffalo via channel 16, VHF—FM.Vessels and persons granted permissionto enter this safety zone shall obey thedirections of the Captain of the PortBuffalo or his designated representative.While within the safety zone, all vesselsshall operate at the minimum speednecessary to maintain a safe course.

This notice of enforcement is issuedunder authority of 33 CFR 165.939 and5 U.S.C. 552(a). In addition to thisnotice in the Federal Register, the CoastGuard will provide the maritimecommunity with advance notification ofthese enforcement periods via BroadcastNotice to Mariners and Local Notice toMariners. If the Captain of the PortBuffalo determines that this safety zoneneed not be enforced for the fullduration stated in this notice; he or shemay use a Broadcast Notice to Marinersto grant general permission to enter therespective safety zone.

Dated: August 7, 2017.

Joseph S. Dufresne,Captain, U. S. Coast Guard, Captain of thePort Buffalo.[fR Doe. 2917—16973 Filed 8—10—17; 8:45 am]

BILLING CODE 9110—04-P

ENVIRONMENTAL PROTECTIONAGENCY

40 CFR Part 710

[EPA—HQ—OPPT—201 6—0426; FRL—9964—22]

RIN 2070—AK24

TSCA Inventory Notification (ActiveInactive) Requirements

AGENCY: Environmental ProtectionAgency (EPA].ACTION: Final rule.

SUMMARY: The 2016 amendments to theToxic Substances Control Act (TSCA)require EPA to designate chemicalsubstances on the TSCA ChemicalSubstance Inventory as either “active”or “inactive” in U.S. commerce. Toaccomplish that, EPA is establishing aretrospective electronic notification ofchemical substances on the TSCAInventory that were manufactured

ORIGiNAL


federal Register/Vol. 82, No. 154/Friday, August 11, 2017/Rules and Regulations 37521

(including imported] for nonexemptcommercial purposes during the 10-yeartime period ending on June 21, 2016,with provision to also allow notificationby processors. EPA will use thesenotifications to distinguish activesubstances from inactive substances.EPA will include the active and inactivedesignations on the TSCA Inventory andas part of its regular publications of theInventory. EPA is also establishingprocedures for forward-lookingelectronic notification of chemicalsubstances on the TSCA Inventory thatare designated as inactive, if and whenthe manufacturing or processing of suchchemical substances for nonexemptcommercial purposes is expected toresume. On receiving forward-lookingnotification, EPA will change thedesignation of the pertinent chemicalsubstance on the TSCA Inventory frominactive to active. EPA is establishingthe procedures regarding the manner inwhich such retrospective and forward-looking activity notifications must besubmitted, the details of the notificationrequirements, exemptions from suchrequirements, and procedures forhandling claims of confidentiality.

DATES: This final rule is effective onAugust 11, 2017.

ADDRESSES: The docket for this action,identified by docket identification (ID)number EPA—HQ—OPPT—2016—0426, isavailable electronically at http://www.regulations.gov or in person at theOffice of Pollution Prevention andToxics Docket (OPPT Docket),Environmental Protection AgencyDocket Center (EPA/DC], West WilliamJefferson Clinton Bldg., Rm. 3334, 1301Constitution Ave. NW., Washington,DC. The Public Reading Room is openfrom 8:30 am. to 4:30 p.m., Mondaythrough Friday, excluding legalholidays. The telephone number for thePublic Reading Room is (202) 566—1744,and the telephone number for the OPPTDocket is (202] 566—0280. Please reviewthe visitor instructions and additionalinformation about the docket availableat http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Fortechnical information contact: Myrta R.Christian, Chemistry, Economics, andSustainable Strategies Division(Mailcode 7406M), Office of PollutionPrevention and Toxics, EnvironmentalProtection Agency, 1200 PennsylvaniaAve. NW., Washington, DC 20460—0001;telephone number: (202] 564—8498;email address: [email protected].

For general information contact: TheTSCA-Hotline, ABVI-Goodwill, 422South Clinton Ave., Rochester, NY14620; telephone number: (202) 554—

1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Who does this action apply to?

You may be affected by this action ifyou domestically manufactured,imported, or processed a chemicalsubstance listed on the TSCA ChemicalSubstance Inventory for nonexemptcommercial purpose during the 10-yeartime period ending on June 21, 2016.You may also be affected by this actionif you intend to domesticallymanufacture, import, or process in thefuture a chemical substance listed onthe TSCA Chemical SubstanceInventory.

The following North AmericanIndustrial Classification System(NAICS) codes are not intended to beexhaustive, but rather provides a guideto help readers determine whether thisaction may apply to them:

• Chemical manufacturing orprocessing (NAICS code 325).

• Petroleum and Coal ProductsManufacturing (NAICS code 324).

In addition, the discussion in UnitII.A. describes in more detail whichchemical substances will and will notbe subject to reporting under this action.You may also consult the regulatory textin this document for further informationon the applicability of exemptions tothis rule.

Note that TSCA’s statutory definitionof “manufacture” includes importing.Accordingly, the regulatory definition of“manufacture” for this rule includesimportation. Since “manufacture” isitself defined (in this rule and in TSCA)to include “import,” it is clear thatimporters are a subset of manufacturers.All references to manufacturing in thisnotice should be understood to alsoencompass importing. Where EPA’sintent is to specifically refer to domesticmanufacturing or importing (bothactivities constitute “manufacture”),this rule will do so expressly.

B. What action is the Agency taking?

On January 13, 2017 (82 FR 4255,FRL—9956—28) (Ref. 1), EPA proposedprocedural reporting requirements forpersons who manufactured (includingimported) in the past or intend tomanufacture in the future chemicalsubstances on the TSCA Inventory(hereafter referred to as the“Inventory”). EPA received numerouspublic comments on the proposed rule.This final rule is based on that proposaland the consideration of the publiccomments received.

This TSCA section 8(b) rule requireselectronic reporting of chemical identityfrom persons who manufactured achemical substance for nonexemptcommercial purpose during the 10-yeartime period ending on June 21, 2016.EPA will accept notices for substancesthat were processed during the sameten-year time period. EPA will use thechemical identity information obtainedfrom this retrospective reporting todesignate as active those substances onthe Inventory for which notices werereceived. If no notice is received duringthis retrospective reporting for asubstance subject to designation on theInventory, then that substance will bedesignated as inactive.

This rule also requires electronicreporting of certain information frompersons who in the future intend tomanufacture or process an inactivesubstance on the Inventory fornonexempt commercial purpose. Theinformation to be reported includeschemical identity and the date whenmanufacturing or processing isanticipated to resume. Upon receipt ofsuch notices, EPA will change thedesignation on the Inventory frominactive to active.

This rule includes procedures forpersons who co-manufacture or coprocess a reportable chemical substance.These procedures will allow thesubmission of a single commercialactivity notice where there has been comanufacturing or co-processing of aparticular volume of a substance. Theseprocedures are similar to TSCAChemical Data Reporting (CDR) rulerequirements (40 CFR 711.22) when twoor more persons are involved in aparticular manufacture or importtransaction.

This rule also includes a simplifiedprocedure for filing a submission,including when specific chemicalidentity information is claimed to beconfidential business information (CBI)by a supplier, and finalizes theproposed procedure for filing a jointsubmission. See response to Comment14 in Unit III. EPA expanded itselectronic reporting system to include apick list from which persons can selectchemicals for reporting. The pick listwill include only reportable chemicalsubstances and will not include CBI.Substances that are on the confidentialportion of the Inventory will be listedon the pick list by EPA accessionnumbers and generic names, as theyappear on public versions of theInventory. In cases where specificchemical identity is claimed CBI by asupplier, a submitter can provide asingle notice to EPA for a CBI substanceif it has in its possession the


37522 Federal Register/Vol. 82, No. 154/Friday, August 11, 2017/Rules and Regulations

corresponding non-CBI chemicalidentifiers (EPA accession number andgeneric name).

If a manufacturer or processor cannotprovide the specific chemical identity ofa reportable chemical substance to EPAbecause the information is claimed CBIby a supplier, and therefore is unknownto the importer, the submitter will berequired to ask the supplier to providethe CBI chemical identity informationdirectly to the Agency in a jointsubmission. EPA will only accept jointsubmissions that are submittedelectronically using CDX. Thisrequirement is similar to CDR rulerequirements (40 CFR 711.15) and willallow EPA to obtain the informationnecessary to identify the specificchemical identity of a reportablesubstance and designate it as active onthe Inventory.

This rule also finalizes proposedchanges to 40 CFR 710.3 definitions.These changes were proposed toconform the definitions applicable tothese reporting requirements with thosethat apply to CDR rule requirements(definitions found at 40 CFR 704.3 and711.3) and the submission ofPremanufacture Notices (PMNs)(definitions found at 40 CFR 720.3].Finally, this rule finalizes recordkeepingrequirements as required by TSCAsection 8(b)(9)(B). Records relevant toretrospective notification must beretained for a period of 5 yearsbeginning on the last day of thesubmission period. Records relevant toforward-looking notification must beretained for a period of 5 yearsbeginning on the day that the notice wassubmitted.

C. Why is the Agency taking this action?

TSCA section 8(b)(4)(A] requires EPAto issue a final rule for retrospectivereporting by June 22, 2017. This rulewill enable EPA to fulfill a statutoryobligation to designate chemicalsubstances on the Inventory as active orinactive in U.S. commerce. TSCAsection 8(b](5](B) further establishes aforward-looking reporting requirementthat goes into effect as soon as EPAdesignates inactive substances. This rulealso establishes the proceduralframework whereby manufacturers andprocessors will discharge their noticeobligations under this section of TSCA.

This rule and designations under therule are not intended to indicateconclusions about the risks of chemicalsubstances on the Inventory.Nonetheless, the designation of asubstance as active or inactive will berelevant to the Agency’s prioritization ofsubstances in U.S. commerce underTSCA section 6(b).

D. What is the Agency’s authority fortaking this action?

EPA is issuing this rule under TSCAsection 8(b), 15 U.S.C. 2607(b). TSCAwas amended by the Frank R.Lautenberg Chemical Safety for the 21stCentury Act, Public Law 114—182. TheGovernment Paperwork Elimination Act(GPEA), 44 U.S.C. 3504, provides that,when practicable, Federal organizationsuse electronic forms, electronic filings,and electronic signatures to conductofficial business with the public.

Under section 553(d) of theAdministrative Procedure Act, 5 U.S.C.553(d), the Agency may make a ruleimmediately effective “for good causefound and published with the rule.”EPA finds that there is “good cause” tomake this rule effective uponpublication in the Federal Registerbecause the deadline for manufacturersto submit retrospective reports underthis rule is fixed by statute at “180 daysafter the date on which the final rule ispublished in the Federal Register.”TSCA section 8(b](4)(A](i). Because thesubmission deadline is tied by statute tothe date of the rule’s publication, ratherthan the effective date of the rule,delaying the effective date of this rulewould not afford any additional time formanufacturers to comply with reportingrequirements. Rather, delaying theeffective date of the rule would pushback the start of the submission periodfor retrospective reporting, but not theend of the submission period (whichremains fixed by statute), leavingmanufacturers with a shorter period(less than 180 days] during whichnotices may be submitted. Thus, anyimpact on the regulated community ofmaking the rule immediately effective isexpected to be beneficial, given that animmediate effective date providesmanufacturers with the greatest possibletiming discretion regarding when tosubmit retrospective reports.

F. What are the estimated incrementalimpacts of this action?

EPA has reevaluated the potentialcosts of establishing the reportingrequirements for manufacturers andprocessors in response to commentsreceived. This analysis, which isavailable in the docket, is discussed inUnit V. and briefly summarized here(Ref. 2).

During the retrospective (or “startup”) period, between approximatelyJune 2017 and June 2018, typical costsper firm are estimated at $1,188 persubmission (with an estimated eighteenchemicals per submission), withpossible additional costs at $41.55 perCDX registration in the event that the

submitter is not currently registered inCDX. Among manufacturers, anestimated 5,322 firms will undertakerule familiarization with 1,585completing compliance determination,form completion, and recordkeeping.For manufacturers, the total burdenduring start-up is estimated at 38,613hours with an associated total cost of$3.09 million. For processors, anestimated 283,993 firms will undertakerule familiarization, with 100completing compliance determination,form completion, and recordkeeping.

For processors completing rulefamiliarization only, the cost entails3.30 hours on average per firm (under$300 per firm). For processors whocomplete a submission, typicallyinvolving one chemical, the burden forrule familiarization, compliancedetermination, form completion andrecordkeeping during the start-up yearis estimated at 500 hours with anassociated cost of $0.04 million. Lastly,for 169 new CDX registrations (forindividuals lacking previous experiencewith electronic reporting to EPA],burden during start-up is estimated at90 hours with an associated cost of$0007 million.

The rule has minimal burden and costimplications related to ongoingreporting with the typical cost per firmestimated at $889 per submission afterthe start-up year. The forward-looking(or “ongoing”) reporting after June 2018involves compliance determination,form completion, and recordkeeping fortwenty manufacturers and/or processorsper year. Burden and cost are estimatedto total 225 burden hours per year withan associated cost of $17,779 per year.

Agency activities due to the ruleinclude CDX and Chemical InformationSubmission System (CISS) capacityexpansions, time to manage commercialactivity notices, and increased costsincurred when making revisions to theInventory. Associated costs areestimated at $3.62 million during startup, and $0.22 million annuallythereafter.

Combining Industry and Agency costestimates, and annualizing over a 10-year period, the total cost of the rule isestimated at $9.7 million per year usinga 3% discount rate, and at S11.8 millionper year using a 7% discount rate.

II. Summary of the Final Rule

EPA is describing in this unit thereporting requirements formanufacturers and processors ofchemical substances pursuant to TSCAsection 8(b). EPA developed twoversions of a Notice of Activity (NOA)reporting form for submitting theinformation described in this rule for


Federal Register/Vol. 82, No. 154/Friday, August 11, 2017/Rules and Regulations 37523

the two reporting scenarios,retrospective and forward-looking (Ref.3). The Notice of Activity Form A (EPAForm No. TBD—1) will be used forretrospective reporting, and the Noticeof Activity Form B (EPA Form No. TBD—2) will be used for forward-lookingreporting.

EPA intends that the provisions ofthis rule be severable. In the event thatany individual provision or part of therule is invalidated, EPA intends thatthis would not render the entire ruleinvalid, and that any individualprovisions that can continue to operatewill be left in place.

A. What chemical substances andactivities are reportable under this rule?

1. Reportable chemical substances.The retrospective reportingrequirements of this rule apply tochemical substances listed on theInventory that were manufactured fornonexempt commercial purposes duringthe 10-year period ending on June 21,2016. This 10-year period, referred tohere as the “lookback period,” is set bystatute. The forward-looking reportingrequirements apply to substances listedas inactive on the Inventory that are tobe reintroduced into U.S. commerce fornonexempt purposes. The Inventory isavailable at https://www.epa.gov/tscainventory.

2. Exemptions from reporting. i.Excluded chemical substances. Thescope of chemical substances coveredunder this rule is reflected in thedefinitions of “chemical substancesubject to commercial activitydesignation,” and “reportable chemicalsubstance,” at 40 CFR 710.23, whichexclude substances that are notchemical substances and substances thatare not listed on the Inventory. Forexample, a substance that is notconsidered a “chemical substance” (asprovided in subsection 3(2)(B) of TSCAand in the definition of “chemicalsubstance” in 40 CFR 7 10.3(d)) is not a“chemical substance subject tocommercial activity designation” or a“reportable chemical substance” and itthus cannot become an “activesubstance” or an “inactive substance.”A similar analysis applies with respectto a mixture (as defined in 40 CFR710.3(d)), although individualInventory-listed substances present inthe mixture may be subject to reporting.Additionally, a substance that has notbeen added to the Inventory because itis manufactured solely under a TSCAsection 5(h) exemption (e.g., lowreleases and low exposures exemption,low volume exemption, polymerexemption, research and developmentexemption, test marketing exemption) is

not a “chemical substance subject tocommercial activity designation” or a“reportable chemical substance” and itcannot become an “active substance” oran “inactive substance.” See response toComment I in Unit III.

Naturally occurring chemicalsubstances also are excluded fromreporting under this rule, as long as themanufacturing and processing of suchsubstances meet the criteria set forth in40 CFR 710.27(b). Naturally occurringsubstances are considered to beautomatically included on the Inventoryas the category “Naturally OccurringChemical Substances” (42 FR 64578).EPA is designating the whole categoryof Naturally Occurring ChemicalSubstances as active substances by thisrule, thereby excluding them fromreporting under this rule.

ii. Manufacturing or processing for anexempt commercial purpose.Manufacturing or processing a chemicalsubstance listed on the Inventory solelyfor an exempt commercial purpose isnot subject to reporting requirementsunder TSCA section 8(b)(4) or 8(b)(5).The statute limits these notificationobligations to manufacturing andprocessing for “nonexempt commercialpurpose.” The scope of manufacturingor processing for an exempt commercialpurpose is set forth in 40 CFR 710.2 7(a).While EPA expects that many chemicalsubstances manufactured or processedfor exempt commercial purposes willnot be listed on the Inventory (due tosimilar exemptions under PMNregulations), and therefore are alreadyexcluded from reporting under this rule,the activity exemptions listed at 40 CFR710.27(a) clarify circumstances underwhich a person is exempt fromreporting requirements for themanufacturing or processing of achemical substance that has been listedon the Inventory (e.g., due to anothermanufacturer’s actions). For example,the manufacturing or processing ofimpurities or byproducts that have nosubsequent commercial purpose willnot trigger reporting obligations underthis rule. See 40 CFR 710.2 7(a)(3).Additionally, manufacturing orprocessing in small quantities solely forresearch and development is exempt asdescribed in 40 CFR 710.3(d) and 40CFR 710.27(a)(1). Furthermore, theimport or processing of substancessolely as part of articles is not subject toreporting under this rule. See 40 CFR710.27(a)(2) and response to Comment 2in Unit III. In response to comments,EPA revised the rule to clarify thatmanufacturing or processing a chemicalsubstance solely for export from theUnited States or for test marketingpurposes are also exempt commercial

purposes not subject to reportingrequirements under this rule. See 40CFR 710.27(a)(4) and (5) and response toComment I in Unit III.

iii. Chemical substances for whichEPA already has an equivalent notice.EPA is establishing an exemption fromthe retrospective reporting requirementfor three different circumstances inwhich EPA has already receivedequivalent notice that a chemicalsubstance was manufactured during thelookback period, and furtherrequirement to submit a notice wouldtherefore be inconsistent with TSCAsection 8(a)(5)(B).

First, chemical substances that are onthe interim list of active substancesdescribed in TSCA section 8(b)(6) willbe designated as active substances, byoperation of this rule, and they areexempted from retrospectivenotification requirements under thisrule. The interim list will be availableon the TSCA Inventory Web page (seehttps://www.epa.gov/tsca-inventory),and is comprised of all chemicalsubstances reported in 2012 or 2016under the CDR rule, 40 CFR part 711.See 82 FR 4259. A CDR notice from2012 or 2016 provides equivalent noticeto EPA that the substance wasmanufactured during the lookbackperiod. In response to comments, thisexemption now applies irrespective ofwhether the substance is on theconfidential portion of the Inventory.See 40 CFR 710.23 for revised definitionof “interim active substance” andresponse to Comment 3 in Unit III.

Second, chemical substances thatwere added to the Inventory during theten-year time period ending on June 21,2016, pursuant to a Notice ofCommencement (NOC) under 40 CFR720.102 received by the Agencybetween June 21, 2006 and June 21,2016, will be designated as activesubstances, by operation of this rule,and they are exempted fromretrospective notification requirementsunder this rule. An NOC is required tobe submitted on or no later than 30calendar days after the first day ofmanufacture for commercial purpose.Additionally, an NOC substance isconsidered to be added to the Inventoryon the date the NOC is received by EPA,provided that the EPA determines theNOC to be valid during its review.Therefore, a processed NOC providesequivalent notice that the substance wasmanufactured or processed during thelookback period. This exemptionapplies irrespective of whether thesubstance is on the confidential portionof the Inventory. See 40 CFR 710.23 forrevised definitions of “activesubstance,” “chemical substance subject



to commercial activity designation,”and response to Comment 4 in Unit III.

Third, a manufacturer is exempt fromthe retrospective notificationrequirements under this rule, for aparticular chemical substance, if themanufacturer has evidence in the formof a CDX receipt, documenting EPA’sreceipt of an NOA Form A from airnthermanufacturer. See 40 CFR 710.25(a) andresponse to Comment 6 in Unit ifi.Manufacturers should keep in mind,however, that they bear the risk offailing to submit a required forward-looking notification (NOA Form B)notice if they rely on this Form Aexemption, and the Form A notice (forwhich they have a CDX receipt) is laterwithdrawn, leading to the substancebeing designated as inactive.Furthermore, one manufacturer’sexpectation that another manufacturerwill later submit an NOA Form A is notan acceptable basis for relying on thisexemption. Since it is only submitterswho will be notified of errors,manufacturers relying on the exemptionare responsible for assuring theirsubstance is designated as commerciallyactive.

iv. Inapplicability of exemptions topersons seeking to maintain an existingCBI claim for specific chemical identity.Persons who manufactured or processeda chemical substance on theconfidential portion of the Inventory,that was added to the Inventory prior toJune 22, 2016, should recognize thatthey must submit an NOA Form A toEPA if they wish to indicate that they“seek to maintain an existing claim forprotection against disclosure of thespecific chemical identity of thesubstance as confidential.” See TSCA8(b)(4)(B)(ii) and response to Comment3 in Unit III. This includes persons that,during the lookback period,manufactured or processed aconfidential substance on the Inventoryfor which EPA already has anequivalent notice (as described inparagraph A.2.iii. of this Unit). It mayalso potentially include persons that,during the lookback period,manufactured or processed aconfidential substance on the Inventoryfor an exempt commercial purpose (asdescribed in paragraph A.2.ii. of thisUnit), if such substance is designatedactive due, for instance, to EPA’s receiptof an equivalent notice (such as an NOCor CDR report). In connection withextending manufacturers’ reportingexemptions to cover substances on theconfidential portion of the Inventory,EPA has revised 40 CFR 710,25(b) toclarify manufacturers’ and processors’discretion to report. If manufacturerselect not to submit a notice because they

are availing themselves of one of theexemptions described previously, thenthey are foregoing their opportunity tomaintain an existing claim forprotection against disclosure of thespecific chemical identity of thesubstance as confidential. EPA isrequired, by statute, to move from theconfidential to the public portion of theInventory any active chemical substancefor which no request is received tomaintain an existing CDI claim forchemical identity. See TSCA section8(b)(4)(B)(iv) and 40 CFR 710.37(a).

3. Chemical substances added to theInventory on or after June 22, 2016.Chemical substances added to theInventory on or after June 22, 2016 willbe designated as active, by operation ofthis rule. Such substances are notsubject to reporting under this rule.Furthermore, such substances arebeyond the scope of the CBI claimmaintenance provision under TSCAsection 8(b)(4)(B)(ii). This CDImaintenance provision is intended toaddress “existing claim[sl for protectionagainst disclosure of the specificchemical identity.” EPA interprets thisto be a reference to CDI claims assertedprior to June 22, 2016. See 40 CFR710.2 3 for revised definition of “activesubstance.”

B. When will reporting be required?

1. Retrospective reporting period formanufacturers. Manufacturers mustreport to EPA not later than 180 daysafter the final rule is published in theFederal Register. The 180-day timeperiod for this retrospective reportingfor manufacturers is the maximum timeallowed under TSCA section 8(b)(4)(A).Following this retrospective reportingfor manufacturers, EPA will include theactive designations, determined by thenotices received, on a draft of theInventory. EPA will publish this draftInventory with the active designationsas soon as is practicable following theclose of the 180-day submission periodfor manufacturers. This draft Inventorywith active designations will not havethe legal effect of actually designatingany chemical substance as inactive.EPA, therefore, does not construe thisdraft Inventory as the list with“designations of active substances andinactive substances” (TSCA section8(b)(5)(A)) from which forward-lookingreporting commences (TSCA section8(b)(5)(B)). EPA concludes that thestatute is referring in both sections tothe completed product of the initialcycle of sorting between active andinactive substances, not the preliminaryproduct of the initial cycle of suchsorting (i.e., a draft Inventory released

between manufacturer and processorreporting).

2. Retrospective reporting period forprocessors. Processors may report toEPA not later than 420 days after thefinal rule is published in the FederalRegister. EPA originally proposed thatprocessors may report not later than 360days after the final rule is published inthe Federal Register. EPA’s rationalewas that the additional 180-day timeperiod for processors would allowprocessors to search EPA’s publicationof the draft Inventory with activedesignations, based on the retrospectivereporting by manufacturers, and toreport only those chemical substancesnot already reported. In response tocomments received that the additional180-day submission period forprocessors should begin on the date onwhich the draft Inventory is published,which EPA anticipates will likely occurapproximately 60 days after the 180-daysubmission period for manufacturerscloses, and to a comment that the ruleshould specify a fixed date on which theprocessor submission period will end,EPA is finalizing the rule such thatprocessors may report not later than 420days, rather than 360 days, after thefinal rule is published in the FederalRegister. See 40 CFR 710.30(a)(2) andresponse to Comment 7 in Unit III.

Processors have the option to simplynot report under TSCA section 8tb)(4)and continue processing until theeffective date of EPA’s designation of achemical substance as inactive on theInventory. At such time, any furtherprocessing of the substance for anonexempt commercial purpose,without prior notification to EPA, willbe prohibited by TSCA section 8(b)(5).Earlier notification under TSCA section8(b)(4) will allow EPA to add thesubstance to the Inventory as an activesubstance, so that processing cancontinue without the need for a laternotification under TSCA section 8(b)(5).

3. Forward-looking reporting. Theforward-looking reporting period beginson the effective date of EPA’s finalactive/inactive substance designations.Manufacturers and processors intendingto reintroduce into U.S. commerce for anonexempt commercial purpose achemical substance designated asinactive on the Inventory must report toEPA not more than 90 days before theanticipated date of manufacturing orprocessing. EPA originally proposedthat forward-looking notices would berequired to be submitted not more than30 days before the date ofmanufacturing or processing. EPAagrees with commenters that noticesshould be submitted based on theanticipated (not actual) date of



manufacturing or processing. EPA alsofinds that extending such submissionperiod from 30 to 90 days prior toresuming manufacturing or processingwill afford manufacturers andprocessors additional time to adjust toinformation and schedule changes andwill not significantly impact theaccuracy of notices submitted. See 40CFR 710.29(c)(2), 40 CFR 710.30(b)(1],and response to Comment 8 in Unit III.

4. Transitional period reporting andeffective dote for inactive substancedesignations. The structure of thereporting requirements under TSCAsections 8(b)(4](A) and 8(b)(5)(B) resultsin a transitional period beginning onJune 22, 2016 (the day after the lookbackperiod for retrospective reporting ends)and ending on the date that EPAdesignates chemical substances on theInventory as active or inactive (the daythat forward-looking reporting begins).It is possible that substances that werenot manufactured or processed duringthe lookback period—and thereforecannot be designated as active throughretrospective reporting—may bereintroduced into U.S. commerce duringthis transitional period. In response tocomments expressing concern thatpersons who began manufacturing orprocessing such substances during thetransitional period might be obliged tocurtail manufacturing or processing onthe date that EPA publishes an inactivesubstance designation, or else findthemselves in violation of the forward-looking notice requirement, EPA isestablishing an effective date provisionfor the designation of a chemicalsubstance as an inactive substance. As“inactive substance” is now defined, asubstance is not designated as an“inactive substance” until 90 days afterEPA has identified the substance forinactive designation. EPA will identifychemical substances for inactivedesignation in a signed actionaccompanying the first version of theInventory with all finalized active-inactive listings. EPA expects to publishthis first version of the Inventory withall listings identified as active orinactive as soon as practicable aftercompilation, in a posting on EPA’sTSCA Inventory Web page (see https://www.epa.gov/tsca-inventory). See 40CFR 710.23 for revised definition of“inactive substance” and response toComment 9 in Unit III.

Accordingly, the rule clarifies that theobligation to submit an NOA Form Bdoes not arise until 90 days after EPAhas identified chemical substances forthe inactive designation. The rule alsoclarifies that manufacturers andprocessors will be permitted to submitan NOA Form B for a substance that

EPA has identified for inactivedesignation, even before the effectivedate of such designation has arrived,and thus before the substance has thelegal status of being inactive. Thus,persons manufacturing or processing asubstance for nonexempt commercialpurpose during the transitional periodare afforded time to react to an inactive

substance identification and arepermitted to file an NOA Form B priorto the effective date of the substancebeing designated as inactive. Similarly,persons that anticipate reintroducing asubstance into U.S. commerce fornonexempt commercial purpose shortlyafter EPA identifies such substance asinactive are afforded time to react to an

inactive substance identification and arepermitted to file an NOA Form B priorto the effective date of the inactivedesignation, so long as such form isfiled no more than 90 days before theanticipated date of manufacturing orprocessing. See 40 CFR 710.30(b)(2) andresponse to Comment 10 in Unit III.

C. What information will be reported?

1. Information reported bymanufacturers during retrospectivereporting. This rule will require thatmanufacturers reporting for theretrospective reporting period provide

chemical identity information andindicate whether they seek to maintainan existing claim for protection againstdisclosure of a CBI chemical identity, ifapplicable. In response to commentsstating concern with burden associatedwith information required to bereported, EPA removed the proposedrequirements to report commercialactivity type and date range, as EPAdetermined these requirements areunnecessary to achieve the objective ofdesignating substances as active orinactive on the Inventory. See 40 CFR710.29(b) and response to Comment 11in Unit III. In response to commentsstating concern for availability ofinformation required to be reported,EPA clarified that persons required toreport under this rule will provideinformation to the extent it is known toor reasonably ascertainable by them. See40 CFR 710.29(a) and response toComment 12 in Unit III. In response tocomments requesting that amanufacturer be able to correct orwithdraw an NOA Form A in the eventthat it discovers errors in the notice,EPA is not establishing a formalcorrections provision in the regulation,but will allow a manufacturer orprocessor to withdraw an NOA Form A,provided that the withdrawn notice issubmitted prior to the end of thesubmission period for processors, i.e.,not later than 420 days after the final

rule is published in the FederalRegister. See response to Comment 13in Unit III. The manufacturer may effecta correction by filing a new NOA FormA following withdrawal, so long as thenew Form A is filed within the timeprovided in the rule for the initial filing(i.e., no later than 180 days after thefinal rule is published in the FederalRegister).

2. Information reported by processorsduring retrospective reporting.Processors that choose to report for theretrospective reporting period will berequired to provide chemical identityinformation and whether they seek tomaintain an existing claim forprotection against disclosure of a CBIchemical identity, if applicable. Inresponse to comments received, EPAremoved the proposed requirements toreport commercial activity type and daterange as these requirements weredeemed unnecessary to achieve theobjective of designating substances asactive or inactive on the Inventory. See40 CFR 710.29(b) and response toComment 11 in Unit III. EPA is notestablishing a formal correctionsprovision in the regulation for an NOAForm A, but will allow a processer towithdraw an NOA Form A, providedthat the withdrawn notice is submittednot later than 420 days after the finalrule is published in the FederalRegister. See 40 CFR 710.30(a)(3) andresponse to Comment 13 in Unit III. Aswith manufacturers, processors caneffectuate a correction by filing a newForm A within the time provided in therule for the initial filing (i.e., no later

than 420 days after the final rule ispublished in the Federal Register].

3. Information reported duringforward-looking reporting. This rule willrequire that persons that intend tomanufacture or process an inactivesubstance for nonexempt commercialpurpose provide chemical identityinformation, the anticipated date ofmanufacturing or processing for

nonexempt commercial purpose, andwhether they seek to maintain anexisting claim for protection againstdisclosure of a CBI chemical identity, ifapplicable. In response to comments,EPA removed the proposed requirementto report commercial activity type asthis requirement was deemedunnecessary to achieve the objective ofre-designating inactive substances asactive, and revised the date of

manufacturing or processing for

nonexempt commercial purpose from

actual to anticipated date. See 40 CFR710.29(c) and response to Comment 11in Unit III. Persons that have alreadycommenced manufacturing or

processing for nonexempt commercial


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purpose (e.g., during the transitionalperiod prior to the effective date of asubstance’s inactive designation) mayprovide the most recent date ofmanufacturing or processing in lieu ofan anticipated future date, if theforward-looking notice is submittedprior to the effective date of thesubstance’s inactive designation. See 40CFR 710.29(c).

EPA’s proposed rule related thetiming of the reporting to a future“actual date of manufacturing andprocessing.” See 82 FR 4267. Inresponse to comments about the needfor greater flexibility regarding thetiming of a forward-looking notice,under the rule the validity of the noticedoes not depend on whether theintended manufacturing or processingactually occurs by the anticipated date.Therefore, manufacturers or processorsneed not supplement a forward-lookingnotice with confirmation of whether theintended manufacturing or processing ofthe chemical substance actuallyoccurred by the anticipated date. By thesame token, EPA will designate suchsubstances as active, irrespective ofsubsequent changes in the intentions ofthe submitter of the forward-lookingnotice. Consistent with the regulatorydefinition of “active substance,” aninactive substance becomes an activesubstance “based on the receipt of anotice under this subpart,” 40 CFR710.23, and the factual basis for thenotice is the submitter’s intent,expressed at time of notification, tomanufacture or process an inactivesubstance for a nonexempt commercialpurpose within 90 days of notification.See 40 CFR 710.25(c) and 40 CFR710.30(b)(2). This simplified approachreduces burdens for both submitters andEPA, is consistent with the statute, andfurthers the orderly and efficientimplementation of the Inventory. SeeTSCA section 8(b)(5)(B)(iii) (requiringEPA to take certain definite actions “onreceiving” the notice). With respect tosubstances re-designated as active forwhich the intended manufacturing orprocessing has not been actualized afteran extended period of time and notcorrected, EPA may later adjust thestatus of such substances, throughprocedures that would be established byfuture rulemaking, to further implementTSCA section 8(b)(5)(A).

Finally, in response to commentrequesting that submitters be able towithdraw an NOA Form B if their intentto re-commence manufacture or processa chemical substance later changes, EPAis allowing a submitter to request towithdraw its NOA Form B, and EPAmay do so, if EPA has not yet altered theInventory status of the substance in

response to the original submission (i.e.,EPA has neither re-designated thesubstance from inactive to active normoved the substance from theconfidential portion of the Inventory tothe public portion Inventory as a resultof a request in the original submissionfor a CBI claim to be withdrawn).Because another person may havecommenced manufacturing orprocessing for non-exempt commercialpurpose in reliance of a substance beingre-designated as active, the rule does notallow for EPA to revert a substance redesignated as active back to inactivestatus based on a request to withdraw anNOA Form B, or for EPA to revert a nonCBI substance back to a CBI substancebased on a request to withdraw a FormB. It would be burdensome andpotentially impossible to implementsuch an approach. See 40 CFR710.30(b)(3) and response to Comment13 in Unit III.

4. Reporting forms. The NOA Form Awill be used by manufacturers for theretrospective reporting period. It willalso be used by processors who chooseto report for the retrospective reportingperiod. The NOA Form B will be usedby manufacturers and processors forforward-looking reporting, whichincludes reporting chemical substancesreintroduced into U.S. commerce duringthe transitional period. For the sake ofclarity, the final rule now defines theterms ‘Notice of Activity Form A’ and‘Notice of Activity Form B’, consistentwith the use of these terms in theproposal. The new NOA forms are basedon EPA’s NOC form (Ref. 4), since theinformation required in an NOA form isthe same or similar to the informationin the NOC form.

D. How will information be submitted toEPA?

The rule requires electronic reportingsimilar to the requirements establishedin 2013 for submitting other informationunder TSCA (see 40 CFR 704.20(e)] andin accordance with section 3.2000 of 40CFR part 3 (CROMERR) (Ref. 5).Submitters will use EPA’s CDX, theAgency’s electronic reporting portal,and EPA’s Chemical InformationSubmission System (CISS), a web-basedreporting tool, for all reporting underthis rule. EPA expects that electronicreporting will minimize timerequirements, support improved dataquality, and provide efficiencies forboth the submitters and the Agency.

In 2013, EPA finalized a rule torequire electronic reporting of certaininformation submitted to the Agencyunder TSCA sections 4, 5, 8(a) and 8(d).(Ref. 6) The rule follows two previousrules requiring similar electronic

reporting of information submitted toEPA for CDR and PMNs.

This rule will require personssubmitting notices of activity to EPAunder TSCA section 8(b) to follow thesame electronic reporting proceduresused for other TSCA submissions, i.e.,to register with EPA’s CDX (if notalready registered] and use CISS toprepare a data file for submission.Registration enables CDX toauthenticate identity and verifyauthorization. To register, the CDXregistrant (also referred to as “ElectronicSignature Holder” or “Public/PrivateKey Holder”) agrees to the Terms andConditions, provides information aboutthe submitter and organization, andselects a user name and password. Userswho have previously registered withCDX for other TSCA submissions willbe able to add the “Submission forChemical Safety and Pesticide Program”(CSPP) service to their currentregistration in CDX and use the CISSweb-based reporting tool.

EPA developed the CISS for use insubmitting data under TSCA sections 4,5, 8(a), and 8(d) to the Agencyelectronically. The web reporting tool isavailable for use with Windows, lOS,Linux, and UNIX based computers anduses “Extensible Markup Language”(XML) specifications for the efficienttransfer of data across the Internet whennotices are submitted to EPA. CISSworks with CDX to secure onlinecommunication, provides user-friendlynavigation, creates a completeddocument in Portable Document Format(PDF) for review prior to submission,and enables information to be submittedeasily in XML format or as PDFattachments.

The NOA forms described in this ruleare included in an e-NOA softwaremodule in CISS. Once a user completesentry of the relevant data fields andmetadata information in the appropriateNOA form, the CISS reporting toolvalidates the submission by performinga basic error check. CISS also allows theuser to choose “Preview,” “Save,” or“Submit.” When “Submit” is selected,the user is asked to provide the username and password that was createdduring the CDX registration process.CISS then submits the data via CDX.Upon successful receipt of thesubmission by EPA, the status of thesubmissions will be flagged as“Submitted.” The user can also login tothe application and download theirCopy of Record.

Any person submitting a reportingform can claim any part or all of theform as confidential. Except asotherwise provided in this rule, anyinformation that is claimed as CBI will



be disclosed by EPA only to the extentand by the means of the procedures setforth in 40 CFR part 2.

E. How will C’BI claims and requests behandled?

Notices pursuant to this rule maycontain two different types of CBIassertions: claims for protection ofinformation other than specificchemical identity, and requests tomaintain existing claims for protectionof specific chemical identity. Inresponse to comments received, EPAhas extensively re-written thesubstantiation questions from theproposed rule in a manner intended tomore succinctly secure responses forCBI assertions of discrete data elementsas well as CBI concerns on the linkageof data elements. See 40 CFR 710.31 andresponse to Comment 17.

1. Information other than specificchemical identity. For all new claims forprotection (i.e., for all CBI assertionsunder this rule other than requests tomaintain existing claims for protectionof specific chemical identity], TSCAsection 14(c](1](B] and 14(c)(5) requirethat persons claiming CBI must providea specific certification statementregarding the basis for the CBI claims.In addition, TSCA section 14(c](3) andthis rule require that all such claims besubstantiated at the time of submission.EPA will review a representative subsetof these claims as specified by TSCAsectionl4(g](1].

2. Requests to maintain existing CBIclaims for chemical identity. Anymanufacturer or processor submitting anNOA under TSCA section 8(b](4](A)may seek to maintain an existing CBIclaim for specific chemical identity,regardless of whether that personasserted the original claim that causedthe specific chemical identity to belisted on the confidential portion of theInventory. EPA believes this is thecorrect interpretation of “amanufacturer or processor. . . thatseeks to maintain an existing claim forprotection against disclosure” ofspecific chemical identity in TSCAsection 8(b)(4](B](ii]. A number ofmanufacturers and processors maylegitimately benefit from theconfidential status of a specificchemical identity, even when suchpersons did not originally report thatchemical identity to EPA and thereforewere not in a position to assert a CBIclaim for that chemical identity.Congress could not have intended thatsuch companies would be forced to relyon another company to request tomaintain the claim. For example, theinitial claimant may no longer exist ormay no longer manufacture or process

the chemical substance, or may simplyfail to file the required NOA. EPA doesnot believe that Congress intended forspecific confidential chemical identitiesto be disclosed without providing theopportunity for manufacturers andprocessors to make a request that theidentities should remain confidentialsimply because the original claimantsdid not file under TSCA section8(b](4](B](ii].

Pursuant to TSCA section8(b](4](B](iv], EPA will move an activesubstance from the confidential portionof the Inventory to the non-confidentialportion if no manufacturer or processorsubmitting an NOA under TSCA section8(b](4)(A] requests to maintain theexisting CBI claim for the specificchemical identity of that chemicalsubstance. See 40 CFR 710.37(a). As acourtesy, EPA practice is to notifyoriginal claimants and/or the publicwhen it has moved substances from theconfidential portion of the Inventory tothe public portion of the Inventory, e.g.,through direct contact with the originalclaimant or publication of a FederalRegister notice. A chemical substancefor which EPA has received a request tomaintain an existing CBI claim forspecific chemical identity will remainon the confidential portion of theInventory pending EPA’s review of theclaim pursuant to a review plan to bepromulgated at a later date inaccordance with TSCA section8(b](4](C]—(D].

While this rule requires submitters toindicate whether they seek to maintainan existing CR1 claim for specificchemical identity, this rule does notinclude mandatory substantiationrequirements for CBI requests forspecific chemical identity on an NOAForm A. TSCA section 8(b)(4)(B)(iii)stipulates that EPA shall “require thesubstantiation of those claims pursuantto section 14 and in accordance with thereview plan described in subparagraphC.” EPA will be conducting a separaterulemaking to establish this reviewplan. The review plan will includemandatory requirements forsubstantiating a CR1 request for specificchemical identity reported in an NOAForm A and specify when suchsubstantiation is to be provided. If EPAreceives an NOA Form A in which thesubmitter requests to maintain anexisting CBI claim for specific chemicalidentity but chooses not to substantiatesuch at the time of filing, EPA willcontinue to list the chemical substanceon the confidential portion of theInventory pending the submission ofany substantiation required under thereview plan and EPA’s review of theclaim pursuant to the review plan.

However, in this rule the Agency isallowing companies to submitsubstantiation for the CBI claims forspecific chemical identity at the sametime that the NOA Form A is filed, ifthey so choose. As long as the periodbetween the date these earliersubstantiations are received and the duedate to be established in the review plan(yet to be proposed) is not more thanfive years, these substantiations willexempt the company from therequirement to submit additionalsubstantiation under the terms of thereview plan. See TSCA section8(b](4)(D). EPA will review requests tomaintain CBI claims for specificchemical identity in accordance withthe TSCA section 8(b)(4)(D) review planin the timeframe mandated by TSCAsection 8(b)(4)(E].

With respect to requests to maintainexisting CR1 claims that are submittedon an NOA Form B, TSCA section8(b](5)(B) stipulates that such requestsmust be substantiated not later than 30days after submitting Form B. See TSCAsection 8(b)(5)(B)(ii](II). Substantiationrequirements for NOA Form B CR1claims for specific chemical identity arefound in 40 CFR 710.37(a)(2).

The Agency will allow companies tosubmit substantiation at the same timethat their NOA Form B is filed, if theyso choose. Persons submitting an NOAForm B may find it more efficient toprovide the substantiation for a CBIclaim for specific chemical identity atthe time of filing.

III. Sununary of Response to CommentsIncluding Changes and ClarificationsFrom the Proposed Rule

This unit summarizes EPA’sresponses to comments for severalgeneral areas from multiplestakeholders. EPA also discusses anychanges to and clarifications from theproposed rule, and where responses areparticularly relevant to the requirementsof the final rule. A separate documentthat summarizes the comments relevantto the proposal and EPA’s responses tothose comments has been prepared andis available in the docket for thisrulemaking (Ref. 7].

Comment 1: Several commentersindicated that EPA should clarify theactivities for which notification is notrequired under the rule, and shouldconfirm that all substances andactivities that are exempt frompremanufacture notificationrequirements are also exempt fromreporting requirements under this rule.The commenters make reference to thefollowing PMN exemptions: export-onlyexemption, low volume exemption, lowreleases/low exposures exemption, test


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marketing exemption, and polymerexemption. One commenter elaboratedthat substances exempted from listingon the TSCA Inventory and othersubstances exempt from premanufacturenotification are exempt from this rulebut are ambiguously stated as such. Twocommenters elaborated that substanceslisted on the Inventory butmanufactured under a low volumeexemption should be exempt fromreporting under this rule by a personmanufacturing the substance under theexemption. One commenterrecommended that all categories ofsubstances for which no reporting isrequired pursuant to the CDR ruleshould be exempt from reporting underthis rule.

Several commenters indicated thatEPA should clarify or confirm thatpolymers are exempt from reportingunder this action. One commenterrequested that EPA clarify whetherpolymers manufactured under the pre1995 polymer exemption rule need to bereported, as technically such polymersare listed on the Inventory. A fewcommenters stated that polymers listedon the Inventory, including polymerswith a “Y” designation, should beincluded on the interim list of activesubstances. One commenter elaboratedthat polymers on the Inventory are notsubject to CDR, that many were placedon the Inventory before EPApromulgated the TSCA section 5polymer exemption rule and wouldlikely meet the current standard for thepolymer exemption, and that such lowrisk polymers should be on the interimactive Inventory.

One commenter expressed concernthat, without an explicit reportingexemption in the rule, a companymanufacturing a chemical substanceunder a polymer, low volume, or testmarketing exemption couldinadvertently violate the reportingrequirements if (without the company’sknowledge] another companymanufacturing the same substanceadded that substance to the confidentialportion of the Inventory, then ceasedmanufacturing, causing the substance tobe designated inactive. Anothercommenter expressed concern that, inthe absence of an explicit reportingexemption in the rule for all companiesmanufacturing chemical substancesunder a PMN exemption, the rule wouldappear to require such companies tosubmit an inquiry to EPA to ascertainwhether the chemical substances inquestion had been added to theconfidential portion of the Inventory byanother manufacturer.

Response: In response to the commentto clarify the reporting status under this

rule of a substance manufactured undera TSCA section 5 exemption and notlisted on the Inventory, EPA confirmsthat such substance is not subject toreporting under this action. The scopeof chemical substances covered underthis rule excludes substances that arenot listed on the Inventory. Seedefinition of “reportable chemicalsubstance” at 40 CFR 710.23. Asubstance that has not been added to theInventory because it is manufacturedsolely under a PMN exemption is not a“reportable chemical substance” and,therefore, cannot become an “activesubstance” or an “inactive substance.”

EPA recognizes that in certain cases,chemical substances manufactured by acompany under a PMN exemption maynevertheless be added to the Inventoryvoluntarily, or may subsequently beadded to the Inventory by anothercompany. Accordingly, in the proposedrule, EPA listed reporting exemptionsfor the following activities, which EPAconstrued as exempt commercialpurposes: The manufacture orprocessing of a substance as describedin 720.30(g) or (h], the manufacture orprocessing of a substance solely in smallquantities for research anddevelopment, and the import of asubstance as part of an article. EPAfinalized the rule to include theseexemptions and, based on comments,revised the rule to include additionalexemptions: the manufacture orprocessing of a substance solely for testmarketing purposes, and themanufacture or processing of asubstance solely for export from theUnited States, except where theAdministrator has made a findingdescribed in TSCA section 12(a)(2). See40 CFR 710.2 7(a)(4) and (5). EPAbelieves that these two additionalactivities also qualify as exemptcommercial purposes based on thelimited nature of these commercialactivities and the exemptions from PMNreporting under TSCA sections 5(h)(1)and 12(a)(1) for substancesmanufactured solely for these purposes.While TSCA section 12(a)(1) authorizesEPA to include substancesmanufactured or processed solely forexport in TSCA section 8 reporting, EPAconstrues manufacturing or processingsolely for export to be an exemptcommercial purpose, given that section12(a)(1) broadly exempts such activitiesfrom other TSCA provisions, includingPMN requirements under section 5.

EPA declined to add additionalreporting exemptions in the final rulefor activities that are exempt from PMNreporting based on rules promulgatedunder TSCA section 5(h)(4] (i.e., lowvolume, low releases/low exposures,

and polymer exemptions]. EPAdisagrees with comments that asubstance manufactured under a TSCAsection 5(h)(4) exemption butnevertheless listed on the Inventoryshould be exempt from reporting underthis rule. EPA does not believe thatmanufacturing or processing under alow volume, low releases/lowexposures, or polymer exemption (1984or 1995 polymer exemption) qualify asexempt commercial purposes underTSCA section 8(b), despite theexemptions from reporting under TSCAsection 5(h)(4] for such substances. Thisis because exemptions promulgatedunder section 5(h)(4) are predicatedupon a risk determination, rather thanthe particular commercial purpose forwhich manufacturing is undertaken.Unlike the other activities that EPA hasexempted from reporting requirementsunder this rule (e.g., research anddevelopment, test marketing, export-only), the activities exempt from PMNreporting pursuant to rules promulgatedunder section 5(h](4] need not beundertaken for any specific and limitedcommercial purpose. Because thecommercial purpose for which asubstance is manufactured is notintegral to an exemption under section5(h](4), and in consideration of thestatutory objective of TSCA section8(b)(4)—(5) to enable EPA to determinewhich chemical substances on theInventory are active in U.S. commerce,EPA does not construe activitiesundertaken pursuant to a section 5(h](4)exemption to be exempt “commercialpurposes” within the meaning ofsection 8(b)(4)(A)(i) and 8(b)(5)(B)(i).EPA emphasizes, however, thatsubstances which (based on such PMNexemptions) have never been added tothe Inventory are excluded from anyreporting requirements under this rule.

EPA also disagrees with commentsthat this rule should provide reportingexemptions for polymers and othercategories of Inventory-listed substancesthat are exempt from CDR for reasonsunrelated to the specific commercialpurpose for which they aremanufactured or processed. A statutoryobjective supported by reporting underthis rule is to enable EPA to determinewhich chemical substances on theInventory are active in U.S. commerce.This statutory objective under TSCAsection 8(b) is distinct from the statutoryobjective for CDR under TSCA section8(a). Whereas polymers and certainother categories of substances listed onthe Inventory are exempt from reportingunder CDR, these substancesnevertheless require designation asactive or inactive under TSCA section



8(b), and are therefore subject toreporting under this rule if they were orare anticipated to be manufactured fornonexempt commercial purpose.Exempting polymers and othercategories of substances under thisTSCA section 8(b) rule for no otherreason than that they are exempt fromCDR under TSCA section 8(a) would notaccomplish the statutory objective ofdesignating substances on the Inventorymanufactured for non-exemptcommercial purposes as active orinactive. EPA does not believe Congressintended for an entire category ofsubstances (such as polymers), that werelisted on the Inventory as of June 22,2016, to be designated inactive despitethe fact that such substances weremanufactured or processed for wide-ranging commercial purposes during the10-year lookback period.

EPA furthermore disagrees withcomments that polymers should beincluded on the interim list of activesubstances. The interim list is definedby TSCA section 8(b)(6) to include onlysubstances reported under CDR duringthe reporting period that most closelypreceded the date of enactment of theTSCA amendments. Substances such aspolymers that are exempt from reportingunder CDR, therefore, are not eligible tobe included on the interim list.Moreover, unless these substances werethe subject of an NOC received duringthe lookback period, EPA has noequivalent notice that such substanceswere manufactured during the lookbackperiod, and therefore no justification fordesignating the substances as active inthis rule.

Finally, in response to commentsexpressing concern that a personmanufacturing under a PMN exemptionmay be unaware that another personsubsequently added the same substanceto the confidential portion of theInventory, EPA notes that it revised 40CFR 710.25(a) and (c) to clarify thatreporting is not required where it is not“known to or reasonably ascertainableby” a company that it manufactured achemical substance subject tocommercial activity designation duringthe lookback period, or that it intends tomanufacture or process an inactivesubstance on the confidential portion ofthe Inventory. EPA anticipates that thepresence of a substance on theconfidential portion of the Inventorymay be information that is not “knownto or reasonably ascertainable by” aperson who is operating under a PMNexemption and who did not submit theconfidentiality claim for the specificchemical identity of that substance.

Changes to Activities that ore Exemptfrom Reporting in the Final Rule: EPA

revised the rule to exempt additionalcommercial activities from reportingrequirements: The manufacture orprocessing of a substance solely for testmarketing purposes, and themanufacture or processing of asubstance solely for export from theUnited States, except where theAdministrator has made a findingdescribed in TSCA section 12(a)(2). See40 CFR 710.27(a)(4) and (5].

Comment 2: One commenter statedthat substances processed as part of anarticle should be exempt from reporting.One commenter indicated thatsubstances contained within importedarticles should be subject to reporting ifand when they are released from thearticle during use and perform aseparate end-use function.

Response: The proposed ruleincluded an exemption from reportingrequirements for persons importing achemical substance as part of an article.EPA agrees with commenter that theprocessing of a chemical substance aspart of an article should likewise beexempt from reporting under this ruleon the grounds that it is processing foran exempt commercial purpose,following the logic of the exemption formanufacture of a chemical as part of anarticle through import. Under TSCA, theimport of a chemical substance as partof an article does not require newchemical reporting. Consequently, theInventory does not list all chemicalsubstances that are processed as part ofarticles since it does not include theprocessing of chemical substances aspart of imported articles. Moregenerally, the processing of a chemicalas part of an article is not a basis to adda chemical substance to the Inventory.EPA believes it would be incongruous toidentify a chemical substance as activesolely based on the fact that it isprocessed as part of an article, whenthat would not be a basis to add thechemical substance to the Inventory inthe first place if there were nomanufacture reportable under TSCAsection 5. In addition, EPA is concernedthat an approach under which chemicalsubstances are listed as active simplybecause they are components of articlesthat are processed in some fashioncould undermine the purpose ofmeaningfully distinguishing active frominactive chemicals. It should be notedthat the extraction of a chemicalsubstance from an article would not beconsidered processing a chemicalsubstance as part of an article and sowould not be exempt from reportingunder this provision. EPA thereforerevised 40 CFR 710.27(a)(2] to exemptpersons processing a chemicalsubstance as part of an article from

reporting requirements for thatsubstance.

Regarding the comment thatsubstances contained within importedarticles should be subject to reporting ifand when they are released from thearticle during use and perform aseparate end-use function, no regulatorychange is necessary. The final rule at 40CFR 710.27(a)(2) refers to “[tihe importor processing of a chemical substance aspart of an article.” EPA’s longstandinginterpretation of this phrase is that achemical substance is only consideredto be imported “as part of an article” ifthe substance is not intended to beremoved from that article and it has noend use or commercial purpose separatefrom the article of which it is a part. See42 FR 64583 (1977). Thus, for the kindsof articles from which a containedchemical substance would be releasedduring use and perform a separate end-use function, the chemical substancewould not be considered to be part ofthe article and would not qualify forexemption on that basis. In any event,as stated previously, even in the casewhere a chemical substance is part of anarticle, the extraction of a chemicalsubstance from an article would not beconsidered processing a chemicalsubstance “as part of an article” and sowould not be exempt from reporting onthis basis. See also TSCA Chemical DataReporting Fact Sheet: Imported Articles,available at https://www.epa.gov/sites/production/files/201 5-12/documents/cdrjact sheet imported articles-final dec2Ol5.pdf (Ref. 8)

Changes to Activities that are Exemptfrom Reporting in the Final Rule: EPAamended the rule to reflect that bothimporting and processing a chemicalsubstance as part of an article areexempt from reporting requirementsunder this rule. See 40 CFR 710.27(a)(2).

Comment 3: Numerous commentersstated that CBI substances reported tothe 2016 or 2012 CDR should be madeactive on the interim Inventory andshould not be subject to retrospectivereporting. Several commenters alsostated that CBI substances reported tothe 2016 CDR should also not be subjectto further substantiation of CBI claimsbecause the claims have already beensubstantiated.

Response: EPA agrees in part with thecomments involving CBI substances.EPA confirms that it had proposed thatboth CR1 and non-CBI substancesreported to the 2012 or 2016 CDR wouldbe made active on the interim list. EPAfinalized this aspect of the rule.Furthermore, EPA revised the rule toreflect that both CBI and non-CBIsubstances reported to the 2012 or 2016CDR will be eligible for exemption from



retrospective notification requirementsunder this rule. See 40 CFR 710.23 and710.25.

However, a company that seeks tomaintain an existing CBI claim forspecific chemical identity cannot availitself of this exemption, and mustsubmit an NOA Form A that includessuch request, because TSCA section8(b)(4)(B)(ii) requires a specific requestto maintain the CBI claim. Pursuant toTSCA section 8(b](4](B)(iv), EPA mustmove to the non-confidential portion ofthe Inventory any active substance forwhich no request is received tomaintain an existing CR1 claim forspecific chemical identity. EPArecognizes in the final rule that theremay be circumstances where acompany, which had previously soughta CBI claim for a specific chemicalidentity, may no longer view the CBIstatus as necessary or currentlydefendable. In such circumstance, thecompany may take advantage of anyretrospective reporting exemption forwhich it is eligible, and decline tosubmit a retrospective notice to EPA.

Regarding substantiation, pursuant toTSCA section 8(bJ(4](D)(i), a previouslysubmitted substantiation may satisfy thesection 8(b)(4)(B](iii) substantiationrequirement if the prior substantiationwas submitted to EPA within five yearsof a deadline to be established in theforthcoming review plan described insection 8(b)(4)(C)—(D). EPA does notexpect that a 2012 CDR submission willsatisfy the five-year substantiationrequirement. Because the deadline forsubmitting substantiation in the reviewplan has not yet been set, EPA does notcurrently know whether substantiationsubmitted for a 2016 CDR submissionwill satisfy the TSCA section8(b)(4)(B)(iii) five-year substantiationrequirement. Note that a voluntarysubstantiation submitted with Form Amight also not fall within the five-yearperiod, depending upon the deadlinethat is set.

Changes to Chemical Substances ThatAre Exempt from RetrospectiveReporting in the Final Rule: EPAchanged the exemptions fromretrospective reporting requirements toreflect that both CBI and non-CBIchemical substances reported to the2012 or 2016 CDR will be eligible. See40 CFR 710.23 for revised definition of“interim active substance.” TSCAsection 8(b)(4)(B](ii) requires a notice tobe submitted only by thosemanufacturers or processors that seek tomaintain an existing CBI claim for thespecific chemical identity of areportable substance.

Comment 4: Several commentersstated that non-CBI substances added to

the Inventory during the ten-yearretrospective reporting period via anNOC should be exempt fromnotification.

Response: EPA agrees with thiscomment. An NOC is required to besubmitted to EPA on or no later than 30calendar days after the first day ofmanufacture of a new chemicalsubstance for commercial purpose andan NOC substance is considered to beadded to the Inventory on the date theNOC is received by EPA, provided thatthe EPA determines the NOC to be validduring its review. Requiringretrospective reporting of substances forwhich an NOC was received during thelookback period would be duplicativebecause EPA already has an equivalentreport (the NOC itself] indicating thatthe substance was manufactured orprocessed during the lookback period.EPA furthermore concludes (consistentwith its response to comments about theavailability of the interim list exemptionfor CBI substances] that the analogousreasoning applies with respect to CBIsubstances added to the Inventoryduring the lookback period. EPA revisedthe rule to reflect that both CR1 and nonCBI substances reported in an NOCduring the lookback period will beeligible for exemption fromretrospective notification requirementsunder this rule. EPA was able tocompile this list of substances anddesignate them as active substances bythe deadline for publication of the rule.EPA’s June 2017 posting of theInventory will include these NOCsubstances designated as active (seehttps://www.epa.gov/tsca-inventory).See 40 CFR 710.23 for reviseddefinitions of “active substance” and“chemical substance subject tocommercial activity designation.”

However, a company that seeks tomaintain an existing CR1 claim forspecific chemical identity cannot availitself of this exemption because TSCAsection 8(b](4)(B](ii] requires a specificrequest to maintain the CR1 claim. Seeresponse to Comment 3 for additionaldiscussion on CR1 substances.

Additionally, substantiation of a CBIclaim for chemical identity submittedwith an NOC may or may not satisfy theTSCA section 8(b](4](B)(iii]substantiation requirement. Pursuant toTSCA section 8(b)(4)(D)(i), a previouslysubmitted substantiation may satisfy thesection 8(b)(4)(B)(iii] substantiationrequirement if the prior substantiationwas submitted to EPA within 5 years ofthe deadline to be established in theforthcoming review plan described insection 8(b](4](C]—(D]. NOCs submittedmore recently may satisfy the 5-yearsubstantiation requirement, while NOCs

submitted earlier in the 10-yearlookback period for retrospectivereporting may not satisfy the 5-yearsubstantiation requirement. Note that avoluntary substantiation submitted withan NOA Form A might also not satisfythe 5-year substantiation requirement,depending upon the deadline that is setin the review plan.

Changes to Chemical Substances ThatAre Exempt from RetrospectiveReporting in the Final Rule: EPA addedan exemption from retrospectivereporting requirements for chemicalsubstances added to the Inventory viaan NOC during the ten-yearretrospective reporting period. See 40CFR 710.23 for revised definitions of“active substance” and “chemicalsubstance subject to commercial activitydesignation.”

Comment 5: Several commentersstated that EPA should update theinterim list and/or publish submissionsfrequently or in real time in order forpotential submitters to see what is beingsubmitted and to avoid or reduceduplicative submissions duringretrospective reporting.

Response: EPA has determined thatpublishing submissions frequently or inreal time is not feasible. In order topublish notices frequently or in realtime, EPA would need to develop, test,and implement an electronic platformthat would be able transfer non-CBInotices from the Agency’s confidentialrepository to a public system. EPA hasnot to date developed nor implementedsuch an electronic platform for TSCApurposes and does not believe that itcould do so by the time it would beneeded to support this action in amanner suggested by these comments.Additionally, because non-CBI noticessuitable for publication would includethose submitted with no CBI claims andthose submitted with claims but forwhich CBI would be redacted, EPAwould need to ensure that such anelectronic platform would appropriatelytransfer only non-CBI notices to a publicsystem. Furthermore, in order forpublished information to be accurateand reliable, EPA believes that noticeswould necessarily need to be fullyprocessed and reviewed, which wouldnot allow the Agency to publish noticesin real time or even frequently,especially since the number of noticessubmitted may increase, possiblysharply, as the submission deadlineapproaches.

Comment 6: Several commentersdisagreed with the proposal that eachmanufacturer must report everynonexempt chemical manufacturedduring the retrospective lookbackperiod. Commenters stated that, for



purposes of designating substances asactive, EPA need only receive onenotice for each reportable substance.Commenters elaborated that EPA shouldallow a “one-and-done” approach forretrospective reporting, i.e., once anotice is received by EPA for aparticular substance, and either thenotice is published and/or the interimlist is updated and published, othermanufacturers need not report the samesubstance. One commenter stated thatEPA appropriately proposed to requirethat each company that hasmanufactured a chemical substance onthe Inventory during the lookbackperiod must notify EPA of suchmanufacture. The commenter elaboratedthat “one-and-done” reporting is legallyimpermissible.

Response: EPA disagrees with thestatement of one commenter that a “one-and-done” reporting exemption isimpermissible under TSCA section8(b)(4)(A)(i]. Section 8(b](4](A](i] statesthat the Administrator “shall requiremanufacturers . . . to notify theAdministrator” of each chemicalsubstance that the manufacturer hasmanufactured during the 10-yearlookback period. The statute does notstate that the Administrator shallrequire all manufacturers to submit sucha notice. Had Congress intended topreclude the Administrator fromimplementing a “one-and-done”reporting process, Congress could havedone so by specifying that theAdministrator shall require allmanufacturers to submit a notice foreach chemical manufactured during thelookback period. Furthermore, EPAbelieves the commenter incorrectlydiscounts the significance of language inTSCA section 8(b)(4)(A](i) admonishingEPA to issue the rule “subject to thelimitations under subsection (a)(5)(A).”TSCA section 8(a](5)(A] provides that“the Administrator shall, to the extentfeasible . . . not require reportingwhich is unnecessary or duplicative.”EPA does not agree with thecommenter’s assertion that subsection(a)(5)(A) is solely concerned with themanner of reporting, such that the scopeof reporting would be unaffected. It isdifficult to see how one could make anotification requirement lessunnecessary or less duplicative exceptby tailoring the scope of persons whoare required to submit the notification.

EPA agrees in part with the othercommenters that a “one-and-done”approach should be allowed forretrospective reporting. Accordingly,EPA has revised the rule to exempt amanufacturer from the retrospectivenotification requirements for aparticular chemical substance, if the

manufacturer has evidence in the formof a CDX receipt, documenting EPA’sreceipt of an NOA Form A from anothermanufacturer. As discussed further inComment 5 in this Unit, it is infeasiblefor EPA to supply “real-time” reports tothe public during the manufacturers’submission period for retrospectivereporting by listing the particularsubstances for which it has alreadyreceived an NOA Form A. However,manufacturers who possess an NOAForm A CDX receipt for a substance(e.g., obtained through a consortiumarrangement), documenting that anNOA Form A has already been receivedby EPA, may avail themselves of thisexemption for that substance.Manufacturers should keep in mind,however, that they bear the risk offailing to submit a required forward-looking notification (NOA Form B)notice if they rely on this Form Aexemption, and the Form A notice (forwhich they have a CDX receipt) is laterwithdrawn, leading to the substancebeing designated as inactive.Furthermore, one manufacturer’sexpectation that another manufacturerwill later submit an NOA Form A is notan acceptable basis for relying on thisexemption. If such an approach wereallowed as a basis for exemption, thenEPA would risk receiving nonotification at all for an activesubstance, based on each manufacturerexpecting that some other manufacturerwould later submit an NOA Form A.Since it is only submitters who will benotified of errors, manufacturers relyingon the exemption are responsible forassuring their substance is properlydesignated as commercially active.

However, a company that seeks tomaintain an existing CBI claim forspecific chemical identity cannot availitself of this exemption because TSCAsection 8(b)(4)(B)(ii) requires a specificrequest to maintain the CBI claim. Seeresponse to Comment 3 for additionaldiscussion on CBI substances.

Changes to Chemical Substances ThatAre Exempt from RetrospectiveReporting in the final Rule: EPA addedan exemption from retrospectivereporting requirements in the rule formanufacturers that have evidence in theform of a copy of a CDX receiptdocumenting EPA’s receipt of an NOAForm A from another person for thesame chemical substance. See 40 CFR710.25(a). However, as noted in Unit IIand in 40 CFR 710.25(a), anymanufacturer relying on anotherperson’s notice remains responsible forconfirming that their substance becomesdesignated as active.

Comment 7: Several commentersrequested that processors be allowed to

report for an additional 180 days thatbegins when the draft Inventory ispublished and not when the 180-daysubmission period for manufacturerscloses. One commenter questionedwhether EPA had legal authority toextend the submission period forprocessors beyond 180 days, butaccepted EPA’s rationale for providingprocessors with additional reportingtime after EPA’s publication of the draftInventory, provided that the extra timefor processor reporting remains a short(i.e., no more than 180 days) and fixedperiod, as proposed.

Response: With respect to EPA’s legalauthority to establish a voluntaryretrospective submission period forprocessors beyond 180 days, EPAbelieves this is implicit in its authorityto establish a mandatory reportingperiod for manufacturers during the first180 days. EPA notes that TSCA does notrequire that the rule impose anyretrospective reporting requirements atall on processors. Nor does TSCAsection 8(b)(4) establish a deadline forthe publication of the Inventorydesignating active and inactivesubstances. Furthermore, allowingprocessors additional time to report isconsistent with the manner in which theoriginal Inventory was assembled, itadvances the statutory objective ofefficiently dividing active substancesfrom inactive substances, and itadvances the statutory objective underTSCA section 8(a)(5) of avoiding (to theextent feasible) unnecessary reporting.Processors may be able to identifycertain active substances thatmanufacturers would not, but requiringthem to report during the same timeperiod as manufacturers might leadthem to duplicate the reports ofmanufacturers.

EPA originally proposed thatprocessors may report not later than 360days after the final rule is published inthe Federal Register. EPA’s rationalewas that the additional 180-daysubmission period for processors,beyond the 180-day submission periodfor manufacturers, would allowprocessors to search EPA’s publicationof the draft Inventory with activedesignations, based on the retrospectivereporting by manufacturers, and toreport only those substances not alreadyreported. EPA agrees with commentsthat the purpose of affording theadditional 180 days for processors isbest served if that 180-day submissionperiod begins on the date on whichprocessors would actually be able toreview the draft Inventory. EPA alsoagrees with the comment that the ruleshould specify a fixed date on which theprocessor submission period will end,


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as originally proposed, but which wouldnot be the case if the 180-daysubmission period were to begin on theunknown date of the publication of thedraft Inventory. EPA intends to publishthe draft Inventory with activedesignations as soon as is practicablefollowing the close of the 180-daysubmission period for manufacturers,which is anticipated to beapproximately 60 days after the 180-daysubmission period for manufacturersends. Based on this anticipatedtimeframe for publishing the draftInventory and in consideration of thesecomments, EPA is finalizing the rule toallow processors to report not later than420 days after the publication of the rulein the Federal Register. See 40 CFR710.30(a)(2). This revised submissionperiod for processors provides a fixeddate on which the processor submissionperiod will end and is anticipated toprovide an approximate 180-day periodfor processor reporting from the date bywhich EPA expects to publish the draftInventory.

Changes to Processor SubmissionPeriod for Retrospective Reporting: EPAchanged the retrospective reportingsubmission period for processors to endnot more than 420 days after thepublication of the rule in the FederalRegister. See 40 CFR 710.30(a)(2).

Comment 8: Two commenters statedthat an estimated date of recommercialization should be able to beprovided rather than an actual date.Two commenters stated that there is noneed to limit the submission period forforward-looking reporting (NOA FormB) to not more than 30 days prior tomanufacturing or processing, asproposed by EPA, citing that the statuteonly requires notification to take place“before” commercialization resumes.One commenter suggests that persons bepermitted to submit an NOA Farm B upto 90 days before re-commercializationinstead of 30 days. Another commentersuggested that the Agency require anNOA Form B to be submitted not lessthan 90 days prior to manufacturing orprocessing to allow sufficient time forthe Agency to evaluate the chemical anddetermine whether a Significant NewUse Rule (SNUR) is needed. Anothercommenter was supportive of theproposed 30-day requirement.

Response: EPA agrees that the datethat must be provided on an NOA FormB should be the anticipated date ofreintroduction of a chemical substancein U.S. commerce, rather than the actualdate. EPA recognizes that any reportingrequired in advance of actualcommercialization is based oninformation and schedules that aresubject to change, and providing an

actual date of commercialization inadvance, therefore, is not alwayspractical. EPA believes that providingan anticipated date ofcommercialization should lessenconcerns expressed by commenters. See40 CFR 710.29(c)(2).

EPA has also decided to modify thedate requirement from originallyproposed, extending it to allow noticeup to 90 days ahead of time, in additionto basing the date requirement on theanticipated date of manufacturing orprocessing rather than the actual date ofmanufacturing or processing. EPAdecided to retain some limitation on thesubmission period because EPA’sexperience with other reporting underTSCA (e.g., PMNs) is that the earlier anotice is submitted, the higher thelikelihood is that the schedule forcommercialization will change or that achemical substance might not becommercialized at all. EPA believes thatretaining a limitation on the submissionperiod for future reporting will reducethe number of notices submitted forsubstances whose schedule forcommercial re-introduction changesappreciably. EPA also believes thatextending the submission period tobegin from 90 days, rather than 30 days,prior to resuming manufacturing orprocessing will afford manufacturersand processers additional time to adjustto information and schedule changesand will not significantly impact theaccuracy of notices submitted. See 40CFR 710.30(b)(1).

Regarding changing the deadline forsubmission of an NOA Form B to be atleast 90 days prior to resumingmanufacturing or processing for thepurposes of Agency action (e.g., SNUR),EPA disagrees with the commenter’sinterpretation that by requiring advancenotification, Congress wanted to provideEPA an opportunity to take action todelay the resumption of manufacturingor processing if it had concerns aboutthe subject chemical. To the contrary,the statute clearly reflects that theobligation to submit a section 8(b)(5)(B)notification was not intended as a toolto impede the resumption ofmanufacturing or processing.Specifically, the statute does notauthorize EPA to structure the rule insuch a manner that if a manufacturer orprocessor submits an NOA Form B, themanufacturer or processor could beobliged to wait longer than the next dayto commence manufacturing andprocessing the chemical substance. SeeTSCA section 8(b)(5)(B)(i). EPA believesthe most plausible explanations for whyCongress imposed the advancenotification requirement were: (1) Toensure that EPA actually receives the

notices (by making the lawfulresumption of manufacturing orprocessing contingent on thenotification) and; (2) to support EPA’ssubsequent prioritization efforts underTSCA section 6(b). See TSCA section8(b)(5)(B)(iii) (IV)

Changes to the Date Requirement forForward-looking Reporting: EPAchanged the limitation on submitting anNOA Form B to be not more than 90days prior to the anticipated date ofmanufacturing or processing. See 40CFR 710.29(c)(2) and 40 CFR710. 30 (b) (1)

Comment 9: A few commenters askedEPA to clarify in the rule how it wouldimplement the requirements of TSCAsection 8(b)(7). For example,commenters requested that EPA confirmin the final rule when the draft and finallists of active and inactive substanceswill be published. One commenterindicated that EPA should identify allsubstances on the Inventory as active orinactive not later than 15 months afterpromulgation of this final rule. Anothercommenter indicated that EPA shouldpublish an updated version of theInventory, with all substancesdesignated as active or inactive, notlater than six months after thecompletion of the retrospectivenotification process. Commenters alsostated that EPA should specify in therule the date when substances will bedesignated as inactive. One commenterstated that EPA should publish aFederal Register notice every 90 dayslisting all substances that EPA hasdesignated as active following receipt ofan NOA Form B.

Response: TSCA section 8(b)(7)requires EPA to make active andinactive designations available to thepublic, but it gives EPA discretion as tothe manner and timing of doing so. EPAintends to publish a draft Inventory assoon as practicable after the close of the180-day submission period formanufacturers, which will include onlyactive designations (based on interimlist designations, NOCs, andmanufacturer reporting); chemicals thathave no designation on this draftInventory should not be assumed to beinactive. EPA intends to publish thefirst Inventory identifying both activeand inactive substances as soon aspracticable after the close of theretrospective submission period forprocessors, in a web posting of theInventory on EPA’s Inventory Web page(see https://www.epa.gov/tscainventory). Given that the statute doesnot mandate a specific deadline for thepublication of the first Inventoryidentifying both active and inactivesubstances, and given the challenges of



foreseeing precisely how much timewill be necessary to review and compilethe data it will receive fromretrospective reporting, EPA has chosennot to impose a regulatory deadline onthe publication of this first Inventory.

The obligation to submit an NOAForm B under TSCA section 8(b)(5)(B)(i)does not arise until a chemicalsubstance has been “designated as aninactive substance.” EPA is establishingan effective date provision for thedesignation of a substance as an inactivesubstance. EPA revised the rule so thatan “inactive substance” designationbecomes effective 90 days after the datethat EPA identifies the substance forinactive designation. See 40 CFR 710.23for revised definition of “inactivesubstance.” EPA will identifysubstances for inactive designation in asigned action accompanying the firstversion of the Inventory with all active-inactive listings following the close ofthe retrospective submission period forprocessors. EPA intends to publish thissigned action together with theInventory in a web posting on EPA’sInventory Web page (see https://www. epa.gov/tsca-inventory).

With respect to Inventory updatesbased on forward-looking reporting, thestatute does not specifically require thatEPA inform the public of thereintroduction of chemical substancesby issuing Federal Register noticesevery 90 days, indicating what

substances (if any) have beenreactivated. EPA intends to includesubstances submitted in forward-looking notices and re-designated asactive on the Inventory in its regularpublications of the Inventory, whichoccur approximately every six months.

Changes to the Final Rule to Establishthe Date When. a Chemical SubstanceWill Be Designated as Inactive: EPArevised the rule so that an inactivesubstance designation is not effectiveuntil 90 days after the date that EPAidentifies a substance for inactivedesignation. See 40 CFR 710.23 forrevised definition of “inactivesubstance.”

Comment 10: A few commentersexpressed concerns about the status ofsubstances manufactured or processedin the period between June 22, 2016 andthe date the first Inventory with activeand inactive designations is finalizedand published. These commentersrequested that EPA clarify the status ofsuch substances.

Response: EPA clarified the status ofthese chemical substances in Unit II andthe final rule. The structure of thereporting requirements under TSCAsections 8(b)(4)(A) and 8(b)(5)(B) resultsin a transitional period beginning on

June 22, 2016 (the day after the lookbackperiod for retrospective reporting ends)and ending on the date the forward-looking reporting period begins (i.e., theeffective date that chemical substancesare designated as inactive, which is 90days after EPA publishes the firstInventory with listings identified asactive or inactive). A person who didnot manufacture or process a particularchemical substance during the lookbackperiod (June 21, 2006 through June 21,2016) is not subject to the retrospectivereporting provisions of this rule withrespect to that substance, and shouldnot submit an NOA Form A for thatsubstance regardless of whether theperson manufactured or processed thesubstance on or after June 22, 2016. Ifthat substance is ultimately designatedby EPA as inactive, however, any personwho intends to manufacture or processthat substance after it is designated asinactive must submit an NOA Form B.

To address concerns about substancesreintroduced into U.S. commerce duringthe transitional period and potentialinterruptions in commercial activitythat could arise upon EPA’s designationof such substances as inactive, EPArevised the rule to reflect that aninactive designation only becomeseffective 90 days after EPA identifies thesubstance for such designation. EPA isclarifying that the obligation to submitan NOA Form B does not begin until theeffective date of an inactive substancedesignation. Because EPA revised therule so that an inactive substancedesignation is not effective until 90 daysafter the date that EPA identifies asubstance for inactive designation,manufacturers and processors areafforded time to react to an inactivesubstance identification. Persons whoare already manufacturing or processinga substance for nonexempt commercialpurpose (e.g., during the transitionalperiod), and wish to continue doing sowithout interruption after EPA’sdesignation of such substance asinactive, are permitted to submit anNOA Form B for such substance prior tothe effective date of the inactivedesignation, which is the date that thesubstance attains the legal status ofbeing inactive. Similarly, persons thatanticipate reintroducing a substanceinto U.S. commerce for nonexemptcommercial purpose shortly after EPAidentifies the substance for inactivedesignation are also afforded time toreact to the inactive substanceidentification and are permitted to filean NOA Form B prior to the effectivedate of the substance’s inactivedesignation, as long as such form is filedno more than 90 days before the

anticipated date of manufacture orprocessing. Manufacturers should beaware that the timely filing of an NOAForm B does not remedy an earlierfailure to comply with the retrospectivereporting requirement; it merely ensuresthat the manufacturer will not also be inviolation of the forward-lookingreporting requirement.

Changes to the Final Rule to Clarifythe Status of Chemical SubstancesManufactured or Processed in betweenthe Retrospective and Forward-LookingReporting Periods: EPA revised the ruleto clarify that manufacturers andprocessors are permitted to submit anNOA Form B for a chemical substancethat EPA has identified for inactivedesignation, even though the effectivedate of such designation has not yetarrived, and thus the substance does notyet have the legal status of beinginactive. See 40 CFR 710.30(b)(2).

Comment 11: Numerous commentersstated that certain data requirementsshould be eliminated or reduced. Twocommenters stated that EPA shouldreduce the proposed requirement for adate range from retrospectivenotification by not requiring exact datesfor the date range for retrospectivenotification, and instead suggested thatthe first and last dates of the range bereported by month and year. Numerouscommenters stated that EPA shouldeliminate the proposed requirement fora date range from retrospectivenotification, indicating that suchinformation would be burdensome toretrieve and evaluate and, in certaincases, may not be available due torecord retention policies. Commentersfurther indicated that such informationis not required to meet the statutoryobjective and that the certificationstatement should be sufficient tosupport data accuracy. Similarly,several commenters also stated that EPAshould eliminate the proposedrequirement for type of commercialactivity from retrospective notification;one commenter indicated that theproposed requirement should also beeliminated from forward-lookingnotification. A few commenterssuggested reducing the proposedrequirement for type of commercialactivity from retrospective notificationby combining “Domesticallymanufactured” and “Imported” into onecategory for reporting. One commenterwas supportive of requiring type ofcommercial activity.

Response: EPA has decided not torequire date range and activity type forretrospective notification. EPA hadproposed such information to serve theobjective of verifying and validatingnotices submitted. However, in response


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to comments received, EPA has beenpersuaded that the collection of a daterange of manufacture, as well as thecollection of information to differentiatebetween domestic manufacture, import,and processing, is unnecessary to servethe underlying objective of reliablydifferentiating active and inactivesubstances. EPA is also mindful thatTSCA section 8(b)(4)(A)(i) speciallyadmonishes the Agency to avoid, to theextent feasible, the collection ofunnecessary information in this rule. Asan alternative to requiring date andinformation, EPA has revised the NOAForm A certification statement torequire an affirmation thatmanufacturing or processing of thechemical substance occurred during thelookback period. If EPA needs to verifythe basis for such a certification, it canobtain and evaluate the documentationthat submitters are required to maintainunder 40 CFR 710.35.

EPA has similarly removed theactivity type requirement for forward-looking notification. This is consistentwith the evidence of Congressionalintent motivating the notificationrequirement. See S. Rep. 114—6 7 at 20(purpose is to categorize the chemicalsubstances on the Inventory as “activeor inactive,” and “[m]anufacturers of aninactive substance may return thesubstance to the active inventory with asimple notification to EPA”). Inresponse to comments received, EPAhas been persuaded that information onactivity type is not necessary toaccomplish the purpose of the ruleregarding differentiating inactivesubstances from active substances. EPAhas also revised the NOA Form Bcertification statement to require anaffirmation that persons submitting anNOA Form B have forward-lookingintent to manufacture or process fornonexempt commercial purpose. If EPAneeds to verify the basis for such acertification, it can obtain and evaluatethe documentation that submitters arerequired to maintain under 40 CFR710.35.

Changes to Required ReportingElements in the Final Rule: EPAremoved the date range and commercialactivity type requirements fromretrospective notification, and revisedthe certification statement on the NOAForm A to clarify that personssubmitting the form are certifying thatmanufacturing or processing of thechemical substance occurred during thelookback period. EPA also removed thecommercial activity type requirementfrom forward-looking notification, andrevised the certification statement onthe NOA Form B to clarify that personssubmitting the form are certifying that

they have forward-looking intent tomanufacture or process the substance.See 40 CFR 710.29(b) and 40 CFR710.29(c).

Comment 12: Numerous commentersstated that EPA should clarify themeaning of “known or reasonablyascertainable,” particularly in thecontext of scenarios involving mergersand acquisitions (e.g., corporatepredecessors and successors] thatoccurred during or after the ten-yearreporting period, and in such scenarios,who is responsible for reporting underthe rule. Some commenters furtherelaborated that if a company no longerhas a legal obligation to retain particularrecords, or if the records are no longerin the possession of the company (e.g.,they are not available due to companydocument retention policies or are inthe possession of an acquiringcompany), the information should beconsidered to be not “Known orReasonably Available/Ascertainable”and reporting should not be required.One commenter suggested amending 40CFR 710,25 to add a new paragraph (b)to address entities formed during thelookback period that may not havehistorical records in their possession orcontrol. Another commenter stated thatEPA’s proposal was still silent as to thelevel of diligence that must be used todetermine which substances must bereported under NOA Form A and FormB, and suggested that EPA assign a“readily obtainable” standard to thatlevel of diligence for the Form A’s.

Response: CFR 40 part 704 defines“Known to or reasonably ascertainableby” as all information in a person’spossession or control, plus allinformation that a reasonable personsimilarly situated might be expected topossess, control, or know. In response tocommenters’ request for clarification ofpossession or control as it relates tocorporate mergers and acquisitions, EPAhas added to 40 CFR 710.23 thedefinition of “Possession or Control”from 40 CFR 704.3. Consistent with itsuse in Part 704, “Possession or Control”is defined as meaning in the possessionor control of any person, or of anysubsidiary, partnership in which theperson is a general partner, parentcompany, or any company orpartnership which the parent companyowns or controls, if the subsidiary,parent company, or other company orpartnership is associated with theperson in the research, development,test marketing, or commercial marketingof the chemical substance in question.Information is in the possession orcontrol of a person if it is: (1] In theperson’s own files including filesmaintained by employees of the person

in the course of their employment, (2)in commercially available data bases towhich the person has purchased access,or (3] maintained in the files in thecourse of employment by other agents ofthe person who are associated withresearch, development, test marketing,or commercial marketing of thechemical substance in question.

EPA believes it is appropriate toconstrue what “a reasonable personsimilarly situated might be expected topossess, control, or know,” based on thetotality of pertinent factors. Prior loss ofrecords consistent with documentretention policies and the otherindividual factors cited by thecommenters could be pertinent inconstruing what information is knownor reasonably ascertainable, but they arenot replacements for the regulatorystandard. In any event, if a personactually knows information, then it isknown or reasonably ascertainable.

In the context of the CDR rule, EPAhas published extensive guidance on theapplication of the “known to.orreasonably ascertainable by” standardand how to address retrospectivereporting in the case of corporatesuccession. See, e.g., TSCA ChemicalData Reporting Fact Sheet: ReportingAfter Changes to Company Ownershipor Legal Identity, available at https://www.epa.gov/sites/production/files/201 5-05/documents/cdrJact sheetcompany changes.pdf (Ref. 9). See also2016 Chemical Data Reporting FrequentQuestions, available at https://www.epa.gov/sites/production/files/201 6-07/documents/cdrjqjinaljuly_112016.pdf (Ref. 10]. EPA finds thatguidance issued on these topics in thecontext of the CDR rule is alsoinstructive in the context of this rule.

EPA agrees with one commenter thatthe level of diligence that must be usedto determine which chemical substancesmust be reported using an NOA Form Ashould be clarified, but disagrees withthe suggestion that manufacturers neednot report their manufacture ofsubstances during the lookback period ifthe knowledge that they conducted theprior manufacture is reasonablyascertainable by them but not “readilyobtainable” by them. EPA revised 40CFR 710.25(a) to clarify that if it is not“known to or reasonably ascertainableby” a manufacturer that the personmanufactured a particular substanceduring the lookback period, then theperson is not obligated to report thatsubstance on an NOA Form A. EPAbelieves that the authority to limitretrospective reporting to informationthat is known or reasonablyascertainable at the time of the reportingobligation is implicit in the grant of



rulemaking authority under TSCAsection 8(b)(4), consistent with TSCAsection 8(a) and the overall statutoryobjectives of TSCA section 8(b), andconsistent with past practice forretrospective reporting on the CDR rule.The commenter set forth little basis foradopting a “readily obtainable”standard and EPA continues to believe(see proposal at 82 FR 4256] that it isappropriate to base this rule on basicreporting concepts that the public isalready familiar with from the CDR. Itwould be confusing to have onestandard governing the need to submitan NOA form A (“readily obtainable”)and another standard (“known to orreasonably ascertainable by”) governingthe information elements that need to bereported on the NOA Form A. Finally,EPA has already significantly addressedcommenters’ broader concern about thepotential burden of conducting aninformation search by eliminating therequirement to report the specific startand end dates of manufacture.

EPA also disagrees with onecommenter that 40 CFR 710.25 shouldbe amended to specifically addressentities formed during the lookbackperiod that do not have historicalrecords in their possession. The revisionto 40 CFR 710.23 to add the definitionof “Possession or Control,” and therevision to 40 CFR 710.25(a) to clarifyapplication of the “known to orreasonably ascertainable by” standard inthe context of retrospective reporting,apply to all persons subject to reportingunder 40 CFR 710.25(a). It is notnecessary to separately address aspecific type of entity, e.g., entitiesformed during the lookback period, in40 CFR 710.25.

With respect to the standard ofdiligence for determining whether achemical substance is subject toforward-looking reporting on an NOAForm B, EPA revised 40 CFR 710.25(c)to clarify that if it is not “known to orreasonably ascertainable by” a personthat the substance being manufacturedor processed is listed on the confidentialportion of the Inventory as an inactivesubstance, then the person is notobligated to report that substance on anNOA Form B. This may be the case, forinstance, if one person manufactures apolymer under a PMN exemption, butanother manufacturer subsequentlyadds the same polymer to theconfidential portion of the Inventoryand then ceases manufacturing beforethe lookhack period, resulting in theconfidential substance being designatedinactive. EPA anticipates that onlypersons operating under PMNexemptions will be able to availthemselves of this revision, since other

persons will have no basis tomanufacture an Inventory chemicalwithout knowing the Inventory identityof the chemical.

With respect to the information thatmust be reported on an NOA Form B,believes that the question of theinformation reporting standard and thestandard of diligence has become moot,with the elimination of all informationsubmission requirements other thanthose that EPA can reasonably expectthe submitter to know. By directoperation of the statute and consistentwith proposed procedural rules at 40CFR 710.25, any person who intends tomanufacture or process an inactivesubstance, except for a nonexemptcommercial purpose, must submit anNOA Form B alerting EPA to “designatethe applicable chemical substance as anactive substance.” TSCA section8(b)(5)(B). Thus, irrespective of anyrulemaking, TSCA itself requires theidentity of the substance to be placed onthe active Inventory to be specified. Theproposed requirement to report the typeof intended commercial activity hasbeen eliminated, along with the “actualdate” by which the inactive substance isto be manufactured or processed. If aperson does not know the date by whichit anticipates that the inactive substanceis to be manufactured or processed, thenfiling NOA Form B would beinconsistent with the timingrequirements of 40 CFR 710.30. Finally,EPA can reasonably expect thesubmitter to know its own identity.Accordingly, EPA has removed, asmoot, the proposed specification in 40CFR 71029(c) that a person required tosubmit information on an NOA Form Bmust report information to the extentthat such information is known orreasonably ascertainable by that person.

Changes to the Final Rule to Clarify“Known or Reasonably Ascertainable”and to Add a Definition for “Possessionor Control:” EPA added a definition for“Possession or Control” in the rule toclarify the existing definition of“Known to or reasonably ascertainableby.” See 40 CFR 710.23. EPA alsorevised 40 CFR 710:25(a) to clarify thatif it is not “known to or reasonablyascertainable by” a manufacturer thatthe person manufactured a particularchemical substance during the lookbackperiod, then the person is not obligatedto report that substance on an NOAForm A. EPA revised 40 CFR 710.2 5(c)to clarify that if it is not “known to orreasonably ascertainable by” a personthat the substance being manufacturedor processed is listed on the confidentialportion of the Inventory as an inactivesubstance, then the person is notobligated to report that substance on an

NOA Form B. EPA removed, as moot,the proposed specification in 40 CFR710.29(c) that a person required tosubmit information on an NOA Form Bmust report information to the extentthat such information is known to orreasonably ascertainable by that person.

Comment 13: Numerous commentersstated that EPA should provide areasonable opportunity or a formalprocess to amend or correctretrospective notices. Severalcommenters suggested a time frame forcorrections, e.g., up until the date thatthe first Inventory with active andinactive designations is published; formanufacturers, during the additional180-day submission period forprocessors; and for processors, 180 daysfrom the date that the first Inventory ispublished. Two commenters stated thatEPA should also allow forward-lookingnotices to be corrected or rescinded.Several commenters indicated thatcorrections should be non-punitive.

Response: EPA agrees in part withthese comments. The 180-dayretrospective submission period formanufacturers is the maximum timeprovided for by the statute. While EPAis not providing a formal correctionsprocess for retrospective reporting to theregulatory text, EPA will allowretrospective reporting noticessubmitted by manufacturers during the180-day submission period formanufacturers to be withdrawn not laterthan 420 days after the publication ofthe final rule in the Federal Register.EPA will allow retrospective reportingnotices submitted by processors duringthe 420-day submission period forprocessors to be withdrawn not laterthan October 5, 2018, should processorsdiscover errors in their original notices.See 40 CFR 710.30(a)(3).

With respect to forward-lookingreporting, EPA is not providing a formalcorrections process but has revised theregulatory text to allow forward-lookingreporting notices submitted bymanufacturers or processors to bewithdrawn if EPA has not yet alteredthe Inventory status of the chemicalsubstance in response to the originalsubmission (i.e., EPA has neither redesignated the substance from inactiveto active nor moved the substance fromthe confidential portion of the Inventoryto the public portion of the Inventory asa result of a request in the originalsubmission for a CBI claim to beTithdrawn) See 40 CFR 710.30(b)(3).Because a forward-looking notice willbe processed even if the intendedmanufacture and processing does notoccur as originally anticipated, andbecause it would be burdensome andpotentially impossible to implement



such an approach, the rule does notallow for EPA to revert a re-activatedsubstance back to inactive status basedon a request to withdraw a Form B, orfor EPA to revert a non-CBI substanceback to a CDI substance based on arequest to withdraw a Form B.

EPA appreciates that retrospectivewithdrawals should be non-punitive.However, after the period allowed forwithdrawal, incorrect informationwould be considered a prohibited actunder Section 15(1) and 15(3).Similarly, incorrect information inforward-looking notices would also beconsidered a prohibited act underSection 15(1) and 15(3), if notwithdrawn prior to EPA altering theInventory status of the chemicalsubstance in the original notice. Personsmaking corrections after theseretrospective and forward-lookingtimeframes and seeking future penaltymitigation considerations may disclosewithin 21 days after they have anobjectively reasonable basis forbelieving that a violation has, or mayhave, occurred, pursuant to EPA’s Self-Disclosure policies. See: https://www. epa .gov/compliance/epasedisciosure.

Changes to the Final Rule to AllowWithdrawal of a Notice of Activity FormA or Form B: EPA revised the rule toallow retrospective notices to bewithdrawn if done so not later thanOctober 5, 2018. See 40 CFR710.30(a)(3). EPA revised the rule toallow forward-looking notices to bewithdrawn if EPA has not yet alteredthe Inventory status of the substance inresponse to the original submission. See40 CFR 710.30(b)(3).

Comment 14: A few commentersrequested clarification on the proposedprocedures for joint submissions. Onecommenter requested that EPA providea different reporting option that avoidsthe need for a joint submission. Twocommenters requested clarification onthe reporting responsibilities ofmanufacturers, importers, andprocessors when a supplier fails tosubmit its information.

Response: EPA proposed proceduresfor joint submissions that will enable acompany to submit a commercialactivity notice for a chemical substanceon the confidential portion of theInventory in situations where thesubmitter does not know the specificchemical identity of the substancebecause a portion of the specificchemical identity is held CBI by asupplier. This rule includes such jointsubmission procedures that allow thesubmitter to provide information on thespecific chemical identity that it has inits possession, and the supplier to

separately provide information on thespecific chemical identity that it has inits possession, in a manner that protectsthe supplier’s CDI from the submitter ofthe NOA.

Additionally, since publication of theproposed rule, EPA expanded itselectronic reporting system to include apick list from which persons can selectchemicals for reporting. The pick listwill include only reportable substancesand will not include CDI. Non-CDTsubstances will be listed by CASRNsand CA index names, as they appear onthe Inventory, and CDI substances willbe listed by EPA accession numbers andgeneric names, as they appear on publicversions of the Inventory. Submitterscan identify substances from the picklist and, therefore, do not have tomanually enter chemical identityinformation. Because the chemicalidentity information selected from thepick list and transmitted on the NOAform will not be CDI, there is no needfor submitters who use this pick list tosupply CDI to EPA. In cases involvingthird party CBI, a submitter can providea single notice to EPA for a CDIsubstance, provided they have in theirpossession the corresponding non-CDTchemical identifiers, EPA accessionnumber and generic name, by selectingthe non-CBI identifiers from the picklist, thereby avoiding the need for a jointsubmission. If a submitting companydoes not know the EPA accessionnumber and generic name, they can useexisting mechanisms (e.g., InventoryCorrespondence) to request suchinformation from EPA.

A submitting company that does notknow the CDT chemical identity of thesubstance that it is required to reportbecause of third party CDI, therefore,has two options for reporting. Suchsubmitter can utilize the jointsubmission functionality in theelectronic reporting tool. Alternatively,such submitter can select from the picklist based on the corresponding non-CDTchemical identifiers, EPA accessionnumber and generic name, providedthey have this information.

Changes to Reporting Options forJoint Submissions: EPA revised the finalrule to add a description of the pick listthat will be provided in the electronicreporting system and which can serve asan alternative to a joint submission,should submitters have in theirpossession non-CDT chemical identifiers(EPA accession number and genericname) for a reportable CDI substance.

Comment 15: A few commentersstated that the estimated reportingburden and costs are too low orunrealistic, citing the following universeestimates as underestimated: Number of

chemicals that are not reported underCDR because of exemptions or reportingthreshold (including ten percent basisfor nonexempt low volume chemicalsand polymers) and total burden forprocessors. One commenterrecommended that EPA revise thenumber of processors or better explainthe origins of EPA’s estimation of161,000 affected processors.Additionally, a few commenters statedthat unit burden estimates per activityand/or respondent are too low,including: Cost per industrysubmission, time needed for datagathering, time needed for duediligence, and rule familiarization (forprocessors).

Response: EPA agrees in part withthese comments. After considering thesecomments, EPA adjusted the universeestimates and certain unit burdenestimates. Regarding the number ofchemicals and associated firms, EPAadds a group of chemicals termed “XUChemicals” that was not included inestimates for the proposed rule. XUchemicals are defined in 40 CFR 711.6and largely consist of polymers. Thisgroup of chemicals is listed on theInventory, but is exempt from thereporting requirements of the CDR rule.Given that the CDR database is theprimary source from which this rule’seconomic analysis draws measurementsfor counts of chemicals and firms, theXU Chemicals needed to be added.Regarding the number of processors, theorigin for the proposed rule estimate of161,550 processors was derived usingthe total chemical count for the initialreporting period combined with a modelfor “processors per chemical.” Themodel is based on a previous analysisfor a different proposed rule (and citedin this proposed rule’s Burden and CostReport.) For the final rule, the model isupdated using the more current CDR2016 data; detailed methodology isprovided in Table 2 footnote (Ref. 2).Due to the increased value of the modelcoupled with the higher chemicalcounts (discussed previously),processors are estimated for the finalrule at 283,993 firms

Regarding unit burden estimates, EPAdeveloped estimates for typicalscenarios during start up and ongoingreporting to use as the representativeaverage and then apply universeestimates to yield total burdenestimates. Individual respondents mayexperience lower or higher levels ofburden. The activities of “time for datagathering,” and “time needed for duediligence” are included in the unitburden estimate for compliancedetermination. Similarly, unit burdenestimate for rule familiarization is based


Federal Register/Vol. 82, No. 154/Friday, August 11, 2017/Rules and Regulations

on the activities expected: “.

becoming familiar with the fullrequirements of the rule, whichincludes reading the rule,understanding the various reporting andadministrative requirements, anddetermining the manner in whichreporting requirements will be met foreach chemical substance” (Ref. 2). EPAalso developed a range of burden hoursestimates for processors’ rulefamiliarization during start up at one tofour hours, based on EPA judgment ofhow processors will familiarizethemselves with the rule.

Changes to the Burden and CostEstimates in the Final Rule: EPA revisedthe universe estimates to add XUChemicals, and to incorporate a revised,larger estimate for the number ofprocessor firms. EPA also revised theunit burden for processors’ rulefamiliarization during start up.

Comment 16: One commenterindicated that EPA should justify whycertification is required for non-CBInotices. Another commenter suggestedthe following changes to the proposedregulatory text for certification: 40 CFR710.37(b)(3] should be corrected to “[amauthorized official of a person” insteadof “person,” 40 CFR 710.29(d)(5) shouldbe extended to substantiations as well asto claims and notices, and 40 CFR710.37(b)(3] should be replicated in 40CFR 710.3 7(a) so that it also applies toCBI claims for chemical identity inaddition to other CBI claims.

Response: Certification statements arerequired under TSCA section 8(b)(9)(A)and are essential whenever informationis submitted to the EPA. Certificationstatements are routinely required fordata submitted to the EPA under TSCAas well as other statutes for both CBIand non-CBI submissions. Suchstatements ensure that the data the EPAultimately relies on are valid andaccurate. It also puts the submitter onnotice of the consequences ofsubmitting false, inaccurate, orincomplete information to the Agency.

EPA agrees in large part with thecomment recommending specificcorrections to 40 CFR 710.3 7(b)(3) and710.29(d)(5), the proposed regulatoryprovisions for certifications. EPA hasrevised the certification provisions inthe rule, which currently appear at 40CFR 710.37(e) (applicable to CBI claimsand associated substantiations) and710.29(d)(5) (applicable to allinformation reported on NOA Forms Aand B). The rule clarifies that an“authorized official” submitting orsubstantiating any new or existing CBIclaim must provide a certification,consistent with the requirements ofTSCA section 14(c)(5).

While EPA does not agree with thecommenter’s implication that a requestto maintain an existing CBI claim forspecific chemical identity is subject toall of the same requirements andprocedures that would apply to theassertion of a new claim under TSCAsection 14(c), EPA finds it appropriateunder the circumstances to require acertification statement for such requeststhat is consistent with TSCA section14(c)(5), in addition to meeting thecertification requirement of TSCAsection 8(b)(9)(A). The earlier assertionof the CBI claim for specific chemicalidentity may have predated currentprovisions under TSCA subsections14(c)(5) and (c)(1)(B) pertaining to thecertification of a specific statementrequired for the assertion of a CBI claim.EPA does not believe that Congressintended the Agency to review existingCBI claims for chemical identity underTSCA section 8(b) without having thebenefit of this certified statement.

Changes to the CertificationStatements in the Final Rule. EPArevised the certification statementapplicable to CBI claims to substitute“authorized official” for “person,” andto address substantiation of claims,consistent with TSCA sections8(b)(9)(A) and 14(c](5).

Comment 17: One commenterindicated that the CBI claims processshould be better defined, particularlywith regard to substantiation. Twocommenters stated that thesubstantiation questions should bereduced in scope.

Response: EPA has extensively rewritten the substantiation questionsfrom the proposal in a manner intendedto more succinctly secure answers forthe basis of the CBI assertions for eachdata element as well as the CBI concernson the linkage of data elements.

Changes to Substantiation Questionsin the Final Rule: EPA has rewritten thesubstantiation questions to moresuccinctly secure answers for the basisof the CBI assertions for each dataelements as well as the CBI concerns onthe linkage of data elements.

IV. References

The following is a listing of thedocuments that are specificallyreferenced in this document. The docketincludes these references and otherinformation considered by EPA. Forassistance in locating these otherdocuments, please consult the technicalcontact listed under FOR FURTHERINFORMATION CONTACT.

1. 2017. EPA. TSCA Inventory Notification(Active-Inactive) Requirements;Proposed Rule. Federal Register (82 FR4255, January 13, 2017) (FRL 9956—28).

37537

2. 2017. EPA. Burden and Cost Report for theFinal Rule: TSCA Inventory NotificationRequirements (RIN 2070—AK24, June 19,2017).

3. 2017. EPA. Notice of Activity Form A andForm B; Final.

4. 2009. EPA. Notice of CommencementForm; Final.

5. 2005. EPA. Cross-Media ElectronicReporting Rule (CROMERR]; Final Rule.Federal Register (70 FR 59848, October13, 2005) (FRL 7977—1).

6. 2013. EPA. Electronic Reporting Under theToxic Substances Control Act; FinalRule. Federal Register (78 FR 72818,December 4, 2013) (FRL 9394—6).

7. 2017. EPA. Response to Comments to theProposed Rule, TSCA InventoryNotification (Active-Inactive)Requirements; RIN 2070—AK24. Docket #EPA—HQ—OPPT—2o16—0426.

8. 2016. EPA. TSCA Chemical Data Reportingfact Sheet: Imported Articles. https://wnw. epa.gov/sites/produ ction /files/2015-1 2/documents/cdrJactsh eetjmported_articles_-_final_dec2Ol 5.pdf.

9. 2016. EPA. TSCA Chemical Data ReportingFact Sheet: Reporting After Changes toCompany Ownership or Legal Identity.https://www.epa.gov/sites/produ ction/files/20 I 5-05/documen ts/cdrjact sheetcompany_changes.pdf.

10. 2016. EPA. Chemical Data ReportingFrequent Questions. https://www. epa .gov/sites/production/files/201 6-07/docunients/cdrjqJinaljulvl 1201 6.pdf.

11. 2017. EPA. Information CollectionRequest for the TSCA section 8(b)Reporting Requirements for TSCAInventory Notifications (EPA ICR No.2562.02).

12. 2017. EPA. Small Entity Analysis Reportfor the Final Rule: TSCA InventoryNotification Requirements (May 30,2017).

V. Statutory and Executive OrderReviews

Additional information about thesestatutes and Executive Orders can befound at http://www2.epa.gov/Ia wsregulations/laws-and-execu tiveorders.

A. Executive Order 12866: RegulatoryPlanning and Review and ExecutiveOrder 13563: Improving Regulation andRegulatory Review

This action is not a significantregulatory action that was submitted tothe Office of Management and Budget(0MB) for review under ExecutiveOrders 12866 (58 FR 51735, October 4,1993) and 13563 (76 FR 3821, January21, 2011).

B. Paperwork Reduction Act (PRA]

The information collection activitiesassociated with this rule have beensubmitted to 0MB for review andapproval under the PRA, 44 U.S.C. 3501et seq. Specifically, EPA has prepared



an Information Collection Request (ICR)(identified under EPA ICR No. 2565.01(0MB Control No. 20 70—0201), thatestimates the potential burden and costsassociated with the paperworkrequirements contained in this rule (Ref.11). You can find a copy of the ICR inthe docket for this rule, and it is brieflysummarized here.

Start-up year burden/cost(Retrospective). Covers respondents!affected entities, i.e., persons whomanufacture chemical substances.

Respondents’ obligation to respond:Mandatory.

Estimated n umber of respon dents:1,685.

Manufacturers: 5,322.Processors: 283,993.Frequency of response: Once and on

occasion.Estimated burden: The term “burden”

is defined at 5 CFR 1320.3(b).Manufacturers: 38,613 hours.Processors: 937,347 hours.Estimated cost:Manufacturers: $3.09 million.Processors: $75.8 million.Start-up year CDX Registrations

burden/cost.Respondents’ obligation to respond:

Mandatory.Estimated number of respondents:

(169 registrations).Frequency of response: Once and on

occasion.Estimated burden: 90 hours.Estimated cost: $7,022.Ongoing annual burden/cost

(Forward-looking): Covers respondents!affected entities, i.e., persons whomanufacture or process chemicalsubstances.

Respondents’ obligation to respond:Mandatory.

Estimated number of respondents: 20.Frequency of response: On-occasion.Total estimated burden: 225 hours.Total estimated cost: $17,779.An Agency may not conduct or

sponsor, and a person is not required torespond to, a collection of informationunless it displays a currently valid 0MBcontrol number. The 0MB controlnumbers for EPA’s regulations in 40CFR are listed in 40 CFR part 9 andincluded on any related collectioninstrument (e.g., the form). When 0MBapproves this ICR, the Agency willannounce that approval in the FederalRegister and publish a technicalamendment to 40 CFR part 9 to displaythe 0MB control number for theapproved information collectionactivities contained in this final rule.

C. Regulatory Flexibility Act (RFA)

EPA certifies under section 605(b) ofthe RFA, 5 U.S.C. 601 et seq., that this

action will not have a significanteconomic impact on a substantialnumber of small entities under the RFA.In making this determination, theimpact of concern is any significantadverse economic impact on smallentities. An agency may certify that arule would not have a significanteconomic impact on a substantialnumber of small entities if the rule hasa very small level of impact on the smallentities subject to the rule.

The entities subject to therequirements of this action aremanufacturers, and processors ofchemical substances, i.e., smallbusinesses in NAICS 325: ChemicalManufacturing, and 324: Petroleum andCoal Products Manufacturing. The mostburdensome conditions are incurredduring the start-up year, when allmanufacturers are expected to report,and all processors are expected tobecome familiar with the requirements,but only a small number of theprocessors will likely also report. EPAhas prepared a detailed analysis toevaluate the potential impactsquantitatively, a copy of which isavailable in the docket (Ref. 12).

The quantitative analysis addressesthe “most affected” subset of entitieswho are expected to incur the highestpotential burden under the rule (18hours and $1,188 per firm) are the smallentities manufacturing (or importing)chemicals that must submit NOAsinvolving an average of eighteenchemicals per entity in the start-up year.Although all processors are assumed toexperience burden from becomingfamiliar with the requirements, only asmall subset are expected to experiencethe burdens associated with submittingthe NOAs.

D. Unfunded Mandates Reform Act(UMRA)

This action does not contain anunfunded mandate as described inUMRA, 2 U.S.C. 1531—1538, and doesnot significantly or uniquely affect smallgovernments. The action is not expectedto impose enforceable duty on any state,local or tribal governments, and therequirements imposed on the privatesector are not expected to result inannual expenditures of $100 million ormore for the private sector. As such,EPA has determined that therequirements of UMRA sections 202,203, 204, or 205 do not apply to thisaction.

E. Executive Order 13132: Federalism

This action does not have federalismimplications as specified in ExecutiveOrder 13132 (64 FR 43255, August 10,1999), because it does not have any

effect on the states, on the relationshipbetween the national government andthe states, or on the distribution ofpower and responsibilities among thevarious levels of government.

F. Executive Order 13175: Consultationand Coordination With Indian TribalGovernments

This action does not have tribalimplications as specified in ExecutiveOrder 13175 (65 FR 67249, November 9,2000), because it is not expected to haveany effect on tribal governments, on therelationship between the Federalgovernment and the Indian tribes, or onthe distribution of power andresponsibilities between the Federalgovernment and Indian tribes.

G. Executive Order 13045: Protection ofChildren From Environmental HealthRisks and Safety Risks

EPA interprets Executive Order 13045(62 FR 19885, April 23, 1997), asapplying only to those regulatoryactions that concern health or safetyrisks, such that the analysis requiredunder section 5—5 01 of Executive Order13045 has the potential to influence theregulation. This action is not subject toExecutive Order 13045 because it doesnot establish an environmental standardintended to mitigate health or safetyrisks.

H. Executive Order 13211:ActionsConcerning Regulations ThatSignificantly Affect Energy Supply,Distribution, or Use

This action is not a “significantenergy action” as defined in ExecutiveOrder 13211 (66 FR 28355, May 22,2001), because it is not likely to have asignificant adverse effect on energy

supply, distribution, or use.

I. National Technology Transfer andAdvancement Act (NTTAA)

Since this action does not involve anytechnical standards, NTTAA section12(d), 15 U.S.C. 272 note, does notapply to this action.

J. Executive Order 12898: FederalActions To Address EnvironmentalJustice in Minority Populations andLow-Income Populations

This action does not entail specialconsiderations of environmental justicerelated issues as delineated byExecutive Order 12898 (59 FR 7629,February 16, 1994), because EPA hasdetermined that this action would nothave disproportionately high andadverse human health or environmentaleffects on minority or low-incomepopulations. This action does not affect



the level of protection provided tohuman health or the environment.

K. Congressional Review Act (CRA)

This action is subject to the CRA, 5U.S.C. 801 et seq., and EPA will submita rule report to the U.S. Senate, the U.S.House of Representatives, and theComptroller General of the UnitedStates. This action is not a “major rule”as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 710

Chemicals, Confidential BusinessInformation, Environmental Protection,Hazardous Substances, Reporting andRecordkeeping Requirements.

Dated: June 22, 2017.

F. Scott Pruitt,Administrator.

Therefore, 40 CFR Chapter I isamended as follows:

PART 710—[AMENDEDJ

• 1. Revise the authority citation for part710 to read as follows:

Authority: 15 U.S.C. 2607(a) and (b).

• 2. Designate § 710.1 through 710.4 assubpart A, and add a heading forsubpart A to read as follows:

Subpart A—General Provisions

* * * * *

I 3. In § 710.1, revise paragraph (b) toread as follows:

§710.1 Scope and compliance.* * * * *

(b) This part applies to the activitiesassociated with the compilation of theTSCA Chemical Substance Inventory(Inventory) and the designation ofchemical substances on the TSCAInventory as active or inactive in U.S.commerce.* * * * *

• 4. In § 710.3, revise paragraph (d) toread as follows:

§710.3 Definitions.* * * * *

(d] The following definitions alsoapply to this part:

Act means the Toxic SubstancesControl Act (TSCA), 15 U.S.C. 2601 etseq.

Administrator means theAdministrator of the U.S.Environmental Protection Agency, anyemployee or authorized representativeof the Agency to whom theAdministrator may either herein or byorder delegate his/her authority to carryout his/her functions, or any otherperson who will by operation of law beauthorized to carry out such functions.

Article means a manufactured item:(1) Which is formed to a specific

shape or design during manufacture,(2) Which has end use function(s)

dependent in whole or in part upon itsshape or design during end use, and

(3) Which has either no change ofchemical composition during its enduse or only those changes ofcomposition which have no commercialpurpose separate from that of the articleand that may occur as described in§ 710.4(d)(5); except that fluids andparticles are not considered articlesregardless of shape or design.

Byproduct means a chemicalsubstance produced without a separatecommercial intent during themanufacture, processing, use, ordisposal of another chemicalsubstance(s) or mixture(s).

CASRN means Chemical AbstractsService Registry Number.

Chemical substance means anyorganic or inorganic substance of aparticular molecular identity, includingany combination of such substancesoccurring in whole or in part as a resultof a chemical reaction or occurring innature, and any chemical element oruncombined radical; except that“chemical substance” does not include:

(1) Any mixture;(2) Any pesticide when manufactured,

processed, or distributed in commercefor use as a pesticide;

(3) Tobacco or any tobacco product,but not including any derivativeproducts;

(4) Any source material, specialnuclear material, or byproduct material;

(5) Any pistol, firearm, revolver,shells, and cartridges; and

(6) Any food, food additive, drug,cosmetic, or device, whenmanufactured, processed, or distributedin commerce for use as a food, foodadditive, drug, cosmetic, or device.

Commerce means trade, traffic,transportation, or other commerce:

(1) Between a place in a State and anyplace outside of such State or

(2) Which affects trade, traffic,transportation, or commerce between aplace in a State and any place outsideof such State.

Customs territory of the United Statesmeans the 50 States, Puerto Rico, andthe District of Columbia.

Distribute in commerce anddistribution in commerce means to sellin commerce, to introduce or deliver forintroduction into commerce, or to holdafter its introduction into commerce.

Domestic means within thegeographical boundaries of the 50United States, the District of Columbia,the Commonwealth of Puerto Rico, theVirgin Islands, Guam, American Samoa,

the Northern Mariana Islands, and anyother territory or possession of theUnited States.

EPA means the U.S. EnvironmentalProtection Agency.

Importer means any person whoimports any chemical substance,including a chemical substance as partof a mixture or article, into the customsterritory of the United States.“Importer” includes the personprimarily liable for the payment of anyduties on the merchandise or anauthorized agent acting on his or herbehalf. The term also includes, asappropriate,

(1) The consignee,(2) The importer of record,(3) the actual owner if an actual

owner’s declaration and supersedingbond has been filed in accordance with19 CFR 141.20, or

(4) The transferee, if the right to drawmerchandise in a bonded warehouse hasbeen transferred in accordance withsubpart C of 19 CFR 144.

Impurity means a chemical substancewhich is unintentionally present withanother chemical substance.

Intermediate means any chemicalsubstance that is consumed, in whole orin part, in chemical reaction(s) used forthe intentional manufacture of otherchemical substance(s) or mixture(s), orthat is intentionally present for thepurpose of altering the rate(s) of suchchemical reaction(s).

Inventory means the TSCA ChemicalSubstance Inventory, which is EPA’scomprehensive list of confidential andnon-confidential chemical substancesmanufactured or processed in theUnited States for nonexemptcommercial purpose that EPA compiledand keeps current under section 8(b) ofthe Act.

Manufacture means to manufacture,produce, or import, for commercialpurposes. Manufacture includes theextraction, for commercial purposes, ofa component chemical substance from apreviously existing chemical substanceor complex combination of chemicalsubstances. When a chemical substance,manufactured other than by import, is:(1) Produced exclusively for anotherperson who contracts for suchproduction, and (2) that other personspecifies the identity of the chemicalsubstance and controls the total amountproduced and the basic technology forthe plant process, then that chemicalsubstance is co-manufactured by theproducing manufacturer and the personcontracting for such production.

Manufacture for commercial purposesmeans: (1) To manufacture, produce, orimport with the purpose of obtaining animmediate or eventual commercial



advantage, and includes, among otherthings, the “manufacture” of anyamount of a chemical substance ormixture (i) for commercial distribution,including for test marketing, or (ii) foruse by the manufacturer, including usefor product research and developmentor as an intermediate. (2) The term alsoapplies to substances that are producedcoincidentally during the manufacture,processing, use, or disposal of anothersubstance or mixture, includingbyproducts that are separated from thatother substance or mixture andimpurities that remain in that substanceor mixture. Byproducts and impuritieswithout separate commercial value arenonetheless produced for the purpose ofobtaining a commercial advantage, sincethey are part of the manufacture of achemical substance for commercialpurposes.

Man ufacturer means a person whomanufactures a chemical substance.

Mixture means any combination oftwo or more chemical substances if thecombination does not occur in natureand is not, in whole or in part, the resultof a chemical reaction; except that“mixture” does include (1) anycombination which occurs, in whole orin part, as a result of a chemical reactionif the combination could have beenmanufactured for commercial purposeswithout a chemical reaction at the timethe chemical substances comprising thecombination were combined, and if allof the chemical substances comprisingthe combination are not new chemicalsubstances, and (2) hydrates of achemical substance or hydrated ionsformed by association of a chemicalsubstance with water, so long as thenonhydrated form is itself not a newchemical substance.

New chemical substance means anychemical substance which is notincluded on the Inventory.

Person includes any individual, firm,company, corporation, joint-venture,partnership, sole proprietorship,association, or any other business entity;any State or political subdivisionthereof; any municipality; any interstatebody; and any department, agency, orinstrumentality of the FederalGovernment.

Process means to process forcommercial purposes. Process includesthe preparation of a chemical substanceor mixture, after its manufacture, (1) inthe same form or physical state as, or ina different form or physical state from,that in which it was received by theperson so preparing such substance ormixture, or (2] as part of a mixture orarticle containing the chemicalsubstance or mixture.

Process for commercial purposesmeans the preparation of a chemicalsubstance or mixture after itsmanufacture for distribution incommerce with the purpose of obtainingan immediate or eventual commercialadvantage for the processor. Processingof any amount of a chemical substanceor mixture is included in this definition.If a chemical substance or mixturecontaining impurities is processed forcommercial purposes, then theimpurities also are processed forcommercial purposes.

Processor means any person whoprocesses a chemical substance ormixture.

Site means a contiguous propertyunit. Property divided only by a publicright-of-way will be considered one site.More than one manufacturing plant maybe located on a single site.

(1] For chemical substancesmanufactured under contract, i.e., by atoll manufacturer, the site is the locationwhere the chemical substance isphysically manufactured.

(2] The site for an importer whoimports a chemical substance describedin § 710.25 is the U.S. site of theoperating unit within the person’sorganization that is directly responsiblefor importing the chemical substance.The import site, in some cases, may bethe organization’s headquarters in theUnited States. If there is no suchoperating unit or headquarters in theUnited States, the site address for theimporter is the U.S. address of an agentacting on behalf of the importer who isauthorized to accept service of processfor the importer..

Small quantities solely for researchand development (or “small quantitiessolely for purposes of scientificexperimentation or analysis or chemicalresearch on, or analysis of, suchsubstance or another substance,including such research or analysis forthe development of a product”) meansquantities of a chemical substancemanufactured, imported, or processedor proposed to be manufactured,imported, or processed solely forresearch and development that are notgreater than reasonably necessary forsuch purposes.

State means any State of the UnitedStates, the District of Columbia, theCommonwealth of Puerto Rico, theVirgin Islands, Guam, American Samoa,the Northern Mariana Islands, or anyother territory or possession of theUnited States.

Technically qualified individualmeans a person:

(1] Who because of his/her education,training, or experience, or acombination of these factors, is capable

of appreciating the health andenvironmental risks associated with thechemical substance which is used underhis/her supervision,

(2) Who is responsible for enforcingappropriate methods of conductingscientific experimentation, analysis, orchemical research in order to minimizesuch risks, and

(3) Who is responsible for the safetyassessments and clearances related tothe procurement, storage, use, anddisposal of the chemical substance asmay be appropriate or required withinthe scope of conducting the researchand development activity. Theresponsibilities in this paragraph maybe delegated to another individual, orother individuals, as long as each meetsthe criteria in paragraph (1) of thisdefinition.

Test marketing means the distributionin commerce of no more than apredetermined amount of a chemicalsubstance, mixture, or article containingthat chemical substance or mixture, bya manufacturer or processor to no morethan a defined number of potentialcustomers to explore market capabilityin a competitive situation during apredetermined testing period prior tothe broader distribution of that chemicalsubstance, mixture, or article incommerce.

United States, when used in thegeographic sense, means all of theStates, territories, and possessions of theUnited States.B 5. Add a new subpart B to read asfollows:

SUBPART B—COMMERCIAL ACTIVITYNOTIFICATION

Sec.71023 Definitions.710.25 Persons subject to the notification

requirement.710.27 Activities for which notification is

not required.710.29 Information required in the

notification.710.30 When to submit notifications.710.33 Co-manufacturers and co-processors.710.35 Recordkeeping requirements.710.37 Confidentiality claims.710.39 Electronic filing.

. 710.23 Definitions.

The following definitions also applyto subpart B of this part.

Active substance means any interimactive substance, any naturallyoccurring chemical substance as definedby § 710.2 7(b), any chemical substancethat was added to the Inventory on orafter June 21, 2006 pursuant to a Noticeof Commencement under § 720.102received by the Agency on or after June21, 2006, and any chemical substance



subject to commercial activitydesignation that the Administratordesignates as active based on the receiptof a notice under this subpart.

Central Data Exchange or CDX meansEPA’s centralized electronic documentreporting portal, or its successors.

Chemical substance subject tocommercial activity designation meansa chemical substance that requires adesignation as either an active or aninactive substance. A chemicalsubstance is subject to commercialactivity designation if it is not aninterim active substance, it was addedto the Inventory before June 21, 2006, itis not a naturally occurring chemicalsubstance as defined by § 710.2 7(b), andit has not yet been designated by theAdministrator as either an active or aninactive substance.

Chemical Information SubmissionSystem or CISS means EPA’s web-basedreporting tool for preparing andsubmitting a Notice of Activity.

e-NOA means EPA’s software modulewithin CISS for generating andcompleting Notice of Activity forms Aand B.

Existing claim for protection ofspecific chemical identity againstdisclosure is a claim for protection ofthe specific chemical identity of achemical substance that is listed on theconfidential portion of the Inventory,asserted prior to June 22, 2016.

Inactive substance means anychemical substance subject tocommercial activity designation, thatthe Administrator designates as inactivebased on the lack of receipt of a noticeunder this subpart, effective 90 daysafter the Administrator identifies thechemical substance for suchdesignation.

Interim active substance means anychemical substance that was reported,pursuant to 40 CFR part 711, as havingbeen manufactured in and of thecalendar years: 2010, 2011, 2012, 2013,2014, or 2015.

Known to or reasonably ascertainableby means all information in a person’spossession or control, plus allinformation that a reasonable personsimilarly situated might be expected topossess, control, or know.

Notice of ActivityForm A means theform for supplying retrospectivenotification under TSCA section 8(b)(4),for which the submission obligation isdescribed in § 710.25(a).

Notice of Activity Form B means theform for supplying forward-lookingreporting under TSCA section 8(b)(5),for which the submission obligation isdescribed in § 710.25(c).

Lookback period means the periodbeginning on June 21, 2006 and endingon June 21, 2016.

Possession or Control means in thepossession or control of any person, orof any subsidiary, partnership in whichthe person is a general partner, parentcompany, or any company orpartnership which the parent companyowns or controls, if the subsidiary,parent company, or other company orpartnership is associated with theperson in the research, development,test marketing, or commercial marketingof the chemical substance in question.Information is in the possession orcontrol of a person if it is:

(1) In the person’s own files includingfiles maintained by employees of theperson in the course of theiremployment.

(2) In commercially available databases to which the person haspurchased access.

(3) Maintained in the files in thecourse of employment by other agents ofthe person who are associated withresearch, development, test marketing,or commercial marketing of thechemical substance in question.

Reportable chemical substance meansa chemical substance that is listed onthe Inventory and that is either:

(1) A chemical substance subject tocommercial activity designation forwhich notification is required orallowed under § 710.25(a) and§ 710.25(b),

(2) A chemical substance that wasadded to the confidential portion of theInventory before June 22, 2016, or (3) aninactive substance for whichnotification is required under§ 710.25(c).

Submission period means theapplicable period for submitting aNotice of Activity under § 710.25.

§ 710.25 Persons subject to thenotification requirement.

The following persons are subject tothe requirements of this subpart.

(a) Who must submit the Notice ofActivity Form A? Any person whomanufactured (including imported) achemical substance subject tocommercial activity designation at anytime during the lookback period, exceptas provided in § 710.27, must submit aNotice of Activity Form A s specifiedunder § 710.29 and § 710.30(a), unlesssuch person has evidence in the form ofa CDX receipt, documenting EPA’sreceipt of a Notice of Activity Form Afrom another person, for the samechemical substance, or unless the priormanufacturing of such a substance isnot known to or reasonablyascertainable by the person. Evidence in

the form of a CDX receipt for a Noticeof Activity Form A is not a basis forexemption from the requirements of§ 710.25(c) if the chemical substance isultimately designated as inactive due towithdrawal of the Notice of ActivityForm A.

(b) Who else may submit the Notice ofActivity Form A? Any person notrequired to submit a Notice of ActivityForm A under § 710.25(a), whomanufactured (including imported) orprocessed a reportable chemicalsubstance, at any time during thelookback period, may submit a Notice ofActivity Form A as specified under§ 710.29 and § 710.30(a).

(c) Who must submit the Notice ofActivity Form B? Any person whointends to manufacture (includingimport) or process an inactivesubstance, except as provided in§ 710,27, after the effective date of theAdministrator’s designation of suchchemical substance as an inactivesubstance, must submit a Notice ofActivity Form B as specified under§ 710.29 and § 710.30(b), unless thepresence of the inactive substance onthe confidential portion of the Inventoryis not known to or reasonablyascertainable by the person.

§ 710.27 Activities for which notification isnot required.

(a) In general. The following activitiesdo not trigger notification requirementsunder this subpart:

(1) The manufacturing or processingof a chemical substance in smallquantities solely for research anddevelopment.

(2) The import or processing of achemical substance as part of an article.

(3) The manufacturing or processingof a chemical substance as described in§ 720.30(g) or (h).

(4) The manufacturing or processingof a chemical substance solely for exportfrom the United States as described in§ 720.30(e) or § 721.3, except where theAdministrator has made a findingdescribed in TSCA section 12(a)(2).

(5) The manufacturing or processingof a chemical substance solely for testmarketing purposes.

(b) Manufacturing or processingnaturally occurring chemicalsubstances. The following activities donot trigger notification requirementsunder this subpart:

(1) The manufacture of a naturallyoccurring chemical substance, asdescribed in § 710.4(b). Some chemicalsubstances can be manufactured both asdescribed in § 7 10.4(b) and by meansother than those described in § 710.4(b).If a person manufactures a chemicalsubstance by means other than those



described in § 710.4(b), this exemptionis inapplicable, regardless of whetherthe chemical substance also could havebeen produced as described in§ 710.4(b). This exemption does notcover the manufacture of a chemicalsubstance from a naturally occurringchemical substance.

(2) The processing of a naturallyoccurring chemical substance only bymanual, mechanical, or gravitationalmeans; by dissolution in water; byflotation; or by heating solely to removewater.

§ 710.29 Information required in thenotification.

(a) Reporting information to EPA. Aperson who reports information to EPAunder this subpart must do so using thee-NOA software module, the CISSreporting tool, and the CDX electronicreporting portal provided by EPA at theaddresses set forth in § 710.39. Fornotices of activity under § 710.25(a) and§ 710.25(b), the submission mustinclude all information described inparagraph (b) of this section. For aNotice of Activity under § 710.25(c), thesubmission must include allinformation described in paragraph (c)of this section. A person must submit aseparate notice for each chemicalsubstance that the person is required toreport. Using e-NOA and CISS andregistering in CDX are described ininstructions available from EPA at theWeb sites set forth in § 710.39.

(b) Information to be reported on theNotice of Activity Form A. A personsubmitting a Notice of Activity Form Aunder § 710.25(a) or § 710.25(b) mustsubmit the information specified in§ 710.29(d) for each reportable chemicalsubstance. A person submittinginformation under § 710.25(a) or§ 710.25(b) must report information tothe extent that such information isknown to or reasonably ascertainable bythat person.

(c) Information to be reported on aNotice of Activity Form B. Any personsubmitting a Notice of Activity Form Bunder § 710.2 5(c) must provide theinformation described in this paragraphfor each inactive substance intended tobe manufactured or processed.

• (1) Information specified in§ 710.29(d).

(2) The anticipated date by which theinactive substance is to be manufacturedor processed in the United States. If theNotice of Activity Form B is filed priorto the effective date of the chemicalsubstance’s inactive designation, themost recent date of manufacturing orprocessing may be provided in lieu ofan anticipated date.

(d) Information to be reported oneither the Notice of Activity Form A orForm B.

(1) Company. The name and addressof the submitting company.

(2) Authorized official. The name andaddress of the authorized official for thesubmitting company.

(3) Technical contact. The name andtelephone number of a person who willserve as technical contact for thesubmitting company and who will beable to answer questions about theinformation submitted by the companyto EPA.

(4) Chemical-specific information.The system described under § 710.29(a)will provide a list of reportablechemical substances from which aperson can select his or her chemical.The list will include the correct CASRNand CA Index name used to list a non-confidential chemical substance on theInventory. For confidential substanceson the Inventory, the list will includethe TSCA Accession Number andgeneric name.

(i) If an importer submitting a noticecannot provide the informationspecified in § 710.29(d)(4) because it isunknown to the importer and claimedas confidential by the supplier of thechemical substance or mixture, theimporter must ask the supplier toprovide the specific chemical identityinformation directly to EPA in a jointsubmission using the same e-NOAsoftware module used for commercialactivity reporting. Such request mustrefer the supplier to EPA’s instructionsfor submitting chemical identityinformation electronically, using eNOA, CISS, and CDX (see § 710.39), andfor clearly referencing the importer’ssubmission. Contact information for thesupplier, a trade name or other name forthe chemical substance or mixture, anda copy of the request to the suppliermust be included with the importer’ssubmission.

(ii) If a manufacturer or processorsubmitting a notice cannot provide theinformation specified in § 710.29(d)(4)because the reportable chemicalsubstance is manufactured or processedusing a reactant having a specificchemical identity that is unknown tothe manufacturer or proceësor andclaimed as confidential by its supplier,the manufacturer or processor must askthe supplier of the confidential reactantto provide the specific chemical identityof the confidential reactant directly toEPA in a joint submission using thesame e-NOA software module used forcommercial activity reporting. Suchrequest must refer the supplier to EPA’sinstructions for submitting chemicalidentity information electronically using

e-NOA, CISS, and CDX (see § 710.39),and for clearly referencing themanufacturer’s or processor’ssubmission. Contact information for thesupplier, a trade name or other name forthe chemical substance, and a copy ofthe request to the supplier must beincluded with the manufacturer’s orprocessor’s submission with respect tothe chemical substance.

(iii) Joint submissions must besubmitted electronically using e-NOA,CISS, and CDX (see § 710.39).

(5) Certification statements. Theauthorized official must certify that thesubmitted information has beencompleted in compliance with therequirements of this part as described inthis paragraph.

(i) The certification must be signedand dated by the authorized official forthe submitting company.

(ii) The following is requiredcertification language for an authorizedofficial submitting a Notice of ActivityForm A under § 710.25(a) or § 710.25(b):“I certify under penalty of law that thisdocument and all attachments wereprepared under my direction orsupervision and the informationcontained therein, to the best of myknowledge, is true, accurate, andcomplete. I also certify that I havemanufactured, imported, or processedthe above chemical between the dates ofJune 21, 2006 and June 21, 2016. I amaware it is unlawful to knowinglysubmit incomplete, false and/ormisleading information, and there aresignificant criminal penalties for suchunlawful conduct, including thepossibility of fine and imprisonment.”

(iii) The following is requiredcertification language for an authorizedofficial submitting a Notice of ActivityForm B under § 710.25(c): “I certifyunder penalty of law that this documentand all attachments were preparedunder my direction or supervision andthe information contained therein, tothe best of my knowledge, is true,accurate, and complete. I also certifythat I have intent to manufacture,import, or process the above chemicalwithin 90 days of submission. I amaware it is unlawful to knowinglysubmit incomplete, false and/ormisleading information, and there aresignificant criminal penalties for suchunlawful conduct, including thepossibility of fine and imprisonment.”

§ 710.30 When to submit notifications.

(a) When most a Notice of ActivityForm A be submitted? The Notice ofActivity Form A required to besubmitted under § 710.25(a) must besubmitted during the applicablesubmission period.



(1) Man ufacturers. The submissionperiod for manufacturers under§ 710.25(a) and § 710.25(b) begins onAugust 11, 2017 and ends on February7, 2018.

(2) Processors. The submission periodfor processors under § 710.25(b) beginson August 11, 2017 and ends on October5, 2018.

(3) Withdrawal of a Notice of ActivityForm A. A Notice of Activity Form Asubmitted under § 710.30(a)(1) or§ 710.30(a)(2] may be withdrawn by thesubmitter no later than October 5, 2018.If EPA receives a timely request towithdraw a previously submitted Noticeof Activity Farm A for a chemicalsubstance subject to commercial activitydesignation, and EPA has not receiveda Notice of Activity Form A fromanother submitter for the same chemicalsubstance, EPA will not designate thechemical substance as active. A Form Awithdrawn under this paragraph willnot satisfy the obligation under this ruleto submit a Form A.

(b) When must a Notice of ActivityForm B be submitted? (1] Manufacturersand processors. The Notice of ActivityForm B required to be submitted under§ 710.25(c) must be submitted before aperson manufactures or processes theinactive substance, but not more than 90days prior to the anticipated date ofmanufacturing or processing.

(2) When else may a Notice of ActivityForm B be submitted? A Notice ofActivity Form B that will later berequired to be submitted under§ 710.25(c) may be submitted during the90-day period between EPA’sidentification of a chemical substancefor inactive designation and theeffective date for such designation, by aperson who is currently manufacturingor processing such chemical substanceor who anticipates manufacturing orprocessing such chemical substancewithin 90 days following submission.

(3) When may EPA execute a requestto withdraw a Notice of Activity Form B?If EPA receives a request to withdraw apreviously submitted Notice of ActivityForm B from the submitter of the Noticeof Activity Form B and EPA has neitheryet moved the subject chemicalsubstance from the inactive to the activeInventory nor yet moved the subjectchemical substance from theconfidential portion of the Inventory tothe public portion of the Inventory as aresult of the original submission, thenEPA may execute the request.

§710.33 Co-manufacturers and coprocessors.

(a) Notice of Activity submitted by coman ufacturers. When, in a singleinstance of manufacturing or importing

a particular volume of a chemicalsubstance during the lookback period,two or more persons qualify as themanufacturer or importer of thatvolume, they may determine amongthemselves who should make therequired submission under § 710.25(a).If no notice is submitted as requiredunder this subpart, EPA will hold eachsuch person liable for failure to submita notice.

(b) Notice of Activity by prospectiveco-manufacturers or co-processors. Iftwo or more persons intend tomanufacture, import, or process aparticular volume of an inactivesubstance, such that multiple personswould qualify as the manufacturer,importer, or processor of that volume,they may determine among themselveswho will submit the required noticeunder § 710.25(c). If no notice issubmitted as required under thissubpart, all of the persons remainsubject to the reporting requirements,and EPA will hold each such personliable for a failure to submit a noticeprior to the date of manufacturing,importing, or processing.

§ 710.35 Recordkeeping requirements.Each person who is subject to the

notification requirements of this partmust retain records that document anyinformation reported to EPA. Recordsrelevant to a Notice of Activity under§ 710.25(a) and § 710.25(b) must beretained for a period of 5 yearsbeginning on the last day of thesubmission period. Records relevant toa Notice of Activity under § 710.25(c)must be retained for a period of 5 yearsbeginning on the day that the notice wassubmitted.

§ 710.37 Confidentiality claims.(a) Chemical identity. A person

submitting information under this partmay request to maintain an existingclaim of confidentiality for the specificchemical identity of a reportablechemical substance, but may do so onlyif the identity of the chemical substanceis listed on the confidential portion ofthe Inventory as of the time the noticeis submitted for that chemical substanceunder this part. A request to maintainan existing claim of confidentiality mustbe made at the time the information issubmitted. If no person submitting theinformation specified in § 710.29(d)(4)for a particular chemical substancerequests that the claim be maintained,EPA will treat the specific chemicalidentity of that chemical substance asnot subject to a confidentiality claimand will move the chemical substanceto the public portion of the Inventory.Except as set forth in this subsection,

information claimed as confidential inaccordance with this section will betreated and disclosed in accordancewith the procedures in 40 CFR part 2,subpart B.

(1) Notice of Activity Form A. Aperson requesting to maintain anexisting claim of confidentiality forspecific chemical identity may submitwith the notice answers to the questionsin paragraphs (c)(1) and(c](2) of thissection, signed and dated by anauthorized official. If these answers aresubmitted less than five years before thedate on which substantiation is duepursuant to TSCA section 8(b)(4)(D)(i),the answers will be deemed to besubstantiations made under TSCAsection (8)(b)(4)(D)(i) and the personwill be exempt from furthersubstantiation requirements underTSCA section (8)(b)(4)(D)(i). Answersthat do not include the answers to allapplicable questions in paragraph (c) ofthis section will not be deemed to besubstantiations made under the TSCAsection (8)(b)(4)(D)(i] requirement.

(2) Notice of Activity Form B. Aperson requesting to maintain anexisting claim of confidentiality forspecific chemical identity must submitanswers to the questions in paragraphs(c)(1) and (c)(2) of this section within 30days of submitting the notice, signedand dated by an authorized official. Ifthis information is not submitted within30 days of submitting the notice, EPAwill consider the confidentiality claimas deficient, so that the specificchemical identity is not subject to aconfidentiality claim, and may make theinformation public without furthernotice.

(b) Information other than specificchemical identity. A person submittinginformation under this part may asserta claim of confidentiality forinformation other than specificchemical identity. Any suchconfidentiality claim must be made atthe time the information is submitted.Except as set forth in this section,information claimed as confidential inaccordance with this subsection will betreated and disclosed in accordancewith 40 CFR part 2, subpart B. A personasserting a claim of confidentialityunder this subsection must submit withthe notice answers to the questions inparagraph (c)(1) of this section, signedand dated by an authorized official. Ifno claim is asserted at the time theinformation is submitted, or if theanswers to the questions in paragraph(c)(1) of this section are not provided,EPA will consider the information asnot subject to a confidentiality claimand may make the information publicwithout further notice.



(c) Substantiation questions. Personsasserting that information is exemptfrom substantiation pursuant to TSCAsection 14(c)(2) must answer only thequestion in paragraph (c)(1)(i] of thissection.

(1) Substantiation questions for anyconfidentiality claim. For anyinformation with a confidentiality claimthat you assert is exempt fromsubstantiation pursuant to TSCA section14(c)(2), answer only the question inparagraph (c)(1)(i) of this section. For allother information with a confidentialityclaim, answer the questions inparagraphs (c)(1)(ii) through (vi] of thissection. If more than one data elementon Form A or Form B is claimed asconfidential, you must answer theapplicable questions individually foreach data element. If the answer to aquestion applies for all confidentialityclaims on the form, indicate this in yoursubstantiation response.

(i) Do you believe that the informationis exempt from substantiation pursuantto TSCA section 14(c)(2)? If youanswered yes, you must individuallyidentify the specific informationclaimed as confidential and specify theapplicable exemption(s).

(ii] Will disclosure of the informationlikely result in substantial harm to yourbusiness’s competitive position? If youanswered yes, describe with specificitythe substantial harmful effects thatwould likely result to your competitiveposition if the information is madeavailable to the public.

(iii] To the extent your businnss hasdisclosed the information to others(both internally and externally], whatprecautions has your business taken?Identify the measures or internalcontrols your business has taken toprotect the information claimed asconfidential: Non-disclosure agreementrequired prior to access; access islimited to individuals with a need-to-know; information is physicallysecured; other internal controlmeasure(s). If yes, explain.

(iv) Does the information appear inany public documents, including (butnot limited to] safety data sheets,advertising or promotional material,professional or trade publication, or anyother media or publications available to

the general public? If you answered yes,explain why the information should be,treated as confidential.

(v] Is the claim of confidentialityintended to last less than 10 years? If so,indicate the ntimber of years (between1—10 years) or the specific date!occurrence after which the claim iswithdrawn.

(vi) Has EPA, another federal agency,or court made any confidentialitydetermination regarding informationassociated with this chemicalsubstance? If you answered yes, explainthe outcome of that determination andprovide a copy of the previousconfidentiality determination or anyother information that will assist inidentifying the prior determination.

(2) Substantiation for confidentialityclaims for chemical identity. Is theconfidential chemical substancepublicly known to have ever beenoffered for commercial distribution inthe United States? If you answered yes,explain why the information should betreated as confidential.

(d) Confidentiality of substantiation. Ifany of the information contained in theanswers to the questions listed inparagraph (c)(1) or (c](2) of this sectionis claimed as confidential businessinformation, the submitter must clearlyindicate such by marking thesubstantiation as confidential businessinformation as provided in a Notice ofActivity Form A or Form B.

(e) Certification statement for claims.An authorized official of a personsubmitting or substantiating a claim ofconfidentiality or a request to maintainan existing claim of confidentiality forspecific chemical identity must certifythat the submission complies with therequirements of this part by signing anddating the following certificationstatement: “I certify that all claims forconfidentiality made or sought to bemaintained with this submission aretrue and correct, and all informationsubmitted herein to substantiate suchclaims is true and correct. Any knowingand willful misrepresentation is subjectto criminal penalty pursuant to 18U.S.C. 1001.” I further certify that it istrue and correct that:

(1] My company has taken reasonablemeasures to protect the confidentialityof the information;

(2] I have determined that theinformation is not required to bedisclosed or otherwise made available tothe public under any other Federal law;

(3) I have a reasonable basis toconclude that disclosure of theinformation is likely to cause substantialharm to the competitive position of mycompany; and

(4) I have a reasonable basis to believethat the information is not readilydiscoverable through reverseengineering.

§ 710.39 Electronic filing.

(a) EPA will accept informationsubmitted under this subpart only ifsubmitted in accordance with thissection. All information must besubmitted electronically to EPA viaCDX. Prior to submission to EPA viaCDX, Notices of Activity and anyassociated information must begenerated and completed using the eNOA software module.

(b] Obtain instructions for registeringin CDX as follows:

(1] Web site. The CDX RegistrationUser Guide is available at https://www.epa.gov/sites/production/files/documents/cdxregistrationguide_vO02.pdf. To register in CDX, go to https://cdx.epa.gov and follow the appropriatelinks.

(2] Telephone. Contact the EPA CDXHelp Desk at 1—888—890—1995.

(3) Email. Email the EPA CDX HelpDesk at [email protected].

(c) Obtain instructions for using CISSand the e-NOA software module asfollows:

(1) Web site. Go to the EPA NewChemicals under the Toxic SubstancesControl Act Web site at https://www. epa .gov/reviewing-newchemicalsunder-toxic-substancescontrol-act-tsca/how-submit-e-pmn andfollow the appropriate links.

(2) Telephone. Contact the EPA TSCAHotline at 1—202—554—1404.

(3) Email. Email the EPA TSCAHotline at TSCA [email protected].[FR Doc. 2017—15736 Filed 8—10—17; 8:45 am]

BILLING CODE 6560—50—P


UNITED STATES COUI+U-FORD1$mQcMqRcU

U1TE Th1tffi’i 1tt UM1A CUUl1 I

ILWJ SJ 1 Q1I

IN THE UNITED STATES COURT OF APPEA S

CEiED FOR THE DISTRICT OF COLUMBIA CIRCU T CLERK

)ENVIRONMENTAL DEFENSE FUND, )

)Petitioner, )

)V. ) No. 17—1201

)UNITED STATES ENVIRONMENTAL )PROTECTION AGENCY, and SCOTT )PRUITT, Administrator, United States )Environmental Protection Agency, )

)R pondents. )

RULE 26.1 DISCLOSURE STATEMENT

Pursuant to Federal Rule of Appellate Procedure 26.1 and D.C. Circuit Rule

26.1, petitioner Environmental Defense Fund (EDF) makes the following

disclosures:

Non-Governmental Corporate Party to this Action: Environmental Defense Fund

(EDF).

Parent Corporations: None.

Publicly Held Company that Owns 10% or More of Party’s Stock: None.

Party’s General Nature and Purpose: EDF, a corporation organized and existing

under the laws of the State of New York, is a national nonprofit organization that


‘ki

links science, economics, and law to create innovative, equitable, and cost-

effective solutions to society’s most urgent environmental problems.

DATED: September 1, 2017 Respectfully submitted,

. s%—Robert P. StockmanEnvironmental Defense Fund1875 Connecticut Ave. NW,Suite 600Washington, DC 20009(202) 572-3398rstockmanedf.orgAttorneyfor PetitionerEnvironmental Defense fund


UN1EDSTATESGOQj

1 O1tIN THE UNITED STATES COURT OF APPE.FOR THE DISTRICT OF COLUMBIA CIRC lIT CLERK

)ENVIRONMENTAL DEFENSE FUND, )

)Petitioner, )

)v. ) No. 17—12.01

)UMIED STATES ENVIRONMENTAL )PROTECTION AGENCY, and SCOTT )PRUITT, Administrator, United States )Environmental Protection Agency, )

)Respondents. )

\%‘‘CERTIFICATE OF SERVICE

I hereby certify that I have served the foregoing Petition for Review and

Rule 26.1 Disclosure Statement on Respondents by sending a copy via hand

delivery to each of the following addresses on this 1st day of September, 2017.

Correspondence Control UnitOffice of General Counsel (2311)U.S. Environmental Protection Agency1200 Pennsylvania Ave. NWWashington, DC 20460

Scott PruittEPA Headquarters (1101 A)U.S. Environmental Protection Agency1200 Pennsylvania Ave. NWWashington, D.C. 20460


Jeff SessionsAttorney GeneralU.S. Department of Justice950 Pennsylvania Avenue NWWashington, D.C. 20530

pJ p’Robert P. StockmanEnvironmental Defense Fund1875 Connecticut Ave. NW,Suite 600Washington, DC 20009(202) 572-3398rstockmanedf.orgAttorneyfor PetitionerEnvironmental Defense Fund


received clerk united states environmental · 2017-09-12 · dated: september 1, 2017 respectfully...

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