Alpha-Omega Services0 Inc.

May 1, 2012

ATTN: Document Control DeskDirector, Division of Spent Fuel Storage and TransportationOffice of Nuclear Material Safety and SafeguardsU.S. Nuclear Regulatory CommissionWashington, DC 20555-001

SUBJECT: REQUEST FOR EXTENSION OF AUTHORIZATION FOR LIMITED SHIPMENTS AOS 5979,TYPE B PACKAGE, USA/5979/B (.

DOCKET: 71-9316, 71-5959TAC No: LA-0129

Dear Sir or Madam,

This letter serves as a request from Alpha-Omega Services, Inc. (AOS) for an extension of theexpiration date of the Authorization for Limited Shipments for the AOS 5979 package, due todelays in the manufacture of the replacement Model No. AOS-100 package and the ElektaGamma Knife Loading Machine. AOS requests that the NRC extend the Authorization for LimitedShipments to December 31, 2012 to allow for completion of the 42 shipments currentlyauthorized under DOT SP-14772 which expires June 30, 2012. No additional shipments arerequested

The Requested Information, per NRC RIS 2008-18, "Information on Requests for Extending Useof Expiring Transport Packages", in addition to the information requested in your lette& datedApril 25, 2012, is attached to this letter. A copy of this letter and its attachment has been sent tothe DOT, in accordance with 49 CFR 107.105.

If you have any questions concerning this request, please contact me at (562) 804-0704 orbrobnett@alpha-omegaserv.com. Thank you for your consideration.

Sincerely,

Bob A. RobnettDirector Operations & Regulatory AffairsAlpha-Omega Services, Inc.9156 Rose StBellflower, CA 90706

9156 Rose Street e P.O. Box 789 o Beliflower, California, U.S.A 90706

Customer Service (800) 346-7894 • (562) 804-0604 * Fax: (562) 804-0610

www.alpha-omegaserv.com

REQUESTED INFORMATION

Licensees or certificate holders who have identified the need to use these packages should provide thefollowing information to NRC and DOT, before the October 1, 2008, expiration date:

(1) Package Information.

NRC Certificate of Compliance Number or DOT Specification Number.

DOT SP-14772

(2) Identification of Shipments.

(a) Number of shipments; (b) number of packages per shipment; (c) packaging serial numbers; (d)package contents; (e) end use of the radioactive material; (f) shipment origin and destination; (g)mode; (h) general timeframe (e.g., first quarter 2009); and (i) date last shipment will be completed.

The proposed shipments under this extension shall consist of Cobalt 60 (Co-60) in SpecialForm encapsulation, for the treatment of brain ailments at domestic hospitals. Becausethese shipments must meet the criteria of Radioactive Materials of Concern (RAMQC), theyare subject to additional security measures, as defined in U.S. NRC Order EA-05-006.Shipment details cannot be published until the shipment has occurred. All shipments will betransported as "Exclusive Use." Shipments will originate at the source fabrication facility,and terminate at a hospital facility where the sources are installed into the Gamma Knifeunit. The projected estimate of number of shipments is 10. In addition, the sources removedfrom the treatment unit in case of a re-load, will be transported from the hospital to therecycling facility. It is estimated that there will be 5 shipments of this type for a total of 15shipments.

AOS 5979 packages S/N AOS I and AOS Il/1IlA are currently used in accordance with specialpermit DOT SP-14772 with 42 authorized shipments to be completed between November 1,2011 and June 30, 2012. Only 20 of the 42 authorized shipments will have taken place by30JUN12. This letter does not request additional shipments, but merely additional time tocomplete the already authorized 42 shipments.

All shipments throughout this authorized extension have been considered "critical" as eachshipment ultimately affects the treatment of patients. The 42 shipments requested as partof the current extension were calculated based on the current schedule at that timemultiplied by 1.5 to allow for any additional shipments.

There are many factors which affect the Co-60 shipment schedule, to include:

a. Loading Machine: Elekta Region North America (Elekta RNA) has only one (1)

loading machine. Therefore Co-60 delivery dates must coincide with the loader's

availability.

b. Contracts: Elekta RNA Sales must commit to an available loader/Co60 during the

sales cycle. Agreements are signed 3-12 months in advance, 36 months in some

cases.

c. Certificate of Need: Some states require a certificate of need prior to the

delivery and/or installation of the Leksell Gamma KnifeTM.

d. Construction/Renovation: Buyers of the Leksell Gamma Knife do not always

factor in accurate construction durations, permits, inspections, etc. Therefore,

their dates can shift 4-12 weeks from the initial contractual deliver and loading

date.

e. Proiect Costs: Buyer's ability to fund the Leksell Gamma Knife project. There

are cases when construction costs exceed the buyer's budget and therefore

need to push the project out into their fiscal quarter/year.

f. Radioactive Materials Licenses: Elekta requires 6-8 weeks prior to the loading

date. In some cases, the client underestimates the time required to receive their

RML from their state or NRC agent. If it is not received in time, the loading date

is shifted down to the next available slot.

g. Weather: During the Project Planning phase, the team decides if there is

potential for risk to the project schedule. For example, tornado season in

Oklahoma, hurricane season in Florida. If it is deemed a high risk, the loading

date is changed to mitigate that risk.

h. Logistics: Logistics required to shut down major streets, use of cranes; blocking

hospital emergency rooms, operating in high traffic areas like city downtowns,

and holidays must be taken into account. During the planning phase, these are

usually identified, and the team selects an'alternative date, if necessary to

mitigate potential risks.

The following Table lists the proposed shipments to take place July 1, 2012 throughDecember 31, 2012.

"Proposed Shipments!July , 2012' Dember 31, 201-2

No. of Pakg- Shimn Shimn Shpet Simn

3I e

AOS I or 192 C0-60 Cleveland Clinic1 1 AOS Il/Il1A sources Foundation Sunol, CA Cleveland, OH RAMQC 2 days 9JUL12

AOS I or 192 CO-60 International Cleveland,AOS II/IlIA sources Isotopes Idaho Inc. OH Idaho Falls, ID RAMQC 2 days 14JUL12

AOS I or 192 CO-60 Akron General1 1 AOS Il/I11A sources Medical Center Sunol, CA Akron, OH RAMQC 2 days 16JUL12

AOS I or 201 CO-60 University of Sunol, CA Fairview, MN RAMQC 2 days 23JUL12AOS Il/lIIA sources Minnesota

AOS I or 201 CO-60 International Fairview, Idaho Falls, ID RAMQC 2 days 28JUL12AOS Il/I11A sources Isotopes Idaho Inc. MN

AOS I or 192 CO-60 Legacy Good Sunol, CA Portland, OR RAMQC 2 days 13AUG12AOS Il/IIIA sources Samaritan

AOS I or 192 CO-60 Barrow Neurological Sunol CA Phoenix, AZ RAMQC 1day 20AUG12AOS II/IIIA sources Institute I St. Joseph

AOS I or 192 CO-60 International Phoenix, Idaho Falls, ID RAMQC 1 days 24AUG12AOS Il/lIlA sources Isotopes Idaho Inc. AZ

AOS IIor 192 CO-60 Sacred Heart Sunol, CA Pensacola, FL RAMQC 3 days 10SEP12AOS IlI/lII A sources

AOS I or 192sCo-60 UCSF Sunol, CA San Francisco, CA RAMQC 1 days 14OCT1211 AOS Il/lIlA sources

AOS Ior 192 CO-60 International SanAOS 11/111A ces Internahonc. Francisco, Idaho Falls, ID RAMQC 1 days 19OCT1211 AOS Il/lIlIA sources Isotopes Idaho Inc. CA

AOS I or 192 CO-60 Barnes Jewish Sunol, CA St. Louis, MO RAMQC 2 days 5NOV12AOS Il/Il1A sources Hospital

AOS I or 192 CO-60 Louisiana State Sunol, CA Shreveport, LA RAMQC 2 days 26NOV12AOS Il/lI1A sources University

AOS I or 201 CO-60 William Beaumont Sunol, CA Royal Oak, MI RAMQC 2 days 03DEC12AOS Il/lI1A sources Hospital

AOS I or XXX CO-60 International Royal Oak, Idaho Falls, ID RAMQC 2 days 08DEC12AOS II/Il1A sources Isotopes Idaho Inc. MI I I I

Table 1

(3) Reasons for Requestinq Extended Use.

Justification for extending the use of expiring packages must describe why acquiring replacementpackages is not practical and why shipments cannot be made before the October 1, 2008, expirationdate. The justification must demonstrate that: (a) there are no alternative domestically approvedpackages available; (b) the contents cannot be re-configured such that transport can be conducted inaccordance with the regulations; and (c) the transport schedule cannot be adjusted so as to beconducted in accordance with the regulations. The justification must also describe any good-faithefforts to acquire replacement packages that meet the current package performance requirements,including a detailed description of past activities and the current status of acquiring replacementpackages. In addition, any adverse impacts that will result if the shipment is not conducted should be

fully described.

The AOS-5979 container is used to transfer either 201 or 192, dependent upon GammaKnife model, of Co-60 sealed sources. Each source contains up to 33 Ci of Co-60. Thesesources are either installed or removed from the Gamma Knife unit, which is manufacturedby Elekta AB, a Swedish company. The AOS-5979 package is docked with the Gamma Knifeunit by use of a "Loading Machine," designed for use with the AOS 5979 for domesticallylocated Gamma Knifes, and the Croft 2773A container for internationally located GammaKnifes.

Without use of the AOS 5979 container, loading and unloading operations of Co-60 sourcesinto/from the Gamma Knife unit will be disrupted at best or completely stopped at worst,resulting in delays and/or suspension of this life-saving procedure to patients in need of thisservice.

To date, there are no compatible replacement packages available commercially. The AOS-100, replacement for the 5979 package, has been under development since 2005 and waslicensed February 28, 2012. The first AOS-100 package is expected to be ready for useapproximately October 1, 2012. Table 2, below, details the AOS-100 package fabricationschedule.

Due to the quantity and activity of the Co-60 sources, the contents cannot be reconfiguredin any way as to allow shipments to be made in accordance with the regulations. Further,the 5979 package is the only domestically approved package available which is compatiblewith the Elekta Gamma Knife Loading Machine.

The transport schedule cannot be adjusted so as to be conducted in accordance with theregulation.

As described above the Elekta Loading Machine is required for loading and unloading theGamma Knife, however the current loading machine is not compatible with the AOS-100package. This issue required Elekta to redesign the Loading Machine to accommodate theAOS-100 package. AOS was only made aware of the delays in design, manufacture, anddelivery of the Elekta Loading Machine on March 5, 2012, at which time, AOS immediatelycommunicated this issue to the NRC and requested a meeting. See Section 5 below for adetailed fabrication schedule of both the AOS-100 package and the Elekta Gamma KnifeLoading Machine.

Table 2 below lists the past activities and current status of the replacement package.

Replacement Package Past Activities and Current Status

125FEB05 - 13APR07 Design, Prototype, and Testing of the AOS Package Prototype

14APR07 - 16OCT07 SAR document preparation

17OCT07 Submitted SAR Rev A

28APR08 Withdrew SAR Rev A

19JUN09 Submitted SAR Rev B

31JUL09 Received SAR Rev B RAI's

15SEP09 Submitted SAR Rev C and RAI Response

24DEC09 Received SAR Rev C RAI's

30SEP10 Submitted SAR Rev D and RAI Response

22MARI1 Received SAR Rev D RAI's

19OCT11 Submitted SAR Rev E and RAI Response

21NOV11 Received Email request for SAR Rev E Clarification

1FEB12 Submitted SAR Rev F

28FEB12 Received Certificate 71-9316

1MAR12 Initiated AOS-100 production

Table 2

(4) Safety Justification for Continued Use and Proposed Compensatory Measures.

Since the expiring package designs may lack safety enhancements included in newer designs, therequest must include a safety justification for continued use and a description of compensatorymeasures that will be used to provide an equivalent level of safety. Examples of compensatorymeasures that may be considered are: (a) special package inspections, tests, or determinations that

ensure that the packaging is in unimpaired physical condition; (b) transport by exclusive use; (c)transport during time of low road usage; and (d) accompaniment of shipment by escort equipped toeffect a recovery in an emergency situation or in case of a transportation accident.

The following measures will be taken to ensure package safety during the extension:

a) Both 5979 packages, S/N's AOS I and AOS Il/IIIA have received successful AnnualInspections within the last 4 months.

b) Conduct all shipments under this extension as "Exclusive Use" in accordance with USNRC Order EA-05-006.

(5) A Plan and Schedule to Acquire Replacement Packaqes or Complete Necessary Shipments.

Details about the planned acquisition of replacement packages must be provided, along with keymilestones, and proposed implementation dates, unless the licensee can show why acquiring areplacement package is not practical and why shipments cannot be made before the October 1, 2008,expiration date.

To date, there are no compatible replacement packages available commercially. The AOS-100, replacement for the 5979 package, has been under development since 2005 and waslicensed February 28, 2012. The first AOS-100 package is expected to be ready for useapproximately October 1, 2012.

The difference in AOS-100 schedule completion dates, JUN 2012 vs. OCT 2012, can beattributed to issues related to the Pallet, Cage, & Tie Down System. Specifically, the originaldesign specified aluminum, which now appears to not retain its strength in the weld zones.This system is now being fabricated using stainless steel. All other anticipated delays in thefabrication schedule have already been taken into account in Table 3, below.

Table 3, below, details the AOS-100 fabrication schedule.

* AOS-100 Fabrication Schedule'

DIat Activity/Milestone

2012Activity

Q1 Q2 Q3 Q4

Received Certificate

Cask & Impact LimiterFabrication M NI

Pallet, Cage, Tie DownSystem Fabrication

Leak Test

Thermal Test

TrainingTable 3

Table 4, below, details the Elekta Gamma Knife Loading Machine fabrication schedule.

[ ~ ~ E " . ' kta Loading Machine Develop ment/Fa brication Schedule

2011 2012Activity

Q3 Q4 Q1 Q2 Q3 Q4

Concept/ PreliminaryDesign

System RequirementSpecifications

Detailed Design

Freeze long Lead TimeItems (Castings)

Freeze long Lead TimeItems (Machining's)

Fabrication - Castings

Fabrication - Machining

Assembly mmVerification and Validation

i able I-1

AOS/Elekta may be able to use Nordion (Ottawa, ON, Canada) as the source supplier, while

using the Croft 2773A package. However, the use of foreign sources is limited by:

* Customer license may not allow Nordion sources

• Croft 2773A package is not approved for domestic shipments

* Nordion manufacturing capacity may not not sufficient to provide all the

sources needed in the US

* AOS Export license limitations

The consequences of not receiving this time extension include:

" Delays in Gamma Knife reloads resulting in the inability to effectively treat patients

in a timely manner

" The number of patients which can be treated (patient throughput) due to low

activity sources

" In the case of new customers, the complete inability to treat patients

*AOSAlpha-Ormga Services, Inc.

May 1, 2012

Associate Administrator for Hazardous Materials Safety

Attention: Special Permits, PHH-31

Pipeline and Hazardous Materials Safety Administration

U.S. Department of Transportation

East Building

1200 New Jersey Ave, SE

Washington, DC 20590-0001

SUBJECT: REQUEST FOR EXTENSION OF SPECIAL PERMIT DOT-SP 14772.

Alpha-Omega Services, Inc. (AOS) in accordance with the Department of Transportation

Hazardous Materials regulations in 49 CFR 107.109, hereby makes application for renewal of

DOT-SP 14772. A request for extension of authorization for limited shipments has been sent to

the NRC.

" Company Name and Address Include Physical Address if different than mailing address:

Alpha-Omega Services, Inc.

9156 Rose Street

Bellflower, CA 90706

Bob A. Robnett

Tel: 562.804.0604

Fax: 562.804.0610

brobnett@alpha-omegaserv.com

* All Locations (Physical Address) Where Permit Will Be Used:

GE-Hitachi Nuclear Energy Americas, LLCVallecitos Nuclear Center6705 Vallecitos RoadSunol, CA 94586

International Isotopes, Inc.4137 Commerce CircleIdaho Falls, ID 83401

Cleveland Clinic Foundation

9600 Cedar Ave.Cleveland, OH 44195

9156 Rose Street * P.O. Box 789 . Bellflower, California, U.S.A 90706Customer Service (800) 346-7894 * (562) 804-0604 * Fax: (562) 804-0610

www.alpha-omegaserv.com

Akron General Medical Center400 Wabash Ave.Akron, Ohio 44307

University of Minnesota - Fairview516 Delaware St. SEMinneapolis, MN 55455

Legacy Good Samaritan1015 NW 22nd Ave.Portland, Oregon 97210

Barrow Neurological Institute I St. Joseph350 W. Thomas RoadPhoenix, AZ 85013

Sacred Heart5153 N. Ninth Ave.Suites 300 and 302Pensacola, FL 32504

UCSF505 Parnassus Ave.San Francisco, CA 94143

Barnes Jewish Hospital1 Barnes Jewish Hospital PlazaSt. Louis, MO 63110

Louisiana State University1501 Kings HighwayShreveport, LA 71103

William Beaumont Hospital3601 West Thirteen Mile RoadRoyal Oak, Michigan 48073

Chief Executive Officer or President:

Troy Hedger

CEO/President

Dun and Bradstreet Data Universal Numbering System (D-U-N-S) Identifier:

06-039-8989

* Certification of Original Application:

I, Bob A. Robnett, certify that the original application, as it may have been updated by

any application for renewal, remains accurate (e.g., all section references, shipping

descriptions, etc. ) and complete.

* Relevant shipping/accident experience:

Alpha-Omega Services, Inc. has made 20 shipments since the last renewal of this special

permit. Alpha-Omega Services, Inc. has had 0 (zero) incidents involving loss of contents

when making shipments under this special permit.

" Class 1 Material:

Not applicable.

* Renewal after expiration:

Not applicable.

* Justification if no shipments made:

Not applicable.

* Additional Information:

Not required.

Alpha-Omega Services, Inc. requests that the DOT extend Special Permit DOT-SP 14772, allowing

AOS to continue to operate its existing AOS 5979 Package fleet until December 31, 2012. A

request for extension of authorization for limited shipments has been sent to the NRC.

If you have any questions concerning this request, please contact me at 562.804.0604. Similar

requests have been sent to the NRC, following the format provided in NRC RIS 2008-18, dated

August 14, 2008.

Sincerely,

Bob A. Robnett

Director Operations & Regulatory Affairs

Alpha-Omega Services, Inc.

9156 Rose St

Bellflower, CA 90706