9
Page 1 of 3 - - NRC FORM 7 U.S. NUCLEAR REGULATORY COMMISSION APPROVED BY OMB: NO. 3150-0027 EXPIRES: 08 31/2012 (8-2010) Eslimaled burden per response to comply with this mandatory collection request 2.4 h urs. This 10 CFR 110 submittal is reviewed to ensure that the applicable statutory, regulatory, and policy con iderations are satisfied. Send comments regarding burden estimate to the Records and FO fIlPrivacy APPLICATION FOR NRC EXPORT OR IMPORT Services Branch (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 2C555-0001, or by internet e-mail to [email protected], and to the Desk Officer Office of LICENSE, AMENDMENT, OR RENEWAL Information and Regulatory Affairs, NEOB-10202, (3150-0027), Office of Management and Budget, Washington, DC 20503. If a means used to impose an information collectio does not (See Instructions on Pages 4 and 5) display a currently valid OMB control number, the NRC may not conduct or sponsor, an a person is not required to respond to, the information collection. -: ~PUBLIC DATE RECEIVED PART A. FOR NRC USE ONlY OR D NON-PlJBLlC nr:r I\.Q ?n11 .; - LICENSE NUMBER DOCKET NUMBER ADA~AC"C~srON NUMBER i\l}n60 lIOO5<1SI PART B. TO BE COMPLETED FOR ALL LICENSES, AMENDMENTS, OR RENEWALS (If more space is needed to complete any of the items, use Pages 3-4 first, and then attach additional sheets, if necessary.) 1. NAME AND ADDRESS OF APPLICANT/LICENSEE la. NAME OF APPLICANT'S CONTACT lb. APPLICANT'S REFERENCE NUMBE GE Hitachi Nuclear Energy, LLC Brenda ConnerlDonald Krause Vallecitos Nuclear Center lc. PHONE NUMBER ld. FAX NUMBER Attention: Donald R. Krause (910) 819-5641 (910) 362-5641 6705 Vallecitos Road le. E-MAIL ADDRESS Sunol, CA 94586 [email protected] [email protected] 2. TYPE OF ACTION REQUESTED (Check One) o EXPORT [ZJ IMPORT 0 AMENDMENT/RENEWAL (Parts B, C, E) (Parts B, D, E) Existing License Number: 3. CONTRACT NUMBER(S) 4. FIRST SHIPMENT DATE 5. LAST SHIPMENT DATE 6. PROPOSED EXPIRATION DAT 02/0112011 12/0112012 03/0112013 PART C. TO BE COMPLETED FOR EXPORT LICENSES, AMENDMENTS, OR RENEWALS (If more space is needed to complete any of the items, use Pages 3-4 first, and then attach additional sheets, if necessary.) 7. NAME(S) 1 ADDRESS(ES) OF SUPPLIERS 8. NAME(S) I ADDRESS(ES) OF INTERMEDIATE 9. NAME(S) 1ADDRESS(ES) OF ULTIMATE AND/OR OTHER PARTIES TO THE EXPORT FOREIGN CONSIGNEE(S) FOREIGN CONSIGNEE(S) I 7a. FUNC1TION(S) PERFORMED/SERVICE(S) PROVIDED 8a. INTERMEDIATE USE(S) 9a. ULTIMATE END USE(S) 10. DESCRIPTION OF RADIOACTIVE MATERIALS, SEALED SOURCES, lOa. MAX TOTAL VOLUME I lOb. MAX ENRICHMENT 10c. MAX ISOTOPE NUC~EAR FACILITIES, EQUIPMENT, OR COMPONENTS; FOR ELEMENT WGT (KG), OR ORWGT% WGT(KG) NUqLEAR EQUIPMENT INCLUDE TOTAL DOLLAR VALUE OF TOTAL ACTIVITY (TBq) EQU1IPMENT FOR EXPORT 11. FOR IGN OBLIGATIONS (BY COUNTRY AND BY PERCENTAGE OF MAXIMUM TOTAL VOLUME) NRC FORM 7 (8-2010) ~ Dt:L 092011 JM

Revised Import Application for GE Hitachi Nuclear Energy ... · max isotop element wgt (kg), or or wgt % wgt (kg) total activity (tbq) 15. description of radioactive materials, sealed

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Page 1 of 3--

NRC FORM 7 U.S. NUCLEAR REGULATORY COMMISSION APPROVED BY OMB: NO. 3150-0027 EXPIRES: 08 31/2012(8-2010) Eslimaled burden per response to comply with this mandatory collection request 2.4 h urs. This10 CFR 110 submittal is reviewed to ensure that the applicable statutory, regulatory, and policy con iderations

are satisfied. Send comments regarding burden estimate to the Records and FO fIlPrivacy

APPLICATION FOR NRC EXPORT OR IMPORT Services Branch (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 2C555-0001,or by internet e-mail to [email protected], and to the Desk Officer Office of

LICENSE, AMENDMENT, OR RENEWAL Information and Regulatory Affairs, NEOB-10202, (3150-0027), Office of Management andBudget, Washington, DC 20503. If a means used to impose an information collectio does not

(See Instructions on Pages 4 and 5)display a currently valid OMB control number, the NRC may not conduct or sponsor, an a personis not required to respond to, the information collection.

-:

~PUBLIC

DATE RECEIVED

PART A. FOR NRC USE ONlY OR D NON-PlJBLlCnr:r I\.Q ?n11.; -

LICENSE NUMBER DOCKET NUMBER ADA~AC"C~srON NUMBER

i\l}n60 lIOO5<1SIPART B. TO BE COMPLETED FOR ALL LICENSES, AMENDMENTS, OR RENEWALS

(If more space is needed to complete any of the items, use Pages 3-4 first, and then attach additional sheets, if necessary.)

1. NAME AND ADDRESS OF APPLICANT/LICENSEE la. NAME OF APPLICANT'S CONTACT lb. APPLICANT'S REFERENCE NUMBE

GE Hitachi Nuclear Energy, LLC Brenda ConnerlDonald Krause

Vallecitos Nuclear Center lc. PHONE NUMBER ld. FAX NUMBER

Attention: Donald R. Krause (910) 819-5641 (910) 362-56416705 Vallecitos Road le. E-MAIL ADDRESS

Sunol, CA 94586 [email protected] [email protected]

2. TYPE OF ACTION REQUESTED (Check One)

o EXPORT [ZJ IMPORT 0 AMENDMENT/RENEWAL(Parts B, C, E) (Parts B, D, E) Existing License Number:

3. CONTRACT NUMBER(S) 4. FIRST SHIPMENT DATE 5. LAST SHIPMENT DATE 6. PROPOSED EXPIRATION DAT

02/0112011 12/0112012 03/0112013

PART C. TO BE COMPLETED FOR EXPORT LICENSES, AMENDMENTS, OR RENEWALS(If more space is needed to complete any of the items, use Pages 3-4 first, and then attach additional sheets, if necessary.)

7. NAME(S) 1ADDRESS(ES) OF SUPPLIERS 8. NAME(S) I ADDRESS(ES) OF INTERMEDIATE 9. NAME(S) 1ADDRESS(ES) OF ULTIMATEAND/OR OTHER PARTIES TO THE EXPORT FOREIGN CONSIGNEE(S) FOREIGN CONSIGNEE(S)

I7a. FUNC1TION(S)PERFORMED/SERVICE(S) PROVIDED 8a. INTERMEDIATE USE(S) 9a. ULTIMATE END USE(S)

10. DESCRIPTION OF RADIOACTIVE MATERIALS, SEALED SOURCES, lOa. MAX TOTAL VOLUME I lOb. MAX ENRICHMENT 10c. MAX ISOTOPENUC~EAR FACILITIES, EQUIPMENT, OR COMPONENTS; FOR ELEMENT WGT (KG), OR ORWGT% WGT(KG)NUqLEAR EQUIPMENT INCLUDE TOTAL DOLLAR VALUE OF TOTAL ACTIVITY (TBq)EQU1IPMENT FOR EXPORT

11. FOR IGN OBLIGATIONS (BY COUNTRY AND BY PERCENTAGE OF MAXIMUM TOTAL VOLUME)

NRC FORM 7 (8-2010)

~ Dt:L 092011JM

Page 2 of 3

U.S. NUCLEAR REGULATORY COMMISSIONNRC FORM 7(8-2010)10 CFR 110

APPLICATION FOR NRC EXPORT OR IMPORTLICENSE, AMENDMENT, OR RENEWAL (Continued)

~E3L1C2.. _.

OR . D NON-PU. LIe"

ADAMS ACCESSION NUMBJ;::RLIC:;ENS.ENUMBER QOCKET NUMBER'"

PART D. TO BE COMPLETED FOR IMPORT LICENSES, AMENDMENTS, OR RENEWALS(If more space is needed to complete any of the items, use Pages 3-4 first, and then attach additional sheets, if necessary.)

14. NAME(S) / ADDRESS(ES) OF ULTIMATE U. ~.CONSIGNEE(S)

12. NAME(S) / ADDRESS(ES) OF FOREIGN 13. NAME(S) / ADDRESS(ES) OF INTERMEDIATESUPPLIERS AND/OR OTHER PARTIES CONSIGNEE(S)TO IMPORT

Chengdu Gaotong Isotope Corporation NIAB Block Development Building28, South Section 3, Yihuan RoadChengdu, Sichuan, 610041 PR ChinaAtten: Mr. Huang Nengwa

GE Hitachi Nuclear Energy, LLCVallecitos Nuclear CenterAttention: Carlos Martinez6705 Vallecitos RoadSunol, CA 94586

12a. NRC EXPORT LICENSE NUMBER(S) 13a. LICENSE NUMBER(S) / EXPIRATION DATE(S)(if applicable)

14a. LICENSE NUMBER(S) / EXPIRATION DATE S)

N/ACA 0017-01 (CA State License in tin elyrenewal)

13b. INTERMEDIATE USE(S) 14b. ULTIMATE END USE(S)

recycling, forensic testing or long tel mstorage.

15a. MAX TOTAL VOLUME / 15b. MAX ENRICHMENT 15c. MAX ISOTOPELEMENT WGT (KG), OR OR WGT % WGT (KG)TOTAL ACTIVITY (TBq)

15. DESCRIPTION OF RADIOACTIVE MATERIALS, SEALED SOURCES,NUCLEAR FACILITIES

210 Co-60 sealed sources, 7955 TBq (215,000 Ci), as ofApril 1, 2011

See Page 3 for "volume".

16. FOREIGN OBLIGATIONS (BY COUNTRY AND BY PERCENTAGE OF MAXIMUM TOTAL VOLUME)

PART E. TO BE COMPLETED FOR ALL LICENSES, AMENDMENTS, OR RENEWALS

DYES [ZJ NO

18 CERTIFICATION' I, the applicant's authorized official, hereby certify that this application is prepared in conformity with Tit! 10,. . Code of Federal Regulations, and that all information provided is correct to the best of my knowledge.

17. ADDITIONAL INFORMATIONPROVIDED ON PAGES 3, 4,AND/OR ON SEPARATE SHEETS?

17a. COPIES OF RECIPIENTS'AUTHORIZATIONS PROVIDED?[ZJ YES D NO

18b. SIGNATURE -- AUTHORIZED OFFICIAL 18c. DATE18a. PRINT NAME AND TITLE OF AUTHORIZED OFFICIAL

Brenda ConnerShipping / Licensing Support Specialist 12/08/2011

Page 3 of

NRC FORM 7(8-2010)10 CFR 110

U.S. NUCLEAR REGULATORY COMMI SSION

APPLICATION FOR NRC EXPORT OR IMPORTLICENSE, AMENDMENT, OR RENEWAL (Continued)

ADAMS ACCESSION NUMBER~ICENSE-NUMBER

~l 1) {)30-

DOCKET NUMBER

ADDITIONAL INFORMATION (Reference applicable block numbers from page 1 and/or page 2 for each entry)

Description of Sealed Sources for Import:Import of210 Cobalt-60 (Co-60) sources, in Special Form, in one shipment from China, using 3 or 4 IAEA approved ntpe BRadioactive Materials Transport Containers. Said sources were manufactured by Amersham International Pic(Buckinghamshire, England) between June 1988 and March 1996.

In addition to forensic testing of some of the sources, GEH plans to pursue reuse, recycle and resale opportunities for theCo-60.

GEH shall take title and risk-of-Ioss to the Co-60 sources upon release by Customs at the U.S. port of entry. The Co-60sources shall be delivered, processed and/or stored at GEH's Vallecitos Nuclear Center, Sunol, CA, in accordance with tateof California Radioactive Material License No. 0017-01, currently under "timely renewal".

The Co-60 sources were previously used in an industrial environment for gamma ray processing in wet and/or dryirradiation plants. The sources are doubly encapsulated in stainless steel and each source is permanently engraved with itunique serial number. The sources will be accompanied by a report documenting the sources are leak-tight. (The Co-60sources were originally certified as meeting the requirements of "Special Form".)

Maximum Quantity of Material and its Chemical and Physical form.210 CobaIt-60 Seal Sources:Total Activity: 7955 TBq (215,000 en, as of April 1, 2011Chemical Form: Metal OxidePhysical Form: Solid

Volume:The volume of the shipment from China to the U.S. is anticipated to be one shipment, of a highway route controlledquantity, in 3 or 4 IAEA Type B certified radioactive materials shipping packages. The anticipated route of shipment is rysea vessel from the China port of export (to be determined) to the U.S. port of import (currently anticipated to be Tacon a,WA) then overland by truck to the Vallecitos site in Sunol, CA.

3

•GE-Hitachi Nuclear Energy

HITACHI Brenda ConnerShipping / Licensing Support

P.O. Box 780MC K54Wilmington, NC 28402USA

T 910 819 5641F 910 362 5641Brenda. [email protected]

2011-CA-02

December 8,2011

U.S. Nuclear Regulatory CommissionScott MooreDeputy DirectorOffice of International Programs11555 Rockville PikeRockville, Maryland 20852

Subject: Application for Import License/Exemption

Attached please find GEH's revised import license application/exemption for the import of 210 Co-60sealed sources from China. Payment of $9,900 was previously sent to the NRC on February 7, 2011,document reference number 337012517.

The Co-60 sources in question were manufactured by Amersham International Pic (Buckinghamshire,England) between June 1988 and March 1996 and operated in 24 irradiator plants located withinChina. With the assistance of China Isotope Corporation (CIC) a subsidiary of China National NuclearCorporation (CNNC), the sources are to be collected at the Chengdu Gaotong central plant andpackaged for export to the U.S., care of GE Hitachi Nuclear Energy Americas, LLC, with operations atthe Vallecitos Nuclear Center, Sunol, California.

General Electric Company, through acquisition of the source manufacturer, has legal responsibility forthe disposal of the above referenced sources. GEH, as a corporate affiliate of the General ElectricCompany, requests this license or license exemption to enable the General Electric Company to fulfillits contractual obligations.

DEe 0'9 20ffGE Hitachi Nuclear Energy

Nuclear Regulatory CommissionImport License ApplicationPage 2

As previously communicated, GEH plans to pursue reuse, recycle and resale opportunities; however,GEH does not presently have contractual commitments for the resale of the Co-60.

If you have any questions regarding the attached application or the contents of this transmittal, pleasegive me a call.

Thank you for your assistance.

Sincerely,

Brenda Conner

cc: Bryce MacDonaldCarlos MartinezTony McFaddenMark Varno

Attachments: NRC Form 7CA State License 0017-01

GE Hitachi Nuclear EnergyDEe 09 201

,.", . ~. - - •.•.... --<. - -- - - ..

... . -." "._ .... ...... . .. _ ...... .... _. .. . . - .... .... ._. _ .... ..... --.. .. . ..... - ... . - .. .. - .. .. ..

_ .l?t.!ite of California-Health and Human Services Agency:

California Department of Public Health

I ..Page 1 of 4 p~ges

I ..- RADIOACTIVE MATERIAL LICENSEI! Pursuant to the California Code of Regufations, Division 1; Titfe 17, Chapter 5, Subchapter 4, Group 2, Licensing of Radioactive Mated t. andI In reliance on statements and representations heretofore made by the licensee, a license is hereby issued authorizing the licensee to TI ceive,

I use, possess, transfer, or dispose of radioactive material listed below; and to use such radioactive material for the purpose(s) and at theplace(s) designated below. This license Is subject to all applicable rules, regulations, and orders of the Department of Public Health r ow or

I hereafter In effect and to any standard or specific condition specified in this license.,

1. Licensee GE - Hitachi Nuclear Energy Americas, LLC 3. License Number

Vallecitos Nuclear Center 0017-01 Amendment Numbe :72

2. Address 6705 Vallecitos Road 4. Expiration date

Sunol, CA 94586 December 6, 2009 (2)Attention: Donald R. Krause 5. fnspection agency Radiologic Health Branch

Radiation Safety Officer North

In response to the letter dated October 13, 2011, with attachments signed by Donald R. Krause, Radiation S fetyOfficer, License Number 0017-01 is hereby amended as follows: .

II

I 6. Nuclide 7. Fonn 8. Possession Limit

I A. Hydrogen-3 A. Any A. Not to exceed 100 curies.

IB. Any radionculide with atomic B. Any B. Not to exceed 100 curies for a y .'

I numbers 3-83 inclusive. one radionuclide except forI Cobalt-60. Cobalt-60 not to

exceed 20,000 Curies. Total Il otto exceed 70,000 curies.

C. Any radionuclide with atomic C. Any C. Not to exceed 100 curies for a ynumbers 84-105 inclusive except: one radionuclide, total not tosource material and special nuclear exceed 10,000 curies.

, material.

I D. Any radionuclide with atomic number D. Liquid waste D. Not to exceed 100 curies.3-83 inclusive except: source materialand special nuclear material.

E. Any radionuclide except: source E. Activation products in E. Not to exceed 500,000 curies t tal.material and special nuclear material. components and materials

removed from nuclear reactorsF. Source material F. Any F. Not to exceed 25,000 pounds.

G. Cobalt-60 G. Any G. Not to exceed 2 megacuries. II

IH. Cesium-137 H. Any H. Not to exceed 200,000 curies.

II. Xenon-133 1. Gas I. Not to exceed 1,000 curies.J. Californium-252 J. Sealed source (General Electric J. One source not to exceed 2 cur es.

Model GE-CF-I00)

9. Authorized Use

, A-C., E., F. and J. To be used for research and development as defined in Title 17, California Code of Regulati ns,Section 30100, manufacturing, calibration of instruments, and distribution or transfer to specific licensees of theU.S. Nuclear Regulatory Commission or Agreement States, or exempt government agencies.

D. To be used incidental to the processing of liquid radioactive waste and in the packaging of processed waste fi rdisposal. Waste processing and packaging shall not be performed as a customer service to other licensees.

G. To be used for fabrication of sealed sources and distribution to specific licensees of the U.S. Nuclear Regulat ryCommission or Agreement States, or exempt government agencies. To be used for the irradiation of materia s.

~ OFe 0'9 2U11cr

State of California·Health arid Human Services Agenc¥ . G~!lfQrnia Qepartment .of Publl

RADIOACTIVE MATERIAL LICENSE

Page 2 of 4

Amendment Numb r: 72

H. To be used for distribution to specific licensees of the U.S. Nuclear Regulatory Commission or AgreementStates, or exempt government agencies. Provide secondary encapsulations for sealed sources.

I. To be used for distributioIl to specific licensees of the U.S. Nuclear Regulatory Commission or Agre mentStates.

LICENSE CONDITIONS

10. Radioactive material shall be.used only at the following location:

(a) 6705 Vallecitos Road,Pleasanton, CA.

11. This license is subject to an annual fee for sources of radioactive material authorized to be possessed at any on timeas specified in Items 6, 7, 8 and 9 of this license. The annual fee for this license is required by and comput d inaccordance with Title 17, California Code of Regulations; Sections 30230-30232 and is also subject to an a nualcost-of-living adjustment pursuant to Section 100425 of the California Health and Safety Code.

12.. Radioactive material may be used only by, or under the supervision of, individuals designated by the area manag r.

13. Except as specifically provided otherwise by this license, the licensee shall possess and use radioactive ma erialdescribed in Items 6, 7, 8 and 9 of this license in accordance with the statements, representations, and proce urescontained in the documents listed below. The Department's regulations shall govern unless the state nts,.representations, and procedures in the licensee's application and correspondence are more restrictive tha theregulations. ..

(a) . The letter with attachment dated July 29, 1996, signed by G. E. Cunningham; the letter dated June 3, 1998,signed by B. M. Murray; the letter with attachments dated July 20, 1998, signed by B. M. Murray; the letter ithattachment dated August 24, 1998, signed by B. M. Murray; the letter with attachment dated January 15, 1 99,signed by C. W. Bassett and the fax letter dated February 10, 1999, signed by C. W. Bassett.

(b) The letter with attachment dated March 16; 1999, signed by B. M. Murray regarding removal of exem tionrequest from renewal application.

(c) The letters dated August 29, 2001 and March 23, 2001, with attachments, both signedby Chris Rami ton,regarding procedures for the Xe-133 shipping calibrator. .

(d) The letters dated September 26, 2003, signed by Louis M. Quintana and March 24, 2004, signed by D vidTurner regarding modifying license conditions 19,20, and 21 for clarification purpose.

(e) The letter with attachments dated April 30, 2004, signed by Keith S. Sherin, Senior Vice President, regar ingdecommissioning funding plan. .

(f) The letter with attachments dated June 26, 2006, signed by David W. Turner, Manager, Vallecitos Nuc earCenter-regarding the appointment of Latonya 1. Martin as Radiation Safety Officer.

(g) The letter with attachment dated February 26, 2007, signed by Latonya 1. Martin, Radiation Safety Offi er,regarding the transfer of the radioactive material license to GE - Hitachi Nuclear Energy Americas, LLC.

(h) The letter with attachments dated September 11, 2008, signed by Donald R. Krause, Manager, Regulatory ndCompliance and EH&S, Vallecitos Nuclear Center regarding the appointment of Donald R. Krause as Radia ionSafety Officer and Thomas A. Caine as Chairperson of the Vallecitos Technological Safety Council.

14. (a) The Radiation Safety Officer in this program shall be Donald R. Krause.

(b) The Chairperson of the Vallecitos Technological Safety Council shall be Thomas A. Caine.

;----.....".---:------t------------:-------:---:--.---.---- ...--.--- -~.-- _..-_.----'.'-."

State of California-Health and Human ServIces Agency. Californi~ DePClr!mli!lJt of Pub"

RADIOACTIVE MATERIAL LICENSE

15. All uses of radioactive materials authorized under this license, 'shall be in accordance with the user's hangeAuthorization request and all modifying requirements imposed pursuant to site safety standards. The rev ew ofChange Authorization requests shall include findings relative to matters specified in California Code of Regul tions,Title 17, Section 30194. The licensee shall maintain records relative to their Radiation Safety Program. Pro isionsof their program shall include audits and reviews of the program's content including implementation proceedin sandbe available for review by the Department or its authorized representative.

16. The licensee shall distribute only sealed sources and/or devices for which a Sealed Source and Device R gistryCertificate has been issued by the California Department of Public Health, the U.S. Nuclear Regulatory Comm ssion,or other Agreement State. Sealed sources and/or devices distributed must adhere to the design specifi tionsdescribed in the Sealed Source and Device Registry Certificate. Any changes in the design or specifications 0 thesesealed sources and/or devices require the distributor to apply for and receive an amendment to the Sealed Sour e andDevice Registry Certificate prior to distribution. The licensee may distribute sources and/or devices without a ealedSource and Device Registry Certificate provided the recipient is authorized to possess such items by I censecondition or applicable State or Federal regulations and laws.

17. Each sealed source fabricated by the licensee shall be inspected and tested for construction defects, leakage,'contamination prior to use or transfer as.a sealed source. Ifthe inspection or test reveals any construction def ts or .0.005 microcuries or greater of contamination, the source shall not be used or transferred as a sealed source u til ithas been repaired, decontaminated; and re-tested.

18. Records of leak test results shall be kept in units of microcuries and maintained for inspection. Recordsm y be'disposed of following Department inspection. Any leak test revealing the presence of 0.005 microcuries or m re ofremovable radioactive material shall be reported to the California Department of Public Health, Radiologic ealthBranch, MS 7610, P.O. BOX 997414, Sacramento, CA 95899-7414, within five days of the test. This report shallinclude a description of the defective source or device, the results of the test, and the corrective action taken.

19. Sealed sources possessed under this license shall be tested for leakage and/or contamination as required by,Titl 17,California Code of Regulations, Section 30275 (c). '

20. The licensee shall conduct a physical inventory every six months to account for all sealed sources and/or de icesreceived and possessed under the license. The physical inventory may be of a sealed container that contains mu tiple.sealed sources with tamper proof seals to ensure the contents of the container have not been changed. Excluded amthe physical inventory requirement are sealed sources that are no longer used and maintained as sealed sou ces.Examples of excluded sealed sources are sources and source sets recovered from customers so that the radioa tivematerial may be recovered and used as raw material. Such recovered sources are subject to the general require entsfor radioactive material and are maintained in Hot Cells or transportation casks in a "security area" as define byorders from the Nuclear Regulatory Commission. Records of the inventories shall be maintained for inspection, andmay be disposed offollowing Department inspection.

21. Sealed sources installed as calibration sources in hot cells, are not subject to the periodic leak testing requiremen s as .specified in California Code of Regulations. Other sealed sources are excluded from California CodeofRegulat onsperiodic leak test requirements provided that:

(a) Such sources are mai~tained in Hot Cells or transportation casks in a "security area" as defined by orders om'the Nuclear Regulatory Commission; such. sources are no longer used as sealed sources and the integrity 0 thesource is not expected to be maintained', or .

(b) Such sources are contained within sealed devices such as ion chambers and leak test survey of the sourc IS

performed prior to and following the disassembly operation of the device for any reason.

22. This license does not authorize any exemptions from federal or state regulations relative to the productio or, distribution of radiopharmaceuticals.

I

i'

I~DEC 0'920 J~~ .

.. ~~ ~ ---: , -. ':-.'--'.::-:---."-'. _., -:.-::-.-::-:.,--,:- .._./ .. ' ..I.. ___ .- -_.. - .1--"·· .. State of Califor~la~Healthand Human Services Agency

II RADIOACTIVE MATERIAL LICENSE

California Dep.~rtl!lE:!ntofPlJ~llgtteaJth

Pag-e4of 4 ages

23. Radioactive waste generated shall be stored in accordance with the statements, representations, and procincluded with the waste storage plan described in Condition l J (a).

24. In accordance with the California Code of Regulations Title 17, Section 30195.1, the licensee shall maint in anacceptable financial instrument in the amount of $46,600,000 that satisfies the requirements outlined i thedecommissioning funding plan dated April 30, 2004 if:

(1) The possession limit of unsealed licensed material specified in this license, has a half life greater tha 120days, and each isotope is greater than 105 times the applicable quantities listed in the Code of FeralRegulations, Title 10, Part 30, Appendix B; or -

(2) The possession limit of unsealed licensed material specified in this license, has a half life greater th 120days, and for a combination of isotopes, R (sum of the ratios) divided by 105 is greater than 1.

25. Each sealed source manufactured after February 6, 2007 that contains a quantity equal to or greater than Categ ry 1or Category 2 levels of any radioactive material (i.e. a nationally tracked source) listed in AppendixE of 10 CF 20,Nationally Tracked Source Thresholds, as published in the November 8, 2006 publication of the Federal Registe (71FR65685 (Nov. 8, 2006)) shall be assigned a unique serial number. Serial numbers shall be composed on y ofalpha-numeric characters. -

26. At least 30 days prior to vacating any address of use listed in Condition 1'0of this license, the licensee shall pr ide-. written notification thereof to the California Department of Public Health, in accordance with Title 17, Calif! rnia

Code of Regulations, Section 30256 (b).

27. The licensee will provide the Low Level Radioactive Waste (LLRW) reports specified in the California Health andSafety Code section 115000.l(h) to the California Department of Public Health (CDPH) on an.annual basis for oth

- shipped and stored LLRW. Alternatively, LLRW shipment information may be provided on a per shipment b sis.LLRW shipment information and annual reports shall be mailed to:

. Attn: LLRW TrackingProgramCalifornia Department of Public HealthRadiologic Health Branch MS 7610P.O. Box 997414Sacramento, CA 95899~7414

28.. The licensee shall comply with the inventory and transaction reporting requirements in 10 CFR 20.2207 (1-1-08 ..Edition) for nationally tracked sources. Note that transaction reports are required for any manufacture, transfer,receipt, disassembly, or disposal of a nationally tracked source, otherwise allowed by this license, by the nextbusiness day after the transaction. A nationally tracked source, as defined in 10 CFR 20.1003 (1-1-08 Edition) ref rsto a sealed source containing a quantity equal to or greater than Category I or Category 2 levels of any radioactivmaterials listed in Appendix E to 10 CFR Part 20 - ''Nationally Tracked Source Thresholds." (1-1-08 Edition).

Date: November 15,2011

Issued for the California Department of Public Health

.By: ~~Ronald Rogus~Senior Health PhysicistRadiologic Health BranchMS 7610, P.O. Box 997414Sacramento, CA 95899-7414

I ~p. ~DEC 0'9 201