UNITED STATES

NUCLEAR REGULATORY COMMISSIONREGION I

475 ALLENDALE ROADKING OF PRUSSIA, PENNSYLVANIA 19406-1415

March 10, 2005

Docket No. .03001317 License No. 08-01738-02•Control No. 135964

COL Thomas M. Fitzpatrick, MCChairperson, Radiation Safety CommitteeDepartment of the ArmyWalter Reed Army Medical CenterMCHL-HP/Health Physics OfficeBuilding 41 Room 38Washington, DC 20307-5001SUBJECT: DEPARTMENT OF THE ARMY, APPLICATION FOR LICENSING ACTION,

CONTROL NO. 135964

Dear Colonel Fitzpatrick:

This refers to your license amendment request. Enclosed with this letter is the amendedlicense. Please note that your license was written in a format compatible with the revised 10CFR Part 35, effective October 24, 2002. The facility at Building T-2 may be released forunrestricted use.

In accordance with NRC Regulatory Issue Summary (RIS) 2004-17: Revised Decay-In-StorageProvisions for the Storage of Radioactive Waste Containing Byproduct Material(http ://www.nrc.qov/reading-rm/doc-collections/qen-comm/reg-issues/2004/ri200417.pdf), yourlicense has been modified. Your license now contains a revised decay-in-storage (DIS)condition. This revised condition-permits greater flexibility for DIS of waste by eliminating a

.specific holding period prior to disposal. Please review the RIS 2004-17, and the revisedcondition carefully to ensure that you understand its requirements.

Please review the enclosed document carefully and be sure that you understand and fullyimplement all the conditions incorporated into the amended license. Please note the lastcondition on your license indicates that, "This license condition applies only to those proceduresthat are required to be submitted in accordance with the regulations." Therefore, anyprocedures submitted that were not required by regulation to be submitted, e.g., calibration ofdose calibrators, will not be considered a part of your license and were not reviewed during thelicensing process. These procedures will be reviewed during inspections, as necessary. Ifthere are any errors or questions, please notify the U.S. Nuclear Regulatory Commission,Region I Office, Licensing Assistance Team, (610) 337-5239, so that we can provideappropriate corrections and answers.

Current NRC regulations and guidance are available at the NRC Web sites listed below or bycontacting the Government Printing Office (GPO) toll-free at 1-888-293-6498. The GPO is openfrom 7:00 a.m. to 9:00 p.m. EST, Mondaythrough Friday (except Federal holidays).

ktorrnation in this recwd was deloW.M accordane

COL T. Fitzpatrick 2Department of the Army

Thank you for your cooperation.Sincerely,

Original signed by Ronald R. Bellamy

Ronald R. Bellamy, ChiefDecommissioning BranchDivision of Nuclear Materials Safety

Enclosure:Amendment No. 78

NRC Web site addressesNRC regulations

http://www.nrc.qov/reading-rm/doc-collections/cfr/Licensing guidance

http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/Sri 556/General Policy and Procedure for NRC Enforcement Actions

Http:/Iwww.nrc.gov/what-we-do/regulatorylenforcementlenforc-pOI.pdf206 of the Energy Reorganization Act of 1974

http://www.nrclqov/who-we-are/qoverninq-laws.html

cc:LTC John R. Mercier, Ph.D., Radiation Safety Officer

COL T. Fitzpatrick 3Department of the Army

DOCUMENT NAME: G:\Docs\Current\Lic Cvr Letter\L08-01738-02.135964.wpd

To receive a copy of this document, indicate in the box: "C" = Copy w/o attach/end "E" = Copy w/ attach/encl "N" = No copy

OFFICE DNMS/RI IN DNMS/RI DNMS/RI• NAME LKauffman ,-•C RBell~Imy V,,DATE 3//0o5 ,0

OFFICIAL RECORD COPY

NCFORM 374 PAGE 1 OF 9 PAGESNRC FORM 374 U.S. NUCLEAR REGULATORY COMMISSION A mEnden O . 78Amendment No. 78

Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Codeof Federal Regulations, Chapter I, Parts 30, 31, 32, 33, 34, 35, 36, 39, 40, and 70, and in reliance on statements and representationsheretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct,source, and special nuclear material designated below; to use such material for the purpose(s) and at the place(s) designated below; todeliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This licenseshall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to allapplicable rules, regulations, and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specifiedbelow.

Licensee

1. Department of the Army

Walter Reed Army Medical Center (WRAMC) •

2. Washington, D.C. 20307-5001

In accordance with the letter received

October 29, 2004

3. License number 08-01738-02 is amended in

entirety to read as follows:•. , . .

4. Expiratio'd',e June 30, 2004 (extended)

5. Docket No. 030M.317

Reference No. 08 -0•738-03

6. Byproduct, source, and/or. special. nuclear material

A. Any byproduct material•withatomic numbers 1-83. W, .

B. Iodine 131

C( Xenon 133 te ?

8. M~ximum amount that licensee may. sess at any one time under thislicense

.A. 4D0 millicuries of each, Rdionuclide with a total;.'ssession limit of 26 curies

B .curies

K 2 curies

' D. 1 curie

E. 2 curies

F. 2 curies

D. Krypton 85 ,JD. Any

E. Phosphorus 32 E. An .

F. Carbon 14

G. iodine 125

H. Iridium 192

1. Chromium 51

J. Sulfur 35

K. Hydrogen 3

F. Any

G. Any

H. Any

I. Any

J. Any

K. Any

G. 1 curie

H.

I. 750 millicuries

J. 1 curie

K. 5 curies

L. 23 curies

DupIo IIU

L. Molybdenum 99

Dup Icate

L. Molybdenum 99/Technetium 99m Generators

Dup.Icate.

NRC FORM 374A U.S. NUCLEAR REGUL

MATERIALS LICENSESUPPLEMENTARY SHEET

.ATORY COMMISSION

D u p-lPAGE 2 of 9 PAGES

License Number

,08p1 738-02mAmEI~et or Reference Num. 7030-01317

Amendment No. 78

6. Byproduct, source, and/or specialnuclear material

7. Chemical and/or physical form 8. Maximum amount that licensee maypossess at any one time under thislicense

M. Technetium 99m

N. Strontium 90

0. Cesium 137

P. Gadolinium 153

Q. Iodine 125

R. Iodine 125

M. Any M. 23 curies

N. Sealed sources N.

, P. Sealed sources r p

Q. Sealed sources .. 1 curie(3M Company seeds)

R. Sealed sources R. f-sources, not to exceed 300

(N(•odard M4 o., ,mod e i'Wllicuries each1 78Aý91 Abr A. C Model'sC235 rC34'or Amor __r

..-S Sealedt sources', S i .,S.

T.U.

V.

Cesium 137

Cobalt 60

Americium 241

Americium 241

U. 100 microcuries,- - V.

W. Nickel 63

X. Iodine 129

Y. Thorium

Z. Uranium

AA. Cesium 137

BB. Americium 241

Dup kate

W. Sealed sources and foils

X. Sealed sources

Y. Any

Z. Any

AA.-Sealed source,

BB. Sealed sources

Duoct

W. 1 curie

X. 1 curie

Y. 5 kilograms

Z. 50 kilograms

AA.

BB.

Du pli'ca tte-

V, ý/- -ý ýII

NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION

MATERIALS LICENSESUPPLEMENTARY SHEET

EJU C1,1hcraPAGE 3 of 9 PAGES

License Number

-M=Q81738-02 -

' D-c'et or Reference Numrber

030-01317

Amenament NO. 78

6. Byproduct, source, and/or specialnuclear material

CC. Palladium 103

DD. Iridium 192

EE. Uranium depleted inUranium 235

FF. Cobalt 60

C

GG. Cesium 137

7. Chemical and/or physical form

CC. Sealed sources

B. Maximum amount that licensee maypossess at any one time under thislicense

CC. 3 curies

DD.DD. Sealed sources

EE. elated Meta•l

F.• . Sealed Sources

,LIN

• GGL ýS

EE. 400 Kilograms

•' F. No single source to exceed themaximum activity per source or

'•naximum activity per device-specified in the certificate of

d BMW,' registration issued by the U.S.Nolear Regulatoryg' 44*

141g., g ( mission or an Agreement

IS State

• &. GG,'No single source to exceed0tle maximum activity per

. source or maximum activity per

,Kmidevice specified in thecertificate of registration issued

•,! by the U.S. Nuclear RegulatoryCommission or an Agreement

State

9. Authorized use:

A. through DD.

EE.FF. and GG.

Dup

Medical diagnosis, therapy and research in humans in accordance with any applicableFood and Drug Administration (FDA) requirements. Research and development asdefined in 10 CFR 30.4, including animal studies; instrument calibration; studentinstruction.Shielding in linear accelerators.For irradiation of materials in self-shielded irradiator devices that have been registeredeither with the U.S. Nuclear Regulatory Commission under 10 CFR 32.210 or with anAgreement State and which have been distributed in accordance with a Commission orAgreement State specific license authorizing distribution to persons specificallyauthorized by a Commissio or Agreemenit State license to receive,, pssessarld usehe_6evices. .U icd L Ju I u aie

CONDITIONS

NRC" FO.RM 374A U.S. NUCLEAR REGULATORY COMMISSION PAGE 4 of 9 PAGES

License Number

Du L e l °738-02F n r I tMATERIALS LICENSE 00o3et or Reference Numb

SUPPLEMENTARY SHEET 030-01317

Amendment No. 78

10. A. Licensed material in Items 6.A through 6.EE may be used only at the licensee's facilities located atthe Walter Reed Army Medical Center, Washington, D. C.; WRAMC Forest Glen Section and Annex,Silver Spring, Maryland; U.S. Army Medical Laboratory, WRAMC Department of Pathology, FortMeade, Maryland; Rickman Building, 13 Taft Court, Rockville, Maryland and Gillette Building, 270Research Center, 1413 Research Boulevard, Rockville, Maryland.

B. Licensed material in Items 6.FF and 6.GG may be used or stored only at the licensee's facilitieslocated at Walter Reed Army Mediedaicaenter,, W'ashiigton, D.C. and Walter Reed Army Institute forResearch, Forest Glen Annex,,Silver Spring, Maryland.

11. A. Licensed material in Items 6.A through 6.EE shall be used by, or under the supervision of, individualsdesignated in writing by the Radiation Safety Committee, Colonel Thomas M. Fitzpatrick,Chairperson.

B. Licensedmaterial initemrs .6.FRF 6.GG shall be used by,•or under thesupervision of, individualswho have received the training descibed ir pplication dated October 15, 2001 and have beendesignated, in writing, by the Radiaio bCSafte Officer.

C. The use of licensLmate I b physician, dentist, or podiatrist as definedin. 10 CFR 35.2.

D. Physicians, dentists, or podiatristsdesignated to Us licensed material in or on humans shall meetthe training criteria etablished F 3 shall be designated inwriting bythelicensee's Radiation Safety Committee.

E. Individuals designated to work as medical physicists for£ ntrav.scular brachytherapy shall meet thetraining and experience criteria establish(d in 10.CFR-5.961; or be named on a current U.S.Nuclear Regulatory Commission or Agreement State license, or a permit issued under a broad scopelicense as a medical physicist; and shall be designated, in writing, by the Radiation Safety

.Committee. In addition, the physicist must meet the recentness of training requirement in 10 CFR35.972 and have recent, device-specific training and experience for each make and model ofintravascular brachytherapy device used by the licensee.

F. The Radiation Safety Officer for this license is Lieutenant Colonel John R. Mercier.

12. In addition to the possession limits in Item 8, the licensee shall further restrict the possession of licensedmaterial at a single location to quantities below the limits specified in 10 CFR 30.72 which requireconsideration of the need for an emergency plan for responding to a release of licensed material.

13. The licensee is exempted from decommissioning financial assurance requirements for possession oficens daial m n,.ealed sources in quatifs geater thathe lmits i 1F0 -O d)forte

purpos ofsor•N'es s onlym This exemptnD Wfogran~edir no more than•O0ldaV f&'~any bresource change.

NRC FOFIM 374A U.S. NUCLEAR REGULATORY COMMISSION

Dpkiate [MATERIALS LICENSESUPPLEMENTARY SHEET

Duphcu

PAGE 5 of 9 PAGES

License Number

-98t01 738-02 ,5ocket or Reference Num•6"r 8-

030-01317

Amendment No. 78

14. Notwithstanding the requirements of 10 CFR 35.49(a) and (b), 35.100, 35.200, 35.300, 35.400 and35.500 the licensee may use for any medical use any byproduct material or reagent kit. The licenseeshall possess and use byproduct material for medical use in accordance with the prescriptive andperformance criteria in the other sections of 10 CFR 35. This does not relieve the licensee fromcomplying with applicable U.S. Food and Drug Administration (FDA) and other Federal and Staterequirements.

15. A. Detector cells containing a titanIurifttilde foil or a=scandium tritide foil shall only be used inconjunction with a properly opertating temperature control ,ec-anism which prevents the foiltemperatures from exceedig Wthat specified in the certificate6f registration referred to in10CFR 32.210.

B. When in use, detecterecells containing a titanium tritide foilthe outside. ,

to

16. The licensee shall conjdevices containing lice35.500 and every six n

17. A. Sealed sources arcontamination at iicertificate of regis

ts to accotnt for all sealed sources andirsuant to IO•CFR 35.59, 35.400 and,vices. -

ýrishall bbtested for leakage and/or-•eother infrvals as are specified by the

o exceecfrthree years.

B. Notwithstanding ParagTrah A of this Conditkio' .ealed-sburces designed to emit alpha particles shallbe tested for leakage an6d/p ocontamination" intervals not to,,ex, Ged three months.

C. In the absence of a certificate from, triFsfeterod inaicating that a leak test has been made within sixmonths prior to the transfer, a sealed source or detector cell received from another person shall notbe put into use until tested.

D. Each sealed source fabricated by the licensee shall be inspected and tested for construction defects,leakage, and contamination prior to any use or transfer as a sealed source.

Duplicate U 1", U IC-ace Duplicate

NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION PAGE. 6 of 9 PAGES

UDuplicateMATERIALS LICENSE

SUPPLEMENTARY SHEET

DupaIcLicense Number"801738'02 'i t4

'ocet or Reference Num5'P - A-030-01317

Amendment No. 78

E. Sealed sources and detector cells need not be leak tested if:

(i) they contain only hydrogen-3; or

(ii) they contain only a radioactive gas; or

(iii) the half-life of the isotope is 30 daysor lessior.

(iv) they contain not more thanitAV0, microcuries of bet andd/or gamma emitting material or not more(v) microcuries,pf "'Ipha emitting material; or .

(v) •they are not designed to emit alpha particles, are in storageaned are not being used. However,when they are {&foved from storage for use or transfer to-anotler person, and have not beentested withinthi' reqliij4 ie-ek test interval, they shall " " t •sted-fore. use or transfer. Nosealed sourd"e6or detector b 'eshall be stored fo" a period of moreihan 10 years without beingtested for leakage and/r;qiait

F. The test shall be baDable of, de t.tetn' "thtest sample. If the test reve#'the peseE1contamination, a re~pprt shallrbejiledith 4detector cell shall be removed iedialteof in accordance witihComnIi .. sin.relatithe leak test result is •nown withNuclear Materials SafdtyBranch, 475-Allereport shall specify the s ofbe or detector

curie-f radioactive material on ther moreof removableory-Commission and the source oritarbinated, repaired, or disposedfile within five days of the date

r•sSion, Region I, ATTN: Chief,,sia, Pennsylvania 19406. Thesults, and corrective action taken.

G. The licensee is authorized to colleqt leak test samples -dr-analysis by the licensee. Alternatively,tests for leakage and/or contamination may be performed by persons specifically licensed by the:Commission or an Agreement State to perform such services.

18. Sealed sources or detector cells containing licensed material shall not be opened or sources removedfrom source holders by the licensee.

19. The licensee shall not repair, remove, replace or alter any of the following: electrical and mechanicalsystems that control irradiator source or shielding movement, the irradiator's shielding or sealed source,safety interlocks, or any component that may affect safe operation of the irradiator. These activities shallbe performed by a person specifically licensed by the U.S. Nuclear Regulatory Commission or anAgreement State to perform such services.

W-11& 51 *u U D[-J% I i cia t e Dupficate [] Duplicate

NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION

MATERIALS LICENSESUPPLEMENTARY SHEET

DuP'*PAGE 7 of 9 PAGES

License Number8.-01738-02p f-p.. .

'io~-et or Reference Num=-r i-030-01317

Amendment No. 78

irradiator installed and used,20. For eachthe licensee shall:

A. Permit the use of the irradiator only when a calibrated and operable radiation survey meter or roommonitor is available; and

B. Permit the irradiator door to be opened o•ly aEfter heOperator has checked visual indicators to verifythat the source has returned to itsýsafe storage 15ositionVand

40C. Have room monitors instafled that will:

(i) Operate at all times when the irradiator is in use; and ell(ii) Activate a visiblieand audible alarm when radiation exceeds 24m!ilrems per hour; and(iii) Detect any radljation.l.eking from the irradiator door a'n4 d(iv) Be visible tolthe irradiato user-.when the. user is, eothe irradiator; or

D. If a room monitorisnot installed, have aavaji aile a cali•rated and operable survey meter which will beii~d ttv

(i) Determine thea-radiatioh levela at thirradiator door e w.i6b t'rhe dooi,_s closed; and

(ii) Check for ay1craeirdato e~vels each time the' ifradiator door is opened.E. If abnormal radiation'[vels o at any time, the

licensee shall cease using. the irra r, r a o the ae-a iousing the irradiator,immediately notify the Radiation Safety Otfi 5-nd submit all•'r•a. allports required, under 10 CFR Parts

20, 21 or 30.

F. Not repair or authorize repairs of the iridiator-except by the manufacturer or other personsspecifically authorized by the U.S. Nuclear Regulatory Commission or an Agreement State to performsuch services.

21. The licensee is authorized to hold byproduct material with a physical half-life of less than or equal to120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee:

A. Monitors byproduct material at the surface before disposal and determines that its radioactivitycannot be distinguished from the background radiation level with an appropriate radiation detectionsurvey meter set on its most sensitive scale and with no interposed shielding; and

B. Removes or obliterates all radiation labels, except for radiation labels on materials that are withincontainers and that will be managed as biomedical waste after they have been released from thelicensee;and

Lit e u-upificatte Dup1,11Cate

-31

NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION

Duplicate' MATERIALS LICENSE

SUPPLEMENTARY SHEET

Du piczPAGE 8 of 9 PAGES

License Number• 9&01738-02. n. tp% i# .--"fo-et or Reference Num6' 1-.

030-01317

Amendment No. 78

C. Maintains records of the disposal of licensed materials for 3 years. The record must include the dateof disposal, the survey instrument used, the background radiation level, the radiation level measuredat the surface of each waste container, and the name of the individual who performed the disposal.

22. The licensee shall possess and use byproduct material for human research in accordance with theprescriptive and performance criteria in. all sections of 10 CFR Part 35 except sections 35.49(a) and (b),35.100, 35.200, and 35.300. . .

23. Experimental animals, or the products from experimental aniffir.s, tbat have been administered licensedmaterials shall not be used for, iman consumption.

24. The licensee is authorized to transport licensed material in accordance with the provisions of10 FRPat7, AN ' V'.- Maea.• .10 CFR Part 71, "Packaging and Transportation of Radioactive Maerial

25. The licensee shall notjaequire nsedrnaeria in a sealeds6ur or device unless the source or devicehwjWthe U.S. I'Nucd iRegu10% C'om unslso 10 CFR 32.210 orhas been registered w, th -' . '.o ms . 5 is on ... pursu

equivalent regulationsfan Agreement tate.

26. Radioactive waste generated shliit thetatemnIts, representations, and

procedures included withthe wasted ýtorae plan dP•ribed in the 2liensee's ietter/appiication datedSeptember 9, 1993 and-October29, 1993'27. NotWithstanding the requl, aini

dg terements of 10'FR-353 !5(a)(7),Ihe licensee. ray control contamination inrooms used to hous~e radio'p,,hirmaceuticaltherapatientsaccordcance with the commitments andprocedures contained in the I 6its dated April 8,1992 and Novembr•,24, 1992.

d -~

Duplicate []Duplicate [] Duplicate

NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION

Dup icate []MATERIALS LICENSESUPPLEMENTARY SHEET

DuplicaPAGE 9 of 9 PAGES

License Number

•,8ý01738-02 ' --'Do0cet or Reference Num~er 9i

030-01317

Amendment No. 78

1 28. Except as specifically provided otherwise in this license, the licensee shall conduct its program inaccordance with the statements, representations, and procedures contained in the documents, includingany enclosures, listed below, except for minor changes. in the medical use radiation safety procedures asprovided in 10 CFR 35.31. The U.S. Nuclear Regulatory Commission's regulations shall govern unlessthe statements, representations, and procedures in the licensee's application and correspondence aremore restrictive than the regulations.

A.B.C.D.E.F.G.H.I.J.

Application dated January 21, 1993, (ML050680436)••j•Letter dated September 9, 19936(lML050680406)Letter dated October 29,1j993 (ML050680369) XLetter dated December'9,, 1993 (ML050680355)Letter dated February 15, 1994 (ML050680347)Letter dated June 2,4994 (ML050680339)Letter dated Deceml~r 6,f!9 3(ML0506801489)Application dated,,ctober 15, {20t(ML01 3020450) .Letter dated August-1 3, 2003, •(MLO3"2o387vLetter dated October 29, 2004 -/Enl6,ures§(ML04322.447, ML04322ý0

Xt __ /;

• .• •_. • -•

•"• ' 4• N :0

ML043220467)

For the U.S. Nuclear Regulatory Commission

Original signed by Ronald R. BellamyDate Marcnh 10, 5>00S By

Ronald R. Bellamy, ChiefDecommissioning BranchDivision of Nuclear Materials Safety

] DupW p1 o, egiinb141 f-Prussia, Pennsylvania-i9406Duplicate