21
g- 4-,rrarawanswers w;srannrarszwnwrrrriTerewswxrawmTrzwsremswrmq'g gj NRc rorm :74 3 g ^ g o en u.s. wucMAR REGUt ATOR7 COMMISDON Amendment No.94 h | MATERIALS LICENSE f * Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, g Code of Federal Regulations, Chapter 1, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representat ( heretofore made by the bcensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, i ( source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below;to | | i N dehver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This ; | U license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is j | ' subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any I ! g conditions specified below. I g I k Ucensee I In accordance with letter dated A | December 23 1992 I g Department of Veterans Affairs 3. License numbe' ,04-00181-04 is amended f I- || Medical Center in its entirety to read as follows: Ig d i k g 2. |j Wadsworth and Brentwood Divisions E | Wilshire and Sawtelle Blvds. 4. Expiration date February 27, 1997 g Los Angeles, CA 90073 s. oocket or lg ( Reference No. 030-01213 !p i 6. Byproouct, source, and/or 7. Chemical and/or physical 8. Maximum amount that licensee |F d special nuclear material form may possess at any one time F , under this license d > 5 A. (1) Any byproduct A. (1) Any A. (1) 100 ik $ material with atomic millicuries of each N[ , !! numbers 3-83 and a radionuclide with g; half-life of less atomic numbers 3- 'p. than 120 days except 83. Total t ({: E as noted below: possession limit Y ( for Subitem A(1) F (( gj not to exceed 10 curies gj | (2) Iodine 125 (2) Any (2) 500 millicuries f | (3) Iodine 131 (3) Any (3) 500 millicuries ( (4) Technetium 99m (4) Any (4) 2.0 curies % R, | (5) Molybdenum 99 (5) Any (5) 1.0 curie ,F 4 t E (6) Phosphorus 32 (6) Any (6) 200 millicuries V,, . q ( (7) Sulfur 35 (7) Any (7) 600 millicuries yF: , 4 q (8) Chromium 51 (8) Any (8) 200 millicuries |g | R t ? | b | N !!D d i ( I< . , d !t - i ( |i= E ,1 l E | l ' 4 ! i q 9407180265 940610 i | | q. PDR ADOCK 03001213 ig r el C PDR ' tp 1vu ubo . dy.s vx t s tstwr e s satst e tt e m m s.smtt e ru m s s t_m.m m e d . __ _

dy.s vx t s tstwr e s satst e tt e m m s.smtt e ru m s s t

  • Upload
    others

  • View
    1

  • Download
    0

Embed Size (px)

Citation preview

Page 1: dy.s vx t s tstwr e s satst e tt e m m s.smtt e ru m s s t

g- 4-,rrarawanswers w;srannrarszwnwrrrriTerewswxrawmTrzwsremswrmq'g-

gj NRc rorm :74 3 g^g o en u.s. wucMAR REGUt ATOR7 COMMISDONAmendment No.94 h

| MATERIALS LICENSE f*

Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10,g Code of Federal Regulations, Chapter 1, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations j'( heretofore made by the bcensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, i

( source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below;to | | i

N dehver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This ; |U license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is j |

'

subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any I !

g conditions specified below. Ig

I kUcenseeI In accordance with letter dated A| December 23 1992 Ig Department of Veterans Affairs 3. License numbe' ,04-00181-04 is amended fI-

|| Medical Center in its entirety to read as follows: Igd i kg 2.

|jWadsworth and Brentwood Divisions E

| Wilshire and Sawtelle Blvds. 4. Expiration date February 27, 1997g Los Angeles, CA 90073 s. oocket or lg( Reference No. 030-01213 !pi 6. Byproouct, source, and/or 7. Chemical and/or physical 8. Maximum amount that licensee |Fd special nuclear material form may possess at any one time F ,

under this license

d >5 A. (1) Any byproduct A. (1) Any A. (1) 100 ik$ material with atomic millicuries of each

N[,

!! numbers 3-83 and a radionuclide withg; half-life of less atomic numbers 3- 'p.than 120 days except 83. Total t({:E as noted below: possession limit Y( for Subitem A(1) F

((gj not to exceed 10curiesgj

| (2) Iodine 125 (2) Any (2) 500 millicuries f| (3) Iodine 131 (3) Any (3) 500 millicuries (

(4) Technetium 99m (4) Any (4) 2.0 curies %R,

| (5) Molybdenum 99 (5) Any (5) 1.0 curie ,F4 tE (6) Phosphorus 32 (6) Any (6) 200 millicuries V,, .q

( (7) Sulfur 35 (7) Any (7) 600 millicuries yF:,

4q (8) Chromium 51 (8) Any (8) 200 millicuries |g |R t ?| b |N !!Dd i( I<. ,

d !t - i

( |i=E ,1 lE | l

'

4 ! i

q 9407180265 940610 i| |

q. PDR ADOCK 03001213 ig r

el C PDR '

tp1vu ubo

.

dy.s vx t s tstwr e s satst e tt e m m s.smtt e ru m s s t_m.m m e d.

__ _

Page 2: dy.s vx t s tstwr e s satst e tt e m m s.smtt e ru m s s t

p._.2.....x.wnwarransweraramwsenemerxerzarsrATsarmram--..:. ....,| NRC Fo m 374A U.S. NUCLEAR KEGULATORY COMMISSION 2 6 IPact o, ,,ces

( (* "I License number I-

1 04-00181-04 1

q MATERIALS LICENSE Iocckeior nererence number I( SUPPLEMENTARY SHE ET 030-01213E F

|>p(g Amendment No.944 >I >

E M

(jn -

iE ifd B. Xenon B. Gas or gas in B. 3.0 Curies jE8 solution that is kf the subject of an fg active (i.e., not j|

'

| withdrawn or '>

I terminated) "New II

I Drug Implication I

| (NDA) ai. proved by $FDA or an active inq ,

4 (i.e., not 31q withdrawn, P

4 terminated or on $;8d " clinical hold")

8 " Notice of Claimed| Investigational !( Exemption for a New p

,

4 Drug" (IND) that jNi

j/d has been accepted

| by FDA

4 C. Calcium 45 C. Any C. 20 millicuries |H-

|H4 |

8|( D. Carbon 14 D. Any D. 100 millicuries '

%>ht| E. Chlorine 36 E. Any E. 10 millicuriesl

F. Nickel 63 F. Any F. 20 millicuries .F

s Fq G. Selenium 75 G. Any G. 10 millicuries

H. Thallium 204 H. Any H. 50 millicuries

| I. Hydrogen 3 I. Any I. 500 millicuries|

4 J. Any byproduct J. Any brachytherapy J. 5.5 curies i

[t material identified source identified '

'g in 10 CFR 35.400 in 10 CFR 35.400,

f K. Hydrogen 3 K. Foils in detector K. 550 millicuries.

q cell s

(: L. Nickel 63 L. Foils in plated L. 100 millicuries jsources in detector j

'

q|4 cells i

4j |'

4, M. Strontium 90 M. Scaled source M. 10 millicuriesI4! (Radiochemicalj Center Model S16.7)'4 :4 ,

'!4

4 ekY&MYerarMr.s:ssrnrMr#MT#MTXsNMtMETXETMEsWCtYrMfMtM%f.2%tXTN

_ _. __

Page 3: dy.s vx t s tstwr e s satst e tt e m m s.smtt e ru m s s t

,myg_ ....fm.----*=,----- .xweenetwasrs arsrzwswnrzwarsh*-y,

U.S. khCUA3 REOULATORY COMMISSION IPAGE OF PACESi NRC Foem 37CAg is est ucense number | |q 04-00181-04 I'

( MATERIALS LICENSE I Ioocket or Reference number

| |SUPPLEMENTARY SHEET 030-01213

| |' Amendment No.94, , , ,

ki| E

i N

I 8

i N. Cesium 137 N. Scaled source (New N. 100 millicuries P

i England Nuclear j '

,

| Model NER-401 H) iI 0. Gadolinium 153 0. Sealed sources 0. 21 millicuries {| (Lunar Radiation g

i Corporation Model y

a GD Series) N

q R!

q P. Americium 241 P. Sealed source P. 200 millicuries n

( (Amersham Model Iq AMC 26) > '

s >d W

8 E

< E

q l4 9. Authorized use R

j4 .

N A. through J. Medical diagnosis and therapy as described in 10 CFR 35.100 through g

| 35.500. Research in humans as approved by the Food and Drug y

y Administration or by an RDRC approved by the FDA. Laboratory y

( research. Research in animals. Instrument calibration. ,N|

hK. through L. For use in gas chromatographs for sample analysis.

|'4H. For use in Nuclear Enterprises Dosimeter Calibrator Type 2503 for calibration of

thimble ionization chambers. ;

i i4 N. Standard for instrument calibration. ;

4 |

| 0. and P. Medical use described in 10 CFR 35.500.

k CONDITIONS f

4|10.:

$ Licensed material shall be used only at the licensee's facilities located at i4l Department of Veterans Affairs Medical Center, Wadsworth and Brentwood Division;f Wilshire and Sawtc11e Blvds.; Los Angeles, California.

11. The Radiation Safety Officer for this license is John E. Basinski, Ph.D.pM

12. A. The use of licensed material in or on humans shall be by a physician, dentist,or podiatrist as defined in 10 CFR 35.2. fq

f B. Physicians, dentists, or podiatrists designated to use licensed material in or4 on humans shall meet the training criteria established in 10 CFR 35, Subpart J !

l Ig and shall be designated by the licensee's Radiation Safety Committee.k |

i,

e

i

b,

Arxx.r.rxrszu.rus.rzmu.ruz.w wxx. m mrux e rx w.v.wm e.1xx m ux?! ,

Page 4: dy.s vx t s tstwr e s satst e tt e m m s.smtt e ru m s s t

pTAmfamm"zNs wm'auxTwsmumL"4N'm*JN2NnN5Nz"2Nm"2222 = = = yU.S. NUCLEAQ REGULATORY COMMISSION PAGE OF PAGE5_j| NRC Form 374A

_ jfg (O 883 License numberl| 04-00181-04 i

-

| MATERIALS LICENSE I3,,,,,,,g,,,,,,,,,,,3,,I( SUPPLEMENTARY SHEET 030-01213

( E

| Amendment No.94 )>(>|

I ilF(

N C. Licensed material for other than human use shall be used by or under the j| supervision of individuals designated by the Radiation Safety Committee. |4 i !

,

i j !

I 13. A. Sealed sources and detector cells shall be tested for leakage and/or {'l contamination at intervals not to exceed 6 months or at such other intervals as !

| specified by the certificate of registration referred to in 10 CFR 32.210.'q B. Notwithstanding Paragraph A of this Condition, sealed sources designed to emit |( alpha particles shall be tested for leakage and/or contamination at intervals

'-

( not to exceed 3 months.N

-

d C. In the absence of a certificate from a transferor indicating that a leak test f| has been made within 6 months prior to the transfer, a sealed source or Vq detector cell received from another person shall not be put into use until f 1

4 tested. it-

;(V [g ,

| D. Each sealed source fabricated by the licensee shall be inspected and tested forconstruction defects, leakage, and contamination prior to any use or transfer 1

|3.qg as a sealed source. ||

4 f4, E. Sealed sources need not be leak tested if: 1E! A

f (i) they contain only hydrogen-3; or ff (ii) they contain only a radioactive gas; or fi i

4 (iii) the half-life of the isotope is 30 days or less; or j-|

4 i9 (iv) they contain not more than 100 microcuries of beta and/or gamma emitting I4

4- material or not more than 10 microcuries of alpha emitting material; or 4;4 (v) they are not designed to emit alpha particles, are in storage, and are not it i

4 being used. However, when they are removed from storage for use or ?%, transferred to another person, and have not been tested within the ff required leak test interval, they shall be tested before use or transfer. p

g| No sealed source or detector cell shall be stored for a period of more p

than 10 years without being tested for leakage and/or contamination. ;p4(I N

4! F. The leak test shall be capable of detecting the presence of 0.005 microcurie ofi radioactive material on the test sample. If the test reveals the presence of jg <

0.005 microcurie or more of removable contamination, a report shall be filed))q

W with the U.S. Nuclear Regulatory Commission in accordance with 10 CFR 30(b)(2),% and the source shall be removed immediately from service and decontaminated, |li4 repaired, or disposed of in accordance with Commission regulations. The report h

( shall be filed within 5 days of the date the leak test result is known with the {9

y4; M

wm.seau.v.aauexasemeaamemaammes

Page 5: dy.s vx t s tstwr e s satst e tt e m m s.smtt e ru m s s t

-ersrrrawmarr* ----.i-, =.. ,...'

| uncr . m a U.S. NUCLE AR QEGULATORY COMMISSION 5 6 IPAGE y ,,cc,

( as4 License number Ii 04-00181-04 li MATERIALS LICENSE 'hpocket or nererence number( SUPPLEMENTARY SHEET 030-01213 |EE |E

Amendment No.94

| 1i P

I U.S. Nuclear Regulatory Commission, Region IV, 611 Ryan Plaza Drive, Suite 400, || Arlington, Texas 76011, ATTN: Director, Division of Radiation Safety and

|#p.

q Safeguards. The report shall specify the source involved, the test results,s and corrective action taken. ; |

1 j |

4 G. Tests for leakage and/or contamination shall be performed by the licensee or by -, 'I other persons specifically licensed by the Commission or an Agreement State to y

Perform such services. ,y),

|b||

4i 14. The licensee shall conduct a physical inventory every 3 months to account for all h|

E3 sources and/or devices received and possessed pursuant to 10 CFR 35.59,[ 10 CFR 35.400 and 10 CFR 35.500 and every 6 months for all other sources and/or f

.

g devices. %4 |t 15. A. Detector cells containing a titanium tritide foil or a scandium tritide foil |'

!|4 shall only be used in conjunction with a properly operating temperature control +

| mechanism which prevents the foil temperature from exceeding that specified bythe manufacturer and approved by U.S. Nuclear Regulatory Commission. p ;g

N |I I

4 B. When in use, detector cells containing a titaniu:a tritide foil or a scandium jN ,

4 tritide foil shall be vented to the outside. iN| ,

{4 |

4 16. Maintenance, repair, cleaning, replacement, and disposal of foils contained in j!g

|! detector cells shall be performed only by the device manufacturer or other persons t.1 ispecifically authorized by the Commission or an Agreement State to perform such 10

(|s services. N

}@4 |

f 17. Sealed sources or detector cells containing licensed material shall not be opened or |

g sources removed from source holders by the licensee. )44 18. The licensee is authorized to hold radioactive material with a physical half-life of |4 less than 65 days for decay-in-storage before disposal in ordinary trash provided: ig :

A. Radioactive waste to be disposed of in this manner shall be held for decay a |( minimum of 10 half-lives, iq

!(4 B. Before disposal as ordinary trash, byproduct material shall be surveyed at the [j4; container surface with the appropriate meter set on its most sensitive scale

A@4 and with no interposed shielding to determine that its radioactivity cannot be| distinguished from background. All radiation labels shall be removed or hobliterated. |pj44i >|

'C. Generator columns shall be segregated so that they may be monitored separately y

to ensure decay to background levels prior to disposal. A '

A,

N I"

M A

m >!

fitsaxxxtttxtassmasszxsx+xttt3xt#xaxwinrxxxxxtzwt#xtttttsli

Page 6: dy.s vx t s tstwr e s satst e tt e m m s.smtt e ru m s s t

p3 EM ** AL''.MNEO MNED' E MI EM3EE$EE1W% i

| NRC Form 3HQ U.S. NUCLE AC] REGULATORY COMMISSION 6 6 I. pggg or PAG E( 0W'ucen,e number f '

| Ob00181-M j~

MATERIALS LICENSE" *''""( SUPPLEMENTARY SHEET !) I

q 030-01213 !p jq $ ,

d Amendment No.94 % j4 i.g ,,,

t

g 6,

4 4 !W !

( 19. The licensee is authorized to transport licensed material only in accordance with I

$ the provisions of 10 CFR Part 71, " Packaging and Transportation of Radioactive |',

i Material".4

;'

|20. The licensee shall maintain records of information related to decommissioning at the i .g address specified in Condition 10 above per the provisions of 10 CFR 30.35(g) until gq this license is terminated by the Commission, gI

k(9}21. Notwithstanding the requirements of 10 CFR 35.49(a) and (b),10 CFR 35.100,4

! 10 CFR 35.200, 10 CFR 35.300, 10 CFR 35.400, and 10 CFR 35.500, the licensee may use k,f for any medical use any byproduct material or reagent kit. The licensee shall fgi possess and use byproduct material for medical use in accordance with the i;

p

<! prescriptive and performance criteria in the other sections of 10 CFR 35. This does6 not relieve the licensee from complying with applicable United States Food and Drug !>p!

,

,

j Administration (FDA) and other Federal and State requirements.,

k{'

|{22. |The licensee shall possess and use byproduct material for human research use in

f::( accordance with the prescriptive and performance criteria in all sections of 10 CFR !

!g Part 35 except Sections 35.49(a) and (b), 35.100, 35.200, and 35.300. jk

23. Except as specifically provided otherwise in this license, the licensee shall |4 conduct its program in accordance with the statements, representations, and g. jq procedures contained in the documents, including any enclosures, listed below, y j

$jexcept for minor changes in the medical use radiation safety procedures as provided M( ;

in 10 CFR 35.31. The Nuclear Regulatory Commission's regulations shall govern h !

$ unless the statements, representations, and procedures in the licensee's application i{ and correspondence are more restrictive than the regulations. i !

,

'4|: i( A. Application dated May 24, 1991 !t |

$|( B. Letter dated July 24, 1991 !F |

C. Letter dated November 25, 1991 %' !$ D. Letter dated December 12, 1991 :

'

f E. Letter dated December 30, 1991 : :

4 F. Letter dated February 3, 1992'4. -

'

4 i

il FOR THE U.S. NUCLEAR REGULATORY COMMISSION !A

i

. Date By i .

% aterials Branch VPj'

'

A Region IV, WCF0 > '

Walnut Creek, California 94596r

sR|

'

a .

b&hsMTz.ttraTakadTMT.r#irt%%T.m.tTz.thas.tE@[email protected] diTs.T!

_ _ _ _ . _

Page 7: dy.s vx t s tstwr e s satst e tt e m m s.smtt e ru m s s t

,

'

# % UNITED STATES'

*. NUCLEAR REGULATORY COMMISSION*.

f j REGION IV- =

f Walnut Creek Field Office\ . , ,| . +j#

1450 Maria LaneWalnut Creek, Cahfornia 94596-5368

m 101994 .

Department of Veterans AffairsMedical CenterWadsworth and Brentwood DivisionsWilshire and Sawtelle Blvds.Los Angeles, California 90073

Attention: John E. Basinski, Ph.D.Radiation Safety Officer

Please find enclosed Amendment No. 94 to your NRC material license. Youshould review this amendment carefully and be sure that you understand allconditions. If you have any questions, you may contact the reviewer whosigned your License Amendment at 510/975-0249.

The revised 10 CFR Part 20, " Standards for Protection Against Radiation,"became effective for 1]l NRC licensees on January 1,1994. Licensees who arenot currently knowledgeable about the new regulations will find it difficultto implement the regulation. If you have not implemented the revised Part 20,you must do so immediately. You should review the enclosed NRC InformationNotices (IN) 93-03, "Recent Revisions to 10 CFR Part 20 and Change of 1

iImplementation Date to January 1,1994," and IN 93-80, " Implementation of theRevised 10 CFR Part 20," carefully. These Notices contain information aboutrevisions to Part 20, about implementing the revised regulation, and about the ;

availability of Regulatory Guides and other useful documents. As stated inIN 93-80, NRC has issued six sets of questions and answers to help youimplement and understand the revised regulations. As of January 1,1994, NRCbegan to inspect and enforce the regulations in the revised Part 20 for alllicensees.

Please note that your license has been written in a format compatible with therevision of 10 CFR Part 35, " Medical Use of Byproduct Material," effectiveApril 1, 1987. Your licensed material activities must be conducted in ,

'

accordance with the revised Part 35 regulations.

The Quality Management (QM) Rule became effective on January 27, 1992. The |

IRule required NRC medical licensees to establish, maintain, and implement awritten Quality Management Program (QMP), then to submit that program to the |NRC. Tie NRC staff has reviewed a representative sample of the submitted i

Iprogram:. Of the programs reviewed, a predominant number containedsignificant weaknesses. You should review your QMP to ensure that yourwritten policies and procedures meet the specific objectives stated in10 CFR 35.32(a)(1) through 35.32 (a)(5). If you identify weaknesses thatshould be corrected, make and implement the appropriate changes and submit )them to Region IV within 30 days.

Page 8: dy.s vx t s tstwr e s satst e tt e m m s.smtt e ru m s s t

,

2

Please be advised that you must conduct your program involving radioactivematerials in accordance with the conditions of 3 :r NRC license,representations made in your license application, and NRC regulations.In particular, note that you must:

1. Operate in accordance with NRC regulations 10 CFR Fart 19, " Notices,Instructions and Reports to Workers: Inspection and Investigations,"10 CFR Part 20, " Standards for Protection Against Radiation," and otherapplicable regulations.

2. Possess radioactive material only in the quantity and form indicated inyour license.

3. Use radioactive material only for the purpose (s) indicated in yourlicense.

4. Notify NRC in writing of any change in mailing address (no fee requiredif the location of radioactive material remains the same).

5. Request and obtain written NRC consent before transferring your licenseor any right thereunder, either voluntarily or involuntarily, directlyor indirectly, through transfer cf control of your license to any personor entity. A transfer of control of your license includes not only atotal change of ownership, but also a change in the controlling interestin your company whether it is a corporation, partnership, or otherentity. In addition, appropriate license amendments must be requestedand obtained for any other planned changes in your facility or programthat are contrary to your license or contrary to representations made inyour license application, as well as supplemental correspondencethereto, which are incorporated into your license. A license fee may becharged for the amendments if you are not in a fee-exempt category.

6. Maintain in a single document decommission records that have beencertified for completeness and accuracy listing all the following itemsapplicable to the license:

e Onsite areas designated and formerly designated as restrictedareas as defined in 10 CFR 20.3(a)(14) or 20.1003.

* Onsi'ce areas, other than restricted areas, where radioactivematerials in quantities greater that amounts listed in Appendix Cto 10 CFR 20.1001-20.2401 have been used, possessed, or stored.

* Onsite areas, other than restricted areas, where spills or otherunusual occurrences involving the spread of contamination in and ,

around the facility, equipment, or site have occurred that |required reporting pursuant to 10 CFR 30.50(b)(1) or (b)(4), |

including areas where subsequent cleanup procedures have removed i

the contamination. j

_ _ _ _ - _ _ _ - - - _ _ _ _ _ _ _ _ _

Page 9: dy.s vx t s tstwr e s satst e tt e m m s.smtt e ru m s s t

-.

3

e Specific locations and radionuclide contents of previous andcurrent burial areas within the site, excluding radioactivematerial with half-lives of 10 days or less, depleted uranium usedonly for shielding or as penetrators in unused munitions, orsealed sources authorized for use at temporary jobsites.

Location and description of all contaminated equipment involved inelicensed operations that is to remain onsite after licensetermination.

7. Submit a complete renewal application with proper fee, or terminationrequest at least 30 days before the expiration date on your license.You will receive a reminder notice approximately 90 days before theexpiration date. Possession of radioactive material after your licenseexpires is a violation of NRC regulations.

8. Request termination of your license if you plan to permanentlydiscontinue activities involving radioactive material.

10 CFR 71.12 provides for a general license to transport, or to deliver to acarrier for transport, licensed material for which a license, certificate ofcompliance, or other approval has been issued by the Nuclear RegulatoryComission (NRC). The general license applies only if you have a qualityassurance program approved by NRC as specified in 10 CFR 71.12(b) and theconditions specified in 10 CFR 71.12(c) and (d) are met. The attached copiesof Regulatory Guide 7.10,10 CFR Part 71, and 10 CFR Part70 may be helpful toyou. A fee for evaluation of Part 71 Quality Assurance Programs as specifiedin Section 10.F in 10 CFR 170.31 must accompany your request for QualityAssurance Program approval.

Please nute that your Quality Assurance Program, associated fee, and transportpackage descriptions should be submitted directly to the Director, Office ofNuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission,Washington, D.C. 20555, as stated in 10 CFR 71.12(c)(3) and 10 CFR 71.101(c).

You will be periodically inspected by NRC. A fee may be charged forinspections in accordance with 10 CFR Part 170. Failure to conduct yourprogram in accordance with NRC regulations, license conditions, andrepresentations made in your license application and supplementalcorrespondence with NRC will result in enforcement action against you. Thiscould include issuance of a notice of violation; imposition of a civilpenalty; or an order suspending, modifying, or revoking your license asspecified in the General Policy and Procedures for NRC Enforcement Action,10CFR Part 2, Appendix C. Since serious consequences to employees and thepublic can result from failure to comply with NRC requirements, prompt andvigorous enforcement action will be taken when dealing with licensees who donot achieve the necessary meticulous attention to detail and the high standardof compliance which the NRC expects of its licensees.

_

Page 10: dy.s vx t s tstwr e s satst e tt e m m s.smtt e ru m s s t

r-

'~

..-

5

,

4

This amendment grants you secember 23, 1992, request to increase possessionlimits for iodine 125, suifur 35 and chromium 51 and to add an americium 241sealed source. Your request for changes in the storage of radioactive waste i

for decay is being reviewed by our Division of Low Level Waste Management andDecommissioning (LLWM). We will complete our action on your request once wereceive a reply from LLWM. |

Thank you for your cooperation.

Sincerely,

*)

James L. MontgomerySenior Materials Specialist ;

Materials Branch :

i

Enclosures: '

As stated

,

,

,

e

!:3

!

:t

hi

:

!

,

!

,

:',

; .

!-

. . _ __- ._ . ._. _ _ . _ _ _-,

Page 11: dy.s vx t s tstwr e s satst e tt e m m s.smtt e ru m s s t

. _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ - _ _ _ _ _ _

..-

Distribution

"NU k#)bcc: License docket folderInspection folder g ,{ffj[tg[gf

4

*'

JMont mery GPYuhas FAWenslawski6 / /vif / / / /

-,

|

REQUEST COPY REQUEST COPY REQUEST COPY REQUEST COPY |YES _ N0g YES NO YES NO YES N0 l

i,

SEND TO DCS SEND TO PDR * Please indicate which documents !

YES 6 NO YES X- N0*-Refer to RV 0502-A8. '

- -should not be sent to PDR. 1

|

Page 12: dy.s vx t s tstwr e s satst e tt e m m s.smtt e ru m s s t

,

. . . ..

b ''Dcpartmont of Memorandum*

.

Veterans Affairs-

DEc 2 a 1992o.,.-

,

lar<om Director (00/115), VAMC West los Angeles -._ -

% Request for arrendment to NRC License #04-181-04 --

-

:

to Director / Chief, Nuclear Medicine Service (115)

VA Medical Center, Ann Arbor, Michigan , ,

,

t$o

1. P] ease forward to the NRC in Walnut Creek, California, the original andtwo copies of the above-referenced subject. A pre-addressed envelope isprovided for your convenience. One copy is for your files.

2. Your assistance is greatly appreciated.

Isannenua

~ "Ikb.Cls ^ ~/,

,

Dir : tor Pr ~'

arn Director *VAMc West Ios Angeles Nar Medicine Svc. (111E)

EnclosuresOrig & 3 copies

" m79 ..

>= a7

i * m.a

SMD/~777<3

'SPDMEd O E 2105

Page 13: dy.s vx t s tstwr e s satst e tt e m m s.smtt e ru m s s t

r- >

-.

'

, DEPARTMENT OF VETERANS AFFAIRSMedical Center <

Wadsworth and Brentwood Divisions I

Wilshire and Sawtelle BoulevardsLos Angeles CA 90073

pc23%1rs Reply Refer To- 691/115

.Ms. Beth A. PrangeSr. Health Physicist (Licensing)Nuclear Materials and Fuel Fabrication BranchU. S. Nuclear Regulatory Ccmnission, Region V1450 Maria Lane, Suite 210 !

Walnut Creek, CA 94596-5368

Docket tb: 030-01213License 10: 04-181-04

Dear Ms. Prange:

The enclosed material requesting an anerdaent to our license is sutrnittedfor your approval. It consists of the following: ,

3

A. Permission to possess an Anericium-241 sealed sourcet

B. Changes in the membership of the Radiation Safety Ccumittee

C. Requested increase in the possession limits for Chrcmium-51, Iodine-125, and Sulfur-35 due to increased use of decay-in-storage and longterm interim storage j

D.| Pe1 mission to decay RIA tubes containing I-125 for five half-lives~~,

s- ;

, D. Pennission to decay Sulfur-35 in storage ['!

F. Pennission for extended interim storage of low level radioactive f7 waste ,

,

Changes C. through F. are required because of the necessity of minimizing [the voltane of Icw level radioactive waste and the lack of an acceptabledisposal site.

;

t

Sincerely,s!

'2/1 (-|

~~,

'

KFREIH J. CIAIEDirector |VAMC West Los Angeles 1

Enclosures

. .

,

J

- . .

Page 14: dy.s vx t s tstwr e s satst e tt e m m s.smtt e ru m s s t

__ _

. .

. ..,

.

.

AMENDMENT OF LICENSE 804-181-04

s A. Permission to Possess Americium-241 Sealed Source

In reference C. of the license, letter dated November 25, 1991, werequested permission to possess an Americium 241 sealed source(Amersham Corp. AMC 26), 200 mci, for use in bone densitometrystudies, this source was inadvertently left off of the license. ~

,

,

B. Changes in the Membership of Radiation Safety Committeefor Radioactive Materials

Please substitute Bob Herron, Assistant Director, for Ramon J.Reevey, Assistant Director, as the management representative, andChristine Melchior, Ph.D., for William H. Oldendorf, M.D., as therepresentative for Brentwood Research Service. Enclosed are thecurricula vita for Mr. Herron and Dr. Melchior.

C. Requested Increase in Possession Limits.

We will utilize Decay-In-Storage as much as possible to reduce thevolume of low level radioactive waste sent to a disposal site.This necessitates increases in the possession limits for Chromium-51, Iodine-125 and Sulfur-35. We request that our possessionlimits be increased as follows:

,

Isotope Current Limit Reauested Limit

Cr-51 100 mci 200 mciI-125 100 mci 500 mci i

S-35 200 mci 600 mci

The above radioisotopes all have half-lives less than 120 days andtherefore our decommissioning requirements should not change. '

D. Permission Requested to Decay RIA Tubes Containing .

Residual I-125 for Five Half-Lives.!

In order to reduce the amount of I-125 stored during the process of ;Decay-In-Storage, we request permission to decay RIA tubes for fivehalf-lives rather than ten. We produce at least 5000 RIA tubes per ,

month with about 0.011 pCi of I-125 per tube. During a decay-in-storage period of 20 months this would lead to 100,000 tubes being !stored.

>

The procedure will be as follows: The RIA tubes will be placed ina plastic bag. A removable radiation warning label will be placed ,

on the outside of the bag. A label identifying the source of thewaste, the isotope, and the date the waste was placed in storagewill also be attached to the bag. The bags containing the RIA

|tubes will be segregated from other I-125 containing waste and ;

r

1:

i

t

. -- . ~ ..-4._ , , - - , - - .,

Page 15: dy.s vx t s tstwr e s satst e tt e m m s.smtt e ru m s s t

.

.

. ,,

I~ *

I

sealed in a 55-gallon drum for five half-lives. At the end of the !storage period, the drums will be unsealed and the bags will be :surveyed with a TBM-6 Radiation Monitor using a Sodium Iodide

!scintillation probe or an equivalent survey meter with a Sodium;Iodide probe. No material, other than the plastic bag, will be!interposed between the tubes and the meter during the survey. If i

the meter reading is indistinguishable from the background reading,the warning label will be removed and the bag placed in the

iordinary trash. The required records shall be maintained such as: jThe date the bag of RIA tubes was placed in storage, the total ;

activity, the date the bag was removed from storage and surveyed,the meter used and its serial number, the background reading, the !

reading at the surface of the bag, and the name of the individual '

performing the survey. In order to assess the level of radiation !

at the time of disposal, a sample of the tubes will be countedi

using a liquid scintillation counter in order to establish a base '

line. This sampling procedure will be repeated once a year.E. Permission Requested to Decay Sulfur-35 in Storage

The regulation, 10 CFR 35.92, permits decay-in-storage of i

radioisotopes with physical half-lives less than 65 days. Sulfur-35, with a half-life of 88 days constitutes 27% of the activity ofthe low level radioactive dry waste produced by the Medical Centerand currently being shipped to a disposal site. When decay-in- ,

storage is begun for Phosphorous-32, Chromium-51 and Iodine-125,Sulfur -35 would become a major portion, 95%, of the activity ofthe waste shipped to Barnwell, South Carolina or placed into longterm storage here at the Medical Center. While it is not possibleto make an estimate of the percent of the total volume of waste

irepresented by Sulfur-35, it is clearly a major portion. If it isassumed that the Ward Valley, California, disposal site will notopen for at least fjve years, then it is essential for us to reduce

ithe volume of waste that we must store on a long term basis.,

Permitting us to decay Sulfur-35 in storage would help us minimize |

the amount of low level radioactive waste we must place in long i

tern storage.i

The procedure of 10 CFR 35.92 will be followed. All the i

radioactive warning labels in the dry waste contaminated withSul fur -35 will be defaced. The waste will be placed in a plasticbag and a removable radioactive warning lacel will be placed on the

ioutside of the bag. A label indicating the laboratory of origin, ithe isotope, and the date it was placed in storage will also be |placed on the bag. The bag will be sealed in a 55 gallon drum and I

held for ten half-lives, 880 days. At the end of this time, thebag will be surveyed using a TBM-3 geiger counter, a PUG-1A, or theequivalent. If the reading at the surface of the bag isindistinguishable from background, the radiation warning label onthe bag will be removed and the bag placed in the ordinary trash.All required records will be maintained. In order to assess thelevel of radiation at the time of disposal, a base line will be

1

|21

)

I

,

Page 16: dy.s vx t s tstwr e s satst e tt e m m s.smtt e ru m s s t

. - _ _ - _ .- - _

.

:. . .

1

established by surveying samples of the waste without the ;

interposed plastic bag and also by counting the samples in a liquid !

scintillation counter. This evaluation process will be repeatedannually. '

F. Permission Requested for Extended Interim Storage of LowLevel Radioactive Waste

i

We request an amendment to permit us to store dry, compacted low '

level radioactive waste in sealed 55 gallon drums until an approved ;disposal site is available to us. The California low-level- :radioactive-waste-disposal site at Ward Valley, Needles, jCalifornia, will not open January 1, 1993, as scheduled. We

'

understand that the Barnwell, South Carolina site will continue toaccept our wastes until June 1994. However, we may not bepermitted by VA Central Office to send wastes to this site due topossible additional Superfund liabilities. Therefore, it may benecessary to store dry, compacted radioactive waste at our facilityfor an indefinite period until a disposal site is available to us.

4

1. Identification of waste to be storedi

a. Possession Limits

If we are denied permission to decay Sulfur -35 in storage, thepossession limit for S-35 would have to be increased to 800 mci.The current limits for 11-3, 500 mci, and C-14, 100 mci will beadequate.

b. Maximum Amount of LLW to be Storedt

Assuming a storage period of five years and if permission to decay e

S-35 in storage is denied, the activities and volume held at theend of that period would be:

Isotope Activity Volume (m^3) !

S-35 590 mci 811 - 3 134 mci 8C-14 9 mci 1.1Rb-86 7 mci .9

c. Characteristics of Low Level Waste to be Stored

1) All the stored waste is Class A. If decayof S-35 in storage is permitted, the total volume of waste would beabout 10 cubic meters, 47- 55 gallon drums. If decay of S-35 isnot permitted the total volume would be about 18 cubic meters (85-55 gallon drums) .

3

.-

Page 17: dy.s vx t s tstwr e s satst e tt e m m s.smtt e ru m s s t

. - - -- ~ . - . -.

.

!

|.,

|-

:,

2) Physical form of the waste:|,

Solid dry waste!1

3) Waste processing

Compacted and sealed in 55 gallon steel drumsi

4) Additional non-radiologic properties

Waste is treated to inactivate biological hazards prior to packing. ;

It does not contain other hazardous materials.!

d. Amount and Type of LLW Currently Being Storedor Processed

Currently low level radioactive waste is hei'd for a maximum ofthree months, until it can be shipped to a disposal site. Theaverage amount at the end of the quarter is about 20, 55 gallon -!barrels. The waste consists of dry, compacP.ed waste, liquidscintillation vials, and animal carcasses. ,

'

Additional Permits or Approvalse.

Liquid scintillation fluid in vials will continue to be shipped toQuadrex in Gainsville, Florida for incineration. No other mixed >

waste will be stored, therefore no additional permits or approvals {should be necessary.j

2. Plans for Final Disposal

Date On-site Storage Will Begina.

:The Barnwell, South Carolina site will be open to receive our low .

level radioactive waste until June 1994. Some questions have been;raised about this site due to a leak of Tritium. It nay be that !further shipments to Barnwell may increase our' liability under jSuperfund. If, on the advice of counsel, VA Central Of fice forbids.

us to use the Barnwell site, on-site storage could begin as soon as '

January 1993. |

b. Disposal racility to be Used for Ultimate !Disposal of LLW '

The ultimate disposal facility for our waste will be Ward Valley,Needles, California. This facility was scheduled to open Jan. 3, |

,

1993. The estimated optimistic date of its opening now is June '

1994, and the estimated pessimistic date is June 1996.

!

4

_ . . . . -,, . _ . . _._ _ _

Page 18: dy.s vx t s tstwr e s satst e tt e m m s.smtt e ru m s s t

- . - - - .

,

!!

*

*.

.

!

c. Date LLW will be Shipped to the Ultimate iDisposal Site ;

The date when we will commence shipping low level waste to Ward ;

Valley is unknown. We are making our contingency plans on thebasis that Ward Valley will never open. If the storage period isonly five years, it is estimated that it will take about one year,four shipments, for the estimated storage inventory to be moved

,

out. +

.

3. Physical Description of Storage Area!

a. Location of LLW Storage Building;

Figure one is a plan of the arer counded by Buildings 113, 114, and i

117. The forty foot long storage container will be located southof the current radioactive waste storage building, Building 346.

.

The scaled 55 gallon drums will be stacked two high and one deep on |each side of a three foot wide central corridor in the storage :container, Figure 2. Each drum will be available for visual {inspection. Waste will be compacted in Building 340 and then' movedto the storage container. The compactor is equipped with a HEPAfilter as marked on the plan.

,

b. Maximum Volume of LLW to be Stored

As described above, the shipping container will store a maximum of.

l64 - 55 gallon drums, about 14 cubic meters, of low level waste.At an anticipated accumulation rate of 17 drums per year, thecontainer will store almost four years of waste. When the firstcontainer is filled, another will be purchased, if needed. Total

ivolume in five years, 85 - 55-gallon drums. ;

c. Type of Building ki

The waste will be stored in an 8 foot wide, 8 foot high, forty foot jlong metal shipping container. The container is completely made of '

metal. The waste will be completely protected from the weather atall times as it is not likely that the roof will rust through ~:

within five years.

d. Control of Access

iThere is only one set of doors at one end of the container andthese will be locked with a padlock with a one centimeter thick

r

stainless steel shank. This type of lock cannot be cut with a bolti

cutter. This lock, and the metal sides, top, and bottom of theshipping container should offer adequate security for the waste. "

!

5

;t

__ < _ . _ _ . . - - _ _ _ _ _ _ _ _ _ - - - - - - - - - - -

Page 19: dy.s vx t s tstwr e s satst e tt e m m s.smtt e ru m s s t

.. _~- -. . - -

*.

* *1

*

:i

e. Ventilation System

As received, the shipping container is not vented. It is plannedto provide vents in the doors and at the end of the container. A !

fan will be installed at the end opposite to the entrance andoperated by a switch at the entrance.

f. Fire Protection

No fire protection or suppression system will be installed as the Iwaste will be contained in steel drums.

g. Adverse Ef fects of Extremes of Temperature andHumidity

.

The drums will be stored inside the metal container out of thedirect rays of the sun. The humidity in Southern California is not.

usually excessive. !

h. Vulnerability to Hazards

Tornados, typhoons, and hurricanes are almost unknown in SouthernCalifornia. There is no industry within more than a mile of the

,

site. The top layers of drums will be restrained by two safetycables running the length of the shipping container to prevent

.movement in the event of a large earthquake.|

4. Packing and Container Integrity,

a. Containers.

iIThe containers to be used are 17H 55-gallon steel drums with lids[and gaskets. These containers are DOT approved for shipping low i

level waste. The waste consists of dry solid material contaminated!with radioactive isotopes. It does not contain corrosives or other *

hazardous materials. If kept away from water, these containers !should have an indefinite shelf life.,

b. Periodic Inspections

I

As new barrels are placed into storage, every three months, the old ibarrels will be inspected to ensure they retain their integrity. !

c. Remote Handling and Repackaging [

Remote handling devices will not be necessary. Leaking or damaged I

drums will be removed using a manual drum stacker. The waste will ;

be treated, if necessary, and repacked in a sound drum.i

!

:6 i

}

II

f

|

-. ,

Page 20: dy.s vx t s tstwr e s satst e tt e m m s.smtt e ru m s s t

*;.

i. .

1*

5. Radiation Protection|

a. Radiation Surveys|

The storage facility will be posted in accordance with 10 CFR |20.203. The drums will be surveyed and swiped before they are |placed into storage. As was stated above, the drums will be placed !in two rows, two drums high. Each drum can be individuallyinspected. Every quarter a radiation survey will be made of the

|central corridor and the outside surface of the shipping container. 1

b. Projected Exposure Rate

The exposure rate at the surface of the drums would be expected to |be approximately background. All of the short lived high energy |f.sotopes are to be decayed-in-storage. No shielding will be !required. No changes in personnel monitoring are anticipated.

]

c. Emergencies

The Medical Center Fire and Safety Section will be informedquarterly of the number of drums in storage and their contents byisotope and activity. They will coordinate with local fire, |police, and emergency medical units,

d. Records

A log book will be maintained which will include the drum number,the date it was placed in storage, the activities, by isotope, the ;

maximum surface reading, the reading at one meter, and the resultof a surface swipe. Records wil3 be kept of any transfer into orout of the facility.

6. Training |

Personnel assigned to pack, handle, place, inspect, survey, orrespond to emergencies concerning radioactive waste will be part ofRadiation Safety. As such, they will receive the three and a halfhour radiation safety training course followed by an examinationwhich they must pass with score of 70% or better. They will thenreceive on the job training in procedures for packaging, handling,placement, inspection, surveying , and emergency procedures.

7. Financial Assurance ||

At cur current rate of accrual, the amounts of radioisotopes with ihalf-lives exceeding 120 days held in long term storage will not

iexceed the limits of our license. The total fraction of the ratios i

of the license limits to the amounts specified in appendix C of 10CFR 20 is 2600. According to 10 CFR 30.35, this requires an amountof financial assurance for decommissioning of $150,000. A letter 1

dated July 20, 1990, was sent from the Medical Center, West Los !!

7 I

I

I

Page 21: dy.s vx t s tstwr e s satst e tt e m m s.smtt e ru m s s t

- ... .-. -~r

. . . ;.

,

-

i,

*.

.

Angeles, to the NRC stating that funds will be obtained whennecessary on the decommissioning of -the Medical Center and thecertification amount was $750,000. Therefore financial resourceswill be in place not only to decommission the licensed operation,but also to provide for the estimated costs for handling, transportand ultimate disposal of all low level waste stored on site. .

8. Emergency Preparedness

The quantitles of isotopes to be stored are less than those listedin Schedule C of 10 CFR 30.72. We will not possess UraniumHexafluoride or Plutonium in any quantities, thus neither40.31(j) (1) nor 70.22 (i) (1) apply. Therefore, an emergency plan isnot required.

,

I

I

|.

|

|

.

$

1

h

,

a

||

f

. - -- . . . - - - .-- _-