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NRC FORW 313 U.S. NUCL E A A llt 0VL A TOR Y consaaestion(7 Sh 0 APPROVID SV Ones

35.C8 R 33. 32,33. 34 APPLICATION FOR MATERIAL LICENSE I. - . 8348.to 3130 0120

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INSTRUCTIONS: $tt THE APPROPRIATE LICEN$E APPLICATION OUIDE FOR OITAILED INSTRUCTIONS FOR COMPLETIAG APPLICATION. $$ND TWO COPIES i

OF THE ENTIRE COMPLETED APPLICATION TO THE NRC OFFICE $PECIFIEO 8ELOW.

APPuCATIONS FOR DISThitWTION Of ExtMPT PRODUCTS FILS APPUCATIONS WITH. IP v^U ARE LOCATED IN.

U S NUCttAR REGULATORY COUWi$ lion ILLINott. INDI ANA. lonA. MICMIC AN, M'%NE60T A. Wl8800RI. 0M60,0RDIYlSiON 08 PktL CVCLt AND WAf TRIAL SAFETY, NW5$ WiSC0% sin, SENO APruCATiONS 10W A&MINGTON, DC 30546

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PtRSONS LOCATED IN AGRIEMENT St Af ts SINO APPUCAfl048 70 TMt U S NUCLE AR At0VLATORY COMWitSION ONLY 17 TMtv WISM 70 P006388 ANO USS LICINSID MAf tRtALgas ST Af t$ SUSJtCT TO U.S. NUCLE AR REGULATORT CoesMresiON Juni&OiCTION.

1. TMIS 85 A% APPuCAfl0N FOR fChere apa*opres ar*/ 2. NAWI AND W AluN3 ADDRESS 08 APPLICANT flac4Wela Coast- Department of Health and Human ServicesA ,, t o uC t .,3 8- PHS/ Food and Drug Administratione AunDWnT To ucast NUWitR

] C. Anin AL O, uCnSt vWetR _ 21-09762-01 1560 E. Jefferson AvenueDetroit, Michigan 48207

3. 4008888 83, nMERG LICt%$tD WAf tni AL mLL st Ust D OR POSSESSED

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juttPMONS.,vW.BR* 9 R 313-226-7658Louis F. SchneiderSVtWst ITEUS S TMROUCN 110% to a 11" PAPim TME TYPt AND SCOPS 081%s0RWAfl0N To ei PR0veD8018 DESCRf tt0 IN TME UCt%88 APPUC ATl04 0Vict

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13 CERTipsCAf t0N fas e ee eempresse er answwtt TMt APPuCA%Y UNDER$7 AND5 TM AT ALL staitWINT8 AND REPRistNT ATIONS W ADt IN TMis APPuCATICue AntesOf%Df%Q 4*0% TME AP8LICA%TTME A*PUCA%T AND ANY 08 8sciAL En tCUtt%Q TMis CtRTipsCATION O% etM ALP 08 TMt APPLIC ANT.N AWED IN ITEM 2. CtRTIFY TM AT TMis APPUCATION isPageantD IN C')%80RWity W11M TITLE 10. CODE 08 flotR AL R10ULAT 0%$.p ARTS 30,32. 33. 34,35. A%D A0 AND TM AT ALL %s0RWATION CONT Ai%tD McRaiN,is TRUE AND CORRICT TO TMt 85sf 08 TattR KNOWLEDGt AND Stuf 8R A R NihG 15 U S C StCTION 1001 ACT 08 Ju%t 25,1848 42 $f AT T49 UAKI$ if A CR'Wi% AL Of FIN $t TO M As E A ntLLFULLY F AL84 $f Af tWINT 08t AtPREltNT ATIONTo ANY DEPARTWENT OR AGl%CV 08 TME U% TED ST Af ts AS TO ANY W ATTER nrTMiN ITS JumisDICTION

$+GN A Tyn t.Ct RTip ya%Q Op siCim TYPSD PRINTED %AW4 TIT L t Daft

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MN1311983

REGION III N3'"_ __ __ ____-_ _ . . . _ _ _ _ _ _ _ . _ _ _. . _ _ -

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Attachment - Application for Material LicenseNRC Form 313

Louis F. Schneider, Laboratory DirectorU.S. Food and Drug Administration - .

1560 E. Jefferson AvenueDetroit, Michigan _48207

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Item 5 - Radioactive Material - '

a. Element and Mass Number:Nickel 63

b. Chemical and/or Physical F'ormNRC approved foil in a scaled source.

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c. Maximum Amount:The number and model of detector cells is notlimited except each cell shall not exceed 25millicuries and is an approved NRC foil in ai

sealed source.

Item 6 - Purpose *

The detector cells will be used in the gaschromatograph for analysis of foods, drugs, andcosmetics. c

Item - 7 Responsible Individuals

Louis F. Schneider, Lab ratory Director. ..

9James E. Westfall, Supervisory ChemistNorbert V. Fehringer, Research ChemistD. Ronald Erney, Residue Specialist 8

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|No repair or maintenarice will be performed onthese scaled detector sources. They will not beopened. They will be returned to a facilityapproved by NRC for repair and maintenance. |

!Item 8 - Training Provided for Individuals

Other users of the gas chromatograph will not bepermitted to perform any maintenance or repairoperation on these sources.

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Attachment - Appilcation for Material LicenseNRC Form 313

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Item 3 - Facilities and Equipment

The laboratory is a controlled access restrictedarea. No unauthorized persons are permitted-in' ' ' " ~ ~ ~

the laboratory. Any visitors must sign in, havea Visitor's_ Badge,=and bo. accompanied at all .

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times by authorized laboratory staff.

Item 10 - Radiation Safety Program

See Attachment (1) for trainin'g of authorizedstaff.

10.1 - No personnel monitoring equipment is maintained.

10.2 - No radiation detection instruments aremaintained..

10.3 - Leak Testing.

Each detector cell is tested every 6 months. Thekits are 2009 Swube kits product of BectonDickinson and Company. The kits are forwardedfor testing to U.S. Food and Drug Administration, dWinchester Engineering and Analytical Center,Winchester, Massachusetts. NRC License20-08361-01. Expires October, 1989.

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10.4 - No maintenance or repai'r is conducted on thedetector sources. They are returned to themanufacturers for repair or r.aintenance.

Item 11 - Waste Management

Disposal of any source will be by transfer of theradioactive material to a licensee specificallyauthorized to possess it.

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_ TRAINING ColmSE AGENDA. o .

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*LICENSING AND SAFE

IIANDLING OF RADIOACTIVE FOILS

(ICW, Buf f alo, N.Y. , June 9,1975 - NAC)

1. Licence Requirements _

A. Tritium Foils

(1) Inventory records of receipt, use, and return of foils.

(2) Labeling of foil containers..

(3) Authorization to:

(a) Remove foils(b) Clean foils

(4) Model-License (attached)

(5) CLC Location

(6) Exhaust System

(7) Scandium vs. Titanium Foils

(8) Posting requirements for 10 CFR 19,20; AEC Form 3, and copy oflicense, CRM.

B. Nickel-63 Cells

(1) Inventory records on receipt, use and return of cells.

-(2) Authorization to clean cells.

(3) Swipe testing

(4) Exchhnge with VEAC

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(1) Amend license(2) Reduce downtime

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LICENSING AND SAFE HANDLING OF RADIOACTIVE FOILS - Page 2 l

311. Mechanism for Obtaining N Fof_ls

(a) Accountability Form I

(b) Distribution and Return Thru Poet Office1

111. Cleaning Foils - TRITIUM |

(a) Intact Cell - flush with solvent,

(b) Disassembled Cell - soak in KOLL - 1-2 hours

(c) Buf falo District - LIB f or anode

IV. Cleaning Foils - Nickel - 63

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(a) Thercal (350 C with normal carrier flow overnight or weekend)

(b) Solvent cleaning - KOR, Mc0LL, Acetone, Benzene or Hexane

V. Swipe Testing - Nickel -63 Cells

(a) Records(b) Frequency - every 6 months(c) Procedure (enclosed)

(1) Swab exit part and cell(2) Mail to L'EAC

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$*9 6.. %

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Health Physicist .

EDR0/REAC109 Holton StreetWinchester, Mass. 01890 May 1975- !4

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STANDARD OPFRATING PROCEDURE (SOP)for >

HANDLING TRITIUM FOILS

1.1. PURPOSE /ViD SCOPE: A tritium foil is classified by the Nuc1 car.

Regulatory Cocaission as licensed radioactive material, and. ,

accountability is_r_equired. It is the purpose of. this $0F to

establish uniform guidelines for the procurement, possession, and

disposal of tritium foils under an NRC license. Particularly,

applicable are sections 10 CFR 30.34 and 10 CFR 33.17 (b).

; 2.1 PROCUREMENT:, The Executive Director for Regional Operations-(EDRO)

of FDA purchases tritium foils in wholesale lots. The EDRO Districts

may order foilt hv :alling EDR0/REAC at 617/729-5700 in Winchester,

Mass. (Attn: Neil Gaeta). The order will be filled and shipped by this' i

office. Users who work at the Bureau of Foods (BF-14) and have,

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approval from the isotopes Committee, may pick up foils at the

; Safety Office, FB-8.>

i 3.1 ACCOUNTABILITY: EDR0/REAC - This office will maintain a Log Book for iJ -

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the issuance of new foils; showing the vendor's serial number for each!

foil, the new location of the foil, the date of transfer ~, and the name

of the naw custodian. A copy of the Accountability Form will be mailedi

to EDRO, UFO-130 when the foils are shipped. '

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|' 3.2' ACCOUNTABILITY: -DISTRICT LABORATORIES - Since District Of fices ' ,

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the. Districts.are responsible ~ ''

maintain their own NRC licenses,

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for transferred ~ material. To comply with;the regulations, they';

must maintain ~ records to show -(a) the date of. acquisition (b)1 the :

:

individual user, and (c) the disposition of the material. When.

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iDistrict Offices receive foils, they will sign the pink copy of the

1 . 4

Accountability Form (Appendix A) that will accompany the shipment, - !

and return it to this Office,. EDRO/WEAC (HFR-1300) . .

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'3. 3. ACCOUNTABILITY OF SPENT FOILS: Spent foils will be returned to

the Health Physicist, EJR0/WEAC. They are ultimately combined.

with other solid radioactive wastes, and shipped for land burial, fThe Healty Physicist will issue a receipt when the foils are returned *

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to him. Some 20% of the initial activity has been lost when foils

are returned. Since each licensee is limited to 1 curie per year. (',

to the sewer, the distribution of this lost activity should be known. '

3.4 _ TRITIUM FOIL ACCOUNTABILITY FORM: This form (Appendix A), in duplicste, .

\-

will a :ompany shipments of new foils. The receiving officer will :-

sign e.he pink copy and return it to this Office,-EDRO/WEAC (HFR-1300) .j

and retain the white copy for his files'. In addition, white copiesiwill be filled by this office (until the pink copy is returned).

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4.1 MFTHOD OF PACKAGING FOILS FOR SilIPMENT: Foils should be packed in

a screw-top sample jar that displays the radiation symbol, listing

the isotope as !H, the activity (number of foils times nominal

activity per foil) and the date. The j ar, in turn, should be suitably

packed with wadding in a carton which is at least 4 by 4 by 4 inches.

No radiation tag or symbol is required on the outer carton when.

tritium foils are shipped. However, the inner package must bear the

words: Radioactive Material. No Outside Label Required. |

|4.2 METHOD OF SHIPMENT: Foils may be shipped as registered mail or by |

\air express. The latter shipment cost the Goverr. ment about $9.00. |The paperwork cost associated with a Government Bill of Lading (GBL) '

is estimated at $25.00 which can be avoided by shipping via Railway

er Federal Air Express. A special contract covering shipments makes

the (GBL) unnecessary. Although a numb .r of foils can be shipped as

cheaply as one, field offices should not accuaulate spent foils until

their inventory exceeds their possessica limit.

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AEr:SM X A..- = -

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.,. Food and Drug Administration*

- ' - EDR0/WEAC'

109 Holton Street . TRITIUM FOIL ACCOUNTABILITY FORX.>

Winchester, Mass. 01890- ]:

INSTRUCTIONS:1. Sign and date lower portion of pink copy and return upon receipt

of your order.2. Retain white copy for your records.

ISSUED TO:

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PER REQUEST OF DATE

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FDIL # RELATIVE INTENSITY DATE OF SUP.VEI - INITIALS-

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RECEIPr;,

THE TRITIUM FOILS DESCRIBED AB')VE WERE RECEIVED IN GOOD CONDITION. ;

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SIGNATURE DATE'

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RETURN TO:Neil Gaeta, Health PhysicistEDRO/WEAC

109 Holton Street I,

Winchester, Mass. 01890

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Reference Control No. 57254.- .

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'MEM010diDUM DEPARTMENT OF. HEALTH, EDUCATION, AND WELFARE*

PUBLIC HEALTH SERVICE-FOOD AND DRUG' ADMINISTRATION

Winchester Engineering and Analytical Center109 Holton Street, Winchester, }M 01890

DATE May 1975

TO: FDA LABORATORIES

FROM: NEIL GAETA, HEALTH PHYSICIST.EDRO/WEAC-

SUBJECT: INSTRUCTIONS FOR SWIPE TEST FOR NICKEL-63 DETECTORS

General: Wipe tests are required at 6-month intervals on allionization detectors containing ''Ni sources.*

The Certificate of. Inspection supplied with thedetector gives the initial wipe test ~results. Thisinformation should be maintained for inspection by ,

NRC. Succeeding wipe > tests must be performed at6-month intervals from that date. All test results~

must be kept for NRC inspection.

Procedure:

1. Purchase single tipped sterile disposable cotton-svabs in 17 x 100 mm' tubes, individually wrapped.

,

These are available from Curtin Matheson Scientific,

Inc. Secure proper container for shipment.|

2. Moisten tip of the swab with solvent (methanol,acetone, benzene or hexane) .

)3. Grasp the holder; rub the moistened tip of the swab i

over the outside surfaces of the detector and all'surfaces immediately adjacent to the detector. Be

particularly careful to wipe the outlet tube terminus.

4. Place swab in a plastic' case. Be careful not to,

touch cotton to the plastic.

5. Fill in inforca' tion on Certificate front ofInspection card (Attachment A-2).*

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6. Properly pack container with swab and card in ashipping container.. Mail by parcel' post to:

Neil Caeta, Health PhysicistEDR0/WEAC109 Holton StreetWinchester, }% 01890

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Certificate of Incoection' :

! !Dic-t ri c t :

- . . _ _ - AEC License No.5.ab Tect|

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DetectorType11odel No.Serial No.

' ate of 5'.eab Test By uhom~

y"- -

|k r, t W5 suits iDate of TestAmount of Contamination microcuriesNc :t Vipe Test Required on _

;Date P.cperted Name,

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00fffR01. No a 5 16 e1

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