ML20128G369

Matls Licensing Package for Amend 24 to License SNM-1319 for Biocontrol Technology,Inc.Control:119960

ML20128G369
Person / Time
Site:	07001342
Issue date:	07/21/1996
From:	Costello F NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
To:
References
119960, NUDOCS 9610090014
Download: ML20128G369 (9)

Text

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( p o-a9) U.S. NUCLEAM REGULATORY COMMISSION PAGE 1 O F -- 3 PAGES F

! MATERIALS LICENSE Amendment No. 24

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l Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,39,4n and 70, and in reliance on statements and representations heretofore fil I

I made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special 0 nucle .r material designated below; to use such material for the purpose (s) and at the place (s) designated below; to deliver or transfer such material I I

to persons authorized to receive it in accordance with tne regulations of the applicable Part(s). This license shall be deerned to contain the conditions k specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regulations and orders of the Nuclear l Regulatory Commission now or hereafter in effect and to any conditions specified below.

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I Licensee I I

In accordance with letter dated I June 23, 1994, Ii l 1. Biocontrol Technology, Inc. 3. IJeense number SNM-1319 is amended in h i its entirety to read as follows:

l i 2 300 Indian Springs Road ,c.

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O I Indiana, Pennsylvania 15701 e is n 4. Expiration date October 31, 1998 I

() cren$ N 070-01342 1 6. Byproduct, source, and/or 7. Chemical and/or physical F I (8. 'Maximum amount that licensee I

special nuclear material

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form '

, may possess at any one time

. under this license l

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V x h A. Plutonium (Principa dfealed sources / A. Not to exceed l radionuclide: N E ('(Pl'utonius batterihi 250 milligrams of *Pu f 1 plutonium 238) q ts-g. ;\i._n.

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per.} sealed source and "

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/eJ 290sgrams total  ;

I B. Plutonium 238 t-- h B M ealed neutron.souFce . / B. 4f73 curies E I

(f) D s)) N(Mdnsanto ~ iT

% ) t i !)J !t)M w ', c '"

(27.5 milligrains) Z l

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Authorized Use -

,? M O 7- , m l . wkdOdl h]a j. d k' t .rA eM d I A. (1) For recovery 'aPa compohenhor abra ctimpletedacemaker-( cl i Mc fel C-100, C%101, C-101-P,3 and Pulsar-N1/ pacemakers ransferred from specificlt,o[f expla f

I licensees. V U.'>" "

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(2) Forstorageasaseahdsource,orbatterycompohiht,orbattery,orasa h

! complete pacemaker of Coratomic Model C-100,N C-101, C-101-P, and Pulsar-N1 L i

i pacemakers.

Wff' [l I (3) For storage of Hittman Atomcell batteries. l I

9610090014 960721  :

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B. For storage only PDR ADOCK 07001342  :

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l CONDITIONS 1 I i i 10. Licensed material may be received and stored only at the licensee's facilities  ;

I located at 300 Indian Springs Road, Indiana, Pennsylvania.  :

l l 11. A. Licensed material shall be received and stored by, or under the supervision of, f g Joseph N. Klingensmith. t i I I B. The Radiation Safety Officer for this license is Joseph N. Klingensmith. t I (

l 12. 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 [g l

t OFFICIAL RECORD COdY ML 10 fI r t

y=w======s M Rwauxrswxwxwstzmmerswararswry l NRC Form 3H A U.S. N R REGULATORY COMMISSloN [j, 2 3 ,

1 License nurnber" 18 i MATERIALS LICENSE ' "'*"""" '

I SUPPLEMENTARY SHEET 070-01342 l

l Amendment No. 24 l

lp i I (12. Continued) CONDITIONS p I li I are specified by the certificate of registration referred to in 10 CFR 32.210, d l not to exceed 3 years. l

! B. Notwithstanding Paragraph A of this condition, sealed sources designed to emit l l l alpha particles shall be tested for leak go and/or contamination at intervals not M l l to exceed 3 months. WI I p C. In the absence of a certificate from a transferor indicating that a test has be~en i l made within six months prior ,totthe transfer, a sealed source or detector cell i l 3 received from another pe,rson ishall not be put into use until tested. y I

• H l I D. Each sealed source fabricated by the licensee shall be inspected and tested for N j l constructio' ifects,) leakage, and contamination prior to any use or transfer as li l a sealed so l l E. Sealed sourc . tid detector cells need not be leak tested'if: l I (i) they contain only hydro , gen 3;-or. p i ,

r w) ~ r l (ii) they coni $,,in only a gas; 6r .N f

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l (iii) the halfg#life of the3 isotope fis.30. days or less; or - r i

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(iv) they contain not'inore than 100 tmicrocuries of beta and/or gamma emitting

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I material or'not more"thanC1.0'microcuries of alpha emitting material; or E I , ,,,.; , i l (v) they are not design'ed tkemit alpha particles, are11n storage, and are not Ig.

i being used. 'However, when they are removed from storage for use or transfer I to another person, sand have not been tested within the required leak test k I interval, they shall be. tested before use or transfer. No sealed source or t:

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detector cell shall bestored for a, period of more than 10 years without I; l being tested for leakage and/or< contamination. [

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q F. The test shall be capable of detecting the presence 4 0.005 microcurie of y I radioactive material on the test sample. Recorc's of leak test results shall be p i kept in units of microcuries and shall be maintained for inspection by the E 8

Commission. If the test reveals the presence of 0.005 microcurie or more of E l removable contamination, a report shall be filed with the U.S. Nuclear Regulatory l 3

Commission and the source shall be removed from service and decontaminated, y q repaired, or disposed of in accordance with Commission regulations. The report g I shall be filed within 5 days of the date the leak test result is known with the 5 I U.S. Nuclear Regulatory Commission, Region I, ATTN: Chief, Nuclear Materials E I Safety Branch, 475 Allendale Road, King of Prussia, Pennsylvania 19406. The I

$ report shall specify the source involved, the test results, and corrective action ( l W taken. I

( i-1 G. The licensee is authorized to collect leak test samples for analysis by the  !

i licensee. Alternatively, tests for leakage and/or contamination may be performed E l by persons specifically licensed by the Commission or an Agreement State to E q perform such services. l

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1 MATERIALS LICENSE SNM-1319 l y

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SUPPLEMENTARY SHEET """N-01342 h I .

j Amendment No. 24 l

l (Continued) CONDITIONS 5

l 13. The licensee shall conduct a physical inventory every six months to account for all '>

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sealed sources and devices containing licensed material received and possessed under P j the license. Records of inventories shall be maintained for five years from the date N y of each inventory, and shall include the quantities and kinds of byproduct material, manufacturer name and model numbers, location of sources and/or devices, and the date of the inventory.

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l 14. The licensee shall maintain legible written records of all receipts, transfers, and l>W

' l disposals of special nuclear material possessed _under this license. The licensee I y shall maintain these records until the y 11cenie(isg erpinated t by the Commission. l l 15. At twelve month intervals,'ihblicensee shall collec d I!

' ] institutions with respect to: (a) accountability, removal',, tally data from all medical.'an p 4

1 of satisfactory performance or the time of service before malfunction; and (c) the N nature of malfunctions '(if appropriate) of all implanted Coratomic Model C-100, C-101, F l

j C-101P, and Pulsar-NI nuclear-powered pacemakers. W thin ninety (90) days of the twelve month period ending August 31, a copy of the r{eport must be sent to the U.S., j 1 Nuclear Regulatory Commission, Region I, Nuclear Materials Safety Branch, 475 h 1 Allendale Road, King of Prussia, Pennsylvania 19406. . '

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s. p j 16. This license does not authorize the~ implantation of nacemakers into humans or animals.

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} 17. The licensee is authorized to transport licensed material in accordance with the 1 provisions of 10 CFR 71, " Packaging and Transportation of Radioactive Material." )

{ . il' . W 3 18. Except as specifically provided otherwise in this' license, the licensee shall conduct W j its program in accordance with the statements, re contained in the documents, including'any enclos' presentations, listed below. and The procedures l

3 ures, Nuclear i y Regulatory Commission's regulations shall govern unless the statements, 1

s representations, and procedures in the licensee's application and correspondence are Ily, 1, more restrictive than the regulations. ,;

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i A. Letter dated August 27, 1990 l B. Letter dated September 22, 1993 1

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i l For the U.S. Nuclear Regulatory Commission 4

Originai Signed By: A

!Date 1

JUL 21 1994 By Francis M. Costello Nuclear Materials Safety Branch f Region I j( King of Prussia, Pennsylvania 19406 flP h

b.um.arrm.m.r.emmeme-sexuaeaseer.z.z.masi

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l JUL 21 1994 License No. SNM-1319 Docket No. 070 01342 l

Control No. 119960 i

Biocontrol Technology, Inc.

ATTN: David L. Purdy President 300 Indian Springs Road Indiana, Pennsylvania 15701

Dear Mr. Purdy:

This refers to your license amendment request. Enclosed with this letter is the amended license.

Please review the enclosed document carefully and be sure that you understand and fully implement all the Conditions incorporated into the amended license. If there are any errors or  ;

questions, please notify the U.S. Nuclear Regulatory Commission, Region I office, the Licensing Assistance Section, (610) 337-5093 or 5239, so that we can provide appiupriate corrections and haswers.

Thank you for your cooperation.

Sincerely, Original Signed By:

Francis M. Costello Francis M. Costello Nuclear Materials Safety Brc.nch Division of Radiation Safety and Safeguards

Enclosures:

Amendment No. 24 .

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i D I DRSS:RI R / Costello l

7/l f /94 7/ lb/94 l

OFFICIAL RECORD COPY - G:\WPS\MLTR\LSNM1319 - 07/19/94 ML 10

l h ] O ~~ h h Y h BIOCONTROL TECHNOLOGY. INC.

300 Indian Springs Road + Indiana. PA 15701 l (412) 349-1811 Fax: (412) 349-8610 U.S. Nuclear Regulatory Commission Region i Nuclear Material Section B i 475 Allendale Road l King of Pnissia, PA 19406 1

re: Request For Amendment To License SNM-1319, Amendment No. 23 To Whom It May Concern:

Biocontrol Technology Inc. requests the following amendment to our license.

1) Under Item 9, Authorized use, please add "A.(3) For storage of Hittman Atomcell batteries."

2) Please change the wording ofItem 9.A.(1) to read "For recovery as a component or as a complete pacemaker of explanted Coratomic Model C-100, C-101, C-101-P, and Pulsar-N1 pacemakers transferred from specific licensees."

3) Please change the wording ofItem 9.A.(2) to read "For storage as a scaledsource, or battery component, or battery, or as a component ofor as a complete pacemaker of Coratomic Model C-100, C-101, C-101-P, and Pulsar-N1 pacemakers."

Item 1) above is required to correct a violation discovered by Mr. Eric H. Reber, Health Physicist, NRC Region I, during a routine inspection of Biocontrol's licensed activities on March 30,1994 (ref. Notice of Violation, Docket No. 070-01342, dated April 26,1994). Biocontrol Technology Inc. received 24 Hittman Atomcell plutonium batteries on May 5,1983 from Hittman Nuclear Development Corporation. These batteries were evaluated for use in Coratomic Model C-100, C-101, C-101-P, or Pulsar-N1 pacemakers, but were never used. Therefore, Authorized use must be amended to include storage of Hittman Atomcell batteries.

Attached is an August 21,1978 letter from Martin A. Rubinstein of Hittman to Fred Shipko of

, Coratomic (now Biocontrol), and Nuclear Battery Corp. dwg B908C425 rev C, both describing the fuel capsule contained in Atomcell batteries. Below is a mmmmv nLnrnrmeinn frnm there sources. Log __h,$h_&__i_________

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Radionuclide: Pu-238

".v"a cr No. / 2Q /

Chemical Form: PuO2 Oxide g_a fg _ _ _ _ _ _ _ _ _ _

Physical Form: Solid, Sealed Source Feucf prj _/S ______,,,,__,,,__

Activity: 2.5+/-0.1 Curies -

Tv ' i o _om2_ _82E-_g.-- _ __

Afler the March 30,1994 NRC Safety Inspection, Biocontro on cr a Pec'd _ 0, ir'm^sN' a,FefdliffdNeMhe NRC license, and determined that two additional changes in w{sding required to more accurately reflect current licensed activities at Biocontrol.

05FICIAL RECORD COPY E a 119960 Your Fhture Brings Out The Best In Us DUN 2 9 l990

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O Item 2) above is requested because the current wording of our license implies that sealed sources are routinely recovered as a component ofexplanted pacemakers transferred to Biocontrol from specific licensees, and this is not the case. Pacemakers transferred to Biocontrol from specific licensees are received as complete pacemakers, tested, and stored as complete pacemakers. If failure analysis requires the pacemaker to be cut open, the isotopic battery may be separated from the pacemaker electronic circuitry and stored separately as a component of the pacemaker.

Therefore, sealed sources contained in explanted pacemakers returned to Biocontrol from specific licensees may be stored as complete pacemakers or as a component of a pacemaker.

Item 3) above is requested because, in addition to storage of complete isotopic pacemakers, Biocontrol is also storing sealed sources, battery components, batteries, and other sub-assemblies of these isotopic pacemakers.

Biocontrol check #14341 for the an.endment fee of $330, vehich would normally accompany this request, was inadvertently mailed on May 6,1994 to Ms. Lea Tremper, USNRC License Fee and Debt Collection, Washington, DC 20555. Ms. Missie Simpson of Biocontrol's accounting department has informed Ms. Tremper that this check is for a license amendment. Please apply Biocontrol check #14341 to this requested license amendment.

Please contact me if you have any questions.

Sincerely, .

%fd8 W~jem -

Joseph N. Klingensmith RSO Attached: August 21,1978 letter from Martin A. Rubinstein to Fred Shipko Nuclear Battery Corp. dwg B908C425 rev C i

cc: David Purdy Kieth Albee Nancy Saxman James Cupp John Klingensmith

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.Jb o b o- o .-

W hW Corporaden 9190 Red Branch Road Columbia, Maryland 21045 301/730-7800 Refer to:

NB-78-152 August 21, 1978

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Coratomic P.O. Box 434 Indiana, PA 15701 ATTEu, TION: Dr. Fred Shipko

SUBJECT:

Fuel Capsule Drawing B908C425 Rev. C Enclosed

Dear Fred:

l Per our conversation, I am enclosing a drawing of the capsule presently used in our Atomcell. The fuel loading is given in the note on the drawing which is in essence Pu-238 and approximately 2.5 curies equivalent to 150 mgm.

1 This capsule has been fully qualified and has been tested to meet all the  !

NRC requirements. I would appreciate your review of this capsule with l regard to possible usage in your nuclear pacer. If at all usable, I l am sure we can work out a mutually satisfactory arrangement to sell you '

up to 50 at this time. ~

3 Very truly yours, BAD - .

herde Martin A. Rubinstein  !

Vice President and General Manager MAR /bp Enclosure ,

cc: K. Rippel - NB Corp.

J. Weir - NB Corp. .

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INFORMATION FROM LTS BETWEEN:  : --------------------

LICEf4SC FEE MAtiAGEMENT " RANCH, ARM ,

PROGRAM C00E: 23300 AND  : S T AT US CODE: C REGI0tlAL LICENSING SECTIONS  : FEE C AT EG31Y : 10

ExP. DATE: 19981031

FEE COMMENTS: _______-...--___--___

DECori FIN ASSUR RE0D: N L IC FilS E FEE TRANSMITTAL A. REG!DN Z

1. APPLIC AT IGN ATTACHED APPLICANT /LICENSEF: BIGC CNTROL TECHNOL3GY, INC.

RECEIVED DATE: 940629 00CKET N O: 7001342 CONTROL NO.; 119760 LICENSE NC.: SNH-1319 ACTION TYrid: AMENDMFNT

2. FFE ATTACHED AMOUNT: __g___

CHECA NJ.: __[__.

3. C o ttM EN T S SIGNED __

aATE

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B. LICENSE FEC MANAGEtiENT GRANCH (CHECK W'1 E N MIL E STON5 03 15 ENTER El / ./)  !

1. FEF C ATE GO R Y AND AMOUNT: _(______________-_________________h_3 .___

2. CORRECT FEE PAID. "

'f* LIC AT IO N M AY SE PROCESSEC FOR:

I AMEN 3 MEN T -------------- 1 REMEWAL '

LICENSE ______________ l

3. OTHER _____________________-________. __

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