ML20151D790

Amend 21 to License SNM-1319 for Biocontrol Technology,Inc, Amending License in Entirety

ML20151D790
Person / Time
Site:	07001342
Issue date:	09/10/1987
From:	Jennifer Davis NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
To:
Shared Package
ML20151D793	List: ML20151D790 ML20151D860 ML20151D884 ML20151D926 ML20151D953
References
NUDOCS 8804140448
Download: ML20151D790 (3)

Text

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's. e ss i U.S. NUCLE AR T.E!ULATOY COMMIS$10N IAGE L O' 3 ' ACES Ll l

. MATERIALS LICENSE Amendment hu. 21 Pursur it to the Atomic Energy Act of 1954, as amended. the Energy Reorganization Act of 1974 (Public Law 93 -438) and litle 10. M f

f Code of Federal R(gulations, Chapter I, Parts 30,31,32.33,34,35,40 and 70, and in reliance on statements and representations 1 heretofore made by the licensee, a license is hereby issued authorizing the licensee to receise, acquire, possess, and transfer by proJuct.

l source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below ;to deliser or transfer such material to persons authorized to receive it in accordance with the regulations of the appheable Part(s). This *

. i license shall be deemed to contain the conditions 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 Regulatory Commission now or hereafter in effect anJ to any ,

l conditions specified below.

t Ucensee 1 In accordance with letter dated .

July 15, 1987, g I- Biocontrol Technology, Inc. 3. Ucense number ShM-1319 is amended in g its entirety to read as follows, p

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2- P.O. Box 434 $

Indiana, Pennsylvania 15701 4. Expiration date Septemoer 30, 1990

5. Docket or d Reference No. .070-01342 p

6. By product, source, and 'or 7 Chemical and/or physical m 5. Maximuni amount that 1:censee M special nudear material form ', may possess at any one time >}

q jtnder this license A. Plutonium (Principal A. Sealed sources A. Not to exceed 250 p! >

radionuclide Pu-238) (Plutoniumbatteries) milligrams of Pu-238 per

, sealed source; 290 grams ljg total $

l B. Plutonium 238 B. Sealed neutron source B. 4.~73 curies  %

(Monsanto) (275 milligrams)

9. Authorized use h g

A. (1) For use as a component in assembled Coraton.4c Model C-101 pacemakers and as a Fj y

component in the assembly (manufacturing) of Coratomic Model C-101-P pacemakers; for distribution to medical institutions authorized to receive h pacemakers pursuant to the terms and conditions of a specific license issued h by the Nuclear Regulatory Commission or an Agreement State. g a

A (2) For recovery as a component of explanted Coratomic Model C-100. C-101 and C-101-P pacemakers transferred from specific licensees. N}

h4 (3) For storage or disassembly and re-furbishing of the battery source from Coratomic Model C-100, C-101 and C-101-P pacemakers, fp 9

B. For use as a calibration source.

CONDITIONS fV l 10. Licensed material shall be used only at the licensee's facilities, 300 Indian g Spring Road, Indiana, Pennsylvania. g A

$ 11. Licensed material shall be used by, or under the supervision uf, individuals who @

have completed the training program as outlined in the letter dated Augu:t 19, 1985 and have been designated by Frederick J. Shipko, Radiation Safety Officer,

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SUPPLEMENTARY SHEET 0-01342 l l >

I Amendment No. 21 p (Continued) CONDITIONS I

l 12. As six tronth intervals the licensee shall collect and tally data from all medical institutions with respect to: (a) accountability, removal and recovery, l f I (b) duration of satisfactory performance or the time of service before malfunction, b I and (c) nature of malfunction (if appropriate) of all implanted Coratomic Model b I C-100, C-101, and C-101P nuclear-powered pacemakers. Within ninety (90) days of the b six month period ending February 28 or August 31, a copy of the report shall be sent I l to the U.S. Nuclear Regulatory Commission, Region I, Nuclear Materials Safety Section, 631 Park Avenue, King of Prussia Pennsylvania 19406.

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lC , h 1 13. The licensee shall maintain records of the' medical institutions approved by the h 1 FDA for participation in 10E G 610104/A2 and the date of FDA's approval of each I institution. l l

14. This license does not authorize the implantation of pacemakers into humans or l animals.

1 t I _ h A(1) Any sealed sources or detector cells specified in Items 7.A amd 7.B shall be >

1 15.

tested for leakage and/or contamination at intervals not'to exceed 6 months.

} Any source or detector cell receiveo from another person which is not p 1

accompanied by a certificate indicating that a test was performed within g 1 6 months before the transfer shall not be put into use until tested. >

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l (2) Notwithstanding the periodic leak test' required by this condition, any >

I licensed sealed source or detector cell is exempt from such leak tests

] when the source or detector cell contains 100 microcuries or less of beta fy

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and/or gamma emitting raterial or 10 microcuries or less of alpha emitting material, ,

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i t Any sealed source or detector cell in storage and not being used need >

1 B.

$ not be tested. When the source or detector cell is removed from storage 4 f for use or transfer to another person, it shall be tested before use or h transfer. p 1

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1 C. The test shall be capable of detecting the presence of 0.005 microcurie >

I of radioactive material on the test sample. If the test reveals the I presence of 0.005 microcurie or more of removable contamination, the >[

E source or detector cell shall be removed from service and decontaminated, p f repaired, or disposed of in accordance with Comission regulations. A p; j

J report shall be filed within 5 days of the date the leak test result is J known with the U.S. Nuclear Regulatory Commission Region 1. ATTh: Chief, y>

l Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, King of >

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Prussia, Pennsylvania 19406. The report shall specify the source involved.

the test results, and corrective action taken. Records of leak test l

be results shall be kept in units of microcuries and shall be maintained for h 1, inspection by the Comission. Records may be disposed of following y q Commission inspection. l 1

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_-----==-------% --- --------- agsT,q l RC Form 374A U. S. E A'I REGULATORY COMMIS$10N ,,a, 3 y 3 ,4ots lh I LJcena nurnter h S 1319 MATERIALS LICENSE ' " " " '

SUPPLEMENTARY SHEET 070-01342 l l >

1 Amendment No. 21 p I (15. continued) CONDITIONS 1

l D. Tests for leakage and/or contamination shall be performed by the licensee i

or by other persons specifically licensed by the Comission or an Agree-I ment State to perform such services.

l I 16. The licensec may transport licensed material in accordance with the provisions I of 10 CFR Part 71, "Packaging and Transportation of Radioactive Material".

17. The licensee shall conduct a physical inventory every 6 months to account for l 1 all sources and/or devices rcceived and possessed under the license. Records >

l of inventories shall be maintained for 2 years from ythe date of each inventory. h I h l10. Except as specifically provided otherwise in this license, the licensee shall conduct its program in accordance with the statements, representations, and

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l procedures contained in the docurrents including any enclosures, listed below. p 1 The Nuclear Regulatory Comission's regulations shall govern unless t.he state- >

I ments, representations and procedures in the licensee's application and corre- t I spondence are more restrictive than the regulations. >

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l A. Application dated May 2,1965 t l'

j B. Letter dated August 19, 1985 p I C. Letter dated July 10, 1986 k l D. Letter dated July 15, 1987 >

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o f For the U.S. Nuclear Regulatory Commission i! '

i '10 SEP 1987

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Tack Devis >I l Date By I huclear baterials Safety anc I Safeguards Branch, Region 1 King of Prussia, Pennsylvania 19406 ki l

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