ML20155F539

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Corrected Amend 21 to License SNM-1319 for Biocontrol Technology,Inc,Amending License in Entirety
ML20155F539
Person / Time
Site: 07001342
Issue date: 10/31/1987
From: Johansen J
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
To:
Shared Package
ML20155F542 List:
References
NUDOCS 8806160422
Download: ML20155F539 (3)
v • d • e


Text

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CORRECTE0 COPY klS. NUCLEAR REGULATORY COMMISSION PAGC [_ OF 3 PAGES

q ts-s o MATERIALS LICENSE Amendment No. 21 Pursu;nt to the AtonQ 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, Paris 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations f heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, p N l source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below;to h' 1[% deliver or transfer such material to persons authorized to receive it in accord.uee withj i the h license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and .sj i subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect aad to any l l

(! conditions specified below. i Lt r Licensee l In accordance with letter dated

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3. fulge 15 a nuab"1987, I

Biocontrol Technology, Inc. SNM-1319 is amended in i its entirety to read as follows:

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2' s P.O. Box 434 - , 4. Expiration date Indiana, Pennsylvania 15701 September 30, 1990 q

5. Docket or gj g Reference No. 070-01342 ad

!4l 6. Byproduct, source.and/or 7. Chemical and/or physical 8. Maximum amount that licensee 3l>

h special nuclear material form may possess at sny one time /

under this license l A. Plutonium (Principal A. Sealed sources A. Not to exceed 250 l l% cadionuclide Pu-238) ~(Pl.utonium batteries) milligrams of Pu-238 per sealed source; 290 grams l4 j{

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,i B. Plutunium 238 B. Sealed neutron source B. 4.73 curies i i -(Monsanto) (275 milligrams)  ;

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9. Authorized use lpl

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%y$A. (1) For use as a component in assembled Coratomic Model C-101 pacemakers and as a l l

{9 component in the assembly (manufacturing) of Coratomic Model C-101-P i pacemakers; for distribution to medical institutions authorizea to receive y

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! pacemakers pursuant to the terms and conditions of a specific license issued by the Nuclear Regulatory Commission or an Agreement State. pl 1

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,i (2) For recovery as a component of explanted Coratomic Model C-100, C-101 and j C-101-P pacemakers transferred from specific licensees. l i

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,l (3) For storage or disassembly and re-furbishing of the battery source from i)p Coratomic Model C-100, C-101 and C-101-P pacemakers. p l N P

>{j B. For use as a calibration source.

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l CONDITIONS l

Licensed material shall be used only at the licensee's facilities, 300 Indian .

l10. Spring Road, Indiana, Pennsylvania.

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A. Licensed material shall be used by, or under the supervision of, individuals l$11. l who have completed the training program as outlined in the letter dated August 19, 1985 and have been designated by Joseph N. Klingensmith, Radiation Safety

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tai Y Officer. l*

8806160422 971031 i

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, SUPPLEMENTARY SHEET >

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070-01342 Y

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  • g CORRECTED COPY Amendment No. 21 >4 4

p)i l4-(11. continued) CONDITIONS h 8

j C. The Radiation Safety Officer for this license is Joseph N. Klingensmith, fg l 12. As six month intervals the 1icensee shall collect and tally data from all medical institutions with respect to: (a) accountability, removal and recovery, pp q

4 (b) duration of satisfactory performance or the time of service before malfunction, h l$ and (c) nature of malfunction (if appropriate) of all implanted Coratomic Model &

i C-100, C-101, and C-101P nuclear-powered pacemakers. Within ninety (90) days of the lp six month peri 0d ending February 28 or August 31, a copy of the report shall be sent l to the U.S. Nuclear Regulatory Commission,; Region I, Nuclear Matericls Safety p 4

'4 Section, 631 Park Avenue, King of Prussia, ' Pennsylvania 19406.

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13. This license does not authorize the implantation of pacemakers into humans or 4

animals. p q

14. A(1) Any sealed sources or detector cells specified in items 7.A and 7.B shall be p; p

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tested for leakage and/or contamination at intervals not to exceed 6 months. jkj i Any source or detector cell' received from another person which is not g 3 accompanied by a certificate indicating that.a. test was performed within g*

4 6 months before the transfer shall not be put-into use until tested.

Q (2) Notwithstanding the peric,dic k leak teit required by this condition, any 3 licensed sealed source or' detector;celliis exempt from such leak tests i when the source or detector cell' contains 100 microcuries or less of beta and/or gamma emitting material'or'10 microcuries or less of alpha emitting

4 material. g%

. pl QI B. Any sealed source or detector cell in storage and not being used need N 3

i not be tested. When the source or-detector cell is removed from storage j f

st for use or transfer to another person, it shall be tested before use or transfer, y

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k C. The test shall be capable of detecting the presence of 0.005 microcurie '

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$ of radioactive material on the test sample. If the test reveals the >;

1l presence of 0.005 microcurie or more of removable contamination, the E

,i source or detector cell shall be removed from service and decontaminated, f

.! repaired, or disposed of in accardance with Commission regulations. A p1

'i report shall be filed within 5 days of the date the leak test result is $

hj known with the U.S. Nuclear Regulatory Commission, Region I, ATTN: Chief. ti 4 Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, King of t 4l! Prussia, Pennsylvania 19406. The report shall specify the source involved, E i4 the test results, and corrective action taken. Records of leak test results shall be kept in units of microcuries and shall be maintained for hl p'

4l 4 inspection by the Commission. Records may be disposed of following p Commission inspection. >

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. ,M ATERIALS LICENSE t>ocket or Reference nun.ber h" Q'4

  • FUPPLEMENTARY SHEET 070-01342 d

i CORRECTED COPY Amendment No. 21 lN i

4 (14. continued) CON 0lT10NS li l

4 i C. Tests for leakage and/or contamination shall be performed by the licensee j or by other persons specifically licensed by the Commission or an Agree-  !

l ment State ta perform such services. l, 4  ;-

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15. The licensee may transport licensed material in accordance with the provisions y, of 10 CFR Part 71, "Packaging and Transportation of Radioactive Material". l4 i

N j 16. The licensee stiall conduct a physical inventory every 6 months to account for all sources and/or devices received and possessed under the license. Records h

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'a of inventories shall be maintained for 2 years.from the date of each inventory. E i>j 4

17. Except as specifically provided otherwise in this license, the licensee shall 3

$ conduct its program in accordance with the statements, representations, and {yl procedures contained in the documents including any enclosures, listed below, p The Nuclear Regulatory Corrmission's regulations shall govern unless the state- p

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ments, representations and procedures in the licensee's application and corre-spondence are more restrictive'than the regulations.

N A. Application dated May 2,1985 f B. Letter dated August 1.9, 1985 h

3 Letter dated July 10,-1986? #,

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'i D. Letter dated July 15, 1987= . N E. Letter dated August 11, 1987 g V

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Original Signed By:

Jenny M. Johansen

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'lOdte I Nuclear Materials Safety ano lW Safeguards Branch, Region I

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