ML20155F539
| 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) | |
Text
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PAGES CORRECTE0 COPY klS. NUCLEAR REGULATORY COMMISSION ts-s o
- q 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 N
heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, p
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 with the j i 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.
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Licensee l
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In accordance with letter dated i
15 j
- 3. fulge nuab"1987, I
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Biocontrol Technology, Inc.
SNM-1319 is amended in its entirety to read as follows:
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s P.O. Box 434
- 4. Expiration date September 30, 1990 Indiana, Pennsylvania 15701 q
- 5. Docket or gj g
3l Reference No.
070-01342 ad
!4l 6. Byproduct, source.and/or
- 7. Chemical and/or physical
- 8. Maximum amount that licensee h
special nuclear material form may possess at sny one time
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under this license l
A. Plutonium (Principal A. Sealed sources A. Not to exceed 250 l
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cadionuclide Pu-238)
~(Pl.utonium batteries) milligrams of Pu-238 per l4 j{
sealed source; 290 grams total x
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,i B. Plutunium 238 B. Sealed neutron source B. 4.73 curies i
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-(Monsanto)
(275 milligrams) i vi l
9.
Authorized use lpl
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,d (1) For use as a component in assembled Coratomic Model C-101 pacemakers and as a l
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{9 component in the assembly (manufacturing) of Coratomic Model C-101-P i
pacemakers; for distribution to medical institutions authorizea to receive h[4 pacemakers pursuant to the terms and conditions of a specific license issued y
Id by the Nuclear Regulatory Commission or an Agreement State.
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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.
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,l (3)
For storage or disassembly and re-furbishing of the battery source from p
l Coratomic Model C-100, C-101 and C-101-P pacemakers.
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>{ B.
For use as a calibration source.
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I CONDITIONS l
l l10.
Licensed material shall be used only at the licensee's facilities, 300 Indian lt Spring Road, Indiana, Pennsylvania.
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{f A.
Licensed material shall be used by, or under the supervision of, individuals l$11.
who have completed the training program as outlined in the letter dated August g
l tai 19, 1985 and have been designated by Joseph N. Klingensmith, Radiation Safety jp3 Y
Officer.
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U.S. NU R REGULAT8RY COMMISSION
- N R C F or m 3 7 4 A PAGE OF PACES 4
LMnse nzmber SNM-1319 h
$.1 M ATERIALS LICENSE y
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, SUPPLEMENTARY SHEET 070-01342
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g CORRECTED COPY Amendment No. 21 p)i l4-(11. continued) 4 h
CONDITIONS 8
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C.
The Radiation Safety Officer for this license is Joseph N. Klingensmith, g
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- 12. As six month intervals the 1icensee shall collect and tally data from all medical q
institutions with respect to:
(a) accountability, removal and recovery, pp 4
(b) duration of satisfactory performance or the time of service before malfunction, h
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and (c) nature of malfunction (if appropriate) of all implanted Coratomic Model lp i
C-100, C-101, and C-101P nuclear-powered pacemakers. Within ninety (90) days of the l
six month peri 0d ending February 28 or August 31, a copy of the report shall be sent 4
to the U.S. Nuclear Regulatory Commission,; Region I, Nuclear Matericls Safety p
'4 Section, 631 Park Avenue, King of Prussia, ' Pennsylvania 19406.
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k 13.
This license does not authorize the implantation of pacemakers into humans or animals.
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3
- 14. A(1) Any sealed sources or detector cells specified in items 7.A and 7.B shall be p;
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9 tested for leakage and/or contamination at intervals not to exceed 6 months.
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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*
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6 months before the transfer shall not be put-into use until tested.
(2) Notwithstanding the peric,dic leak teit required by this condition, any k
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 g%
- 4 material.
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. pl 3
B.
Any sealed source or detector cell in storage and not being used need N
i not be tested. When the source or-detector cell is removed from storage j
f for use or transfer to another person, it shall be tested before use or y
st
- transfer, g
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k C.
The test shall be capable of detecting the presence of 0.005 microcurie bi 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 report shall be filed within 5 days of the date the leak test result is
'i hj known with the U.S. Nuclear Regulatory Commission, Region I, ATTN:
Chief.
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Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, King of t
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Prussia, Pennsylvania 19406. The report shall specify the source involved, E
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the test results, and corrective action taken. Records of leak test 4
results shall be kept in units of microcuries and shall be maintained for p'
4l inspection by the Commission.
Records may be disposed of following p
4
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'il Commission inspection.
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,M ATERIALS LICENSE t>ocket or Reference nun.ber FUPPLEMENTARY SHEET 070-01342 d
i CORRECTED COPY Amendment No. 21 lN i
4 (14. continued)
CON 0lT10NS li l
4i C.
Tests for leakage and/or contamination shall be performed by the licensee j
l or by other persons specifically licensed by the Commission or an Agree-ment State ta perform such services.
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4
- 15. The licensee may transport licensed material in accordance with the provisions y,
of 10 CFR Part 71, "Packaging and Transportation of Radioactive Material".
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- 16. The licensee stiall conduct a physical inventory every 6 months to account for h
j all sources and/or devices received and possessed under the license.
Records g
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'a of inventories shall be maintained for 2 years.from the date of each inventory.
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- 17. Except as specifically provided otherwise in this license, the licensee shall conduct its program in accordance with the statements, representations, and procedures contained in the documents including any enclosures, listed below, p
The Nuclear Regulatory Corrmission's regulations shall govern unless the state-p
'4 4
ments, representations and procedures in the licensee's application and corre-is spondence are more restrictive'than the regulations.
N f
A.
Application dated May 2,1985 h
3 B.
Letter dated August.9, 1985 1
4 C.
Letter dated July 10,-1986?
'i D.
Letter dated July 15, 1987=.
N E.
Letter dated August 11, 1987 g
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For the U.S. Nuclear Regulatory Conmission
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Original Signed By:
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Jenny M. Johansen l
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By jpj I
Nuclear Materials Safety ano lW
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- l Safeguards Branch, Region I b
King of Prussia, Pennsylvania 19406
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