ML20215F173
| ML20215F173 | |
| Person / Time | |
|---|---|
| Site: | 07001342 |
| Issue date: | 09/18/1986 |
| From: | Purdy D BIOCONTROL TECHNOLOGY, INC. (FORMERLY CORATOMIC |
| To: | Glenn J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| Shared Package | |
| ML20215F162 | List: |
| References | |
| NUDOCS 8610160110 | |
| Download: ML20215F173 (2) | |
Text
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C = ratomica i
COR ATOMIC,1NC.
September 18, 1986 300 INDIAN SPRINGS ROAD P.O. BOX 434 INDIANA, PENNSYLVAN!A 15701 PHON E: (412) 349-1811 e TELEX 86-6658 Dr. John E. Glenn, Ph.D., Chief Nuclear Materials Safety Section B Division of Radiation Safety and Safeguards United States Nuclear Regulatory Commission Region 1 631 Park Avenue King of Prussia, PA 19406 License No. SNM-1319 Docket No.
070-01342
SUBJECT:
INSPECTION NO. 86-01 Dr. Glenn:
The following is an item by item response to Appendix A, Notice of Violation, contained in your August 21, 1986 letter to Coratomic.
Item A When regulations changed in 1983 (48 FR10226, March 10,1983 and 48 FR13432, March 31, 1983, as amended at 48 FR31218 and 31219, July 7, 1983) and air carriers chose to comply with International Air Transport Association (IATA) regulations rather than 49 CFR, Coratomic consulted several air carriers as to the proper way to ship our nuclear-powered pacemakers.
They advised Coratomic to ship under UN2911 Radioactive Material, Instruments and Articles, and accepted our nuclear-powered pacemakers for foreign and domestic shipment under UN2911 through May 7, 1986.
Item Al The number of curies contained in a package are not required to be listed on labeling or shipping paperwork under UN2911. Therefore, exceeding the 3 curie limit for international shipment of plutonium - 238 in a Type A package was not obvious to air carriers or to Coratomic until the July 10, 1986 NRC inspection pointed out that our nuclear-powered pacemaker (N 4.3 curies) could not be shipped under UN2911 (see Item A2).
Coratomic ceased international shipment of our nuclear-powered pacemaker in a Type A package as of July 10, 1986, the date of NRC inspection, with the last foreign shipment occurring November 22, 1985.
Coratomic will not ship nuclear-powered pacemakers internationally until an approved Type B package can be obtained, or until an exemption fo; shipment of nuclear-powered pacemakers in a Type A package similar to footnote 1 of 49 CFR 173.435 can be granted under IATA regulations.
8610160110 861003 REG 1 LIC70 PDR SNM-1319 ADVANCED TECHNOLOGY SERVING MEDICINE
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page 2
.iI Item A2 While Coratomic was in compliance with the package limits of 49 CFR 173.422 (b) and 49 CFR 173.423 Table 7, for domestic shipment of our nuclear-powered pacemaker under UN2911, we did exceed the individual instrument or article limit in Table 7.
Therefore, Coratomic will no longer ship nuclear-powered pacemakers under UN2911.
Our last shipment under UN2911 occurred on May 7, 1986.
In the future, Coratomic will ship domestically under UN2974, Radioactive Material, Special Form, n.o.s.
Item C Coratomic requested a license amendment for the plutonium-beryllium sealed neutron source in a letter from David L. Purdy to Dr. John E Glenn dated July 10, 1986. Amendment number 20 was granted August 21, 1986.
Item B and D On July 10, 1986, the neutron source was moved to the center of the Quarantine Laboratory, reducing the radiation level in the surrounding unrestricted areas to less than 2 millirem per hour.
The-locked door to the Quarantine Laboratory was posted with a sign bearing the radiation caution symbol and the words
" Caution Radioactive Materials", and the area inside the Quarantine Laboratory was posted with a sign bearing the radiation caution symbol and the words
" Caution Radiation Area".
The following day, the neutron source was moved to the center of an empty locked room. Access to this room is limited to film badged employees.
The door was posted with a sign bearing the radiation caution symbol and the words " Caution Radioactive Materials", and the area inside the room was posted with a sign bearing the radiation caution symbol and the words " Caution Radiation Area".
All unrestricted areas surrounding the room were surveyed and radiation levels were found to be less than 2 millirem per hour. A wipe test was performed on the outside surface of the shipping container in which the source is stored, and no removable contamination was found.
The unrestricted areas surrounding the room in which the neutron source is stored will be surveyed every 6 months to assure radiation levels in unrestricted areas do not exceed 2 millirem per hour.
Sincerely, jm[a m
David L. Purdy President Coratomic, Inc.
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