ML20155G901
| ML20155G901 | |
| Person / Time | |
|---|---|
| Issue date: | 07/13/1988 |
| From: | Ebneter S NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | Smith Holston FOOD & DRUG ADMINISTRATION |
| Shared Package | |
| ML20155G876 | List: |
| References | |
| FOIA-88-424 NUDOCS 8810180087 | |
| Download: ML20155G901 (2) | |
Text
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JUL 131988 U.S. Food and Drug Administration ATTN: Ms. Sharon Smith Holston Associate Commissioner for Management and Operations 5600 Fishers Lane Room 14-72, HFA-1 Rockville, Maryland 20857 Gentlemen:
Ouring the week of August 8-12, 1988, an NRC Region I inspection team will perform an operational safety assessment at E. R. Squibb and Sons, Inc., located in New Brunswick, New Jersey.
Ihis will be a broad safety assessment of fire, chemical, and industrial safety and product quality, as well as radiation safety.
The inspection team will be composed of five or six members from the Nuclear Regulatory Commission and representatives from the Environmental Protection Agency and the Occupational Safety and Health Administration. We would also like to include a representative from your agency knowledgeable in good manufac-turing practices as part of the team. Dr. Josephine Piccone of my staff, who has responsibility for coordinating this inspection, recently discussed this matter with Mr. M. Lewis and Dr. N. Chawla of your staf f.
We believe that mutual benefits will accrue a; a result of such a multi-agency safety review at the E. R. Squibb facility. We plan to issue a formal report citing both regulatory violations and recommendations for improved safety for the consideration of facility management.
If you are able to support this request, please identify the individua) who will assist in the operational safety assessment to Dr. Piccone (215-337-5169, FTS 346-5169) by July 22, 1988.
Your support in this matter is appreciated.
Sincerely, 0.1 c.'
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478 ALLENDALE ROAD xiNo or raussi A. eswee0YLVANIA 19408 JUL, i 41988 Docket No. 70-00698 License No. SNM-770 Westinghouse Electric Corporation ATTN: Mr. Dave Galm Radiation Safety Officer P.O. Box 355 Pittsburgh, Pennsylvania 15230-0355 Gentlemen:
SUBJECT:
OPERATIONAL SAFETY REVIEW As a result of the accident involving the release of uranium hexafluoride from Kerr-McGee's Sequoyah Fuels Facility in Gore, Oklahoma, on January 4,1986, the NRC is conducting operational safety reviews of selected major fuel cycle and materials facilities. Your Waltz Mill facility has been selected for a review to be conducted by a team representing the Nuclear Regulatory Commission, the Environmental Protection Agency and the Occupational Safety and Health Administration. The review has been scheduled for the period between August 8 and August 12, 1988.
The team leader, Mr. John Miller, will contact your of fice at a later date to arrange a time for the entrance briefing.
The purpose of this review is to examine your facility and operations to to determine if there are potential safety hazards that could impact public health and safety. The team will also examine the adequacy of existing systems and procedures relative to the use, processing and handling of hazardous materials which could ef fect radiological safety.
The aspects expected to be reviewed are personnel training, industrial safety, waste management, and facility operations, including procedure control, equipment maintenance, radioactive and non-radioactive chemical control, fire protection and radiological contingency planning.
In order to facilitate the review, please provide to this of fice by July 25, 1988, a copy of your existing procedures which cover employee training, waste management, operational safety and contingency planning.
The response requested by this letter is not subject to the clearance procedures of the Office of Managerrent and Budget as required by the Paperwork Reduction Act of 1980, PL 96-511.
If you have any questions concerning the review, please contact Mr. J. White at (215) 337-5102 or Mr. Miller at (215) 337-5304.
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Thank you for your cooperation.
Sincerely,
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Stewart D. Ebneter, Director Division of Radiation Safety and Safe <2uards cc:
Public Document Room (POR) local Public Document Room (LPDR)
Nuclear Safety Information Center (NSIC)
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JUL. i 91988 Docket No. 030-02470 License No. 29-03297-02 CAL No. 88-19 EA No.88-197 Mountainside Hospital ATTN: Louis A. Racioppe Senior Vice President Bay and Highland Avenues Montclair, New Jersey 07042 Gentlemen:
This letter documents comitrents made during a telephone discussion on July 19, 1988 between yourself and James H. Joyner of this office regarding our concerns about the use of microwave ovens located in unrestricted areas for 'he preparation of eggs spiked with technetium-99m (Tc-99m) and apperent con.
flicting infomation as discussed with you by Ms. Judy Joustra of this office on July 15, 1988.
The NRC findings are based on an inspection of your facili y conducted by Ms. Joustra on July 15.
Based on your discussion with Mr. Joyner,
we understand that you have instituted or will institute the following treediate actions:
1.
Evaluate the dose received by direct exposure or by ingestion of Tc-99m by any individual who may have used a microwave oven during or efter the preparation of Tc-99m spiked eggs and submit the results to this office for our review.
2.
Inunediately limit, to areas to which access to radioactive materials is restricted, the preparation of food or other items containing radio-pharamceuticals for administration to patients.
3.
Investigate to resolve the conflicting infonnation, as provided to you by Ms. Joustra, and detemine the reason (s) why your staff used the microwave ovens for preparing licensed material, who on your staff initiated this procedure and how long the practice has been followed. The complete report of this investigation will be provided to NRC Region I by July 29, 1988.
Issuance of this Confimatory Action letter does not preclude the issuance of an Order fonnalizing the above ccvm11tments.
If your understanding of the comitnents differs from those set forth above, please call me irrediately.
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Mountainside Hospital 2
The response required by this letter is not subject to the clearance procedures of the Office of Management and Budget as required by the Paperwork Reduction Act of 1980, PL 96-511.
Sincerely,
,h!". Y Sy !M Glen L. Sjoblos. Acting Director Division of Radiation Safety and Safeguards
Enclosure:
10 CFR Parts 19, 20 and 35 CC:
Public Document Room (PDR)
Nuclear Safety Information Center (NSIC)
State of New Jersey bec:
Region 1 Occket Roce (w/ concurrences)
J. Lieberman, OE L. Chandler, OGC J. Goldberg, OGC J. Taylor DEDRO R. Cunningharn, NMS$
W. Russell, RI J. Allan, R!
G. Sjoblom, RI l
J. Gutierrez, R!
O. Holody, R1 J. Joyner, R!
J. Glenn, R1 J. Joustra, R!
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