ML20155G892
| ML20155G892 | |
| Person / Time | |
|---|---|
| Issue date: | 07/07/1988 |
| From: | Sjoblom G NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | Gaughan D LABOR, DEPT. OF |
| Shared Package | |
| ML20155G876 | List: |
| References | |
| FOIA-88-424 NUDOCS 8810180083 | |
| Download: ML20155G892 (1) | |
Text
f'c UNITED $TATES NUCLEAR REGULATORY COMMISSIEN j
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478 ALLENDALE ROAD NING oF PAUSSIA, P(NNSYLVANIA 19408 a 0 71968 U.S. Department of Labor Occupational Safety and Health Administration ATTN:
Mr. Dennis Gaughan Area Director 1030 St. George Avenue Avenel, New Jersey 07001 Gentlemen:
During 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.
and industrial safety, as well as radiation safety.This will be a broad safety ass 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 Food and Drug Administration.
We would also like to include a representative from your agency knowledgeable in occupational safety / industrial hygiene as part of the team.
Dr. Josephine Piccone of my staf f, who has responsibility for coordinating this inspection, recently discussed this matter with Mr. A. Busicchia of your staf f.
We believe that mutual benefits will accrue as a result of such a multi-agency safety review at the E. R. Squibb f acility. 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 individual who will assist in the operational safety assessment to Dr. piccone (215-337-5169, FTS 346-5169) by July 15, 1988.
Your support in this matter is appreciated.
Sincerely,
'2mv.M $
s en L. Sjobi
, Acting Ofrector Division of Radiation Safety and Safeguards Alf pg o1l g 000915 FELTON00-424 pig
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NUCLEAR RE'ULATCRY COMMISSl:N
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475 ALLIN0 ALE ROAD of KING OF PMuestA. PENNSYLVANIA 19400 JUL 0 7 le88 Docket No. 30-00763 License No. 20-01537-02 EA 88-146 Massachusetts Institute of Technology ATTN: Mr. Paul C. Powell Assistant Director, Office of Sponsored Programs Room E19-721 77 Massachusetts Avenue Cambridge, Massachusetts 02139 Gentlemen:
SUBJECT:
NOTICE OF VIOLATION (NRC Inspection Report No. 30-00763/88-001)
This letter refers to the NRC inspection conducted on Janusry 28 and April 20-22, 1988, at your facility in Cambridge, Massachusetts, to review the circumstances associated with a violation identified by your staf f and reported to the NRC.
The violation involved a radiation exposure of 22.91 rem to the right wrist of an authorized user at your facility during the third calendar quarter of 1987.
This exposure is in excess of the regulatory limit of 18.75 rem. During the inspection, another violation of NRC requirements was identi-fied. The report of the inspection was forwarded to you on June 8,1988. On June 22, 1933, we held an enforcement cer.ference with you and members of your staf f to discuss the violations, their causes, and your corrective actions.
This cumulative exposure in excess of the regulatory limit occurred when the individual researcher was performing certain animal experiments involving the use of curie and millicurie quantities, respectively, of dysprosium-165 and holmium-166. Apparently, the procedures for conducting the experiments were changed in September 1987, to use the holmium-166 instead of the previously used dysprosium-165. Although the use of holmium-166 created a potential for auch higher dose rates because of a longer half-life, an evaluation of the effects of this procedure change was not performed by the authorized user or the Radiation Safety Officer prior to its approval and implementation. As a result, when the individual began using the holmium-166 in September 1987, he received a 15.04 rem exposure for that month which resulted in the 22.91 rem exposure for the third calendar quarter of 1987.
The NRC recognizes, based on this inspection and your prior good enforcement history, that management of your facility has normally exercised adequate control and supervision of licensed activities.
Nonetheless, the NRC is concerned that an adequate evaluation of the effects of the use of both these two isotopes was not performed by authorized user, the Radiation Safety Officer, or the Radiation $4fety Comittee prior to the Radiation Safety Comittee's approval in October 1986 to use the holmium-166.
This evnnt demonstrates the importance of (1) adequate evaluations whenever changes aae made at the facility, vIf f' '
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(2) prompt assessment of the causes of any unusually high exposure, even if the specific exposure is not in excess of the regulatory limit, and (3) prompt actions to prevent recurrence of any unusually high exposure.
The violation involving the exposure in excess of the regulatory limit is described in the enclosed Notice of Violation and is classified at Severity Level IV in accordance with Supplement IV of the "General Statement of Policy and Procedures for Enforcement Actions" (Enforcement Policy),10 CFR 2, L
Appendix C (1988) since the ilo1ation involves a cumulative exposure that reflects an isolated weakness in your radiation protection program, rather than a programmatic breakdown.
Nonetheless, we emphasize that any similar violations in the future may result in additional enforcement action.
The other violation set forth in the enclosed Notice is also classified at Severity Level IV.
The inspection report forwarded to you on June 8,1988, identified two instances of failure to perform required evaluations.
These included an apparent failure to evaluate missing ring dosimetry in January and May 1987 and an apparent failure to evaluate an October 1987 extremity dose prior to permitting the individual to continue working with radioactive materials in November. Based on the information provired durir; the enforcement conference, we have concluded that these evaluations w3re, in fact, performed in accord-ance with regulatory requirements and, thus, these items are not being cited.
You are required to re: pond to this letter and the enclosed Notice, and you should follow the instructions specified in the enclosed Notice when preparing your response.' In your response, you should document the specific actions taken and any additional actions you plan to prevent recurrence.
In particular, your response should addrest long term actions designed to identify and correct unanticipated problems associated with new uses cc applications of licensed material. Af ter reviewing your response to this Notice, including your proposed corrective actions and the results of future inspections, the NRC will determine whether further NRC anforcement action is necessary to ensure compliance with NRC regulatory requirements.
In accordance with Section 2.790 of the NRC's "Rules of Practice," Part 2, Title 10, Code of Federal Regulations, a copy of this letter and its enclosure will be placed in the NRC Public Document Room.
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The responses directed by this letter and the enclosed Notice are not subject to the clearance procedures of the Of fice of Management and Budget as required by the Paperwork Reduction Act of 1980, PL Number 96-511.
Sincerely, I
h.
oblom, AcEng Director
,ivision of Radiation Safety and Safeguards
Enclosure:
Notice of Violatien cc w/ encl:
P.blic Document Rood.:d;: j N. clear Safety Inf..:. ion Center (NSIC)
C: monwealth of Massadiusetts
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RegionIDocketRoom(w/ concurrences)
D. Holody, Ri J. Lieberman, OE L. Chandler, OGC R. Cunningham, NMSS
NOTICE OF VIOLATION Massachusetts Institute of Technology Docket No. 30-00753 Cambridge, Massachusetts 02139 License No. 20-01537-02 EA 88-146 On January 28 and April 20-22, 1988, an NRC inspection was conducted at the licensee's facility in Cambridge, Massachusetts to review the circumstances associated with a violation identified by the licensee and reported to the NRC.
During tha inspection, another violation of NRC requirements was identified.
In accordance with the "General Statement of Policy and Procedure for NRC Enforcenent Actions," 10 CFR Part 2. Appendix C (1987), the violations are set forth below:
A.
10 CFR 20.101(a) requires, in part, that no licensee possess, use, or transfer licensed material in such a manner as to cause any individual in a restricted area to receive in any period of one calendar quarter, a total exposure to the hands of 18.75 rems.
Centrary to the above, during the third quarter of 1987, an authorized user working with curie and millicurie quantities of dysprosium-165 and holmium-166, respectively, in the Nuclear Reactor Laboratory, a restricted area, received a radiation exposure to the right wrist of 22.91 rems.
This is a Severity level IV violation (Supplement IV) 8.
10 CR 2C.201(b) requires that each licensee make such surveys as may be necessary for the licensee to comply with the regulations in Part 20. As defined in 10 CFR 20.201(a), "survey" means an evaluation of the radiation hazards incident to the production, use, disposal, or presence of radio-active materials or other sources of radiation.
Contrary to the above, adequate surveys were not made to assure compliance with 10 CFR 20.101(a), a regulation which limits the radiation dose to individuals in restricted areas.
Specifically, adequate radiation surveys were not performed prior to September 1987 to determine the dose rates associated with animal studies involving the use of millicurie quantities of holmium-166.
This is a Severity Level IV violation (Supplement IV).
Pursuant to the provisions of 10 CFR 2.201, Massachusetts Institute of Technology is hereby required to submit a written statement or explanation to the Director of Enforcement, U.S. Nuclear Regulatory Commission, ATTN:
Document Control Oest, Washington, DC 20555, with a copy to the Regional Administrator, Region I, 475 Allendale Road, King of Prussia, Pennsylvania 19406, within 30 days of the date of the letter transmitting this Notice.
This reply should be clearly marked as a "Reply to a Notice of Violation" and should include for each violation: (1) the reason for the violation if admitted, (2) the corrective steps that have been taken and the results achieved, (3) the y&J20 Y
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corrective steps that will be taken to avoid further violations, and (4) the date when full compliance will be achieved.
Consideration may be given to extending the response time for good cause shown, FOR THE NUCLEAR REGULATORY COMMISSION h0s, f T w bb.
61e'n L. Sjobl e ing Director Division of Radiation Safety and Safeguards I
Dated at King of Prussia, Pennsylvania this 7th day of July 1988 l
\\g UNITED STATES NUCLEAR REGULATCRY COMMISSION 3
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KING OF PMutSIA.pgNassyLvANIA tedes JVL.I11888 Docket No. 030-28916 License No. 20-20916-01 CAL No. 88-18 EA No.88-187 James E. Zuckerman, M.D.
John Cummings Building, Suite 520 Old Road to Nine Acres Corner Concord, Massachusetts 01742
Dear Dr. Zuckerman:
This letter documents commitments made during the NRC inspection conducted on July 7,1988 through discussion between yourself, Mr. John Pelchat of my staff, and Mr. Thomas Mathews of the Commonwealth of Massachusetts.
Based on this discussion, we understand that you have instituted or will institute the following immediate actions:
1.
Obtain packaging from Amersham-Tech OPS, Burlington, Massachusetts, that is appropriate for the transportation of the gadolinium-153 source you are licensed to possess, ar.d deliver the packaging to the Covonwealth of Massachusetts, Office of Radiation Control.
2.
Af ter your gadolinium-153 source that is currently held by tha Of fice of Radiation Control has been placed in the package, arrange for the package to be picked up by an express delivery service from the Commonwealth of Massachusetts and shipped to A.ersham-Tech OPS.
3.
Complete Form NRC 314, Oisposition of Material, and submit the form to NRC Region I with a letter requesting termination of your NRC license.
A copy of Form NRC 314 is enclosed with this letter.
Issuance of this Confirmatory Action letter does not preclude the issuance of an Order formalizing the above commitments.
If your understanding of the commitments dif fers from that set forth above, please call me imediately.
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, won l
w S' ewart D. Ebrrder, Director t
' Division of Radiation Safety l
and Safeguards
Enclosure:
NRC Form 314, Disposition of Material Ah j q, g y g /) 3 O C/
pg.
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JUL.1 11988 Jimes E. Zuckerman, M.D.
2
- 44 cc:
Public Document Room (PDR)
Nuclear Safety Information Center (NSIC)
Commonwealth of Massachusetts bec:
Region ! Docket Room (w/ concurrences)
J. Lieberman, OE L. Chandler, OGC J. Goldberg, OGC J. Taylor, DEDRO R. Cunningham, NMSS W. Russell, RI J. Allan, R1 S. Ebneter, RI J. Gutierrez, RI D. Holody, RI J. Joyner, RI J. Glenn, RI J. Pelchat, R1 L. M. Trip.3, RI o