ML20052C729
| ML20052C729 | |
| Person / Time | |
|---|---|
| Issue date: | 04/13/1982 |
| From: | Deyoung R NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | |
| Shared Package | |
| ML20052C730 | List: |
| References | |
| EA-82-016, EA-82-16, NUDOCS 8205050438 | |
| Download: ML20052C729 (3) | |
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Appendix NOTICE OF VIOLATION AND PROPOSED IMPOSITIOF 3F CIVIL PENALTIES Pharmatopes, Incorporated License No. 34-16654-01MD 10646 North End EA 82-16 Ferndale, Michigan 48220 As a result of the inspection conducted at the licensee's facility at Toledo, Ohio, on November 3 and 4, 1981, NRC identified the violations listed below.
These violations demonstrate a lack of control over the radiation safety program in that the licensee did not adequately evaluate the cause and significance of an extremity exposure.
This resulted in an individual incurring a radiation dose in excess of regulatory limits.
In order to emphasize the responsibility of licensees to properly control their licensed programs, the Nuclear Regulatory Commission proposes to impose civil penalties in the cumulative amount of Four Thousand Dollars for this matter.
In accordance with the NRC Enforcement Policy (10 CFR Part 2, Appendix C) 47 FR 9987 (March 9, 1982) and pursuant to Section 234 of the Atomic Energy Act of 1954, as amended ("Act"), 42 U.S.C. 2282, PL 96-295, and 10 CFR 2.205, the particular violations and the associated civil penalties are set forth in Section I below:
I.
CIVIL PENALTY VIOLATIONS A.
10 CFR 20.201(b) requires each licensee to make or cause to be made such surveys (evaluations) as may be necessary for him to comply with the regulations in Part 20.
Contrary to this requirement, the licensee failed to make an adequate evaluation of the cause and significance of an extremity exposure that was approximately three quarters of the NRC limit.
Specifically, the licensee was notified by the film badge supplier on August 31, 1981, that an individual had received a 13.99-res extremity dose during the period July 15 through August 14, 1981.
The licensee did not adequately evaluate the significance of this individual's extremity dose and permitted him to continue working with-licensed material until October 5, 1981.
This resulted in a total extremity radiation dose of approximately 25.23 rems for the third calendar quarter of 1981.
This is a Severity Level III Violation (Supplement IV).
(Civil Penalty - $2,500).
8205050438 820413
$ 1N h 01M PDR 1
Appendix (Continued) B.
10 CFR 20.101(a), " Radiation Dose Standards for Individuals in Restricted Areas," limits the occupational dose to hands and forearms, feet and ankles of an individual working in a restricted area to 18.75 rems per calendar quarter.
Contrary to this requirement, during the third quarter of 1981 an individual received an occrjational dose of approximately 25.23 rems to the hands.
This is a Severity Level III Violation (Supplement IV).
(Civil Penalty - $1,500).
II.
VIOLATION NOT ASSESSED A CIVIL PENALTY t
License Condition No. 14 requires that each sealed source containing licensed material be tested for leakage and/or contamination at intervals not to exceed 6 months.
Contrary to this requirement, the licensee's cesium-137 sealed source No. 208-134-19 (217 microcuries) was not tested for leakage and/or contamination from August 1, 1978, to August 8, 1979, and the barium-133 sealed source No. 3580479A-25 (283 microcuries) was not tested for leakage and/or contamination from March 29, 1979, to January 7, 1980.
This is a Severity Level V Violation (Supplement VI).
Pursuant to the provisions of 10 CFR 2.201, Pharmatopes, Incorporated is hereby required to submit to this office within thirty days of the date of this Notice a written statement or explanation, including for each alleged violation:
(1) admission or denial of the alleged violation; (2) the reasons for the violation, if admitted; (3) the corrective steps that have been taken and the results achieved;-(4) the corrective steps that will be taken to avoid further viola-i tions; and (5) the date when full compliance will be achieved.
Consideration l
may be given to extending the response time for good cause shown.
Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.
Within the same time as provided for the response required above under 10 CFR 2.201, Pharmatopes, Incorporated may pay the civil penalties in the cumulative amount of Four Thousand Dollars or may protest imposition of the civil penalties in whole or in part by a written answer.
Should Pharmatopes, Incorporated fail to answer within the time specified, this office will issue an Order imposing the. civil penalties in the amounts proposed above.
Should Pharmatopes, Incorporated elect to file an answer in accordance with 10 CFR 2.205 protesting the civil penalties, such answer may:
(1) deny the violations listed in this Notice in whole or in part; (2) demonstrate extenuating circumstances; (3) show error in this Notice; or (4) show other reasons why the penalties should not be imposed.
In addition to protesting the civil penalties in whole or in part,
Appendix (Continued) such answer may request remission or mitigation of the penalties.
In requesting mitigation of the proposed penalties, the five factors contained in Section IV(B) of 10 CFR Part 2, Appendix C should be addressed.
Any written answer in accordance with 10 CFR 2.205 should be set forth separately from the statement or expl.anation in reply pursuant to 10 CFR 2.201, but may incorporate by specific reference (e.g., citing page and paragraph numbers) to avoid repetition.
We direct the attention of Pharmatopes, Incorporated to the other provisions of 10 CFR 2.205 regarding the procedure for imposing a civil penalty.
Upon failure to pay any civil penalties due, which have been subsequently determined in accordance with the applicable provisions of 10 CFR 2.205, this matter may be referred to the Attorney General, and the penalties,'
unless compromised, remitted, or mitigater', may be collected by civil action pursuant to Section 234c of the Act, 42 U.S.C. 2282.
FOR THE NUCLEAR REGULATORY COMISSION
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Richard C. De,oung, O rector Office of Inspection and Enforcement Dated at Bethesda, Maryland this 13 day of April 1982 l
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