ML20031G114
| ML20031G114 | |
| Person / Time | |
|---|---|
| Issue date: | 10/06/1981 |
| From: | Stello V NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | NUCLEAR DIAGNOSTICS, INC., FERNDALE, MI |
| Shared Package | |
| ML20031G107 | List: |
| References | |
| REF-SSINS, REF-SSINS-SSINS EA-81-079, EA-81-79, NUDOCS 8110210119 | |
| Download: ML20031G114 (4) | |
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APPENDIX NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTIES Nuclear Diagnostics, Incorporated License No. 21-14161-01G 575 Robbins Drive EA 81-79 Troy, Michigan 48084 As a result of the inspection conducted at the licensee's facility at Troy, Michigan, on June 4, 1981, the violations listed below were identified.
These violations demonstrate a lack of control over the radiation safety program, including inadequate surveys, and a failure to ensure that contamination from iodine-125 would not result in individuals incurring uptakes in excess of regu-latory limits.
The iodine-125 uptake described in this Notice is indicative of that weakness.
Because of the significance of the iodine-125 thyroid uptake and in accordance with the Interim Enforcement Policy, 45 FR 66754 (October 7, 1980), the Nuclear Regulatory Comnission proposes to impose civil penalties 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 in the amounts set forth for the violations listed in Section I below.
I CIVIL PENALTY VIOLATIONS A.
10 CFR 20.201(b) requires that each licensee shall make or cause to be made such surveyr, as may be necessary for him to comply with the regulations in Par. 20.
A survey as defined in 20.201(a) is an evaluation of the radiation hazards incident to the use of radio-active material under a specific set of conditions.
Contrary to the above, the licensee failed to make such surveys or evaluations as were necessary to assure that an individual who handled significant quantities of iodine-125 did not receive an uptake exceeding the limits specified in 10 CFR 20.103.
Speci-fically, surveys for contamination conducted as a result of iodina-tions and other uses of the licensed material were not adequate or com-mensurate with the substantial increase in the amounts of I-125 used in iodinations (as high as 60 millicuries compared to 2-3 millicuries used in the past).
This is a Severity Level III violation (Supplement IV).
(Civil Penalty - $650).
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Appendix (Continued) B.
10 CFR 20.103(a)(1) states no licensee shall possess, use or transfer licensed material in such a manner as to permit an individual in a restricted area to inhale a quantity of radioactive material in any period of one calendar quarter greater than the quantity which would result from inhalation for 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> per week for 13 weeks at uniform concentrations of radioactive material in air specified in Appendix B, Table 1, Column 1.
If the radioactive material is of such form that intake by absorption through the skin is likely, individual exposures to radioactive material shall be controlled so that the uptake of radioactive material by any organ from either inhalation or absorption or both routes of intake in any calendar quarter does not exceed that which would result from inhaling such radioactive material for 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> per week for 13 weeks at uniform concentrations specified in Appendix B, Table I, Column 1.
Significant intake by ingestion or injection must be evaluated and accounted for by techniques and procedures as may be appropriate to the circumstances of the occurrence.
Exposures so evaluated shall be included in determining whether the limitation on individual exposures in 10 CFR 20.103(a)(1) has been exceeded.
Contrary to the above, the licensee's bioassay records showed that an individual working in a restricted area during the first quarter of 1981 had an uptake of iodine-125 that resulted from an intake greater than the equivalent of inhaling iodine-125 for 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> per week for 13 weeks at the uniform concentration specified in 10 CFR 20, Appendix B, Table 1, Column 1.
Specifically, a bioassay conducted on March 16, 1981, showed the individual's uptake of iodine-125 was about 3 times the 13 week limit.
This is a Severity Level III violation (SLpplement IV).
(Civil Penalty - $350).
II VIOLATIONS NOT ASSESSED CIVIL PENALTIES A.
10 CFR 20.405(a) states each licensee shall make a report in writing within 30 days to the appropriate NRC Regional Office listed in Appendix D, with a copy to the Director of Inspection and Enforcement, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555 of each exposure of an individual to radioactive material in excess of the applicable limits in 10 CFR 20.103(a)(1).
Contrary to the above, as of June 4, 1981, a written report had not been submitted to the Region III Director or to the Director of Inspection and Enforcement of an exposure of an individual to radio-active material in excess of the applicable limits during the first quarter of 1981.
This is a Severity Level IV violation (Supplement IV).
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Appendix (Continued) B.
10 CFR 19.13(d) states that when a,,
use required pursuant to 20.405 to report to the Comaission any -p::are of an individual to radiation or radioactive material the licensee shall also provide the indiviJual a report of his exposure data included therein.
Such report shall be transmitted at a time not later than the transmittal to the Commissior,.
Contrary to the above, as of June 4,1981, a report had not been sebmitted to the individual exposed as described in Item I.B.
This is a Severity Level IV violation (Supplement IV).
C.
10 CFR 20.203(f) requires that each container of licensed material in excess of 1 microcurie of iodine-125 and 10 microcuries of iron-59 shall bear a durable, clearly visible label identifying the radio-active contents.
The label shall bear the radiation caution symbol and the words, " Caution Radioactive Material."
Contrary to the above, on June 4,1981, the inspector observed waste storage drums containing millicurie quantities of iodine-125 and 20 microcuries of iron-59 that were not labelled as required.
This is a Severity Level VI violation (Supplement IV).
Pursuant to the provisions of 10 CFR 2.201 Nuclear Diagnostics, Incorporated is hereby required to submit to this office within 30 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 viola-
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tion if admitted; (3) the corrective steps which have been taken and the results achieved; (4) the corrective steps which will be taken to avoid fu-ther viola-tions; and (5) the date when full compliance will be achieved.
Consideration
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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, Nuclear Diagnostics, Incorporated may pay the civil penalties in the cumulative amount of One Thousand Dollars or may protest imposition of the civil penalties in whole or in part by a written answer.
Should Nuclear Diagnostics, Incorporated fail to answer within the time specified, this office will issue an Order imposing the civil penalties in the amounts proposed above.
Should Nuclear Diagnostics, 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 exten-uating 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, such answer may request remission or mitigation of the penalties.
Any written answer in accordance with 10 CFR 2.205 should be set forth separately from the statement or explanation in reply pursuant to
Appendix (Continued) 10 CFR 2.201, but may incorporate by specific reference (e.g., giving page and paragraph numbers) to avoid repetition.
Nuclear Diagnostics, Incorporated's attention is directed to the other provisions of 10 CFR 2.205 regarding the procedure for impo.-ing a civil penalty.
Upon failure to pay any civil penalties due, which have been subsequently determined in accordance with tne applicable provisions of 10 CFR 2.205, this matter may be referred to the Attorney General, and the penalties, unless j
compromised, remitted or mitigated, may be collected by civil action pursuant to section 234c of the Act, 42 U.S.C. 2282.
The responses directed by this Notice are not subject to the clearance prcce-dures of the Office of Management and Budget as required by the Paperwork Reduction Act of 1980, PL 96-511.
4 FOR THE NUCLEAR REGULATORY COMMISSION Victor Stello, Jr., Director Office of Inspection and Enforcement Dated at Bethesda, Maryland this 6 day October 1981 1
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