ML20028H172
| ML20028H172 | |
| Person / Time | |
|---|---|
| Issue date: | 11/05/1990 |
| From: | Martin T NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20028H171 | List: |
| References | |
| EA-90-144, NUDOCS 9011150114 | |
| Download: ML20028H172 (3) | |
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NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY Syncor International Corporation Docket No.
030-15125 Folcroft, Pennsylvania License No.
37-18461-01MD EA 90-144 During on NRC inspection conducted on August 9, 1990, violations of NRC requirem+nts were identified.
In accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions," 10 CFR Part 2, Appendix C (1990), the Nuclear Regulatory Commission proposes to impose a civil penalty pursuant to Section 234 of the Atomic Energy Act of 1954, as amended ( Act), 42 U.S.C. 2282, and 10 CFR 2.205.
The particular violations and associated civil penalty are set forth below:
1.
VIOLATION ASSESSED A civil PENALTY 10 CFR 20.207(a) requires that licensed materials stored in an unrestricted area be secured against unauthorized removal from the place of storage.
10 CFR 20.207(b) requires that materials not in storage be under constant surveillance and immediate control of the licensee. As defined in 10 CFR 20.3(a)(17), an unrestricted area is at./ area, the access to which is not controlled by the licensee for purposes of protection of individuals from exposure to radiation and radioactive materials.
Contrary to the above, on August 9, 1990, millicurie quantities of licensed materials (specifically, technetium-99m and iodine-131) were placed in two motor vehicles located in the licensee's parking lot (unrestricted area) in 'Folcrof t, Pennsylvania, and for approximately ten minutes on that date, the materials were neither secured against unauthorized removal nor under constant surveillance and immediate control of the licensee. Specifically, both vehicles were left unlocked and unattended and one of the vehicles had i
the keys in the ignition with the motor running, This is a Severity level III violation (Supplement VI).
Civil Penalty.512,500 II.
VIOLATION NOT ASSESSED A CIVIL PENALTY Condition 17 of License No. 37-18461-01MD requires that licensed material be transported in accordance with the provisions of 10 CFR 71.
10 CFR 71.5(a) requires, in part, that transportation of licensed material outside i
of the confines of the licensee's facility or other place of use be made in accordance with the applicable requirements of the Department of Transportation in 49 CFR 170-189.
49 CFR 173.448(a) requires that each shipment of radioactive materials be secured in order to prevent shifting during normal transportation.
OFFICIAL RECORD COPY SYNCOR CP EA 90-144 10/31 - 0005.0.0 11/01/90 9011150114 901105 REG 1 LIC30 37-18461-01MD PDC
Contrary to the above, on August 9, 1990, transport cases, containing millicurie quantities of licensed material consisting of technetium 99m and iodine-131, were placed in che storage area of a lisensee vehicle in preparation for shipment, and were not secured to prevent the packager, shifting during normal transportation.
This is a Severity Level IV violation (Supplement VI)
Pursuant to the provisions of 10 CFR 2.201, Syncor International Corporation (Licensee) is hereby required to submit a written statement or explanation to the Director, Office of Enforcement, U.S. Nuclear Regulatury Commission, within 30 days of the date of this Notice.
This reply should be clearly marked as a
" Reply to a Notice of Violation" and should include for each alleged violation:
(1) admission or denial of the alleged violation, (2) the reasons for the viola-tion if admitted, and if denied, the reasons why, (3) the corrective steps that have been taken and the results achieved, (4) the corrective steps that will be taken to avoid further violations, and (5) the date when full compliance will be achieved.
If an adequate reply is not received within the time spacified in this Notice, an order may be issued to show cause why the license should not be modified, suspended, or revoked or why such other action as may be proper should not be taken.
Consideration may be given to extending the response time for good cause shown. Under the authority of Section 182 of the Atomic Energy Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.
Vithin the same time as provided for the response required above under 10 CFR 2,201, the Licensee may pay the civil penalty by letter to the Director, Office
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of Enforcement, U.S. Nuclear Regulatory Commission, with a check, draf t, money order, or electronic transfer payable to the Treasurer of the United States in the amount of the civil penalty proposed above, or may protest itposition of the civil. penalty in whole or in part by a written answer addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission.
Should the Licensee fail to. answer within the time specified, an order imposing the civil penalty will be issued.
Should the Licensee elect to file an answer in accorcance with 10 CFR 2.205 protesting the civil penalty, in whole or in part, such answer should be clearly marked as an " Answer to a Notice of Violation" and may:
(1) deny the violations listed in this Notice in whole or in part, (2) demon-strate extenuating circumstances, (3) show error in this Notice, or (4) show other reasons why the penalty should not be imposed.
In additVon to protesting the civil penalty, such answer may request remission or it.'tigation of the penalty.
In requesting mitigation of the proposed penalty, thn factors addressed in Section V.B of 10 CFR Part 2, Appendix C (1990), should be addressed. Any written answer in accordance with 10 CFR 2.205 should be set farth separately from the statement or explanation in reply pursuant to 10 CFA 2.201, but may incorporate parts of the 10 CFR 2.201 reply by specific reference (e.g., citing page and paragraph numbers) to avoid repetition.
The attention of the Licensee is directed to the other provisior.c of 10 CFR 2.205, regarding the procedure for imposing a civil penalty.
OFFICIAL RECORD COPY SYNCOR CP EA 90-144 10/31 - 0006.0.0 11/01/90
Notite of Violation 3
Upon failure to pay any civil penalty due which subsequently has been determined in accordance with the applicable provisions of 10 CFR 2.205, this matter may be referred to the Attorney General, and the pensity, unless compromised, remitted, or mitigated, may be collected by civil a tion pursuant to Section 234c of the Atomic Energy Act, 42 U.S.C. 2282(c).
The response noted above (Reply to a Notice ;f Vituation, letter wi!.h payment of civil penalty, and Answer to a N0tice of Violation) should be addressed to:
Director, Of fice of Enforcement, U.S. Haclear Regulatory Coinmission, ATTN:
Document Control Desk Washington, DC 20555 with a copy to the Regional Administrator, U.S. Nuclear Regulatory Commission, Region I, 475 Allendale Road, King of Prussia, Pennsylvania 19406.
FOR THE NUCLEAR REGULATORY COMMISSION Ornd Si rd [!y:
Thomas T. Marun Thomas T. Mar *.in Regional Administrator Dated at King of Prustia, Pennsylvania this g day of November 1990 0FFICIAL RECORD COPY SYNCOR CP EA 90-144 10/31 - 0007.0.0 11/01/90 I
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