ML20198P282
| ML20198P282 | |
| Person / Time | |
|---|---|
| Site: | 07003078 |
| Issue date: | 01/12/1998 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20198P275 | List: |
| References | |
| 70-3078-97-01, 70-3078-97-1, NUDOCS 9801220059 | |
| Download: ML20198P282 (3) | |
Text
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4 NOTICE OF VIOLATION Atlantic Richfield Company Docket No. 070-03078 Los Angeles, Califor^ia License No. SNM 1993
. During an NRC inspection conducted on December 11,1997, violations of NRC i requirements were identified, in accordance with the " General Statement of Policy and Procedure for NRf; Enforcement Actions," (Enforcement Policy), NUREG 1600, the violations are listed below:
A. Condition 12 of License No. SNM 1993 requires, is 3 art, that the licensee shall collect, tally and report to the NRC, at no more than 12 month intervals, data from allinvestigators as indicated in the "Research Protucol for Clinical Investigation of the ARCO Nuclear NU 5 Pacemaker" dated March 25,1974.
Cnntrary to the above, the licensee did not report to the NRC at no more than 12 month intervals. Specifically, the NRC received a report dated
. February 9,1996 and at the time of the inspection, the licensee providad a report dated May 21997, an interval greater than 12 months.
This is a Severity Level IV violation (Supplement VI).
B. Condition 14 of License No. SNM 1993 requires, in p tt, that the licensee shall conduct its program in accordance with .itatements, representations, and procedures containe.d in the application dated February 24,1992.
The application dated February 24,1992 states,in part, that ARCO nuclear radioisotope powered pacemakers will be surveyed and inventoried quarterly.
Specifically, on a quarterly calendar basis the interior of each pacemaker storage container in use will be wipe tested and sent for analysis, and the inventory of the pacemakers in storage will be verified.
Contraiy to the above, the licensee did not perform surveys and inventories quarterly. Specifically, a survey and inventory was performed on April 25, 1997 and the next survey and inventory was performed on October 22,1997 an interval exceeding a calendar quarter.
This is a Severity Level IV violation (Supplement VI).
Pursuant to the provisions of 10 CFR 2.201, is hereby required to submit a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN:
Document Control Desk, Warhington, D.C. 20555, with a copy to the Regional Administrator, Region I, within 30 bys o' the date of the letter transmitting this Notice of Violation (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, or, if contested, the basis for disputing the violation, (2) the corrective steps OFFICIAL RECORD COPY DON O 78 C PDH _ ]s -
s o-lll l p- 2 l I
t hat have been taken and the results achieved, (3) the corrective steps that v;ill be )
taken to avoid further violations, and (4) the date when full compliance will be achieved. Your response may reference or include previous docketed correspondence, -
if the correspondence adequately addresses the required response, if an adequate reply is not recolved within the time specified in this Notice, an order or a Demand for - ,
information may be issued as to why the licSnse should not be modified, su pended, 1 or revoked, or why such other action as may be proper should not be taken. Where :
good cause is shown, consideration will be given to extending the response time.
Because your response will be placed in the NRC Public Document Room (PDR), to the l
- extent possible, it should not include any personal privacy, proprietary, or safeguarde '
. information so that it can be placed in the PDR without redaction. However, if you find it necessary to include such information, you should clearly indicate the spec;fic information that you desire not to be placed in the PDR, and provide the legal basis to ;
support your request for withholding the information from the public.
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OFFICIAL RECORD COPY:
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