ML20133F813
| ML20133F813 | |
| Person / Time | |
|---|---|
| Issue date: | 01/13/1997 |
| From: | Lieberman J NRC OFFICE OF ENFORCEMENT (OE) |
| To: | Fishman D NDC SYSTEMS |
| Shared Package | |
| ML20133F817 | List: |
| References | |
| REF-QA-99990004-970113 EA-96-342, EA-96-539, NUDOCS 9701150017 | |
| Download: ML20133F813 (3) | |
Text
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UNITED STATES g
NUCLEAR REGULATORY COMMISSION o
WASHINGTON, D.C. 2066M001
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January 13, 1997 EAs96-342 & 96-539 NDC Systems ATTN: Mr. Daniel Fishman President and Radiation Safety Officer 5314 N. Irwindale Avenue Irwindale, California 91706
SUBJECT:
NOTICE OF VIOLATION AND CONFIRMATORY ORDER MODIFYING LICENSE i
(NRC Investigation Report 4-96-14) 4
Dear Mr. Fishman:
This refers to the predecisional enforcement conference held on October 23, 1996, in the NRC Region IV office in Arlington, Texas. The conference was held to discuss the circumstances surrounding an apparent violation identified to you by letter dated October 2, 1996.
Based on information developed during the investigation, and the information that you provided during the conference, the NRC has determined that a violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding it are described in our October 2,1996 letter to you.
The violation involves a willful failure to comply with NRC export requirements (10 CFR 110.50) in that packaging of certain gauging devices containing americium-241 was not in accordance with Department of Transportation (DOT) requirements.
NDC representatives stated that the circumstances surrounding the failure to comply with D0T requirements began around 1989 with the practice of improperly labeling gauges that were going to certain countries.
Gauges going to certain countries were purposefully mislabeled to reflect a lower activity of 25 mci, even though NDC personnel knew that the gauges contained 150 mci.
(This occurred after Amersham, the manufacturer of the sources, began shipping to NDC 150 mci cylinder sources rather than 25 mci d'-F sources.) NDC personnel stated they rationalized that this mislabeling wa:. teceptable because the radiation output of the gauges was essentially the same, although the sources were of different activities.
Since the mislabeled gauges appeared to be within the DOT limit for excepted packaging, NDC personnel improperly packaged them in excepted packaging rather than in the required Type A packaging.
Thus, NDC shipping nersonnel were packaging and sending gauges going to certain countries i; excepted packsging, while the same model gauges, which wera correctly labelled, were shipped to other countries in Type A packaging.
kk Some NDC personnel stated that they raised concerns about the practice of mislabeling the gauge to senior NDC management on a number of occasions.
Although NDC senior management agreed the practice was improper, NDC personnel t
were instructed to continue the practice despite their concerns. At the A
conference, you stated that this inappropriate practice was condoned by senior 970'1150017 970113 REG 4 GA999 ENVNDC 99990004 PDR 100005
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management with the rationalization that it would be a temporary practice until the devices were registered in those certain countries.
All involved NDC personnel stated that there was no discussion of mispackaging the devices, which was the natural consequence of the mislabeling.
Due to your admitted
" sloppy" practices and total lack of oversight, NDC senior management inadequately evaluated the mislabeling concern and did not consider that the mislabeling would result in mispackaging. Thus, the NRC has concluded that this violation was willful based on, at least, the careless disregard by senior NDC management for applicable regulatory requirements.
During the conference, you stated that the root causes of the violation are:
(1) a lack of management oversight of the NDC shipping program to ensure compliance with D0T regulations; and (2) a lack of a thorough understanding of applicable D0T regulations.
In addition, NDC proposed various corrective actions that it had taken and planned to take to preclude recurrence of this violation and future D0T violations.
In later discussions with NDC, the corrective actions were enhanced to address specific NRC concerns.
By letter dated November 21, 1996, the NRC described to NDC the NRC's understanding of NDC's modified corrective actions. NDC subsequently confirmed that these corrective action be incorporated into ifcense conditions by letter signed November 29, 1996.
To address the weaknesses which led to the violation, the NRC has determined that the public health and safety require that these conditions be confirmed by the attached Confirmatory Order Modifying License (Order).
In brief, the Order requires an audit of NDC's transportation activities by an outside organization to be completed within specified timeframes, formal classroom training for individuals performing and supervising shipping activities, and a second comprehensive audit to be conducted in about a year to ensure NDC's corrective actions have been effective.
The NRC recognizes that the actual and potential safety significance of the violation is minor.
00T regulations changed in November 1995 to allow the higher activity sources to be transported in excepted packaging.
However, the violation is of regulatory significance because the violation was committed with, at least, careless disregard for regulatory requirements.
Therefore, this violation has been catego;ized in accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy),
NUREG-1600, at Severity Level III.
Normally, a base civil penalty in the amount of $2,500 is considered for Severity Level III violations, in accordance with the Enforcement Policy.
However, in light of the issuance of the enclosed Order, the NRC is not proposing a civil penalty in this case.
Pursuant to section 223 of the Atomic Energy Act of 1954, as amended, any person who willfully violates, attempts to violate, or conspires to violate, any provision of the Confirmatory Order shall be subject to criminal prosecution as set forth in that section.
Violation of this order may also subject the person to civil monetary penalty.
T NDC Systems Questions concerning this Order should be addressed to Mr. James Lieberman, Director, Office of Enforcement, who can be reached at (301) 415-2741.
In accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter, its enclosures, and your response will be placed in the NRC Public Document Room (PDR). To the extent possible, your response should not include any personal privacy or proprietary information so that it can be placed in the PDR without redaction.
If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information.
If you request withholding of such material, you must specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information).
Sincerely, p,,. - s..;. t~
James Lieberman, Director Office of Enforcement Docket No. 999-90004 General License Pursuant to Part 110
Enclosures:
As Stated CC:
State of California Daryl Shapiro Morgan, Lewis, and Bockius 1800 M Street NW Washington DC 20036