EA-96-049 - Oklahoma, University of
Joseph J. Ferretti, Ph.D.
Senior Vice President and Provost
University of Oklahoma
Health Sciences Center
P.O. Box 26901
Oklahoma City, Oklahoma 73190
SUBJECT: NOTICE OF VIOLATION & PROPOSED IMPOSITION OF $2,500 CIVIL PENALTY (NRC Inspection Report No. 030-12750/95-01 and Investigation Report No. 4-95-057)
Dear Dr. Ferretti:
This is in reference to the University of Oklahoma's May 13, 1996 written response to an apparent violation identified in the NRC's April 9, 1996 letter and enclosed inspection report. As stated in the NRC's April 9 letter, the inspection and a subsequent investigation identified an apparent violation involving a failure to secure licensed radioactive material in the public domain. Specifically, on September 26, 1995, an NRC inspector observed a driver employed by the University of Oklahoma leave radiopharmaceuticals unattended in an unlocked vehicle during a delivery to Mercy Health Center. This incident was brought to the attention of the university by the NRC on the same date.
In your reply to the apparent violation, you did not deny that a violation had occurred, described the reasons for the violation from the university's perspective, and described your corrective actions. Your corrective actions consisted of: issuing verbal and written reprimands to the driver, instructing all delivery personnel in the requirements and methods to secure material, establishing a requirement to prevent the dispatch of a delivery vehicle lacking proper security, establishing a schedule of disciplinary actions for violations of security requirements, and notifying all radioactive materials users through a campus safety newsletter of the significance of failing to secure radioactive material that is left unattended in an area where members of the public have access. The director of the nuclear pharmacy also informed all delivery personnel that customer service, although important, is subordinate to the requirement to comply with all NRC requirements and the conditions of the license.
Based on the information developed during the inspection and investigation and the information that you provided in your response to the inspection report, the NRC has determined that the September 26, 1995 incident did violate NRC requirements. The violation is cited in the enclosed Notice of Violation and Proposed Imposition of Civil Penalty; the circumstances surrounding it were described in detail in the subject inspection report. Although the incident in question resulted in material being left unattended for only a brief period of time, the NRC's inspection and investigation found that the involved driver made a decision to leave the material unattended despite being aware of requirements to secure such material, and that he left material unattended on other occasions, including deliveries performed earlier on the same day. As an NRC licensee, you are responsible for ensuring that licensed material is protected from loss into the public domain, where it could be subject to theft or tampering. Therefore, this violation has been categorized in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, at Severity Level III.
In accordance with Section VI.B.2 of the Enforcement Policy, a civil penalty is considered for a Severity Level III violation. The base value for such a penalty in this case is $2,500. Because this violation was found by the NRC to have been committed willfully, the NRC considered whether credit was warranted for Identification and Corrective Action in accordance with the civil penalty assessment process in the Enforcement Policy. As discussed above, this violation was discovered by an NRC inspector; thus, credit for identification is not warranted. Based on the corrective actions that you described in your letter, which are summarized above, credit for corrective actions is warranted. This results in the assessment of a penalty at the base value.
Therefore, to emphasize the significance of failing to secure radioactive material left unattended in the public domain, as well as the importance of identifying such problems, and to further emphasize the importance of ensuring that your employees are complying with all NRC requirements, I have been authorized, after consultation with the Director, Office of Enforcement, to issue the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice) in the base amount of $2,500 for the Severity Level III violation discussed above. Based on the disciplinary actions you have already taken against the driver who caused this violation, the NRC is not pursuing enforcement action against him.
You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. In your response, you should document the specific actions taken and any additional actions you plan to prevent recurrence. In doing so, you may make reference to information previously provided to the NRC so as to avoid duplication. After reviewing your response to this Notice, including your proposed corrective actions and the results of future inspections, the NRC will determine whether further NRC enforcement action is necessary to ensure compliance with NRC regulatory requirements.
In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosure, 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, proprietary, or safeguards information so that it can be placed in the PDR without redaction.
Sincerely, org signed by L. J. Callan Regional Administrator
License No. 35-03176-04MD
Notice of Violation and Proposed Imposition of Civil Penalty
State of Oklahoma
University of Oklahoma Health Sciences Center Docket No. 030-12750 Oklahoma City, Oklahoma License No. 35-03176-04MD EA 96-049
During an NRC inspection and investigation conducted September 25, 1995 to February 28, 1996, a violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, 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 violation and associated civil penalty are set forth below:
10 CFR 20.1801 requires, in part, that the licensee secure from unauthorized removal licensed materials that are stored in unrestricted areas. 10 CFR 20.1802 requires, in part, that the licensee control and maintain constant surveillance of licensed material that is in an unrestricted area and that is not in storage. An unrestricted area means an area to which access is neither limited nor controlled by the licensee.
Contrary to the above, on September 26, 1995, a licensee employee did not secure from unauthorized removal or maintain constant surveillance of licensed material, i.e., radiopharmaceuticals, that was in an unrestricted area. Specifically, an NRC inspector observed a driver employed by the University of Oklahoma leave radiopharmaceuticals unattended in an unlocked vehicle during a delivery to Mercy Health Center, Oklahoma City. (01013)
This is a Severity Level III violation (Supplement IV).
Civil Penalty - $2,500
Pursuant to the provisions of 10 CFR 2.201, the University of Oklahoma Health Sciences Center (Licensee) is hereby required to submit a written statement or explanation to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, within 30 days of the date of this Notice of Violation and Proposed Imposition of Civil Penalty (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 violation 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 specified in this Notice, an order or a Demand for Information may be issued as 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 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, the Licensee may pay the civil penalty by letter addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, with a check, draft, 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 imposition 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 accordance 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 violation(s) 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 penalty should not be imposed. In addition to protesting the civil penalty in whole or in part, such answer may request remission or mitigation of the penalty.
In requesting mitigation of the proposed penalty, the factors addressed in Section VI.B.2 of the Enforcement Policy should be addressed. Any written answer in accordance with 10 CFR 2.205 should be set forth separately from the statement or explanation in reply pursuant to 10 CFR 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 provisions of 10 CFR 2.205, regarding the procedure for imposing a civil penalty.
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 penalty, unless compromised, remitted, or mitigated, may be collected by civil action pursuant to Section 234c of the Act, 42 U.S.C. 2282c.
The response noted above (Reply to Notice of Violation, letter with payment of civil penalty, and Answer to a Notice of Violation) should be addressed to: James Lieberman, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North, 11555 Rockville Pike, Rockville, MD 20852-2738, with a copy to the Regional Administrator, ATTN: Enforcement Officer, U.S. Nuclear Regulatory Commission, Region IV, 611 Ryan Plaza Drive, Suite 400, Arlington, Texas, 76011.
Because your response will be placed in the NRC Public Document Room (PDR), to the extent possible, it should not include any personal privacy, proprietary, or safeguards 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 specific 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.
Dated at Arlington, Texas,
this 17th day of June 1996