EA-00-203 - Oklahoma State University

December 7, 2000

EA-00-203

Dr. Thomas Collins
Office of the Vice President of Research
Oklahoma State University
203 Whitehurst
Stillwater, Oklahoma 74078

SUBJECT:

NOTICE OF VIOLATION & EXERCISE OF ENFORCEMENT DISCRETION (NRC Inspection Report 030-00945/00-01; Investigation Case No. 4-2000-023A)

Dear Dr. Collins:

This refers to the inspection and concurrent investigation conducted by the NRC's Office of Investigations (OI) at Oklahoma State University's (OSU) College of Veterinary Medicine, Stillwater, Oklahoma, completed on September 13, 2000. The purpose of the inspection was to review an event that occurred on March 22, 2000. The purpose of the investigation was to determine whether there had been any willful violations of NRC requirements associated with the March 22, 2000 event. During the inspection, apparent violations of NRC requirements were identified. An inspection report documenting the results of this inspection and summarizing the results of the investigation was sent to you by letter dated September 22, 2000. A predecisional enforcement conference was conducted on October 11, 2000, between NRC representatives and you and other OSU representatives in the NRC's Region IV Arlington, Texas office.

The apparent violations included: (1) the use of licensed material, tritium (tritiated thymadine), in a research laboratory that was not authorized as a location of use by OSU's Radiation Safety Committee (RSC); (2) the use of licensed material by two individuals who were not authorized by the RSC; (3) the use of licensed material by two individuals not trained in accordance with your radiation safety program; (4) the failure to secure licensed material in a research laboratory; and (5) the failure of personnel to notify the radiation safety officer (RSO) of a contamination event promptly as required by the license.

Following the conference, on October 13, 2000, you provided NRC a written response to each of the apparent violations and other NRC concerns discussed at the conference. In brief, you acknowledged apparent violations 1, 3 and 4; requested reconsideration of apparent violations 2 and 5; and stated, based on your own interviews of personnel involved in apparent violation 1, that you did not believe there was any willfulness on the part of the two individuals who used radioactive material in a laboratory not authorized for that use. Your letter also described numerous corrective actions OSU has taken or will take to address these violations and related issues. These are summarized below.

The NRC has carefully considered all of the information provided by OSU in reaching an enforcement decision. As discussed below, the NRC has determined that four violations of NRC requirements occurred. These are described in the enclosed Notice of Violation (Notice) and the details surrounding them were contained in our inspection report. As indicated above, you requested reconsideration of two violations. The NRC has determined that the use of radioactive materials by unauthorized individuals did not constitute a violation of NRC requirements; we agree with your position that these individuals were working under an authorized user and were not required to be individually authorized by the RSC. The apparent violation involving failure to notify the RSO promptly of a contamination event resulting from discovery of radioactive material in a container labeled as bleach has been recharacterized to reflect the NRC's conclusion that, while notification took place, the RSO's follow-up actions did not constitute an "investigation" as required by your radiation safety program. In particular, the RSO did not conduct a contamination survey of the laboratory or follow up on an employee's concern that she may have ingested radioactive material.

Your October 13 letter stated that neither individual involved in using tritium in an unauthorized laboratory had knowledge at the time of their actions that the laboratory had to be authorized and that you did not consider their actions willful. The NRC has reviewed the transcribed interviews of these individuals conducted by OI and has verified that these individuals had knowledge that the research laboratory of an assistant professor at OSU had not been authorized for the use of radioactive materials and chose, out of convenience, to use the laboratory for their research. The NRC has therefore concluded based on the interviews conducted, that the individuals recognized at the time that this was not a permitted location.

The use of radioactive materials in unauthorized locations is of concern because university personnel charged with responsibility for radiation safety cannot discharge their responsibilities if unaware an activity is occurring. Since there is no evidence that these individuals used radioactive materials unsafely, this violation (Violation A) would be categorized as a Severity Level IV violation due to the low safety significance. However, the NRC is particularly concerned since there is willfulness associated with this violation and, therefore, has categorized this violation at Severity Level III, in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, dated November 9, 1999.

In accordance with the Enforcement Policy, a civil penalty with a base value of $2,750 is considered for a Severity Level III violation. Because the violation was determined to be willful, the NRC considered whether credit was warranted for Identification and Corrective Action in accordance with the civil penalty assessment process in Section VI.C.2 of the Enforcement Policy.

This violation was not identified or acted upon by OSU until the NRC became involved; thus, no credit is warranted for identification. Based on the corrective actions discussed at the conference and in OSU's October 13 letter, the NRC has determined that credit for corrective action is warranted. OSU's description of its short-term corrective actions included: the issuance of notices of violation by OSU's RSC to the laboratory manager and personnel involved in the unauthorized use of tritium in the unauthorized laboratory; the requirement that the laboratory request and receive authorization to utilize radioactive materials; training of 130 faculty, staff and graduate students using radioactive materials; expansion of the RSC to include an additional representative from each college that uses radioactive material, other key offices and a certified health physicist; a requirement by OSU's Director of University Research Compliance that each college using radioactive materials develop a plan for monitoring and ensuring compliance at the college level; and the transfer of administrative responsibilities from the RSO to the University Research Compliance office to permit the RSO to commit time to regulatory compliance activities. OSU also committed to the following long-term corrective actions: ongoing reviews of resource needs to ensure that adequate resources are committed to compliance requirements; to retain independent technical expertise in health physics to provide independent program assessments; and ongoing reviews of its radiation safety program to ensure that the health and safety of OSU employees are monitored and that training requirements are met.

While application of the civil penalty assessment process would result in a civil penalty being proposed, NRC has decided to exercise discretion, as provided for in section VII.B.6 of the Enforcement Policy, and not assess a civil penalty. Specifically, the NRC has taken into consideration the breadth and scope of OSU's corrective actions and commitments to improve the monitoring of radioactive material use at the university and the fact that the evidence in this case indicates that the individuals involved used only small amounts of radioactive material and, therefore, the risk was low.⁽¹⁾

Violations B, C and D in the enclosed Notice did not involve willfulness and were deemed to be of low safety significance. Thus, each of these violations has been classified at Severity Level IV in accordance with the Enforcement Policy. Civil penalties are not considered for Severity Level IV violations.

In that the State of Oklahoma assumed responsibility for OSU's license on September 29, 2000, you are not required to provide a response to the NRC. If you choose to respond, the instructions for doing so are contained in the enclosed Notice. The NRC encourages you to inform Oklahoma's Department of Environmental Quality (DEQ) regarding the completion of your corrective actions and your overall efforts to improve your radiation safety program. In addition, we recommend that you contact DEQ regarding requirements to post the enclosed Notice of Violation. We believe the state has requirements identical to NRC requirements in 10 CFR 19.11 which require Notices of Violation related to radiological working conditions be posted within two working days after receipt.

In its September 22, 2000, letter forwarding the Inspection Report, the NRC also had expressed concern that the memorandum written by the Assistant Professor at OSU shortly after the discovery of a bottle in his laboratory labeled as containing bleach which contained radioactive material might be interpreted as a criticism of the employee who brought forward the concern about the unmarked bottle and its contents. In its October 13, 2000, letter, OSU explained that the memorandum was unrelated to the raising of nuclear safety concerns, and restated its commitment to maintaining an atmosphere in which employees are encouraged to raise such concerns. The NRC considers this matter closed.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosure, and any response you choose to submit will be made available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of NRC's document system (ADAMS). ADAMS is accessible from the NRC Web site at the Public NRC Library.

		Sincerely,
		/Thomas P. Gwynn Acting for/
		Ellis W. Merschoff Regional Administrator

Docket No. 030-00945
License No. 35-00237-03

Enclosure: Notice of Violation

cc w/Enclosure:
Mike Broderick, State of Oklahoma DEQ

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NOTICE OF VIOLATION
Oklahoma State University Stillwater, Oklahoma		Docket No. 030-00945 License No. 35-00237-03 EA-00-203

During an NRC inspection completed September 13, 2000, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, dated November 9, 1999, the violations are listed below:

A.	License Condition 30 requires, in part, that the licensee conduct its program in accordance with statements, representations, and procedures contained in the license application dated May 13, 1993, and letter dated November 23, 1997, including a copy of the Radiation Safety Handbook (Revision date October 1997). Item 10, Radiation Safety Program, Administrative Procedures, of the letter dated November 23, 1997, specifies that the RSO, Radiation Safety Committee (RSC), and the Vice President for Research will review and approve all applications for use of licensed materials. Each application specifies authorized users and authorized areas of use. Contrary to the above, on several occasions in calendar year 2000, licensed material, tritium (tritiated thymadine), was used in Room No.159 in the College of Veterinary Medicine, a location not authorized or approved by the RSO, the RSC and the Vice President for Research. This is a Severity Level III violation (Supplement VI).
B.	License Condition 30 requires, in part, that the licensee conduct its program in accordance with statements, representations, and procedures contained in the license application dated May 13, 1993, and letter dated November 23, 1997, including a copy of the Radiation Safety Handbook (Revision date October 1997). Item 8, Radiation Safety Program, Training For Individuals Working In Or Frequenting Restricted Areas, of the letter dated November 23, 1997, specifies that all technician-level staff, veterinary medicine interns, graduate students, post-doctoral students, and other individuals who frequent restricted areas are required to complete the RSO's required radiation safety training course. In addition, each authorized user is required to provide performance-based instruction to all personnel who may be involved in the use of radioisotopes. Refresher training in radiation safety is required every two years after initial radiation safety training. Contrary to the above, in calendar year 2000, licensed material, tritium (tritiated thymadine), was used in the College of Veterinary Medicine by both a College of Veterinary Medicine graduate student and a research laboratory assistant who had not received training in accordance with the above requirements. Specifically, the research laboratory assistant had received initial radiation safety training in calendar year 1995, but had not received the two year refresher radiation safety training since that time, and the graduate student had not received initial radiation safety training. This is a Severity Level IV violation (Supplement VI).
C.	10 CFR 20.1801 requires, in part, that the licensee secure from unauthorized removal or access 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. As defined in 10 CFR 20.1003, unrestricted area means an area, access to which is neither limited nor controlled by the licensee. Contrary to the above, in calendar year 2000, the licensee did not secure from unauthorized removal, limit access to, or maintain constant surveillance of unknown quantities of tritium (tritiated thymadine) located in room 159 of Oklahoma State University's College of Veterinary Medicine, an unrestricted area. Specifically, licensed material was used and stored in this laboratory, a location which had not been authorized for this purpose, and no controls were in place to limit access or maintain surveillance of this material. This is a Severity Level IV violation (Supplement VI).
D.	License Condition 30 requires, in part, that the licensee conduct its program in accordance with statements, representations, and procedures contained in the license application dated May 13, 1993, and letter dated November 23, 1997, including a copy of the Radiation Safety Handbook (Revision date October 1997). Section II of the Radiation Safety Handbook, Regulations Concerning The Procurement And Usage Of Radioisotopes, Equipment And Services, Subsection A. 4, Responsibility Of The RSO, specifies the responsibilities of the RSO, including the responsibility to investigate any reported accident or spill of radioisotopes on university property. Contrary to the above, on March 29, 2000, OSU's RSO was notified by an OSU department head of a report of radioactive material contamination. Subsequently, the RSO learned that a laboratory research assistant possibly ingested radioactive material. The RSO failed to conduct a proper investigation of the circumstances involving this reported event. Specifically, the RSO's response was to dispatch two radiation safety technicians to the laboratory suspected of being contaminated to search for a container that had been labeled as containing bleach which had been found in the laboratory and which was reported to contain radioactive material. The RSO failed to perform a contamination evaluation of the laboratory and failed to evaluate a laboratory research assistant's possible ingestion of radioactive material. This is a Severity Level IV violation (Supplement VI).

Because regulatory authority for this license was transferred to the State of Oklahoma effective September 29, 2000, Oklahoma State University is not required to submit a response to this Notice to the NRC.

If a reply is submitted, send it to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555, with a copy to the Regional Administrator, Region IV, within 30 days of 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."

If you contest the violations in this Notice, please also provide a copy of your response, with the basis for your denial, to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 20555-0001.

Because any response you choose to submit will be made available to the Public, to the extent possible, it should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the Public 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). If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.

Dated this 7th day of December 2000

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^1. The NRC notes that a bleach bottle containing radioactive waste materials found in this laboratory could not be traced to these individuals.