EA-97-417 - Virginia Commonwealth University

October 28, 1997

EA 97-417

Virginia Commonwealth University
ATTN: William L. Dewey, Ph.D.
Vice President for Research
and Graduate Studies
P. O. Box 112, MCV Station
Richmond, Virginia 23298-0001

SUBJECT:

NOTICE OF VIOLATION (NRC INSPECTION REPORT NO. 45-00048-17/97-01)

Dear Dr. Dewey:

This refers to the inspection conducted on August 11-13, 1997, at your facility in Richmond, Virginia. The purpose of the inspection was to determine whether activities authorized by the license were conducted safely and in accordance with regulatory requirements. The results of the inspection were discussed with you on August 13, 1997, and were formally transmitted to you by letter dated September 4, 1997. That letter also provided you the opportunity to respond to the apparent violations in writing or request a predecisional enforcement conference. Subsequently, you declined a conference, and by letter dated October 2, 1997, you submitted additional information to us regarding the apparent violations, the root causes, and your corrective actions to preclude recurrence. We have reviewed the inspection results and the additional information you provided and have concluded that sufficient information is available to determine the appropriate enforcement action in this matter.

Based on the information developed during the inspection and the information that was provided in your October 2, 1997 letter, the NRC has determined that violations of NRC requirements occurred. The violations are cited in the enclosed Notice of Violation (Notice), and the circumstances surrounding them are described in detail in the subject inspection report.

Violation A includes two examples of the failure to secure licensed materials against unauthorized removal or access. The root cause of the violation was the failure of the authorized users to properly secure laboratories housing radioactive materials when unattended. A similar violation was identified at your facility by the NRC in June 1996, when 4 of 20 laboratories were found to contain unsecured licensed materials. Violation A is a repeat violation because fully effective implementation of the corrective actions for the June 1996 violation should have precluded recurrence of the circumstances leading to Violation A.

Security of licensed materials is a significant safety issue because of the potential radiological consequences of access to these materials by unauthorized and/or untrained individuals. The NRC expects licensees to maintain a high degree of compliance with security requirements to properly control licensed materials. In this case, although only two of 74 laboratories were found to be unlocked, the laboratories contained significant quantities of licensed material including quantities of Phosphorus-32 (P-32). Theft or loss of P-32 could pose potential risk since this radionuclide has a high specific activity which, if uncontrolled, could result in substantial unplanned exposures. In addition, repetitive violations are of significant regulatory concern because they indicate a failure to implement effective corrective actions for a previous violation. Therefore, Violation A is classified in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, as a Severity Level III violation.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2250 is considered for a Severity Level III violation. Because your facility has not been the subject of escalated enforcement action within the last two years or two inspections, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process described in Section VI.B.2 of the Enforcement Policy. Your corrective action included retraining and counseling of appropriate staff members and, more importantly, planned implementation of strict disciplinary actions for security violations. The NRC concluded that: (1) your policy and procedural controls, if properly implemented, should be effective in controlling licensed materials; (2) radioactive materials security has received increased emphasis during periodic audits and surveillances; (3) research personnel now have a heightened awareness of security; and, (4) the incidence of documented security violations has decreased. Based on these facts, the NRC determined that credit was warranted for the factor of Corrective Action, resulting in no civil penalty for the Severity Level III violation.

Therefore, to encourage prompt identification and comprehensive correction of violations, I have been authorized, after consultation with the Office of Enforcement, not to propose a civil penalty in this case. However, significant violations in the future could result in a civil penalty.

Violation B involves the failure to wear required protective clothing while handling unsealed radioactive materials. Your September 28, 1997 license renewal application stated that, when applicable, protective clothing should be worn. During our inspection, your radiation safety staff informed the NRC inspector that individuals were required to wear a lab coat when unsealed radioactive material was handled. Your corrective actions included obtaining proper protective clothing for the individual involved, and planned revisions to your program to increase emphasis on compliance with protective clothing requirements during training and your routine laboratory inspections. Violation B has been characterized as a Severity Level IV violation.

The NRC has concluded that the reason for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence, and the date when full compliance will be achieved are adequately addressed on the docket in your letter to the NRC dated October 2, 1997. Therefore, no response to this letter is required unless the description therein or described above does not accurately reflect your corrective actions or your position. In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice. With the issuance of the Notice of Violation, EEI 45-00048-17/97-01-01 and EEI 45-00048-17/97-01-02 are 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 will be placed in the NRC Public Document Room (PDR). To the extent possible, a response should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction.

Sincerely,

Luis A. Reyes Regional Administrator

Docket No. 030-03297
License No. 45-00048-17

Enclosure: Notice of Violation

cc w/encl:
Commonwealth of Virginia

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NOTICE OF VIOLATION

Virginia Commonwealth University Medical College of Virginia

Docket No.030-03297 License No.45-00048-17 EA 97-417

During an NRC inspection conducted on August 11-13, 1997, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions," (NUREG-1600), the violations are listed below:

A. 10 CFR 20.1801 requires that the licensee secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas. 10 CFR 20.1802 requires that the licensee control and maintain constant surveillance of licensed material that is in a controlled or unrestricted area and that is not in storage. As defined in 10 CFR 20.1003, controlled area means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee for any reason; and unrestricted area means an area, access to which is neither limited nor controlled by the licensee.

Contrary to the above, on August 12 and 13, 1997, the licensee did not secure from unauthorized removal or limit access to approximately 2.25 millicuries (mCi) of phosphorus 32 (P-32) and 1.4 mCi of sulfur 35 (S-35) located in Room 2-030 of Sanger Hall and approximately 3.75 mCi of P-32, 3.12 mCi of hydrogen 3, 1 mCi of S-35, 1.34 mCi of carbon 14, and 1 mCi of iodine 125 located in Room H-515 of the licensee's Medical Sciences Building, which were controlled areas, nor did the licensee control and maintain constant surveillance of these licensed materials. (01013)

This is a Severity Level III violation (Supplement VI).

B. Condition No. 51 of NRC License No. 45-00048-17 requires that except as specifically provided otherwise in the license and as provided in 10 CFR 35.51, the licensee shall conduct its program in accordance with statements, representations, and procedures contained in the documents, including any enclosures, listed on page 14 of the license. The list includes the license renewal application dated September 28, 1993.

Attachment 10.2.4.a of the license renewal application dated September 28, 1993, described the rules for the use of radioactive materials in research areas. Item 16 stated that, when applicable, protective clothing and gloves should be worn. The licensee radiation safety staff stated that wearing a laboratory coat was required when handling unsealed licensed materials.

Contrary to the above, on August 13, 1997, an individual handling unsealed licensed materials, in Room 2-108 of the Massey Cancer Center, was not wearing a laboratory coat. (02014)

This is a Severity Level IV violation (Supplement IV).

The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence, and the date when full compliance will be achieved are already adequately addressed on the docket in your letter to the NRC dated October 2, 1997. However, Virginia Commonwealth University is required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to respond, clearly mark your response as a "Reply to Notice of Violation," and send it to the U. S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, D. C. 20555 with a copy to the Regional Administrator, Region II, within 30 days of the date of the letter transmitting this Notice of Violation (Notice).

Under the authority of Section 182 of the Act, 42 U. S. C. 2232, any response shall be submitted under oath or affirmation.

If you choose to provide a response, it will be placed in the NRC Public Document Room (PDR), and 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.

Dated at Atlanta, Georgia
this 28th day of October 1997