EA-98-536 - University of Medicine and Dentistry of New Jersey

December 29, 1998

EA 98-536


Mr. Louis C. Goetting
Executive Director for Materials Management
University of Medicine and Dentistry of New Jersey
65 Bergen Street
University Heights
Newark, New Jersey 07107-3001

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report No. 030-09926/98-001)

Dear Mr. Goetting:

This refers to the NRC inspection conducted on November 17-19, 1998, at the above location, to determine whether activities authorized by your NRC license were conducted safely and in accordance with NRC requirements. At the conclusion of the inspection, the findings were discussed with those members of your staff identified in the inspection report. During the inspection, two apparent violations of NRC requirements were identified involving the failure to appropriately secure licensed radioactive material at your facility. The apparent violations were described in the NRC inspection report transmitted with our letter, dated December 15, 1998. On December 23, 1998, a predecisional enforcement conference was held with you and members of your staff to discuss each of the apparent violations, the causes, and your corrective actions. A copy of the enforcement conference report is enclosed. At the conference, you also provided the NRC a letter, dated December 23, 1998, summarizing your corrective actions.

Based on further review of the information developed during the inspection and the information you provided during the conference, the NRC has determined that one violation of NRC requirements occurred. That violation involved three examples of failure to secure licensed materials in an unrestricted area. One example of the violation is cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding it are described in detail in the subject inspection report. The remaining two examples of the violation were not cited as discussed below.

The cited violation involved the failure to secure approximately 136 microcuries (uCi) of polonium-210 (Po-210) in one of your research laboratories. Specifically, the NRC inspector discovered that a research laboratory in the Medical School Building at your facility was unsecured and unattended. In this case, the laboratory was shared by individuals who use licensed material, as well as individuals who did not use licensed materials. Since the amount of Po-210 in the laboratory was greater than 1000 times the levels set forth in 10 CFR Part 20, Appendix C (approximately 36 times the Annual Limit on Intake), and since the material existed in a liquid form (polonium chloride), failure to maintain security of the laboratory constitutes a significant safety concern in that, it could have resulted in the material being lost, stolen, or misused by an individual. Ingestion of such material would have resulted in a significant exposure. Therefore, the violation is classified at Severity Level III in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level III violation. Because your facility has not been the subject of an escalated enforcement action within the last two years, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Credit for corrective actions is warranted because your corrective actions, at the time of the enforcement conference, were considered prompt and comprehensive. These actions, which were described at the enforcement conference, included, but not limited to, (1) review of all 125 laboratories located in the four buildings containing radioactive material to ensure availability of locking refrigerators, storage, or locked storage within locking refrigerators; (2) placement of a locking device on the only laboratory which is being utilized by both individuals who use licensed material, as well as individuals who do not use material; (3) issuance of a notice to all users of licensed material emphasizing the importance of security of material, and informing them that a mandatory six month probation period would be imposed for any violation of security requirements; (4) enhanced training of all individuals who do not use licensed material but work in laboratories where licensed material is used; and (5) increasing the frequency of inspections of the laboratories by your radiation safety staff from monthly to twice monthly.

Therefore, to encourage prompt and comprehensive correction of violations, I have been authorized not to propose a civil penalty in this case. However, similar violations in the future could result in further escalated enforcement action.

The second example of the violation involved the failure to secure approximately 50 uCi of carbon-14 (C-14) in a research laboratory. Your corrective actions for this problem were appropriate also. This occurrence was of minor safety significance and is not subject to formal enforcement action.

The third example of the violation of security requirements occurred in December 1997 and resulted in the loss of control of a package containing 5 millicuries of tritium. Although this violation was identified as a result of an event, namely, the loss of the material, the NRC has determined that this example of the violation was caused by an isolated human error with minimal opportunity for prevention, and you exerted noteworthy effort in ferreting out the root cause of the loss of the material and taking corrective actions. Therefore, this example of the violation is being treated as a noncited violation consistent with Section VII.B.1 of the Enforcement Policy.

The NRC has concluded that information regarding the reason for the violation, the corrective actions taken and planned to correct the violation and prevent recurrence, and the date when full compliance was achieved is already adequately addressed on the docket in your December 23, 1998 letter. Therefore, you are not required to respond to this letter unless the description therein 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.

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).

		Sincerely,
		Original Signed by: James T. Wiggins for:
		Hubert J. Miller Regional Administrator

Docket No. 030-09926
License No. 29-02957-13

Enclosures:
1. Notice of Violation
2. Predecisional Enforcement Conference Summary Report

cc w/encls:
State of New Jersey

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NOTICE OF VIOLATION
University of Medicine and Dentistry    of New Jersey Newark, New Jersey		Docket No. 030-09926 License No. 29-02957-13 EA No. 98-536

During an NRC inspection conducted on November 17-19, 1998, a violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG 1600, the violation is listed below:

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 November 18, 1998, the licensee did not secure from unauthorized removal or limit access to licensed material stored in controlled or unrestricted areas. Specifically, licensee personnel left two vials of polonium-210 (containing a total of 136 microcuries liquid polonium chloride) unattended and unsecured in Room F451 of the Medical Science Building. (01013)

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

The NRC has concluded that information regarding the reason for the violation, the corrective actions taken and planned to correct the violation and prevent recurrence and the date when full compliance was achieved is already adequately addressed on the docket in the licensee's December 23, 1998 letter to the NRC. However, the licensee is required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description therein does not accurately reflect its corrective actions or its position. In that case, or if the licensee chooses to respond, the licensee shall clearly mark its response as a "Reply to a Notice of Violation," and send it to the U.S. Nuclear Regulatory Commission, ATTN:  Document Control Desk, Washington, DC 20555 with a copy to the Regional Administrator, Region I, within 30 days of the date of the letter transmitting this Notice of Violation (Notice).

If you contest this enforcement action, you should also provide a copy of your response to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 20555-0001.

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

If the licensee chooses to respond, its response will be placed in the NRC Public Document Room (PDR). Therefore, to the extent possible, the response should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction.

In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.


Dated at King of Prussia, Pennsylvania
this 29th day of December 1998