EA-04-219 - University of Sciences

December 21, 2004

EA 04-219

Mr. Philip P. Gerbino, Pharm. D.
President
University of the Sciences
600 South 43rd Street
Philadelphia, PA 19104-4495

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report No. 030-00953/2004-001)

Dear Dr. Gerbino:

This letter refers to the unannounced, routine NRC inspection conducted on September 9, 2004, at your facility located in Philadelphia, PA, as well as the subsequent in-office review of additional information received from your staff dated September 10, 2004. The enclosed inspection report documents the findings of the inspection, which were discussed with Mr. Mark Blum and Ms. Renee Siegel of your staff on October 4, 2004. You subsequently provided information regarding your corrective and preventive actions in a letter dated October 25, 2004.

Based on the findings from this inspection, 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 detail in the subject inspection report. On December 2, 2004, James Dwyer of my staff informed Ms. Renee Siegel, your Director of Environmental Health and Radiation Safety, that this violation was being considered for escalated enforcement action, and the NRC did not need any additional information to make an enforcement decision. However, Mr. Dwyer provided Ms. Siegel an opportunity for your organization to attend a predecisional enforcement conference or to provide a written response, prior to the NRC determining appropriate enforcement action. During this conversation, Ms. Siegel declined the opportunity to attend a conference or to provide a written response.

During our inspection, NRC inspectors toured laboratories, cold rooms, and radioactive waste rooms where licensed material was utilized and stored. The inspectors identified three laboratories that were unoccupied and in which licensed material was present and unsecured. The failure to secure, control or maintain constant surveillance of the licensed material is a violation of NRC requirements. In addition, the NRC is concerned that unsecured radioactive materials were found in the same laboratories during previous audits performed by your Radiation Safety Office staff and actions taken to correct and prevent recurrence following these audits were apparently ineffective.

Although the material remained in the three laboratories the entire time, and it was unlikely that unauthorized persons came into direct contact with the material, this violation is of concern to the NRC because (1) the failure to control radioactive material could result in the loss of the material; and (2) unintended radiation doses to members of the public could occur since classes were in session and students were seen entering and exiting the building. Therefore, this violation is categorized 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 $3,000 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 in Section VI.C.2 of the Enforcement Policy. Credit for corrective actions is warranted because your corrective actions were considered prompt and comprehensive. These corrective actions included, but were not limited to: (1) immediately securing the laboratories; (2) discussing this incident with the authorized users responsible for the laboratories; (3) posting signs on laboratory doors to remind your staff of the security requirements; (4) double locking licensed material; (5) increasing the authority of your Radiation Safety Officer over the storage and security of licensed material; and (6) performing periodic inspections to gauge the effectiveness of your corrective actions.

Therefore, to encourage prompt and comprehensive correction of violations, I have been authorized, after consultation with the Director, Office of Enforcement, to issue the enclosed Notice of Violation without a civil penalty for this Severity Level III violation. However, you should be aware that significant violations in the future could result in a civil penalty. In addition, issuance of this Notice constitutes escalated enforcement action that may subject you to increased inspection effort.

The NRC has concluded that information regarding the reasons 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 this letter and inspection report. Therefore, you are not required to respond to this violation unless the description herein 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 2.390 of the NRC's "Rules of Practice," a copy of this letter, its enclosures, and your response 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. (Note:Public access to ADAMS has been temporarily suspended so that security reviews of publicly available documents may be performed and potentially sensitive information removed. Please check the NRC website for updates on the resumption of ADAMS access.) To the extent possible, your response should not include any personal privacy, proprietary or safeguards information so that it can be made available to the public without redaction. The NRC also includes Issued Significant Enforcement Actions on its Web site.

		Sincerely,
		/RA James T. Wiggins Acting For/
		Samuel J. Collins Regional Administrator

Docket No. 030-00953
License No. 37-00582-02

Enclosures:
1. Notice of Violation
2. NRC Region I Inspection Report 030-00953/2004-001

cc w/encls:
Commonwealth of Pennsylvania

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ENCLOSURE 1

NOTICE OF VIOLATION

University of the Sciences Philadelphia, PA

Docket No. 030-000953 License No. 37-00582-02 EA 04-219

During an NRC inspection conducted on September 9, 2004, as well as an in-office review of additional information received from your staff dated September 10, 2004, a violation of NRC requirements was identified. The violation was discussed with the licensee during an exit meeting on October 4, 2004. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG-1600, the violation is set forth 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 September 9, 2004, the licensee did not secure from unauthorized removal or access, licensed material in laboratories, which are controlled areas, nor did the licensee control and maintain constant surveillance of this licensed material. Specifically on that date, the inspectors found:

	1.	384 microcuries of hydrogen-3 (H-3), 41 microcuries of carbon-14 (C-14) and 190 microcuries of iodine-125 (I-125) unsecured in a research room;
	2.	0.1 microcuries of H-3, 1.9 microcuries of C-14 and 0.3 microcuries of I-125 unsecured in another research room; and
	3.	979 microcuries of H-3 and 176 microcuries of C-14 unsecured in another research room.

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

The NRC has concluded that information regarding the reasons 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 this letter and NRC Inspection Report No. 030-00953/2004-001. However, you are 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 a Notice of Violation, EA 04-219" 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 the violation, you should 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.

If you choose to respond, your response will be made available electronically for public inspection in the NRC Public Document Room or from the NRC's document system (ADAMS), which is accessible from the NRC Web site at the Public NRC Library. Therefore, to the extent possible, the response should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the Public without redaction.

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

Dated this 21st day of December 2004