EA-97-067 - Dana-Farber Cancer Institute

March 28, 1997

EA 97-067

Mr. William M. Corbett, Jr.
Director, Research Administration
Dana-Farber Cancer Institute
44 Binney Street
Boston, Massachusetts 02115

SUBJECT:

NOTICE OF VIOLATION AND NRC CLOSURE OF CONFIRMATORY ACTION LETTER 1-97-003 (NRC Inspection Report No. 030-20020/97-001)

Dear Mr. Corbett:

This refers to the NRC inspection conducted on January 30-31, 1997, at your facility in Boston, Massachusetts. The purpose of the inspection was to determine whether activities authorized by the licenses were conducted safely and in accordance with NRC requirements. At the conclusion of the inspection, the findings were discussed with you and the members of your staff identified in the Inspection Report. During the inspection, an apparent violation of NRC requirements was identified. The apparent violation was described in a Confirmatory Action Letter sent to you on February 4, 1997, as well as in the NRC inspection report transmitted with our letter, dated February 27, 1997. In the February 27, 1997 letter, the NRC provided you an opportunity to either respond in writing to the apparent violation addressed in the inspection report or request a predecisional enforcement conference. You responded to the apparent violation in a letter to the NRC, dated March 19, 1997.

Based on the information developed during the inspection and the information you provided in your March 19, 1997 response, 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. The violation involves examples of failure to secure licensed radioactive material or limit access to the material at the facilities. Specifically, millicurie quantities of phosphorus-32 and sulfur-35 were located in posted laboratories (Rooms 605, 607, 626, and D11646). These laboratories are unrestricted areas, and at the time, access to the material was not limited and your staff did not control nor maintain constant surveillance of this licensed material.

This violation represents a significant regulatory concern because the failure to maintain appropriate security of material could result in the material being lost or stolen, and also has the potential to cause exposures to members of your staff as well as members of the public. The violation is classified 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 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 were both prompt and comprehensive. These actions, which were described in your March 19, 1997 letter, included, but were not limited to: (1) issuance by the Radiation Safety Officer (RSO) of an electronic mail message on February 4, 1997, to all permit holders requiring attendance at a mandatory meeting set for February 13, 1997 at which the violation and corrective actions were discussed; (2) requiring all permit holders to submit plans, by February 21, 1997, for enhanced security over radioactive materials; (4) ordering 85 acrylic lock-boxes to assist the permit holders with securing material; and (4) plans for the RSO to use random tours of the facility, including weekdays, evenings, weekends and holidays to assure compliance.

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 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 March 19, 1997 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.

Also, because regulatory responsibility for your license was transferred from the NRC to the Commonwealth of Massachusetts on March 21, 1997, the NRC will turn over to the Commonwealth responsibility for following-up on your corrective actions and tracking completion of the CAL actions effective March 21, 1997. From this date forward, all correspondence related to the CAL and other aspects of your program should be sent to the Director, Radiation Control Program, Department of Public Health, 305 South Street, Jamaica Plain, Massachusetts 02130.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosure, and any response, if you choose to provide one, and your March 12, 1997 letter, will be placed in the NRC Public Document Room (PDR).

Sincerely,

Hubert J. Miller Regional Administrator

Docket No.: 030-20020
License No.: 20-19761-02

Enclosure: Notice of Violation

cc w/encl:
Commonwealth of Massachusetts

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NOTICE OF VIOLATION

Dana-Farber Cancer Institute Boston, Massachusetts

Docket No. 030-20020 License No. 20-19761-02 EA 97-067

During an NRC inspection conducted on January 30 and 31, 1997, a violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," 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, unrestricted area means an area, access to which is neither limited nor controlled by the licensee.

Contrary to the above, on January 30, 1997, the licensee did not secure from unauthorized removal or limit to access millicurie quantities of sulfur- 35 and phosphorus-32 located in posted laboratories (Rooms 605, 627, 626 and D1646), unrestricted areas, nor did the licensee control and maintain constant surveillance of this licensed material. (01013)

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

The NRC has concluded that information regarding the reason for the violation, and the corrective actions taken and planned to correct the violation and prevent recurrence, is already adequately addressed on the docket in the licensee's March 19, 1997 letter in response to the NRC letter dated February 27, 1997. However, you are required to respond to the provisions of 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," 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 I, within 30 days of the date of the letter transmitting this Notice of Violation (Notice).

Dated at King of Prussia, Pennsylvania
this 28th day of March 1997