EA-96-068 - Harvard University

April 18, 1996

EA 96-068

Mr. Thomas E. Vautin, E.B.S.
Associate Vice President for Facilities
and Environmental Services
Harvard University
1350 Massachusetts Avenue, Room 871
Cambridge, Massachusetts 02138

SUBJECT:

NOTICE OF VIOLATION (NRC INSPECTION REPORT NO. 030-00753/96-001)

Dear Mr. Vautin:

This letter refers to the NRC inspection conducted on February 12-16, 1996, at your facilities in Cambridge, Boston (Longwood area) and Southborough, Massachusetts, of activities authorized by NRC License No. 20-00297-53. The exit meeting for the inspection was held on February 16, 1996. During the inspection, seven apparent violations of NRC requirements were identified. A copy of the NRC inspection report was sent to you on March 12, 1996. On April 2, 1996, a predecisional enforcement conference was conducted with you and other members of your staff to discuss the apparent violations, their causes, and your corrective actions. A copy of the Enforcement Conference Report was issued on April 10, 1996.

Based on the information developed during the inspection, information provided in your response dated March 1, 1996, to the Confirmatory Action Letter (CAL) issued on February 16, 1996, and information provided during the conference, the NRC has determined that six 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 described in the enclosed Notice is the most significant violation, your staff failed to secure from unauthorized removal, or limit access to, licensed material in several laboratories at your facility, nor did your staff maintain control or surveillance of this licensed material.

The NRC is concerned because the failure to maintain control and surveillance of radioactive materials could result in the material being lost or stolen, or could result in unnecessary radiation exposure to, or contamination of, individuals. The NRC also is concerned because the violation involved several examples of failure to secure, or to maintain under constant surveillance, licensed material that was in unrestricted areas. Of particular concern was a vial containing 50 millicuries of phosphorus-32 which was stored in an unsecured freezer in an unlocked laboratory, and was not under constant surveillance. This violation constitutes a significant regulatory concern and is categorized at Severity Level III in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions," (Enforcement Policy) NUREG-1600. The violation demonstrates the importance of increased attention to this aspect of your radiation safety program to ensure that regulatory requirements are understood and followed, and your activities are conducted safely and in accordance with those requirements.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,500 is considered for this Severity Level III violation. Because your facility has not been the subject of escalated enforcement in the past two inspections, 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 was warranted for your prompt and comprehensive corrective actions taken in response to the inspection findings. Your corrective actions, which were described in the CAL, your letters dated March 1, 1996 and April 5, 1996, included, but were not limited to: (1) immediate institution of appropriate controls to ensure security of licensed material in the facilities of Harvard University, especially in the laboratories where lack of security was identified during the current NRC inspection, including notification of all users of licensed material at Harvard University of the NRC security requirements and to assure that all stock solutions are locked in containers when not in use and to lock all unoccupied laboratories; (2) performance of an assessment of the status of security of licensed material possessed and used under the Harvard University licenses, and development and distribution of specific written minimum security requirements to be implemented at the facilities authorized by the Harvard University licenses; (3) assurance that routine radiation survey procedures of Harvard University laboratories where licensed materials are used or stored include an evaluation of the security of licensed materials, including a review by the Environmental Health and Safety Radiation Protection staff of the revised security requirements and of the radiation survey procedures with those individuals responsible for implementing the radiation survey procedures; and (4) plans to conduct by April 12, 1996, an audit of a representative sample of laboratories where licensed materials are used to determine the status of security of licensed materials.

Therefore, to encourage prompt and comprehensive correction of violations, and in recognition of the absence of previous escalated enforcement action, I have been authorized not to propose a civil penalty in this case. However, any similar violations in the future could result in more significant escalated enforcement action, including issuance of a civil penalty.

In addition to the violations, nine weaknesses in your program also were identified during the inspection. At the predecisional enforcement conference you specified that procedures were in place at the time of the inspection that would have addressed some of the areas identified; however, these procedures had not been implemented by users and were not surveyed by Radiation Protection Office staff. Corrective actions for some weaknesses have not yet been instituted, but you indicated that you have plans to address them promptly. We are concerned that the violations of NRC requirements along with these weaknesses indicate that there has been a general relaxation in implementation of your radiation safety program. These weaknesses will be examined during future inspections.

The NRC has concluded that information regarding the reasons for the violations, and the corrective actions taken and planned to correct these violations and prevent recurrence and the date when full compliance will be achieved is already addressed on the docket in your March 1, 1996 letter and your letter dated April 5, 1996. Therefore, unless the description therein does not accurately reflect your corrective actions or your position, you are not required to respond to this letter. 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 any additional response will be placed in the NRC Public Document Room (PDR). To the extent possible, your response should not include any personal privacy, proprietary, or safeguards information, so that it can be placed in the PDR without redaction.

Sincerely,

Thomas T. Martin Regional Administrator

Docket No. 030-00753
License No. 20-00297-53

Enclosure: Notice of Violation

c w/encl:
Jacob Shapiro, Ph.D, Radiation Protection Officer
Bertha Madras, Ph.D., Chairperson, Radiation Safety Committee
Commonwealth of Massachusetts

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NOTICE OF VIOLATION

Harvard University Cambridge, Massachusetts

Docket No. 030-00753 License No. 20-00297-53 EA 96-068

During an NRC inspection conducted on February 12-16, 1996, a violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure 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 restriced area but inside the site boundary, access to which can be limited by the licensee for any reason; unrestricted area means an area, access to which is neither limited nor controlled by the licensee.

Contrary to the above, between February 14-16, 1996, the licensee did not secure from unauthorized removal or limit access to licensed material stored in several laboratory areas which were unrestricted areas nor did the licensee control and maintain constant surveillance of this licensed material. For example, one area (located at the Longwood Area Campus) housed an unopened 50 millicurie stock vial of phosphorus-32, and seven other vials containing between 0.25 to 5 millicuries of phosphorus-32 and sulfur-35. A second area (located in Cambridge) housed approximately 20 millicuries of hydrogen-3 and approximately 0.5 millicuries of phosphorus-32. A third area (located in Cambridge) housed approximately 5 microcuries of phosphorus-32 and less than 200 microcuries of sulfur-35. (01013)

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

B. 10 CFR 20.2001(a) requires that the licensee dispose of licensed material only by certain specified procedures.

Contrary to the above, between June 23-24, 1994, the licensee disposed of 1 millicurie of sulfur-35 by release to the non-radioactive trash, a method not authorized by ?20.2001. (02014)

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

C. 10 CFR 20.1501(a) requires that each licensee make or cause to be made surveys that may be necessary for the licensee to comply with the regulations in Part 20 and that are reasonable under the circumstances to evaluate the extent of radiation levels, concentrations or quantities of radioactive material, and the potential radiological hazards that could be present.

Pursuant to 10 CFR 20.1003, survey means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of radioactive material or other sources of radiation.

Contrary to the above, as of February 16, 1996, the licensee did not make surveys to assure compliance with 10 CFR 20.2003(a)(1), which limits the disposal of licensed material into the sanitary sewerage to material that is readily soluble (or readily dispersible biological material) in water. Specifically, the licensee routinely disposed of licensed material into the sanitary sewerage, but had not determined whether the material discharged was readily soluble (or readily dispersible biological material) in water. (03014)

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

D. Condition 23 of License No. 20-00297-53 requires, in part, that the licensee shall conduct its program in accordance with statements, representations, and procedures contained in a letter dated November 30, 1989 with enclosed application.

1. Item 10, subitem 2 of the application states, in part, that the Radiation Safety Committee is responsible for investigating all proposals for radionuclide use and conditions of use. Item 10, subitem 4.5 of the application states, in part, that radioactive materials use applicants will be instructed to complete an application that includes listing training and experience.

Contrary to the above, as of February 16, 1996, the Radiation Safety Committee did not investigate all proposals for radionuclide use and conditions of use in that, the Committee did not review the applicant's training and experience. The Committee relied, instead, on the recommendations of Radiation Protection Office staff rather that a review of the application that included training and experience. (04014)

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

2. Item 10, subitem 3 of the application states, in part, that the Radiation Protection Officer is responsible for investigating all proposals for radionuclide use and conditions of use and giving provisional approval to satisfactory proposals.

Contrary to the above, as of February 16, 1996, the Radiation Protection Officer was not responsible for investigating all proposals for radionuclide use and giving provisional approval to satisfactory proposals. Specifically, new proposal applications were routinely reviewed and provisionally approved by the Radiation Protection Office staff and not the Radiation Protection Officer. (05014)

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

3. Item 10, subitem 3 of the application requires, in part, that the Radiation Protection Officer conduct a semiannual inventory of all radionuclides at the institution.

Contrary to the above, as of February 16, 1996, the Radiation Protection Officer did not conduct a semiannual inventory of all radionuclides at the institution. Specifically, while the Radiation Protection Officer collected data on the quantities of radionuclides from several hundred authorized users and tabulated radionuclides in waste semiannually, the Radiation Protection Officer did not sum the individual quantities. (06014)

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

The NRC has concluded that information regarding the reasons for the violations, and the corrective actions taken and planned to correct the violations and prevent recurrence and the date when full compliance will be achieved is already adequately addressed on the docket in your March 1, 1996 letter and your letter dated April 5, 1996. 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," 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, 475 Allendale Road, King of Prussia, Pennsylvania 19406, 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, this response shall be submitted under oath or affirmation.

Because your response will be placed in the NRC Public Document Room (PDR), 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. However, if you find it necessary to include such information, you should clearly indicate the specific information that you desire not to be placed in the PDR, and provide the legal basis to support your request for witholding the information from the public.

Dated at King of Prussia, Pennsylvania
this 18th day of April 1996