EA-97-080 - Health & Human Services, Department of

March 20, 1997

EA 97-080

Elizabeth D. Jacobson, Ph.D.
Deputy Director for Science
Center for Devices and Radiological Health (HFZ-2)
9200 Corporate Boulevard
Rockville, Maryland 20850-4030

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report No. 030-04544/97-001)

Dear Dr. Jacobson:

This refers to the NRC inspection conducted on January 6-7 and 21, 1997, at several of your facilities in Rockville, Maryland, for which an exit meeting was held with you and members of your staff on February 6, 1997. The inspection was conducted to determine whether activities authorized by the license were conducted safely and in accordance with NRC requirements. During the inspection, seven apparent violations of NRC requirements were identified, as described in the NRC inspection report transmitted with our letter, dated February 21, 1997. In the February 21, 1997 letter, the NRC provided you an opportunity to either respond in writing to the apparent violations addressed in the inspection report or request a predecisional enforcement conference. You responded to the apparent violations, in a letter to the NRC, dated March 12, 1997.

Based on the information developed during the inspection and the information you provided in your March 12, 1997 response, 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. The violations involve (1) failure of the Radiation Safety Committee (RSC) to meet on a scheduled basis at intervals not exceeding 3-months; (2) failure of the Radiation Safety Officer (RSO) to conduct an annual audit of each approved project; (3) failure to review the radiation protection program content and implementation at least annually; (4) failure to conduct fixed and removable contamination surveys at least once each month in laboratories where radionuclides are used; (5) failure to provide one hour of annual training to each individual working with radioactive material; (6) failure to conduct a physical inventory every six months to account for all sealed sources and devices containing licensed material; and (7) failure to label each container of licensed material with the required caution label.

These violations indicate a significant lack of attention to licensed activities by the RSO and the Radiation Safety Committee (RSC). In fact, some of the violations that occurred were the direct responsibility of the RSO or RSC. Management attention to the radiation safety program is warranted to ensure that licensed activities are conducted safely and in accordance with requirements. While the violations in question did not have an impact on the health and safety of the public, or your staff, such violations are potential precursors to more serious problems, and therefore, it is important that the RSO and RSC actively look for, identify, and correct such problems. At your facility, this did not occur. Therefore, these violations have been classified in the aggregate as a Severity level III problem 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 12, 1997 letter, and/or during the inspection, included, but were not limited to: (1) scheduling the RSC meetings for the remainder of 1997; (2) conduct of audits of all ten of your approved projects which were completed by February 28, 1997; (3) conduct of a training session with staff on February 4, 1997, and February 20, 1997, with plans for annual training thereafter; (4) plans to have the RSO provide a written report regarding inventory findings during to the RSC during the second and fourth quarterly meetings; and (5) appropriately labeling of containers that had not been labelled, and covering the need for such labelling during the February 4, 1997 training session.

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 12, 1996 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 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,

ORIGINAL SIGNED BY WILLIAM L. AXELSON for Hubert J. Miller Regional Administrator

Docket No.: 030-04544
License No.: 19-07538-01

Enclosure: Notice of Violation

cc w/encl:
Edward S. Tupin, RSO
State of Maryland

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NOTICE OF VIOLATION

Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Rockville, Maryland

Docket No. 030-04544 License No. 19-07538-01 EA 97-080

During an NRC inspection conducted on January 6-7 and 21, 1997, at various of your facilities in Rockville, Maryland, for which an exit meeting was held on February 6, 1997, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy) NUREG-1600, the violations are listed below:

A. Condition 22 of License No. 19-07538-01 requires that licensed material be possessed and used in accordance with the statements, representations, and procedures contained in a letter, dated November 2, 1994.

1. Enclosure 1 of the November 2, 1994 letter states that the radiation safety committee shall meet on a scheduled basis not exceeding 3-month intervals.

   Contrary to the above, the radiation safety committee did not meet on a scheduled basis not exceeding 3-month intervals. Specifically, during calendar year 1996, the radiation safety committee did not meet between March 29 and October 2, an interval exceeding 3 months. (01013)

1. Item 5.b on page 2 of the November 2, 1994 letter states that an audit of each approved project and the individuals working on that project will be conducted annually by the RSO or his designee. The audit will include, but not be limited to: inventory records, user survey records, evaluation of training needs, independent work area surveys, and authorization terms compliance.

   Contrary to the above, in 1995 and 1996, the RSO did not conduct an audit of each approved project, and the individuals working on that project. (01023)

2. Enclosure 7 of the November 2, 1994 letter states that each laboratory should be surveyed for fixed and removable contamination at least once each month in which radionuclides are used by the radiation users in that laboratory.

   Contrary to the above, on several occasions in 1995 and 1996, surveys for fixed and removable contamination were not performed at least once each month for certain laboratories in which radionuclides were used by the radiation users. Specifically, radionuclides were used at the 12709 Twinbrook facility in Room 23 in September, October, and December 1996; in Room 37 in November 1996; and in Room 4C in March, July, September, November 1995 and February 1996 and contamination wipe surveys were not performed during those months. (01033)

3. Enclosure 3 of the November 2, 1994 letter, Item 2.b, states that each individual working with radioactive materials is expected to receive at least one hour of continuing education each year. This may be met through attending short courses, seminars, briefings or topical presentations, on subjects relevant to radiation safety, given by the RSO or other individuals knowledgeable in radiation safety.

Contrary to the above, in 1995 and 1996, individuals working with radioactive material did not receive at least one hour of continuing education. Specifically, short courses, seminars, briefings or topical presentations, on subjects relevant to radiation safety, were not given by the RSO or other individuals knowledgeable in radiation safety in 1995 and 1996. (01043)

B. 10 CFR 20.1101(c) requires that the licensee shall periodically (at least annually) review the radiation protection program content and implementation.

Contrary to the above, as of January 21, 1997, the licensee did not review the radiation protection program content and implementation at least annually. Specifically, a review of the radiation protection program content and implementation for 1995 had not been completed at the time of the inspection. (01053)

C. Condition 15 of License No. 19-07538-01 requires that the licensee conduct a physical inventory every six months to account for all sealed sources and devices containing licensed material received and possessed under the license.

Contrary to the above, in 1995 and 1996, physical inventories were not conducted to account for all sealed sources and devices containing licensed material. (01063)

D. 10 CFR 20.1904(a) requires the licensee to ensure that each container of licensed material bears a durable, clearly visible label bearing the words "CAUTION, RADIOACTIVE MATERIAL," or "DANGER, RADIOACTIVE MATERIAL." The label must also provide sufficient information (such as the radionuclide(s) present, an estimate of the quantity of radioactivity, the date for which the activity is estimated, etc.) to permit individuals handling or using the containers, or working in the vicinity of the containers, to take precautions to avoid or minimize exposures.

Contrary to the above, as of January 21, 1997, six containers of liquid licensed material stored in the radioactive waste storage area did not bear labels that identified the radionuclides or the quantity of radioactivity, and an additional container of liquid waste did not identify the radionuclide, nor did these containers otherwise bear sufficient information to permit individuals handling or using the container, or working in the vicinity of the containers, to take precautions to avoid or minimize exposure. (01073)

These violations are classified in the aggregate as a Severity Level III problem. (Supplements IV and VI)

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 the licensee's March 12, 1997 letter in response to Inspection Report No. 30-04544/97-01. 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 1, within 30 days of the date of the letter transmitting this Notice of Violation (Notice).

Dated at King of Prussia, Pennsylvania
this 20th day of March 1997