EA-01-001 - National Institutes of Health
January 17, 2001
Michael M. Gottesman, M.D.
Deputy Director for Intramural Research
National Institutes of Health
NIH Building 1, Room 114
9000 Rockville Pike
Bethesda, MD 20892
|SUBJECT:||NOTICE OF VIOLATION (NRC Inspection Report No. 030-01786/00-003)|
Dear Dr. Gottesman:
This refers to the NRC inspection, conducted on December 11 - 14, 2000, at the National Institutes of Health (NIH) facility in Bethesda, Maryland. The inspection was performed to review the circumstances associated with a contamination incident at the facility that resulted in an unplanned exposure to a minor who was a student working at NIH as an intern. This incident resulted in a substantial potential for overexposure to the student. The findings of the inspection were discussed with Dr. Philip Chen, Dr. Lance Liotta, Mr. Robert Zoon, and others from your organization at the conclusion of the inspection.
In a telephone conversation on January 8, 2001, Mr. Zoon informed Mr. J. Dwyer and Ms. T. Darden of my staff that NIH did not believe a predecisional enforcement conference was needed to discuss this matter, nor did he believe that NIH needed to provide any additional information prior to the NRC deciding on appropriate enforcement action.
The contamination incident, which is fully described in the attached Inspection Report, occurred after a radioactive material spill of approximately 250 microcuries of phosphorous-32 on August 8, 2000. The NRC is concerned because the student did not monitor herself, or the work area, for contamination after the incident and the incident was not identified until the following day. In addition, other personnel, including the student's supervisor, did not perform adequate surveys necessary for the timely identification of the skin contamination and assessment of the student's skin dose. As a result, the student left the facility at the end of the day without a survey of the contamination to her hair, clothing and skin. Subsequent dose assessments indicated that the highest skin dose was approximately 2 rem to the student's extremity (wrist). However, the student's skin dose could have been substantially higher if the student had not showered at home on the same day as the incident. As a result, although the regulatory limit was not exceeded in this case, a substantial potential for an overexposure existed.
Based on the information developed during the inspection, one violation of NRC requirements is being cited. The violation is described in the enclosed Notice of Violation (Notice) and involves the failure to complete surveys that were necessary for compliance with the regulations. Although the NRC determined that this incident appeared to be an isolated occurrence, which you identified and for which you took appropriate corrective action, this violation was significant because it created a substantial potential for an overexposure to the skin of the individual. Therefore, this violation 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 current Enforcement Policy is included on the NRC's website at www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html.
In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level III violation or problem. Because your facility has not been the subject of an 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.B.2 of the Enforcement Policy. Credit for corrective actions is warranted because your corrective actions, at the time of the inspection, were considered prompt and comprehensive. These actions include, but are not limited to: (1) the suspension of radioactive material use by researchers, and the supervisors of these researchers, responsible for the contamination event until the corrective actions were completed and training was provided; (2) reinforcement of the requirement to perform surveys after handling radioactive materials; (3) implementation of a prohibition on the use of radioactive materials by minors under the age of sixteen; (4) implementation of a general restriction on the use of radioactive materials by minors aged sixteen and seventeen unless approved by the Radiation Safety Officer; (5) implementation of a general requirement for direct supervision of all radioactive material use by minors; (6) implementation of a prohibition against the handling of concentrated sources of radioactive material by minors; and (7) reinforcement of the requirement to wear a lab coat when handling radioactive materials.
Therefore, to encourage prompt and comprehensive correction of violations, I have been authorized to not propose a civil penalty in this case. However, similar violations in the future could result in further escalated enforcement action. In addition, issuance of this Notice constitutes escalated enforcement action that may subject you to increased inspection effort.
A second finding was noted during the inspection regarding the failure of the student to wear a lab coat while working with radioactive materials. This finding was identified by your staff and corrected through remedial training. This non-repetitive, non-willful, licensee-identified and corrected violation is being treated as a non-cited violation consistent with Section VI.A of the NRC Enforcement Policy.
The NRC has concluded that information regarding the reason for the violations, and the corrective actions taken and planned to correct the violations and prevent recurrence, were already described adequately during the inspection and are adequately addressed on the docket in this 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.
Should you have any questions, please contact Dr. Mohamed Shanbaky at (610) 337-5209.
In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter and your response (if you are providing one at this point) 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 http://www.nrc.gov/reading-rm/adams.html (the Public NRC Library). 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.
|/RA/ James T. Wiggins Acting For
|Hubert J. Miller
Docket No. 030-01786
License No. 19-00296-10
Enclosure: Notice of Violation
State of Maryland
|National Institues of Health
|Docket No. 030-01786
License No. 19-00296-10
During an NRC inspection conducted on December 11 - 14, 2000, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG -1600, one violation is listed below:
10 CFR 20.1501(a) requires, in part, that each licensee make or cause to be made surveys that may be necessary to comply with the regulations and are reasonable under the circumstances to evaluate the magnitude and extent of radiation levels, and concentrations or quantities of radioactive material, and the potential radiological hazards. 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.
Item 9.0 of the Licensee's application dated April 26, 1995, Section 9.2, requires, in part, that in radionuclide areas, individuals are required to monitor their work areas for contamination daily if they have used radioactive materials.
Contrary to the above, on August 8, 2000, the licensee did not make surveys that were necessary to assure compliance with 10 CFR 20.1207 and 10 CFR 20.1201 (a)2(ii) which limit radiation exposure to the skin of a minor to 5 rem. Specifically, a minor student/researcher did not monitor herself or the work area for contamination after a radioactive material spill of approximately 250 microcuries of P-32. In addition, other personnel, including the student's supervisor, did not perform adequate surveys necessary for the timely identification of skin contamination and assessment of the student's skin dose. As a result, the student's skin became contaminated for a longer period of time and she received a skin dose of approximately 2 rem to one extremity (wrist). The student's skin dose could have been substantially higher if the student had not taken a shower at home on the same day as the incident, essentially reducing the amount of P-32 on her skin.
This is a Severity Level III violation (Supplements IV and VI).
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 were adequately described during inspection, and are already adequately addressed on the docket in the NRC inspection report and in the attached letter. 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, 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, with the basis for your denial, to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 20555-0001.
If you choose to respond, 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). To the extent possible, it should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the public without redaction. ADAMS is accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html (the Public NRC Library). If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, you must specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information).
In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.
Dated this 17th day of January 2001