EA-02-105 - Veterans Health Administration

July 30, 2002

EA-02-105

Lynn McGuire, Director
National Health Physics Program (115HP/NLR)
Department of Veterans Affairs
Veterans Health Administration
2200 Fort Roots Drive
North Little Rock, AR 72114

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY -$6,000 (NRC SPECIAL INSPECTION REPORT NO. 03002267/2002-001(DNMS) (V.A. MEDICAL CENTER, ST. LOUIS, MISSOURI)

Dear Mr. McGuire:

This refers to the inspection conducted on May 2, 2002, at the V.A. Medical Center in St. Louis, Missouri. The purpose of the inspection was to review the circumstances surrounding two events involving disposal of licensed radioactive material to a non-radioactive trash landfill. The results of the inspection identified two apparent violations involving the failure to dispose of radioactive material properly and to provide immediate notification to the NRC, once the inappropriate disposal was identified. The apparent violations were described in our inspection report transmitted to you in a May 24, 2002, letter. On June 18, 2002, a predecisional enforcement conference was conducted in the Region III office with you, Mr. Peter McBrady, Associate Director, V.A. Medical Center in St. Louis, and members of your respective staffs to discuss the apparent violations, their significance, their root causes, and your corrective actions.

Based on the information developed during the inspection and the information that you provided during the conference, the NRC has determined that violations of NRC requirements occurred. These violations are cited in the enclosed Notice of Violation and the circumstances surrounding them are described in detail in the subject inspection report. On two occasions in March 2002, V.A. Medical Center staff placed radioactive waste in a normal trash receptacle rather than a specially designated container, resulting in unauthorized disposal of licensed material to non-radioactive trash. On March 18 and 29, 2002, the Illinois Department of Nuclear Safety informed the NRC of the events and the NRC notified your staff. On April 11, 2002, the V.A. Medical Center staff determined that one of these disposals contained approximately 2 millicuries of iodine-131, 2000 times the quantity specified in Appendix C to 10 CFR Part 20. However, after determining the quantity of iodine-131 disposed, the V.A. Medical Center staff failed to notify the NRC Operations Center as required by 10 CFR 20.2201 until requested to do so by NRC staff on April 30, 2002.

While the amount of radioactive material was small, and calculations indicate that significant exposure to the public from the improper disposal was unlikely, this violation, nonetheless, represents a regulatory concern because it involved the improper disposal of radioactive material. The improper disposal of radioactive material is a significant safety concern because of the potential for inadvertent and unnecessary exposures to employees and members of the public. Additionally, the V.A. Medical Center was cited in December 2001, for unauthorized disposal of a small quantity of sulfur-35. Although the circumstances were different and corrective actions implemented for that violation would not have prevented the March disposals, the NRC is concerned that there have been three unauthorized disposals in the past year. Finally, the NRC depends on timely reporting of events in order to respond effectively when required. Therefore, these violations are categorized collectively in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, as a Severity Level III problem.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $3,000 is considered for a Severity Level III problem. Because your facility has been the subject of escalated enforcement actions within the last two years,⁽¹⁾ the NRC considered whether credit was warranted for Identification and Corrective Action in accordance with the civil penalty assessment process in Section VI.C.2 of the Enforcement Policy. Credit for identification is not warranted, since the improper disposal resulted in the landfill facility contacting the Illinois Department of Nuclear Safety who in turn informed the NRC of the event. Credit for corrective actions is not warranted because your actions were not comprehensive in that they were narrowly focused on the lab where the waste was generated and did not include other locations of use listed on your license. In addition, your corrective actions excluded users of pure beta- emitting radionuclides.

Therefore, to emphasize the importance of timely and proper notification, and of prompt identification and comprehensive correction of violations, and in recognition of your previous escalated enforcement action, I have been authorized, after consultation with the Director, Office of Enforcement, to issue the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice) in the amount of $6,000, twice the base amount of $3,000, for the Severity Level III problem. In addition, issuance of this Notice constitutes escalated enforcement action, that may subject you to increased inspection effort.

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.

In accordance with 10 CFR 2.790 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.

		Sincerely,
		/RA/
		J. E. Dyer Regional Administrator

Docket No. 030-02267
License No. 24-00144-05

Enclosures:
1. Notice of Violation and Proposed Imposition of Civil Penalty
2. NUREG/BR-0254 Payment Methods (Licensee only)

cc w/encl 1:
Linda Kurz, Director
V.A. Medical Center - St. Louis

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NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

V.A. Medical Center St. Louis, Missouri

Docket No. 030-02267 License No. 24-00144-05 EA-02-105

During an NRC inspection conducted on May 2, 2002, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the NRC proposes to impose a civil penalty pursuant to Section 234 of the Atomic Energy Act of 1954, as amended (Act), 42 U.S.C. 2282, and 10 CFR 2.205. The particular violations and associated civil penalty are set forth below:

A.

10 CFR 20.2001(a) requires that the licensee dispose of licensed material only by transfer to an authorized recipient; by decay in storage; by release in effluents within the limits in 10 CFR 20.1301; or as authorized by the NRC. Condition 26 of License No. 24-00144-05 requires, in part, that the licensee conduct its program in accordance with the statements, representations, and procedures contained in the letter dated July 22, 1997 (excluding the licensee's Quality Management Program). Item 11.2.G of the letter dated July 22, 1997, requires that radioactive waste be disposed only in specially designated containers. Contrary to the above, on or about March 14 and 28, 2002, the licensee disposed of licensed material by a method not authorized by 10 CFR 20.2001 or License Condition 26. Specifically, the licensee used a regular waste container to dispose of approximately 150 microcuries of technetium-99m and 2 millicuries of iodine-131, resulting in release to the non-radioactive trash.

B.

10 CFR 20.2201 (a)(1)(i) requires, in part, that each licensee report by telephone to the NRC, immediately after its occurrence becomes known, any lost, stolen, or missing licensed material in an aggregate quantity equal to or greater than 1,000 times the quantity specified in Appendix C to 10 CFR Part 20, under such circumstances that it appears to the licensee that an exposure could result to persons in unrestricted areas. Contrary to the above, the licensee did not immediately report to the NRC the loss of licensed material in an aggregate quantity greater than 1,000 times the quantity specified in Appendix C to 10 CFR Part 20 that could result in an exposure to persons in unrestricted areas. Specifically, on April 11, 2002, the licensee discovered that approximately 2 millicuries of iodine-131 was lost by disposal to non-radioactive trash with resulting exposures to persons in unrestricted areas, and did not report the loss to the NRC until April 30, 2002.

This is a Severity Level III problem (Supplement IV).
Civil Penalty - $6,000.

Pursuant to the provisions of 10 CFR 2.201, V.A. Medical Center (Licensee) is hereby required to submit a written statement or explanation to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, within 30 days of the date of this Notice of Violation and Proposed Imposition of Civil Penalty (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation" and should include for each alleged violation: (1) admission or denial of the alleged violation, (2) the reasons for the violation if admitted, and if denied, the reasons why, (3) the corrective steps that have been taken and the results achieved, (4) the corrective steps that will be taken to avoid further violations, and (5) the date when full compliance will be achieved. Your response may reference or include previous docketed correspondence, if the correspondence adequately addresses the required response. If an adequate reply is not received within the time specified in this Notice, an order or a Demand for Information may be issued as to why the license should not be modified, suspended, or revoked or why such other action as may be proper should not be taken. Consideration may be given to extending the response time for good cause shown.

Within the same time as provided for the response required above under 10 CFR 2.201, the Licensee may pay the civil penalty proposed above or the cumulative amount of the civil penalties if more than one civil penalty is proposed, in accordance with NUREG/BR-0254 and by submitting to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, a statement indicating when and by what method payment was made, or may protest imposition of the civil penalty in whole or in part, by a written answer addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission. Should the Licensee fail to answer within 30 days of the date of this Notice of Violation and Proposed Imposition of Civil Penalty, an order imposing the civil penalty will be issued. Should the Licensee elect to file an answer in accordance with 10 CFR 2.205 protesting the civil penalty, in whole or in part, such answer should be clearly marked as an "Answer to a Notice of Violation" and may: (1) deny the violations listed in this Notice, in whole or in part, (2) demonstrate extenuating circumstances, (3) show error in this Notice, or (4) show other reasons why the penalty should not be imposed. In addition to protesting the civil penalty in whole or in part, such answer may request remission or mitigation of the penalty.

In requesting mitigation of the proposed penalty, the factors addressed in Section VI.C.2 of the Enforcement Policy should be addressed. Any written answer in accordance with 10 CFR 2.205 should be set forth separately from the statement or explanation in reply pursuant to 10 CFR 2.201, but may incorporate parts of the 10 CFR 2.201 reply by specific reference (e.g., citing page and paragraph numbers) to avoid repetition. The attention of the Licensee is directed to the other provisions of 10 CFR 2.205, regarding the procedure for imposing a civil penalty.

Upon failure to pay any civil penalty due which subsequently has been determined in accordance with the applicable provisions of 10 CFR 2.205, this matter may be referred to the Attorney General, and the penalty, unless compromised, remitted, or mitigated, may be collected by civil action pursuant to Section 234c of the Act, 42 U.S.C. 2282c.

The response noted above (Reply to Notice of Violation, statement as to payment of civil penalty, and Answer to a Notice of Violation) should be addressed to: Frank J. Congel, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North, 11555 Rockville Pike, Rockville, MD 20852-2738, with a copy to the Regional Administrator, U.S. Nuclear Regulatory Commission, Region III, 801 Warrenville Road, Suite 255, Lisle, IL 60532-4351.

Because 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 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). If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.

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

Dated this 30^th day of July 2002.

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^1. A Severity Level III violation was issued on December 28, 2001 (EA-01-312).