Alfred C. Burris, Senior, M.D. (Dr. Burris) is a self-employed cardiologist, who is licensed to practice medicine in the State of Maryland and the District of Columbia. Dr. Burris submitted an application for an NRC license dated February 2, 2004, to authorize use of byproduct material for diagnostic nuclear medicine.
An investigation was initiated by the NRC Office of Investigations (OI) on May 24, 2004, (OI Case No. 1-2004-028) to determine if Dr. Burris submitted inaccurate and/or misleading information to the NRC in his NRC application to be the sole authorized user (AU) as well as the Radiation Safety Officer (RSO) on a license for use of byproduct material for medical imaging and diagnostic purposes. During the course of this investigation, OI identified that an NRC licensee, a mobile cardiac imaging company, may have provided the same inaccurate information in support of their amendment request to add Dr. Burris and another physician to its NRC materials license as Authorized Users. On August 6, 2004, OI initiated a separate investigation (OI Case No. 1-2004-034) to determine if Dr. Burris submitted false information to an NRC Start Printed Page 6099licensee to become an AU on their existing NRC license. Based on the evidence developed during its investigations, OI concluded that Dr. Burris deliberately submitted false and/or inaccurate information (1) to the NRC as an applicant for an NRC license and (2) to an NRC licensee with the purpose to become an AU on their existing NRC license. The results of the two investigations were completed by OI on April 15, 2005 and June 15, 2005, and were sent to Dr. Burris in two letters dated September 15, 2005.
Subsequent to becoming aware of the details of the apparent violation, Dr. Burris took several prompt actions to assure that these events would not recur. These actions included: (a) Correcting inaccurate information for the record in a letter dated July 26, 2004; (b) providing details of the violation to associates in the process of getting character references; (c) supplementing his work experience in May 2004, when he began working with the nuclear medicine technologists at Greater Southeast Community Hospital; and (d) undertaking efforts to better understand regulatory requirements through self study and review of his consultant's letter of May 4, 2004.
In response to the NRC's September 15, 2005 letters, Dr. Burris requested the use of Alternative Dispute Resolution (ADR) to resolve this apparent violation and pending enforcement action. ADR is a process in which a neutral mediator, with no decision-making authority, assists the NRC and the individual to resolve any disagreements on whether a violation occurred, the appropriate enforcement action, and the appropriate corrective actions. An ADR session was held between Dr. Burris and the NRC in Rockville, MD, on December 1, 2005, and was mediated by a professional mediator, arranged through Cornell University's Institute of Conflict Management. During that ADR session, a settlement agreement was reached. The elements of the settlement agreement consisted of the following:
1. Dr. Burris agreed that he was in violation of NRC requirements when, in an application for a new NRC license, dated February 2, 2004, Dr. Burris submitted inaccurate information contrary to 10 CFR 30.9(a). Specifically, his application indicated that Dr. Burris was listed as an authorized user (AU) on the Greater Southeast Community Hospital license, when he was not. In addition, the preceptor statement, prepared by a radiologist and attached to his application, inaccurately described required supervised work experience in handling nuclear materials.
2. While NRC and Dr. Burris agreed the violation was not deliberate, NRC maintained that it was in careless disregard of NRC's regulation.
3. Dr. Burris, subsequent to becoming aware of the details of the violation, took prompt actions to assure that he learned from this violation and provided the NRC with assurance that it would not recur. These actions included: (a) Correcting inaccurate information for the record in a letter dated July 26, 2004; (b) providing details of the violation to associates in the process of getting character references; (c) supplementing his work experience in May 2004, when Dr. Burris began working with the nuclear medicine technologists at Greater Southeast Community Hospital; and (d) undertaking efforts to better understand regulatory requirements through self study and review of his consultant's letter of May 4, 2004.
4. During the ADR mediation session, Dr. Burris recognized an opportunity for other potential Authorized Users/Radiation Safety Officers in the industry to learn from his participation in the NRC enforcement process and his experiences regarding the necessity to provide complete and accurate information to the NRC. Therefore, Dr. Burris agreed to take the following future corrective actions: (a) Submit an article for consideration to an appropriate medical journal that reaches an audience of cardiologists; (b) offer to speak at a training session at a meeting of the American Society of Nuclear Cardiology, a similar society, or at a Nuclear Cardiology symposium; and (c) write a letter to local cardiologists describing his experiences. In addition, Dr. Burris agreed to meet with a hospital RSO who has a knowledge of imaging and localization studies in order to review NRC requirements.
5. Dr. Burris agreed to complete the additional actions in Item 4 within 12 months of the date of the Order, and send a letter to the NRC informing the NRC that these actions are completed. Dr. Burris agreed to send this letter to the NRC within 30 days of completion of all actions.
6. In light of the actions Dr. Burris took as described in Item 3, those actions Dr. Burris has committed to take as described in Item 4, and his cooperation in providing information during the ADR session, the NRC agreed to issue a Severity Level III Notice of Violation (10 CFR 30.9) to Dr. Burris with no civil penalty. This action will be publicly available in ADAMS, will appear on the NRC “Significant Enforcement Actions—Individuals” Web site for a period of 1 year, and will be discussed in a press release announcing the ADR agreement between Dr. Burris and the NRC.
7. Any license application received from Dr. Burris will be reviewed without prejudice.
8. Dr. Burris agreed to issuance of a Confirmatory Order confirming this agreement.
In light of the actions Dr. Burris has taken and agreed to take to correct the violation and prevent recurrence, as set forth in Section III above, the NRC has concluded that its concerns regarding the violation can be resolved through the NRC's confirmation of the commitments as outlined in this Confirmatory Order.
I find that Dr. Burris' commitments as set forth in Section III above are acceptable. However, in view of the foregoing, I have determined that these commitments shall be confirmed by this Confirmatory Order. Based on the above, and Dr. Burris' consent, this Confirmatory Order is immediately effective upon issuance.
Accordingly, pursuant to Sections 103, 161b, 161i, 161o, 182, and 186 of the Atomic Energy Act of 1954, as amended, and the Commission's regulations in 10 CFR 2.202 and 10 CFR part 30 and 35, it is hereby ordered, that:
1. Dr. Burris will (a) submit an article for consideration to an appropriate medical journal that reaches an audience of cardiologists; (b) offer to speak at a training session at a meeting of the American Society of Nuclear Cardiology, a similar society, or at a Nuclear Cardiology symposium; and (c) write a letter to local cardiologists describing his experiences. In addition, Dr. Burris agreed to meet with a hospital RSO who has a knowledge of imaging and localization studies in order to review NRC requirements.
2. Dr. Burris will complete the actions in Section V.1 within 12 months of the date of this Order, and send a letter to the NRC informing the NRC that these actions are completed within 30 days of completion of all actions.
The Director, Office of Enforcement, may relax or rescind, in writing, any of the above conditions upon a showing by Dr. Burris of good cause.
Any person adversely affected by this Confirmatory Order, other than Dr. Burris, may request a hearing within 20 days of its issuance. Where good cause is shown, consideration will be given to extending the time to request a hearing. A request for extension of time must be made in writing to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555, and must include a statement of good cause for the extension. Any request for Start Printed Page 6100a hearing shall be submitted to the Secretary, U.S. Nuclear Regulatory Commission, ATTN: Chief, Rulemaking and Adjudications Staff, Washington, DC 20555. Copies of the hearing request shall also be sent to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555, to the Assistant General Counsel for Materials Litigation and Enforcement, and to the Director of the Division of Regulatory Improvement Programs at the same address. Because of continuing disruptions in delivery of mail to United States Government offices, it is requested that answers and requests for hearing be transmitted to the Secretary of the Commission either by means of facsimile transmission to 301-415-1101 or by e-mail to email@example.com and also to the Office of the General Counsel by means of facsimile transmission to 301-415-3725 or e-mail to OGCMailCenter@nrc.gov. If such a person requests a hearing, that person shall set forth with particularity the manner in which his interest is adversely affected by this Order and shall address the criteria set forth in 10 CFR § 2.309(d) and (f).
If a hearing is requested by a person whose interest is adversely affected, the Commission will issue an Order designating the time and place of any hearing. If a hearing is held, the issue to be considered at such hearing shall be whether this Confirmatory Order shall be sustained. An answer or a request for a hearing shall not stay the effectiveness date of this order.Start Signature
Dated this 27th day of January, 2006.
For the Nuclear Regulatory Commission.
Director, Office of Enforcement.
[FR Doc. E6-1570 Filed 2-3-06; 8:45 am]
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