[Federal Register Volume 71, Number 24 (Monday, February 6, 2006)]
[Notices]
[Pages 6098-6100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-1570]
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NUCLEAR REGULATORY COMMISSION
[EA 05-110]
In the Matter of Alfred C. Burris, Senior, M.D.; Confirmatory
Order (Effective Immediately)
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
[[Page 6099]]
licensee 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
[[Page 6100]]
a 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 protected] and also to the Office of the General Counsel by
means of facsimile transmission to 301-415-3725 or e-mail to
[email protected]. 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 Sec. 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.
Dated this 27th day of January, 2006.
For the Nuclear Regulatory Commission.
Michael Johnson,
Director, Office of Enforcement.
[FR Doc. E6-1570 Filed 2-3-06; 8:45 am]
BILLING CODE 7590-01-P