[Federal Register Volume 62, Number 183 (Monday, September 22, 1997)]
[Notices]
[Pages 49536-49538]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25080]
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NUCLEAR REGULATORY COMMISSION
[IA 97-070]
In the Matter of Magdy Elamir, Newark, New Jersey; Order
Superseding Order Prohibiting Involvement in NRC-Licensed Activities
(Effective Immediately)
I
Magdy Elamir, M.D. (Dr. Elamir), is the Owner/President of Newark
Medical Associates, P.A. (licensee). The licensee holds Byproduct
Nuclear Material License No. 29-30282-01 (license) issued by the
Nuclear Regulatory Commission (NRC or Commission) pursuant to 10 CFR
Part 30. The license authorizes possession and use of any
radiopharmaceutical identified in 10 CFR 35.200 for any imaging and
localization procedure approved in 10 CFR 35.200. The license was
originally issued on September 25, 1996, and is due to expire on
September 30, 2001.
II
During a new license inspection conducted on January 29, 1997, at
the licensee's facility, several apparent violations of NRC
requirements were identified. Subsequent to the inspection, the NRC
initiated an investigation which led the NRC to issue to Dr. Elamir, on
July 31, 1997, an Order Prohibiting Involvement in NRC Licensed
Activities (Effective Immediately) Pending Further Order (62 FR 43360).
That Order was issued pending completion of the NRC staff review of the
results of the investigation, which was conducted by the NRC's Office
of Investigations (OI). The NRC staff's review of the results of the OI
investigation is now complete.
III
The OI investigation focused, in part, on Dr. Elamir's actions in
causing the licensee to be in violation of NRC requirements. The NRC
learned during the investigation that Dr. Elamir transmitted an
inaccurate license application (NRC Form 313, dated February 21, 1996)
to the NRC. The license application named Newark Medical Associates as
the prospective licensee. The license application was inaccurate in
that it named Gerard W. Moskowitz, M.D. (Dr. Moskowitz), as the only
authorized user and Radiation Safety Officer (RSO) without Dr.
Moskowitz's consent or knowledge, and without Dr. Moskowitz's ever
having been affiliated or associated with the licensee. Dr. Moskowitz
did not ever perform the role of authorized user or RSO at the
licensee's facility, and did not become aware that he was listed on the
application and the license until notified by the NRC on February 6,
1997, more than four months after the license was originally issued.
These inaccurate statements in the license application submitted by Dr.
Elamir, formed, in part, the basis for the issuance of the license to
Newark Medical Associates on September 25, 1996.
On October 17, 1996, Dr Elamir notified the NRC by letter that
Newark Medical Associates was initiating activities authorized by the
license; and during the period from November 1996 through February 6,
1997, Dr. Elamir, in his capacity as president and owner of Newark
Medical Associates, caused and permitted the licensee to conduct NRC-
licensed activities even though he knew that the licensee did not
employ the authorized user or the RSO named in the license application
and, subsequently, on the NRC license, and that the named individual
did not serve in these capacities. Based on the results of the OI
investigation, the NRC has determined that Dr. Elamir's actions
constitute violations of the Commission's requirements as follows:
A. 10 CFR 30.10(a)(2) requires, in part, that any licensee or
employee of a licensee may not deliberately submit to
[[Page 49537]]
the NRC information that the person submitting the information knows to
be incomplete or inaccurate in some respect material to the NRC.
During a February 6, 1997 telephone conversation between Dr. Elamir
and an NRC inspector, Dr. Elamir stated to the NRC inspector that the
Newark Medical Associates license was current with respect to the
authorized user and RSO even though Dr. Elamir knew that the individual
named on the license as the authorized user and RSO was not performing
those duties and was not ever affiliated with the licensee in any
capacity. This inaccurate statement was material because it had the
ability to influence an NRC inspection.
B. 10 CFR 30.10 (a)(1), (c)(1), and (c)(2) require, in part, that
any licensee or employee of a licensee not engage in deliberate
misconduct that causes or, but for detection, would have caused a
licensee to be in violation of: (1) Any rule, regulation, or order, or
any term, condition, or limitation of any license issued by the
Commission; or (2) any requirement, procedure, instruction, contract,
purchase order or policy of a licensee.
1. 10 CFR 35.21 requires that a licensee appoint a Radiation Safety
Officer responsible for implementing the radiation safety program; and
requires that the licensee, through the Radiation Safety Officer,
ensure that radiation safety activities are being performed in
accordance with approved procedures and regulatory requirements in the
daily operation of the licensee's byproduct material program.
10 CFR 35.13 requires that a licensee apply for and receive a
license amendment before it changes Radiation Safety Officers.
Byproduct Material License No. 29-30282-01, Condition 12, dated
September 25, 1996 states that the Radiation Safety Officer for this
License is Gerard W. Moskowitz, M.D.
On October 17, 1996, Dr Elamir notified the NRC by letter that
Newark Medical Associates was initiating activities authorized by the
license; and, during the period from November 1996 through February 6,
1997, Dr. Elamir caused Newark Medical Associates to be in violation of
the requirements in Section III.B.1 above by deliberately causing and
permitting the licensee to conduct licensed activities even though Dr.
Elamir knew that the individual designated as the RSO on the Newark
Medical Associates license application and subsequent license did not
ever serve as the Radiation Safety Officer under that license and was
not ever affiliated with the licensee in any capacity.
2. 10 CFR 35.11 (a) and (b) permit an individual to use licensed
material for medical use only in accordance with a specific license
issued by the Commission or under the supervision of an authorized user
as provided in 10 CFR 35.25.
Byproduct Material License No. 29-30282-01, dated September 25,
1996, states in Condition 13 that licensed material is only authorized
for use by, or under the supervision of, Gerard W. Moskowitz, M.D.
On October 17, 1996, Dr Elamir notified the NRC by letter that
Newark Medical Associates was initiating activities authorized by the
license; and during the period from November 1996 through February 6,
1997, Dr. Elamir caused Newark Medical Associates to be in violation of
the requirements in Section III.B.2 above by deliberately causing and
permitting licensed activities to be conducted by a technologist who
did not hold a specific license issued by the NRC and who was not under
the supervision of the authorized user specified on the license. Dr.
Elamir knew that the individual designated as the only authorized user
on the Newark Medical Associates license application and subsequent
license did not ever serve as the authorized user under that license
and was not ever affiliated with the licensee in any capacity.
IV
Based on the above, the NRC staff has concluded that Dr. Elamir
deliberately caused the licensee to be in violation of NRC requirements
by causing and permitting the licensee to conduct licensed activities
in the absence of the authorized user and RSO named on the license
application and on the NRC license. The NRC must be able to rely on the
licensee and its employees to comply with NRC requirements.
Consequently, I lack the requisite reasonable assurance that licensed
activities can be conducted in compliance with the Commission's
requirements and that the health and safety of the public, including
patients receiving radiation from byproduct material for medical
purposes, will be protected if Dr. Elamir were permitted at this time
to be involved in NRC-licensed activities. Therefore, the public
health, safety and interest require that Dr. Elamir be prohibited from
any involvement in NRC-licensed activities for a period of five years.
Furthermore, pursuant to 10 CFR 2.202, I find that the significance of
Dr. Elamir's conduct described above is such that the public health,
safety and interest require that this Order be immediately effective.
V
Accordingly, pursuant to sections 81, 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 30.10, Part 35, and 10 CFR
150.20, It Is Hereby Ordered That, Effective Immediately.
1. The Order of July 31, 1997, is superseded, in its entirety.
2. Dr. Elamir is prohibited from engaging in NRC-licensed
activities for a period of five years from July 31, 1997. This
prohibition applies to Dr. Elamir as an officer, employee, contractor,
consultant, or other agent of a licensee and includes, but is not
limited to: (1) Any use of NRC-licensed materials; (2) supervising
licensed activities, including (but not limited to) hiring of
individuals engaged in licensed activities or directing or managing
individuals engaged in licensed activities; (3) any involvement in
radiation safety activities including (but not limited to) functions of
the Radiation Safety Officer; and (4) development of license
applications, procedures, and policies to meet license requirements,
providing training to meet license requirements, and providing
professional services to meet license requirements. NRC-licensed
activities are those activities that are conducted pursuant to a
specific or general NRC license, including, but not limited to, those
activities of Agreement State licensees conducted in areas of NRC
jurisdiction pursuant to the authority granted by 10 CFR 150.20.
3. If, as of July 31, 1997, Dr. Elamir was involved in NRC-licensed
activities other than at Newark Medical Associates, P.A., he must: (1)
Immediately cease such activities; (2) inform the NRC of the name,
address and telephone number of the NRC-licensed entity or entities
where the activities are being conducted; and (3) provide a copy of
this order to all such NRC-licensed entities.
4. For any entities, other than Newark Medical Associates, P.A.,
where Dr. Elamir was involved in NRC-licensed activities for the period
beginning three years prior to the date of this Order, Dr. Elamir must,
within 30 days of the date of this Order, inform the NRC of the name,
address and telephone number of the NRC-licensed entities where those
activities were conducted.
5. For the five years immediately following the five year
prohibition in paragraph V.2 above, the first time that Dr. Elamir is
employed or involved in NRC-licensed activities following the five year
prohibition, he shall notify the Director, Office of Enforcement, at
the
[[Page 49538]]
address in Section VI below, prior to engaging in NRC-licensed
activities, including activities under an Agreement State license when
activities under that license are conducted in areas of NRC
jurisdiction pursuant to 10 CFR 150.20. This notice shall include the
name, address, and telephone number of the NRC or Agreement State
licensee and the location where licensed activities will be performed;
and shall include a statement as to why the NRC should have confidence
that Dr. Elamir will not, in the future, commit deliberate violations
of Commission requirements.
The Director, Office of Enforcement, may, in writing, relax or
rescind any of the above conditions upon demonstration by the licensee
of good cause.
VI
In accordance with 10 CFR 2.202, Dr. Elamir must, and any other
person adversely affected by this Order may, submit an answer to this
Order and may request a hearing on this Order, within 20 days of the
date of this Order. 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, D.C.
20555, and include a statement of good cause for the extension. The
answer may consent to this Order. Unless the answer consents to this
Order, the answer shall, in writing and under oath or affirmation,
specifically admit or deny each allegation or charge made in this Order
and shall set forth the matters of fact and law on which Dr. Elamir or
other person adversely affected relies and the reasons as to why the
Order should not have been issued. Any answer or request for a hearing
shall be submitted to the Secretary, U.S. Nuclear Regulatory
Commission, Attn: Chief, Rulemaking and Adjudications, Washington, DC
20555. Copies also shall be sent to the Director, Office of
Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555,
to the Assistant General Counsel for Hearings and Enforcement at the
same address, to the Regional Administrator, NRC Region I, 475
Allendale Road, King of Prussia, Pennsylvania 19406, and to Dr. Elamir
if the answer or hearing request is by a person other than Dr. Elamir.
If a person other than Dr. Elamir requests a hearing, that person shall
set forth with particularity the manner in which his or her interest is
adversely affected by this Order and shall address the criteria set
forth in 10 CFR 2.714(d).
If a hearing is requested by Dr. Elamir or 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 Order should be
sustained.
Pursuant to 10 CFR 2.202(c)(2)(i), Dr. Elamir may, in addition to
demanding a hearing, at the time the answer is filed or sooner, move
the presiding officer to set aside the immediate effectiveness of the
Order on the ground that the Order, including the need for immediate
effectiveness, is not based on adequate evidence but on mere suspicion,
unfounded allegations, or error.
In the absence of any request for hearing, or written approval of
an extension of time in which to request a hearing, the provisions
specified in Section IV above shall be final 20 days from the date of
this Order without further order or proceedings. If an extension of
time for requesting a hearing has been approved, the provisions
specified in Section IV shall be final when the extension expires if a
hearing request has not been received. An answer or a request for
hearing shall not stay the immediate effectiveness of this order.
Dated at Rockville, Maryland this 15th day of September 1997.
For the Nuclear Regulatory Commission.
Ashok C. Thadani,
Deputy Executive Director for Regulatory Effectiveness.
[FR Doc. 97-25080 Filed 9-19-97; 8:45 am]
BILLING CODE 7590-01-P
