[Federal Register Volume 62, Number 156 (Wednesday, August 13, 1997)]
[Notices]
[Pages 43360-43361]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21363]
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NUCLEAR REGULATORY COMMISSION
[IA 97-064]
Order Prohibiting Involvement in NRC-Licensed Activities
(Effective Immediately) Pending Further Order; Magdy Elamir, M.D.,
Newark, New Jersey
I
Magdy Elamir, M.D., (Dr. Elamir), is the Owner/President of Newark
Medical Associates, P.A. (licensee), an NRC licensee who is the holder
of 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
On January 29, 1997, the NRC conducted an inspection at the
licensee's facility in Newark, New Jersey. During the inspection,
several apparent violations of NRC requirements were identified. One of
the violations involved the continued use of radioactive material by
the licensee despite the fact that the only authorized user listed on
the license (who was also listed as the Radiation Safety Officer
(RSO)), had not ever performed any authorized user or RSO duties and
had not ever been affiliated with the company. Specifically, Gerard W.
Moskowitz, M.D. (Dr. Moskowitz), was listed on the application as the
RSO and authorized user without his knowledge. Dr. Moskowitz 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.
Subsequent to the inspection, the NRC verified, based on an
investigation by the NRC Office of Investigations (OI), that the
licensee's letter, dated February 22, 1996, signed by Dr. Elamir,
transmitting the license application (NRC Form 313), dated February 2,
1996, was inaccurate in that it listed Dr. Moskowitz as the authorized
user and Radiation Safety Officer without Dr. Moskowitz's consent or
knowledge and without Dr. Moskowitz ever having been affiliated or
associated with the licensee. Further, Dr. Moskowitz did not ever
perform the role of RSO at the licensee's facility. As such, the
licensee's application for a material license to possess and use
byproduct material was provided with information that was not complete
and accurate in all material respects. These inaccurate statements in
the licensee's application, signed by Dr. Elamir, formed, in part, the
basis for the issuance of the license to Newark Medical Associates on
September 25, 1996. Further, the licensee continued to conduct NRC-
licensed activities even though Dr. Elamir knew that the licensee did
not have an RSO.
III
Although the NRC staff's review of the results of the OI
investigation is ongoing, the evidence that NRC has obtained indicates
that Dr. Elamir's actions in causing violations of NRC requirements
were deliberate. The NRC must be able to rely on the licensee and its
employees to comply with NRC requirements. Condition No. 13 of the
license required that each use of licensed material be done by, or
under the supervision of Dr. Moskowitz as the authorized user named
therein. NRC requires that the RSO named on the license implement a
radiation safety program pursuant to 10 CFR 35.21. NRC also requires
that all communications between the licensee and the NRC be complete
and accurate in all material respects, pursuant to 10 CFR 30.9.
[[Page 43361]]
Pursuant to 10 CFR 30.10, deliberate misconduct on the part of a
licensee or its employee or contractor is prohibited. The term
``deliberate misconduct'' includes an intentional act that the person
knows would violate a Commission requirement. The evidence to date
demonstrates that Dr. Elamir, acting in violation of 10 CFR 30.10,
deliberately violated 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
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 pending further order.
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.
IV
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. Pending further order, Dr. Elamir is prohibited from engaging in
NRC-licensed activities. This prohibition applies to Dr. Elamir as an
employee, contractor, consultant, or other agent of a license 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) 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
license issued by the NRC, 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.
2. If Dr. Elamir is currently involved in NRC-licensed activities
other than at Newark Medical Associates, P.A., he must, as of the
effective date of this Order: (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.
The Director, Office of Enforcement, may, in writing, relax or
rescind any of the above conditions upon demonstration by the licensee
of good cause.
V
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, DC 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, Docketing and Service Section, 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 a 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 a
hearing shall not stay the immediate effectiveness of this order.
For the Nuclear Regulatory Commission.
Edward L. Jordan,
Deputy Executive Director for Regulatory Effectiveness.
[FR Doc. 97-21363 Filed 8-12-97; 8:45 am]
BILLING CODE 7590-01-P
