[Federal Register Volume 62, Number 156 (Wednesday, August 13, 1997)]
[Notices]
[Pages 43357-43358]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21364]
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NUCLEAR REGULATORY COMMISSION
[IA 97-065]
Order Prohibiting Involvement in NRC-Licensed Activities
(Effective Immediately) Pending Further Order; Aharon Ben-Haim, Ph.D.,
Upper Montclair, New Jersey
I
Aharon Ben-Haim, Ph.D. (Dr. Ben-Haim), Medical Physicist, Upper
Montclair, New Jersey, is a consultant for Newark Medical Associates,
P.A. (licensee), 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,
licensee President, 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. The
NRC also learned that Dr. Ben-Haim, in his capacity as a consultant,
had completed the license application for Dr. Elamir. As such, the
licensee's application for a 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, and prepared by Dr. Ben-
Haim, 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. Ben-Haim,
as the licensee consultant, 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. Ben-Haim's actions in causing violations of NRC requirements
were deliberate. The NRC
[[Page 43358]]
must be able to rely on the licensee and its employees and consultants/
contractors to comply with NRC requirements. Condition No. 13 of the
license required that each use of material by the licensee 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 as required by 10 CFR 35.21. NRC requires that
all communications between the licensee and the NRC be complete and
accurate in all material respects, pursuant to 10 CFR 30.9. 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. Ben-Haim, acting in violation of 10 CFR 30.10, deliberately
caused the licensee to be in violation of NRC requirements by the
licensee's conducting licensed activities without the authorized user
or RSO named on the license application and on the NRC license.
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. Ben-Haim were permitted at this time to be
involved in NRC-licensed activities. Therefore, the public health,
safety and interest require that Dr. Ben-Haim 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. Ben-Haim'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. Ben-Haim is prohibited from engaging
in NRC-licensed activities. This prohibition applies to Dr. Ben-Haim 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. Ben-Haim 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.
IV
In accordance with 10 CFR 2.202, Dr. Ben-Haim 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. Dr. Ben-Haim
may consent to this Order. Unless Dr. Ben-Haim consents to this Order,
Dr. Ben-Haim 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. Ben-Haim
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. Ben-
Haim if the answer or hearing request is by a person other than Dr.
Ben-Haim. If a person other than Dr. Ben-Haim 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. Ben-Haim 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. Ben-Haim 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 31st day of July 1997.
For the Nuclear Regulatory Commission.
Edward L. Jordan,
Deputy Executive Director for Regulatory Effectiveness.
[FR Doc. 97-21364 Filed 8-12-97; 8:45 am]
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