[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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