[Federal Register Volume 62, Number 173 (Monday, September 8, 1997)]
[Notices]
[Pages 47224-47226]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23695]
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NUCLEAR REGULATORY COMMISSION
[IA 97-068]
Order Superseding Order Prohibiting Involvement in NRC-Licensed
Activities (Effective Immediately)
I
Aharon Ben-Haim, Ph.D. (Dr. Ben-Haim), Medical Physicist, Upper
Montclair, New Jersey, is a contractor 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
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. Ben-Haim,
on July 31, 1997, an Order Prohibiting Involvement in NRC Licensed
Activities (Effective Immediately) Pending Further Order (62 FR 43357).
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. Ben-Haim's actions in
causing the licensee to be in violation of NRC requirements. The NRC
learned during the investigation that Dr. Ben-Haim, in his capacity as
a contractor-consultant to the licensee, had prepared the license
application (NRC Form 313) dated February 21, 1996, for Newark Medical
Associates, and that 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 prepared by Dr. Ben-Haim, formed, in part, the
basis for the issuance of the license to Newark Medical Associates on
September 25, 1996.
During the period from November 1997 through February 6, 1997, Dr.
Ben-Haim, in his role as contractor-consultant to the licensee, aided
and assisted the licensee in continuing to conduct NRC-licensed
activities even though the licensee did not employ the authorized user
or the RSO named in the license application and, subsequently, on the
NRC license, nor did the named individual serve in these capacities.
Based on the results of the OI investigation, the NRC has determined
that Dr. Ben-Haim's actions constitute
[[Page 47225]]
violations of 10 CFR 30.10, ``Deliberate misconduct'', as follows:
A. 10 CFR 30.10 (a)(1), (c)(1) and (c)(2) require, in part, that
any contractor of a licensee not engage in deliberate misconduct that
causes or, but for detection, would have caused, a licensee to be in
violation of any rule, regulation, or order, or any term, condition, or
limitation of any license issued by the Commission; or 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.
During the period from November 1996 through February 6, 1997, Dr.
Ben-Haim caused Newark Medical Associates to be in violation of the
requirements in Section III.A.1 above by performing the functions of
the Radiation Safety Officer (RSO), even though he knew that: (1) The
RSO named on the license application and, subsequently, on the license,
was Gerard Moskowitz, M.D., and (2) he, Dr. Ben-Haim, was not the RSO
named on the license application or the license.
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.
10 CFR 35.53(c)(3) requires, in part, that the licensee retain a
record of the measurement of each dosage of a photon-emitting
radionuclide prior to medical use to include, among other things, the
prescribed dosage. Pursuant to 10 CFR 35.2: Prescribed dosage means the
quantity of radiopharmaceutical activity as documented in a written
directive or diagnostic clinical procedures manual or in any
appropriate record in accordance with the directions of the authorized
user; Written directive means an order in writing for a specific
patient dated and signed by an authorized user; Diagnostic clinical
procedures manual means a collection of written procedures that
includes, among other things, where each diagnostic procedure has been
approved by the authorized user and the radiopharmaceutical, dosage,
and route of administration; and Authorized user means a physician,
dentist, or podiatrist who is (1) Board certified by at least one of
the boards listed in Paragraph (a) of 10 CFR Part 35, sections 35.910,
35.920, 35.930, 35.940, 35.950, or 35.960, (2) identified as an
authorized user on a Commission or Agreement State license that
authorizes the medical use of byproduct material, or (3) identified as
an authorized user on a permit issued by a Commission or Agreement
State specific license of broad scope that is authorized to permit the
medical use of byproduct material.
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.
Byproduct Material License No. 29-30282-01, dated September 25,
1996, requires in part, in Condition 14, that the licensee conduct its
program in accordance with the statements, representations, and
procedures contained in the Application dated February 21, 1996. This
application, which was prepared by Dr. Ben-Haim, requires, in Item
10.6, ``Ordering and Receiving'', that the licensee follow procedures
in Appendix K to Regulatory Guide 10.8, Revision 2. The procedures in
Appendix K require, in part, that the Radiation Safety Officer or a
designee must authorize each order for radioactive materials and ensure
that the requested materials and quantities are authorized by the
license for use by the requesting authorized user.
During the period from November 1996 through February 6, 1997,
Aharon Ben-Haim, who is not a physician, caused Newark Medical
Associates to be in violation of the requirements in Section III.A.2
above by prescribing, in writing, the radiopharmaceuticals and dosages
to be ordered and administered to patients by technologists for bone
scans and cardiac images (which are medical uses), even though he knew
that: (1) He was not an authorized user nor under the supervision of an
authorized user; (2) he had prepared the Newark Medical Associates
license application to specify the name of Gerard Moskowitz as the sole
physician authorized user and Radiation Safety Officer; (3) Gerard
Moskowitz, as the sole physician user named on the license, was the
only individual who could prescribe a radiopharmaceutical and dosage
for a technologist to administer to a patient; and (4) Gerard
Moskowitz, as the Radiation Safety Officer named on the license, was
the only individual who could authorize, or delegate to a technologist
the authority to authorize, each order of byproduct material for
medical use.
IV
Based on the above, the NRC staff has concluded that Dr. Ben-Haim,
acting as a contractor consultant to the licensee, 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. The NRC must be able
to rely on the licensee and its contractors 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. Ben-Haim is 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 for a period
of five years. 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.
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 entirely.
2. Dr. Ben-Haim is prohibited from engaging in NRC-licensed
activities for a period of five years from July 31, 1997. This
prohibition applies to Dr. Ben-Haim 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
[[Page 47226]]
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. For those facilities, other than Newark Medical Associates,
P.A., where Dr. Ben-Haim was involved in NRC-licensed activities as of
July 31, 1997, Dr. Ben-Haim must: (1) Immediately cease such
activities; (2) inform the NRC of the name, address and telephone
number of the NRC-licensed entities where the activities were being
conducted; and (3) provide a copy of this order to all such NRC-
licensed entities within five business days of any ruling by an NRC
Atomic Safety and Licensing Board upholding the immediate effectiveness
of this requirement of this Order or, if Dr. Ben-Haim does not
challenge the immediate effectiveness of this Order, within five
business days of the termination of the time to request a hearing in
Section VI of this Order.
4. For those facilities, other than Newark Medical Associates,
P.A., where Dr. Ben-Haim was involved in NRC-licensed activities for
the period beginning three years prior to the date of this Order, Dr.
Ben-Haim 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, the first time that Dr. Ben-Haim is
employed or involved in NRC-licensed activities following the five year
prohibition, he shall notify the Director, Office of Enforcement, at
the address in Section VI below, within 20 days of 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. Ben-Haim 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. 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, on or before September
19, 1997. 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 Atomic Safety and Licensing Board appointed to preside
in this proceeding. Copies shall also 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, 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. The Atomic Safety and Licensing Board designated to preside in
the proceeding on the Order of July 31, 1997, has already granted a
joint motion in which it set September 3, 1997, as the date by which
Dr. Ben-Haim should move to set aside the immediate effectiveness of
this Order.
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 on September 19, 1997,
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 27th day of August 1997.
For the Nuclear Regulatory Commission.
James Lieberman,
Director, Office of Enforcement.
[FR Doc. 97-23695 Filed 9-5-97; 8:45 am]
BILLING CODE 7590-01-P
