[Federal Register Volume 59, Number 179 (Friday, September 16, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-22984]
[[Page Unknown]]
[Federal Register: September 16, 1994]
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NUCLEAR REGULATORY COMMISSION
[Docket No. 030-02551 License No. 29-12417-01 IA 94-023]
Confirmatory Order (Effective Immediately)
I
Jerome E. Bodian (Licensee or Dr. Bodian) was the holder of NRC
License No. 29-12417-01 (License) issued by the Nuclear Regulatory
Commission (NRC or Commission) pursuant to 10 CFR Parts 30 and 35 on
September 11, 1967 and last renewed in its entirety on August 20, 1990.
The License authorized the Licensee to possess and use iodine-131 as
iodide for uptake studies, thyroid imaging, and the treatment of
hypothyroidism and cardiac disfunction. The License was due to expire
on August 30, 1995; however on January 25, 1993, the Licensee requested
that the License be terminated. The NRC granted this request for
termination, and Amendment No. 07 was issued to the Licensee on
September 27, 1993, terminating the License.
II
On April 6, 1992, an NRC inspection was conducted at the Licensee's
facility in Englewood, New Jersey. During the inspection, the NRC
identified several violations of NRC requirements, including the
failure to possess and use a dose calibrator to assay therapeutic doses
of iodine-131 prior to administration to patients. Also during the
inspection, Dr. Bodian told the inspector that he took doses of iodine-
131 to Englewood Hospital for calibration. During a telephone
conversation with Region I staff on April 7, 1992, Dr. Bodian stated
that: (1) although he did not possess a dose calibrator, he had a
technologist at Englewood Hospital perform the dose measurements for
almost all patients he had treated; (2) all measurements of doses were
within 10 percent of the prescribed dose; and (3) the
results of these measurements were recorded in the patient charts.
Shortly after the inspection, the NRC issued a Confirmatory Action
Letter to the Licensee on April 9, 1992, which confirmed, in part, the
Licensee's agreement to terminate patient treatments with any
radiopharmaceutical authorized by the NRC until such time as the
Licensee established, and submitted to the NRC for approval, a program
that included all of the required equipment and procedures required by
10 CFR Part 35. Such a program was not established and patient
treatment has not resumed. The NRC Office of Investigations initiated
an investigation on May 22, 1992. Dr. Bodian requested, in a letter
dated January 25, 1993, that the License be terminated.
In view of Dr. Bodian's willful failure to adhere to NRC
requirements, as well as the apparently willful failure to provide
complete and accurate information to the NRC, thereby endangering
patients to whom the doses were administered, the NRC needed certain
information to determine whether there existed reasonable assurance
that Dr. Bodian's activities conducted under other NRC licenses would
be performed safely and in accordance with requirements. Accordingly, a
Demand for Information (DFI) was issued to Dr. Bodian on June 24, 1993,
that requested him to list all NRC licenses on which he was then listed
as an authorized user, and to explain why the NRC should not issue an
order to preclude him from any involvement in licensed activities in
the future.
On July 20, 1993, Dr. Bodian responded to the Demand for
Information stating that (1) on infrequent occasions a precalibrated
dose of radioiodine was administered without prior use of dose
calibrator; (2) a request for termination of his license (No. 29-12417-
01) was made on January 25, 1993; and (3) his listing (as an authorized
user) on the Englewood Hospital license (No. 29-08519-01) was a carry
over from years ago, and that any administration of
radiopharmaceuticals to his patients at Englewood hospital was done
under the supervision of the hospital radiology department.
The NRC OI report issued July 26, 1993 determined that
notwithstanding Dr. Bodian's statements to the NRC, the doses, with a
few exceptions, were not assayed with a dose calibrator prior to
administration, even though Dr. Bodian was aware that such assays were
required. This finding is based on the fact that although the
Licensee's records indicate that 30 iodine-131 doses were provided to
patients between January 1990 and April 1992, the NRC has found that
most doses were not assayed for the Licensee in the Hospital's dose
calibrator during that time. This willful failure to adhere to this
requirement, as well as the willful false statements to the NRC during
the inspection on April 6, 1992 and the April 7, 1992 telephone
conversation, constitute violations of 10 CFR 35.53, 10 CFR 30.9, and
10 CFR 30.10.
III
Based on the above, it appears that Dr. Bodian, the Licensee,
engaged in deliberate misconduct that constitutes a violation of 10 CFR
30.10(a)(1) and that has caused the Licensee to be in violation of 10
CFR 35.53. It further appears that Dr. Bodian deliberately provided to
NRC inspectors information that he knew to be incomplete or inaccurate
in some respect material to the NRC, in violation of 10 CFR 30.09 and
CFR 30.10(a)(2). Dr. Bodian has demonstrated an unwillingness to comply
with Commission requirements. NRC must be able to rely on its licensees
to comply with NRC requirements, including the requirement to provide
complete and accurate information. Willful violations are of particular
concern to the Commission because they undermine the Commission's
reasonable assurance that licensed activities will be conducted in
accordance with NRC requirements. Dr. Bodian's actions have raised
serious doubt as to whether he can be relied upon to comply with NRC
requirements and to provide complete and accurate information to the
NRC. Consequently, protection of the public health, safety and interest
require that Dr. Bodian be prohibited from engaging in NRC-licensed
activities for a period of 5 years and to notify the NRC prior to
resumption of any NRC-licensed activities at any facility after
termination of the five year prohibition.
In telephone conversations on July 18, 19, and 20, 1994, with Dr.
Ronald R. Bellamy of the NRC Region I office, Dr. Bodian agreed not to
be involved in any NRC-licensed activities for a period of five years,
and to notify the NRC prior to resumption of any licensed activities at
any facility after that five year prohibition. I find that the Dr.
Bodian's commitments as set forth in that conversation are acceptable
and necessary and conclude that with these commitments the protection
of the public health and safety is reasonably assured. In view of the
foregoing, I have determined that the public health and safety require
that the Dr. Bodian's commitments in the telephone conversations of
July 18, 19, and 20, 1994 be confirmed by this Order. Dr. Bodian has
agreed to this action. Pursuant to 10 CFR 2.202, I have also determined
that the significance of the violations described above is such that
the public health and safety require that this Order be immediately
effective.
IV
Accordingly, pursuant to section 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 Parts 30 and 35, It is hereby
ordered that:
1. For a period of five years from the date of this Confirmatory
Order, Jerome E. Bodian, M.D., shall not engage in any NRC-licensed
activities. NRC-licensed activities are those activities which are
conducted pursuant to a specific or general license issued by the NRC,
including, but not limited to, those activities of Agreement State
licenses conducted pursuant to the authority granted by 10 CFR 150.20.
2. When, for the first time, Dr. Bodian is employed in NRC-licensed
activities following the five year prohibition, he shall notify the
Regional Administrator, NRC Region I, 475 Allendale Road, King of
Prussia, Pennsylvania 19406, within 20 days 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. The 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.
The Director, Office of Enforcement, may, in writing, relax or
rescind any of the above conditions upon a showing by Dr. Bodian of
good cause.
V
Any person adversely affected by this Confirmatory Order (Effective
Immediately), other than Dr. Bodian, may request a hearing within 20
days of its issuance. Any request for a hearing shall be submitted to
the Secretary, U.S. Nuclear Regulatory Commission, ATTN: Chief,
Docketing and Service Section, Washington, D.C. 20555. Copies also
shall be sent to the Director, Office of Enforcement, U.S. Nuclear
Regulatory Commission, Washington D.C. 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. Bodian. If such a person
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 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 Confirmatory Order (Effective
Immediately) should be sustained.
Pursuant to 10 CFR 2.202(c)(2)(i), any person adversely affected by
this Order, other than Dr. Bodian, 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, the provisions specified
in Section IV above shall be final 20 days from the date of this Order
without further order or proceedings. An answer or request for a
hearing shall not stay the immediate effectiveness of this order.
Dated at Rockville, Maryland, this 8th day of September 1994.
For The Nuclear Regulatory Commission.
Hugh L. Thompson, Jr.,
Deputy Executive Director for Nuclear Materials Safety, Safeguards, and
Operations Support.
[FR Doc. 94-22984 Filed 9-15-94; 8:45 am]
BILLING CODE 7590-01-M
