[Federal Register Volume 62, Number 90 (Friday, May 9, 1997)]
[Notices]
[Pages 25673-25674]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12159]
=======================================================================
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
[Docket No. 030-31085; License No. 31-28369-01 EA 97-019]
Roy Sadovsky, D.V.M. Floral Park, New York; Notice of Denial of
License Renewal and Order Terminating License
I
Roy Sadovsky, D.V.M., (Licensee or Dr. Sadovsky) is the holder of
Byproduct Nuclear Material License No. 31-28369-01 (License) issued by
the Nuclear Regulatory Commission (NRC or Commission) pursuant to 10
CFR Part 30. The License authorizes possession and use of licensed
material (i.e., gold-198 seeds) for implantation in horses for the
treatment of leg injuries and diseases in accordance with the
conditions specified therein. Condition 10 of the License requires that
licensed material be used only at the Meadowlands Race Track in East
Rutherford, New Jersey, or Showplace Farm and Gaitway Farm in Millstone
Township, New Jersey. The License, originally issued on December 22,
1989, was amended on January 10, 1992, and was due to expire on January
31, 1995. The license has remained in effect, however, pursuant to 10
CFR 30.36(a), based on a request made by the Licensee in an application
for renewal filed on January 24, 1995.
II
On August 26, and September 5, 1996, the NRC conducted an
inspection at the Licensee's office in Elmont, New York, and at the
Gaitway Farm in Millstone Township, New Jersey. During the inspection,
it was determined that the Licensee had continued to use licensed
radioactive material consisting of gold-198 seeds at White Birch Farm,
in Allentown, New Jersey, a location not authorized by the license,
despite being cited for that violation in an NRC Notice of Violation
(NOV) issued in January 1992, and despite informing the NRC in February
1992 that he would no longer use the material at the unauthorized
location.
During the inspection, the NRC inspector determined, through review
of records and interview of the Licensee, that Dr. Sadovsky continued
to use gold-198 seeds at the White Birch Farm location on 15 occasions
between 1992 and 1996. In addition to this finding of a deliberate
violation of an NRC requirement, the August-September 1996 inspection
also identified other violations of NRC requirements, each of which are
documented in a related Notice of Violation and Proposed Imposition of
Civil Penalty issued on this date. These violations include: (1)
Failing to secure from unauthorized removal or access, licensed
materials (approximately 120 millicuries of gold-198) that were stored
in the Licensee's unlocked, open vehicle on September 5, 1996, as
required by 10 CFR 20.1801 and 20.1802; (2) transporting licensed
material in violation of 10 CFR 71.5 and the applicable requirements of
the U.S. Department of Transportation regulations, including failure to
use a Type A package as required by 49 CFR 173.415, failure to apply
the radioactive material Yellow-II label as required by 49 CFR 172.403,
and failure to describe the material on the shipping paper as required
by 49 CFR 172.200; (3) failing to provide individual monitoring devices
to personnel who assisted in the Licensee's use of licensed material,
and to ensure the use of those devices by such personnel, when provided
as required by Condition 15 of the License; and (4) conducting
operations with licensed material (gold-198) in a manner that caused
dose rates in an unrestricted area to exceed 2 millirem in any one
hour, as prohibited by 10 CFR 20.1301(a)(2).
On September 13, 1996, the NRC issued an Order Suspending the
License (Effective Immediately) and Demand for Information (DFI) to the
Licensee, based on the findings of the inspection. As noted in the
Order, the violations involving use of licensed material at White Birch
Farm were apparently willful, in that the Licensee had been put on
notice in 1992 that the license limited use of licensed material to
only the locations authorized on the license, and was aware that this
material was being used at Allentown, New Jersey, a location not
authorized on the NRC license.
Subsequently, the NRC Office of Investigations conducted an
investigation of this matter. The investigation determined that the
Licensee's use of gold-198 at an unauthorized location during the
period from February 22, 1992, to October 19, 1994, was deliberate, and
that the use of this licensed material at this location subsequent to
January 1995 was willful.
By letter dated October 15, 1996, the Licensee responded to the
Order and Demand for Information. In his response, the Licensee stated,
among other things, that he did not willfully use licensed material at
a location not authorized by his license and that he believed that his
license had been amended to include use of licensed material at White
Birch Farm. The Licensee repeated his position in a letter dated
January 7, 1997.
On February 26, 1997, an enforcement conference was held with the
Licensee. At the enforcement conference, the Licensee again denied that
he had committed a willful violation of NRC requirements, and again
maintained his belief that his license had been amended to authorize
work at White Birch Farm.
Notwithstanding the Licensee's assertion, the NRC has concluded
that the Licensee's action of performing licensed activity at White
Birch Farm, an unauthorized location, was deliberate. This conclusion
is supported by the fact that the Licensee used licensed material at
White Birch Farm in February and March 1992, only a short time after he
was put on notice by the Notice of Violation issued in January 1992
that such use was not authorized by his License. In addition,
notwithstanding the Licensee's assertion that he believed that he had
then submitted a license amendment to allow use of licensed material at
White Birch Farm, this request was not submitted until January 1995.
III
Based on the above, the NRC has concluded that the Licensee
deliberately violated NRC requirements. Furthermore, the additional
violations, which were identified during the 1996 inspection, are of
significant concern in that they have the potential to impact public
health and safety. In particular, the radiation level from the quantity
of gold-198 that the Licensee typically used is approximately 2.5 rem
per hour at 10 centimeters and, when implanted in horses, the legs of
the treated horses produce radiation levels of more than 200 millirem
per hour at a distance of 30 centimeters. Given these radiation levels,
the failure to provide and to ensure the use of individual monitoring
by a worker raises a question as to
[[Page 25674]]
whether workers were exposed to radiation in excess of NRC
requirements. The Licensee's failure to use personnel monitoring
devices also raises the question of whether the Licensee was exposed to
radiation in excess of NRC requirements. Furthermore, the Licensee's
failure to secure licensed material, as well as the transport of this
material without proper packaging, without affixing proper labels, and
without including accurate shipping papers, are of serious concern to
the NRC.
The NRC must be able to rely on its Licensees to comply with NRC
requirements. It is important that licensed material be used in
accordance with the applicable requirements. The Licensee's deliberate,
continued use of licensed material at an unauthorized location, the
Licensee's failure to provide individual monitoring devices to
personnel who assisted in the Licensee's use of licensed material, and
the Licensee's failure to take the necessary action to correct the
violation of NRC requirements previously cited in January 1992,
demonstrate that the Licensee is either unwilling or unable to comply
with NRC requirements. Given the safety significance of the identified
violations and the deliberate nature of one of the violations, the NRC
no longer has reasonable assurance that public health and safety will
be protected.
Consequently, I lack the requisite reasonable assurance that the
Licensee is willing and able to conduct operations under License No.
31-28369-01 in compliance with the Commission's requirements, and that
the health and safety of the public will be protected. Therefore, the
public health, safety and interest require that, pursuant to 10 CFR
2.103, the application for renewal of the License be denied and that
the License be terminated.
IV
Accordingly, pursuant to sections 81, 161b, 182 and 186 of the
Atomic Energy Act of 1954, as amended, and the Commission's regulations
in 10 CFR 2.103, it is hereby ordered that the Application for renewal
of License No. 31-28369-01 is denied and License No. 31-28369-01 is
terminated.
V
In accordance with 10 CFR 2.103, the Licensee may request a hearing
on this denial of license renewal within 20 days of the date of this
denial. 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, Division of Industrial
and Medical Nuclear Safety, Office of Nuclear Material Safety and
Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555,
and include a statement of good cause for the extension. Any request
for 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 Director, Division of Industrial and Medical Nuclear
Safety, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear
Regulatory Commission, Washington, DC 20555, to the Assistant General
Counsel for Hearings and Enforcement, U.S. Nuclear Regulatory
Commission, Washington, DC 20555, and to the Regional Administrator,
NRC Region I, 475 Allendale Road, King of Prussia, Pennsylvania 19406-
1415.
If a hearing is requested by the Licensee, the Commission will
issue an Order designating the time and place of the hearing. If a
hearing is held, the issue to be considered at such hearing shall be
whether, on the basis of NRC findings and violations described in
Sections II and III of this Notice, denial of the application for
renewal of the License should be sustained.
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 of this Order shall be final when the extension
expires if a hearing request has not been received.
For the Nuclear Regulatory Commission.
Dated at Rockville, Maryland this 1st day of May 1997.
Edward L. Jordan,
Deputy Executive Director for Regulatory Effectiveness, Program
Oversight, Investigations and Enforcement.
[FR Doc. 97-12159 Filed 5-8-97; 8:45 am]
BILLING CODE 7590-01-P