[Federal Register Volume 61, Number 184 (Friday, September 20, 1996)]
[Notices]
[Pages 49499-49501]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24135]
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NUCLEAR REGULATORY COMMISSION
[Docket No. 30-31085; License No. 31-28369-01; EA 96-349]
Roy Sadovsky, D.V.M., Floral Park, New York; Order Suspending
License (Effective Immediately) and Demand for Information
I
Roy Sadovsky, D.V.M., (Licensee) 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
[[Page 49500]]
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 expired on January 31, 1995.
The Licensee filed an application for renewal on January 24, 1995.
II
On December 4 and 5, 1991, the NRC conducted an inspection at the
Hyatt Hotel in New Brunswick, New Jersey, and at the Gaitway Farm in
Millstone Township, New Jersey. During the inspection, the inspector
determined that the Licensee had used licensed material at a location
not authorized by the License. Specifically, the Licensee had used
licensed material consisting of gold-198 seeds at White Birch Farm in
Allentown, New Jersey, an unauthorized location.
In response to a Notice of Violation issued on January 23, 1992,
the Licensee stated that he had not realized that the License did not
allow work at White Birch Farm, and that ``full compliance to avoid
further violations will commence immediately and [my] procedures will
be limited to the 3 sites allowed by [my] license.'' The letter was
signed by Roy Sadovsky, D.V.M.
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,
the NRC inspector determined that the Licensee had continued to conduct
licensed activities at a location not authorized by Condition 10 of the
License. Specifically, the inspector determined, through review of
records and interview of the Licensee, that gold-198 seeds were used at
White Birch Farm in Allentown, New Jersey, a location not listed on the
License, on at least five occasions in 1996, five occasions in 1995,
and one occasion in 1994. These violations 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.
Although the NRC investigation and inspection into this matter is
ongoing, based on information developed to date, it appears that the
Licensee violated additional NRC requirements by: (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 without
complying with the applicable requirements of the U.S. Department of
Transportation regulations, as required by 10 CFR 71.5, including
failure to use a Type A package as required by 49 CFR 173.415, failure
to apply the radioactive material yellow II label 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, in at least one instance in
March 1996, to provide individual monitoring devices to personnel who
assist in the Licensee's use of licensed material and to ensure the use
of those devices by such personnel, as required by Condition 15 of the
License (incorporating Item 10 of the application dated March 20,
1989); and (4) conducting operations with gold-198 licensed material,
so as to cause dose rates in an unrestricted area to exceed 2 millirem
in any one hour, as prohibited by 10 CFR 20.1301(a)(2).
III
Based on the above, it appears that the Licensee has willfully
violated NRC requirements. Moreover, these violations are of
significant concern in that they have the potential to impact the
public health and safety. In particular, the radiation level from the
quantity of gold-198 which the Licensee typically uses is approximately
2.5 rem per hour at 10 centimeters, and, when implanted in horses, the
legs of the treated horses produce radiation levels at more than 200
millirem per hour at a distance of 30 centimeters.
Given the high radiation levels emitted by this licensed material,
the Licensee's storage of this licensed material in an unsecured
vehicle, transport of this material without proper packaging, failure
to affix proper labels which would have required a radioactive material
yellow level II label, and failure to include shipping papers which
accurately described the nature of this licensed material are of
serious concern to the NRC. Moreover, given the high radiation levels
associated with these sources, the failure to provide and to ensure the
use of individual monitoring by a worker raises a question as to
whether workers were exposed to radiation levels in excess of NRC
requirements.
The NRC must be able to rely on the Licensee to comply with NRC
requirements. It is important that licensed material be used in
accordance with the applicable requirements. It appears that the
Licensee has failed to comply with numerous Commission requirements and
has also failed to take the necessary action to correct a violation of
NRC requirements as described in a letter from the Licensee received by
the NRC on February 7, 1992. While the NRC's investigation and
inspection is continuing, given the safety significance of the
identified violations and the apparent willful nature of one violation,
the Licensee's actions raise serious doubt as to whether the Licensee
is able or willing to comply with NRC requirements and whether the
public health and safety will be protected.
Consequently, I lack the requisite reasonable assurance that the
Licensee's current operations can be conducted 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 License No. 31-28369-01
be suspended pending the completion of the NRC's investigation and
inspection, and further order. Furthermore, pursuant to 10 CFR 2.202, I
find that the significance of the violations 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 Part 30, It is hereby ordered,
effective immediately, that license no. 31-28369-01 is suspended as
follows:
Pending further investigation, inspection, and Order by the NRC:
A. All NRC-licensed material in the Licensee's possession shall
immediately be placed in locked storage.
B. The Licensee shall suspend all activities under the License to
use, receive, or transfer licensed material. All other requirements of
the License remain in effect.
C. All records related to licensed activities must be maintained in
their original form and must not be removed or altered in any way.
The Regional Administrator, Region I, may, in writing, relax or
rescind any of the above conditions upon demonstration by the Licensee
of good cause.
[[Page 49501]]
V
In accordance with 10 CFR 2.202, the Licensee 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, and include a statement of good cause for the extension.
The answer may consent to this Order. Unless the answer consents to
this Order, the answer 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 the Licensee
or other person adversely affected relies and the reasons why the Order
should not have been issued. Any answer or 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 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 19406-1415, and to the Licensee, if the answer or
hearing request is by a person other than the Licensee. If a person
other than the Licensee 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 the Licensee 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), the Licensee, or any other
person adversely affected by this Order, may, in addition to demanding
a hearing, at the same 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 Part IV of this Order 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.
VI
In addition, pursuant to sections 161c, 161o, 182 and 186 of the
Atomic Energy Act if 1954, as amended, and the Commission's
requirements in 10 CFR 2.204 and 10 CFR 30.32(b), in order for the
Commission to determine whether License No. 31-28369-01 should be
further modified, suspended, or revoked, or other enforcement action
taken to ensure compliance with NRC regulatory requirements, the
Licensee is required to submit to the Director, Office of Enforcement,
U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, within 20
days of the date of this Order and Demand For Information, a response
in writing and under oath or affirmation:
A. Explaining why the License should not be revoked, or in the
alternative not renewed, in light of the NRC findings described herein;
B. Describing all locations where licensed material has been used
since February 1992, and the date thereof; and
C. Providing the identity and, if known, addresses and telephone
numbers of all persons who have assisted with treatments or cared for
treated horses, and whether such persons wore individual personnel
dosimetry:
1. If such dosimetry was used, provide the dosimetry records of
those persons;
2. If no such dosimetry was used, an estimate of the radiation
exposure received by each such person during each year since the
License was issued.
Copies also shall be sent to the Assistant General Counsel for
Hearings and Enforcement at the same address, and to the Regional
Administrator, NRC Region I, 475 Allendale Road, King of Prussia,
Pennsylvania 19406.
After reviewing your response, the NRC will determine whether
further enforcement action is necessary to ensure compliance with
regulatory requirements.
Dated at Rockville, Maryland this 13th day of September 1996.
For the Nuclear Regulatory Commission.
Hugh L. Thompson, Jr.,
Deputy Executive Director for Nuclear Materials Safety, Safeguards, and
Operations Support.
[FR Doc. 96-24135 Filed 9-19-96; 8:45 am]
BILLING CODE 7590-01-P
