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EA-97-019 - Sadovsky, Roy (DVM)

May 1, 1997

EA 97-019
EA 97-150

Roy Sadovsky, D.V.M.
Post Office Box 20243
Floral Park, New York 11002

SUBJECT:

NOTICE OF DENIAL OF LICENSE RENEWAL AND ORDER TERMINATING LICENSE; ORDER PROHIBITING INVOLVEMENT IN LICENSED ACTIVITIES; AND NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY - $4,000
(NRC Inspection No. 030-31085/96-001)

Dear Dr. Sadovsky:

The enclosed Notice of Denial of License Renewal and Order Terminating License, Order Prohibiting Involvement in Licensed Activities (Effective Immediately), and Notice of Violation and Proposed Imposition of Civil Penalty are being issued because of your violation of NRC requirements, including the deliberate violation of certain NRC requirements.

Your license, originally issued on December 22, 1989, 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 timely request made by you in an application for renewal filed on January 24, 1995. On September 13, 1996, the NRC issued an Order Suspending License (Effective Immediately) and Demand for Information (DFI), due to your apparent willful use of licensed material at a location not authorized by your license, as well as your failure to comply with numerous additional NRC requirements. The violations were identified during an NRC inspection conducted in August and September 1996, the report of which was forwarded to you on December 10, 1996. In addition, an investigation was conducted by the NRC Office of Investigations (OI) subsequent to the inspection. As noted in the synopsis of the OI report forwarded to you with our February 14, 1997 letter, OI determined that you deliberately violated a condition of your license by implanting gold-198 seeds in horses at a location not authorized by your license. As a result, an enforcement conference was conducted with you on February 26, 1997, to discuss the violations, their causes, and your corrective actions.

The September 13, 1996 Suspension Order required that you: (1) place all NRC-licensed material in your possession in locked storage; (2) suspend all activities under your license to use, receive, or transfer licensed material; and (3) maintain all records related to licensed activities in their original form and not alter or remove any of the records in any way. The DFI required that you submit information, in writing and under oath or affirmation, as to: (1) why your license should not be revoked, or in the alternative not renewed; (2) all locations where licensed material has been used since February 1992, and the dates thereof; and (3) the identity of all persons who have assisted with treatments or cared for treated horses and an estimate of the radiation exposure received by each such person.

In your October 15, 1996 response to that Order, you indicated that you had no NRC-licensed material in your possession; you had suspended all activities under your license; you had not received, used or transferred any licensed material since your license was suspended; and you would maintain all required records. Also, in response to the DFI, you indicated that you could not offer any adequate response why your license should not be revoked, and stated that, in fact, you had submitted a letter requesting that your license be terminated. You also indicated, as you subsequently did during the February 26, 1997 enforcement conference, that you did not willfully use the material at a location not authorized by your license, and you believed your license had been amended to include authorization for work at the location in question, namely, the White Birch Farm in Allentown, New Jersey. You also stated that if there was any attempt to willfully use the material at a location not listed on your license, you would not have kept such accurate records. Subsequently, in your January 7, 1997 response to the December 10, 1996 inspection report, you stated that, upon reconsideration, you did not wish to voluntarily terminate your license and requested that the NRC reinstate the operational status of your license upon the completion of its inquiry. You also reiterated your belief that you had submitted a license amendment to allow use of licensed material at White Birch Farm. Finally, you noted that you had retained the services of a consultant to provide operational review of your radiation safety practices after your license was reinstated.

Notwithstanding your contentions during the enforcement conference and in your two letters, we have concluded that your actions in violating NRC requirements by continuing to perform work at White Birch Farm, an unauthorized location, were deliberate. Particularly disturbing is the fact that you used the licensed material at the unauthorized location in February and March 1992 only a short time after you were cited in a Notice of Violation (NOV) issued in January 1992 for the same violation, and you informed the NRC, in your February 1992 response to the NOV, that you would confine use of the material to the authorized locations. Although you asserted that you believed you had submitted a license amendment to allow use of licensed material at White Birch Farm, this request was not submitted until January 1995.

Therefore, given this deliberate violation, as well as the potential safety consequence of the other violations, including inadequate security of licensed material and inadequate control of exposure to the gold-198 seeds, the NRC has determined that your license should not be renewed, that your license should be terminated, and that you should be precluded from involvement in licensed activities for a period of one year. The NRC considered prohibiting you from involvement in NRC-licensed activities for a longer period, but has decided not to do so because: (1) you accepted responsibility for the violations at the conference; (2) you have already been prohibited from performing licensed activities since issuance of the September 13, 1996 Suspension Order; and (3) you retained a consultant who has described plans to upgrade and monitor your program, should the NRC allow you to be engaged in licensed activities in the future.

Pursuant to Section 223 of the Atomic Energy Act of 1954, as amended, any person who willfully violates, attempts to violate, or conspires to violate, any provision of these Orders shall be subject to criminal prosection as set forth in that section. Violation of these Orders may also subject the person to civil monetary penalty.

In addition to these Orders, the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice) are being issued in view of the nature, number, and significance of the violations identified during the inspection. Given the deliberate violation, as well as the significant lack of attention to ensuring your activities were conducted safely and in accordance with NRC requirements, the violations have been classified in the aggregate as a Severity Level II problem in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.

The violation involving the deliberate use of licensed material at an unauthorized location is of particular concern because the regulatory program is based on licensees acting with integrity and communicating with candor. The remaining violations are also of significant concern because such failures pose a potential safety consequence to the public including your workers. In the aggregate, the violations in the enclosed Notice are of very significant regulatory concern.

Therefore, to emphasize the significance that the NRC attaches to deliberate violations, as well as the importance of strict adherence to NRC requirements, I am issuing the enclosed Notice and proposed civil penalty in the base amount of $4,000 for this Severity Level II problem. This penalty is based on exercise of enforcement discretion pursuant to Sections VII.A.1.(a) and (c) of the Enforcement Policy.

You are required to respond to this letter and the enclosed Notice and should follow the instructions specified in the Notice when preparing your response. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.

In the inspection report sent to you with our letter dated December 10, 1996, we discussed potential exposures to you in excess of regulatory limits. We have reviewed your letter dated January 7, 1997, in which you concluded that no exposures in excess of regulatory limits occurred. Based on the information available to the NRC, there is uncertainty as to whether exposures in excess of regulatory limits occurred and, therefore, no enforcement action is being taken on that specific issue. However, there is sufficient evidence that the gold-198 seed treatment procedure has the potential to result in doses to persons in excess of regulatory limits if proper radiation safety practices are not rigorously implemented. We expect meticulous attention to the radiation safety measures described in any future application to the NRC for use of licensed material.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosures, and your response will be placed in the NRC Public Document Room.

Questions concerning these actions should be addressed to Mr. James Lieberman, Director, Office of Enforcement, who may be reached at (301) 415-2741.

Sincerely,

Edward L. Jordan

Deputy Executive Director for Regulatory Effectiveness, Program Oversight, Investigations and Enforcement

Docket No. 030-31085
License No. 31-28369-01

Enclosures:
1. Notice of Denial of License Renewal and Order Terminating License
2. Order Prohibiting Involvement in NRC-Licensed Activities (Effective Immediately)
3. Notice of Violation and Proposed Imposition of Civil Penalty

cc w/encls:
State of New York
State of New Jersey

UNITED STATES
NUCLEAR REGULATORY COMMISSION

In the Matter of

ROY SADOVSKY, D.V.M.
National Institutes of Health
Floral Park, New York

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Docket No. 030-31085
License No. 31-28369-01
EA 97-019

NOTICE OF DENIAL OF LICENSE RENEWAL
AND ORDER TERMINATING LICENSE

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.

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 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.

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.

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, US 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

Edward L. Jordan
Deputy Executive Director for Regulatory Effectiveness, Program Oversight, Investigations and Enforcement

Dated at Rockville, Maryland
this 1st day of May 1997

UNITED STATES
NUCLEAR REGULATORY COMMISSION

In the Matter of

ROY SADOVSKY, D.V.M.
Floral Park, New York

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IA 97-024

ORDER PROHIBITING INVOLVEMENT IN
NRC-LICENSED ACTIVITIES
(EFFECTIVE IMMEDIATELY)

As noted in a Notice of Denial of License Renewal and Order Terminating License issued to Dr. Sadovsky concurrently on this date, the NRC has found, based on an inspection and investigation, that Dr. Sadovsky has deliberately engaged in violations of NRC requirements, as detailed in the Notice of Denial of License Renewal and Order Terminating License. Notwithstanding the denial of Dr. Sadovsky's license renewal, given Dr. Sadovsky's deliberate failure to adhere to regulatory requirements, as well as the significance of additional violations of other requirements as set forth in the Notice of Denial of License Renewal and Order Terminating License, the NRC no longer has the necessary assurance that Dr. Sadovsky's activities, if performed under any other NRC license, would be performed safely and in accordance with 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 will be protected if Dr. Sadovsky were permitted at this time to be involved in NRC-licensed activities. Therefore, the public health, safety and interest require that Dr. Sadovsky be prohibited from any involvement in NRC-licensed activities for a period of one year from the date of this Order, and if he is currently involved with another licensee in NRC-licensed activities, he must immediately cease such activities, and inform the NRC of the name, address and telephone number of the employer, and provide a copy of this order to the employer. Additionally, Dr. Sadovsky is required to notify the NRC of his first employment in NRC-licensed activities following the prohibition period. Furthermore, pursuant to 10 CFR 2.202, I find that the willfulness and significance of Dr. Sadovsky's conduct described above is such that the public health, safety and interest require that this Order be immediately effective.

III

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, IMMEDIATELY EFFECTIVE, THAT:

1. For a period of one year from the date of this Order, Roy Sadovsky, D.V.M., is prohibited from engaging in NRC-licensed activities. 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. For a period of one year from the date of this Order, Dr. Sadovsky shall provide a copy of this Order to any prospective employer who engages in NRC-licensed activities (as described in Section III.1 above) prior to his acceptance of employment involving non-NRC-licensed activities with such prospective employer. The purpose of this requirement is to ensure that the employer is aware of the prohibition on Dr. Sadovsky from engaging in NRC-licensed activities.

3. The first time Dr. Sadovsky is employed in NRC-licensed activities following the one year prohibition, he shall notify the Regional Administrator, NRC Region I, 475 Allendale Road, King of Prussia, Pennsylvania 19406, 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 demonstration by the Licensee of good cause.

In accordance with 10 CFR 2.202, Dr. Sadovsky 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. 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 Dr. Sadovsky 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, to Dr. Sadovsky if the answer or hearing request is by a person other than Dr. Sadovsky. If a person other than Dr. Sadovsky 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. Sadovsky, 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. Sadovsky 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.

FOR THE NUCLEAR REGULATORY COMMISSION

Edward L. Jordan
Deputy Executive Director for Regulatory Effectiveness, Program Oversight, Investigations and Enforcement

Dated at Rockville, Maryland
this 1st day of May 1997

NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

Roy Sadovsky, D.V.M.
Floral Park, New York

Docket No. 030-31085
License No. 31-28369-01
EA 97-150

During an NRC inspection conducted on various dates between August 26, 1996 and October 24, 1996, as well as a subsequent investigation by the NRC Office of Investigations, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the NRC proposes to impose a civil penalty pursuant to Section 234 of the Atomic Energy Act of 1954, as amended (Act), 42 U.S.C. 2282, and 10 CFR 2.205. The particular violations and associated civil penalty are set forth below:

I. VIOLATION INVOLVING USE OF LICENSED MATERIAL AT UNAUTHORIZED LOCATION

Condition 10 of License No. 31-28369-01 requires that radioactive 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.

Contrary to the above, the licensee used licensed material (gold-198 seeds) on at least 15 occasions, at White Birch Farm from May 14, 1992, to July 15, 1996, a location not authorized on the license.

II. VIOLATION OF SECURITY REQUIREMENTS

10 CFR 20.1801 requires that the licensee shall secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas. 10 CFR 20.1802 requires that the licensee shall control and maintain constant surveillance of licensed material that is in a controlled or unrestricted area and that is not in storage. As defined in 10 CFR 20.1003, controlled area means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee for any reason; and unrestricted area means an area, access to which is neither limited nor controlled by the licensee.

Contrary to the above, on September 5, 1996, the licensee did not secure from unauthorized removal or access licensed materials that were stored in an unrestricted area, and did not control and maintain constant surveillance of the licensed material in an unrestricted area that was not in storage. Specifically, on that date, approximately 120 millicuries of gold-198 seeds, in the back of the licensee's vehicle with its rear door open located at the Gaitway Farm, Millstone Township, New Jersey, were not secured and were not under constant surveillance.

III. VIOLATIONS RELATED TO INADEQUATE EXPOSURE CONTROL

A. 10 CFR 20.1501 requires that each licensee make or cause to be made surveys that may be necessary for the licensee to comply with the regulations in Part 20 and that are reasonable under the circumstances to evaluate the extent of radiation levels, concentrations or quantities of radioactive materials, and the potential radiological hazards that could be present.

Pursuant to 10 CFR 20.1003, survey means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of radioactive material or other sources of radiation.

Contrary to the above, on September 5, 1996, the licensee did not make surveys to assure compliance with 10 CFR 20.1301(a)(2), which limits radiation exposure in unrestricted areas to 0.002 rem in any one hour. Specifically, the licensee did not make surveys at the Gaitway Farm of dose rates in unrestricted areas where gold-198 seeds had been used in the treatment of horses.

B. Condition 15 of License No. 31-28369-01 requires that licensed material be possessed and used in accordance with statements, representations and procedures contained in an application dated March 20, 1989.

Item No. 10(6) of this application requires that film badges will be used by all persons in the area where gold-198 is in use.

Contrary to the above, on March 22, 1996, the licensee did not supply and require the use of an individual monitoring device (i.e., film badge) by a horse trainer who was subject to radiation levels from the use of gold-198. In addition, from 1992 until April 1996, film badges were not used by the licensee's doctor of veterinary medicine during his use of gold-198 or by other persons in the area during the treatment of horses with gold-198.

C. 10 CFR 20.1301(a)(2) requires that the licensee conduct operations so that the dose in any unrestricted area from external sources does not exceed 2 millirem in any one hour.

Contrary to the above, on September 5, 1996, licensee operations resulted in a dose of 75 millirem in one hour measured at one foot from the outside of a horse stall at Gaitway Farm, an unrestricted area.

IV. VIOLATIONS OF TRANSPORTATION REQUIREMENTS

10 CFR 71.5(a) requires that each licensee who transports licensed material outside the site of usage, as specified in the NRC license, or where transport is on public highways, or who delivers licensed material to a carrier for transport, shall comply with the applicable requirements of the DOT regulations in 49 CFR parts 170-189 appropriate to the mode of transport.

A. 49 CFR 172.200(a) requires, with exceptions not applicable here, that each person who offers a hazardous material for transportation describe the hazardous material on the shipping paper in the manner required by subpart C of 49 CFR Part 172. Pursuant to 49 CFR 172.101, radioactive material is classified as hazardous material.

Contrary to the above, on September 5, 1996, the licensee transported approximately 120 millicuries of gold-198 seeds from the Federal Express building in Moonachie, New Jersey to Gaitway Farm, Millstone Township, New Jersey and did not include with the shipment a shipping paper describing the material.

B. 49 CFR 172.403 requires, in part, with exceptions not applicable here, that each package of radioactive material be labeled, as appropriate, with two RADIOACTIVE WHITE-I, RADIOACTIVE YELLOW-II, or RADIOACTIVE YELLOW-III labels on opposite sides of the package. The contents, activity, and transport index must be entered in the blank spaces on the label.

Contrary to the above, on September 5, 1996, the licensee transported approximately 120 millicuries of gold-198 seeds from the Federal Express building located in Moonachie, New Jersey to Gaitway Farm, Millstone Township, New Jersey without the required labels. Specifically, the licensee removed the lead pig containing the gold-198 seeds from the shipping package at the Federal Express building and transported the lead pig to Gaitway Farm, without applying the required labels.

C. 49 CFR 173.448(a) requires that each shipment of radioactive materials be secured in order to prevent shifting during normal transportation conditions.

Contrary to the above, on September 5, 1996, the licensee transported from the Federal Express building located in Moonachie, New Jersey to Gaitway Farm, Millstone Township, New Jersey a package containing approximately 120 millicuries of gold-198 seeds that was not properly secured to prevent shifting during transport. Specifically, the licensee placed the lead pig in a drawer located in the back of its vehicle and the lead pig was not properly blocked and braced in order to prevent shifting during normal transportation conditions.

D. 49 CFR 173.415(a) requires that each shipper of a DOT Specification 7A Type A package must maintain on file for at least one year after the latest shipment a complete documentation of tests and an engineering evaluation or comparative data showing that the construction methods, packaging design, and materials of construction comply with the specification as described in 49 CFR 178.350.

Contrary to the above, on September 5, 1996, the licensee shipped approximately 120 millicuries of gold-198 seeds that required a Type A package and the package used was not certified by the licensee as a Type A package. Specifically, the licensee neither performed nor maintained on file for at least one year after the latest shipment a complete documentation of tests and an engineering evaluation or comparative data showing that the construction methods, packaging design, and materials of construction comply with the specification as described in 49 CFR 178.350.

These violations represent a Severity Level II problem (Supplements IV, V, and VI)
Civil Penalty - $4,000

Pursuant to the provisions of 10 CFR 2.201, Dr. Sadovsky is hereby required to submit a written statement or explanation to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, within 30 days of the date of this Notice of Violation and Proposed Imposition of Civil Penalty (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation" and should include for each alleged violation: (1) admission or denial of the alleged violation, (2) the reasons for the violation if admitted, and if denied, the reasons why, (3) the corrective steps that have been taken and the results achieved, (4) the corrective steps that will be taken to avoid further violations, and (5) the date when full compliance will be achieved. If an adequate reply is not received within the time specified in this Notice, an Order or a Demand for Information may be issued as why other action as may be proper should not be taken. Consideration may be given to extending the response time for good cause shown. Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.

Within the same time as provided for the response required above under 10 CFR 2.201, the Licensee may pay the civil penalty by letter addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, with a check, draft, money order, or electronic transfer payable to the Treasurer of the United States in the amount of the civil penalty proposed above, or the cumulative amount of the civil penalties if more than one civil penalty is proposed, or may protest imposition of the civil penalty in whole or in part, by a written answer addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission. Should the Licensee fail to answer within the time specified, an order imposing the civil penalty will be issued. Should the Licensee elect to file an answer in accordance with 10 CFR 2.205 protesting the civil penalty, in whole or in part, such answer should be clearly marked as an "Answer to a Notice of Violation" and may: (1) deny the violation listed in this Notice, in whole or in part, (2) demonstrate extenuating circumstances, (3) show error in this Notice, or (4) show other reasons why the penalty should not be imposed. In addition to protesting the civil penalty in whole or in part, such answer may request remission or mitigation of the penalty.

In requesting mitigation of the proposed penalty, the factors addressed in Section VI.B.2 of the Enforcement Policy should be addressed. Any written answer in accordance with 10 CFR 2.205 should be set forth separately from the statement or explanation in reply pursuant to 10 CFR 2.201, but may incorporate parts of the 10 CFR 2.201 reply by specific reference (e.g., citing page and paragraph numbers) to avoid repetition. The attention of the Licensee is directed to the other provisions of 10 CFR 2.205, regarding the procedure for imposing a civil penalty.

Upon failure to pay any civil penalty due which subsequently has been determined in accordance with the applicable provisions of 10 CFR 2.205, this matter may be referred to the Attorney General, and the penalty, unless compromised, remitted, or mitigated, may be collected by civil action pursuant to Section 234c of the Act, 42 U.S.C. 2282c.

The response noted above (Reply to Notice of Violation, letter with payment of civil penalty, and Answer to a Notice of Violation) should be addressed to: James Lieberman, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North, 11555 Rockville Pike, Rockville, MD 20852-2738, with a copy to the Regional Administrator, U.S. Nuclear Regulatory Commission, Region I.

Because your response will be placed in the NRC Public Document Room (PDR), to the extent possible, it should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction. If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, you must specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information). If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.

Dated at Rockville, Maryland
this 1st day of May 1997

Page Last Reviewed/Updated Thursday, March 25, 2021