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EA-96-242 - Overhoff Technology Corporation

April 16, 1998

EA 96-242

Mario W. Overhoff, Ph.D., President
Overhoff Technology Corporation
P.O. Box 182
Milford, OH 45150

SUBJECT: NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY -$2500
(Inspection Report 030-33731/96001(DNMS) and OI Investigation Report 3-96-028)

Dear Dr. Overhoff:

This refers to the inspection conducted on May 16, 1996 through July 3, 1996, and the investigation initiated on May 21, 1996, by the NRC Office of Investigations (OI) and completed on February 17, 1998, at Overhoff Technology Corporation (OTC) in Milford, Ohio. The subject inspection report was sent to you by letter dated July 9, 1996. A transcribed predecisional enforcement conference was held in the NRC Region III office with you on July 30, 1996, to discuss the apparent violations, their causes, and proposed corrective actions. As a result of the issues raised during the conference an OI investigation was conducted. A copy of the synopsis of the OI investigation report is enclosed with this action.

Based on the information developed during the inspection, the OI investigation, and the information that was provided during the conference, the NRC has determined that violations of NRC requirements occurred. These violations are cited in the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice) and the circumstances surrounding them are described in detail in the subject inspection report.

The NRC has concluded that the violations cited in Section I of the Notice, the failure to ensure that the quantity of tritium contained in gas calibrator devices did not exceed the 10 CFR 30.71 limits, and the failure to ensure that no more than 10 exempt quantities were transferred in any single transaction, are willful. Based upon statements made during the transcribed predecisional enforcement conference and during the OI investigation, the reason given for these violations is that there was confusion of the requirements between OTC's "G" license and the "E" license. However, these very same issues regarding exempt quantities and shipping practices were discussed at length between you and the NRC reviewer during the licensing process for the "E" license. It is the NRC's view that OTC staff was aware of the "E" license requirements, and demonstrated careless disregard by failing to meet those "E" license requirements. Willful violations are of concern because the NRC's regulatory programs are based on licensees and their employees acting with integrity. This is particularly true in this case because you have the authority to ship radioactive materials to persons who are exempt from the regulations. A consideration in permitting the distribution of radioactive material to persons exempt from an NRC license is the limitation imposed on the quantity that may be distributed in order to minimize the potential for harm.

It is essential that the NRC be able to maintain the highest trust in individuals working with licensed material and that licensees appropriately manage their programs to ensure that all individuals fully understand the importance of complying with regulatory requirements. Because of the willful nature of the violations and your involvement, as an OTC official, the violations in Section I of the Notice are classified in the aggregate in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, as a Severity Level III problem.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,500 is considered for a Severity Level III problem. Because the violations were deemed as willful, the NRC considered whether credit was warranted for Identification and Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Credit for identification was not warranted because the violations were identified by the NRC during a routine inspection. A Confirmatory Action Letter (CAL) dated August 19, 1996, discussed the actions OTC agreed to take in response to the violations. The actions included, but were not limited to: (1) a review of the NRC license including all referenced documents and pertinent NRC rules by all staff; (2) development of written procedures to ensure that all calibrator bottles contained the appropriate quantity of tritium; and (3) training of all staff regarding written procedures for filling gas cylinders and shipping material to customers. Subsequent to the CAL, a re-inspection of OTC's license activities confirmed that the corrective actions had been implemented; therefore, credit for Corrective Action is warranted.

Therefore, to emphasize that willful violations of NRC requirements will not be tolerated and to ensure prompt identification of violations, I have been authorized, after consultation with the Director, Office of Enforcement, to issue the enclosed Notice of Violation and Proposed Imposition of Civil Penalty in the amount of $2,500 for the Severity Level III problem in Section I of the Notice.

The violation in Section II of the Notice involves the failure to label tritium gas calibrators in accordance with the license documents is categorized as a Severity Level IV violation in accordance with the Enforcement Policy.

You are required to respond to this letter and should follow the instructions specified in the enclosed 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 addition, issuance of this Notice constitutes escalated enforcement action that may subject you to increased inspection effort.

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.

Sincerely, A. Bill Beach
Regional Administrator

Docket No. 030-33731
License No. 34-18214-03E

Enclosures:
1. Notice of Violation and Proposed Imposition of Civil Penalty
2. OI synopsis

NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

Overhoff Technology Corporation
Milford, Ohio		 Docket No. 030-33731
License No. 34-18214-03E
EA 96-242

During the NRC inspection conducted from May 16 through July 3, 1996, and the OI investigation conducted between May 21,1996 and February 17, 1998, 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 civil penalties 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. Violations Assessed a Civil Penalty

A. License No. 34-18214-03E authorizes the licensee to distribute check sources containing byproduct material listed in 10 CFR 30.71, Schedule B and tritium gas calibrators in accordance with the license application dated October 3, 1994, and letters dated September 8, 1995, September 13, 1995, and September 30, 1995.

Section 6.2 of the license application dated October 3, 1994, states, in part, that in gas form, quantities of each byproduct material will not exceed 10 CFR 30.71, Schedule B. The Schedule B limit for tritium (hydrogen-3) is one millicurie.

Contrary to the above, in March 1996, devices were distributed that contained quantities of byproduct material in excess of the limits listed in 10 CFR 30.71, Schedule B. Specifically, two calibrators were distributed to Kirtland Air Force base and Argonne National Laboratories, each containing approximately 9.0 millicuries {333 MBq} of tritium gas. (01013)

B. 10 CFR 32.19(a) requires that no more than 10 exempt quantities set forth in Schedule B of 10 CFR 30.71 shall be sold or transferred in any single transaction.

Contrary to the above, between March 18 and 22, 1996, seven transactions were made involving 687 krypton-85 calibration sources. These transactions were made in six transfers in lots of 100 exempt quantities at a time and one transfer of 87 exempt quantities. (01023)

These violations represent a Severity Level III problem (Supplement VI).
Civil Penalty – $2,500

II. Violation Not Assessed a Civil Penalty

License No. 34-18214-03E authorizes the distribution of check sources containing byproduct material listed in 10 CFR 30.71, Schedule B and tritium gas calibrators in accordance with the license application dated October 3, 1994, and letters dated September 8, 1995, September 13, 1995, and September 30, 1995.

Item 2 of the letter dated September 30, 1995, references drawing N090695-1 with related drawings N032895-4 and N032895-6, which describe the dimensions of the lecture bottle radioactive calibration standard as well as type, quantities, and locations of the labeling to be applied on the tritium calibrators.

Contrary to the above, tritium calibrators distributed in March 1996, specifically, Serial Nos. 1939 and 1919, were not labeled in accordance with the representation in drawings N090695-1 and N032895-6. (02014)

This is a Severity Level IV violation (Supplement VI).

Pursuant to the provisions of 10 CFR 2.201, Overhoff Technology Corporation (Licensee) 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 Penalties (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 the license should not be modified, suspended, or revoked or why such 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 penalty 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 violations 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 III, 801 Warrenville Road, Lisle, Illinois 60532-4351.

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 Lisle, Illinois
this 16th day of April 1998

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