EA-96-242 - Overhoff Technology Corporation

August 19, 1998

EA 96-242

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


Dear Dr. Overhoff:

This refers to your letter dated May 12, 1998, in response to the Notice of Violation and Proposed Imposition of Civil Penalty (Notice) sent to you by our letter dated April 16, 1998. Our letter and the Notice described two violations which were classified in the aggregate as a Severity Level III problem. A civil penalty of $2,500 was proposed for the violations to emphasize that willful violations of NRC requirements will not be tolerated and to ensure prompt identification of violations. In addition, one other violation classified at Severity Level IV was not assessed a civil penalty.

In the response to the Notice, you admitted the violations; however, you denied that they were willful, argued that they were without safety consequence, and requested full mitigation of the civil penalty.

The term "willfulness" as discussed in the NRC Enforcement Policy, embraces a spectrum of violations ranging from deliberate intent to violate or falsify to and including careless disregard for requirements. After considering your response to the Notice, the NRC staff concludes that the violations do represent careless disregard for requirements, as determined by the circumstances associated with Overhoff's application for its exempt distribution license, as well as statements made by you and your staff during the inspection, the NRC investigation by the Office of Investigations, and the transcribed predecisional enforcement conference.

Your response to the Notice indicates the cause for Violation I.A was oversight due to work pressures and the desire to provide good customer service, and that you believe you met the spirit of the regulations. In addition, the response stated the shipments were of negligible quantities and had no safety consequences. The NRC agrees that the amounts of material shipped were relatively small; however, they exceeded the regulatory limits for the amount of radioactive material which may be distributed to persons exempt from a license. These regulatory limits are based upon minimizing the potential for harm. It is apparent that Overhoff was aware of these limits because the license application dated October 3, 1994, stated that quantities of tritium gas in any single lecture bottle would not exceed the limits listed in 10 CFR 30.71, Schedule B (1 millicurie). The application also specified that each lecture bottle would not exceed 1 millicurie. However, you stated to the OI investigator that, during March 1996, two tritium gas calibrators were filled in excess of allowable limits because you did not do any calculations prior to filling the calibrators. You stated that you "made a judgement on the fly" because you thought the gas being used to fill the calibrators was "pretty weak" and thus did not perform the calculations prior to filling the calibrators. You were aware that you did not know the specific activity, you were aware of the requirement, and you made a conscious decision to proceed without checking. Under these circumstances, exceeding regulatory limits in March 1996 by distributing two calibrators, each containing several times the permitted level of radioactive gas (tritium), demonstrates careless disregard for regulatory requirements.

Your response to Violation I.B indicates the violation was caused by confusion between the requirements of Overhoff's licenses for manufacturing, general distribution, and exempt distribution. However, during the licensing process for the exempt distribution license, the shipping requirements for exempt distribution were discussed at length between yourself and the NRC licensing reviewer. Additionally, in Overhoff's initial application for its exempt distribution license, you quoted the regulations for shipping exempt sources word-for-word and made a request for an exemption to them. Specifically, you requested that Overhoff be allowed to ship 50 exempt sources per package rather than the required 10 sources per package. This request was not granted. At the time of licensing, the requirement was clear. Therefore, the NRC does not accept your argument regarding confusion. During the May 16 through July 3, 1996 inspection, NRC found that Overhoff shipped 100 sources per package in six shipments and 87 sources per package in one shipment.

You state in your response that the Navy, which was a recipient of greater than ten exempt quantities, holds an NRC license; and that the Navy did the actual distribution to persons exempt. However, Overhoff shipped these sources to the Navy labeled for exempt distribution. Therefore, while the Navy may hold an NRC license, it was under no obligation to treat these sources as licensed material, and their receipt and use by the Navy was not in any way controlled by the Navy's NRC license. Overhoff, not the Navy, holds the license that permits distribution to persons exempt. Under these circumstances, it is Overhoff, not the Navy, that must control the exempt distribution and assure that it is in accordance with 10 CFR 32.19.

For these reasons, the NRC staff has determined that the violations occurred as stated and that you did not provide an adequate basis for your contention that the violations were not willful. However, upon reconsideration of the types and quantities of material involved in the violations, together with the fact that Overhoff constitutes a small entity for purposes of the Small Business Regulatory Enforcement Fairness Act (SBREFA), I have been authorized, after consultation with the Deputy Executive Director for Regulatory Effectiveness, to exercise enforcement discretion and withdraw the civil penalty assessed for the two violations constituting a Severity Level III problem. The withdrawal of this civil penalty should not be considered a lessening of the seriousness with which the NRC views willful violations, and similar treatment should not be expected for any future violations. You should now be aware of the importance of maintaining full compliance with NRC requirements. You are on notice that work pressures and the desire to provide good customer service do not excuse violations of regulatory requirements. Therefore, willful noncompliance in the future may result in a significant civil penalty, as well as modification, suspension, or revocation of your license(s).

Based upon the actions that Overhoff agreed to take in response to the violations, as documented in the Confirmatory Action Letter (CAL) dated August 19, 1996, as well as the results of a follow-up inspection conducted on October 28, 1997, the NRC staff has concluded that a further response to the Notice of Violation is not necessary. In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter and the enclosures will be placed in the NRC's Public Document Room.

Sincerely, R. W. Borchardt, Acting Director
Office of Enforcement

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

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