EA-96-061 - Omnitron International, Inc.

June 21, 1996

EA 96-061

Richard V. Calfee, Ph.D.
President and Director
Omnitron International, Inc.
8990 Kirby Drive, Suite 200
Houston, Texas 77054

(NRC Inspection Report No. 150-00017/95-01 and Investigation Report No. 4-95-038)

Dear Dr. Calfee:

This refers to the inspection and investigation conducted on June 7, 1995 through April 4, 1996 at Omnitron International, Inc.'s facilities in Houston, Texas, and Lake Charles, Louisiana. The findings of the inspection were discussed with members of your staff during telephonic exit briefings on April 4 and 10, 1996, and the subject inspection report was subsequently issued on April 24, 1996. The inspection report identified one apparent violation, and Omnitron responded to the apparent violation by letter dated May 21, 1996.

Based on the information developed during the inspection and investigation, and the information provided in Omnitron's May 21 response to the inspection report, the NRC has determined that a violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation and Proposed Imposition of Civil Penalty and the circumstances surrounding it are described in detail in the subject inspection report. The violation involved the failure to receive authorization under either a specific or general NRC license prior to performing activities during calendar years 1992-1995 involving possession and use of byproduct material in non-Agreement States and other areas where the NRC maintains jurisdiction. Specifically, Omnitron performed iridium-192 source exchanges in remote afterloading devices and other services related to preparing the sources for return to Omnitron's facility in Edgerly, Louisiana. In our April 24 letter, the NRC also expressed concern about the fact the violation occurred over an extended period of time.

In its May 21 letter, Omnitron stated that the reason for the violation was the lack of specific knowledge by a certain former Omnitron employee, and the lack of clear explicit communications between this individual (who had contacted NRC) and the NRC concerning reciprocity requirements. Also, in response to NRC's concern about the duration of the apparent violation, Omnitron noted that it was contacted by two radiation control agencies concerning reciprocity requirements for work in those states, "and the assumption was that other radiation control agencies would also contact Omnitron, if applicable, since the same information was available to them." Although NRC will contact companies concerning reciprocity issues when the NRC becomes aware of the issues, we would highlight to you that it is Omnitron's responsibility to ensure compliance with NRC requirements.

As stated in our April 24, 1996, letter, the NRC considers the failure to seek and receive authorization under either a specific or general license prior to conducting activities using byproduct material in areas where it maintains jurisdiction to be a matter of significant regulatory concern. The failure to do so prevents the NRC from performing inspections of such activities to ensure that they are conducted safely and in accordance with NRC requirements. Therefore, this violation has been categorized in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600 at Severity Level III.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $5,000 is considered for a Severity Level III violation. Because your facility has not been the subject of escalated enforcement actions within the last 2 years, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Omnitron's corrective actions included immediate filing of reciprocity notification, developing a written procedure to ensure that appropriate radiation control agencies are notified, reaffirming the responsibility for regulatory affairs with the Radiation Safety Officer, and engaging the services of a consultant for reviewing and periodically auditing Omnitron's system. These actions warrant credit for the Corrective Action factor. Therefore, in accordance with the NRC's Enforcement Policy, no civil penalty will be assessed for this violation.

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. In your response, you should document the specific actions taken and any additional actions you plan to prevent recurrence. As noted in the Notice, you may refer to previously submitted correspondence in order to avoid duplication. After reviewing your response to this Notice, including your proposed corrective actions and the results of future inspections, the NRC will determine whether further NRC enforcement action is necessary to ensure compliance with NRC regulatory requirements.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosure, and your response will be placed in the NRC Public Document Room (PDR). To the extent possible, your response should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction.

Sincerely, org signed by
L. J. Callan
Regional Administrator

Docket No. 150-00017
License No. LA 6430-L01

Enclosure: Notice of Violation

cc w/enclosure:
Louisiana Radiation Control Program
Texas Radiation Control Program


Omnitron International, Inc.
Houston, Texas
Docket No. 150-00017
License No. LA-6430-L01
EA 96-061

During an NRC inspection and investigation conducted on June 7, 1995 through April 4, 1996, a violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the violation is listed below:

10 CFR 30.3 requires in relevant part, that no person shall possess or use byproduct material except as authorized by a specific or general license issued by the NRC.

10 CFR 150.20(a) provides in part that any person who holds a specific license from an Agreement State is granted an NRC general license to conduct the same activity in non-Agreement States subject to the provisions of 10 CFR 150.20(b).

10 CFR 150.20(b)(1) requires, in part, that any person engaging in activities in non-Agreement States shall, at least 3 days before engaging in each such activity, file 4 copies of NRC Form-241, "Report of Proposed Activities in Non-Agreement States", with the Regional Administrator of the appropriate NRC regional office.

Contrary to the above, during calendar years 1992-1995, Omnitron International, Inc., a licensee of the state of Louisiana, used iridium-192, in the states of New Jersey and Pennsylvania, non-Agreement States, without a specific license issued by the NRC or without filing Form-241 with the NRC. (01013)

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

Pursuant to the provisions of 10 CFR 2.201, Omnitron International, Inc., is hereby required to submit a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, D.C. 20555, with a copy to the Regional Administrator, Region IV, within 30 days of the date of the letter transmitting this Notice of Violation (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation" and should include for each violation: (1) the reason for the violation, or, if contested, the basis for disputing the violation, (2) the corrective steps that have been taken and the results achieved, (3) the corrective steps that will be taken to avoid further violations, and (4) the date when full compliance will be achieved. Your response may reference or include previous docketed correspondence, if the correspondence adequately addresses the required response. 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 to why the license should not be modified, suspended, or revoked, or why such other action as may be proper should not be taken. Where good cause is shown, consideration will be given to extending the response time.

Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.

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. However, if you find it necessary to include such information, you should clearly indicate the specific information that you desire not to be placed in the PDR, and provide the legal basis to support your request for withholding the information from the public.

Dated at Arlington, Texas,
this 21st day of June 1996

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