EA-99-123 - SibTech, Inc.

May 21, 1999

EA 99-123

Joseph Backer, Ph.D.
CEO
SibTech, Inc.
P.O. Box 579
Elmsford, NY 10523-0579


SUBJECT:   NOTICE OF VIOLATION
                     (NRC Office of Investigations Report No. 1-98-035)


Dear Dr. Backer:

This refers to the investigation conducted by the NRC Office of Investigations (OI) to determine if SibTech, Inc. (SibTech) knowingly engaged in the import and distribution of byproduct (radioactive) materials without a license. A copy of the OI synopsis is enclosed. Based on its investigation, OI concluded that you, as the Chief Executive Officer (CEO) of SibTech, imported and transferred byproduct material both domestically and internationally from 1993-1995 without a license, and distributed byproduct material to others from 1995-1998. OI did not substantiate that you deliberately violated the NRC regulations.

While most of these activities were conducted from the New York Medical College (NYMC) located in Valhalla, New York, which is under the jurisdiction of the State of New York, a NRC Agreement State, you acknowledged, during the investigation, that you had taken byproduct material as tritiated compounds to your former home in Tenafly, New Jersey (a location under NRC jurisdiction) during 1993-1995. Although you also indicated that you only repackaged the compounds at that location, your actions, nonetheless, violated NRC requirements since you received, possessed, and transferred NRC licensable radioactive materials in New Jersey without an NRC license. The violation is described in the enclosed Notice of Violation (Notice).

The circumstances surrounding this violation, its significance, and the need for lasting corrective actions were discussed with you during a telephone conversation with Ms. Judy Joustra, NRC Region 1, on May 12, 1999. During that call, you stated that you (1) admit that you violated an NRC requirement, (2) did not do so deliberately, (3) had stopped the activities that constituted the violation, and (4) had taken action to preclude the violation from happening again by applying for an NRC license on June 18, 1998. During that call, you were informed that while the NRC was considering escalated enforcement action for this violation, it may not be necessary to conduct an Predecisional Enforcement Conference since the NRC has an understanding of your corrective action. You indicated that you also did not see the need for a conference.

By possessing material in New Jersey without having an NRC license to do so, you operated outside the regulatory framework established to assure that the possession, use, and distribution of radioactive materials do not adversely affect public health and safety. As such, the NRC was unable to conduct inspections to verify whether the methods and controls you established for possessing, using, and distributing radioactive materials were in accordance with regulatory requirements established to protect public health and safety. Given the importance of proper controls over the possession, use, and distribution of radioactive material, the violation is classified at Severity Level III in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level III violation. Since your company has not been the subject of any escalated enforcement action in the past, 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. Credit for corrective actions is warranted because your corrective action was considered prompt and comprehensive at the time the OI report was issued. This action consisted of filing of an application to possess and use such material in the State of Connecticut (a location under NRC jurisdiction). Therefore, I have been authorized to not propose a civil penalty in this case. However, similar violations in the future could result in escalated enforcement action.

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 also address (1) what actions you have taken to ensure that there was no contamination at your former residence in Tenafly, New Jersey; and (2) why the NRC should have confidence that you will continue to comply with NRC requirements in the future. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements and to decide on the appropriate action on your application for an NRC license.

The OI findings also indicate that you performed activities in New York (at NYMC and your current residence in Mount Kisco) which may be violations of New York State requirements, including the New York State license issued to NYMC. Therefore, a copy of this letter, the attached Notice of Violation, and the OI synopsis, will be forwarded to the State of New York for whatever action it deems appropriate.

In accordance with Section 2.790 of NRC's "Rules of Practice," Part 2, Title 10, Code of Federal Regulations, a copy of this letter and your reply will be placed in the Public Document Room (PDR). Your cooperation with us is appreciated.

		Sincerely,
		Hubert J. Miller Regional Administrator

Enclosure:   Notice of Violation

cc:
State of New York
State of New Jersey
State of Connecticut
New York Medical College

---

ENCLOSURE 1
NOTICE OF VIOLATION
SibTech, Inc. Elmsford, NY		EA 99-123

During an NRC investigation conducted by the NRC Office of Investigations (OI), a violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG-1600, the violation is listed below:

10 CFR 30.3 requires, in part, that except for persons exempt, no person shall produce, transfer, receive, acquire, own, or possess byproduct material except as authorized in a specific or general license issued pursuant to Title 10, Chapter, Code of Federal Regulations. Contrary to the above, between 1993-1995, SibTech, Inc. transferred, received, acquired, owned and possessed millicurie amounts of tritiated (H-3) compounds at the then private residence of the SibTech Chief Executive Officer in Tenafly, New Jersey, and at the time, SibTech did not possess a valid NRC license to do so, and SibTech, Inc. was not exempt from the requirements for a license. This is a Severity Level III violation (Supplement VI).

Pursuant to the provisions of 10 CFR 2.2001, SibTech, Inc. is hereby required to submit a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555, with a copy to the Regional Administrator, Region 1, 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 or severity level, (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.

If you contest this enforcement action, you should also provide a copy of your response, with the basis for your denial, to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 20555-0001.

Under the authority of Section 182 of the Act, 42 U.S.C. 2232, your 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 or proprietary 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).


Dated at King of Prussia, PA
This 21th day of May 1999