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
