[Federal Register Volume 67, Number 211 (Thursday, October 31, 2002)]
[Notices]
[Pages 66425-66427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-27698]


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NUCLEAR REGULATORY COMMISSION

[IA 02-018]


In the Matter of Mr. Kenneth M. Baab; Order Prohibiting 
Involvement in NRC-Licensed Activities (Effective Immediately)

I

    Mr. Kenneth M. Baab (Mr. Baab) is Vice President of Advanced 
Medical

[[Page 66426]]

Imaging and Nuclear Services (AMINS). AMINS is the holder of Byproduct 
Nuclear Material License No. 37-30603-01 issued by the Nuclear 
Regulatory Commission (NRC or Commission) pursuant to 10 CFR Part 30. 
The license authorizes AMINS to possess and use any byproduct material 
listed in 10 CFR 35.100 and 10 CFR 35.200. The license was issued on 
February 16, 2001, and is due to expire on February 28, 2011.

II

    On November 30, 2001, the NRC conducted an inspection at AMINS. 
During the inspection, violations of NRC requirements were identified. 
The most significant violations involved the receipt, possession, and 
use of NRC licensed material between March 2001 and November 2001, 
without an Authorized User (AU) and Radiation Safety Officer (RSO) at 
the facility, contrary to 10 CFR 35.11(a) and 10 CFR 35.21. As a result 
of this finding, the NRC issued a Confirmatory Action Letter (CAL) on 
December 3, 2001, confirming AMINS commitment, in part, to: (1) 
Immediately place all byproduct material in its possession in secured 
storage; and (2) cease all licensed activities until AMINS retained an 
AU and RSO, and received approval (via a license amendment from the 
NRC) for the changes to bring the licensee's program into full 
compliance with 10 CFR part 35. The NRC subsequently issued an Order 
Suspending the license on December 14, 2001, as well as a Demand for 
Information on December 21, 2001, requesting information, in part, as 
to why the license should not be revoked.
    Between December 5, 2001 and March 27, 2002, the NRC Office of 
Investigations conducted an investigation of activities at the AMINS 
facility. During the investigation, the NRC determined that, (1) Mr. 
Babb, the AMINS Vice President (VP), and another individual (the Chief 
Operating Officer (COO)) operated the AMINS facility with the knowledge 
that the facility did not have an AU and RSO in deliberate violation of 
NRC regulations; (2) Mr. Babb and the COO knowingly caused false and 
misleading information to be provided to a radiopharmaceutical company 
to acquire the radiopharmaceuticals needed for diagnostic testing of 
AMINS patients; and (3) the records maintained by AMINS were 
inaccurate, since they named a physician as the AU, when, in fact, the 
individual was not acting as the AU. The evidence to support these 
conclusions include:
    [sbull] The AMINS VP prepared the NRC license application in 
October 2000, with the aid of a consulting physicist, and named an 
individual as the AU and RSO on the application; however, the 
individual named on the application stated that he was never employed 
by AMINS and never performed the duties of the AU and RSO at AMINS.
    [sbull] In March 2001, AMINS staff began performing licensed 
activities, including ordering and administering radiopharmaceuticals 
to patients on approximately 590 occasions between June 2001 and 
November 2001, using the name of an individual as the requesting AU 
who, in fact, was not the AU and had never been hired by AMINS.
    [sbull] In October 2001, a consulting physicist conducted an audit 
that revealed that the duties of the AU/RSO had not been performed, and 
he briefed Mr. Babb and the COO regarding the problem at the end of the 
audit, yet NRC licensed activities continued until the NRC inspection 
on November 30, 2001.
    [sbull] Mr. Babb, when interviewed by the OI investigator, admitted 
that he knew the facility was required to have an AU and RSO and knew 
that it was a problem in June 2001, but Mr. Babb did not take action to 
cease all licensed activities. In addition, he admitted to the OI 
investigator that there were financial considerations associated with 
keeping the facility open.

III

    The NRC's requirements in 10 CFR 30.10(a)(1) prohibit an employee 
of a licensee from engaging in deliberate misconduct that causes or, 
but for detection, would have caused, a licensee to be in violation of 
any rule, regulation, or order, or any term, condition, or limitation 
of any license, issued by the Commission. 10 CFR 35.11 requires, in 
part, that a person shall not use byproduct material for medical use 
except in accordance with a specific license or under the supervision 
of an authorized user as provided in 10 CFR 35.25. 10 CFR 35.21(a) 
requires that a licensee shall appoint a Radiation Safety Officer 
responsible for implementing the radiation safety program. Further, 10 
CFR 30.9 requires, in part, that information required to be maintained 
by the license shall be complete and accurate in all material respects.
    Based on the inspection and investigation, the NRC has concluded 
that Mr. Baab, as the VP of AMINS, violated 10 CFR 30.10. Specifically, 
Mr. Baab violated 10 CFR 30.10(a)(1) in that he engaged in deliberate 
misconduct that caused the Licensee to violate NRC requirements by: (1) 
Operating the AMINS facility without an AU, contrary to 10 CFR 35.11; 
(2) operating the AMINS facility without an RSO, contrary to 10 CFR 
35.21(a); and (3) maintaining inaccurate records, contrary to 10 CFR 
30.9, in that the records (which were used to order the radioactive 
material from a radiopharmacy) indicated that the material was being 
ordered by a physician listed as the AU, when in fact, the individual 
had never been employed by the licensee. The violations are significant 
because, by allowing licensed activities to continue even though he 
knew that AMINS did not have an AU and RSO, Mr. Babb's actions created 
the potential for unnecessary radiation exposures to workers and 
members of the public.

IV

    The NRC must be able to rely on the Licensee, and Licensee 
employees, to comply with NRC requirements, including the requirement 
to provide information that is complete and accurate in all material 
respects. Mr. Baab's deliberate violation of Commission regulations 
raises serious questions as to whether he can be relied upon to comply 
with NRC requirements including the maintenance of complete and 
accurate information.
    Consequently, I lack the requisite reasonable assurance that 
licensed activities can be conducted in compliance with the 
Commission's requirements and that the health and safety of the public 
would be protected if Kenneth M. Baab were permitted at this time to be 
involved in NRC-licensed activities. Therefore, the NRC has determined 
that the public health, safety and interest require that Kenneth M. 
Baab be prohibited from any involvement in NRC-licensed activities for 
a period of one year. Since licensed activities at AMINS ceased on 
December 14, 2001, with the NRC issuance of the Order Suspending 
License, and since Mr. Babb has not been involved in licensed 
activities since that time, the one-year prohibition period will 
retroactively begin on December 14, 2001, and end on December 14, 2002. 
However, if Kenneth M. Baab is currently involved in NRC-licensed 
activities at any NRC licensed facility, Mr. Baab must immediately 
cease such activities, and inform the NRC of the name, address and 
telephone number of the employer, and provide a copy of this Order to 
the employer. Additionally, Mr. Baab is required to notify the NRC of 
his first employment in NRC-licensed activities following the one-year 
prohibition period.
    Pursuant to 10 CFR 2.202, I find that the significance of Mr. 
Baab's conduct

[[Page 66427]]

described above is such that the public health, safety and interest 
require that this Order be immediately effective.

V

    Accordingly, pursuant to Sections 81, 161b, 161i, 161o, 182 and 186 
of the Atomic Energy Act of 1954, as amended, and the Commission's 
regulations in 10 CFR 2.202, 10 CFR 30.10, and 10 CFR 150.20, it is 
hereby ordered, effective immediately, that:
    1. Kenneth M. Baab is prohibited from engaging in NRC-licensed 
activities for one year effective from December 14, 2001. NRC-licensed 
activities are those activities that are conducted pursuant to a 
specific or general license issued by the NRC, including, but not 
limited to, those activities of Agreement State licensees conducted 
pursuant to the authority granted by 10 CFR 150.20.
    2. If Kenneth M. Baab is currently involved in NRC-licensed 
activities, Mr. Baab must immediately cease such activities, and inform 
the NRC of the name, address and telephone number of the employer, and 
provide a copy of this Order to the employer.
    3. For a period of one year after the one-year period of 
prohibition has expired, Mr. Baab shall, within 20 days of his 
acceptance of each employment offer involving NRC-licensed activities, 
as defined in Paragraph V.1 above, provide notice to the Director, 
Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, 
DC 20555, of the name, address, and telephone number of the employer or 
the entity where he is, or will be, involved in the NRC-licensed 
activities. In the first notification, Mr. Baab shall include a 
statement of his commitment to compliance with regulatory requirements 
and the basis why the Commission should have confidence that he will 
now comply with applicable NRC requirements.
    The Director, Office of Enforcement, may, in writing, relax or 
rescind any of the above conditions upon demonstration by Mr. Baab of 
good cause.

VI

    In accordance with 10 CFR 2.202, Kenneth M. Baab must, and any 
other person adversely affected by this Order may, submit an answer to 
this Order, and may request a hearing on this Order, within 20 days of 
the date of this Order. Where good cause is shown, consideration will 
be given to extending the time to request a hearing. A request for 
extension of time must be made in writing to the Director, Office of 
Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555, 
and include a statement of good cause for the extension. The answer may 
consent to this Order. Unless the answer consents to this Order, the 
answer shall, in writing and under oath or affirmation, specifically 
admit or deny each allegation or charge made in this Order and shall 
set forth the matters of fact and law on which Mr. Baab or other person 
adversely affected relies and the reasons as to why the Order should 
not have been issued. Any answer or request for a hearing shall be 
submitted to the Secretary, U.S. Nuclear Regulatory Commission, Attn: 
Chief, Rulemakings and Adjudications Staff, Washington, DC 20555. 
Copies also shall be sent to the Director, Office of Enforcement, U.S. 
Nuclear Regulatory Commission, Washington, DC 20555, to the Assistant 
General Counsel for Materials Litigation and Enforcement at the same 
address, to the Regional Administrator, NRC Region I, U.S. Nuclear 
Regulatory, 475 Allendale Road, King of Prussia, Pennsylvania 19406, 
and to Mr. Baab if the answer or hearing request is by a person other 
than Mr. Baab. Because of continuing disruptions in delivery of mail to 
United States Government offices, it is requested that answers and 
requests for hearing be transmitted to the Secretary of the Commission 
either by means of facsimile transmission to 301-415-1101 or by e-mail 
to [email protected] and also to the Assistant General Counsel 
either by means of facsimile transmission to 301-415-3725 or by e-mail 
to [email protected]. If a person other than Mr. Baab requests a 
hearing, that person shall set forth with particularity the manner in 
which his interest is adversely affected by this Order and shall 
address the criteria set forth in 10 CFR 2.714(d).\1\
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    \1\ The most recent version of Title 10 of the Code of Federal 
Regulations, published January 1, 2002, inadvertently omitted the 
last sentence of 10 CFR 2.714(d) and paragraphs (d)(1) and (2), 
regarding petitions to intervene and contentions. For the complete, 
corrected text of 10 CFR 2.714(d), please see 67 FR 20884; April 29, 
2002.
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    If a hearing is requested by Mr. Baab or a person whose interest is 
adversely affected, the Commission will issue an Order designating the 
time and place of any hearing. If a hearing is held, the issue to be 
considered at such hearing shall be whether this Order should be 
sustained.
    Pursuant to 10 CFR 2.202(c)(2)(i), the licensee may, in addition to 
demanding a hearing, at the time the answer is filed or sooner, move 
the presiding officer to set aside the immediate effectiveness of the 
Order on the ground that the Order, including the need for immediate 
effectiveness, is not based on adequate evidence but on mere suspicion, 
unfounded allegations, or error.
    In the absence of any request for hearing, or written approval of 
an extension of time in which to request a hearing, the provisions 
specified in Section V above shall be final twenty (20) days from the 
date of this Order without further order or proceedings. If an 
extension of time for requesting a hearing has been approved, the 
provisions specified in Section V shall be final when the extension 
expires if a hearing request has not been received. An answer or a 
request for hearing shall not stay the immediate effectiveness of this 
order.

    Dated: Dated this 22nd day of October 2002.

    For the Nuclear Regulatory Commission.
Carl J. Paperiello,
Deputy Executive Director for Materials, Research, and State Programs.
[FR Doc. 02-27698 Filed 10-30-02; 8:45 am]
BILLING CODE 7590-01-P