[Federal Register Volume 59, Number 179 (Friday, September 16, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-22988]
[[Page Unknown]]
[Federal Register: September 16, 1994]
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NUCLEAR REGULATORY COMMISSION
[IA 94-022]
Dr. William F. Kusmik; Order Prohibiting Involvement in Certain
NRC-Licensed Activities (Effective Immediately)
I
Creative Biomolecules, Inc. (Licensee) is the holder of Byproduct
License No. 20-20592-01 (License) issued by the Nuclear Regulatory
Commission (NRC or Commission) pursuant to 10 CFR Part 30. The License
authorizes the Licensee to use certain stated byproduct materials for
research and development as defined in Section 30.4(q) of 10 CFR Part
30. At the time of an NRC inspection in November 1992, Dr. William F.
Kusmik was the Radiation Safety Officer at the facility. The License,
originally issued on April 20, 1983, was amended in its entirety on
March 3, 1993, and was due to expire on March 31, 1994, but has
remained in effect since that time due to a timely renewal request made
pursuant to 10 CFR 30.37(b).
II
On November 10-11, 1992, the NRC performed an inspection at the
Licensee's facility in Hopkinton, Massachusetts. During the inspection,
the NRC identified numerous violations of NRC requirements. As a result
of the inspection findings, a Confirmatory Action Letter was issued to
the Licensee on November 12, 1992. The inspector also found indications
that information provided by Dr. William F. Kusmik (the Radiation
Safety Officer (RSO) at the facility at the time of an NRC inspection
in November 1992) in a letter dated September 21, 1992, did not appear
to be accurate, and that records of monthly wipe tests at the facility
may have been falsified. As a result, an investigation was conducted by
the NRC Office of Investigations (0I).
As a result of the 0I investigation, a transcribed enforcement
conference was conducted on June 7, 1994, with Dr. Kusmik, to address
whether he: (1) deliberately directed a Licensee employee to falsify
certain NRC-required wipe test records; and (2) deliberately provided
false or misleading information to the NRC in a letter dated September
21, 1992, in response to a previous Notice of Violation (Notice) issued
by the NRC on July 29, 1992.
With respect to the issue of records falsification, Dr. Kusmik
admitted during the enforcement conference that in 1991 he directed an
employee to fabricate records of wipe tests for certain months (at a
minimum, for November 1990 and February 1991), even though the tests
had not been performed for those months.
With respect to the information provided in the September 21, 1992
letter sent to the NRC under Dr. Kusmik's signature, Dr. Kusmik
admitted during the enforcement conference that he had stated in the
letter that certain actions had been taken in response to NRC
inspection findings articulated in the July 29, 1992 letter and Notice,
when, in fact, those stated actions had not been taken. Specifically,
in response to the July 29, 1992 Notice involving the failure to
perform surveys of a certain laboratory required to be performed by
License Condition 14, the September 21, 1991 letter stated that ``To
avoid a repetition of these discrepancies, three individuals within the
laboratory have been trained to perform these surveys.'' This statement
was not accurate in that Dr. Kusmik stated during the enforcement
conference that while he intended to provide such training, no such
training subsequent to the July 29, 1992 Notice had been provided at
the time Dr. Kusmik signed and sent the September 21, 1992 letter to
the NRC. In addition, in response to a concern expressed in the NRC's
July 29, 1992 letter transmitting the Notice, involving the licensee's
plans to obtain access to a thyroid phantom or some other method to
quantitatively determine thyroid uptakes of personnel, the licensee's
September 21, 1992 letter stated that ``A calibrated survey meter with
a Sodium Iodine [iodide] crystal has been recalibrated for thyroid
counting using a thyroid phantom consisting of a plexiglas block
approximately three inches thick.'' This statement was not accurate in
that Dr. Kusmik admitted during the enforcement conference that the
sodium iodide crystal had not been recalibrated at the time he had
signed and sent the letter to the NRC.
Based on the above, the NRC has concluded that in 1991, Dr. Kusmik
caused the Licensee to be in violation of 10 CFR 30.9(a). Specifically,
Dr. Kusmik deliberately directed an employee to fabricate records,
required to be maintained by the License, of wipe tests for certain
months (at a minimum, for November 1990 and February 1991), even though
the tests had not been performed during those months. In addition, on
September 21, 1992, Dr Kusmik violated 10 CFR 30.10(a) by engaging in
deliberate misconduct that caused the Licensee to be in violation of 10
CFR 30.9(a). Specifically, Dr. Kusmik deliberately submitted to the NRC
false information in the September 21, 1992 letter in which he stated
that: (1) three individuals within the laboratory had been trained to
perform surveys; and (2) a calibrated survey meter with a Sodium Iodide
crystal had been recalibrated for thyroid counting.
III
As a result, the NRC has serious concerns regarding Dr. Kusmik's
performance and supervision of NRC-licensed activities, and in
particular, the supervision of such activities. The actions of Dr.
Kusmik, described above, were particularly serious since, as the RSO at
the facility, Dr. Kusmik was charged with ensuring that Licensee staff
adhered to requirements and performed activities in a safe manner.
Rather than properly discharging those responsibilities, Dr. Kusmik set
an unacceptable example for the individuals to whom he gave direction,
as well as to others engaged in NRC-licensed activities at the
facility.
While Dr. Kusmik did not cooperate during the OI investigation, he
did provide information during the transcribed enforcement conference
on June 7, 1994. Specifically, Dr. Kusmik stated that he: (1) directed
an employee to falsify NRC-required wipe test records; and (2) provided
false or misleading information to the NRC in a letter, dated September
21, 1992, in response to a Notice of Violation. The NRC recognizes Dr.
Kusmik was candid and straightforward with the NRC when questioned
during the enforcement conference. The NRC also recognizes that Dr.
Kusmik was contrite and expressed remorse for his actions. However, Dr.
Kusmik's actions cannot and will not be tolerated by the NRC.
Consequently, I lack the requisite reasonable assurance that
information provided to the NRC by Dr. Kusmik, or required to be
maintained by Dr. Kusmik or the Licensee, will be complete and accurate
in all material respects, and that the health and safety of the public
will be protected if Dr. Kusmik were permitted at this time to be an
authorized user listed on any NRC license or act as an RSO.
Therefore, the public health, safety and interest require that Dr.
Kusmik: (1) be prohibited from being an authorized user and from acting
as an RSO for a period of one year from the date of this Order; (2) for
a period of three years from the date of the Order, notify the NRC
within 20 days of his acceptance of an employment offer involving NRC-
licensed activities; and (3) Dr. Kusmik, within 30 days from the date
of this Order, provide a statement of his commitment to comply with NRC
requirements and the basis why the Commission should have confidence
that he will comply with applicable NRC requirements. Furthermore,
pursuant to 10 CFR 2.202, I find that the significance of the conduct
described above is such that the public health, safety and interest
require that this Order be effective immediately.
IV
Accordingly, pursuant to sections 81, 161b, 161i, 182 and 186 of
the Atomic Energy Act of 1954, as amended, and the Commission's
regulations in 10 CFR 2.202 and 10 CFR 30.10, it is hereby ordered,
effective immediately, that:
A. Dr. William F. Kusmik is prohibited from being an authorized
user and from acting as an RSO on any NRC license for a period of one
year from the date of this Order. During this one-year period, an NRC
licensee may allow Dr. Kusmik to perform NRC-licensed activities only
if he is under the direct supervision of an authorized user as defined
below. 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. During
this time period, Dr. Kusmik must also provide a copy of this Order to
prospective employers who engage in NRC-licensed activities.
Supervision of Dr. Kusmik during this period shall be performed as
follows:
1. The licensee must document the name of the authorized user
responsible for supervising Dr. Kusmik's activities and ensuring
compliance with all applicable NRC requirements.
2. The authorized user supervising Dr. Kusmik shall routinely
observe and review all radiological safety records generated by Dr.
Kusmik's activities. On monthly basis, records generated by Dr. Kusmik
will be reviewed and initialed by the supervising authorized user to
assure that the records are complete and accurate. Any record found not
to be in accordance with NRC requirements shall be reported to the RSO.
3. The RSO shall:
a. ensure and document that he/she has provided training to Dr.
Kusmik on the License, its conditions, and all applicable NRC
requirements including the Licensee's radiation safety procedures;
b. perform documented audits of all NRC-licensed activities
performed by Dr. Kusmik on quarterly basis; and
c. review and institute corrective actions for any violations
noted.
4. Records of NRC--licensed activities conducted by Dr. Kusmik must
be retained until the next NRC inspection.
B. For a period of three years from the date of the Order, Dr.
Kusmik shall, within 20 days of his acceptance of each employment offer
involving NRC-licensed activities, as defined in Paragraph IV.A above,
provided notice to the Director, Office of Enforcement, U.S. Nuclear
Regulatory Commission, Washington, D.C. 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.
C. Dr. Kusmik shall, within 30 days of the date of this order,
provide a statement to the Director, Office of Enforcement, U.S.
Nuclear Regulatory Commission, Washington, D.C. 20555, of this
commitment to comply with regulatory requirements and the basis why the
Commission should have confidence that he will now comply with
applicable NRC requirements.
D. For purposes of this Order, an authorized user is a person who
is listed on an NRC license as a user of, or is an individual who
supervises other persons using, NRC-licensed material.
The Director, Office of Enforcement, may, in writing, relay or
rescind any of the above conditions upon demonstration by Dr. Kusmik of
good cause.
V
In accordance with 10 CFR 2.202, Dr. Kusmik 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. The answer may consent to this Order. Unless the
answer consents to this Order, and 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 or which Dr. Kusmik 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, Docketing and Service
Section, 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 Hearings and
Enforcement at the same address, to the Regional Administrator, NRC
Region I, 475 Allendale Road, King of Prussia, Pennsylvania 19406, and
to Dr. Kusmik if the answer or hearing request is by a person other
than Dr. Kusmik. If a person other than Dr. Kusmik requests a hearing,
that person shall set forth with particularly the manner in which his
or her interest is adversely affected by this Order and shall address
the criteria set forth in 10 CFR 2.714(d).
If a hearing is requested by Dr. Kusmik 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), Dr. Kusmik, or any other person
adversely affected by this Order, 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 suspension, unfounded
allegations, or error.
In the absence of any request for hearing, the provisions specified
in Section IV above shall be final 20 days from the date of this Order
without further order or proceedings. An Answer Or a Request For
Hearing Shall Not Stay The Immediate Effectiveness of This Order.
Dated at Rockville, Maryland this 7th day of September 1994.
For the Nuclear Regulatory Commission.
Hugh L. Thompson, Jr.,
Deputy Executive Director for Nuclear Materials Safety, Safeguards, and
Operations Support.
[FR Doc. 94-22988 Filed 9-15-94; 8:45 am]
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