[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: 94-22986]
[[Page Unknown]]
[Federal Register: September 16, 1994]
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NUCLEAR REGULATORY COMMISSION
[Docket No. 030-19953 License No. 20-20592-01 EA 94-136]
Creative Biomolecules, Inc.; Hopkinton, MA; Order Modifying
License (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 Sec. 30.4(q) of 10 CFR Part 30.
The License, originally issued on April 20, 1983, was amended in its
entirety of 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 (OI).
As a result of the OI 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 signed by Dr. Kusmik and sent to the NRC, 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, 1992 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 License Condition 14, 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 sated 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. Dr. Kusmik's actions
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.
The NRC must be able to rely on the Licensee and its employees to
comply with NRC requirements, including the requirement to provide
information and maintain records that are complete and accurate in all
material respects. Dr. Kusmik's actions in causing the Licensee to
violate 10 CFR 30.9 and his misrepresentations to the NRC have raised
serious doubt as to whether he can be relied upon to comply with NRC
requirements and to provide complete and accurate information to the
NRC, if he was employed as an RSO or authorized user.
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,
including the licensee's employees, will be protected if Dr. Kusmik
were permitted at this time to be an authorized user listed on the
License or act as an RSO. Therefore, the public health, safety and
interest require that License No. 20-20592-01 be modified to: (1)
Remove Dr. Kusmik from being named on the License as an authorized user
and prohibit Dr. Kusmik from acting as an RSO; and (2) require that Dr.
Kusmik be directly supervised by an authorized user should he perform
NRC-licensed activities. 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
immediately effective.
IV
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 and 10 CFR Part 30, it is hereby ordered,
effective immediately, that license no. 20-20592-01 is modified as
follows:
A. Dr. William F. Kusmik, for a period one year from the date of
this Order, is:
1. removed from Condition 11.A of License No. 20-20592-01 as an
authorized user; and
2. prohibited from acting as an RSO.
B. During the one-year period set forth in Paragraph IV.A of this
Order, the 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 License No. 20-20592-01. 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 supervising authorized user shall routinely observe and
review all radiological safety records generated by Dr. Kusmik's
activities. On a 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 radiological safety activities
conducted by Dr. Kusmik on quarterly basis; and
c. review and institute corrective actions for any violations
noted.
4. The documents required in Paragraph IV.B of this Order must be
retained until the next NRC inspection following the one-year
restriction of Dr. Kusmik.
C. For purposes of this Order, an authorized user is a person who
is listed on the 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, relax or
rescind any of the above conditions upon demonstration by the Licensee
of good cause.
V
In accordance with 10 CFR 2.202, the Licensee must, and Dr. Kusmik
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, 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 the Licensee, 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 the Licensee and Dr. Kusmik if the
answer or hearing request is by a person other than the Licensee or Dr.
Kusmik. If a person other than the Licensee or Dr. Kusmik 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).
If a hearing is requested by the Licensee, Dr. Kusmik, or any other
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, Dr. Kusmik, or any
other person adversely affected by this Order, may, in addition to
demanding a hearing, at the same 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, 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. 94-22986 Filed 9-15-94; 8:45 am]
BILLING CODE 7590-01-M
