[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]


-----------------------------------------------------------------------

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]
BILLING CODE 7590-01-M