[Federal Register Volume 61, Number 170 (Friday, August 30, 1996)]
[Notices]
[Pages 45994-45995]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22183]


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NUCLEAR REGULATORY COMMISSION

[Docket Nos. 030-31621, 030-31622; License Nos. 20-27938-03G, 20-27938-
02; EA 96-234]


HNU Systems, Inc., Newton Highlands, Massachusetts; Confirmatory 
Order Modifying License (Effective Immediately)

I

    HNU Systems, Inc. (Licensee or HNU), is the holder of Byproduct 
Materials License Nos. 20-27938-03G and 20-27938-02 (Licenses) issued 
by the Nuclear Regulatory Commission (NRC or Commission) pursuant to 10 
CFR Part 30. The Licenses authorize the distribution, possession, and 
use of sealed sources in devices generally licensed, not to exceed 100 
millicuries per source and 1,000 millicuries per foil, in accordance 
with the conditions specified therein. The Licenses were due to expire 
on March 31, 1996. However, on February 29, 1996, the Licensee filed a 
renewal application and, in accordance with 10 CFR 30.36(a), the 
Licenses are under a timely renewal.

II

    As a result of a June 1995 inspection, a Confirmatory Action Letter 
(CAL) was issued on June 15, 1995 and a Notice of Violation (NOV) was 
issued on July 27, 1995 to HNU for numerous violations characterized in 
the aggregate as a Severity Level III problem. The violations included 
the failure to: (1) notify the NRC that the Radiation Safety Officer 
(RSO) listed on the Licenses had been laid off and had not been 
replaced; (2) conduct a physical inventory of radioactive materials; 
(3) conduct leak tests of sealed sources at the required six month 
intervals; (4) calibrate survey instruments at the required six month 
intervals; (5) perform monthly surveys; (6) monitor exposures of 
individuals to radiation and radioactive material; (7) review the 
radiation protection program content and implementation at least 
annually; (8) report to the NRC any transfers of generally licensed 
devices; (9) maintain radiation safety record notebooks; and (10) 
provide training to Licensee staff.
    Subsequently, the NRC conducted a follow-up inspection from 
December 8, 1995, to April 23, 1996, to review the Licensee's 
implementation of the corrective actions taken in response to the June 
1995 CAL and July 1995 NOV. Based on this inspection, the NRC 
identified several repetitive violations and determined that the 
Licensee had not implemented adequately the corrective actions in 
response to the Notice and CAL.
    Therefore, the Commission required further information from HNU in 
order to determine whether the Commission can have reasonable assurance 
that in the future, should HNU be permitted by the NRC to continue to 
perform licensed activities under the Licenses, it will conduct the 
activities in accordance with NRC requirements, and whether further 
enforcement action is warranted against HNU. Accordingly, the NRC 
issued a Demand for Information (DFI) to the Licensee on June 7, 1996, 
which required the Licensee to submit, among other things to the NRC, 
within 30 days of the date of the DFI, in writing and under oath or 
affirmation:
    1. a statement as to whether the Licensee will apply sufficient 
resources to manage an effective radiation safety program; and
    2. a statement as to why the Licenses should not be revoked in 
light of the financial concerns and the repetitive violations.
    In a letter, dated June 18, 1996, the Licensee responded to the DFI 
and indicated that it would: (1) commit the necessary resources to 
permit the RSO (who works part-time) to work up to 20 hours per week 
until full compliance with the radiation safety program requirement was 
achieved, which it stated could be done in 4 months, after which it 
believes that it can maintain compliance by the RSO working 10-12 hours 
per week; (2) designate an assistant RSO from a qualified member of the 
staff; (3) complete, by August 1, 1996, a Radiation Safety Refresher 
Course, including testing, for employees dealing with instruments 
containing sealed sources; (4) conduct an annual audit of the radiation 
safety program, and update quarterly reports of source transfers by 
October 1, 1996; (5) perform wipes of all sources taken from storage; 
(6) calibrate a second survey meter by July 15, 1996, to ensure one 
calibrated survey meter is available at all times; (7) continue its 
search for a missing 50 mCi Fe-55 source; (8) provide locked files for 
radiation safety records; (9) have an outside auditor conduct an audit 
of the organization after the program is brought into full compliance; 
and (10) meet the specified payment schedule that it negotiated with 
the NRC Fees Branch for the payment of fees.
    In a followup call with the Licensee on July 18, 1996, the Licensee 
agreed that: (1) the RSO would work at least 20 hours per week, rather 
than 10-12 hours per week, until this condition was relaxed by the NRC; 
(2) it would have an outside auditor complete an audit of the 
organization by December 1, 1996; and (3) it would meet the other 
commitments made in its June 18, 1996 letter.
    On August 7, 1996, the Licensee consented to issuing this Order 
with the commitments, as described in Section III below. The Licensee 
further agreed in its August 7, 1996 letter that this Order is to be 
effective upon issuance and that it has waived its right for a hearing. 
Implementation of these commitments will provide enhanced assurance 
that sufficient resources will be applied to the radiation safety 
program, and that the program will be conducted safely and in 
accordance with NRC requirements.

[[Page 45995]]

    Therefore, I find that the Licensee's commitments as set forth in 
its June 18, 1996, and August 7, 1996 letters are acceptable and 
necessary, and conclude that with these commitments, the public health 
and safety are reasonably assured. In view of the foregoing, I have 
determined that the public health and safety require that the 
Licensee's commitments be confirmed by this Order. Based on the above 
and on the Licensee's consent, the Order is immediately effective upon 
issuance.

III

    Accordingly, pursuant to sections 81, 161b, 161i, 161o, 182, and 
186 of the Atomic Energy Act of 1954, as amended, and the Commissions's 
regulations in 10 CFR 2.202 and 10 CFR Part 30, it is hereby ordered, 
effective immediately upon issuance, that License Nos. 20-27938-03g and 
20-27938-02, are modified as follows:
    1. The Licensee's Radiation Safety Officer will work a minimum of 
20 hours per week until this commitment is relaxed by the NRC;
    2. An assistant RSO will be designated within 15 days of the date 
of the Order, and the Licensee will provide written notification to NRC 
Region I of the individual designated as assistant RSO and the 
individual's qualifications within 30 days of the date of the Order;
    3. A radiation safety refresher course, including testing, will be 
given by October 1, 1996 to all employees working with instruments 
containing sealed sources.
    4. The required annual audit of the radiation safety program, and 
all previously submitted quarterly reports of source transfers, will be 
completed by October 1, 1996, and submitted to NRC Region I by November 
1, 1996;
    5. Wipes will be performed of all sources taken from storage; in 
determining compliance with License Condition 12, appropriate actions 
will be taken if contamination greater than 0.005 Uci is identified, 
and appropriate wipe tests and source disposition records will be 
maintained, effective immediately;
    6. At least one calibrated survey meter will be available at all 
times;
    7. Radiation Safety Records will be placed in locked files within 
15 days of the date of the issuance of this Confirmatory Order;
    8. An experienced outside independent auditor will conduct and 
complete an audit of the Licensee's adherence to the requirements of 
its NRC Licenses by December 1, 1996. The Licensee shall submit the 
name and qualifications of the outside auditor to the NRC for approval 
by October 1, 1996, and the outside auditor shall provide the audit 
results simultaneously to both HNU and the NRC; and
    9. The Licensee will notify Mr. Francis Costello, Chief, Nuclear 
Materials Safety Branch 3, NRC Region I, if it does not adhere to the 
specified payment schedule that it negotiated with the NRC Fees Branch 
for the payment of fees, as noted in the Conditional Order Extending 
Time, dated June 24, 1996. If the payment schedule is not met, 
notification will be made within 10 business days from the missed 
payment due date.
    The Regional Administrator, Region I, may relax or rescind, in 
writing, any of the above conditions upon a showing by the Licensee of 
good cause.

IV

    Any person adversely affected by this Confirmatory Order, other 
than the Licensee, may request a hearing within 20 days of its 
issuance. 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, D.C. 20555, and include 
a statement of good cause for extension. Any request for a hearing 
shall be submitted to the Secretary, U.S. Nuclear Regulatory 
Commission, ATTN: Chief, Docketing and Service Section, Washington, 
D.C. 20555. Copies also shall be sent to the Director, Office of 
Enforcement, U.S. Nuclear Regulatory Commission, Washington, D.C. 
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. If such a person 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 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 Confirmatory Order should be 
sustained.
    Pursuant to 10 CFR 2.202(c)(2)(i), any person other than the 
Licensee, 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 suspicion, 
unfounded allegations, or error.
    This Order is immediately effective upon issuance. 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 III 
above shall be final 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 III 
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 
effectiveness of this Order.

    Dated at Rockville, Maryland this 22d day of August, 1996.

    For the Nuclear Regulatory Commission.
Joseph R. Gray,
Acting Director, Office of Enforcement.
[FR Doc. 96-22183 Filed 8-29-96; 8:45 am]
BILLING CODE 7590-01-P