[Federal Register Volume 59, Number 220 (Wednesday, November 16, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-28256]
[[Page Unknown]]
[Federal Register: November 16, 1994]
=======================================================================
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
[Docket Nos. 030-02640; 030-31605; and 030-32479 License Nos. 34-00293-
02; 34-00293-14; and 34-00293-15 EA 94-215]
The Ohio State University, Columbus, Ohio; Confirmatory Order
Modifying License, Effective Immediately
I.
The Ohio State University (Licensee) is the holder of eight NRC
materials licenses, including broadscope License No. 34-00293-02;
License No. 34-00293-14, authorizing use of cobalt-60 sources in a wet
storage irradiator for in-water irradiation studies; and License No.
34-00293-15, authorizing use of a cobalt-60 source in a teletherapy
unit for treatment of animals. The broadscope license authorizes the
Licensee to possess, in part: (1) Radiopharmaceuticals and
brachytherapy sources in quantities as needed for medical diagnosis and
therapy; (2) ten curses (370 GBq) of iridium-192 in a remote
afterloading brachytherapy device for therapeutic treatments; (3) curie
quantities of any byproduct materials (with atomic numbers 1 to 83) in
any form for research and development (R&D) pursuant to 10 CFR 30.4,
and for student instruction and calibration of instruments; (4) curie
quantities of any byproduct material (with atomic numbers 3 to 83) in
the form of irradiated metals for R&D; and (5) millicurie to curie
quantities of specifically-listed sealed and unsealed byproduct
materials for use in analytical instruments, gauging devices, and for
instrument calibration, student instruction and R&D. The broadscope
license was issued on July 19, 1956, and is due to expire on June 30,
1997. License Nos. 34-00293-14 and 34-00293-15 expire on July 31, 1996
and December 31, 1996, respectively.
II.
Between September 27 and November 4, 1993, the NRC conducted a
safety inspection of licensed activities at the Ohio State University
authorized under License Nos. 34-00293-02, 34-00293-14 and 34-00293-15.
Numerous violations and other concerns were identified during the
inspection. The findings of the inspection were documented in
Inspection Report Nos. 030-02640/93001, 030-31605/93001 and 030-32479/
93001, issued to the Licensee on December 16, 1993.
The problems identified during the inspection were discussed with
the Licensee during an Enforcement Conference held at the NRC Region
III office on March 7, 1994. During the Enforcement Conference, the
Licensee presented various corrective actions that were taken or were
planned to be taken to prevent recurrence of the violations, ensure
compliance with NRC requirements and strengthen its overall NRC-
licensed programs.
On June 10, 1994, the NRC issued a Notice of Violation and Proposed
Imposition of Civil Penalties (Notice) in the amount of $17,750 (EA 94-
032). The Notice listed 32 violations covering numerous areas,
including decommissioning funding, radiation safety requirements for
irradiators, and medical quality management program requirements. The
violations represented a significant breakdown in the management of the
radiation safety program and consequently were of significant
regulatory concern. The significant of the inspection findings was
exacerbated because many of the violations appeared to have been known
or suspected to exist by those responsible for the radiation protection
program, yet continued uncorrected. Moreover, conditions such as a lack
of radiation safety office staff and adequate radiation safety office
facilities were also known but were not corrected in a timely fashion.
The root cause of the problems identified during the inspection was a
lack of effective management involvement with NRC-licensed activities,
coupled with a failure to provide sufficient resources for the
radiation protection program.
The June 10, 1994, Notice required the Licensee to respond to the
specific violations. In addition to that response, the NRC requested
that, within 60 days of the Notice, the Licensee develop and submit a
detailed Radiation Safety Improvement Plan (RSIP) that includes a
description of the changes to be implemented, the specific improvements
in management oversight, and the additional resources to be dedicated
to upgrade the radiation safety program. The RSIP was to address
several specific topics including a program of audits and surveillances
to assess program effectiveness, a schedule for completing all actions
described in the plan, and a system for monitoring and tracking the
plan's completion status.
III.
On July 8, 1994, the Licensee provided a written response to the
Notice and remitted full payment of the $17,750 proposed civil
penalties. The Licensee did not contest the violations in the Notice
except for one violation pertaining to the failure to complete an
evaluation of radiation doses incurred by an individual in September
1991. The NRC responded to the Licensee's July 8, 1994, submittal in a
letter dated August 18, 1994.
On August 2, 1994, the Licensee submitted the requested RSIP.
Following discussion of the RSIP with the Licensee, the Licensee
submitted supplemental information in a letter dated September 15,
1994. Key elements of the RSIP include: (1) A system of ongoing
evaluations of the radiation safety program to determine compliance
with NRC regulations and license conditions; (2) an assessment of
personnel training and improvements in user training including cross-
training of radiation safety office health physicists; (3) a
compilation of radiation safety deficiencies identified during program
evaluations and a description of short term and long term corrective
actions necessary to address those deficiencies for lasting corrective
action; (4) an increase in health physicist, technician and support
staff for the radiation safety office; and (5) enhanced facilities and
equipment for the radiation safety office.
In light of the violations underlying the June 10, 1994,
enforcement action, the public health and safety require improvement of
the Licensee's radiation safety program. The NRC staff has reviewed the
Licensee's RSIP, as supplemented, and finds that the commitments as set
forth in its letters of August 2, 1994, and September 15, 1994, are
acceptable and conclude that if these commitments are effectively
implemented, 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 in its August 2, 1994,
and September 15, 1994, letters be confirmed by this Order.
The Licensee consented to the issuance of this Confirmatory Order
during a telephone call between Ms. B.J. Holt and Mr. Wayne Slawinski,
of the NRC Region II staff, and Dr. Cecil Smith, Assistant Vice
President for Environmental Health and Safety, and Mr. Joseph Allgeier,
Radiation Safety Officer, of the Licensee's staff on November 4, 1994.
Pursuant to 10 CFR 2.202, I have also determined that, based on the
Licensee's consent to this Order and the significance of the necessary
program improvements described above, the public health and safety
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 Parts 20, 30 and 35, it is
hereby ordered that, effective immediately, License Nos. 34-00293-02,
34-00293-14 and 34-00293-15 are modified as follows:
The Licensee shall complete the specific action items within the
time limitations stated in the Radiation Safety Improvement Plan
submitted to the NRC in its letter dated August 2, 1994, as
supplemented by letter dated September 15, 1994. If additional time is
required to meet a step or goal, a prior written request must be
submitted with the reason for the request and the new time frame for
completion. Until approved in writing by the Regional Administrator,
Region III, the previously approved schedule must be met. The Regional
Administrator, Region III, may relax or rescind, in writing, any aspect
of the above condition upon a showing by the Licensee of good cause.
V.
Any person adversely affected by this Confirmatory Order, other
than the Licensee, may request a hearing within 20 days of its
issuance. 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 III, 801 Warrenville Road, Lisle, Illinois
60532-4351, 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.
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 8th day of November 1994.
For the Nuclear Regulatory Commission.
James Lieberman,
Director, Office of Enforcement.
[FR Doc. 94-28256 Filed 11-15-94; 8:45 am]
BILLING CODE 7590-01-M
