[Federal Register Volume 65, Number 128 (Monday, July 3, 2000)]
[Notices]
[Pages 41109-41110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16729]



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NUCLEAR REGULATORY COMMISSION

[Docket No. 030-00001; License No. 24-04206-01; EA-00-143]


Mallinckrodt, Inc., St Louis, Missouri; Confirmatory Order 
Modifying License

I

    Mallinckrodt, Inc. (Mallinckrodt), is the holder of NRC License No. 
24-04206-01 issued by the Nuclear Regulatory Commission (NRC or 
Commission) pursuant to 10 CFR part 30. The license authorizes 
Mallinckrodt to use byproduct materials in manufacturing, processing 
and packaging of radiopharmaceuticals and radiochemicals for 
distribution to holders of a specific license issued by the Commission 
or an Agreement State. The license also authorizes Mallinckrodt to use 
byproduct material for research and development of 
radiopharmaceuticals. The license was issued on October 8, 1958, was 
most recently amended on March 27, 1998, and is currently in the 
renewal process.

II

    On April 13, 2000, Mallinckrodt identified a potential extremity 
exposure in excess of regulatory limits to an individual working on the 
molybdenum/technetium generator manufacturing line and immediately 
notified the NRC of the incident. The NRC initiated a special 
inspection on April 14, 2000, to review the circumstances, and root and 
contributing causes of the event. On April 28, 2000, Mallinckrodt 
identified additional potential exposures in excess of regulatory 
limits involving additional processing areas. Based on the additional 
potential exposures and the complexity of the processes, the NRC 
expanded the special inspection to an Augmented Inspection Team (AIT). 
The AIT inspected Mallinckrodt between May 4 and May 26, 2000.
    Based upon the AIT results, the NRC concluded that programmatic 
deficiencies exist in Mallinckrodt's ability to conduct: (1) 
Comprehensive assessments of its radiation protection program; (2) 
accurate root cause determinations for deficiencies identified through 
its problem identification program; and, (3) radiological evaluations 
of manufacturing processes. The results of these deficiencies included 
the failure to identify that significant differences existed in dose 
rates between fingertips and extremity monitoring devices when handling 
unshielded containers of radioactive material, the identification that 
operating procedures did not reflect actual work practices, and that 
supervisors overseeing laboratory activities did not recognize the 
potential radiological consequences of work habits in their area. The 
NRC is concerned that inadequate controls over the safe use of licensed 
material continue to exist. NRC concerns along with various remedial 
and corrective actions, designed to improve Mallinckrodt's radiation 
safety program, were discussed with Mallinckrodt during a telephone 
call between members of NRC and Mallinckrodt staff on June 8, 2000. By 
letter dated June 9, 2000, NRC proposed conditions that could be taken 
to identify and correct the licensee's programmatic weaknesses. By 
letter dated June 16, 2000, Mallinckrodt agreed to implement the 
proposed conditions with minor modifications. These modifications have 
been incorporated into this Order.

III

    By letter dated June 16, 2000, Mallinckrodt has agreed to:
    (1) Retain an independent organization to assess the radiation 
safety program and the radiation safety aspects of its radioactive 
material manufacturing processes;
    (2) Provide written assurance that workers have received training 
and understand procedures and practices in place to maintain radiation 
exposures as low as is reasonably achievable;
    (3) Develop a plan to review operations for the last five years to 
determine if any individuals have received exposures in excess of 
regulatory limits; and,
    (4) Request an amendment to its license incorporating a program 
that will identify and correct deficiencies associated with radiation 
safety.
    On June 16, 2000, Mallinckrodt consented to issuance of this Order 
with the commitments, as described in Section IV below. Mallinckrodt 
further agreed in its June 16, 2000, letter that this Order is to be 
effective upon issuance and has waived its right to a hearing. 
Implementation of these commitments will provide enhanced assurance 
that sufficient attention will be applied to the radiation safety 
program, and that the program will be conducted safely and in 
accordance with NRC requirements.
    I find that Mallinckrodt's commitments as set forth in Section IV 
are acceptable and necessary. Further, I 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 Mallinckrodt's commitments be confirmed by this 
Order. Based on the above and Mallinckrodt's consent, this Order is 
immediately effective upon issuance.

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. 24-04206-01 Is Modified As 
Follows:
    A. Mallinckrodt shall retain the services of one or more 
independent individuals or organizations capable of evaluating 
radiation safety program implementation and manufacturing processes 
associated with radioactive materials at large facilities to perform 
the following:
    1. An assessment of Mallinckrodt's radiation protection program. At 
a minimum the assessment shall include:
    a. Roles and responsibilities of the Radiation Safety Office and 
Officer;
    b. Effectiveness of Mallinckrodt's Radiation Safety and Dose 
Reduction Committees;
    c. Current radiation protection organization staffing levels to 
determine if sufficient resources are available to support plant 
operations;
    d. Effectiveness of the occupational exposure monitoring program 
(deep-dose equivalent; shallow dose equivalent, whole body and maximum 
extremity; and committed effective dose equivalent) to assure that all 
recorded exposures (e.g., finger and hand exposures) are representative 
of maximum exposures received;
    e. Effectiveness of Mallinckrodt in resolving previous radiation 
protection issues; and
    f. Effectiveness of Mallinckrodt's radiation safety training 
program, including on the job training for radiation workers.
    2. A radiation safety assessment of Mallinckrodt's radioactive 
materials manufacturing processes. At a minimum the assessment shall 
include:
    a. The radiation safety practices and related engineering controls 
associated with Mallinckrodt's processes involving radioactive 
materials;
    b. Adequacy of and adherence to Standard Operating Procedures 
affecting radiation safety; and
    c. The process that Mallinckrodt uses for evaluating radiation 
safety issues associated with new and modified product lines involving 
radioactive materials.
    Mallinckrodt shall inform NRC Region III of the individual(s) or

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organization(s) hired for each of these assessments. These 
notifications shall be made within seven days of the date of this 
Order, and include the audit plan. Each assessment shall be completed 
within 60 days of the date of this Order. Within 90 days of the date of 
this Order, Mallinckrodt shall ensure that the individual(s) or 
organization(s) conducting each assessment submit to Mallinckrodt and 
NRC Region III, at the same time, the results of each assessment, 
including the deficiencies identified.
    Mallinckrodt shall evaluate the root causes and develop corrective 
actions associated with any identified findings and submit to NRC 
Region III the schedules to implement those corrective actions. 
Mallinckrodt shall provide to NRC Region III the radiation protection 
program assessment corrective actions within 150 days of the date of 
this Order. Mallinckrodt shall provide to NRC Region III the corrective 
actions to the radiation safety assessment of the radioactive materials 
manufacturing processes within 180 days of the date of this Order. 
Should Mallinckrodt disagree with any assessment finding or plan not to 
initiate any corrective action arising from the assessments, 
Mallinckrodt must provide a written explanation of the rationale for 
such disagreement to NRC Region III within the respective 150-day or 
180-day period.
    B. Mallinckrodt shall provide to NRC Region III, a written 
statement that all applicable Mallinckrodt workers have been trained 
and that Mallinckrodt has assessed the effectiveness of the training to 
ensure workers understand the procedures and practices in place to 
maintain radiation exposures as-low-as-is-reasonably-achievable. This 
written assurance shall be submitted to NRC Region III within 15 days 
of the date of this Order.
    C. Mallinckrodt shall develop a plan to review past operations to 
determine if any individuals could have received radiation exposures in 
excess of the applicable NRC limits in 10 CFR Part 20. This review 
shall encompass activities for a period of five years prior to the date 
of this Order. Mallinckrodt shall provide NRC Region III the plan and 
implementing schedule within 90 days of the date of this Order. The 
provisions of this Order do not relieve Mallinckrodt from complying 
with the reporting requirements in 10 CFR Part 20 should an exposure in 
excess of regulatory limits be identified during the review.
    D. Mallinckrodt shall request an amendment to its license 
incorporating a program that will identify and correct deficiencies 
associated with radiation safety. This program shall include, as a 
minimum, provisions for: (1) Worker identification of radiation related 
safety issues; (2) prompt notification to management of significant 
issues; (3) root cause analysis, including associated training for all 
managers, supervisors, and radiation protection staff involved with 
performing and reviewing root cause evaluations; and (4) tracking of 
identified deficiencies. This amendment request shall be submitted to 
NRC Region III within 180 days of the date of this Order.
    The Regional Administrator, Region III, may relax or rescind, in 
writing, any of the above conditions upon a showing by Mallinckrodt of 
good cause.

V

    Any person adversely affected by this Confirmatory Order, other 
than Mallinckrodt, 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, DC 20555, and include a 
statement of good cause for the extension. Any request for a hearing 
shall be submitted to the Secretary, U.S. Nuclear Regulatory 
Commission, ATTN: Rulemakings and Adjudications Staff, 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 Materials Litigation and 
Enforcement at the same address, to the Regional Administrator, NRC 
Region III, 801 Warrenville Road, Lisle, Illinois, and to Mallinckrodt. 
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.
    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 IV 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 IV 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 immediate effectiveness of this order.

    Dated this 22nd day of June, 2000.

    For the Nuclear Regulatory Commission.
R.W. Borchardt,
Director, Office of Enforcement.
[FR Doc. 00-16729 Filed 6-30-00; 8:45 am]
BILLING CODE 7590-01-P