01-31332. Mallinckrodt, Inc.; Notice of Consideration of Request for Temporary Exemption

AGENCY:

Nuclear Regulatory Commission.

ACTION:

Notice of consideration of request for temporary exemption.

SUMMARY:

The Nuclear Regulatory Commission (Commission) is considering the issuance of a temporary exemption from the requirement to perform an emergency preparedness (EP) exercise every 2 years for Mallinckrodt, Inc. The request for temporary exemption is necessary because the licensee had to postpone the required scheduled EP exercise due to the terrorist attacks on the United States, lack of availability of State and local agencies, and the current heightened alert status of the plant. Mallinckrodt expects to conduct the EP exercise by July 30, 2002. The NRC has prepared an environmental assessment with a finding of no significant impact on the request.

FOR FURTHER INFORMATION CONTACT:

Kevin G. Null, Senior Health Physicist, Nuclear Materials Licensing Branch, Division of Nuclear Materials Safety, U.S. Nuclear Regulatory Commission, Region III, Lisle, Illinois. Telephone: [phone], e-mail [e-mail].

SUPPLEMENTARY INFORMATION:

The Commission is considering the issuance of a temporary exemption from the requirement to perform an emergency preparedness exercise every 2 years, pursuant to 10 CFR part 30, for Mallinckrodt, Inc., located in Maryland Heights, Missouri. The facility is authorized to use byproduct material for research and development, manufacturing, processing, and packaging of radiopharmaceuticals and/or radiochemicals.

Mallinckrodt was scheduled to conduct an EP exercise on September 11, 2001. This exercise was postponed because of the terrorist attacks on the United States that occurred on September 11. Because of the ongoing high alert status of the plant and the need to coordinate with several offsite agencies and groups, the exercise will not be performed this calendar year. Mallinckrodt expects to conduct the exercise no later than July 30, 2002.

The last EP exercise conducted at the Mallinckrodt facility was held on September 9, 1999. Mallinckrodt's Emergency Plan, in accordance with 10 CFR 30.32(i)(3)(xii), requires that plant personnel plan and conduct biennial EP exercises. Because the next exercise will not be conducted during calendar year 2001, the licensee has requested a temporary exemption from the requirement to conduct biennial EP exercises. The NRC staff has prepared an environmental assessment of the proposed action and reached a finding of no significant impact.

Environmental Assessment

Identification of the Proposed Action

The proposed action would grant temporary relief from the requirement pursuant to 10 CFR 30.32(i)(3)(xii) to perform a biennial EP exercise during calendar year 2001. The proposed action would allow Mallinckrodt to conduct their 2001 biennial exercise as late as July 30, 2002. The proposed action is in accordance with Mallinckrodt's request for exemption dated November 26, 2001.

Need for the Proposed Action

Due to the heightened state of security alert that the plant is under and the unavailability of State and local agencies to participate, Mallinckrodt has determined that it would not be prudent to hold the 2001 biennial EP exercise during calendar year 2001. Allowing the delay would avoid overlap with the current state of high alert and allow fuller participation by other agencies and groups.

Environmental Impacts of the Proposed Action

The proposed action would not materially affect the emergency response capabilities of the Mallinckrodt facility. The last exercise was conducted on September 9, 1999. Direct observation of the exercise by NRC inspectors noted deficiencies that did not require immediate corrective action. On November 17, 1999, Mallinckrodt identified an inadvertent release of xenon-133, declared an alert and implemented their Emergency Plan (EP). NRC conducted a special inspection to review the circumstances of the event and the effectiveness of Malinckrodt's implementation of their EP. With the exception of 1 violation that was identified, NRC review of real time activation of the EP indicated that Mallinckrodt has addressed the issues identified during the September 9, 1999 exercise. In addition, NRC license reviews and inspections conducted since November 17, 1999, have not identified a decline in the effectiveness of Mallinckrodt's emergency response capability. The postponement should have no impact on the effectiveness of Mallinckrodt's emergency response capability. The proposed action will not increase the probability or consequences of accidents; no changes are being made in the amounts or types of any effluents that could be released offsite, and there is no increase in individual or cumulative radiation exposure. Accordingly, the Commission concludes that there are no significant radiological impacts associated with the proposed action.

With regard to potential nonradiological impacts, the proposed action does not affect nonradiological plant effluents and has no other environmental impact. Accordingly, the Commission concludes that there are no significant nonradiological impacts associated with the proposed action.

Alternatives to the Proposed Action

Since the Commission has concluded that there is no discernible environmental impact associated with the proposed action, any alternatives with equal or lesser impact need not be evaluated. As an alternative to the proposed action, the staff considered denial of the proposed action. Denial of the proposed action would result in no change in environmental impacts but would result in hardship to Mallinckrodt, and perhaps other participants. The environmental impacts of the proposed action and the alternative action are similar.

Alternative Use of Resources

The proposed action does not involve the use of any resources beyond those already necessary to conduct the EP exercise during 2001, and would merely delay the exercise.

Agencies and Persons Consulted

In accordance with its stated policy, the NRC staff consulted with the following officials regarding the environmental impact of the proposed action: William Brandes, Chair, Local Emergency Planning Committee, St. Louis, Missouri; Nick Granani, Deputy Director, Office of Emergency Management, Chesterfield, Missouri; Keith Henke, State Emergency Management Agency, Jefferson City, Missouri; Charles Hooper, Missouri Department of Health, Jefferson City, Missouri; and Tom Lange, Sr. Planner, Office of the Director, Missouri Department of Natural Resources. No objections were received.

Finding of No Significant Impact

Based on the environmental assessment, the Commission concludes that the proposed action will not have a significant affect on the quality of the human environment. Accordingly, the Commission has determined not to prepare an environmental impact statement for the proposed action.

List of Preparers

This document was prepared by Kevin G. Null, Senior Health Physicist, Nuclear Materials Licensing Branch, Division of Nuclear Materials Safety, U.S. Nuclear Regulatory Commission, Region III, Lisle, Illinois. Mr. Null is the Licensing Project Manager for the Nuclear Materials License issued to Mallinckrodt, Inc.

For further details with respect to the proposed action, see the Mallinckrodt letter dated November 26, 2001, available for public inspection at the Commission's Public Document Room at One White Flint North, 11555 Rockville Pike, Rockville, MD, and accessible electronically through the ADAMS Public Electronic Reading Room link at the NRC Web Site (http://www.nrc.gov).

Dated at Rockville, Maryland this 13th day of December, 2001.

For the Nuclear Regulatory Commission.

John W. Hickey,

Chief, Materials Safety and Inspection Branch, Division of Industrial and Medical Nuclear Safety, Office of Nuclear Material Safety and Safeguards.