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SECY-03-0096

June 6, 2003

• PURPOSE
• SUMMARY
• BACKGROUND
• DISCUSSION
• COORDINATION
• RECOMMENDATIONS

PURPOSE:

To request Commission approval of the proposed Agreement with Wisconsin.

SUMMARY:

The Governor of Wisconsin has requested that the Commission enter into an Agreement under Section 274b of the Atomic Energy Act of 1954, as amended (Act). The Commission, through SECY-03-0030, agreed to publish a notice of the proposed Agreement in the Federal Register (FR). The notice was published as required by the Act and comments were requested. The comment period ended on May 8, 2003.

Based on staff's review of the proposed Wisconsin program and analysis of the comments, staff recommends that the Commission approve the Agreement (Attachment 1 ).

BACKGROUND:

In SECY-03-0030, staff presented a draft of its assessment of the Wisconsin Agreement and discussed the statutory and policy background of the Agreement State program. As required by Section 274e of the Act, the proposed Agreement was published in the FR on April 8, 2003 (68 FR 17090), April 15, 2003 (68 FR 18297), April 22, 2003 (68 FR 19860), and April 29, 2003 (68 FR 22759). The full text of the staff assessment was made available in the Public Document Room, and on the NRC website.

The Agreement will allow Wisconsin to assume regulatory authority over 11e.(1) byproduct material, source material, and special nuclear material (SNM) in quantities not sufficient to form a critical mass. Wisconsin is not seeking authority: (a) to conduct safety evaluations of sealed sources and devices manufactured in Wisconsin and distributed in interstate commerce; (b) to regulate the disposal of low-level radioactive waste at a land disposal site as described in 10 CFR Part 61; or (c) to regulate 11e.(2) byproduct material resulting from the extraction or concentration of source material from ore processed primarily for its source material content, and its management and disposal.

DISCUSSION:

(1) Public Comments

NRC staff received two comment letters in response to the Federal Register notice published on April 8, April 15, April 22, and April 29, 2003. Comments were requested in two categories: (a) the proposed Agreement; and (b) the NRC staff's assessment of the Wisconsin radiation control program.

A letter received from the Executive Director of the Conference of Radiation Control Program Directors, Inc., (CRCPD) strongly supported the proposed Agreement between the Nuclear Regulatory Commission and the State of Wisconsin. The letter stated that the CRCPD members and staff worked with the State of Wisconsin for several years while they prepared to become an Agreement State. The comment encouraged approval of the Agreement.

A second letter was received from the Principal Radiophysicist in the Radiological Health Unit of the New York State Department of Labor providing two comments on the proposed Agreement. Although this letter was issued and received after the comment period expired, the NRC staff has addressed both comments in Attachment 3 . The commenter objected to the commitment by the State of Wisconsin to use its best efforts to cooperate with the NRC and other Agreement States in the formulation of standards and regulations and to assure that Wisconsin's program will continue to be compatible. Questions regarding cooperation and compatibility were considered by the combined NRC/Agreement State Compatibility Working Group and were published for public review and comment. The NRC published the Final Policy on Adequacy and Compatibility for Agreement State Programs on September 3, 1997. This policy provides guidance to the staff on applying the Commission's compatibility policy to Agreement State regulations and other program activities. The commenter also expressed a strong difference of opinion on whether the Atomic Energy Act reserves Sealed Source and Device Evaluation authority to the Commission as a separate activity. The Commission approved this policy by issuing Staff Requirements Memorandum SECY-95-136 - Options To Improve And Standardize The Evaluation And Approval Of Sealed Sources And Devices Manufactured in Agreement States, on June 30, 1995.

Both comments appear to challenge Commission authority on established policy issues which were developed cooperatively with the States and carefully considered over a period of several years. The ultimate interpretation of these policies rests with the Commission and the comments have no direct bearing on the Agreement negotiations between the State of Wisconsin and the NRC nor do they affect the NRC staff's assessment which finds that the Wisconsin Agreement materials program is adequate to protect public health and safety and compatible with the NRC's program and thus Wisconsin meets NRC's criteria for an Agreement. An analysis of public comments is contained in Attachment 3 .

(2) SECY-03-0030

In the March 27, 2003, Staff Requirements Memorandum, the Commission directed the staff to address a number of changes to the Draft FR notice. These changes were addressed and are reflected in the as published version of the Final FR notice of the proposed Agreement.

(3) Transfer of Licenses

Currently, there are approximately 267 NRC licensees in Wisconsin. Staff has identified 263 licenses that will be transferred to the State in whole or in part. NRC will retain 3 licenses, which regulate Federal agencies and one license which authorizes possession of greater than critical mass quantities of SNM.

Staff is working with the Wisconsin Radiation Protection Section (RPS) staff to effect a smooth transition. The staff has coordinated with the RPS staff on current or pending licensing, inspection, and enforcement activities involving the licenses to be transferred, to assure the smooth continuation of regulatory actions after the transfer.

(4) Actions Pending Against Licensees to be transferred

The Office of Investigations has one pending investigation which may result in an escalated enforcement action against a Wisconsin licensee. The Region III office anticipates that this case will be referred to the Office of Enforcement (OE) for final action before the Agreement becomes effective, however final resolution of this case may occur after the Agreement becomes effective. The OE has no other current or pending enforcement actions or confirmatory action letters against licensees.

(5) Effective Date of the Agreement

The NRC and RPS staffs have targeted August 22, 2003, as the effective date for the Agreement. To meet this date and provide adequate time for an orderly transfer of files, and assumption of authority by Wisconsin on the effective date of the Agreement, the Commission should approve the Agreement by June 27, 2003.

(6) Procedure for Reviewing Proposed Agreements

Staff processed the Wisconsin Agreement request under the streamlined procedure for proposed Agreements that was designed to improve the efficiency and effectiveness of the reviews. The procedure directed the staff to use a self-directed team approach and to perform one comprehensive review of the application. The single comprehensive review was preceded by a team review of the draft application for completeness to ensure that the State had assembled the information required for the comprehensive review. The team members were represented by the Offices of State and Tribal Programs, Nuclear Material Safety and Safeguards, General Counsel, Region III, and Nuclear Security and Incident Response. The procedure used for this review was Office of State and Tribal Programs Internal Procedure SA-700, dated April 2, 2001.

Implementation

Following the execution of the Agreement, staff will continue a program of active interaction with the new Agreement State. The program consists of the exchange of regulatory information, notices of NRC training courses, and periodic on-site reviews of the State's program for regulation of Agreement materials. Communications are generally more frequent with a new Agreement State during the first years after the Agreement is signed. The regulatory information exchange includes reports of incidents, significant enforcement actions, and amendments to policies, regulations, or guidance.

An orientation meeting of NRC and RPS staff will be planned to occur about nine months after the Agreement becomes effective to discuss the initial program implementation. The first Integrated Materials Performance Evaluation Program (IMPEP) review of the Wisconsin program is planned for about 18 months after the effective date of the Agreement. Subsequent routine Agreement State program IMPEP reviews usually occur at 12 - 48 month intervals, with good performance resulting in the longer intervals between reviews.

If approved by the Commission, Wisconsin will bring the number of Agreement States to 33.

COORDINATION:

This paper has been coordinated with the Office of the General Counsel, which has no legal objection. The Office of the Chief Financial Officer has reviewed this paper for resource implications and has no objections. Staff has obtained concurrence from the Office of Management and Budget (OMB) that this action does not constitute a "major rule" under the Small Business Regulatory Enforcement and Fairness Act of 1996 (SBREFA).

RECOMMENDATIONS:

That the Commission:

1. Find:

1. That the proposed Wisconsin program for the regulation of byproduct material, source material, and SNM in quantities not sufficient to form a critical mass is compatible with the Commission's program for the regulation of like material; and

2. That the proposed Wisconsin program is adequate to protect public health and safety within the State with respect to the materials and uses covered by the proposed Agreement.

2. Approve:

1. The proposed Agreement between the State of Wisconsin and the Nuclear Regulatory Commission pursuant to Section 274 of the Act, as set forth in Attachment 1 .

2. The proposed Agreement by June 27, 2003, if practicable, to afford adequate time for the signing of the Agreement, the orderly transfer of license files, and the assumption of regulatory authority by Wisconsin on August 22, 2003.

3. Note:

1. The Governor of Wisconsin does not desire to sign the Agreement in a formal ceremony. Three formal copies of the Agreement will be provided, upon approval by the Commission, for signature by the Chairman and the Governor of Wisconsin.

2. Pursuant to the Act, SBREFA, and Commission guidance, the Speaker of the House of Representatives, the President of the Senate, the Wisconsin Congressional delegation, and the director of the General Accounting Office will be informed of the Commission's decision.

3. The Office of Public Affairs will issue a press release.

4. The text of the Agreement will be published in the FR as required by Section 274e, within 30 days after the Agreement is signed.

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