2013-29303. SHINE Medical Technologies, Inc.

AGENCY:

Nuclear Regulatory Commission.

ACTION:

License application; docketing.

SUMMARY:

The U.S. Nuclear Regulatory Commission (NRC) staff has determined that the second and final part of the application for a construction permit, submitted by SHINE Medical Technologies, Inc. (SHINE) is acceptable for docketing.

ADDRESSES:

Please refer to Docket ID NRC-2013-0053 when contacting the NRC about the availability of information regarding this document. You may access publicly-available information related to this document using any of the following methods:

• Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2013-0053. Address questions about NRC dockets to Carol Gallagher; telephone: [phone]; email: [e-mail]. For technical questions, contact the individual(s) listed in the FOR FURTHER INFORMATION CONTACT section of this document.
• NRC's Agencywide Documents Access and Management System (ADAMS): You may access publicly available documents online in the NRC Library at http://www.nrc.gov/​reading-rm/​adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [e-mail]. The ADAMS accession number for each document referenced in this document (if that document is available in ADAMS) is provided the first time that a document is referenced.
• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

FOR FURTHER INFORMATION CONTACT:

Steven Lynch, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC, 20555-0001; telephone: [phone]; email: [e-mail].

SUPPLEMENTARY INFORMATION:

By letter dated May 31, 2013 (SMT-2013-023, ADAMS Accession No.), SHINE submitted the second and final part of its two-part application for a construction permit. By letter dated September 25, 2013 (ADAMS Accession No. ML13269A378), SHINE supplemented this submission with a discussion of preliminary plans for coping with emergencies, as required by section 50.34(a)(10) of Title 10 of the Code of Federal Regulations (10 CFR), completing its application for a construction permit. An exemption from certain requirements of 10 CFR 2.101(a)(5) granted by the Commission on March 20, 2013 (ADAMS Accession No. ML13072B195), in response to a letter from SHINE dated February 18, 2013 (ADAMS Accession No. ML13051A007), allowed SHINE to submit its construction permit application in two parts. Specifically, the exemption allowed SHINE to submit a portion of its application for a construction permit up to six months prior to the remainder of the application regardless of whether or not an environmental impact statement or a supplement to an environmental impact statement is prepared during the review of its application. If granted, the construction permit would allow SHINE to construct a medical radioisotope production facility in Janesville, Wisconsin.

Part one of SHINE's construction permit application was submitted by letter dated March 26, 2013 (ADAMS Accession No. ML13088A192). In accordance with 10 CFR 2.101(a)(5), this partial application submittal contained the following:

• The description and safety assessment of the site required by 10 CFR 50.34(a)(1)
• The environmental report required by 10 CFR 50.30(f)
• The filing fee information required by 10 CFR 50.30(e) and 10 CFR 170.21
• The general information required by 10 CFR 50.33
• The agreement limiting access to classified information required by 10 CFR 50.37

The NRC staff acknowledged receipt of this partial application for a construction permit under 10 CFR part 50, “Domestic Licensing of Production and Utilization Facilities,” in the Federal Register (78 FR 29390) on May 20, 2013. On June 25, 2013, NRC staff determined that part one of SHINE's application for a construction permit was complete and acceptable for docketing (ADAMS Accession No. ML13150A280), assigning the application Docket No. 50-608.

The NRC staff has now completed its acceptance review of part two of SHINE's application for a construction permit and determined that this second and final portion of SHINE's two-part construction permit application, as supplemented, contains the remainder of the preliminary safety analysis report required by 10 CFR 50.34(a) and was submitted in accordance with the requirements of 10 CFR 2.101(a)(5). Therefore, the application is complete and acceptable for docketing. SHINE's construction permit application, in its entirety, has been placed under Docket No. 50-608. Please reference this docket number in all future correspondence concerning the review of the SHINE construction permit application.

The NRC staff is now prepared to begin a detailed technical review of the SHINE construction permit application. In the coming weeks, a review schedule will be published that identifies significant milestones and an expected review completion date. Docketing of the application does not preclude the NRC from requesting additional information from the applicant as the review proceeds, nor does it predict whether the Commission will grant or deny the requested construction permit. In support of the review of the SHINE construction permit application, a hearing will be conducted by the Commission or a Board designated by the Chief of the Atomic Safety and Licensing Board Panel in accordance with procedures in 10 CFR Part 2, “Agency Rules of Practice and Procedure.” A copy of the construction permit application will be referred to the Advisory Committee on Reactor Safeguards for a review and report consistent with 10 CFR 50.58, “Hearings and report of the Advisory Committee on Reactor Safeguards.” A future Federal Register notice will announce the opportunity to petition for leave to intervene in the hearing required for the application by 10 CFR 50.58 as well as the time and place of the hearing. Additionally, in accordance with 10 CFR Part 51, “Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions,” the Commission will also prepare an environmental impact statement for the proposed action. If the Commission finds that the SHINE construction permit application meets the applicable standards of the Atomic Energy Act and the Commission's regulations, and that required notifications to other agencies and bodies have been made, the Commission will issue a construction permit, in the form and containing conditions and limitations that the Commission finds appropriate and necessary.

This notice of docketing of the construction permit application does not begin a review to determine whether the proposed SHINE facility should operate. A separate application for an operating license must be submitted for NRC review and approval and, if docketed, would be the subject of a separate Federal Register notice.

Dated at Rockville, Maryland, this 2nd day of December, 2013.

For the Nuclear Regulatory Commission.

Alexander Adams, Jr.,

Chief, Research and Test Reactors Licensing Branch, Division of Policy and Rulemaking, Office of Nuclear Reactor Regulation.