Northwest Medical Isotopes, LLC

AGENCY:

Nuclear Regulatory Commission.

ACTION:

Construction permit application; docketing.

SUMMARY:

The U.S. Nuclear Regulatory Commission (NRC) has determined that the second and final part of the application for a construction permit, submitted by Northwest Medical Isotopes, LLC (NWMI) is acceptable for docketing. NWMI proposes to build a medical radioisotope production facility located in Columbia, Missouri.

ADDRESSES:

Please refer to Docket ID NRC-2013-0235 when contacting the NRC about the availability of information regarding this document. You may obtain 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-2013-0235. Address questions about NRC dockets to Carol Gallagher; telephone: 301-415-3463; email: Carol.Gallagher@nrc.gov. For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.
• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection 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 pdr.resource@nrc.gov. 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:

Michael Balazik, Office of Nuclear Reactor Regulation, telephone: 301-415-2856; email: Michael.Balazik@nrc.gov; U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

SUPPLEMENTARY INFORMATION:

By letter dated July 20, 2015 (ADAMS Accession No. ML15210A114), NWMI filed with the NRC, pursuant to Section 103 of the Atomic Energy Act of 1954, as amended (AEA), and part 50 of title 10 of the Code of Federal Regulations (10 CFR), “Domestic Licensing of Production and Utilization Facilities,” the second and final part of its two-part application for a construction permit for a medical radioisotope production facility. If granted, the construction permit would allow NWMI to construct a production facility in Columbia, Missouri. On June 8, 2015, the NRC published in the Federal Register its acceptance of part one of NWMI's application for a construction permit (80 FR 32418).

The NRC has completed its acceptance review of part two of NWMI's application for a construction permit for a production facility as defined in 10 CFR 50.2, “Definitions.” The NRC has determined that part two was submitted in accordance with the requirements of 10 CFR 2.101(a)(5), completes the information required by 10 CFR 50.34(a), and is acceptable for docketing. NWMI's construction permit application, in its entirety, has been placed under Docket No. 50-609. Please reference this docket number in all future correspondence.

The NRC expects that NWMI will submit an application for fabricating low enriched uranium targets under 10 CFR part 70, “Domestic Licensing of Special Nuclear Materials,” as stated in paragraph six (page 2) of NWMI's letter dated July 20, 2015.

The NRC's staff has started a review of the NWMI construction permit application. The NRC's staff will provide NWMI with a schedule that identifies significant milestones and the expected review completion date. The schedule will include provisions for the NRC to request additional information, if necessary.

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.”

In support of the review of the NWMI 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 future Federal Register notice (FRN) will announce the opportunity to petition for leave to intervene in a hearing on the application 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 NRC will also prepare an environmental impact statement for the proposed action. The environmental impact statement will evaluate the environmental impacts for construction, operation and decommissioning of NWMI's radioisotope production facility. This review will cover all activities at NWMI's radioisotope production facility, including those under 10 CFR parts 50 and 70.

The docketing of the application does not predict whether the NRC will grant or deny the requested construction permit. If the NRC finds that NWMI's construction permit application meets the applicable standards of the AEA and the NRC's regulations, and that required notifications to other agencies and bodies have been made, the NRC will issue a construction permit for a production facility under 10 CFR part 50, in the form and containing conditions and limitations that the NRC finds appropriate and necessary.

This notice only addresses the start of a review to determine whether the NRC will issue a construction permit for the proposed NWMI facility. In order to operate and produce radioisotopes in its facility, a separate application must be submitted by NWMI for the NRC's review and approval, and, if docketed, would be the subject of a separate FRN.