ML15341A112

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Northwest Medical Isotopes, LLC - Acceptance for Docketing of Part Two of the Application for a Production Facility Construction Permit (Tac No. MF6138)
ML15341A112
Person / Time
Site: Northwest Medical Isotopes
Issue date: 12/24/2015
From: Michael Balazik
Research and Test Reactors Branch B
To: Haass C
Northwest Medical Isotopes
Balazik M, NRR/DPR, 301-415-2856
References
TAC MF6135
Download: ML15341A112 (3)


Text

December 24, 2015 Carolyn C. Haass Chief Operating Officer Northwest Medical Isotopes, LLC 815 Northwest 9th Street, Suite 256 Corvallis, OR 97330

SUBJECT:

NORTHWEST MEDICAL ISOTOPES, LLC - ACCEPTANCE FOR DOCKETING OF PART TWO OF THE APPLICATION FOR A PRODUCTION FACILITY CONSTRUCTION PERMIT (TAC NO. MF6138)

Dear Ms. Haass:

By letter dated July 20, 2015 (NWMI-LTR-2015-006, Agencywide Documents Access and Management System Accession No. ML15210A114), Northwest Medical Isotopes, LLC (NWMI) filed with the U.S. Nuclear Regulatory Commission (NRC), pursuant to Section 103 of the Atomic Energy Act of 1954, as amended (the Act), and Title 10 of the Code of Federal Regulations (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities, the second 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, NRC published in the Federal Register its acceptance of part one of NWMIs application for a construction permit (80 FR 32418).

The staff has completed its acceptance review of part two of NWMIs application for a construction permit for a production facility as defined in 10 CFR 50.2 Definitions. The staff 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. NWMIs construction permit application, in its entirety, has been placed under Docket No. 50-609. Please reference this docket number in all future correspondence.

The staff 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 NWMIs letter dated July 20, 2015.

The staff has started a review of the NWMI construction permit application. The staff will provide NWMI with a schedule that identifies significant milestones and the expected review completion date by January 31, 2016. The schedule will include provisions for staff 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 NWMIs radioisotope production facility. This review covers all activities at NWMIs radioisotope production facility, including those under 10 CFR Parts 50 and 70.

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

The NRC will publish an FRN informing the public of the NRCs decision to docket part two of NWMIs application for a construction permit of a production facility under 10 CFR Part 50. 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 NRC review and approval, and, if docketed, would be the subject of a separate FRN.

If you have any questions, please contact me at 301-415-2856, or Michael.Balazik@nrc.gov.

Sincerely,

/RA/

Michael Balazik, Project Manager Research and Test Reactors Licensing Branch Division of Policy and Rulemaking Office of Nuclear Reactor Regulation Docket No. 50-609

ML15341A112

  • concurrence via e-mail NRR-106 OFFICE NRR/DPR/PRLB*

NRR/DPR/PRLB/LA*

NMSS/FCSE/FMB/PM* OGC (Part 50)

NAME MBalazik NParker DTiktinsky MYoung (NLO)

DATE 12/4/2015 12/7/2015 12/7/2015 12/16/2015 OFFICE OGC (Part 70)

NRR/DPR/PRLB/BC NMSS/FCSE/FMB/BC NRR/DPR/PRLB/PM NAME JBielecki (NLO)

AAdams RJohnson MBalazik DATE 12/22/2015 12/10/2015 12/10/2015 12/24/2015