ML17061A155

Summary of November 10, 2016, Public Meeting with Northwest Medical Isotopes, LLC

ML17061A155
Person / Time
Site:	Northwest Medical Isotopes
Issue date:	03/27/2017
From:	Michael Balazik NRC/NRR/DPR/PRLB
To:	Northwest Medical Isotopes
Balazik M
References
Download: ML17061A155 (4)

Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 March 27, 2017 APPLICANT: Northwest Medical Isotopes, LLC

SUMMARY

OF NOVEMBER 10, 2016, PUBLIC MEETING WITH NORTHWEST MEDICAL ISOTOPES, LLC On November 10, 2016, a Category 1 public meeting was held between the U.S. Nuclear Regulatory Commission (NRC) staff and representatives of Northwest Medical Isotopes, LLC (NWMI) at NRC Headquarters, One White Flint North, 11555 Rockville Pike, Rockville, Maryland. The purpose of this meeting was for NWMI to discuss with the NRC staff overarching technical topics associated with its construction permit application that may relate to the NRCs request for additional information (RAI) issued on September 29, 2016. A portion of this meeting was closed to the public to discuss proprietary information related to the specifics of design and operation of the proposed medical isotope production facility. The meeting notice and agenda, dated July 29, 2016, are available in the Agencywide Documents Access and Management System (ADAMS) at Accession No. ML16223A156. A list of meeting attendees is provided as an enclosure. The information request issued to NWMI is available under ADAMS Accession No. ML16236A013.

NWMI representatives presented an overview of the status of its proposed radioisotope facility project. NWMI indicated that it has initiated final design and development of its future operating license application and the selection of a contractor for construction activities. Additionally, NWMI is continuing research and development of a test generator and the irradiation of a prototype target. NWMI indicated that it plans to submit responses to all RAIs that were issued on September 29, 2016, within the 60 day period and that all of the responses will be incorporated into NWMIs revised preliminary safety analysis report. NWMI briefly described the design objectives of its facility and that specific codes and standards will be included in the operating license application. NWMI presented information on the design criteria of structure, systems, and components. NWMI also explained the different quality levels related to their quality assurance plan. NWMI then discussed proposed changes to the accident analysis methodology. At the close of the meeting, NWMI indicated that NRC staff had an action to determine the applicability of Title 10 of the Code of Federal Regulations (10 CFR) 70.21(f) to their future Part 70 license application for target fabrication. The NRC staff will evaluate this action further and will provide NWMI a response. Further details on the public meeting are included in the presentation slides (ADAMS Accession No. ML16309A208).

During the closed portion of the meeting, NWMI went into proprietary-level detail related to criticality validation analysis and facility software demonstration for the proposed Molybdenum-99 production process.

Northwest Medical Isotopes, LLC Please direct any inquiries to me at 301-415-2856, or Michael.Balazik@nrc.gov.

/RA/

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

Enclosure:

As stated

ML17061A155 (Summary); ML16309A208 (Presentation);

• concurrence via e-mail NRC-001 OFFICE NRR/DPR/PRLB/PM NRR/DPR/PRLB/LA* NRR/DPR/PRLB/BC NRR/DPR/PRLB/PM NAME MBalazik NParker AAdams MBalazik DATE 3/9/17 3/8/17 3/27/17 3/27/17 LIST OF ATTENDEES PUBLIC MEETING WITH NORTHWEST MEDICAL ISOTOPES November 10, 2016 9:00 A.M. - 3:30 P.M.

Name Organization Jeff Bartelme SHINE Medical Technologies, Inc.

James Hammelman U.S. Nuclear Regulatory Commission Steven Lynch U.S. Nuclear Regulatory Commission Linh Tran U.S. Nuclear Regulatory Commission Charles Teal U.S. Nuclear Regulatory Commission Michael Balazik U.S. Nuclear Regulatory Commission Mitzi Young U.S. Nuclear Regulatory Commission Mirela Gavrilas U.S. Nuclear Regulatory Commission Marilyn Diaz U.S. Nuclear Regulatory Commission David Drucker U.S. Nuclear Regulatory Commission Robert Johnson U.S. Nuclear Regulatory Commission Nancy Martinez U.S. Nuclear Regulatory Commission Lisa London U.S. Nuclear Regulatory Commission Mollie Semmes U.S. Nuclear Regulatory Commission Alex Sapountzis U.S. Nuclear Regulatory Commission Kara McCullough U.S. Nuclear Regulatory Commission Jenny Weil U.S. Nuclear Regulatory Commission Carl Weber U.S. Nuclear Regulatory Commission Christopher Tripp U.S. Nuclear Regulatory Commission Annie Ramirez U.S. Nuclear Regulatory Commission John Adams U.S. Nuclear Regulatory Commission Terry Gitnick Information Systems Laboratories, Inc.

Steve Reese Northwest Medical Isotopes Carolyn Haass Northwest Medical Isotopes Michael Corum Atkins (Northwest Medical Isotopes)

Gary Dunford AEM Consulting (Northwest Medical Isotopes)

James Masterlock Atkins (Northwest Medical Isotopes)

Enclosure