ML16288A488

Summary of Public Meeting with Northwest Medical Isotopes, LLC

ML16288A488
Person / Time
Site:	Northwest Medical Isotopes
Issue date:	10/20/2016
From:	Michael Balazik NRC/NRR/DPR/PRLB
To:	Northwest Medical Isotopes
Balazik M, NRR/DPR, 301-415-4246
References
TAC MF6138
Download: ML16288A488 (4)

Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 October 20, 2016 APPLICANT: Northwest Medical Isotopes, LLC

SUMMARY

OF AUGUST 11, 2016, PUBLIC MEETING WITH NORTHWEST MEDICAL ISOTOPES, LLC (TAC NO. MF6138)

On August 11, 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 to discuss NWMIs planned submittal of an operating license application for its proposed molybdenum-99 (Mo-99) medical isotopes production facility. A portion of this meeting was closed to the public to discuss security-related and 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) Accession No. ML16223A156. A list of meeting attendees is provided as an enclosure.

The NRC staff opened the meeting providing a status update on the environmental and construction permit application review. The NRC staff informed NWMI that the review of the environmental and construction permit application is on schedule. NWMI representatives then provided a general project status update on its proposed medical isotope facility to be located in Discovery Ridge Research Park, Columbia, Missouri. NWMI representatives presented an overview of its proposed change control and design change processes to be implemented prior to and during construction. NWMI representatives also shared some potential project challenges such as licensing strategies, integration of Title 10 of the Code of Federal Regulations (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities, and 10 CFR Part 70, Domestic Licensing of Special Nuclear Material, and change control during construction. The NRC staff and NWMI agreed to conduct a future public meeting regarding a proposed 10 CFR Parts 50 and 70 crosswalk in detail. NWMI also discussed pre-construction activities and what constituted construction and excavation. The NRC staff directed NWMI to the definition of construction in 10 CFR 50.2 and construction activities in 10 CFR 50.10. The NRC staff informed NWMI representatives that they can submit a proposal for non-construction activities for NRC review. During the meeting, NWMI expressed concerns with submitting documents using the Electronics Information Exchange (EIE) system because of certain limitations of the EIE system. During the meeting, the NRC staff endorsed the use of the EIE system for supporting efficient and prompt document submission. NWMI representatives informed the NRC staff that it has not attempted to use the EIE system within the last year. No questions from the public were presented to the NRC staff during the public comment period of the meeting. Further details on the public meeting are included in the presentation slides (ADAMS Accession No. ML16221A037).

During the closed portion of the meeting, NWMI went into proprietary-level detail related to research and development and operating license schedule for its proposed Mo-99 production process. Additionally, the NRC staff discussed security-related information regarding the development of NWMIs safeguards information program physical security plan, and material control and accounting program.

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

ML16288A488 (Summary); ML16216A186 (Presentation);

• concurrence via e-mail NRC-001 OFFICE NRR/DPR/PRLB/PM NRR/DPR/LA*

NRR/DPR/PRLB/BC NRR/DPR/PRLB/PM NAME MBalazik NParker AAdams MBalazik DATE 10/18/2016 10/18/2016 10/19/2016 10/20/2016

Enclosure LIST OF ATTENDEES PUBLIC MEETING WITH NORTHWEST MEDICAL ISOTOPES AUGUST 11, 2016 9:30 A.M. - 4:15 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 Tim Harris U.S. Nuclear Regulatory Commission Mitzi Young U.S. Nuclear Regulatory Commission Larry Harris U.S. Nuclear Regulatory Commission Robert Hoffman 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 Kevin Folk U.S. Nuclear Regulatory Commission Jessica Bielecki U.S. Nuclear Regulatory Commission Suzanne Ani U.S. Nuclear Regulatory Commission Thomas Pham 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 Joseph Anderson 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 Cathy Kanatas 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 James Danna U.S. Nuclear Regulatory Commission Tyrone Naquin U.S. Nuclear Regulatory Commission Louise Lund U.S. Nuclear Regulatory Commission Robert Norman U.S. Nuclear Regulatory Commission Gerard Jackson U.S. Nuclear Regulatory Commission Steve Reese Northwest Medical Isotopes Carolyn Haass Northwest Medical Isotopes Michael Corum Atkins (Northwest Medical Isotopes)

Gary Dunford AEM Consulting (Northwest Medical Isotopes)

Ryan Molen McCarthy Building (Northwest Medical Isotopes)