ML19071A181

Shine Medical Technologies, Inc. - January 31, 2019 Public Meeting Summary

ML19071A181
Person / Time
Site:	SHINE Medical Technologies
Issue date:	03/22/2019
From:	Steven Lynch Research and Test Reactors Licensing Projects Branch
To:	SHINE Medical Technologies
Lynch S
Shared Package
ML19071A179	List: ML19071A181
References
EPID L-2017-PMP-0014
Download: ML19071A181 (5)

Text

March 22, 2019 LICENSEE: SHINE Medical Technologies, Inc.

SUMMARY

OF JANUARY 31, 2019, MEETING WITH SHINE MEDICAL TECHNOLOGIES, INC. (EPID NO. L-2017-PMP-0014)

On January 31, 2019, a Category 1 public meeting was held between the U.S. Nuclear Regulatory Commission (NRC) staff and representatives of SHINE Medical Technologies, Inc.

(SHINE) at NRC Headquarters, One White Flint North, 11555 Rockville Pike, Rockville, Maryland. The purpose of this meeting was to discuss topics related to SHINE Medical Isotope Production Facility technology and design, as well as to discuss the organization and content of the SHINE operating license application. This meeting served to inform NRC staff of the development status of key design and programmatic elements of SHINEs proposed medical radioisotope production project to prepare the NRC staff for the review of an operating license application. Portions of this meeting were closed to public participation to discuss proprietary and security-related information related to SHINEs technology and structural analysis. The meeting notice and agenda, dated January 29, 2019, are available in the Agencywide Documents Access and Management System (ADAMS) at Accession No. ML19029B344. A list of meeting attendees is provided as an enclosure to this summary.

The NRC staff opened the meeting at 9:00 a.m. with a summary of the status of its interactions with SHINE. SHINE has proposed to construct a medical radioisotope facility in Janesville, Wisconsin for the production of molybdenum-99. A construction permit was issued to SHINE on February 29, 2016, authorizing SHINE to construct eight accelerator-driven subcritical operating assemblies and one production facility for the irradiation and processing of special nuclear material. As of this public meeting, the NRC expects SHINE to begin construction of its facility and submit an operating license application in 2019.

Following the NRCs opening remarks, SHINE provided the NRC staff with an overview of its proposed medical radioisotope production technology. In the portion of this presentation that was open to the public, SHINE described, in part, its company mission; the location of its proposed Medical Isotope Production Facility in Janesville, Wisconsin; its medical radioisotope production process; and technological approach. SHINE also provided details on its safety philosophy, which includes a focus on a low decay heat, low pressure, and low temperature system; limited common cause failures, and ability to respond safely to accidents without required operator actions. Additionally, SHINE discussed the completion of construction of Building One, which will be used to demonstrate technology, including accelerator demonstrations, mockups, and prototypes. Building One will also be used for future employee training and technology development. During the portion of the technology overview presentation that was closed to the public, SHINE provided additional information on its facility layout, systems, and processes.

Following the technology overview presentation, SHINE presented on the structural design of its facility in a closed meeting session. During this session, SHINE provided an update on the building design and construction method; the safety-related building envelope; the seismic analysis methodology; the aircraft impact analysis methodology; and an overview of other structural loads. In an update to a May 2018 public meeting presentation on a pre-cast building design, SHINE announced that it had returned to its plans for using cast-in-place construction.

In the final public meeting session of the day, SHINE discussed the scope of its proposed operating license application, including a description of the general information to be submitted with the application, the final safety analysis report, and other programs and plans to be submitted with the application. In addition to the submission of an operating license application, SHINE also anticipates submitting a materials license application for use of material onsite prior to facility operation. The operating license application will describe all eight proposed irradiation units and one production facility. After a period of time following the initial submission of the operating license application, SHINE anticipates submitting a supplement requesting staggered licensing approach.

Further details on the information discussed during this meeting are included in the public presentation slides (ADAMS Accession No. ML19024A352).

Please direct any inquiries to me at 301-415-1524 or Steven.Lynch@nrc.gov.

/RA/

Steven T. Lynch, Project Manager Research and Test Reactors Licensing Branch Division of Licensing Projects Office of Nuclear Reactor Regulation Docket No. 50-608

Enclosure:

As stated cc: w/enclosure:

Mr. Jeff Bartelme Licensing Manager SHINE Medical Technologies, Inc.

101 E. Milwaukee Street, Suite 600 Janesville, WI 53545

ML19071A179, Pkg; ML19029B344, Notice; ML19071A181, Mtg. Summary; ML1907A180, Withholding Ltr.; ML19024A352, Slides *concurred via email NRC-001 OFFICE NRR/DLP/PRLB/PM NRR/DLP/PRLB/LA NRR/DLP/PRLB/ABC NRR/DLP/PRLB/PM NAME SLynch NParker WKennedy SLynch DATE 03/11/2019 03/13/2019 03/21/2019 03/22/2019 LIST OF ATTENDEES JANUARY 31, 2019, MEETING WITH SHINE MEDICAL TECHNOLOGIES, INC.

9:00 A.M. - 4:00 P.M.

Name Organization Jim Costedio SHINE Medical Technologies, Inc.

Jeff Bartelme SHINE Medical Technologies, Inc.

Eric Van Abel SHINE Medical Technologies, Inc.

Abbey Donahue SHINE Medical Technologies, Inc.

Christopher Hewitt Simpson, Gumpertz, & Heger Diane Mlynarczyk Information Systems Laboratories, Inc.

Dan Prelewicz Information Systems Laboratories, Inc.

Terry Gitnick Information Systems Laboratories, Inc.

Brian Grimes NUMARK Associates Abe Weitzburg Information Systems Laboratories, Inc.

Jason Williams Information Systems Laboratories, Inc.

John Atchison Information Systems Laboratories, Inc.

Steven Lynch U.S. Nuclear Regulatory Commission Charles Teal U.S. Nuclear Regulatory Commission Phil Natividad U.S. Nuclear Regulatory Commission Linh Tran U.S. Nuclear Regulatory Commission Tom Pham U.S. Nuclear Regulatory Commission Anita Gray U.S. Nuclear Regulatory Commission Rebecca Susko U.S. Nuclear Regulatory Commission Richard Jervey U.S. Nuclear Regulatory Commission David Hanks U.S. Nuclear Regulatory Commission Jeremy Wachutka U.S. Nuclear Regulatory Commission James Hammelman U.S. Nuclear Regulatory Commission Glenn Tuttle U.S. Nuclear Regulatory Commission Suzanne Ani U.S. Nuclear Regulatory Commission Mirabelle Shoemaker U.S. Nuclear Regulatory Commission Michael Salay U.S. Nuclear Regulatory Commission Mitzi Young U.S. Nuclear Regulatory Commission David Ditto U.S. Nuclear Regulatory Commission Donna-Beth Howe U.S. Nuclear Regulatory Commission William Kennedy U.S. Nuclear Regulatory Commission Yawar Faraz U.S. Nuclear Regulatory Commission James Rubenstone U.S. Nuclear Regulatory Commission Michelle Moser U.S. Nuclear Regulatory Commission Joseph Staudenmeier U.S. Nuclear Regulatory Commission Benjamin Beasley U.S. Nuclear Regulatory Commission Dan Barss U.S. Nuclear Regulatory Commission Paul Carman U.S. Nuclear Regulatory Commission Patricia Pelke U.S. Nuclear Regulatory Commission Carl Weber U.S. Nuclear Regulatory Commission Enclosure

LIST OF ATTENDEES (Continued)

JANUARY 31, 2019, MEETING WITH SHINE MEDICAL TECHNOLOGIES, INC.

9:00 A.M. - 4:00 P.M.

Name Organization Charity Pantalo U.S. Nuclear Regulatory Commission Cassandra Frazier U.S. Nuclear Regulatory Commission Michael Balazik U.S. Nuclear Regulatory Commission Lisa Dimmick U.S. Nuclear Regulatory Commission Alex Sapountzis U.S. Nuclear Regulatory Commission