ML18162A138
| ML18162A138 | |
| Person / Time | |
|---|---|
| Site: | SHINE Medical Technologies |
| Issue date: | 06/18/2018 |
| From: | Steven Lynch Research and Test Reactors Licensing Projects Branch |
| To: | |
| Lynch S, NRR/DLP, 301-415-1524 | |
| Shared Package | |
| ML18162A136 | List: |
| References | |
| EPID L-2017-PMP-0014 | |
| Download: ML18162A138 (5) | |
Text
June 18, 2018 LICENSEE:
SHINE Medical Technologies, Inc.
SUBJECT:
SUMMARY
OF MAY 23 - 24, 2018, MEETING WITH SHINE MEDICAL TECHNOLOGIES, INC. (EPID NO. L-2017-PMP-0014)
On May 23 - 24, 2018, 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 construction planning, licensing strategy, and the results of preliminary hazards analysis associated with the SHINE medical isotope production project. This meeting served to inform NRC staff of SHINEs significant facility design changes and schedules for beginning construction and submitting an operating license application. Portions of this meeting were closed to public participation to discuss proprietary information related to SHINEs construction planning, preliminary hazards and operability study results, and elements of the structural facility design. The meeting notice and agenda, dated May 11, 2018, are available in the Agencywide Documents Access and Management System (ADAMS) at Accession No. ML18131A371. A list of meeting attendees for each day is provided as an enclosure to this summary.
NRC staff opened the May 23, 2018, meeting at 9:00 a.m. with a summary of the status of its interactions with SHINE. SHINE has proposed to construct a medical isotope 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 the fall of 2018.
Following the NRCs opening remarks, SHINE presented on construction planning. As part of its presentation, SHINE covered topics related to the initial scope of construction and shared systems; configuration management; modifications to its operating units; provisions for constructing during operations; design packages; and construction schedule. Significant discussions during this presentation related to SHINEs proposed phased approach to operations, including how SHINE would track progress of construction during operation and efficiently share information with the NRC to inform construction and operation oversight activities. With respect to its construction schedule, SHINE indicated that it anticipates beginning concrete work in October 2018 with process system installation starting nine months later.
SHINEs next presentation addressed its licensing strategy for its medical isotope production facility. SHINE indicated that it intends to request the issuance of a single operating license for its eight proposed utilization facilities and one production facility. As part of its operating license application, SHINE will also include an addendum to its final safety analysis report describing a phased approach to full operation of its facility. For each phase of operation, SHINE will
describe and analyze structures, systems, and components (SSCs) to be installed or impacted and will address necessary administrative controls to be in place. To support this phased approach to licensing, SHINE also recommended that the NRC condition its operating license to require NRC approval before SHINE may begin operation of additional utilization facilities or expand processing capacity of its production facility. At this time, SHINE intends to submit its operating license application in October 2018.
During the portion of the May 23, 2018, meeting that was closed to the public, SHINE went into proprietary-level detail related to the scope of construction; design changes; and its hazard evaluation. Discussions during this portion of the meeting focused on the evolution of SHINEs facility design since the issuance of its construction permit, including details on its design and safety philosophies; identification of safety-related SSCs; and hazard analysis methodology.
The May 24, 2018, meeting on the structural design of SHINEs proposed facility was closed in its entirety to the public due to the proprietary nature of certain design changes and SHINEs approach to construction.
Further details on the discussions had during this meeting are included in the presentation slides (ADAMS Accession No. ML18138A291).
Please direct any inquiries to me at 301-415-1524 or Steven.Lynch@nrc.gov.
Sincerely,
/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
ML18162A136, Pkg; ML18131A371, Notice; ML18162A138, Mtg. Summary; ML18162A140, Withholding Ltr.; ML18138A291, Slides
- concurred via email NRC-001 OFFICE NRR/DLP/PRLB/PM NRR/DLP/PRLB/LA NRR/DLP/PRLB/BC NRR/DLP/PRLB/PM NAME SLynch NParker AAdams SLynch DATE 06/14/18 06/14/18 06/15/18 06/18/18
Enclosure LIST OF ATTENDEES May 23, 2018 MEETING WITH SHINE MEDICAL TECHNOLOGIES, INC.
9:00 A.M. - 4:30 P.M.
Name Organization Jeff Bartelme SHINE Medical Technologies, Inc.
Steve Miltenberger SHINE Medical Technologies, Inc.
Jim Costedio SHINE Medical Technologies, Inc.
Eric Van Abel SHINE Medical Technologies, Inc.
Joe Christensen SHINE Medical Technologies, Inc.
John Olvera SHINE Medical Technologies, Inc.
Steve Hunt SHINE Medical Technologies, Inc.
Steven Lynch U.S. Nuclear Regulatory Commission Alexander Adams, Jr.
U.S. Nuclear Regulatory Commission Michael Balazik U.S. Nuclear Regulatory Commission MaryJane Ross-Lee U.S. Nuclear Regulatory Commission Richard Jervey U.S. Nuclear Regulatory Commission Charles Teal U.S. Nuclear Regulatory Commission Mitzi Young U.S. Nuclear Regulatory Commission Michelle Moser U.S. Nuclear Regulatory Commission Carl Weber U.S. Nuclear Regulatory Commission Donna-Beth Howe U.S. Nuclear Regulatory Commission Linh Tran U.S. Nuclear Regulatory Commission Michele Kaplan U.S. Nuclear Regulatory Commission Phil OBryan U.S. Nuclear Regulatory Commission Charity Pantalo U.S. Nuclear Regulatory Commission Jason Eargle U.S. Nuclear Regulatory Commission Cassandra Frazier U.S. Nuclear Regulatory Commission Geoffrey Wertz U.S. Nuclear Regulatory Commission Yawar Faraz U.S. Nuclear Regulatory Commission Victor Hall U.S. Nuclear Regulatory Commission Annie Ramirez U.S. Nuclear Regulatory Commission Mollie Semmes U.S. Nuclear Regulatory Commission Jonathan Marcano U.S. Nuclear Regulatory Commission David Tiktinsky U.S. Nuclear Regulatory Commission James Hammelman U.S. Nuclear Regulatory Commission Jeremy Wachutka U.S. Nuclear Regulatory Commission Tom Pham U.S. Nuclear Regulatory Commission Kentaro Ozaki (foreign assignee)
U.S. Nuclear Regulatory Commission Joseph Staudenmeier U.S. Nuclear Regulatory Commission Pete Karcz National Nuclear Security Administration
LIST OF ATTENDEES May 24, 2018 MEETING WITH SHINE MEDICAL TECHNOLOGIES, INC.
9:00 A.M. - 12:00 P.M.
Name Organization Jeff Bartelme SHINE Medical Technologies, Inc.
Jim Costedio SHINE Medical Technologies, Inc.
Eric Van Abel SHINE Medical Technologies, Inc.
Steven Hunt SHINE Medical Technologies, Inc.
Christopher Hewitt Sargent & Lundy Sungjin Bae Sargent & Lundy Ronald Hamburger Simpson Gumpertz & Heger Inc.
Steve Lynch U.S. Nuclear Regulatory Commission Michael Balazik U.S. Nuclear Regulatory Commission Alexander Adams, Jr.
U.S. Nuclear Regulatory Commission MaryJane Ross-Lee U.S. Nuclear Regulatory Commission Richard Jervey U.S. Nuclear Regulatory Commission Mitzi Young U.S. Nuclear Regulatory Commission Carl Weber U.S. Nuclear Regulatory Commission Donna-Beth Howe U.S. Nuclear Regulatory Commission Linh Tran U.S. Nuclear Regulatory Commission Phil OBryan U.S. Nuclear Regulatory Commission Charity Pantalo U.S. Nuclear Regulatory Commission Jason Eargle U.S. Nuclear Regulatory Commission James Hammelman U.S. Nuclear Regulatory Commission Jonathan Marcano U.S. Nuclear Regulatory Commission Patrick Koch U.S. Nuclear Regulatory Commission David Tiktinsky U.S. Nuclear Regulatory Commission Jeremy Wachutka U.S. Nuclear Regulatory Commission Jacob Zimmerman U.S. Nuclear Regulatory Commission