Letter Sequence Meeting |
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EPID:L-2017-PMP-0014, Shine Medical Technologies, Inc., Submittal of Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 (Open) |
Initiation
- Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request
- Acceptance...
Results
Other: ML18054A077, ML18087A340, ML18127B706, ML18128A034, ML18155A603, ML18162A117, ML18162A118, ML18162A129, ML18193A141, ML18268A344, ML18340A171, ML18340A276, ML19015A352, ML19071A185
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MONTHYEARML18030A7422017-07-14014 July 2017
Irrevocable Standby Letter of Credit (Redacted)
Project stage: Request
ML18054A0772018-03-0808 March 2018
Irrevocable Standby Letter of Credit for the Aerotest Radiography and Research Reactor
Project stage: Other
ML18092A0872018-03-27027 March 2018
Irrevocable Standby Letter of Credit for the Aerotest Radiography and Research Reactor
Project stage: Request
ML18087A3892018-03-28028 March 2018
Meeting Slides for the April 3, 2018, Public Meeting Between Shine Medical Technologies. Inc. and the NRC
Project stage: Request
ML18162A0542018-03-28028 March 2018, 29 March 2018, 3 April 2018, 18 June 2018
Shine Medical Technologies, Inc. April 3, 2018 Public Meeting
Project stage: Request
ML18096A6882018-04-0303 April 2018
Confirmatory Action Letter (CAL) No. NRR-2011-001
Project stage: Request
ML18096A4552018-04-0303 April 2018
Shine Operating License Pre-Application Meeting (Environmental Presentation Slides)
Project stage: Request
ML18087A3402018-04-0303 April 2018
Response to Request for Extension of Time to Respond to Letter Regarding Irrevocable Standby Letter of Credit for the Aerotest Radiography and Research Reactor
Project stage: Other
ML18096A6892018-04-0303 April 2018
Arrr Restart Plan (4/3/2018) Approach to Critical, Control Rod and Power Calibrations
Project stage: Request
ML18130A5782018-05-0707 May 2018
Irrevocable Standby Letter of Credit for the Aerotest Radiography and Research Reactor
Project stage: Request
ML18162A1362018-05-11011 May 2018, 18 June 2018
Shine Medical Technologies, Inc. May 23, 2018 Public Meeting
Project stage: Request
ML18138A2912018-05-16016 May 2018
Shine Medical Technologies, Inc. - Submittal of Meeting Slides for the May 23 and 24, 2018 with NRC
Project stage: Request
ML18128A0342018-05-16016 May 2018
Response to Second Request for Extension of Time to Respond to Letter Regarding Irrevocable Standby Letter of Credit for the Aerotest Radiography and Research Reactor
Project stage: Other
ML18156A1302018-06-0101 June 2018
Inc. - Irrevocable Standby Letter of Credit for the Aerotest Radiography and Research Reactor
Project stage: Request
ML18155A6032018-06-0707 June 2018
Response to Third Request for Extension of Time to Respond to Letter Regarding Irrevocable Standby Letter of Credit for the Aerotest Radiography and Research Reactor
Project stage: Other
ML18162A1172018-06-18018 June 2018
Shine Medical Technologies Acknowledgment of Receipt of 2016 Annual Financial Report
Project stage: Other
ML18162A0552018-06-18018 June 2018
Shine Medical Technologies April 3, 2018 Public Meeting Summary
Project stage: Meeting
ML18162A1162018-06-18018 June 2018
Shine Medical Technologies Annual Financial Report
Project stage: Request
ML18162A1182018-06-18018 June 2018
Shine Medical Technologies Response to Request for Withholding Letter for 2016 Annual Financial Report
Project stage: Other
ML18162A1292018-06-18018 June 2018
Shine Medical Technologies, Inc. - Acknowledgment of Receipt of Periodic Reports on Construction Permit Conditions
Project stage: Other
ML18162A1382018-06-18018 June 2018
May 23-24, 2018, Summary of Meeting with Shine Medical Technologies, Inc
Project stage: Meeting
ML18127B7062018-06-21021 June 2018
Closure of NRC Confirmatory Action Letter No. NRR-2011-001
Project stage: Other
ML18221A4532018-06-27027 June 2018, 17 August 2018
Shine Medical Technologies, Inc. June 2018 Public Meeting
Project stage: Request
ML18187A2162018-07-0202 July 2018
Resubmittal of Meeting Slides for the June 28, 2018, Public Meeting Between Shine Medical Technologies, Inc. and the NRC
Project stage: Request
ML18197A0802018-07-10010 July 2018
Irrevocable Standby Letter of Credit for the Aerotest Radiography and Research Reactor
Project stage: Request
ML18193A1412018-07-16016 July 2018
Response to Fourth Request for Extension of Time to Respond to Letter Regarding Irrevocable Standby Letter of Credit for the Aerotest Radiography and Research Reactor
Project stage: Other
ML18277A1962018-07-17017 July 2018
Amendment to Standby Letter of Credit (Redacted)
Project stage: Request
ML18206A7262018-07-18018 July 2018
Irrevocable Standby Letter of Credit for the Aerotest Radiography and Research Reactor (Redacted)
Project stage: Request
ML18221A4542018-08-17017 August 2018
Summary of Meeting with Shine Medical Technologies, Inc.
Project stage: Meeting
ML18239A2192018-08-27027 August 2018
Request for Confirmation of the 10 CFR Part 140 Financial Protection Requirements for the Shine Facility
Project stage: Request
ML18268A3442018-10-0202 October 2018
Letter of Appreciation for the Tour of the Research Test Reactor Fuel Fabrication Facility Provided to the U.S. Nuclear Regulatory Commission on August 21, 2018 EPID No. L-2017-PMP-0014
Project stage: Other
ML18340A1712018-12-10010 December 2018
Shine Medical Technologies, Inc. - Acknowledgement of Receipt of Periodic Report on Construction Permit Conditions
Project stage: Other
ML18340A2762018-12-19019 December 2018
Shine Medical Technologies, Inc. - Acknowledgment of Receipt of Request for Confirmation of Applicable Financial Protection Requirements
Project stage: Other
ML19025A2642019-01-22022 January 2019
Shine Medical Technologies, Inc. Submittal of Meeting Slides for the January 29 and 30, 2019 Meeting with the NRC
Project stage: Request
ML19024A3522019-01-22022 January 2019
Shine Medical Technologies - Meeting Slides for the January 31, 2019 Public Meeting Between Shine Medical Technologies, Inc. and the NRC
Project stage: Request
ML19025A2752019-01-22022 January 2019
Shine Medical Technologies, Inc. Submittal of Meeting Slides for the January 29 and 30, 2019 Meeting with the NRC
Project stage: Request
ML19015A3522019-02-15015 February 2019
Irrevocable Standby Letter of Credit for the Aerotest Radiography and Research Reactor
Project stage: Other
ML19071A1852019-03-22022 March 2019
Shine Medical Technologies, Inc. - Request for Withholding from Public Disclosure
Project stage: Other
ML19071A1812019-03-22022 March 2019
Shine Medical Technologies, Inc. - January 31, 2019 Public Meeting Summary
Project stage: Meeting
ML19071A1792019-03-22022 March 2019
Shine Medical Technologies, Inc. January 31, 2019 Public Meeting
Project stage: Request
ML19071A1802019-03-22022 March 2019
Shine Medical Technologies, Inc. - Request for Withholding Information from Public Disclosure
Project stage: Withholding Request Acceptance
2018-06-18
[Table View] |
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Category:Meeting Summary
MONTHYEARML23156A6122023-06-0707 June 2023
Summary of Public Meeting with Shine Technologies
ML22258A3132022-09-27027 September 2022
Meeting Summary to Discuss Draft Environmental Impact Statement Supplement Related to the Operating License for the Shine Medical Isotope Production Facility
ML22258A3122022-09-27027 September 2022
July 27, 2022, Shine Draft Supplemental Environmental Impact Statement Public Meeting - Summary
ML22188A2412022-07-14014 July 2022
Meeting with Shine Medical Technologies, LLC (EPID No. L-2019-NEW-0004), to Discuss Development of Shine'S Cybersecurity Program for It'S Medical Isotope Production Facility
ML22118A8542022-05-0303 May 2022
Shine January 20, 2022 Public Meeting Summary
ML21313A4282021-11-15015 November 2021
Summary of September 27, 2021 Meeting with Shine Medical Technologies, LLC
ML21019A1592021-01-27027 January 2021
Public Meeting Summary January 12 2021
ML19071A1812019-03-22022 March 2019
Shine Medical Technologies, Inc. - January 31, 2019 Public Meeting Summary
ML18221A4542018-08-17017 August 2018
Summary of Meeting with Shine Medical Technologies, Inc.
ML18162A0552018-06-18018 June 2018
Shine Medical Technologies April 3, 2018 Public Meeting Summary
ML17025A4172017-01-27027 January 2017
12/01/2016 Summary of SHINE Medical Technologies, Inc. Public Meeting on Design Changes and Operating License Structure
ML16215A4082016-08-0404 August 2016
05/26/2016 - Public Meeting Summary - SHINE Medical Technologies on Eligible Facilities List and Construction Inspection
ML15169B1352015-07-0101 July 2015
June 10, 2015, Summary of Public Meeting to Discuss the Draft Environmental Impact Statement for the Construction Permit for the Proposed Shine Medical Radioisotope Production Facility
ML14120A4732014-05-0202 May 2014
03/19 & 20/2014 Summary of Category 1 Public Meeting with Shine Medical Technologies, Inc
ML13227A3912013-09-23023 September 2013
Summary of Public Meetings Conducted Related to the Review of the Proposed Shine Radioisotope Production Facility
2023-06-07
[Table view] |
Text
August 17, 2018 LICENSEE: SHINE Medical Technologies, Inc.
SUBJECT:
SUMMARY
OF JUNE 28, 2018, MEETING WITH SHINE MEDICAL TECHNOLOGIES, INC. (EPID NO. L-2017-PMP-0014)
On June 28, 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 the development of SHINEs operating license application for a medical radioisotope facility, including instrumentation and control (I&C), material control and accounting (MC&A) of special nuclear material (SNM), and design changes. This meeting served to inform NRC staff of the development status of key design and programmatic elements of SHINEs proposed medical radioisotope production project. Portions of this meeting were closed to public participation to discuss proprietary information related to SHINEs process vessel vent system and safety-related I&C design updates. The meeting notice and agenda, dated June 27, 2018, are available in the Agencywide Documents Access and Management System (ADAMS) at Accession No. ML18178A651. A list of meeting attendees is provided as an enclosure to this summary.
NRC staff opened the meeting at 8:30 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 SNM. 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 and requested NRC staff feedback on its approach to the development of an MC&A plan for its proposed facility. As part of its presentation, SHINE described the preliminary stages of the development of an MC&A plan that meets the requirements of Subpart D of Title 10 of the Code of Federal Regulations (10 CFR)
Part 74, Material Control and Accounting of Special Nuclear Material. SHINE indicated that it is basing its MC&A plan on the draft guidance contained in NUREG-2159, Acceptable Standard Format and Content for the Material Control and Accounting Plan Required for Special Nuclear Material of Moderate Strategic Significance, issued in September 2013. SHINE intends to submit its MC&A plan as part of its operating license application.
In response to SHINEs MC&A presentation, NRC staff confirmed that meeting the requirements of Subpart D of 10 CFR Part 74 and following the draft guidance in NUREG-2159 are an acceptable approach to developing an MC&A plan for SHINEs proposed facility. However, the staff acknowledged that the current 10 CFR Part 74 requirements and draft guidance in
NUREG-2159 are likely to change with the expected publication of a final rule revising and consolidating the requirements for MC&A of SNM in 10 CFR Part 74 in 2019. Draft versions of documents the final rule package, including specific rule language and guidance revisions, will be made publicly available in the coming months following internal NRC concurrence.
During the portions of the meeting that was closed to the public, SHINE went into proprietary-level detail related to design updates and improvements to its process vessel vent system as well as safety-related I&C system. SHINE has selected Rock Creek Innovations (RCI) to design and build its I&C systems. RCI has designed the Highly Integrated Protection System (HIPS) platform, which has previously been selected by NuScale for its I&C systems.
The HIPS platform is logic-based and does not use software or microprocessors for operation.
The HIPS platform is implemented using discrete components and field programmable gate array technology to implement complex digital circuits that do not incorporate software for their operation. The HIPS platform incorporates several design principles for safety; including independence; redundancy; diversity and defense-in-depth; and predictability and repeatability.
Further details on the discussions had during this meeting are included in the presentation slides (ADAMS Accession No. ML18187A216).
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
ML18221A453, Pkg; ML18178A651, Notice; ML18221A454, Mtg. Summary; ML18221A455, Withholding Ltr.; ML18187A216, 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 08/09/2018 08/14/2018 08/17/2018 08/17/2018 LIST OF ATTENDEES June 28, 2018 MEETING WITH SHINE MEDICAL TECHNOLOGIES, INC.
8:30 A.M. - 4:30 P.M.
Name Organization Jeff Bartelme SHINE Medical Technologies, Inc.
Jim Costedio SHINE Medical Technologies, Inc.
Eric Van Abel SHINE Medical Technologies, Inc.
Matt Coe SHINE Medical Technologies, Inc.
Adam Gonnering SHINE Medical Technologies, Inc.
Gregg Clarkson Rock Creek Innovations, LLC Jason Pottorf Rock Creek Innovations, LLC Martha Williams Talisman International Steven Lynch U.S. Nuclear Regulatory Commission Michael Balazik U.S. Nuclear Regulatory Commission Glenn Tuttle U.S. Nuclear Regulatory Commission David Ditto U.S. Nuclear Regulatory Commission Tom Pham U.S. Nuclear Regulatory Commission Duane Hardesty U.S. Nuclear Regulatory Commission Carl Weber U.S. Nuclear Regulatory Commission James Rubenstone U.S. Nuclear Regulatory Commission Linh Tran U.S. Nuclear Regulatory Commission Edward Helvenston U.S. Nuclear Regulatory Commission Jeremy Wachutka U.S. Nuclear Regulatory Commission Norbert Carte U.S. Nuclear Regulatory Commission Rossnyev Alvarado U.S. Nuclear Regulatory Commission Luis Betancourt U.S. Nuclear Regulatory Commission Rick Jervey U.S. Nuclear Regulatory Commission Mitzi Young U.S. Nuclear Regulatory Commission Ismael Garcia U.S. Nuclear Regulatory Commission Charity Pantalo U.S. Nuclear Regulatory Commission Lynnea Wilkins U.S. Nuclear Regulatory Commission Paul Carman U.S. Nuclear Regulatory Commission Darren Piccirillo U.S. Nuclear Regulatory Commission Enclosure