Letter Sequence RAI |
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EPID:L-2019-NEW-0004, Shine Medical Technologies, LLC Application for an Operating License (Approved, Closed) |
Initiation
- Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request
- Acceptance, Acceptance
- Supplement, Supplement, Supplement, Supplement, Supplement, Supplement, Supplement, Supplement, Supplement, Supplement, Supplement, Supplement
Results
Other: ML19235A308, ML19324F963, ML20057F950, ML20114E315, ML20126G523, ML20226A262, ML21029A103, ML21053A261, ML21089A228, ML21089A334, ML21096A250, ML21130A314, ML21145A060, ML21161A115, ML21209A997, ML21210A438, ML22042A018, ML22075A331, ML22075A336, ML22095A067, ML22124A073, ML22125A040, ML22152A108, ML22187A134, ML22206A208, ML22216A112, ML22220A261, ML22308A233, ML22322A212, ML22322A223, ML22347A177, ML22347A214, ML22348A067, ML22348A070, ML22348A072, ML23006A185
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MONTHYEARML19211C0442019-07-17017 July 2019 Shine Medical Technologies, LLC Application for an Operating License Project stage: Request ML19211C1432019-07-17017 July 2019 Shine Medical Technologies, LLC Application for an Operating License Project stage: Request ML19235A3082019-09-0505 September 2019 Shine Medical Technologies, LLC - Cover Letter for Notice of Receipt and Availability of Operating License Application Project stage: Other ML19276D4112019-10-0808 October 2019 Shine Medical Technologies, LLC - Acceptance for Docketing Letter Project stage: Acceptance Review ML19276D4092019-10-0808 October 2019 Shine Medical Technologies, LLC - Operating License Application Acceptance Review Results Project stage: Request ML19276D4102019-10-0808 October 2019 Shine Medical Technologies, LLC - Acceptance for Docketing Federal Register Notice Project stage: Acceptance Review ML19337A2752019-11-14014 November 2019 Shine Medical Technologies, LLC Supplement 1 to Final Safety Analysis Report Project stage: Request ML19331A6472019-11-14014 November 2019 Shine Medical Technologies, LLC Supplement 1 to Final Safety Analysis Report, Chapter 18, Highly Enriched to Low Enriched Uranium Conversion Project stage: Request ML19353C6872019-12-19019 December 2019 Environmental Site Audit Regarding Shine Medical Technologies, LLC - Proposed Medical Isotope Production Facility Project stage: Request ML19324F9632020-01-0202 January 2020 Shine Medical Technologies, LLC - Cover Letter for Notice of Opportunity for Hearing and Petition for Leave to Intervene Project stage: Other ML19324F9622020-01-0202 January 2020, 6 January 2020 Shine Medical Technologies, LLC - Notice of Opportunity for Hearing and Petition for Leave to Intervene Project stage: Request ML20057F9502020-03-0606 March 2020 Shine Medical Technologies, LLC - Instrumentation and Control Regulatory Audit Plan Project stage: Other ML20105A2952020-03-27027 March 2020 Shine Medical Technologies, LLC, Supplement 2 to License Application, Rev.2 to Final Safety Analysis Report Project stage: Supplement ML20114E3152020-04-30030 April 2020 Shine Medical Technologies, LLC - Operating License Application Technical Review Schedule Project stage: Other ML20126G5232020-05-0707 May 2020 Shine Medical Technologies, LLC - Regulatory Audit Plan Related to Electrical Power Systems Project stage: Other ML20226A2622020-08-14014 August 2020 Shine Medical Technologies, LLC - Accident Analysis and Criticality Safety Audit Plan Project stage: Other ML20255A0272020-08-28028 August 2020 Shine Medical Technologies, LLC Operating License Application Response to Request for Additional Information and Supplement No. 3 Project stage: Supplement ML21309A0192020-10-16016 October 2020 Shine Medical Technologies, LLC - Request for Additional Information Related to Chapters 2, 3, and 8 Project stage: RAI ML20311A1242020-10-30030 October 2020 Shine Medical Technologies, LLC, Operating License Application Supplement No. 4 Submittal of a Revision to the Shine Physical Security Plan Project stage: Supplement ML21309A0232020-11-10010 November 2020 Shine Medical Technologies, LLC - Request for Additional Information Related to Chapters 6 and 13 Project stage: RAI ML20325A0262020-11-13013 November 2020 Submittal of a Mark-Up to the Draft NRG-Proposed SHINE-Specific Security Measures Project stage: Request ML20357A0862020-12-10010 December 2020 Enclosure 1 - Final Safety Analysis Report Change Summary Project stage: Request ML21011A2242020-12-15015 December 2020 Shine Medical Technologies, LLC - Operating License Application Supplement No. 6 and Response to Request for Additional Information Project stage: Supplement ML20352A2252020-12-18018 December 2020 Shine Environmental RAIs - Cumulative Impacts Project stage: RAI ML21019A1592021-01-27027 January 2021 Public Meeting Summary January 12 2021 Project stage: Meeting ML21309A0442021-01-27027 January 2021 Shine Medical Technologies, LLC - Request for Additional Information Related to Chapters 9 and 11 Project stage: RAI ML21029A1022021-01-29029 January 2021 Shine Medical Technologies, LLC Operating License Application Response to Request for Additional Information Project stage: Response to RAI ML21029A0382021-01-29029 January 2021 Request for Exemption from Criticality Accident Alarm System Monitoring Requirements for the Shine Irradiation Unit Cells and Material Staging Building Project stage: Request ML21029A1032021-01-29029 January 2021 Enclosure 1 - Response to Final Safety Analysis Report Chapters 2, 3, and 8 Requests for Additional Information Project stage: Other ML21057A0052021-02-26026 February 2021 Shine Medical Technologies. LLC Application for an Operating License Commitment Change Related to the Submission of a Revision to the Technical Specifications Project stage: Request ML21053A2612021-03-11011 March 2021 Shine Medical Technologies - Geotechnical Audit Plan Project stage: Other ML21075A0122021-03-16016 March 2021 Shine Medical Technologies, LLC - Application for an Operating License, Revision 1 of Shine Response to Request for Additional Information 2.4-1 Project stage: Response to RAI ML21095A2292021-03-23023 March 2021 Shine Medical Technologies, LLC, Response to Request for Additional Information and Supplement No. 7 Project stage: Supplement ML21095A2222021-03-23023 March 2021 Shine Medical Technologies, LLC, Revisions to Final Safety Analysis Report, Chapter 5, Cooling Systems Project stage: Request ML21095A2142021-03-23023 March 2021 Shine Medical Technologies, LLC, Revisions to Final Safety Analysis Report, Chapter 6, Engineered Safety Features Project stage: Request ML21095A2352021-03-23023 March 2021 Shine Medical Technologies, LLC, Cover Letter for Response to Request Tor Additional Information and Supplement No. 7 Project stage: Supplement ML21089A3342021-04-0707 April 2021 Shine Medical Technologies, LLC - Summary of Audit Related to Geotechnical Topics Project stage: Other ML21089A0012021-04-0808 April 2021 Shine Medical Technologies, LLC - Request for Additional Information Related to Meteorological Data, Cooling Systems, and Physical Security Project stage: RAI ML21096A2502021-04-0808 April 2021 Shine Medical Technologies - Fire Protection Audit Plan Project stage: Other ML21106A1362021-04-16016 April 2021 Shine Medical Technologies, LLC Application for an Operating License Revision 1 of Shine Response to Request for Additional Information 3.4-6 Project stage: Response to RAI ML21089A2282021-04-21021 April 2021 Shine Medical Technologies, LLC - Physical Security Plan Audit Summary Project stage: Other ML21130A3142021-05-12012 May 2021 Shine Medical Technologies, LLC - Instrumentation and Control Systems Audit Plan Project stage: Other ML21130A3132021-05-12012 May 2021 Shine Medical Technologies, LLC - Instrumentation and Control Systems Audit Topics Enclosure 2 Project stage: Request ML21145A0602021-06-0202 June 2021 Shine Medical Technologies - Ch 6 8 13 and Exemption RAI Project stage: Other ML21161A1162021-06-10010 June 2021 Shine Medical Technologies, LLC - Cyber Security Audit Plan W/ 2 Encl Project stage: Request ML21161A1152021-06-10010 June 2021 Shine Medical Tech Ltr - Cyber Security Audit Plan Enclosure 1 Project stage: Other ML21172A1952021-07-0101 July 2021 Shine Medical Technologies, LLC - Request for Additional Information Related to Instrumentation and Control Systems Project stage: RAI ML21162A3182021-07-0101 July 2021 Shine Medical Technologies, LLC - Request for Additional Information Related to Fire Protection Project stage: RAI ML21208A1352021-07-27027 July 2021 Shine Medical Technologies, LLC Application for an Operating License Response to Request for Additional Information Project stage: Response to RAI ML21209A9972021-08-0303 August 2021 Shine Medical Technologies, LLC - Update to Operating License Application Technical Review Schedule Project stage: Other 2020-08-14
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Category:Letter
MONTHYEARML24128A2162024-05-0707 May 2024 Shine Technologies, LLC, Submittal of Annual Financial Report ML23229A0202023-08-17017 August 2023 Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 ML23087A2272023-05-0505 May 2023 Shine Technologies, LLC - Issuance of Amendment No. 4 to Construction Permit No. CPMIF-001 for the Receipt and Possession of Contained Special Nuclear Material ML23086C0502023-04-27027 April 2023 Shine Technologies, LLC - Letter, Environmental Assessment and Finding of No Significant Impact ML23088A3382023-04-0505 April 2023 Shine Technologies, LLC - Review of the Physical Security Plan in Support of an Operating License for a Medical Radioisotope Production Facility ML23010A1982023-02-24024 February 2023 Shine Technologies, LLC - Letter: Safety Evaluation Report for the Shine Medical Radioisotope Production Facility Operating License Application ML23048A2442023-02-17017 February 2023 Shine Technologies, LLC Request to Amend Construction Permit No. CPMIF-001 Response to Request for Additional Information ML23010A2382023-02-0303 February 2023 Shine Technologies, LLC - Individual Notice of Consideration FRN Letter ML23034A1872023-02-0303 February 2023 Shine Medical Technologies, LLC Notice of Availability of Environmental Impact Statement Supplement Related to the Operating License for the Shine Medical Isotope Production Facility (Docket Number: 50-608) ML23023A0942023-02-0202 February 2023 Notice of Availability of the Environmental Impact Statement Supplement Related to the Operating License for the Shine Medical Isotope Production Facility ML23023A0922023-02-0202 February 2023 Notice of Availability of the Environmental Impact Statement Supplement Related to the Operating License for the Shine Medical Isotope Production Facility ML23023A0862023-02-0202 February 2023 Notice of Availability of the Environmental Impact Statement Supplement Related to the Operating License for the Shine Medical Isotope Production Facility ML23024A1682023-02-0101 February 2023 Letter to Ken Westlake, EPA Region 5 - Issuance of Final EIS Supplement Related to the Operating License ML23024A1742023-02-0101 February 2023 Dr. Gregory Piefer, Chief Executive Officer - Issuance of Final EIS Supplement Related to the Operating License ML22287A1852023-02-0101 February 2023 Shine Technologies, LLC Regulatory Report on the Audit of Phased Startup Operations Application Supplement ML22308A2332023-01-0909 January 2023 Shine Technologies LLC - Regulatory Audit Report for Chapter 8 - Irradiation Facility and Radioisotope Production Facility Electrical Power Systems ML22347A2142023-01-0404 January 2023 Shine Technologies LLC - Regulatory Audit Report for I&C Combined Sessions ML22356A1932022-12-22022 December 2022 Shine Technologies, LLC Application for an Operating License - Response to Request for Confirmatory Information ML22347A1772022-12-14014 December 2022 Shine Technologies LLC - Regulatory Audit Report for Programmable Logic Lifecycle ML22301A1492022-12-0707 December 2022 Shine Technologies, LLC - Regulatory Audit Report for Chapter 13 - Accident Analysis and Criticality Safety ML22322A2122022-12-0202 December 2022 Shine Medical Technologies - Cybersecurity Audit Summary Report ML22322A2232022-12-0202 December 2022 Shine Medical Technologies - Fire Protection Audit Summary Report ML22348A0672022-12-0101 December 2022 Shine Technologies, LLC - Request for Confirmatory Information Related to Instrumentation and Control Systems ML22335A5722022-12-0101 December 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22292A3192022-11-30030 November 2022 Shine Medical Technologies, LLC Issuance of Order and Amendment No. 3 to Construction Permit No. CPMIF-001 ML22318A1782022-11-14014 November 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22304A1262022-10-31031 October 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22279A9512022-10-0606 October 2022 Shine Technologies, LLC Request to Amend Construction Permit No. CPMIF-001 ML22271A9632022-09-28028 September 2022 Shine Technologies, LLC Application for an Operating License Supplement No. 31 Revision to the Phased Startup Operations Application Supplement ML22263A3442022-09-20020 September 2022 Shine Technologies, LLC Application for an Operating License - Response to Request for Additional Information ML22263A0272022-09-19019 September 2022 Shine Technologies, LLC - Application for an Operating License - Response to Request for Confirmatory Information ML22220A2612022-09-12012 September 2022 Shine Technologies LLC - Regulatory Report on the Audit Chapter 14, Technical Specifications ML22251A3272022-09-0808 September 2022 Shine Technologies, LLC Application for an Operating License Revision 1 of Shine Response to Requests for Additional Information 7-38, 7-40, and 7-48 ML22249A1252022-08-31031 August 2022 Shine Technologies, LLC Final Safety Analysis Report - Application for an Operating License Supplement No. 30, Cover Letter ML22105A1102022-08-26026 August 2022 Shine Medical Technologies LLC - Request for Additional Information Related to the OGC Review of Phrase Approach ML22061A2122022-08-24024 August 2022 Shine Medical Technologies LLC - Regulatory Audit Plan for Phased Approach - Session 1 ML22213A0492022-08-0101 August 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22187A1342022-08-0101 August 2022 Shine Technologies, LLC - Update to Operating License Application Technical Review Schedule ML22206A2082022-07-27027 July 2022 Shine Medical Technologies, LLC - Request for Confirmatory Information Related to Radiation Protection Program and Waste Management ML22207A0062022-07-26026 July 2022 Shine Technologies, LLC Application for an Operating License Supplement No. 29 ML22202A4492022-07-21021 July 2022 Shine Technologies, LLC Operating License Application Supplement No. 28 - Submittal of a Revision to the Shine Emergency Plan 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 ML22175A0392022-07-11011 July 2022 Letter to Reid Nelson, Achp Notice of Availability and Request for Comments on the Draft EIS Supplement Related to the Operating License for the Shine Facility ML22175A0542022-07-0808 July 2022 Letter to Gregory Piefer - Notice of Availability of the Draft EIS Supplement Related to the Operating License for the Shine Medical Isotope Production Facility ML22175A0912022-07-0808 July 2022 Notice of Availability and Request for Comments on the Draft Environmental Impact Statement Supplement Related to the Operating License for the Shine (Multiple Tribal Letters) ML22175A0772022-07-0808 July 2022 Letter to Daina Penkiunas - Notice of Availability and Request for Comments on the Draft EIS Supplement Related to the Operating License for the Shine Facility ML22175A0632022-07-0808 July 2022 Letter to Ken Westlake, EPA Region 5 - Notice of Availability and Request for Comments on the Draft EIS Supplement Related to the Operating License for the Shine Facility ML22188A1942022-07-0707 July 2022 Shine Technologies, LLC, Application for an Operating License Supplement No. 27 ML22188A0562022-07-0707 July 2022 Shine Technologies, LLC Operating License Application Supplement No. 26 Submittal of a Revision to the Shine Material Control and Accounting Plan ML22223A0662022-07-0606 July 2022 Shine Technologies, LLC, Application for an Operating License, Revision 1 of the Response to Requests for Additional Information Related to Cyber Security 2024-05-07
[Table view] Category:Request for Additional Information (RAI)
MONTHYEARML23041A0402023-02-0909 February 2023 NRR E-mail Capture - Request for Additional Information Construction Permit (Cp), License Amendment Request (LAR) ML22348A0672022-12-0101 December 2022 Shine Technologies, LLC - Request for Confirmatory Information Related to Instrumentation and Control Systems ML22348A0702022-11-10010 November 2022 (E-MAIL) Shine Medical Technologies, LLC Request for Confirmatory Information Related to Instrumentation and Control Systems ML22348A0722022-10-28028 October 2022 (Email) Shine Medical Technologies, LLC Request for Confirmatory Information Related to Accident Analysis ML22105A1102022-08-26026 August 2022 Shine Medical Technologies LLC - Request for Additional Information Related to the OGC Review of Phrase Approach ML22063A7042022-05-0606 May 2022 Shine Medical Technologies, LLC - Request for Additional Information Related to the Phased Approach ML22088A1662022-04-18018 April 2022 Shine Medical Technologies, LLC - Request for Additional Information Related to the Process Integrated Control System ML22012A2032022-01-27027 January 2022 Shine Medical Technologies, LLC - Request for Additional Information Related to the Neutron Flux Detection System ML22007A2172022-01-11011 January 2022 Shine Medical Technologies, LLC - Request for Additional Information Related to Instrumentation and Control Systems ML21355A3602021-12-23023 December 2021 Shine Medical Technologies, LLC - Request for Additional Information Related to Radiation Damage ML21280A3382021-10-22022 October 2021 Shine Medical Technologies, Llc Request for Additional Information Related to Operator Training and Requalification Program ML21252A7532021-09-29029 September 2021 Shine Medical Technologies, LLC - Request for Additional Information Related to Instrumentation and Control Systems ML21210A4382021-08-13013 August 2021 Shine Medical Technologies, LLC - Cyber Security RAI ML21162A3182021-07-0101 July 2021 Shine Medical Technologies, LLC - Request for Additional Information Related to Fire Protection ML21172A1952021-07-0101 July 2021 Shine Medical Technologies, LLC - Request for Additional Information Related to Instrumentation and Control Systems ML21173A0122021-06-28028 June 2021 Shine Medical Technologies - Structural RAIs ML21145A0602021-06-0202 June 2021 Shine Medical Technologies - Ch 6 8 13 and Exemption RAI ML21089A0012021-04-0808 April 2021 Shine Medical Technologies, LLC - Request for Additional Information Related to Meteorological Data, Cooling Systems, and Physical Security ML21309A0442021-01-27027 January 2021 Shine Medical Technologies, LLC - Request for Additional Information Related to Chapters 9 and 11 ML20352A2252020-12-18018 December 2020 Shine Environmental RAIs - Cumulative Impacts ML21309A0232020-11-10010 November 2020 Shine Medical Technologies, LLC - Request for Additional Information Related to Chapters 6 and 13 ML21309A0192020-10-16016 October 2020 Shine Medical Technologies, LLC - Request for Additional Information Related to Chapters 2, 3, and 8 ML20148M2802020-05-26026 May 2020 Request for Additional Information Related to Shine Medical Technologies, LLC Operating License Application (Enclosure) ML20092L5922020-04-14014 April 2020 Letter to G. Piefer Clarification on Request for Additional Information Responses for Environmental Review of the Shine Medical Technologies, LLC - Proposed Medical Isotope Production Facility Operating License Application (Dkt No. 50-608) ML19024A5302019-02-13013 February 2019 Shine Medical Technologies, Inc. - Request for Additional Information Regarding the Application for Indirect License Transfer and Conforming Amendment ML17031A4432017-02-0606 February 2017 Shine Medical Technologies, Inc. - Request for Additional Information Regarding Safeguards Information Protection Program ML17031A4402017-01-26026 January 2017 Draft Request for Additional Information Regarding Shine SGI Protection Program ML17031A4392017-01-26026 January 2017 Review of Shine SGI Protection Program Procedures (E-mail) ML15259A1642015-09-24024 September 2015 Shine Medical Technologies, Inc., - Request for Additional Information Regarding Application for Construction Permit ML15244A7712015-08-27027 August 2015 Draft Request for Additional Information Shine Medical Technologies, Inc. Preliminary Safety Analysis Report Supporting a Construction Permit Application ML15099A6072015-04-15015 April 2015 Shine Medical Technologies, Inc., - Request for Additional Information Regarding Application for Construction Permit(Tac Nos. MF2305, MF2307, and MF2308) ML15055A1162015-03-25025 March 2015 Shine Medical Technologies, Inc., - Request for Additional Information Regarding Application for Construction Permit ML15005A4072015-01-0606 January 2015 Shine Medical Technologies, Inc., Request for Additional Information Regarding Application for Construction Permit ML14195A1592014-09-19019 September 2014 Shine Medical Technologies, Inc. - Request for Additional Information Regarding Application for Construction Permit ML14209B0642014-07-24024 July 2014 Shine Revised Draft Request for Additional Information Regarding Application for Construction Permit ML13231A0412013-09-11011 September 2013 Requests for Additional Information Shine 2023-02-09
[Table view] |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 April 8, 2021 Dr. Gregory Piefer, Chief Executive Officer SHINE Medical Technologies, LLC 101 East Milwaukee Street, Suite 600 Janesville, WI 53545
SUBJECT:
SHINE MEDICAL TECHNOLOGIES, LLC - REQUEST FOR ADDITIONAL INFORMATION RELATED METEOROLOGICAL DATA, COOLING SYSTEMS, AND PHYSICAL SECURITY PLAN (EPID NO. L-2019-NEW-0004)
Dear Dr. Piefer:
By letter dated July 17, 2019 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML19211C044), as supplemented by letters dated November 14, 2019 (ADAMS Accession No. ML19337A275), March 27, 2020 (ADAMS Accession No. ML20105A295), August 28, 2020 (ADAMS Accession No. ML20255A027),
November 13, 2020 (ADAMS Accession No. ML20325A026), December 10, 2020 (ADAMS Accession No. ML20357A084), and December 15, 2020 (ADAMS Accession No. ML21011A264), SHINE Medical Technologies, LLC (SHINE) submitted to the U.S. Nuclear Regulatory Commission (NRC) an operating license application for its proposed SHINE Medical Isotope Production Facility in accordance with the requirements contained in Title 10 of the Code of Federal Regulations (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities.
During the NRC staffs review of SHINEs operating license application, questions have arisen for which additional information is needed. The enclosed request for additional information (RAI) identifies information needed for the NRC staff to continue its review of the SHINE final safety analysis report (FSAR), submitted as part of the operating license application, and prepare a safety evaluation report. The specific chapters of the SHINE operating license application covered by this RAI includes the following:
- Chapter 2, Site Characteristics
- Chapter 4, Irradiation Unit and Radioisotope Production Facility Description
- Physical Security Plan to this letter contains publicly available RAIs related to SHINE FSAR Chapters 2 and 4. Enclosure 2 to this letter contains non-public security-related information related to SHINEs physical security plan. It is requested that SHINE provide responses to the enclosed RAI within 30 days from the date of this letter. In accordance with 10 CFR 50.30(b), Oath or affirmation, SHINE must execute its response in a signed original document under oath or affirmation. The response must be submitted in accordance with 10 CFR 50.4, Written communications. Information included in the response that is considered sensitive or proprietary, that SHINE seeks to have withheld from the public, must be marked in accordance
G. Piefer with 10 CFR 2.390, Public inspections, exemptions, requests for withholding. Any information related to safeguards should be submitted in accordance with 10 CFR 73.21, Protection of Safeguards Information: Performance Requirements. Following receipt of the additional information, the NRC staff will continue its evaluation of the subject chapters and technical areas of the SHINE operating license application.
As the NRC staff continues its review of SHINEs operating license application, additional RAIs for other chapters and technical areas may be developed. The NRC staff will transmit any further questions to SHINE under separate correspondence.
If SHINE has any questions, or needs additional time to respond to this request, please contact me at 301-415-1524, or by electronic mail at Steven.Lynch@nrc.gov.
Sincerely, Steven T. Digitally signed by Steven T. Lynch Lynch Date: 2021.04.08 17:55:42 -04'00' Steven T. Lynch, Senior Project Manager Non-Power Production and Utilization Facility Licensing Branch Division of Advanced Reactors and Non-Power Production and Utilization Facilities Office of Nuclear Reactor Regulation Docket No. 50-608 Construction Permit No. CPMIF-001
Enclosures:
As stated cc: See next page
SHINE Medical Technologies, LLC Docket No. 50-608 cc:
Jeff Bartelme Licensing Manager SHINE Medical Technologies, LLC 101 East Milwaukee Street, Suite 600 Janesville, WI 53545 Nathan Schleifer General Counsel SHINE Medical Technologies, LLC 101 East Milwaukee Street, Suite 600 Janesville, WI 53545 Christopher Landers Director, Office of Conversion National Nuclear Security Administration, NA 23 U.S. Department of Energy 1000 Independence Avenue, SW Washington, DC 20585 Mark Paulson Supervisor Radiation Protection Section Wisconsin Department of Health Services P.O. Box 2659 Madison, WI 53701-2659 Test, Research and Training Reactor Newsletter Attention: Amber Johnson Dept. of Materials Science and Engineering University of Maryland 4418 Stadium Drive College Park, MD 20742-2115 Mark Freitag City Manager P.O. Box 5005 Janesville, WI 53547-5005 Bill McCoy 1326 Putnam Avenue Janesville, WI 53546 Alfred Lembrich 541 Miller Avenue Janesville, WI 53548
PKG: ML21089A000 NRR-088 OFFICE NRR/DANU/PM NRR/DANU/LA NRR/DANU/BC NRR/DANU/BC (A) NRR/DANU/PM NAME SLynch NParker TTate DHardesty SLynch DATE 3/31/2021 4/1/2021 4/08/2021 4/08/2021 4/08/2021 OFFICE OF NUCLEAR REACTOR REGULATION REQUEST FOR ADDITIONAL INFORMATION REGARDING OPERATING LICENSE APPLICATION FOR SHINE MEDICAL TECHNOLOGIES, LLC CONSTRUCTION PERMIT NO. CPMIF-001 SHINE MEDICAL ISOTOPE PRODUCTION FACILITY DOCKET NO. 50-608 By letter dated July 17, 2019 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML19211C044), as supplemented by letters dated November 14, 2019 (ADAMS Accession No. ML19337A275), March 27, 2020 (ADAMS Accession No. ML20105A295), August 28, 2020 (ADAMS Accession No. ML20255A027),
November 13, 2020 (ADAMS Accession No. ML20325A026), December 10, 2020 (ADAMS Accession No. ML20357A084), and December 15, 2020 (ADAMS Accession No. ML21011A264), SHINE Medical Technologies, LLC (SHINE) submitted to the U.S. Nuclear Regulatory Commission (NRC) an operating license application for its proposed SHINE Medical Isotope Production Facility in accordance with the requirements contained in Title 10 of the Code of Federal Regulations (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities.
During the NRC staffs review of the SHINE operating license application, questions have arisen for which additional information is needed. This request for additional information (RAI) identifies information needed for the NRC staff to continue its review of the SHINE final safety analysis report (FSAR), submitted as part of the operating license application, and prepare a safety evaluation report. Specific chapters and technical areas of the SHINE operating license application covered by this RAI include the following:
- Chapter 2, Site Characteristics
- Chapter 4, Irradiation Unit and Radioisotope Production Facility Description Applicable Regulatory Requirements and Guidance Documents The NRC staff is reviewing the SHINE operating license application, which describes the SHINE irradiation facility, including the irradiation units, and radioisotope production facility, using the applicable 10 CFR requirements, as well as the guidance contained in NUREG-1537, Part 1, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Format and Content, issued February 1996 (ADAMS Accession No. ML042430055), and NUREG-1537, Part 2, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Standard Review Plan and Acceptance Criteria, issued February 1996 (ADAMS Accession No. ML042430048). The NRC staff is also using the Final Interim Staff Guidance [ISG] Augmenting NUREG-1537, Part 1, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors: Format and Content, for Licensing Radioisotope Production Facilities and Aqueous Homogeneous Reactors, dated October 17, 2012 (ADAMS Accession No. ML12156A069), and Final Interim Staff Guidance Augmenting Enclosure 1
NUREG-1537, Part 2, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors: Standard Review Plan and Acceptance Criteria, for Licensing Radioisotope Production Facilities and Aqueous Homogeneous Reactors, dated October 17, 2012 (ADAMS Accession No. ML12156A075). As applicable, additional guidance cited in SHINEs FSAR or referenced in NUREG-1537, Parts 1 and 2, or the ISG Augmenting NUREG-1537, Parts 1 and 2, has been utilized in the review of the SHINE operating license application.
For the purposes of this review, the term reactor, as it appears in NUREG-1537, the ISG Augmenting NUREG-1537, and other relevant guidance can be interpreted to refer to SHINEs irradiation unit, irradiation facility, or radioisotope production facility, as appropriate within the context of the application and corresponding with the technology described by SHINE in its application. Similarly, for the purposes of this review, the term reactor fuel, as it appears in the relevant guidance listed above, may be interpreted to refer to SHINEs target solution.
Responses to the following RAI are needed to continue the review of the SHINE operating license application.
Chapter 2 - Site Characteristics SHINE FSAR Section 2.3, Meteorology The following regulatory requirement is applicable to RAIs 2.3-1 and 2.3-2:
Paragraph (a)(1) of 10 CFR 20.1301, Dose Limits for Individual Members of the Public, states, in part, that [e]ach license shall conduct operations such that [t]he total effective dose equivalent to individual members of the public from the licensed operation does not exceed 0.1 rem (1 mSv) in a year.
The requests for information that follow are intended to confirm that SHINE has provided and developed sufficient analyses applicable to and commensurate with the risks of the dispersion of airborne releases of radioactive material in the unrestricted environment at the site, and any doses received by members of the public are within the regulatory limits of 10 CFR Part 20, Standards for Protection against Radiation.
RAI 2.3-1 The acceptance criteria for Section 2.3, Meteorology, of NUREG-1537, Part 2, states, in part, that the information on meteorology, and local weather conditions is sufficient to support dispersion analyses for postulated airborne releases.
As stated, in part, in Section 2.3.2.2, Local Data Sources, of the SHINE FSAR,
[s]urface meteorological data were available from the Southern Wisconsin Regional Airport (SWRA) in Janesville, Wisconsin (NOAA station identifier KJVL), and were used to support relative atmospheric concentration and radiological dose assessments. Regulatory Guide (RG) 1.23, Meteorological Monitoring Programs for Nuclear Power Plants, provides guidance for designing and operating an onsite meteorological measurements program, including the resolution and specification for meteorological instrumentation. Although there is no requirement that SHINE use RG 1.23, or follow the guidance therein, the RG provides the basis for the meteorology data used in NRC-approved atmospheric dispersion models. With this in mind, the NRC staff developed the following information requests to confirm the quality and appropriate use of the meteorological data from the SWRA in SHINEs dispersion modeling:
- a. SHINE has provided wind direction, as shown in the Annual Wind Rose data from the SWRA in Figure 2.3 of the SHINE FSAR, only by wind direction sector (N, NNW, NW, etc.), and not discrete degrees, resulting in wind directions being recorded every 22.5 degrees.
Discuss and account for any bias introduced by using wind direction sector rather than discrete wind direction degrees.
- b. Wind speed instrumentation at National Weather Service stations or airfields may have insufficient resolution at lower wind speeds which could result in underestimated X/Q values.
Discuss the resolution of the SWRA wind speed instrumentation and its acceptability for accurately calculating the X/Q values.
- c. As discussed in FSAR Section 2.3.2.5, Atmospheric Stability, SHINE determined stability classes using the Turner 1964 method. However, the vertical temperature difference is the preferred method for determining Pasquill stability classes for NRC licensing purposes, as specified in RG 1.145, Atmospheric Dispersion Models for Potential Accident Consequence Assessments at Nuclear Power Plants, Revision 1, Section 1.1, Meteorological Data Input.
Discuss any differences in the parameters and approach SHINE used to determine atmospheric stability via the Turner 1964 method as compared to the vertical temperature difference method. Discuss any bias introduced into the dispersion results by using the Turner 1964 method.
RAI 2.3-2 The acceptance criteria for Section 2.3 of NUREG-1537, Part 2, states, in part, that [h]istorical summaries of local meteorological data based on available onsite measurements and National Weather Service station summaries or summaries from other nearby sources are presented.
As stated in part, in Section 2.3.2.2 of the SHINE FSAR, [s]urface meteorological data were available from the Southern Wisconsin Regional Airport (SWRA) in Janesville, Wisconsin (NOAA station identifier KJVL) and were used to support relative atmospheric concentration and radiological dose assessments. However, the NRC staff is seeking additional information to confirm that the data used by SHINE is representative of onsite conditions for the facility.
Discuss the representativeness of the offsite meteorological measurements for the local conditions at the SHINE site, specifically addressing the dispersion characteristics of the modeled releases. Note any differences in dispersion characteristics between the SHINE site and the Southern Wisconsin Regional Airport.
The information requested in RAIs 2.3-1 and 2.3-2 is necessary to support the NRC staffs evaluation findings, consistent with Section 2.3 of NUREG-1537, Part 2. Specifically, the requested information is intended to support the NRC staffs determination that meteorological information presented by SHINE in its FSAR is sufficient to support analyses applicable to and commensurate with the risks of the dispersion of airborne releases of radioactive material in the unrestricted environment at the site. The methods and assumptions are applied to releases from both normal facility operations and postulated accidents at the facility.
Chapter 4 - Irradiation Unit and Radioisotope Production Facility Description RAI 4a-15 Paragraph (b)(2) of Section 50.34, Contents of applications; technical information, to 10 CFR Part 50 requires, in part, that an FSAR include a description and analysis of the structures, systems, and components of the facility, with emphasis upon performance requirements, the bases, and the evaluations required to show that safety functions will be accomplished. The description shall be sufficient to permit understanding of the system designs and their relationship to safety evaluations.
The ISG to NUREG-1537, Part 2, Section 4a2.6, "Thermal-Hydraulic Design, states that the criteria for the thermal-hydraulic design should include that there be no coolant flow instability in any cooling coil that could lead to a decrease in cooling, and that the departure from nucleate boiling (DNB) ratio should be no less than 2.0 along a cooling coil. The NRC staff did not identify information in the FSAR to confirm that that any primary closed loop cooling system (PCLS) heat transfer surface, under any design conditions, will not undergo DNB.
Clarify whether any PCLS cooling surface, considering all system design conditions, could exceed critical heat flux resulting in DNB. If so, explain how such a condition is prevented and mitigated. If not, explain how much margin is available to avoid DNB in the worse-case scenario.
This information is necessary to confirm that primary coolant hydraulics and thermal conditions have been specified for the SHINE facility, consistent with the evaluation findings in the ISG to NUREG-1537, Part 2, Section 4a2.6. The analysis provided by the applicant should consider the various approaches and systems for heat removal, such as the cooling coils, the pool, and the gas management system. The analyses should give the limiting conditions of the features that ensure barrier integrity.