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MONTHYEARML21245A0552021-09-0202 September 2021 Shine Medical Technologies, LLC Schedule Update Project stage: Request ML21320A0662021-11-16016 November 2021 Shine Technologies, LLC Operating License Application Supplement No. 12 Submittal of a Revision to the Shine Supplement to the Environmental Report Project stage: Supplement ML22027A3542022-01-27027 January 2022 Shine Technologies, LLC, Submittal of Application for an Operating License Supplement No. 15 Submittal of the Phased Startup Operations Application Supplement Project stage: Supplement ML22027A3532022-01-27027 January 2022 Shine Technologies, LLC, Submittal of Application for an Operating License Supplement No. 15 Submittal of the Phased Startup Operations Application Supplement Project stage: Request ML22047A1792022-02-17017 February 2022 Shine Review Schedule Update Letter-Phased Approach Project stage: Other ML22063A7042022-05-0606 May 2022 Shine Medical Technologies, LLC - Request for Additional Information Related to the Phased Approach Project stage: RAI ML22094A1142022-05-23023 May 2022 Shine Medical Technologies LLC - Draft Regulatory Audit Plan for Phased Approach Session 2 Project stage: Draft Other ML22061A2122022-08-24024 August 2022 Shine Medical Technologies LLC - Regulatory Audit Plan for Phased Approach - Session 1 Project stage: Other ML22105A1102022-08-26026 August 2022 Shine Medical Technologies LLC - Request for Additional Information Related to the OGC Review of Phrase Approach Project stage: RAI ML22263A0272022-09-19019 September 2022 Shine Technologies, LLC - Application for an Operating License - Response to Request for Confirmatory Information Project stage: Request 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 ML22287A1852023-02-0101 February 2023 Shine Technologies, LLC Regulatory Report on the Audit of Phased Startup Operations Application Supplement Project stage: Other 2022-05-06
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Category:Letter
MONTHYEARML24128A2162024-05-0707 May 2024 Shine Technologies, LLC, Submittal of Annual Financial Report ML24047A0392024-02-16016 February 2024 Shine Technologies, LLC - Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 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) 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 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 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 ML22287A1852023-02-0101 February 2023 Shine Technologies, LLC Regulatory Report on the Audit of Phased Startup Operations Application Supplement ML23024A1742023-02-0101 February 2023 Dr. Gregory Piefer, Chief Executive Officer - Issuance of Final EIS Supplement Related to the Operating License 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 ML22187A1342022-08-0101 August 2022 Shine Technologies, LLC - Update to Operating License Application Technical Review Schedule ML22213A0492022-08-0101 August 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information 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 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
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SHINE Medical Technologies, LLC May 5, 2022 Dr. Gregory Piefer Chief Executive Officer SHINE Technologies, LLC 3400 Innovation Court Janesville, WI 53546
SUBJECT:
SHINE MEDICAL TECHNOLOGIES, LLC - REQUEST FOR ADDITIONAL INFORMATION RELATED TO THE PHASED STARTUP OPERATIONS APPLICATION SUPPLEMENT (EPID NO. L-2022-NEW-0004)
Dear Dr. Piefer:
By letter dated January 27, 2022 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML22027A353), SHINE Medical Technologies, LLC (SHINE) submitted to the U.S. Nuclear Regulatory Commission (NRC), Application for an Operating License Supplement No.15, Submittal of the Phased Startup Operations Application Supplement, related to its 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 phased startup operations application supplement, 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, submitted in connection with the operating license application and phased startup operations application supplement, and prepare a safety evaluation report. The specific technical area of the SHINE operating license application covered by this RAI is Chapter 5, Cooling Systems.
It is requested that SHINE provide responses to the enclosed RAI within 30 days from the date of this letter. To facilitate a timely and complete response to the enclosed RAI, the NRC staff is available to meet with SHINE to clarify the scope of information and level of detail expected to be included in the RAI response. SHINE may coordinate the scheduling and agendas for any such meetings with the responsible project manager assigned to this project.
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 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.
G. Piefer As the NRC staff continues its review of SHINEs phased startup operations application supplement, 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) 415-1053, or by electronic mail at Holly.Cruz@nrc.gov.
Sincerely, Signed by Cruz, Holly on 05/05/22 Holly D. Cruz, 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
Enclosure:
As stated cc w/enclosure: See next page
SHINE Medical Technologies, LLC Docket No. 50-608 cc:
Jeff Bartelme Mark Freitag Licensing Manager City Manager SHINE Technologies, LLC P.O. Box 5005 3400 Innovation Court Janesville, WI 53547-5005 Janesville, WI 53546 Bill McCoy Nathan Schleifer 1326 Putnam Avenue General Counsel Janesville, WI 53546 SHINE Technologies, LLC 3400 Innovation Court Alfred Lembrich Janesville, WI 53546 541 Miller Avenue Janesville, WI 53548 Christopher Landers Director, Office of Conversion National Nuclear Security Administration, NA 23 U.S. Department of Energy 1000 Independence Ave SW Washington, DC 20585 Mark Paulson, Supervisor Radiation Protection Section Wisconsin Department of Health Services P.O. Box 2659 Madison, WI 53701-2659 Shelley Warwick Environmental Analysis Specialist-South Team Wisconsin Department of Natural Resources 3911 Fish Hatchery Road Fitchburg, WI 53711 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
ML22063A704 NRR-106 OFFICE NRR/DANU/PM NRR/DANU/LA NRR/DANU/BC NRR/DANU/PM NAME HCruz NParker JBorromeo HCruz DATE 3/31/2022 3/31/2022 5/5/2022 5/5/2022 OFFICE OF NUCLEAR REACTOR REGULATION REQUEST FOR ADDITIONAL INFORMATION REGARDING PHASED STARTUP OPERATIONS APPLICATION SUPPLEMENT TO OPERATING LICENSE APPLICATION CONSTRUCTION PERMIT NO. CPMIF-001 SHINE MEDICAL TECHNOLOGIES, LLC SHINE MEDICAL ISOTOPE PRODUCTION FACILITY DOCKET NO. 50-608 By letter dated January 27, 2022 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML22027A353), SHINE Medical Technologies, LLC (SHINE) submitted to the U.S. Nuclear Regulatory Commission (NRC), Application for an Operating License Supplement No.15, Submittal of the Phased Startup Operations Application Supplement, related to its 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 Part 50, Domestic Licensing of Production and Utilization Facilities.
During the NRC staffs review of SHINEs phased startup operations application supplement, questions have arisen for which additional information is needed. This 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 in connection with the operating license application and phased startup operations application supplement, and prepare a safety evaluation report. The specific technical area of the SHINE operating license application covered by this RAI is Chapter 5, Cooling Systems.
Applicable Regulatory Requirements and Guidance Documents The NRC staff is reviewing the SHINE operating license application and phased startup operations application supplement, using the applicable regulations, 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 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).
Enclosure
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 during this review.
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.
Chapter 5 - Cooling Systems RCPS [Radioisotope Process Facility Cooling System] Analyses Section 5a2.3 of the phased startup operations application supplement states, in part:
The RPCS interface points with IU [irradiation unit] specific systems are isolated to support phased startup operation (i.e., interfaces with unit specific systems supporting IUs 3 through 8 are isolated during Phase 1 operation, interfaces with unit specific systems supporting IUs 6 through 8 are isolated during Phase 2 operation), as follows:
The RPCS supply and return interfaces with PCLS [primary closed loop cooling system] are each isolated with a manual valve and a blind flange or cap.
The RPCS supply and return interfaces with NDAS [neutron driver assembly system] cooling cabinets are each isolated with a manual valve and a blind flange or cap.
The RPCS supply and return interfaces with TOGS [target solution vessel (TSV) off-gas system] are each isolated with a manual valve and a blind flange or cap.
The RPCS supply and return interfaces with the RVZ1r [radiological ventilation zone 1 recirculating cooling subsystem] IU supplemental cooling are each isolated with a manual valve and a blind flange or cap.
NUREG-1537, Part 2, Section 5a2.3, Secondary Cooling System, describes, in part, that
[t]he secondary cooling system of an AHR should be designed to transfer reactor heat from the primary and possibly other cooling systems to the environment. The secondary cooling system should be designed for continuous operation at the licensed power level. Therefore, the secondary cooling system in these reactors must be designed to dissipate heat continuously. In this section of the SAR, the applicant should justify how any necessary heat dissipation is accomplished.
RAI 5-1 SHINE Design Criteria 26 Section 5a2.3.2 of the FSAR states that the RPCS cooling water will be maintained at a higher pressure than those systems with potential to contaminate the RPCS, which is referred to as a pressure cascade. Section 5a2.3 of the phased construction approach supplement describes modifications that will be made to the RPCS piping in order to isolate it from unit-specific systems that have not yet been installed.
Confirm that the pressure cascade will be maintained in each RPCS piping configuration employed in the phased construction approach.