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| | docket = 05000608 | | | docket = 05000608 |
| | license number = | | | license number = |
| | contact person = Lynch S T, NRR/DPR, 415-1524 | | | contact person = Lynch S, NRR/DPR, 415-1524 |
| | case reference number = TAC MF2305, TAC MF2307 | | | case reference number = TAC MF2305, TAC MF2307 |
| | package number = ML15244A501 | | | package number = ML15244A501 |
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| {{#Wiki_filter:DRAFT REQUEST FOR ADDITIONAL INFORMATION SHINE MEDICAL TECHNOLOGIES, INC. REGARDING THE PRELIMINARY SAFETY ANALYSIS REPORT SUPPORTING A CONSTRUCTION PERMIT APPLICATION DOCKET NO. 50-608 TAC NOS. MF2305 AND MF2307 CHAPTER 6 ENGINEERED SAFETY FEATURES The following request for information is based on a review of Chapter 6 of the SHINE PSAR (ADAMS Accession No. ML15175A213) using NUREG-1537, Parts 1 and 2 in conjunction with the Final ISG Augmenting NUREG- responses to requests for additional information (RAIs). Section 6b.3 Nuclear Criticality Control RAI 6b.3-34 As required by 10 CFR 50.34(a), Contents of applications; technical informationa preliminary safety analysis reanalysis and evaluation of the design and performance of structures, systems, and components of the facility with the objective of assessing the risk to public , and the adequacy of structures, systems, and components provided for the prevention of accidents Additionally, the preliminary design of the facility should provide reasonable assurance to the NRC staff that the final design will conform to its design bases with adequate margin for safety. With respect to nuclear criticality control, the Interim Staff Guidance (ISG) Augmenting NUREG-1537, Part 2, Section the Procshould be provided for criticality safety, and a description of their safety function should be described. The applicant should use enough safety controls to demonstrate that, under normal and abnormal credible conditions, all nuclear controlled parameters will be established to ensure that all nuclear processes are subcritical, including an adequat The ISG Augmenting NUREG-1537, Part 2, Section 6b.3, states, in part, that the of subcriticality for safety is sufficient to provide reasonabl In response to RAI 6b.3-4, SHINE states it intends to utilize a subcritical margin of 0.05 with additional considerations for uncertainty in the validation and modeling. In addition, SHINE states in multiple places in the PSAR that (assuming a subcritical margin of 0.05). s to RAIs 6b.3-1 and 6b.3-26 found that there was insufficient benchmarking of the code against experiments utilizing the materials . For this reason, the proposed subcritical margin of 0.05 is not sufficient to adequately address the uncertainty associated with the neutron interactions of these process materials. The subcritical margin of 0.05, which SHINE quoted from NUREG-1520, was intended for facilities with enrichment less than five percent utilizing well established processes and for which there is significant experience and data. In contrast, the SHINE facility will be a first-of-a-kind facility using materials not normally utilized and of an enrichment up to 20 percent. Provide additional information describing how SHINE has or will sufficiently benchmark against experiments utilizing the materials and enrichments expected to be used in SHINE facility processes for its proposed margin of subcriticality, or propose a new margin of subcriticality that appropriately takes into account materials and enrichment.}} | | {{#Wiki_filter:DRAFT REQUEST FOR ADDITIONAL INFORMATION SHINE MEDICAL TECHNOLOGIES, INC. |
| | REGARDING THE PRELIMINARY SAFETY ANALYSIS REPORT SUPPORTING A CONSTRUCTION PERMIT APPLICATION DOCKET NO. 50-608 TAC NOS. MF2305 AND MF2307 CHAPTER 6 - ENGINEERED SAFETY FEATURES The following request for information is based on a review of Chapter 6 of the SHINE PSAR (ADAMS Accession No. ML15175A213) using NUREG-1537, Parts 1 and 2 in conjunction with the Final ISG Augmenting NUREG-1537, Parts 1 and 2, as supplemented by SHINEs responses to requests for additional information (RAIs). |
| | Section 6b.3 - Nuclear Criticality Control RAI 6b.3-34 As required by 10 CFR 50.34(a), Contents of applications; technical information, a preliminary safety analysis report should include [a] preliminary analysis and evaluation of the design and performance of structures, systems, and components of the facility with the objective of assessing the risk to public health and safety resulting from operation of the facility, and the adequacy of structures, systems, and components provided for the prevention of accidents and the mitigation of the consequences of accidents. Additionally, the preliminary design of the facility should provide reasonable assurance to the NRC staff that the final design will conform to its design bases with adequate margin for safety. |
| | With respect to nuclear criticality control, the Interim Staff Guidance (ISG) |
| | Augmenting NUREG-1537, Part 2, Section 6b.3, Nuclear Criticality Safety for the Processing Facility, states, in part that [c]riticality process safety controls should be provided for criticality safety, and a description of their safety function should be described. The applicant should use enough safety controls to demonstrate that, under normal and abnormal credible conditions, all nuclear processes remain subcritical and that NCS [nuclear criticality safety] limits on controlled parameters will be established to ensure that all nuclear processes are subcritical, including an adequate margin of subcriticality for safety. |
| | The ISG Augmenting NUREG-1537, Part 2, Section 6b.3, states, in part, that the reviewer should determine whether the margin of subcriticality for safety is sufficient to provide reasonable assurance of subcriticality. |
| | In response to RAI 6b.3-4, SHINE states it intends to utilize a subcritical margin of 0.05 with additional considerations for uncertainty in the validation and modeling. In addition, SHINE states in multiple places in the PSAR that processes will be maintained to a keff 0.95 (assuming a subcritical margin of 0.05). |
| | The NRC staffs review of SHINEs responses to RAIs 6b.3-1 and 6b.3-26 found that there was insufficient benchmarking of the code against experiments utilizing the materials and enrichments expected in SHINEs processes. For this reason, |
| | |
| | the proposed subcritical margin of 0.05 is not sufficient to adequately address the uncertainty associated with the neutron interactions of these process materials. |
| | The subcritical margin of 0.05, which SHINE quoted from NUREG-1520, was intended for facilities with enrichment less than five percent utilizing well established processes and for which there is significant experience and data. In contrast, the SHINE facility will be a first-of-a-kind facility using materials not normally utilized and of an enrichment up to 20 percent. |
| | Provide additional information describing how SHINE has or will sufficiently benchmark against experiments utilizing the materials and enrichments expected to be used in SHINE facility processes for its proposed margin of subcriticality, or propose a new margin of subcriticality that appropriately takes into account materials and enrichment.}} |
Letter Sequence Draft RAI |
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MONTHYEARML13172A3612013-05-31031 May 2013 Part Two of the Shine Medical Technologies, Inc. Application for Construction Permit Project stage: Request ML13269A3782013-09-25025 September 2013 Shine Medical Technologies, Inc., Submittal of Preliminary Emergency Plan Project stage: Other ML14119A0432014-03-17017 March 2014 Affidavit for Shine Medical Technologies, Inc. Discussion Notes Associated with March 20, 2014 Meeting Project stage: Request ML14121A5342014-05-0808 May 2014 Shine Medical Technologies, Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML14195A1592014-09-19019 September 2014 Shine Medical Technologies, Inc. - Request for Additional Information Regarding Application for Construction Permit Project stage: RAI ML14356A5282014-12-0303 December 2014 Shine Medical Technologies, Inc. Application for Construction Permit Response to Request for Additional Information Project stage: Response to RAI ML15005A4072015-01-0606 January 2015 Shine Medical Technologies, Inc., Request for Additional Information Regarding Application for Construction Permit Project stage: RAI ML15043A3952015-02-0606 February 2015 Shine Medical Technologies, Inc. - Application for Construction Permit - Response to Request for Additional Information Project stage: Response to RAI ML15037A2492015-03-0303 March 2015 Shine Medical Technologies, Inc., - Proposed Review Schedule, Notice of Hearing, Opportunity to Petition for Leave to Intervene, and Order Imposing Procedures Project stage: Other ML15037A1082015-03-0404 March 2015 Federal Register Notice - Notice of Hearing, Opportunity to Petition for Leave to Intervene, and Order Imposing Procedures for Access to Sensitive Unclassified Non-Safeguards Information for Contention Preparation on a Construction Permit f Project stage: Request ML15092A4072015-03-23023 March 2015 Shine Medical Technologies, Inc., Application for Construction Permit, Response to Request for Additional Information 11.1-9 Project stage: Response to RAI ML15055A1162015-03-25025 March 2015 Shine Medical Technologies, Inc., - Request for Additional Information Regarding Application for Construction Permit Project stage: RAI ML15120A2412015-04-10010 April 2015 Shine Medical Technologies, Inc., Application for Construction Permit, Response to Request for Additional Information Project stage: Response to RAI ML15099A6072015-04-15015 April 2015 Shine Medical Technologies, Inc., - Request for Additional Information Regarding Application for Construction Permit(Tac Nos. MF2305, MF2307, and MF2308) Project stage: RAI ML15131A4622015-05-0101 May 2015 Shine Medical Technologies, Inc. Application for Construction Permit, Response to Request for Additional Information Project stage: Response to RAI ML15147A2032015-05-14014 May 2015 Shine Medical Technologies, Inc., Application for Construction Permit, Response to Request for Additional Information Project stage: Response to RAI ML15140A7342015-05-20020 May 2015 Shine Medical Technologies, Inc. Application for Construction Permit, Response to Request for Additional Information 13a2.2-5 Project stage: Response to RAI ML15140A7252015-05-21021 May 2015 Shine Technologies, Inc. - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15140A7222015-05-21021 May 2015 Shine Medical Technologies, Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15140A7262015-05-21021 May 2015 Shine Technologies, Inc. - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15140A7312015-05-21021 May 2015 Shine Technologies, Inc. - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15140A7242015-05-21021 May 2015 Shine Technologies, Inc. - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15161A3432015-05-21021 May 2015 Shine Medical Technologies, Inc. Preliminary Safety Analysis Report Revisions Resulting from Request for Additional Information Responses Project stage: Request ML15140A7232015-05-21021 May 2015 Shine Medical Technologies, Inc. - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15175A1312015-06-16016 June 2015 Shine Medical Technologies, Inc. Application for Construction Permit Revision to Sections 13b.3 and 19.4 of the Preliminary Safety Analysis Report Project stage: Request ML15175A2132015-06-16016 June 2015 Shine Medical Technologies V. 0 - Chapter 06 - Engineered Safety Features Project stage: Request ML15183A2902015-06-19019 June 2015 Shine Medical Technologies, Inc. Application for Construction Permit - Response to Request for Additional Information Project stage: Response to RAI ML15222A2012015-07-23023 July 2015 Shine Medical Technologies, Inc. Application for Construction Permit Response to Request for Additional Information 6b.3-30 Project stage: Response to RAI ML15236A1272015-08-0707 August 2015 Shine Medical Technologies, Inc. Application for Construction Permit Submittal of Atkins-NS-TR-SHN-15-06, Revision 1 Project stage: Request ML15219A3352015-08-27027 August 2015 Shine Medical Technologies Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15219A1632015-08-27027 August 2015 Shine Medical Technologies Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15219A1822015-08-27027 August 2015 Shine Medical Technologies Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15219A2632015-08-27027 August 2015 Shine Medical Technologies Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15219A3032015-08-27027 August 2015 Shine Medical Technologies Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15244A5062015-08-27027 August 2015 E-mail from Steven Lynch to Jim Costedio Transmitting Draft Request for Additional Information Supporting Shine PSAR Project stage: Draft RAI ML15219A3852015-08-27027 August 2015 Shine Medical Technologies Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15219A4252015-08-27027 August 2015 Shine Medical Technologies Inc. - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15244A7712015-08-27027 August 2015 Draft Request for Additional Information Shine Medical Technologies, Inc. Preliminary Safety Analysis Report Supporting a Construction Permit Application Project stage: Draft RAI ML15247A0672015-09-0202 September 2015 Shine Medical Technologies, Inc. Application for Construction Permit Response to Request for Additional Information Project stage: Response to RAI ML15259A0242015-09-15015 September 2015 Shine Medical Technologies, Inc. - Application for Construction Permit, Revision 1 of Shine Response to Request for Additional Information 6b.3-34 Project stage: Response to RAI ML15259A1642015-09-24024 September 2015 Shine Medical Technologies, Inc., - Request for Additional Information Regarding Application for Construction Permit Project stage: RAI ML15267A2912016-01-0606 January 2016 June 19, 2015 Shine Technologies, Inc., - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15267A2672016-01-0606 January 2016 July 23, 2015 Shine Technologies, Inc., - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance 2015-04-15
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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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Text
DRAFT REQUEST FOR ADDITIONAL INFORMATION SHINE MEDICAL TECHNOLOGIES, INC.
REGARDING THE PRELIMINARY SAFETY ANALYSIS REPORT SUPPORTING A CONSTRUCTION PERMIT APPLICATION DOCKET NO. 50-608 TAC NOS. MF2305 AND MF2307 CHAPTER 6 - ENGINEERED SAFETY FEATURES The following request for information is based on a review of Chapter 6 of the SHINE PSAR (ADAMS Accession No. ML15175A213) using NUREG-1537, Parts 1 and 2 in conjunction with the Final ISG Augmenting NUREG-1537, Parts 1 and 2, as supplemented by SHINEs responses to requests for additional information (RAIs).
Section 6b.3 - Nuclear Criticality Control RAI 6b.3-34 As required by 10 CFR 50.34(a), Contents of applications; technical information, a preliminary safety analysis report should include [a] preliminary analysis and evaluation of the design and performance of structures, systems, and components of the facility with the objective of assessing the risk to public health and safety resulting from operation of the facility, and the adequacy of structures, systems, and components provided for the prevention of accidents and the mitigation of the consequences of accidents. Additionally, the preliminary design of the facility should provide reasonable assurance to the NRC staff that the final design will conform to its design bases with adequate margin for safety.
With respect to nuclear criticality control, the Interim Staff Guidance (ISG)
Augmenting NUREG-1537, Part 2, Section 6b.3, Nuclear Criticality Safety for the Processing Facility, states, in part that [c]riticality process safety controls should be provided for criticality safety, and a description of their safety function should be described. The applicant should use enough safety controls to demonstrate that, under normal and abnormal credible conditions, all nuclear processes remain subcritical and that NCS [nuclear criticality safety] limits on controlled parameters will be established to ensure that all nuclear processes are subcritical, including an adequate margin of subcriticality for safety.
The ISG Augmenting NUREG-1537, Part 2, Section 6b.3, states, in part, that the reviewer should determine whether the margin of subcriticality for safety is sufficient to provide reasonable assurance of subcriticality.
In response to RAI 6b.3-4, SHINE states it intends to utilize a subcritical margin of 0.05 with additional considerations for uncertainty in the validation and modeling. In addition, SHINE states in multiple places in the PSAR that processes will be maintained to a keff 0.95 (assuming a subcritical margin of 0.05).
The NRC staffs review of SHINEs responses to RAIs 6b.3-1 and 6b.3-26 found that there was insufficient benchmarking of the code against experiments utilizing the materials and enrichments expected in SHINEs processes. For this reason,
the proposed subcritical margin of 0.05 is not sufficient to adequately address the uncertainty associated with the neutron interactions of these process materials.
The subcritical margin of 0.05, which SHINE quoted from NUREG-1520, was intended for facilities with enrichment less than five percent utilizing well established processes and for which there is significant experience and data. In contrast, the SHINE facility will be a first-of-a-kind facility using materials not normally utilized and of an enrichment up to 20 percent.
Provide additional information describing how SHINE has or will sufficiently benchmark against experiments utilizing the materials and enrichments expected to be used in SHINE facility processes for its proposed margin of subcriticality, or propose a new margin of subcriticality that appropriately takes into account materials and enrichment.