Letter Sequence Response to RAI |
---|
|
Administration
- Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance
|
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 ML15140A7222015-05-21021 May 2015 Shine Medical Technologies, Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15140A7232015-05-21021 May 2015 Shine Medical 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 ML15140A7252015-05-21021 May 2015 Shine 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 ML15161A3432015-05-21021 May 2015 Shine Medical Technologies, Inc. Preliminary Safety Analysis Report Revisions Resulting from Request for Additional Information Responses Project stage: Request ML15175A2132015-06-16016 June 2015 Shine Medical Technologies V. 0 - Chapter 06 - Engineered Safety Features Project stage: Request 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 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 ML15219A3032015-08-27027 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 ML15219A3352015-08-27027 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 ML15219A3852015-08-27027 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 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 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 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
[Table View] |
|
---|
Category:Letter
MONTHYEARML23229A0202023-08-17017 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 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) ML23010A2382023-02-0303 February 2023 Shine Technologies, LLC - Individual Notice of Consideration FRN Letter 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 ML22175A0742022-07-0101 July 2022 Letter to Mary Buelow Maintenance of Reference Materials at the Hedberg Public Library for the Environmental Review of Shine Medical Technologies, LLC Operating License Application 2023-08-17
[Table view] Category:Response to Request for Additional Information (RAI)
MONTHYEARML23048A2442023-02-17017 February 2023 Shine Technologies, LLC Request to Amend Construction Permit No. CPMIF-001 Response to Request for Additional Information ML22356A1932022-12-22022 December 2022 Shine Technologies, LLC Application for an Operating License - Response to Request for Confirmatory Information ML22335A5722022-12-0101 December 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information 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 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 ML22178A0352022-06-27027 June 2022 Enclosure 2 - Shine Technologies, LLC Application for an Operating License Revision 1 of the Shine Response to Requests for Additional Information 9-8 and 9-9 ML22143A8142022-05-23023 May 2022 Shine Technologies, LLC, Application for an Operating License Response to Request for Additional Information ML22112A1952022-04-22022 April 2022 Shine Technologies, LLC Application for an Operating License - Response to Request for Additional Information ML22094A0452022-04-0404 April 2022 Shine Technologies, LLC - Application for an Operating License Revision 1 of Shine Response to Part (C) of Request for Additional Information 7-9 ML22077A0862022-03-18018 March 2022 Shine Technologies, LLC Application for an Operating License - Supplement No. 20 and Response to Request for Additional Information ML22059A0202022-02-28028 February 2022 Enclosure 2: Shine Technologies, LLC - Response to Request to Additional Information ML22032A3422022-02-0101 February 2022 Shine Technologies, LLC, Application for an Operating License Revision 1 of the Shine Response to Request for Additional Information 11-2 ML22028A2242022-01-28028 January 2022 Shine Technologies, LLC, Response to Request for Additional Information on Application for an Operating License ML21364A0552021-12-30030 December 2021 Shine Technologies, LLC, Application for an Operating License Response to Request for Additional Information ML21350A1912021-12-16016 December 2021 Shine Technologies, LLC - Application for an Operating License Response to Request for Additional Information ML21326A2092021-11-22022 November 2021 Enclosure 3: Response to Request for Additional Information - Public Version ML21307A3062021-11-0303 November 2021 Shine Technologies, LLC, Application for an Operating License Response to Request for Additional Information ML21272A3442021-09-29029 September 2021 Shine Medical Technologies, LLC - Response to Request for Additional Information (Public Version) ML21271A0762021-09-28028 September 2021 Shine Medical Technologies, LLC, Application for an Operating License Revision 1 of Shine Response to Request for Additional Information 3.4-12 ML21243A2692021-08-31031 August 2021 Enclosure 2 - Response to Request for Additional Information Public Version ML21239A0492021-08-27027 August 2021 Shine Medical Technologies, LLC Application for an Operating License Response to Request for Additional Information ML21232A5872021-08-20020 August 2021 Shine Medical Technologies, LLC - Application for an Operating License Response to Request for Additional Information ML21232A6202021-08-20020 August 2021 Shine Medical Technologies, LLC Request to Amend Construction Permit No. CPMIF-001 - Response to Request for Additional Information ML21232A6232021-08-20020 August 2021 Enclosure 3: Request to Amend Construction Permit No. CPMIF-001 Response to Request for Additional Information ML21232A6212021-08-20020 August 2021 Enclosure 1: Request to Amend Construction Permit No. CPMIF-001 Response to Request for Additional Information ML21208A1352021-07-27027 July 2021 Shine Medical Technologies, LLC Application for an Operating License Response to Request for Additional Information ML21183A1282021-07-0202 July 2021 Enclosure 2: Shine Medical Technologies, LLC, Application for an Operating License, Response to Request for Additional Information Public Version ML21154A3032021-06-0303 June 2021 Shine Medical Technologies, LLC Application for an Operating License Response to Request for Additional Information 4a-15 ML21127A0512021-05-0707 May 2021 Shine Medical Technologies, LLC Application for an Operating License Response to Request for Additional Information ML21095A2352021-03-23023 March 2021 Shine Medical Technologies, LLC, Cover Letter for Response to Request Tor Additional Information and Supplement No. 7 ML21095A2292021-03-23023 March 2021 Shine Medical Technologies, LLC, Response to Request for Additional Information and Supplement No. 7 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 ML21029A1032021-01-29029 January 2021 Enclosure 1 - Response to Final Safety Analysis Report Chapters 2, 3, and 8 Requests for Additional Information ML21029A1052021-01-29029 January 2021 Enclosure 3 - Response to Final Safety Analysis Report Chapters 6 and 13 Requests for Additional Information ML21022A0272021-01-22022 January 2021 Shine Medical Technologies, LLC Application for an Operating License, Response to Environmental Requests for Additional Information ML21011A2402020-12-15015 December 2020 Shine Medical Technologies, LLC - Operating License Application Supplement No. 6 and Response to Request for Additional Information ML20357A0872020-12-10010 December 2020 Enclosure 3 - Response to Request for Additional Information ML20255A0282020-08-28028 August 2020 Enclosure 1 - Response to Request for Additional Information ML20188A3022020-06-17017 June 2020 Shine Medical Technologies, LLC - Response to Request for Additional Information on Operating License Application ML20129J9202020-05-0808 May 2020 Shine Medical Technologies, LLC, Application for an Operating License Response to Supplemental Environmental Requests for Additional Information ML20073E8802020-03-13013 March 2020 Shine Medical Technologies, LLC Application for an Operating License Response to Environmental Requests for Additional Information ML19071A0562019-03-0808 March 2019 Shine Medical Technologies, Inc., Affidavit & Response to Request for Additional Information to Application for Order Approving Indirect Transfer of Control of Construction Permit Response to Request for Additional Information ML17040A1382017-02-0707 February 2017 Shine Medical Technologies, Inc. Safeguards Information (SGI) Protection Program Response to Request for Additional Information 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 ML15247A0672015-09-0202 September 2015 Shine Medical Technologies, Inc. Application for Construction Permit Response to Request for Additional Information ML15258A5982015-08-27027 August 2015 Enclosure 2 - Revision 1 of the Shine Response to RAI 12.1-1 and RAI 12.2-1 ML15222A2422015-07-23023 July 2015 Enclosure 2 - Attachment 3 - Atkins-NS-DAC-SHN-15-02, Revision 0 ML15222A2442015-07-23023 July 2015 Enclosure 2 - Attachment 2 - Atkins-NS-DAC-SHN-15-04, Revision 0 2023-02-17
[Table view] |
Text
September 15, 2015 SMT-2015-042 10 CFR 50.30 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555
References:
(1) SHINE Medical Technologies, Inc. letter to NRC, dated March 26, 2013, Part One of the SHINE Medical Technologies, Inc. Application for Construction Permit (ML130880226)
(2) SHINE Medical Technologies, Inc. letter to NRC, dated May 31, 2013, Part Two of the SHINE Medical Technologies, Inc. Application for Construction Permit (ML13172A324)
(3) NRC electronic mail to SHINE Medical Technologies, Inc., dated August 26, 2015, Draft Request for Additional Information Supporting SHINE Preliminary Safety Analysis Report (ML15239B051)
(4) NRC electronic mail to SHINE Medical Technologies, Inc., dated August 27, 2015, Draft Request for Additional Information Supporting SHINE Preliminary Safety Analysis Report (ML15244A501)
(5) SHINE Medical Technologies, Inc. letter to NRC, dated September 2, 2015, SHINE Medical Technologies, Inc. Application for Construction Permit, Response to Request for Additional Information (ML15247A067)
SHINE Medical Technologies, Inc. Application for Construction Permit Revision 1 of SHINE Response to Request for Additional Information 6b.3-34 Pursuant to 10 CFR 50.30, SHINE Medical Technologies, Inc. (SHINE) submitted an application for a construction permit to construct a medical isotope facility to be located in Janesville, WI (References 1 and 2). Via References (3) and (4), the NRC staff determined that additional information was required to enable the staffs continued review of the SHINE construction permit application. SHINE responded to the NRC staffs requests via Reference (5). SHINE has determined that the SHINE Response to Request for Additional Information (RAI) 6b.3-34, previously provided via Reference (5), requires revision. provides Revision 1 of the SHINE Response to RAI 6b.3-34.
If you have any questions, please contact Mr. Jim Costedio, Licensing Manager, at 608/210-1730.
2555 Industrial Drive l Monona, WI 53713 l P (608) 210-1060 l F (608) 210-2504 l www.shinemed.com
Document Control Desk Page2 I declare under the penalty of perjury that the foregoing is true and correct.
Executed on September 15, 2015.
Very truly yours, Gregory Piefer, Ph.D.
Chief Executive Officer SHINE Medical Technologies, Inc.
Docket No. 50-608 Enclosure cc: Administrator, Region Ill, USNRC Project Manager, USNRC Environmental Project Manager, USNRC Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health
ENCLOSURE 1 SHINE MEDICAL TECHNOLOGIES, INC.
SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMIT REVISION 1 OF SHINE RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION 6B.3-34 The NRC staff determined that additional information was required (References 1 and 2) to enable the continued review of the SHINE Medical Technologies, Inc. (SHINE) application for a construction permit to construct a medical isotope facility (References 3 and 4). SHINE responded to the NRC staffs requests via Reference (5). SHINE has determined that the SHINE Response to Request for Additional Information (RAI) 6b.3-34, previously provided via Reference (5), requires revision. The following information is provided as Revision 1 of the SHINE Response to RAI 6b.3-34.
CHAPTER 6 - ENGINEERED SAFETY FEATURES 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).
Page 1 of 3
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.
SHINE Response In the previous SHINE Response to RAI 6b.3-34 (Reference 5), SHINE stated that the calculated uranyl sulfate volumes from the modeling information in the IEU-SOL-THERM-001 benchmark were approximately 3% less than the critical uranyl sulfate volumes specified in the benchmark description. Since the submittal of that RAI response, SHINE has determined that an error exists in the computer model that was created to match the benchmark. This model error led to the apparent low volume found in the cases, which led to Monte Carlo N-Particle Transport Code (MCNP) keff values being significantly below (-1.6% to -2.7%) the experimental keff values. An Issues Management Report (IMR) has been initiated to resolve this issue.
Based on the above, SHINE has determined that there is not an inconsistency of the data in the International Criticality Safety Benchmark Evaluation Project (ICSBEP) Handbook description of IEU-SOL-THERM-001. Based on current modeling, the IEU-SOL-THERM-001 cases result in keff values of approximately 0.99 to 1.0, which may decrease the Upper Subcritical Limit (USL) calculated in the validation report if these cases were included.
The SHINE criticality safety validation report, Atkins-NS-DAC-SHN-15-03, Revision 2, provided as Attachment 4 to Enclosure 1 of Reference (6), sufficiently benchmarks against experiments using materials and enrichments expected to be used in the SHINE facility processes.
However, given that this benchmark is applicable to the SHINE design, that the benchmark is not inconsistent, and that including these four IEU-SOL-THERM-001 cases could decrease the USL, SHINE plans to include this benchmark in the SHINE criticality safety validation report in a future revision. An IMR has been initiated to track the inclusion of these four IEU-SOL-THERM-001 cases in a future revision to the SHINE criticality safety validation report.
Since the four IEU-SOL-THERM-001 cases are not included in the criticality safety validation report, SHINE proposes a new Margin of Subcriticality (MOS) of 0.06 to bound expected changes in the USL from the inclusion of these cases.
Therefore, SHINE shall apply a minimum margin of subcriticality of 0.06 to demonstrate that the radioisotope production facility (RPF) is subcritical under normal and credible abnormal conditions. A margin of subcriticality of 0.05 may be applied if it is technically justified in a validation report accepted by the NRC.
Page 2 of 3
In accordance with 10 CFR 50.34(a)(8), SHINE will provide a schedule with milestones to resolve this issue at or before the latest date stated in the application for completion of construction of the facility. Following resolution of this issue, SHINE will provide the NRC-accepted MOS in the Final Safety Analysis Report (FSAR). An IMR has been initiated to track the inclusion of the NRC-accepted MOS in the FSAR.
References (1) NRC electronic mail to SHINE Medical Technologies, Inc., dated August 26, 2015, Draft Request for Additional Information Supporting SHINE Preliminary Safety Analysis Report (ML15239B051)
(2) NRC electronic mail to SHINE Medical Technologies, Inc., dated August 27, 2015, Draft Request for Additional Information Supporting SHINE Preliminary Safety Analysis Report (ML15244A501)
(3) SHINE Medical Technologies, Inc. letter to NRC, dated March 26, 2013, Part One of the SHINE Medical Technologies, Inc. Application for Construction Permit (ML130880226)
(4) SHINE Medical Technologies, Inc. letter to NRC, dated May 31, 2013, Part Two of the SHINE Medical Technologies, Inc. Application for Construction Permit (ML13172A324)
(5) SHINE Medical Technologies, Inc. letter to NRC, dated September 2, 2015, SHINE Medical Technologies, Inc. Application for Construction Permit, Response to Request for Additional Information (ML15247A067)
(6) SHINE Medical Technologies, Inc. letter to NRC, dated July 23, 2015, SHINE Medical Technologies, Inc. Application for Construction Permit, Response to Request for Additional Information 6b.3-30 (ML15222A231)
Page 3 of 3