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| {{#Wiki_filter:}} | | {{#Wiki_filter:June 10, 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 REGULATORY AUDIT OF CYBER SECURITY TOPICS RELATED TO SHINE OPERATING LICENSE APPLICATION (EPID NO. L-2019-NEW-0004) |
| | |
| | ==Dear Dr. Piefer:== |
| | |
| | By {{letter dated|date=July 17, 2019|text=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), December 15, 2020 (ADAMS Accession No. ML21011A264), |
| | and March 23, 2021 (ADAMS Accession No. ML21095A235). 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 Part 50, Domestic Licensing of Production and Utilization Facilities. |
| | To support its review of cyber security topics described in SHINEs operating license application, the NRC staff will conduct a virtual regulatory audit on June 15, 2021, to gain a better understanding of the application. The audit may include review of documentation and discussions with SHINE personnel and management. The audit plan in Enclosure 1 provides additional details of the objective and scope of the audit. To facilitate an efficient audit, please provide ready access to the necessary documentation identified in the audit topics as part of (ADAMS Accession No. ML21161A125). |
| | Following completion of the audit, the NRC staff will provide an audit summary. The summary will include a description of any information identified during the audit that will need to be docketed to supplement the application and allow the NRC staff to continue its review. |
| | |
| | G. Piefer If you have any questions, please contact me at (301) 415-1524, or by electronic mail at Steven.Lynch@nrc.gov. |
| | Sincerely, Signed by Lynch, Steven on 06/10/21 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. ML21161A116, LTR. ML21161A115, Encl. ML# 21161A125 OFFICE NRR/DANU/PM NRR/DANU/LA NRR/DANU/BC NRR/DANU/PM NAME SLynch NParker JBorromeo SLynch DATE 06/10/2021 6/10/2021 06/10/2021 06/10/2021 OFFICE OF NUCLEAR REACTOR REGULATION REGULATORY AUDIT PLAN REGARDING CYBER SECURITY TOPICS DESCRIBED IN OPERATING LICENSE APPLICATION CONSTRUCTION PERMIT NO. CPMIF-001 SHINE MEDICAL TECHNOLOGIES, LLC SHINE MEDICAL ISOTOPE PRODUCTION FACILITY DOCKET NO. 50-608 |
| | |
| | ===Background=== |
| | The U.S. Nuclear Regulatory Commission (NRC) staff is continuing its review of the SHINE Medical Technologies, LLC (SHINE) operating license application, submitted 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), and March 23, 2021 (ADAMS Accession No. ML21095A235). This regulatory audit is intended to assist the NRC staff in its review of cyber security topics described in the SHINE final safety analysis report (FSAR), |
| | submitted as part of SHINEs operating license application. |
| | Regulatory Bases for the Audit The purpose of this audit is to support the NRC staffs review of the licensees cyber security topics in accordance with the applicable regulatory requirements of Title 10 of the Code of Federal Regulations and applicable guidance. |
| | Regulatory Scope for the Audit The NRC staff will review the SHINE FSAR, technical specification (TS) requirements, and supporting reference documentation related to SHINE cyber security topics. This audit will provide information necessary to continue the NRC staffs evaluation of the SHINE operating license application. In addition, the regulatory audit may identify additional information that will be required to be docketed to support the basis of the licensing decision and will allow NRC staff to more efficiently gain insights on the operating license application. To support this audit, the NRC staff will review documentation and participate in teleconference and video conference discussions with the licensee. |
| | Enclosure 1 |
| | |
| | Information Needed for the Audit SHINE should be prepared to support the NRC staff by having a copy of SHINEs FSAR, including information related to SHINEs cyber security topics readily available. Additionally, the licensee should be prepared to provide supporting documents and reports to support the analysis documented in the FSAR, bases for TSs, or rationale for any required plans and procedures, as necessary. |
| | Audit Team The NRC staff performing this audit will be: |
| | Steven Lynch, Senior Project Manager Daniel Warner, Cyber Security Specialist Audit Team Logistics The audit will take place on June 15, 2021. The audit may be extended, as needed, until the NRC staff has an adequate understanding of the issues to be addressed to facilitate the continued review of the operating license application. Audit activities may be conducted as teleconferences and video conferences, as appropriate and efficient to the gathering of information by the NRC staff. Additional audit activities may be planned in advance, as necessary, to support the understanding of information necessary to facilitate the continued review of the operating license application. |
| | Deliverables At the completion of the regulatory audit the NRC staff will issue requests for additional information within 30 days after the audit and issue a regulatory audit summary within 90 days after the audit. The regulatory audit summary will include the documents reviewed and the audit activities performed. |
| | Audit Topics and Questions The topics and questions for discussion during the regulatory audit are primarily based on the regulatory audit topics (ADAMS Accession No. ML21161A125). |
| | Proposed Audit Schedule (Eastern Daylight Time) |
| | Tuesday, June 15, 2021 10:00 AM Entrance meeting 10:10 AM Audit discussions 11:50 AM Summary and exit meeting 12:00 PM End audit}} |
Letter Sequence Other |
---|
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
|
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
[Table View] |
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Category:Audit Plan
MONTHYEARML22061A2122022-08-24024 August 2022 Shine Medical Technologies LLC - Regulatory Audit Plan for Phased Approach - Session 1 ML22216A1122022-08-0808 August 2022 Shine Technologies LLC - Regulatory Audit Plan of Logic Lifecycle Described in Operating License ML22152A1082022-06-0606 June 2022 Shine Medical Technologies LLC - Regulatory Audit Plan for Tech Specs ML22094A1142022-05-23023 May 2022 Shine Medical Technologies LLC - Draft Regulatory Audit Plan for Phased Approach Session 2 ML22095A0672022-04-0606 April 2022 Shine Medical Technologies LLC - Regulatory Audit Plan for I&C Session 3 ML22042A0182022-02-15015 February 2022 Shine Medical Technologies LLC - Regulatory Audit Plan for I&C ML21161A1252021-06-10010 June 2021 Shine Cyber Security Audit Topics _ Enclosure 2 ML21161A1152021-06-10010 June 2021 Shine Medical Tech Ltr - Cyber Security Audit Plan Enclosure 1 ML21137A3392021-05-24024 May 2021 Shine Medical Technologies - Hfe Audit Plan Letter ML21130A3142021-05-12012 May 2021 Shine Medical Technologies, LLC - Instrumentation and Control Systems Audit Plan ML21096A2502021-04-0808 April 2021 Shine Medical Technologies - Fire Protection Audit Plan ML21096A2492021-04-0808 April 2021 Shine Medical Technologies - Fire Protection Audit Topics (V2) ML21053A2612021-03-11011 March 2021 Shine Medical Technologies - Geotechnical Audit Plan ML20226A2622020-08-14014 August 2020 Shine Medical Technologies, LLC - Accident Analysis and Criticality Safety Audit Plan ML20126G5232020-05-0707 May 2020 Shine Medical Technologies, LLC - Regulatory Audit Plan Related to Electrical Power Systems ML20126G5242020-05-0707 May 2020 Shine Medical Technologies, LLC - Regulatory Audit Topics Related to Electrical Power Systems ML20057F9502020-03-0606 March 2020 Shine Medical Technologies, LLC - Instrumentation and Control Regulatory Audit Plan ML20057F9522020-03-0606 March 2020 Shine Medical Technologies, LLC - Instrumentation and Control Regulatory Audit Questions ML19353C7152019-12-19019 December 2019 Enclosure 2 - Environmental Site Audit Needs List ML19353C7192019-12-19019 December 2019 Enclosure 3 - Draft Environmental Site Audit Schedule ML19353C7202019-12-19019 December 2019 Enclosure 1 - Shine Medical Technologies, LLC Environmental Audit Plan ML13168A5622013-07-0303 July 2013 Environmental Site Audit Regarding Sine Medical Inc. Proposed Radioisotope Production Facility 2022-08-08
[Table view] 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
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Text
June 10, 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 REGULATORY AUDIT OF CYBER SECURITY TOPICS RELATED TO SHINE OPERATING LICENSE APPLICATION (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), December 15, 2020 (ADAMS Accession No. ML21011A264),
and March 23, 2021 (ADAMS Accession No. ML21095A235). 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 Part 50, Domestic Licensing of Production and Utilization Facilities.
To support its review of cyber security topics described in SHINEs operating license application, the NRC staff will conduct a virtual regulatory audit on June 15, 2021, to gain a better understanding of the application. The audit may include review of documentation and discussions with SHINE personnel and management. The audit plan in Enclosure 1 provides additional details of the objective and scope of the audit. To facilitate an efficient audit, please provide ready access to the necessary documentation identified in the audit topics as part of (ADAMS Accession No. ML21161A125).
Following completion of the audit, the NRC staff will provide an audit summary. The summary will include a description of any information identified during the audit that will need to be docketed to supplement the application and allow the NRC staff to continue its review.
G. Piefer If you have any questions, please contact me at (301) 415-1524, or by electronic mail at Steven.Lynch@nrc.gov.
Sincerely, Signed by Lynch, Steven on 06/10/21 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. ML21161A116, LTR. ML21161A115, Encl. ML# 21161A125 OFFICE NRR/DANU/PM NRR/DANU/LA NRR/DANU/BC NRR/DANU/PM NAME SLynch NParker JBorromeo SLynch DATE 06/10/2021 6/10/2021 06/10/2021 06/10/2021 OFFICE OF NUCLEAR REACTOR REGULATION REGULATORY AUDIT PLAN REGARDING CYBER SECURITY TOPICS DESCRIBED IN OPERATING LICENSE APPLICATION CONSTRUCTION PERMIT NO. CPMIF-001 SHINE MEDICAL TECHNOLOGIES, LLC SHINE MEDICAL ISOTOPE PRODUCTION FACILITY DOCKET NO. 50-608
Background
The U.S. Nuclear Regulatory Commission (NRC) staff is continuing its review of the SHINE Medical Technologies, LLC (SHINE) operating license application, submitted 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), and March 23, 2021 (ADAMS Accession No. ML21095A235). This regulatory audit is intended to assist the NRC staff in its review of cyber security topics described in the SHINE final safety analysis report (FSAR),
submitted as part of SHINEs operating license application.
Regulatory Bases for the Audit The purpose of this audit is to support the NRC staffs review of the licensees cyber security topics in accordance with the applicable regulatory requirements of Title 10 of the Code of Federal Regulations and applicable guidance.
Regulatory Scope for the Audit The NRC staff will review the SHINE FSAR, technical specification (TS) requirements, and supporting reference documentation related to SHINE cyber security topics. This audit will provide information necessary to continue the NRC staffs evaluation of the SHINE operating license application. In addition, the regulatory audit may identify additional information that will be required to be docketed to support the basis of the licensing decision and will allow NRC staff to more efficiently gain insights on the operating license application. To support this audit, the NRC staff will review documentation and participate in teleconference and video conference discussions with the licensee.
Enclosure 1
Information Needed for the Audit SHINE should be prepared to support the NRC staff by having a copy of SHINEs FSAR, including information related to SHINEs cyber security topics readily available. Additionally, the licensee should be prepared to provide supporting documents and reports to support the analysis documented in the FSAR, bases for TSs, or rationale for any required plans and procedures, as necessary.
Audit Team The NRC staff performing this audit will be:
Steven Lynch, Senior Project Manager Daniel Warner, Cyber Security Specialist Audit Team Logistics The audit will take place on June 15, 2021. The audit may be extended, as needed, until the NRC staff has an adequate understanding of the issues to be addressed to facilitate the continued review of the operating license application. Audit activities may be conducted as teleconferences and video conferences, as appropriate and efficient to the gathering of information by the NRC staff. Additional audit activities may be planned in advance, as necessary, to support the understanding of information necessary to facilitate the continued review of the operating license application.
Deliverables At the completion of the regulatory audit the NRC staff will issue requests for additional information within 30 days after the audit and issue a regulatory audit summary within 90 days after the audit. The regulatory audit summary will include the documents reviewed and the audit activities performed.
Audit Topics and Questions The topics and questions for discussion during the regulatory audit are primarily based on the regulatory audit topics (ADAMS Accession No. ML21161A125).
Proposed Audit Schedule (Eastern Daylight Time)
Tuesday, June 15, 2021 10:00 AM Entrance meeting 10:10 AM Audit discussions 11:50 AM Summary and exit meeting 12:00 PM End audit