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Category:Letter
MONTHYEARML24128A2162024-05-0707 May 2024 Shine Technologies, LLC, Submittal of Annual Financial Report ML24047A0392024-02-16016 February 2024 Shine Technologies, LLC - Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 ML23229A0202023-08-17017 August 2023 Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 ML23087A2272023-05-0505 May 2023 Shine Technologies, LLC - Issuance of Amendment No. 4 to Construction Permit No. CPMIF-001 for the Receipt and Possession of Contained Special Nuclear Material ML23086C0502023-04-27027 April 2023 Shine Technologies, LLC - Letter, Environmental Assessment and Finding of No Significant Impact ML23088A3382023-04-0505 April 2023 Shine Technologies, LLC - Review of the Physical Security Plan in Support of an Operating License for a Medical Radioisotope Production Facility ML23010A1982023-02-24024 February 2023 Shine Technologies, LLC - Letter: Safety Evaluation Report for the Shine Medical Radioisotope Production Facility Operating License Application ML23048A2442023-02-17017 February 2023 Shine Technologies, LLC Request to Amend Construction Permit No. CPMIF-001 Response to Request for Additional Information ML23010A2382023-02-0303 February 2023 Shine Technologies, LLC - Individual Notice of Consideration FRN Letter ML23034A1872023-02-0303 February 2023 Shine Medical Technologies, LLC Notice of Availability of Environmental Impact Statement Supplement Related to the Operating License for the Shine Medical Isotope Production Facility (Docket Number: 50-608) ML23023A0922023-02-0202 February 2023 Notice of Availability of the Environmental Impact Statement Supplement Related to the Operating License for the Shine Medical Isotope Production Facility ML23023A0942023-02-0202 February 2023 Notice of Availability of the Environmental Impact Statement Supplement Related to the Operating License for the Shine Medical Isotope Production Facility ML23023A0862023-02-0202 February 2023 Notice of Availability of the Environmental Impact Statement Supplement Related to the Operating License for the Shine Medical Isotope Production Facility ML23024A1682023-02-0101 February 2023 Letter to Ken Westlake, EPA Region 5 - Issuance of Final EIS Supplement Related to the Operating License ML22287A1852023-02-0101 February 2023 Shine Technologies, LLC Regulatory Report on the Audit of Phased Startup Operations Application Supplement ML23024A1742023-02-0101 February 2023 Dr. Gregory Piefer, Chief Executive Officer - Issuance of Final EIS Supplement Related to the Operating License ML22308A2332023-01-0909 January 2023 Shine Technologies LLC - Regulatory Audit Report for Chapter 8 - Irradiation Facility and Radioisotope Production Facility Electrical Power Systems ML22347A2142023-01-0404 January 2023 Shine Technologies LLC - Regulatory Audit Report for I&C Combined Sessions ML22356A1932022-12-22022 December 2022 Shine Technologies, LLC Application for an Operating License - Response to Request for Confirmatory Information ML22347A1772022-12-14014 December 2022 Shine Technologies LLC - Regulatory Audit Report for Programmable Logic Lifecycle ML22301A1492022-12-0707 December 2022 Shine Technologies, LLC - Regulatory Audit Report for Chapter 13 - Accident Analysis and Criticality Safety ML22322A2122022-12-0202 December 2022 Shine Medical Technologies - Cybersecurity Audit Summary Report ML22322A2232022-12-0202 December 2022 Shine Medical Technologies - Fire Protection Audit Summary Report ML22348A0672022-12-0101 December 2022 Shine Technologies, LLC - Request for Confirmatory Information Related to Instrumentation and Control Systems ML22335A5722022-12-0101 December 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22292A3192022-11-30030 November 2022 Shine Medical Technologies, LLC Issuance of Order and Amendment No. 3 to Construction Permit No. CPMIF-001 ML22318A1782022-11-14014 November 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22304A1262022-10-31031 October 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22279A9512022-10-0606 October 2022 Shine Technologies, LLC Request to Amend Construction Permit No. CPMIF-001 ML22271A9632022-09-28028 September 2022 Shine Technologies, LLC Application for an Operating License Supplement No. 31 Revision to the Phased Startup Operations Application Supplement ML22263A3442022-09-20020 September 2022 Shine Technologies, LLC Application for an Operating License - Response to Request for Additional Information ML22263A0272022-09-19019 September 2022 Shine Technologies, LLC - Application for an Operating License - Response to Request for Confirmatory Information ML22220A2612022-09-12012 September 2022 Shine Technologies LLC - Regulatory Report on the Audit Chapter 14, Technical Specifications ML22251A3272022-09-0808 September 2022 Shine Technologies, LLC Application for an Operating License Revision 1 of Shine Response to Requests for Additional Information 7-38, 7-40, and 7-48 ML22249A1252022-08-31031 August 2022 Shine Technologies, LLC Final Safety Analysis Report - Application for an Operating License Supplement No. 30, Cover Letter ML22105A1102022-08-26026 August 2022 Shine Medical Technologies LLC - Request for Additional Information Related to the OGC Review of Phrase Approach ML22061A2122022-08-24024 August 2022 Shine Medical Technologies LLC - Regulatory Audit Plan for Phased Approach - Session 1 ML22187A1342022-08-0101 August 2022 Shine Technologies, LLC - Update to Operating License Application Technical Review Schedule ML22213A0492022-08-0101 August 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22206A2082022-07-27027 July 2022 Shine Medical Technologies, LLC - Request for Confirmatory Information Related to Radiation Protection Program and Waste Management ML22207A0062022-07-26026 July 2022 Shine Technologies, LLC Application for an Operating License Supplement No. 29 ML22202A4492022-07-21021 July 2022 Shine Technologies, LLC Operating License Application Supplement No. 28 - Submittal of a Revision to the Shine Emergency Plan ML22188A2412022-07-14014 July 2022 Meeting with Shine Medical Technologies, LLC (EPID No. L-2019-NEW-0004), to Discuss Development of Shine'S Cybersecurity Program for It'S Medical Isotope Production Facility ML22175A0392022-07-11011 July 2022 Letter to Reid Nelson, Achp Notice of Availability and Request for Comments on the Draft EIS Supplement Related to the Operating License for the Shine Facility ML22175A0542022-07-0808 July 2022 Letter to Gregory Piefer - Notice of Availability of the Draft EIS Supplement Related to the Operating License for the Shine Medical Isotope Production Facility ML22175A0912022-07-0808 July 2022 Notice of Availability and Request for Comments on the Draft Environmental Impact Statement Supplement Related to the Operating License for the Shine (Multiple Tribal Letters) ML22175A0772022-07-0808 July 2022 Letter to Daina Penkiunas - Notice of Availability and Request for Comments on the Draft EIS Supplement Related to the Operating License for the Shine Facility ML22175A0632022-07-0808 July 2022 Letter to Ken Westlake, EPA Region 5 - Notice of Availability and Request for Comments on the Draft EIS Supplement Related to the Operating License for the Shine Facility ML22188A1942022-07-0707 July 2022 Shine Technologies, LLC, Application for an Operating License Supplement No. 27 ML22188A0562022-07-0707 July 2022 Shine Technologies, LLC Operating License Application Supplement No. 26 Submittal of a Revision to the Shine Material Control and Accounting Plan 2024-05-07
[Table view] Category:License-Application for Facility Operating License (Amend/Renewal) DKT 50
MONTHYEARML22271A9662022-09-28028 September 2022 Enclosure 3: Phase Startup Operations Application Supplement (Public Version) ML22271A9642022-09-28028 September 2022 Enclosure 1: Phased Startup Operations Application Supplement Change Summary ML22103A0462022-04-13013 April 2022 Shine Technologies, LLC Application for an Operating License Supplement No. 21 ML22027A3562022-01-27027 January 2022 Shine Technologies, LLC, Application for an Operating License Supplement No. 15 Submittal of the Phased Startup Operations Application Supplement 2022-09-28
[Table view] Category:Technical Specification
MONTHYEARML22249A1292022-08-31031 August 2022 Shine Technologies, LLC, Final Safety Analysis Report, Rev. 6, Technical Specifications and Bases ML22103A0462022-04-13013 April 2022 Shine Technologies, LLC Application for an Operating License Supplement No. 21 ML21239A0492021-08-27027 August 2021 Shine Medical Technologies, LLC Application for an Operating License Response to Request for Additional Information 2022-08-31
[Table view] Category:Amendment
MONTHYEARML22103A0462022-04-13013 April 2022 Shine Technologies, LLC Application for an Operating License Supplement No. 21 ML21239A0492021-08-27027 August 2021 Shine Medical Technologies, LLC Application for an Operating License Response to Request for Additional Information 2022-04-13
[Table view] |
Text
April 13, 2022 2022-SMT-0046 10 CFR 50.30 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555
References:
(1) SHINE Medical Technologies, LLC letter to the NRC, SHINE Medical Technologies, LLC Application for an Operating License, dated July 17, 2019 (ML19211C143)
SHINE Technologies, LLC Application for an Operating License Supplement No. 21 Pursuant to 10 CFR Part 50.30, SHINE Technologies, LLC (SHINE) submitted an application for an operating license for a medical isotope production facility to be located in Janesville, Wisconsin via Reference 1. SHINE has determined that revisions to the technical specifications are necessary to address considerations discussed with the NRC Staff during a March 29, 2022 clarification call and to address identified administrative errors.
Enclosure 1 provides the Technical Specifications Change Summary, including a markup of affected technical specifications pages.
If you have any questions, please contact Mr. Jeff Bartelme, Director of Licensing, at 608/210-1735.
I declare under the penalty of perjury that the foregoing is true and correct.
Executed on April 13, 2022.
Very truly yours, James Costedio Vice President of Regulatory Affairs and Quality SHINE Technologies, LLC Docket No. 50-608 Enclosure cc: Project Manager, USNRC SHINE General Counsel Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health 3400 Innovation Ct.
- www.SHINEtechnologies.com
ENCLOSURE 1 SHINE TECHNOLOGIES, LLC SHINE TECHNOLOGIES, LLC APPLICATION FOR AN OPERATING LICENSE SUPPLEMENT NO. 21 TECHNICAL SPECIFICATIONS CHANGE
SUMMARY
Summary Description of Changes TS Impacts Administrative corrections, including correction of Section 5.3 inconsistencies and typographical errors.
Update to clarify the applicability of the SHINE nuclear Section 5.5.1 safety program.
Update to clarify the regulatory considerations of the Section 5.5.4 SHINE configuration management program.
A markup of the technical specifications (TS) changes is provided as Attachment 1.
Page 1 of 1
ENCLOSURE 1 ATTACHMENT 1 SHINE TECHNOLOGIES, LLC SHINE TECHNOLOGIES, LLC APPLICATION FOR AN OPERATING LICENSE SUPPLEMENT NO. 21 TECHNICAL SPECIFICATIONS CHANGE
SUMMARY
TECHNICAL SPECIFICATIONS MARKUP
- d. The SHINE Facility emergency plan and implementing procedures: at least once every other calendar year (interval between audits not to exceed 30 months);
- e. The radiation protection plan: at least once per calendar year (interval between audits not to exceed 15 months);
- f. The QAPD: at least once every other calendar year (interval between audits not to exceed 30 months);
- g. The physical security plan: at least once every other calendar year (interval between audits not to exceed 30 months); and
- h. The nuclear criticality safety program: at least once every third calendar year (interval between audits not to exceed 36 months).
- 2. Deficiencies identified during the audit will be entered into the Corrective Action Program. Deficiencies uncovered that affect nuclear safety shall immediately be reported to Level 1 management. A written report of the findings of the audit shall be submitted to Level 1 management and the review and audit committee members within three months after the audit has been completed.
5.3 Radiation Safety The Radiation Protection Manager (RPM) shall be responsible for the implementation of the radiation protection program. The requirements of the radiation protection program are established by 10 CFR Part 20. The program shall use the guidelines of ANSI/ANS 15.11-19932016, Radiation Protection at Research Reactor Facilities. Furthermore, SHINE is committed to ensuring that radiation exposures are ALARA and in maintaining andan effective ALARA Program.
The radiation protection department is independent of facility operations. This independence ensures that the radiation protection department maintains its objectivity and is focused only on implementing sound radiation protection principalsprinciples necessary to achieve occupational doses and doses to members of the public that are ALARA.
Radiation protection staff maintain the ability to raise safety issues with the review and audit committee or executive management.
5.4 Procedures
- 1. Procedures for the operation and use of the SHINE Facility provide appropriate direction to ensure that the facility is operated normally within its design basis, and in compliance with technical specifications. Procedures also provide guidance for addressing abnormal and emergency situations. These procedures are written, reviewed, approved by appropriate management, as well as controlled and monitored to ensure that the content is technically correct, and the wording and format are clear and concise.
- 2. The process required to make changes to procedures, including substantive and minor permanent changes, and temporary deviations to accommodate special or unusual circumstances during operation shall be in compliance with ANSI/ANS 15.1-2007.
Page 5.0-6 Revision 56
significance of the consequences of error. The process for making changes and revisions to procedures is documented. A controlled copy of all operations procedures is maintained in the control room. Activities and tasks are performed in accordance with approved implementing procedures.
5.5 Programs The following programs shall be established, implemented, and maintained.
5.5.1 Nuclear Safety Program The SHINE nuclear safety program documents and describes the methods used to minimize the probability and consequences of accidents resulting in radiological or chemical release. The program applies a graded approach to the design and management of processes to assure plant safety through risk reduction and satisfaction of SHINEs performance goals. The safety program accomplishes these goals through development and maintenance of the accident analysis, identification of safety-related structures, systems, and components (SSCs)controls credited for the prevention or mitigation of accidents mitigation, and establishment of programmatic administrative controls to ensure reliability of the credited SSCscontrols.
5.5.2 Training and Qualification The SHINE training and qualification programs include initial and requalification training programs for Licensed Operators, which were developed to conform to the requirements of 10 CFR Part 55, as it pertains to non-power facilities, following the guidance contained in ANSI/ANS 15.4-2016, Selection and Training of Personnel for Research Reactors.
5.5.3 Radiation Protection The SHINE radiation protection program is provided to protect the radiological health and safety of workers and the public. The program meets the requirements of 10 CFR 20, Subpart B, and is consistent with the guidance provided in ANSI/ANS 15.11-2016, Radiation Protection at Research Reactor Facilities, and Regulatory Guide 8.2, Revision 1, Administrative Practices in Radiation Surveys and Monitoring. In addition, SHINE has established this program to maintain occupational radiation exposures and releases to the environment ALARA.
5.5.4 Configuration Management The SHINE configuration management program provides oversight and control of design information, safety information, and records of modifications that might impact the ability of safety-related SSCs to perform their functions. The configuration management program is applied to all safety-related SSCs and is used to evaluate each change to the SHINE Facility for the potential to affect safety-related SSCs. The configuration management program is used to maintain consistency among the design requirements, the physical configuration and the facility documentation, and ensures changes are made in accordance with 10 CFR 50.59, 10 CFR 70.72, and the administrative controls and reviews specified by this program.
Table 5.5.4 lists controls derived from the accident analysis not otherwise included in Sections 3, 4, or 5 of the technical specifications. SHINE maintains these controls under the configuration management program and will not modify the characteristics of the items listed in Table 5.5.4 without prior NRC approval.
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