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| {{#Wiki_filter:February 23, 2018 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555 2018-SMT-0011 10 CFR 50.4 | | {{#Wiki_filter:February 23, 2018 2018-SMT-0011 10 CFR 50.4 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555 |
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| ==References:== | | ==References:== |
| (1) NRC letter to SHINE Medical Technologies, Inc., "SHINE Medical Technologies, Inc. -Issuance of Construction Permit for Medical Isotope Facility," dated February 26, 2016 (ML 16041 A473) (2) SHINE Medical Technologies, Inc. letter to NRC, "Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001," dated August 23, 2017 (ML 17235A 110) Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 Pursuant to the License Conditions described in Section 3.D.(1) of the SHINE Medical Technologies, Inc. (SHINE) Construction Permit (Reference 1 ), SHINE is submitting the enclosed periodic report, updating the NRC staff on progress related to nuclear criticality safety and radiation protection since SHINE's previous periodic report (Reference 2). If you have any questions, please contact Mr. Jeff Bartelme, Licensing Manager, at 608/210-1735. I declare under the penalty of perjury that the foregoing is true and correct. Executed on February 23, 2018. Very truly yours, Costedio Vice President of Regulatory Affairs and Quality SHINE Medical Technologies, Inc. Docket No. 50-608 Enclosure cc: Project Manager, USNRC Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health 101 E. Milwaukee St., Suite 600 I Janesville, WI 53545 IP (608) 210-1060 IF (608) 210-2504 I www.shinemed.com ENCLOSURE SHINE MEDICAL TECHNOLOGIES, INC. PERIODIC REPORT REQUIRED BY THE LICENSE CONDITIONS IN SECTION 3.D.(1) OF CPMIF-001 Pursuant to the License Conditions described in Section 3.0.(1) of the SHINE Medical Technologies, Inc. (SHINE) Construction Permit (Reference 1 ), SHINE is providing the following periodic report, updating the NRG staff on progress related to nuclear criticality safety and radiation protection. License Condition 3.D.(1)(a) The technical basis for the design of the criticality accident alarm system (CAAS), including a description of the methodology for determining detector placement. The technical basis shall demonstrate that the CAAS will meet the requirements of 10 CFR 70.24(a) and the commitments listed on page 6b-19 of the Preliminary Safety Analysis Report, Revision 0. SHINE Update Since the submittal of SHINE's previous periodic report updating the NRG staff on progress related to nuclear criticality safety and radiation protection (Reference 2), a preliminary analysis of the SHINE facility has been performed using a ray-tracing method to develop an initial estimate of the scope and complexity of the criticality accident alarm system (CAAS) installation that will be required to provide coverage for the SHINE facility. From this report, SHINE will develop a detailed analysis to determine the final placement of detectors as part of the technical basis for the design of the CAAS. Future SHINE work includes developing the technical basis for the design of the CAAS, including a description of the methodology for determining detector placement, demonstrating that the CAAS meets the requirements of 1 O CFR 70.24(a) and the commitments listed on Page 6b-19 of the SHINE Preliminary Safety Analysis Report (PSAR). License Condition 3.D.(1){b) The basis for determining that criticality events are "not credible" for radioisotope production facility (RPF) processes even though fissile materials may be present. The basis shall demonstrate that the each such event satisfies the definition of "not credible," as described in the SHINE integrated safety analysis Summary. SHINE Update Since the submittal of SHINE's previous periodic report updating the NRG staff on progress related to nuclear criticality safety and radiation protection (Reference 2), SHINE has worked to update the validation of the use of Monte Carlo N-Particle (MCNP) in calculating reactivities at SHINE by applying additional benchmark experiments that bound the relevant nuclear parameters in the SHINE target solution. SHINE has also begun work on evaluating the impact Page 1 of 3 of pipe configuration on target solution reactivity. Additionally, preliminary work has been performed to evaluate the impact of target solution homogeneity on target solution reactivity. These analyses will support the final evaluation of criticality events for Radioisotope Production Facility (RPF) processes. Future SHINE work includes evaluating criticality events for RPF processes. For any criticality event SHINE determines to be "not credible" even though fissile material may be present, SHINE will provide the basis for the determination, demonstrating that each such event satisfies the definition of "not credible," as described in the SHINE Integrated Safety Analysis (ISA) Summary. License Condition 3.D.(1)(c) Summaries of the criticality safety analysis for the affected processes that include the following: (1) a list of identified criticality hazards, (2) a list of controlled parameters, (3) a description of evaluated normal and abnormal conditions, (4) a description of the licensee's approach to meeting the double contingency principle, and (5) a list of anticipated passive and active engineered controls, including any assumptions, to ensure the process(es) will remain subcritical under normal and credible abnormal conditions. The criticality safety analysis summaries shall demonstrate that all RPF processes will remain subcritical under all normal and credible abnormal conditions and will satisfy the double contingency principle. SHINE Update Since the submittal of SHINE's previous periodic report updating the NRC staff on progress related to nuclear criticality safety and radiation protection (Reference 2), SHINE has worked to update the validation of the use of MCNP in calculating reactivities at SHINE by applying additional benchmark experiments that bound the relevant nuclear parameters in the SHINE target solution. SHINE has also begun work on evaluating the impact of pipe configuration on target solution reactivity. Additionally, preliminary work has been performed to evaluate the impact of target solution homogeneity on target solution reactivity. These analyses will support the final evaluation of criticality events for RPF processes and the identification of criticality hazards. Future SHINE work includes evaluating criticality events for RPF processes. SHINE will summarize the evaluations of the affected processes, including a list of identified criticality hazards; a list of controlled parameters; a description of evaluated normal and abnormal conditions; a description of SHINE's approach to meeting the double contingency principle; and a list of anticipated passive and active engineered controls, including any assumptions, to ensure the processes will remain subcritical under normal and credible abnormal conditions. The summaries will demonstrate that all RPF processes will remain subcritical under all normal and credible abnormal conditions and will satisfy the double contingency principle. License Condition 3.D.(1)(d) The relevant nuclear criticality safety evaluations (NCSEs) shall address the reactivity contributions from all fissile isotopes or SHINE shall apply an additional subcritical margin to account for neglecting these nuclides. The treatment of fissile nuclides other than U-235, whether through the NCSEs or the addition of subcritical margin, shall demonstrate that all RPF processes will remain subcritical under all normal and credible abnormal conditions. Page 2 of 3 SHINE Update Since the submittal of SHINE's previous periodic report updating the NRC staff on progress related to nuclear criticality safety and radiation protection (Reference 2), SHINE has continued work on evaluating reactivity contributions from all fissile isotopes and comparing those reactivity contributions against a bounding enrichment of U-235 to be used in nuclear criticality safety evaluations (NCSEs). Whichever condition provides a more conservative estimate of reactivity, as determined by this evaluation, will be used in future NCSEs. Future SHINE work includes completing the reactivity evaluation and evaluating criticality events for RPF processes, addressing the reactivity contributions from all fissile isotopes or applying additional subcritical margin to account for neglecting these nuclides. The treatment of fissile nuclides other than U-235, whether through the NCSEs or the addition of subcritical margin, will demonstrate that all RPF processes will remain subcritical under all normal and credible abnormal conditions. License Condition 3.D.(1)(e) The design information on the RPF supercells, tank vaults containing the liquid waste storage tanks, evaporation hot cells, and liquid waste solidification hot cells demonstrating shielding, and occupancy times within the RPF are consistent with as low as is reasonably achievable practices and dose requirements of 1 O CFR Part 20. SHINE Update Since the submittal of SHINE's previous periodic report updating the NRC staff on progress related to nuclear criticality safety and radiation protection (Reference 2), work on additional design information on RPF supercells, tank vaults containing liquid waste storage tanks, evaporation hot cells, and liquid waste solidification hot cells has continued to determine required tank vault sizing, tank elevations, and facility locations. SHINE has also determined RPF supercell shielding requirements. Future SHINE work includes using the design information on RPF supercells, tank vaults containing liquid waste storage tanks, evaporation hot cells, and liquid waste solidification hot cells to update or perform shielding analyses and occupancy time analyses demonstrating shielding and occupancy times within the RPF are consistent with as low as is reasonably achievable practices and the dose requirements of 1 O CFR Part 20. REFERENCES (1) NRC letter to SHINE Medical Technologies, Inc., "SHINE Medical Technologies, Inc. -Issuance of Construction Permit for Medical Isotope Facility," dated February 26, 2016 (ML 16041 A473) (2) SHINE Medical Technologies, Inc. letter to NRC, "Periodic Report Required by the License Conditions in Section 3.0.(1) of CPMIF-001," dated August 23, 2017 (ML 17235A 110) Page 3 of 3}}
| | (1) NRC letter to SHINE Medical Technologies, Inc., "SHINE Medical Technologies, Inc. - Issuance of Construction Permit for Medical Isotope Facility," dated February 26, 2016 (ML16041A473) |
| | (2) SHINE Medical Technologies, Inc. letter to NRC, "Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001," dated August 23, 2017 (ML17235A110) |
| | Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 Pursuant to the License Conditions described in Section 3.D.(1) of the SHINE Medical Technologies, Inc. (SHINE) Construction Permit (Reference 1), SHINE is submitting the enclosed periodic report, updating the NRC staff on progress related to nuclear criticality safety and radiation protection since SHINE's previous periodic report (Reference 2). |
| | If you have any questions, please contact Mr. Jeff Bartelme, Licensing Manager, at 608/210-1735. |
| | I declare under the penalty of perjury that the foregoing is true and correct. |
| | Executed on February 23, 2018. |
| | Very truly yours, |
| | ~ames Costedio Vice President of Regulatory Affairs and Quality SHINE Medical Technologies, Inc. |
| | Docket No. 50-608 Enclosure cc: Project Manager, USNRC Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health 101 E. Milwaukee St., Suite 600 I Janesville, WI 53545 IP (608) 210-1060 IF (608) 210-2504 I www.shinemed.com |
| | |
| | ENCLOSURE SHINE MEDICAL TECHNOLOGIES, INC. |
| | PERIODIC REPORT REQUIRED BY THE LICENSE CONDITIONS IN SECTION 3.D.(1) OF CPMIF-001 Pursuant to the License Conditions described in Section 3.0.(1) of the SHINE Medical Technologies, Inc. (SHINE) Construction Permit (Reference 1), SHINE is providing the following periodic report, updating the NRG staff on progress related to nuclear criticality safety and radiation protection. |
| | License Condition 3.D.(1)(a) |
| | The technical basis for the design of the criticality accident alarm system (CAAS), including a description of the methodology for determining detector placement. The technical basis shall demonstrate that the CAAS will meet the requirements of 10 CFR 70.24(a) and the commitments listed on page 6b-19 of the Preliminary Safety Analysis Report, Revision 0. |
| | SHINE Update Since the submittal of SHINE's previous periodic report updating the NRG staff on progress related to nuclear criticality safety and radiation protection (Reference 2), a preliminary analysis of the SHINE facility has been performed using a ray-tracing method to develop an initial estimate of the scope and complexity of the criticality accident alarm system (CAAS) installation that will be required to provide coverage for the SHINE facility. From this report, SHINE will develop a detailed analysis to determine the final placement of detectors as part of the technical basis for the design of the CAAS. |
| | Future SHINE work includes developing the technical basis for the design of the CAAS, including a description of the methodology for determining detector placement, demonstrating that the CAAS meets the requirements of 10 CFR 70.24(a) and the commitments listed on Page 6b-19 of the SHINE Preliminary Safety Analysis Report (PSAR). |
| | License Condition 3.D.(1){b) |
| | The basis for determining that criticality events are "not credible" for radioisotope production facility (RPF) processes even though fissile materials may be present. The basis shall demonstrate that the each such event satisfies the definition of "not credible," as described in the SHINE integrated safety analysis Summary. |
| | SHINE Update Since the submittal of SHINE's previous periodic report updating the NRG staff on progress related to nuclear criticality safety and radiation protection (Reference 2), SHINE has worked to update the validation of the use of Monte Carlo N-Particle (MCNP) in calculating reactivities at SHINE by applying additional benchmark experiments that bound the relevant nuclear parameters in the SHINE target solution. SHINE has also begun work on evaluating the impact Page 1 of 3 |
| | |
| | of pipe configuration on target solution reactivity. Additionally, preliminary work has been performed to evaluate the impact of target solution homogeneity on target solution reactivity. |
| | These analyses will support the final evaluation of criticality events for Radioisotope Production Facility (RPF) processes. |
| | Future SHINE work includes evaluating criticality events for RPF processes. For any criticality event SHINE determines to be "not credible" even though fissile material may be present, SHINE will provide the basis for the determination, demonstrating that each such event satisfies the definition of "not credible," as described in the SHINE Integrated Safety Analysis (ISA) |
| | Summary. |
| | License Condition 3.D.(1)(c) |
| | Summaries of the criticality safety analysis for the affected processes that include the following: |
| | (1) a list of identified criticality hazards, (2) a list of controlled parameters, (3) a description of evaluated normal and abnormal conditions, (4) a description of the licensee's approach to meeting the double contingency principle, and (5) a list of anticipated passive and active engineered controls, including any assumptions, to ensure the process(es) will remain subcritical under normal and credible abnormal conditions. The criticality safety analysis summaries shall demonstrate that all RPF processes will remain subcritical under all normal and credible abnormal conditions and will satisfy the double contingency principle. |
| | SHINE Update Since the submittal of SHINE's previous periodic report updating the NRC staff on progress related to nuclear criticality safety and radiation protection (Reference 2), SHINE has worked to update the validation of the use of MCNP in calculating reactivities at SHINE by applying additional benchmark experiments that bound the relevant nuclear parameters in the SHINE target solution. SHINE has also begun work on evaluating the impact of pipe configuration on target solution reactivity. Additionally, preliminary work has been performed to evaluate the impact of target solution homogeneity on target solution reactivity. These analyses will support the final evaluation of criticality events for RPF processes and the identification of criticality hazards. |
| | Future SHINE work includes evaluating criticality events for RPF processes. SHINE will summarize the evaluations of the affected processes, including a list of identified criticality hazards; a list of controlled parameters; a description of evaluated normal and abnormal conditions; a description of SHINE's approach to meeting the double contingency principle; and a list of anticipated passive and active engineered controls, including any assumptions, to ensure the processes will remain subcritical under normal and credible abnormal conditions. |
| | The summaries will demonstrate that all RPF processes will remain subcritical under all normal and credible abnormal conditions and will satisfy the double contingency principle. |
| | License Condition 3.D.(1)(d) |
| | The relevant nuclear criticality safety evaluations (NCSEs) shall address the reactivity contributions from all fissile isotopes or SHINE shall apply an additional subcritical margin to account for neglecting these nuclides. The treatment of fissile nuclides other than U-235, whether through the NCSEs or the addition of subcritical margin, shall demonstrate that all RPF processes will remain subcritical under all normal and credible abnormal conditions. |
| | Page 2 of 3 |
| | |
| | SHINE Update Since the submittal of SHINE's previous periodic report updating the NRC staff on progress related to nuclear criticality safety and radiation protection (Reference 2), SHINE has continued work on evaluating reactivity contributions from all fissile isotopes and comparing those reactivity contributions against a bounding enrichment of U-235 to be used in nuclear criticality safety evaluations (NCSEs). Whichever condition provides a more conservative estimate of reactivity, as determined by this evaluation, will be used in future NCSEs. |
| | Future SHINE work includes completing the reactivity evaluation and evaluating criticality events for RPF processes, addressing the reactivity contributions from all fissile isotopes or applying additional subcritical margin to account for neglecting these nuclides. The treatment of fissile nuclides other than U-235, whether through the NCSEs or the addition of subcritical margin, will demonstrate that all RPF processes will remain subcritical under all normal and credible abnormal conditions. |
| | License Condition 3.D.(1)(e) |
| | The design information on the RPF supercells, tank vaults containing the liquid waste storage tanks, evaporation hot cells, and liquid waste solidification hot cells demonstrating shielding, and occupancy times within the RPF are consistent with as low as is reasonably achievable practices and dose requirements of 10 CFR Part 20. |
| | SHINE Update Since the submittal of SHINE's previous periodic report updating the NRC staff on progress related to nuclear criticality safety and radiation protection (Reference 2), work on additional design information on RPF supercells, tank vaults containing liquid waste storage tanks, evaporation hot cells, and liquid waste solidification hot cells has continued to determine required tank vault sizing, tank elevations, and facility locations. SHINE has also determined RPF supercell shielding requirements. |
| | Future SHINE work includes using the design information on RPF supercells, tank vaults containing liquid waste storage tanks, evaporation hot cells, and liquid waste solidification hot cells to update or perform shielding analyses and occupancy time analyses demonstrating shielding and occupancy times within the RPF are consistent with as low as is reasonably achievable practices and the dose requirements of 10 CFR Part 20. |
| | REFERENCES (1) NRC letter to SHINE Medical Technologies, Inc., "SHINE Medical Technologies, Inc. - |
| | Issuance of Construction Permit for Medical Isotope Facility," dated February 26, 2016 (ML16041A473) |
| | (2) SHINE Medical Technologies, Inc. letter to NRC, "Periodic Report Required by the License Conditions in Section 3.0.(1) of CPMIF-001," dated August 23, 2017 (ML17235A110) |
| | Page 3 of 3}} |
Letter Sequence Request |
|---|
EPID:L-2018-LLM-0154, Shine Medical Technologies, Inc., Submittal of Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 (Approved, Closed) |
Initiation
- Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request
- Acceptance...
|
MONTHYEARML16238A0342016-08-25025 August 2016
Shine Medical Technologies, Inc., Submittal of Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001
Project stage: Request
ML17055A5732017-02-24024 February 2017
Shine Medical Technologies, Inc. - Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001
Project stage: Request
ML17235A1102017-08-23023 August 2017
Shine Medical Technologies, Inc. - Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001
Project stage: Request
ML18054A0022018-02-23023 February 2018
Shine Medical Technologies - Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001
Project stage: Request
ML18166A1782018-06-13013 June 2018
Shine Medical Technologies, Inc., Submittal of Annual Financial Report
Project stage: Request
ML18234A0202018-08-22022 August 2018
Shine Medical Technologies, Inc. - Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001
Project stage: Request
ML18347A2152018-12-11011 December 2018
Shine Medical Technologies - Application for Order Approving Indirect Transfer of Control of Construction Permit and Conforming Administrative Construction Permit Amendment
Project stage: Request
ML19024A5302019-02-13013 February 2019
Shine Medical Technologies, Inc. - Request for Additional Information Regarding the Application for Indirect License Transfer and Conforming Amendment
Project stage: RAI
ML19010A1722019-02-13013 February 2019
Shine Medical Technologies, Inc. - Request for Withholding Information from Public Disclosure
Project stage: Withholding Request Acceptance
ML19010A0952019-02-13013 February 2019, 14 February 2019
Shine Medical Technologies, Inc. Application for Indirect License Transfer
Project stage: Request
ML19010A0962019-02-13013 February 2019
Shine Medical Technologies, Inc. - Notice of Consideration of Approval of Indirect License Transfer and Conforming Amendment and Opportunity for a Hearing and Petition for Leave to Intervene
Project stage: Other
ML19010A0972019-02-14014 February 2019
Shine Medical Technologies, Inc. - Federal Register Notice Related to Consideration of Approval of Transfer of License and Conforming Amendment
Project stage: Other
ML19053A2782019-02-22022 February 2019
Shine Medical Technologies - Periodic Report Required by the License Conditions in Section 3.0.(1) of CPMIF-001
Project stage: Request
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
Project stage: Response to RAI
ML19071A0552019-03-0808 March 2019
Shine Medical Technologies, Inc., Application for Order Approving Indirect Transfer of Control of Construction Permit Response to Request for Additional Information
Project stage: Response to RAI
ML19102A3482019-05-0202 May 2019
Shine Medical Technologies, Inc. - Response to Withholding Request Related to Indirect Transfer of and Conforming Amendment to Construction Permit No. CPMIF-001
Project stage: Other
ML19102A3212019-05-0202 May 2019, 20 May 2019, 30 May 2019
Shine Medical Technologies, Inc. - Indirect Transfer of and Conforming Amendment to Construction Permit No. CPMIF-001
Project stage: Request
ML19102A3242019-05-20020 May 2019
Shine Medical Technologies, Inc. - Order Approving Indirect Transfer of and Conforming Amendment to Construction Permit No. CPMIF-001
Project stage: Request
ML19102A3232019-05-20020 May 2019
Shine Medical Technologies, Inc. - Cover Letter for Indirect Transfer of and Conforming Amendment to Construction Permit No. CPMIF-001
Project stage: Other
ML19162A0262019-07-0101 July 2019
Shine Medical Technologies, LLC - Amendment No. 1 to Shine Medical Isotope Production Facility Construction Permit No. CPMIF-001
Project stage: Other
ML19162A0242019-07-0101 July 2019
Shine Medical Technologies, LLC - Issuance of Amendment Reflecting Indirect Transfer of Construction Permit No. CPMIF-001
Project stage: Request
ML19162A0252019-07-0101 July 2019
Shine Medical Technologies, LLC - Issuance of Amendment Reflecting Indirect Transfer of Construction Permit No. CPMIF-001
Project stage: Approval
ML19234A0472019-08-22022 August 2019
Shine Medical Technologies - Periodic Report Required by the License Conditions in Section 3.0.(1) of CPMIF-001
Project stage: Request
ML19331A8322019-11-14014 November 2019
Shine Medical Technologies, LLC Supplement 1 to Final Safety Analysis Report
Project stage: Request
ML20052C7942020-02-21021 February 2020
Shine Medical Technologies, Inc., Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001
Project stage: Other
2019-02-13
[Table View] |
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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 Shines Cybersecurity Program for Its 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] |
Text
February 23, 2018 2018-SMT-0011 10 CFR 50.4 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555
References:
(1) NRC letter to SHINE Medical Technologies, Inc., "SHINE Medical Technologies, Inc. - Issuance of Construction Permit for Medical Isotope Facility," dated February 26, 2016 (ML16041A473)
(2) SHINE Medical Technologies, Inc. letter to NRC, "Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001," dated August 23, 2017 (ML17235A110)
Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 Pursuant to the License Conditions described in Section 3.D.(1) of the SHINE Medical Technologies, Inc. (SHINE) Construction Permit (Reference 1), SHINE is submitting the enclosed periodic report, updating the NRC staff on progress related to nuclear criticality safety and radiation protection since SHINE's previous periodic report (Reference 2).
If you have any questions, please contact Mr. Jeff Bartelme, Licensing Manager, at 608/210-1735.
I declare under the penalty of perjury that the foregoing is true and correct.
Executed on February 23, 2018.
Very truly yours,
~ames Costedio Vice President of Regulatory Affairs and Quality SHINE Medical Technologies, Inc.
Docket No. 50-608 Enclosure cc: Project Manager, USNRC Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health 101 E. Milwaukee St., Suite 600 I Janesville, WI 53545 IP (608) 210-1060 IF (608) 210-2504 I www.shinemed.com
ENCLOSURE SHINE MEDICAL TECHNOLOGIES, INC.
PERIODIC REPORT REQUIRED BY THE LICENSE CONDITIONS IN SECTION 3.D.(1) OF CPMIF-001 Pursuant to the License Conditions described in Section 3.0.(1) of the SHINE Medical Technologies, Inc. (SHINE) Construction Permit (Reference 1), SHINE is providing the following periodic report, updating the NRG staff on progress related to nuclear criticality safety and radiation protection.
License Condition 3.D.(1)(a)
The technical basis for the design of the criticality accident alarm system (CAAS), including a description of the methodology for determining detector placement. The technical basis shall demonstrate that the CAAS will meet the requirements of 10 CFR 70.24(a) and the commitments listed on page 6b-19 of the Preliminary Safety Analysis Report, Revision 0.
SHINE Update Since the submittal of SHINE's previous periodic report updating the NRG staff on progress related to nuclear criticality safety and radiation protection (Reference 2), a preliminary analysis of the SHINE facility has been performed using a ray-tracing method to develop an initial estimate of the scope and complexity of the criticality accident alarm system (CAAS) installation that will be required to provide coverage for the SHINE facility. From this report, SHINE will develop a detailed analysis to determine the final placement of detectors as part of the technical basis for the design of the CAAS.
Future SHINE work includes developing the technical basis for the design of the CAAS, including a description of the methodology for determining detector placement, demonstrating that the CAAS meets the requirements of 10 CFR 70.24(a) and the commitments listed on Page 6b-19 of the SHINE Preliminary Safety Analysis Report (PSAR).
License Condition 3.D.(1){b)
The basis for determining that criticality events are "not credible" for radioisotope production facility (RPF) processes even though fissile materials may be present. The basis shall demonstrate that the each such event satisfies the definition of "not credible," as described in the SHINE integrated safety analysis Summary.
SHINE Update Since the submittal of SHINE's previous periodic report updating the NRG staff on progress related to nuclear criticality safety and radiation protection (Reference 2), SHINE has worked to update the validation of the use of Monte Carlo N-Particle (MCNP) in calculating reactivities at SHINE by applying additional benchmark experiments that bound the relevant nuclear parameters in the SHINE target solution. SHINE has also begun work on evaluating the impact Page 1 of 3
of pipe configuration on target solution reactivity. Additionally, preliminary work has been performed to evaluate the impact of target solution homogeneity on target solution reactivity.
These analyses will support the final evaluation of criticality events for Radioisotope Production Facility (RPF) processes.
Future SHINE work includes evaluating criticality events for RPF processes. For any criticality event SHINE determines to be "not credible" even though fissile material may be present, SHINE will provide the basis for the determination, demonstrating that each such event satisfies the definition of "not credible," as described in the SHINE Integrated Safety Analysis (ISA)
Summary.
License Condition 3.D.(1)(c)
Summaries of the criticality safety analysis for the affected processes that include the following:
(1) a list of identified criticality hazards, (2) a list of controlled parameters, (3) a description of evaluated normal and abnormal conditions, (4) a description of the licensee's approach to meeting the double contingency principle, and (5) a list of anticipated passive and active engineered controls, including any assumptions, to ensure the process(es) will remain subcritical under normal and credible abnormal conditions. The criticality safety analysis summaries shall demonstrate that all RPF processes will remain subcritical under all normal and credible abnormal conditions and will satisfy the double contingency principle.
SHINE Update Since the submittal of SHINE's previous periodic report updating the NRC staff on progress related to nuclear criticality safety and radiation protection (Reference 2), SHINE has worked to update the validation of the use of MCNP in calculating reactivities at SHINE by applying additional benchmark experiments that bound the relevant nuclear parameters in the SHINE target solution. SHINE has also begun work on evaluating the impact of pipe configuration on target solution reactivity. Additionally, preliminary work has been performed to evaluate the impact of target solution homogeneity on target solution reactivity. These analyses will support the final evaluation of criticality events for RPF processes and the identification of criticality hazards.
Future SHINE work includes evaluating criticality events for RPF processes. SHINE will summarize the evaluations of the affected processes, including a list of identified criticality hazards; a list of controlled parameters; a description of evaluated normal and abnormal conditions; a description of SHINE's approach to meeting the double contingency principle; and a list of anticipated passive and active engineered controls, including any assumptions, to ensure the processes will remain subcritical under normal and credible abnormal conditions.
The summaries will demonstrate that all RPF processes will remain subcritical under all normal and credible abnormal conditions and will satisfy the double contingency principle.
License Condition 3.D.(1)(d)
The relevant nuclear criticality safety evaluations (NCSEs) shall address the reactivity contributions from all fissile isotopes or SHINE shall apply an additional subcritical margin to account for neglecting these nuclides. The treatment of fissile nuclides other than U-235, whether through the NCSEs or the addition of subcritical margin, shall demonstrate that all RPF processes will remain subcritical under all normal and credible abnormal conditions.
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SHINE Update Since the submittal of SHINE's previous periodic report updating the NRC staff on progress related to nuclear criticality safety and radiation protection (Reference 2), SHINE has continued work on evaluating reactivity contributions from all fissile isotopes and comparing those reactivity contributions against a bounding enrichment of U-235 to be used in nuclear criticality safety evaluations (NCSEs). Whichever condition provides a more conservative estimate of reactivity, as determined by this evaluation, will be used in future NCSEs.
Future SHINE work includes completing the reactivity evaluation and evaluating criticality events for RPF processes, addressing the reactivity contributions from all fissile isotopes or applying additional subcritical margin to account for neglecting these nuclides. The treatment of fissile nuclides other than U-235, whether through the NCSEs or the addition of subcritical margin, will demonstrate that all RPF processes will remain subcritical under all normal and credible abnormal conditions.
License Condition 3.D.(1)(e)
The design information on the RPF supercells, tank vaults containing the liquid waste storage tanks, evaporation hot cells, and liquid waste solidification hot cells demonstrating shielding, and occupancy times within the RPF are consistent with as low as is reasonably achievable practices and dose requirements of 10 CFR Part 20.
SHINE Update Since the submittal of SHINE's previous periodic report updating the NRC staff on progress related to nuclear criticality safety and radiation protection (Reference 2), work on additional design information on RPF supercells, tank vaults containing liquid waste storage tanks, evaporation hot cells, and liquid waste solidification hot cells has continued to determine required tank vault sizing, tank elevations, and facility locations. SHINE has also determined RPF supercell shielding requirements.
Future SHINE work includes using the design information on RPF supercells, tank vaults containing liquid waste storage tanks, evaporation hot cells, and liquid waste solidification hot cells to update or perform shielding analyses and occupancy time analyses demonstrating shielding and occupancy times within the RPF are consistent with as low as is reasonably achievable practices and the dose requirements of 10 CFR Part 20.
REFERENCES (1) NRC letter to SHINE Medical Technologies, Inc., "SHINE Medical Technologies, Inc. -
Issuance of Construction Permit for Medical Isotope Facility," dated February 26, 2016 (ML16041A473)
(2) SHINE Medical Technologies, Inc. letter to NRC, "Periodic Report Required by the License Conditions in Section 3.0.(1) of CPMIF-001," dated August 23, 2017 (ML17235A110)
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