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| docket = 05000608 | | docket = 05000608 | ||
| license number = | | license number = | ||
| contact person = Lynch S | | contact person = Lynch S | ||
| package number = ML17142A431 | | package number = ML17142A431 | ||
| document type = Letter | | document type = Letter | ||
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=Text= | =Text= | ||
{{#Wiki_filter: | {{#Wiki_filter:July 14, 2017 Gregory Piefer, Ph.D. | ||
Chief Executive Officer SHINE Medical Technologies, Inc. | |||
Gregory Piefer, Ph.D. | 101 E. Milwaukee Street, Suite 600 Janesville, WI 53545 | ||
Chief Executive Officer SHINE Medical Technologies, Inc. 101 E. Milwaukee Street, Suite 600 Janesville, WI | |||
==SUBJECT:== | ==SUBJECT:== | ||
SHINE MEDICAL TECHNOLOGIES, INC. - U.S. NUCLEAR REGULATORY COMMISSION STAFF RESPONSE TO REQUEST REGARDING THE APPLICABILITY OF THE DEFINITION OF UTILIZATION FACILITY TO THE SHINE DEMONSTRATION UNIT | SHINE MEDICAL TECHNOLOGIES, INC. - U.S. NUCLEAR REGULATORY COMMISSION STAFF RESPONSE TO REQUEST REGARDING THE APPLICABILITY OF THE DEFINITION OF UTILIZATION FACILITY TO THE SHINE DEMONSTRATION UNIT | ||
==Dear Dr. Piefer:== | ==Dear Dr. Piefer:== | ||
| Line 28: | Line 27: | ||
On February 29, 2016, the U.S. Nuclear Regulatory Commission (NRC or Commission) authorized the construction of the SHINE Medical Isotope Production Facility, consisting of eight utilization facilities (irradiation units) and one production facility, under Construction Permit No. | On February 29, 2016, the U.S. Nuclear Regulatory Commission (NRC or Commission) authorized the construction of the SHINE Medical Isotope Production Facility, consisting of eight utilization facilities (irradiation units) and one production facility, under Construction Permit No. | ||
CPMIF-001 (Agencywide Documents Access and Management System [ADAMS] Accession No. ML16041A471) for the production of medical radioisotopes. | CPMIF-001 (Agencywide Documents Access and Management System [ADAMS] Accession No. ML16041A471) for the production of medical radioisotopes. | ||
By letters dated March 17, 2017, and June 22, 2017 (ADAMS Accession Nos. ML17079A476 and ML17173A013, respectively), SHINE Medical Technologies, Inc. (SHINE) submitted to the NRC information on its plans to conduct a series of short-duration tests within an accelerator-driven subcritical operating assembly (demonstration unit) using a less than critical mass of low enriched uranium (LEU). SHINE would operate this demonstration unit to show certain operating characteristics of the proposed irradiation units described in the preliminary safety analysis report (PSAR) (ADAMS Accession No. ML15258A431) included in its construction permit application and assigned Docket No. 50-608. | By letters dated March 17, 2017, and June 22, 2017 (ADAMS Accession Nos. ML17079A476 and ML17173A013, respectively), SHINE Medical Technologies, Inc. (SHINE) submitted to the NRC information on its plans to conduct a series of short-duration tests within an accelerator-driven subcritical operating assembly (demonstration unit) using a less than critical mass of low enriched uranium (LEU). SHINE would operate this demonstration unit to show certain operating characteristics of the proposed irradiation units described in the preliminary safety analysis report (PSAR) (ADAMS Accession No. ML15258A431) included in its construction permit application and assigned Docket No. 50-608. SHINEs March 17, 2017, letter requests that the NRC staff confirm that the planned demonstration unit would not meet the definition of utilization facility in Title 10 of the Code of Federal Regulations (10 CFR) | ||
As described in the March 17, 2017, letter, the demonstration unit would primarily consist of a deuterium-tritium accelerator, full-scale multiplier, and solution vessel. The demonstration unit would be contained within a concrete, light water-filled pit of dimensions similar to the irradiation unit cells of | Section 50.2, Definitions. | ||
Previously, the NRC staff had determined in SECY-14-0061, Direct Final Rule: Adding SHINE Medical Technologies, Inc.s Accelerator-Driven Subcritical Operating Assembly to the Definition of Utilization Facility, that the safety considerations associated with SHINEs proposed irradiation units closely resembled those of former and currently operating non-power reactors (ADAMS Accession No. ML14052A123). The NRC staff thus proposed, and the Commission approved, a direct final rule that modified the definition of utilization facility in 10 CFR 50.2 to include SHINEs proposed irradiation units. The direct final rule was published in the Federal Register on October 17, 2014 (79 FR 62329). | |||
As described in the March 17, 2017, letter, the demonstration unit would primarily consist of a deuterium-tritium accelerator, full-scale multiplier, and solution vessel. The demonstration unit would be contained within a concrete, light water-filled pit of dimensions similar to the irradiation unit cells of SHINEs proposed irradiation facility described in the construction permit application assigned Docket No. 50-608. | |||
In response to | G. Piefer However, unlike the proposed irradiation units, SHINE does not expect that the demonstration unit would need to include a primary or other active cooling system; reactivity protection system; engineered safety features to meet 10 CFR Part 20, Standards for Protection Against Radiation, dose limits; or safety systems for the control of fission gases, the radiolytic decomposition of water and associated oxygen and hydrogen gas generation, or fission product inventory. | ||
As described in the enclosure to this letter, the NRC staff has concluded that the demonstration unit would not meet the definitions of | In response to SHINEs request, the NRC staff considered the definitions of utilization facility in 10 CFR Part 50, Domestic Licensing of Production and Utilization Facilities, and the Atomic Energy Act of 1954, as amended (AEA); the safety and security characteristics of the demonstration unit and associated special nuclear material (SNM); and the relationship between SHINEs proposed irradiation units and the demonstration unit. In particular, the NRC staff considered the thermal power level, effective multiplication factor, potential accident scenarios, quantities of SNM, intended use, and location associated with the proposed operation of the demonstration unit to support its conclusions. | ||
Since the information provided in | As described in the enclosure to this letter, the NRC staff has concluded that the demonstration unit would not meet the definitions of utilization facility in either 10 CFR 50.2 or the AEA. In particular, the demonstration unit, as described, is not a nuclear reactor. It is also not an accelerator-driven subcritical operating assembly used for the irradiation of materials containing SNM and described in the application assigned Docket No. 50-608. Further, it appears that the demonstration unit, if designed to operate as described, would not require engineered safety features or other safety systems to mitigate radiological releases to meet 10 CFR Part 20 dose limits and would not require a physical protection system. Therefore, the demonstration unit would not be capable of making use of SNM or atomic energy in such quantity as to be of significance to the common defense and security or in such manner as to affect the health and safety of the public and would not be considered an important component part especially designed for a utilization facility. | ||
G. Piefer | Since the information provided in SHINEs March 17, 2017, and June 22, 2017, letters is preliminary and does not constitute a license application, this NRC staff response does not constitute either a review or approval of the design of the demonstration unit or a verification that the planned demonstration unit would perform as described. In addition, if the actual demonstration unit differs from the descriptions and information in SHINEs March 17, 2017, and June 22, 2017, letters, the NRC staff could reach different conclusions. | ||
G. Piefer If you have any questions, please contact Steven Lynch at 301-415-1524, or by electronic mail at Steven.Lynch@nrc.gov. | |||
Sincerely, | |||
/RA/ | |||
Louise Lund, Director Division of Policy and Rulemaking Office of Nuclear Reactor Regulation | |||
==Enclosure:== | ==Enclosure:== | ||
Response on Applicability of Definition of Utilization Facility | Response on Applicability of Definition of Utilization Facility cc: See next page | ||
TRTR Newsletter University of Florida Department of Nuclear | SHINE External Stakeholder Mailing List Jeff Bartelme Licensing Manager SHINE Medical Technologies, Inc. | ||
101 E. Milwaukee Street, Suite 600 Janesville, WI 53545 Jeff Chamberlin National Nuclear Security Administration, NA-231 U.S. Department of Energy 1000 Independence Ave SW Washington, DC 20585 Mark Paulson Supervisor Radiation Protection Section Wisconsin Department of Health Services P.O. Box 2659 Madison, WI 53701-2659 TRTR Newsletter University of Florida Department of Nuclear Engineering Sciences 202 Nuclear Sciences Center Gainesville, FL 32611 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 Gerald and Muriel Bumgarner 1735 S Osborne Ave Janesville, WI 53546 | |||
Package: ML17142A431; Letter: ML17142A432; | |||
Package: | |||
==Enclosure:== | ==Enclosure:== | ||
ML17142A433; *concurred via email | ML17142A433; *concurred via email NRR-088 OFFICE NRR/DPR/PRLB/PM* NRR/DPR/PROB/LA* NMSS/FCSE/ECB/BC* | ||
}} | NAME SLynch NParker JZimmerman DATE 5/24/17 5/24/17 6/21/17 OFFICE NMSS/MSTR/ASPB/BC* NSIR/DPCP/FCTSB/BC* NRR/DPR/PROB/BC NAME PMichalak WGott AMendiola DATE 6/16/17 6/15/17 6/15/17 OFFICE RIII/DNMS/D* OGC NRR/DPR/PRLB/BC NAME JGiessner MYoung AAdams DATE 6/21/17 6/29/17 6/29/17 OFFICE NRR/DPR/D NAME LLund DATE 7/14/17}} | ||
Latest revision as of 02:55, 30 October 2019
| ML17142A432 | |
| Person / Time | |
|---|---|
| Site: | SHINE Medical Technologies |
| Issue date: | 07/14/2017 |
| From: | Louise Lund NRC/NRR/DPR/PRLB |
| To: | Piefer G SHINE Medical Technologies |
| Lynch S | |
| Shared Package | |
| ML17142A431 | List: |
| References | |
| Download: ML17142A432 (5) | |
Text
July 14, 2017 Gregory Piefer, Ph.D.
Chief Executive Officer SHINE Medical Technologies, Inc.
101 E. Milwaukee Street, Suite 600 Janesville, WI 53545
SUBJECT:
SHINE MEDICAL TECHNOLOGIES, INC. - U.S. NUCLEAR REGULATORY COMMISSION STAFF RESPONSE TO REQUEST REGARDING THE APPLICABILITY OF THE DEFINITION OF UTILIZATION FACILITY TO THE SHINE DEMONSTRATION UNIT
Dear Dr. Piefer:
On February 29, 2016, the U.S. Nuclear Regulatory Commission (NRC or Commission) authorized the construction of the SHINE Medical Isotope Production Facility, consisting of eight utilization facilities (irradiation units) and one production facility, under Construction Permit No.
CPMIF-001 (Agencywide Documents Access and Management System [ADAMS] Accession No. ML16041A471) for the production of medical radioisotopes.
By letters dated March 17, 2017, and June 22, 2017 (ADAMS Accession Nos. ML17079A476 and ML17173A013, respectively), SHINE Medical Technologies, Inc. (SHINE) submitted to the NRC information on its plans to conduct a series of short-duration tests within an accelerator-driven subcritical operating assembly (demonstration unit) using a less than critical mass of low enriched uranium (LEU). SHINE would operate this demonstration unit to show certain operating characteristics of the proposed irradiation units described in the preliminary safety analysis report (PSAR) (ADAMS Accession No. ML15258A431) included in its construction permit application and assigned Docket No. 50-608. SHINEs March 17, 2017, letter requests that the NRC staff confirm that the planned demonstration unit would not meet the definition of utilization facility in Title 10 of the Code of Federal Regulations (10 CFR)
Section 50.2, Definitions.
Previously, the NRC staff had determined in SECY-14-0061, Direct Final Rule: Adding SHINE Medical Technologies, Inc.s Accelerator-Driven Subcritical Operating Assembly to the Definition of Utilization Facility, that the safety considerations associated with SHINEs proposed irradiation units closely resembled those of former and currently operating non-power reactors (ADAMS Accession No. ML14052A123). The NRC staff thus proposed, and the Commission approved, a direct final rule that modified the definition of utilization facility in 10 CFR 50.2 to include SHINEs proposed irradiation units. The direct final rule was published in the Federal Register on October 17, 2014 (79 FR 62329).
As described in the March 17, 2017, letter, the demonstration unit would primarily consist of a deuterium-tritium accelerator, full-scale multiplier, and solution vessel. The demonstration unit would be contained within a concrete, light water-filled pit of dimensions similar to the irradiation unit cells of SHINEs proposed irradiation facility described in the construction permit application assigned Docket No. 50-608.
G. Piefer However, unlike the proposed irradiation units, SHINE does not expect that the demonstration unit would need to include a primary or other active cooling system; reactivity protection system; engineered safety features to meet 10 CFR Part 20, Standards for Protection Against Radiation, dose limits; or safety systems for the control of fission gases, the radiolytic decomposition of water and associated oxygen and hydrogen gas generation, or fission product inventory.
In response to SHINEs request, the NRC staff considered the definitions of utilization facility in 10 CFR Part 50, Domestic Licensing of Production and Utilization Facilities, and the Atomic Energy Act of 1954, as amended (AEA); the safety and security characteristics of the demonstration unit and associated special nuclear material (SNM); and the relationship between SHINEs proposed irradiation units and the demonstration unit. In particular, the NRC staff considered the thermal power level, effective multiplication factor, potential accident scenarios, quantities of SNM, intended use, and location associated with the proposed operation of the demonstration unit to support its conclusions.
As described in the enclosure to this letter, the NRC staff has concluded that the demonstration unit would not meet the definitions of utilization facility in either 10 CFR 50.2 or the AEA. In particular, the demonstration unit, as described, is not a nuclear reactor. It is also not an accelerator-driven subcritical operating assembly used for the irradiation of materials containing SNM and described in the application assigned Docket No. 50-608. Further, it appears that the demonstration unit, if designed to operate as described, would not require engineered safety features or other safety systems to mitigate radiological releases to meet 10 CFR Part 20 dose limits and would not require a physical protection system. Therefore, the demonstration unit would not be capable of making use of SNM or atomic energy in such quantity as to be of significance to the common defense and security or in such manner as to affect the health and safety of the public and would not be considered an important component part especially designed for a utilization facility.
Since the information provided in SHINEs March 17, 2017, and June 22, 2017, letters is preliminary and does not constitute a license application, this NRC staff response does not constitute either a review or approval of the design of the demonstration unit or a verification that the planned demonstration unit would perform as described. In addition, if the actual demonstration unit differs from the descriptions and information in SHINEs March 17, 2017, and June 22, 2017, letters, the NRC staff could reach different conclusions.
G. Piefer If you have any questions, please contact Steven Lynch at 301-415-1524, or by electronic mail at Steven.Lynch@nrc.gov.
Sincerely,
/RA/
Louise Lund, Director Division of Policy and Rulemaking Office of Nuclear Reactor Regulation
Enclosure:
Response on Applicability of Definition of Utilization Facility cc: See next page
SHINE External Stakeholder Mailing List Jeff Bartelme Licensing Manager SHINE Medical Technologies, Inc.
101 E. Milwaukee Street, Suite 600 Janesville, WI 53545 Jeff Chamberlin National Nuclear Security Administration, NA-231 U.S. Department of Energy 1000 Independence Ave SW Washington, DC 20585 Mark Paulson Supervisor Radiation Protection Section Wisconsin Department of Health Services P.O. Box 2659 Madison, WI 53701-2659 TRTR Newsletter University of Florida Department of Nuclear Engineering Sciences 202 Nuclear Sciences Center Gainesville, FL 32611 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 Gerald and Muriel Bumgarner 1735 S Osborne Ave Janesville, WI 53546
Package: ML17142A431; Letter: ML17142A432;
Enclosure:
ML17142A433; *concurred via email NRR-088 OFFICE NRR/DPR/PRLB/PM* NRR/DPR/PROB/LA* NMSS/FCSE/ECB/BC*
NAME SLynch NParker JZimmerman DATE 5/24/17 5/24/17 6/21/17 OFFICE NMSS/MSTR/ASPB/BC* NSIR/DPCP/FCTSB/BC* NRR/DPR/PROB/BC NAME PMichalak WGott AMendiola DATE 6/16/17 6/15/17 6/15/17 OFFICE RIII/DNMS/D* OGC NRR/DPR/PRLB/BC NAME JGiessner MYoung AAdams DATE 6/21/17 6/29/17 6/29/17 OFFICE NRR/DPR/D NAME LLund DATE 7/14/17