ML23087A227
| ML23087A227 | |
| Person / Time | |
|---|---|
| Site: | SHINE Medical Technologies |
| Issue date: | 05/05/2023 |
| From: | Michael Balazik NRC/NRR/DANU/UNPL |
| To: | Piefer G SHINE Technologies |
| References | |
| EPID L-2022--LLA-0163 | |
| Download: ML23087A227 (1) | |
Text
Dr. Gregory Piefer Chief Executive Officer SHINE Technologies, LLC 3400 Innovation Court Janesville, WI 53546
SUBJECT:
SHINE TECHNOLOGIES, LLC - ISSUANCE OF AMENDMENT NO. 4 TO CONSTRUCTION PERMIT NO. CPMIF-001 FOR THE SHINE MEDICAL ISOTOPE PRODUCTION FACILITY RELATED TO THE RECEIPT AND POSSESSION OF CONTAINED SPECIAL NUCLEAR MATERIAL (EPID NO. L-2022--LLA-0163)
Dear Dr. Piefer:
The U.S. Nuclear Regulatory Commission (the Commission) has issued the enclosed Amendment No. 4 to Construction Permit No. CPMIF-001 for the SHINE Technologies, LLC (SHINE) Medical Isotope Production Facility. This amendment adds one new condition, 3.G, and revises the Commissions finding 1.K related to the construction permit in response to the application dated October 6, 2022 (Agencywide Documents Access and Management System Accession No. ML22279A951), as supplemented by letter dated February 17, 2023 (ML23048A244). This amendment allows the receipt and possession of contained special nuclear material in the form of neutron detectors to be installed during the construction of the SHINE Medical Isotope Production Facility.
A copy of the related safety evaluation is also enclosed. The Notice of Issuance will be included in the Commissions monthly Federal Register notice.
May 5, 2023
G. Piefer If you have any questions, please contact Michael Balazik at (301) 415-2856, or by email to Michael.Balazik@nrc.gov.
Sincerely, Michael F. Balazik, 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:
- 1. Amendment No. 4 to Construction Permit No. CPMIF-001
- 2. Safety Evaluation cc: GovDelivery Subscribers Signed by Balazik, Michael on 05/05/23
ML23087A227 NRR-058 OFFICE NRR/DANU/UNPL/PM NRR/DANU/UNPL/LA OGC/NLO NAME MBalazik NParker JWachutka DATE 4/14/2023 4/20/2023 5/2/2023 OFFICE NRR/DANU/UNPL/BC NRR/DANU/UNPL/PM NAME JBorromeo MBalazik DATE 5/5/2023 5/5/2023 SHINE TECHNOLOGIES, LLC DOCKET NO. 50-608 SHINE MEDICAL ISOTOPE PRODUCTION FACILITY AMENDMENT TO CONSTRUCTION PERMIT Amendment No. 4 Construction Permit No. CPMIF-001 1.
The U.S. Nuclear Regulatory Commission (the Commission) has found that:
A. The application for an amendment to Construction Permit No. CPMIF-001 filed by SHINE Technologies, LLC (the licensee) on October 6, 2022, as supplemented by letter dated February 17, 2023, complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commissions rules and regulations set forth in Title 10 of the Code of Federal Regulations (10 CFR) Chapter I; B. The facility will be constructed in conformity with the application, as supplemented, the provisions of the Act, and the rules and regulations of the Commission; C. There is reasonable assurance that (i) the activities authorized by this amendment can be conducted without endangering the health and safety of the public, and (ii) such activities will be conducted in compliance with the Commissions regulations; D. The issuance of this amendment will not be inimical to the common defense and security or to the health and safety of the public; and E. The issuance of this amendment is in accordance with 10 CFR Part 51, Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions, of the Commissions regulations and all applicable requirements have been satisfied.
2.
Accordingly, Construction Permit No. CPMIF-001 is amended as indicated in the attachment to this amendment.
3.
This amendment is effective as of its date of issuance and shall be implemented within 60 days.
FOR THE NUCLEAR REGULATORY COMMISSION Joshua M. Borromeo, Chief Non-Power Production and Utilization Facility Licensing Branch Division of Advanced Reactors and Non-Power Production and Utilization Facilities Office of Nuclear Reactor Regulation
Attachment:
Changes to Construction Permit No. CPMIF-001 Date of Issuance: May 5, 2023 Joshua M.
Borromeo Digitally signed by Joshua M. Borromeo
Attachment ATTACHMENT TO AMENDMENT NO. 4 SHINE MEDICAL ISOTOPE PRODUCTION FACILITY CONSTRUCTION PERMIT NO. CPMIF-001 DOCKET NO. 50-608 Replace the following pages of Construction Permit No. CPMIF-001 with the attached revised pages. The revised pages are identified by amendment number and contain marginal lines indicating the areas of change.
Construction Permit No. CPMIF-001 Remove Insert 1
1 2
2 4
4
1 Amendment No. 4 May 5, 2023 SHINE TECHNOLOGIES, LLC DOCKET NO. 50-608 MEDICAL ISOTOPE PRODUCTION FACILITY CONSTRUCTION PERMIT Amendment No. 4 Construction Permit No. CPMIF-001 1.
The Nuclear Regulatory Commission (NRC or the Commission) has found that:
A. The application for a construction permit, as supplemented and revised (the application),
filed by SHINE Medical Technologies, LLC1 (SHINE, the applicant), complies with the requirements of the Atomic Energy Act of 1954, as amended (the Act), and the rules and regulations of the Commission set forth in Title 10 of the Code of Federal Regulations (10 CFR) Chapter I - Nuclear Regulatory Commission. There is reasonable assurance that the activities authorized by the permit will be conducted in compliance with the rules and regulations of the Commission, and all required notifications to other agencies or bodies have been duly made; B. The applicant has described the proposed design of the facility, including, but not limited to, the principal architectural and engineering criteria for the design, and has identified the major features or components incorporated therein for the protection of the health and safety of the public; C. Such further technical or design information as may be required to complete the safety analysis, and which can reasonably be left for later consideration, will be supplied in the final safety analysis report; D. Safety features or components, if any, which require research and development have been described by the applicant. The applicant has identified, and will conduct, a research and development program reasonably designed to resolve any safety questions associated with such features or components; E. On the basis of the foregoing, there is reasonable assurance that: (i) such safety questions will be satisfactorily resolved at or before the latest date stated in the application for the completion of construction of the proposed facility, and (ii) taking into consideration the site criteria contained in 10 CFR Part 100,2 the proposed facility can be constructed and operated at the proposed location without undue risk to the health and safety of the public; 1
The permit holders name was administratively changed from SHINE Medical Technologies, LLC to SHINE Technologies, LLC as part of Amendment No. 3.
2 While the site criteria contained in 10 CFR Part 100 are applicable to nuclear power reactors, and not the SHINE facility, the staff considered in Chapter 2 of its safety evaluation report, site-specific conditions similar to those listed in 10 CFR Part 100. Using the guidance in NUREG-1537, the staff evaluated SHINEs analysis of site geography and demography; nearby industrial, transportation, and military facilities; site meteorology; site hydrology; and site geology, seismology, and geotechnical engineering to ensure that issuance of the permit will not be inimical to the common defense and security or to the health and safety of the public.
2 Amendment No. 4 May 5, 2023 F. The processes to be performed provide reasonable assurance the applicant will comply with the regulations in 10 CFR Chapter I, including the regulations in 10 CFR Part 20, and that the health and safety of the public will not be endangered.;
G. SHINE is technically qualified to design and construct the facility in accordance with the Commissions regulations set forth in 10 CFR Chapter I; H. SHINE is financially qualified to design and construct the facility in accordance with the Commissions regulations set forth in 10 CFR Chapter I; I.
The issuance of a permit for the construction of the facility will not be inimical to the common defense and security or to the health and safety of the public; and J.
After weighing the environmental, economic, technical and other benefits of the facility against environmental and other costs and considering reasonable available alternatives, the issuance of this construction permit, subject to the conditions for protection of the environment set forth herein, is in accordance with Subpart A of 10 CFR Part 51 of the Commissions regulations and all applicable requirements have been satisfied.
K. The receipt and possession of byproduct material, source material, and special nuclear material as authorized by this license will be in accordance with the Commissions regulations in 10 CFR Parts 30, 40, and 70.
2.
On the basis of the foregoing findings regarding this facility, construction permit No. CPMIF-001 is hereby issued to SHINE pursuant to Sections 103 and 185a of the Act and 10 CFR Part 50 for eight utilization facilities and one production facility designed for the production of medical radioisotopes, as described in the application, filed in this matter by the applicant and as more fully described in the evidence received at the public hearing upon that application. The facility, known as the SHINE Medical Isotope Production Facility, owned by SHINE Technologies, LLC, will be located on previously undeveloped agricultural property in Rock County, Wisconsin, within the southern corporate boundaries of the City of Janesville, and is described in the application.
3.
This permit shall be deemed to contain and be subject to the conditions specified in 10 CFR 50.54(b)-(f), (h), (v), (aa), and (cc) and 10 CFR 50.55; is subject to all applicable provisions of the Act, and rules, regulations, and orders of the Commission now or hereafter in effect; and is subject to the conditions specified or incorporated below:
A. The earliest date for the completion of the construction of the facility is December 31, 2017, and the latest date for completion is December 31, 2025.
B. The facility shall be constructed and located at the site as described in the application, in the City of Janesville, Rock County, Wisconsin.
C. The construction permit authorizes the applicant to construct the facility described in the application and the hearing record, in accordance with the principal architectural and engineering criteria and environmental protection commitments set forth therein.
D. The permit is subject to, and SHINE shall comply with, the conditions specified and incorporated below:
4 Amendment No. 4 May 5, 2023 (1) to receive and possess, in connection with construction of the facility, up to 10,000 kilograms (kg) of natural uranium in the form of neutron multipliers; and (2) to receive and possess, in connection with construction of the facility, up to 10 kg of depleted uranium in the form of tritium storage beds.
G. Pursuant to the Act and 10 CFR Part 70, the following activities are authorized:
(1) to receive and possess, in connection with construction of the facility, up to 15 grams of contained uranium-235 enriched to any enrichment in the form of neutron detectors.
4.
This permit is subject to the limitation that a license authorizing operation of the facility will not be issued by the Commission unless: (a) the applicant submits to the Commission the complete final safety analysis report, portions of which may be submitted and evaluated from time to time; (b) the Commission finds that the final design provides reasonable assurance that the health and safety of the public will not be endangered by the operation of the facility in accordance with procedures approved by it in connection with the issuance of said license; (c) the Commission finds that operation of the facility will be in accordance with 10 CFR Part 51 of the Commissions regulations and all applicable requirements were satisfied; and (d) the applicant submits proof of financial protection and executes an indemnity agreement as required by Section 170 of the Act.
5.
This permit is effective as of February 29, 2016 and shall expire on the latest completion date indicated in paragraph 3.A. above.
FOR THE NUCLEAR REGULATORY COMMISSION
/RA/
William M. Dean, Director Office of Nuclear Reactor Regulation Appendix:
Appendix A - Environmental Protection Plan Date of Issuance: February 29, 2016 SAFETY EVALUATION BY THE OFFICE OF NUCLEAR REACTOR REGULATION RELATED TO AMENDMENT NO. 4 TO CONSTRUCTION PERMIT NO. CPMIF-001 SHINE TECHNOLOGIES, LLC SHINE MEDICAL ISOTOPE PRODUCTION FACILITY DOCKET NO. 50-608
1.0 INTRODUCTION
By letter dated October 6, 2022 (Agencywide Documents Access and Management System Accession No. ML22279A951), as supplemented by letter dated February 17, 2023 (ML23048A244), SHINE Technologies, LLC (SHINE) applied for an amendment to Construction Permit No. CPMIF-001 for the SHINE Medical Isotope Production Facility (the SHINE facility).
The license amendment request (LAR) proposed to add one new condition, 3.G, to the construction permit and to revise the Commissions finding 1.K related to the construction permit to allow for the receipt and possession of special nuclear material (SNM) contained in neutron detectors to be installed during the construction of the SHINE facility.
2.0 REGULATORY EVALUATION
The U.S. Nuclear Regulatory Commission (NRC, the Commission) staff reviewed the LAR and evaluated the proposed changes to the construction permit, based on the following regulations and guidance:
Title 10 of the Code of Federal Regulations (10 CFR) Part 19, Notices, Instructions and Reports to Workers: Inspection and Investigations, 10 CFR Part 20, Standards for Protection Against Radiation, and 10 CFR Part 70, Domestic Licensing of Special Nuclear Material, which provide the requirements for radiation protection and the contents of applications for SNM, including training and experience of individuals using licensed material, radiation safety, and waste management.
NUREG-1556, Volume 17, Revision 1, Consolidated Guidance About Materials Licenses:
Program-Specific Guidance About Special Nuclear Material of Less Than Critical Mass Licenses (ML18190A207), which provides program-specific guidance to assist applicants and licensees in preparing applications for specific licenses to receive, possess, use, and transfer SNM in quantities less than a critical mass.
3.0 TECHNICAL EVALUATION
SHINE has proposed to construct and operate a facility in Janesville, Wisconsin for the production of molybdenum-99 (Mo-99) through the irradiation and processing of a uranyl sulfate solution. The proposed facility would comprise an irradiation facility and a radioisotope production facility. The irradiation facility would consist of eight subcritical operating assemblies (or irradiation units), which would each be licensed as a utilization facility, as defined in 10 CFR 50.2, Definitions, and supporting structures, systems, and components (SSCs) for the irradiation of low-enriched uranium. The radioisotope production facility would consist of hot cell structures, licensed collectively as a production facility, as defined in 10 CFR 50.2, and associated SSCs for the processing of irradiated material and extraction and purification of Mo-99. The irradiation facility and radioisotope production facility are collectively referred to as the SHINE facility.
The SHINE facility is currently under construction at the site described in the application, in the City of Janesville, Rock County, Wisconsin. The SHINE construction permit, CPMIF-001, Amendment No. 3, does not authorize SHINE to receive or possess SNM. The LAR proposed to add one new condition, 3.G, to the construction permit and to revise the Commissions finding 1.K related to the construction permit to allow for the receipt and possession of SNM (i.e.,
uranium enriched in uranium-235) contained in neutron detectors (i.e., fission chambers) to be installed during the construction of the SHINE facility. The proposed new condition is as follows:
G. Pursuant to the Act and 10 CFR Part 70, the following activities are authorized:
(1) to receive and possess, in connection with construction of the facility, up to 15 grams of contained uranium-235 enriched to any enrichment in the form of neutron detectors.
The proposed revised Commission finding 1.K is as follows:
K. The receipt and possession of byproduct material, source material, and special nuclear material as authorized by this license will be in accordance with the Commissions regulations in 10 CFR Parts 30, 40, and 70.
The NRC staff evaluated the SHINE proposal to amend the SHINE facility construction permit to authorize the receipt and possession of SNM contained in neutron detectors using the guidance in NUREG-1556, Volume 17, Revision 1. Specifically, the NRC staff used appendix B to NUREG-1556, Volume 17, Revision 1, which provides the suggested format for providing information requested in items 5 through 11 of NRC Form 313, Application for Materials License. In the LAR, SHINE requested to receive and possess SNM (i.e., uranium enriched in uranium-235) contained in neutron detectors to be installed in the neutron flux detection system (NFDS) during the construction of the SHINE facility.
The following sections provide the NRC staffs evaluation of the information that SHINE submitted to meet the applicable requirements of 10 CFR Parts 19, 20, and 70 using appendix B to NUREG-1556, Volume 17, Revision 1.
Item 5 - Radioactive Material In its application, SHINE identified the SNM to be included within the scope of the amended construction permit, including identification of the radioisotope (i.e., uranium enriched in uranium-235). SHINE also provided the SNM chemical/physical form as solid metal that is not in a readily dispersible form, as well as the maximum possession limit of 15 grams of contained uranium-235 enriched to any enrichment of uranium-235. This means that, under this amendment, SHINE could receive and possess a maximum of 15 grams of uranium enriched to any enrichment of uranium-235.
SHINE also committed to maintaining records important to decommissioning and transferring such records to an NRC or Agreement State licensee before licensed activities are transferred or assigned, as required by the NRCs regulations.
The quantity, form, and type of SNM that the proposed amendment would allow SHINE to receive and possess in the form of neutron detectors (i.e., fission chambers) does not require an emergency plan under 10 CFR 70.22, Contents of applications, paragraph (i) because SHINE is not requesting to receive or possess uranium hexafluoride or plutonium and is not requesting to possess enriched uranium for which a criticality accident alarm system (CAAS) is required by 10 CFR 70.24, Criticality accident requirements. Per 10 CFR 70.24(a), a CAAS is required for the possession of SNM in a quantity exceeding 700 grams of contained uranium-235, 520 grams of uranium-233, 450 grams of plutonium, 1,500 grams of contained uranium-235 if no uranium enriched to more than 4 percent by weight of uranium-235 is present, 450 grams of any combination thereof, or one-half such quantities if massive moderators or reflectors made of graphite, heavy water, or beryllium may be present. The NRC staff determined that SHINEs proposed quantity of 15 grams of contained uranium-235 enriched to any enrichment is below the limits in 10 CFR 70.24 for requiring a CAAS and, therefore, such receipt and possession would not require an emergency plan under the related 10 CFR 70.22(i) criterion.
The quantity, form, and type of SNM that the proposed amendment would allow SHINE to receive and possess in the form of neutron detectors does not require a decommissioning funding plan or a certification of financial assurance for decommissioning under 10 CFR 70.22(a)(9) and 10 CFR 70.25, Financial assurance and recordkeeping for decommissioning, paragraph (a) because (1) the SHINE facility is not a uranium enrichment facility and (2) the quantity of uranium-235 requested does not exceed 105 times the uranium-235 quantity in appendix B, Quantities of Licensed Material Requiring Labeling, to 10 CFR Part 30, Rules of General Applicability to Domestic Licensing of Byproduct Material. This amendment would permit SHINE to possess up to 15 grams of uranium-235 of any enrichment. Assuming an enrichment of 100% and using the specific activity for uranium-235 of 2.16x10-6 curies per gram, the NRC staff determined that the total curie amount for 15 grams of uranium-235 is 3.24x10-5 curies. Appendix B to 10 CFR Part 30 provides a quantity of 0.01 microcuries for uranium-235. The value specific to the proposed amendment is less than 105 times the 10 CFR Part 30, appendix B, quantity for uranium-235 of 0.01 microcuries (105x [0.01x10-6 curies]
1.0x10-3 curies). Since the specific activity of uranium-235 is higher than the specific activity of uranium-238 and the limits in 10 CFR Part 30, appendix B, are the same for uranium-235 and uranium-238, the value resulting from the previous calculation bounds that value that would be produced by a similar calculation involving a combination of uranium-235 and uranium-238.
Therefore, the SNM that would be received and possessed by SHINE would not require a decommissioning funding plan or a certification of financial assurance for decommissioning under the 10 CFR 70.25(a)(2) criterion or, accordingly, under 10 CFR 70.22(a)(9).
Based on its review of the information provided by SHINE, the NRC staff finds that SHINE has provided information consistent with the guidance regarding Item 5 in appendix B to NUREG-1556, Volume 17, Revision 1 and meets the applicable regulatory requirements in 10 CFR Part 70, including 10 CFR 70.22(a)(4). Further, for the reasons discussed above, the requirements in 10 CFR 70.22(a)(9) and (i), 10 CFR 70.24(a), and 10 CFR 70.25(a) do not apply to this application.
Item 6 - Purpose(s) for which Licensed Material Will Be Used In its application, SHINE listed the specific purposes for the SNM by referencing descriptions provided in chapter 7, Instrumentation and Control Systems (ML22249A136), of the final safety analysis report (FSAR) supporting the SHINE application for an operating license for the SHINE facility. The use of this SNM is for the SHINE facility that the NRC authorized SHINE to construct as documented in Construction Permit No. CPMIF-001. If the NRC were to grant SHINE an operating license, it would do so under section 103 of the Atomic Energy Act.
Therefore, if this material is used, it would be used in activities licensed under section 103 of the Atomic Energy Act. The specific purposes during operation for the neutron detectors with contained SNM to be installed during the construction of the SHINE facility are as follows:
As described in FSAR subsection 7.8.1, System Description, the NFDS monitors variables important to the safety functions of the irradiation units to provide input for the actuation of safety functions. Additionally, the FSAR describes that the NFDS provides continuous indication of the neutron flux during operation, from filling through maximum power during irradiation.
As described in FSAR subsection 7.8.2.2, NFDS System Design Criteria, the NFDS includes a fission chamber detector that is primarily sensitive to thermal neutrons.
As described in FSAR subsection 7.8.3.2, Simplicity, the NFDS provides voltage pulses corresponding to pulses from the associated fission chamber detector.
Based on its review of the information provided by SHINE, the NRC staff finds that SHINE has specified the purposes for which the SNM contained in neutron detectors to be installed in the NFDS during the construction of the SHINE facility will be used during operation consistent with the guidance regarding Item 6 in appendix B to NUREG-1556, Volume 17, Revision 1 and meets the applicable regulatory requirements in 10 CFR Part 70, including 10 CFR 70.22(a)(2) and 10 CFR 70.23, Requirements for the approval of applications, paragraph (a)(1).
Item 7 - Individual(s) Responsible for Radiation Safety Program and their Training and Experience In its application, as supplemented, SHINE provided the name of the radiation safety officer (RSO), including information demonstrating that the RSO is qualified by training and experience.
Information that SHINE provided included the following:
formal training and education in radiation safety
experience using licensed materials
experience performing the duties of an RSO Based on its review of the information provided by SHINE, the NRC staff finds that the RSOs training and experience is applicable to and consistent with the types and quantities of licensed material to be listed on the SHINE facility construction permit. The NRC staff finds that SHINE has provided information consistent with the guidance regarding Item 7 in appendix B to NUREG-1556, Volume 17, Revision 1 and meets the applicable regulatory requirements in 10 CFR Part 70, including 10 CFR 70.22(a)(6) and 10 CFR 70.23(a)(2).
Item 8 - Training for Individuals Working in or Frequenting Restricted Areas (Occupationally Exposed Individuals and Ancillary Personnel)
In its application, SHINE provided a description of the radiation safety training program, including topics covered, groups of workers, assessment of training, qualifications of instructors, and the method and frequency of training.
Based on its review of the information provided by SHINE, the NRC staff finds that individuals whose assigned duties involve exposure to radiation or radioactive material and in the course of their employment are likely to receive in a year an occupational dose of radiation greater than 1 millisievert (100 millirem), will receive instruction commensurate with their duties and responsibilities, as required by 10 CFR 19.12, Instruction to workers. The NRC staff finds that SHINE has provided information consistent with the guidance regarding Item 8 in appendix B to NUREG-1556, Volume 17, Revision 1 and meets the applicable regulatory requirements in 10 CFR Parts 19 and 70, including 10 CFR 19.11, Posting of notices to workers, 10 CFR 19.12, and 10 CFR 70.23(a)(2).
Item 9 - Facilities and Equipment In its application, SHINE described the facilities and equipment that will be available at each location where radioactive material would be received, stored, and installed during construction.
The application includes a description of the area(s) assigned for the receipt, storage, security, installation, and use of radioactive materials. SHINE referenced figures 1.3-1, Main Production Facility Building General Arrangement, 1.3-2, Main Production Facility Building General Arrangement Section A-A, and 1.3-3, Site Overview (ML22249A141), of the FSAR, which provide depictions of the general arrangement floor plan; section drawings of the SHINE facility showing the layout of major structures; and the SHINE facility site overview. These figures show the locations of shielding, the proximity of radiation sources to unrestricted areas, and other items related to radiation safety. SHINE stated that the SNM would be received and securely stored in an access-controlled area prior to installation away from construction activities. SHINE also stated that the secured storage area is controlled as a restricted area and posted with the requirements of 10 CFR 20.1902, Posting requirements. SHINE described how the SHINE facility design and procedures for construction will minimize contamination of the facility and the environment. The neutron detectors containing the SNM will be installed in the facility to detect neutron flux to determine the multiplication factor and power level during target solution vessel filling and irradiation.
Based on its review of the information provided by SHINE, the NRC staff finds that the facilities and equipment described by SHINE will be adequate to protect health and minimize danger to life or property. Facilities and equipment will minimize the possibility of contamination and keep exposures to workers and the public consistent with as low as is reasonably achievable (ALARA) principles. The SHINE facility design and procedures for construction will minimize, to the extent practicable, contamination of the facility and the environment. The NRC staff finds that SHINE has provided information consistent with the guidance regarding Item 9 in appendix B to NUREG-1556, Volume 17, Revision 1 and meets the applicable regulatory requirements in 10 CFR Parts 20 and 70, including paragraph (b) of 10 CFR 20.1101, Radiation protection programs, 10 CFR 20.1406, Minimization of contamination, 10 CFR 20.1902, and 10 CFR 70.23(a)(3).
Item 10 - Radiation Safety Program Radiation Monitoring Instruments and Calibration In its application, SHINE described the instrumentation that will be used to perform required surveys, which includes portable dose rate meters with ionization chambers or Geiger-Mueller probes; portable dose rate meters with helium-3 proportional probes; and friskers with Geiger-Mueller pancake probes.
SHINE also stated that it would meet the radiation monitoring instrument specifications in appendix F, Model Radiation Survey Instrument Calibration Program, to NUREG-1556, Volume 17, Revision 1. This appendix covers the acceptable types of instrumentation for radiation safety and compliance activities. It also covers the calibration of dose and dose rate measurement instruments, calibration records, surface contamination measurement instruments, and instruments used to collect samples for indirect dose measurements such as air sampling. SHINE stated that radiation monitoring instruments will be calibrated before first use, at least annually thereafter, and after any repair, by a vendor that the NRC or an Agreement State has licensed to perform instrument calibration.
Based on its review of the information provided by SHINE, the NRC staff finds that SHINE will possess, or have access to, radiation monitoring instruments that are necessary to protect health and minimize danger to life or property. The NRC staff finds that SHINE has provided information consistent with the guidance regarding Item 10 in appendix B to NUREG-1556, Volume 17, Revision 1 and meets the applicable regulatory requirements in 10 CFR Parts 20 and 70, including paragraph (c) of 10 CFR 20.1501, General, paragraph (a) of 10 CFR 20.2103, Records of surveys, and 10 CFR 70.22(a)(7).
Material Receipt and Accountability In its application, SHINE stated the following, consistent with the guidance regarding Item 10 in appendix B to NUREG-1556, Volume 17, Revision 1:
SHINE will develop, implement, and maintain procedures for ensuring accountability of licensed materials at all times. Physical inventories will be conducted at intervals not to exceed 6 months, to account for all sealed sources and devices received and possessed under the license. Records of inventory will be maintained for a period of 3 years from the date of each inventory, and will include the radionuclides, quantities, manufacturers name and model numbers, and the date of the inventory.
Based on its review of the above statement made by SHINE in its application, the NRC staff finds that SHINE meets the applicable regulatory requirements in 10 CFR Parts 20 and 70, including 10 CFR 20.1501(a), 10 CFR 20.1801, Security of stored material, 10 CFR 20.1802, Control of material not in storage, 10 CFR 70.22(a)(8), and 10 CFR 70.23(a)(4).
Occupational Dose In its application, SHINE stated the following, consistent with the guidance regarding Item 10 in appendix B to NUREG-1556, Volume 17, Revision 1:
SHINE will monitor individuals in accordance with the guidance in the section titled, Radiation Safety Program-Occupational Dose in NUREG-1556, Volume 17, Revision 1.
Based on its review of the above statement made by SHINE in its application, the NRC staff finds that SHINE will evaluate the potential occupational exposure of all workers and monitor occupational exposure consistent with the guidance in NUREG-1556, Volume 17, Revision 1 and meets the applicable regulatory requirements in 10 CFR Parts 19 and 20, including 10 CFR 19.13, Notifications and reports to individuals, 10 CFR 20.1201, Occupational dose limits for adults, 10 CFR 20.1501, and 10 CFR Part 20, appendix B, Annual Limits on Intake (ALIs) and Derived Air Concentrations (DACs) of Radionuclides for Occupational Exposure; Effluent Concentrations; Concentrations for Release to Sewerage.
Operating and Emergency Procedures In its application, SHINE stated the following, consistent with the guidance regarding Item 10 in appendix B to NUREG-1556, Volume 17, Revision 1:
Procedures for safe and secure use of materials and emergencies have been developed or will be developed before receipt of licensed material. Procedures may be revised if:
the changes are reviewed and approved by SHINE management, including the radiation protection manager, in writing;
the SHINE staff is provided training in the revised procedures prior to implementation;
the changes are in compliance with the NRC regulations and the license; and
the changes do not degrade the effectiveness of the program.
The quantity, form, and type of contained SNM that the proposed amendment would allow SHINE to receive and possess in the form of neutron detectors falls below the threshold for physical security plan requirements under subparagraph (h)(1) and paragraph (k) of 10 CFR 70.22. Per 10 CFR 70.22(h)(1) and (k), a physical security plan is required if the licensee possess either a formula quantity of strategic SNM, SNM of moderate strategic significance, or 10 kilograms or more of SNM of low strategic significance. Those terms are defined in 10 CFR 70.4, Definitions, as follows:
Formula quantity means strategic special nuclear material in any combination in a quantity of 5000 grams or more computed by the formula, grams = (grams contained U-235) + 2.5 (grams U-233 + grams plutonium). This class of material is sometimes referred to as a Category I quantity of material.
Special nuclear material of moderate strategic significance means:
(1) Less than a formula quantity of strategic special nuclear material but more than 1,000 grams of uranium-235 (contained in uranium enriched to 20 percent or more in the U-235 isotope) or more than 500 grams of uranium-233 or plutonium, or in a combined quantity of more than 1,000 grams when computed by the equation, grams = (grams contained U-235) + 2 (grams U-233 + grams plutonium); or (2) 10,000 grams or more of uranium-235 (contained in uranium enriched to 10 percent or more but less than 20 percent in the U-235 isotope).
Special nuclear material of low strategic significance means:
(1) Less than an amount of special nuclear material of moderate strategic significance as defined in paragraph (1) of the definition of strategic nuclear material of moderate strategic significance, but more than 15 grams of uranium-235 (contained in uranium enriched to 20 percent or more in U-235 isotope) or 15 grams of uranium-233 or 15 grams of plutonium or the combination of 15 grams when computed by the equation, grams = (grams contained U-235) + (grams plutonium) + (grams U-233); or (2) Less than 10,000 grams but more than 1,000 grams of uranium-235 (contained in uranium enriched to 10 percent or more but less than 20 percent in the U-235 isotope); or (3) 10,000 grams or more of uranium-235 (contained in uranium enriched above natural but less than 10 percent in the U-235 isotope).
If granted, this amendment would allow SHINE to receive and possess 15 grams of uranium-235 of varying enrichments. Regardless of the specific enrichment, however, the quantity of uranium-235 will fall below the thresholds in all three definitions. Therefore, the NRC staff determined that based on the quantity, form, and type of contained SNM that would be received and possessed by SHINE to be installed during the construction of the SHINE facility that a physical security plan is not required to support the issuance of the proposed amendment to the construction permit. In its application, ITEM 9 - FACILITIES AND EQUIPMENT, SHINE stated, in part, that the SNM would be received and securely stored and locked in an access-controlled area prior to installation away from construction activities. SHINE also stated, in part, that the secured storage area is controlled as a restricted area.
Based on its review of the above statement made by SHINE in its application and the descriptions of facilities and equipment provided in support of Item 9, the NRC staff finds that SHINE will keep radiation doses to workers and members of the public ALARA and ensure security of licensed material and meet the applicable regulatory requirements in 10 CFR Part 20, including 10 CFR 20.1101, 10 CFR 20.1406, 10 CFR 20.1801, and 10 CFR 20.1802.
Surveys and Leak Tests In its application, SHINE stated the following, consistent with the guidance regarding Item 10 in appendix B to NUREG-1556, Volume 17, Revision 1:
Surveys SHINE will survey the facility and maintain contamination levels in accordance with the survey frequencies and contamination levels published in Appendix I in NUREG-1556, Volume 17, Revision 1.
Leak Tests No sealed sources are within the scope of this request.
Based on its review of the above statements made by SHINE in its application, the NRC staff finds that SHINE will make the required 10 CFR 20.1501 surveys of potential radiological hazards to determine whether there is any contamination released from the neutron detectors.
The NRC staff finds that SHINE has provided information consistent with the guidance regarding Item 10 in appendix B to NUREG-1556, Volume 17, Revision 1 and meets the applicable regulatory requirements in 10 CFR Parts 20 and 70, including 10 CFR 20.1501, 10 CFR 20.2103, and 10 CFR 70.23(a)(4).
Item 11 - Waste Management In its application, SHINE stated that it does not expect to generate radiological waste during construction activities. As such, SHINE would not need to meet the requirements for waste disposal in accordance with the regulations in Subpart K, Waste Disposal, of 10 CFR Part 20.
Based on its review of the information provided by SHINE, the NRC staff finds that SHINE is not expected to generate radiological waste during construction activities based on the proposed receipt and possession of SNM contained in neutron detectors to be installed in the NFDS during the construction of the SHINE facility.
Findings Based on the above information, the NRC staff finds that the proposed amendment to the SHINE facility construction permit to authorize the receipt and possession of SNM contained in neutron detectors to be installed during the construction of the SHINE facility meets the applicable requirements of 10 CFR Parts 19, 20, and 70. The information in the application demonstrates that SHINE has taken the appropriate considerations to protect health and minimize danger to life or property. Facilities and equipment will minimize the possibility of contamination and keep exposures to workers and the public consistent with ALARA principles.
The SHINE facility design and procedures for construction will minimize, to the extent practicable, contamination of the facility and the environment. The RSOs training and experience is applicable to and generally consistent with the types and quantities of licensed material to be listed on the SHINE facility construction permit. Individuals whose assigned duties involve exposure to radiation or radioactive material will receive instruction commensurate with their duties and responsibilities. Therefore, the NRC staff concludes that the addition of condition 3.G and the revision to the Commissions finding 1.K to Construction Permit No.
CPMIF-001 for the SHINE facility to authorize the receipt and possession of SNM contained in neutron detectors to be installed during the construction of the SHINE facility is acceptable.
4.0 STATE CONSULTATION
In accordance with the Commissions regulations, the Wisconsin State official was notified on May 2, 2023, of the proposed issuance of the amendment (ML23124A047). The State official had no comments.
5.0 ENVIRONMENTAL CONSIDERATION
Pursuant to 10 CFR 51.21, Criteria for and identification of licensing and regulatory actions requiring environmental assessments, 10 CFR 51.32, Finding of no significant impact, and 10 CFR 51.35, Requirement to publish finding of no significant impact; limitation on Commission action, an environmental assessment and finding of no significant impact regarding the LAR was published in the Federal Register on May 2, 2023 (88 FR 27532).
Accordingly, based upon the environmental assessment, the Commission has determined that the issuance of the amendment will not have a significant effect on the quality of the human environment.
6.0 CONCLUSION
The Commission has concluded, based on the considerations discussed above, that (1) there is reasonable assurance that the health and safety of the public will not be endangered by construction in the proposed manner, (2) there is reasonable assurance that such activities will be conducted in compliance with the Commissions regulations, and (3) the issuance of the amendment will not be inimical to the common defense and security or to the health and safety of the public.
Principal Contributor: M. Balazik, NRR Date: May 5, 2023