SHINE Medical Technologies, LLC; SHINE Medical Isotope Production Facility, 67737-67740 [2021-25911]

Download as PDF Federal Register / Vol. 86, No. 226 / Monday, November 29, 2021 / Notices khammond on DSKJM1Z7X2PROD with NOTICES risk significance of the material being protected. Unirradiated reactor fuel brought onsite at nuclear power reactors typically constitutes a Category III quantity of SNM. Because of its low enrichment, unirradiated reactor fuel poses no significant risk to public health and safety and protecting it in accordance with § 73.67 would not be inimical to the common defense and security. The NRC has determined that it is appropriate to protect unirradiated reactor fuel and other non-fuel SNM brought onsite at an NRC-licensed commercial nuclear power reactor in accordance with § 73.67. Therefore, requiring SNC to implement the requirements of §§ 73.55 and 73.56 to protect unirradiated reactor fuel and other non-fuel SNM that is already being adequately protected in accordance with the requirements of § 73.67 is an unnecessary burden on SNC. Based on the above, the NRC finds that the exemption is otherwise in the public interest. D. Environmental Considerations As further discussed, the NRC has determined that granting this exemption from the requirements of §§ 73.55(a)(4) and 73.56(a)(3) meets the criteria for a categorical exclusion in 10 CFR 51.22(c)(25) because (i) there is no significant hazards consideration, (ii) there is no significant change in the types or significant increase in the amounts of any effluents that may be released offsite, (iii) there is no significant increase in individual or cumulative public or occupational radiation exposure, (iv) there is no significant construction impact, (v) there is no significant increase in the potential for or consequences from radiological accidents, and (vi) the exemption is from scheduling requirements. The granting of this exemption involves no significant hazards consideration (as defined by 10 CFR 50.92(c)) because: • The exemption does not alter the design, function, or operation of any plant equipment; therefore, granting the exemption would not involve a significant increase in the probability or consequences of an accident previously evaluated. • The exemption does not alter the design, function, or operation of any plant equipment or create any new failure mechanisms, malfunctions, or accident initiators. Therefore, granting the exemption would not create the possibility of a new or different kind of accident from any accident previously evaluated. VerDate Sep<11>2014 16:55 Nov 26, 2021 Jkt 256001 • The exemption does not adversely affect any structure, system, or component (SSC), SSC design function, or method of performing or controlling a design function. The exemption does not affect safety-related equipment or fission product barriers. No safety analysis or design basis acceptance limit or criterion is challenged or exceeded by the exemption. Therefore, granting the exemption would not involve a significant reduction in a margin of safety. The requested exemption does not alter the design, function, or operation of any plant equipment, and there are no changes to effluent types, plant radiological or non-radiological effluent release quantities, any effluent release path, or the functionality of any design or operational feature credited with controlling the release of effluents during plant operation or construction. Therefore, the proposed exemption does not involve a significant change in the types or significant increase in the amounts of any effluents that may be released offsite. There are no changes to plant radiation zones, nor any change to controls required under 10 CFR part 20 that preclude a significant increase in individual or cumulative public or occupational radiation exposure. Therefore, the proposed exemption does not involve a significant increase in individual or cumulative public or occupational radiation exposure. The requested exemption does not alter the materials or methods for constructing or testing of any SSCs, and there is no change to the design or construction of the facility as a result of this exemption. Therefore, the proposed exemption does not involve a significant construction impact. Finally, the NRC determined, per § 51.22(c)(25)(vi)(G), that the requirements from which the exemption is sought involve scheduling requirements because 10 CFR 73.55(a)(4) and 73.56(a)(3) govern when the requirements of 10 CFR 73.55 and 73.56 must be implemented. Accordingly, the exemption meets the eligibility criteria for categorical exclusion set forth in § 51.22(c)(25). Therefore, in accordance with § 51.22(b), no environmental impact statement or environmental assessment need be prepared in connection with granting the requested exemption. IV. Granting of Exemption For the reasons stated in this notice, the Commission is granting the following exemption for VEGP Units 3 and 4 because it has determined, pursuant to § 73.5, that the exemption is PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 67737 authorized by law, will not endanger life or property or the common defense and security, and is otherwise in the public interest: • Effective immediately, the Commission hereby grants SNC an exemption for VEGP Unit 3 from the schedule requirements of §§ 73.55(a)(4) and 73.56(a)(3) to allow SNC to implement the physical protection requirements in accordance with § 73.55, and the personnel access authorization requirements in accordance with § 73.56, after the Commission makes its finding under § 52.103(g) for Unit 3 and prior to the start of Unit 3’s initial fuel load into the reactor. The exemption for VEGP Unit 3 expires when SNC implements the requirements of 10 CFR 73.55 and 10 CFR 73.56 for VEGP Unit 3, which must occur before initial fuel load for VEGP Unit 3. • Effective immediately, the Commission hereby grants SNC an exemption for VEGP Unit 4 from the schedule requirements of §§ 73.55(a)(4) and 73.56(a)(3) to allow SNC to implement the physical protection requirements in accordance with § 73.55, and the personnel access authorization requirements in accordance with § 73.56, after the Commission makes its finding under § 52.103(g) for Unit 4 and prior to the start of Unit 4’s initial fuel load into the reactor. The exemption for VEGP Unit 4 expires when SNC implements the requirements of 10 CFR 73.55 and 10 CFR 73.56 for VEGP Unit 4, which must occur before initial fuel load for VEGP Unit 4. For the Nuclear Regulatory Commission. Dated: November 23, 2021. Gregory T. Bowman, Director, Vogtle Project Office, Office of Nuclear Reactor Regulation. [FR Doc. 2021–25952 Filed 11–26–21; 8:45 am] BILLING CODE 7590–01–P NUCLEAR REGULATORY COMMISSION [Docket No. 50–608; NRC–2021–0140] SHINE Medical Technologies, LLC; SHINE Medical Isotope Production Facility Nuclear Regulatory Commission. ACTION: Environmental assessment and finding of no significant impact; issuance. AGENCY: The U.S. Nuclear Regulatory Commission (NRC) is issuing an environmental assessment (EA) and SUMMARY: E:\FR\FM\29NON1.SGM 29NON1 khammond on DSKJM1Z7X2PROD with NOTICES 67738 Federal Register / Vol. 86, No. 226 / Monday, November 29, 2021 / Notices finding of no significant impact (FONSI) regarding the NRC’s consideration of issuance of a proposed amendment to the SHINE Medical Technologies, LLC (SHINE, the licensee) Construction Permit No. CPMIF–001, issued on February 29, 2016. The permit authorizes the construction of the SHINE Medical Isotope Production Facility (SHINE facility) in Rock County, Wisconsin. If approved, the proposed amendment would authorize the receipt and possession of certain radioactive materials necessary for the continued construction of the SHINE facility. DATES: The EA and FONSI referenced in this document are available on November 29, 2021. ADDRESSES: Please refer to Docket ID NRC–2021–0140 when contacting the NRC about the availability of information regarding this document. You may obtain publicly available information related to this document using any of the following methods: • Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC–2021–0140. Address questions about Docket IDs in Regulations.gov to Stacy Schumann; telephone: 301–415–0624; email: Stacy.Schumann@nrc.gov. For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document. • NRC’s Agencywide Documents Access and Management System (ADAMS): You may obtain publicly available documents online in the ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/ adams.html. To begin the search, select ‘‘Begin Web-based ADAMS Search.’’ For problems with ADAMS, please contact the NRC’s Public Document Room (PDR) reference staff at 1–800–397–4209, 301– 415–4737, or by email to PDR.Resource@nrc.gov. For the convenience of the reader, instructions about obtaining materials referenced in this document are provided in the ‘‘Availability of Documents’’ section. • NRC’s PDR: You may examine and purchase copies of public documents, by appointment, at the NRC’s PDR, Room P1 B35, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. To make an appointment to visit the PDR, please send an email to PDR.Resource@nrc.gov or call 1–800–397–4209 or 301–415– 4737, between 8:00 a.m. and 4:00 p.m. (ET), Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: Michael Balazik, Office of Nuclear Reactor Regulation, U.S. Nuclear VerDate Sep<11>2014 16:55 Nov 26, 2021 Jkt 256001 Regulatory Commission, Washington, DC 20555–0001, telephone: 301–415– 2856; email: Michael.Balazik@nrc.gov. SUPPLEMENTARY INFORMATION: I. Introduction The NRC is considering issuance of an amendment to Construction Permit No. CPMIF–001, issued to SHINE for the construction of the SHINE facility in Rock County, Wisconsin. SHINE requested the amendment by letter dated April 29, 2021, as supplemented by letter dated August 20, 2021, in accordance with Section 50.90 of title 10 of the Code of Federal Regulations (10 CFR), ‘‘Application for amendment of license, construction permit, or early site permit,’’ and 10 CFR 50.34, ‘‘Contents of applications; technical information.’’ The amendment would authorize the receipt and possession of certain radioactive materials necessary for the continued construction of the SHINE facility. In accordance with 10 CFR 51.21, ‘‘Criteria for and identification of licensing and regulatory actions requiring environmental assessments,’’ the NRC prepared an EA, pursuant to 10 CFR 51.30, ‘‘Environmental assessment,’’ that analyzes the environmental impacts of the proposed amendment and alternatives as appropriate. Based on the results of this EA, which is set forth in Section II in this document, and in accordance with 10 CFR 51.31(a), the NRC has determined not to prepare an environmental impact statement for the proposed amendment and is issuing a FONSI, which is set forth in Section III in this document. II. Environmental Assessment Description of the Proposed Action The proposed action would amend Construction Permit No. CPMIF–001 to authorize SHINE to receive and possess the radioactive materials of natural uranium, depleted uranium, and americium-241/beryllium (AmBe), which are necessary for the continued construction of the SHINE facility in Rock County, Wisconsin. The proposed action is requested in the licensee’s application dated April 29, 2021, as supplemented by letter dated August 20, 2021. Need for the Proposed Action The radioactive materials described in the licensee’s application are byproduct and source materials required for the continued construction of the SHINE facility and would be installed within the facility’s tritium purification system and subcritical assembly systems. The PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 licensee’s request to receive and possess these byproduct and source materials is in accordance with applicable provisions in 10 CFR part 30, ‘‘Rules of General Applicability to Domestic Licensing of Byproduct Material,’’ and 10 CFR part 40, ‘‘Domestic Licensing of Source Material,’’ respectively. Specifically, SHINE requested to receive and possess the source material of natural uranium in the form of neutron multipliers; the source material of depleted uranium in the form of tritium storage beds; and the byproduct material of AmBe sealed neutron sources. The natural uranium would be contained within neutron multipliers, as described in Subsection 4a2.2.6 of the SHINE Final Safety Analysis Report (FSAR), for installation within the subcritical assembly systems. The depleted uranium would be contained within tritium storage beds, as described in Subsection 9a2.7.1 of the SHINE FSAR, for installation within the tritium purification system. The AmBe sealed neutron sources would be used as subcritical multiplication sources, as described in Subsection 4a2.2.4 of the SHINE FSAR, for installation within the subcritical assembly systems. The NRC regulations in 10 CFR part 30 and 10 CFR part 40 contain requirements for the receipt, possession, use, and transfer of byproduct material and source material, respectively. Environmental Impacts of the Proposed Action The NRC has completed its environmental review of the proposed action and concludes that there are no significant environmental impacts associated with the proposed action. As an initial matter, the proposed action would amend the SHINE construction permit to authorize the receipt and possession of byproduct and source materials necessary for continued construction of the SHINE facility in accordance with applicable provisions in 10 CFR parts 30 and 40, which ensure the safety of such receipt and possession. Thus, before the NRC could approve the proposed action, it would have to conclude that the applicable provision in 10 CFR parts 30 and 40 are satisfied. Additionally, the NRC previously evaluated the environmental impacts associated with constructing, operating, and decommissioning the SHINE facility in NUREG–2183, ‘‘Environmental Impact Statement for the Construction Permit for the SHINE Medical Radioisotope Production Facility,’’ dated October 2015. The licensee is also required to comply with occupational dose limits (10 CFR part E:\FR\FM\29NON1.SGM 29NON1 khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 86, No. 226 / Monday, November 29, 2021 / Notices 20, subpart C) and radiation dose limits for individual members of the public (10 CFR part 20, subpart D) at all times. As provided in the application, the proposed amendment authorizing the receipt and possession of the requested byproduct and source materials would not change the types or amounts of radioactive materials in effluents, wastes, and products of the SHINE facility, nor would it increase the probability of accidents. The requested materials would be received and securely stored in an access-controlled area prior to installation into the tritium purification system and the subcritical assembly systems. SHINE would inspect, inventory, and place the requested materials into secure storage in accordance with the requirements of 10 CFR 20.1902, ‘‘Posting requirements.’’ Shielding would be used as appropriate to minimize radiation exposure of personnel while the requested materials are in storage in accordance with 10 CFR 20.1201, ‘‘Occupational dose limits for adults.’’ The requested materials would be in the form of sealed sources or solids contained within enclosed components that do not present contamination or accidental release hazards. Finally, the application provided that the receipt and possession of the requested materials would not result in the generation of radiological waste. Additionally, the application provided that there would be no new or substantially different radiological hazards resulting from the receipt and possession of the requested byproduct and source materials as compared to the construction-related radiological hazards discussed in Section 4.8.1.1, ‘‘Radiological,’’ of NUREG–2183. In NUREG–2183, the NRC staff determined that SHINE has adequate controls in place to ensure that the dose to workers and the public from radioactive materials is within the dose limits of 10 CFR part 20, including a radiation safety program. The transportation of the requested byproduct and source materials would be required to adhere to the applicable regulatory packaging and transportation requirements in NRC regulations (10 CFR parts 20, 40, and 71), the State of Wisconsin Administrative Code Chapter 326, ‘‘Transportation,’’ and Department of Transportation requirements (49 CFR parts 172 and 173). Based on the above, the NRC staff concludes that the proposed action would not have significant radiological human health impacts. Nonradiological impacts to human health of the construction, operation, and decommissioning of the SHINE VerDate Sep<11>2014 16:55 Nov 26, 2021 Jkt 256001 facility were previously assessed in Section 4.8.1.2 of NUREG–2183. The application provided that the proposed amendment would not result in any new or substantially different nonradiological hazards resulting from the receipt and possession of the requested byproduct and source materials; therefore, the NRC staff concludes that nonradiological impacts during construction would remain small. The proposed action would result in no additional direct impacts on land use or water resources, including terrestrial and aquatic biota, because the proposed action involves no new construction or modification of SHINE facility operational systems previously assessed in NUREG–2183. For this same reason, there would be no changes to the types or quantity of nonradiological effluents previously assessed in NUREG–2183 and, therefore, no changes to the facility’s Wisconsin Pollutant Discharge Elimination System permit are needed. Similarly, there would be no changes in ambient air quality, no noticeable effect on socioeconomic conditions in the region, no environmental justice impacts, and no impacts to historic and cultural resources. Therefore, the NRC staff concludes that there would be no significant nonradiological impacts associated with the proposed action. Environmental Impacts of the Alternatives to the Proposed Action As an alternative to the proposed action, the NRC staff considered denial of the proposed action (i.e., the ‘‘noaction’’ alternative). Denial of the license amendment request would result in the licensee being unable to complete construction and begin operation of the SHINE facility. However, because the direct impacts on land use and water resources from construction have largely already occurred and because the remaining construction, operating, and decommissioning impacts would generally be small as evaluated in NUREG–2183, the environmental impacts of the proposed action and the alternative action are similar. Alternative Use of Resources There are no unresolved conflicts concerning alternative uses of available resources under the proposed action. Agencies and Persons Consulted No additional agencies or persons were consulted regarding the environmental impact of the proposed action. On November 15, 2021, the NRC notified the Wisconsin Department of Health Services of the EA and FONSI. The state provided no comments. The PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 67739 NRC staff determined that the proposed action would have no effect on Federally listed threatened or endangered species or critical habitat that could occur on or near the SHINE facility site and would have no effect on any historic properties. Therefore, consultation was not required under Section 7 of the Endangered Species Act of 1973, as amended, or under Section 106 of the National Historic Preservation Act of 1966, as amended. III. Finding of No Significant Impact The proposed action is the issuance of an amendment to SHINE Construction Permit No. CPMIF–001 to authorize SHINE to receive and possess certain source and byproduct materials necessary for the continued construction of the SHINE facility in Rock County, Wisconsin. Consistent with 10 CFR 51.21, the NRC prepared an EA to determine the impacts of the proposed action. On the basis of the EA included in Section II in this document and incorporated by reference in this finding, the NRC concludes that the proposed action would not have a significant adverse effect on the probability of an accident occurring and would not have any significant radiological or nonradiological impacts. Therefore, the NRC concludes that the proposed action will not have a significant effect on the quality of the human environment. Accordingly, the NRC has determined not to prepare an environmental impact statement for the proposed action. Other than the application dated April 29, 2021, as supplemented by letter dated August 20, 2021, the related environmental document is NUREG– 2183. NUREG–2183 provides the latest environmental review of the construction, operation, and decommissioning of the SHINE facility and description of the environmental conditions at the SHINE facility. This EA and FONSI and other related documents are accessible online in the ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/ adams.html. Persons who do not have access to ADAMS or who encounter problems in accessing the documents located in ADAMS should contact the NRC’s PDR reference staff at 1–800– 397–4209, 301–415–4737, or by email to PDR.Resource@nrc.gov. IV. Availability of Documents The documents identified in the following table are available to interested persons through ADAMS, as indicated. E:\FR\FM\29NON1.SGM 29NON1 67740 Federal Register / Vol. 86, No. 226 / Monday, November 29, 2021 / Notices Document ADAMS accession No. NUREG–2183, Environmental Impact Statement for the Construction Permit for the SHINE Medical Radioisotope Production Facility, dated October, 2015. Construction Permit No. CPMIF–001 for the SHINE Medical Isotope Production Facility, dated February 29, 2016 SHINE Medical Technologies, LLC’s Revisions to Final Safety Analysis Report, Chapter 4, Irradiation Unit and Radioisotope Production Facility Description, Rev. 1, dated March 23, 2021. SHINE Medical Technologies, LLC’s Revisions to Final Safety Analysis Report, Chapter 9, Auxiliary Systems, Rev. 0, dated March 23, 2021. SHINE Medical Technologies, LLC, Request to Amend Construction Permit No. CPMIF–001, dated April 29, 2021 SHINE Medical Technologies, LLC, Request to Amend Construction Permit No. CPMIF–001 Response to Request for Additional Information, dated August 20, 2021. Dated: November 23, 2021. 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. [FR Doc. 2021–25911 Filed 11–26–21; 8:45 am] BILLING CODE 7590–01–P NUCLEAR REGULATORY COMMISSION [NRC–2021–0001] Sunshine Act Meetings Weeks of November 29, December 6, 13, 20, 27, 2021, January 3, 2022. PLACE: Commissioners’ Conference Room, 11555 Rockville Pike, Rockville, Maryland. STATUS: Public. MATTERS TO BE CONSIDERED: TIME AND DATE: Week of November 29, 2021 There are no meetings scheduled for the week of November 29, 2021. Week of December 6, 2021—Tentative khammond on DSKJM1Z7X2PROD with NOTICES Tuesday, December 7, 2021 10:00 a.m. Briefing on Equal Employment Opportunity, Affirmative Employment, and Small Business (Public Meeting) (Contact: Larniece McKoy Moore: 301–415– 1942) Additional Information: The public is invited to attend the Commission’s meeting live by webcast at the Web address—https://video.nrc.gov/. For those who would like to attend in person, note that all visitors are required to complete the NRC Self-Health Assessment and Certification of Vaccination forms. Visitors who certify that they are not fully vaccinated or decline to complete the certification must have proof of a negative Food and Drug Administration-approved polymerase chain reaction (PCR) or Antigen (including rapid tests) COVID– VerDate Sep<11>2014 16:55 Nov 26, 2021 Jkt 256001 19 test specimen collection from no later than the previous 3 days prior to entry to an NRC facility. The forms and additional information can be found here https://www.nrc.gov/about-nrc/ covid-19/guidance-for-visitors-to-nrcfacilities.pdf. Thursday, December 9, 2021 9:00 a.m. Briefing on 10 CFR part 53 Licensing and Regulations of Advanced Nuclear Reactors (Public Meeting) (Contact: Donna Williams: 301–415–1322) Additional Information: The public is invited to attend the Commission’s meeting live by webcast at the Web address—https://video.nrc.gov/. For those who would like to attend in person, note that all visitors are required to complete the NRC Self-Health Assessment and Certification of Vaccination forms. Visitors who certify that they are not fully vaccinated or decline to complete the certification must have proof of a negative Food and Drug Administration-approved PCR or Antigen (including rapid tests) COVID– 19 test specimen collection from no later than the previous 3 days prior to entry to an NRC facility. The forms and additional information can be found here https://www.nrc.gov/about-nrc/ covid-19/guidance-for-visitors-to-nrcfacilities.pdf. Week of December 13, 2021—Tentative There are no meetings scheduled for the week of December 13, 2021. Week of December 20, 2021—Tentative There are no meetings scheduled for the week of December 20, 2021. ML15288A046. ML16041A473. ML21095A226. ML21095A225. ML21119A165 (Package). ML21242A028 (Package). Wesley.Held@nrc.gov. The schedule for Commission meetings is subject to change on short notice. The NRC Commission Meeting Schedule can be found on the internet at: https://www.nrc.gov/public-involve/ public-meetings/schedule.html. The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings or need this meeting notice or the transcript or other information from the public meetings in another format (e.g., braille, large print), please notify Anne Silk, NRC Disability Program Specialist, at 301–287–0745, by videophone at 240–428–3217, or by email at Anne.Silk@nrc.gov. Determinations on requests for reasonable accommodation will be made on a case-by-case basis. Members of the public may request to receive this information electronically. If you would like to be added to the distribution, please contact the Nuclear Regulatory Commission, Office of the Secretary, Washington, DC 20555, at 301–415–1969, or by email at Tyesha.Bush@nrc.gov or Betty.Thweatt@ nrc.gov. The NRC is holding the meetings under the authority of the Government in the Sunshine Act, 5 U.S.C. 552b. Dated: November 24, 2021. For the Nuclear Regulatory Commission. Wesley W. Held, Policy Coordinator, Office of the Secretary. [FR Doc. 2021–26015 Filed 11–24–21; 11:15 am] BILLING CODE 7590–01–P Week of December 27, 2021—Tentative NUCLEAR REGULATORY COMMISSION There are no meetings scheduled for the week of December 27, 2021. [Docket Nos. 52–025 and 52–026; NRC– 2008–0252] Week of January 3, 2022—Tentative There are no meetings scheduled for the week of January 3, 2022. Southern Nuclear Operating Company, Inc.; Vogtle Electric Generating Plant Units 3 and 4 CONTACT PERSON FOR MORE INFORMATION: AGENCY: For more information or to verify the status of meetings, contact Wesley Held at 301–287–3591 or via email at PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 Nuclear Regulatory Commission. ACTION: Exemption; issuance. E:\FR\FM\29NON1.SGM 29NON1

Agencies

[Federal Register Volume 86, Number 226 (Monday, November 29, 2021)]
[Notices]
[Pages 67737-67740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25911]


-----------------------------------------------------------------------

NUCLEAR REGULATORY COMMISSION

[Docket No. 50-608; NRC-2021-0140]


SHINE Medical Technologies, LLC; SHINE Medical Isotope Production 
Facility

AGENCY: Nuclear Regulatory Commission.

ACTION: Environmental assessment and finding of no significant impact; 
issuance.

-----------------------------------------------------------------------

SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing an 
environmental assessment (EA) and

[[Page 67738]]

finding of no significant impact (FONSI) regarding the NRC's 
consideration of issuance of a proposed amendment to the SHINE Medical 
Technologies, LLC (SHINE, the licensee) Construction Permit No. CPMIF-
001, issued on February 29, 2016. The permit authorizes the 
construction of the SHINE Medical Isotope Production Facility (SHINE 
facility) in Rock County, Wisconsin. If approved, the proposed 
amendment would authorize the receipt and possession of certain 
radioactive materials necessary for the continued construction of the 
SHINE facility.

DATES: The EA and FONSI referenced in this document are available on 
November 29, 2021.

ADDRESSES: Please refer to Docket ID NRC-2021-0140 when contacting the 
NRC about the availability of information regarding this document. You 
may obtain publicly available information related to this document 
using any of the following methods:
     Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2021-0140. Address 
questions about Docket IDs in Regulations.gov to Stacy Schumann; 
telephone: 301-415-0624; email: [email protected]. For technical 
questions, contact the individual listed in the FOR FURTHER INFORMATION 
CONTACT section of this document.
     NRC's Agencywide Documents Access and Management System 
(ADAMS): You may obtain publicly available documents online in the 
ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``Begin Web-based ADAMS 
Search.'' For problems with ADAMS, please contact the NRC's Public 
Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or 
by email to [email protected]c.gov. For the convenience of the reader, 
instructions about obtaining materials referenced in this document are 
provided in the ``Availability of Documents'' section.
     NRC's PDR: You may examine and purchase copies of public 
documents, by appointment, at the NRC's PDR, Room P1 B35, One White 
Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. To make 
an appointment to visit the PDR, please send an email to 
[email protected] or call 1-800-397-4209 or 301-415-4737, between 
8:00 a.m. and 4:00 p.m. (ET), Monday through Friday, except Federal 
holidays.

FOR FURTHER INFORMATION CONTACT: Michael Balazik, Office of Nuclear 
Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 
20555-0001, telephone: 301-415-2856; email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Introduction

    The NRC is considering issuance of an amendment to Construction 
Permit No. CPMIF-001, issued to SHINE for the construction of the SHINE 
facility in Rock County, Wisconsin. SHINE requested the amendment by 
letter dated April 29, 2021, as supplemented by letter dated August 20, 
2021, in accordance with Section 50.90 of title 10 of the Code of 
Federal Regulations (10 CFR), ``Application for amendment of license, 
construction permit, or early site permit,'' and 10 CFR 50.34, 
``Contents of applications; technical information.'' The amendment 
would authorize the receipt and possession of certain radioactive 
materials necessary for the continued construction of the SHINE 
facility.
    In accordance with 10 CFR 51.21, ``Criteria for and identification 
of licensing and regulatory actions requiring environmental 
assessments,'' the NRC prepared an EA, pursuant to 10 CFR 51.30, 
``Environmental assessment,'' that analyzes the environmental impacts 
of the proposed amendment and alternatives as appropriate. Based on the 
results of this EA, which is set forth in Section II in this document, 
and in accordance with 10 CFR 51.31(a), the NRC has determined not to 
prepare an environmental impact statement for the proposed amendment 
and is issuing a FONSI, which is set forth in Section III in this 
document.

II. Environmental Assessment

Description of the Proposed Action

    The proposed action would amend Construction Permit No. CPMIF-001 
to authorize SHINE to receive and possess the radioactive materials of 
natural uranium, depleted uranium, and americium-241/beryllium (AmBe), 
which are necessary for the continued construction of the SHINE 
facility in Rock County, Wisconsin. The proposed action is requested in 
the licensee's application dated April 29, 2021, as supplemented by 
letter dated August 20, 2021.

Need for the Proposed Action

    The radioactive materials described in the licensee's application 
are byproduct and source materials required for the continued 
construction of the SHINE facility and would be installed within the 
facility's tritium purification system and subcritical assembly 
systems. The licensee's request to receive and possess these byproduct 
and source materials is in accordance with applicable provisions in 10 
CFR part 30, ``Rules of General Applicability to Domestic Licensing of 
Byproduct Material,'' and 10 CFR part 40, ``Domestic Licensing of 
Source Material,'' respectively. Specifically, SHINE requested to 
receive and possess the source material of natural uranium in the form 
of neutron multipliers; the source material of depleted uranium in the 
form of tritium storage beds; and the byproduct material of AmBe sealed 
neutron sources. The natural uranium would be contained within neutron 
multipliers, as described in Subsection 4a2.2.6 of the SHINE Final 
Safety Analysis Report (FSAR), for installation within the subcritical 
assembly systems. The depleted uranium would be contained within 
tritium storage beds, as described in Subsection 9a2.7.1 of the SHINE 
FSAR, for installation within the tritium purification system. The AmBe 
sealed neutron sources would be used as subcritical multiplication 
sources, as described in Subsection 4a2.2.4 of the SHINE FSAR, for 
installation within the subcritical assembly systems.
    The NRC regulations in 10 CFR part 30 and 10 CFR part 40 contain 
requirements for the receipt, possession, use, and transfer of 
byproduct material and source material, respectively.

Environmental Impacts of the Proposed Action

    The NRC has completed its environmental review of the proposed 
action and concludes that there are no significant environmental 
impacts associated with the proposed action.
    As an initial matter, the proposed action would amend the SHINE 
construction permit to authorize the receipt and possession of 
byproduct and source materials necessary for continued construction of 
the SHINE facility in accordance with applicable provisions in 10 CFR 
parts 30 and 40, which ensure the safety of such receipt and 
possession. Thus, before the NRC could approve the proposed action, it 
would have to conclude that the applicable provision in 10 CFR parts 30 
and 40 are satisfied.
    Additionally, the NRC previously evaluated the environmental 
impacts associated with constructing, operating, and decommissioning 
the SHINE facility in NUREG-2183, ``Environmental Impact Statement for 
the Construction Permit for the SHINE Medical Radioisotope Production 
Facility,'' dated October 2015. The licensee is also required to comply 
with occupational dose limits (10 CFR part

[[Page 67739]]

20, subpart C) and radiation dose limits for individual members of the 
public (10 CFR part 20, subpart D) at all times.
    As provided in the application, the proposed amendment authorizing 
the receipt and possession of the requested byproduct and source 
materials would not change the types or amounts of radioactive 
materials in effluents, wastes, and products of the SHINE facility, nor 
would it increase the probability of accidents. The requested materials 
would be received and securely stored in an access-controlled area 
prior to installation into the tritium purification system and the 
subcritical assembly systems. SHINE would inspect, inventory, and place 
the requested materials into secure storage in accordance with the 
requirements of 10 CFR 20.1902, ``Posting requirements.'' Shielding 
would be used as appropriate to minimize radiation exposure of 
personnel while the requested materials are in storage in accordance 
with 10 CFR 20.1201, ``Occupational dose limits for adults.'' The 
requested materials would be in the form of sealed sources or solids 
contained within enclosed components that do not present contamination 
or accidental release hazards. Finally, the application provided that 
the receipt and possession of the requested materials would not result 
in the generation of radiological waste.
    Additionally, the application provided that there would be no new 
or substantially different radiological hazards resulting from the 
receipt and possession of the requested byproduct and source materials 
as compared to the construction-related radiological hazards discussed 
in Section 4.8.1.1, ``Radiological,'' of NUREG-2183. In NUREG-2183, the 
NRC staff determined that SHINE has adequate controls in place to 
ensure that the dose to workers and the public from radioactive 
materials is within the dose limits of 10 CFR part 20, including a 
radiation safety program.
    The transportation of the requested byproduct and source materials 
would be required to adhere to the applicable regulatory packaging and 
transportation requirements in NRC regulations (10 CFR parts 20, 40, 
and 71), the State of Wisconsin Administrative Code Chapter 326, 
``Transportation,'' and Department of Transportation requirements (49 
CFR parts 172 and 173).
    Based on the above, the NRC staff concludes that the proposed 
action would not have significant radiological human health impacts.
    Nonradiological impacts to human health of the construction, 
operation, and decommissioning of the SHINE facility were previously 
assessed in Section 4.8.1.2 of NUREG-2183. The application provided 
that the proposed amendment would not result in any new or 
substantially different nonradiological hazards resulting from the 
receipt and possession of the requested byproduct and source materials; 
therefore, the NRC staff concludes that nonradiological impacts during 
construction would remain small.
    The proposed action would result in no additional direct impacts on 
land use or water resources, including terrestrial and aquatic biota, 
because the proposed action involves no new construction or 
modification of SHINE facility operational systems previously assessed 
in NUREG-2183. For this same reason, there would be no changes to the 
types or quantity of nonradiological effluents previously assessed in 
NUREG-2183 and, therefore, no changes to the facility's Wisconsin 
Pollutant Discharge Elimination System permit are needed. Similarly, 
there would be no changes in ambient air quality, no noticeable effect 
on socioeconomic conditions in the region, no environmental justice 
impacts, and no impacts to historic and cultural resources. Therefore, 
the NRC staff concludes that there would be no significant 
nonradiological impacts associated with the proposed action.

Environmental Impacts of the Alternatives to the Proposed Action

    As an alternative to the proposed action, the NRC staff considered 
denial of the proposed action (i.e., the ``no-action'' alternative). 
Denial of the license amendment request would result in the licensee 
being unable to complete construction and begin operation of the SHINE 
facility. However, because the direct impacts on land use and water 
resources from construction have largely already occurred and because 
the remaining construction, operating, and decommissioning impacts 
would generally be small as evaluated in NUREG-2183, the environmental 
impacts of the proposed action and the alternative action are similar.

Alternative Use of Resources

    There are no unresolved conflicts concerning alternative uses of 
available resources under the proposed action.

Agencies and Persons Consulted

    No additional agencies or persons were consulted regarding the 
environmental impact of the proposed action. On November 15, 2021, the 
NRC notified the Wisconsin Department of Health Services of the EA and 
FONSI. The state provided no comments. The NRC staff determined that 
the proposed action would have no effect on Federally listed threatened 
or endangered species or critical habitat that could occur on or near 
the SHINE facility site and would have no effect on any historic 
properties. Therefore, consultation was not required under Section 7 of 
the Endangered Species Act of 1973, as amended, or under Section 106 of 
the National Historic Preservation Act of 1966, as amended.

III. Finding of No Significant Impact

    The proposed action is the issuance of an amendment to SHINE 
Construction Permit No. CPMIF-001 to authorize SHINE to receive and 
possess certain source and byproduct materials necessary for the 
continued construction of the SHINE facility in Rock County, Wisconsin.
    Consistent with 10 CFR 51.21, the NRC prepared an EA to determine 
the impacts of the proposed action. On the basis of the EA included in 
Section II in this document and incorporated by reference in this 
finding, the NRC concludes that the proposed action would not have a 
significant adverse effect on the probability of an accident occurring 
and would not have any significant radiological or nonradiological 
impacts. Therefore, the NRC concludes that the proposed action will not 
have a significant effect on the quality of the human environment. 
Accordingly, the NRC has determined not to prepare an environmental 
impact statement for the proposed action.
    Other than the application dated April 29, 2021, as supplemented by 
letter dated August 20, 2021, the related environmental document is 
NUREG-2183. NUREG-2183 provides the latest environmental review of the 
construction, operation, and decommissioning of the SHINE facility and 
description of the environmental conditions at the SHINE facility.
    This EA and FONSI and other related documents are accessible online 
in the ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. Persons who do not have access to ADAMS or who 
encounter problems in accessing the documents located in ADAMS should 
contact the NRC's PDR reference staff at 1-800-397-4209, 301-415-4737, 
or by email to [email protected].

IV. Availability of Documents

    The documents identified in the following table are available to 
interested persons through ADAMS, as indicated.

[[Page 67740]]



------------------------------------------------------------------------
                    Document                        ADAMS accession No.
------------------------------------------------------------------------
NUREG-2183, Environmental Impact Statement for    ML15288A046.
 the Construction Permit for the SHINE Medical
 Radioisotope Production Facility, dated
 October, 2015.
Construction Permit No. CPMIF-001 for the SHINE   ML16041A473.
 Medical Isotope Production Facility, dated
 February 29, 2016.
SHINE Medical Technologies, LLC's Revisions to    ML21095A226.
 Final Safety Analysis Report, Chapter 4,
 Irradiation Unit and Radioisotope Production
 Facility Description, Rev. 1, dated March 23,
 2021.
SHINE Medical Technologies, LLC's Revisions to    ML21095A225.
 Final Safety Analysis Report, Chapter 9,
 Auxiliary Systems, Rev. 0, dated March 23, 2021.
SHINE Medical Technologies, LLC, Request to       ML21119A165 (Package).
 Amend Construction Permit No. CPMIF-001, dated
 April 29, 2021.
SHINE Medical Technologies, LLC, Request to       ML21242A028 (Package).
 Amend Construction Permit No. CPMIF-001
 Response to Request for Additional Information,
 dated August 20, 2021.
------------------------------------------------------------------------


    Dated: November 23, 2021.

    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.
[FR Doc. 2021-25911 Filed 11-26-21; 8:45 am]
BILLING CODE 7590-01-P