ML22292A319

Shine Medical Technologies, LLC Issuance of Order and Amendment No. 3 to Construction Permit No. CPMIF-001

ML22292A319
Person / Time
Site:	SHINE Medical Technologies
Issue date:	11/30/2022
From:	Holly Cruz NRC/NRR/DANU/UNPL
To:	Piefer G SHINE Medical Technologies
Cruz H
References
EPID L-2022-LLA-0063
Download: ML22292A319 (23)

Text

November 30, 2022 Dr. Gregory Piefer Chief Executive Officer SHINE Technologies, LLC 3400 Innovation Court Janesville, WI 53546

SUBJECT:

SHINE MEDICAL TECHNOLOGIES, LLC - ISSUANCE OF ORDER AND AMENDMENT NO. 3 TO CONSTRUCTION PERMIT NO. CPMIF-001 FOR THE SHINE MEDICAL ISOTOPE PRODUCTION FACILITY TO CHANGE THE PERMIT HOLDERS NAME AND TO EXTEND THE LATEST DATE FOR COMPLETION OF CONSTRUCTION (EPID NO. L-2022-LLA-0063)

Dear Dr. Piefer:

The U.S. Nuclear Regulatory Commission (NRC) has issued the enclosed order to SHINE Medical Technologies, LLC (SHINE) in response to the SHINE request dated April 1, 2022 (Agencywide Documents Access and Management System Accession No. ML22091A093). The order amends Construction Permit No. CPMIF-001 for the SHINE Medical Isotope Production Facility (SHINE facility) by extending the latest date for completion of the construction of the SHINE facility from December 31, 2022, to December 31, 2025, and by administratively changing the name of the construction permit holder from SHINE Medical Technologies, LLC to SHINE Technologies, LLC.

Amendment No. 3 to Construction Permit No. CPMIF-001 and the related safety evaluation are also enclosed. The environmental assessment and finding of no significant impact for the extension of the latest date for completion of construction was published in the Federal Register on November 10, 2022 (87 FR 67965).

The enclosed order has been forwarded to the Office of the Federal Register for publication.

G. Piefer 2

If you have any questions, please contact me at (301) 415-1053 or by email to Holly.Cruz@nrc.gov.

Production and Utilization Facilities Office of Nuclear Reactor Regulation Docket No. 50-608 Construction Permit No. CPMIF-001

Enclosures:

1. Order

2. Amendment No. 3 to Construction Permit No. CPMIF-001

3. Safety Evaluation cc w/enclosures: See next page Sincerely, Holly Cruz, Senior Project Manager Non-Power Production and Utilization Facility Licensing Branch Division of Advanced Reactors and Non-Power

SHINE Medical Technologies, LLC Docket No. 50-608 cc: Jeff Bartelme Director of Licensing SHINE Technologies, LLC 3400 Innovation Court Janesville, WI 53546 Nathan Schleifer General Counsel SHINE Technologies, LLC 3400 Innovation Court Janesville, WI 53546 Christopher Landers Director, Office of Conversion National Nuclear Security Administration, NA-23 U.S. Department of Energy 1000 Independence Avenue, SW Washington, DC 20585 Mark Paulson, Supervisor Radiation Protection Section Wisconsin Department of Health Services P.O. Box 2659 Madison, WI 53701 Test, Research and Training Reactor Newsletter Attention: Amber Johnson Dept. of Materials Science and Engineering University of Maryland 4418 Stadium Drive College Park, MD 20742 Mark Freitag City Manager P.O. Box 5005 Janesville, WI 53547 Bill McCoy 1326 Putnam Avenue Janesville, WI 53546 Alfred Lembrich 541 Miller Avenue Janesville, WI 53548

ML22292A319 NRR-058 OFFICE NRR/DANU/UNPL/PM NRR/DANU/UNPL/LA OGC/NLO NRR/DANU/UNPL/BC NAME HCruz NParker JWachutka JBorromeo DATE 10/19/2022 10/21/2022 11/18/2022 11/28/2022 OFFICE NRR/DANU/DD NRR/DANU/UNPL/PM NAME CCarusone HCruz DATE 22/28/2022 11/30/20222

UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION In the Matter of

)

)

SHINE Medical Technologies, LLC

) Docket No. 50-608

) Construction Permit No. CPMIF-001 (SHINE Medical Isotope Production Facility)

)

ORDER I.

SHINE Medical Technologies, LLC (SHINE, licensee, permit holder) is the holder of Construction Permit (CP) No. CPMIF-001, which the U.S. Nuclear Regulatory Commission (NRC, the Commission) issued on February 29, 2016 (Agencywide Documents Access and Management System (ADAMS) Package Accession No. ML16041A473), for the construction of the SHINE Medical Isotope Production Facility (SHINE facility) in Rock County, Wisconsin. CP No. CPMIF-001 includes December 31, 2022 as the latest date for completion of the construction of the SHINE facility and expires on the latest date of completion. The SHINE facility is currently under construction.

By letter dated April 1, 2022 (ML22091A093), SHINE submitted to the NRC a license amendment request in accordance with section 50.90, Application for amendment of license, construction permit, or early site permit, of title 10 of the Code of Federal Regulations (10 CFR) and 10 CFR 50.55(b). The license amendment request seeks to extend the latest date for completion of the construction of the SHINE facility from December 31, 2022, to December 31, 2025, and to change the name of the CP holder from SHINE Medical Technologies, LLC to SHINE Technologies, LLC. SHINE stated that the proposed name change is administrative because it does not involve any transfer of control of the CP or a change to ownership, organization, rights, or liabilities of SHINE.

II.

Upon review of the license amendment request, the NRC staff determined that SHINE had shown good cause for extending the latest date for completion of the construction of the SHINE facility from December 31, 2022, to December 31, 2025 and that the name change of the CP holder from SHINE Medical Technologies, LLC to SHINE Technologies, LLC is administrative in nature. The staff also determined that the license amendment request involves no significant hazards consideration. The staff prepared an environmental assessment and finding of no significant impact for the requested extension of the latest date for completion of construction and published it in the Federal Register on November 10, 2022 (87 FR 67965). On the basis of the environmental assessment, the staff concluded that the requested extension will not have a significant effect on the quality of the human environment. The findings set forth above are supported by an NRC staff safety evaluation dated November 30, 2022, which is available at ML22292A319.

III.

Within 60 days after the date of publication of this notice, any persons (petitioner) whose interest may be affected by this action may file a request for a hearing and petition for leave to intervene (petition) with respect to the action. The scope of this order extending the latest date for completion of construction and administratively changing the name of the CP holder and any proceeding hereunder is limited to direct challenges to the CP holders asserted reasons that show good cause for the extension and to the name change. Petitions shall be filed in accordance with the Commissions Agency Rules of Practice and Procedure in 10 CFR part 2.

Interested persons should consult a current copy of 10 CFR 2.309. The NRCs regulations are accessible electronically from the NRC Library on the NRCs website at https://www.nrc.gov/reading-rm/doccollections/cfr/. Alternatively, a copy of the regulations is available at the NRCs Public Document Room, located at One White Flint North, Room P1 B35,

11555 Rockville Pike, Rockville, Maryland 20852. If a petition is filed, the Commission or a presiding officer will rule on the petition and, if appropriate, a notice of a hearing will be issued.

As required by 10 CFR 2.309(d), the petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements for standing: (1) the name, address, and telephone number of the petitioner; (2) the nature of the petitioners right to be made a party to the proceeding; (3) the nature and extent of the petitioners property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the petitioners interest.

In accordance with 10 CFR 2.309(f), the petition must also set forth the specific contentions which the petitioner seeks to have litigated in the proceeding. Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the petitioner must provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the petitioner intends to rely in proving the contention at the hearing. The petitioner must also provide references to the specific sources and documents on which the petitioner intends to rely to support its position on the issue. The petition must include sufficient information to show that a genuine dispute exists with the applicant or licensee on a material issue of law or fact. Contentions must be limited to matters within the scope of the proceeding. The contention must be one which, if proven, would entitle the petitioner to relief. A petitioner who fails to satisfy the requirements at 10 CFR 2.309(f) with respect to at least one contention will not be permitted to participate as a party.

Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene. Parties have the opportunity to participate fully in the conduct of the hearing with respect to resolution of that partys admitted contentions, including the opportunity to present evidence, consistent with the NRCs regulations, policies, and procedures.

Petitions must be filed no later than 60 days from the date of publication of this notice.

Petitions and motions for leave to file new or amended contentions that are filed after the deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i) through (iii).

The petition must be filed in accordance with the filing instructions in the section of this document discussing electronic submissions (E-Filing).

If a hearing is requested, and the Commission has not made a final determination on the issue of no significant hazards consideration, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to establish when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing would take place after issuance of the amendment. If the final determination is that the amendment request involves a significant hazards consideration, then any hearing held would take place before the issuance of the amendment unless the Commission finds an imminent danger to the health or safety of the public, in which case it will issue an appropriate order or rule under 10 CFR part 2.

A State, local governmental body, Federally recognized Indian Tribe, or agency thereof, may submit a petition to the Commission to participate as a party under 10 CFR 2.309(h)(1).

The petition should state the nature and extent of the petitioners interest in the proceeding. The petition should be submitted to the Commission no later than 60 days from the date of publication of this notice. The petition must be filed in accordance with the filing instructions in the section of this document discussing electronic submissions (E-Filing), and should meet the requirements for petitions set forth in this section, except that under 10 CFR 2.309(h)(2) a State, local governmental body, or Federally recognized Indian Tribe, or agency thereof does not need to address the standing requirements in 10 CFR 2.309(d) if the facility is located within its

boundaries. Alternatively, a State, local governmental body, Federally recognized Indian Tribe, or agency thereof may participate as a non-party under 10 CFR 2.315(c).

If a hearing is granted, any person who is not a party to the proceeding and is not affiliated with or represented by a party may, at the discretion of the presiding officer, be permitted to make a limited appearance pursuant to the provisions of 10 CFR 2.315(a). A person making a limited appearance may make an oral or written statement of his or her position on the issues but may not otherwise participate in the proceeding. A limited appearance may be made at any session of the hearing or at any prehearing conference, subject to the limits and conditions as may be imposed by the presiding officer. Details regarding the opportunity to make a limited appearance will be provided by the presiding officer if such sessions are scheduled.

IV.

All documents filed in NRC adjudicatory proceedings, including a request for hearing and petition for leave to intervene (petition), any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene, and documents filed by interested governmental entities that request to participate under 10 CFR 2.315(c), must be filed in accordance with the NRCs E-Filing rule (72 FR 49139; August 28, 2007, as amended at 77 FR 46562; August 3, 2012). The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases to mail copies on electronic storage media. Detailed guidance on making electronic submissions may be found in the Guidance for Electronic Submissions to the NRC and on the NRC website at https://www.nrc.gov/site-help/e-submittals.html. Participants may not submit paper copies of their filings unless they seek an exemption in accordance with the procedures described below.

To comply with the procedural requirements of E-Filing, at least 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at hearing.docket@nrc.gov, or by telephone at 301-415-1677, to (1) request a digital identification

(ID) certificate, which allows the participant (or its counsel or representative) to digitally sign submissions and access the E-Filing system for any proceeding in which it is participating; and (2) advise the Secretary that the participant will be submitting a petition or other adjudicatory document (even in instances in which the participant, or its counsel or representative, already holds an NRC-issued digital ID certificate). Based upon this information, the Secretary will establish an electronic docket for the hearing in this proceeding if the Secretary has not already established an electronic docket.

Information about applying for a digital ID certificate is available on the NRCs public website at https://www.nrc.gov/site-help/e-submittals/getting-started.html. Once a participant has obtained a digital ID certificate and a docket has been created, the participant can then submit adjudicatory documents. Submissions must be in Portable Document Format (PDF).

Additional guidance on PDF submissions is available on the NRCs public website at https://www.nrc.gov/site-help/electronic-sub-ref-mat.html. A filing is considered complete at the time the document is submitted through the NRCs E-Filing system. To be timely, an electronic filing must be submitted to the E-Filing system no later than 11:59 p.m. Eastern Time on the due date. Upon receipt of a transmission, the E-Filing system time-stamps the document and sends the submitter an email notice confirming receipt of the document. The E-Filing system also distributes an email notice that provides access to the document to the NRCs Office of the General Counsel and any others who have advised the Office of the Secretary that they wish to participate in the proceeding, so that the filer need not serve the document on those participants separately. Therefore, applicants and other participants (or their counsel or representative) must apply for and receive a digital ID certificate before adjudicatory documents are filed so that they can obtain access to the documents via the E-Filing system.

A person filing electronically using the NRCs adjudicatory E-Filing system may seek assistance by contacting the NRCs Electronic Filing Help Desk through the Contact Us link located on the NRCs public website at https://www.nrc.gov/site-help/e-submittals.html, by email

to MSHD.Resource@nrc.gov, or by a toll-free call at 1-866-672-7640. The NRC Electronic Filing Help Desk is available between 9 a.m. and 6 p.m., Eastern Time, Monday through Friday, excluding government holidays.

Participants who believe that they have a good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing stating why there is good cause for not filing electronically and requesting authorization to continue to submit documents in paper format. Such filings must be submitted by: (1) first class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff; or (2) courier, express mail, or expedited delivery service to the Office of the Secretary, 11555 Rockville Pike, Rockville, Maryland 20852, Attention: Rulemaking and Adjudications Staff. Participants filing adjudicatory documents in this manner are responsible for serving the document on all other participants. Filing is considered complete by first-class mail as of the time of deposit in the mail, or by courier, express mail, or expedited delivery service upon depositing the document with the provider of the service. A presiding officer, having granted an exemption request from using E-Filing, may require a participant or party to use E-Filing if the presiding officer subsequently determines that the reason for granting the exemption from use of E-Filing no longer exists.

Documents submitted in adjudicatory proceedings will appear in the NRCs electronic hearing docket which is available to the public at https://adams.nrc.gov/ehd, unless excluded pursuant to an order of the Commission or the presiding officer. If you do not have an NRC-issued digital ID certificate as described above, click cancel when the link requests certificates and you will be automatically directed to the NRCs electronic hearing dockets where you will be able to access any publicly available documents in a particular hearing docket. Participants are requested not to include personal privacy information, such as social security numbers, home addresses, or personal phone numbers in their filings, unless an NRC regulation or other law

requires submission of such information. For example, in some instances, individuals provide home addresses in order to demonstrate proximity to a facility or site. With respect to copyrighted works, except for limited excerpts that serve the purpose of the adjudicatory filings and would constitute a Fair Use application, participants are requested not to include copyrighted materials in their submission.

The attorney for the CP holder is Nathan Schleifer, General Counsel, SHINE Technologies, LLC, 3400 Innovation Court, Janesville, WI 53546.

V.

Accordingly, pursuant to Sections 161b and 161i of the Atomic Energy Act of 1954, as amended; 42 U.S.C. Sections 2201(b) and 2201(i); and 10 CFR 50.90 and 10 CFR 50.55(b), IT IS HEREBY ORDERED that CP No. CPMIF-001 is amended to extend the latest date for completion of the construction of the SHINE facility from December 31, 2022, to December 31, 2025, and to change the name of the CP holder from SHINE Medical Technologies, LLC to SHINE Technologies, LLC.

This order is effective upon issuance.

Dated: NOVEMBER 30, 2022.

FOR THE NUCLEAR REGULATORY COMMISSION.

Caroline Carusone, Deputy Director, Division of Advanced Reactors and Non-Power Production and Utilization Facilities, Office of Nuclear Reactor Regulation.

Caroline L.

Carusone Digitally signed by Caroline L. Carusone Date: 2022.11.30 14:44:05

-05'00'

SHINE MEDICAL TECHNOLOGIES, LLC DOCKET NO. 50-608 SHINE MEDICAL ISOTOPE PRODUCTION FACILITY AMENDMENT TO CONSTRUCTION PERMIT Amendment No. 3 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 the SHINE Medical Technologies, LLC (the licensee) on April 1, 2022, 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, 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; 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; and F.

Prior notice of this amendment was not required by 10 CFR 2.105, Notice of proposed action, and publication of a notice of issuance for this amendment is not required by 10 CFR 2.106, Notice of issuance.

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 90 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:

1. Changes to Construction Permit No. CPMIF-001 Date of Issuance: November 30, 2022 Joshua M.

Borromeo Digitally signed by Joshua M.

Borromeo Date: 2022.11.30 13:27:43

-05'00'

Attachment ATTACHMENT TO AMENDMENT NO. 3 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.

Replace the following page of Appendix A, Environmental Protection Plan, with the attached revised page. The revised page is identified by amendment number and contains a marginal line indicating the area of change.

Construction Permit No. CPMIF-001 Remove Insert 1

1 2

2 Appendix A, Environmental Protection Plan Remove Insert A-1 A-1

1 Amendment No. 3 November 30, 2022 SHINE TECHNOLOGIES, LLC DOCKET NO. 50-608 MEDICAL ISOTOPE PRODUCTION FACILITY CONSTRUCTION PERMIT Amendment No. 3 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. 3 November 30, 2022 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 and source material as authorized by this license will be in accordance with the Commissions regulations in 10 CFR Parts 30 and

40.

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:

A-1 Amendment No. 3 November 30, 2022 APPENDIX A TO FACILITY CONSTRUCTION PERMIT NO. CPMIF-001 SHINE TECHNOLOGIES, LLC MEDICAL ISOTOPE PRODUCTION FACILITY DOCKET NO. 50-608 ENVIRONMENTAL PROTECTION PLAN (NONRADIOLOGICAL)

February 29, 2016 TABLE OF CONTENTS 1.0 Objective of the Environmental Protection Plan 2.0 Environmental Protection Issues 2.1 Ecological Resources Issues 2.2 Endangered Species Act of 1973 3.0 Consistency Requirements 4.0 Administrative Procedures 4.1 Plant Reporting Requirements: Non-routine Reports 4.2 Review and Audit 4.3 Records Retention 4.4 Changes in Environmental Protection Plan

SAFETY EVALUATION BY THE OFFICE OF NUCLEAR REACTOR REGULATION RELATED TO AMENDMENT NO. 3 TO CONSTRUCTION PERMIT NO. CPMIF-001 SHINE MEDICAL TECHNOLOGIES, LLC SHINE MEDICAL ISOTOPE PRODUCTION FACILITY DOCKET NO. 50-608

1.0 INTRODUCTION

By letter dated April 1, 2022 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML22091A093), SHINE Medical Technologies, LLC (SHINE, the licensee) submitted to the U.S. Nuclear Regulatory Commission (NRC, the Commission) a license amendment request (LAR) for Construction Permit No. CPMIF-001 for the SHINE Medical Isotope Production Facility (SHINE facility). The proposed amendment would extend the latest date for completion of the construction of the SHINE facility from December 31, 2022, to December 31, 2025, and would change the name of the construction permit holder from SHINE Medical Technologies, LLC to SHINE Technologies, LLC.

2.0 REGULATORY EVALUATION

The NRC staff reviewed the LAR and evaluated the proposed changes to Construction Permit No. CPMIF-001 based on the following regulations and guidance:

Title 10 of the Code of Federal Regulations (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities, Section 50.55, Conditions of construction permits, early site permits, combined licenses, and manufacturing licenses, which provides, in part, the terms and conditions to which each construction permit is subject. These include 10 CFR 50.55(b), which states that if the proposed construction of a facility is not completed by the latest completion date, the construction permit will expire. However, the regulation further states that, upon good cause shown, the Commission will extend the completion date for a reasonable period of time.

10 CFR 50.90, Application for amendment of license, construction permit, or early site permit, which states, in part, that whenever a holder of a construction permit desires to amend the permit, application for an amendment must be filed with the Commission fully describing the changes desired, and following as far as applicable, the form prescribed for original applications.

10 CFR 50.92, Issuance of amendment, which states, in part, that in determining whether an amendment to a construction permit will be issued to the applicant, the Commission will be guided by the considerations which govern the issuance of initial construction permits to the extent applicable and appropriate.

10 CFR 50.80, Transfer of licenses, which states, in part, that no license for a production or utilization facility, or any right thereunder, shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of the license to any person, unless the Commission gives its consent in writing.

NUREG-1577, Revision 1, Standard Review Plan on Power Reactor Licensee Financial Qualifications and Decommissioning Funding Assurance, which states, in connection with staff reviews of transfers of licenses, that:

The reviewer should treat applications involving changes of ownership, mergers, formation of holding companies, and other restructuring proposals that go beyond corporate name changes or internal reorganizations as potential transfers of licenses, directly or indirectly, through transfer of control of the license, as subject to section 50.80 review, and not merely subject to a section 50.90 license amendment review.

(A name change of a licensee that does not involve license transfer considerations under section 50.80 will be effected by a license amendment issued administratively under section 50.90.)

3.0 TECHNICAL EVALUATION

Construction Permit No. CPMIF-001 authorizes SHINE to construct the SHINE facility in Rock County, Wisconsin to produce molybdenum-99 (Mo-99) through the irradiation and processing of a uranyl sulfate solution. The SHINE 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 be licensed as utilization facilities, as defined in 10 CFR 50.2, Definitions. 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 structures, systems, and components for the processing of irradiated material and extraction and purification of Mo-99.

License Condition 3.A of Construction Permit No. CPMIF-001 states, in part, that the latest date of construction completion is December 31, 2022. Construction Permit No. CPMIF-001 also identifies SHINE Medical Technologies, LLC to be the current name of the permit holder. In its LAR, SHINE proposed to amend License Condition 3.A to extend the latest date of construction completion to December 31, 2025, to allow SHINE to finish construction due to delays.

Additionally, SHINE proposed to amend the construction permit to change the permit holders name to SHINE Technologies, LLC.

The following sections provide a summary of the NRC staffs evaluation of the LAR against the applicable requirements and using the appropriate guidance.

Extension of the Latest Date of Construction Completion The NRCs regulation at 10 CFR 50.55(b) states that upon good cause shown, the Commission will extend the completion date of a construction permit for a reasonable period of time and will recognize, among other things, developmental problems attributable to the experimental nature of the facility or fire, flood, explosion, strike, sabotage, domestic violence, enemy action, an act of the elements, and other acts beyond the control of the permit holder, as a basis for extending the completion date.

In LAR Section 3.2, Construction Completion Extension, SHINE stated that it had completed a review of the construction schedule for the SHINE facility and determined that construction will not be completed by December 31, 2022, the latest date for completion of the construction of the SHINE facility prescribed by Construction Permit No. CPMIF-001. SHINE stated that the delays for the completion of construction are attributable to the first-of-a-kind nature of the SHINE facility, which has included efforts contributing to engineering detailed design progression, procurement of unique and one-of-a-kind components, construction of a first-of-a-kind facility, and progression of an operating license application that has no precedent. SHINE also stated that the Coronavirus Disease 2019 (COVID-19) public health emergency has slowed efforts related to obtaining the workforce and equipment resources needed to procure and install the necessary equipment to complete the construction of the SHINE facility. SHINE stated that given these factors, and including an abundance of caution and conservatism, a reasonable period of time for the extension would be December 31, 2025. Finally, SHINE stated that authorizing such an extension would not authorize any new activities and would not have any radiological consequences.

Based on the information in the LAR, the NRC staff finds that, in accordance with 10 CFR 50.55(b) and 10 CFR 50.90, SHINE has shown good cause for amending Construction Permit No. CPMIF-001 to extend the latest date for construction completion to December 31, 2025, and that this is a reasonable period of time. The staffs finding is based on the considerations that (1) the proposed new latest date for construction completion is based on a detailed review and includes conservatism, (2) the reasons for the delay include developmental problems attributable to the first-of-a-kind nature of the SHINE facility and circumstances beyond SHINEs control, and (3) the proposed amendment to the construction permit only reflects this extension and does not authorize any new activities and does not have any radiological consequences.

Therefore, consistent with 10 CFR 50.55(b) and 10 CFR 50.92, the staff concludes that the amendment to Construction Permit No. CPMIF-001 to extend the latest date for completion of the construction of the SHINE facility from December 31, 2022, to December 31, 2025, is acceptable.

Permit Holder Name Change In LAR Section 3.1, Name Change, SHINE stated that its proposed amendment to Construction Permit No. CPMIF-001 to change the name of the construction permit holder from SHINE Medical Technologies, LLC to SHINE Technologies, LLC does not involve a transfer of control of the license and does not involve any change to the ownership, organization, obligations, rights, or liabilities of SHINE. SHINE also stated that there are no changes to the technical capabilities, financial qualifications, or obligations of SHINE as a result of the name change and that all of the licensees financial responsibilities remain the same.

Consistent with its guidance in NUREG-1577, the NRC staff determined that the proposed amendment to change the name of the construction permit holder from SHINE Medical Technologies, LLC to SHINE Technologies, LLC does not involve license transfer considerations under 10 CFR 50.80, but is, instead, appropriately subjected only to a 10 CFR 50.90 license amendment review.

Based on the information in the LAR, the NRC staff finds that SHINE has appropriately requested a license amendment, rather than a license transfer, to change the name of the construction permit holder from SHINE Medical Technologies, LLC to SHINE Technologies, LLC. This amendment would not affect the financial and technical qualifications of the licensee to hold the construction permit and to construct the SHINE facility consistent with the construction permit and would not change the ownership, organization, obligations, rights, or liabilities of SHINE. Therefore, consistent with 10 CFR 50.92, the staff concludes that the amendment to Construction Permit No. CPMIF-001 to change the name of the construction permit holder from SHINE Medical Technologies, LLC to SHINE Technologies, LLC is administrative in nature and acceptable.

4.0 STATE CONSULTATION

In accordance with the Commissions regulations, the Wisconsin State official was notified on October 13, 2022, of the proposed issuance of the amendment (ML22319A226). The State official had no comments.

5.0 ENVIRONMENTAL CONSIDERATION

With respect to the extension of the latest date for completion of the construction of the SHINE facility from December 31, 2022, to December 31, 2025, 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, the Commission issued an environmental assessment and finding of no significant impact in the Federal Register on November 10, 2022 (87 FR 67965). 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.

With respect to the change of the name of the construction permit holder from SHINE Medical Technologies, LLC to SHINE Technologies, LLC, the amendment relates to changes to the permit holders name. Accordingly, the amendment meets the eligibility criteria for categorical exclusion set forth in 10 CFR 51.22(c)(10)(iii). Pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared in connection with the issuance of the amendment.

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 Contributors: Holly Cruz Justin Hudson Michael Balazik Date: November 30, 2022