ML25226A150
| ML25226A150 | |
| Person / Time | |
|---|---|
| Site: | SHINE Medical Technologies |
| Issue date: | 08/14/2025 |
| From: | Bartelme J SHINE Technologies |
| To: | Office of Nuclear Reactor Regulation, Document Control Desk |
| References | |
| 2025-SMT-0031, CPMIF-001 | |
| Download: ML25226A150 (1) | |
Text
3400 Innovation Ct.
- Janesville, WI 53546
- 877.512.6554
- www.SHINEfusion.com August 14, 2025 2025-SMT-0031 10 CFR § 50.4 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555
References:
(1)
NRC letter to SHINE Technologies, LLC, 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), dated May 5, 2023 (ML23087A227)
SHINE Technologies, LLC Request to Amend Construction Permit No. CPMIF-001 In accordance with 10 CFR § 50.90, SHINE Technologies, LLC (SHINE) hereby submits the enclosed request to amend Construction Permit No. CPMIF-001 (Reference 1) to extend the latest date for the completion of construction of the SHINE medical isotope production facility. provides the amendment request. SHINE requests that the NRC approve this amendment request by December 31, 2025, to allow for the continued construction of the SHINE medical isotope production facility.
If you have any questions, please contact me at 608/210-1735.
I declare under the penalty of perjury that the foregoing is true and correct.
Executed on August 14, 2025.
Very truly yours, Jeff Bartelme Senior Director of Regulatory Affairs SHINE Technologies, LLC Docket No. 50-608 cc:
Project Manager, USNRC SHINE General Counsel Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health
Page 1 of 4 ENCLOSURE 1 SHINE TECHNOLOGIES, LLC SHINE TECHNOLOGIES, LLC REQUEST TO AMEND CONSTRUCTION PERMIT NO. CPMIF-001 TABLE OF CONTENTS
- 1. INTRODUCTION
- 2. PROPOSED CHANGES
- 3. REGULATORY EVALUATION
- 4. ENVIRONMENTAL CONSIDERATION
- 5. REFERENCES ATTACHMENT 1 - CONSTRUCTION PERMIT (CHANGES) MEDICAL ISOTOPE PRODUCTION FACILITY CONSTRUCTION PERMIT NO. CPMIF-001 ATTACHMENT 2 - CONSTRUCTION PERMIT (CLEAN) MEDICAL ISOTOPE PRODUCTION FACILITY CONSTRUCTION PERMIT NO. CPMIF-001
Page 2 of 4
- 1. INTRODUCTION In accordance with 10 CFR § 50.90, SHINE Technologies, LLC (SHINE) hereby requests to amend Construction Permit No. CPMIF-001 (Reference 1) to extend the latest date for the completion of construction of the SHINE medical isotope production facility.
SHINE requests that the NRC approve this amendment request by December 31, 2025, to allow for the continued construction of the SHINE medical isotope production facility.
- 2. PROPOSED CHANGES SHINE requests to amend Construction Permit No. CPMIF-001 to extend the latest date for the completion of construction of the SHINE medical isotope production facility identified in Condition 3.A. of Reference 1 to December 31, 2029. The changes proposed for the construction permit are provided in Attachment 1 and clean pages are provided in Attachment 2.
- 3. REGULATORY EVALUATION SHINE requests that NRC extend the construction permit (Reference 1) expiration date to December 31, 2029. The additional time will allow SHINE to complete the construction, pre-operational testing, and licensing of each of the four phases of the phased approach to initial SHINE medical isotope production facility operations.
Since issuance of the construction permit in 2016, SHINE has been progressing towards meeting the national need for Mo-99 production as soon as possible while ensuring all requirements related to public health and safety are met. SHINE broke ground at the construction site of the SHINE medical isotope production facility in May 2019. SHINE submitted the operating license application in July 2019. SHINE completed construction of the main production facility structure (i.e., the production facility structure was weather tight) in March 2021.
The majority of the SHINE medical isotope production facility process equipment components have been procured and are currently on site. Installation of process equipment within the SHINE medical isotope production facility has begun and continues to progress. Substantial progress has been made since issuance of the construction permit in 2016.
SHINE completed a detailed review of the SHINE medical isotope production facility schedule and developed a revised estimate of the time and resources necessary to complete the facility.
SHINE expects the construction of the first phase of the phased approach to initial facility operations to be substantially complete in 2027 and expects the last phase of construction to be substantially complete in 2029. While SHINE will begin commercially producing molybdenum-99 upon completion of the first phase, SHINE has identified the need to extend the expiration date of the construction permit to support substantial completion of all four phases of the phased approach to initial facility operations. Accordingly, and with conservatism that is necessary and prudent when requesting such an extension, SHINE is requesting a construction permit expiration date of December 31, 2029.
The extension request is the result of developmental effort delays attributable to the first of a kind nature of the SHINE medical isotope production facility. This has included efforts contributing to engineering detailed design progression, procurement of unique and one-of-a-
Page 3 of 4 kind components, construction of a first of a kind facility, and progression of an operating license application that has no precedent.
The regulations of 10 CFR § 50.55(b) state, in part:
... upon good cause shown, the Commission will extend the completion date for a reasonable period of time. The Commission 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 accordance with 10 CFR § 50.55(b), SHINE has shown good cause and requested a reasonable time period for the extension of the construction permit completion date.
SHINE does not request or propose any modifications to the terms of the construction permit other than to extend the completion time. The extension of the construction permit completion time does not authorize any new activities and does not have any radiological consequences.
- 4. ENVIRONMENTAL CONSIDERATION The construction completion date extension does not affect the environmental impacts of operating and decommissioning the SHINE medical isotope facility. Environmental impacts of construction may be affected, but this effect is limited to the extended duration of construction activities. The environmental impact of construction, as described in Reference 2, is expected to remain small to moderate for each resource category based on the following:
Land Use - The extended duration of construction does not alter the land usage on the SHINE site; therefore, the impacts on land use during construction remain SMALL.
Visual Resources - The extended duration of construction does not alter the location or sizing of structures on the SHINE site; therefore, the impacts on visual resources during construction remain SMALL.
Air Quality - The extended duration of construction does not alter the annual gaseous effluents during construction, nor does it alter the pollution control measures required to be in place; therefore, the impacts on air quality during construction remain SMALL.
Noise - The extended duration of construction does not alter the minimal noise emissions during construction; therefore, the impacts on noise during construction remain SMALL.
Geologic Environment - The extended duration of construction does not alter the geological environment for the SHINE site; therefore, the impacts on the geological environment during construction remain SMALL.
Water Resource - The extended duration of construction does not alter the considerations related to surface-water and groundwater for the SHINE site; therefore, the impacts on water hydrology, quality, and use from construction remain SMALL.
Ecological Resources - The extended duration of construction does not alter the considerations related to ecological resources for the SHINE site; therefore, the impacts on ecological resources from construction remain SMALL.
History and Cultural Resources - The extended duration of construction does not alter the considerations related to historical and cultural resources for the SHINE site; therefore, the impacts on historical and cultural resources from construction remain SMALL.
Page 4 of 4 Socioeconomics - The extended duration of construction does not alter the considerations related to socioeconomics for the SHINE site (e.g., construction activities continue to occur during a limited timeframe and do not require relocation of construction personnel to Rock County); therefore, the impacts on socioeconomics from construction remain SMALL.
Human Health - The extended duration of construction does not alter the considerations related to human health for the SHINE site; therefore, the impacts on human health from construction remain SMALL.
Waste Management - The extended duration of construction does not alter the considerations related to waste management for the SHINE site; therefore, the impacts on waste management from construction remain SMALL.
Transportation - The extended duration of construction does not alter the considerations related to transportation during construction for the SHINE site (e.g., average daily traffic flow); therefore, the impacts on transportation from construction remain MODERATE.
Overall, the environmental impacts of construction, operations, and decommissioning for the SHINE medical isotope facility are expected to remain small to moderate as described in References 2, 3, and 4.
- 5. REFERENCES
- 1. NRC letter to SHINE Technologies, LLC, 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), dated May 5, 2023 (ML23087A227)
- 2. U.S. Nuclear Regulatory Commission, Environmental Impact Statement for the Construction Permit for the SHINE Medical Radioisotope Production Facility - Final Report, NUREG-2183, dated October 2015 (ML15288A046)
- 3. SHINE Technologies, LLC letter to the NRC, SHINE Technologies, LLC Operating License Application Supplement No. 19 Submittal of a Revision to the SHINE Supplement to the Environmental Report, dated March 16, 2022 (ML22075A144)
- 4. U.S. Nuclear Regulatory Commission, Environmental Impact Statement Supplement Related to the Operating License for the SHINE Medical Isotope Production Facility - Final Report, NUREG-2183, Supplement 1, dated January 2023 (ML23026A312)
1 page follows ENCLOSURE 1 ATTACHMENT 1 SHINE TECHNOLOGIES, LLC SHINE TECHNOLOGIES, LLC REQUEST TO AMEND CONSTRUCTION PERMIT NO. CPMIF-001 CONSTRUCTION PERMIT (CHANGES)
MEDICAL ISOTOPE PRODUCTION FACILITY CONSTRUCTION PERMIT NO. CPMIF-001
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, 20252029.
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:
1 page follows ENCLOSURE 1 ATTACHMENT 2 SHINE TECHNOLOGIES, LLC SHINE TECHNOLOGIES, LLC REQUEST TO AMEND CONSTRUCTION PERMIT NO. CPMIF-001 CONSTRUCTION PERMIT (CLEAN)
MEDICAL ISOTOPE PRODUCTION FACILITY CONSTRUCTION PERMIT NO. CPMIF-001
2 Amendment No.
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, 2029.
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: