ML22279A951

Shine Technologies, LLC Request to Amend Construction Permit No. CPMIF-001

ML22279A951
Person / Time
Site:	SHINE Medical Technologies
Issue date:	10/06/2022
From:	Jim Costedio SHINE Technologies
To:	Document Control Desk, Office of Nuclear Reactor Regulation
References
2022-SMT-0105
Download: ML22279A951 (15)

Text

3400 Innovation Ct

• Janesville, WI 53546

• 877.512.6554

• info@shinemed.com

• www.SHINEtechnologies.com October 6, 2022 2022-SMT-0105 10 CFR 50.90 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555

References:

(1)

NRC letter to SHINE Medical Technologies, Inc., SHINE Medical Technologies, Inc. - Issuance of Construction Permit for Medical Isotope Facility, dated February 26, 2016 (ML16041A473)

SHINE Technologies, LLC Request to Amend Construction Permit No. CPMIF-001 In accordance with 10 CFR 50.90, SHINE Medical Technologies, LLC (SHINE) hereby submits the enclosed request to amend Construction Permit No. CPMIF-001 (Reference 1) to permit SHINE to receive and possess radioactive material necessary for the continued construction of the SHINE medical isotope production facility. provides the amendment request. SHINE requests that the NRC approve this amendment request by February 14, 2023 to allow SHINE to procure, receive, and install the requested radioactive material, to support timely construction of the SHINE facility.

If you have any questions, please contact Mr. Jeff Bartelme, Director of Licensing, at 608/210-1735.

I declare under the penalty of perjury that the foregoing is true and correct.

Executed on October 6, 2022.

Very truly yours, James Costedio Vice President of Regulatory Affairs and Quality SHINE Technologies, LLC Docket No. 50-608 Enclosure cc:

Project Manager, USNRC SHINE General Counsel Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health






   



ENCLOSURE 1 SHINE MEDICAL TECHNOLOGIES, LLC SHINE MEDICAL TECHNOLOGIES, LLC REQUEST TO AMEND CONSTRUCTION PERMIT NO. CPMIF-001 Table of Contents

1. INTRODUCTION

2. PROPOSED CHANGES

3. INFORMATION REQUESTED IN ITEMS 5 THROUGH 11 OF NRC FORM 313

4. 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 8

1. INTRODUCTION In accordance with 10 CFR 50.90, SHINE Medical Technologies, LLC (SHINE) hereby requests to amend Construction Permit No. CPMIF-001 (Reference 1) to permit SHINE to receive and possess certain radioactive materials necessary for the continued construction of the SHINE medical isotope production facility.

SHINE requests that the NRC approve this amendment request by February 14, 2023 to allow SHINE time to procure, receive, and install the requested radioactive material, to support timely construction of the SHINE facility.

SHINE requests NRC authorization to receive and possess highly enriched uranium, in the form of neutron detectors (i.e., fission chambers), for installation within the neutron flux detection system (NFDS), as described in Section 7.8 of the Final Safety Analysis Report (FSAR)

(Reference 2). These neutron detectors are required to be installed within SHINE systems as part of construction activity sequencing.

To ensure compliance with the applicable regulations of 10 CFR Part 70, SHINE has prepared the content of this amendment request considering the guidance of NUREG-1556, Volume 17, Revision 1, Consolidated Guidance About Materials Licenses - Program-Specific Guidance About Special Nuclear Material of Less Than Critical Mass Licenses (Reference 3). The content of the amendment request follows the Suggested Response guidance provided in Appendix B of NUREG-1556, Volume 17, by providing the information requested in Items 5 through 11 of NRC Form 313. The amendment request is independent of the on-going NRC review of the SHINE operating license application and does not rely on any programs or plans currently under review by the NRC Staff.

2. PROPOSED CHANGES SHINE proposes that the following condition be added to Section 3 of Construction Permit No. CPMIF-001:

G. Pursuant to the Act and 10 CFR Part 70, the following activities are authorized:

(1) to receive and possess, in connection with construction of the facility, up to 15 grams of contained uranium-235 enriched to any enrichment in the form of neutron detectors.

3. INFORMATION REQUESTED IN ITEMS 5 THROUGH 11 OF NRC FORM 313 The content of this section follows the Suggested Response guidance provided in Appendix B of NUREG-1556, Volume 17, by providing the information requested in Items 5 through 11 of NRC Form 313.

ITEM 5 - RADIOACTIVE MATERIAL UNSEALED SOURCE Radioisotope Uranium enriched to any enrichment Chemical / Physical Form Solid metal (not in a readily dispersible form)

Maximum Possession Limit 15 grams contained uranium-235

Page 3 of 8 Pursuant to 10 CFR 70.25(g) and 10 CFR 70.51(b)(3), SHINE will maintain records important to decommissioning and transfer records important to decommissioning to an NRC or Agreement State licensee before licensed activities are transferred or assigned, in accordance with 10 CFR 70.36.

ITEM 6 - PURPOSE FOR WHICH LICENSED MATERIAL WILL BE USED The highly enriched uranium is contained within neutron detectors, which are described in Section 7.8 of the FSAR, for installation within the NFDS.

ITEM 7 - INDIVIDUALS RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING AND EXPERIENCE SHINE staff is qualified by training and experience to use the material for the purpose requested in such manner as to protect health and minimize danger to life or property. The Commission has previously concluded that SHINE is technically qualified to engage in the activities authorized under the terms of the Construction Permit (Reference 4). The SHINE staff includes individuals responsible for radiation safety whose experience encompasses responsibilities such as:

performing the duties of radiation safety officer and authorized user planning and conducting evaluations, surveys, and measurements hands on experience using licensed materials of similar types, forms, and quantities maintaining security and control of licensed materials monitoring inventory of materials possessed under the license; maintaining records of receipts, transfers, and disposal of licensed materials storing, handling, disposing, and documenting of radioactive waste materials planning, conducting, and documenting audits of the radiation safety program evaluating and documenting radiation exposures maintaining required records and providing required reports formal training or education in radiation safety including:

o radiation protection principles o characteristics of ionizing radiation o units of radiation dose and quantities o radiation detection and measurement instrumentation o biological hazards of exposure to radiation o NRC regulatory requirements and standards ITEM 8 - TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS The level of radiation safety training is based on the potential radiological health risks associated with an employee's work responsibilities. Personnel whose duties may require them to work in the vicinity of radioactive material but will not likely receive in a year an occupational dose of radiation greater than 1 mSv (100 mrem), will receive information about radiation hazards and precautions. The development and implementation of this general employee training considers subjects such as an overview of ionizing radiation and its associated hazards, the areas on-site where radiation or radioactive materials are located, an overview of radiation protection principles, and NRC Form 3, Notice to Workers.

Page 4 of 8 Personnel whose assigned duties involve exposure to radiation or radioactive material, and in the course of their employment are likely to receive in a year an occupational dose of radiation greater than 1 mSv (100 mrem), receive annual instruction commensurate with their duties and responsibilities, as required by 10 CFR 19.12. The development and implementation of this radiation worker training considers the following subjects:

Topics covered in Regulatory Guide 8.10 - Operating Philosophy for Maintaining Occupational and Public Radiation Exposures As Low As Reasonably Achievable (Reference 5), including procedures and/or engineering controls as applicable to achieve occupational doses and doses to members of the public which are ALARA in accordance with 10 CFR 20.1101.

Topics covered in Regulatory Guide 8.13 - Instructions Concerning Prenatal Radiation Exposure (Reference 6), including how to declare pregnancy and the applicable occupational exposure limits of a declared pregnant woman.

Topics covered in Regulatory Guide 8.29 - Instructions Concerning Risks from Occupational Radiation (Reference 7), including instruction required by 10 CFR 19.12.

Topics covered in ASTM E1168 Radiological Protection Training for Nuclear Facility Workers (Reference 8), including standard work practices, procedures, and measurement methods for radiological protection as applicable.

Radiation vs. contamination, internal vs. external exposure, the biological effects of radiation, and the use of time, distance, and shielding to minimize exposure.

Material control and accountability, recordkeeping, surveys, instrumentation, and labeling.

Personnel dosimetry, personal protection equipment, radioactivity measurements, monitoring techniques, and usage of monitoring instrumentation as applicable.

Emergencies, handling and reporting of incidents or events, and workers responsibility to report unsafe conditions.

Receiving, opening, and examining packages containing radioactive materials as applicable.

Areas on-site where radioactive material is used or stored and potential hazards.

Applicable regulations, notices, license conditions, required postings, and the workers right to be informed of occupational radiation exposure.

Training for personnel likely to receive in a year an occupational dose of radiation greater than 1 mSv (100 mrem) is assessed via written and/or performance exams. Training is provided by instructors that are knowledgeable of the topics covered with content that is approved by radiation protection personnel (e.g., personnel familiar with the radiation protection program and with qualifications similar to those of a radiation safety officer or an authorized user). Instructor performance is assessed via observation and feedback. Training may be in the form of lecture, demonstrations, videotape, computer-based training, or self-study. Training emphasizes practical subjects important to the safe use of licensed material. The training program is reviewed annually. The training program is assessed via a performance evaluation process which may include in-field observations, interviews, surveys, corrective action program review, and a review of training materials, as applicable.

ITEM 9 - FACILITIES AND EQUIPMENT The SHINE medical isotope production facility is located on the south side of the City of Janesville corporate boundaries, in Rock County, Wisconsin. Geographical coordinates of the SHINE site are provided in Section 2.1 of the FSAR (Reference 2). The SHINE main production facility consists of an irradiation facility (IF), radioisotope production facility (RPF), shipping and

Page 5 of 8 receiving area, and other areas that contain various support systems and equipment, each currently at various stages of construction. General arrangement floor plan and section drawings of the facility showing the layout of major structures are provided in Figures 1.3-1 and 1.3-2 of the FSAR. The SHINE facility site overview is provided in Figure 1.3-3 of the FSAR.

The material specified in Item 5 is received and securely stored in an access-controlled area prior to installation. Licensed material is received and placed into secure storage (e.g., locked storage building, locked sea van, or locked intermodal container) located on the SHINE site, away from primary construction activities. The secure storage area is controlled as a restricted area and posted in accordance with the requirements of 10 CFR 20.1902. Upon receipt, incoming packages are inspected, inventoried, and placed into secure storage. Shielding is used as needed to minimize radiation exposure of personnel while the material is in storage.

The material specified in Item 5 is solid metal contained within enclosed components which do not present contamination or accidental release hazards. Contamination of equipment, facility, or the environment is not expected. Internal dose hazards are not expected. Radiological waste is not expected during the scope of construction activities.

The highly enriched uranium sources are used within neutron detectors for neutron flux detection to determine the multiplication factor and power level during filling and irradiation of the target solution vessel. The neutron detectors each contain 2 grams of uranium (total uranium) enriched to 93% in the isotope uranium-235. Each irradiation unit (IU) contains a three-division system with three detectors positioned around the subcritical assembly support structure (SASS) at approximately 120-degree intervals to the target solution vessel. Once the target section of the SASS is installed the neutron detectors are not easily accessible due to IU cell space restrictions. Partial disassembly of IU components would be required to gain access to the neutron detectors. Once a detector is installed, the area is posted in accordance with the requirements of 10 CFR 20.1902. The material specified in Item 5 supports the installation of neutron detectors in IUs 1 and 2, with sufficient spares on-hand. The neutron detectors are described in Section 7.8 of the FSAR. The IU cell locations are provided in Figure 1.3.1 of the FSAR.

The radiological hazards associated with the uranium sources are minimal. The neutron detectors are transported in shielded containers and stored within shielded containers to mitigate radiological hazards. Transfers of the neutron detectors between containers and installation in the IU cell is performed in a manner consistent with as low as reasonably achievable (ALARA) principles. The distance and shielding between the uranium sources and the areas of occupation during subsequent installation of the neutron driver assembly system (NDAS) components is expected to provide adequate protection from radiological hazards.

Temporary shielding and restricted area access control boundaries are used as needed to maintain ALARA principles.

While receipt and possession of the requested radioactive material during construction was not specifically addressed in the SHINE construction permit application, such receipt and possession would not affect the NRC staffs conclusions on the environmental impacts of construction documented in NUREG-2183, Environmental Impact Statement for the Construction Permit for the SHINE Medical Radioisotope Production Facility - Final Report (Reference 9).

Radiological impacts to human health during construction are described in Section 4.8.1.1 of NUREG-2183. While there are no specific radioactive materials identified in Section 4.8.1.1 of NUREG-2183, there are no new or substantially different radiological hazards resulting from the

Page 6 of 8 receipt and possession of the requested special nuclear material from the radiological hazards described in Section 4.8.1.1 of NUREG-2183. Therefore, consistent with the conclusion stated in Section 4.8.1.1 of NUREG-2183, the radiological impacts to workers and the public during construction remain small. Furthermore, no new or substantially different nonradiological (occupational) hazards result from the receipt and possession of the requested special nuclear material from the nonradiological hazards described in Section 4.8.1.2 of NUREG-2183; therefore, the nonradiological impacts during construction remain small.

NUREG-2183 describes specific types and curies of radioactive materials in effluents, wastes, and products of the SHINE production facility. The material requested does not represent changes in the types or curies of radioactive materials in effluents, wastes, and products of the SHINE production facility as compared to the descriptions in NUREG-2183. Human health impacts are described in Section 4.8 of NUREG-2183, including the impacts during construction described in Sections 4.8.1.1 and 4.8.1.2, which encompasses impacts associated with radioactive materials stored and managed at the SHINE production facility during construction.

Consistent with the conclusions stated in Table 6-1 of NUREG-2183, the human health impacts during construction remain small.

Transportation impacts during construction are described in Section 4.10.1 of NUREG-2183, including packaging and transportation of radioactive materials shipped to the SHINE production facility during construction. The requested radioactive material does not impact the assessments described in Section 4.10.1 of NUREG-2183. Consistent with the conclusions stated Table 6-1 of NUREG-2183, the transportation impacts during construction remain small to moderate.

ITEM 10 - RADIATION SAFETY PROGRAM Radiation Monitoring Instruments SHINE will use instrumentation, such as the following, to perform required surveys:

portable dose rate meter with ionization chamber or Geiger-Mueller (GM) probe (beta/gamma),

portable dose rate meter with He-3 proportional probe (neutron), and frisker with GM pancake probe.

SHINE will use instruments that meet the radiation monitoring instrument specifications published in Appendix F of NUREG-1556, Volume 17, Revision 1, Program-Specific Guidance About Special Nuclear Material of Less Than Critical Mass Licenses. SHINE reserves the right to upgrade survey instruments as necessary.

Radiation monitoring instruments will be calibrated before first use, at least annually thereafter, and after any repair, by a vendor that the NRC or an Agreement State has licensed to perform instrument calibration.

Material Receipt and Accountability SHINE will develop, implement, and maintain procedures for ensuring accountability of licensed materials at all times. Physical inventories will be conducted at intervals not to exceed 6 months, to account for all sealed sources and devices received and possessed under the license.

Records of inventory will be maintained for a period of 3 years from the date of each inventory, and will include the radionuclides, quantities, manufacturers name and model numbers, and the date of the inventory.

Page 7 of 8 Occupational Dose SHINE will monitor individuals in accordance with the guidance in the section titled, Radiation Safety Program-Occupational Dose in NUREG-1556, Volume 17, Revision 1, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Special Nuclear Material of Less than Critical Mass Licenses.

Operating and Emergency Procedures Procedures for safe and secure use of materials and emergencies have been developed or will be developed before receipt of licensed material. Procedures may be revised if:

the changes are reviewed and approved by SHINE management, including the radiation protection manager, in writing; the SHINE staff is provided training in the revised procedures prior to implementation; the changes are in compliance with the NRC regulations and the license; and the changes do not degrade the effectiveness of the program.

Surveys SHINE will survey the facility and maintain contamination levels in accordance with the survey frequencies and contamination levels published in Appendix I in NUREG-1556, Volume 17, Revision 1, Program-Specific Guidance About Special Nuclear Material of Less Than Critical Mass Licenses.

Leak Tests No sealed sources are within the scope of this request.

ITEM 11 - WASTE MANAGEMENT SHINE does not expect to generate radiological waste during construction activities.

4. REFERENCES

1. NRC letter to SHINE Medical Technologies, Inc., "SHINE Medical Technologies, Inc. -

Issuance of Construction Permit for Medical Isotope Facility," dated February 26, 2016 (ML16041A473)

2. SHINE Technologies, LLC letter to the NRC, SHINE Technologies, LLC Application for an Operating License Supplement No. 30, dated August 31, 2022 (ML22249A125)

3. U.S. Nuclear Regulatory Commission, Consolidated Guidance About Materials Licenses:

Program-Specific Guidance About Special Nuclear Material of Less than Critical Mass Licenses. NUREG-1556, Volume 17, Revision 1, July 2018

4. U.S. Nuclear Regulatory Commission Memorandum and Order, CLI-16-04, In the Matter of SHINE Medical Technologies, Inc. (Medical Radioisotope Production Facility), dated February 25, 2016 (ML16056A094)

5. U.S. Nuclear Regulatory Commission, Operating Philosophy for Maintaining Occupational Radiation Exposures as Low as Is Reasonably Achievable, Regulatory Guide 8.10, Revision 2, August 2016

Page 8 of 8

6. U.S. Nuclear Regulatory Commission, Instructions Concerning Prenatal Radiation Exposure, Regulatory Guide 8.13, Revision 3, June 1999

7. U.S. Nuclear Regulatory Commission, Instructions Concerning Risks from Occupational Radiation Exposure, Regulatory Guide 8.29, Revision 1, February 1996

8. ASTM International, Standard Guide for Radiological Protection Training for Nuclear Facility Workers, ASTM E1168-95(2020), Last Reapproval 2020

9. U.S. Nuclear Regulatory Commission, Environmental Impact Statement for the Construction Permit for the SHINE Medical Radioisotope Production Facility - Final Report, NUREG-2183, October 2015 (ML15288A046)

2 pages follow ENCLOSURE 1 ATTACHMENT 1 SHINE MEDICAL TECHNOLOGIES, LLC SHINE MEDICAL 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.

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. SHINE is technically qualified to design and construct the facility in accordance with the Commissions regulations set forth in 10 CFR Chapter I; 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, and special nuclear material as authorized by this license will be in accordance with the Commissions regulations in 10 CFR Parts 30 and, 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 Medical 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, 2022.

B. The facility shall be constructed and located at the site as described in the application, in the City of Janesville, Rock County, Wisconsin.

C. The construction permit authorizes the applicant to construct the facility described in the application and the hearing record, in accordance with the principal architectural and engineering criteria and environmental protection commitments set forth therein.

D. The permit is subject to, and SHINE shall comply with, the conditions specified and incorporated below:

4 Amendment No.

(1) to receive and possess, in connection with construction of the facility, up to 10,000 kilograms (kg) of natural uranium in the form of neutron multipliers; and (2) to receive and possess, in connection with construction of the facility, up to 10 kg of depleted uranium in the form of tritium storage beds.

G. Pursuant to the Act and 10 CFR Part 70, the following activities are authorized:

(1) to receive and possess, in connection with construction of the facility, up to 15 grams of contained uranium-235 enriched to any enrichment in the form of neutron detectors.

4. This permit is subject to the limitation that a license authorizing operation of the facility will not be issued by the Commission unless: (a) the applicant submits to the Commission the complete final safety analysis report, portions of which may be submitted and evaluated from time to time; (b) the Commission finds that the final design provides reasonable assurance that the health and safety of the public will not be endangered by the operation of the facility in accordance with procedures approved by it in connection with the issuance of said license; (c) the Commission finds that operation of the facility will be in accordance with 10 CFR Part 51 of the Commissions regulations and all applicable requirements were satisfied; and (d) the applicant submits proof of financial protection and executes an indemnity agreement as required by Section 170 of the Act.

5. This permit is effective as of February 29, 2016 and shall expire on the latest completion date indicated in paragraph 3.A. above.

FOR THE NUCLEAR REGULATORY COMMISSION

/RA/

William M. Dean, Director Office of Nuclear Reactor Regulation Appendix:

Appendix A - Environmental Protection Plan Date of Issuance: February 29, 2016

2 pages follow ENCLOSURE 1 ATTACHMENT 2 SHINE MEDICAL TECHNOLOGIES, LLC SHINE MEDICAL 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. SHINE is technically qualified to design and construct the facility in accordance with the Commissions regulations set forth in 10 CFR Chapter I; 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, 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.

5. 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 Medical 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.

6. 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, 2022.

B. The facility shall be constructed and located at the site as described in the application, in the City of Janesville, Rock County, Wisconsin.

C. The construction permit authorizes the applicant to construct the facility described in the application and the hearing record, in accordance with the principal architectural and engineering criteria and environmental protection commitments set forth therein.

D. The permit is subject to, and SHINE shall comply with, the conditions specified and incorporated below

4 Amendment No.

(1) to receive and possess, in connection with construction of the facility, up to 10,000 kilograms (kg) of natural uranium in the form of neutron multipliers; and (2) to receive and possess, in connection with construction of the facility, up to 10 kg of depleted uranium in the form of tritium storage beds.

G. Pursuant to the Act and 10 CFR Part 70, the following activities are authorized:

(1) to receive and possess, in connection with construction of the facility, up to 15 grams of contained uranium-235 enriched to any enrichment in the form of neutron detectors.

4. This permit is subject to the limitation that a license authorizing operation of the facility will not be issued by the Commission unless: (a) the applicant submits to the Commission the complete final safety analysis report, portions of which may be submitted and evaluated from time to time; (b) the Commission finds that the final design provides reasonable assurance that the health and safety of the public will not be endangered by the operation of the facility in accordance with procedures approved by it in connection with the issuance of said license; (c) the Commission finds that operation of the facility will be in accordance with 10 CFR Part 51 of the Commissions regulations and all applicable requirements were satisfied; and (d) the applicant submits proof of financial protection and executes an indemnity agreement as required by Section 170 of the Act.

5. This permit is effective as of February 29, 2016 and shall expire on the latest completion date indicated in paragraph 3.A. above.

FOR THE NUCLEAR REGULATORY COMMISSION

/RA/

William M. Dean, Director Office of Nuclear Reactor Regulation Appendix:

Appendix A - Environmental Protection Plan Date of Issuance: February 29, 2016