(Information)

October 22, 2015 SECY-15-0130

FOR: The Commissioners

FROM: Victor M. McCree

Executive Director for Operations

SUBJECT: STAFF STATEMENT IN SUPPORT OF THE UNCONTESTED HEARING 

FOR ISSUANCE OF CONSTRUCTION PERMIT FOR THE SHINE 

MEDICAL TECHNOLOGIES, INC. MEDICAL RADIOISOTOPE 

PRODUCTION FACILITY

PURPOSE:

The U.S. Nuclear Regulatory Commission (NRC) staff (the staff) has completed its review of the 

SHINE Medical Technologies, Inc. (SHINE), Medical Radioisotope Production Facility

construction permit application. The proposed facility would be located in the City of Janesville, 

Rock County, Wisconsin. This paper does not address any new commitments or resource 

implications.

This paper serves as the staff’s primary pre-filed testimony for the uncontested (mandatory) 

hearing for issuance of the SHINE construction permit.1

 This paper, with its references, also 

provides the information requested to support the Commission’s determination that the staff’s

review has been adequate to support the findings for issuance of a construction permit. These 

findings are set forth in Title 10 of the Code of Federal Regulations (10 CFR) 50.35, “Issuance 

of construction permits,” 10 CFR 50.40, “Common Standards,” 10 CFR 50.50, “Issuance of 

licenses and construction permits,” and 10 CFR 51.105, “Public hearings in proceedings for 

issuance of construction permits or early site permits; limited work authorizations.”

CONTACTS: Steven T. Lynch, NRR/DPR

301-415-1524

Michelle R. Moser, NRR/DLR

301-415-6509

 1 In SRM-SECY-15-0088 (Agencywide Documents Access & Management System (ADAMS) Accession No. 

ML15238B093), the Commission agreed to conduct the mandatory hearings associated with construction permit 

applications for medical radioisotope production and utilization facilities and directed the NRC staff to follow 

Chapter IV of the Internal Commission Procedures, “Conduct of Mandatory Hearings on Applications for 

Combined Licenses,” to the extent practical.

POLICY ISSUE
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In accordance with the internal Commission procedures, this paper focuses on nonroutine

matters supporting the findings related to 10 CFR Part 50, “Domestic Licensing of Production 

and Utilization Facilities,” and 10 CFR Part 51, “Environmental Protections Regulations for 

Domestic Licensing and Related Regulatory Functions.” Nonroutine matters with regard to 

areas of particular importance are matters that relate to any unique features of the facility or 

novel issues that arose as part of the review process. 

SUMMARY:

This paper follows the issuance of the SHINE safety evaluation report (SER) on October 20,

2015 (ADAMS Accession No. ML15288A076), and the final environmental impact statement 

(final EIS) on October 16, 2015 (NUREG-2183, ADAMS Accession No. ML15288A046). Drafts

of the SHINE construction permit and record of decision are referenced in this paper and are 

available under ADAMS Accession Nos. ML15272A009 and ML15272A019, respectively.

The staff’s review of the SHINE construction permit application is complete. The agency issued 

a final rule amending the 10 CFR Part 50 definition of utilization facility on October 17, 2014. 

The rule became effective on December 31, 2014. 

This paper addresses the findings in 10 CFR 50.35, 10 CFR 50.40, 10 CFR 50.50, 

and 10 CFR 51.105 and provides an adequate basis for the Commission to conclude that each 

of these findings can be made for the SHINE construction permit application. This paper 

focuses on nonroutine matters that arose as part of the review process, such as unique features 

of the facility or novel issues. This paper does not address routine aspects of the safety and 

environmental review process.

BACKGROUND:

I. Application History

Guidance Developed by Staff Based on Pre-Application Discussions with SHINE and Other 

Potential Applicants

In anticipation of receiving construction permit applications for utilization and production facilities 

dedicated to the production of molybdenum-99 (Mo-99), the staff developed technology-specific 

Interim Staff Guidance (ISG) augmenting NUREG-1537 for aqueous homogeneous reactors 

(AHRs) and production facilities in October 2012. SHINE used the final ISG, as applicable, in 

preparing its application. 

Application, Ownership, and Location

As allowed by an exemption granted March 20, 2013 (78 FR 19537), SHINE submitted the first 

part of its two-part 10 CFR Part 50 construction permit application to construct a medical 

radioisotope production facility on March 26, 2013. Part one of SHINE’s application consisted 

primarily of an environmental report, but also included a description and safety assessment of

the site and general financial information (ADAMS Accession No. ML13088A192). On May 31, 

2013, SHINE submitted the second part of its construction permit application (ADAMS 
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Accession No. ML13172A361).

2

 On September 25, 2013, SHINE supplemented its construction 

permit application with a discussion of preliminary plans for coping with emergencies, as 

required by 10 CFR 50.34(a)(10), completing its application for a construction permit (ADAMS

Accession No. ML13269A378). SHINE most recently updated its construction permit 

application on August 27, 2015 (ADAMS Accession No. ML15258A431). As applicable, SHINE 

used the ISG to develop its preliminary safety analysis report (PSAR). 

The publicly available portions of the application are available in ADAMS and on the NRC Web 

site at http://www.nrc.gov/reading-rm/adams.html. There are portions of the application that 

contain non-public information and have been withheld in accordance with 10 CFR 2.390, 

“Public inspections, exemptions, requests for withholding.” The non-public version of the 

application is available in ADAMS, but is restricted to authorized users. 

SHINE identifies itself as a Wisconsin corporation, a private organization that was created for 

the purpose of designing, constructing, and operating a medical radioisotope production facility 

which will be located on previously undeveloped agricultural property in Rock County, 

Wisconsin, within the southern corporate boundaries of the City of Janesville. SHINE would 

construct, own, and operate the proposed facility.

Additional information about SHINE and ownership is available in “Part One of the SHINE 

Medical Technologies, Inc. Application for Construction Permit,” as provided by letter dated 

March 26, 2013, and supplemented by letters dated May 15, 2014, and September 16, 2015 

(ADAMS Accession Nos. ML13088A192, ML14135A360, and ML15259A272, respectively). 

Additional information about the site location and characteristics appears in Chapters 1 and 2 of 

the construction permit application (ADAMS Accession Nos. ML15258A369 and ML15258A370, 

respectively), as well as in the SHINE Environmental Review, PSAR Section 19.2, “Proposed 

Action” (ADAMS Accession No. ML15258A413).

Overview of the SHINE Safety Review Approach for the Construction Permit Application

The staff’s safety review was tailored to the nature of SHINE’s application and was informed by 

the staff’s ISG, NUREG-1537, as well as other relevant guidance cited therein, cited in the 

application, or used based on the staff’s technical judgment. In particular, SHINE’s 

10 CFR Part 50 application only seeks authorization to construct the proposed SHINE facility. 

Therefore, the level of detail needed in the application and the staff’s corresponding SER is 

different than for a combined license or operating license. For the purposes of issuing a 

construction permit, the SHINE facility may be adequately described at a functional or 

conceptual level in the PSAR. As such, SHINE has deferred providing many design and 

analysis details until the submission of its final safety analysis report (FSAR) with its operating 

license application. 

The objective of the staff’s evaluation was to assess the sufficiency of information contained in 

the PSAR for the issuance of a construction permit in accordance with 10 CFR 50.35(a), 

10 CFR 50.40, and 10 CFR 50.50. An in-depth evaluation of the SHINE design will be 

performed following the staff’s receipt of SHINE’s FSAR.

 2 Because SHINE’s proposed medical radioisotope production facility is not a nuclear power plant, 

10 CFR Part 52, “Licenses, Certifications, and Approvals for Nuclear Power Plants,” does not apply. See 

10 CFR 52.0 (providing scope and applicability of 10 CFR Chapter I provisions).
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The staff’s safety review was also tailored to the unique and novel technology described in 

SHINE’s construction permit application. SHINE proposes to construct an Irradiation Facility 

(IF) and a Radioisotope Production Facility (RPF). The proposed IF consists of eight subcritical 

operating assemblies (or irradiation units [IUs]), each of which would be licensed as a utilization 

facility as defined in 10 CFR 50.2, “Definitions.” The proposed RPF consists of three 

“supercells” for the separation of Mo-99 from irradiated target solution, plus hot-cell and 

glove-box structures for the processing of irradiated and un-irradiated low-enriched uranium 

(LEU) materials, and licensed collectively as a production facility, as defined in 10 CFR 50.2. In 

the staff’s evaluation and in this paper, the IF and RPF are collectively referred to as the SHINE 

facility. 

Given the similarities in SHINE’s proposed facility and non-power research reactors, the staff 

used established guidance documents and the Commission’s regulations to determine the 

acceptance criteria for demonstrating compliance with 10 CFR regulatory requirements. For 

example, the staff used: 

• NUREG-1537, Part 1, “Guidelines for Preparing and Reviewing Applications for the 

Licensing of Non-Power Reactors, Format and Content,” issued February 1996 

(ADAMS Accession No. ML042430055); 

• NUREG-1537, Part 2, “Guidelines for Preparing and Reviewing Applications for the 

Licensing of Non-Power Reactors, Standard Review Plan and Acceptance Criteria,” 

issued February 1996 (ADAMS Accession No. ML042430048); 

• “Final Interim Staff Guidance [ISG] Augmenting NUREG-1537, Part 1, ‘Guidelines for 

Preparing and Reviewing Applications for the Licensing of Non-Power Reactors: Format 

and Content,’ for Licensing Radioisotope Production Facilities and Aqueous 

Homogeneous Reactors,” dated October 17, 2012 (ADAMS Accession No. 

ML12156A069); and 

• “Final Interim Staff Guidance [ISG] Augmenting NUREG-1537, Part 2, ‘Guidelines for 

Preparing and Reviewing Applications for the Licensing of Non-Power Reactors: 

Standard Review Plan and Acceptance Criteria,’ for Licensing Radioisotope Production 

Facilities and Aqueous Homogeneous Reactors,” dated October 17, 2012 

(ADAMS Accession No. ML12156A075). 

In applying these criteria, the staff used its judgement as to which acceptance criteria were 

relevant to SHINE’s proposed facility, as much of this guidance was originally developed for 

nuclear reactors. The staff evaluated the sufficiency of the SHINE preliminary design, as 

described in the PSAR, based on SHINE’s design methodology and ability to provide 

reasonable assurance that the final design will conform to the design bases and allow adequate 

margin for safety. Importantly, the staff’s evaluation of SHINE’s preliminary design does not

constitute approval of any design feature or specification. Such approval would be made 

following the evaluation of SHINE’s final design and analysis, submitted in support of SHINE’s 

operating license application.

The staff has prepared a draft construction permit for the SHINE facility. The draft permit is 

available to the Commission (ADAMS, Accession No. ML15272A009). 
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Advisory Committee on Reactor Safeguards

To support the Advisory Committee on Reactor Safeguards (ACRS) in providing an independent 

review and report to the Commission regarding the SHINE construction permit application, the 

staff presented the results of its safety evaluation to the Radiation Protection & Nuclear 

Materials Subcommittee at four meetings on: June 23, 2015, June 24, 2015, August 19, 2015,

and September 22, 2015. The staff presented the results of its SHINE construction permit 

application review to the ACRS full committee on October 8, 2015. The ACRS issued a letter 

on October 15, 2015 (ADAMS Accession No. ML15286A426), fulfilling the requirement of 

10 CFR 50.58, “Hearings and report of the Advisory Committee on Reactor Safeguards,” that 

the ACRS review and report on construction permits for a facility of the type described in 

10 CFR 50.22, “Class 103 licenses; for commercial and industrial facilities.” The ACRS 

conclusions and recommendations, as well as the staff’s response, are discussed later in this 

paper.

II. Outreach

Public Meetings

At SHINE’s request, the staff hosted public meetings at NRC headquarters prior to docketing 

the SHINE construction permit application in 2013. These meetings were used to discuss 

technical and environmental information related to the development of the application, clarify the 

applicability of relevant guidance, and address public questions on the NRC’s review process. 

Public meetings were also held following the receipt of SHINE’s construction permit application 

to discuss design changes.

On July 17, 2013, the staff held two meetings in Janesville, Wisconsin, to discuss the 

environmental scoping process and to give members of the public an opportunity to provide 

comments on environmental issues the NRC should consider during its review of the 

application. After issuing the draft EIS on May 31, 2015 (ADAMS Accession No. 

ML15127A241), the staff held two more public meetings in Janesville, Wisconsin, on June 10, 

2015, to provide an overview of the draft EIS and to accept public comments on the document.

In total, the staff conducted approximately 15 public meetings and teleconferences prior to and 

during the review of the application. 

Federal Register Notices

The NRC published the following Federal Register (FR) notices, as required, for key milestones 

in the licensing process:

• On April 1, 2013, the NRC published a notice of exemption from 10 CFR 2.101(a)(5), 

allowing SHINE to submit its application in two parts (78 FR 19537).

• After the NRC received part one of SHINE’s two-part application on March 26, 2013, the 

agency published a notice of receipt and availability on May 20, 2013 (78 FR 29390).
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• The NRC docketed part one of the SHINE construction permit application on 

June 25, 2013, and published a notice of acceptance for docketing on July 1, 2013 

(78 FR 39342). 

• On July 1, 2013, the NRC published a notice of intent to prepare an EIS and to conduct 

scoping (78 FR 39343).

• After the NRC received the second and final part of SHINE’s two-part application on 

May 31, 2013, the agency published a notice of receipt and availability on 

August 23, 2013 (78 FR 52579).

• The NRC docketed the second and final part of the SHINE construction permit 

application on December 2, 2013, and published a notice of docketing on 

December 9, 2013 (78 FR 73897). On June 4, 2014, the staff published a notice of 

correction of the December 9, 2013, notice of docketing of the SHINE application 

(79 FR 32333).

• On October 17, 2014, the NRC issued a direct final rule, which became effective 

December 31, 2014, amending the definition of utilization facility in 10 CFR 50.2 to 

include SHINE’s IUs, so that they could be licensed under 10 CFR Part 50 

(79 FR 62329). 

• On March 12, 2015, the NRC published a notice of hearing, opportunity to intervene, and 

order imposing procedures for access to Sensitive Unclassified Non-Safeguards 

Information (80 FR 13036).

• On May 14, 2015, the NRC published a notice of availability of the draft EIS for public 

comment and notice of public meetings to present an overview of the draft EIS and to 

accept public comments on the document (80 FR 27710).

• On October 22, 2015, the NRC published a notice of availability of the final EIS 

(80 FR 64025).

Consultations

In accordance with Section 657 of the Energy Policy Act of 2005, the NRC consulted with the 

U.S. Department of Homeland Security concerning the potential vulnerabilities of the location of 

the proposed irradiation facility to terrorist attack. As part of its environmental review, in 

accordance with the National Environmental Policy Act (NEPA) and other applicable statutes, 

including the Endangered Species Act, the National Historic Preservation Act,and the American 

Medical Isotopes Production Act of 2012, the staff consulted with and obtained input from 

appropriate Federal, State, and local agencies, as well as Tribal organizations.

Adjudicatory Actions

On March 12, 2015, the NRC published in the Federal Register (80 FR 13036) a notice of 

hearing, opportunity to petition for leave to intervene, and order imposing procedures for access 
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to Sensitive Unclassified Non-Safeguards Information. No petitions for leave to intervene were 

filed following publication of this notice.

III. Review Process/ Methodology

The staff used the processes and methodologies, as applicable, described in the following 

documents to ensure quality, consistency, and completeness in preparation of the SER and final 

EIS:

1. NUREG-1537, Part 1, “Guidelines for Preparing and Reviewing Applications for the 

Licensing of Non-Power Reactors, Format and Content” (ADAMS Accession No. 

ML042430055). The principal purpose of the format and content guide is to suggest a 

uniform format for presenting information in non-power reactor applications, help ensure 

completeness of information provided, assist the staff and others in locating information, 

and aid in increasing the efficiency of the review process. While this guide presents a 

format for applications that is acceptable to the staff, conformance is not required.

2. NUREG-1537, Part 2, “Guidelines for Preparing and Reviewing Applications for the 

Licensing of Non-Power Reactors, Standard Review Plan and Acceptance Criteria” 

(ADAMS Accession No. ML042430048). The principal purpose of the standard review 

plan (SRP) is to ensure the quality and uniformity of staff safety reviews. It is also a 

vehicle for disseminating information on regulatory matters concerning non-power 

reactors and clarifying the staff review process for applicants, licensees, and the public. 

Each section of the SRP outlines areas of review, acceptance criteria, review 

procedures, and evaluation findings to guide the staff’s review. The SRP is the most 

definitive basis available for evaluating whether an application meets the set of 

regulations established by the Commission.

3. Interim Staff Guidance. For areas in which the existing SRP does not contain review 

guidance, the staff prepared and used ISGs documents. The ISGs clarify technical 

review approaches and address questions related to regulatory processes and licensing 

activities. The staff used the following ISGs in the SHINE construction permit application 

review:

• “Final Interim Staff Guidance Augmenting NUREG-1537, Part 1, ‘Guidelines for 

Preparing and Reviewing Applications for the Licensing of Non-Power Reactors: 

Format and Content,’ for Licensing Radioisotope Production Facilities and Aqueous 

Homogeneous Reactors,” dated October 17, 2012 (ADAMS Accession No. 

ML12156A069).

• “Final Interim Staff Guidance Augmenting NUREG-1537, Part 2, ‘Guidelines for 

Preparing and Reviewing Applications for the Licensing of Non-Power Reactors: 

• Standard Review Plan and Acceptance Criteria,’ for Licensing Radioisotope 

Production Facilities and Aqueous Homogeneous Reactors,” dated October 17, 2012 

(ADAMS Accession No. ML12156A075).
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4. NUREG-0849, “Standard Review Plan for the Review and Evaluation of Emergency 

Plans for Research and Test Reactors” (ADAMS Accession No. ML062190191). 

This SRP assures that complete and uniform reviews are made of research and test 

reactor radiological emergency plans. As applicable and described in the ISG 

Augmenting NUREG-1537, this standard review plan was used to evaluate the SHINE 

preliminary emergency plan submitted in accordance with Appendix E, “Emergency 

Planning and Preparedness for Production and Utilization Facilities,” to 10 CFR Part 50.

5. Regulatory Guides. Regulatory guides (RGs) provide guidance to licensees and 

applicants on implementing specific parts of the NRC’s regulations, techniques used by 

the staff in evaluating specific problems and scenarios, and information needed by the 

staff in its review of applications for permits or licenses. Consistent with the ISG 

Augmenting NUREG-1537, RGs from Division 2, “Research and Test Reactors,” were 

generally found to be applicable to SHINE. SHINE’s PSAR identifies RGs relevant to 

the construction permit application and whether the SHINE conformed to or departed 

from each RG. As appropriate, regulatory guides endorse American National Standards 

Institute/American Nuclear Society standards for use in the staff’s reviews.

6. Office Instructions. In its review, the staff followed administrative guidance contained 

in a number of office instructions. These internal documents address a range of 

procedural matters, including the staff’s process for issuing a request for additional 

information (RAI), handling audits, ensuring the qualification and training of technical 

staff and managers, ensuring consistency between staff offices, and overseeing 

interactions with applicants, intervenors, and the public.

IV. Advisory Committee on Reactor Safeguards Review

The ACRS review of the SHINE construction permit culminated with a letter to the Commission 

dated October 15, 2015, recommending that the SHINE construction permit should be approved

(ADAMS Accession No. ML15286A426). 

The ACRS letter identified two safety concerns that could impact the operation of the SHINE 

facility, if not sufficiently addressed during construction: (1) the facility’s layup capability, and (2) 

the facility’s ability to withstand potential aircraft impact. The ACRS noted that “nuclear 

chemical processing facilities need to have built-in capability to support layup following 

unexpected process interruptions. It must be possible to stop the process, safely remove 

materials within the system, clean the system, and place it in a safe condition for an extended 

period in a way that does not challenge the facility piping systems and chemical reactors.” 

SHINE and the NRC staff: (1) provided information addressing the provisions made to address 

facility layup, and (2) clarified the analysis of the SHINE facility’s ability to withstand aircraft 

impacts. Additionally, SHINE clarified the relationship between safety-related structures, 

systems, and components (SSCs) and safety-related activities by defining safety-related 

activities. 

SHINE has committed to providing procedures for facility layup and an updated quality 

assurance program description that includes its definition of safety-related activities in its FSAR. 

The staff is tracking these commitments in Appendix A of its SER. 
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Based on discussions during the subcommittee and full committee meetings, the ACRS 

determined that SHINE and the NRC staff provided sufficient information to address facility 

layup and potential aircraft impact, such that it could recommend the issuance of a construction 

permit. The ACRS letter closed by acknowledging that the NRC staff demonstrated an ability to 

develop a practical licensing approach for a unique facility.

DISCUSSION: 

I. Excluded Matters

Excluded from consideration in this uncontested hearing are issues resolved by the direct final 

rule associated with SHINE’s IUs. A full discussion of this rulemaking can be found in the final 

rule (79 FR 62329) published October 17, 2014. As explained in the statements of 

consideration for this direct final rule of particular applicability, the Commission determined by 

rule that each of SHINE’s IUs is a utilization facility subject to 10 CFR Part 50. Therefore, this 

uncontested hearing does not involve consideration of whether 10 CFR Part 50 is the 

appropriate regulatory framework for licensing SHINE’s IUs as that has been resolved by rule. 

The NRC’s rule amending the definition of utilization facility became effective December 31,

2014, and states, in relevant part, that: 

Utilization facility means:

(2) An accelerator-driven subcritical operating assembly used for the 

irradiation of materials containing special nuclear material and described 

in the application assigned Docket Number 50–608.

II. Exemption

Exemption from NRC Regulations

Prior to the submission of SHINE’s construction permit application, SHINE sought and was 

granted an exemption from the stipulation of 10 CFR 2.101(a)(5) that applications for a 

construction permit under 10 CFR Part 50 must be of the type requiring an EIS or a 

supplement to an EIS as described in 10 CFR 51.20(b) (ADAMS Accession No. 

ML13051A007) in order to submit such an application in two parts. Since SHINE’s application 

is not of the type requiring an EIS or supplement to an EIS in 10 CFR 51.20(b), the application 

could not be submitted in two parts. Therefore, the exemption allowed SHINE to submit part 

one of its construction permit up to 6 months prior to the submittal of the remainder of the 

application regardless of whether or not an EIS or a supplement to an EIS would be prepared 

for its construction permit application. SHINE submitted the following in part one of its 

construction permit application:

• The environmental report required by 10 CFR 50.30(f);

• The description and safety assessment of the site required by 10 CFR 50.34(a)(1);

• The filing fee required by 10 CFR 50.30(e) and 10 CFR 170.21;
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• The general information required by 10 CFR 50.33; and

• The agreement limiting access to Classified Information required by 10 CFR 50.37.

Part two of SHINE’s construction permit application contained the remainder of the PSAR 

required by 10 CFR 50.34(a).

In its exemption request, SHINE noted that the underlying purpose of the regulation was to 

remove unnecessary obstacles to the timely and efficient licensing and construction of nuclear 

facilities that are of national interest. SHINE’s exemption request argued that the nation’s 

demand for medical radioisotopes is a significant public health and safety concern, similar to 

the concerns over energy sources and supply for which the initial rule was created to address. 

SHINE stated that an exemption would facilitate the completion of the environmental review 

and ultimate issuance of the construction permit, eliminating delays in construction of the 

SHINE facility.

The staff evaluated the exemption request and determined that such an exemption was 

authorized by law, would not present an undue risk to public health or safety, and was 

consistent with the common defense and security, and that special circumstances were present 

as described in 10 CFR 50.12(a)(2)(ii). The staff determined that the underlying purpose of 

10 CFR 2.101(a)(5), as discussed above, is to facilitate the application submittal process for 

construction permit applicants when it is in the interest of the public to remove unnecessary 

obstacles to meet the needs of the nation. Recognizing that SHINE’s proposed medical 

radioisotope production facility would contribute towards meeting the nation’s domestic 

demands for Mo-99 and its decay product (technetium-99m) in nuclear medicine procedures, 

the staff determined that the underlying purpose of the rule was achieved and special 

circumstances were present. The staff’s evaluation and issuance of the exemption request 

appeared in the Federal Register on April 1, 2013 (78 FR 19537). A summary of this evaluation 

appears in Section 1.1 of the SER.

III. Nonroutine Unique Facility Features and Novel Issue

Safety Matters

a. Licensing Considerations

The proposed SHINE facility presents novel and unique licensing considerations for the staff, 

requiring unique application of statutory and regulatory provisions, issuance of a direct final rule, 

and development of technology-specific guidance. 

Applicability of Atomic Energy Act Section 103

Past non-power utilization facilities licensed under 10 CFR Part 50 have been nuclear reactors 

useful in the conduct of research and development activities and/or used in medical therapy, 

also known as “research and test reactors.” All such facilities have been licensed pursuant to 

Section 104 of the Atomic Energy Act (AEA). However, neither the RPF nor the IUs within the 

IF is a reactor. Neither is useful in the conduct of research or medical therapy. Instead, 

SHINE’s proposed facility is intended to be primarily for commercial purposes (i.e., the 
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production of materials or products for sale or commercial distribution). Therefore, the staff 

determined that SHINE’s proposed facility should be licensed under Section 103 of the AEA. 

As a Section 103 facility, SHINE’s proposed facility is subject to review by the ACRS and a 

mandatory hearing, pursuant to 10 CFR 50.58.

Applicability of 10 CFR Part 50 Regulations 

SHINE’s proposed RPF and the IUs presented unique licensing considerations under 

10 CFR Part 50,3 since SHINE is not proposing to construct and operate nuclear reactors. 

SHINE’s facility includes new technology to produce medical radioisotopes. For example, the 

IU consists of a neutron driver, subcritical assembly, light water pool, target solution vessel 

off-gas system, and other supporting systems. The SHINE IUs will not be operated such that 

the effective neutron multiplication factor (keff) is greater than or equal to 1.0, a range for which 

nuclear reactors are designed, analyzed, and licensed to operate safely. Instead, the irradiation 

units will operate in a minimally subcritical range of keff. 

While the individual components of the irradiation units are familiar to the staff, the compilation 

of these components into the SHINE IUs represents largely new technology. In particular, the 

accelerator and neutron multiplier achieve a fission rate with a thermal power level comparable 

to that of non-power reactors licensed as utilization facilities under 10 CFR Part 50. Because of 

their thermal power levels, the IUs share similar safety considerations with other non-power 

reactors (e.g., AHRs), including the following:

• Provisions for removal of fission heat during operation;

• Passive decay heat generation after shutdown;

• Inherent negative reactivity feedback;

• Fission gas release during operation and gas management engineering safety features;

• Radiolytic decomposition of water into oxygen and hydrogen;

• Fission products; and

• Accident scenarios, such as loss of coolant, reactivity addition, and fission product 

release.

Given these safety considerations and the functional similarities of the IUs to non-power 

reactors, the NRC staff used its technical judgment in determining applicable acceptance criteria 

for SHINE’s construction permit application and the applicable regulations. 

 3 The RPF meets the definition of production facility in 10 CFR 50.2. The IUs were designated by rule to be 

utilization facilities in the direct final rule effective December 31, 2014. See 79 FR 62329. 
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Licensing Production Facilities

Another unique aspect of licensing SHINE’s proposed facility is that the SHINE RPF represents 

the first production facility licensed by the NRC since West Valley, which ceased operations in 

1972. The SHINE RPF consists of hot cells used to process irradiated target solution for Mo-99 

separation and purification. According to the SHINE PSAR Section 1.5.1, “[t]he hot cell design 

is conventional and is similar to the design used in many other facilities.” The primary chemical 

processes occurring in the hot cells are molybdenum extraction, molybdenum purification, 

uranyl nitrate conversion, uranium extraction, evaporation and thermal denitration, waste 

evaporation and solidification, and tritium purification. The staff determined that the SHINE RPF 

meets the third definition of “production facility” in 10 CFR 50.2, which defines a production 

facility as any facility designed or used for the processing of irradiated materials containing 

special nuclear material.

While the NRC has historically licensed production facilities, no such facilities are currently 

operating. Only two previously-licensed NRC facilities have conducted activities similar to the 

SHINE RPF (Cintichem and West Valley), and both ceased operations at least 25 years ago. 

Cintichem, which operated until 1990, employed a molybdenum purification process similar to 

SHINE’s purification process. The primary difference between the two processes is a slight 

change in chemistry to accommodate the change in chemical and isotopic composition caused 

by the switch from highly-enriched uranium to LEU. Similar to Cintichem, shielding and 

confinement will serve as the principal engineered safety features in reducing worker doses at 

the SHINE facility. However, in contrast to SHINE, the Cintichem purification processing was 

licensed under 10 CFR Part 70, “Domestic Licensing of Special Nuclear Material.” 

The staff also considered whether the RPF was a fuel reprocessing facility. The SHINE 

uranium extraction (UREX) process is a modification of the widely-used plutonium and uranium 

extraction (PUREX) process in which irradiated fuel goes through dissolution, fission product 

and waste separation, and uranyl and plutonium nitrate purification. The PUREX process was 

developed in the late 1940s and uses tributyl phosphate to selectively remove uranium and 

plutonium from a nitric acid solution typically containing a host of fission product and other 

actinide contaminants. The only NRC-licensed facility to use the UREX process was West 

Valley, a fuel reprocessing facility that ceased operations in 1972.

There is currently neither a statutory nor regulatory definition for what does and does not 

constitute a fuel reprocessing facility. While fuel reprocessing plants are considered production 

facilities under 10 CFR Part 50, more specific definitions and interpretations have varied over 

the years, as evidenced in Federal Register notices, staff-generated SECY Papers, and Nuclear 

Energy Institute white papers (see: http://www.nrc.gov/materials/reprocessing.html, “Additional 

Documents,” and 39 FR 26293).

In 2006, the Commission directed the Advisory Committee on Nuclear Waste and Materials (the 

Committee) to define the issues most important to the NRC concerning fuel reprocessing 

facilities. As a result, the Committee published NUREG-1909, “Background, Status, and Issues 

Related to the Regulation of Advanced Spent Nuclear Fuel Recycle Facilities,” in June 2008, 

which describes “reprocessing” as the separation of spent nuclear fuel into its constituent 

components (ADAMS Accession No. ML082100043). As defined in 10 CFR 72.3, spent nuclear 

fuel or spent fuel means “fuel that has been withdrawn from a nuclear reactor following 
The Commissioners - 13 -

irradiation, has undergone at least one year’s decay since being used as a source of energy in a 

power reactor, and has not been chemically separated into its constituent elements by 

reprocessing...”. Based on these definitions of fuel reprocessing and spent nuclear fuel, the 

staff concluded that only fuel from a nuclear power reactor is considered spent nuclear fuel, and 

therefore, only fuel from a nuclear power reactor may be reprocessed. Since the SHINE RPF 

will only process the LEU target solution previously irradiated in the IF and will not be 

processing spent nuclear fuel, as defined in 10 CFR 72.3, the processing of SHINE’s irradiated 

LEU target solution does not constitute fuel reprocessing. Therefore, the staff concluded that 

SHINE’s production facility is not a fuel reprocessing facility.

b. Accident Analysis Methodology

Accident analyses for 10 CFR Part 50 facilities need to show that the health and safety of both 

the public and workers are protected; potential radiological and non-radiological consequences 

have been considered in the event of malfunctions; and the 10 CFR Part 50 facility is capable of 

accommodating disturbances in the functioning of SSCs. Additionally, accident analyses need 

to demonstrate that design features, safety limits, limiting safety system settings, and limiting 

conditions for operation ensure that no credible accident could lead to unacceptable radiological 

consequences to people or the environment.

For the SHINE facility, two accident analysis methodologies were applied to analyze accident 

scenarios based on the guidance contained in NUREG-1537 and the ISG Augmenting 

NUREG-1537. Accident analyses at the SHINE facility were evaluated against the radiological 

exposure limits prescribed in 10 CFR Parts 20 and 50. Radiological events at the IF and RPF 

were evaluated using the maximum hypothetical accident methodology typically used at 

non-power reactors licensed under 10 CFR Part 50. For the RPF accident analysis, the staff 

determined that use of Integrated Safety Analysis methodologies as described in 

10 CFR Part 70 and incorporated into the ISG augmenting NUREG-1537 is an acceptable way 

of demonstrating safety given the RPF’s similarity to existing fuel cycle facilities licensed under 

10 CFR Part 70, which is unique for a facility licensed under 10 CFR Part 50. 

In addition to radiological exposure considerations, per the guidance in the ISG augmenting 

NUREG-1537, the RPF accident analyses used consequence and likelihood criteria for potential 

accidents resulting in chemical exposure to workers or members of the public. Additionally, 

consistent with the guidance in the ISG augmenting NUREG-1537, the chemical performance 

requirements in 10 CFR 70.61(b)(4) and (c)(4) were used as criteria for chemical-related 

accident sequences. 

Radiological Accidents

For radiological accidents within the IF and RPF, analyzed scenarios ranged from anticipated 

events (e.g., a loss of normal electrical power) to a postulated fission-product release with 

radiological consequences exceeding those of any accident considered to be credible. The 

latter of these two scenarios is referred to as the maximum hypothetical accident (MHA), as 

described in NUREG-1537. Because the MHA is not expected to occur, the scenario need not 

be entirely credible. The initiating event and the scenario details need not be analyzed, but the 

potential consequences are analyzed and evaluated. 
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SHINE postulated MHAs for both the IF and RPF and determined that the bounding scenario for 

the facility occurred in the RPF. This bounding scenario (i.e., the MHA) involves a release of 

radiological material from the Noble Gas Removal System tanks that results in the maximum 

doses to workers and individual members of the public. For the MHA, a total effective dose 

equivalent (TEDE) of 3.59 roentgen equivalent man (rem) was calculated for the workers at the 

facility, which is less than the 5 rem regulatory limit specified in 10 CFR 20.1201. A TEDE of 

0.0820 rem was calculated for a member of the public at the site boundary, and a TEDE of 

0.0115 rem was calculated at the nearest residence. The off-site doses are less than the 0.1 

rem regulatory limit specified in 10 CFR 20.1301. Thus, the dose consequences of the MHA 

were all within the regulatory limits of 10 CFR Part 20. 

Non-radiological Accidents

The staff also conducted a chemical process safety review for the SHINE RPF. This review 

covered chemical safety-related accidents, chemical safety controls, and the corresponding 

surveillance requirements. The scope included equipment and facilities that protect against 

releases of and chemical exposures to licensed material or hazardous chemicals produced from 

licensed material. The staff also looked at chemical risks of plant conditions that affect the 

safety of licensed material. As described in the ISG augmenting NUREG-1537, Part 2, this 

review is conducted as part of the 1988 “Memorandum of Understanding Between the NRC and 

the Occupational Safety and Health Administration” (53 FR 43950). The staff determined that 

SHINE’s preliminary facility design, proposed operations, and anticipated safety controls for 

chemical safety provide reasonable assurance that they will function as intended and, thus, that 

they will be adequate to protect public health and safety and the environment.

Environmental Matters

a. Determination to Prepare an Environmental Impact Statement and to Make Findings In 

10 CFR 51.105

One novel consideration for the environmental review of the SHINE construction permit 

application was determining the appropriate methodology and level of detail for the staff’s 

environmental findings. Environmental reviews for licensing actions, such as construction 

permits, operating licenses, or license amendments, fall into one of three categories: those 

identified as categorical exclusions, those requiring the preparation of an Environmental 

Assessment (EA), and those requiring the preparation of an EIS. The regulations in 

10 CFR 51.20, “Criteria for and identification of licensing and regulatory actions requiring 

environmental impact statements,” describe several types of actions that would require an EIS. 

Construction permits and operating licenses for medical radioisotope facilities are not 

specifically included in 10 CFR 51.20. Such activities may require an EA or an EIS, depending 

on the action’s potential for significant impacts that may affect the quality of the human 

environment. 

An EA is used to determine if the impacts from the proposed action may be significant and 

whether a finding of no significant impact can be made. If an EA concludes that the proposed 

action could result in significant impacts to the human environment, then an EIS will be 

prepared. In some cases, the NRC may decide to prepare an EIS, rather than an EA, if there is 
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the potential for significant impacts to the human environment or the proposed action involves a 

matter that the Commission, by discretion, has determined should be covered by an EIS. 

After reviewing the environmental report and the nature of the application, the NRC staff 

determined, as a matter of discretion, that an EIS was appropriate to assess the environmental 

impacts of the proposed action. This determination was made because of the potential for 

significant environmental impacts and the considerations of a first-of-a-kind application for a 

medical radioisotope production facility with a unique application of technologies. The EIS 

process also allowed for maximum public involvement, such as a comment period during the 

scoping period to develop the draft EIS, a comment period after publication of the draft EIS, and 

public meetings in Janesville, Wisconsin, during each of the two comment periods.

Another unique aspect of the SHINE construction permit review is that the staff had to use its 

technical judgment to determine the appropriate environmental findings to make in support of 

issuance of a construction permit, as required by 10 CFR 50.40 and 10 CFR Part 51. After 

reviewing the application and the Commission’s 10 CFR Part 51 regulations implementing 

NEPA, the staff determined that 10 CFR 51.105(a) provided the applicable findings given that 

the proposed action is the issuance of a construction permit, and the generic NEPA findings in 

that regulation are required to license similar facilities.4

b. Department of Energy as a Cooperating Agency

Another nonroutine aspect of the SHINE construction permit environmental review is that two 

Federal agencies are obligated to conduct environmental reviews under the NEPA, as amended 

(42 U.S.C. 4321 et seq.). NRC is required to conduct an environmental review under NEPA to 

decide whether to grant SHINE a construction permit. The U.S. Department of Energy (DOE) is 

required to conduct an environmental review under NEPA to engage in cost-sharing activities to 

accelerate domestic endeavors to demonstrate and produce a reliable supply of Mo-99 using a 

technology that does not rely on the use of highly-enriched uranium.

NEPA provisions lay the groundwork for coordination between two (or more) agencies that may 

both have jurisdiction by law or special expertise on an environmental issue. One agency is 

considered the lead agency and has the primary role in preparing an EIS, while the other 

Federal agency, referred to as a “cooperating agency,” is responsible for assisting the lead 

agency in the development of the EIS. The cooperating agency provides technical input to the 

environmental analysis and provides staff support, as needed, to the lead agency. 

In addition to the NRC’s and DOE’s obligations under NEPA, the National Defense 

Authorization Act for fiscal year 2013, Title XXXI, Subtitle F, known as the American Medical 

Isotopes Production Act of 2012 (42 U.S.C. 2065 et seq.), directs the NRC and DOE to ensure, 

to the maximum extent practicable, that environmental reviews for facilities to produce medical 

radioisotopes are complementary and not duplicative. 

Based on NEPA groundwork for coordinating environmental review efforts and the need to 

coordinate environmental reviews as described in the American Medical Isotopes Production 

Act, the NRC and DOE decided to enter into a cooperative agreement to make the most 

 4 See, e.g., 10 CFR 51.107, “Public hearings in proceedings for issuance of combined licenses; limited work 

authorizations,” and 51.109, “Public hearings in proceedings for issuance of materials license with respect to a 

geologic repository.”
The Commissioners - 16 -

effective and efficient use of Federal resources in reviewing SHINE’s construction permit 

application. On December 1, 2014, and February 3, 2015, the NRC and DOE signed a 

Memorandum of Agreement (MOA) on the review of the SHINE application (ADAMS Accession 

No. ML13304B666). The goal of this agreement is to develop one EIS that serves the NRC 

licensing process and the DOE funding process. The MOA designates the NRC as the lead 

Federal agency and DOE as a cooperating agency in developing an EIS for the proposed 

SHINE facility. The MOA also provides that DOE, as a cooperating agency, will commence the 

process to adopt the final EIS after it is completed.

c. Range of Reasonable Alternatives

Chapter 5 of the EIS describes alternatives to granting a construction permit for the proposed 

SHINE facility and the environmental impacts of those alternatives. The need to compare the 

proposed action with alternatives arises from the requirement in Section 102(2)(C)(iii) of NEPA. 

NEPA states that an EIS shall include an analysis of alternatives to the proposed action. The 

NRC implements this requirement through regulations in 10 CFR Part 51 and its ISG 

augmenting NUREG–1537, which state that the EIS will include an analysis that considers and 

weighs the environmental effects of the proposed action, the environmental impacts of 

alternatives to the proposed action, and alternatives available for reducing or avoiding adverse 

environmental effects.

As part of the EIS, the NRC staff considered alternative technologies to produce Mo-99. This 

analysis was novel for the SHINE review because several entities have proposed new 

technologies to produce Mo-99 and the proposed new technologies are at various stages of 

development. When a large number of potential alternatives exist, NEPA requires that an 

agency analyze a reasonable number of examples, covering the full spectrum of alternatives, in 

the EIS (46 FR 18026). For the alternative technologies analysis, the NRC staff initially 

narrowed down the broad range of potential alternatives by considering three alternative 

technologies that received cooperative agreements from DOE-National Nuclear Security 

Administration (NNSA) and appeared to be technologically reasonable. In awarding these 

cooperative agreements, DOE-NNSA based its decision, in part, on an evaluation of the 

technical feasibility. The three alternative technologies included:

(1) Neutron capture technology,

(2) Aqueous homogenous reactor technology, and

(3) Linear-accelerator-based technology.

The NRC staff then considered whether sufficient environmental data existed to conduct a 

meaningful alternatives analysis for each of the three technologies. For the neutron capture and 

aqueous homogenous reactor technology, the NRC staff determined that due to the lack of 

environmental data regarding the potential impacts from construction, operations, and 

decommissioning, insufficient environmental information existed to meaningfully analyze the 

environmental impacts of these two alternatives. The NRC staff determined that sufficient 

environmental data existed for the linear-accelerator-based alternative, whereby Mo-99 would 

be produced by utilizing an accelerator to irradiate natural molybdenum that has been enriched 

in the radioisotope Mo-100. The NRC staff analyzed this alternative in depth and evaluated the 
The Commissioners - 17 -

environmental impacts of construction, operations, and decommissioning a hypothetical 

linear-accelerator-based facility to produce Mo-99. The NRC staff determined that the impacts 

from construction, operations, and decommissioning would be SMALL for all resource areas, 

with the exception of transportation. The impacts to transportation would be SMALL to 

MODERATE because of the noticeable increase in average daily traffic flow. During 

construction and decommissioning, traffic would increase due to the removal of excavated 

materials, shipment of construction materials or dismantled buildings to or from the site, 

transport of worker personnel, and movement of heavy equipment for onsite construction or 

decommissioning activities. During operations, traffic would increase due to transport of worker 

personnel, shipments of hazardous and radioactive waste to treatment and disposal facilities; 

receipt of processing materials (e.g., acids and other chemicals); receipt of target materials; 

shipment of the Mo-99 and other medical radioisotopes; and, potentially, the return of 

technetium-99m generators.

IV. Findings

10 CFR 50.35(a) 

(1) 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.

The principal architectural and engineering criteria incorporated into the proposed design of the 

SHINE facility to protect the health and safety of the public are presented in the SHINE PSAR. 

Principal design criteria, design bases, administrative controls, passive safety features, and

active safety features are found in the following PSAR chapters:

Chapter 1 The Facility

Chapter 2 Site Characteristics

Chapter 3 Design of Structures, Systems, and Components

Chapter 4 Reactor and Isotope Production Facility Design

Chapter 5 Coolant Systems

Chapter 6 Engineered Safety Features

Chapter 7 Instrumentation and Control Systems

Chapter 8 Electrical Power Systems

Chapter 9 Auxiliary Systems

Chapter 13 Accident Analysis

Chapter 14 Technical Specifications

The staff evaluated SHINE’s preliminary design to ensure the sufficiency of principal design 

criteria; design bases; and information relative to materials of construction, general 

arrangement, and approximate dimensions. Special attention was given to design and 

operating characteristics, unusual or novel design features, and principal safety considerations. 

Based on its evaluation, the staff concludes that SHINE’s preliminary facility design is sufficient 

to provide reasonable assurance that the final design will conform to the design basis. In 

addition, the staff reviewed SHINE’s identification and justification for the selection of variables, 
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conditions, or other items that are probable subjects of technical specifications for the SHINE 

facility.

In areas where the staff found that the information submitted initially was incomplete or 

insufficient to allow the staff to reach a conclusion, the staff issued RAIs to SHINE. The staff 

reviewed SHINE’s RAI responses to ensure that the additional information provided was 

sufficient to support the staff’s conclusion. Where necessary, SHINE provided supplemental 

RAI responses. The staff also conducted audits of SHINE’s records and calculations and 

performed its own confirmatory calculations.

The staff finds that the preliminary design and analysis of the SHINE IF and RPF: (1) provides 

reasonable assurance that the final design will conform to the design basis, (2) includes an 

adequate margin of safety, (3) SSCs adequately provide for the prevention of accidents and the 

mitigation of consequences of accidents, and (4) meets all applicable regulatory requirements 

and acceptance criteria in or referenced in NUREG-1537 and the ISG augmenting 

NUREG-1537. Furthermore, the staff’s review confirmed that radiological releases and human 

doses during both normal operation and accident scenarios will remain within the regulatory 

limits of 10 CFR Part 20. This supports the staff’s conclusion that issuance of the permit will not 

be inimical to the common defense and security or to the health and safety of the public. As 

discussed in Chapter 1 of the SHINE SER, the staff made its inimicality finding after determining 

that SHINE met all applicable regulations and acceptance criteria. 

The staff concludes that SHINE 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. SHINE meets the applicable standards and requirements of the Atomic 

Energy Act of 1954, as amended, and the Commission’s regulations.

(2) 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.

The staff evaluated the sufficiency of the preliminary design of the SHINE facility based on 

SHINE’s design methodology and ability to provide reasonable assurance that the final design 

will conform to the design bases with adequate margin for safety. As such, the staff’s evaluation 

of SHINE’s preliminary design does not constitute approval of the safety of any design feature 

or specification. Such approval would be made following the evaluation of SHINE’s final design 

and analysis, as described in the FSAR submitted as part of SHINE’s operating license 

application.

Throughout the PSAR, and in responses to RAIs, SHINE clearly indicated areas in which further 

technical or design information would be provided in the FSAR to complete the safety analysis. 

For those areas identified in responses to RAIs, SHINE has generated Issues Management 

Reports (IMRs) as a means of internally tracking unresolved issues requiring follow-up in the 

FSAR. The staff is independently tracking SHINE’s IMRs as regulatory commitments, 

enumerated as Appendix A of the SHINE construction permit SER. 
The Commissioners - 19 -

Based on its review of the application and RAIs, the staff has determined that SHINE has 

provided reasonable assurance that further technical or design information, which can 

reasonably be left for later consideration, will be supplied in the FSAR. Thus, the staff 

concludes that SHINE has met the applicable standards and requirements of the Atomic Energy 

Act of 1954, as amended, and the Commission’s regulations.

(3) Safety features or components, if any, which require research and development have 

been described by the applicant and the applicant has identified, and there will be 

conducted, a research and development program reasonably designed to resolve any 

safety questions associated with such features or components.

As described in SHINE PSAR Section 1.3.9, “Research and Development,” and in response to 

RAI G-1, SHINE has identified two ongoing research and development activities:

• Irradiation and corrosion testing at Oak Ridge National Laboratory to study mechanical 

performance of materials, as described in the PSAR; and

• Precipitation studies at Argonne National Laboratory to ensure precipitation of uranyl 

peroxide in the target solution will not occur, as described in response to RAI G-1.

In support of these activities, SHINE has provided descriptions of affected SSCs, the remaining 

work to be performed, and anticipated schedules for completion.

However, the staff has determined that additional information is needed to address certain 

matters related to nuclear criticality safety and radiation protection in the RPF. Accordingly, the 

construction permit is conditioned upon SHINE providing information related to nuclear criticality 

safety and radiation protection. The draft construction permit lists these conditions. The 

conditions of the construction permit are confirmatory in nature and must be satisfied prior to the 

completion of construction. Additional details on the basis for each condition appear in the 

technical evaluations of the SHINE construction permit SER, Chapters 6 and 11, “Radiation 

Protection Program and Waste Management.” 

On the basis of the staff’s review of the SHINE construction permit application, the staff 

concludes that SHINE has described safety features and components that require research and 

development. Furthermore, SHINE will conduct a research and development program 

reasonably designed to resolve any safety questions associated with mechanical performance 

of materials and uranyl peroxide precipitation. Such further matters associated with nuclear 

criticality safety and radiation protection that require additional information are addressed by 

conditions of the permit. Thus, the staff concludes that SHINE meets the applicable standards 

and requirements of the Atomic Energy Act of 1954, as amended, and the Commission’s 

regulations.

(4) 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 completion of construction of the proposed facility, and
The Commissioners - 20 -

By letter dated September 29, 2015 (ADAMS Accession No. ML15272A395), SHINE has stated 

that the latest date for completion of construction is expected to be December 31, 2022. Based 

on the schedules provided in response to RAI G-1, SHINE’s two research and development 

activities would be resolved in advance of the estimated completion of construction. As 

described in Chapters 6 and 11 of the staff’s SER, the conditions of SHINE’s permit must also 

be satisfied prior to the completion of construction.

On the basis of the staff’s review of the SHINE construction permit application, the staff 

concludes that there is reasonable assurance that SHINE’s research and development activities 

will be satisfactorily completed at or before the latest date for the completion of construction of 

the SHINE facility. Thus, the staff concludes that the applicable standards and requirements of 

the Atomic Energy Act of 1954, as amended, and the Commission’s regulations have been met.

(ii) taking into consideration the site criteria contained in part 100 of this chapter, the 

proposed facility can be constructed and operated at the proposed location without 

undue risk to the health and safety of the public.

The staff reviewed the application to assure that issuance of the permit will not be inimical to the 

common defense and security or to the health and safety of the public. While the site criteria 

contained in 10 CFR Part 100 are applicable to nuclear power reactors, and not the SHINE 

facility, the staff considered site-specific conditions similar to those in 10 CFR Part 100 in 

Chapter 2 of its SER. Using the guidance in NUREG-1537, the staff evaluated SHINE’s 

analysis of site-specific conditions, including the geography and demography of the site; 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 in 

Chapter 2 of the staff’s SER. The review also evaluated SSCs and equipment designed to 

ensure safe operation, performance, and shutdown when subjected to extreme weather, floods, 

seismic events, missiles (including aircraft impacts), chemical and radiological releases, and 

loss of offsite power.

As discussed in Chapters 11 and 13 of the staff’s SER, the review confirmed that radiological 

releases and doses during both normal operation and accident scenarios will remain within the 

regulatory limits of 10 CFR Part 20. Thus, the staff concludes that the issuance of the 

construction permit will not be inimical to the common defense and security or to the health and 

safety of the public. 

The staff’s review of SHINE’s preliminary emergency planning information concluded that the 

preliminary emergency plan contains the information required in Appendix E, to 10 CFR Part 50. 

Therefore, as discussed in Chapter 12 of the staff’s SER, the plan is acceptable and supports 

the staff’s conclusion that issuance of the permit will not be inimical to the common defense and 

security or to the health and safety of the public.

On the basis of the staff’s review of the application, as discussed in this paper and the 

referenced documents, the staff concludes that there is reasonable assurance that the proposed 

facility can be constructed and operated at the proposed location without undue risk to the 

health and safety of the public. The staff also concludes that the provisions of the Atomic 

Energy Act of 1954, as amended, and the Commission’s regulations have been met. In some 
The Commissioners - 21 -

cases, the staff’s “reasonable assurance” finding required the inclusion of conditions in the 

permit. The draft construction permit lists these conditions. 

10 CFR 51.105(a):

(i) Determine whether the requirements of Sections 102(2) (A), (C), and (E) of NEPA and

the regulations in Subpart A of 10 CFR Part 51 have been met.

Although not expressly applicable to a construction permit application for SHINE’s proposed 

facility, the staff reviewed the application and the Commission’s regulations in 10 CFR Part 51 

and determined that 10 CFR 51.105(a) provided the applicable environmental findings. The 

staff performed this evaluation using applicable portions of the environmental standard review 

plan (NUREG-1537) and the ISG augmenting NUREG-1537. 

In accordance with NEPA Section 102(2)(A) (42 U.S.C. § 4332(2)(A)), the staff prepared the 

final EIS (NUREG-2183) based on its independent assessment of the information provided by 

SHINE and information developed independently by the staff, including through consultation 

with other agencies. The staff’s technical analysis used a systematic, interdisciplinary approach 

to integrate information from many fields, including the natural and social sciences as well as 

the environmental design arts. Consequently, the staff concludes that its review comports with 

the NRC’s requirements in Appendix A, “Format for Presentation of Material in Environmental 

Impact Statements,” to 10 CFR Part 51. The staff concludes that environmental findings in the 

final EIS constitute the “hard look” required by NEPA and have reasonable support in logic and 

fact.

In accordance with NEPA Sections 102(2)(C)(i–v) (42 USC § 4332(2)(C)(i–v), the final EIS for 

the SHINE construction permit addresses: (1) the environmental impact of the proposed action, 

(2) any unavoidable adverse environmental effects, (3) alternatives to the proposed action, (4) 

the relationship between local short-term uses of the environment and the maintenance and 

enhancement of long-term productivity, and (5) any irreversible and irretrievable commitments 

of resources that would be involved in the proposed action should it be implemented.

As supported by correspondence presented in Appendices C and D to the final EIS, the staff 

concludes that it fulfilled the requirement of NEPA Section 102(2)(C) by consulting with and 

obtaining comments from other Federal, State, and local agencies with jurisdiction by law or 

special expertise (see 42 USC § 4332(2)(C)). The DOE fully participated with the NRC in 

preparing this EIS as a cooperating agency and participated collaboratively on the review team 

under the NRC’s memorandum of agreement with the DOE. The staff also filed the final EIS

with the U.S. Environmental Protection Agency (EPA), furnished it to commenting agencies, and 

made the final EIS available to the public. 

The staff concludes that the final EIS demonstrates that the staff adequately considered 

alternatives to the proposed action to the extent that it involves unresolved conflicts concerning 

alternative uses of available resources, consistent with the requirements of NEPA 

Section 102(2)(E) (42 USC § 4332(2)(E)). The alternatives considered in the final EIS include 

the no-action alternative, alternative sites, and alternative technologies.
The Commissioners - 22 -

(ii) Independently consider the final balance among conflicting factors contained in the

record of the proceeding with a view to determining the appropriate action to be taken.

Section 5.4 of the final EIS provides the staff’s cost-benefit balancing. The staff concluded that 

in weighing the costs and benefits, the overall benefits of constructing, operating, and 

decommissioning the proposed SHINE facility at the Janesville site outweigh the disadvantages 

and costs based upon the following considerations:

• U.S. policy is to ensure a reliable supply of medical radioisotopes while 

minimizing the use of highly enriched uranium for civilian purposes;

• The small environmental impact, including radiological impacts and risk to 

human health, which would be caused by constructing, operating, and 

decommissioning the proposed SHINE facility at the Janesville site;

• The economic benefit of constructing and operating the proposed SHINE

facility to communities located near the Janesville site; and

• The increased availability of medical radioisotopes for U.S. public health

needs.

(iii) Determine, after weighing the environmental, economic, technical, and other benefits

against environmental and other costs, and considering reasonable alternatives, whether

the construction permit...should be issued, denied, or appropriately conditioned to 

protect environmental values.

As noted above, in its final EIS, the NRC staff considered the cost-benefit balancing as well as 

reasonable alternatives. Based on that analysis, the staff recommends that the construction 

permit be issued. The NRC staff based its recommendation on: (1) the SHINE environmental 

report submitted as part of its construction permit application; (2) consultation with Federal, 

State, and local agencies and Tribes; (3) the NRC staff’s own independent review; (4) the NRC 

staff’s consideration of public scoping comments related to the environmental review; (5) the 

NRC staff’s consideration of public comments on the draft EIS; and (6) the assessments 

summarized in the EIS, including the potential mitigation measures identified in the 

environmental report and in the EIS. In addition, in making its recommendation, the staff 

determined that none of the alternative sites are environmentally preferable to the proposed 

Janesville site.

(iv) Determine, in an uncontested proceeding, whether the NEPA review conducted by the 

NRC staff has been adequate.

The staff conducted an independent evaluation of the application; developed independent, 

reliable information; and conducted a systematic, interdisciplinary review of the potential 

impacts of the proposed action on the human environment and reasonable alternatives to 

SHINE’s proposal. Before development of the draft EIS, the staff issued a notice of intent and 

invited the public to provide any information relevant to the environmental review. The staff also 

provided opportunities for governmental and general public participation during the public 

meeting on the draft EIS and used publicly available guidance in the development of its final 
The Commissioners - 23 -

EIS. The contents of the final EIS are in conformance with the requirements of Appendix A to 

10 CFR Part 51.

The staff considered the purpose of and need for the proposed action, the environment that 

could be affected by the action, and the consequences of the proposed action, including 

mitigation that could reduce impacts. The final EIS considered the no-action alternative, 

alternative sites, and alternative technologies. The final EIS compared the alternatives to the 

proposed action. The staff considered any adverse environmental effects that could not be 

avoided should the proposed action be implemented, the relationship between short-term uses 

of the human environment and the maintenance and enhancement of long-term productivity, 

and any irreversible or irretrievable commitments of resources that would be involved in the 

proposed project.

The NRC filed the draft EIS with the EPA for its review consistent with its requirements of 

Section 309 of the Clean Air Act (see 42 U.S.C. § 7609). The staff considered all comments 

received on the draft EIS and, in Appendix A to the final EIS, described the manner in which 

each comment was dispositioned.

On these bases, the staff concludes that, for the purpose of issuing the construction permit, it 

conducted a thorough and complete environmental review that was sufficient to meet the 

requirements of NEPA and adequate to inform the Commission’s action on the construction 

permit request.

CONCLUSION:

Based on the findings of its review in accordance with 10 CFR 50.35(a) and 10 CFR 51.105, the 

staff concludes that there is sufficient information for the Commission to issue the subject 

construction permit to SHINE, as guided by the following considerations described in 

10 CFR 50.40 and 10 CFR 50.50, and described in Chapter 1, “The Facility,” of the staff’s SER:

• There is reasonable assurance: (i) that the construction of the SHINE facility will not 

endanger the health and safety of the public, and (ii) that construction activities can be 

conducted in compliance with the Commission’s regulations;

• SHINE is technically qualified to engage in the construction of its proposed facility in 

accordance with the Commission’s regulations;

• SHINE is financially qualified to engage in the construction of its proposed facility in 

accordance with the Commission’s regulations;

• The issuance of a permit for the construction of the facility would not be inimical to the 

common defense and security or to the health and safety of the public; 

• 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 
The Commissioners - 24 -

10 CFR Part 51 of the Commission’s regulations and all applicable requirements have 

been satisfied; and

• The application meets the standards and requirements of the AEA and the 

Commission’s regulations, and that notifications, if any, to other agencies or bodies have 

been duly made.

COORDINATION:

The Office of the General Counsel has reviewed this paper and has no legal objection.

/RA/

Victor M. McCree

Executive Director

 for Operations
The Commissioners - 24 -

• SHINE is financially qualified to engage in the construction of its proposed facility in 

accordance with the Commission’s regulations;

• The issuance of a permit for the construction of the facility would not be inimical to the 

common defense and security or to the health and safety of the public; 

• 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 Commission’s regulations and all applicable requirements have 

been satisfied; and

• The application meets the standards and requirements of the AEA and the 

Commission’s regulations, and that notifications, if any, to other agencies or bodies have 

been duly made.

COORDINATION:

The Office of the General Counsel has reviewed this paper and has no legal objection.

/RA/

Victor M. McCree

Executive Director

 for Operations

ADAMS Accession No.: ML15272A004 *via e-mail SECY-012

OFFICIAL RECORD COPY

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DATE 09/28/15 9/29/15 10/01/15 9/29/15 9/28/15

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DATE 10/01/15 10/01/15 10/02/15 10/02/15 10/08/15

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NAME CHaney (SMoore for)* BSheron (SWest for) LKokajko WDean VMcCree

DATE 10/09/15 10/13/15 10/02/15 10/07/15 10/22/15