UNITED STATES OF AMERICA 

NUCLEAR REGULATORY COMMISSION 

COMMISSIONERS: 

Stephen G. Burns, Chairman 

Kristine L. Svinicki 

William C. Ostendorff 

Jeff Baran 

In the Matter of 

SHINE MEDICAL TECHNOLOGIES, INC. 

(Medical Radioisotope Production Facility) 

Docket No. 50-608-CP 

CLI-16-04

MEMORANDUM AND ORDER 

On December 15, 2015, we held a hearing on the application of SHINE Medical 

Technologies, Inc. for a permit to construct a medical radioisotope production facility in 

Janesville, Wisconsin.1 The purpose of the evidentiary hearing was to consider the sufficiency 

of the NRC Staff’s review of SHINE’s application. As discussed below, we conclude that the 

Staff’s review was adequate to support the findings set forth in our regulations. We authorize 

issuance of the construction permit. 

 

 

1 See SHINE Medical Technologies, Inc.; Notice of Hearing, 80 Fed. Reg. 67,435 (Nov. 2, 2015) 

(Notice of Hearing); Tr. at 1-220 (attached as Appendix B to Order of the Secretary (Adopting 

Proposed Transcript Corrections, Admitting Post-Hearing Exhibits, and Closing the Record of 

the Proceeding) (Jan. 14, 2016) (unpublished) (Transcript Correction Order)). 
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I. BACKGROUND 

A. Proposed Action 

SHINE seeks to build a medical radioisotope production facility primarily to produce 

molybdenum-99. Molybdenum-99 decays to technetium-99m, a radioisotope used in medical 

diagnostic procedures, including bone scans and cardiac stress tests.2 SHINE requested and 

received an exemption to submit its application in two parts.3 It submitted Part 1 on March 26, 

2013, and Part 2 on May 31, 2013.4

The Staff has spent approximately 16,000 hours, with an additional 6,000 hours from 

outside technical experts, reviewing SHINE’s application to determine whether it complies with 

the Atomic Energy Act of 1954, as amended, and the NRC’s regulations.5 The Staff’s review 

included an analysis of the environmental impacts of constructing, operating, and 

decommissioning the SHINE facility, in accordance with the National Environmental Policy Act 

of 1969 (NEPA).6

Technical reviewers from the Office of Nuclear Reactor Regulation, the Office of Nuclear 

Material Safety and Safeguards, the Office of Nuclear Regulatory Research, and the Office of 

 

2 Tr. at 15-16. 

3 See SHINE Medical Technologies, Inc.; Exemption, 78 Fed. Reg. 19,537 (Apr. 1, 2013). 

4 See SHINE Medical Technologies, Inc., 78 Fed. Reg. 39,342 (July 1, 2013) (docketing Part 1 

of the application); SHINE Medical Technologies, Inc., 78 Fed. Reg. 73,897 (Dec. 9, 2013) 

(docketing Part 2 of the application). See generally Ex. NRC-006A to NRC-006H, NRC-006J to 

NRC-006R, SHINE Medical Technologies, Inc., Construction Permit Application (Construction 

Permit Application). Staff exhibits NRC-007A to NRC-007D contain the non-public portions of 

the Construction Permit Application, and as such, they were filed on the non-public docket for 

this proceeding. 

5 Ex. NRC-014, NRC Staff Responses to Post-Hearing Questions (Dec. 29, 2015), at 2 

(unnumbered). 

6 Id.
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New Reactors contributed to the review of SHINE’s application. The Staff also engaged the 

support of other federal and state agencies and local governments, including the Department of 

Energy, National Nuclear Security Administration; the Environmental Protection Agency; the 

U.S. Fish and Wildlife Service; the Advisory Council on Historic Preservation; the Wisconsin 

Department of Health Services; and the Janesville City Council.7 The Advisory Committee on 

Reactor Safeguards (ACRS), a committee of technical experts charged with reviewing and 

reporting on safety studies and applications for construction permits and facility operating 

licenses, provided an independent assessment of the safety aspects of the application.8 The 

ACRS recommended that the construction permit be issued.9

B. Review Standards

The Atomic Energy Act, section 189a., requires that we hold a hearing on an application 

to construct a commercial production or utilization facility.10 The Staff published in the Federal 

Register a notice of hearing and provided an opportunity for interested members of the public to 

 

7 NRC-010, Construction Permit Application Review, SHINE Medical Technologies, Overview 

(Dec. 8, 2015), at 5 (Staff Overview Presentation); Tr. at 58-59 (Mr. Dean). 

8 AEA § 182b., 42 U.S.C. § 2232(b); 10 C.F.R. §§ 1.13, 50.58; see Letter from John W. Stetkar, 

Chairman of the ACRS, to Stephen G. Burns, Chairman of the NRC (Oct. 15, 2015) (ADAMS 

accession no. ML15286A426) (ACRS Letter). 

9 ACRS Letter at 1; see Letter from Victor M. McCree, NRC Executive Director for Operations, 

to John W. Stetkar, Chairman of the ACRS (Nov. 25, 2015) (ML15309A005) (responding to the 

ACRS Letter). 

10 AEA § 189a., 42 U.S.C. § 2239(a) (“The Commission shall hold a hearing after thirty days’ 

notice and publication once in the Federal Register, on each application under section 103 or 

104b. for a construction permit for a facility, and on any application under section 104c. for a 

construction permit for a testing facility.”). Early in the review process, the Staff determined that 

the proposed SHINE facility qualifies as a section 103 facility because it is intended “primarily 

for commercial purposes.” Ex. NRC-001, “Staff Statement in Support of the Uncontested 

Hearing for Issuance of Construction Permit for the SHINE Medical Technologies, Inc. Medical 

Radioisotope Production Facility,” Commission Paper SECY-15-0130 (Oct. 22, 2015), at 10-11 

(unnumbered) (Staff Information Paper). 
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petition for leave to intervene.11 No petitions to intervene were filed. Therefore, there was no 

separate contested hearing. 

We issued a second notice that set the time and place for the uncontested hearing and 

outlined the standards for our review.12 The standards track the two major areas of focus for the 

review of a license application: the Staff’s safety and environmental reviews. On the safety 

side, we must determine whether: 

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; 

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; 

3. safety features or components, if any, that 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; and 

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 

 

(ii) taking into consideration the site criteria contained in 10 C.F.R Part 100, 

the proposed facility can be constructed and operated at the proposed 

location without undue risk to the health and safety of the public.13

In making these findings, we are guided by the additional considerations in 10 C.F.R. 

§ 50.40. We consider whether: 

 

11 SHINE Medical Technologies, Inc.; Notice of Hearing, Opportunity to Intervene, Order 

Imposing Procedures, 80 Fed. Reg. 13,036 (Mar. 12, 2015). 

12 Notice of Hearing, 80 Fed. Reg. at 67,436. 

13 10 C.F.R. § 50.35(a); Notice of Hearing, 80 Fed. Reg. at 67,436. 
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1. the processes to be performed, the operating procedures, facility and equipment, 

the use of the facility, and other technical specifications, or the proposals, in 

regard to any of the foregoing collectively provide reasonable assurance that the 

applicant will comply with NRC regulations, including the regulations in 10 C.F.R. 

Part 20, and that the health and safety of the public will not be endangered; 

2. the applicant is technically and financially qualified to engage in the proposed 

activities; 

3. 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; and 

4. any applicable requirements of Subpart A of 10 C.F.R. Part 51 have been 

satisfied.14

Overlapping this last consideration are the environmental findings that we must make to 

support issuance of the construction permit.15 The findings reflect our agency’s obligations 

under NEPA, a statute that requires us to consider the impacts of NRC actions on 

environmental values.16 To ensure that these obligations are fulfilled for this construction permit 

proceeding, we must: 

1. determine whether the requirements of NEPA section 102(2)(A), (C), and (E), 

and the applicable regulations in 10 C.F.R. Part 51, have been met; 

2. 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; 

3. 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; and 

 

14 10 C.F.R. § 50.40(a)-(d). 

15 See, e.g., id. § 51.105(a). 

16 See NEPA § 102(2), 42 U.S.C. § 4332(2); 10 C.F.R. § 51.10. 
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4. determine whether the NEPA review conducted by the NRC Staff has been 

adequate.17

If we determine that the application meets the standards and requirements of the Atomic Energy 

Act and the NRC’s regulations and that any notifications to other agencies or bodies have been 

duly made, we will issue a construction permit “in such form and containing such conditions and 

limitations” that we deem “appropriate and necessary.”18 We do not review SHINE’s application 

de novo; rather, we consider the sufficiency of the Staff’s review—that is, we determine whether 

the Staff’s review was sufficient to support the required findings.19

C. The Hearing Process 

The Staff completed its review of the SHINE application in October 2015.20 At that time, 

the Staff published its Safety Evaluation Report (SER) and Final Environmental Impact 

Statement (FEIS), triggering the timeline of activities for the uncontested hearing.21 We 

 

17 Notice of Hearing, 80 Fed. Reg. at 67,436 (citing 10 C.F.R. § 51.105). 

18 10 C.F.R. § 50.50. 

19 See Exelon Generation Co. (Early Site Permit for Clinton ESP Site), CLI-05-17, 62 NRC 5, 

34-36 (2005). 

20 See Ex. NRC-008, Safety Evaluation Report Related to SHINE Medical Technologies, Inc. 

Construction Permit Application for a Medical Radioisotope Production Facility (Oct. 2015; 

revised Dec. 2015) (SER); infra note 144 (discussing revisions to the SER); Ex. NRC-009, “Final 

Environmental Impact Statement for the Construction Permit for the SHINE Medical 

Radioisotope Production Facility,” NUREG-2183 (Oct. 2015) (FEIS). 

21 See Staff Requirements—SECY-15-0088—Selection of Presiding Officer for Mandatory 

Hearings Associated with Early Site Permit Applications and Construction Permit Applications 

for Medical Isotope Production and Utilization Facilities (Aug. 25, 2015), at 1 (ML15238B093) 

(directing that the first uncontested hearing on a construction permit for a medical isotope 

production facility follow the Commission’s Internal Procedures for uncontested combined 

license proceedings); Internal Commission Procedures, ch. IV, “Commission 

Meetings/Hearings,” at IV-12 to IV-21 (ML11269A125). 
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received the Staff’s information paper, which serves as its pre-filed testimony, shortly after 

issuance of the SER.22

1. Pre-hearing Activities 

We then set the schedule for the parties to file their lists of witnesses, as well as for 

SHINE to provide its pre-filed testimony.23 We issued questions on environmental and safetyrelated topics for SHINE and the Staff to answer in writing in advance of the hearing.24 In 

addition, we invited interested states, local government bodies, and federally recognized Indian 

Tribes to provide statements for us to consider as part of the uncontested proceeding.25 We 

received no responses to our invitation. 

2. The Hearing

The scheduling note, issued to the parties before the hearing, set the topics for and the 

order of presentations at the hearing.26 In the first panel, witnesses for SHINE and the Staff 

provided an overview of the construction permit application and the Staff’s review. The next two 

panels focused on safety-related issues, and the final panel focused on environmental issues. 

 

22 See Ex. NRC-001, Staff Information Paper, at 1. The Staff also provided a Draft Construction 

Permit and Draft Record of Decision. Ex. NRC-002-R, Draft Construction Permit; Ex. NRC-003, 

Draft Record of Decision. 

23 Notice of Hearing, 80 Fed. Reg. at 67,436. 

24 See Order of the Secretary (Transmitting Pre-Hearing Questions) (Nov. 10, 2015; corrected 

Nov. 20, 2015) (unpublished) (Pre-Hearing Questions). We also issued three questions that 

contain sensitive unclassified non-safeguards information and that therefore were filed on the 

non-public docket for the proceeding. The parties’ responses to those questions were likewise 

filed on the non-public docket. 

25 Notice of Hearing, 80 Fed. Reg. at 67,436. 

26 Memorandum from Annette Vietti-Cook, Secretary of the Commission, to Counsel for SHINE 

and the Staff (Dec. 3, 2015) (ML16028A336) (Scheduling Note). 
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The Staff made available forty-four witnesses at the hearing.27 Twelve of these 

witnesses were scheduled panelists; the remainder stood by to answer questions on topics 

relating to their expertise.28 A total of twenty-two witnesses offered testimony on behalf of 

SHINE on panels at the hearing and in pre-filed written testimony.29

a. Summary of the Overview Panels 

Greg Piefer, SHINE Chief Executive Officer, Jim Costedio, SHINE Licensing Manager, 

Bill Hennessy, SHINE Engineering Manager, Eric Van Abel, SHINE Engineering Supervisor, 

and Katrina Pitas, SHINE Vice President for Business Development, represented SHINE on the 

overview panel.30 Dr. Piefer provided background on the company and its mission.31 Mr. 

Costedio provided background on the location and general design of the facility, and Mr. Van 

Abel described SHINE’s production process.32 Mr. Hennessy answered questions relating to 

the facility’s design, and Ms. Pitas answered questions regarding public engagement during the 

site-selection process.33

 

27 See NRC Staff Revised Exhibit List and Witness List (Dec. 11, 2015); NRC Staff Proposed 

Transcript Corrections and Notification of Additional Sworn Witness (Dec. 28, 2015); Tr. at 11. 

28 Scheduling Note at 1-5; Tr. at 11. 

29 See Revised List of Anticipated Witnesses for SHINE Medical Technologies, Inc. for the 

Hearing on Uncontested Issues (Dec. 8, 2015); Tr. at 9; Ex. SHN-001, Applicant’s Pre-Filed 

Testimony of James Costedio for the Mandatory Hearing on Uncontested Issues for the SHINE 

Medical Technologies, Inc.’s Medical Radioisotope Production Facility (Nov. 24, 2015) (SHINE 

Pre-Filed Testimony). 

30 Tr. at 13, 37; Scheduling Note at 1. 

31 Tr. at 14. 

32 Id. at 23-36. 

33 Id. at 37-38, 39-40, 47-48. 
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William Dean, Director of the Office of Nuclear Reactor Regulation, Mirela Gavrilas, 

Deputy Director of the Division of Policy and Rulemaking in the Office of Nuclear Reactor 

Regulation, Jane Marshall, Deputy Director of the Division of License Renewal in the Office of 

Nuclear Reactor Regulation, and Marissa Bailey, Director of the Division of Fuel Cycle Safety, 

Safeguards, and Environmental Review in the Office of Nuclear Material Safety and 

Safeguards, provided background on the Staff’s review of the construction permit application.34 

Mr. Dean described the purpose of the facility and the Staff’s efforts to prepare for its review of 

the application.35 Dr. Gavrilas discussed the Staff’s safety review and the regulatory standards 

by which the Staff conducted its review, and Ms. Marshall discussed the Staff’s environmental 

analysis.36 Ms. Bailey provided the Staff’s findings in support of issuance of the construction 

permit.37

b. Summary of the Safety Panels 

The first safety panel focused on the proposed design of the SHINE facility and the 

unique regulatory challenges that the Staff faced during its review of the construction permit 

application, as detailed in chapters 1 and 4 of the SER.38 Eric Van Abel testified for SHINE.39 

With him on the panel were Bill Hennessy and Catherine Kolb, SHINE Engineering 

 

34 Scheduling Note at 2; Tr. at 54-55. 

35 Tr. at 55-58. 

36 Id. at 58-66. 

37 Id. at 66-70. 

38 See Scheduling Note at 2; Ex. SHN-027, Commission Mandatory Hearing, SHINE 

Construction Permit Application, Safety—Panel 1, Facility (Dec. 8, 2015); Ex. NRC-011, 

Construction Permit Application Review, SHINE Medical Technologies, Safety Panel 1 (Dec. 8, 

2015) (Staff Safety Panel 1 Presentation). 

39 Tr. at 99-103. 
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Supervisor.40 Alexander Adams, Chief of the Research and Test Reactors Licensing Branch in 

the Office of Nuclear Reactor Regulation, Steven Lynch, Project Manager, Research and Test 

Reactors Licensing Branch, Office of Nuclear Reactor Regulation, and Mary Adams, Senior 

Environmental Engineer, Enrichment and Conversion Branch, Office of Nuclear Material Safety 

and Safeguards, provided testimony for the Staff.41 In addition to chapters 1 and 4, SER 

chapters 2, 3, 5, 6, and 7 were subject to our examination during the first safety panel.42

The second safety panel focused on chapter 13 of the SER, which addressed the 

applicant’s analyses for radiological and chemical exposure accidents.43 In particular, the 

discussion centered on the novel application of accident analysis methodologies from 10 C.F.R. 

Parts 50 and 70.44 Eric Van Abel again testified for SHINE, with Bill Hennessy, Jim Costedio, 

and Catherine Kolb on the panel.45 Steven Lynch, Joseph Staudenmeier, Senior Reactor 

Systems Engineer, Reactor Systems Code Development Branch, Office of Nuclear Regulatory 

Research, and Kevin Morrissey, Project Manager, Fuel Manufacturing Branch, Office of Nuclear 

Material Safety and Safeguards, provided testimony for the Staff.46 Chapters 8, 9, 11, 12, 14, 

and 15 also were subject to our examination during the second safety panel.47

 

 

40 Scheduling Note at 2. 

41 Tr. at 103-10; Scheduling Note at 2. 

42 Scheduling Note at 3. 

43 Id.

44 Id.

45 Tr. at 133-37. 

46 Id. at 137-44. 

47 Scheduling Note at 3. 
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c. Summary of the Environmental Panel 

The environmental panel discussed the Staff’s decision to prepare an environmental 

impact statement (EIS) for the SHINE facility; the Staff’s consultation with other agencies on the 

EIS, as well as its interaction with the Department of Energy as a cooperating agency; the 

Staff’s consideration of environmental impacts; and the Staff’s analysis of alternatives to the 

proposed action.48 Katrina Pitas testified for SHINE, with Bill Hennessy, Catherine Kolb, and 

Tim Krause, an Environmental Specialist from Sargent and Lundy, on the panel.49 Jane 

Marshall, David Wrona, Chief of the Environmental Review and Guidance Update Branch in the 

Office of Nuclear Reactor Regulation, and Michelle Moser, Project Manager and Biologist in the 

Office of Nuclear Reactor Regulation, provided testimony for the Staff.50

3. Post-hearing Questions 

After the hearing, we issued additional questions for written answers from SHINE and 

the Staff.51 We admitted SHINE’s and the Staff’s responses as exhibits, and we adopted 

corrections to the hearing transcript.52 We also admitted a revised Staff exhibit and then closed 

the evidentiary record for the uncontested hearing.53

II. DISCUSSION 

Before we begin our discussion of the SHINE application, we emphasize what this 

decision does not do. First, although we authorize issuance of the construction permit, our 

 

48 Id. at 4. 

49 Tr. at 160-68; Scheduling Note at 4. 

50 Tr. at 168-87; Scheduling Note at 4. 

51 Order of the Secretary (Transmitting Post-Hearing Questions) (Dec. 21, 2015) (unpublished). 

52 Transcript Correction Order at 1. 

53 Id. at 1-2. 
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decision does not constitute approval of the design.54 SHINE has represented that it will apply 

for an operating license and submit with that application a Final Safety Analysis Report, which 

will contain the final detailed design.55 And second, this decision does not discuss all of the 

aspects of SHINE’s construction permit application, the Staff’s review, or our sufficiency review. 

Rather, we provide here a survey of the key facts that support our findings. We base our 

decision, however, on the record in its entirety. 

A. The Proposed Design 

1. Principal Features of SHINE’s Medical Radioisotope Production Facility 

SHINE’s proposed design is first-of-a-kind.56 Although some of the general concepts 

underlying SHINE’s proposed approach to medical isotope production have individually been 

used in other applications, SHINE’s facility would be the first to bring them together in its 

production process.57 There are two “facilities,” housed within the same 55,000 square foot 

building, that would make up the SHINE Medical Radioisotope Production Facility: the 

“Irradiation Facility” and the “Radioisotope Production Facility.”58 The SHINE facility would be 

 

54 See 10 C.F.R. § 50.35(b) (“A construction permit will constitute authorization to the applicant 

to proceed with construction but will not constitute Commission approval of the safety of any 

design feature or specification unless the applicant specifically requests such approval and such 

approval is incorporated in the permit.”). 

55 See id. § 50.35(c); Tr. at 39-40 (Mr. Hennessy), 46 (Mr. Costedio). 

56 See Ex. NRC-006C, Construction Permit Application, Preliminary Safety Analysis Report 

(PSAR), at 1-1; Ex. NRC-011, Staff Safety Panel 1 Presentation, at 5-7. 

57 See Ex. NRC-010, Construction Permit Application Review, SHINE Medical Technologies, 

Overview (Dec. 8, 2015), at 8 (Staff Overview Panel Presentation); Ex. NRC-011, Staff Safety 

Panel 1 Presentation, at 5-7; Ex. NRC-006C, Construction Permit Application, PSAR, at 1-14 to 

1-17. 

58 Ex. SHN-026, Commission Mandatory Hearing, SHINE Construction Permit Application 

Overview (Dec. 8, 2015), at 7-8 (SHINE Overview Panel Presentation); Tr. at 23 (Mr. Costedio). 
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located in the center of an undeveloped, 91-acre (36.8-hectare) agricultural parcel in Janesville, 

Wisconsin.59

SHINE would generate the molybdenum-99 in the Irradiation Facility, using a neutron 

driver to induce fission in a vessel that contains a solution of low-enriched uranium and sulfuric 

acid (uranyl sulfate)—the “Target Solution Vessel.”60 The neutron driver uses a deuterium 

accelerator and tritium gas target to create neutrons through a fusion reaction. The neutrons 

then drive the fission reaction inside the Target Solution Vessel.61 The fission process would 

continue for about 5.5 days, after which time the irradiated solution in the Target Solution Vessel 

would be drained and stored for a short period of decay before it is piped to supercells in the 

Radioisotope Production Facility to separate the molybdenum-99 from other isotopes in the 

solution.62

The Target Solution Vessel and a neutron multiplier, which aids the fission reaction, sit 

within the “Subcritical Assembly Support Structure.”63 This structure would serve to contain any 

leaks from the Target Solution Vessel.64 An annular dump tank, the “Target Solution Vessel 

Dump Tank,” surrounds the bottom of the structure, with fail-open valves that would open to 

allow the target solution to drain passively (via gravity) out of the Target Solution Vessel.65 

 

59 Ex. SHN-026, SHINE Overview Panel Presentation, at 7; Tr. at 23 (Mr. Costedio). 

60 Tr. at 26-27 (Mr. Van Abel). 

61 Ex. NRC-006C, Construction Permit Application, PSAR, at 1-9. 

62 Tr. at 27 (Mr. Van Abel); Ex. SHN-026, SHINE Overview Panel Presentation, at 20. 

63 Ex. SHN-026, SHINE Overview Panel Presentation, at 16; Tr. at 29-30 (Mr. Van Abel). 

64 Tr. at 30 (Mr. Van Abel). 

65 Ex. SHN-026, SHINE Overview Panel Presentation, at 15-16. 
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Together these components comprise the “Subcritical Assembly,” which would be submerged in 

a light water pool to provide cooling and radiation shielding.66

The Subcritical Assembly and the neutron driver, along with other supporting systems, 

make up an “Irradiation Unit.”67 SHINE proposes to operate up to eight Irradiation Units at a 

time.68 The other supporting systems include the “Target Solution Vessel Off-Gas System,” 

which would sit adjacent to the accelerator and the Subcritical Assembly and remove gases 

generated during the irradiation process; the light water pool; the primary closed loop cooling 

system, which cools the Target Solution Vessel during the irradiation process; and the tritium 

purification system, which supplies clean gases to the neutron driver.69

Key to SHINE’s proposed design, the Irradiation Units would remain subcritical at all 

times.70 To ensure that they remain subcritical, SHINE will determine the appropriate uranium 

concentration and corresponding maximum allowable fill height of the Target Solution Vessels 

using startup physics tests and computer models.71 The vessels would then be “filled to a level 

five percent by volume below the predicted critical volume.”72 Moreover, during the irradiation 

 

66 Id.; Tr. at 31 (Mr. Van Abel). 

67 Ex. SHN-026, SHINE Overview Panel Presentation, at 15. 

68 Id.; Tr. at 23-24 (Mr. Costedio), 36 (Mr. Van Abel). 

69 Ex. SHN-026, SHINE Overview Panel Presentation, at 15; Tr. at 28-29 (Mr. Van Abel). The 

deuterium and tritium gases are mixed in the fusion process; the purification system separates 

the gases and supplies purified tritium back to the neutron driver. Tr. at 28, 30-31 (Mr. Van 

Abel). 

70 See Tr. at 22 (Dr. Piefer), 23-24 (Mr. Costedio). 

71 Ex. SHN-002, SHINE Medical Technologies, Inc.’s Responses to Commission’s Public PreHearing Questions (Dec. 8, 2015), at 27-28 (SHINE Responses to Pre-Hearing Questions); Tr. 

at 31-32 (Mr. Van Abel). 

72 Ex. SHN-002, SHINE Responses to Pre-Hearing Questions, at 29; see also Tr. at 32 (Mr. Van 

Abel). 
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process, fission in the target solution would increase temperature and void fraction, which also 

would cause a decrease in reactivity and drive the system further subcritical.73 Other, automatic 

safety features would ensure that criticality is not reached: the system would be designed to 

shut down under certain conditions, such as high neutron flux or high primary coolant 

temperature.74 Under these conditions, the driver would shut down to stop generating source 

neutrons and the solution would drain to the Target Solution Vessel Dump Tank, which itself 

would be geometrically designed to prevent criticality.75

Once irradiated, the target solution would be piped to a separate area of the building, the 

“Radioisotope Production Facility,” where the molybdenum-99 would then be extracted, purified, 

packaged, and shipped to customers.76 After the molybdenum-99 is separated, the uranium 

solution would return to the Irradiation Facility for reuse in another irradiation cycle.77 SHINE 

plans to clean the recycled solution periodically to remove other fission products.78

In the Radioisotope Production Facility, criticality safety is treated much like it would be 

in a fuel cycle facility and is focused on the “detection and annunciation” of criticality accidents.79 

 

73 Tr. at 32-33 (Mr. Van Abel). The increasing void fraction during the irradiation process is due 

to radiolytic bubble formation from a mixture of gas species, including hydrogen and noble 

gases. See Ex. SHN-002, SHINE Responses to Pre-Hearing Questions, at 21. 

74 Tr. at 32 (Mr. Van Abel). 

75 Ex. NRC-004-R, NRC Staff Responses to Commission Pre-Hearing Questions (Dec. 8, 2015), 

at 16 (Staff Responses to Pre-Hearing Questions). 

76 Tr. at 24 (Mr. Costedio), 33 (Mr. Van Abel). The Radioisotope Production Facility is also 

where the uranium solution would be created in the first instance. Ex. SHN-026, SHINE 

Overview Panel Presentation, at 10. 

77 Tr. at 27 (Mr. Van Abel). 

78 Id. at 27-28 (Mr. Van Abel). 

79 See Ex. NRC-004-R, Staff Responses to Pre-Hearing Questions, at 14-15. 
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In the Radioisotope Production Facility, the piping, vessels, and components would be designed 

in criticality-safe geometries.80 SHINE would employ a “Criticality Accident and Alarm System” 

to detect and alert operators in the event of a criticality accident.81 To determine the likelihood 

of such an event, SHINE analyzed various scenarios that might result in a possible inadvertent 

criticality.82 For example, SHINE looked at the supercell area where the molybdenum-99 would 

be extracted and determined that an inadvertent criticality could result either from “[l]eaks in the 

piping resulting in target solution collecting in the sump and/or trenches” leading to “a criticality 

unsafe accumulation of fissile material,” or “[c]hanges in piping design or valve alignment that 

may result in misdirection to a tank that is not designed to be criticality-safe.”83 For all of the 

analyzed scenarios, however, SHINE determined that a criticality accident in the Radioisotope 

Production Facility would be highly unlikely.84

In addition to its criticality safety analyses, SHINE evaluated other accident initiating 

events and scenarios.85 One such analysis considered the “Maximum Hypothetical Accident” 

for both the Irradiation Facility and the Radioisotope Production Facility.86 The Maximum 

Hypothetical Accident analysis was used to establish an upper limit to the radiation doses to 

 

80 See Ex. NRC-006G, Construction Permit Application, PSAR, at 3-106. 

81 See Ex. NRC-004-R, Staff Responses to Pre-Hearing Questions, at 14; Ex. NRC-006G, 

Construction Permit Application, PSAR, at 6b-15, 7b-37. 

82 Ex. NRC-006G, Construction Permit Application, PSAR, at 13b-25 to 13b-29. 

83 Id. at 13b-26. 

84 Id. at 13b-27. 

85 See Ex. SHN-028, Commission Mandatory Hearing, SHINE Construction Permit Application, 

Safety—Panel 2, Accident Analysis (Dec. 8, 2015) (SHINE Safety Panel 2 Presentation); Ex. 

NRC-006G, Construction Permit Application, PSAR, ch. 13. 

86 Ex. SHN-028, SHINE Safety Panel 2 Presentation, at 2; Tr. at 134-37 (Mr. Van Abel). 
- 17 -

workers and the public for all credible accidents at the facility.87 The Maximum Hypothetical 

Accident itself is considered not credible, and non-mechanistic—that is, its hypothetical cause, 

whatever it may be, is not taken into account.88

For the Irradiation Facility, SHINE hypothesized that one of the Target Solution Vessels 

and its surrounding Subcritical Assembly Support Structure would be breached, releasing the 

maximum inventory of target solution for that vessel.89 The presence of the light water pool, 

which surrounds the Subcritical Assembly Support Structure, was ignored, but SHINE assumed 

that the high radiation would be detected, initiating alarms and mechanisms to confine the 

material.90

In the Maximum Hypothetical Accident, the Irradiation Unit cell would remain intact, and 

other safety features, including high efficiency particulate air (HEPA) filters and charcoal 

absorbers would further limit the release of radioactive material.91 SHINE calculated the dose 

consequences of such an accident to be 3.1 rem total effective dose equivalent (TEDE) for a 

worker, and 0.017 rem (17 millirem) TEDE to a member of the public at the site boundary.92

 

87 Ex. SHN-028, SHINE Safety Panel 2 Presentation, at 2; Ex. NRC-006G, Construction Permit 

Application, PSAR, at 13a2-2. 

88 See NRC-006G, Construction Permit Application, PSAR, at 13a2-2 to 13a2-3. 

89 Id. at 13a2-3; Ex. SHN-028, SHINE Safety Panel 2 Presentation, at 3. 

90 Ex. NRC-006G, Construction Permit Application, PSAR, at 13a2-3 to 13a2-4; Ex. SHN-028, 

SHINE Safety Panel 2 Presentation, at 3. 

91 Ex. SHN-028, SHINE Safety Panel 2 Presentation, at 3; Tr. at 135 (Mr. Van Abel); Ex. 

NRC-006G, Construction Permit Application, PSAR, at 13a2-3 to 13a2-4. 

92 Ex. SHN-028, SHINE Safety Panel 2 Presentation, at 3. 
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For the Radioisotope Production Facility, SHINE assumed the simultaneous rupture of 

the five tanks that would be used to store noble gases removed during the irradiation process.93 

These tanks would contain their maximum inventory, and their contents would be instantly 

released.94 The high radiation detection alarms would be initiated, and redundant isolation 

dampers would close.95 The concrete walls surrounding the storage tanks also would remain 

intact and confine a majority of the release.96 For this hypothetical accident, SHINE calculated 

the dose consequences to be 3.6 rem TEDE for a worker and 0.082 rem (82 millirem) TEDE for 

a member of the public at the site boundary.97 As this scenario provided higher dose 

consequences, the Radioisotope Production Facility Maximum Hypothetical Accident is 

considered the bounding scenario for the entire SHINE facility.98 SHINE’s dose consequence 

estimates from this accident scenario would be within the dose limits for normal operation in 

10 C.F.R. Part 20.99

Because of the conservatisms included in the analysis, however, SHINE expects that 

any accident doses would be lower than those calculated.100 The proposed design incorporates 

several engineered safety features to protect the public health and safety in the event of an 

 

93 Id. at 4; Ex. NRC-006G, Construction Permit Application, PSAR, at 13a2-4. 

94 Ex. SHN-028, SHINE Safety Panel 2 Presentation, at 4. 

95 Id.

96 Ex. NRC-006G, Construction Permit Application, PSAR, at 13a2-4. 

97 Ex. SHN-028, SHINE Safety Panel 2 Presentation, at 5. 

98 See id. at 4-5; Tr. at 135 (Mr. Van Abel). 

99 See 10 C.F.R. §§ 20.1201, 20.1301 (governing maximum dose to workers and members of 

the public during normal operation). 

100 See Ex. SHN-028, SHINE Safety Panel 2 Presentation, at 5. 
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accident, some of which SHINE did not credit in its Maximum Hypothetical Accident 

scenarios.101 Principal among the proposed design’s safety features are biological shielding—

heavy concrete—surrounding the Irradiation Units and the supercells, isolation valves on piping 

systems, and ventilation systems, all of which would confine radiological releases.102 Moreover, 

the SHINE facility would have a low radionuclide inventory—up to 10,000 times less than a 

power reactor—and it would be operating at low temperature and pressure, and therefore 

dispersion forces are expected to be lower than those calculated in the event of an accident.103

SHINE also analyzed design-basis accidents initiated by external events, including 

flooding, aircraft impacts, tornadoes, and rain and snow load on the roof of the facility.104 Once 

in operation, the facility also will house a number of chemical hazards, including the acids that 

will be used to prepare the target solution. SHINE identified twenty-four “chemicals of concern,” 

eleven of which were studied closely due to their toxicity, dispersibility, or inventory.105

2. The Staff’s Review Methodology 

The Staff began preparing for SHINE’s construction permit application in 2009, several 

years in advance of its submittal.106 The Staff created an interoffice working group, gathering 

personnel with expertise in a number of technical areas to ensure an efficient review process.107 

 

101 See id. at 3, 5; Ex. SHN-026, SHINE Overview Panel Presentation, at 22. 

102 Tr. at 34-35 (Mr. Van Abel). 

103 Tr. at 34 (Mr. Van Abel); Ex. SHN-026, SHINE Overview Panel Presentation, at 22. 

104 Tr. at 149 (Ms. Kolb), 150 (Mr. Lynch); Ex. NRC-006G, Construction Permit Application, 

PSAR, at 13a2-15. 

105 Tr. at 151 (Mr. Van Abel); see also Ex. NRC-006G, Construction Permit Application, PSAR, 

at 13b-37 to 13b-51. 

106 Ex. NRC-010, Staff Overview Panel Presentation, at 5; Tr. at 57 (Mr. Dean). 

107 Ex. NRC-010, Staff Overview Panel Presentation, at 5; Tr. at 57 (Mr. Dean). 
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Based on an early understanding of the design, the Staff believed that both the Irradiation 

Facility and the Radioisotope Production Facility fit the “production facility” definition in 

10 C.F.R. § 50.2 and therefore could be licensed under Part 50.108 When it received SHINE’s 

application, however, the Staff determined that only the Radioisotope Production Facility 

qualified as a production facility under our rules.109 The Irradiation Facility did not fit the 

definition of a “production facility.”110 Because they would remain subcritical, the Irradiation 

Units also did not fit the definition of a “utilization facility” in 10 C.F.R. § 50.2.111 The Staff 

reasoned, however, that the units otherwise would be designed with several features of a 

nuclear reactor, with a power level similar to non-power reactors that are licensed as utilization 

facilities under Part 50.112 Accordingly, with our approval, the Staff issued a direct final rule to 

amend the definition of a “utilization facility” in 10 C.F.R. § 50.2 to include the SHINE Irradiation 

Facility.113 The rule became effective on December 31, 2014, thus enabling the entire SHINE 

facility to be licensed under Part 50.114

 

108 Direct Final Rule, Definition of a Utilization Facility, 79 Fed. Reg. 62,329, 62,330 (Oct. 17, 

2014) (Direct Final Rule). 

109 Id. at 62,331. 

110 Id. at 62,331-32. 

111 Id. at 62,332. 

112 Id.; see also Tr. at 107-08 (Mr. Lynch). 

113 Direct Final Rule, 79 Fed. Reg. at 62,335. That section now states: “Utilization facility 

means: (1) Any nuclear reactor other than one designed or used primarily for the formation of 

plutonium or U-233; or (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.” 10 C.F.R. § 50.2 (2015) (emphasis added). 

114 Direct Final Rule, 79 Fed. Reg. at 62,329. 
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The Staff also updated its guidance documents to support its review of SHINE’s 

application.115 Because of the similarity of SHINE’s proposed design to a non-power reactor, 

the Staff used the Standard Review Plan for Non-Power Reactors, NUREG-1537.116 In addition, 

the Staff created interim guidance to supplement NUREG-1537 that specifically addresses 

applications for medical radioisotope production facilities, including SHINE’s.117 The interim 

staff guidance incorporates relevant guidance from NUREG-1520, the Standard Review Plan for 

applications for fuel cycle facilities.118 SHINE followed the guidance in these documents when it 

prepared its application.119

Because of the uniqueness of SHINE’s proposed design, we focused part of the hearing 

on the Staff’s review methodology.120 The Staff also had identified its licensing process as a 

novel issue in its pre-filed testimony.121 We asked the parties to discuss the application of Part 

50 to the SHINE application and to discuss SHINE’s use of the General Design Criteria in 

 

115 See Tr. at 57-58 (Mr. Dean). 

116 See id. (Mr. Dean); “Guidelines for Preparing and Reviewing Applications for Licensing NonPower Reactors: Standard Review Plan and Acceptance Criteria,” NUREG-1537, Parts 1 and 2 

(Feb. 1996) (ML12251A353 (package)) (NUREG-1537). 

117 Tr. at 57-58 (Mr. Dean); Final Interim Staff Guidance Augmenting NUREG-1537, “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 Homogenous Reactors, Parts 1 and 2 (ML12156A069 and ML12156A075) (Oct. 2012) 

(Interim Staff Guidance Augmenting NUREG-1537). A notice of its issuance was published in 

the Federal Register. 77 Fed. Reg. 65,728 (Oct. 30, 2012). 

118 See Interim Staff Guidance Augmenting NUREG-1537, Part 1, at v (explaining that the Staff 

borrowed extensively from NUREG-1520 in the areas of facility description and accident 

analyses). 

119 Ex. SHN-026, SHINE Overview Panel Presentation, at 12; Tr. at 25 (Mr. Costedio). 

120 See, e.g., Pre-Hearing Questions at 2-3. 

121 Ex. NRC-001, Staff Information Paper, at 10-13. 
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10 C.F.R. Part 50, Appendix A, for the proposed design.122 In particular, we explored with the 

parties their technical judgment in determining the regulatory scheme to apply and whether any 

exemptions from our regulations were necessary to license the SHINE facility.123 SHINE stated 

that it prepared its application to “fully address the requirements in 10 [C.F.R.] Part 50 that apply 

to Construction Permits, and that are applicable to the SHINE facility.”124 SHINE represented 

that because its facility is not a power reactor, it applied all of the regulations necessary for a 

construction permit application except those that expressly apply only to “power reactors” or 

“nuclear power plants,” consistent with the guidance in NUREG-1537, Part 1, Appendix A.125 

The Staff took the same approach. It reviewed SHINE’s construction permit application “under 

every applicable section of . . . [Part 50]."126 The Staff did not apply regulations that pertained 

only to reactors or power reactors.127 The Staff explained that because SHINE addressed all of 

the applicable regulations and because SHINE did not separately request any exemptions from 

those requirements, the Staff did not find it necessary to issue any exemptions from Part 50.128

 

122 Prehearing Questions at 2. 

123 Id. at 2-3. 

124 Ex. SHN-002, SHINE Responses to Pre-Hearing Questions, at 2. 

125 Id.

126 Ex. NRC-004-R, Staff Responses to Pre-Hearing Questions, at 2. 

127 Id. For example, in response to a pre-hearing question regarding the applicability of the 

definition of “safety-related structures, systems, and components” in 10 C.F.R. § 50.2, the Staff 

explained that SHINE complied with only those portions that did not expressly apply to power 

reactors, which is consistent with the Staff’s practice when licensing non-power reactors. Id. at 

4-5. 

128 Id. at 2. The Staff represented that the only exemption issued for the SHINE application was 

an exemption from 10 C.F.R. § 2.101(a)(5), which allowed SHINE to submit its application in 

two parts. See Ex. NRC-001, Staff Information Paper, at 9-10. 
- 23 -

With regard to the General Design Criteria in Part 50, Appendix A, SHINE explained that 

it “undertook a systematic process to identify potentially applicable [General Design Criteria]” to 

address the requirement that its construction permit application include the principal design 

criteria for the proposed facility.129 Even though these criteria apply to the design of nuclear 

power plants and therefore do not expressly apply to SHINE’s application, SHINE considered 

the General Design Criteria to “provide a proven basis with which to develop an initial 

assessment of the safety of the design of the SHINE facility.”130 SHINE’s process is 

documented in sections 3.5a and 3.5b of its Preliminary Safety Analysis Report.131 Using the 

General Design Criteria to inform its review, the Staff independently assessed the adequacy of 

SHINE’s principal design criteria.132

We also asked the Staff to discuss any challenges it encountered during its review and 

to explain how it determined which aspects of the design were necessary for the issuance of a 

construction permit and which could be left to the operating license stage.133 As noted above, 

the Staff based its review on the criteria in 10 C.F.R. § 50.34 and the guidance in NUREG-1537 

and the Staff’s interim guidance document.134 In addition, the Staff noted that the findings for 

issuance of a construction permit contemplate that the design might be preliminary in nature (as 

 

129 Ex. SHN-002, SHINE Responses to Pre-Hearing Questions, at 3. See generally 10 C.F.R. 

§ 50.34(a)(3)(i). 

130 Ex. SHN-002, SHINE Responses to Pre-Hearing Questions, at 3. 

131 Ex. NRC-006G, Construction Permit Application, PSAR, §§ 3.5a, 3.5b, at 3-57 to 3-106. 

132 Ex. NRC-004-R, Staff Responses to Pre-Hearing Questions, at 3. 

133 Pre-Hearing Questions at 2. 

134 Ex. NRC-004-R, Staff Responses to Pre-Hearing Questions, at 1-2. 
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it is here) and that issuance of the permit would not constitute approval of the final design.135 

With these considerations in mind, the Staff reviewed the application to ensure that SHINE 

adequately described its preliminary design, including the principal design criteria, design 

bases, general arrangement, and approximate dimensions; that SHINE provided a preliminary 

analysis of structures, systems, and components, including the ability to prevent and mitigate 

accidents; and that SHINE identified ongoing research and development.136

According to the Staff, when determining the amount of design detail necessary for 

SHINE’s construction permit application, the issue of criticality safety in the Radioisotope 

Production Facility proved particularly challenging.137 And the Staff found that the “most 

challenging aspect of the criticality review was ensuring a properly benchmarked criticality code 

with sufficient margin to ensure subcriticality.”138

Using the applicable guidance, the Staff ensured that SHINE had addressed all of the 

design criteria for criticality safety.139 The Staff focused on particular passive engineered 

features of SHINE’s proposed facility and processes “that could not readily be changed” after 

construction.140 The Staff examined whether SHINE had provided a “validated criticality code, 

an acceptable minimum margin of subcriticality, and [sufficient] conservative margin, to ensure 

the facility and process[es] will be designed to be subcritical under normal and credible 

 

135 Id. at 1. 

136 Id.

137 Id. at 2. 

138 Id.

139 See id. at 2; Ex. NRC-008, SER, at 6-30 to 6-31. 

140 Ex. NRC-004-R, Staff Responses to Pre-Hearing Questions, at 2. 
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abnormal conditions,” and “commitments to ensure compliance with the double contingency 

principle.”141 The Staff also evaluated SHINE’s proposed criticality accident alarm system.142

The Staff requested additional information from SHINE, and based on SHINE’s 

responses, the Staff determined that SHINE had provided sufficient information for the 

construction permit stage of the proceeding but that SHINE would need to provide additional 

information before completing construction.143 The Staff proposed four criticality-safety permit 

conditions that would require SHINE to submit periodic reports with additional information on: 

(1) the basis for the design of the criticality safety accident alarm system; (2) the basis for 

SHINE’s determination that a criticality event in the Radioisotope Production Facility is not 

credible; (3) summaries of criticality safety analyses demonstrating that all processes in the 

Radioisotope Production Facility will remain subcritical under all normal and credible abnormal 

conditions and will satisfy the double contingency principle; and (4) nuclear criticality safety 

evaluations for all fissile isotopes or application of additional subcritical margin to account for 

these isotopes, either of which shall demonstrate that all processes in the Radioisotope 

Production Facility will remain subcritical under all normal and credible abnormal conditions.144

 

141 Id. The “double contingency principle” states that the “‘design should incorporate sufficient 

factors of safety to require at least two unlikely, independent, and concurrent changes in 

process conditions before a criticality accident is possible.’” Ex. NRC-008, SER, at 6-34 

(quoting a report from the American National Standards Institute/American Nuclear Society, 

“Nuclear Criticality Safety in Operations with Fissionable Materials Outside Reactors,” 

ANSI/ANS-8.1-1998 (2007)). 

142 Ex. NRC-004-R, Staff Responses to Pre-Hearing Questions, at 2. 

143 See Ex. NRC-008, SER, at 6-31 to 6-32. The requests for additional information “covered 

topics such as SHINE’s treatment of controlled parameters, application of the [double 

contingency principle], and [SHINE’s] ability to demonstrate that, under normal and abnormal 

credible conditions, all nuclear processes remain subcritical.” Id. at 6-31. 

144 See id. at 6-32 to 6-41; Ex. NRC-011, Staff Safety Panel 1 Presentation, at 8; Ex. NRC-002-

R, Draft Construction Permit, at 2-3. A fifth permit condition, relating to radiation protection, 

would require SHINE to provide periodic information on components within the Radioisotope 
- 26 -

In addition to exploring the scope of the Staff’s review, we asked several questions 

directed to the adequacy of the Staff’s review of SHINE’s accident analyses. With regard to the 

Maximum Hypothetical Accident for the Irradiation Facility, we asked the Staff to explain why it 

found sufficient SHINE’s consideration of the failure of one Target Solution Vessel, rather than 

multiple vessels.145 The Staff stated that the facility would be designed to withstand any event 

that might cause multiple vessel failures, and the Target Solution Vessels would be isolated 

from one another under robust concrete shielding, without a way for the failure of one unit to 

trigger the failure of others.146 SHINE responded that it looked at potential events that might 

involve multiple units but found that none of them would be worse than what was hypothesized 

for the Maximum Hypothetical Accident analysis.147

We also asked the parties to address their consideration of accidents initiated by 

external events, including aircraft impacts.148 The SHINE facility would be located directly 

 

Production Facility, demonstrating that shielding and occupancy times are “consistent with as 

low as is reasonably achievable practices” and 10 C.F.R. Part 20 dose requirements. Ex. NRC002-R, Draft Construction Permit, at 3. 

Another permit condition would have established a screening process for construction changes 

that would require pre-approval from the NRC. A similar process was developed for combined 

licenses (the preliminary amendment request, or “PAR,” process). After responding to our prehearing questions, however, the Staff revised its pre-filed testimony, SER, and Draft 

Construction Permit to remove this condition, finding on further reflection that such a process 

would not be appropriate with respect to a construction permit where, as here, the applicant has 

not sought approval of a final design. See NRC Exhibit List and Notice of Revisions (Dec. 8, 

2015); Pre-Hearing Questions at 21-22; Ex. NRC-004-R, Staff Responses to Pre-Hearing 

Questions, at 45-47. 

145 Tr. at 145 (Commissioner Baran). This question was a follow-up from the Staff’s response to 

our pre-hearing question on the same topic. See Ex. NRC-004-R, Staff Responses to PreHearing Questions, at 6-7. 

146 Tr. at 145 (Dr. Staudenmeier). 

147 Id. at 147 (Mr. Van Abel). 

148 See, e.g., id. at 121 (Commissioner Baran); Pre-Hearing Questions at 6. 
- 27 -

adjacent to a small airport, the Southern Wisconsin Regional Airport.149 Although SHINE’s 

proximity to the airport would allow timely shipment of its finished product—molybdenum-99 has 

a sixty-six-hour half-life150—it also places the facility in a location where aircraft impacts might 

be an issue of heightened concern. During its review the ACRS also identified aircraft impacts 

as an area of concern.151

SHINE’s application included an aircraft impact analysis on the proposed facility’s safetyrelated structures, which evaluated the types of aircraft expected near the SHINE facility and the 

ability of the facility to withstand impacts from those aircraft.152 At the hearing, the Staff 

explained that its review accounted for the probability of an aircraft landing or taking off at the 

Southern Wisconsin Regional Airport or flying in the vicinity of the SHINE facility, no matter its 

size.153 If the probability was below a certain threshold, it was excluded from further 

examination.154 Based on the probabilities, SHINE considered two types of aircraft: the 

Challenger 605 and the Hawker 400.155 The Staff reviewed SHINE’s analysis as well as 

SHINE’s responses to the Staff’s requests for additional information and determined that 

 

149 See Ex. NRC-006G, Construction Permit Application, PSAR, at 3-34; Ex. SHN-029, 

Commission Mandatory Hearing, SHINE Construction Permit Application, Environmental 

Overview (Dec. 8, 2015), at 5 (SHINE Environmental Panel Presentation) (showing bird’s-eye 

view of airport and SHINE facility). 

150 See Tr. at 15 (Dr. Piefer), 46 (Mr. Hennessy). 

151 See ACRS Letter at 3. 

152 See Ex. NRC-006G, Construction Permit Application, PSAR, § 3.4.5.1; Tr. at 121-23 (Mr. 

Marschke). 

153 Tr. at 207 (Mr. Lynch). 

154 Id. (Mr. Lynch). 

155 Id. (Mr. Lynch); Ex. NRC-006G, Construction Permit Application, PSAR, at 3-35, 3-43 to 

3-44. 
- 28 -

SHINE’s analysis was satisfactory.156 The ACRS also was satisfied that “[a]ll areas of the . . . 

[facility] that contain safety-related systems and equipment . . . [would be] protected against 

damage from the identified design-basis aircraft impacts.”157

B. Technical and Design Information for Later Consideration 

SHINE has described the principal design features and the technology that it plans to 

use, but additional detail, some of which will be obtained after further research and 

development, will be supplied when SHINE submits its operating license application.158 In 

particular, SHINE identified two ongoing research and development activities.159 Oak Ridge 

National Laboratory will conduct irradiation and corrosion testing to study the mechanical 

performance of SHINE’s systems.160 And Argonne National Laboratory will conduct studies to 

ensure that uranyl peroxide will not precipitate out of the target solution.161 The Staff will be 

“tracking these activities and will verify their resolution prior to the completion of construction.”162 

SHINE represented that it expects to complete construction of its Medical Radioisotope 

Production Facility by December 2022.163

 

156 See Ex. NRC-008, SER, at 2-12 to 2-14. 

157 ACRS Letter at 3. 

158 See, e.g., Tr. at 39-40 (Mr. Hennessy). 

159 Ex. NRC-008, SER, at 1-8. 

160 Id.

161 Id.

162 Id.; see also id. at A-36. 

163 Id. at 1-8. 
- 29 -

SHINE also has planned additional work on the computer codes that will be used to 

model the thermal-hydraulics behavior of SHINE’s Subcritical Assembly.164 Los Alamos 

National Laboratory “is writing a transient systems modeling code to analyze the coupled 

nuclear and thermal-hydraulics behavior of solution systems,” including SHINE’s Subcritical 

Assembly.165 And Los Alamos is validating the code to ensure that it “matches the behavior of 

aqueous systems,” like SHINE’s, “under a wide range of conditions.”166 SHINE plans to use this 

code to perform part of its transient modeling for accident and normal operating conditions for its 

operating license application.167

Other code validation will be performed using data from experiments that have been 

conducted on systems comparable to what will be used in SHINE’s irradiation process.168 

Thermal-hydraulic experiments were performed at the University of Wisconsin—Madison on an 

assembly designed to simulate the design of the Target Solution Vessel.169 The experiments 

used “[e]lectric heaters and bubble injection . . . to replicate the power generation and gas 

production in the SHINE facility” in a rectangular assembly, with two of the walls of the assembly 

cooled by cooling water.170 The experiments “were used to determine the heat transfer 

coefficients and void fractions expected for this system over a range of power conditions.”171 An 

 

164 Ex. SHN-002, SHINE Responses to Pre-Hearing Questions, at 45-46. 

165 Id. at 46. 

166 Id. 

167 Id.

168 See id. at 46-47. 

169 Id. at 47. 

170 Id.

171 Id.
- 30 -

experiment was performed at Argonne National Laboratory to simulate conditions in the Target 

Solution Vessel, using a scanned electron beam to irradiate a uranyl sulfate solution in a 

rectangular vessel with cooled walls.172 The temperature distributions were recorded throughout 

the vessel, and these temperatures, along with the properties of the solution and the power 

distribution of the electron beam, will be used for code validation.173 In addition to the data 

obtained from the University of Wisconsin and Argonne experiments, data from previous studies 

also will be used to validate the thermal-hydraulics codes.174 The Staff will review the adequacy 

of SHINE’s code validation efforts at the operating license stage.175

The Staff will be tracking several other items, listed as regulatory commitments in 

Appendix A of the SER, that SHINE must include in its Final Safety Analysis Report with its 

operating license application.176 For its part, SHINE will track these items in its Corrective 

Action Program.177 We list only some of these commitments here. 

For example, SHINE committed to provide a seismic qualification for components used 

in the SHINE facility, either by analytical methods, tests, or combined methods.178 SHINE also 

committed to installing a “non-safety-related seismic monitoring system to help establish the 

acceptability of continued operation of the plant following a seismic event.”179 The monitoring 

 

172 Id.

173 Id.

174 Id. at 46-48. 

175 Ex. NRC-004-R, Staff Responses to Pre-Hearing Questions, at 22. 

176 Ex. NRC-008, SER, app. A. 

177 See id. at A-3, A-35; Ex. SHN-002, SHINE Responses to Pre-Hearing Questions, at 5-6. 

178 Ex. NRC-008, SER, at A-3. 

179 Id.
- 31 -

system “will provide acceleration time histories or response spectra experienced at the facility to 

assist in verifying that structures, systems, and components (SSCs) important to safety at the 

SHINE facility can continue to perform their safety functions.”180 As another example, SHINE 

will provide the locations of the isolation valves, which, as discussed above, are part of the 

planned confinement system for the Irradiation Facility, and which would be actuated under 

certain accident conditions, including a tritium leak from the neutron driver system.181 And 

SHINE will provide a complete list of parameters that will trigger an automatic trip to shut down 

an Irradiation Unit and ensure safe operation of the facility.182 These parameters will be 

determined using the results of SHINE’s planned transient system modeling, which will in turn 

affect the layout and position of sensors within the Irradiation Units.183 SHINE currently expects 

the parameters to include “primary system pressure, sweep gas flow, and hydrogen 

concentration measurements.”184

 

180 Id.; see also Ex. SHN-002, SHINE Responses to Pre-Hearing Questions, at 44-45. 

181 See Ex. NRC-008, SER, at 6-8, 13-23, A-5 to A-6. SHINE considered a tritium leak from the 

tritium purification system as one of its design basis accidents. See Ex. NRC-006G, 

Construction Permit Application, PSAR, at 13a2-59; Ex. NRC-008, SER at 13-23 to 13-25. The 

isolation valves are just one of the components that would be used to confine tritium in the event 

of a release. See Ex. NRC-006G, Construction Permit Application, PSAR, at 13a2-60. In 

addition, the piping for the tritium purification system and the neutron driver system would be 

double-walled, and isolation dampers would close in the event of a high-radiation alarm or other 

actuation signal. See id. at 13a2-59 to 13a2-60; see also id. at 13a2-17 (describing the doublewalled piping for the neutron driver system). 

182 See Ex. NRC-008, SER, at A-4 to A-5; Ex. SHN-002, SHINE Responses to Pre-Hearing 

Questions, at 39-40. 

183 Ex. SHN-002, SHINE Responses to Pre-Hearing Questions, at 39-40. 

184 Id. at 40; Ex. NRC-008, SER, at A-5. 
- 32 -

Additionally, SHINE provided a Preliminary Emergency Plan that discusses provisions 

for coping with radiological emergencies and minimizing accident consequences.185 Among 

other things, the Preliminary Emergency Plan describes the roles and responsibilities of the 

Emergency Response Organization, the emergency classification system, and facilities and 

equipment necessary for responding to emergencies.186 Appendix A of the SER contains 

several commitments for SHINE to provide detailed emergency planning information when it 

submits its Final Safety Analysis Report.187

In meeting with the Staff, the ACRS identified items that also should be included in 

SHINE’s Final Safety Analysis Report, and the Staff’s list of tracked commitments includes 

these items.188 To fulfill these commitments, SHINE will provide a strategy for addressing an 

extended shutdown of the SHINE facility, and SHINE will provide a definition of safety-related 

activities to be used in its Quality Assurance Program Description in its operating license 

application.189 In its letter, the ACRS noted that it had additional questions that it expected 

would be addressed at the operating license stage concerning “criticality control and margin, 

adequacy of confinement, systems that provide support to safety-related systems, partial losses 

of electrical power, hydrogen generation and control, underwater maintenance issues, and 

possible ‘red oil’ and acetohydroxamic acid reactions.”190 We asked the parties to explain their 

 

185 Ex. NRC-008, SER, at 12-2. The emergency plan contains non-public information and was 

filed on the non-public docket for this proceeding. 

186 Id. at 12-3. 

187 Id. at A-10 to A-14. 

188 See id. at A-35. 

189 Id.

190 ACRS Letter at 4. The ACRS identified red oil and acetohydroxamic acid as compounds that 

have been implicated in industrial accidents and may be present in the SHINE facility. Id.
- 33 -

plans to address these items.191 SHINE stated that although these items are not tracked as 

commitments in the SER, SHINE will track these topics along with its regulatory commitments in 

its Corrective Action Program.192 The Staff stated that it intends to follow up on all issues raised 

by the ACRS at the operating license stage.193

C. The Proposed Site 

SHINE plans to build its Medical Radioisotope Production Facility on a 91-acre (36.8-

hectare) agricultural parcel that lies just south of the corporate boundaries of the City of 

Janesville in Rock County, Wisconsin.194 The area surrounding the site is rural and is used 

primarily for agriculture.195 The population within 5 miles (8 kilometers) of the SHINE site, based 

on 2010 estimates, is approximately 43,000.196 The nearest permanent residence is about half 

a mile (a little less than 1 kilometer) northwest of the center of the site.197 Several industrial 

facilities and the Southern Wisconsin Regional Airport are located within 5 miles (8 kilometers) 

of the SHINE site.198

The findings for the issuance of a construction permit require that we “tak[e] into 

consideration” the site criteria in 10 C.F.R. Part 100 to ensure that the proposed facility can be 

constructed and operated at the proposed location without undue risk to the health and safety of 

 

191 Pre-Hearing Questions at 3. 

192 Ex. SHN-002, SHINE Responses to Pre-Hearing Questions, at 6; Tr. at 53 (Mr. Costedio). 

193 Tr. at 85-86 (Dr. Gavrilas), 105-06 (Mr. Adams). 

194 Ex. NRC-008, SER, at 2-2. 

195 Id.

196 Id.; Ex. NRC-006C, Construction Permit Application, PSAR, at 2.1-7. 

197 Ex. NRC-008, SER, at 2-2. 

198 Id. at 2-5; Ex. NRC-006C, Construction Permit Application, PSAR, at 2.2-1 to 2.2-2. 
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the public.199 The site criteria in Part 100 apply to nuclear reactors, and therefore do not 

expressly apply to the SHINE facility, but the Staff considered conditions similar to those in Part 

100 in its review of the suitability of the proposed site.200 The Staff reviewed SHINE’s analyses 

of the geography and demography of the site; the proposed facility’s interaction with nearby 

industrial, transportation, and military facilities; and site-specific issues relating to meteorology, 

hydrology, geology, seismology, and geotechnical engineering.201 This review also included 

SHINE’s analyses of structures, systems, and components 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.”202 After reviewing SHINE’s analyses, the Staff concluded 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.203

At the hearing, we asked SHINE to describe its seismic hazard evaluation.204 Dr. Alan 

Hull, a seismic hazard specialist with Golder Associates, testified for SHINE.205 Dr. Hull 

explained that the proposed facility is located in a low seismic hazard zone.206 SHINE’s analysis 

 

199 10 C.F.R. § 50.35(a)(4)(ii). 

200 Ex. NRC-001, Staff Information Paper, at 20; Ex. NRC-008, SER, at 2-1. 

201 Ex. NRC-001, Staff Information Paper, at 20; Ex. NRC-008, SER, at 2-1; cf. 10 C.F.R. 

§ 100.10 (listing factors to be considered when selecting sites for nuclear reactors, including 

population density, seismology, meteorology, geology, and hydrology). 

202 Ex. NRC-001, Staff Information Paper, at 20. 

203 Id.

204 Tr. at 126 (Chairman Burns). 

205 Id. (Dr. Hull). 

206 Id. at 126-27 (Dr. Hull). 
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used the Central Eastern United States-Seismic Source Characterization catalog, among other 

references, to establish the design basis earthquake for the SHINE facility—a 5.8 magnitude 

earthquake.207

We also asked SHINE to describe its flooding hazard analysis.208 SHINE looked at the 

probable maximum precipitation event and the probable maximum flood at the proposed site.209 

The Rock River is about 2 miles (3.2 kilometers) from the site, but even in the event of the 

probable maximum flood, the water would be about 50 feet (15.2 meters) below the elevation of 

the site; therefore SHINE determined that flooding would not pose a hazard to the facility.210 

The probable maximum precipitation event would come up to the facility elevation, but SHINE 

determined that it would not flood the structure.211 Berms would be constructed around the 

perimeter of the plant to prevent flooding due to off-site runoff.212

 

 

207 Ex. NRC-006C, Construction Permit Application, PSAR, at 2.5-14, 2.5-17; Tr. at 127 (Dr. 

Hull). 

208 Tr. at 128 (Chairman Burns). 

209 Id. (Ms. Kolb). The probable maximum precipitation event “is defined as the theoretical 

greatest depth of precipitation for a given duration that is physically possible over a particular 

drainage area at a certain time of year.” Ex. NRC-006C, Construction Permit Application, 

PSAR, at 2.4-13. The probable maximum flood is estimated using NRC Regulatory Guides 1.59 

and 3.40 and data from the U.S. Army Corps of Engineers. Id. at 2.4-11. See generally

Regulatory Guide 1.59, “Design Basis Floods for Nuclear Power Plants,” Rev. 2 (Aug. 1977) 

(ML003740388); Regulatory Guide 3.40, “Design Basis Floods for Fuel Reprocessing Plants 

and for Plutonium Processing and Fuel Fabrication Plants,” Rev. 1 (Dec. 1977) (ML003739400). 

210 Tr. at 128 (Ms. Kolb); see also Ex. NRC-006C, Construction Permit Application, PSAR, at 

2.4-9, 2.4-11 to 2.4-13 (noting the difference between site elevation and the probable maximum 

flood at 51 feet (15.5 meters)). 

211 Tr. at 128 (Ms. Kolb); see also Ex. NRC-006C, Construction Permit Application, PSAR, at 

2.4-6 to 2.4-9; Ex. NRC-008, SER, at 2-16 to 2-20 (finding acceptable SHINE’s consideration of 

hydrologic events for the proposed site). 

212 Ex. NRC-006C, Construction Permit Application, PSAR, at 2.4-9. 
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D. Additional Safety Considerations 

SHINE also must demonstrate that it is financially qualified to construct the proposed 

Medical Radioisotope Production Facility.213 SHINE provided information on the estimated 

costs of constructing the facility and related fuel cycle costs, and it described the sources of 

funding that it would use to cover those costs.214 It explained that it has obtained funding from 

various sources of financing, including equity, debt, and government grants.215 Among these 

sources, SHINE has received funding commitments to date totaling $58 million; a cost-sharing 

agreement with the Department of Energy, National Nuclear Security Administration would 

provide $25 million of that amount.216 SHINE is in the process of obtaining equity investment 

financing.217 SHINE also expects to enter into a short-term lease, a debt agreement, or some 

combination of the two, but expects that it would fully own the facility within five years of 

startup.218 Although not required at the construction permit stage, SHINE also provided 

information on the costs and expected sources of funds during facility operation and 

 

213 See 10 C.F.R. §§ 50.33(f)(1), 50.40(b); see also 10 C.F.R. pt. 50, app. C. 

214 Ex. NRC-006G, Construction Permit Application, PSAR, at 15-1; see 10 C.F.R. § 50.33(f)(1) 

(requiring an applicant for a construction permit to demonstrate that it “possesses or has 

reasonable assurance of obtaining the funds necessary to cover estimated construction costs 

and related fuel cycle costs”). 

215 Ex. NRC-006G, Construction Permit Application, PSAR, at 15-2. 

216 Id.

217 Id.

218 Id.
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decommissioning, which the Staff will consider when SHINE submits its operating license 

application.219

The Staff reviewed SHINE’s financial qualifications information, including SHINE’s 

responses to requests for additional information.220 The Staff requested itemized information on 

SHINE’s construction costs and requested that SHINE provide the basis for each estimated cost 

in its application.221 The Staff found reasonable SHINE’s construction estimates, which were 

prepared by an established construction company with experience across a variety of 

industries.222 The Staff also found reasonable SHINE’s estimated fuel cycle costs, which were 

based on information obtained from the Department of Energy, National Nuclear Security 

Administration for the cost of a one-year supply of low enriched uranium.223 After reviewing 

SHINE’s cost and funding information, the Staff concluded that SHINE had met the financial 

qualifications requirements for the issuance of a construction permit.224

 

219 Id. at 15-3 to 15-5; Ex. NRC-008, SER, at 15-1. The expected construction costs and 

anticipated revenue from operating the SHINE facility are proprietary and are not included in the 

public version of the application. 

SHINE also provided information on nuclear insurance and indemnity pursuant to the PriceAnderson Act. See AEA § 170, 42 U.S.C. § 2210; 10 C.F.R. pt. 140. But because SHINE has 

not applied to possess special nuclear material, the Staff determined that this information was 

outside the scope of the construction permit application. Ex. NRC-006G, Construction Permit 

Application, PSAR, at 15-7; Ex. NRC-008, SER, at 15-6 to 15-7. The Staff stated that it will 

review this information when SHINE submits its operating license application or applies for a 

Part 70 license to possess special nuclear material. Ex. NRC-008, SER, at 15-6 to 15-7. 

220 Ex. NRC-008, SER, at 15-3 to 15-4. 

221 Id. at 15-4. 

222 Id.

223 Id.

224 Id. at 15-4 to 15-5. 
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SHINE also provided information on whether it would be subject to foreign ownership, 

control, or domination.225 SHINE explained that it is a private corporation that has 

approximately 25 shareholders.226 SHINE employees also participate in a stock options plan. 

SHINE stated that “[t]o the best of [its] knowledge, all of [its] current shareholders holding 1 

percent or more of SHINE’s stock are U.S. citizens or entities owned or controlled by U.S. 

citizens” and “[a]ll of [its] current employees holding stock options are U.S. citizens.”227 SHINE 

further represented that six of the seven directors on SHINE’s Board are U.S. citizens.228 Based 

on its review, the Staff found that SHINE had provided sufficient information to demonstrate that 

it “is not owned, controlled, or dominated by an alien, foreign corporation, or foreign 

government.”229

E. The Staff’s Environmental Review 

The Staff prepared an EIS given “the potential for . . . significant impacts and unique 

considerations . . . [for] a first-of-a-kind application for a medical radioisotope production 

facility.”230 After publishing a notice of its intent to prepare an EIS, the Staff held two public 

scoping meetings in Janesville to gather input on issues to consider in its environmental 

 

225 Ex. NRC-006G, Construction Permit Application, PSAR, at 15-6; see 10 C.F.R. § 50.33(d)(iii) 

(requiring an applicant that is a corporation to state “[w]hether it is owned, controlled, or 

dominated by an alien, a foreign corporation, or foreign government, and if so, give details”). 

226 Ex. NRC-006G, Construction Permit Application, PSAR, at 15-6. 

227 Id.

228 Id. One of the directors is a Canadian citizen with U.S. permanent resident status. Id.

229 Ex. NRC-008, SER, at 15-6. 

230 Tr. at 171 (Mr. Wrona). 
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review.231 The Staff received comments on a variety of topics, including impacts to 

groundwater, nearby agricultural land, impacts from potential aircraft accidents, and alternative 

sites and technologies.232 The Staff responded to the scoping comments in the draft EIS 

(DEIS).233 The DEIS was itself put out for public comment, and those comments received were 

addressed in the FEIS.234

In its preparation of the EIS, the Staff worked with the Department of Energy as a 

cooperating agency. The Department of Energy itself was obliged under NEPA to conduct an 

environmental review due to its financial support of the project, and the American Medical 

Isotopes Production Act of 2012 requires the NRC and the Department of Energy to ensure that 

their “environmental reviews of facilities to produce medical radioisotopes are [complementary] 

and not duplicative.”235 To that end, the Staff and the Department of Energy entered into a 

Memorandum of Agreement, which designated the NRC as the lead agency with the primary 

role in preparing the EIS; the Department of Energy provided assistance as the cooperating 

agency.236

 

231 SHINE Medical Technologies, Inc., 78 Fed. Reg. 39,343 (July 1, 2013); Tr. at 172 

(Mr. Wrona); Ex. NRC-009, FEIS, at xvii. 

232 Tr. at 172-73 (Mr. Wrona). 

233 Id. at 173 (Mr. Wrona). 

234 See Construction Permit Application for the SHINE Medical Radioisotope Production Facility, 

80 Fed. Reg. 27,710 (May 14, 2015); Ex. NRC-009, FEIS, app. A. 

235 Tr. at 173-74 (Mr. Wrona); see 42 U.S.C. § 2065(d) (“The Department and the Nuclear 

Regulatory Commission shall ensure to the maximum extent practicable that environmental 

reviews for the production of the medical isotopes shall complement and not duplicate each 

review.”). 

236 Tr. at 174 (Mr. Wrona); Ex. NRC-009, FEIS, at 1-5; Ex. NRC-004-R, Staff Responses to PreHearing Questions, at 40-41. 
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The Staff evaluated the environmental impacts of constructing, operating, and 

decommissioning the SHINE facility across a variety of resource areas, including ecological 

resources, water resources, and socioeconomic conditions.237 The Staff concluded that the 

potential impacts of the proposed action would be small for all resource areas, except for traffic, 

where impacts could range from small to moderate due to increased vehicle traffic to and from 

the site.238 The Staff’s review also considered the environmental impacts of waste generated 

from operating the SHINE facility, a topic that we explored with the parties in pre-hearing 

questions and at the hearing.239 In addition to other waste streams, we asked the parties to 

address plans for disposal of any Greater-Than-Class-C (GTCC) waste generated during 

SHINE’s production process.240 SHINE stated that it has been in discussions with facilities that 

are licensed to accept GTCC waste for storage.241 Further, SHINE explained that a provision in 

the American Medical Isotopes Production Act requires the Department of Energy to take back 

and dispose of waste without a disposal path.242 SHINE also raised the possibility that its 

finalized design might limit or eliminate any GTCC waste stream.243

 

237 Tr. at 175 (Ms. Moser); see also Ex. NRC-009, FEIS, ch. 4. 

238 Tr. at 175 (Ms. Moser); Ex. NRC-009, FEIS, at 6-1, 6-4. 

239 See Tr. at 154-55 (Commissioner Svinicki), 202 (Commissioner Baran); Pre-Hearing 

Questions at 20; Ex. NRC-004-R, Staff Responses to Pre-Hearing Questions, at 42. 

240 See Tr. at 154-55 (Commissioner Svinicki), 202 (Commissioner Baran); Pre-Hearing 

Questions at 20. 

241 Tr. at 155 (Ms. Kolb). 

242 Id. at 155-56 (Ms. Kolb), 203 (Dr. Vann Bynum); see 42 U.S.C. § 2065(c)(3)(A)(ii) (requiring 

that the uranium lease contracts must require the Secretary of Energy “to take title to and be 

responsible for the final disposition of radioactive waste created by the irradiation, processing, 

or purification of uranium leased under this section for which the Secretary determines the 

producer does not have access to a disposal path”). 

243 Tr. at 155 (Ms. Kolb). The Environmental Protection Agency commented on this issue in the 

DEIS. See Ex. NRC-009, FEIS, at A-36 to A-37. After the Secretary closed the record for this 
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The Staff also evaluated whether any threatened or endangered species were present 

onsite that could be affected by the project. Section 7 of the Endangered Species Act of 1973 

requires an agency, in consultation with and with the assistance of the Secretary of the Interior 

or the Secretary of Commerce (as appropriate), to ensure that “any action authorized, funded, 

or carried out by such agency . . . is not likely to jeopardize the continued existence of any 

endangered species or threatened species or result in the destruction or adverse modification of 

[critical] habitat of such species.”244 The U.S. Fish and Wildlife Service (under the Department 

of the Interior) and the National Marine Fisheries Service (under the Department of Commerce) 

jointly administer the Act. 

SHINE conducted ecological surveys of the proposed site and the offsite area where 

construction of the sewer line would occur.245 The Staff reviewed this information, as well as 

information obtained from the U.S. Fish and Wildlife database and concluded that no 

endangered species were present in this area.246 The Staff also contacted the U.S. Fish and 

Wildlife Service, which stated that no federally listed, proposed, or candidate species would be 

expected within the project area and that no critical habitat is present.247 The Staff conducted a 

 

proceeding, the Staff informed us that the Environmental Protection Agency had again raised 

this issue in comments on the FEIS. The Staff attached its response, which explained that the 

Environmental Protection Agency had based its comments on a non-public draft of the FEIS that 

did not include the Staff’s finalized discussion of the GTCC issue. The Staff provided to the 

Environmental Protection Agency the response from the published FEIS and supplemented that 

response with testimony from the hearing. See Notification of Correspondence Between the 

NRC Staff and the Environmental Protection Agency Regarding the Final Environmental Impact 

Statement (Jan. 15, 2016). 

244 Endangered Species Act § 7(a)(2), 16 U.S.C. § 1536(a)(2). 

245 Ex. NRC-009, FEIS, at 3-35. 

246 Id.

247 Id. The Staff determined that because the site does not contain any surface water features 

and the nearby Rock River “does not contain marine or anadromous fish species,” there would 
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similar review for state-listed species and determined that none would be present at the 

proposed site or nearby adjacent areas.248 The Wisconsin Department of Natural Resources 

also determined that the site would not provide a suitable habitat for state-listed species, 

therefore there would be no potential for them to exist on the site.249

In accordance with the National Historic Preservation Act of 1966, the Staff reviewed 

whether the proposed action would have any effect on historic and cultural resources.250 SHINE 

commissioned an archeological survey of the site, but “did not identify any archaeological sites 

or evidence of cultural resources within the survey area.”251 The Staff contacted the Advisory 

Council on Historic Preservation and the Wisconsin Historical Society.252 The Staff also visited 

the Wisconsin Historical Society and reviewed listings of archeological resources.253 Based on 

the information it gathered, the Staff concluded that there were no historic properties or historic 

and cultural resources on the proposed site.254 The Wisconsin Historical Society confirmed that 

no historic properties would be affected by the proposed action.255

 

be no federally listed species within the action area under the jurisdiction of the National Marine 

Fisheries Service. Id.

248 Id. at 3-35 to 3-36. 

249 Id. at 3-36. 

250 Id. at 3-40, 4-28 to 4-29. 

251 Id. at 3-40; see also Ex. NRC-004-R, Staff Responses to Pre-Hearing Questions, at 43. 

252 Ex. NRC-009, FEIS, at 4-28 to 4-29. 

253 Id.; Ex. NRC-004-R, Staff Responses to Pre-Hearing Questions, at 43. 

254 Ex. NRC-009, FEIS at 4-28 to 4-29; Ex. NRC-004-R, Staff Responses to Pre-Hearing 

Questions, at 43. 

255 Ex. NRC-009, FEIS, at 4-29. 
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Also as part of this review, the Staff initiated consultation with 13 federally recognized 

Indian Tribes with historic ties to southern Wisconsin.256 The Staff received scoping comments 

from one tribe, the Forest County Potawatomi, which stated that the proposed project would be 

located on Potawatomi ancestral land, expressed concern for any impacts to historic and 

cultural properties in that area, and requested to receive the results of the historic and cultural 

investigation.257 The Staff attempted to contact the Tribe to share information about its 

review.258 It also provided copies of the DEIS and FEIS to the Forest County Potawatomi, along 

with the other affected Tribes.259 The Peoria Tribe of Indians of Oklahoma commented on the 

DEIS and stated that the proposed action would not appear to affect items of cultural 

significance to the Tribe but requested immediate notification and consultation if items covered 

under the Native American Graves Protection and Repatriation Act are discovered onsite.260

The Staff also analyzed alternatives to the proposed action.261 This review included 

consideration of the no-action alternative, alternative sites, and alternative technologies.262 For 

the no-action alternative, i.e., if the construction permit were to be denied, the Staff found that 

no changes would occur on the site, but that alternative also would not meet the purpose of the 

 

256 Id.

257 Id.; Ex. NRC-004-R, Staff Responses to Pre-Hearing Questions, at 31-33. 

258 Ex. NRC-004-R, Staff Responses to Pre-Hearing Questions, at 32. The Staff represented 

that it provided information about the availability of SHINE’s archeological survey report to the 

Potawatomi Tribe in March 2015. Id.

259 Id. 

260 Id.

261 See Ex. NRC-009, FEIS, ch. 5. 

262 Id. at 5-1. 
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proposed action—to provide a domestic supply of molybdenum-99.263 After reviewing the 

applicant’s systematic site-selection process, the Staff examined two alternative sites, both in 

the State of Wisconsin—one in Chippewa Falls, and one in Stevens Point.264 The Staff 

compared the environmental costs and benefits of the proposed action at these alternative sites 

with the costs and benefits of the proposed action at the Janesville site.265 The Staff found that 

impacts at the Chippewa Falls site would be small for all resource areas except for noise and 

traffic.266 It found that impacts at the Stevens Point site would be small for all resource areas 

except for traffic, noise, and visual impacts to the surrounding landscape.267 With “small to 

moderate impacts” in fewer resource areas, the Staff concluded that the Janesville site was the 

environmentally preferable alternative site.268

The Staff considered three technologies for the production of medical isotopes that it 

found to be feasible: neutron capture technology, aqueous homogenous reactor technology, 

and linear-accelerator-based technology.269 The Staff selected these technologies because at 

the time the Staff was preparing the EIS, they had been selected to receive funding from the 

National Nuclear Security Administration.270 The Staff further narrowed its review of these 

 

263 Id. at 5-1 to 5-2. 

264 Id. at 5-2 to 5-6. 

265 Id. at 5-103 to 5-105. 

266 Ex. NRC-013, Construction Permit Application Review, SHINE Medical Technologies, 

Environmental Panel (Dec. 8, 2015), at 12 (Staff Environmental Panel Presentation). 

267 Id.

268 Tr. at 181 (Ms. Moser). 

269 Ex. NRC-009, FEIS, at 5-92. 

270 Id. at 5-92 to 5-93. 
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alternatives, however, to one technology—the linear accelerator—because sufficient information 

was not available to review the other alternatives.271 The Staff concluded that the linear 

accelerator technology, if constructed, operated, and decommissioned at the Janesville site, 

would have similar impacts to SHINE’s proposed technology—small impacts in all resource 

areas except for traffic, which would be small to moderate.272

Considering the results of its environmental review the Staff recommended the issuance 

of the construction permit to SHINE.273 At the operating license stage, the Staff will prepare a 

supplement to the FEIS to address any new and significant information that was not available 

during its review of the construction permit application.274

F. Findings

We have conducted an independent review of the sufficiency of the Staff’s safety 

findings, with particular attention to the topics discussed above. Our findings, however, are 

based on the record as a whole. Based on the evidence presented in the uncontested hearing, 

including the Staff’s review documents and the testimony provided, we find 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 major features or 

components incorporated therein for the protection of the health and safety of the public. 

Further technical or design information as may be required to complete the safety analysis has 

reasonably been left for later consideration and will be supplied in the Final Safety Analysis 

Report. SHINE has described the safety features or components that require research and 

 

271 Id. at 5-93 to 5-94; Tr. at 179-80 (Ms. Moser). 

272 Ex. NRC-009, FEIS, at 5-104 to 5-105. 

273 Id. at 6-13. 

274 Ex. NRC-004-R, Staff Responses to Pre-Hearing Questions, at 40. 
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development and has identified, and there will be conducted, a research and development 

program reasonably designed to resolve any safety questions associated with these features or 

components. On the basis of the foregoing, we find that there is reasonable assurance that 

open safety questions will be resolved satisfactorily at or before the latest date stated in the 

application for completion of construction of the proposed facility, and that, taking into 

consideration the site criteria in 10 C.F.R. Part 100, the proposed facility can be constructed and 

operated at the proposed location without undue risk to the health and safety of the public. 

In making these findings, we also conclude that: there is reasonable assurance that 

construction of the facility will not endanger the health and safety of the public, and that the 

authorized activities can be conducted in compliance with the NRC’s regulations, including the 

requirements in 10 C.F.R. Part 20; SHINE is technically and financially qualified to engage in 

the activities authorized; issuance of the construction permit will not be inimical to the common 

defense and security or to the health and safety of the public; and SHINE’s application meets 

the standards and requirements of the Atomic Energy Act and the NRC’s regulations, and the 

required notifications to other agencies or bodies have been duly made.275 Additionally, we find 

that the Staff’s proposed permit conditions are appropriately drawn and sufficient to provide 

reasonable assurance of adequate protection of public health and safety.276

We also conducted an independent review of the Staff’s environmental analysis in the 

FEIS, taking into account the particular requirements of NEPA. NEPA section 102(2)(A) 

requires agencies to use “a systematic, interdisciplinary approach which will insure the 

 

275 See, e.g., 10 C.F.R. § 2.104(a); Ex. NRC-009, FEIS, at 1-6 to 1-7. 

276 See 10 C.F.R. §§ 50.35(b), 50.50; Ex. NRC-002-R, Draft Construction Permit, at 2-3. We 

agree with the Staff’s decision to remove the proposed permit condition that would have set 

forth criteria for SHINE to obtain pre-approval for certain construction changes. See Ex. 

NRC-004-R, Staff Responses to Pre-Hearing Questions, at 45-47; see also supra note 144. 
- 47 -

integrated use of the natural and social sciences and the environmental design arts” in decisionmaking that may impact the environment.277 We find that the environmental review team used 

the systematic, interdisciplinary approach that NEPA requires.278 The environmental review 

team consisted of over twenty individuals with expertise in disciplines including ecology, 

geology, hydrology, human health, socioeconomics, and cultural resources.279

NEPA section 102(2)(E) calls for agencies to study, develop, and describe appropriate 

alternatives.280 The alternatives analysis is the “heart of the environmental impact statement.”281 

Based on the Staff’s testimony at the hearing, as well as the discussion in the FEIS, we find that 

the environmental review identified an appropriate range of alternatives with respect to the noaction alternative, alternative technologies, and alternative sites and adequately described the 

environmental impacts of each alternative.282 We find reasonable the Staff’s conclusion that 

none of the alternatives considered is environmentally preferable to the proposed action.283

NEPA section 102(2)(C) requires us to assess the relationship between local short-term 

uses and long-term productivity of the environment, to consider alternatives, and to describe the 

unavoidable adverse environmental impacts and the irreversible and irretrievable commitments 

 

277 NEPA § 102(2)(A), 42 U.S.C. § 4332(2)(A). 

278 See, e.g., Tr. at 170-87 (providing an overview of the Staff’s environmental review 

methodology and findings); Ex. NRC-013, Staff Environmental Panel Presentation, at 5-16. 

279 Ex. NRC-009, FEIS, at 7-1 (listing contributors from the NRC; Department of Energy, 

National Nuclear Security Administration; Los Alamos Technical Associates; and Idoneous 

Consulting). 

280 NEPA § 102(2)(E), 42 U.S.C. § 4332(2)(E). 

281 10 C.F.R. pt. 51, subpt. A, app. A, § 5. 

282 See, e.g., Tr. at 176-82, 188-89 (Ms. Moser); Ex. NRC-009, FEIS, ch. 5. 

283 See, e.g., Tr. at 181-83 (Ms. Moser); Ex. NRC-009, FEIS, at 6-4. 
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of resources associated with the proposed action.284 The discussion of alternatives is in 

Chapter 5 of the FEIS; the other items are discussed in Chapter 6.285 The environmental review 

team found that the short-term uses of the environment—construction, operation, and 

decommissioning of the SHINE facility—would commit land and energy indefinitely or 

permanently.286 After the facility is decommissioned, the land could return to productive use, but 

it may not be suitable for farming, depending on the condition of the soil, and would be further 

limited if the land is used to meet waste disposal needs.287 Also in the short term, however, the 

project would bring increased employment, expenditures, and tax revenues that would directly 

benefit local, regional, and state economies.288 Additionally, there could be long-term benefits 

from “[l]ocal governments investing project-generated tax revenues into infrastructure and other 

required services,” which would enhance economic productivity; and the additional infrastructure 

resulting from the SHINE facility (e.g., connection to water and sewer systems) “would be 

available and beneficial for any future use of the proposed SHINE facility after its 

decommissioning.”289

Chapter 6 of the FEIS includes a chart of the unavoidable adverse environmental 

impacts during construction, operation, and decommissioning, along with actions to mitigate 

those impacts.290 The environmental review team found that the unavoidable adverse impacts 

 

284 NEPA § 102(2)(C)(ii)-(v), 42 U.S.C. § 4332(2)(C)(ii)-(v). 

285 Ex. NRC-009, FEIS, chs. 5-6. 

286 Id. at 6-11 to 6-12. 

287 Id. at 6-12. 

288 Id.

289 Id.

290 Id. tbl. 6-2. 
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of the project would be small for all resource areas, except for increased traffic during 

construction and decommissioning, which could be small to moderate.291 To mitigate traffic 

impacts, “SHINE would stagger construction work-shift schedules to reduce the hourly traffic 

flow . . . and schedule truck deliveries early in the day to help reduce traffic congestion.”292 

SHINE also would follow delivery routes and avoid residential areas.293

Finally, with regard to irreversible and irretrievable commitments of resources, the 

environmental review team concluded that construction of the SHINE facility would irretrievably 

consume construction materials, unless SHINE recycles them after decommissioning.294 The 

soils on the property could be irreversibly damaged, such that they would no longer be suitable 

for farming.295 During operation, the uranium used in the production of molybdenum-99 “would 

be the main resource that would be irreversibly and irretrievably committed.”296 The Staff also 

found that electricity, fuel, and water would be expended, but that the amounts used for 

constructing, operating, and decommissioning the SHINE facility would not be expected “to 

deplete available supplies or exceed available system capacities.”297

We must weigh these unavoidable adverse environmental impacts and resource 

commitments—the environmental “costs” of the project—against the project’s benefits.298 

 

291 Id. at 6-5, 6-9; Tr. at 65-66 (Ms. Marshall). 

292 Ex. NRC-009, FEIS, at 6-9. 

293 Id.

294 Id. at 6-12. 

295 Id.

296 Id.

297 Id. at 6-13. 

298 Cf. 10 C.F.R. § 51.105(a). 
- 50 -

Considering the need for a reliable supply of medical isotopes in the United States and the 

expected increase in jobs and tax revenue described during the hearing and in the FEIS, we 

find that the benefits of the project outweigh the costs described above. Moreover, we have 

considered each of the requirements of NEPA section 102(2)(C) and find nothing in the record 

that would lead us to disturb the Staff’s conclusions on those requirements. 

In sum, for each of the topics discussed at the hearing and in today’s decision, we find 

that the Staff’s review was reasonably supported in logic and fact and sufficient to support the 

Staff’s conclusions. Based on our review of the FEIS, we also find that the remainder of the 

FEIS was reasonably supported and sufficient to support the Staff’s conclusions. Therefore, as 

a result of our review of the FEIS, and in accordance with the Notice of Hearing for this 

uncontested proceeding, we find that the requirements of NEPA section 102(2)(A), (C), and (E), 

and the applicable regulations in 10 C.F.R. Part 51, have been satisfied with respect to the 

construction permit application. We independently considered the final balance among 

conflicting factors contained in the record of this proceeding. We find, after weighing the 

environmental, economic, technical, and other benefits against environmental and other costs, 

and considering reasonable alternatives, that the construction permit should be issued. 

 
- 51 -

III. CONCLUSION 

We find that, with respect to the safety and environmental issues before us, the Staff’s 

review of SHINE’s construction permit application was sufficient to support issuance of the 

construction permit. We authorize the Director of the Office of Nuclear Reactor Regulation to 

issue the permit for the construction of the SHINE Medical Radioisotope Production Facility. 

Additionally, we authorize the Staff to issue the record of decision, subject to its revision as 

necessary to reflect the findings in this decision. 

IT IS SO ORDERED. 

 For the Commission 

 NRC Seal 

 /RA/ 

 ________________________ 

 Annette L. Vietti-Cook 

 Secretary of the Commission 

Dated at Rockville, Maryland, 

this 25th day of February, 2016. 
UNITED STATES OF AMERICA 

NUCLEAR REGULATORY COMMISSION 

In the Matter of ) 

 ) 

SHINE Medical Technologies, Inc. ) Docket No. 50-608-CP 

 ) 

 (Mandatory Hearing) ) 

 

CERTIFICATE OF SERVICE 

I hereby certify that copies of the foregoing COMMISSION MEMORANDUM AND ORDER 

(CLI-16-04) have been served upon the following persons by the Electronic Information Exchange. 

U.S. Nuclear Regulatory Commission 

Office of Commission Appellate Adjudication 

Mail Stop: O-7H4 

Washington, DC 20555-0001 

 E-mail: ocaamail@nrc.gov

U.S. Nuclear Regulatory Commission 

Office of the Secretary of the Commission 

Mail Stop: O-16C1 

Washington, DC 20555-0001 

Hearing Docket 

E-mail: hearingdocket@nrc.gov

Morgan, Lewis & Bockius, LLP 

1111 Pennsylvania Ave., NW 

Washington, DC 20004 

Counsel for the Applicant 

Paul M. Bessette, Esq. 

Stephen J. Burdick, Esq. 

Andrea N. Threet, Esq. 

Mary Freeze, Assistant 

Audrea Salters, Legal Secretary 

E-mail: 

pbessette@morganlewis.com

sburdick@morganlewis.com

andrea.threet@morganlewis.com

mfreeze@morganlewis.com

asalters@morganlewis.com

U.S. Nuclear Regulatory Commission 

Office of the General Counsel 

Mail Stop - O-15 D21 

Washington, DC 20555-0001 

Mitzi A. Young, Esq. 

Catherine E. Kanatas, Esq. 

Edward L. Williamson, Esq. 

E-mail: 

mitzi.young@nrc.gov

catherine.kanatas@nrc.gov

edward.williamson@nrc.gov

 

OGC Mail Center : 

OGCMailCenter@nrc.gov

[Original signed by Clara Sola ] 

Office of the Secretary of the Commission 

Dated at Rockville, Maryland 

this 25th day of February, 2016