ML16056A094

Commission Memorandum and Order (CLI-16-04)

ML16056A094
Person / Time
Site:	SHINE Medical Technologies
Issue date:	02/25/2016
From:	Annette Vietti-Cook NRC/SECY
To:
SECY RAS
References
50-608-CP, CLI-16-04, Mandatory Hearing 2, RAS 50947
Download: ML16056A094 (52)

Text

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 Staffs review of SHINEs application. As discussed below, we conclude that the Staffs 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Transcript Corrections, Admitting Post-Hearing Exhibits, and Closing the Record of the Proceeding) (Jan. 14, 2016) (unpublished) (Transcript Correction Order)).

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 hours0 days <br />0 hours <br />0 weeks <br />0 months <br />, with an additional 6,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> from outside technical experts, reviewing SHINEs application to determine whether it complies with the Atomic Energy Act of 1954, as amended, and the NRCs regulations.5 The Staffs 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.

New Reactors contributed to the review of SHINEs 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).

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 Staffs 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.

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 agencys 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.

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 NRCs 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 SHINEs application de novo; rather, we consider the sufficiency of the Staffs reviewthat is, we determine whether the Staffs 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 RequirementsSECY-15-0088Selection 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 Commissions Internal Procedures for uncontested combined license proceedings); Internal Commission Procedures, ch. IV, Commission Meetings/Hearings, at IV-12 to IV-21 (ML11269A125).

received the Staffs 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 safety-related 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 Staffs 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).

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 SHINEs production process.32 Mr. Hennessy answered questions relating to the facilitys 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, Applicants 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.

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 Staffs review of the construction permit application.34 Mr. Dean described the purpose of the facility and the Staffs efforts to prepare for its review of the application.35 Dr. Gavrilas discussed the Staffs safety review and the regulatory standards by which the Staff conducted its review, and Ms. Marshall discussed the Staffs environmental analysis.36 Ms. Bailey provided the Staffs 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, SafetyPanel 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.

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 applicants 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.

c.

Summary of the Environmental Panel The environmental panel discussed the Staffs decision to prepare an environmental impact statement (EIS) for the SHINE facility; the Staffs consultation with other agencies on the EIS, as well as its interaction with the Department of Energy as a cooperating agency; the Staffs consideration of environmental impacts; and the Staffs 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 SHINEs and the Staffs 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.

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 SHINEs construction permit application, the Staffs 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 SHINEs Medical Radioisotope Production Facility SHINEs proposed design is first-of-a-kind.56 Although some of the general concepts underlying SHINEs proposed approach to medical isotope production have individually been used in other applications, SHINEs 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).

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.

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 SHINEs 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 Commissions Public Pre-Hearing 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).

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.

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, SafetyPanel 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).

workers and the public for all credible accidents at the facility.87 The Maximum Hypothetical Accident itself is considered not credible, and non-mechanisticthat 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.

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 SHINEs 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.

accident, some of which SHINE did not credit in its Maximum Hypothetical Accident scenarios.101 Principal among the proposed designs safety features are biological shielding heavy concretesurrounding 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 inventoryup to 10,000 times less than a power reactorand 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 Staffs Review Methodology The Staff began preparing for SHINEs 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).

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 SHINEs 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.

The Staff also updated its guidance documents to support its review of SHINEs application.115 Because of the similarity of SHINEs 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 SHINEs.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 SHINEs proposed design, we focused part of the hearing on the Staffs 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 SHINEs 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 Non-Power 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.

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 SHINEs 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 Staffs 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.

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 SHINEs 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 SHINEs 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 SHINEs 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 Staffs 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.

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 SHINEs 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 SHINEs 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.

abnormal conditions, and commitments to ensure compliance with the double contingency principle.141 The Staff also evaluated SHINEs proposed criticality accident alarm system.142 The Staff requested additional information from SHINE, and based on SHINEs 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 SHINEs 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 SHINEs treatment of controlled parameters, application of the [double contingency principle], and [SHINEs] 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

In addition to exploring the scope of the Staffs review, we asked several questions directed to the adequacy of the Staffs review of SHINEs accident analyses. With regard to the Maximum Hypothetical Accident for the Irradiation Facility, we asked the Staff to explain why it found sufficient SHINEs 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. NRC-002-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 pre-hearing 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 Staffs response to our pre-hearing question on the same topic. See Ex. NRC-004-R, Staff Responses to Pre-Hearing 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.

adjacent to a small airport, the Southern Wisconsin Regional Airport.149 Although SHINEs proximity to the airport would allow timely shipment of its finished productmolybdenum-99 has a sixty-six-hour half-life150it 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 SHINEs application included an aircraft impact analysis on the proposed facilitys safety-related 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 SHINEs analysis as well as SHINEs responses to the Staffs 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 birds-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.

SHINEs 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 SHINEs 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.

SHINE also has planned additional work on the computer codes that will be used to model the thermal-hydraulics behavior of SHINEs 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 SHINEs Subcritical Assembly.165 And Los Alamos is validating the code to ensure that it matches the behavior of aqueous systems, like SHINEs, 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 SHINEs irradiation process.168 Thermal-hydraulic experiments were performed at the University of WisconsinMadison 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.

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 SHINEs 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.

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 SHINEs 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 double-walled 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.

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 SHINEs Final Safety Analysis Report, and the Staffs 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.

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.

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 SHINEs analyses of the geography and demography of the site; the proposed facilitys 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 SHINEs 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 SHINEs 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 SHINEs 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).

used the Central Eastern United States-Seismic Source Characterization catalog, among other references, to establish the design basis earthquake for the SHINE facilitya 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 SHINEs consideration of hydrologic events for the proposed site).

212 Ex. NRC-006C, Construction Permit Application, PSAR, at 2.4-9.

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.

decommissioning, which the Staff will consider when SHINE submits its operating license application.219 The Staff reviewed SHINEs financial qualifications information, including SHINEs responses to requests for additional information.220 The Staff requested itemized information on SHINEs construction costs and requested that SHINE provide the basis for each estimated cost in its application.221 The Staff found reasonable SHINEs construction estimates, which were prepared by an established construction company with experience across a variety of industries.222 The Staff also found reasonable SHINEs 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 SHINEs 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 Price-Anderson 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.

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 SHINEs 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 SHINEs 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 Staffs 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).

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 Pre-Hearing Questions, at 40-41.

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 Staffs 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 SHINEs 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

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 Staffs 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

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.

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 SHINEs 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.

proposed actionto provide a domestic supply of molybdenum-99.263 After reviewing the applicants systematic site-selection process, the Staff examined two alternative sites, both in the State of Wisconsinone 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.

alternatives, however, to one technologythe linear acceleratorbecause 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 SHINEs proposed technologysmall 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 Staffs 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 Staffs 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.

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 NRCs 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 SHINEs application meets the standards and requirements of the Atomic Energy Act and the NRCs regulations, and the required notifications to other agencies or bodies have been duly made.275 Additionally, we find that the Staffs 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 Staffs 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 Staffs 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.

integrated use of the natural and social sciences and the environmental design arts in decision-making 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 Staffs 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 no-action alternative, alternative technologies, and alternative sites and adequately described the environmental impacts of each alternative.282 We find reasonable the Staffs 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 Staffs 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.

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 environmentconstruction, operation, and decommissioning of the SHINE facilitywould 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.

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 commitmentsthe environmental costs of the projectagainst the projects 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).

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 Staffs conclusions on those requirements.

In sum, for each of the topics discussed at the hearing and in todays decision, we find that the Staffs review was reasonably supported in logic and fact and sufficient to support the Staffs 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 Staffs 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.

III.

CONCLUSION We find that, with respect to the safety and environmental issues before us, the Staffs review of SHINEs 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

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 Staffs review of SHINEs application. As discussed below, we conclude that the Staffs 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)).

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 hours0 days <br />0 hours <br />0 weeks <br />0 months <br />, with an additional 6,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> from outside technical experts, reviewing SHINEs application to determine whether it complies with the Atomic Energy Act of 1954, as amended, and the NRCs regulations.5 The Staffs 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.

New Reactors contributed to the review of SHINEs 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).

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 Staffs 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.

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 agencys 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.

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 NRCs 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 SHINEs application de novo; rather, we consider the sufficiency of the Staffs reviewthat is, we determine whether the Staffs 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 RequirementsSECY-15-0088Selection 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 Commissions Internal Procedures for uncontested combined license proceedings); Internal Commission Procedures, ch. IV, Commission Meetings/Hearings, at IV-12 to IV-21 (ML11269A125).

received the Staffs 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 safety-related 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 Staffs 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).

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 SHINEs production process.32 Mr. Hennessy answered questions relating to the facilitys 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, Applicants 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.

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 Staffs review of the construction permit application.34 Mr. Dean described the purpose of the facility and the Staffs efforts to prepare for its review of the application.35 Dr. Gavrilas discussed the Staffs safety review and the regulatory standards by which the Staff conducted its review, and Ms. Marshall discussed the Staffs environmental analysis.36 Ms. Bailey provided the Staffs 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, SafetyPanel 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.

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 applicants 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.

c.

Summary of the Environmental Panel The environmental panel discussed the Staffs decision to prepare an environmental impact statement (EIS) for the SHINE facility; the Staffs consultation with other agencies on the EIS, as well as its interaction with the Department of Energy as a cooperating agency; the Staffs consideration of environmental impacts; and the Staffs 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 SHINEs and the Staffs 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.

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 SHINEs construction permit application, the Staffs 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 SHINEs Medical Radioisotope Production Facility SHINEs proposed design is first-of-a-kind.56 Although some of the general concepts underlying SHINEs proposed approach to medical isotope production have individually been used in other applications, SHINEs 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).

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.

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 SHINEs 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 Commissions Public Pre-Hearing 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).

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.

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, SafetyPanel 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).

workers and the public for all credible accidents at the facility.87 The Maximum Hypothetical Accident itself is considered not credible, and non-mechanisticthat 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.

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 SHINEs 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.

accident, some of which SHINE did not credit in its Maximum Hypothetical Accident scenarios.101 Principal among the proposed designs safety features are biological shielding heavy concretesurrounding 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 inventoryup to 10,000 times less than a power reactorand 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 Staffs Review Methodology The Staff began preparing for SHINEs 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).

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 SHINEs 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.

The Staff also updated its guidance documents to support its review of SHINEs application.115 Because of the similarity of SHINEs 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 SHINEs.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 SHINEs proposed design, we focused part of the hearing on the Staffs 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 SHINEs 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 Non-Power 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.

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 SHINEs 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 Staffs 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.

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 SHINEs 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 SHINEs 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 SHINEs 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 Staffs 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.

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 SHINEs 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 SHINEs 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.

abnormal conditions, and commitments to ensure compliance with the double contingency principle.141 The Staff also evaluated SHINEs proposed criticality accident alarm system.142 The Staff requested additional information from SHINE, and based on SHINEs 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 SHINEs 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 SHINEs treatment of controlled parameters, application of the [double contingency principle], and [SHINEs] 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

In addition to exploring the scope of the Staffs review, we asked several questions directed to the adequacy of the Staffs review of SHINEs accident analyses. With regard to the Maximum Hypothetical Accident for the Irradiation Facility, we asked the Staff to explain why it found sufficient SHINEs 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. NRC-002-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 pre-hearing 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 Staffs response to our pre-hearing question on the same topic. See Ex. NRC-004-R, Staff Responses to Pre-Hearing 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.

adjacent to a small airport, the Southern Wisconsin Regional Airport.149 Although SHINEs proximity to the airport would allow timely shipment of its finished productmolybdenum-99 has a sixty-six-hour half-life150it 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 SHINEs application included an aircraft impact analysis on the proposed facilitys safety-related 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 SHINEs analysis as well as SHINEs responses to the Staffs 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 birds-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.

SHINEs 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 SHINEs 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.

SHINE also has planned additional work on the computer codes that will be used to model the thermal-hydraulics behavior of SHINEs 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 SHINEs Subcritical Assembly.165 And Los Alamos is validating the code to ensure that it matches the behavior of aqueous systems, like SHINEs, 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 SHINEs irradiation process.168 Thermal-hydraulic experiments were performed at the University of WisconsinMadison 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.

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 SHINEs 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.

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 SHINEs 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 double-walled 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.

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 SHINEs Final Safety Analysis Report, and the Staffs 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.

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.

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 SHINEs analyses of the geography and demography of the site; the proposed facilitys 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 SHINEs 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 SHINEs 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 SHINEs 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).

used the Central Eastern United States-Seismic Source Characterization catalog, among other references, to establish the design basis earthquake for the SHINE facilitya 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 SHINEs consideration of hydrologic events for the proposed site).

212 Ex. NRC-006C, Construction Permit Application, PSAR, at 2.4-9.

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.

decommissioning, which the Staff will consider when SHINE submits its operating license application.219 The Staff reviewed SHINEs financial qualifications information, including SHINEs responses to requests for additional information.220 The Staff requested itemized information on SHINEs construction costs and requested that SHINE provide the basis for each estimated cost in its application.221 The Staff found reasonable SHINEs construction estimates, which were prepared by an established construction company with experience across a variety of industries.222 The Staff also found reasonable SHINEs 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 SHINEs 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 Price-Anderson 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.

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 SHINEs 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 SHINEs 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 Staffs 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).

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 Pre-Hearing Questions, at 40-41.

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 Staffs 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 SHINEs 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

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 Staffs 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

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.

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 SHINEs 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.

proposed actionto provide a domestic supply of molybdenum-99.263 After reviewing the applicants systematic site-selection process, the Staff examined two alternative sites, both in the State of Wisconsinone 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.

alternatives, however, to one technologythe linear acceleratorbecause 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 SHINEs proposed technologysmall 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 Staffs 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 Staffs 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.

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 NRCs 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 SHINEs application meets the standards and requirements of the Atomic Energy Act and the NRCs regulations, and the required notifications to other agencies or bodies have been duly made.275 Additionally, we find that the Staffs 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 Staffs 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 Staffs 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.

integrated use of the natural and social sciences and the environmental design arts in decision-making 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 Staffs 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 no-action alternative, alternative technologies, and alternative sites and adequately described the environmental impacts of each alternative.282 We find reasonable the Staffs 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 Staffs 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.

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 environmentconstruction, operation, and decommissioning of the SHINE facilitywould 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.

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 commitmentsthe environmental costs of the projectagainst the projects 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).

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 Staffs conclusions on those requirements.

In sum, for each of the topics discussed at the hearing and in todays decision, we find that the Staffs review was reasonably supported in logic and fact and sufficient to support the Staffs 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 Staffs 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.

III.

CONCLUSION We find that, with respect to the safety and environmental issues before us, the Staffs review of SHINEs 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