Environmental Impact Statement for the Construction Permit for the SHINE Medical Radioisotope Production Facility Draft Report for Comment

Office of Nuclear Reactor Regulation

NUREG-2183

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Environmental Impact Statement for the Construction Permit for the SHINE Medical Radioisotope Production Facility Draft Report for Comment Manuscript Completed: April 2015 Date Published: May 2015 Michelle Moser, NRC Project Manager Office of Nuclear Reactor Regulation

NUREG-2183

COMMENTS ON DRAFT REPORT 1

Any interested party may submit comments on this report for consideration by the NRC staff. 2 Comments may be accompanied by additional relevant information or supporting data. Please 3 specify the report number NUREG-2183 in your comments, and send them by the end of the 4 comment period specified in the Federal Register notice announcing the availability of this 5 report. 6

Addresses: You may submit comments by any one of the following methods. Please include 7 Docket ID NRC-2013-0053 in the subject line of your comments. Comments submitted in 8 writing or in electronic form will be posted on the NRC website and on the Federal rulemaking 9 website http://www.regulations.gov. 10

Federal Rulemaking Website: Go to http://www.regulations.gov and search for documents 11 filed under Docket ID NRC-2013-0053. Address questions about NRC dockets to Carol 12 Gallagher at 301-415-3463 or by e-mail at Carol.Gallagher@nrc.gov. 13

Mail comments to: Cindy Bladey, Chief, Rules, Announcements, and Directives Branch 14 (RADB), Division of Administrative Services, Office of Administration, Mail Stop: 15

OWFN-12-H08, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. 16

For any questions about the material in this report, please contact: Ms. Michelle Moser, 17 Environmental Project Manager, 301-415-6509 or by e-mail at Michelle.Moser@nrc.gov. 18

Please be aware that any comments that you submit to the NRC will be considered a public 19 record and entered into the Agencywide Documents Access and Management System 20 (ADAMS). Do not provide information you would not want to be publicly available. 21

http://www.regulations.gov/http://www.regulations.gov/mailto:Carol.Gallagher@nrc.gov

COVER SHEET 1

Responsible Agency: U.S. Nuclear Regulatory Commission (NRC), Office of Nuclear Reactor 2 Regulation. The U.S. Department of Energy is a cooperating agency involved in the preparation 3 of this environmental impact statement (EIS). 4 Title: Environmental Impact Statement for the Construction Permit for the SHINE Medical 5 Radioisotope Production Facility, Draft Report for Comment 6

The proposed SHINE Medical Technologies, Inc. (SHINE), facility would be located in 7 Janesville, Wisconsin. 8

Additional information or copies of this document are available through the following: 9

Division of License Renewal 10 U.S. Nuclear Regulatory Commission (NRC) 11

Office of Nuclear Reactor Regulation 12 Mail Stop O-11F1 13

11555 Rockville Pike 14 Rockville, MD 20852 15

Phone: 1-800-368-5642, extension 6509 16 Fax: 301-415-2002 17

E-mail: Michelle.Moser@nrc.gov 18

ABSTRACT 19

The U.S Nuclear Regulatory Commission (NRC) has prepared this environmental impact 20 statement (EIS) in response to an application submitted by SHINE Medical Technologies, Inc. 21 (SHINE), for a construction permit of a medical radioisotope production facility. The EIS 22 includes the analysis that evaluates the environmental impacts of the proposed action and 23 considers the following three alternatives to the proposed action: (1) the no-action alternative 24 (i.e., the construction permit is denied), (2) two alternative sites, and (3) one alternative 25 technology. 26

After weighing the environmental, economic, technical, and other benefits against environmental 27 and other costs, and considering reasonable alternatives, the NRC staff recommends, unless 28 safety issues mandate otherwise, the issuance of the proposed construction permit to SHINE. 29 The NRC staff based its recommendation on the following factors: 30

SHINEs Environmental Report; 31

the NRC staffs consultation with Federal, State, and local agencies; 32

the NRC staffs independent environmental review; and 33

the NRC staffs consideration of public comments received. 34

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mailto:Michelle.Moser@nrc.gov

TABLE OF CONTENTS 1

ABSTRACT .............................................................................................................................. iii 2 TABLE OF CONTENTS ............................................................................................................ v 3 FIGURES .................................................................................................................................. xi 4 TABLES ................................................................................................................................. xiii 5 EXECUTIVE SUMMARY ....................................................................................................... xvii 6 ABBREVIATIONS AND ACRONYMS .................................................................................... xxi 7

INTRODUCTION ......................................................................................................... 1-1 8 1.1 Background ...................................................................................................... 1-1 9

1.1.1 Molybdenum-99 ................................................................................. 1-1 10 1.1.2 Iodine-131 ......................................................................................... 1-2 11 1.1.3 Xenon-133 ......................................................................................... 1-2 12

1.2 Proposed Federal Action .................................................................................. 1-2 13 1.3 Purpose and Need for the Proposed Federal Action ........................................ 1-3 14 1.4 U.S. Nuclear Regulatory Commission Environmental Review .......................... 1-4 15 1.5 Cooperating Agency ........................................................................................ 1-6 16 1.6 Consultation and Correspondence ................................................................... 1-6 17 1.7 Status of Compliance ....................................................................................... 1-7 18 1.8 References ...................................................................................................... 1-7 19

PROPOSED FEDERAL ACTION ................................................................................ 2-1 20 2.1 Site Location and Layout .................................................................................. 2-1 21 2.2 Construction Activities ...................................................................................... 2-5 22 2.3 Facility Operations ........................................................................................... 2-7 23

2.3.1 Proposed Technology ........................................................................ 2-7 24 2.3.2 Radioisotope Production Process Overview ...................................... 2-9 25

2.4 Power Requirements ..................................................................................... 2-12 26 2.5 Water Use, Treatment, and Discharges ......................................................... 2-13 27

2.5.1 Water Use ....................................................................................... 2-13 28 2.5.2 Water Treatment ............................................................................. 2-13 29 2.5.3 Water Discharges ............................................................................ 2-13 30

2.6 Cooling and Heating Dissipation Systems ...................................................... 2-14 31 2.6.1 Cooling Systems ............................................................................. 2-14 32 2.6.2 Heating Systems ............................................................................. 2-14 33

2.7 Storage, Treatment, and Transportation of Radioactive and 34 Nonradioactive Waste .................................................................................... 2-14 35 2.7.1 Radioactive Wastes ......................................................................... 2-15 36 2.7.2 Nonradioactive Waste ..................................................................... 2-17 37 2.7.3 Waste Minimization and Pollution Prevention Program .................... 2-18 38

2.8 Facility Decommissioning ............................................................................... 2-19 39

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2.9 Related Actions .............................................................................................. 2-20 1 2.10 References .................................................................................................... 2-20 2

AFFECTED ENVIRONMENT ...................................................................................... 3-1 3 3.1 Land Use and Visual Resources ...................................................................... 3-1 4

3.1.1 Land Use ........................................................................................... 3-1 5 3.1.2 Visual Resources............................................................................... 3-8 6

3.2 Meteorology, Air Quality, and Noise ............................................................... 3-11 7 3.2.1 Meteorology and Climatology .......................................................... 3-11 8 3.2.2 Air Quality ........................................................................................ 3-13 9 3.2.3 Noise ............................................................................................... 3-18 10

3.3 Geologic Environment .................................................................................... 3-20 11 3.3.1 Site Geology .................................................................................... 3-20 12 3.3.2 Soils ................................................................................................ 3-23 13 3.3.3 Seismic Setting ................................................................................ 3-24 14

3.4 Water Resources ........................................................................................... 3-25 15 3.4.1 Surface Water ................................................................................. 3-25 16 3.4.2 Groundwater .................................................................................... 3-29 17

3.5 Ecological Resources .................................................................................... 3-31 18 3.5.1 Ecoregion ........................................................................................ 3-31 19 3.5.2 Site .................................................................................................. 3-32 20 3.5.3 Habitats in the Vicinity of the Proposed Site .................................... 3-33 21 3.5.4 Protected Species and Habitats ....................................................... 3-36 22

3.6 Historic and Cultural Resources ..................................................................... 3-40 23 3.6.1 Cultural Background ........................................................................ 3-40 24 3.6.2 Historic and Archaeological Resources ........................................... 3-42 25

3.7 Socioeconomics ............................................................................................. 3-42 26 3.7.1 Population Growth Rates and Projections ....................................... 3-42 27 3.7.2 Race and Ethnicity ........................................................................... 3-43 28 3.7.3 Transient Population ........................................................................ 3-44 29 3.7.4 Labor Force, Employment, and Unemployment ............................... 3-44 30 3.7.5 Income and Wages .......................................................................... 3-46 31 3.7.6 Poverty Rates .................................................................................. 3-46 32 3.7.7 Housing ........................................................................................... 3-47 33 3.7.8 Local Employers .............................................................................. 3-47 34 3.7.9 Taxes .............................................................................................. 3-48 35 3.7.10 Education ........................................................................................ 3-49 36 3.7.11 Tourism, Activity Centers, and Recreation for the City of 37

Janesville and Rock County ............................................................ 3-49 38 3.7.12 Public Services ................................................................................ 3-51 39

3.8 Human Health ................................................................................................ 3-52 40 3.8.1 Regulatory Radiological Requirements ............................................ 3-52 41

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3.8.2 Chemical Hazards ........................................................................... 3-54 1 3.8.3 Other Hazards ................................................................................. 3-54 2

3.9 Transportation Environments ......................................................................... 3-54 3 3.9.1 Roads .............................................................................................. 3-54 4 3.9.2 Airports ............................................................................................ 3-58 5 3.9.3 Rail .................................................................................................. 3-58 6

3.10 References .................................................................................................... 3-59 7

ENVIRONMENTAL IMPACTS OF CONSTRUCTION, OPERATIONS, AND 8 DECOMMISSIONING .................................................................................................. 4-1 9 4.1 Land Use and Visual Resources ...................................................................... 4-1 10

4.1.1 Land Use ........................................................................................... 4-1 11 4.1.2 Visual Resources............................................................................... 4-3 12

4.2 Air Quality and Noise ....................................................................................... 4-5 13 4.2.1 Construction ...................................................................................... 4-5 14 4.2.2 Operations ......................................................................................... 4-9 15 4.2.3 Decommissioning ............................................................................ 4-13 16

4.3 Geologic Environment .................................................................................... 4-16 17 4.3.1 Construction .................................................................................... 4-16 18 4.3.2 Operations ....................................................................................... 4-17 19 4.3.3 Decommissioning ............................................................................ 4-18 20

4.4 Water Resources ........................................................................................... 4-18 21 4.4.1 Surface Water ................................................................................. 4-18 22 4.4.2 Groundwater .................................................................................... 4-21 23

4.5 Ecological Resources .................................................................................... 4-24 24 4.5.1 Construction .................................................................................... 4-24 25 4.5.2 Operations ....................................................................................... 4-25 26 4.5.3 Decommissioning ............................................................................ 4-26 27 4.5.4 Federally Protected Species ............................................................ 4-26 28

4.6 Historic and Cultural Resources ..................................................................... 4-27 29 4.6.1 Historic and Cultural Resources ...................................................... 4-27 30 4.6.2 Proposed Action .............................................................................. 4-27 31 4.6.3 Consultation .................................................................................... 4-27 32 4.6.4 Impact Analysis ............................................................................... 4-28 33

4.7 Socioeconomic Impacts ................................................................................. 4-30 34 4.7.1 Construction .................................................................................... 4-30 35 4.7.2 Operations ....................................................................................... 4-32 36 4.7.3 Decommissioning ............................................................................ 4-34 37

4.8 Human Health ................................................................................................ 4-35 38 4.8.1 Construction .................................................................................... 4-35 39 4.8.2 Operations ....................................................................................... 4-36 40 4.8.3 Decommissioning ............................................................................ 4-38 41

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4.9 Waste Management ....................................................................................... 4-40 1 4.9.1 Radioactive Waste ........................................................................... 4-40 2 4.9.2 Nonradioactive Waste ..................................................................... 4-41 3

4.10 Transportation ................................................................................................ 4-42 4 4.10.1 Construction .................................................................................... 4-42 5 4.10.2 Operations ....................................................................................... 4-43 6 4.10.3 Decommissioning ............................................................................ 4-44 7

4.11 Accidents ....................................................................................................... 4-45 8 4.11.1 Maximum Hypothetical Accident ...................................................... 4-46 9 4.11.2 Hazardous Chemical Accidents ....................................................... 4-48 10

4.12 Environmental Justice .................................................................................... 4-51 11 4.13 Cumulative Impacts ....................................................................................... 4-59 12

4.13.1 Land Use and Visual Resources ...................................................... 4-60 13 4.13.2 Air Quality and Noise ....................................................................... 4-61 14 4.13.3 Geologic Environment ..................................................................... 4-63 15 4.13.4 Water Resources ............................................................................. 4-64 16 4.13.5 Ecological Resources ...................................................................... 4-67 17 4.13.6 Historic and Cultural Resources ...................................................... 4-68 18 4.13.7 Socioeconomics .............................................................................. 4-69 19 4.13.8 Human Health ................................................................................. 4-70 20 4.13.9 Waste Management ........................................................................ 4-71 21 4.13.10 Transportation ................................................................................. 4-73 22 4.13.11 Environmental Justice ..................................................................... 4-73 23 4.13.12 Summary ......................................................................................... 4-74 24

4.14 References .................................................................................................... 4-77 25

ALTERNATIVES ......................................................................................................... 5-1 26 5.1 No-Action Alternative ....................................................................................... 5-1 27 5.2 Alternative Sites ............................................................................................... 5-2 28

5.2.1 Description of Alternative Site-Selection Process .............................. 5-2 29 5.2.2 Chippewa Falls Site ........................................................................... 5-7 30 5.2.3 Stevens Point Site ........................................................................... 5-49 31

5.3 Alternative Technologies ................................................................................ 5-94 32 5.3.1 Identification of Reasonable Alternatives ......................................... 5-94 33 5.3.2 Neutron Capture Alternative ............................................................ 5-95 34 5.3.3 Aqueous Homogenous Reactor Alternative ..................................... 5-95 35 5.3.4 Linear-Accelerator-Based Alternative .............................................. 5-96 36

5.4 Cost-Benefit Comparison ............................................................................. 5-101 37 5.4.1 Benefit and Costs of Alternatives ................................................... 5-105 38 5.4.2 Cost Benefit Conclusions ............................................................... 5-106 39

5.5 Alternatives Summary .................................................................................. 5-107 40 5.6 References .................................................................................................. 5-108 41

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CONCLUSIONS .......................................................................................................... 6-1 1 6.1 Environmental Impacts of the Proposed Action ................................................ 6-1 2 6.2 Comparison of Alternatives .............................................................................. 6-4 3 6.3 Resource Commitments ................................................................................... 6-5 4

6.3.1 Unavoidable Adverse Environmental Impacts .................................... 6-5 5 6.3.2 Relationship Between Local Short-Term Uses of the 6

Environment and the Maintenance and Enhancement of Long-7 Term Productivity............................................................................... 6-9 8

6.3.3 Irreversible and Irretrievable Commitment of Resources ................. 6-11 9 6.4 Recommendation ........................................................................................... 6-11 10 6.5 References .................................................................................................... 6-12 11

LIST OF PREPARERS ............................................................................................... 7-1 12 INDEX ......................................................................................................................... 8-1 13 LIST OF AGENCIES, ORGANIZATIONS, AND PERSONS TO WHOM COPIES 14 OF THIS ENVIRONMENTAL IMPACT STATEMENT ARE SENT .............................. 9-1 15

APPENDIX A: COMMENTS RECEIVED ON THE SHINE MEDICAL RADIOISOTOPE 16 PRODUCTION FACILITY ENVIRONMENTAL REVIEW .............................. A-1 17

APPENDIX B: APPLICABLE LAWS, REGULATIONS, AND OTHER 18 REQUIREMENTS ......................................................................................... B-1 19

APPENDIX C: CHRONOLOGY OF ENVIRONMENTAL REVIEW 20 CORRESPONDENCE .................................................................................. C-1 21

APPENDIX D: CONSULTATION CORRESPONDENCE ..................................................... D-1 22

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FIGURES 1

Figure 11. Environmental Review Process .......................................................................... 1-5 2 Figure 21. Region Surrounding the Proposed SHINE Facility .............................................. 2-3 3 Figure 22. Proposed SHINE Facility and Surrounding Area Within a 1-mi (1.6-km) 4

Radius ................................................................................................................ 2-4 5 Figure 23. Proposed SHINE Facility Conceptual Site Layout ............................................... 2-5 6 Figure 24. Conceptual View of the Proposed SHINE Facility ............................................... 2-7 7 Figure 25. Cutaway Conceptual Interior View of the SHINE Device ..................................... 2-8 8 Figure 26. Conceptual Model of an Irradiation Unit .............................................................. 2-9 9 Figure 27. SHINE Radioisotope Production System Flow Diagram .................................... 2-10 10 Figure 31. Aerial View of the Proposed SHINE Site ............................................................. 3-2 11 Figure 32. Cities and Major Roadways Within 5 mi (8 km) of the Proposed SHINE 12

Site ..................................................................................................................... 3-4 13 Figure 33. Prime Farmland and Farmland of Statewide Importance on the Proposed 14

SHINE Site ......................................................................................................... 3-6 15 Figure 34. Visual Setting of the Proposed SHINE Site ....................................................... 3-10 16 Figure 35. Annual Average Wind Rose as Measured at the Southern Wisconsin 17

Regional Airport ................................................................................................ 3-13 18 Figure 36. Proposed SHINE Facility Map Showing Noise Sources and Receptors ............ 3-20 19 Figure 37. Geologic Cross-Section of the Proposed SHINE Site and Vicinity ..................... 3-22 20 Figure 38. Surface-Water Features in the Vicinity of the Proposed SHINE Site ................. 3-26 21 Figure 39. Existing Transportation Network Near the Proposed SHINE Facility ................. 3-56 22 Figure 41. Conceptual Rendering of Proposed SHINE Facility ............................................ 4-4 23 Figure 42. Minority Populations Within 5 mi (8 km) of the Proposed SHINE Site in 24

Janesville .......................................................................................................... 4-53 25 Figure 43. Low-Income Populations Within 5 mi (8 km) of the Proposed SHINE 26

Facility in Janesville .......................................................................................... 4-55 27 Figure 51. Population Centers and Transportation Features in Chippewa County, 28

Wisconsin ........................................................................................................... 5-8 29 Figure 52. Chippewa Falls Site ............................................................................................ 5-9 30 Figure 53. Minority Populations Within 5 mi (8 km) of the Chippewa Falls Site .................. 5-35 31 Figure 54. Low-Income Populations Within 5 mi (8 km) of the Chippewa Falls Site ........... 5-36 32 Figure 55. Population Centers and Transportation Features in Portage County, 33

Wisconsin ......................................................................................................... 5-51 34 Figure 56. Stevens Point Site ............................................................................................ 5-52 35 Figure 57. Minority Populations Within 5 mi (8 km) of the Stevens Point Site ..................... 5-79 36 Figure 58. Low-Income Populations Within 5 mi (8 km) of the Stevens Point Site .............. 5-80 37

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TABLES 1

Table ES1. Summary of NRC Conclusions on the Environmental Impacts of 2 Construction, Operations, and Decommissioning of the Proposed SHINE 3 Facility ................................................................................................................. xix 4

Table 21. Estimated Construction Material Requirements .................................................. 2-6 5 Table 22. Gaseous Radioactive Effluents ......................................................................... 2-16 6 Table 23. Summary of Major(a) Chemical Inventory and Quantity at the Proposed 7

SHINE Facility................................................................................................... 2-19 8 Table 31. Summary of Land Use and Land Cover Within the Proposed SHINE Site 9

and Vicinity ......................................................................................................... 3-3 10 Table 32. Crop Production Estimates for the Proposed SHINE Site and Within Rock 11

County, Wisconsin .............................................................................................. 3-7 12 Table 33. Land Use in the City of Janesville ....................................................................... 3-8 13 Table 34. Annual and Seasonal Precipitation and Temperature Data for the City of 14

Janesville, Wisconsin ........................................................................................ 3-11 15 Table 35. National Ambient Air Quality Standards ............................................................ 3-15 16 Table 36. Regional Air Emissions Inventory ..................................................................... 3-16 17 Table 37. Sound Levels and Human Response ................................................................ 3-18 18 Table 38. Common and Abundant Wildlife Observed on or Near the Proposed Site ......... 3-33 19 Table 39. Common Fish Species in the Rock River and Tributaries Within 5 mi 20

(8 km) of the Proposed Site .............................................................................. 3-36 21 Table 310. Federally and State-Listed Species Within a 6-mi (10-km) Radius of the 22

Proposed SHINE Site ....................................................................................... 3-38 23 Table 311. Resident Population for Rock County (19702050) .......................................... 3-43 24 Table 312. Race and Ethnicity for the City of Janesville and Rock County, Wisconsin, 25

in 2010 .............................................................................................................. 3-43 26 Table 313. Labor Force, Employment, and Unemployment Rates in the City of 27

Janesville, Rock County, and the State of Wisconsin ........................................ 3-45 28 Table 314. Employment by Industry in Rock County for 2012 ............................................. 3-46 29 Table 315. Median Family Income and Per Capita Income for City of Janesville, Rock 30

County, and the State of Wisconsin .................................................................. 3-46 31 Table 316. People Living Below U.S. Census Poverty Thresholds for the City of 32

Janesville, Rock County, and State of Wisconsin .............................................. 3-47 33 Table 317. Housing Unit Characteristics for the City of Janesville and Rock County .......... 3-47 34 Table 318. Ten Largest Employers in the City of Janesville (2014) ..................................... 3-48 35 Table 319. Ten Largest Employers in Rock County (2014) ................................................. 3-48 36 Table 320. State-Owned Natural Areas in Rock County ..................................................... 3-50 37 Table 321. Average Annual Daily Traffic Counts in the Vicinity of the Proposed Site .......... 3-57 38 Table 322. Estimated Annual Average Peak and Daily Total Traffic Counts in the 39

Vicinity of the Proposed SiteNumber of Vehicles ........................................... 3-57 40 Table 41. Acres of Land Required for Construction of the Proposed SHINE Facility ........... 4-2 41 Table 42. Equipment Used During Construction ................................................................. 4-6 42

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Table 43. Annual Air Emissions During Construction .......................................................... 4-7 1 Table 44. Fuel Combustion Sources ................................................................................. 4-10 2 Table 45. Fuel Combustion Emissions During Operations ................................................ 4-10 3 Table 46. SHINE Air Dispersion Modeling Results............................................................ 4-11 4 Table 47. Vehicle Emissions During Operation ................................................................. 4-12 5 Table 48. Diesel Equipment Used During Decommissioning ............................................ 4-13 6 Table 49. Air Emissions During Decommissioning ............................................................ 4-15 7 Table 410. Water Requirements for SHINE FacilityConstruction ..................................... 4-22 8 Table 411. Water Requirements for SHINE FacilityOperations ....................................... 4-23 9 Table 412. Comparison of SHINE Work Force Estimates by Occupation with 10

Employment by Occupation in ROI ................................................................... 4-31 11 Table 413. SHINE Hazardous Chemical Source Terms and Concentrations ...................... 4-49 12 Table 414. Minority Populations Within 5 mi (8 km) of the Proposed SHINE Site in 13

Janesville .......................................................................................................... 4-54 14 Table 415. Low-Income Populations Within 5 mi (8 km) of the Proposed SHINE 15

Facility in Janesville .......................................................................................... 4-56 16 Table 416. Past, Present, and Reasonably Foreseeable Projects and Other Actions 17

Retained for the Cumulative Impacts Analysis .................................................. 4-59 18 Table 417. Cumulative Air Emission Effects Summary During SHINE Operation ................ 4-62 19 Table 418. Cumulative Impacts on Environmental Resources, Including the Impacts 20

of the Proposed Project .................................................................................... 4-75 21 Table 51. Proposed SHINE Site-Selection Scoring Criteria ................................................ 5-6 22 Table 52. Potential Land Use and Natural Habitat Impacts at the Chippewa Falls 23

Site ................................................................................................................... 5-10 24 Table 53. Federally and State-Protected Species Within a 6-mi (10-km) Radius of 25

the Chippewa Falls Site .................................................................................... 5-21 26 Table 54. Annual Average Daily Traffic CountsVicinity of Chippewa Falls Site .............. 5-29 27 Table 55. Estimated Annual Average Peak and Daily Total Traffic CountsVicinity 28

of Chippewa Falls SiteNumber of Vehicles .................................................... 5-29 29 Table 56. Minority Populations Within 5 mi (8 km) of the Chippewa Falls Site .................. 5-34 30 Table 57. Low-Income Populations Within 5 mi (8 km) of the Chippewa Falls Site ........... 5-36 31 Table 58. Past, Present, and Reasonably Foreseeable Future Projects and Other 32

Actions Within a 5-mi (8-km) Radius of the Chippewa Falls Site ....................... 5-40 33 Table 59. Potential Land Use and Natural Habitat Impacts at the Stevens Point Site ....... 5-53 34 Table 510. Vegetation on the Stevens Point Site ................................................................ 5-64 35 Table 511. Federally and State-Protected Species Within a 6-mi (10-km) Radius of 36

the Stevens Point Site ....................................................................................... 5-65 37 Table 512. Annual Average Daily Traffic CountsVicinity of Stevens Point Site ................ 5-73 38 Table 513. Estimated Annual Average Peak and Daily Total Traffic CountsVicinity 39

of the Stevens Point SiteNumber of Vehicles ................................................ 5-74 40 Table 514. Minority Populations Within 5 mi (8 km) of the Stevens Point Site ..................... 5-78 41 Table 515. Low-Income Populations Within 5 mi (8 km) of the Stevens Point Site .............. 5-80 42

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Table 516. Past, Present, and Reasonably Foreseeable Future Projects and Other 1 Actions Retained for the Cumulative Impacts Analysis Within a 5-mi 2 (8-km) ROI of the Stevens Point Site ................................................................ 5-84 3

Table 517. Costs and Benefits of Constructing, Operating, and Decommissioning the 4 Proposed SHINE Facility at the Janesville, Wisconsin, Site ............................ 5-102 5

Table 518. Comparison of Impacts for the Proposed SHINE Facility, Proposed 6 Alternative Sites, and No-Action ..................................................................... 5-106 7

Table 519. Comparison of Technologies at the Proposed SHINE Facility in Janesville ..... 5-106 8 Table 61. Summary of Environmental Impacts from Construction, Operations, and 9

Decommissioning of the Proposed SHINE Facility at the Janesville Site............. 6-2 10 Table 62. Unavoidable Adverse Environmental Impacts ..................................................... 6-5 11 Table 71. List of Preparers ................................................................................................. 7-1 12 Table 91. List of Agencies, Organizations, and Persons to Whom Copies of This 13

Environmental Impact Statement Are Sent ......................................................... 9-1 14 Table A1. Individuals Providing Comments During the Scoping Comment Period .............. A-2 15 Table A2. Issue Categories ................................................................................................. A-2 16 Table B1. Potentially Applicable Federal Statutes, Regulations, and Orders ....................... B-2 17 Table B2. Potentially Applicable Wisconsin State Requirements ......................................... B-6 18 Table B3. City of Janesville and Rock County, Wisconsin, Ordinances and Plans .............. B-8 19 Table B4. Permits and Approvals Required for Construction and Operation ....................... B-9 20 Table C1. Environmental Review Correspondence ............................................................. C-1 21 Table D1. Section 7 Consultation Correspondence ............................................................. D-3 22 Table D2. NHPA Correspondence ...................................................................................... D-4 23

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EXECUTIVE SUMMARY 1

BACKGROUND 2

By letter dated March 26, 2013, SHINE Medical Technologies, Inc. (SHINE), submitted Part 1 of 3 a two-part application to the U.S. Nuclear Regulatory Commission (NRC) for a construction 4 permit for a medical radioisotope production facility (SHINE facility) in Janesville, Wisconsin. To 5 issue a permit, the NRC is required to consider the environmental impacts of the proposed 6 action under the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq., herein 7 referred to as NEPA). The NRCs environmental protection regulations that implement NEPA in 8 Title 10 of the Code of Federal Regulations (10 CFR) Part 51describe several types of actions 9 that would require an environmental impact statement (EIS). The regulation at 10 CFR 51.20 10 does not specifically identify construction permits and operating licenses for production and 11 utilization facilities as an action that would require an EIS. However, for the SHINE 12 environmental review, the NRC staff determined that an EIS was appropriate to assess the 13 environmental impacts of the proposed action. The NRC staff made this determination because 14 of the potential for significant environmental impacts and the unique considerations of a 15 first-of-a-kind application for a medical radioisotope production facility with a unique application 16 of technologies, as well as to allow public involvement in the environmental review process. 17

Upon acceptance of Part 1 of SHINEs application, the NRC staff began the environmental 18 review process described in 10 CFR Part 51 by publishing a Notice of Intent in the Federal 19 Register (78 FR 39343) to prepare an EIS and to conduct scoping activities. In preparation of 20 this EIS, the NRC staff performed the following: 21

conducted public scoping meetings on July 17, 2013, in Janesville, Wisconsin; 22

conducted a site audit at the proposed SHINE site and alternative sites from 23 July 30, 2013, to August 1, 2013; 24

reviewed SHINEs Environmental Report; 25

consulted with Federal, State, and local agencies; 26

conducted a review of the guidance in Final Interim Staff Guidance Augmenting 27 NUREG-1537, Part 1, Guidelines for Preparing and Reviewing Applications for the 28 Licensing of Non-Power Reactors: Format and Content, for Licensing Radioisotope 29 Production Facilities and Aqueous Homogeneous Reactors; and Part 2, Guidelines 30 for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors: 31 Standard Review Plan and Acceptance Criteria; and 32

considered public comments received. 33

PROPOSED ACTION 34

The proposed Federal action is for the NRC to decide whether to issue a construction permit 35 under 10 CFR Part 50 that would allow construction of a medical radioisotope production facility. 36 If the NRC were to issue a construction permit, SHINE could build the proposed facility on a 37 91-acre (37-hectare) site in Rock County, which is located about 4 miles (6 kilometers) south of 38 the city center of Janesville, Wisconsin. The SHINE facility would produce, package, and ship 39 medical radioisotopes, specifically molybdenum-99, iodine-131, and xenon-133. 40

The U.S. Department of Energy is a cooperating agency on this EIS. If the NRC issues the 41 required permits and licenses, the proposed Federal action for the U.S. Department of Energy 42

xvii

Executive Summary

National Nuclear Security Administration is to decide whether to provide cost-sharing financial 1 support to SHINE under a cooperative agreement to accelerate the commercial production of 2 medical radioisotopes without the use of highly enriched uranium. The funding would help 3 accelerate activities, such as construction, purchase of equipment, and initial operation using a 4 subcritical fission process. 5

PURPOSE AND NEED FOR ACTION 6

The purpose of this proposed Federal action is to evaluate the applicants proposal to construct 7 a facility that would ultimately produce medical radioisotopes. The determination of need and 8 the decision to produce radioisotopes are at the discretion of applicants or other medical 9 radioisotope production decisionmakers. This definition of purpose and need reflects the NRCs 10 recognition that, unless there are findings in the safety review required by the Atomic Energy 11 Act of 1954, as amended, or findings in the environmental analysis under NEPA that would lead 12 the NRC to reject a construction permit application, the agency does not have a role in the 13 planning decisions as to whether a particular radioisotope production facility should be 14 constructed and operated. 15

The proposed Federal action for the U.S. Department of Energy National Nuclear Security 16 Administration is to decide whether, if the NRC grants a permit(s) and license(s), to provide 17 cost-sharing financial support to SHINE under a cooperative agreement to accelerate the 18 establishment of the commercial production of medical radioisotopes without the use of highly 19 enriched uranium. The funding would help to accelerate activities such as construction, 20 purchase of equipment, and initial operation using a subcritical fission process if the NRC were 21 to give SHINE a construction permit and operating license. 22

ENVIRONMENTAL IMPACTS OF CONSTRUCTION, OPERATIONS, AND 23 DECOMMISSIONING 24

The EIS evaluates the potential environmental impacts of the proposed action. The 25 environmental impacts from the proposed action are designated as SMALL, MODERATE, or 26 LARGE. The following definitions of these three significance levels, as presented in the final 27 interim staff guidance to NUREG1537, apply: 28

SMALL: Environmental effects are not detectable or are so minor that they would 29 neither destabilize nor noticeably alter any important attribute of the resource. In 30 assessing radiological impacts, the NRC has concluded that those impacts that do not 31 exceed permissible levels in the agencys regulations are considered SMALL. 32

MODERATE: Environmental effects are sufficient to alter noticeably, but not to 33 destabilize, important attributes of the resource. 34

LARGE: Environmental effects are clearly noticeable and are sufficient to destabilize 35 important attributes of the resource. 36

Table ES1 summarizes the NRC staffs findings on the level of impacts on environmental 37 resources from the construction, operations, and decommissioning of the SHINE facility. 38

xviii

Executive Summary

Table ES1. Summary of NRC Conclusions on the Environmental Impacts of 1 Construction, Operations, and Decommissioning of the Proposed SHINE Facility 2

Resource Area Impacts Land Use and Visual Resources SMALL Air Quality and Noise SMALL Geologic Environment SMALL Water Resources SMALL Ecological Resources SMALL Historic and Cultural Resources SMALL Socioeconomic Impacts SMALL Human Health SMALL Waste Management SMALL Transportation SMALL to MODERATE Accidents SMALL Environmental Justice See note below.(a) Cumulative Impacts Land Use and Visual Resources Air Quality and Noise Geologic Environment Water Resources Ecological Resources Historic and Cultural Resources Socioeconomics Impacts Human Health Waste Management Transportation Environmental Justice

SMALL SMALL SMALL SMALL MODERATE SMALL SMALL SMALL SMALL SMALL to MODERATE See note below.(a)

(a) There would be no disproportionately high and adverse impacts to minority and low-income populations and subsistence consumption from the proposed action and from cumulative impacts.

ALTERNATIVES 3

The NRC staff considered the environmental impacts associated with the following alternatives 4 to constructing the SHINE facility at the Janesville site: 5

the no-action alternative; 6

construction, operations, and decommissioning of the SHINE facility at the Chippewa 7 Falls site (Alternative Site No. 1); 8

construction, operations, and decommissioning of the SHINE facility at the Stevens 9 Point site (Alternative Site No. 2); and 10

construction, operations, and decommissioning of a linear-accelerator-based facility 11 at the SHINE site (alternative technology). 12

The NRC staff evaluated each alternative using the same resource areas that were used in 13 evaluating impacts from the proposed action. The NRC staff determined that the no-action 14 alternative would result in SMALL impacts to all resource areas. However, the no-action 15 alternative does not fulfill the purpose and need of the project. The environmentally preferred 16 alternatives are the construction, operations, and decommissioning of the SHINE facility and the 17 linear-accelerator-based facility at the Janesville site. The impacts associated with the 18 proposed action and the alternative technology would be SMALL for all resource areas with the 19

xix

Executive Summary

exception of traffic, which would incur SMALL to MODERATE impacts. The NRC staff 1 determined that the construction, operations, and decommissioning of building the SHINE 2 facility at the alternative sites would likely result in greater impacts than the proposed action. 3

RECOMMENDATION 4

After weighing the environmental, economic, technical, and other benefits against environmental 5 and other costs, and considering reasonable alternatives, the NRC staff recommends, unless 6 safety issues mandate otherwise, the issuance of the proposed construction permit to SHINE. 7 The NRC staff based its recommendation on the following factors: 8

SHINEs Environmental Report; 9

the NRC staffs consultation with Federal, State, and local agencies; 10

the NRC staffs independent environmental review; and 11

the NRC staffs consideration of public comments received. 12

xx

ABBREVIATIONS AND ACRONYMS 1

C degree(s) Celsius 2

F degree(s) Fahrenheit 3

ac acre(s) 4

ACHP Advisory Council on Historic Preservation 5

ADAMS Agencywide Documents Access and Management System 6

AEGL Acute Exposure Guideline Level 7

AERMOD American Meteorological Society/Environmental Protection 8 Agency Regulatory Model 9

ALARA as low as is reasonably achievable 10

APE area of potential effect 11

AQCR air quality control region 12

BGEPA Bald and Golden Eagle Protection Act 13

bgs below ground surface 14

BIA U.S. Bureau of Indian Affairs 15

BLS U.S. Bureau of Labor Statistics 16

BMP best management practice 17

B.P. before present 18

bu bushel(s) 19

CAA Clean Air Act 20

Ci curie 21

CEQ Council on Environmental Quality 22

CFR Code of Federal Regulations 23

cfs cubic feet per second 24

CH4 methane 25

cm centimeter 26

CO carbon monoxide 27

CO2 carbon dioxide 28

CO2eq carbon dioxide equivalent 29

CRMP cultural resource management plan 30

CWA Clean Water Act 31

dB decibel(s) 32

dBA decibels on the A-weighted scale 33

DBA design-basis accident 34

xxi

Abbreviations and Acronyms

DOE U.S. Department of Energy 1

DOL U.S. Department of Labor 2

DOT U.S. Department of Transportation 3

EA environmental assessment 4

ECHO Enforcement and Compliance History Online [air data search tool] 5

EIA Energy Information Administration 6

EIS environmental impact statement 7

EO Executive Order 8

EPA U.S. Environmental Protection Agency 9

ER Environmental Report 10

ERPG Emergency Response Planning Guideline 11

ESA Endangered Species Act 12

ES&H Environment, Health, and Safety [Manager] 13

FAA U.S. Federal Aviation Administration 14

FEMA U.S. Federal Emergency Management Agency 15

FHWA U.S. Federal Highway Administration 16

FR Federal Register 17

ft foot (feet) 18

ft2 square foot (feet) 19

FWS U.S. Fish and Wildlife Service 20

GAI Golder Associates, Inc. 21

gal gallon(s) 22

GHG greenhouse gas 23

GM General Motors 24

gpd gallons per day 25

gpm gallons per minute 26

GTCC greater than Class C 27

GWP global warming potential 28

ha hectare(s) 29

HAP hazardous air pollutant 30

HEPA high-efficiency particulate air 31

HEU highly enriched uranium 32

hp horsepower 33

hr hour(s) 34

IAEA International Atomic Energy Agency 35

xxii

Abbreviations and Acronyms

in. inch 1

IOM Institute of Medicine 2

JBWI Rockford, IllinoisJanesvilleBeloit, Wisconsin, Interstate 3

K kindergarten 4

km kilometer(s) 5

kph kilometer(s) per hour 6

km2 square kilometer(s) 7

L liter(s) 8

LDN day-night sound intensity level 9

Lpd liter(s) per day 10

m meter(s) 11

m2 square meter(s) 12

m3 cubic meter(s) 13

m3/day cubic meter(s) per day 14

m3/min cubic meter(s) per minute 15

mi3/s cubic mile(s) per second 16

mg/L milligram(s) per liter 17

mg/m3 milligram(s) per cubic meter 18

mgd million gallon(s) per day 19

m/s meter(s) per second 20

MAR material at risk 21

MBTA Migratory Bird Treaty Act 22

mgd million gallons per day 23

MHA maximum hypothetical accident 24

mi mile 25

min minute 26

mph mile(s) per hour 27

mi2 square mile(s) 28

g microgram 29

m microns 30

g/m3 microgram per cubic meter 31

MMI Modified Mercalli Intensity 32

MOA memorandum of agreement 33

MOI maximum offsite individual 34

mrem milliroentgen equivalent man 35

xxiii

Abbreviations and Acronyms

MSL mean sea level 1

mSv millisievert 2

MT metric ton(s) 3

NAAQS National Ambient Air Quality Standards 4

NAC noise abatement criteria 5

NCDC National Climatic Data Center 6

NCES National Center for Education Statistics 7

NEA Nuclear Energy Agency 8

NEPA National Environmental Policy Act 9

NHPA National Historic Preservation Act 10

NNSA National Nuclear Security Administration 11

NO2 nitrogen dioxide 12

NOx nitrogen oxide 13

NOAA National Oceanic and Atmospheric Administration 14

NPDES National Pollutant Discharge Elimination System 15

NPS U.S. National Park Service 16

NRC U.S. Nuclear Regulatory Commission 17

NRCS Natural Resources Conservation Service 18

NRHP National Register of Historic Places 19

NUREG NRC technical report designation (Nuclear Regulatory 20 Commission) 21

OSHA Occupational Safety and Health Administration 22

PAC protective action criterion/criteria 23

PGA peak ground acceleration 24

PM particulate matter 25

ppb parts per billion 26

ppm parts per million 27

PSAR preliminary safety analysis report 28

PSD prevention of significant deterioration 29

RCA radiation-controlled area 30

RCRA Resource Conservation and Recovery Act 31

ROI region of influence 32

RM river mile 33

SER safety evaluation report 34

SHINE SHINE Medical Technologies, Inc. 35

xxiv

Abbreviations and Acronyms

SHPO State Historic Preservation Office 1

SIL significant impact level 2

SNM Society of Nuclear Medicine and Molecular Imaging 3

SO2 sulfur dioxide 4

SPCC Spill Prevention, Control, and Countermeasure 5

SSC species of special concern 6

TDS total dissolved solids 7

TEEL Temporary Emergency Exposure Limit 8

TIF Tax Increment Finance 9

TMDL total maximum daily load 10

TNM traffic noise model 11

TPY tons per year 12

TSP total suspended particles 13

TSV target solution vessel 14

g microgram(s) 15

m micron(s) 16

U.S. United States 17

U.S.C. United States Code 18

USCB U.S. Census Bureau 19

USDA U.S. Department of Agriculture 20

USDOI U.S. Department of Interior 21

USGCRP U.S. Global Change Research Program 22

USGS U.S. Geological Service 23

VOC volatile organic compound(s) 24

WAC Wisconsin Administrative Code 25

WDOA Wisconsin Department of Administration 26

WDATCP Wisconsin Department of Agriculture Trade and Consumer 27 Protection 28

WDNR Wisconsin Department of Natural Resources 29

WDOT Wisconsin Department of Transportation 30

WDPI Wisconsin Department of Public Instruction 31

WDR Wisconsin Department of Revenue 32

WDWD Wisconsin Department of Workforce Development 33

WGNHS Wisconsin Geological and Natural History Survey 34

WHS Wisconsin Historical Society 35

xxv

Abbreviations and Acronyms

WI Wisconsin 1

WPDES Wisconsin Pollutant Discharge Elimination System 2

WTP Wastewater Treatment Plant 3

yd3 cubic yard(s) 4

Y-12 Y-12 National Security Complex 5

xxvi

INTRODUCTION 1

By letter dated March 26, 2013, SHINE Medical Technologies, Inc. (SHINE), submitted Part 1 of 2 a two-part application to the U.S. Nuclear Regulatory Commission (NRC) for a construction 3 permit under Title 10 of the Code of Federal Regulations (10 CFR) Part 50 that would allow 4 construction of a medical radioisotope production facility (SHINE facility) in Janesville, 5 Wisconsin (SHINE 2013). The Atomic Energy Act of 1954 (42 U.S.C. 2011 et seq.) authorizes 6 the NRC to issue construction permits for production and utilization facilities. To issue a 7 construction permit, the NRC is required to consider the environmental impacts of the proposed 8 action under the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq., herein 9 referred to as NEPA). The NRCs environmental protection regulations that implement NEPA in 10 10 CFR Part 51 describe several types of actions that would require an environmental impact 11 statement (EIS). Construction permits and operating licenses for production and subcritical 12 utilization facilities are not specifically identified in 10 CFR 51.20 as an action that would require 13 an EIS. Such activities may require an environmental assessment (EA) or an EIS, depending 14 on their potential for significant impacts that may affect the quality of the human environment 15 (NRC 2012). 16

An EA is used to determine whether the impacts from the proposed action may be significant 17 and whether a finding of no significant impact can be made. If, based on the EA, the NRC 18 concludes that the proposed action could result in significant impacts to the human 19 environment, the agency should prepare an EIS. In some cases, the NRC may decide to 20 prepare an EIS rather than an EAif there is the potential for significant impacts to the human 21 environment or the proposed action involves a matter that the Commission, in the exercise of its 22 discretion, has determined should be covered by an EIS. For the SHINE environmental review, 23 the NRC staff determined that an EIS was appropriate to assess the environmental impacts of 24 the proposed action. The NRC staff made this determination because of the potential for 25 significant environmental impacts and the unique considerations of a first-of-a-kind application 26 for a medical radioisotope production facility with a unique application of technologies, as well 27 as to allow public involvement in the environmental review process. 28

1.1 Background 29

Nuclear medicine practitioners frequently use a variety of radioisotopes to diagnose and treat 30 illnesses in patients. Out of the many radioisotopes in use, three are relevant for this EIS31 molybdenum-99, iodine-131, and xenon-133. 32

1.1.1 Molybdenum-99 33

Molybdenum-99 is the radioisotope currently in highest demand (NRC 2012) for medical use. 34 Molybdenum-99 decays with a 66-hour half-life to technetium-99m, which in turn decays with a 35 6-hour half-life to technetium-99. Technetium-99m is the most commonly used medical 36 radioisotope in the world. It is used in about 20 to 25 million medical diagnostic procedures 37 annually, or about 80 percent of all diagnostic nuclear medicine procedures (IAEA 2013). Uses 38 for technetium-99m include the following (SHINE 2013): 39

bone scans, 40

lung perfusion imaging, 41

kidney scans and functional imaging, 42

1-1

Introduction

liver scans, 1

sentinel lymph node localization, 2

cardiac perfusion imaging, 3

brain perfusion imaging, 4

gall bladder function imaging, 5

blood pool imaging, 6

thyroid and salivary gland imaging, and 7

Meckels scans. 8

Molybdenum-99 is commonly produced through the neutron activation of naturally occurring 9 molybdenum or as a by-product of uranium-235 fission. No U.S. domestic producers of 10 molybdenum-99 exist. Almost the entire U.S. supply of molybdenum-99, as well as about 11 85 percent of the worlds supply, is produced at the National Research Universal reactor in 12 Chalk River, Ontario, Canada, or at the High Flux Reactor in Petten, the Netherlands (National 13 Research Council 2009). The only other international producers are located in South Africa, 14 Australia, Belgium, Poland, Czech Republic, and France. Serious domestic and international 15 shortages over the last decade resulted from planned and unplanned maintenance shutdowns 16 at these facilities (National Research Council 2009). In addition to issues of production 17 reliability, global demand for the radioisotope is increasing, and transporting the radioisotope 18 across international borders is becoming more difficult (National Research Council 2009). 19

1.1.2 Iodine-131 20

Iodine-131 is produced for medical use through irradiation of tellurium-130 or as a by-product of 21 uranium-235 fission. Iodine-131 has a half-life of about 8 days. Uses of iodine-131 include the 22 following: (1) radiation therapy and (2) radioactive labeling for diagnostic pharmaceuticals 23 (SHINE 2013). 24

Three companiesDRAXIMAGE, Covidien, and MDS Nordionsupply iodine-131 for the 25 U.S. market (Nuclear Energy Agency (NEA) 2011). As with molybdenum-99, reactor shutdowns 26 have caused recent shortages in iodine-131. For example, in November 2013, the National 27 Research Universal reactor shutdown led to a global shortage of a variety of medical isotopes 28 (NEA 2011; Bloomberg 2013). 29

1.1.3 Xenon-133 30

Xenon-133 is produced as a by-product of uranium-235 fission. Its half-life is about 5 days. 31 Uses of xenon-133 include the following: (1) lung imaging, (2) diagnostic evaluation of 32 pulmonary function, and (3) assessment of cerebral blood flow (SHINE 2013). 33

The domestic supply of xenon-133 also has been susceptible to shortages because of 34 production and availability issues (Society of Nuclear Medicine and Molecular Imaging 35 (SNM) 2013). 36

1.2 Proposed Federal Action 37

The proposed Federal action is for the NRC to decide whether to issue a construction permit 38 under 10 CFR Part 50 that would allow construction of a medical radioisotope production facility 39 (which would include utilization facilities). If the NRC were to issue a construction permit, 40

1-2

Introduction

A curie (Ci) is a unit of measurement describing the radioactive disintegration rate of a substance; 1 Ci is 3.700x1010 disintegrations per second (Institute of Medicine (IOM) 1995).

The term 6-day Ci comes from producers to determine the number of curies present in a shipment 6 days after it leaves the production facility (National Research Council 2009).

SHINE could build the proposed facility on a 91-acre (37-hectare) site in Rock County, which is 1 located about 4 mi (6 km) south of the city center of Janesville, Wisconsin. The issuance of a 2 construction permit is a separate licensing action from the issuance of an operating license. If 3 the NRC issues a construction permit, then SHINE must submit a separate application for an 4 operating license, pursuant to the NRCs requirements, and must obtain NRC approval before it 5 can operate the medical radioisotope production facility. If the NRC were to issue an operating 6 license, SHINE could operate the proposed SHINE facility and produce radioisotopes, including 7 molybdenum-99, iodine-131, and xenon-133 (SHINE 2013). To conduct an efficient and 8 effective environmental review, this EIS covers the potential impacts from construction, 9 operations, and decommissioning. If SHINE were to submit an application for an operating 10 license, the NRC staff would prepare a supplement to this EIS in accordance with 11 10 CFR 51.95(b). 12

As described in Section 1.6, the U.S. Department of Energy (DOE) is a cooperating agency on 13 this EIS. If the NRC issues the required permits and licenses, the proposed Federal action for 14 the DOE National Nuclear Security Administration (NNSA) is to decide whether to provide 15 additional cost-sharing financial support to SHINE under a cooperative agreement to accelerate 16 the commercial production of medical radioisotopes without the use of highly enriched uranium. 17 The funding would help accelerate activities such as construction, purchase of equipment, and 18 initial operation using a subcritical fission process. Funding of these activities is a different 19 action from the lease and takeback of uranium by DOE/NNSA. If SHINE were to request that 20 NNSA provide it with low-enriched uranium or take back waste for which SHINE has no other 21 disposal path, such activities would require a review under NEPA before DOE/NNSA could 22 make any decision about these activities. 23

1.3 Purpose and Need for the Proposed Federal Action 24

The purpose of and need for this proposed Federal 25 action is to evaluate the applicants proposal to construct 26 a facility that would ultimately produce medical 27 radioisotopes. For the past 2 decades, the United States 28 has relied on imported medical radioisotopes, such as 29 molybdenum-99, iodine-131, and xenon-133. 30 Molybdenum-99, for example, is used to perform about 31 50,000 medical procedures daily in the United States. 32 Global shortages of medical radioisotopes in 2009 and 33 2010 have highlighted the need for prompt action to 34 ensure a reliable domestic supply. Demand in the United States for molybdenum-99 is 35 approximately 5,000 6-day curies (Ci) (2x1014 and 3x1014 6-day becquerels) (Bq) per week. 36 This demand is expected to increase about 0.5 percent per year (OECD 2014). In recent years, 37 U.S. policy has aimed to ensure a reliable supply of medical radioisotopes while minimizing the 38 use of highly enriched uranium for civilian purposes through, among other things, supporting 39 commercial projects that produce medical radioisotopes domestically without the use of highly 40 enriched uranium (NNSA 2011; White House 2012). 41

In response to these shortages, and pursuant to the January 2013 enactment of the National 42 Defense Authorization Act for fiscal year 2013, Title XXXI, Subtitle F, known as the American 43 Medical Isotopes Production Act of 2012 (42 U.S.C. 3171 et seq.), DOE/NNSA has entered into 44 cooperative agreements with domestic commercial firms. These agreements enable 45 DOE/NNSA to engage in cost-sharing activities to accelerate domestic endeavors to 46 demonstrate and produce a reliable supply of molybdenum--99 using technologies that do not 47

1-3

Introduction

rely on the use of highly enriched uranium, in accordance with Section 988 of the Energy Policy 1 Act of 2005 (42 U.S.C. 16352) (NNSA 2011). 2

The proposed action for the NRC is to decide whether to issue a construction permit, which 3 would allow SHINE to construct a medical radioisotope production facility that uses low-enriched 4 uranium to produce molybdenum-99, iodine-131, and xenon-133. If the construction permit is 5 granted, SHINE would then have to apply for an operating license. The NRC would conduct a 6 separate review to decide on issuing an operating license. If the facility is licensed to operate, 7 SHINE expects to produce up to 8,200 6-day Ci (3.0x1014 6-day Bq) of molybdenum-99 per 8 week (SHINE 2013). 9

1.4 U.S. Nuclear Regulatory Commission Environmental Review 10

The NRCs process to review applications for construction permits consists of two separate, 11 parallel reviews. The safety review evaluates the applicants ability to meet the NRC regulatory 12 safety requirements. The NRC staff documents the findings of the safety review in a Safety 13 Evaluation Report. The environmental review, governed by the requirements in 14 10 CFR Part 51, evaluates the environmental impacts of, and alternatives to, the proposed 15 action. This draft EIS presents the results of this evaluation. The NRC considers the findings in 16 both the EIS and the Safety Evaluation Report in its decision to grant or deny the issuance of a 17 construction permit. 18

To guide its assessment of the environmental impacts of the proposed action or alternative 19 actions, the NRC established a standard of significance for impacts using the Council on 20 Environmental Quality terminology for significantly (40 CFR 1508.27). Based on this, the NRC 21 established three levels of significance for potential impacts: SMALL, MODERATE, and 22 LARGE, as defined below. 23

SMALL: Environmental effects are not 24 detectable or are so minor that they will neither 25 destabilize nor noticeably alter any important 26 attribute of the resource. 27

MODERATE: Environmental effects are 28 sufficient to alter noticeably, but not to 29 destabilize, important attributes of the resource. 30

LARGE: Environmental effects are clearly 31 noticeable and are sufficient to destabilize important attributes of the resource. 32

In March 2013, SHINE submitted its Environmental Report (SHINE 2013) with Part 1 of its 33 application for a construction permit. After reviewing Part 1 of the application for sufficiency, on 34 July 1, 2013, the NRC staff published a Notice of Acceptance for Docketing in the Federal 35 Register (78 FR 39342) and a separate Federal Register notice of its intent to prepare an EIS 36 and conduct a scoping process (78 FR 39343). The July 1, 2013, scoping notice began the 37 60-day scoping period. 38

On July 17, 2013, the NRC held two public scoping meetings in Janesville, Wisconsin. The 39 NRCs report entitled, Environmental Impact Statement Scoping Process Summary Report for 40 the SHINE Medical Radioisotope Production Facility, presents the comments received during 41 the scoping process (NRC 2015). 42

In July and August 2013, the NRC staff conducted a site audit at the proposed and alternative 43 SHINE facility sites to verify information in SHINEs Environmental Report. During the site audit, 44

The American Medical Isotopes Production Act of 2012 directs DOE to improve the reliability of a domestic supply of molybdenum-99 by carrying out a technology-neutral program to support non-Federal entities in the United States in developing capabilities to produce molybdenum-99 without the use of highly enriched uranium.

1-4

Introduction

the NRC staff met with SHINE personnel; reviewed specific documentation; toured the proposed 1 and alternative sites; and met with interested Federal, State, and local agencies. 2

Figure 11 shows the major milestones in the public review of an EIS. After the scoping period 3 and site audit, the NRC staff compiles its findings in a draft EIS. The draft EIS is available for 4 public comment for 45 days. During this time, the NRC staff hosts public meetings and collects 5 public comments. Based on the information gathered, the NRC staff will amend the draft EIS 6 findings as necessary and then publish a final EIS. 7

Figure 11. Environmental Review Process 8

9

NRC staff reviews

application

Staff conducts site

environmental audit

NRC issues draft EIS

Application submitted to NRC

*Scoping process

*Draft EIS process

NRC issues final EIS

NRC makes decision on whether to issue permit and

license

*Opportunities for public involvement

1-5

Introduction

1.5 Cooperating Agency 1

NEPA lays the groundwork for coordination between the lead agency preparing an EIS and 2 other Federal agencies that may have special expertise on an environmental issue or that have 3 jurisdiction by law. These other agencies, referred to as cooperating agencies, are 4 responsible for assisting the lead agency through early participation in the NEPA process, 5 including scoping. The cooperating agencies provide technical input to the environmental 6 analysis and provide staff support, as needed, to the lead agency. 7

The American Medical Isotopes Production Act of 2012 directs DOE and the NRC to ensure, to 8 the maximum extent practicable, that environmental reviews for facilities to produce medical 9 radioisotopes are complementary and not duplicative. 10

The NRC makes license decisions under the Atomic Energy Act of 1954, as amended, and 11 DOE makes funding decisions under the American Medical Isotopes Production Act of 2012 and 12 the Energy Policy Act of 2005 (42 U.S.C. 16352). The NRC is required to conduct an 13 environmental review under NEPA to decide whether to grant SHINE a construction permit. 14 DOE is required to conduct an environmental review under NEPA for providing financial support 15 to SHINE. The NRC and DOE decided to enter into a cooperative agreement to make the most 16 effective and efficient use of Federal resources in reviewing SHINEs proposal. On December 17 1, 2014, and February 3, 2015, the NRC and DOE signed a Memorandum of Agreement on the 18 review of the SHINE application (DOE and NRC 2015). The goal of this agreement is to 19 develop one EIS that serves the NRC licensing process and the DOE funding process. 20 Although both agencies must meet NEPA requirements, they also must meet mission 21 requirements. As a cooperating agency, DOE/NNSA plans to adopt the final EIS in accordance 22 with the DOE/NEPA implementing procedures in 10 CFR 1021.103. 23

The Memorandum of Agreement designates the NRC as the lead Federal agency and DOE as 24 a cooperating agency in developing an EIS for the proposed SHINE facility. Under Federal law, 25 each agency has jurisdiction related to parts of the proposed project as major Federal actions 26 that could significantly affect the quality of the human environment. 27

1.6 Consultation and Correspondence 28

The Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq.), and the National 29 Historic Preservation Act of 1966 (16 U.S.C. 470 et seq.) require Federal agencies to consult 30 with applicable State and Federal agencies and groups before taking actions that may affect 31 endangered species, fisheries, and historic and archaeological resources. In addition to 32 correspondence, as part of formal consultation requirements, the NRC staff contacted Federal, 33 State, regional, local, and tribal agencies with environmental expertise in the areas that the 34 proposed project could potentially affect. Agencies contacted during the formal consultation 35 processes and the SHINE environmental review process included the following: 36

U.S. Fish and Wildlife Service, 37

Wisconsin Department of Natural Resources, 38

Citizen Potawatomi Nation, 39

Bad River Band of the Lake Superior Tribe of Chippewa Indians, 40

St. Croix Chippewa Indians of Wisconsin, 41

Menominee Indian Tribe of Wisconsin, 42

Flandreau Santee Sioux Tribe of South Dakota, 43

1-6

Introduction

Iowa Tribe, 1

Forest County Potawatomi Community, 2

Hannahville Indian Community, 3

Ho-Chunk Nation of Wisconsin, 4

Sac and Fox Nation, 5

Lower Sioux Indian Community, 6

Prairie Band of Potawatomi Nation, 7

Prairie Island Indian Community, 8

Santee Sioux Nation, 9

Sisseton-Wahpeton Oyate of the Lake Traverse Reservation, 10

Spirit Lake Tribe, 11

Upper Sioux Community, 12

Peoria Tribe of Indians of Oklahoma, 13

Winnebago Tribe of Nebraska, 14

Advisory Council on Historic Preservation, and 15

Wisconsin State Historic Preservation Office. 16

Chapter 9 provides a list of those who received a copy of this EIS. Appendix C contains a 17 chronological list of all correspondence sent and received during the environmental review. 18

1.7 Status of Compliance 19

SHINE is responsible for complying with applicable NRC regulations and other Federal, State, 20 and local requirements. Appendix B to this EIS includes a list of the permits and licenses that 21 Federal, State, and local authorities must issue to SHINE before construction or operation of the 22 proposed facility. 23

1.8 References 24

10 CFR Part 50. Code of Federal Regulations, Title 10, Energy, Part 50, Domestic licensing of 25 production and utilization facilities. 26

10 CFR Part 51. Code of Federal Regulations, Title 10, Energy, Part 51, Environmental 27 protection regulations for domestic licensing and related regulatory functions. 28

10 CFR Part 1021. Code of Federal Regulations, Title 10, Energy, Part 1021, National 29 Environmental Policy Act implementing procedures. 30

40 CFR Part 1508. Code of Federal Regulations, Title 40, Protection of Environment, 31 Part 1508, Terminology and index. 32

78 FR 39342. U.S. Nuclear Regulatory Commission. SHINE Medical Technologies, Inc.33 notice; acceptance for docketing. Federal Register 78(126):3934239343. July 1, 2013. 34

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Introduction

78 FR 39343. U.S. Nuclear Regulatory Commission. SHINE Medical Technologies, Inc.1 intent to prepare environmental impact statement and conduct scoping process; public 2 meeting. Federal Register 78(126):3934339344. July 1, 2013. 3

American Medical Isotopes Production Act of 2012. 42 U.S.C. 3171 et seq. 4

Atomic Energy Act of 1954, as amended. 42 U.S.C. 2011 et seq. 5

[Bloomberg] Bloomberg News. 2013. Global Medical Isotope Shortage Follows S. Africa Plant 6 Leak. November 15, 2013. Available at (accessed 21 February 2014). 8

[DOE and NRC]. U.S. Department of Energy and U.S. Nuclear Regulatory Commission. 2015. 9 Memorandum of Agreement Between the U.S. Department of Energy-National Nuclear Security 10 Administration and the U.S. Nuclear Regulatory Commission, Office of Nuclear Reactor 11 Regulation, on the Environmental Review Related to the Issuance of Authorizations To 12 Construct and Operate SHINE Medical Technologies, Inc., Facility. ADAMS 13 No. ML13304B666. 14 Endangered Species Act of 1973, as amended. 16 U.S.C. 1531 et seq. 15

Energy Policy Act of 2005. 42 U.S.C. 16352. 16

[IAEA] International Atomic Energy Agency. 2013. Coordinated Research Projects (CRP) on 17 Production of Mo-99 from LEU or Neutron Activation. Available at 18 (accessed 19 13 June 2013). 20

[IOM] Institute of Medicine. 1995. Isotopes for Medicine and the Life Sciences. 21 Washington, DC: The National Academies Press. February 10, 1995. 22

National Environmental Policy Act of 1969, as amended. 42 U.S.C. 4321 et seq. 23

National Historic Preservation Act of 1966. 16 U.S.C. 470 et seq. 24

[NEA] Nuclear Energy Agency. 2011. The Supply of Medical RadioisotopesThe Path to 25 Reliability. Organisation for Economic Co-operation and Development. Available at 26 (accessed 27 14 June 2013). 28

[NNSA] National Nuclear Security Administration. 2011. NNSA Works to Minimize the Use of 29 HEU in Medical Isotope Production. NNSA Fact Sheet 20100125. November 1, 2011. 30 Available at 31 (accessed 14 June 2013). 32

[NRC] National Research Council. 2009. Medical Isotope Production Without Highly Enriched 33 Uranium. Washington, DC: The National Academies Press. Available at 34 (accessed 13 June 2013). 35

[NRC] U.S. Nuclear Regulatory Commission. 2012. Final Interim Staff Guidance Augmenting 36 NUREG-1537, Part 1, Guidelines for Preparing and Reviewing Applications for the Licensing of 37 Non-Power Reactors: Format and Content, and Part 2, Guidelines for Preparing and 38 Reviewing Applications for the Licensing of Non-Power Reactors: Standard Review Plan and 39 Acceptance Criteria, for Licensing Radioisotope Production Facilities and Aqueous 40 Homogeneous Reactors. Washington, DC: NRC. October 17, 2012. ADAMS 41 Nos. ML12156A069 and ML12156A075. 42

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http://www.bloomberg.com/news/2013-11-15/global-medical-isotope-shortage-follows-south-africa-plant-leak.htmlhttp://www.bloomberg.com/news/2013-11-15/global-medical-isotope-shortage-follows-south-africa-plant-leak.htmlhttp://www.iaea.org/OurWork/ST/NE/NEFW/Technical_Areas/RRS/mo99.htmlhttp://www.oecd-nea.org/med-radio/reports/med-radio-reliability.pdfhttp://www.nnsa.energy.gov/mediaroom/factsheets/factsheet20100125http://www.nap.edu/catalog.php?record_id=12569

Introduction

[NRC] U.S. Nuclear Regulatory Commission. 2015. Environmental Impact Statement Scoping 1 Process Summary Report for the SHINE Medical Radioisotope Production Facility. ADAMS 2 No. ML15062A111. 3

[OECD] Organisation for Economic Co-operation and DevelopmentNuclear Energy Agency. 4 2014. The Supply of Medical RadioisotopesMedical Isotope Supply in the Future: Production 5 Capacity and Demand Forecast for the 99Mo/99mTc Market, 2015-2020. Organisation for 6 Economic Co-operation and Development. Available at (accessed 26 February 2015). 8

[SHINE] SHINE Medical Technologies, Inc. 2013. Preliminary Safety Analysis Report (PSAR), 9 Chapter 19, Environmental Report. Monona, WI: SHINE. March 26, 2013. ADAMS 10 No. ML14052A349. 11

[SNM] Society of Nuclear Medicine and Molecular Imaging. 2013. Xenon-133 Shortage 12 Information. Available at (accessed 13 14 June 2013). 14

White House. 2012. Fact Sheet: Encouraging Reliable Supplies of Molybdenum-99 Produced 15 without Highly Enriched Uranium. Office of the Press Secretary. June 7, 2012. Available at 16 (accessed 14 June 2013). 18

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http://www.oecd-nea.org/med-radio/reports/sen-hlgmr2014-2.pdfhttp://www.oecd-nea.org/med-radio/reports/sen-hlgmr2014-2.pdfhttp://interactive.snm.org/index.cfm?PageID=11637http://www.whitehouse.gov/the-press-office/2012/06/07/fact-sheet-encouraging-reliable-supplies-molybdenum-99-produced-without-http://www.whitehouse.gov/the-press-office/2012/06/07/fact-sheet-encouraging-reliable-supplies-molybdenum-99-produced-without-

PROPOSED FEDERAL ACTION 1

The proposed Federal action for the U.S. Nuclear Regulatory Commission (NRC) is to decide 2 whether to issue a construction permit that would allow SHINE Medical Technologies, Inc. 3 (SHINE), to construct a medical radioisotope production facility that would produce, package, 4 and ship medical radioisotopes, specifically molybdenum-99, iodine-131, and xenon-133. This 5 facility would employ a new medical radioisotope production technology that uses a 6 nonreactor-based subcritical fission process. 7

The proposed Federal action for the U.S. Department of Energy (DOE) National Nuclear 8 Security Administration (NNSA) is to decide whether, if the NRC grants a permit(s) and 9 license(s), to provide cost-sharing financial support to SHINE under a cooperative agreement to 10 accelerate the establishment of the commercial production of medical radioisotopes without the 11 use of highly enriched uranium (HEU). The funding would help to accelerate activities such as 12 construction, purchase of equipment, and initial operation using a subcritical fission process if 13 the NRC were to give SHINE a construction permit and operating license. 14

2.1 Site Location and Layout 15

SHINE would construct and operate the proposed facility on land annexed by the City of 16 Janesville, Wisconsin, which is located approximately 4 mi (6.4 km) south of the city center of 17 Janesville, 13 mi (21 km) north of the Wisconsin-Illinois border, and 63 mi (101 km) west of 18 Lake Michigan. The proposed site encompasses approximately 91 acres (ac) (37 hectares 19 (ha)) of undeveloped land that is currently bordered by U.S. Highway 51 and the South