ML15161A182

Shine Medical Technologies V. 0 - Section 19.01 - Introduction to the Environmental Report

ML15161A182
Person / Time
Site:	SHINE Medical Technologies
Issue date:	05/21/2015
From:	Bynum R Shine Medical Technologies
To:	Office of Nuclear Reactor Regulation
Lynch S
References
SHINE, SHINE.SUBMISSION.18, SHN.PSAR.P, SHN.PSAR.P.8
Download: ML15161A182 (16)

Text

Chapter 19 - Environmental Review Table of Contents SECTION

19.1 INTRODUCTION

OF THE ENVIRONMENTAL REPORT Table of Contents Section Title Page

19.1 INTRODUCTION

OF THE ENVIRONMENTAL REPORT...............................19.1-1 19.1.1 PURPOSE AND NEED FOR THE PROPOSED ACTION ........................19.1-1 19.1.2 REGULATORY PROVISIONS, PERMITS, AND REQUIRED CONSULTATIONS....................................................................................19.1-3 SHINE Medical Technologies 19.1-i Rev. 0

Chapter 19 - Environmental Review List of Tables List of Tables Number Title 19.1.2-1 Permits and Approvals Required for Construction and Operation 19.1.2-2 Consultations Required for Construction and Operation SHINE Medical Technologies 19.1-ii Rev. 0

Chapter 19 - Environmental Review List of Figures List of Figures Number Title None SHINE Medical Technologies 19.1-iii Rev. 0

Chapter 19 - Environmental Review Acronyms and Abbreviations Acronyms and Abbreviations Acronym/Abbreviation Definition CFR Code of Federal Regulations COE U.S. Army Corps of Engineers CP Construction Permit DOE U.S. Department of Energy EA Environmental Assessment ER Environmental Report ERR Endangered Resources Review FAA Federal Aviation Administration FDA U.S. Food and Drug Administration FWS U.S. Fish and Wildlife Service HEU highly enriched uranium HFR High Flux Reactor I-131 iodine-131 IRE Institut National des Radioéléments LEU low enriched uranium Mo-99 molybdenum-99 NEPA National Environmental Policy Act NRC U.S. Nuclear Regulatory Commission NRCL National Research Council NRU National Research Universal NTP Nuclear Technology Products Radioisotopes OL Operating License SHINE SHINE Medical Technologies, Inc.

SHPO State Historic Preservation Office SPCC Spill Prevention, Control and Countermeasure SHINE Medical Technologies 19.1-iv Rev. 0

Chapter 19 - Environmental Review Acronyms and Abbreviations Acronyms and Abbreviations (contd)

Acronym/Abbreviation Definition Tc-99m technetium-99m U-235 uranium-235 WNN World Nuclear News Xe-133 xenon-133 SHINE Medical Technologies 19.1-v Rev. 0

Chapter 19 - Environmental Review Introduction of the Environmental Report CHAPTER 19

19.1 INTRODUCTION

OF THE ENVIRONMENTAL REPORT In accordance with the provisions of Title 10 of the Code of Federal Regulations (CFR) Part 50 Domestic Licensing of Production and Utilization Facilities, and supporting guidance, SHINE Medical Technologies, Inc. (SHINE) is providing this Environmental Report (ER) in support of an application to construct and operate a radioisotope facility in Janesville, Wisconsin. SHINE is providing this comprehensive ER as required with its application. The ER provides information to the U.S. Nuclear Regulatory Commission (NRC) to facilitate preparation of an Environmental Assessment (EA) in accordance with the provisions of 10 CFR 51 Subpart A, National Environmental Policy Act - Regulations Implementing Section 102 (2). This chapter provides an introduction to the assessment of the environmental effects of construction, operation, and decommissioning of this facility on the site and surrounding areas.

This ER follows the content and organization of the Final Interim Staff Guidance Augmenting NUREG-1537, Part 1, Chapter 19 (NRC, 2012). This ER supports the regulatory review that is performed by the NRC under 10 CFR 51. This regulation requires that environmental impacts from the project be evaluated and described in a concise, clear, and analytical manner. This ER describes the project, potential alternatives, and the methods and sources used in the environmental impact analysis.

This ER discusses the existing environment at the proposed Janesville, Wisconsin site (referred to throughout the ER as the SHINE site) and vicinity, and summarizes the environmental impacts of construction, operation, and decommissioning. In addition, this ER considers appropriate impact mitigation measures, and reviews alternative sites and technologies.

The SHINE facility produces molybdenum-99 (Mo-99), iodine-131 (I-131), and xenon-133 (Xe-133). The decay product of Mo-99, technetium-99m (Tc-99m), is used for diagnostic nuclear medicine procedures. The purpose and need for the proposed action is provided in Section 19.1.1 and a description of the proposed action is provided in Section 19.2.

19.1.1 PURPOSE AND NEED FOR THE PROPOSED ACTION The proposed federal action is the issuance of a Construction Permit (CP) and Operating License (OL), under the provisions of 10 CFR 50, that would allow SHINE to construct and operate a radioisotope facility to produce Mo-99, I-131, and Xe-133. Further discussion of the proposed action is provided in Section 19.2.

Molybdenum-99 There is currently no domestic production of Mo-99 and its daughter isotope technetium-99m (Tc-99m). The U.S. is forced to import its entire supply of these isotopes, which are used in 80 percent of nuclear medicine procedures. Tc-99m is an essential ingredient in diagnostic radiopharmaceuticals used for:

• Bone scans

• Lung perfusion imaging

• Kidney scans and functional imaging

• Liver scans SHINE Medical Technologies 19.1-1 Rev. 0

Chapter 19 - Environmental Review Introduction of the Environmental Report

• Sentinel lymph node localization

• Cardiac perfusion imaging

• Brain perfusion imaging

• Gall bladder function imaging

• Blood pool imaging

• Thyroid and salivary gland imaging

• Meckels scans Between 95 and 98 percent of the worlds supply of Mo-99 is produced by just four organizations (NRCL, 2009):

• MDS Nordion (Canada).

• Covidien (Netherlands).

• Institut National des Radioéléments (IRE) (Belgium).

• Nuclear Technology Products Radioisotopes (Pty) Ltd. (NTP) (South Africa).

Two of these companies (MDS Nordion [approximately 60 percent of the U.S. supply] and Covidien [approximately 40 percent of U.S. supply]) supply nearly all of the Mo-99 used in the U.S. These two companies obtain the vast majority of their Mo-99 from two reactors (NRCL, 2009):

• National Research Universal (NRU) reactor in Chalk River, Ontario, Canada.

• High Flux Reactor (HFR) in Petten, the Netherlands.

The NRU reactor has been in operation since 1957 and HFR has been in operation since 1961.

Due to the age of these reactors, disruption of the supply of Mo-99 is an ongoing concern.

The most recent disruptions of Mo-99 supply resulted from the shutdown of HFR from August 2008 to February 2009 and again from February 2010 to September 2010 for repairs. Concurrent with the HFR shutdown, the NRU reactor was also shut down for repairs from May 2009 to August 2010 (WNN, 2009; Fissile Material, 2010; MSNBC, 2010). While both reactors were shut down, there was an increase in production from other Mo-99 producers in Europe and South Africa; however, the U.S. experienced a shortage of Mo-99/Tc-99m, resulting in hospitals and clinics postponing or cancelling diagnostic imaging procedures (NRCL, 2009).

In addition to the age of the HFR and NRU reactors, there are three other supply reliability concerns:

• Increasing demand, both domestically and globally, for Mo-99.

• Increasing difficulty of transporting Mo-99 across international borders, especially by air, due to security concerns.

• The short half-life of Mo-99 (2.75 days) and Tc-99m (6.01 hours1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br />).

Because of these supply reliability concerns and national security concerns, U.S. government policy and law is to encourage the domestic production of Mo-99. The SHINE facility makes a significant contribution toward accomplishing these goals.

Current U.S. demand for Mo-99 is between 5000 and 7000 6-day curies per week, and this demand is projected to grow in the range of 3 to 10 percent per year (NRCL, 2009). The SHINE facility can produce up to 8200 6-day curies of Mo-99 per week.

SHINE Medical Technologies 19.1-2 Rev. 0

Chapter 19 - Environmental Review Introduction of the Environmental Report The SHINE facility also helps achieve U.S. government nonproliferation objectives. Most of the worlds production of Mo-99 is achieved by irradiating highly enriched uranium (HEU) targets in research and test reactors. The U.S. is the primary supplier of HEU for Mo-99 production. In 1992 Congress passed the Energy Policy Act of 1992 (U.S. Government, 1992). One of the nonproliferation objectives of the Energy Policy Act of 1992 was to create a strategy to phase out U.S. exports of HEU for radioisotope production. Based on this, the U.S. is encouraging Mo-99 producers to eliminate use of HEU in medical isotope production. The SHINE facility uses LEU (less than 20 percent enrichment) to produce Mo-99.

Iodine-131 There are two methods used to produce I-131: irradiation of tellerium-130 in a nuclear reactor, and generation as a by-product of the irradiation of uranium-235 (U-235) for Mo-99 production.

Both methods are used to supply the U.S. I-131 is used for (NM, 2012):

• Radiation therapy.

• Radioactive labeling for diagnostic radiopharmaceuticals.

Currently, there is no commercial production of I-131 in the U.S. The U.S. supply of I-131 is provided by DRAXIMAGE (66 percent), Covidien (26 percent), and MDS Nordion (8 percent).

These companies obtain their I-131 for U.S. consumption from two reactors (OECD, 2010):

• NRU reactor in Chalk River, Ontario, Canada.

• SAFARI-1, Pelindaba, South Africa.

The SAFARI-1 reactor has been in operation since 1965 (OECD, 2010). As discussed above for Mo-99, due to the ages of the reactors, disruption of the supply of I-131 is an ongoing concern.

Xenon-133 Xe-133 gas is produced as a by-product of the irradiation of U-235 for Mo-99 production. Xe-133 is used for (RxList, 2012):

• Lung imaging.

• Diagnostic evaluation of pulmonary function.

• Assessment of cerebral blood flow.

19.1.2 REGULATORY PROVISIONS, PERMITS, AND REQUIRED CONSULTATIONS This section lists and summarizes the status of federal, state, local, and other permits and consultations required for the construction and operation of the proposed SHINE radioisotope facility. The applicable law, ordinance, or regulation that governs each permit and/or consultation is also identified.

Table 19.1.2-1 lists the permits and other approvals required for construction and operation of the SHINE facility. The table provides the following information for each permit or approval, as applicable:

• Name of the responsible regulatory agency

• Applicable law, ordinance, or regulation SHINE Medical Technologies 19.1-3 Rev. 0

Chapter 19 - Environmental Review Introduction of the Environmental Report

• Name of the permit or approval

• Activity covered by the permit or approval

• Current status Table 19.1.2-2 lists the consultations required for construction and operation of the SHINE facility.

The table provides the following information for each consultation, as applicable:

• Name of the responsible regulatory agency

• Applicable law, ordinance, or regulation

• Required consultation

• Summary of any surveys required to complete the consultation

• Current status In addition to the formal consultations listed in Table 19.1.2-2, SHINE has made informal contacts with the U.S. Nuclear Regulatory Commission, the National Nuclear Security Administration, the Bureau of Indian Affairs, the Wisconsin Department of Health Services, and the City of Janesville Community Development Department. The purpose of these informal consultations was to inform the agencies about the project and to coordinate project planning.

An on-site field delineation completed in accordance with U.S. Army Corps of Engineers (COE) guidance (COE, 2010) found no jurisdictional wetlands or waters of the United States on the SHINE site. Therefore, no permitting or consultation with the COE is expected to be required.

No potential administrative delays or other problems have been identified that would prevent any required agency consultations or approvals. The SHINE facility is designed and planned to comply with all applicable environmental quality standards and regulatory requirements. The facility also will comply with current Good Manufacturing Practices followed by the pharmaceutical industry.

SHINE Medical Technologies 19.1-4 Rev. 0

Chapter 19 - Environmental Review Introduction of the Environmental Report Table 19.1.2-1 Permits and Approvals Required for Construction and Operation (Sheet 1 of 5)

Agency Regulatory Authority Permit or Approval Activity Covered Status U.S. Nuclear Atomic Energy Act Construction Permit Construction of the SHINE Addressed in this license Regulatory facility application Commission 10 CFR 50.50 10 CFR 50.57 Operating License Operation of the SHINE facility Addressed in this license application 10 CFR 40 Source Material License Possession, use, and transfer Addressed in this license of radioactive source material application 10 CFR 30 By-Product Material License Production, possession, and Addressed in this license transfer of radioactive application by-product material 10 CFR 70 Special Nuclear Material Receipt, possession, use, and Addressed in this license License transfer of special nuclear application material National Environmental Policy Environmental Assessment or Site approval for construction Addressed in this license Act (NEPA) Environmental Impact and operation of a application Statement in accordance with radioisotope facility 10 CFR 51 NEPA Federal Aviation Federal Aviation Act Construction Notice Construction of structures that SHINE submitted structure Administration (FAA) potentially may impact air evaluation requests on October 14 CFR 77 navigation 26, 2011. The FAA issued Determinations of No Hazard to Air Navigation on November 9 and 15, 2011.

U.S. Environmental Resource Conservation and Acknowledgement of Generation of hazardous Notification not yet submitted Protection Agency Recovery Act Notification of Hazardous waste Waste Activity 40 CFR 261 and 262 Clean Water Act Spill Prevention, Control and Storage of oil during SPCC Plans not yet prepared Countermeasure (SPCC) Plans construction and operation 40 CFR 112, Appendix F for Construction and Operation U.S. Department of Hazardous Material Certificate of Registration Transportation of hazardous Registration application not yet Transportation Transportation Act materials submitted 40 CFR 107 SHINE Medical Technologies 19.1-5 Rev. 0

Chapter 19 - Environmental Review Introduction of the Environmental Report Table 19.1.2-1 Permits and Approvals Required for Construction and Operation (Sheet 2 of 5)

Agency Regulatory Authority Permit or Approval Activity Covered Status Wisconsin Federal Clean Air Act Air Pollution Control Construction of an air pollution Permit application not yet Department of Construction Permit emission source that is not submitted Natural Resources Wisconsin Statutes Chapter 285 specifically exempted Wisconsin Administrative Code Chapter NR 406 Federal Clean Air Act Air Pollution Control Operation Operation of an air pollution Permit application not yet Permit emission source that is not submitted Wisconsin Statutes Chapter 285 specifically exempted Wisconsin Administrative Code Chapter NR 407 SHINE Medical Technologies 19.1-6 Rev. 0

Chapter 19 - Environmental Review Introduction of the Environmental Report Table 19.1.2-1 Permits and Approvals Required for Construction and Operation (Sheet 3 of 5)

Agency Regulatory Authority Permit or Approval Activity Covered Status Wisconsin Federal Clean Water Act Construction Storm Water Discharge of storm water Notice of Intent to be covered Department of Discharge Permit runoff from the construction by general permit not yet Natural Resources, Wisconsin Statutes Chapter 283 site submitted continued Wisconsin Administrative Code Chapter NR 216 Federal Clean Water Act Industrial Storm Water Discharge of storm water Notice of Intent to be covered Discharge Permit runoff from the site during by general permit not yet Wisconsin Statutes Chapter 283 facility operation submitted. The facility may be eligible for an industrial Storm Wisconsin Administrative Code Water Discharge Permit Chapter NR 216 exclusion under Wisconsin Admistrative Code NR 216.21(3)

Wisconsin Statutes Chapters Approval Letters Construction by the City of Plans and specifications not yet 280 ad 281 Janesville of water and submitted sanitary sewer extensions to Wisconsin Administrative Code the SHINE facility Chapter NR 809 Wisconsin Statutes Chapter 291 Compliance with hazardous Generation of hazardous Notification not yet submitted; waste notification, record waste other requirements become Wisconsin Administrative Code keeping, and reporting applicable during operation Chapter NR 660, 662, and/or requirements 666 Wisconsin Wisconsin Statutes Chapter 101 Building Plan Review Compliance with state building Plans not yet submitted Department of codes; required before a local Safety and Wisconsin Administrative Code building permit can be issued Professional Chapters SPS 361 and 362 for a commercial building Services Wisconsin Wisconsin Statutes Chapter 85 Permit for Connection to State Construction of driveway Permit application not yet Department of Trunk Highway connection to U.S. Route 51 submitted Transportation Wisconsin Administrative Code Chapters Trans 231 SHINE Medical Technologies 19.1-7 Rev. 0

Chapter 19 - Environmental Review Introduction of the Environmental Report Table 19.1.2-1 Permits and Approvals Required for Construction and Operation (Sheet 4 of 5)

Agency Regulatory Authority Permit or Approval Activity Covered Status Wisconsin Wisconsin Statutes Chapter 85 Right of Entry Permit Construction by the City of Permit application not yet Department of Janesville of utility extensions submitted Transportation Wisconsin Administrative Code across U.S. Route 51 continued Chapters Trans 231 Wisconsin Statutes Chapter 114 Variance from Height Limitation Construction of structures that Plans not yet submitted for Zoning Ordinances exceed height limitations review Wisconsin Administrative Code established for Southern Chapters Trans 56 Wisconsin Regional Airport City of Janesville City of Janesville Ordinance Site Plan Approval (includes Administrative approval of the Plans not yet submitted for Community 18.24.050.A Building Site Permit for the site layout and plans for review Development Southern Wisconsin Regional parking, lighting, landscaping, Department Airport Overlay District) etc.

City of Janesville Ordinance Storm Water Plan Approval Administrative approval of Plans not yet submitted for 15.06.070 (may be included in Site Plan grading and drainage plans review Approval)

City of Janesville Ordinance Erosion Control Permit (may be Administrative approval of Plans not yet submitted for 15.05.080 included in Site Plan Approval) erosion control plans review City of Janesville Ordinance Building Permit Construction of buildings Permit application not yet 15.01.100.A submitted City of Janesville Ordinance Plumbing Plan Approval Installation of plumbing Permit application not yet 15.01.100.A systems submitted City of Janesville Ordinance HVAC Plan Approval Installation of heating, Permit application not yet 15.04.010.A ventilation, and air submitted conditioning systems City of Janesville Ordinance Fire Sprinkler and Alarm Permit Installation of sprinkler and Permit application not yet 8.32.010 alarm systems submitted City of Janesville Ordinance Occupancy Permit Occupancy of completed Permit application not yet 15.01.190.A buildings submitted SHINE Medical Technologies 19.1-8 Rev. 0

Chapter 19 - Environmental Review Introduction of the Environmental Report Table 19.1.2-1 Permits and Approvals Required for Construction and Operation (Sheet 5 of 5)

Agency Regulatory Authority Permit or Approval Activity Covered Status City of Janesville City of Janesville Ordinance Sanitary Sewer and Water Administrative approval of Permit application not yet Community 13.16 Supply Facility Approvals construction, installation, and submitted Development operation of connections to Department the municipal sewer and water continued supply systems City of Janesville City of Janesville Ordinance Conditional Use Permit (when Construction of multiple Permit application not yet Plan Commission 18.24.040 the site property is annexed by buildings on the same site submitted the City, the property will automatically be zoned for industrial use)

Rock County Wisconsin Statutes Chapter 84 Permit to Construct, Maintain, Construction by the City of Permit application not yet Highway and Operate Utilities within Janesville of utility extensions submitted Department Rock County Utility Highway Right-of-Way across County Trunk Highway Accommodation Policy 96.00 G Note: No jurisdictional wetlands or waters of the United States have been identified on the SHINE site; therefore, authorization under Section 404 of the Clean Water Act is not expected to be required for construction or operation.

Sources for identification of permit requirements: City of Janesville, 2012; State of Wisconsin, 2012; Wisconsin Department of Natural Resources, 2012.

SHINE Medical Technologies 19.1-9 Rev. 0

Chapter 19 - Environmental Review Introduction of the Environmental Report Table 19.1.2-2 Consultations Required for Construction and Operation (Sheet 1 of 2)

Agency Regulatory Authority Required Consultation Surveys Required Status U.S. Fish and Wildlife Endangered Species Act, 16 Consultation regarding potential to None Consultation letter was Service (FWS) USC 1536 adversely impact protected submitted to the FWS on species; concurrence with no December 16, 2011; FWS adverse impact or consultation on issued a response on appropriate mitigation measures January 25, 2012, stating no further action required.

Bald and Golden Eagle Consultation regarding potential to None Consultation letter and Protection Act, 16 USC adversely impact eagles; response as above.

668-668c concurrence with no adverse impact or consultation on appropriate mitigation measures Wisconsin State National Historic Preservation Consultation regarding potential to Phase I archaeological Phase I survey was Historic Preservation Act, Section 106 adversely impact historic survey completed on December 15, Office (SHPO) resources; concurrence with no 2011. Consultation letter was adverse impact or consultation on submitted to the SHPO on appropriate mitigation measures February 15, 2012; response was received on March 12, 2012 stating agreement with finding that no historic properties will be affected.

Wisconsin Wisconsin Statutes Chapter 29, Endangered Resources Review None Request for ERR was Department of Section 604 (ERR) to document recorded submitted on January 16, Natural Resources occurrence of protected species or 2012; ERR response was rare natural habitats issued on February 1, 2012, stating no further action required.

SHINE Medical Technologies 19.1-10 Rev. 0

Chapter 19 - Environmental Review Introduction of the Environmental Report Table 19.1.2-2 Consultations Required for Construction and Operation (Sheet 2 of 2)

Agency Regulatory Authority Required Consultation Surveys Required Status Native American National Environmental Policy Consultation regarding protection None Consultation letters were Nations: Act of traditional Native American sent to the Native American religious and cultural resources tribes on July 26, 2012. The

- Citizen Potawatomi National Historic Preservation Winnebago Tribe of Nation, Oklahoma Act Nebraska responded on

- Flandreau Santee August 2, 2012, requesting Sioux Tribe of South Native American Graves notification if any burial sites Dakota Protection and Repatriation Act are discovered. No other

- Forest County Potawatomi responses have been Community, received.

Wisconsin

- Hannahville Indian Community, Michigan

- Ho-Chunk Nation of Wisconsin

- Lower Sioux Indian Community, Minnesota

- Prairie Band of Potawatomi Nation, Kansas

- Prairie Island Indian Community, Minnesota

- Santee Sioux Nation, Nebraska

- Sisseton-Wahpeton Oyate, South Dakota

- Spirit Lake Tribe, North Dakota

- Upper Sioux Community, Minnesota

- Winnebago Tribe of Nebraska SHINE Medical Technologies 19.1-11 Rev. 0