ML15161A182

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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)
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Text

Chapter 19 - Environmental ReviewTable of ContentsSHINE Medical Technologies19.1-iRev. 0SECTION

19.1INTRODUCTION

OF THE ENVIRONMENTAL REPORTTable of Contents SectionTitle Page

19.1INTRODUCTION

OF THE ENVIRONMENTAL REPORT...............................19.1-119.1.1PURPOSE AND NEED FOR THE PROPOSED ACTION........................19.1-119.1.2REGULATORY PROVISIONS, PERMITS, AND REQUIREDCONSULTATIONS....................................................................................19.1-3 Chapter 19 - Environmental ReviewList of TablesSHINE Medical Technologies19.1-iiRev. 0List of Tables NumberTitle19.1.2-1Permits and Approvals Required for Construction and Operation19.1.2-2Consultations Required for Construction and Operation Chapter 19 - Environmental ReviewList of FiguresSHINE Medical Technologies 19.1-iiiRev. 0List of Figures NumberTitle None Chapter 19 - Environmental ReviewAcronyms and AbbreviationsSHINE Medical Technologies 19.1-iv Rev. 0Acronyms and Abbreviations Acronym/AbbreviationDefinition CFRCode of Federal Regulations COEU.S. Army Corps of Engineers CP Construction Permit DOEU.S. Department of Energy EAEnvironmental Assessment EREnvironmental Report ERREndangered Resources ReviewFAAFederal Aviation Administration FDAU.S. Food and Drug Administration FWSU.S. Fish and Wildlife Service HEUhighly enriched uranium HFRHigh Flux ReactorI-131iodine-131 IREInstitut National des Radioéléments LEUlow enriched uranium Mo-99molybdenum-99NEPANational Environmental Policy Act NRC U.S. Nuclear Regulatory Commission NRCL National Research Council NRU National Research Universal NTPNuclear Technology Products Radioisotopes OL Operating License SHINESHINE Medical Technologies, Inc.

SHPOState Historic Preservation Office SPCCSpill Prevention, Control and Countermeasure Chapter 19 - Environmental ReviewAcronyms and AbbreviationsSHINE Medical Technologies19.1-v Rev. 0Tc-99mtechnetium-99m U-235uranium-235WNNWorld Nuclear NewsXe-133xenon-133Acronyms and Abbreviations (cont'd)

Acronym/AbbreviationDefinition Chapter 19 - Environmental ReviewIntroduction of the Environmental ReportSHINE Medical Technologies 19.1-1Rev. 0CHAPTER 19

19.1INTRODUCTION

OF THE ENVIRONMENTAL REPORTIn 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 10CFR 51 Subpart A, National Environmental Policy Act - Regulations Implementing Section102 (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 regulat ory 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 Section19.2.19.1.1PURPOSE AND NEED FOR THE PROPOSED ACTIONThe 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-99There 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 80percent 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 Chapter 19 - Environmental ReviewIntroduction of the Environmental ReportSHINE Medical Technologies 19.1-2Rev. 0*Sentinel lymph node localization*Cardiac perfusion imaging*Brain perfusion imaging*Gall bladder function imaging

  • Blood pool imaging*Thyroid and salivary gland imaging*Meckel's scansBetween 95 and 98 percent of the world's 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 diagn ostic 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.

Chapter 19 - Environmental ReviewIntroduction of the Environmental ReportSHINE Medical Technologies 19.1-3Rev. 0The SHINE facility also helps achieve U.S. government nonproliferation objectives. Most of the world's 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-131There 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 di agnostic 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-133Xe-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.19.1.2REGULATORY PROVISIONS, PERMITS, AND REQUIREDCONSULTATIONSThis 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 Chapter 19 - Environmental ReviewIntroduction of the Environmental ReportSHINE Medical Technologies 19.1-4Rev. 0*Name of the permit or approval*Activity covered by the permit or approval*Current statusTable 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 statusIn 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.

Chapter 19 - Environmental ReviewIntroduction of the Environmental ReportSHINE Medical Technologies 19.1-5Rev. 0Table 19.1.2-1 Permits and Approvals Required for Construction and Operation (Sheet 1 of 5)AgencyRegulatory AuthorityPermit or ApprovalActivity CoveredStatusU.S. Nuclear Regulatory Commission Atomic Energy Act10 CFR 50.50Construction PermitConstruction of the SHINE facilityAddressed in this license application10 CFR 50.57Operating LicenseOperation of the SHINE facilityAddressed in this license application10 CFR 40Source Material LicensePossession, use, and transfer of radioactive source materialAddressed in this license application10 CFR 30By-Product Material LicenseProduction, possession, and transfer of radioactive by-product materialAddressed in this license application10 CFR 70Special Nuclear Material LicenseReceipt, possession, use, and transfer of special nuclear materialAddressed in this license applicationNational Environmental Policy Act (NEPA)10 CFR 51Environmental Assessment or Environmental Impact Statement in accordance with NEPASite approval for construction and operation of a radioisotope facilityAddressed in this license applicationFederal Aviation Administration (FAA)Federal Aviation Act14 CFR 77Construction NoticeConstruction of structures that potentially may impact air navigation SHINE submitted structure evaluation requests on October 26, 2011. The FAA issued Determinations of No Hazard to Air Navigation on November 9 and 15, 2011.U.S. Environmental Protection AgencyResource Conservation and

Recovery Act40 CFR 261 and 262Acknowledgement of Notification of Hazardous Waste ActivityGeneration of hazardous

waste Notification not yet submittedClean Water Act40 CFR 112, Appendix FSpill Prevention, Control and Countermeasure (SPCC) Plans for Construction and OperationStorage of oil during construction and operationSPCC Plans not yet preparedU.S. Department of TransportationHazardous Material Transportation Act40 CFR 107Certificate of RegistrationTransportation of hazardous materialsRegistration application not yet submitted Chapter 19 - Environmental ReviewIntroduction of the Environmental ReportSHINE Medical Technologies 19.1-6Rev. 0 Wisconsin Department of Natural ResourcesFederal Clean Air ActWisconsin Statutes Chapter 285Wisconsin Administrative Code Chapter NR 406Air Pollution Control Construction PermitConstruction of an air pollution emission source that is not specifically exemptedPermit application not yet

submittedFederal Clean Air ActWisconsin Statutes Chapter 285Wisconsin Administrative Code Chapter NR 407Air Pollution Control Operation PermitOperation of an air pollution emission source that is not specifically exemptedPermit application not yet submittedTable 19.1.2-1 Permits and Approvals Required for Construction and Operation (Sheet 2 of 5)AgencyRegulatory AuthorityPermit or ApprovalActivity CoveredStatus Chapter 19 - Environmental ReviewIntroduction of the Environmental ReportSHINE Medical Technologies 19.1-7Rev. 0 Wisconsin Department of

Natural Resources, continuedFederal Clean Water ActWisconsin Statutes Chapter 283Wisconsin Administrative Code Chapter NR 216Construction Storm Water Discharge PermitDischarge of storm water runoff from the construction

siteNotice of Intent to be covered by general permit not yet

submittedFederal Clean Water ActWisconsin Statutes Chapter 283 Wisconsin Administrative Code Chapter NR 216Industrial Storm Water Discharge PermitDischarge of storm water runoff from the site during facility operationNotice of Intent to be covered by general permit not yet submitted. The facility may be eligible for an industrial Storm Water Discharge Permit exclusion under Wisconsin Admistrative Code NR 216.21(3)Wisconsin Statutes Chapters 280 ad 281Wisconsin Administrative Code Chapter NR 809Approval LettersConstruction by the City of Janesville of water and sanitary sewer extensions to the SHINE facilityPlans and specifications not yet submittedWisconsin Statutes Chapter 291Wisconsin Administrative Code Chapter NR 660, 662, and/or 666Compliance with hazardous waste notification, record keeping, and reporting requirementsGeneration of hazardous

waste Notification not yet submitted; other requirements become applicable during operation Wisconsin Department of Safety and Professional ServicesWisconsin Statutes Chapter 101Wisconsin Administrative Code Chapters SPS 361 and 362Building Plan ReviewCompliance with state building codes; required before a local building permit can be issued for a commercial buildingPlans not yet submitted Wisconsin Department of TransportationWisconsin Statutes Chapter 85Wisconsin Administrative Code Chapters Trans 231Permit for Connection to State Trunk HighwayConstruction of driveway connection to U.S. Route 51Permit application not yet

submittedTable 19.1.2-1 Permits and Approvals Required for Construction and Operation (Sheet 3 of 5)AgencyRegulatory AuthorityPermit or ApprovalActivity CoveredStatus Chapter 19 - Environmental ReviewIntroduction of the Environmental ReportSHINE Medical Technologies 19.1-8Rev. 0 Wisconsin Department of Transportation continuedWisconsin Statutes Chapter 85Wisconsin Administrative Code Chapters Trans 231Right of Entry PermitConstruction by the City of Janesville of utility extensions across U.S. Route 51Permit application not yet

submittedWisconsin Statutes Chapter 114Wisconsin Administrative Code Chapters Trans 56Variance from Height Limitation Zoning Ordinances Construction of structures that exceed height limitations established for Southern Wisconsin Regional AirportPlans not yet submitted for reviewCity of Janesville Community Development DepartmentCity of Janesville Ordinance 18.24.050.ASite Plan Approval (includes

Building Site Permit for the Southern Wisconsin Regional Airport Overlay District)Administrative approval of the site layout and plans for parking, lighting, landscaping, etc.Plans not yet submitted for reviewCity of Janesville Ordinance 15.06.070Storm Water Plan Approval (may be included in Site Plan Approval)Administrative approval of grading and drainage plansPlans not yet submitted for

reviewCity of Janesville Ordinance 15.05.080Erosion Control Permit (may be included in Site Plan Approval)Administrative approval of erosion control plans Plans not yet submitted for

reviewCity of Janesville Ordinance 15.01.100.ABuilding PermitConstruction of buildingsPermit application not yet submittedCity of Janesville Ordinance 15.01.100.APlumbing Plan ApprovalInstallation of plumbing systemsPermit application not yet

submittedCity of Janesville Ordinance 15.04.010.AHVAC Plan ApprovalInstallation of heating, ventilation, and air conditioning systemsPermit application not yet submittedCity of Janesville Ordinance 8.32.010Fire Sprinkler and Alarm PermitInstallation of sprinkler and alarm systemsPermit application not yet

submittedCity of Janesville Ordinance 15.01.190.AOccupancy PermitOccupancy of completed buildings Permit application not yet

submittedTable 19.1.2-1 Permits and Approvals Required for Construction and Operation (Sheet 4 of 5)AgencyRegulatory AuthorityPermit or ApprovalActivity CoveredStatus Chapter 19 - Environmental ReviewIntroduction of the Environmental ReportSHINE Medical Technologies 19.1-9Rev. 0City of Janesville Community Development Department continuedCity of Janesville Ordinance 13.16Sanitary Sewer and Water Supply Facility ApprovalsAdministrative approval of construction, installation, and operation of connections to the municipal sewer and water supply systemsPermit application not yet

submittedCity of Janesville Plan CommissionCity of Janesville Ordinance 18.24.040Conditional Use Permit (when the site property is annexed by the City, the property will automatically be zoned for industrial use)Construction of multiple buildings on the same sitePermit application not yet

submitted Rock County Highway DepartmentWisconsin Statutes Chapter 84Rock County Utility Accommodation Policy 96.00Permit to Construct, Maintain, and Operate Utilities within Highway Right-of-WayConstruction by the City of Janesville of utility extensions across County Trunk Highway GPermit application not yet

submittedNote: 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.Table 19.1.2-1 Permits and Approvals Required for Construction and Operation (Sheet 5 of 5)AgencyRegulatory AuthorityPermit or ApprovalActivity CoveredStatus Chapter 19 - Environmental ReviewIntroduction of the Environmental ReportSHINE Medical Technologies19.1-10Rev. 0Table 19.1.2-2 Consultations Required for Construction and Operation (Sheet 1 of 2)AgencyRegulatory AuthorityRequired ConsultationSurveys RequiredStatusU.S. Fish and Wildlife Service (FWS)Endangered Species Act, 16 USC 1536Consultation regarding potential to adversely impact protected species; concurrence with no adverse impact or consultation on appropriate mitigation measuresNoneConsultation letter was submitted to the FWS on December 16, 2011; FWS issued a response on January 25, 2012, stating no further action required.Bald and Golden Eagle Protection Act, 16 USC 668-668cConsultation regarding potential to adversely impact eagles; concurrence with no adverse impact or consultation on appropriate mitigation measuresNoneConsultation letter and response as above.Wisconsin State Historic Preservation Office (SHPO)National Historic Preservation Act, Section 106Consultation regarding potential to adversely impact historic resources; concurrence with no adverse impact or consultation on appropriate mitigation measuresPhase I archaeological

surveyPhase I survey was completed on December 15, 2011. Consultation letter was submitted to the SHPO on February 15, 2012; response was received on March 12, 2012 stating agreement with finding that no historic properties will be affected.

Wisconsin Department of Natural Resources Wisconsin Statutes Chapter 29, Section 604Endangered Resources Review (ERR) to document recorded occurrence of protected species or rare natural habitatsNoneRequest for ERR was submitted on January 16, 2012; ERR response was issued on February 1, 2012, stating no further action required.

Chapter 19 - Environmental ReviewIntroduction of the Environmental ReportSHINE Medical Technologies19.1-11Rev. 0Native American Nations:-Citizen Potawatomi Nation, Oklahoma-Flandreau Santee Sioux Tribe of South Dakota-Forest County Potawatomi Community, 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 NebraskaNational Environmental Policy ActNational Historic Preservation ActNative American Graves Protection and Repatriation Act Consultation regarding protection of traditional Native American religious and cultural resourcesNoneConsultation letters were sent to the Native American tribes on July 26, 2012. The Winnebago Tribe of Nebraska responded on August 2, 2012, requesting notification if any burial sites are discovered. No other responses have been received.Table 19.1.2-2 Consultations Required for Construction and Operation (Sheet 2 of 2)AgencyRegulatory AuthorityRequired ConsultationSurveys RequiredStatus

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