Text

Summary Record of Decision Regarding Construction Permit Application for the Northwest Medical Isotopes, LLC Medical Radioisotope Production Facility
	ML18053A074
Person / Time
Site:	Northwest Medical Isotopes
Issue date:	05/09/2018
From:	David Drucker; NRC/NRR/DMLR/MRPB
To:	Haass C; Northwest Medical Isotopes
	Drucker D
References
	Download: ML18053A074 (10)
	v • d • e

SUMMARY

RECORD OF DECISION U.S. NUCLEAR REGULATORY COMMISSION DOCKET NO. 50-609 CONSTRUCTION PERMIT APPLICATION FOR THE NORTHWEST MEDICAL ISOTOPES, LLC MEDICAL RADIOISOTOPE PRODUCTION FACILITY BACKGROUND:

By letter dated November 7, 2014, Northwest Medical Isotopes, LLC (NWMI) submitted Part 1 of a two-part application to the U.S. Nuclear Regulatory Commission (NRC or the Commission) for a construction permit under Title 10 of the Code of Federal Regulations (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities, for the NWMI medical radioisotope production facility in Columbia, Missouri, which included an Environmental Report (ER). By letter dated February 5, 2015, NWMI withdrew and resubmitted Part 1 of its construction permit application to include a discussion of connected actions in the ER. In June 2015, the ER was updated to reflect maturation of the facility design and this version of the ER is available in the NRCs Agencywide Documents Access and Management System (ADAMS) under Accession Nos. ML15210A123, ML15210A128, ML15210A129, and ML15210A131.1 The NWMI construction permit application describes a single proposed building divided into two separate areas where processes subject to different regulatory requirements will take place.

Specifically, the application describes the following processes that will be performed within one area of the building: (1) irradiated low-enriched uranium (LEU) target receipt from a network of U.S. research reactors; (2) irradiated LEU target disassembly and dissolution; (3) molybdenum 99 (Mo-99) recovery and purification; (4) uranium recovery and recycle; (5) waste management; and (6) associated laboratory and support area activities. These processes would be conducted within a production facility, as defined in 10 CFR 50.2. Therefore, this area of the building is subject to the licensing requirements of 10 CFR Part 50 and construction of only this portion of the building would be authorized by the issuance of a construction permit in response to NWMIs application. The NRC staff refers to these processes as the production facility processes, and the area of the building within which they will be performed as the NWMI production facility.

The NWMI construction permit application also describes another process, target fabrication, which will be performed within a separate area of the building. Specifically, the target fabrication process, as described in the application, consists generally of receiving fresh LEU in metal form from a U.S. Department of Energy (DOE) supplier; fabricating LEU target material using uranyl nitrate, which consists of a combination of fresh LEU, recovered scrap LEU from off-specification unirradiated targets, and LEU recovered from the processing of irradiated targets; assembling, loading, and fabricating targets; and packaging the targets for shipment to a network of U.S. research reactors. The NRC staff refers to this process as target fabrication, and the area of the building within which it will be performed as the target fabrication area.

Although the NWMI construction permit application discusses this process, it states in the NWMI Preliminary Safety Analysis Report Section 1.1 that the activities supporting its target fabrication process will be licensed under 10 CFR Part 70, Domestic Licensing of Special Nuclear Material, which will be applied for under a separate license application submittal. The NRC staff refers to the NWMI production facility, target fabrication area, and associated support buildings as the NWMI facility.

1 Documents with an ADAMS Accession No. are publicly available at: https://adams.nrc.gov/wba/. Instructions for using ADAMS are available at: https://www.nrc.gov/reading-rm/adams.html.

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The Atomic Energy Act of 1954 (42 U.S.C. 2011 et seq.) authorizes the NRC to issue construction permits and operating licenses for production facilities. To issue a construction permit, the NRC is required to consider the environmental impacts of the proposed action under the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321 et seq.). The NRCs environmental protection regulations that implement NEPA in 10 CFR Part 51, Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions, describe several types of actions that would require an environmental impact statement (EIS).

Construction permits and operating licenses for a medical radioisotope production facility are not specifically identified in 10 CFR 51.20 as an action that would require an EIS. Such activities may require an environmental assessment (EA) or an EIS, depending on their potential for significant impacts to the quality of the human environment.

An EA is used to determine whether the impacts from the proposed action may be significant and whether a finding of no significant impact can be made. If, based on the EA, the NRC concludes that the proposed action could result in significant impacts to the human environment, the agency would prepare an EIS. In some cases, the NRC may decide to prepare an EIS without first preparing an EA if there is the potential for significant impacts to the human environment or the proposed action involves a matter that the Commission, in the exercise of its discretion, has determined should be covered by an EIS. For the NWMI production facility environmental review, the NRC staff determined that, pursuant to 10 CFR 51.20(a)(2), the proposed action should be covered by an EIS as a matter of discretion.

The NRC staff made this determination because (1) of the potential that an EA might not support a finding of no significant impact and (2) operation of the proposed NWMI production facility will include the connected actions of target fabrication and scrap recovery, processes similar to the processes that fuel fabrication facilities use and 10 CFR 51.20(b)(7) requires an EIS for the issuance of a license that authorizes possession and use of special nuclear material (SNM) for processing and fuel fabrication and for scrap recovery.

Consistent with 10 CFR Part 51, the NRC staff published a Notice of Acceptance for Docketing in the Federal Register (FR) on June 8, 2015 (80 FR 32418). On November 18, 2015, the NRC staff published a Federal Register notice (80 FR 72115) of its intent to prepare an EIS and conduct a scoping process. This notice began a 45-day scoping period. On December 8, 2015, the NRC held a public scoping meeting in Columbia, Missouri. The NRCs report entitled, Summary of the Public Scoping Meeting Conducted Related to the Review of the Proposed Northwest Medical Isotopes, LLC, Radioisotope Production Facility, presents the comments received during the scoping process (ADAMS Accession No. ML15356A096). In September 2015, the NRC staff conducted a site audit at the proposed and alternative NWMI facility sites to verify information in NWMIs ER. During the site audit, the NRC staff met with NWMI personnel; reviewed specific documentation; and toured the proposed site, the alternative site, and the University of Missouri Research Reactor (MURR), one of the reactors where NWMI plans to have its targets irradiated.

After the scoping period and the site audit, the NRC staff compiled its findings in a draft EIS (ADAMS Accession No. ML16305A029). The public comment period for the draft EIS was from November 10, 2016, through December 29, 2016 (81 FR 79019). During this time, the NRC staff held a public meeting (ADAMS Accession No. ML17003A149) and collected public comments. On May 15, 2017, the NRC issued the Environmental Impact Statement for the Construction Permit for the Northwest Medical Isotopes Radioisotope Production Facility, Final Report (NUREG-2209) (ADAMS Accession No. ML17130A862) (final EIS). Comments received on the draft EIS, as well as the NRC staff responses, are included in Appendix A of the final EIS. The U.S. Environmental Protection Agency issued a Notice of Availability for the final EIS on May 26, 2017 (82 FR 24345).

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Pursuant to 10 CFR 51.102 and 51.103(a)(1)-(4), the NRC staff has prepared this Summary Record of Decision (ROD) to accompany the NRCs action on the construction permit application. This Summary ROD incorporates by reference materials contained in the final EIS.

See 10 CFR 51.103(c).

DECISION:

The NRC makes the decision to grant or deny the construction permit application based on whether the applicant has met all applicable requirements, including the NRCs safety and environmental regulations. The NRCs safety review of the application is documented in the safety evaluation report (SER) issued in November 2017 (ADAMS Accession No. ML17310A368).

The final EIS presents the NRC staffs environmental review of the application. As documented in the final EIS, after weighing the environmental, economic, technical, and other benefits of the facility against environmental and other costs, and considering reasonable alternatives, the NRC staff recommended issuance of the construction permit. The NRC staff determined that this recommendation is in accordance with NEPA and the NRCs implementing regulations in Subpart A of 10 CFR Part 51, and that all applicable environmental requirements have been satisfied.

On May 3, 2018, the Commission issued a Memorandum and Order, CLI-18-06 (ADAMS Accession No. ML18123A374), which (1) concluded that the application satisfied the applicable requirements of NEPA section 102 and 10 CFR Parts 50 and 51 and (2) authorized the issuance of the construction permit, contingent upon the inclusion of a revised safety permit condition.

Accordingly, on May 9, 2018, the NRC issued Construction Permit No. CPMIF-002 to NWMI for a 10 CFR Part 50 production facility designed for the production of medical radioisotopes in Columbia, Missouri. The construction permit is effective as of its date of issuance.

AGENCIES ROLES AND RESPONSIBILITIES:

The final EIS includes information on a broad range of issues that may be regulated by other Federal, State, or local agencies. As documented in the final EIS, NWMI must obtain and maintain permits from other Federal, State, or local agencies in order to construct the NWMI facility.

Pursuant to Section 401(a) of the Federal Water Pollution Control Act (i.e., Clean Water Act of 1972, as amended (CWA)), an applicant for a Federal license or permit, which may result in a discharge into navigable waters of the United States, must provide to the Federal licensing or permitting agency the certification, or a waiver, from the State in which the discharge originates.

A Federal agency cannot issue such a license or permit to an applicant until the required certification is obtained. As described in the final EIS, NWMI would have to obtain and comply with a State-issued general permit for stormwater discharges associated with construction activity. Best management practices and other requirements imposed by the State issued stormwater discharge permit would ensure that runoff during construction of the proposed facility will meet applicable State water quality standards. By letter dated September 15, 2017 (ADAMS Accession No. ML17268A303), the State of Missouri issued a water quality certification for the NWMI facility.

PURPOSE AND NEED:

As identified in Section 1.3 of the final EIS, the purpose and need of the proposed Federal action is to provide a medical radioisotope production option that could help meet the need for a Page 3 of 10

domestic source of Mo-99. If the facility is licensed to operate, NWMI expects to produce up to 2,500 6-day Curies (Ci) (9.3x1013 6-day Becquerel (Bq)) of Mo-99 per week. Global shortages of medical radioisotopes in the last decade have highlighted the need for prompt action to ensure a reliable domestic supply. In recent years, U.S. policy has aimed to ensure a reliable supply of medical radioisotopes while minimizing the use of highly enriched uranium for civilian purposes through, among other things, supporting commercial projects that produce medical radioisotopes domestically without the use of highly enriched uranium.

PROPOSED FEDERAL ACTION:

The proposed Federal action is for the NRC to decide whether to issue a construction permit under 10 CFR Part 50 that would allow construction of the NWMI production facility. If the NRC were to issue a construction permit, NWMI could build the proposed production facility on a 3.0-hectare (ha) (7.4-acre (ac)) site, Lot 15 of the Discovery Ridge Research Park, in Boone County, Columbia, Missouri. The issuance of a 10 CFR Part 50 construction permit is a separate licensing action from the issuance of a 10 CFR Part 50 operating license or the issuance of a 10 CFR Part 70 license. Before NWMI can operate the NWMI facility, as described in its application, NWMI must (1) submit a 10 CFR Part 50 application for an operating license and a 10 CFR Part 70 application to receive and possess special nuclear material for its processes, pursuant to the NRC requirements, (2) substantially complete construction of the production facility in accordance with an NRC-issued construction permit, and (3) obtain a 10 CFR Part 50 operating license and a 10 CFR Part 70 license. If NWMI were to submit a 10 CFR Part 50 operating license application, the NRC staff would prepare a supplement to the final EIS in accordance with 10 CFR 51.95(b). The staff expects that a similar approach to supplementing the final EIS could be adopted for the review of an NWMI 10 CFR Part 70 application relating to target fabrication.

NRC EVALUATION OF THE PROPOSED ACTION:

Section 102(2)(C)(iii) of NEPA states that EISs are to include a detailed statement on alternatives to the proposed action. The NRC staff examined the environmental impacts from the construction, operations, and decommissioning of the 10 CFR Part 50 production facility; the construction, operations, and decommissioning related to the target fabrication process described in the NWMI application; and the transporting and irradiating of LEU targets at the identified research reactors for the following resource areas: land use and visual resources; meteorology, air quality, and noise; geologic resources; water resources; ecological resources; historic and cultural resources; socioeconomics; human health; waste management; transportation; accidents; and environmental justice. These resource areas were also considered with other developments or activities that affect the resources cumulatively. The NRC staff also evaluated the environmental impacts of the no-action alternative, an alternative site, and alternative technologies to determine the environmentally preferable alternative and as part of the NRC staffs need to weigh the costs and benefits of the proposed action and alternatives to the proposed action.

To guide its assessment of the environmental impacts of the proposed action and alternatives, the NRC has established a standard of significance for impacts based on Council on Environmental Quality guidance (40 CFR 1508.27). Based on this, the NRC established three levels of significance for potential impacts: SMALL, MODERATE, and LARGE. The definitions of these three significance levels, which are presented in the Interim Staff Guidance to NUREG-1537, Part 2, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors (ADAMS Accession No. ML12156A075), are:

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

MODERATEenvironmental effects are sufficient to alter noticeably, but not to destabilize, important attributes of the resource.

LARGEenvironmental effects are clearly noticeable and are sufficient to destabilize important attributes of the resource.

The final EIS presents the NRC staffs analysis, which considers and weighs the environmental impacts of the proposed action at the Discovery Ridge Research Park, in Boone County, Columbia, Missouri. The NRC staff determined that the impacts from the proposed action and connected actions would be SMALL for all resource areas.

Evaluation of Alternatives:

In Chapter 5 of the final EIS, the NRC staff considered the following alternatives to construction, operations, and decommissioning of the NWMI facility at the Discovery Ridge Research Park, in Boone County, Columbia, Missouri:

the no-action alternative;

construction, operations, and decommissioning of the NWMI facility at the University of Missouri Research Reactor (alternative site);

construction, operations, and decommissioning of a linear accelerator-based facility at the Discovery Ridge site (Alternative Technology No. 1); and

construction, operations, and decommissioning of a subcritical fission-based facility at the Discovery Ridge site (Alternative Technology No. 2).

i. No-Action Alternative Under the no-action alternative, discussed in Section 5.1 of the final EIS, the NRC would deny the construction permit, and the NWMI facility would not be constructed. The no-action alternative does not involve the determination of whether radioisotopes are needed or should be generated. The decision to produce radioisotopes is at the discretion of applicants.

Under the no-action alternative, no changes would occur to the proposed NWMI site in Columbia, Missouri. Therefore, impacts on all resource areas would be SMALL.

The no-action alternative is the only alternative considered by the NRC staff that does not satisfy the purpose and need for the final EIS, because this alternative does not satisfy the need for a U.S. supply of Mo-99. Assuming that the need for a U.S. supplier of Mo-99 continues to exist, another private company would likely construct and operate a medical radioisotope production facility.

ii. Alternative Site The NRC staff independently evaluated NWMIs process for screening potential alternative sites, which followed a prescriptive methodology by applying exclusionary criteria appropriate to the proposed facility. NRCs site-selection process guidance calls for a systematic process to evaluate a broad range of potential sites and select sites to analyze in detail.

NWMIs site-selection process assessed a variety of economic and environmental factors to determine reasonable sites to construct and operate the NWMI facility. NWMI determined that proximity to an existing university research reactor was the most important factor in determining Page 5 of 10

site location because the production process relies upon one or more research reactors to irradiate targets. The NRC staff evaluated NWMIs site-selection process and concluded that the process for selecting and evaluating alternative sites was reasonable and logical and adequately satisfied applicable NRC guidance.

The two sites considered in detail in the final EIS for the location of the NWMI facility are the Discovery Ridge Research Park site in Columbia, Missouri (proposed site), and MURR in Columbia, Missouri (alternative site).

The NRC staff determined that the impacts at the alternative site would be SMALL for all resource areas except from noise which would be SMALL to MODERATE. Additionally, in 2010, during the MURR operating license renewal review, the Missouri State Historic Preservation Office (SHPO) informed the NRC that MURR is eligible for inclusion in the National Register of Historic Places (NRHP) (ADAMS Accession No. ML101950104). Because the Missouri SHPO has determined that MURR is eligible for listing on the NRHP, it is considered a historic property as defined under 36 CFR 800.16(l). Construction of the NWMI facility at the MURR site would occur on previously disturbed, paved and open space land currently in industrial use. The NWMI facility would be designed to blend in with the architecture of the existing MURR facilities. Nonetheless, construction could result in an adverse effect if it is found to alter the historic characteristics that qualify MURR for inclusion on the NRHP (36 CFR 800.5(a)(1)). However, any adverse effects could be minimized or mitigated because NWMI has indicated that the facility would be located and designed to blend in with the historic fabric of the MURR site.

The NRC staff determined that the impacts at the Discovery Ridge site would be SMALL for all resource areas and no historic properties would be affected. Therefore, the NRC staff concluded that the Discovery Ridge site would be the environmentally preferable site.

iii. Alternative Technologies For the alternative technologies analysis, the NRC staff initially narrowed down the broad range of potential alternatives by considering the following five alternative technologies that received cooperative agreements from the U.S. Department of Energy/National Nuclear Security Administration and appeared to be technologically reasonable:

neutron capture technology,

aqueous homogenous reactor technology,

selective gas extraction technology,

uranium fission technology, and

linear accelerator-based technology.

The NRC staff then considered whether sufficient environmental data existed to conduct a meaningful alternatives analysis for each of the technologies. The NRC staff did not find sufficient data to describe the potential environmental impacts from the construction and operations of the neutron capture technology, aqueous homogenous reactor technology, or the selective gas extraction technology and excluded them from further consideration.

The NRC staff determined that sufficient environmental data exist regarding the potential impacts of construction, operations, and decommissioning for the uranium fission alternative and the linear accelerator-based alternative. The NRC staff evaluated the potential environmental impacts if these technologies were constructed, operated, and decommissioned at the proposed Discovery Ridge Research Park site and determined that the environmental impacts would result in the same impacts as the construction, operation, and decommissioning of the NWMI facility at the Discovery Ridge Research Park site.

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iv. Comparison of the Costs and Benefits of the Alternatives In Chapters 4 and 5 of the final EIS, the NRC staff described the costs and benefits of the proposed action as well as alternatives to the proposed action. In weighing the costs and benefits, the NRC staff concluded that the overall benefits of constructing, operating, and decommissioning the proposed NWMI production facility at the Discovery Ridge Research Park site outweigh the disadvantages and costs based upon the following considerations:

U.S. policy is to ensure a reliable supply of medical radioisotopes while minimizing the use of highly enriched uranium for civilian purposes,

the small environmental impact, including radiological impacts and risk to human health, which would be caused by constructing, operating, and decommissioning the proposed NWMI production facility at the Discovery Ridge Research Park site,

the economic benefit of constructing and operating the proposed NWMI production facility to communities located near the Discovery Ridge Research Park site, and

the increased availability of medical isotopes for U.S. public health needs.

Constructing, operating, and decommissioning the NWMI production facility at the Discovery Ridge site would have slightly less environmental costs than at the alternative site because impacts from noise would be SMALL to MODERATE at the MURR site, due to the close proximity of the existing MURR workforce to heavy equipment noise that would be associated with construction and decommissioning. In addition, constructing, operating, and decommissioning the NWMI production facility at the MURR site could result in an adverse effect to historic properties if it alters the characteristics that qualify MURR for inclusion on the NRHP. However, the overall benefits of constructing and operating the proposed NWMI production facility at either site would outweigh the environmental or other costs for the reasons outlined above.

Installation of alternative technologies (e.g., linear accelerator-based or subcritical fission-based) would not result in any greater economic advantages or disadvantages over the proposed NWMI technology, and the environmental costs and benefits would be similar to those described for the proposed NWMI production facility at the Discovery Ridge site. Therefore, the overall benefits of utilizing an alternative technology at the Discovery Ridge site would be the same and would outweigh the environmental and other costs for the reasons outlined above.

MITIGATION MEASURES:

The NRC has taken all practicable measures within its jurisdiction to avoid or minimize environmental harm from the proposed action. Construction, operations, and decommissioning of the NWMI production facility would have SMALL environmental impacts in all resource areas.

An Environmental Protection Plan (Appendix A of the Construction Permit) is included in the Construction Permit to ensure compliance with the Endangered Species Act of 1973, as amended (ESA), and to ensure that the Commission is kept informed of other environmental matters. The Environmental Protection Plan describes reporting requirements regarding potential impacts to protected environmental resources during construction activities. The Environmental Protection Plan is intended to be consistent with Federal, State, and local requirements for environmental protection. The NRC is not otherwise imposing any license conditions regarding mitigation measures or requiring any new environmental monitoring programs.

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Below are mitigation measures and best management practices (BMPs) described in the final EIS with respect to individual resource areas.

Land Use NWMI would restore temporarily affected areas with vegetation that is common to the Discovery Ridge Research Park. Ground vegetation would include grasses, shrubs, trees and/or ornamental flowers including native species. The facility would be built and operated consistent with all local zoning requirements.

Visual Resources NWMI would revegetate open areas with grasses, shrubs, trees and/or ornamental flowers including native species.

Air Quality NWMI would control fugitive dust by watering unpaved and disturbed areas, stabilizing spoil piles, revegetating slopes, and minimizing soil disturbance through phased grading. NWMI would reduce equipment idle times, use ultra-low sulfur diesel fuel, and install pollution control devices on construction equipment to minimize construction equipment related emissions.

NWMI would develop a comprehensive program for controlling greenhouse gas (GHG) emissions associated with operation of the NWMI production facility. This will include developing a GHG emission inventory, implementing methods for avoiding or minimizing GHG emissions identified in the inventory, and encouraging carpooling and other measures to minimize GHG emissions due to vehicle traffic during operation.

Noise Distance to sensitive receptors would limit offsite noise levels. Facility design (e.g., wall thickness and physical barriers) would limit noise of operating equipment inside buildings.

Geologic Resources NWMI would conduct construction activities in accordance with the provisions of a Land Disturbance Permit and City of Columbia approved site development plan, which would require implementation of construction-related BMPs for soil erosion and sediment control and stormwater pollution prevention during site development, facility construction, and post development.

Water Resources Stormwater runoff from the NWMI production facility site would be managed by an engineered stormwater management system, including necessary detention/retention structures, constructed and operated in compliance with State and municipal stormwater management plans, procedures, and practices. NWMI would be required to obtain a Land Disturbance Permit from the City of Columbia, which would require appropriate soil erosion and sediment control BMPs to be used to minimize soil erosion and the stormwater transport of suspended sediment and other pollutants.

NWMI would be required to adhere to a City-approved stormwater management plan to control the peak flow rates of stormwater discharge associated with specified design storms.

Wastewater must meet the acceptance criteria of the Columbia Regional Wastewater Treatment Plan. Waste handling and pollution prevention practices and spill prevention and response procedures would be observed so that no materials or contaminants would be released to soils or exposed to stormwater, where they could contaminate underlying groundwater.

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Ecological Resources NWMI would mitigate impacts from herbicide applications by implementing BMP requirements that would limit their use and contain the broad application throughout the site. During construction at night, NWMI would use BMPs, such as light source shielding and appropriate directional lighting, to mitigate impacts associated with artificial nighttime illumination.

Historic and Cultural Properties If cultural or historical resources are identified during construction, NWMI will contact the SHPO immediately.

Socioeconomics The availability of construction workers and housing within the region of influence and the short duration of construction (18 months) would minimize any socioeconomic impacts within the region of influence. New operations jobs would help maintain employment levels and would generate a small amount of additional property and sales tax revenue.

Human Health NWMI would have facility design features and use procedures to minimize radiation exposure to occupational workers and members of the public. NWMI would maintain radiation exposure to facility workers to within the occupational dose limits in 10 CFR 20.1201. Radiation exposure within the proposed facility would be minimized using shielding, optimized process designs, radiological work planning, protective equipment and materials, access controls, and contamination control measures that will all be used to keep doses to personnel as low as is reasonably achievable (ALARA). NWMI would have a radiological effluent monitoring program to ensure that the types and quantities of radioactive material released from the proposed facility are within expected parameters, such that the limits in 10 CFR 20.1301 and 10 CFR 20.1101(d) would not be exceeded.

Transportation of radioactive materials, both on public highways and by air, must comply with the applicable U.S. Department of Transportation regulations in 49 CFR Parts 172, 173, 175, 177, and 397, as well as the NRC packaging requirements for radioactive material in 10 CFR Part 71.

NWMI would employ normal construction safety practices contained in Occupational Safety and Health Administration (OSHA) regulations, such as safety training, safety equipment, and supervision of the work force to promote worker safety and reduce the likelihood of worker injury during construction. Use of access controls, proper personal protective equipment, and safety practices would reduce instances of accidents or exposure to hazardous materials. An emergency response plan would be used to reduce the impact to human health and the environment.

Waste Management NWMI would implement a waste minimization and pollution prevention program that would include a recycling and reclamation program, and require employees to consider waste minimization and pollution prevention during performance of their jobs.

Transportation NWMI would encourage carpooling.

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Accidents The potential radiological and chemical accident consequences must comply with applicable NRC regulations. NWMI would incorporate engineering design features and administrative controls to ensure that exposure from accidents would be within regulatory limits.

DETERMINATION:

Based on an independent review, analysis, and evaluation contained in the final EIS; careful consideration of all of the identified social, economic, and environmental factors and input received from other Federal, State, and local agencies, Tribes, organizations, and the public; consideration of the mitigation measures outlined above; and the input received during the mandatory hearing, it is determined that the standards for issuance of a construction permit, as described in 10 CFR Part 50, have been met and that the requirements of Section 102 of NEPA have been satisfied.

PREPARED BY:

/RA/

David M. Drucker, Senior Project Manager License Renewal Projects Branch Division of Materials and License Renewal Office of Nuclear Reactor Regulation REVIEWED BY:

/RA/

Benjamin G. Beasley, Chief Environmental Review and NEPA Branch Division of Materials and License Renewal Office of Nuclear Reactor Regulation APPROVED BY:

/RA/

Brian E. Holian, Acting Director Office of Nuclear Reactor Regulation Page 10 of 10

SUMMARY

RECORD OF DECISION U.S. NUCLEAR REGULATORY COMMISSION DOCKET NO. 50-609 CONSTRUCTION PERMIT APPLICATION FOR THE NORTHWEST MEDICAL ISOTOPES, LLC MEDICAL RADIOISOTOPE PRODUCTION FACILITY BACKGROUND:

By letter dated November 7, 2014, Northwest Medical Isotopes, LLC (NWMI) submitted Part 1 of a two-part application to the U.S. Nuclear Regulatory Commission (NRC or the Commission) for a construction permit under Title 10 of the Code of Federal Regulations (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities, for the NWMI medical radioisotope production facility in Columbia, Missouri, which included an Environmental Report (ER). By letter dated February 5, 2015, NWMI withdrew and resubmitted Part 1 of its construction permit application to include a discussion of connected actions in the ER. In June 2015, the ER was updated to reflect maturation of the facility design and this version of the ER is available in the NRCs Agencywide Documents Access and Management System (ADAMS) under Accession Nos. ML15210A123, ML15210A128, ML15210A129, and ML15210A131.1 The NWMI construction permit application describes a single proposed building divided into two separate areas where processes subject to different regulatory requirements will take place.

Specifically, the application describes the following processes that will be performed within one area of the building: (1) irradiated low-enriched uranium (LEU) target receipt from a network of U.S. research reactors; (2) irradiated LEU target disassembly and dissolution; (3) molybdenum 99 (Mo-99) recovery and purification; (4) uranium recovery and recycle; (5) waste management; and (6) associated laboratory and support area activities. These processes would be conducted within a production facility, as defined in 10 CFR 50.2. Therefore, this area of the building is subject to the licensing requirements of 10 CFR Part 50 and construction of only this portion of the building would be authorized by the issuance of a construction permit in response to NWMIs application. The NRC staff refers to these processes as the production facility processes, and the area of the building within which they will be performed as the NWMI production facility.

The NWMI construction permit application also describes another process, target fabrication, which will be performed within a separate area of the building. Specifically, the target fabrication process, as described in the application, consists generally of receiving fresh LEU in metal form from a U.S. Department of Energy (DOE) supplier; fabricating LEU target material using uranyl nitrate, which consists of a combination of fresh LEU, recovered scrap LEU from off-specification unirradiated targets, and LEU recovered from the processing of irradiated targets; assembling, loading, and fabricating targets; and packaging the targets for shipment to a network of U.S. research reactors. The NRC staff refers to this process as target fabrication, and the area of the building within which it will be performed as the target fabrication area.

Although the NWMI construction permit application discusses this process, it states in the NWMI Preliminary Safety Analysis Report Section 1.1 that the activities supporting its target fabrication process will be licensed under 10 CFR Part 70, Domestic Licensing of Special Nuclear Material, which will be applied for under a separate license application submittal. The NRC staff refers to the NWMI production facility, target fabrication area, and associated support buildings as the NWMI facility.

1 Documents with an ADAMS Accession No. are publicly available at: https://adams.nrc.gov/wba/. Instructions for using ADAMS are available at: https://www.nrc.gov/reading-rm/adams.html.

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The Atomic Energy Act of 1954 (42 U.S.C. 2011 et seq.) authorizes the NRC to issue construction permits and operating licenses for production facilities. To issue a construction permit, the NRC is required to consider the environmental impacts of the proposed action under the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321 et seq.). The NRCs environmental protection regulations that implement NEPA in 10 CFR Part 51, Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions, describe several types of actions that would require an environmental impact statement (EIS).

Construction permits and operating licenses for a medical radioisotope production facility are not specifically identified in 10 CFR 51.20 as an action that would require an EIS. Such activities may require an environmental assessment (EA) or an EIS, depending on their potential for significant impacts to the quality of the human environment.

An EA is used to determine whether the impacts from the proposed action may be significant and whether a finding of no significant impact can be made. If, based on the EA, the NRC concludes that the proposed action could result in significant impacts to the human environment, the agency would prepare an EIS. In some cases, the NRC may decide to prepare an EIS without first preparing an EA if there is the potential for significant impacts to the human environment or the proposed action involves a matter that the Commission, in the exercise of its discretion, has determined should be covered by an EIS. For the NWMI production facility environmental review, the NRC staff determined that, pursuant to 10 CFR 51.20(a)(2), the proposed action should be covered by an EIS as a matter of discretion.

The NRC staff made this determination because (1) of the potential that an EA might not support a finding of no significant impact and (2) operation of the proposed NWMI production facility will include the connected actions of target fabrication and scrap recovery, processes similar to the processes that fuel fabrication facilities use and 10 CFR 51.20(b)(7) requires an EIS for the issuance of a license that authorizes possession and use of special nuclear material (SNM) for processing and fuel fabrication and for scrap recovery.

Consistent with 10 CFR Part 51, the NRC staff published a Notice of Acceptance for Docketing in the Federal Register (FR) on June 8, 2015 (80 FR 32418). On November 18, 2015, the NRC staff published a Federal Register notice (80 FR 72115) of its intent to prepare an EIS and conduct a scoping process. This notice began a 45-day scoping period. On December 8, 2015, the NRC held a public scoping meeting in Columbia, Missouri. The NRCs report entitled, Summary of the Public Scoping Meeting Conducted Related to the Review of the Proposed Northwest Medical Isotopes, LLC, Radioisotope Production Facility, presents the comments received during the scoping process (ADAMS Accession No. ML15356A096). In September 2015, the NRC staff conducted a site audit at the proposed and alternative NWMI facility sites to verify information in NWMIs ER. During the site audit, the NRC staff met with NWMI personnel; reviewed specific documentation; and toured the proposed site, the alternative site, and the University of Missouri Research Reactor (MURR), one of the reactors where NWMI plans to have its targets irradiated.

After the scoping period and the site audit, the NRC staff compiled its findings in a draft EIS (ADAMS Accession No. ML16305A029). The public comment period for the draft EIS was from November 10, 2016, through December 29, 2016 (81 FR 79019). During this time, the NRC staff held a public meeting (ADAMS Accession No. ML17003A149) and collected public comments. On May 15, 2017, the NRC issued the Environmental Impact Statement for the Construction Permit for the Northwest Medical Isotopes Radioisotope Production Facility, Final Report (NUREG-2209) (ADAMS Accession No. ML17130A862) (final EIS). Comments received on the draft EIS, as well as the NRC staff responses, are included in Appendix A of the final EIS. The U.S. Environmental Protection Agency issued a Notice of Availability for the final EIS on May 26, 2017 (82 FR 24345).

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Pursuant to 10 CFR 51.102 and 51.103(a)(1)-(4), the NRC staff has prepared this Summary Record of Decision (ROD) to accompany the NRCs action on the construction permit application. This Summary ROD incorporates by reference materials contained in the final EIS.

See 10 CFR 51.103(c).

DECISION:

The NRC makes the decision to grant or deny the construction permit application based on whether the applicant has met all applicable requirements, including the NRCs safety and environmental regulations. The NRCs safety review of the application is documented in the safety evaluation report (SER) issued in November 2017 (ADAMS Accession No. ML17310A368).

The final EIS presents the NRC staffs environmental review of the application. As documented in the final EIS, after weighing the environmental, economic, technical, and other benefits of the facility against environmental and other costs, and considering reasonable alternatives, the NRC staff recommended issuance of the construction permit. The NRC staff determined that this recommendation is in accordance with NEPA and the NRCs implementing regulations in Subpart A of 10 CFR Part 51, and that all applicable environmental requirements have been satisfied.

On May 3, 2018, the Commission issued a Memorandum and Order, CLI-18-06 (ADAMS Accession No. ML18123A374), which (1) concluded that the application satisfied the applicable requirements of NEPA section 102 and 10 CFR Parts 50 and 51 and (2) authorized the issuance of the construction permit, contingent upon the inclusion of a revised safety permit condition.

Accordingly, on May 9, 2018, the NRC issued Construction Permit No. CPMIF-002 to NWMI for a 10 CFR Part 50 production facility designed for the production of medical radioisotopes in Columbia, Missouri. The construction permit is effective as of its date of issuance.

AGENCIES ROLES AND RESPONSIBILITIES:

The final EIS includes information on a broad range of issues that may be regulated by other Federal, State, or local agencies. As documented in the final EIS, NWMI must obtain and maintain permits from other Federal, State, or local agencies in order to construct the NWMI facility.

Pursuant to Section 401(a) of the Federal Water Pollution Control Act (i.e., Clean Water Act of 1972, as amended (CWA)), an applicant for a Federal license or permit, which may result in a discharge into navigable waters of the United States, must provide to the Federal licensing or permitting agency the certification, or a waiver, from the State in which the discharge originates.

A Federal agency cannot issue such a license or permit to an applicant until the required certification is obtained. As described in the final EIS, NWMI would have to obtain and comply with a State-issued general permit for stormwater discharges associated with construction activity. Best management practices and other requirements imposed by the State issued stormwater discharge permit would ensure that runoff during construction of the proposed facility will meet applicable State water quality standards. By letter dated September 15, 2017 (ADAMS Accession No. ML17268A303), the State of Missouri issued a water quality certification for the NWMI facility.

PURPOSE AND NEED:

As identified in Section 1.3 of the final EIS, the purpose and need of the proposed Federal action is to provide a medical radioisotope production option that could help meet the need for a Page 3 of 10

domestic source of Mo-99. If the facility is licensed to operate, NWMI expects to produce up to 2,500 6-day Curies (Ci) (9.3x1013 6-day Becquerel (Bq)) of Mo-99 per week. Global shortages of medical radioisotopes in the last decade have highlighted the need for prompt action to ensure a reliable domestic supply. In recent years, U.S. policy has aimed to ensure a reliable supply of medical radioisotopes while minimizing the use of highly enriched uranium for civilian purposes through, among other things, supporting commercial projects that produce medical radioisotopes domestically without the use of highly enriched uranium.

PROPOSED FEDERAL ACTION:

The proposed Federal action is for the NRC to decide whether to issue a construction permit under 10 CFR Part 50 that would allow construction of the NWMI production facility. If the NRC were to issue a construction permit, NWMI could build the proposed production facility on a 3.0-hectare (ha) (7.4-acre (ac)) site, Lot 15 of the Discovery Ridge Research Park, in Boone County, Columbia, Missouri. The issuance of a 10 CFR Part 50 construction permit is a separate licensing action from the issuance of a 10 CFR Part 50 operating license or the issuance of a 10 CFR Part 70 license. Before NWMI can operate the NWMI facility, as described in its application, NWMI must (1) submit a 10 CFR Part 50 application for an operating license and a 10 CFR Part 70 application to receive and possess special nuclear material for its processes, pursuant to the NRC requirements, (2) substantially complete construction of the production facility in accordance with an NRC-issued construction permit, and (3) obtain a 10 CFR Part 50 operating license and a 10 CFR Part 70 license. If NWMI were to submit a 10 CFR Part 50 operating license application, the NRC staff would prepare a supplement to the final EIS in accordance with 10 CFR 51.95(b). The staff expects that a similar approach to supplementing the final EIS could be adopted for the review of an NWMI 10 CFR Part 70 application relating to target fabrication.

NRC EVALUATION OF THE PROPOSED ACTION:

Section 102(2)(C)(iii) of NEPA states that EISs are to include a detailed statement on alternatives to the proposed action. The NRC staff examined the environmental impacts from the construction, operations, and decommissioning of the 10 CFR Part 50 production facility; the construction, operations, and decommissioning related to the target fabrication process described in the NWMI application; and the transporting and irradiating of LEU targets at the identified research reactors for the following resource areas: land use and visual resources; meteorology, air quality, and noise; geologic resources; water resources; ecological resources; historic and cultural resources; socioeconomics; human health; waste management; transportation; accidents; and environmental justice. These resource areas were also considered with other developments or activities that affect the resources cumulatively. The NRC staff also evaluated the environmental impacts of the no-action alternative, an alternative site, and alternative technologies to determine the environmentally preferable alternative and as part of the NRC staffs need to weigh the costs and benefits of the proposed action and alternatives to the proposed action.

To guide its assessment of the environmental impacts of the proposed action and alternatives, the NRC has established a standard of significance for impacts based on Council on Environmental Quality guidance (40 CFR 1508.27). Based on this, the NRC established three levels of significance for potential impacts: SMALL, MODERATE, and LARGE. The definitions of these three significance levels, which are presented in the Interim Staff Guidance to NUREG-1537, Part 2, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors (ADAMS Accession No. ML12156A075), are:

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

MODERATEenvironmental effects are sufficient to alter noticeably, but not to destabilize, important attributes of the resource.

LARGEenvironmental effects are clearly noticeable and are sufficient to destabilize important attributes of the resource.

The final EIS presents the NRC staffs analysis, which considers and weighs the environmental impacts of the proposed action at the Discovery Ridge Research Park, in Boone County, Columbia, Missouri. The NRC staff determined that the impacts from the proposed action and connected actions would be SMALL for all resource areas.

Evaluation of Alternatives:

In Chapter 5 of the final EIS, the NRC staff considered the following alternatives to construction, operations, and decommissioning of the NWMI facility at the Discovery Ridge Research Park, in Boone County, Columbia, Missouri:

the no-action alternative;

construction, operations, and decommissioning of the NWMI facility at the University of Missouri Research Reactor (alternative site);

construction, operations, and decommissioning of a linear accelerator-based facility at the Discovery Ridge site (Alternative Technology No. 1); and

construction, operations, and decommissioning of a subcritical fission-based facility at the Discovery Ridge site (Alternative Technology No. 2).