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###### Nuclear Regulatory Commission

          - [Docket No. 50-0609; NRC-2018-0184]

# AGENCY:

Nuclear Regulatory Commission.

# ACTION:

Environmental assessment and finding of no significant impact; issuance.

# SUMMARY:

The U.S. Nuclear Regulatory Commission (NRC) is considering issuing an exemption to Northwest Medical Isotopes, LLC (NWMI) from its regulations, to waive the requirement that NWMI submit an application to the NRC for a license to possess and use special nuclear material for processing and fuel fabrication, scrap recovery or conversion of uranium hexafluoride, or for the conduct of any other activity which the NRC has determined will significantly affect the quality of the environment, at least 9 months prior to commencement of construction of the plant or facility in which the activity will be conducted. The NRC has prepared an environmental assessment (EA) and finding of no significant impact (FONSI) for this exemption request.

# DATES:

The EA and FONSI referenced in this document are available on the 24th day of August, 2018.

# ADDRESSES:

Please refer to Docket ID NRC-2018-0184 when contacting the NRC about the availability of information regarding this document. You may access publicly-available information related to this document using any of the following methods:
      -  Federal Rulemaking Website:                          Go to                          http://www.regulations.gov                          and search for Docket ID NRC-2018-0184. Address questions about NRC dockets to Jennifer Borges; telephone: 301-287-9127; email:                          Jennifer.Borges@nrc.gov.                          For technical questions, contact the individual listed in the                          FOR FURTHER INFORMATION CONTACT                          section of this document.                    
      -  NRC's Agencywide Documents Access and Management System (ADAMS):                          You may obtain publicly-available documents online in the ADAMS Public Documents collection at                          http://www.nrc.gov/​reading-rm/​adams.html.                          To begin the search, select “                         Begin Web-based ADAMS Search.                         ” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to                          pdr.resource@nrc.gov.                          The ADAMS accession number for each document referenced (if it is available in ADAMS) is provided the first time that it is mentioned in this document.                    
      -  NRC's PDR:                          You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.                    

# FOR FURTHER INFORMATION CONTACT:

                        David Tiktinsky, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-8740, email:                         *David.Tiktinsky@nrc.gov.*

# SUPPLEMENTARY INFORMATION:

## I. Background

                    The NRC is considering issuing an exemption to NWMI from section 70.21(f) in title 10 of the                     *Code of Federal Regulations*                     (10 CFR), which requires the submission of an application to the NRC under 10 CFR part 70, “Domestic Licensing of Special Nuclear Material,” for a license to possess and use special nuclear material for processing and fuel fabrication, scrap recovery or conversion of uranium hexafluoride, or for the conduct of any other activity which the NRC has determined pursuant to subpart A of 10 CFR part 51 will significantly affect the quality of the environment, at least 9 months prior to commencement of construction of the plant or facility in which the activity will be conducted. The exemption would allow NWMI to commence construction of the entire NWMI medical radioisotope production facility (RPF) based upon the environmental review conducted for the 10 CFR part 50 construction permit issued to NWMI on May 9, 2018. The exemption was requested by NWMI in a letter dated December 18, 2017 (ADAMS Accession No. ML17362A040), as supplemented on March 12, 2018 (ADAMS Accession No. ML18088A175).                

                    The NWMI 10 CFR part 50 construction permit application, which included an environmental report, discussed processes that would fall under 10 CFR 70.21(f). The NRC staff environmental review of the 10 CFR part 50 construction permit application discussed, as a connected action, the environmental impacts of this process, consistent with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321*et seq.*) and the NRC's environmental protection regulations that implement NEPA in 10 CFR part 51. The NRC staff documented the evaluation and conclusions of its environmental review of the NWMI 10 CFR part 50 construction permit application in an environmental impact statement (EIS), NUREG-2209, “Environmental Impact Statement for the Construction Permit for the Northwest Medical Isotopes Radioisotope Production Facility,” issued in May 2017 (ADAMS Accession No. ML17130A862).                

As required by 10 CFR 51.21, the NRC staff prepared an EA that analyzes the environmental impacts of the proposed exemption in accordance with NEPA. Based on the EA that follows, the NRC has determined not to prepare an EIS for the proposed exemption, and is issuing a FONSI.

## II. Environmental Assessment

### Identification of the Proposed Action

The proposed action is the issuance of an exemption in response to a request dated December 18, 2017 (ADAMS Accession No. ML17362A040), as supplemented by a letter dated March 12, 2018 (ADAMS Accession No. ML18088A175), from NWMI. The purpose of the proposed action is to exempt NWMI from the requirement that NWMI submit an application to the NRC for a license under 10 CFR part 70 at least 9 months prior to commencement of construction of the plant or facility in which the 10 CFR part 70 activities will be conducted. The activities that will be subject to the 10 CFR part 70 license application are described in the construction permit application that NWMI previously submitted to the NRC under 10 CFR part 50 for an RPF to be constructed in Columbia, Missouri. (NWMI Preliminary Safety Analyses Report, Chapter 19, “Environmental Report.” Corvallis, OR, revision OA dated June 2015, (ADAMS Accession Nos. ML15210A123, ML15210A128, ML15210A129, and ML15210A131)).

The NWMI exemption request asks the NRC to exempt NWMI from the timing requirement in order to allow NWMI to begin construction of the 10 CFR part 70 components of the RPF upon the issuance of the 10 CFR part 50 construction permit.

### Need for the Proposed Action

                    NWMI received a construction permit under 10 CFR part 50 to construct the RPF, which would fabricate low-enriched uranium (LEU) targets and ship them to a network of U.S. research reactors for irradiation, receive irradiated LEU targets, disassemble and dissolve irradiated LEU targets, and recover and purify Molybdenum-99 (Mo-99). These processes would take place in a single RPF building divided into two separate areas where processes                           ( print page 44069)                        subject to different regulatory regimes would take place. The processes involved in receipt of irradiated LEU targets, LEU target disassembly and dissolution, and Mo-99 recovery and purification are subject to the licensing requirements of 10 CFR part 50. The processes involved in target fabrication that NWMI plans to perform in a separate area of the RPF and would be subject to the separate licensing requirements of 10 CFR part 70.                

NWMI submitted a 10 CFR part 50 construction permit application seeking authorization to construct the portion of the RPF where the processes subject to the 10 CFR part 50 regulations would occur. NWMI submitted an environmental report with its construction permit application, providing environmental information about all of the processes that would occur in both portions of the RPF. In accordance with Section 102(2)(C) of NEPA and the NRC's regulations in 10 CFR part 51, the NRC staff prepared an EIS (NUREG-2209) assessing the potential impacts of the construction, operation, and decommissioning of the proposed RPF on the quality of the human environment and reasonable alternatives. The construction and operation impacts from the portion of the RPF in which 10 CFR part 70 target fabrication activities would occur were evaluated as a connected action to the 10 CFR part 50 construction permit.

Because the NRC has evaluated the environmental impacts from the 10 CFR part 70 target fabrication activities in the RPF, as part of its EIS supporting NWMI's 10 CFR part 50 construction permit application, NWMI is requesting an exemption from the requirement that the application for these 10 CFR part 70 activities must be submitted at least 9 months prior to commencement of construction of the 10 CFR part 70 components of the RPF. The exemption would allow NWMI to initiate construction of the 10 CFR part 70 components of the RPF upon the issuance of the 10 CFR part 50 construction permit for the RPF even if the 10 CFR 70.21(f) timing requirement has not been met.

### Environmental Impacts of the Proposed Action

The environmental impacts associated with the construction of the target fabrication portion of the RPF were evaluated and discussed in the EIS issued for the construction permit application for the 10 CFR part 50 portion of the RPF (see NUREG-2209, Section 6-4). The EIS concluded that “[a]fter weighing the environmental, economic, technical, and other benefits against environmental and other costs, and considering reasonable alternatives, the NRC staff's recommendation, unless safety issues mandate otherwise, is the issuance of the construction permit under 10 CFR part 50 to NWMI.”

The purpose of the timing requirement in 10 CFR 70.21(f) is to allow the NRC sufficient time to conduct its environmental review of certain 10 CFR part 70 activities before commencement of construction of the facility in which they will occur. As explained above, the NRC considered the environmental impacts of the processes that will take place in 10 CFR part 70 portion of the RPF, where target fabrication processes will occur, as part of its review of the 10 CFR part 50 construction permit application. Because the exemption request concerns only the timing of when construction of the 10 CFR part 70 portion of the RPF begins, the proposed exemption would not: (a) Affect the probabilities of evaluated accidents; (b) impact margins of safety; (c) reduce the effectiveness of programs contained in licensing documents; (d) increase effluents; (e) increase occupational radiological exposures; or (f) impact operations or decommissioning activities of the RPF. The staff's safety review performed for issuance of the 10 CFR part 50 construction permit is documented in the staff's Safety Evaluation Report dated November 2017 (ADAMS Accession No. ML17310A368).

The requested exemption does not impact the scope of the proposed action or the connected actions at the RPF that were evaluated in the EIS. Accordingly, it does not involve any additional impacts or represent a significant change to those impacts described and analyzed in the environmental information submitted as part of the 10 CFR part 50 construction permit application. Based on the foregoing, the NRC staff has concluded that the proposed action would have no significant environmental impact.

### Environmental Impacts of the Alternatives to the Proposed Action

                    A possible alternative to the proposed action would be to deny the exemption request (                    *i.e.,*                     the “no-action” alternative). If the NRC denies the exemption request, then NWMI may need to defer the initiation of construction of the 10 CFR part 70 components of the RPF to meet the timing requirements in 10 CFR 70.21(f). Since the exemption request relates to the timing of the initiation of construction and not to the scope of construction, then the impacts of this alternative would not be significantly different than if the NRC approved the exemption request.                

### Alternative Use of Resources

Since NWMI has no plans to perform any new activities that were not considered in previous environmental reviews, the change in timing to initiate construction does not involve the use of resources not previously considered.

### Agencies and Persons Consulted

In a letter dated May 17, 2018 (ADAMS Accession No. ML18113A504), the NRC staff consulted with officials from the Missouri Department of Natural Resources regarding the environmental impact of the proposed action. The State responded on July 13, 2018, and stated that it had no comments (ADAMS Accession No. ML18197A199).

                    The NRC staff also reviewed the proposed action in accordance with the Section 106 process of the National Historic Preservation Act of 1966, as amended (NHPA) (54 U.S.C. 300101*et seq.*), which requires federal agencies to consider the effects of their undertakings on historic properties. The NRC has determined that the proposed action, which would only affect the timing of commencement of construction of a portion of the facility, is not the type of action that has the potential to cause any additional impacts or a significant change from the impacts related to historic properties discussed and analyzed in NUREG-2209, the NRC's EIS for the 10 CFR part 50 construction permit for the RPF. Therefore, in accordance with 36 CFR 800.3(a)(1), no consultation is required under Section 106 of the NHPA.                

                    Under Section 7 of the Endangered Species Act of 1973 (16 U.S.C. 1531*et seq.*), prior to taking a proposed action, a federal agency must determine whether: (i) Endangered and threatened species or their critical habitats are known to be in the vicinity of the proposed action and, if so, whether (ii) the proposed federal action may affect listed species or critical habitats. The NRC has determined that the proposed action will not have any additional impacts or a significant change from the impacts related to threatened or endangered species or critical habitats analyzed in the NRC's EIS for the 10 CFR part 50 construction permit for the RFP in NUREG-2209.                

## III. Finding of No Significant Impact

                    NWMI requested an exemption from 10 CFR 70.21(f) that would allow it to initiate construction of the 10 CFR part 70 components of the RPF upon the issuance of the 10 CFR part 50      ( print page 44070)                        construction permit for the RPF even if the 10 CFR 70.21(f) timing requirement has not been met. The NRC is considering issuing the requested exemption. The proposed action would not significantly: (a) Affect probabilities of evaluated accidents; (b) affect margins of safety; (c) affect the effectiveness of programs contained in licensing documents; (d) increase effluents; (e) increase occupational radiological exposures; or (f) affect operations or decommissioning activities of the RPF. The reason the environment would not be significantly affected is because the requested exemption affects only the timing of construction and does not affect the previous evaluation regarding the environmental impacts of constructing and operating the NWMI RPF, as described in the Environmental Impact Statement for Construction Permit for the Northwest Medical Isotopes Radioisotope Production Facility, Final Report (NUREG-2209). The impacts of connected 10 CFR part 70 actions at the RPF were evaluated in NUREG-2209. On the basis of the EA included in Section II of this document, and incorporated herein by reference, the NRC has determined not to prepare an EIS for the proposed action. The related environmental documents are: (a) NWMI Exemption request dated December 17, 2017, as supplemented on March 12, 2018 (ADAMS Accession Nos. ML17362A040 and ML18088A175); (b) NWMI Preliminary Safety Analyses Report, Chapter 19, “Environmental Report,” Corvallis, OR, revision OA dated June 2015, (ADAMS Accession Nos. ML15210A123, ML15210A128, ML15210A129, and ML15210A131; and (c) NUREG-2209, “Environmental Impact Statement for the Construction Permit for the Northwest Medical Isotopes Radioisotope Production Facility,” issued in May 2018 (ADAMS Accession No. ML17130A862).                

                    This FONSI and other related environmental documents may be examined, and/or copied for a fee, at the NRC's PDR, located at One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. Publicly-available records are also accessible online in the ADAMS Public Documents collection at                     *http://www.nrc.gov/​reading-rm/​adams.html.*                     Persons who do not have access to ADAMS or who encounter problems in accessing the documents located in ADAMS should contact the NRC's PDR reference staff by telephone at 1-800-397-4209 or 301-415-4737, or by email to                     *pdr.resource@nrc.gov.*

Dated at Rockville, Maryland this 24th day of August, 2018.

For the Nuclear Regulatory Commission.

Brian W. Smith,

Deputy Director, Division of Fuel Cycle Safety, Safeguards, and Environmental Review, Office of Nuclear Material Safety and Safeguards.

[FR Doc. 2018-18757 Filed 8-28-18; 8:45 am]

 BILLING CODE 7590-01-P