[Federal Register Volume 83, Number 168 (Wednesday, August 29, 2018)]
[Notices]
[Pages 44068-44070]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18757]



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NUCLEAR REGULATORY COMMISSION

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


Target Fabrication Portion of the Northwest Medical Isotopes 
Radioisotope Production Facility

AGENCY: Nuclear Regulatory Commission.

ACTION: Environmental assessment and finding of no significant impact; 
issuance.

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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: [email protected]. 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 [email protected]. 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: 
[email protected].

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

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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

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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 [email protected].

    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