Exemption; Issuance: Northwest Medical Isotopes, LLC; Medical Radioisotope Production Facility, 56379-56380 [2018-24312]

Agencies

• NUCLEAR REGULATORY COMMISSION

[Federal Register Volume 83, Number 219 (Tuesday, November 13, 2018)]
[Notices]
[Pages 56379-56380]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24312]


=======================================================================
-----------------------------------------------------------------------

NUCLEAR REGULATORY COMMISSION

[Docket No. 50-0609; NRC-2018-0225]


Exemption; Issuance: Northwest Medical Isotopes, LLC; Medical 
Radioisotope Production Facility

AGENCY: Nuclear Regulatory Commission.

ACTION: Exemption; issuance.

-----------------------------------------------------------------------

SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing an 
exemption to Northwest Medical Isotopes, LLC (NWMI) from the 
requirement that an application for an NRC 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 (and the associated environmental 
report), be submitted at least 9 months prior to commencement of 
construction of the plant or facility in which the activity will be 
conducted.

DATES: This exemption is being issued on November 13, 2018.

ADDRESSES: Please refer to Docket ID NRC-2018-0225 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 https://www.regulations.gov and search for Docket ID NRC-2018-0225. Address 
questions about Docket IDs in Regulations.gov 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 https://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

    NWMI is the holder of Construction Permit No. CPMIF-002 (issued on 
May 9, 2018 (ADAMS Accession No. ML18037A308) under Part 50 of title 10 
of the Code of Federal Regulations (10 CFR)), which authorizes NWMI to 
construct a medical radioisotope production facility (RPF) in Columbia, 
Missouri. The facility 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 subject to different regulatory 
regimes would take place. The processes involved in the production 
area, which include receipt of irradiated LEU targets, LEU target 
disassembly and dissolution, and Mo-99 recovery and purification, are 
subject to the NRC 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 would be subject to the separate NRC 
licensing requirements of 10 CFR part 70.
    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 the National Environmental Policy Act of 1969 
(NEPA) (42 U.S.C. 4321 et seq.) and the NRC's regulations in 10 CFR 
part 51, the NRC staff prepared an environmental impact statement 
(EIS), NUREG-2209, ``Environmental Impact Statement for the 
Construction Permit for the Northwest Medical Isotopes Radioisotope 
Production Facility,'' dated May 2017 (ADAMS Accession No. ML17130A862) 
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. A 10 CFR part 50 
construction permit was issued to NWMI on May 9, 2018.

II. Request/Action

    The exemption request from NWMI was submitted by letter dated 
December 18, 2017 (ADAMS Accession No. ML17362A040), as supplemented by 
a letter dated March 12, 2018 (ADAMS Accession No. ML18088A175). NWMI 
is requesting an exemption from the requirement that the application 
(and associated environmental report required by 10 CFR part 51) for 10 
CFR part 70 activities be submitted at least 9 months prior to 
commencement of construction of the 10 CFR part 70 components of the 
RPF. 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 0A

[[Page 56380]]

dated June 2015 (ADAMS Accession Nos. ML15210A123, ML15210A128, 
ML15210A129, and ML15210A131).
    The NRC 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. 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 is not met.

III. Discussion

    Pursuant to 10 CFR 70.17(a), the Commission may, upon application 
of any interested person or upon its own initiative, grant such 
exemptions from the requirements of 10 CFR part 70 as it determines are 
authorized by law and will not endanger life or property or the common 
defense and security and are otherwise in the public interest.

Authorized by Law

    The applicant has stated that the requested exemption from the 
requirement to submit an application and associated environmental 
report at least 9 months prior to the commencement of construction of 
the RPF, including 10 CFR part 70 components (i.e., the target 
fabrication facility), will enable it to initiate construction of the 
entire RPF based upon the environmental review for the 10 CFR part 50 
construction permit. The applicant has also stated there have been no 
significant changes to the environmental information that was 
previously submitted to the NRC as part of the 10 CFR part 50 
construction permit application. NWMI also stated that it will submit 
the application and environmental report required by 10 CFR 70.21(f) as 
part of a consolidated operating license application for both the 10 
CFR part 50 Production Facility and to possess and use special nuclear 
material for the 10 CFR part 70 target fabrication facility activities.
    The staff evaluated the environmental impacts of the RPF, including 
the 10 CFR part 70 target fabrication activities as a connected action, 
in the EIS dated May 31, 2017 (NUREG-2209, ``Environmental Impact 
Statement for the Construction Permit for the Northwest Medical 
Isotopes Radioisotope Production Facility'', ADAMS Accession No. 
ML17130A862). The staff concludes, as documented in the EIS, that after 
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 a construction permit to NWMI.
    The NRC regulation, 10 CFR 70.17, allows the NRC to grant 
exemptions from the requirements of 10 CFR part 70 provided certain 
findings are made. Granting the applicant's proposed exemption is not 
otherwise inconsistent with NRC regulations or other applicable laws. 
As explained below, the proposed exemption will not endanger life or 
property, or the common defense and security, and is otherwise in the 
public interest.
    NWMI indicates that it will submit an environmental report with its 
application for an operating license for the entire RPF which the NRC 
will be able to review for any significant new information. The NRC 
will not make a decision on an application to operate the production 
portion of the facility under 10 CFR part 50 or a license to possess 
and use special nuclear material for target fabrication under 10 CFR 
part 70 until after the NRC has completed a NEPA review based on NWMI's 
proposed application and environmental report, and made the appropriate 
regulatory findings. Therefore, the exemption is authorized by law.

Will Not Endanger Life or Property or the Common Defense and Security

    Construction of the facility has not yet begun. Since the exemption 
request relates to the timing of when construction may begin, the 
proposed exemption would not: (a) Impact the probabilities of evaluated 
accidents; (b) affect margins of safety; (c) affect effectiveness of 
programs contained in licensing documents; (d) increase effluents; (e) 
increase occupational radiological exposures; or (f) impact operations 
or decommissioning activities. The proposed exemption also will not 
have an impact on common defense and security since the exemption only 
relates to the timing of construction. NWMI's construction permit does 
not authorize possession of any nuclear material at the RPF.
    Based on its evaluation, the NRC staff has determined that this 
exemption will not endanger life or property or the common defense and 
security.

Otherwise in the Public Interest

    The NRC staff has determined that granting the proposed exemption 
would allow for efficient construction of the NWMI RPF at an earlier 
date. The purpose of the NWMI RPF is to produce medical isotopes and 
help meet the U.S. goal of establishing a domestic supply of Mo-99 as 
stated in the American Medical Isotopes Production Act, 42 U.S.C. 2065 
et seq. Accordingly, the NRC staff has determined that granting the 
requested exemption is otherwise in the public interest.

IV. Environmental Consideration

    As required by 10 CFR 51.21, the NRC performed an environmental 
assessment (EA) that analyzes the environmental impacts of the proposed 
exemption in accordance with NEPA. Based on that EA, the NRC staff has 
determined not to prepare an EIS for the proposed exemption, and has 
issued a finding of no significant impact (FONSI). The EA and FONSI 
were published in the Federal Register on August 29, 2018 (83 FR 44068-
44070).

V. Conclusion

    Accordingly, the NRC has determined that, pursuant to 10 CFR 70.17, 
the exemption is authorized by law, will not endanger life or property 
or the common defense and security, and is otherwise in the public 
interest. Therefore, the NRC hereby grants NWMI an exemption from the 
10 CFR 70.21(f) requirement to submit a 10 CFR part 70 application, and 
the associated environmental report, 9 months prior to the commencement 
of construction, to allow NWMI to begin construction of the 10 CFR part 
70 portions of the facility along with the rest of the RPF.

    Dated at Rockville, Maryland, this 1st day of November 2018.

    For the Nuclear Regulatory Commission.
LaDonna Suggs,
Acting Deputy Director, Division of Fuel Cycle Safety, Safeguards, and 
Environmental Review, Office of Nuclear Material Safety and Safeguards.
[FR Doc. 2018-24312 Filed 11-9-18; 8:45 am]
 BILLING CODE 7590-01-P