[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]
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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.
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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 http://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 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
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