[Federal Register Volume 87, Number 217 (Thursday, November 10, 2022)]
[Notices]
[Pages 67965-67967]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24488]
[[Page 67965]]
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NUCLEAR REGULATORY COMMISSION
[Docket No. 50-608; NRC-2021-0140]
SHINE Medical Technologies, LLC; SHINE Medical Isotope 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 issuing an
environmental assessment (EA) and finding of no significant impact
(FONSI) regarding the SHINE Medical Technologies, LLC (SHINE, the
licensee) request to amend Construction Permit No. CPMIF-001 for the
SHINE Medical Isotope Production Facility (SHINE facility) in Rock
County, Wisconsin. The amendment request seeks, in part, NRC approval
to extend the latest date for completion of the construction of the
SHINE facility from December 31, 2022, to December 31, 2025.
DATES: The EA and FONSI referenced in this document are available on
November 10, 2022.
ADDRESSES: Please refer to Docket ID NRC-2021-0140 when contacting the
NRC about the availability of information regarding this document. You
may obtain 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-2021-0140. Address
questions about Docket IDs in Regulations.gov to Stacy Schumann;
telephone: 301-415-0624; 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]. For the convenience of the reader,
instructions about obtaining materials referenced in this document are
provided in the ``Availability of Documents'' section.
NRC's PDR: You may examine and order copies of public
documents, by appointment, at the NRC's PDR, Room P1 B35, One White
Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. To make
an appointment to visit the PDR, please send an email to
[email protected] or call 1-800-397-4209 or 301-415-4737, between
8:00 a.m. and 4:00 p.m. Eastern Time (ET), Monday through Friday,
except Federal holidays.
FOR FURTHER INFORMATION CONTACT: Michael Balazik, Office of Nuclear
Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC
20555-0001; telephone: 301-415-2856; email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Introduction
The NRC is considering issuance of an amendment to Construction
Permit No. CPMIF-001, issued to SHINE for the construction of the SHINE
facility in Rock County, Wisconsin. SHINE requested the amendment by
letter dated April 1, 2022, in accordance with section 50.90 of title
10 of the Code of Federal Regulations (10 CFR), ``Application for
amendment of license, construction permit, or early site permit,'' and
10 CFR 50.33, ``Contents of applications; general information.'' The
amendment would extend the latest date for completion of the
construction of the SHINE facility from December 31, 2022, to December
31, 2025.
In accordance with 10 CFR 51.21, ``Criteria for and identification
of licensing and regulatory actions requiring environmental
assessments,'' the NRC prepared an EA, pursuant to 10 CFR 51.30,
``Environmental assessment,'' that analyzes the environmental impacts
of the proposed amendment and alternatives as appropriate. Based on the
results of this EA, which is set forth in Section II in this document,
and in accordance with 10 CFR 51.31(a), the NRC has determined not to
prepare an environmental impact statement for the proposed amendment
and is issuing a FONSI, which is set forth in Section III in this
document.
II. Environmental Assessment
Description of the Proposed Action
The proposed action would amend Construction Permit No. CPMIF-001
to extend the latest date for completion of the construction of the
SHINE facility from December 31, 2022, to December 31, 2025. The
proposed action is requested in the licensee's application dated April
1, 2022.
The proposed action would not allow any work to be performed that
is not already authorized by the construction permit. The proposed
action would grant SHINE more time to complete the construction of the
SHINE facility in accordance with the construction permit.
Need for the Proposed Action
SHINE completed a review of the construction schedule for the SHINE
facility and determined that construction will not be completed by
December 31, 2022, the latest date for completion of the construction
of the SHINE facility prescribed by the construction permit. SHINE
stated that developmental effort delays have occurred due to the first-
of-a-kind nature of the SHINE facility. Furthermore, the COVID-19
public health emergency slowed efforts related to obtaining the
workforce and equipment resources needed to procure and install the
necessary process equipment to complete facility construction. SHINE
now expects the construction of the SHINE facility to be substantially
completed in May 2023 and the remaining uncompleted items of
construction completed by August 2025. To accommodate this construction
schedule and to incorporate conservatism, SHINE is requesting to extend
the latest date for completion of the construction of the SHINE
facility to December 31, 2025.
The NRC regulation in 10 CFR 50.55(b) states that upon good cause
shown, the Commission will extend the completion date for a reasonable
period of time and that the Commission will recognize, among other
things, ``developmental problems attributable to the experimental
nature of the facility or fire, flood, explosion, strike, sabotage,
domestic violence, enemy action, an act of the elements, and other acts
beyond the control of the permit holder,'' as a basis for extending the
completion date.
Environmental Impacts of the Proposed Action
The NRC has completed its environmental review of the proposed
action and concludes that there are no significant environmental
impacts associated with the proposed action.
The proposed action would only extend the period of construction
activities already authorized by the construction permit and would not
authorize any new construction activities, any additional land
disturbance, or any modifications to the facility from the terms in the
construction permit.
In 2015, the NRC evaluated the environmental impacts associated
with constructing, operating, and decommissioning the SHINE facility in
[[Page 67966]]
NUREG-2183, ``Environmental Impact Statement for the Construction
Permit for the SHINE Medical Radioisotope Production Facility.'' NUREG-
2183 concluded that the environmental impacts associated with the
construction of the SHINE facility would be SMALL for all resource
areas with the exception of traffic, which would incur MODERATE
impacts. In 2022, the NRC issued NUREG-2183, Supplement 1,
``Environmental Impact Statement Related to the Operating License for
the SHINE Medical Isotope Production Facility: Draft Report for
Comment,'' which updates NUREG-2183 and only covers matters that differ
from those or that reflect significant new information relative to that
discussed in NUREG-2183. NUREG-2183, Supplement 1 considered any
different information since NUREG-2183 and concluded that there is no
significant new information with respect to the environmental impacts
of the SHINE facility.
In May 2019, SHINE commenced site-preparation work and NRC-
authorized construction of the exterior of the SHINE facility. SHINE
completed the construction of the main production facility building in
March 2021. Therefore, most of the construction impacts discussed in
NUREG-2183 and NUREG-2183, Supplement 1 have already occurred. The
proposed action would not result in additional worker vehicles,
additional truck deliveries, new land disturbance, new construction, or
modification of the SHINE facility from what was previously assessed in
NUREG-2183 and NUREG-2183, Supplement 1. No changes to the facility's
Wisconsin Pollutant Discharge Elimination System permit are needed.
There would be no changes to the types or quantity of non-radiological
effluents previously assessed in NUREG-2183 and NUREG-2183, Supplement
1. The proposed action would not represent a change in the types or
quantity of radioactive materials in effluents, wastes, and products of
the SHINE facility. SHINE continues to be required to comply with
occupational dose limits for adults (10 CFR part 20, subpart C) and
radiation dose limits for individual members of the public (10 CFR part
20, subpart D) at all times. The proposed action would not have a
significant adverse effect on the probability of an accident occurring.
Since the proposed action would only extend the period of already
authorized construction activities, it does not involve any different
impacts or significant changes to those impacts described and analyzed
in the previous environmental documents. Therefore, there would be no
significant non-radiological or radiological environmental impacts
associated with the proposed action.
Environmental Impacts of the Alternatives to the Proposed Action
As an alternative to the proposed action, the NRC staff considered
denial of the proposed action (i.e., the ``no-action'' alternative).
Denial of the amendment request would result in the licensee being
unable to complete construction and begin operation of the SHINE
facility. However, because the direct impacts on land use and water
resources from construction have largely already occurred and because
the remaining construction, operating, and decommissioning impacts
would generally be small as evaluated in NUREG-2183 and NUREG-2183,
Supplement 1, the environmental impacts of the proposed action and the
alternative action are similar.
Alternative Use of Resources
There are no unresolved conflicts concerning alternative uses of
available resources under the proposed action. The proposed action does
not involve the use of any resources not previously considered in
NUREG-2183 and NUREG-2183, Supplement 1.
Agencies and Persons Consulted
No additional agencies or persons were consulted regarding the
environmental impact of the proposed action. On October 11, 2022, the
NRC notified the Wisconsin Department of Health Services of the EA and
FONSI. The state provided no comments. The NRC staff determined that
the proposed action would have no effect on Federally listed threatened
or endangered species or critical habitat that could occur on or near
the SHINE facility site and would have no effect on any historic
properties. Therefore, consultation was not required under section 7 of
the Endangered Species Act of 1973, as amended, or under section 106 of
the National Historic Preservation Act of 1966, as amended.
III. Finding of No Significant Impact
The proposed action is the issuance of an amendment to SHINE
Construction Permit No. CPMIF-001 to extend the latest date for
completion of the construction of the SHINE facility from December 31,
2022, to December 31, 2025. Consistent with 10 CFR 51.21, the NRC
prepared an EA to determine the impacts of the proposed action. On the
basis of the EA included in Section II in this document and
incorporated by reference in this finding, the NRC concludes that the
proposed action would not have a significant adverse effect on the
probability of an accident occurring and would not have any significant
radiological or non-radiological impacts. Therefore, the NRC concludes
that the proposed action will not have a significant effect on the
quality of the human environment. Accordingly, the NRC has determined
not to prepare an environmental impact statement for the proposed
action.
Other than the application dated April 1, 2022, the related
environmental documents are NUREG-2183, ``Environmental Impact
Statement for the Construction Permit for the SHINE Medical
Radioisotope Production Facility,'' and NUREG-2183, Supplement 1,
``Environmental Impact Statement Related to the Operating License for
the SHINE Medical Isotope Production Facility: Draft Report for
Comment,'' which provide the latest environmental review of the
construction, operation, and decommissioning of the SHINE facility and
description of the environmental conditions at the SHINE facility site.
This EA and FONSI and other related documents are accessible online
in the ADAMS Public Documents collection at https://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 at 1-800-397-4209 or 301-415-
4737, or by email to [email protected].
IV. Availability of Documents
The documents identified in the following table are available to
interested persons through ADAMS, as indicated.
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Document ADAMS accession No.
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NUREG-2183, ``Environmental Impact Statement for ML15288A046.
the Construction Permit for the SHINE Medical
Radioisotope Production Facility,'' dated
October 2015.
NUREG-2183, Supplement 1, ``Environmental Impact ML22179A346.
Statement Related to the Operating License for
the SHINE Medical Isotope Production Facility:
Draft Report for Comment,'' dated June 2022.
[[Page 67967]]
Construction Permit No. CPMIF-001 for the SHINE ML16041A471.
Medical Isotope Production Facility, dated
February 29, 2016.
SHINE Medical Technologies, LLC, ``Request to ML22091A093.
Amend Construction Permit No. CPMIF-001,''
dated April 1, 2022.
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Dated: November 4, 2022.
For the Nuclear Regulatory Commission.
Joshua M. Borromeo,
Chief, Non-Power Production and Utilization Facility Licensing Branch,
Division of Advanced Reactors and Non-Power Production and Utilization
Facilities, Office of Nuclear Reactor Regulation.
[FR Doc. 2022-24488 Filed 11-9-22; 8:45 am]
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