[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]



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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

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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.

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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]
BILLING CODE 7590-01-P