[Federal Register Volume 86, Number 226 (Monday, November 29, 2021)]
[Notices]
[Pages 67737-67740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25911]
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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
[[Page 67738]]
finding of no significant impact (FONSI) regarding the NRC's
consideration of issuance of a proposed amendment to the SHINE Medical
Technologies, LLC (SHINE, the licensee) Construction Permit No. CPMIF-
001, issued on February 29, 2016. The permit authorizes the
construction of the SHINE Medical Isotope Production Facility (SHINE
facility) in Rock County, Wisconsin. If approved, the proposed
amendment would authorize the receipt and possession of certain
radioactive materials necessary for the continued construction of the
SHINE facility.
DATES: The EA and FONSI referenced in this document are available on
November 29, 2021.
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 purchase 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. (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 29, 2021, as supplemented by letter dated August 20,
2021, 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 50.34,
``Contents of applications; technical information.'' The amendment
would authorize the receipt and possession of certain radioactive
materials necessary for the continued construction of the SHINE
facility.
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 authorize SHINE to receive and possess the radioactive materials of
natural uranium, depleted uranium, and americium-241/beryllium (AmBe),
which are necessary for the continued construction of the SHINE
facility in Rock County, Wisconsin. The proposed action is requested in
the licensee's application dated April 29, 2021, as supplemented by
letter dated August 20, 2021.
Need for the Proposed Action
The radioactive materials described in the licensee's application
are byproduct and source materials required for the continued
construction of the SHINE facility and would be installed within the
facility's tritium purification system and subcritical assembly
systems. The licensee's request to receive and possess these byproduct
and source materials is in accordance with applicable provisions in 10
CFR part 30, ``Rules of General Applicability to Domestic Licensing of
Byproduct Material,'' and 10 CFR part 40, ``Domestic Licensing of
Source Material,'' respectively. Specifically, SHINE requested to
receive and possess the source material of natural uranium in the form
of neutron multipliers; the source material of depleted uranium in the
form of tritium storage beds; and the byproduct material of AmBe sealed
neutron sources. The natural uranium would be contained within neutron
multipliers, as described in Subsection 4a2.2.6 of the SHINE Final
Safety Analysis Report (FSAR), for installation within the subcritical
assembly systems. The depleted uranium would be contained within
tritium storage beds, as described in Subsection 9a2.7.1 of the SHINE
FSAR, for installation within the tritium purification system. The AmBe
sealed neutron sources would be used as subcritical multiplication
sources, as described in Subsection 4a2.2.4 of the SHINE FSAR, for
installation within the subcritical assembly systems.
The NRC regulations in 10 CFR part 30 and 10 CFR part 40 contain
requirements for the receipt, possession, use, and transfer of
byproduct material and source material, respectively.
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.
As an initial matter, the proposed action would amend the SHINE
construction permit to authorize the receipt and possession of
byproduct and source materials necessary for continued construction of
the SHINE facility in accordance with applicable provisions in 10 CFR
parts 30 and 40, which ensure the safety of such receipt and
possession. Thus, before the NRC could approve the proposed action, it
would have to conclude that the applicable provision in 10 CFR parts 30
and 40 are satisfied.
Additionally, the NRC previously evaluated the environmental
impacts associated with constructing, operating, and decommissioning
the SHINE facility in NUREG-2183, ``Environmental Impact Statement for
the Construction Permit for the SHINE Medical Radioisotope Production
Facility,'' dated October 2015. The licensee is also required to comply
with occupational dose limits (10 CFR part
[[Page 67739]]
20, subpart C) and radiation dose limits for individual members of the
public (10 CFR part 20, subpart D) at all times.
As provided in the application, the proposed amendment authorizing
the receipt and possession of the requested byproduct and source
materials would not change the types or amounts of radioactive
materials in effluents, wastes, and products of the SHINE facility, nor
would it increase the probability of accidents. The requested materials
would be received and securely stored in an access-controlled area
prior to installation into the tritium purification system and the
subcritical assembly systems. SHINE would inspect, inventory, and place
the requested materials into secure storage in accordance with the
requirements of 10 CFR 20.1902, ``Posting requirements.'' Shielding
would be used as appropriate to minimize radiation exposure of
personnel while the requested materials are in storage in accordance
with 10 CFR 20.1201, ``Occupational dose limits for adults.'' The
requested materials would be in the form of sealed sources or solids
contained within enclosed components that do not present contamination
or accidental release hazards. Finally, the application provided that
the receipt and possession of the requested materials would not result
in the generation of radiological waste.
Additionally, the application provided that there would be no new
or substantially different radiological hazards resulting from the
receipt and possession of the requested byproduct and source materials
as compared to the construction-related radiological hazards discussed
in Section 4.8.1.1, ``Radiological,'' of NUREG-2183. In NUREG-2183, the
NRC staff determined that SHINE has adequate controls in place to
ensure that the dose to workers and the public from radioactive
materials is within the dose limits of 10 CFR part 20, including a
radiation safety program.
The transportation of the requested byproduct and source materials
would be required to adhere to the applicable regulatory packaging and
transportation requirements in NRC regulations (10 CFR parts 20, 40,
and 71), the State of Wisconsin Administrative Code Chapter 326,
``Transportation,'' and Department of Transportation requirements (49
CFR parts 172 and 173).
Based on the above, the NRC staff concludes that the proposed
action would not have significant radiological human health impacts.
Nonradiological impacts to human health of the construction,
operation, and decommissioning of the SHINE facility were previously
assessed in Section 4.8.1.2 of NUREG-2183. The application provided
that the proposed amendment would not result in any new or
substantially different nonradiological hazards resulting from the
receipt and possession of the requested byproduct and source materials;
therefore, the NRC staff concludes that nonradiological impacts during
construction would remain small.
The proposed action would result in no additional direct impacts on
land use or water resources, including terrestrial and aquatic biota,
because the proposed action involves no new construction or
modification of SHINE facility operational systems previously assessed
in NUREG-2183. For this same reason, there would be no changes to the
types or quantity of nonradiological effluents previously assessed in
NUREG-2183 and, therefore, no changes to the facility's Wisconsin
Pollutant Discharge Elimination System permit are needed. Similarly,
there would be no changes in ambient air quality, no noticeable effect
on socioeconomic conditions in the region, no environmental justice
impacts, and no impacts to historic and cultural resources. Therefore,
the NRC staff concludes that there would be no significant
nonradiological 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 license 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, 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.
Agencies and Persons Consulted
No additional agencies or persons were consulted regarding the
environmental impact of the proposed action. On November 15, 2021, 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 authorize SHINE to receive and
possess certain source and byproduct materials necessary for the
continued construction of the SHINE facility in Rock County, Wisconsin.
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 nonradiological
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 29, 2021, as supplemented by
letter dated August 20, 2021, the related environmental document is
NUREG-2183. NUREG-2183 provides the latest environmental review of the
construction, operation, and decommissioning of the SHINE facility and
description of the environmental conditions at the SHINE facility.
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, 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.
[[Page 67740]]
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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.
Construction Permit No. CPMIF-001 for the SHINE ML16041A473.
Medical Isotope Production Facility, dated
February 29, 2016.
SHINE Medical Technologies, LLC's Revisions to ML21095A226.
Final Safety Analysis Report, Chapter 4,
Irradiation Unit and Radioisotope Production
Facility Description, Rev. 1, dated March 23,
2021.
SHINE Medical Technologies, LLC's Revisions to ML21095A225.
Final Safety Analysis Report, Chapter 9,
Auxiliary Systems, Rev. 0, dated March 23, 2021.
SHINE Medical Technologies, LLC, Request to ML21119A165 (Package).
Amend Construction Permit No. CPMIF-001, dated
April 29, 2021.
SHINE Medical Technologies, LLC, Request to ML21242A028 (Package).
Amend Construction Permit No. CPMIF-001
Response to Request for Additional Information,
dated August 20, 2021.
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Dated: November 23, 2021.
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. 2021-25911 Filed 11-26-21; 8:45 am]
BILLING CODE 7590-01-P