SHINE Medical Technologies, LLC; SHINE Medical Isotope Production Facility, 67737-67740 [2021-25911]
Download as PDF
<![CDATA[
Federal Register / Vol. 86, No. 226 / Monday, November 29, 2021 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
risk significance of the material being
protected. Unirradiated reactor fuel
brought onsite at nuclear power reactors
typically constitutes a Category III
quantity of SNM. Because of its low
enrichment, unirradiated reactor fuel
poses no significant risk to public health
and safety and protecting it in
accordance with § 73.67 would not be
inimical to the common defense and
security. The NRC has determined that
it is appropriate to protect unirradiated
reactor fuel and other non-fuel SNM
brought onsite at an NRC-licensed
commercial nuclear power reactor in
accordance with § 73.67. Therefore,
requiring SNC to implement the
requirements of §§ 73.55 and 73.56 to
protect unirradiated reactor fuel and
other non-fuel SNM that is already
being adequately protected in
accordance with the requirements of
§ 73.67 is an unnecessary burden on
SNC.
Based on the above, the NRC finds
that the exemption is otherwise in the
public interest.
D. Environmental Considerations
As further discussed, the NRC has
determined that granting this exemption
from the requirements of §§ 73.55(a)(4)
and 73.56(a)(3) meets the criteria for a
categorical exclusion in 10 CFR
51.22(c)(25) because (i) there is no
significant hazards consideration, (ii)
there is no significant change in the
types or significant increase in the
amounts of any effluents that may be
released offsite, (iii) there is no
significant increase in individual or
cumulative public or occupational
radiation exposure, (iv) there is no
significant construction impact, (v)
there is no significant increase in the
potential for or consequences from
radiological accidents, and (vi) the
exemption is from scheduling
requirements.
The granting of this exemption
involves no significant hazards
consideration (as defined by 10 CFR
50.92(c)) because:
• The exemption does not alter the
design, function, or operation of any
plant equipment; therefore, granting the
exemption would not involve a
significant increase in the probability or
consequences of an accident previously
evaluated.
• The exemption does not alter the
design, function, or operation of any
plant equipment or create any new
failure mechanisms, malfunctions, or
accident initiators. Therefore, granting
the exemption would not create the
possibility of a new or different kind of
accident from any accident previously
evaluated.
VerDate Sep<11>2014
16:55 Nov 26, 2021
Jkt 256001
• The exemption does not adversely
affect any structure, system, or
component (SSC), SSC design function,
or method of performing or controlling
a design function. The exemption does
not affect safety-related equipment or
fission product barriers. No safety
analysis or design basis acceptance limit
or criterion is challenged or exceeded by
the exemption. Therefore, granting the
exemption would not involve a
significant reduction in a margin of
safety.
The requested exemption does not
alter the design, function, or operation
of any plant equipment, and there are
no changes to effluent types, plant
radiological or non-radiological effluent
release quantities, any effluent release
path, or the functionality of any design
or operational feature credited with
controlling the release of effluents
during plant operation or construction.
Therefore, the proposed exemption does
not involve a significant change in the
types or significant increase in the
amounts of any effluents that may be
released offsite.
There are no changes to plant
radiation zones, nor any change to
controls required under 10 CFR part 20
that preclude a significant increase in
individual or cumulative public or
occupational radiation exposure.
Therefore, the proposed exemption does
not involve a significant increase in
individual or cumulative public or
occupational radiation exposure.
The requested exemption does not
alter the materials or methods for
constructing or testing of any SSCs, and
there is no change to the design or
construction of the facility as a result of
this exemption. Therefore, the proposed
exemption does not involve a significant
construction impact.
Finally, the NRC determined, per
§ 51.22(c)(25)(vi)(G), that the
requirements from which the exemption
is sought involve scheduling
requirements because 10 CFR
73.55(a)(4) and 73.56(a)(3) govern when
the requirements of 10 CFR 73.55 and
73.56 must be implemented.
Accordingly, the exemption meets the
eligibility criteria for categorical
exclusion set forth in § 51.22(c)(25).
Therefore, in accordance with
§ 51.22(b), no environmental impact
statement or environmental assessment
need be prepared in connection with
granting the requested exemption.
IV. Granting of Exemption
For the reasons stated in this notice,
the Commission is granting the
following exemption for VEGP Units 3
and 4 because it has determined,
pursuant to § 73.5, that the exemption is
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
67737
authorized by law, will not endanger
life or property or the common defense
and security, and is otherwise in the
public interest:
• Effective immediately, the
Commission hereby grants SNC an
exemption for VEGP Unit 3 from the
schedule requirements of §§ 73.55(a)(4)
and 73.56(a)(3) to allow SNC to
implement the physical protection
requirements in accordance with
§ 73.55, and the personnel access
authorization requirements in
accordance with § 73.56, after the
Commission makes its finding under
§ 52.103(g) for Unit 3 and prior to the
start of Unit 3’s initial fuel load into the
reactor. The exemption for VEGP Unit 3
expires when SNC implements the
requirements of 10 CFR 73.55 and 10
CFR 73.56 for VEGP Unit 3, which must
occur before initial fuel load for VEGP
Unit 3.
• Effective immediately, the
Commission hereby grants SNC an
exemption for VEGP Unit 4 from the
schedule requirements of §§ 73.55(a)(4)
and 73.56(a)(3) to allow SNC to
implement the physical protection
requirements in accordance with
§ 73.55, and the personnel access
authorization requirements in
accordance with § 73.56, after the
Commission makes its finding under
§ 52.103(g) for Unit 4 and prior to the
start of Unit 4’s initial fuel load into the
reactor. The exemption for VEGP Unit 4
expires when SNC implements the
requirements of 10 CFR 73.55 and 10
CFR 73.56 for VEGP Unit 4, which must
occur before initial fuel load for VEGP
Unit 4.
For the Nuclear Regulatory Commission.
Dated: November 23, 2021.
Gregory T. Bowman,
Director, Vogtle Project Office, Office of
Nuclear Reactor Regulation.
[FR Doc. 2021–25952 Filed 11–26–21; 8:45 am]
BILLING CODE 7590–01–P
NUCLEAR REGULATORY
COMMISSION
[Docket No. 50–608; NRC–2021–0140]
SHINE Medical Technologies, LLC;
SHINE Medical Isotope Production
Facility
Nuclear Regulatory
Commission.
ACTION: Environmental assessment and
finding of no significant impact;
issuance.
AGENCY:
The U.S. Nuclear Regulatory
Commission (NRC) is issuing an
environmental assessment (EA) and
SUMMARY:
E:\FR\FM\29NON1.SGM
29NON1
khammond on DSKJM1Z7X2PROD with NOTICES
67738
Federal Register / Vol. 86, No. 226 / Monday, November 29, 2021 / Notices
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:
Stacy.Schumann@nrc.gov. 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
PDR.Resource@nrc.gov. 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 PDR.Resource@nrc.gov
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
VerDate Sep<11>2014
16:55 Nov 26, 2021
Jkt 256001
Regulatory Commission, Washington,
DC 20555–0001, telephone: 301–415–
2856; email: Michael.Balazik@nrc.gov.
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
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
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
E:\FR\FM\29NON1.SGM
29NON1
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 226 / Monday, November 29, 2021 / Notices
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
VerDate Sep<11>2014
16:55 Nov 26, 2021
Jkt 256001
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 ‘‘noaction’’ 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
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
67739
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
PDR.Resource@nrc.gov.
IV. Availability of Documents
The documents identified in the
following table are available to
interested persons through ADAMS, as
indicated.
E:\FR\FM\29NON1.SGM
29NON1
67740
Federal Register / Vol. 86, No. 226 / Monday, November 29, 2021 / Notices
Document
ADAMS accession No.
NUREG–2183, Environmental Impact Statement for the Construction Permit for the SHINE Medical Radioisotope
Production Facility, dated October, 2015.
Construction Permit No. CPMIF–001 for the SHINE Medical Isotope Production Facility, dated February 29, 2016
SHINE Medical Technologies, LLC’s Revisions to 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 Final Safety Analysis Report, Chapter 9, Auxiliary Systems,
Rev. 0, dated March 23, 2021.
SHINE Medical Technologies, LLC, Request to Amend Construction Permit No. CPMIF–001, dated April 29, 2021
SHINE Medical Technologies, LLC, Request to Amend Construction Permit No. CPMIF–001 Response to Request
for Additional Information, dated August 20, 2021.
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
NUCLEAR REGULATORY
COMMISSION
[NRC–2021–0001]
Sunshine Act Meetings
Weeks of November 29,
December 6, 13, 20, 27, 2021, January 3,
2022.
PLACE: Commissioners’ Conference
Room, 11555 Rockville Pike, Rockville,
Maryland.
STATUS: Public.
MATTERS TO BE CONSIDERED:
TIME AND DATE:
Week of November 29, 2021
There are no meetings scheduled for
the week of November 29, 2021.
Week of December 6, 2021—Tentative
khammond on DSKJM1Z7X2PROD with NOTICES
Tuesday, December 7, 2021
10:00 a.m. Briefing on Equal
Employment Opportunity,
Affirmative Employment, and Small
Business (Public Meeting) (Contact:
Larniece McKoy Moore: 301–415–
1942)
Additional Information: The public is
invited to attend the Commission’s
meeting live by webcast at the Web
address—https://video.nrc.gov/. For
those who would like to attend in
person, note that all visitors are required
to complete the NRC Self-Health
Assessment and Certification of
Vaccination forms. Visitors who certify
that they are not fully vaccinated or
decline to complete the certification
must have proof of a negative Food and
Drug Administration-approved
polymerase chain reaction (PCR) or
Antigen (including rapid tests) COVID–
VerDate Sep<11>2014
16:55 Nov 26, 2021
Jkt 256001
19 test specimen collection from no
later than the previous 3 days prior to
entry to an NRC facility. The forms and
additional information can be found
here https://www.nrc.gov/about-nrc/
covid-19/guidance-for-visitors-to-nrcfacilities.pdf.
Thursday, December 9, 2021
9:00 a.m. Briefing on 10 CFR part 53
Licensing and Regulations of
Advanced Nuclear Reactors (Public
Meeting) (Contact: Donna Williams:
301–415–1322)
Additional Information: The public is
invited to attend the Commission’s
meeting live by webcast at the Web
address—https://video.nrc.gov/. For
those who would like to attend in
person, note that all visitors are required
to complete the NRC Self-Health
Assessment and Certification of
Vaccination forms. Visitors who certify
that they are not fully vaccinated or
decline to complete the certification
must have proof of a negative Food and
Drug Administration-approved PCR or
Antigen (including rapid tests) COVID–
19 test specimen collection from no
later than the previous 3 days prior to
entry to an NRC facility. The forms and
additional information can be found
here https://www.nrc.gov/about-nrc/
covid-19/guidance-for-visitors-to-nrcfacilities.pdf.
Week of December 13, 2021—Tentative
There are no meetings scheduled for
the week of December 13, 2021.
Week of December 20, 2021—Tentative
There are no meetings scheduled for
the week of December 20, 2021.
ML15288A046.
ML16041A473.
ML21095A226.
ML21095A225.
ML21119A165 (Package).
ML21242A028 (Package).
Wesley.Held@nrc.gov. The schedule for
Commission meetings is subject to
change on short notice.
The NRC Commission Meeting
Schedule can be found on the internet
at: https://www.nrc.gov/public-involve/
public-meetings/schedule.html.
The NRC provides reasonable
accommodation to individuals with
disabilities where appropriate. If you
need a reasonable accommodation to
participate in these public meetings or
need this meeting notice or the
transcript or other information from the
public meetings in another format (e.g.,
braille, large print), please notify Anne
Silk, NRC Disability Program Specialist,
at 301–287–0745, by videophone at
240–428–3217, or by email at
Anne.Silk@nrc.gov. Determinations on
requests for reasonable accommodation
will be made on a case-by-case basis.
Members of the public may request to
receive this information electronically.
If you would like to be added to the
distribution, please contact the Nuclear
Regulatory Commission, Office of the
Secretary, Washington, DC 20555, at
301–415–1969, or by email at
Tyesha.Bush@nrc.gov or Betty.Thweatt@
nrc.gov.
The NRC is holding the meetings
under the authority of the Government
in the Sunshine Act, 5 U.S.C. 552b.
Dated: November 24, 2021.
For the Nuclear Regulatory Commission.
Wesley W. Held,
Policy Coordinator, Office of the Secretary.
[FR Doc. 2021–26015 Filed 11–24–21; 11:15 am]
BILLING CODE 7590–01–P
Week of December 27, 2021—Tentative
NUCLEAR REGULATORY
COMMISSION
There are no meetings scheduled for
the week of December 27, 2021.
[Docket Nos. 52–025 and 52–026; NRC–
2008–0252]
Week of January 3, 2022—Tentative
There are no meetings scheduled for
the week of January 3, 2022.
Southern Nuclear Operating Company,
Inc.; Vogtle Electric Generating Plant
Units 3 and 4
CONTACT PERSON FOR MORE INFORMATION:
AGENCY:
For more information or to verify the
status of meetings, contact Wesley Held
at 301–287–3591 or via email at
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
Nuclear Regulatory
Commission.
ACTION: Exemption; issuance.
E:\FR\FM\29NON1.SGM
29NON1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]c.gov. 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]]
------------------------------------------------------------------------
Document ADAMS accession No.
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
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
