[Federal Register Volume 88, Number 220 (Thursday, November 16, 2023)]
[Rules and Regulations]
[Pages 80050-80078]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25163]
[[Page 80049]]
Vol. 88
Thursday,
No. 220
November 16, 2023
Part III
Nuclear Regulatory Commission
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10 CFR Parts 50, 52, and 72
Emergency Preparedness for Small Modular Reactors and Other New
Technologies; Final Rule
Federal Register / Vol. 88 , No. 220 / Thursday, November 16, 2023 /
Rules and Regulations
[[Page 80050]]
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NUCLEAR REGULATORY COMMISSION
10 CFR Parts 50, 52, and 72
[NRC-2015-0225]
RIN 3150-AJ68
Emergency Preparedness for Small Modular Reactors and Other New
Technologies
AGENCY: Nuclear Regulatory Commission.
ACTION: Final rule and guidance; issuance.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is amending its
regulations to include new alternative emergency preparedness
requirements for small modular reactors and other new technologies.
This final rule acknowledges technological advancements and other
differences from large light-water reactors that are inherent in small
modular reactors and other new technologies. The NRC is concurrently
issuing Regulatory Guide 1.242, ``Performance-Based Emergency
Preparedness for Small Modular Reactors, Non-Light-Water Reactors, and
Non-Power Production or Utilization Facilities.''
DATES: This final rule is effective on December 18, 2023.
ADDRESSES: Please refer to Docket ID NRC-2015-0225 when contacting the
NRC about the availability of information for this action. You may
obtain publicly available information related to this action by any of
the following methods:
Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2015-0225. Address
questions about NRC dockets to Dawn Forder; telephone: 301-415-3407;
email: [email protected]. For technical questions, contact the
individuals 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, at 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: The PDR, where you may examine and order copies
of publicly available documents, is open by appointment. 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
a.m. and 4 p.m. eastern time, Monday through Friday, except Federal
holidays.
FOR FURTHER INFORMATION CONTACT: Robert Beall, Office of Nuclear
Material Safety and Safeguards, telephone: 301-415-3874, email:
[email protected] and Eric Schrader, Office of Nuclear Security and
Incident Response, telephone: 301-287-3789, email:
[email protected]. Both are staff of the U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001.
SUPPLEMENTARY INFORMATION:
Executive Summary
A. Need for the Regulatory Action
Certain existing requirements and guidance are focused on large
light-water reactors (LWRs) and currently operating non-power reactors
(also referred to as research and test reactors), as defined in part 50
of title 10 of the Code of Federal Regulations (10 CFR), ``Domestic
Licensing of Production and Utilization Facilities.'' Through this
final rule, the NRC is amending its regulations to create an
alternative emergency preparedness (EP) framework for small modular
reactors (SMRs) and other new technologies (ONTs). These new
alternative EP requirements and implementing guidance in Regulatory
Guide 1.242 adopt a performance-based, technology-inclusive, risk-
informed, and consequence-oriented approach. The new alternative EP
requirements (1) continue to provide reasonable assurance that adequate
protective measures can and will be implemented by an SMR or ONT
licensee; (2) promote regulatory stability, predictability, and
clarity; (3) reduce the need for requests for exemptions from EP
requirements; (4) recognize advances in design and technological
advancements embedded in design features; (5) credit safety
enhancements in evolutionary and passive systems; and (6) credit the
potential benefits of smaller sized reactors and non-LWRs associated
with postulated accidents, including slower transient response times,
and relatively small and slow release of fission products. This final
rule and guidance could affect existing SMR and non-LWR applicants and
licensees as well as SMRs, non-LWRs, and non-power production or
utilization facilities that would be licensed after the effective date
of this final rule. Those applicants and licensees have the option to
develop a performance-based EP program as an alternative to using the
existing, deterministic EP requirements in 10 CFR part 50. This final
rule does not include within its scope emergency planning, preparation,
or response for large LWRs, fuel cycle facilities,\1\ or currently
operating non-power reactors. For the purposes of this final rule,
large LWRs are reactors that are licensed to produce greater than 1,000
megawatts thermal power.
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\1\ Emergency planning requirements for facilities licensed
under 10 CFR part 70, ``Domestic Licensing of Special Nuclear
Material,'' are set forth in Sec. 70.22(i).
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B. Major Provisions
Major provisions of this final rule and guidance include the
addition of:
A new alternative performance-based EP framework,
including requirements for demonstrating effective response in drills
and exercises for emergency and accident conditions;
A requirement for a hazard analysis of any facility
contiguous to or near an SMR or ONT, that considers any hazard that
would adversely impact the implementation of emergency plans developed
under this framework;
A scalable approach for determining the size of the plume
exposure pathway emergency planning zone; and
A requirement to describe ingestion response planning in
the emergency plan, including the offsite capabilities and resources
available to prevent contaminated food and water from entering the
ingestion pathway.
C. Costs and Benefits
The NRC prepared a final regulatory analysis of the expected
quantitative costs and benefits of this final rule and associated
guidance as well as the qualitative factors considered in the NRC's
rulemaking decision. The conclusion from the analysis is that this
final rule and associated guidance result in net averted costs to the
industry and the NRC ranging from $7.98 million using a 7-percent
discount rate to $14.9 million using a 3-percent discount rate.
The regulatory analysis considered qualitative aspects, such as
greater regulatory stability, predictability, and clarity to the
licensing process. These benefits result from applicants and licensees
not needing to use the exemption process to establish EP criteria
commensurate with design- and site-specific considerations. Another
[[Page 80051]]
qualitative consideration is promoting a performance-based regulatory
framework that specifies requirements to be met and provides
flexibility to an applicant or licensee regarding the information or
approach needed to satisfy those requirements.
For more information, the final regulatory analysis is available as
indicated in the ``Availability of Documents'' section of this
document.
Table of Contents
I. Background
II. Discussion
III. Opportunities for Public Participation
IV. Public Comment Analysis
V. Section-by-Section Analysis
VI. Regulatory Flexibility Certification
VII. Regulatory Analysis
VIII. Backfitting and Issue Finality
IX. Cumulative Effects of Regulation
X. Plain Writing
XI. Environmental Assessment and Final Finding of No Significant
Environmental Impact
XII. Paperwork Reduction Act
XIII. Congressional Review Act
XIV. Criminal Penalties
XV. Voluntary Consensus Standards
XVI. Availability of Guidance
XVII. Availability of Documents
I. Background
In December 2016, the NRC developed and published ``NRC Vision and
Strategy: Safely Achieving Effective and Efficient Non-Light Water
Reactor Mission Readiness,'' with a goal to further develop the NRC's
non-light-water reactor (non-LWR) regulatory, technical, and policy
infrastructure to be ready to review potential licensing applications
for non-LWR technologies. This final rule contributes to the NRC's
efforts to optimize non-LWR regulatory readiness. In particular, the
NRC's objective for this final rule is to create alternative emergency
preparedness (EP) requirements that: (1) continue to provide reasonable
assurance that adequate protective measures can and will be implemented
by a small modular reactor (SMR) or other new technology (ONT)
licensee; (2) promote regulatory stability, predictability, and
clarity; (3) reduce the need for requests for exemptions from EP
requirements; (4) recognize advances in design and technology
advancements embedded in design features; (5) credit safety
enhancements in evolutionary and passive systems; and (6) credit the
potential benefits of smaller sized reactors and non-LWRs associated
with postulated accidents, including slower transient response times,
and relatively small and slow release of fission products.
Within the SUPPLEMENTARY INFORMATION section of this document, the
NRC uses the term ``ONTs'' to refer to new technologies, such as non-
LWRs and medical radioisotope facilities licensed under part 50 of
title 10 of the Code of Federal Regulations (10 CFR). Further, within
this document, the NRC uses the term ``existing'' or ``current'' in the
context of the NRC's regulations to mean the requirements in Sec.
50.47, ``Emergency plans,'' and appendix E to 10 CFR part 50,
``Emergency Planning and Preparedness for Production and Utilization
Facilities,'' before December 18, 2023 and, when referring to
applicants or licensees for an SMR or ONT facility, to mean applicants
or licensees for an SMR or ONT facility as of December 18, 2023.
This final rule also defines ``non-power production or utilization
facility'' (NPUF) to clarify the applicability of the performance-based
EP framework. The definition includes production or utilization
facilities, licensed under Sec. 50.21(a), Sec. 50.21(c), or Sec.
50.22, as applicable, that are not nuclear power reactors or production
facilities as defined under paragraphs (1) and (2) of the definition of
Production facility in Sec. 50.2. In the context of this final rule,
medical radioisotope facilities licensed under 10 CFR part 50 are
included within this definition of NPUF. The term ``non-power
production or utilization facility'' is used in this final rule to
distinguish between those medical radioisotope facilities licensed as
production or utilization facilities under 10 CFR part 50 and other
facilities to be used for the production of medical radioisotopes
licensed under the regulations in 10 CFR parts 30, ``Rules of General
Applicability to Domestic Licensing of Byproduct Material,'' 40,
``Domestic Licensing of Source Material,'' and 70, ``Domestic Licensing
of Special Nuclear Material.'' Those facilities licensed under 10 CFR
parts 30, 40, or 70 are subject to existing emergency planning
requirements in those parts. Relevant 10 CFR part 70 fuel facility
emergency planning considerations (e.g., inadvertent criticality
accidents and hazardous chemical exposures) applicable to 10 CFR part
50 production facilities have been incorporated into this final rule
and associated guidance. As such, the scope of this final rule is
limited to those ONT facilities (e.g., non-LWRs licensed as power
reactors, new non-power reactors, and medical radioisotope facilities)
for which the NRC expects to receive license applications under 10 CFR
parts 50 or 52, ``Licenses, Certifications, and Approvals for Nuclear
Power Plants.'' Those NPUFs that are not considered ONTs (i.e.,
currently operating non-power reactors) are not within the scope of
this final rule. Currently operating non-power reactors continue to
implement existing emergency planning requirements and guidance.
A. Existing Emergency Preparedness Framework for Nuclear Power Reactors
Appendix E to 10 CFR part 50 identifies the specific items
currently required to be included in emergency plans. Additionally,
Sec. 50.47 provides EP requirements for nuclear power reactors,
including planning standards for onsite and offsite emergency response
plans. Other relevant regulations include paragraphs (q), (s), and (t)
of Sec. 50.54, ``Conditions of licenses.''
For large LWRs, the most notable guidance documents for the
development and maintenance of emergency plans are: NUREG-0654/FEMA-
REP-1, Revision 1, ``Criteria for Preparation and Evaluation of
Radiological Emergency Response Plans and Preparedness in Support of
Nuclear Power Plants,'' dated November 1980, which provides guidance
and evaluation criteria for the development and evaluation of operating
power reactors' and offsite response organizations' (OROs) radiological
emergency response plans; NUREG-0654/FEMA-REP-1, Revision 2, ``Criteria
for Preparation and Evaluation of Radiological Emergency Response Plans
and Preparedness in Support of Nuclear Power Plants,'' dated December
2019, which reflects changes to NRC regulations, guidance, and
policies, as well as advances in technology and best practices that
occurred since issuance of the 1980 version; Regulatory Guide (RG)
1.219, Revision 1, ``Guidance on Making Changes to Emergency Plans for
Nuclear Power Reactors,'' dated July 2016, which provides guidance for
operating power reactor licensees implementing requirements in Sec.
50.54(q) for evaluating and making changes to emergency plans; NUREG-
0800, ``Standard Review Plan for the Review of Safety Analysis Reports
for Nuclear Power Plants: LWR Edition,'' Section 13.3, ``Emergency
Planning,'' dated March 2007, which provides the criteria that the NRC
uses in reviewing applicants' emergency plans as described in the
applications' safety analysis reports; and NUREG-0800, Section 14.3.10,
``Emergency Planning--Inspections, Tests, Analyses, and Acceptance
Criteria,'' dated March 2007, which provides the criteria that the NRC
uses in reviewing 10 CFR part 52 applicants' proposed inspections,
tests, and analyses applicable to emergency planning that the licensee
performs, and the associated acceptance
[[Page 80052]]
criteria. This regulatory framework has defined the EP programs for the
current operating fleet of power reactors for several decades. These
standards have been effectively used in practice and provided a basis
to draw from in developing this EP regulatory framework for SMRs and
ONTs.
Currently, applicants for light-water SMR licenses can use the
guidance used by large LWRs described in the preceding paragraph.
Applicants for non-LWR licenses can use NUREG-0654/FEMA-REP-1, Revision
1 or 2; RG 1.219, Revision 1; and RG 1.233, Revision 0, ``Guidance for
a Technology-Inclusive, Risk-Informed, and Performance-Based
Methodology to Inform the Licensing Basis and Content of Applications
for Licenses, Certifications, and Approvals for Non-Light-Water
Reactors,'' which provides guidance on the selection of licensing-basis
events; classification and special treatments of structures, systems,
and components; and assessment of defense in depth.
B. Existing Emergency Preparedness Framework for Non-Power Production
or Utilization Facilities
The EP requirements applicable to a particular applicant or
licensee can vary depending on the type of facility. In the August 19,
1980, final rule, ``Emergency Planning'' (45 FR 55402) (referred to
herein as the ``1980 Final Rule''), the NRC established in appendix E
to 10 CFR part 50 emergency planning requirements for research and test
reactors (RTRs) that reflected the lower potential radiological hazards
associated with these facilities. The RTRs and other NPUFs must meet
the emergency planning requirements of Sec. Sec. 50.34(a)(10),
50.34(b)(6)(v), and 50.54(q) and appendix E to 10 CFR part 50. The
requirements of Sec. 50.47 do not apply to RTRs and other NPUFs.
Additionally, in section I.3. of appendix E to 10 CFR part 50, the NRC
differentiates between emergency planning requirements for nuclear
power reactors and those for other facilities, stating that the size of
emergency planning zones (EPZs) and the degree to which compliance with
sections I through V of appendix E to 10 CFR part 50 is necessary are
determined on a case-by-case basis for facilities other than power
reactors.
Further, footnote 2 of appendix E to 10 CFR part 50 provides that
RG 2.6, ``Emergency Planning for Research and Test Reactors,'' is used
as guidance for the acceptability of RTR emergency response plans.
Regulatory Guide 2.6 was initially issued in January 1979 and most
recently updated to Revision 2, ``Emergency Planning for Research and
Test Reactors and Other Non-power Production and Utilization
Facilities,'' in September 2017. Consistent with the radiological risks
associated with operating power levels between 5 watts thermal and 20
megawatts thermal (MWt) for currently operating RTRs, RG 2.6, Revision
2 endorses the use of the emergency planning guidance based on source
term and power level contained in American National Standards Institute
(ANSI) and American Nuclear Society (ANS) standard ANSI/ANS-15.16-2015,
``Emergency Planning for Research Reactors.'' Similarly, RG 2.6,
Revision 2 endorses the use of ANSI/ANS-15.16-2015 for other NPUFs. The
ANSI/ANS-15.16, originally developed in 1982, and updated in 2008 and
2015, provides specific criteria and guidance for RTRs to comply with
the applicable requirements set forth in Sec. Sec. 50.34, ``Contents
of applications; technical information,'' and 50.54, and appendix E to
10 CFR part 50.
In October 1983, the NRC issued NUREG-0849, ``Standard Review Plan
for the Review and Evaluation of Emergency Plans for Research and Test
Reactors.'' Consistent with ANSI/ANS-15.16, NUREG-0849 provides areas
of review, planning standards, and evaluation items for the NRC to
evaluate compliance with the applicable emergency planning
requirements, previously described. Notably, the guidance contained in
both ANSI/ANI-15.16 and NUREG-0849 addresses EPZs for RTRs ranging from
the operations boundary \2\ to 800 meters from the operations boundary
for facilities up to 50 MWt. Both guidance documents state that the
EPZs for facilities operating above 50 MWt are to be considered on a
case-by-case basis. Section 12.7, ``Emergency Planning,'' of the non-
power reactor standard review plan, NUREG-1537, Parts 1 and 2,
``Guidelines for Preparing and Reviewing Applications for the Licensing
of Non-power Reactors'' and the Interim Staff Guidance augmenting
NUREG-1537, Parts 1 and 2, for the licensing of radioisotope production
facilities and aqueous homogeneous reactors provide additional
emergency planning considerations for NPUFs. For example, this
additional guidance includes relevant radioisotope production facility
emergency planning considerations (e.g., hazardous chemicals) contained
in the Interim Staff Guidance augmenting NUREG-1537 based on NUREG-
1520, Revision 1, ``Standard Review Plan for the Review of a License
Application for a Fuel Cycle Facility.''
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\2\ As defined in ANSI/ANS-15.16-2015, ``operations boundary''
refers to the area within the site boundary such as the reactor
building (or the nearest physical personnel barrier in cases where
the reactor building is not a principal physical personnel barrier)
where the reactor chief administrator has direct authority over all
activities.
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These criteria and guidance provide a basis for NPUF applicants and
licensees to develop acceptable emergency response plans for their
facilities. This existing regulatory framework for EP at NPUFs provides
the planning necessary to reflect the lower potential radiological
hazards associated with the operation of these facilities compared to
large LWRs. These EP standards provide additional information for
developing the consequence-oriented approach to establishing EPZs and
the planning commensurate with the radiological risk for SMRs and ONTs.
C. Evolution of the Emergency Preparedness Regulatory Framework for
Small Modular Reactors and Other New Technologies
The use and regulation of small reactors and other advanced reactor
designs have been active topics of discussion between the NRC and the
nuclear reactor industry for more than 30 years. The NRC has worked
with stakeholders to develop an initial framework for the
implementation of performance-based EP regulations and licensing of
non-LWR designs, culminating in the current EP rulemaking activities.
This section describes the history of small and advanced reactor
designs that led to this final rule.
1. Emerging Interest in Advanced Nuclear Reactor Technology
Concurrent with large LWR deployment and design evolution, the
United States and other countries have developed and promoted several
different reactor designs that are either light-water SMRs with passive
safety features or reactors that do not use light-water as a coolant.
This latter category is commonly referred to as non-LWR technology.
Advanced designs using non-LWR technology include liquid-metal-cooled
reactors, gas-cooled reactors, and molten-salt-cooled reactors. These
advanced designs could have a rated thermal power ranging from low to
very high and may apply modular construction concepts.
As advanced reactor technology evolved in the 1980s and early
1990s, the NRC considered the prospect of a regulatory regime for these
emerging technologies. On July 8, 1986, the Commission issued a policy
statement, ``Regulation of Advanced Nuclear Power Plants, Statement of
Policy'' (51 FR
[[Page 80053]]
24643), outlining the Commission's early thoughts on the regulation of
advanced reactor designs. In the policy statement, the Commission
provided a high-level framework for the review and consideration of
advanced reactor designs. Following issuance of the policy statement,
the NRC published NUREG-1226, ``Development and Utilization of the NRC
Policy Statement on the Regulation of Advanced Nuclear Power Plants''
in June 1988 to provide guidance on implementing and utilizing the
policy statement. With the issuance of this initial guidance came
questions concerning EP requirements for such designs.
In response, the NRC staff proposed in SECY-93-092, ``Issues
Pertaining to the Advanced Reactor (PRISM, MHTGR, and PIUS) and CANDU 3
Designs and Their Relationship to Current Regulatory Requirements,''
\3\ dated April 8, 1993, that no change to existing EP regulations for
advanced reactors was then needed. The NRC staff noted that regulatory
direction would be given at or before the start of the design
certification phase of advanced reactors so that design implications
for EP could be addressed in the licensing process.
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\3\ ``PRISM,'' ``MHTGR,'' ``PIUS,'' and ``CANDU'' are
abbreviations for Power Reactor Innovative Small Module, Modular
High-Temperature Gas-Cooled Reactor, Process Inherent Ultimate
Safety, and CANadian Deuterium-Uranium, respectively.
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The Commission agreed and stated in the Staff Requirements
Memorandum (SRM) for SECY-93-092, dated July 30, 1993, that it was
premature to reach a conclusion on EP for advanced reactors and that
existing regulatory requirements should be used for ongoing review
processes. However, the Commission directed that:
[T]he staff should remain open to suggestions to simplify the
emergency planning requirements for reactors that are designed with
greater safety margins. To that end, the staff should submit to the
Commission recommendations for proposed technical criteria and
methods to use to justify simplification of existing emergency
planning requirements.
In response to the Commission's direction, the NRC performed an
evaluation to develop technical criteria and methods for EP for
evolutionary and advanced reactor designs. The evaluation focused on
evolutionary and passive advanced LWR designs due to the availability
of design and risk assessment data and because applicants were pursuing
certification of these designs. In SECY-97-020, ``Results of Evaluation
of Emergency Planning for Evolutionary and Advanced Reactors,'' dated
January 27, 1997, the staff determined that the rationale upon which EP
for current reactor designs is based, that is, potential consequences
from a spectrum of accidents, is appropriate for use as the basis for
EP for evolutionary and passive advanced LWR designs and is consistent
with the Commission's defense-in-depth safety philosophy.
In the early 2000s, performance-based EP became an important
component of LWR licensing and relicensing discussions. As part of an
EP exemption request review, in SECY-04-0236, ``Southern Nuclear
Operating Company's Proposal to Establish a Common Emergency Operating
Facility at its Corporate Headquarters,'' dated December 23, 2004, the
staff noted the following:
[A]s part of the top-down review of Emergency Preparedness, the
staff has identified 10 CFR 50 Appendix E section E.8 and 10 CFR
50.47(b)(3) as opportunities to enhance the emergency preparedness
regulatory structure. The staff will propose rulemaking to remove
``near-site'' from the regulations, as a more performance-based
requirement is appropriate. . . .
The Commission agreed, highlighting the potential value of
performance-based EP for LWRs in the SRM for SECY-04-0236, dated
February 23, 2005, as follows:
The staff should consider revising 10 CFR part 50 to make the
requirements for EOFs [emergency operations facilities] more
performance-based to allow other multi-plant licensees to
consolidate their EOFs, if those licensees can demonstrate their
emergency response strategies will adequately cope with an emergency
at any of the associated plants.
In this decision, the Commission allowed for the development of a
performance-based EP requirement.
In SECY-06-0200, ``Results of the Review of Emergency Preparedness
Regulations and Guidance,'' dated September 20, 2006, the staff sought
Commission approval to explore the feasibility of a voluntary,
performance-based EP regulatory regimen. Specifically, the staff
stated:
[A]s the EP program has matured and industry performance has
improved, the staff recognized the benefits of a performance-based
regulatory structure. Thus, the staff is proposing a new voluntary
performance-based regulatory regimen. The staff has conceptualized
the basis for a voluntary performance-based EP regulatory regimen. .
. . This regimen could be adopted in lieu of the existing EP
regulations contained in 10 CFR part 50. The current regimen tends
to emphasize compliance with, and control over, emergency plans and
facilities. The performance-based regimen would focus licensee
efforts on actual performance competencies, rather than control of
emergency plans and procedures. Regulatory oversight would focus on
licensee performance, instead of licensee processes and procedures.
Creating a performance-based EP regulatory regimen could achieve a
higher level of preparedness, as the regimen would focus on results
and abilities rather than on means. The performance-based regimen
would provide the NRC with enhanced oversight of the actual
competencies important to protection of public health and safety
while allowing licensees increased flexibility.
In SECY-06-0200, the staff also outlined several high-level
performance-based concepts for large LWRs related to performance goals,
staffing, and performance indicators (PIs). In the SRM for SECY-06-
0200, dated January 8, 2007, the Commission approved several staff
recommendations, including the staff's request to begin activities to
explore a voluntary performance-based EP regulatory concept.
During the early development of a performance-based EP regulatory
concept, the NRC published a ``Policy Statement on the Regulation of
Advanced Reactors,'' dated October 14, 2008 (73 FR 60612). The policy
statement expressed the Commission's expectation that advanced reactor
designers would ensure that security and emergency response are
considered alongside safety during the early stages of plant design.
By 2014, the NRC had finalized its study and review of the
potential to enhance the oversight of performance-based nuclear power
plant EP programs as directed in the SRM for SECY-06-0200. In SECY-14-
0038, ``Performance-Based Framework for Nuclear Power Plant Emergency
Preparedness Oversight,'' dated April 4, 2014, the staff stated:
A systematic review and revision of EP requirements to employ a
more performance-based oversight regimen (regulation, inspection,
and enforcement) has the potential to enhance many aspects of
emergency response and oversight. A performance-based oversight
regimen could simplify EP regulations and focus inspection more
fully on response-related performance rather than the current focus
on plan maintenance and compliance.
Although the staff asserted that the performance-based framework
would simplify EP regulations and focus inspections more on response-
related performance, the staff recommended that the existing framework
continue to be used with operating plants because changing the EP
approach for those plants would require significant resources and could
introduce regulatory uncertainty. Additionally, the staff recognized
that existing EP programs provided reasonable assurance of adequate
protection of public health
[[Page 80054]]
and safety and therefore recommended maintaining the current EP
regimen.
In the SRM to SECY-14-0038, dated September 16, 2014, the
Commission directed that:
The staff should be vigilant in continuing to assess the NRC's
emergency preparedness program and should not rule out the
possibility of moving to a performance-based framework in the
future. The Commission notes the potential benefit of a performance-
based emergency preparedness regimen for small modular reactors, and
the staff should return to the Commission if it finds that
conditions warrant rulemaking.
2. Approach to Emergency Preparedness for Small Modular Reactors and
Other New Technologies
In the late 2000s, the discussion of modernizing EP and developing
alternative performance-based requirements for LWRs merged with the
NRC's ongoing discussions of advanced reactor designs. By this time,
several advanced reactor designs were under discussion in the U.S.,
including the U.S. Department of Energy's (DOE's) Next Generation
Nuclear Plant and SMR programs, and by private sector companies seeking
to introduce an alternative to large LWRs. By 2010, the NRC began
considering the possibility of developing a performance-based approach
to EP for SMRs and ONTs. In SECY-10-0034, ``Potential Policy,
Licensing, and Key Technical Issues for Small Modular Nuclear Reactor
Designs,'' issued on March 28, 2010, the staff identified EP as a key
technical issue for the licensing of SMRs and other advanced reactor
designs. The enclosure to the SECY stated that resolution of offsite EP
requirements would be of interest to the Federal Emergency Management
Agency (FEMA) and the public, as well as to applicants trying to
support their business case at the design certification stage.
Contemporaneous with the issuance of SECY-10-0034, the NRC held a
series of public meetings with other Federal agencies, industry
leaders, and key stakeholders to discuss potential policy, licensing,
and technical issues associated with advanced reactor designs.
Summaries of the October 8-9, 2009, and July 28, 2010, meetings are
available in ADAMS, as provided in the ``Availability of Documents''
section of this document. Discussions included the proposed framework
of potential EP requirements. Emergency preparedness was a significant
policy issue for SMR designers because SMR designs may have reduced
accident consequences offsite per reactor module, potentially forming
the basis for smaller EPZs relative to large LWRs.
The staff discussed the public's input from those meetings in SECY-
11-0152, ``Development of an Emergency Planning and Preparedness
Framework for Small Modular Reactors'' on October 28, 2011. The paper
informed the Commission of the staff's proposed actions to develop an
emergency planning and preparedness framework for SMR facilities. In
the document, the staff stated its intent to develop a technology-
neutral (now technology-inclusive), dose-based, consequence-oriented EP
framework for SMR sites that would take into account the various
designs, modularity, and co-location of these facilities with other
NRC-licensed facilities and industrial facilities not licensed by the
NRC, as well as the size of the EPZs. The staff also stated that
``[t]he staff will work with stakeholders to develop general guidance
on calculating the offsite dose, and is anticipating that the industry
will develop and implement the detailed calculation method for review
and approval by the staff.''
In response to SECY-11-0152, the Nuclear Energy Institute (NEI)
prepared a white paper to provide perspective to the NRC and SMR
developers in establishing EPZs for SMRs. In the ``White Paper on
Proposed Methodology and Criteria for Establishing the Technical Basis
for Small Modular Reactor Emergency Planning Zone,'' submitted in
December 2013, NEI noted the NRC expectation in SECY-11-0152 that SMR
license applicants will provide a well-justified technical basis for
NRC's review and consideration. The 2013 White Paper was designed to
``discuss a generic methodology and criteria that can be adopted and
used by the SMR developers and plant operating license applicants for
establishing the design-specific and site-specific technical basis for
SMR-appropriate EPZs.'' In the paper, NEI stated that the intent of the
paper was to ``serve as a vehicle to support the continuing dialogue
with the staff that should result in a mutually agreeable methodology
and criteria, and thus provide the SMR developers and applicants
sufficient guidance as they proceed to develop their design-specific
and site-specific technical basis.'' As stated in the paper, NEI's
approach was rooted in the following:
(1) the expectation of enhanced safety inherent in the design of
SMRs (e.g., increased safety margin, reduced risk, smaller and
slower fission product accident release, and reduced potential for
dose consequences to population in the vicinity of the plant); (2)
the applicable SECY-11-0152 concepts including utilization of
existing emergency preparedness regulatory framework and dose
savings criteria of NUREG-0396; and (3) the significant body of risk
information available to inform the technical basis for SMR-
appropriate EPZ, including severe accident information developed
since NUREG-0396 was published in 1978, and information from the
design-specific and plant-specific probabilistic risk assessments
(PRAs) which will support SMR design and licensing.
The NEI 2013 White Paper addressed only SMRs with light-water-
cooled and moderated designs and the plume exposure pathway EPZ. It did
not address other designs or the ingestion pathway EPZ (IPZ). The NRC
reviewed the White Paper and discussed the development of the
regulatory framework with NEI and stakeholders; however, the NRC did
not endorse the paper.
In the enclosure to SECY-10-0034, the staff stated, ``Should it be
necessary, the staff will propose changes to existing regulatory
requirements and guidance or develop new guidance concerning reduction
of offsite emergency preparedness for SMRs in a timeframe consistent
with the licensing schedule.'' In 2015, the NRC determined that SMR EP
issues were a key concern for potential SMR and ONT applicants, and
that addressing those issues would enhance regulatory predictability
for both applicants and the NRC. In May 2015, the staff sought
Commission approval to initiate rulemaking to revise the EP regulations
and guidance for SMRs and ONTs. In SECY-15-0077, ``Options for
Emergency Preparedness for Small Modular Reactors and Other New
Technologies,'' dated May 29, 2015, the staff proposed a consequence-
oriented approach to establishing EP requirements commensurate with the
potential consequences to public health and safety and the common
defense and security at SMR and ONT facilities. The staff stated that
the need for EP is based on the projected offsite dose in the unlikely
occurrence of a severe accident. In SRM-SECY-15-0077, the Commission
approved the staff's recommendation to proceed with rulemaking, keeping
a performance-based framework in mind as previously directed in SRM-
SECY-14-0038. The Commission further directed that, for any SMR reviews
conducted prior to the establishment of a regulation, the staff should
be prepared to adapt an approach to EPZs for SMRs under the exemption
process.
In June 2015, NEI issued a White Paper supporting the NRC proposal
in SECY-15-0077 and recommending the revision of EP regulations and
guidance
[[Page 80055]]
for SMR facilities. In ``White Paper: Proposed Emergency Preparedness
Regulations and Guidance for Small Modular Reactors Facilities,'' dated
July 2015, NEI provided proposed revisions to the planning standards
set forth in Sec. 50.47 and appendix E to 10 CFR part 50 as well as
associated EP guidance. The proposed revisions were developed by NEI to
``constructively inform the staff's deliberations concerning the
development of an SMR EP framework, and serve as a basis for future
public meeting engagement.'' The NRC has considered NEI's
recommendations in the development of this final rule.
In addition to the NEI white papers, the NRC has had several
interactions with the public concerning licensing issues related to
SMRs and ONTs, including joint DOE-NRC Workshops on Advanced Non-Light-
Water Reactors held on September 1-2, 2015, and June 7-8, 2016. The NRC
held these workshops to obtain stakeholder feedback regarding the
proposed rule and inform the public on the proposed approach.
Additional information on these workshops may be found in their
summaries.
3. Rulemaking Activity
In response to SRM-SECY-15-0077, on May 31, 2016, the staff
submitted a rulemaking plan to the Commission (SECY-16-0069,
``Rulemaking Plan on Emergency Preparedness for Small Modular Reactors
and Other New Technologies'') to propose rulemaking to address EP for
SMRs and ONTs. In SECY-16-0069, the staff provided a proposed
rulemaking schedule, outlining the need to develop EP requirements for
SMRs and ONTs commensurate with the potential consequences to public
health and safety posed by these facilities. On June 22, 2016, the
Commission issued SRM-SECY-16-0069 approving the staff's rulemaking
plan.
On August 22, 2016, the NRC held a public meeting to request
feedback from stakeholders on a potential performance-based approach
for EP for SMRs and ONTs. The participants supported a performance-
based approach for EP, indicating that it would be more effective
because it would focus on achieving desired outcomes. Participants also
favored the performance-based approach because it would allow for
innovation and flexibility in addressing the EP requirements. The
potential need for an entire new suite of guidance documents, including
the process by which licensees make changes to their emergency plans
(i.e., change process), was the only disadvantage identified by
participants as it would require additional up-front work to reflect
the new approach. A summary of this public meeting is available in
ADAMS, as provided in the ``Availability of Documents'' section of this
document. After considering the feedback received from the stakeholders
in support of the performance-based approach to EP, the NRC developed a
draft regulatory basis that included an option to proceed with
rulemaking to implement this approach.
On April 13, 2017, the NRC issued a draft regulatory basis for a
75-day public comment period (82 FR 17768). In the draft regulatory
basis, the NRC requested feedback from the public on questions related
to the scope of the draft regulatory basis, performance-based approach,
regulatory impacts, and cumulative effects of regulation (CER). In
addition, the NRC held a public meeting on May 10, 2017, to discuss the
draft regulatory basis with interested stakeholders. A summary of this
public meeting is available in ADAMS, as provided in the ``Availability
of Documents'' section of this document.
The NRC received comment submissions from 57 individuals and
organizations on the draft regulatory basis and the associated
regulatory analysis, including 223 individual comments related to EP.
The commenters included individuals, environmental groups, industry
groups, a Tribal government, States, and FEMA. The NRC reviewed all
comments submitted on the draft regulatory basis, grouped the comments
into categories by comment topic, and developed a resolution for each
topic. Comments included topics such as: consequence-based approach,
co-location, dose assessment, EPZ and offsite EP, general rulemaking
approach, siting of multi-module facilities, performance-based
approach, regulatory analysis, scope of the draft regulatory basis,
safety, and technology-inclusive approach. The NRC considered those
comments and discussions from the public meeting as it finalized the
regulatory basis. The NRC published a notification in the Federal
Register announcing the public availability of the regulatory basis on
November 15, 2017 (82 FR 52862).
On May 12, 2020, the NRC published the proposed rule, ``Emergency
Preparedness for Small Modular Reactors and Other New Technologies,''
for a 75-day public comment period (85 FR 28436). On May 25, 2020, the
NRC published a notification to correct the definition of ``Non-power
production or utilization facility'' (85 FR 32308). The NRC held a
public meeting on June 24, 2020, to engage with external stakeholders
on the proposed rule and associated draft guidance document. Additional
information about this public meeting is detailed in the meeting
summary. The NRC received several requests to extend the comment period
by 6 months or more due to the Coronavirus Disease 2019 (COVID-19)
public health emergency. On July 21, 2020, the NRC extended the comment
period by 60 days with a closing date of September 25, 2020 (85 FR
44025). The NRC received comment submissions from 2,212 individuals and
organizations, including 2,087 form letters and form letters with non-
substantive additional text. The staff's analysis identified 649 unique
comments on the proposed rule and associated guidance, the regulatory
analysis, and the environmental assessment. The commenters included
State and local governments, Tribal governments and Tribal
organizations, Federal agencies, members of the nuclear power industry,
non-governmental organizations, and private citizens. A summary of the
comments and the NRC's responses to the comments are available as
indicated in the ``Availability of Documents'' section of this
document. The NRC used these comments to develop this final rule.
II. Discussion
A. Objective and Applicability
This final rule creates alternative EP requirements that: (1)
continue to provide reasonable assurance that adequate protective
measures can and will be implemented by an SMR or ONT licensee; (2)
promote regulatory stability, predictability, and clarity; (3) reduce
the need for requests for exemptions from EP requirements; (4)
recognize advances in design and technology advancements embedded in
design features; (5) credit safety enhancements in evolutionary and
passive systems; and (6) credit the potential benefits of smaller sized
reactors and non-LWRs associated with postulated accidents, including
slower transient response times, and relatively small and slow release
of fission products. This final rule applies to existing and future SMR
and ONT facilities. These applicants and licensees have the option to
develop a performance-based EP program designed for SMRs and ONTs, as
an alternative to complying with the existing, deterministic EP
requirements in 10 CFR part 50.
This final rule does not include within its scope emergency
planning, preparation, and response for large LWRs, which for the
purposes of this final rule are those LWRs that are
[[Page 80056]]
licensed to produce greater than 1,000 MWt power; fuel cycle
facilities; or currently operating non-power reactors. The current
operating fleet of power reactors has an established EP regulatory
framework under Sec. 50.47 and appendix E to 10 CFR part 50. Emergency
planning requirements for facilities licensed under 10 CFR part 70 are
set forth in Sec. 70.22(i). The NRC established in appendix E to 10
CFR part 50 emergency planning requirements for RTRs that reflect the
lower potential radiological hazards associated with these facilities.
The plume exposure pathway EPZ for the current operating fleet of
nuclear power reactors consists of an area about 10 miles (16 km) in
radius and the IPZ for such facilities consists of an area about 50
miles (80 km) in radius. See current Sec. Sec. 50.33(g) and 50.47(c).
As discussed in the ``Background'' section of this document, in the
early 2000s, the NRC anticipated that future SMR and ONT applications
would reflect a wide range of potential designs that have smaller
source terms and incorporate EP considerations as part of the design.
In the Policy Statement on the Regulation of Advanced Reactors (73 FR
60612), the Commission stated that it ``expects that advanced reactors
will provide enhanced margins of safety and/or use simplified,
inherent, passive, or other innovative means to accomplish their safety
and security functions.'' Under the current EP framework, Sec. Sec.
50.33(g) and 50.47(c)(2) provide that the size of plume exposure
pathway EPZs and IPZs for gas-cooled nuclear reactors and for reactors
with an authorized power level less than 250 MWt may be determined on a
case-by-case basis. Section I.3 of appendix E to 10 CFR part 50 states
that the EPZs for facilities other than power reactors may also be
determined on a case-by-case basis. In addition, applicants and
licensees for power reactors may also request that the size of the EPZs
and IPZs for their facilities be determined on a case-by-case basis by
seeking an exemption under Sec. 50.12, ``Specific exemptions,'' from
the requirements in Sec. Sec. 50.33(g) and 50.47(c)(2) regardless of
authorized power level. Furthermore, appendix E to 10 CFR part 50,
provides the flexibility to determine other emergency planning
considerations, such as organization, assessment actions, activation of
emergency organization, emergency facilities, and equipment, on a case-
by-case basis for certain facilities.
The NRC initiated this rule to seek a wide-range of public views
and increase regulatory predictability and flexibility in the
development of an alternative, generic approach that designers,
vendors, and applicants may use to determine the appropriate EP
requirements for SMRs and ONTs, for which emergency planning may
otherwise be addressed on a case-by-case basis. In particular, this
final rule provides additional predictability and flexibility for
advanced reactor developers that use simplified or other innovative
means to accomplish their safety functions and provide enhanced margins
of safety. Large LWRs were not included by the NRC in the scope of this
final rule because an EP licensing framework already exists for those
reactors, and licensees for those plants have not expressed a clear
interest in changing that framework.
For clarity, this final rule defines the different types of
affected facilities. The NRC amends Sec. 50.2 to include the terms
``small modular reactor,'' ``non-light-water reactor,'' and ``non-power
production or utilization facility.'' The NRC has included a definition
of ``non-light-water reactor'' to address ONTs, including liquid-metal-
cooled reactors, gas-cooled reactors, and molten-salt-cooled reactors.
Having a separate definition for these non-LWR technologies clarifies
the applicability of the existing EP standards and requirements in 10
CFR part 50, which are specific to LWRs, and maintains consistency
between this final rule and the ``Variable Annual Fee Structure for
Small Modular Reactors'' final rule (81 FR 32617; May 24, 2016).
The NRC evaluated the suitability of using the existing definition
of ``small modular reactor'' in Sec. 171.5, ``Definitions'' for the
purposes of this EP final rule. The Sec. 171.5 definition of ``small
modular reactor'' means, for the purpose of calculating fees, the class
of light-water power reactors having a licensed thermal power rating
less than or equal to 1,000 MWt per module. This rating is based on the
thermal power equivalent of a light-water SMR with an electrical power
generating capacity of 300 megawatts electric or less per module.
Although similar, this final rule's definition of ``small modular
reactor'' does not include reference to electrical power generating
capacity. For the fee-related regulations in 10 CFR part 171, ``Annual
Fees For Reactor Licenses and Fuel Cycle Licenses and Materials
Licenses, Including Holders of Certificates of Compliance,
Registrations, and Quality Assurance Program Approvals and Government
Agencies Licensed by the NRC,'' the NRC determined that using the
thermal power equivalent of electric power generating capacity would be
equitable because SMRs should pay annual fees that are commensurate
with the economic benefit received from their license (81 FR 32617).
However, because electric power generating capacity is not a criterion
the NRC uses to determine EP requirements, this final rule's definition
focuses on thermal power rating.
The NRC received a public comment on the proposed rule that the
definition of ``small modular reactor'' should indicate that an SMR can
have a licensed thermal power up to 1,000 MWt, and that this limit
applies to each module in a facility rather than the total thermal
power of all modules in a facility. The proposed rule's definition of
``small modular reactor'' provided that an SMR was a power reactor
licensed to produce heat energy up to 1,000 MWt, which may be of
modular design as defined in Sec. 52.1, ``Definitions.'' The NRC
agreed that this definition could be subject to more than one
interpretation and revised the definition of ``small modular reactor''
to read: ``a power reactor, which may be of modular design as defined
in Sec. 52.1 of this chapter, licensed under Sec. 50.21 or Sec.
50.22 to produce heat energy up to 1,000 megawatts thermal per
module.'' The ``per module'' language is also consistent with the
definition of ``small modular reactor'' in Sec. 171.5.
B. Need for Changes to Existing Regulatory Framework
As mentioned in the ``Background'' section of this document, in
SECY-10-0034, the NRC identified potential policy and licensing issues
for SMRs based on the preliminary design information supplied in pre-
application interactions and discussions with SMR designers and the
DOE. In general, these issues result from the key differences between
the new designs and the current-generation large LWRs, such as rated
thermal power, moderator, coolant, and fuel design. In SECY-10-0034,
the NRC described designs discussed in pre-application interactions
with DOE and SMR designers. The rated thermal power of these designs
ranged from 30 MWt to 1,000 MWt. The designs included the use of helium
gas, sodium, and light-water as coolants. While some SMR designs employ
conventional LWR radiological barrier designs, some designs may employ
a non-traditional containment approach.
In addition to licensing issues associated with differences in
designs, some of the licensing issues resulted from industry-proposed
review approaches and industry-proposed modifications to current
policies and practices, including standard review plans and design-
specific review
[[Page 80057]]
standards. The potential for smaller reactor core sizes, lower power
densities, lower probability of severe accidents, slower accident
progression, and smaller accident offsite consequences per module that
characterize some SMR designs have led DOE, SMR designers, and
potential operators to revisit the determination of the size of the
EPZs, the extent of onsite and offsite emergency planning, and the
number of onsite response staff needed.
Historically, licensees of small reactors have requested exemptions
from EP regulations because those EP requirements would have imposed a
regulatory burden on the applicants that was not necessary to protect
the public health and safety due to the facilities' designs. The NRC
anticipates that existing or future SMR and ONT applicants could also
have designs that differ substantially from the existing fleet of large
LWRs. These applicants could also request exemptions from EP
requirements that are potentially unnecessary to protect the public
health and safety. Although the exemption process provides the
flexibility to address these existing or future applicants, regulating
by exemption generally provides little opportunity for public
engagement in the exemption process and can lead to undue burden and
lack of predictability for applicants, licensees, and the NRC stemming
from the applicant or licensee specific nature of exemption requests.
This final rule creates a transparent alternative EP regulatory
framework for SMR and ONT applicants and licensees that continues to
provide reasonable assurance that adequate protective measures can and
will be implemented in a radiological emergency. The final alternative
EP requirements consider a wide range of views, acknowledge
technological advancements and other differences from large LWRs
inherent in SMRs and ONTs, and reduce regulatory burden by precluding
the need for exemptions from EP requirements as applicants request
permits and licenses. This final rule also supports the principles of
good regulation, including openness, clarity, and reliability.
1. Technical Basis
This final rule is a performance-based, technology-inclusive, risk-
informed, and consequence-oriented alternative approach to EP for SMRs
and ONTs. These approaches form the basis for the NRC's final rule, and
the following discussion addresses the technical basis for each.
a. Performance-Based Approach to Emergency Planning
The NRC's current regulatory framework for EP in 10 CFR part 50
requires that site-specific emergency plans be developed and maintained
in compliance with 16 planning standards for nuclear power reactors.
This deterministic structure does not provide performance standards,
but the regulations and guidance for emergency response organizations
(EROs) emphasize requirements for emergency plans and facilities. The
existing EP requirements for large LWRs are based on decades of
research on the risks posed by these facilities. The risks for these
facilities are well understood, and, as such, a deterministic approach
to regulating EP is an effective method for providing reasonable
assurance that protective measures can and will be taken in a
radiological emergency.
The NRC anticipates that existing and future SMR and ONT
applications will use a wide range of potential designs and source
terms. Advances in designs could enhance the EP for these facilities.
At the same time, EP itself is improving through technological
innovations like FEMA's Integrated Public Alert & Warning System.
Because the technology for EP and certain SMR and ONT designs are
evolving, a performance-based approach could allow for more regulatory
flexibility, provide a basis for appropriate EP through review of
design- and site-specific accident scenarios, and minimize the need for
exemption requests that would otherwise be anticipated under a
prescriptive regulatory framework. In this context, a performance-based
approach bases the adequacy of EP upon the NRC's identification of
emergency response functions that affect the protection of public
health and safety and the licensee's successful execution of those
functions. The NRC's performance-based framework, inspection and
enforcement program, and design-specific review process provide
reasonable assurance that protective measures can and will be taken in
the event of an emergency at an SMR or ONT facility. The NRC has
previously explored the idea of a performance-based EP framework, as
discussed in the ``Performance-Based Emergency Preparedness'' section
of this document, and the Commission noted that a performance-based
approach was a potential benefit to regulating EP for SMRs. The
performance-based approach could simplify EP regulations and focus
inspections more fully on response-related performance.
The NRC also considered a graded approach to EP that would take
into account the magnitude of any credible hazard involved, the
particular characteristics and status of a facility, and the balance
between radiological and non-radiological hazards. A graded approach to
EP has a longstanding regulatory history. The 16 EP planning standards
for nuclear power reactors, outlined in Sec. 50.47(b), and the
associated evaluation criteria in NUREG-0654/FEMA-REP-1, Revision 1 and
NUREG-0654/FEMA-REP-1, Revision 2, are part of a continuum of planning
standards for radiological EP. The existing regulations in Sec.
50.47(c)(2) for EPZ size determinations for gas-cooled reactors and
reactors with power levels less than 250 MWt, the EP regulations for
production and utilization facilities other than nuclear power reactors
in appendix E to 10 CFR part 50, and the EP regulations for fuel cycle
facilities in Sec. 70.22(i) and independent spent fuel storage
installations (ISFSIs) in Sec. 72.32, ``Emergency plan,'' are also
part of a graded approach to EP that is commensurate with the relative
radiological risk, source term, and potential hazards, among other
considerations.
b. Technology-Inclusive Approach to Emergency Planning
As previously mentioned, the NRC has licensed, reviewed, or had
pre-application discussions with stakeholders supporting a range of
technology types that are included in the scope of this final rule.
Based on the information currently available to the NRC, unique design
considerations (e.g., passive safety characteristics, advanced fuel
types, and chemical processes) and the potential for multi-module
facilities and siting contiguous to, or near, NRC-licensed facilities
or facilities not licensed by the NRC could lead to a variety of
accident frequencies, progression times, and potential consequences for
SMRs or ONTs. To incorporate recent and potential technology
advancements and reduce the need for future EP rulemaking, this final
rule offers a technology-inclusive approach to EP for SMRs and ONTs. In
this context, technology-inclusive means the establishment of
performance requirements for any SMR or ONT applicant or licensee to
use in its emergency plan, developed using methods of evaluation that
are flexible and practicable for application to a variety of reactor
technologies.
As described further in the ``Performance-Based Framework'' section
of this document, the NRC's
[[Page 80058]]
final alternative framework for SMRs and ONTs consists of two major
elements--an EPZ size determination process and a set of performance-
based requirements. The size of an EPZ determined by this process is
scalable based on factors such as accident source term, fission product
release, and associated dose characteristics, and the same process can
be applied to all SMR and ONT designs. Further, the performance-based
requirements in Sec. 50.160, ``Emergency preparedness for small
modular reactors, non-light-water reactors, and non-power production or
utilization facilities,'' do not contain any technology specific
language. Rather, applicants and licensees demonstrate how they meet
the EP performance-based framework based on their design- and site-
specific considerations through the implementation of a performance
objective scheme and the conduct of drills and exercises.
c. Consequence-Oriented and Risk-Informed Approaches to Emergency
Planning
This final rule offers a consequence-oriented approach to establish
EP requirements for SMRs and ONTs. In this context, consequence-
oriented means the principle of basing decisions regarding the scope of
EP upon the potential consequences from a spectrum of accidents,
including those that could result in an offsite radiological release.
The decisions regarding EP should be based upon projected offsite dose
from such accidents and the pre-determined plume exposure pathway EPZ
for pre-planned protective measures.
The NRC reviewed the current EP requirements associated with
various nuclear facilities, including large and small operating
reactors, material facilities, fuel facilities, ISFSIs, NPUFs, and
decommissioning large LWRs (including SECY-18-0055, ``Proposed Rule:
Regulatory Improvements for Production and Utilization Facilities
Transitioning to Decommissioning,'' dated May 22, 2018). In this
review, the NRC identified that all of the existing types of NRC-
licensed nuclear facilities use a consequence-oriented approach and
take into account other considerations, such as the likelihood of the
accident, to establish the boundary of the plume exposure pathway EPZ
(or other planning area). The consequence or dose considerations are
based on the U.S. Environmental Protection Agency (EPA) early-phase
Protective Action Guides (PAGs) (EPA-520/1-75-001), issued in September
1975. The PAGs were revised and republished as EPA-400-R-92-001 in May
1992, and a subsequent revision, EPA400/R-17/001, was issued in January
2017.
The general considerations from the existing planning basis for EP,
established in NUREG-0396/EPA 520/1-78-016, ``Planning Basis for the
Development of State and Local Government Radiological Emergency
Response Plans in Support of Light Water Nuclear Power Plants,''
introduced the concept of generic EPZs as the basis for preplanned
response actions. These planning distance considerations were intended
to result in dose savings to members of the public in the environs of a
nuclear facility when the EPA PAGs were used as the threshold to
trigger the preplanned protective measures in the event of a reactor
accident that would result in offsite dose consequences. Planning
should also be based upon knowledge of the potential consequences,
timing, and radiological release characteristics from a spectrum of
accidents, including severe accidents. The joint NRC-EPA task force
that developed NUREG-0396 considered several possible rationales for
establishing the size of the EPZs, including risk, cost effectiveness,
and the accident consequence spectrum (e.g., dose and significant
health effects). After reviewing these alternatives, the NRC-EPA task
force concluded that the objective of emergency response plans should
be to provide dose savings for a spectrum of accidents that could
produce offsite doses in excess of the EPA PAGs for those members of
the public who would most likely receive exposure as a result of a
significant release.
In the 1980 Final Rule, based on the guidance in NUREG-0396, the
NRC established plume exposure pathway and ingestion pathway EPZ
requirements for large LWRs of about 10 miles (16 km) and 50 miles (80
km), respectively. The NRC also clarified that the size of the EPZ
could be determined on a case-by-case basis for gas-cooled nuclear
reactors and for reactors with an authorized power level less than 250
MWt. The NRC stated that this requirement was based on the lower
potential hazard from these facilities (i.e., lower radionuclide
inventory and longer times to release significant amounts of activity
in many scenarios) and clarified that the radionuclides to be
considered in planning for large LWR accident scenarios were set forth
in NUREG-0396. Similarly, the NRC established in the 1980 Final Rule
that the degree to which compliance with sections I through V of
appendix E to 10 CFR part 50 would apply to RTRs and fuel cycle
facilities would be determined on a case-by-case basis because the
radiological hazards to the public associated with the operation of
RTRs and fuel cycle facilities involve considerations different than
those associated with nuclear power reactors.
This final rule for SMRs and ONTs continues this consequence-
oriented approach for determining the size of the plume exposure
pathway EPZ. The primary purpose of the plume exposure pathway EPZ is
to define the area where predetermined, prompt protective measures are
necessary, which results in dose savings and a reduction in early
health effects. In this final rule, the NRC establishes in Sec.
50.33(g)(2)(i) two criteria for determining a plume exposure pathway
EPZ size. The first criterion is that the plume exposure pathway EPZ is
the area within which public dose, as defined in Sec. 20.1003,
``Definitions,'' is projected to exceed 10 millisieverts (mSv) (1 rem)
total effective dose equivalent (TEDE) over 96 hours from the release
of radioactive materials from the facility considering accident
likelihood and source term, timing of the accident sequence, and
meteorology. The second criterion is that the plume exposure pathway
EPZ is the area where predetermined, prompt protective measures are
necessary.
The principle of using dose versus distance to determine EPZ size
has been used in the past when the NRC licensed several small reactors
with a reduced EPZ size of 5 miles (8 km). These reactors include the
Fort St. Vrain high-temperature gas-cooled reactor (HTGR) (842 MWt),
the Big Rock Point boiling water reactor (BWR) (240 MWt), and the La
Crosse BWR (165 MWt). Pre-application discussions between the NRC and
SMR designers have indicated that SMRs also could have reduced offsite
dose consequences in the unlikely event of an accident. With the
expected safety enhancements in SMR designs and the potential for
reduced accident source terms and fission product releases from SMRs
and ONTs, this final rule provides an alternative EP framework that
allows SMR and ONT applicants to develop EPZ sizes commensurate with
their accident source terms, fission product releases, and accident
dose characteristics considering site-specific meteorology.
To support this final rule, the NRC conducted research on EPZ size
determinations for SMRs and ONTs. Because of the potential variations
in SMR or ONT designs, the NRC cannot conduct a comprehensive
evaluation of source terms and spectra of accidents as part of this
final rule. Instead, the research study, ``Generalized Dose Assessment
Methodology for Informing
[[Page 80059]]
Emergency Planning Zone Size Determinations,'' dated June 2018,
reviewed the dose assessment methodologies that informed the EPZ size
determinations in NUREG-0396 and developed a general methodology for
determining plume exposure pathway EPZ size based on NUREG-0396.
Information from that review and a subsequent set of recommended
analyses documented in ``Required Analyses for Informing Emergency
Planning Zone Size Determinations,'' dated June 2018, was used to
develop the methodology described in Appendix A, ``General Methodology
for Establishing Plume Exposure Pathway EPZ Size,'' of RG 1.242.
This final rule requires applicants that choose to comply with
Sec. 50.160 to submit an analysis under Sec. 50.33(g)(2) to provide
the technical basis justifying the proposed plume exposure pathway EPZ
size. The NRC evaluates each application on a case-specific basis. The
``Emergency Planning Zones'' section in this document contains
additional discussion on the NRC's consequence-oriented approach to EPZ
size determinations for an SMR or ONT facility.
The proposed rule included a plume exposure pathway EPZ in which
public dose is projected to be above 10 mSv (1 rem) TEDE over 96 hours
from the release of radioactive materials, resulting from a spectrum of
credible accidents for the facility. The NRC received public comments
concerning the need for clarification on the plume exposure pathway EPZ
determination requirements, including the 10 mSv (1 rem) TEDE over 96
hours from the release of radioactive materials and the definition of
``spectrum of credible accidents.'' The NRC removed the phrase
``spectrum of credible accidents'' in this final rule. The
determination of whether accidents are credible for a facility is a
part of the applicant's safety analysis required for its application.
As part of the NRC's safety review of the application, the NRC reviews
the applicant's assessment of licensing basis events, event likelihood,
and public dose consequences. The NRC's determination of the
acceptability of the applicant's assessment supports the agency's
separate review of the applicant's emergency plan.
As a result of these comments on the proposed rule, the NRC revised
the requirements by listing in Sec. 50.33(g)(2)(i)(A) the major
considerations for the radiological consequence analysis to be used in
determining the plume exposure pathway EPZ size for the facility:
accident likelihood and source term, timing of the accident sequence,
and meteorology. Consideration of accident likelihood in combination
with event sequences makes it possible to arrive at the spectrum of
accidents used to develop the basis for the applicant's site-specific
plume exposure pathway EPZ. Source terms are used to determine dose
consequences. Timing of the accident sequence facilitates determining
if prompt protective measures are warranted. Meteorology input is
essential in determining the weather conditions that impact dose
consequences due to atmospheric transport and dispersion of the
radioactive plume. Meteorological inputs should consider, but not be
limited to, wind speeds, wind directions, atmospheric stability,
precipitation, and mixing height, for temporal and geographical
representativeness. Regulatory Guide 1.242 provides guidance on these
considerations and developing the dose-consequence analysis.
The NRC also added a second criterion to the plume exposure pathway
EPZ size determination in Sec. 50.33(g)(2)(i)(B): the plume exposure
pathway EPZ is the area in which predetermined, prompt protective
measures are necessary. This rule provision adds a functional criterion
to the EPZ to be consistent with the planning basis approach in NUREG-
0396 and Federal guidance contained in the EPA PAG Manual.
The risk-informed planning basis for EP, established in NUREG-0396,
was endorsed in the Commission policy statement, ``Planning Basis for
Emergency Responses to Nuclear Power Reactor Accidents,'' dated October
23, 1979 (44 FR 61123), and incorporated in the 1980 Final Rule. In the
policy statement, the Commission said, ``Predetermined protective
action plans are needed for the EPZs.'' As described in NUREG-0396, for
very serious accidents, predetermined, prompt protective actions would
be taken if projected doses, at any place and time during an actual
accident, appeared to be at or above the applicable proposed PAGs,
based on information readily available in the reactor control room
(i.e., at predetermined emergency action levels).
The planning basis established in NUREG-0396 determined that the
scope of the planning effort needs to include: (1) the distance to
which detailed planning for predetermined protective actions is
warranted, (2) the time dependent characteristics of potential releases
and exposures, and (3) the radioactive materials potentially released.
The specified planning distance ensures that the locations of at-risk
populations are identified, the responsible authorities who would carry
out these actions will be notified, and the means of communication to
these authorities are included in the detailed planning. The time
available between recognition of the initiation of a serious accident
and the beginning of the radioactive release to the environment is
critical in determining what predetermined protective actions would be
appropriate.
The planning basis in NUREG-0396 used the accident analyses and
assumptions of NUREG-75/014, ``Reactor Safety Study--An Assessment of
Accident Risks in U.S. Commercial Nuclear Power Plants,'' (WASH-1400),
Appendices III and IV; Appendix V; Appendix VI; and Appendices VII-X,
dated October 1975. These analyses assume that the range of times for
the onset of radiological accident conditions and the start of a major
radiological release could be from less than an hour to several hours.
The potential for a major atmospheric release would necessitate
consideration of predetermined, prompt protective measures. The length
of time from the initiation of an event to the time of release in
relation to the ability for OROs to determine and initiate protective
measures is key to reducing dose and providing for public health and
safety. If OROs have sufficient time to determine what protective
measures, if any, are necessary to take for releases occurring after a
delay from the initiating event (e.g., several hours), then
predetermined, prompt protective measures may not be necessary. As an
example of an analysis of timing considerations, the Low-Power Rule
(``Emergency Planning and Preparedness Requirements for Nuclear Power
Plant Fuel Loading and Low-Power Testing,'' Final Rule, 53 FR 36955;
September 23, 1988) included an analysis on the need for predetermined,
prompt protective measures. Due to the substantial reduction in the
likelihood of an accident and potential accident consequences for low
power testing as compared to continuous full power operation, the
analysis for this example identified a time period of 10 hours from the
start time of the initiating event to the start time of a potential
major release as a reasonable amount of time for OROs to take
appropriate response actions that provide for public health and safety
without the need for predetermined, prompt protective measures.
This timing of a potential major release is the basis for requiring
predetermined, prompt protective
[[Page 80060]]
measures triggered by plant conditions or dose projections in response
to a General Emergency declaration. Because SMRs and ONTs are expected
to have accident timing characteristics different from large light-
water reactor technologies considered in NUREG-0396, and because
technology important to emergency planning and response continues to
improve, the NRC added a functional criterion to this final rule to
ensure that the need for predetermined, prompt protective measures is
evaluated in the planning considerations.
This final rule requires applicants and licensees choosing to
comply with Sec. 50.160 to describe in their emergency plan the
information that demonstrates compliance with the elements set forth in
Sec. 50.160(b). This includes the capability to assess and classify
emergency events, establish and maintain effective communications,
assess radiological conditions in and around the facility, and
recommend protective measures to offsite authorities as conditions
warrant. If an applicant or licensee determines under Sec.
50.33(g)(2)(i)(B) that pre-determined, prompt protective measures are
warranted, which would occur only if Sec. 50.33(g)(2)(i)(A) is also
met, then an EPZ is required. The need for pre-determined, prompt
protective measures is assumed to exist unless an applicant can
demonstrate that the timing of accidents in relation to the proposed
capabilities for assessment and notification are such that
predetermined, prompt protective measures are not warranted. That is,
the applicant must demonstrate that plant condition-based,
predetermined, prompt protective measures are not required because
sufficient time is available, and the capability exists, to initiate
appropriate response actions offsite as conditions warrant. RG 1.242
provides guidance for the EPZ functional criterion.
The capability for taking protective measures is not dependent upon
an established EPZ. The EPZ is a planning tool to ensure predetermined,
prompt protective measures can and will be taken if accident conditions
warrant. If both Sec. 50.33(g)(2)(i) criteria are met, then an EPZ is
required. However, if there is no need for predetermined, prompt
protective measures, then the final rule still requires licensees to
develop and maintain capabilities to assess, classify, notify, and
recommend protective measures as conditions warrant. In all cases, the
NRC will not issue an initial operating license (OL) or combined
license (COL) unless the NRC finds that there is reasonable assurance
that adequate protective measures can and will be taken in the event of
a radiological emergency.
This final rule does not provide for a specific IPZ. This final
rule includes ingestion response planning requirements instead of an
IPZ at a set distance as part of the performance-based framework.
Ingestion response planning focuses planning efforts on identification
of major exposure pathways for ingestion of contaminated food and
water. This final rule requires applicants and licensees who comply
with Sec. 50.160 to describe in their emergency plan the licensee,
Federal, State, and local resources for ingestion emergency response
capabilities available to sample, assess, and implement a quarantine or
embargo of food and water to protect against contaminated food and
water entering the ingestion pathway. For those applicants and
licensees using Sec. 50.47(b) and appendix E to 10 CFR part 50, the
IPZ requirements remain unchanged.
These ingestion emergency response capabilities are implemented
either by the licensee within the site boundary or by Federal, State,
and local authorities in the intermediate or later-stage response to an
accident involving the release of radioactive material. The sampling,
assessing, and imposing of a quarantine or embargo are longer-term
issues. Federal and State authorities frequently issue precautionary
actions or implement quarantines or embargos for non-radiological
contamination of foods. Further, Federal resources are available upon
request to State, local, and Tribal response to any nuclear or
radiological incident. Current State and local plans include sampling,
assessing, and implementing precautionary actions prior to exceeding
dose thresholds or PAGs.
2. Performance-Based Framework
This final rule creates a new section, Sec. 50.160, that provides
a performance-based EP framework for SMRs and ONTs as an alternative to
the current regulations. Under Sec. 50.54(q)(2)(ii) in this final
rule, licensees are required to follow and maintain either an emergency
plan that meets the requirements in Sec. 50.160 or an emergency plan
that meets the requirements in appendix E to 10 CFR part 50 and, for
nuclear power reactor licensees, the planning standards of Sec.
50.47(b). Sections 50.34 and 52.79, ``Contents of applications;
technical information in final safety analysis report,'' stipulate that
SMR and ONT applicants have the option to choose either approach.
Section 50.160 includes: (1) emergency response functions that must be
demonstrated through the regular development and maintenance of
performance objectives and periodic drills and exercises, (2) onsite
and offsite planning activities to be met by applicants and licensees
to which the provision applies, (3) requirements for considering
credible hazards associated with contiguous or nearby NRC-licensed
facilities and industrial facilities not licensed by the NRC, and (4) a
requirement for applicants and licensees to determine and describe in
the emergency plan the boundary and physical characteristics of the
plume exposure pathway EPZ and ingestion response planning
capabilities. Licensees complying with Sec. 50.160 are required under
Sec. 50.160(b)(1) to demonstrate effective response in drills and
exercises and describe in their emergency plans how they will maintain
preparedness. To comply, emergency plans must include a description of
how the emergency response functions in Sec. 50.160(b)(1)(iii) and the
planning activities in Sec. 50.160(b)(1)(iv), if applicable, will be
met.
The NRC has a long history of successful implementation of
performance-based EP requirements (e.g., performance-based requirements
for emergency facilities and staffing, and the Reactor Oversight
Process).\4\ Under this final rule's performance-based approach to EP,
performance and results are the primary basis for regulatory
decisionmaking, and the applicant or licensee has the flexibility to
determine how to meet the established performance criteria for an
effective EP program. The performance-based regimen focuses on actual
performance competencies, rather than control of emergency plans and
procedures. Regulatory oversight focuses on performance, instead of
processes and procedures. The performance-based regimen provides the
NRC with enhanced oversight of the actual competencies important to the
protection of public health and safety while allowing applicants and
licensees increased flexibility.
---------------------------------------------------------------------------
\4\ For further information on the Reactor Oversight Process,
see: https://www.nrc.gov/reactors/operating/oversight.html.
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The performance-based requirements in Sec. 50.160 address the most
risk-significant aspects of EP (e.g., classification, notification,
protective action recommendation, mitigation), as well as several
planning activities currently required under appendix E to 10 CFR part
50. Compliance with Sec. 50.160 is demonstrated by performance during
drills or exercises
[[Page 80061]]
and the NRC's review of performance objectives and corrective actions.
The NRC, in consultation with FEMA when an EPZ extends beyond the site
boundary, ensures that reasonable assurance is maintained based on
demonstrations of required emergency response functions through drills
and exercises and NRC inspections. Between drills and exercises,
licensees maintain a set of performance objectives to measure emergency
response performance. See the ``Reasonable Assurance'' section of this
document for a discussion of how this final rule maintains reasonable
assurance that adequate protective measures can and will be taken in
the event of a radiological emergency.
In responding to a public comment related to risks associated with
the loading and storage of irradiated fuel, the NRC determined that a
conforming change is needed to 10 CFR part 72, ``Licensing Requirements
for the Independent Storage of Spent Nuclear Fuel, High-Level
Radioactive Waste, and Reactor-Related Greater that Class C Waste.'' A
10 CFR part 72 specific license ISFSI must comply with the EP
requirements in Sec. 72.32. Most power reactor licensees have 10 CFR
part 72 general licenses for their ISFSIs. For these ISFSIs, Sec.
72.32(c) provides that the emergency plan required by Sec. 50.47
satisfies the EP requirements of Sec. 72.32. This provision means that
an emergency plan that meets the requirements of Sec. 50.47 satisfies
the EP requirements of Sec. 72.32. This same policy applies to an
ISFSI on the site of a power reactor whose licensee is complying with
Sec. 50.160. To allow for this, the NRC revised Sec. 72.32(c) to
clarify that the emergency plan that meets either the requirements in
Sec. 50.160 or the requirements in appendix E to part 50 and Sec.
50.47(b) satisfies the EP requirements of Sec. 72.32.
a. Application Process
Current applicants for a construction permit (CP), early site
permit (ESP), OL, or COL are required to provide emergency planning
information as described in Sec. 50.33, Sec. 50.34, Sec. 52.17,
``Contents of applications; technical information,'' and Sec. 52.79.
In particular, Sec. 50.34(a)(10) requires applicants for CPs to
describe within the preliminary safety analysis report (PSAR) their
preliminary plans for coping with emergencies. Under Sec. 52.17(b),
ESP applicants must identify within their site safety analysis report
physical characteristics of the proposed site that could pose a
significant impediment to the development of emergency plans and, as
applicable, measures for mitigating or eliminating the significant
impediments. Within the site safety analysis report, ESP applicants
also have the option of proposing either major features of emergency
plans (under Sec. 52.17(b)(2)(i)) or complete and integrated emergency
plans (under Sec. 52.17(b)(2)(ii)) for NRC review and approval.
Applicants for OLs and COLs, as well as ESP applicants choosing to
provide emergency plans under Sec. 52.17(b)(2)(ii), must submit
radiological emergency response plans of State and local governments
wholly or partially within the plume exposure pathway EPZ and State
governments wholly or partially within the IPZ under Sec. 50.33(g).
Under Sec. Sec. 50.34(b)(6)(v) and 52.79, OL and COL applicants also
must include in their final safety analysis report (FSAR) their plans
for coping with emergencies.
Because SMR and ONT licensees are given a choice between complying
with either Sec. 50.160 or complying with the requirements in appendix
E to 10 CFR part 50 and, for nuclear power reactor licensees, the
planning standards in Sec. 50.47, this final rule includes a number of
conforming changes to clarify application requirements for applicants
choosing the performance-based requirements.
Construction permit and OL applicants must include
emergency planning information in their PSARs and FSARs, respectively,
and Sec. 50.34(a)(10) and (b)(6)(v) require that the information
describe how the applicant complies with either appendix E to 10 CFR
part 50 or Sec. 50.160.
In order to maintain applicability to applicants and
licensees choosing to comply with Sec. 50.160, the NRC has added
references to Sec. 50.160 in Sec. 50.47(c)(1), Sec. 50.47(c)(1)(i),
and Sec. 50.47(e).
Combined license and ESP applicants must continue to
include emergency planning information in their site safety analysis
report and FSAR; Sec. Sec. 52.17(b)(2), 52.18, and 52.79(a)(21)
require that the information describe how the applicant complies with
either the applicable requirements in Sec. 50.47 and appendix E to 10
CFR part 50, or the requirements in Sec. 50.160.
Applicants choosing to comply with Sec. 50.160 must
describe how their emergency plans meet the requirements in Sec.
50.160(b). A revision to Sec. 52.1 clarifies that, for applicants
choosing the performance-based approach, the definition for ``major
feature of the emergency plans'' includes aspects of plans necessary to
address the requirements of Sec. 50.160(b).
Section 50.33(g)(2)(ii)(A) clarifies requirements to
submit State, local, and participating Tribal emergency response plans
for SMR, non-LWR, and NPUF applicants. Namely, if the application is
for an OL or COL, or for an ESP that contains plans for coping with
emergencies, and the plume exposure pathway EPZ extends beyond the site
boundary (as defined in Sec. 20.1003), the applicant must submit
State, local, and participating Tribal emergency response plans. For
purposes of this final rule, the term ``participating Tribal''
government means a Federally recognized Tribal government that has
decided to participate in FEMA's offsite radiological emergency
preparedness (REP) program and act as an independent entity with its
own radiological emergency plan. The NRC included participating Tribal
emergency response plans in this requirement to reflect the
Commission's January 9, 2017 ``Tribal Policy Statement'' (82 FR 2402)
and the 2019 issuance of NUREG-0654/FEMA-REP-1, Revision 2, which
encourages the involvement of Tribal governments in NRC activities, and
to reflect that Tribes have the option to participate in emergency
planning in the communities where they are located. A Tribal government
that has its own radiological emergency response plan can participate
in State or local emergency response planning as an independent entity.
A Tribe also has the option of being part of a State or local emergency
response plan without participating in exercises or other community
emergency response planning. To the extent that the Tribe elects to be
included in State and local plans or does not participate in community
emergency planning, FEMA will evaluate the adequacy of the State or
local emergency response plan to provide for adequate protection of the
members of the Tribal nation.
The requirements in Sec. 50.33(g)(2) also include submission of an
analysis for determining the plume exposure pathway EPZ, which is
discussed in the ``Emergency Planning Zones'' section of this document.
b. Performance Objectives
Applicants and licensees adopting the alternative performance-based
regulations must describe how they intend to maintain the effectiveness
of their emergency plans to meet the performance-based requirements,
which includes the implementation of a performance objective scheme
that reflects the emergency response functions under Sec.
50.160(b)(1)(iii). The NRC anticipates that performance objectives
needed to demonstrate
[[Page 80062]]
compliance with performance-based requirements will vary by design.
Therefore, the NRC or industry may develop additional guidance related
to performance objectives for specific designs or classes of designs.
Section 50.160(b)(1)(ii) requires applicants and licensees using
Sec. 50.160 to describe in the emergency plan an approach to develop
and maintain at the beginning of each calendar quarter a list of
performance objectives for that calendar quarter. Each licensee also
must maintain records showing the implemented performance objectives
and associated metrics during each calendar quarter for the previous
eight calendar quarters. The NRC monitors the performance objectives
and metrics to ensure that licensees are maintaining adequate emergency
planning and preparedness. During evaluated exercises, the NRC assesses
the performance of the licensee and reviews the ability of the licensee
to take corrective actions in a timely manner.
c. Drills and Exercises
A key feature of this final rule is the use of drills and exercises
to demonstrate that the applicant or licensee can implement the
emergency plan to carry out an effective response to emergency and
accident conditions. Current regulations in appendix E to 10 CFR part
50, section IV.F include a requirement for periodic drills and
exercises for nuclear power reactor licensees to be conducted during an
eight-year drill and exercise cycle. The eight-year cycle requirement
affords sufficient time for a licensee to vary exercise scenario
content to provide ERO members the opportunity to demonstrate
proficiency in the key skills necessary to respond to several specific
scenario elements. Similarly, Sec. 50.160(b)(1)(iii) requires the use
of drills and exercises to demonstrate the licensee's capabilities in
the enumerated emergency response functions listed in Sec.
50.160(b)(1)(iii)(A)-(H). Additionally, maintenance of these
capabilities is demonstrated through continued drills and exercises.
And, unlike the exercise cycle requirements in appendix E to 10 CFR
part 50, this final rule's performance-based requirements do not define
the required frequency of drills and exercises or their scenarios.
However, the exercise cycle frequency adopted by applicants and
licensees should afford sufficient time during which ERO members will
be provided ample opportunities to demonstrate their emergency response
function capabilities listed in Sec. 50.160(b)(1)(iii)(A)-(H).
Applicants and licensees are required to describe exercise scenario
elements necessary to demonstrate the emergency response functions in
their emergency plans.
For facilities with EPZs that do not extend beyond the site
boundary, OROs are not required to participate in radiological drills
and exercises. Participation is not required because State, local, and
Tribal government organizations do not need to provide for
predetermined, prompt protective measures or take specialized actions
in response to an event, other than providing onsite firefighting, law
enforcement, and ambulance/medical services. Applicants and licensees
may consider allowing State, local, or Tribal government organizations
to participate in drills when requested by the offsite authorities. The
``Offsite Radiological Emergency Preparedness Planning Activities''
section of this document addresses ORO participation for facilities
with EPZs that extend beyond the site boundary.
Under Sec. 50.160(b)(1)(iii), the applicant's or licensee's
emergency response team needs to have sufficient capability to
demonstrate the following emergency response functions:
Event classification and mitigation. The applicant or
licensee needs to establish an emergency classification and action
level scheme with established criteria for determining the need for
notification of State, local, and Tribal governments, and participation
of those governments in emergency response such that demonstration of
the scheme can be achieved through the performance of drills or
exercises within a performance-based framework. Applicants and
licensees need to demonstrate the ability to assess, classify, monitor,
and repair facility malfunctions and return the facility to safe
conditions. The term ``safe conditions'' means that the facility has
been restored to a radiologically safe and stable condition.
Protective actions. The drill and exercise program needs
to demonstrate the capability to implement and maintain protective
actions for onsite personnel, as warranted. Applicants and licensees
need to demonstrate the ability to recommend protective actions to
offsite authorities as conditions warrant.
Communications. The drill and exercise program needs to
demonstrate that control room staff are capable of making effective
communications to the ERO, including personnel and organizations who
may have responsibilities for responding during emergencies. Control
room staff and the emergency response team must have a means for
maintaining communication with the NRC as needed, and with OROs based
on prior arrangements. For example, the applicant or licensee may need
to notify and maintain communications with the onsite fire brigade;
offsite fire departments, rescue squad, or medical dispatch; and local
law enforcement according to established agreements. As EP programs are
developed, applicants and licensees need to determine if notification
to OROs is appropriate. If notification to OROs is necessary, then
drills and exercises need to demonstrate notifying the appropriate
Federal, State, local, and Tribal officials of an emergency.
Command and control. The drill or exercise needs to
demonstrate continuity of operations through one or more shift changes
of emergency response personnel, including the augmentation of the ERO.
The supporting organizational structure needs to have defined roles,
responsibilities, and authorities, and the drill or exercise needs to
show how key ERO functions (e.g., communications, command and control
of operations, notification of OROs, accident/incident assessment,
information dissemination to OROs and media, radiological monitoring,
protective response, security) will be maintained around the clock
throughout the emergency.
Staffing and operations. The drills or exercises need to
demonstrate effective emergency response with the level of staffing at
the SMR or ONT as described in the emergency plan. There needs to be
sufficient on-shift staff to perform all necessary tasks until
augmenting staff arrive to provide assistance. This is of particular
interest to the NRC because of the potential for reduced staffing
levels at SMRs and ONTs, as compared to large LWRs. For example, some
SMR and ONT designs may use multiple modules at one site with a single,
centralized control room. Designers have indicated that they are
considering designs that can operate with a staffing complement that is
less than what is currently required of large LWRs by Sec. 50.54(m),
which sets forth the minimum licensed operator staffing requirements.
Under this final rule, drills and exercises provide the NRC the
opportunity to consider the sufficiency of emergency response staffing
to implement the roles and responsibilities described in the emergency
plan. The performance opportunities allow applicant and licensee staff
to develop, maintain, or demonstrate key skills and provide applicants,
licensees, and the NRC the opportunity to identify and correct any
weaknesses or deficiencies.
Radiological Assessment. During the drills or exercises,
control room
[[Page 80063]]
staff, on-shift personnel, and the emergency response team need to
demonstrate the ability to assess radiological conditions, including
the ability to: monitor and assess dose to personnel resulting from
radiological releases and inadvertent criticality accidents; conduct
radiological surveys; assess and report information to the ERO such as
early indications of loss of adequate core cooling and radiological
releases, including the release of hazardous chemicals produced from
licensed material; and use protective equipment to implement protective
action strategies. The NRC received a public comment suggesting a
revision to Sec. 50.160(b)(1)(iii)(F)(1), ``Radiological conditions,''
Sec. 50.160(b)(1)(iii)(F)(3), ``Core or vessel damage,'' and Sec.
50.160(b)(1)(iii)(F)(4), ``Releases.'' The commenter recommended the
NRC change the phrase ``and report radiological conditions to the
response organization'' to read ``and report radiological conditions to
the onsite and offsite response organizations.'' In the proposed rule,
the NRC explained that the information to be reported under Sec.
50.160(b)(1)(iii)(F)(1), (F)(3) and (F)(4) (i.e., radiological
conditions; the extent and magnitude of damage to the core or other
vessel containing irradiated special nuclear material; and the extent
and magnitude of all radiological releases, including releases of
hazardous chemicals produced from licensed material, respectively)
would be reported to the ERO. However, considering the public comment,
the NRC determined that that information would need to be reported to
only certain personnel within the ERO. Therefore, the NRC changed these
rule provisions, so the information is reported to the ``applicable
response personnel.''
Reentry. Reentry is the temporary movement of people into
an area of actual or potential hazard. The applicant or licensee also
needs to demonstrate general plans for reentry after an emergency
through drills or exercises. The applicant or licensee needs to
demonstrate reentry plans for the site boundary, including determining
when facility conditions are acceptable to justify reentry (e.g., based
on air and soil sampling and analysis to determine levels of
radiological contamination and projected dose). Certain individuals who
have been evacuated or relocated from a restricted area may be allowed
to reenter under controlled conditions to perform specified activities.
Critique and corrective actions. The performance of
emergency response functions in drills and exercises (or responses to
actual emergencies) is evaluated to identify weaknesses or deficiencies
in ERO performance and the EP program. The applicant or licensee needs
to use a corrective action program to evaluate, track, and correct EP
weaknesses and deficiencies identified in drills and exercises (or
responses to actual emergencies). Weaknesses and deficiencies may
include items such as errors in the emergency plan or implementing
procedures, ERO performance weaknesses, or degraded conditions in
emergency response facilities, systems, and equipment resulting in a
performance objective not being met. Corrective actions include
remedial exercises to demonstrate that the deficiencies have been fully
addressed.
d. Planning Activities
In addition to an applicant's or licensee's performance
demonstrations through drills and exercises, this final rule includes a
set of required planning activities in Sec. 50.160(b)(1)(iv) to
account for certain EP-related activities that are not readily
observable or effectively measured through drills and exercises. This
final rule includes two sets of planning activities: Sec.
50.160(b)(1)(iv)(A) establishes planning activities for all applicants
and licensees complying with Sec. 50.160; and Sec.
50.160(b)(1)(iv)(B) establishes planning activities that apply to
applicants and licensees with a plume exposure pathway EPZ that extends
beyond the site boundary.
Currently, Sec. 50.47(b) requires licensees to be capable of
maintaining prompt communication among the response organizations and
the public. In Sec. 50.160(b)(1)(iv)(A)(1), SMR and ONT applicants and
licensees are required to be capable of preparing and issuing
information to the public during emergencies to protect public health
and safety. The NRC is establishing in Sec. 50.160(b)(1)(iv)(A)(2)
that applicants and licensees also must be capable of implementing the
NRC-approved emergency response plan in conjunction with the Licensee
Safeguards Contingency Plan. In implementing the emergency response
plan, licensees should coordinate security-related and emergency
response activities to ensure an adequate and efficient response to a
radiological event. The regulations in Sec. 50.160(b)(1)(iv)(A)(3)
require the capability to establish voice and data communications with
the NRC for use during emergencies. Voice communication through the
Emergency Notification System (ENS) and data communication through an
electronic data link provide timely updates to the NRC on the
implementation of the emergency plan during and after an emergency.
Section 50.160(b)(1)(iv)(A)(4) requires the capability to establish
emergency response facilities to support the emergency response
functions required in Sec. 50.160(b). Applicants and licensees need to
establish a facility from which effective direction can be given and
effective control can be executed for the duration of an emergency.
Depending on design- and site-specific considerations, applicants and
licensees may need to establish multiple emergency response facilities
to demonstrate the capability to support emergency response functions.
Emergency plans need to include descriptions of the facilities'
functional capabilities, activation times, staffing, and communication
systems.
In this final rule, the NRC moved the proposed requirement in Sec.
50.160(b)(1)(iv)(B)(4) to new Sec. 50.160(b)(1)(iv)(A)(5). This
provision requires applicants and licensees to provide site
familiarization training to individuals whose assistance may be needed
in the event of a radiological emergency, including personnel from
offsite response organizations. The NRC moved this provision to ensure
that all applicants and licensees complying with Sec. 50.160 provide
this offsite organization training, notwithstanding whether an
applicant's or licensee's plume exposure pathway EPZ extends beyond the
site boundary.
Finally, the NRC moved the proposed requirement in Sec.
50.160(b)(1)(iv)(B)(11) to new Sec. 50.160(b)(1)(iv)(A)(6). This
provision requires applicants and licensees to maintain up to date the
emergency plan, contacts and arrangements with OROs, procedures, and
evacuation time estimates (ETEs). Emergency plans need to include a
description of the periodic coordination with OROs. The NRC moved this
provision to ensure that all applicants and licensees complying with
Sec. 50.160 maintain their emergency plans, notwithstanding whether
the plume exposure pathway EPZ extends beyond the site boundary.
e. Offsite Radiological Emergency Preparedness Planning Activities
Current requirements for offsite radiological emergency response
plans are included in Sec. 50.47 and appendix E to 10 CFR part 50. In
select cases, the NRC has granted exemptions from these requirements to
licensees based partially on a demonstration that an offsite
radiological release would not exceed the EPA PAGs at the site
boundary. For SMR and ONT applicants and licensees complying with Sec.
50.160
[[Page 80064]]
that have no plume exposure pathway EPZ or establish a plume exposure
pathway EPZ at the site boundary, the NRC does not mandate offsite
radiological emergency planning activities. Section 50.160(b)(1)(iv)(B)
establishes offsite planning activities that must be described in the
emergency plan for applicants and licensees with plume exposure pathway
EPZs extending beyond the site boundary. These activities include:
Contacts/arrangements with governmental agencies.
Applicants and licensees need to describe in emergency plans their
contacts and arrangements with OROs for offsite radiological emergency
response. Applicants and licensees need to ensure regular coordination
with these organizations, including review of emergency plan changes.
Notification of OROs. Applicants and licensees need to
establish primary and backup means of notifying OROs and a message
authentication scheme. The emergency plan needs to include the proposed
time period within which notifications to OROs would be made.
Protective measures. Applicants and licensees need to
maintain the capability to issue offsite protective action
recommendations to OROs (e.g., evacuation, sheltering). The emergency
plan needs to describe the procedures by which protective measures are
implemented, maintained, and discontinued in their emergency plans.
Evacuation time estimate study. Applicants and licensees
need to conduct an evacuation time estimate (ETE) study and maintain
the ETE up to date. The ETE is primarily used in the development of
protective action strategies and to inform offsite protective action
decisionmaking. In the proposed rule, Sec. 50.160(b)(1)(iv)(B)(5)
would have required an ETE ``of the areas beyond the site boundary and
within the EPZ.'' The NRC received comments that the phrase, ``areas
beyond the site boundary'' could be interpreted to exclude, rather than
include, the area within the site boundary. As a result, in this final
rule, the NRC removed the phrase ``beyond the site boundary and'' to
clarify that an ETE is intended to estimate the time to evacuate
various sectors and distances within a licensee's plume exposure
pathway EPZ, which includes the area within the plant site boundary.
However, for a site boundary EPZ, the NRC is not requiring an ETE
because predetermined, prompt offsite protective actions are not
required. In addition, in this final rule Sec. 50.160(b)(1)(iv)(B)(5)
is renumbered to Sec. 50.160(b)(1)(iv)(B)(4).
Emergency response facilities. Applicants and licensees
need to describe in their emergency plans an offsite facility and any
backup facilities for coordination of the response with OROs.
Offsite dose projections. Applicants and licensees need to
be capable of making offsite dose assessments and communicating their
results to OROs. The emergency plan needs to describe the methods and
instruments available for conducting these assessments.
Dissemination of public information. Applicants and
licensees need to describe in their emergency plans the means of
providing initial and updated information to the public during an
emergency (e.g., communication with the news media, coordination with
OROs). Applicants and licensees need to describe the public alert and
notification system.
Reentry. Applicants and licensees need to describe in
their emergency plans coordination with OROs on offsite reentry plans
including the conditions necessary to allow reentry into the EPZ during
and after an emergency. Some conditions may include: (1) use of access
control points to issue dosimetry and train reentering individuals on
its use; (2) use of stay times (as used here, the amount of time a
person can safely stay in a restricted zone without exceeding their
exposure limit), depending on the location of the reentry destination;
(3) use of a health physicist escort or other personnel escort trained
in the use of dosimetry; and (4) provision of monitoring and
decontamination for exiting individuals. Reentry plans cover private
citizens. For example, reentry plans may cover scenarios such as
farmers being permitted to reenter the affected area to provide
essential care for livestock.
Offsite drills and exercises. Applicants and licensees
need to describe in their emergency plans how offsite radiological
emergency response is incorporated into their drills and exercises
without mandatory public participation. Drill and exercise programs
need to incorporate offsite response, and applicants and licensees need
to coordinate with offsite response organizations, including FEMA, for
their participation in drills and exercises and implementation of
corrective actions.
In carrying out its responsibility under the Atomic Energy Act of
1954, as amended (AEA), the NRC establishes regulatory standards for
onsite and offsite radiological emergency planning. If an applicant's
or licensee's emergency plan meets the NRC's regulations, then the NRC
has reasonable assurance that adequate protective measures can and will
be taken in the event of a radiological emergency. In the case of
existing EP regulations for NPUFs, fuel cycle facilities, and ISFSIs,
there are no regulatory requirements for dedicated offsite radiological
emergency plans as part of the NRC license. Accordingly, NRC guidance
for such facilities states that FEMA findings and determinations are
not needed to support NRC licensing decisions. Similarly, for SMRs and
ONTs within the scope of this final rule, FEMA findings and
determinations regarding reasonable assurance under Sec. 50.54(s)(3)
are only needed for a facility where a plume exposure pathway EPZ
extends beyond the site boundary requiring dedicated offsite
radiological EP plans for the facility.
This final rule, which does not require offsite planning activities
for facilities without plume exposure pathway EPZs or with plume
exposure pathway EPZs at the site boundary, does not affect the
authority that FEMA has under its regulations in Chapter I, ``Federal
Emergency Management Agency, Department of Homeland Security,'' of 44
CFR, ``Emergency Management and Assistance,'' for overall emergency
management and assistance to State and local response organizations,
nor does it affect the responsibilities of State and local governments
to establish and maintain comprehensive emergency management plans.
Under its role as described in the National Response Framework, the NRC
remains ready to provide FEMA and State, local, and Tribal governments
with technical advice related to the safety and security of any
proposed SMR or ONT facility.
In cases where a plume exposure pathway EPZ does not extend beyond
the site boundary, even in the absence of NRC requirements for offsite
radiological emergency planning, the responsible OROs would continue to
take actions to protect the health and safety of the public. Each of
the States has established an emergency management organization to
facilitate the safeguarding of the life and property of its
citizens.\5\
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\5\ See FEMA's Emergency Management Agencies website https://www.fema.gov/emergency-management-agencies.
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The NRC has confidence in the ability of OROs to implement
appropriate response actions when necessary, using comprehensive ``all-
hazards'' emergency planning. The OROs' general emergency response
capabilities are not unique to radiological emergency response. The
NRC's confidence is expressed in the NRC's regulations in Sec.
50.47(c)(1)(iii) and further strengthened by the NRC's
[[Page 80065]]
recognition of national-level efforts (e.g., National Incident
Management System,\6\ National Preparedness Goal,\7\ Core
Capabilities,\8\ National Preparedness System,\9\ National Planning
Frameworks \10\), in which the NRC participates, to improve the state
of emergency planning at all levels of government and within the whole
community.\11\ Consequently, for SMR and ONT facilities without plume
exposure pathway EPZs or with plume exposure pathway EPZs at the site
boundary, there is reasonable assurance that appropriate response
actions can and will be taken in the event of a radiological emergency,
without the need for regulatory standards for offsite radiological
emergency response plans and the associated FEMA findings and
determinations that offsite plans are adequate and can be implemented.
---------------------------------------------------------------------------
\6\ For further information on the National Incident Management
System, see: https://www.fema.gov/pdf/emergency/nims/nimsfaqs.pdf.
\7\ For further information on the National Preparedness Goal,
see: https://www.fema.gov/national-preparedness-goal.
\8\ For further information on Core Capabilities, see: https://www.fema.gov/core-capabilities.
\9\ For further information on the National Preparedness System,
see: https://www.fema.gov/national-preparedness-system.
\10\ For further information on the National Planning
Frameworks, see: https://www.fema.gov/national-planning-frameworks.
\11\ For more information on the definition of ``whole
community,'' see: https://www.fema.gov/whole-community#.
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The requirements in this final rule do not alter exemptions from EP
regulations previously granted to power reactor licensees that have
transitioned to decommissioning. In particular, the changes to Sec.
50.47 in this rule clarify when Sec. 50.47(b) does not apply to
offsite emergency plans once certain conditions are met, consistent
with the exemptions.
f. Changes to Emergency Plans
Section 50.54(q) currently establishes the process for evaluation,
submission, and review of changes to emergency plans. The NRC is
establishing that SMRs and ONTs continue to follow the existing process
for changes to emergency plans, whether the facilities are following
the performance-based approach to EP under Sec. 50.160 or the approach
to EP under Sec. 50.47(b) and appendix E to 10 CFR part 50. This final
rule includes conforming changes to Sec. 50.54(q).
Existing Sec. 50.54(q)(2) requires licensees to follow and
maintain the effectiveness of an emergency plan that meets the
requirements in appendix E to 10 CFR part 50 and, for power reactor
licensees, the planning standards in Sec. 50.47(b), and existing Sec.
50.54(q)(3) and (4) describe the process for analyzing, submitting, and
making changes to emergency plans. The NRC is revising Sec.
50.54(q)(2) through (4) to include cross-references to the requirements
under Sec. 50.160 for licensees choosing the performance-based
approach and to clarify that licensees must follow and maintain an
emergency plan that meets either the applicable requirements of Sec.
50.160 or the requirements of appendix E to 10 CFR part 50 and, for
nuclear power reactor licensees, the planning standards of Sec.
50.47(b). The NRC is not making any changes to the emergency plan
change process. Licensees choosing the performance-based approach to EP
must evaluate changes to their emergency plans against the performance-
based requirements under Sec. 50.160 using the same reduction in
effectiveness criteria as current licensees and submit changes that
reduce the effectiveness of the plan to the NRC for approval prior to
implementation. The NRC is revising the definition of ``emergency
planning function'' under Sec. 50.54(q)(1) to remove references to
appendix E to 10 CFR part 50 and Sec. 50.47(b) because emergency
planning functions are addressed under both these sections and under
Sec. 50.160, and the NRC does not consider the references essential to
the definition.
For any existing or future holder of an OL or COL for an SMR or
non-LWR, or any future holder of an OL for an NPUF, Sec. 50.54(q)(7)
stipulates that a licensee desiring to change its emergency plan to
comply with the performance-based approach to EP needs to submit a
license amendment request with the proposed changes to its emergency
plan. The request needs to include an explanation of the schedule and
analyses supporting the implementation of a performance-based EP
program.
g. Emergency Response Data System
Appendix E to 10 CFR part 50, section VI, ``Emergency Response Data
System,'' outlines a set of system, testing, and implementation
requirements for the emergency response data system (ERDS) for
operating nuclear power reactor licensees, and Sec. 50.72, ``Immediate
notification requirements for operating nuclear power reactors,''
includes requirements for activation of ERDS. In contrast, the 10 CFR
part 50, appendix E ERDS requirement and Sec. 50.72 ERDS activation
requirement are not applicable to applicants and licensees choosing to
comply with Sec. 50.160. Applicants and licensees choosing Sec.
50.160 need to describe in their emergency plans the data links with
the NRC for use in emergencies. Specific parameters to be reported are
determined for the specific technology during the license application
process under 10 CFR part 50 or part 52. The NRC must review each
applicant's data transmission capabilities on a case-specific basis.
The NRC is not making any changes to its ERDS regulations.
3. Hazard Analysis of Contiguous or Nearby Facilities
The NRC anticipates that SMRs and ONTs may be located on the same
site or close to large LWRs or other types of reactors; industrial,
military, or transportation facilities; or a combination of these or
other facilities. The presence of such facilities requires additional
EP considerations relative to an independently sited facility. For
example, SMRs or ONTs may need to be prepared for events associated
with contiguous or nearby facilities' hazards.
Although the NRC's regulations do not extend to the licensing,
operations, or oversight of non-nuclear facilities, the NRC has
authority over the activities of NRC applicants and licensees that are
located on or close to an industrial site or other facility not
licensed by the NRC. For example, a nuclear power facility could be
sited contiguous to or near an industrial facility to supply process
heat or electrical power, or an SMR could be used to power a
desalination facility located on the same site. There are many
potential examples of licensees that may be located contiguous to or
near a facility not licensed by the NRC; under each scenario, the
hazards of the facility not licensed by the NRC must be factored into
the EP program of the nuclear facility to ensure the protection of
public health and safety.
For SMR or ONT applicants and licensees located contiguous to or
near another facility, Sec. 50.160(b)(2) requires the applicant or
licensee to perform a hazard analysis to assess any credible hazards
that would adversely impact the implementation of emergency plans at
the SMR or ONT facility. The analysis needs to identify site-specific,
credible hazards from other, non-nuclear facilities that require the
applicant's or licensee's emergency plan to include arrangements that
would otherwise not be needed in the absence of the facility. For
example, these arrangements might include notifying contiguous or
nearby facilities regarding emergencies, classifying a hazard from
another facility that may negatively impact the safe operation of the
nuclear facility, and providing for protective actions for the other
facility's personnel or other on-site individuals, such as visitors. A
credible hazard could include any event at another facility's site that
would lead
[[Page 80066]]
to an emergency response at the SMR or ONT facility. It may be
appropriate for SMRs or ONTs with contiguous or nearby facilities to
consider a quantitative or qualitative assessment of all postulated
accident scenarios at the other facilities. The applicant's or
licensee's EP program must reflect these credible hazards and the
planning activities needed to address the hazards. For example, the
location of facilities on the same site or close to an SMR or ONT may
affect the applicant's or licensee's determinations about the EPZ size.
Looking across all facilities, the applicant or licensee must assess
the combined radiological and industrial hazards at the site.
The NRC is issuing RG 1.242 with this final rule, which includes
guidance on hazard analyses for contiguous or nearby facilities.
4. Emergency Planning Zones
The NRC is establishing a consequence-oriented, technology-
inclusive approach to EPZ size determinations for SMRs and ONTs. This
approach is similar to the dose/distance rationale historically used by
the NRC, in part, to determine EPZ size for production or utilization
facilities. Under the existing regulations, SMRs or ONTs, depending on
their capacity and technology, are either required to establish a 10-
mile (16-km) plume exposure pathway EPZ and a 50-mile (80-km) IPZ or
follow the case-by-case EPZ size determination process under Sec. Sec.
50.33(g), 50.47(c)(2), and section I.3. of appendix E to 10 CFR part
50. Preapplication discussions and previous applications for EP
exemption requests from SMRs and ONTs have indicated that these
technologies could have reduced offsite dose consequences in the
unlikely event of an accident, and the standard 10-mile (16-km) EPZ and
50-mile (80-km) IPZ may not be necessary to ensure public health and
safety for these facilities. Because of the range of potential source
terms and designs for SMRs or ONTs, the NRC is establishing an
alternative scalable methodology for determining EPZ size on a case-
specific basis. This methodology is established in guidance (RG 1.242)
generically without design- or site-specific information regarding
source term, fission products, or projected offsite dose. Applicants
must provide the design- and site-specific information regarding source
term, fission products, or projected offsite dose for NRC review in an
application.
As mentioned in the ``Technical Basis'' section of this document,
NUREG-0396 established the planning basis for EP and established EPZs
for large LWRs based on the conclusion that the objective of emergency
response plans should be to provide dose savings for a spectrum of
accidents that could produce offsite doses in excess of the EPA PAGs.
This final rule is offering an EPZ size determination process that is
consistent with this philosophy. Section 50.33(g)(2) establishes EPZ
size determination requirements for SMR, non-LWR, and NPUF applicants
complying with Sec. 50.160. Small modular reactor and non-LWR
applicants for an OL, COL, CP, or ESP and NPUF applicants for a CP or
OL must submit the analysis used to establish their proposed plume
exposure pathway EPZ size. Applicants need to establish their EPZ as
the area within which public dose, as defined in Sec. 20.1003, is
projected to exceed 10 mSv (or 1 rem) TEDE over 96 hours from the
release of radioactive materials from the facility considering accident
likelihood and source term, timing of the accident sequence, and
meteorology. In addition, applicants need to show that the plume
exposure pathway EPZ is the area in which predetermined, prompt
protective measures are necessary. If the plume exposure pathway EPZ
extends beyond the site boundary and if the application is for an SMR
or non-LWR OL, COL, an ESP that contains plans for coping with
emergencies under Sec. 52.17(b)(2)(ii), or an ESP that proposes major
features of the emergency plans and describes the EPZ, then Sec.
50.33(g)(2) requires that the exact configuration of the plume exposure
pathway EPZ be determined in relation to local emergency response needs
and capabilities, as they are affected by such conditions as
demography, topography, land characteristics, access routes, and
jurisdictional boundaries. Section 50.160(b)(3) requires applicants to
describe in their emergency plans the boundary and physical
characteristics of the EPZ.
Upon receiving an OL, COL, ESP, or CP applicant's technical basis
for proposed site-specific plume exposure pathway EPZ size, the NRC
must review the design and licensing information to ensure that the
information that the applicant provides on the offsite dose
consequences is commensurate with the requested EPZ size and that the
applicable performance-based requirements are met to ensure adequate
protection of public health and safety. Some of this information may
have already been provided as part of a certified design referenced in
an application or in a topical report related to the design. The NRC
also must assess the need to provide site-specific guidance concerning
the accident scenarios being considered.
The plume exposure pathway EPZ determination requirements could
result in an applicant having no plume exposure pathway EPZ. For this
result to occur, the applicant's analysis required by Sec. 50.33(g)(2)
would need to show that one or both of the criteria in Sec.
50.33(g)(2)(i) are not met. For purposes of complying with Sec.
50.160, this applicant would be similar to an applicant with a site
boundary plume exposure pathway EPZ. Both applicants would need to have
an emergency plan that meets the requirements of Sec. 50.160(a),
(b)(1)(i)-(iv)(A), (b)(2), (b)(4) and (c). An applicant with a site
boundary plume exposure pathway EPZ would also need to comply with
Sec. 50.160(b)(3), which requires the applicant to determine and
describe in its emergency plan the boundary and physical
characteristics of the EPZ.
In addition to the plume exposure pathway EPZ size determination
process, the NRC is including ingestion response planning requirements
under Sec. 50.160(b)(4). Applicants and licensees complying with Sec.
50.160 are required to describe in their emergency plans the
capabilities to prevent contaminated food and water from entering the
ingestion pathway. The proposed rule would have required applicants and
licensees to describe in their emergency plans the capabilities to
protect contaminated food and water from entering the ingestion
pathway. Although the goal is to protect the public from contaminated
food and water, this goal can be achieved by preventing contaminated
food and water from entering the ingestion pathway. Therefore, in the
final rule, the NRC revised Sec. 50.160(b)(4) to require applicants
and licensees to describe in their emergency plans the capabilities to
prevent contaminated food and water from entering the ingestion
pathway.
The capabilities described in the emergency plan need to address
major exposure pathways associated with the ingestion of contaminated
food and water. The duration of any exposure to contaminated food or
water could range from weeks to months and represents a long-term
response need. Even in cases where the facility's plume exposure
pathway EPZ is bounded by the site boundary, the applicant or licensee
must reference capabilities of Federal, State, and local authorities.
Examples of demonstrated capabilities in response to ingestion of
contaminated food or water include three notable large-scale
quarantines documented by the Centers for Disease Control and
Prevention: the multi-state
[[Page 80067]]
outbreaks of E. Coli O157:H7 infections from spinach (September-October
2006); the multi-state outbreak of human salmonella enteritis
infections associated with shell eggs (July-December 2010); and, the
multi-state outbreak of fungal meningitis and other infections (October
2012). In each case, the successful quarantine and removal from public
access of contaminated food and water products in response to
biological contamination demonstrates that a response to prevent
ingestion of contaminated foods and water could be performed in an
expeditious manner without a predetermined ingestion planning zone.
5. Implementation
This final rule includes implementation schedules for existing and
future applicants and licensees of facilities choosing to comply with
Sec. 50.160. The NRC received public comments on the proposed
requirement for applicants to conduct an initial exercise to
demonstrate effectiveness of the EP program no later than 18 months
before the issuance of an OL or the scheduled date for initial loading
of fuel for a part 52 COL holder. The comments suggested that an
initial exercise ``no later than 18 months before'' the issuance of an
OL for a part 50 applicant or the scheduled date for initial loading of
fuel for a part 52 COL holder is not the appropriate time frame. In
reviewing these comments, the NRC determined that the wording in the
proposed rule needed revision. Specifically, in Sec. 50.160(c)(1), the
NRC is revising the rule language to require an applicant for an OL
issued under 10 CFR part 50 after the effective date of this final rule
that desires to comply with the performance-based approach to EP to
establish, implement, and maintain an EP program that meets the
requirements of Sec. 50.160(b), as described in the emergency plan and
license, and conduct an initial exercise to demonstrate this compliance
within 2 years before the issuance of an OL for the first unit
described in the license application. Similarly, in Sec. 50.160(c)(2),
a holder of a COL issued under 10 CFR part 52 desiring to comply with
the performance-based approach to EP before the Commission has made the
finding under Sec. 52.103(g) is required to establish, implement, and
maintain an EP program that meets the requirements of Sec. 50.160(b),
as described in the emergency plan and license, and conduct an initial
exercise to demonstrate this compliance within 2 years before the
scheduled date for initial loading of fuel. These changes allow greater
flexibility in demonstrating regulatory compliance and ensure
consistency with appendix E to 10 CFR part 50, which requires an
applicant to conduct a full-participation emergency planning exercise
within 2 years before the issuance of an OL for a part 50 applicant or
the scheduled date for initial loading of fuel for a part 52 COL
holder.
As discussed in the ``Changes to Emergency Plans'' section of this
document, for existing or future SMRs or ONTs that hold OLs or COLs,
Sec. 50.54(q)(7) stipulates that facilities desiring to change their
emergency plans to comply with the performance-based approach to EP,
shall submit a license amendment request with these changes.
a. Reasonable Assurance
The NRC's authority to regulate the use of radioactive materials is
set forth in the AEA. The AEA confers broad regulatory powers to the
Commission and specifically authorizes it to issue regulations it deems
necessary to fulfill its responsibilities under that statute. Section
161.b of the AEA authorizes the Commission to establish by rule,
regulation, or order such standards and instructions to govern the
possession and use of special nuclear material, source material, and
byproduct material as the Commission may deem necessary or desirable to
promote the common defense and security or to protect health or to
minimize danger to life or property. Under Section 161.i of the AEA,
the Commission may prescribe such regulations or orders, as it may deem
necessary, to protect health and to minimize danger to life or
property.
The NRC's regulations include standards for both onsite and offsite
emergency response plans. The Commission, based on its authority under
the AEA, determined that these standards are necessary for operating
power reactors to provide for public health and safety. The regulations
in Sec. Sec. 50.47 and 50.54 prescribe how the NRC makes licensing
decisions or takes appropriate enforcement action by using findings of
reasonable assurance that adequate protective measures can and will be
taken to protect public health and safety in the event of a
radiological emergency. The NRC bases reasonable assurance findings on:
(1) the NRC's assessment of the adequacy of the applicant's or
licensee's onsite emergency plan and whether there is reasonable
assurance the plan can be implemented, and (2) the NRC's review of FEMA
findings and determinations as to whether State and local emergency
plans are adequate and whether there is reasonable assurance that they
can be implemented.
The performance-based approach to EP under Sec. 50.160 provides an
adequate basis for an acceptable state of EP and ensures that
coordination and applicable arrangements with offsite agencies are
maintained (e.g., notification and assistance resources). Reasonable
assurance is maintained under the performance-based approach through:
(1) submission and case-specific review of design- and site-specific
analyses to support the proposed plume exposure pathway EPZ size; (2)
review of site-specific emergency plans to ensure compliance with the
performance-based requirements; (3) demonstration of emergency response
functions through drills and exercises; (4) regular tracking of
performance objective information; (5) analysis of potential hazards
associated with contiguous or nearby NRC-licensed facilities or
facilities not licensed by the NRC; and (6) the NRC's inspection and
enforcement program.
For applicants and licensees with plume exposure pathway EPZs
beyond the site boundary, the NRC, in consultation with FEMA, continues
to ensure that reasonable assurance is maintained based on the
performance-based requirements, as demonstrated through drills and
exercises. As described in the ``Offsite Radiological Emergency
Preparedness Planning Activities'' section of this document, FEMA
findings and determinations regarding reasonable assurance under Sec.
50.54(s)(3) are not needed for SMRs or ONTs without plume exposure
pathway EPZs or with plume exposure pathway EPZs that do not extend
beyond the site boundary. The NRC makes reasonable assurance
determinations regarding onsite EP requirements for these facilities,
and every licensee must follow and maintain the effectiveness of its
emergency plan if the NRC is to continue to find, under Sec.
50.54(s)(2)(ii), that there is reasonable assurance that adequate
protective measures can and will be taken in the event of a
radiological emergency at that site.
In this final rule, the NRC revised Sec. 50.160(b) from the
proposed rule to state that the reasonable assurance finding made under
Sec. 50.47(a)(1) necessary to issue an OL, COL, or ESP to an applicant
complying with Sec. 50.47 and appendix E to part 50 is also necessary
to issue an OL, COL, or ESP to a power reactor applicant complying with
Sec. 50.160. The NRC also revised Sec. 50.47(a)(1)(iv) to reflect
that an applicant for an ESP that proposes major features of the
emergency plan
[[Page 80068]]
under Sec. 52.17(b)(2)(i) can choose to comply with Sec. 50.160.
b. Administrative and Clarifying Changes to the Regulations
The NRC is making clarifying changes to the following paragraphs.
1. Section 50.54(q)(4), which required after February 21, 2012, any
changes to a licensee's emergency plan that reduce the effectiveness of
the plan as defined in paragraph (q)(1)(iv) to be submitted to the NRC
for approval before implementation. As the date of the provision has
expired, the NRC is deleting ``after February 21, 2012'' and retaining
the remainder of the provision.
2. Section 50.54(q)(5), which required licensees to submit a report
of each change made without prior NRC approval, as allowed under Sec.
50.54(q)(3), after February 21, 2012, including a summary of its
analysis, within 30 days after the change is put into effect. The NRC
is deleting ``after February 21, 2012'' from this provision, as the
date has expired, and retaining the remainder of the provision.
3. Section 50.54(s)(2)(ii), which allows the NRC to take
enforcement action to shut down power reactors that do not provide
reasonable assurance that adequate protective measures would be taken
in the event of a radiological emergency after April 1, 1981. There is
no longer a need for the date requirement of this provision because any
future determinations made under Sec. 50.54(s) will occur after April
1, 1981. The NRC is deleting ``after April 1, 1981'' and retaining the
remainder of the provision.
The NRC is revising these requirements in the interest of
regulatory clarity. Eliminating or revising these requirements does not
relax currently effective regulatory requirements or cause any
regulatory burden for existing or future licensees.
III. Opportunities for Public Participation
The NRC published the proposed rule on May 12, 2020 (85 FR 28436),
and the comment period was open until July 27, 2020. On July 21, 2020
(85 FRN 44025), the NRC extended the public comment period by an
additional 60 days to September 25, 2020, to allow more time for
members of the public and other stakeholders to develop and submit
their comments.
The NRC hosted one public meeting to engage with external
stakeholders on the proposed rule and associated draft guidance
document during the public comment period. This public meeting was held
on June 24, 2020. A summary of the public meeting is available in
ADAMS, as provided in the ``Availability of Documents'' section. The
feedback from this public meeting informed the development of this
final rule.
IV. Public Comment Analysis
The NRC prepared a summary and analysis of public comments received
on the 2020 proposed rule and draft regulatory guide, as referenced in
the ``Availability of Documents'' section. In response to the proposed
rule and draft regulatory guide, the NRC received 2,212 comment
submissions.
The public comment submittals are available from the Federal e-
Rulemaking website at https://www.regulations.gov under Docket ID NRC-
2015-0225. Responses to the public comments, including a summary of how
this final rule or the guidance changed as a result of the public
comments, can be found in the public comment analysis document as
indicated in the ``Availability of Documents'' section of this
document.
For more information about the associated guidance document, see
the ``Availability of Guidance'' section of this document.
V. Section-by-Section Analysis
The following paragraphs describe the specific changes within this
final rule.
Section 50.2 Definitions
In Sec. 50.2, this final rule adds the definitions for Non-light-
water reactor, Non-power production or utilization facility, and Small
modular reactor.
Section 50.8 Information Collection Requirements; OMB Approval
In Sec. 50.8, this final rule adds new Sec. 50.160 to the list of
approved information collection requirements contained in 10 CFR part
50.
Section 50.10 License Required; Limited Work Authorization
In Sec. 50.10, this final rule revises paragraph (a)(1)(vii) to
include onsite emergency facilities necessary to comply with new Sec.
50.160 requirements within the scope of items for which a CP or limited
work authorization is necessary to commence construction.
Section 50.33 Contents of Applications; General Information
In Sec. 50.33, this final rule revises paragraph (g) to create new
subparagraphs (g)(1) and (2). Paragraph (g)(1) contains the original
text of paragraph (g) and adds the qualifier ``Except as provided in
paragraph (g)(2) of this section.''
Paragraph (g)(2) establishes EPZ size determination requirements
for SMR, non-LWR, and NPUF applicants complying with Sec. 50.160.
Section 50.34 Contents of Applications; Technical Information
In Sec. 50.34, this final rule revises paragraph (a)(10) to
require SMR, non-LWR, or NPUF CP applicants to describe in their PSARs
the preliminary plans for coping with emergencies based on the
requirements in either Sec. 50.160 or appendix E to 10 CFR part 50.
This final rule also revises paragraph (b)(6)(v) to require SMR,
non-LWR, and NPUF applicants for an OL to include in their FSARs their
plans for coping with emergencies based on the requirements in either
Sec. 50.160 or appendix E to 10 CFR part 50.
Section 50.47 Emergency Plans
In Sec. 50.47, this final rule makes conforming changes to
paragraphs (a)(1)(iv), (b) introductory text, (c)(1) introductory text,
(c)(1)(i), and (e) and adds new paragraph (f) denoting when the offsite
emergency response plan requirements in Sec. 50.47(a)(2), (b), and
(c)(2) do not apply.
Section 50.54 Conditions of Licenses
In Sec. 50.54, this final rule revises paragraph (q)(1)(iii) to
remove the references to appendix E to 10 CFR part 50 and Sec.
50.47(b).
This final rule revises paragraph (q)(2) to include new
subparagraphs (q)(2)(i) and (ii). Paragraph (q)(2)(i) contains the
original text of paragraph (q)(2) and adds the qualifier ``except as
provided in paragraph (q)(2)(ii) of this section,'' and paragraph
(q)(2)(ii) allows SMR, non-LWR, and NPUF licensees to follow and
maintain the effectiveness of an emergency plan that meets the
requirements of Sec. 50.160 or appendix E to 10 CFR part 50 and, for
nuclear power reactor licensees, Sec. 50.47(b).
This final rule also revises paragraph (q)(3) to include new
subparagraphs (q)(3)(i) and (ii). Paragraph (q)(3)(i) contains the
original text of paragraph (q)(3) and adds the qualifier ``except as
provided in paragraph (q)(3)(ii) of this section'' and paragraph
(q)(3)(ii) specifies when an SMR, non-LWR, or NPUF licensee choosing to
comply with the performance-based EP regulations could make changes to
its emergency plan without prior NRC approval.
Paragraphs (q)(4) and (5) are amended to remove the date February
21, 2012, and paragraph (q)(4) is further revised to specify that
licensees that choose to comply with the new requirements of Sec.
50.160, when making an emergency plan change that reduces plan
effectiveness, need to specify the basis for concluding how their
revised
[[Page 80069]]
emergency plans continue to meet the requirements of that section.
This final rule adds new paragraph (q)(7) that contains the details
for submitting license amendment requests for SMR, non-LWR, or NPUF
licensees implementing EP programs with the associated plan
modifications necessary to meet the requirements of new Sec. 50.160.
Paragraph (s)(2)(ii) is amended to remove the date April 1, 1981,
and to replace the word ``reactor'' with the word ``facility.''
This final rule revises paragraph (s)(3) by adding clarification at
the beginning of the sentence that if the standards apply to offsite
emergency response plans, or if the planning activities in new Sec.
50.160(b)(1)(iv)(B) apply, then the NRC bases its findings on a review
of FEMA's findings and determinations.
This final rule also revises paragraph (gg)(1) introductory text to
include the option for SMR, non-LWR, or NPUF applicants to use new
Sec. 50.160, as applicable.
Section 50.160 Emergency Preparedness for Small Modular Reactors, Non-
Light-Water Reactors, and Non-Power Production or Utilization
Facilities
This final rule adds a new subpart, ``Small Modular Reactors, Non-
Light-Water Reactors, and Non-power Production or Utilization
Facilities,'' after Sec. 50.155 and new Sec. 50.160, which contains
alternative EP requirements for SMRs, non-LWRs, and NPUFs.
Appendix E to Part 50--Emergency Planning and Preparedness for
Production and Utilization Facilities
This final rule revises paragraph I.3 and footnote 2 to clarify
that the potential radiological hazards to the public associated with
the operation of NPUFs and fuel facilities involve considerations
different than those associated with power reactors. This paragraph is
also amended to replace ``as necessary'' with ``is necessary,''.
Section 52.1 Definitions
This final rule revises the definition of Major feature of the
emergency plans to include new Sec. 50.160, as applicable.
Section 52.17 Contents of Applications; Technical Information
This final rule revises paragraphs (b)(2)(i) and (ii) to include
new Sec. 50.160, as applicable.
Section 52.18 Standards for Review of Applications
This final rule revises Sec. 52.18 to make editorial changes and
to include references to new Sec. 50.160, as applicable.
Section 52.79 Contents of Applications; Technical Information in Final
Safety Analysis Report
This final rule revises paragraph (a)(21) to require applicants for
SMRs or non-LWRs to comply with either the requirements in Sec. 50.160
or the requirements in appendix E to 10 CFR part 50 and Sec. 50.47(b).
Section 72.32 Emergency Plans
In Sec. 72.32, this final rule revises paragraph (c)(2) to replace
the words ``required by'' with ``that meets either the requirements
in'' and to add a reference to new Sec. 50.160.
VI. Regulatory Flexibility Certification
Under the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b), the
Commission certifies that this rule does not have a significant
economic impact on a substantial number of small entities. This final
rule affects only the licensing and operation of nuclear power
facilities and NPUFs. The companies, universities, and government
agencies that own these facilities do not fall within the scope of the
definition of ``small entities'' set forth in the Regulatory
Flexibility Act or the size standards established by the NRC (Sec.
2.810).
VII. Regulatory Analysis
The NRC has prepared a final regulatory analysis on this
regulation. The analysis examines the costs and benefits of the
alternatives considered by the NRC. The conclusion from the analysis is
that this final rule and associated guidance results in net savings to
the industry and the NRC of $7.98 million using a 7-percent discount
rate and $14.9 million using a 3-percent discount rate. The final
regulatory analysis is available as indicated in the ``Availability of
Documents'' section of this document.
VIII. Backfitting and Issue Finality
This final rule contains new alternative requirements for SMR and
ONT applicants and licensees. Because these alternative requirements
are not imposed upon applicants and licensees and do not prohibit
applicants and licensees from following existing requirements, the
requirements do not constitute backfitting under 10 CFR part 50 or part
72 or affect the issue finality of any approval issued under 10 CFR
part 52.
As described in Section XVI, ``Availability of Guidance,'' in this
document, the NRC is issuing RG 1.242, which provides guidance on
methods acceptable to the NRC for complying with this final rule.
Issuance of the RG does not constitute backfitting under Sec. Sec.
50.109 and 72.62 and does not affect the issue finality of any approval
issued under 10 CFR part 52. As discussed in the ``Implementation''
section of the RG, the NRC has no current intention to impose the RG on
holders of an OL, ESP, or COL. If, in the future, the NRC seeks to
impose positions stated in the RG in a manner that would constitute
backfitting or affect the issue finality of an approval under 10 CFR
part 52, the NRC would need to make the showing as set forth in Sec.
50.109 or address the regulatory criteria set forth in the applicable
issue finality provision, as applicable, that would allow the NRC to
impose the position.
IX. Cumulative Effects of Regulation
Cumulative Effects of Regulation (CER) consists of the challenges
licensees may face in addressing the implementation of new regulatory
positions, programs, and requirements (e.g., rulemaking, guidance,
generic letters, backfits, inspections). The CER may manifest in
several ways, including the total burden imposed on licensees by the
NRC from simultaneous or consecutive regulatory actions that can
adversely affect the licensee's capability to implement those
requirements, while continuing to operate or construct its facility in
a safe and secure manner.
The goals of the NRC's CER effort were met throughout the
development of this final rule. The NRC engaged external stakeholders
at public meetings and by soliciting public comments on the proposed
rule and associated draft guidance document. The NRC held a public
meeting on June 24, 2020, to discuss the proposed rule. A summary of
the public meeting is available in ADAMS, as provided in the
``Availability of Documents'' section of this document.
Although the new alternative EP requirements for SMRs and ONT are
voluntary, the NRC included in the Federal Register notice for the
proposed rule a request for feedback related to CER. Specifically, the
NRC requested feedback on the implementation and potential unintended
consequences of the proposed rule. The NRC received two comments in
response to the CER questions in the proposed rule, but neither
required a change to the rule.
X. Plain Writing
The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal
agencies to write documents in a clear, concise, and well-organized
manner. The NRC has
[[Page 80070]]
written this document to be consistent with the Plain Writing Act as
well as the Presidential Memorandum, ``Plain Language in Government
Writing,'' published June 10, 1998 (63 FR 31885).
XI. Environmental Assessment and Final Finding of No Significant
Environmental Impact
The Commission has determined under the National Environmental
Policy Act of 1969, as amended, and the Commission's regulations in
subpart A of 10 CFR part 51, that this final rule is not a major
Federal action significantly affecting the quality of the human
environment and, therefore, an environmental impact statement is not
required. The basis of this determination reads as follows: The
majority of the provisions in this final rule are administrative or
procedural in nature and either do not affect the physical environment
or would have no noticeable effects. Further, the NRC has evaluated the
final requirements of interest to stakeholders based on interactions
described in section 6, ``Environmental Impacts of the Proposed
Action,'' of this environmental assessment that have the potential to
affect the human environment, including the scalable approach for
determining the size of the plume exposure pathway EPZ under Sec.
50.33(g) and the ingestion response planning requirements under Sec.
50.160(b)(4), and determined that this final rule does not have a
significant environmental impact for the following reasons. Under the
existing EP requirements and these final alternative EP requirements,
the dose criteria under which predetermined protective measures would
be taken (e.g., evacuation, sheltering) would be similar under both
rules, and therefore, the dose consequence to the public is similar.
The ingestion response planning requirements under Sec. 50.160(b)(4),
while not requiring SMR and ONT applicants and licensees to establish
an IPZ, provide the same capabilities available to identify and
interdict contaminated food and water in the event of a radiological
emergency as required under existing EP regulations. The environmental
effects of the final ingestion response planning requirements are
similar to that of the existing EP requirements. For these reasons, the
NRC concludes that the EPZ requirement under Sec. 50.33(g) and
ingestion response planning requirement under Sec. 50.160(b)(4) do not
have a significant impact on the physical environment. Therefore, this
rulemaking does not warrant preparation of an environmental impact
statement. Accordingly, the NRC has determined that a Finding of No
Significant Impact is appropriate.
The determination of this environmental assessment is that there is
no significant offsite impact to the public from this action. The
environmental assessment is available as indicated under the
``Availability of Documents'' section.
XII. Paperwork Reduction Act
This final rule contains new or amended collections of information
subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et
seq.). The collections of information were approved by the Office of
Management and Budget (OMB), approval numbers 3150-0011 and 3150-0151.
The burden to the public for the information collections is
estimated to average a reduction of 548 hours per response for 10 CFR
part 50 and a reduction of 200 hours per response for 10 CFR part 52,
including the time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and
reviewing the information collection.
The information collections create a transparent alternative EP
regulatory framework that allows SMR and ONT applicants and licensees
to submit for NRC approval a performance-based EP program, to include a
scalable plume exposure pathway EPZ and licensee-defined performance
objectives and metrics, while continuing to provide reasonable
assurance that adequate protective measures can and will be implemented
in a radiological emergency. Applicants or licensees requesting
approval to construct or operate utilization or production facilities
are required by the AEA to provide information and data that the NRC
may determine necessary to ensure the adequate protection of health and
safety of the public. The submission of emergency plans to the NRC is
required in order to allow the NRC to determine that the emergency
plans and EP programs provide reasonable assurance that adequate
protective measures can and will be taken in the event of a
radiological emergency. Information is used by the NRC to evaluate the
adequacy of the alternative EP program for approval, assess ongoing
adequacy once implemented, determine whether to take actions, such as
to conduct inspections or to alert other licensees to prevent similar
events that may have generic implications, and to update information in
the NRC Emergency Operation Center used in support of an NRC response
to an actual emergency, drill, or exercise. Responses to these
collections of information are required for applicants and licensees
choosing to comply with 10 CFR 50.160. Confidential and proprietary
information submitted to the NRC is protected in accordance with NRC
regulations at 10 CFR 9.17(a) and 10 CFR 2.390(b).
You may submit comments on any aspect of the information
collections, including suggestions for reducing the burden, by the
following methods:
Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0225.
Mail comments to: FOIA, Library, and Information
Collections Branch, Office of Information Services, Mail Stop: T6-A10M,
U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 or to the
OMB reviewer at: OMB Office of Information and Regulatory Affairs
(3150-0011 and 3150-0151), Attn: Desk Officer for the Nuclear
Regulatory Commission, 725 17th Street NW, Washington, DC 20503; email:
[email protected].
Public Protection Notification
The NRC may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless the document requesting
or requiring the collection displays a currently valid OMB control
number.
XIII. Congressional Review Act
This final rule is a rule as defined in the Congressional Review
Act (CRA) (5 U.S.C. 801-808). However, OMB has not found it to be a
major rule as defined in the CRA.
XIV. Criminal Penalties
For the purposes of Section 223 of the AEA, the NRC is issuing this
final rule that will amend Sec. Sec. 50.10, 50.34, 50.47, 50.54,
50.160, and appendix E to 10 CFR part 50 under one or more of Sections
161b, 161i, or 161o of the AEA. Willful violations of the rule would be
subject to criminal enforcement. Criminal penalties as they apply to
regulations in 10 CFR part 50 are discussed in Sec. 50.111.
XV. Voluntary Consensus Standards
The National Technology Transfer and Advancement Act of 1995,
Public Law 104-113, requires that Federal agencies use technical
standards that are developed or adopted by voluntary consensus
standards bodies unless the use of such a standard is inconsistent with
applicable law or otherwise impractical. In this final rule, the NRC
revises regulations associated with EP in 10 CFR parts 50, 52, and 72.
This action does not constitute the establishment of
[[Page 80071]]
a standard that contains generally applicable requirements.
XVI. Availability of Guidance
The NRC is issuing new guidance, RG 1.242, ``Performance-Based
Emergency Preparedness for Small Modular Reactors, Non-Light-Water
Reactors, and Non-Power Production or Utilization Facilities,'' that
support implementation of the requirements in this final rule. The
guidance is available in ADAMS, as provided in the ``Availability of
Documents'' section of this document. You may access information and
comment submissions related to the guidance by searching on https://www.regulations.gov under Docket ID NRC-2015-0225.
The guidance document is intended for use by applicants, licensees,
and NRC staff, and describes an approach and method acceptable for
implementing the requirements of this final rule. As a guidance
document, RG 1.242 does not establish additional requirements, and
applicants and licensees are able to propose alternative ways for
demonstrating compliance with the requirements in Sec. 50.160.
XVII. Availability of Documents
The documents identified in the following table are available to
interested persons through one or more of the following methods, as
indicated.
------------------------------------------------------------------------
ADAMS accession No./web
Document link/Federal Register
citation
------------------------------------------------------------------------
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3 Designs and Their Relationship to
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30, 1993.
NUREG-1537, Part 1, ``Guidelines for ML042430055.
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the Licensing of Non-Power Reactors,
Format and Content,'' February 1996.
NUREG-1537, Part 2, ``Guidelines for ML042430048.
Preparing and Reviewing Applications for
the Licensing of Non-Power Reactors,
Standard Review Plan and Acceptance
Criteria,'' February 1996.
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Emergency Planning for Evolutionary and
Advanced Reactors,'' January 27, 1997.
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directive-5.
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Corporate Headquarters,'' December 23,
2004.
SRM-SECY-04-0236, ``Staff Requirements-- ML050550131.
SECY-04-0236--Southern Nuclear Operating
Company's Proposal to Establish a Common
Emergency Operating Facility at its
Corporate Headquarters,'' February 23,
2005.
SECY-06-0200, ``Results of the Review of ML061910707.
Emergency Preparedness Regulations and
Guidance,'' September 20, 2006.
SRM-SECY-06-0200, ``Staff Requirements-- ML070080411.
SECY-06-0200--Results of the Review of
Emergency Preparedness Regulations and
Guidance,'' January 8, 2007.
NUREG-0800, ``Standard Review Plan for the ML063410307.
Review of Safety Analysis Reports for
Nuclear Power Plants: LWR Edition,''
Section 13.3, ``Emergency Planning,''
March 2007.
NUREG-0800, Section 14.3.10, ``Emergency ML070730206.
Planning--Inspections, Tests, Analyses,
and Acceptance Criteria,'' March 2007.
``Policy Statement on Regulation of 73 FR 60612.
Advanced Reactors,'' October 14, 2008.
[[Page 80072]]
``Summary of Workshop on Small and Medium- ML092940138.
Sized Nuclear Reactors (SMRs),'' October
22, 2009.
SECY-10-0034, ``Potential Policy, ML093290268.
Licensing, and Key Technical Issues for
Small Modular Reactor Designs,'' March 28,
2010.
NUREG-1520, ``Standard Review Plan for the ML101390110.
Review of a License Application for a Fuel
Cycle Facility,'' Revision 1, May 1, 2010.
``Summary of July 28, 2010, Category 2 ML102380209.
Meeting with Small Modular Reactor Design
Representatives to Discuss Small Modular
Reactor Key Licensing Issues (TAC NO.
Q00269),'' August 26, 2010.
Presidential Policy Directive/PPD-8, https://www.dhs.gov/
``National Preparedness,'' March 30, 2011. presidential-policy-
directive-8-national-
preparedness.
SECY-11-0152, ``Development of an Emergency ML112570439.
Planning and Preparedness Framework for
Small Module Reactors,'' October 28, 2011.
``Enhancements to Emergency Preparedness 76 FR 72560.
Regulations,'' Final Rule, November 23,
2011.
Interim Staff Guidance for NUREG-1537, ML12156A069.
``Final Interim Staff Guidance Augmenting
NUREG-1537, Part 1, `Guidelines for
Preparing and Reviewing Applications for
the Licensing of Non-Power Reactors,
Format and Content' for Licensing
Radioisotope Production Facilities and
Aqueous Homogenous Reactors,'' October 17,
2012.
Final Interim Staff Guidance for NUREG- ML12156A075.
1537, ``Final Interim Staff Guidance
Augmenting NUREG-1537, Part 2, `Guidelines
for Preparing and Reviewing Applications
for the Licensing of Non-Power Reactors,
Standard Review Plan and Acceptance
Criteria' for Licensing Radioisotope
Production Facilities and Aqueous
Homogenous Reactors,'' October 17, 2012.
NEI 99-02, ``Regulatory Assessment ML13261A116.
Performance Indicator Guideline,''
Revision 7, August 13, 2013.
NEI White Paper, ``White Paper: Proposed ML13364A345.
Methodology and Criteria Establishing the
Technical Basis for Small Modular Reactor
Emergency Planning Zone,'' December 23,
2013.
SECY-14-0038, ``Performance-Based Framework ML13238A018.
for Nuclear Power Plant Emergency
Preparedness Oversight,'' April 4, 2014.
SECY-14-0066, ``Request by Dominion Energy ML14072A257.
Kewaunee Inc., for Exemptions from Certain
Emergency Planning Requirements,'' June
27, 2014.
SRM-SECY-14-0038, ``Staff Requirements-- ML14259A589.
SECY-14-0038--Performance-Based Framework
for Nuclear Power Plant Emergency
Preparedness Oversight,'' September 16,
2014.
SECY-14-0118, ``Request by Duke Energy ML14219A444.
Florida, Inc., for Exemptions from Certain
Emergency Planning Requirements,'' October
29, 2014.
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Research Reactors,'' American Nuclear
Society, La Grange Park, IL, February 2015.
SECY-15-0077, ``Options for Emergency ML15037A176.
Preparedness for Small Module Reactors and
Other New Technologies,'' May 29, 2015.
``Summary of June 7-8, 2015, Department of ML16188A226.
Energy and Nuclear Regulatory Commission
Co-Hosted Workshop on Advanced Non-Light
Water Reactors,'' July 7, 2015.
NEI White Paper, ``Proposed Emergency ML15194A275.
Preparedness Regulations and Guidance for
Small Modular Reactor Facilities,'' July
2015.
SRM-SECY-15-0077, ``Staff Requirements-- ML15216A492.
SECY-15-0077--Options for Emergency
Preparedness for Small Module Reactors and
Other New Technologies,'' August 4, 2015.
``Summary of September 1-2, 2015, Nuclear ML15265A165.
Regulatory Commission and Department of
Energy Co-Hosted Workshop on Advanced Non-
Light Water Reactors,'' October 1, 2015.
``Variable Annual Fee Structure for Small 80 FR 68268.
Modular Reactors,'' Proposed Rule,
November 4, 2015.
``Memorandum of Understanding Between the ML15344A371.
Department of Homeland Security/Federal
Emergency Management Agency and Nuclear
Regulatory Commission Regarding
Radiological Emergency Response, Planning,
and Preparedness,'' December 7, 2015.
``Variable Annual Fee Structure for Small 81 FR 32617.
Modular Reactors,'' Final Rule, May 24,
2016.
SECY-16-0069, ``Rulemaking Plan on ML16020A388.
Emergency Preparedness for Small Module
Reactors and Other New Technologies,'' May
31, 2016.
Nuclear Innovation Alliance, ``Enabling https://docs.wixstatic.com/
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Advanced Reactor Licensing,'' June 7, 2016. 5b05b3_71d4011545234838aa2
7005ab7d757f1.pdf.
SRM-SECY-16-0069, ``Staff Requirements-- ML16174A166.
SECY-16-0069--Rulemaking Plan on Emergency
Preparedness for Small Module Reactors and
Other New Technologies,'' June 22, 2016.
RG 1.219, Revision 1, ``Guidance on Making ML16061A104.
Changes to Emergency Plans for Nuclear
Power Reactors,'' July 2016.
``Summary of August 22, 2016, Public ML16257A510.
Meeting to Discuss a Performance-Based
Approach to Emergency Preparedness for
Small Modular Reactors and Other New
Technologies,'' September 15, 2016.
``NRC Vision and Strategy: Safely Achieving ML16356A670.
Effective and Efficient Non-Light Water
Reactor Mission Readiness,'' December 2016.
[[Page 80073]]
EPA-400/R-17/001, ``PAG Manual: Protective https://www.epa.gov/sites/
Action Guides and Planning Guidance for production/files/2017-01/
Radiological Incidents,'' January 2017. documents/
epa_pag_manual_final_revis
ions_01-11-
2017_cover_disclaimer_8.pd
f.
``Tribal Policy Statement,'' January 9, 82 FR 2402.
2017.
``Emergency Preparedness for Small Modular 82 FR 17768.
Reactors and Other New Technologies,''
Draft Regulatory Basis, April 13, 2017.
``Summary of May 10, 2017, Public Meeting ML17139C860.
on the Draft Regulatory Basis for the
Rulemaking for Emergency Preparedness for
Small Modular Reactors and Other New
Technologies,'' May 24, 2017.
RG 2.6, ``Emergency Planning for Research ML17263A472.
and Test Reactors and Other Non-Power
Production and Utilization Facilities,''
September 2017.
``Emergency Preparedness for Small Modular 82 FR 52862.
Reactors and Other New Technologies,''
Regulatory Basis, November 15, 2017.
``Regulatory Improvements for Power 82 FR 55954.
Reactors Transitioning to Decommissioning
Rulemaking,'' Regulatory Basis, November
27, 2017.
SECY-18-0055, ``Proposed Rule: Regulatory ML18012A019.
Improvements for Production and
Utilization Facilities Transitioning to
Decommissioning,'' May 22, 2018.
``Generalized Dose Assessment Methodology ML18064A317.
for Informing Emergency Planning Zone Size
Determinations,'' June 2018.
``Required Analyses for Informing Emergency ML18114A176.
Planning Zone Size Determinations,'' June
2018.
SRM-SECY-18-0103, ``Staff Requirements-- ML19351C729.
SECY-18-0103--Proposed Rule: Emergency
Preparedness for Small Modular Reactors
and Other New Technologies (RIN 3150 AJ68;
NRC-2015-0225),'' December 17, 2019.
NUREG-0654/FEMA-REP-1, Revision 2, ML19347D139.
``Criteria for Preparation and Evaluation
of Radiological Emergency Response Plans
and Preparedness in Support of Nuclear
Power Plants,'' December 2019.
RG 1.233, ``Guidance for a Technology- ML20091L698.
Inclusive, Risk-Informed, and Performance-
Based Methodology to Inform the Licensing
Basis and Content of Applications for
Licenses, Certifications, and Approvals
for Non-Light Water Reactors,'' June 2020.
Summary of June 24, 2020, Public Meeting to ML20196L775
Discuss the Proposed Emergency
Preparedness for Small Modular Reactors
and Other New Technologies Rule, July 14,
2020.
``Regulatory Analysis for the Final Rule: ML23226A027.
Emergency Preparedness for Small Modular
Reactors and Other New Technologies,''
January 2022.
``Environmental Assessment for the Final ML23226A031.
Rule--Emergency Preparedness for Small
Modular Reactors and Other New
Technologies,'' November 2023.
``Supporting Statement for Information ML21200A185.
Collections Contained in the Emergency
Preparedness for Small Modular Reactors
and Other New Technologies Final Rule; 10
CFR Part 50, Domestic Licensing of
Production and Utilization Facilities,''
November 2023.
``Supporting Statement for Information ML21200A190.
Collections Contained in the Emergency
Preparedness for Small Modular Reactors
and Other New Technologies Final Rule; 10
CFR Part 52, Licensing, Certifications,
and Approvals for Nuclear Power Plants,''
November 2023.
RG 1.242, ``Performance-Based Emergency ML23226A036.
Preparedness for Small Modular Reactors,
Non-Light-Water Reactors, and Non-Power
Production or Utilization Facilities,''
November 2023.
``NRC Response to Public Comments; ML23229A227.
Emergency Preparedness for Small Modular
Reactors and Other New Technologies''.
SECY-22-0001, ``Final Rule: Emergency ML21200A059.
Preparedness for Small Modular Reactors
and Other New Technologies,'' January 3,
2022.
SRM-M230814, ``Affirmation Session--SECY-22- ML23226A184,
0001: Rulemaking: Final Rule: Emergency ML23226A218.
Preparedness for Small Modular Reactors
and Other New Technologies,'' August 14,
2023.
------------------------------------------------------------------------
List of Subjects
10 CFR Part 50
Administrative practice and procedure, Antitrust, Backfitting,
Classified information, Criminal penalties, Education, Emergency
planning, Fire prevention, Fire protection, Intergovernmental
relations, Nuclear power plants and reactors, Penalties, Radiation
protection, Reactor siting criteria, Reporting and recordkeeping
requirements, Whistleblowing.
10 CFR Part 52
Administrative practice and procedure, Antitrust, Combined license,
Early site permit, Emergency planning, Fees, Inspection, Issue
finality, Limited work authorization, Nuclear power plants and
reactors, Probabilistic risk assessment, Prototype, Reactor siting
criteria, Redress of site, Penalties, Reporting and recordkeeping
requirements, Standard design, Standard design certification.
10 CFR Part 72
Administrative practice and procedure, Hazardous waste, Indians,
Intergovernmental relations, Nuclear energy, Penalties, Radiation
protection, Reporting and recordkeeping requirements, Security
measures, Spent fuel, Whistleblowing.
For the reasons set out in the preamble and under the authority of
the
[[Page 80074]]
Atomic Energy Act of 1954, as amended; the Energy Reorganization Act,
as amended; and 5 U.S.C. 552 and 553, the NRC is adopting the following
amendments to 10 CFR parts 50, 52, and 72:
PART 50--DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION
FACILITIES
0
1. The authority citation for part 50 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 11, 101, 102, 103,
104, 105, 108, 122, 147, 149, 161, 181, 182, 183, 184, 185, 186,
187, 189, 223, 234 (42 U.S.C. 2014, 2131, 2132, 2133, 2134, 2135,
2138, 2152, 2167, 2169, 2201, 2231, 2232, 2233, 2234, 2235, 2236,
2237, 2239, 2273, 2282); Energy Reorganization Act of 1974, secs.
201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); Nuclear Waste
Policy Act of 1982, sec. 306 (42 U.S.C. 10226); National
Environmental Policy Act of 1969 (42 U.S.C. 4332); 44 U.S.C. 3504
note; Sec. 109, Pub. L. 96-295, 94 Stat. 783.
0
2. In Sec. 50.2, add in alphabetical order definitions for ``Non-
light-water reactor'', ``Non-power production or utilization
facility'', and ``Small modular reactor'' to read as follows:
Sec. 50.2 Definitions.
* * * * *
Non-light-water reactor means a nuclear power reactor using a
coolant other than light water.
Non-power production or utilization facility means a production or
utilization facility, licensed under Sec. 50.21(a) or (c), or Sec.
50.22, as applicable, that is not a nuclear power reactor or a
production facility as defined under paragraphs (1) and (2) of the
definition of Production facility in this section.
* * * * *
Small modular reactor means a power reactor, which may be of
modular design as defined in Sec. 52.1 of this chapter, licensed under
Sec. 50.21 or Sec. 50.22 to produce heat energy up to 1,000 megawatts
thermal per module.
* * * * *
Sec. 50.8 [Amended]
0
3. In Sec. 50.8, in paragraph (b), add the citation ``50.160,'' after
the citation ``50.155,''.
0
4. In Sec. 50.10, revise paragraph (a)(1)(vii) to read as follows:
Sec. 50.10 License required; limited work authorization.
(a) * * *
(1) * * *
(vii) Onsite emergency facilities necessary to comply with either
Sec. 50.160 or Sec. 50.47 and appendix E to this part, as applicable.
* * * * *
0
5. In Sec. 50.33, revise paragraph (g) to read as follows:
Sec. 50.33 Contents of applications; general information.
* * * * *
(g)(1) Except as provided in paragraph (g)(2) of this section, if
the application is for an operating license or combined license for a
nuclear power reactor, or if the application is for an early site
permit and contains plans for coping with emergencies under Sec.
52.17(b)(2)(ii) of this chapter, the applicant shall submit the
radiological emergency response plans of State and local governmental
entities in the United States that are wholly or partially within the
plume exposure pathway emergency planning zone (EPZ),\4\ as well as the
plans of State governments wholly or partially within the ingestion
pathway EPZ.\5\ If the application is for an early site permit that,
under 10 CFR 52.17(b)(2)(i), proposes major features of the emergency
plans describing the EPZs, then the descriptions of the EPZs must meet
the requirements of this paragraph. Generally, the plume exposure
pathway EPZ for nuclear power reactors shall consist of an area about
10 miles (16 km) in radius and the ingestion pathway EPZ shall consist
of an area about 50 miles (80 km) in radius. The exact size and
configuration of the EPZs surrounding a particular nuclear power
reactor shall be determined in relation to the local emergency response
needs and capabilities as they are affected by such conditions as
demography, topography, land characteristics, access routes, and
jurisdictional boundaries. The size of the EPZs also may be determined
on a case-by-case basis for gas-cooled reactors and for reactors with
an authorized power level less than 250 MW thermal. The plans for the
ingestion pathway shall focus on such actions as are appropriate to
protect the food ingestion pathway.
* * * * *
\4\ Emergency planning zones (EPZs) are discussed in NUREG-0396,
EPA 520/1-78-016, ``Planning Basis for the Development of State and
Local Government Radiological Emergency Response Plans in Support of
Light Water Nuclear Power Plants,'' December 1978.
\5\ If the State and local emergency response plans have been
previously provided to the NRC for inclusion in the facility docket,
the applicant need only provide the appropriate reference to meet
this requirement.
(2) Small modular reactor, non-light-water reactor, or non-power
production or utilization facility applicants complying with Sec.
50.160 who apply for a construction permit or an operating license
under this part, or small modular reactor or non-light-water reactor
applicants complying with Sec. 50.160 who apply for a combined license
or an early site permit under part 52 of this chapter, must submit as
part of the application the analysis used to determine whether the
criteria in Sec. 50.33(g)(2)(i)(A) and (B) are met and, if they are
met, the size of the plume exposure pathway EPZ.
(i) The plume exposure pathway EPZ is the area within which:
(A) Public dose, as defined in Sec. 20.1003 of this chapter, is
projected to exceed 10 mSv (1 rem) total effective dose equivalent over
96 hours from the release of radioactive materials from the facility
considering accident likelihood and source term, timing of the accident
sequence, and meteorology; and
(B) Pre-determined, prompt protective measures are necessary.
(ii) If the application is for an operating license or combined
license or if the application is for an early site permit and contains
plans for coping with emergencies under Sec. 52.17(b)(2)(ii) of this
chapter, and if the plume exposure pathway EPZ extends beyond the site
boundary:
(A) The applicant shall submit radiological emergency response
plans of State, local, and participating Tribal governmental entities
in the United States that are wholly or partially within the plume
exposure pathway EPZ.
(B) The exact configuration of the plume exposure pathway EPZ
surrounding the facility shall be determined in relation to the local
emergency response needs and capabilities as they are affected by such
conditions as demography, topography, land characteristics, access
routes, and jurisdictional boundaries.
(iii) If the application is for an early site permit that, under
Sec. 52.17(b)(2)(i) of this chapter, proposes major features of the
emergency plans and describes the EPZ, and if the EPZ extends beyond
the site boundary, then the exact configuration of the plume exposure
pathway EPZ surrounding the facility shall be determined in relation to
the local emergency response needs and capabilities as they are
affected by such conditions as demography, topography, land
characteristics, access routes, and jurisdictional boundaries.
* * * * *
0
6. In Sec. 50.34, revise paragraphs (a)(10) and (b)(6)(v) to read as
follows:
[[Page 80075]]
Sec. 50.34 Contents of applications; technical information.
(a) * * *
(10) A discussion of the applicant's preliminary plans for coping
with emergencies based on:
(i) Except as provided in paragraph (a)(10)(ii) of this section,
the requirements in appendix E to this part.
(ii) For a small modular reactor, a non-light-water reactor, or
non-power production or utilization facility construction permit
applicant, the requirements in either Sec. 50.160 or appendix E to
this part.
* * * * *
(b) * * *
(6) * * *
(v) Plans for coping with emergencies based on:
(A) Except as provided in paragraph (b)(6)(v)(B) of this section,
the requirements in appendix E to this part.
(B) For a small modular reactor, a non-light-water reactor, or a
non-power production or utilization facility operating license
applicant, the requirements in either Sec. 50.160 or appendix E to
this part.
* * * * *
0
7. In Sec. 50.47, revise paragraphs (a)(1)(iv), (b) introductory text,
(c)(1) introductory text, (c)(1)(i), and (e) and add paragraph (f) to
read as follows:
Sec. 50.47 Emergency plans.
* * * * *
(a) * * *
(1) * * *
(iv) If an application for an early site permit proposes major
features of the emergency plans under 10 CFR 52.17(b)(2)(i), no early
site permit will be issued unless a finding is made by the NRC that the
major features are acceptable in accordance with the applicable
standards of either this section and appendix E to this part, or the
applicable requirements of Sec. 50.160, within the scope of emergency
preparedness matters addressed in the major features.
* * * * *
(b) The onsite and, except as provided in paragraphs (d) and (f) of
this section, offsite emergency response plans for nuclear power
reactors must meet the following standards:
(c)(1) Failure to meet the applicable standards set forth in either
Sec. 50.160 or paragraph (b) of this section may result in the
Commission declining to issue an operating license; however, the
applicant will have an opportunity to demonstrate to the satisfaction
of the Commission that deficiencies in the plans are not significant
for the plant in question, that adequate interim compensating actions
have been or will be taken promptly, or that there are other compelling
reasons to permit plant operations. Where an applicant for an operating
license asserts that its inability to demonstrate compliance with the
requirements in either Sec. 50.160 or paragraph (b) of this section
results wholly or substantially from the decision of State and/or local
governments not to participate further in emergency planning, an
operating license may be issued if the applicant demonstrates to the
Commission's satisfaction that:
(i) The applicant's inability to comply with the requirements in
either Sec. 50.160 or paragraph (b) of this section is wholly or
substantially the result of the non-participation of State and/or local
governments.
* * * * *
(e) Notwithstanding the requirements of paragraph (b) of this
section and the provisions of Sec. 52.103 of this chapter, a holder of
a combined license under part 52 of this chapter that is complying with
the requirements of paragraph (b) of this section and appendix E to
this part may not load fuel or operate except as provided in accordance
with appendix E to this part and Sec. 50.54(gg), and a holder of a
combined license under part 52 of this chapter that is complying with
the requirements of Sec. 50.160 may not load fuel or operate except as
provided in accordance with Sec. 50.160(c)(2) and Sec. 50.54(gg).
(f) Paragraphs (a)(2), (b), and (c)(2) of this section do not apply
to offsite radiological emergency response plans if the onsite
emergency plan is not required to meet paragraph (b) of this section or
if the plume exposure pathway EPZ does not extend beyond the site
boundary.
0
8. In Sec. 50.54:
0
a. Revise paragraphs (q)(1)(iii) and (q)(2) through (4);
0
b. In paragraph (q)(5), remove the words ``made after February 21,
2012'';
0
c. Add paragraph (q)(7);
0
d. In paragraph (s)(2)(ii), in the first sentence:
0
i. Remove the words ``after April 1, 1981,'';
0
ii. Remove the word ``reactor'' and add in its place the word
``facility''; and
0
iii. Add the words ``or cease operation'' after the words ``shut
down''; and
0
e. Revise paragraphs (s)(3) and (gg)(1) introductory text.
The revisions and addition read as follows:
Sec. 50.54 Conditions of licenses.
* * * * *
(q) * * *
(1) * * *
(iii) Emergency planning function means a capability or resource
necessary to prepare for and respond to a radiological emergency.
* * * * *
(2)(i) Except as provided in paragraph (q)(2)(ii) of this section,
a holder of a license under this part, or a combined license under part
52 of this chapter after the Commission makes the finding under Sec.
52.103(g) of this chapter, shall follow and maintain the effectiveness
of an emergency plan that meets the requirements in appendix E to this
part and, for nuclear power reactor licensees, the planning standards
of Sec. 50.47(b).
(ii) A holder of a license under this part for a non-power
production or utilization facility, a holder of a license under this
part for a small modular reactor or a non-light water reactor, or a
holder of a combined license under part 52 of this chapter after the
Commission makes the finding under Sec. 52.103(g) of this chapter for
a small modular reactor or a non-light-water reactor, shall follow and
maintain the effectiveness of either an emergency plan that meets the
requirements in Sec. 50.160 or an emergency plan that meets the
requirements in appendix E to this part and, for nuclear power reactor
licensees, the planning standards of Sec. 50.47(b).
(3)(i) Except as provided in paragraph (q)(3)(ii) of this section,
the licensee may make changes to its emergency plan without NRC
approval only if the licensee performs and retains an analysis
demonstrating that the changes do not reduce the effectiveness of the
plan and the plan, as changed, continues to meet the requirements in
appendix E to this part and, for nuclear power reactor licensees, the
planning standards of Sec. 50.47(b).
(ii) A non-power production or utilization facility, small modular
reactor, or non-light-water reactor licensee may make changes to its
emergency plan without NRC approval only if the licensee performs and
retains an analysis demonstrating that the changes do not reduce the
effectiveness of the plan and the plan, as changed, continues to meet
either the requirements in Sec. 50.160 or the requirements in appendix
E to this part and, for nuclear power reactor licensees, the planning
standards of Sec. 50.47(b).
(4) The changes to a licensee's emergency plan that reduce the
effectiveness of the plan as defined in paragraph (q)(1)(iv) of this
section may not be implemented without prior approval by the NRC. A
licensee
[[Page 80076]]
desiring to make such a change shall submit an application for an
amendment to its license. In addition to the filing requirements of
Sec. Sec. 50.90 and 50.91, the request must include all emergency plan
pages affected by that change and must be accompanied by a forwarding
letter identifying the change, the reason for the change, and the basis
for concluding that the licensee's emergency plan, as revised, will
continue to meet either the requirements in Sec. 50.160 or the
requirements in appendix E to this part and, for nuclear power reactor
licensees, the planning standards of Sec. 50.47(b).
* * * * *
(7) Each holder of an operating license under this part or a
combined license under part 52 of this chapter for a small modular
reactor or non-light-water reactor or each holder of an operating
license under this part issued after December 18, 2023 for a non-power
production or utilization facility that wishes to transition to Sec.
50.160 shall submit to the Commission, as specified in Sec. 50.90, a
license amendment request for implementing an emergency preparedness
program with the associated plan modification necessary to meet the
requirements of Sec. 50.160(b). This submittal must include an
explanation of the schedule and analyses supporting the implementation
of the emergency preparedness program.
* * * * *
(s)
(3) If the planning standards for radiological emergency
preparedness apply to offsite emergency response plans, or if the
planning activities in Sec. 50.160(b)(1)(iv)(B) apply, then the NRC
will base its finding on a review of the FEMA findings and
determinations as to whether State and local emergency plans are
adequate and capable of being implemented, and on the NRC assessment as
to whether the licensee's emergency plans are adequate and capable of
being implemented. Nothing in this paragraph shall be construed as
limiting the authority of the Commission to take action under any other
regulation or authority of the Commission or at any time other than
that specified in this paragraph.
* * * * *
(gg)(1) Notwithstanding Sec. 52.103 of this chapter, if, following
the conduct of the exercise required by either paragraph IV.f.2.a of
appendix E to this part or Sec. 50.160(c)(2), as applicable, FEMA
identifies one or more deficiencies in the state of offsite emergency
preparedness, the holder of a combined license under part 52 of this
chapter may operate at up to 5 percent of rated thermal power only if
the Commission finds that the state of onsite emergency preparedness
provides reasonable assurance that adequate protective measures can and
will be taken in the event of a radiological emergency. The NRC will
base this finding on its assessment of the applicant's onsite emergency
plans against the pertinent standards in either Sec. 50.47 and
appendix E to this part, or Sec. 50.160, as applicable. Review of the
applicant's emergency plans will include the following standards with
offsite aspects:
* * * * *
0
9. After Sec. 50.155, add an undesignated center heading and Sec.
50.160 to read as follows:
Small Modular Reactors, Non-Light-Water Reactors, and Non-Power
Production or Utilization Facilities
Sec. 50.160 Emergency preparedness for small modular reactors, non-
light-water reactors, and non-power production or utilization
facilities.
(a) Definitions. For the purpose of this section:
(1) Site boundary means site boundary as defined in Sec. 20.1003
of this chapter.
(2) [Reserved]
(b) Requirements. The emergency plan shall contain information
needed to demonstrate compliance with the elements set forth in this
paragraph. The applicable requirements of Sec. 50.47(a)(1) apply to
applications submitted under this section.
(1) Performance-based framework. Demonstrate effective response in
drills and exercises for emergency and accident conditions.
(i) Maintenance of performance. Maintain in effect preparedness to
respond to emergency and accident conditions and describe in an
emergency plan the provisions to be employed to maintain preparedness.
(ii) Performance objectives. (A) By the beginning of each calendar
quarter, develop and maintain a complete list of performance objectives
for that calendar quarter; and
(B) Maintain records showing the implemented performance objectives
and associated metrics during each calendar quarter for the previous
eight calendar quarters.
(iii) Emergency response performance. The emergency response team
must have sufficient capability to demonstrate the following emergency
response functions using drills or exercises:
(A) Event classification and mitigation. Assess, classify, monitor,
and repair facility malfunctions in accordance with the emergency plan
to return the facility to safe conditions.
(B) Protective actions. Implement and maintain protective actions
for onsite personnel for emergency conditions, and recommend protective
actions to offsite authorities as conditions warrant.
(C) Communications. Establish and maintain effective communications
with the emergency response organization, and make notifications to
response personnel and organizations who may have responsibilities for
responding during emergencies.
(D) Command and control. Establish and maintain effective command
and control for emergencies by using a supporting organizational
structure with defined roles, responsibilities, and authorities for
directing and performing emergency response functions as described in
paragraph (b) of this section.
(E) Staffing and operations. Establish staffing for the facility
necessary to implement the roles and responsibilities in paragraph
(b)(1)(iii) of this section.
(F) Radiological assessment. Assess radiological conditions in and
around the facility during emergencies, including:
(1) Radiological conditions. Assess, monitor, and report
radiological conditions to the applicable response personnel using
installed or portable equipment.
(2) Protective equipment. Issue and use protective equipment
necessary to continue and expand mitigation and protective action
strategies.
(3) Core or vessel damage. Assess, monitor, and report to the
applicable response personnel the extent and magnitude of damage to the
core or other vessel containing irradiated special nuclear material,
such as fuel or targets, as applicable.
(4) Releases. Assess, monitor, and report to the applicable
response personnel the extent and magnitude of all radiological
releases, including releases of hazardous chemicals produced from
licensed material.
(G) Reentry. Develop and implement reentry plans for accessing the
facility after emergencies.
(H) Critique and corrective actions. Critique emergency response
functions and implement corrective actions after drills and exercises,
and after emergencies, if they occur.
(iv) Planning activities. (A) Maintain the capability to:
(1) Prepare and issue public information during emergencies.
(2) Implement the NRC-approved emergency response plan in
conjunction
[[Page 80077]]
with the licensee's Safeguards Contingency Plan.
(3) Establish voice and data communications with the NRC for
emergencies.
(4) Establish an emergency facility or facilities from which
effective direction can be given and effective control can be exercised
during an emergency, with capabilities to support the emergency
response functions as described in paragraph (b)(1)(iii) of this
section.
(5) Provide site familiarization training for any offsite
organization that may respond to the site in the event of an emergency.
(6) Establish methods for maintaining the emergency plan, contacts
and arrangements, procedures, and evacuation time estimate up to date,
including periodic reviews by the onsite and offsite organizations.
(B) For a plume exposure pathway EPZ that extends beyond the site
boundary, the emergency plan must describe:
(1) The contacts and arrangements made and documented with Federal,
State, local, and Tribal governmental agencies, as applicable, with
responsibilities for coping with emergencies, including the
identification of the principal coordinating agencies, and the
coordinated reviews of changes in offsite and onsite planning and
preparation;
(2) Offsite organizations responsible for coping with emergencies
and the means of notifying, in the event of an emergency, persons
assigned to the emergency organizations, including the means of
validating notifications, the time period by which notifications must
be completed, and primary and secondary methods to complete
notification;
(3) The protective measures to be taken within the EPZ to protect
the health and safety of the public in the event of an emergency,
including the procedures by which the protective measures are
implemented, maintained, and discontinued;
(4) An evacuation time estimate of the areas within the EPZ;
(5) The offsite facility and any backup facilities to coordinate
the onsite response with the offsite response;
(6) The means of making offsite dose projections and the means of
communicating the offsite dose projections to the offsite response
coordinating agencies;
(7) The means by which public information is provided to the
members of the public concerning emergency planning information, public
alert notification system, and any prompt actions that need to be taken
by the public;
(8) The general plans and methods to allow reentry into the EPZ
during and after an emergency; and
(9) The drill and exercise program that tests and implements major
portions of planning, preparations, and the coordinated response by the
onsite response organization with the offsite response organizations
within the EPZ without mandatory public participation.
(2) Hazard analysis. Conduct a hazard analysis of any contiguous or
nearby facility, such as industrial, military, and transportation
facilities, and include any credible hazard into the licensee's
emergency preparedness program that would adversely impact the
implementation of emergency plans.
(3) Emergency planning zone. For an applicant whose analysis
required by Sec. 50.33(g)(2) meets the criteria in Sec.
50.33(g)(2)(i), determine and describe the boundary and physical
characteristics of the EPZ in the emergency plan.
(4) Ingestion response planning. Describe or reference in the
emergency plan the capabilities that provide actions to prevent
contaminated food and water from entering into the ingestion pathway.
(c) Implementation. (1) An applicant for an operating license
issued under this part after December 18, 2023 must establish,
implement, and maintain an emergency preparedness program that meets
the requirements of paragraph (b) of this section, as described in the
emergency plan and license, and conduct an initial exercise to
demonstrate this compliance within 2 years before the issuance of an
operating license for the facility described in the license
application.
(2) A holder of a combined license issued under part 52 of this
chapter before the Commission has made the finding under Sec.
52.103(g) of this chapter, must establish, implement, and maintain an
emergency preparedness program that meets the requirements of paragraph
(b) of this section, as described in the approved emergency plan and
license, and conduct an initial exercise to demonstrate this compliance
within 2 years before the scheduled date for initial loading of fuel.
0
10. In appendix E to part 50, revise paragraph I.3. and footnote 2 to
I.3 to read as follows:
Appendix E to Part 50--Emergency Planning and Preparedness for
Production and Utilization Facilities
* * * * *
I. * * *
3. The potential radiological hazards to the public associated with
the operation of non-power production or utilization facilities
licensed under this part and fuel facilities licensed under 10 CFR part
70 involve considerations different than those associated with nuclear
power reactors. Consequently, the size of Emergency Planning Zones \1\
(EPZs) for facilities other than power reactors and the degree to which
compliance with the requirements of this section and sections II, III,
IV, and V of this appendix is necessary, will be determined on a case-
by-case basis.\2\
\1\ EPZs for power reactors are discussed in NUREG-0396; EPA
520/1-78-016, ``Planning Basis for the Development of State and
Local Government Radiological Emergency Response Plans in Support of
Light Water Nuclear Power Plants,'' December 1978. The size of the
EPZs for a nuclear power plant shall be determined in relation to
local emergency response needs and capabilities as they are affected
by such conditions as demography, topography, land characteristics,
access routes, and jurisdictional boundaries. The size of the EPZs
also may be determined on a case-by-case basis for gas-cooled
nuclear reactors and for reactors with an authorized power level
less than 250 MW thermal. Generally, the plume exposure pathway EPZ
for nuclear power plants with an authorized power level greater than
250 MW thermal shall consist of an area about 10 miles (16 km) in
radius and the ingestion pathway EPZ shall consist of an area about
50 miles (80 km) in radius.
\2\ Regulatory Guide 2.6, ``Emergency Planning for Research and
Test Reactors and Other Non-power Production and Utilization
Facilities,'' may be used as guidance for the acceptability of non-
power production or utilization facility emergency response plans.
* * * * *
PART 52--LICENSES, CERTIFICATIONS, AND APPROVALS FOR NUCLEAR POWER
PLANTS
0
11. The authority citation for part 52 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 11, 101, 102, 103,
104, 105, 108, 122, 147, 149, 161, 181, 182, 183, 184, 185, 186,
187, 189, 223, 234 (42 U.S.C. 2014, 2131, 2132, 2133, 2134, 2135,
2138, 2152, 2167, 2169, 2201, 2231, 2232, 2233, 2234, 2235, 2236,
2237, 2239, 2273, 2282); Energy Reorganization Act of 1974, secs.
201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); Nuclear Waste
Policy Act of 1982, sec. 306 (42 U.S.C. 10226); National
Environmental Policy Act of 1969 (42 U.S.C. 4332); 44 U.S.C. 3504
note; Sec. 109, Pub. L. 96-295, 94 Stat. 783.
0
12. In Sec. 52.1, in paragraph (a), revise the definition of ``Major
feature of the emergency plans'' to read as follows:
Sec. 52.1 Definitions.
(a) * * *
[[Page 80078]]
Major feature of the emergency plans means an aspect of those plans
necessary to:
(i) Address in whole or part either one or more of the 16 standards
in 10 CFR 50.47(b) or the requirements of 10 CFR 50.160(b), as
applicable; or
(ii) Describe the emergency planning zones as required in 10 CFR
50.33(g).
* * * * *
0
13. In Sec. 52.17, revise paragraphs (b)(2)(i) and (ii) to read as
follows:
Sec. 52.17 Contents of applications; technical information.
* * * * *
(b) * * *
(2) * * *
(i) Propose major features of the emergency plans, in accordance
with either the requirements in Sec. 50.160 of this chapter, or the
requirements in appendix E to part 50 of this chapter and Sec.
50.47(b) of this chapter, as applicable, such as the exact size and
configuration of the emergency planning zones, for review and approval
by the NRC, in consultation with the Federal Emergency Management
Agency (FEMA), as applicable, in the absence of complete and integrated
emergency plans; or
(ii) Propose complete and integrated emergency plans for review and
approval by the NRC, in consultation with FEMA, as applicable in
accordance with either the requirements in Sec. 50.160 of this
chapter, or the requirements in appendix E to part 50 of this chapter
and Sec. 50.47(b) of this chapter. To the extent approval of emergency
plans is sought, the application must contain the information required
by Sec. 50.33(g) and (j) of this chapter.
* * * * *
0
14. Revise Sec. 52.18 to read as follows:
Sec. 52.18 Standards for review of applications.
Applications filed under this subpart will be reviewed according to
the applicable standards set out in 10 CFR part 50 and its appendices
and 10 CFR part 100. In addition, the Commission shall prepare an
environmental impact statement during review of the application, in
accordance with the applicable provisions of 10 CFR part 51. The
Commission shall determine, after consultation with Federal Emergency
Management Agency, as applicable, whether the information required of
the applicant by Sec. 52.17(b)(1) shows that there is not a
significant impediment to the development of emergency plans that
cannot be mitigated or eliminated by measures proposed by the
applicant, whether any major features of emergency plans submitted by
the applicant under Sec. 52.17(b)(2)(i) are acceptable in accordance
with either the requirements in Sec. 50.160 of this chapter, or the
requirements in appendix E to part 50 of this chapter and Sec.
50.47(b) of this chapter, and whether any emergency plans submitted by
the applicant under Sec. 52.17(b)(2)(ii) provide reasonable assurance
that adequate protective measures can and will be taken in the event of
a radiological emergency.
0
15. In Sec. 52.79, revise paragraph (a)(21) to read as follows:
Sec. 52.79 Contents of applications; technical information in final
safety analysis report.
(a) * * *
(21) Emergency plans complying with the requirements of Sec. 50.47
of this chapter, and appendix E to part 50 of this chapter, or for a
small modular reactor or a non-light-water reactor license applicant,
emergency plans complying with either the requirements in Sec. 50.160
of this chapter, or the requirements in appendix E to part 50 of this
chapter and Sec. 50.47(b) of this chapter;
* * * * *
PART 72--LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF
SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-
RELATED GREATER THAN CLASS C WASTE
0
16. The authority citation for part 72 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 51, 53, 57, 62, 63,
65, 69, 81, 161, 182, 183, 184, 186, 187, 189, 223, 234, 274 (42
U.S.C. 2071, 2073, 2077, 2092, 2093, 2095, 2099, 2111, 2201, 2210e,
2232, 2233, 2234, 2236, 2237, 2238, 2273, 2282, 2021); Energy
Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C.
5841, 5842, 5846, 5851); National Environmental Policy Act of 1969
(42 U.S.C. 4332); Nuclear Waste Policy Act of 1982, secs. 117(a),
132, 133, 134, 135, 137, 141, 145(g), 148, 218(a) (42 U.S.C.
10137(a), 10152, 10153, 10154, 10155, 10157, 10161, 10165(g), 10168,
10198(a)); 44 U.S.C. 3504 note.
0
17. In Sec. 72.32, revise paragraph (c)(2) to read as follows:
Sec. 72.32 Emergency plan.
* * * * *
(c) * * *
(2) Located within the exclusion area as defined in 10 CFR part
100, of a nuclear power reactor licensed for operation by the
Commission, the emergency plan that meets either the requirements in
Sec. 50.160 of this chapter, or the requirements in appendix E to part
50 of this chapter and Sec. 50.47(b) of this chapter shall be deemed
to satisfy the requirements of this section.
* * * * *
Dated: November 9, 2023.
For the Nuclear Regulatory Commission.
Carrie M. Safford,
Secretary of the Commission.
[FR Doc. 2023-25163 Filed 11-15-23; 8:45 am]
BILLING CODE 7590-01-P