[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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \5\ See FEMA's Emergency Management Agencies website https://www.fema.gov/emergency-management-agencies.
---------------------------------------------------------------------------

    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#.
---------------------------------------------------------------------------

    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
------------------------------------------------------------------------
EPA/520/1-75-001, ``Manual of Protective     ML20203M064.
 Action Guides and Protective Actions for
 Nuclear Incidents,'' September 1975.
NUREG-75/014, ``Reactor Safety Study--An     ML070610293,
 Assessment of Accident Risks in U.S.        ML070530533,
 Commercial Nuclear Power Plants,'' (WASH-   ML070600389,
 1400), October 1975 (Appendices III-IV,     ML070600376.
 Appendix V, Appendix VI, Appendices VII-X).
NUREG-0396, ``Planning Basis for the         ML051390356.
 Development of State and Local Government
 Radiological Emergency Response Plans in
 Support of Light Water Nuclear Power
 Plants,'' December 1978.
RG 2.6, ``Emergency Planning for Research    ML12184A008.
 Reactors,'' January 1979.
``10 CFR Parts 50 and 70, Emergency          45 FR 55402.
 Planning,'' Final Rule, August 19, 1980.
NUREG-0654/FEMA-REP-1, Revision 1,           ML040420012.
 ``Criteria for Preparation and Evaluation
 of Radiological Emergency Response Plans
 and Preparedness in Support of Nuclear
 Power Plants,'' November 1980.
``Emergency Planning and Preparedness,''     47 FR 30232.
 Final Rule, July 13, 1982.
NUREG-0849, ``Standard Review Plan for the   ML062190191.
 Review and Evaluation of Emergency Plans
 for Research and Test Reactors,'' October
 1983.
``Specific Exemptions; Clarification of      50 FR 50764.
 Standards,'' Final Rule, December 12, 1985.
``Regulation of Advanced Nuclear Power       51 FR 24643.
 Plants, Statement of Policy,'' July 8,
 1986.
NUREG-1226, ``Development and Utilization    ML13253A431.
 of the NRC Policy Statement on the
 Regulation of Advanced Nuclear Power
 Plants,'' June 1988.
``Emergency Planning and Preparedness        53 FR 36955.
 Requirements for Nuclear Power Plant Fuel
 Loading and Low-Power Testing,'' Final
 Rule, September 23, 1988.
``Early Site Permits; Standard Design        54 FR 15372.
 Certifications; and Combined Licenses for
 Nuclear Power Plants,'' Final Rule, April
 18, 1989.
EPA-400-R-92-001, ``Manual of Protection     https://www.epa.gov/sites/
 Action Guides and Protective Actions for     production/files/2016-03/
 Nuclear Incidents,'' May 1992.               documents/pags.pdf.
SECY-93-092, ``Issues Pertaining to the      ML040210725.
 Advanced Reactor (PRISM, MHTGR, and PIUS)
 and CANDU 3 Designs and Their Relationship
 to Current Regulatory Requirements,''
 April 8, 1993.
SRM-SECY-93-092, ``Staff Requirements--SECY- ML003760774.
 93-092--Issues Pertaining to the Advanced
 Reactor (PRISM, MHTGR, and PIUS) and CANDU
 3 Designs and Their Relationship to
 Current Regulatory Requirements,'' July
 30, 1993.
NUREG-1537, Part 1, ``Guidelines for         ML042430055.
 Preparing and Reviewing Applications for
 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.
SECY-97-020, ``Results of Evaluation of      ML992920024.
 Emergency Planning for Evolutionary and
 Advanced Reactors,'' January 27, 1997.
Homeland Security Presidential Directive 5,  https://www.dhs.gov/
 ``Management of Domestic Incidents,''        publication/homeland-
 February 28, 2003.                           security-presidential-
                                              directive-5.
SECY-04-0236, ``Southern Nuclear Operating   ML042590576.
 Company's Proposal to Establish a Common
 Emergency Operating Facility at its
 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.
American National Standards Institute/       https://webstore.ansi.org/
 American Society Standard (ANSI/ANS)         standards/ansi/
 15.16--2015. ``Emergency Planning for        ansians15162015.
 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/
 Nuclear Innovation: Strategies for           ugd/
 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