80050 Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 / Rules and Regulations 

1Emergency planning requirements for facilities 

licensed under 10 CFR part 70, ‘‘Domestic 

Licensing of Special Nuclear Material,’’ are set forth 

in § 70.22(i). 

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. 

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: Dawn.Forder@nrc.gov. 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 

PDR.Resource@nrc.gov. For the 

convenience of the reader, instructions 

about obtaining materials referenced in 

this document are provided in the 

‘‘Availability of Documents’’ section. 

• NRC’s PDR: 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 PDR.Resource@nrc.gov 

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: Robert.Beall@nrc.gov 

and Eric Schrader, Office of Nuclear 

Security and Incident Response, 

telephone: 301–287–3789, email: 

Eric.Schrader@nrc.gov. 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 lightwater 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, technologyinclusive, 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. 

B. Major Provisions 

Major provisions of this final rule and 

guidance include the addition of: 

• A new alternative performancebased 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 


lotter on DSK11XQN23PROD with RULES3
Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 / Rules and Regulations 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-lightwater 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 § 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 ‘‘nonpower production or utilization facility’’ 

(NPUF) to clarify the applicability of the 

performance-based EP framework. The 

definition includes production or 

utilization facilities, licensed under 

§ 50.21(a), § 50.21(c), or § 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 

§ 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 nonpower 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 nonpower 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, § 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 § 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 § 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 


lotter on DSK11XQN23PROD with RULES3
80052 Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 / Rules and Regulations 

2As 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. 

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 TechnologyInclusive, Risk-Informed, and 

Performance-Based Methodology to 

Inform the Licensing Basis and Content 

of Applications for Licenses, 

Certifications, and Approvals for NonLight-Water Reactors,’’ which provides 

guidance on the selection of licensingbasis 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 

§§ 50.34(a)(10), 50.34(b)(6)(v), and 

50.54(q) and appendix E to 10 CFR part 

50. The requirements of § 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 §§ 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 nonpower 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.’’ 

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 lightwater as a coolant. This latter category 

is commonly referred to as non-LWR 

technology. Advanced designs using 

non-LWR technology include liquidmetal-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 


lotter on DSK11XQN23PROD with RULES3
Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 / Rules and Regulations 80053 

3 ‘‘PRISM,’’ ‘‘MHTGR,’’ ‘‘PIUS,’’ and ‘‘CANDU’’ 

are abbreviations for Power Reactor Innovative 

Small Module, Modular High-Temperature GasCooled Reactor, Process Inherent Ultimate Safety, 

and CANadian Deuterium-Uranium, respectively. 

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. 

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 performancebased 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, performancebased 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 performancebased regulatory structure. Thus, the staff is 

proposing a new voluntary performancebased 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 performancebased 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 performancebased 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 performancebased nuclear power plant EP programs 

as directed in the SRM for SECY–06– 

0200. In SECY–14–0038, ‘‘PerformanceBased 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 performancebased 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 


lotter on DSK11XQN23PROD with RULES3
80054 Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 / Rules and Regulations 

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 performancebased 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 technologyinclusive), dose-based, consequenceoriented 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 designspecific 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 consequenceoriented 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 performancebased 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 


lotter on DSK11XQN23PROD with RULES3
Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 / Rules and Regulations 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 

§ 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, performancebased 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: consequencebased approach, co-location, dose 

assessment, EPZ and offsite EP, general 

rulemaking approach, siting of multimodule 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 nonsubstantive 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, nongovernmental 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 


lotter on DSK11XQN23PROD with RULES3
80056 Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 / Rules and Regulations 

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 § 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 § 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 §§ 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, §§ 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 § 50.12, 

‘‘Specific exemptions,’’ from the 

requirements in §§ 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-bycase 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-bycase 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 § 50.2 to include the terms 

‘‘small modular reactor,’’ ‘‘non-lightwater reactor,’’ and ‘‘non-power 

production or utilization facility.’’ The 

NRC has included a definition of ‘‘nonlight-water reactor’’ to address ONTs, 

including liquid-metal-cooled reactors, 

gas-cooled reactors, and molten-saltcooled 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 § 171.5, 

‘‘Definitions’’ for the purposes of this EP 

final rule. The § 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 § 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 § 52.1 of 

this chapter, licensed under § 50.21 or 

§ 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 § 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 lightwater 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 


lotter on DSK11XQN23PROD with RULES3
Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 / Rules and Regulations 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 sitespecific 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 performancebased framework, inspection and 

enforcement program, and designspecific 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 performancebased 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 responserelated 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 § 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 § 50.47(c)(2) 

for EPZ size determinations for gascooled 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 § 70.22(i) and 

independent spent fuel storage 

installations (ISFSIs) in § 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 preapplication 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, NRClicensed 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 


lotter on DSK11XQN23PROD with RULES3
80058 Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 / Rules and Regulations 

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 

§ 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 RiskInformed Approaches to Emergency 

Planning 

This final rule offers a consequenceoriented 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 preplanned 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 § 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 § 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 hightemperature gas-cooled reactor (HTGR) 

(842 MWt), the Big Rock Point boiling 

water reactor (BWR) (240 MWt), and the 

La Crosse BWR (165 MWt). Preapplication 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 


lotter on DSK11XQN23PROD with RULES3
Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 / Rules and Regulations 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 § 50.160 to 

submit an analysis under § 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 consequenceoriented 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 

§ 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 doseconsequence analysis. 

The NRC also added a second 

criterion to the plume exposure 

pathway EPZ size determination in 

§ 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 atrisk 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 LowPower 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 


lotter on DSK11XQN23PROD with RULES3
80060 Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 / Rules and Regulations 

4For further information on the Reactor Oversight 

Process, see: https://www.nrc.gov/reactors/ 

operating/oversight.html. 

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 

§ 50.160 to describe in their emergency 

plan the information that demonstrates 

compliance with the elements set forth 

in § 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 

§ 50.33(g)(2)(i)(B) that pre-determined, 

prompt protective measures are 

warranted, which would occur only if 

§ 50.33(g)(2)(i)(A) is also met, then an 

EPZ is required. The need for predetermined, 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 § 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 performancebased 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 § 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 

§ 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, 

§ 50.160, that provides a performancebased EP framework for SMRs and 

ONTs as an alternative to the current 

regulations. Under § 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 § 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 

§ 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 

§ 50.160 are required under 

§ 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 § 50.160(b)(1)(iii) 

and the planning activities in 

§ 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. 

The performance-based requirements 

in § 50.160 address the most risksignificant 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 

§ 50.160 is demonstrated by 

performance during drills or exercises 


lotter on DSK11XQN23PROD with RULES3
Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 / Rules and Regulations 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 § 72.32. Most power 

reactor licensees have 10 CFR part 72 

general licenses for their ISFSIs. For 

these ISFSIs, § 72.32(c) provides that the 

emergency plan required by § 50.47 

satisfies the EP requirements of § 72.32. 

This provision means that an emergency 

plan that meets the requirements of 

§ 50.47 satisfies the EP requirements of 

§ 72.32. This same policy applies to an 

ISFSI on the site of a power reactor 

whose licensee is complying with 

§ 50.160. To allow for this, the NRC 

revised § 72.32(c) to clarify that the 

emergency plan that meets either the 

requirements in § 50.160 or the 

requirements in appendix E to part 50 

and § 50.47(b) satisfies the EP 

requirements of § 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 § 50.33, § 50.34, § 52.17, 

‘‘Contents of applications; technical 

information,’’ and § 52.79. In particular, 

§ 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 § 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 § 52.17(b)(2)(i)) or complete and 

integrated emergency plans (under 

§ 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 

§ 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 

§ 50.33(g). Under §§ 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 § 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 

§ 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 

§ 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 

§ 50.160. 

• In order to maintain applicability to 

applicants and licensees choosing to 

comply with § 50.160, the NRC has 

added references to § 50.160 in 

§ 50.47(c)(1), § 50.47(c)(1)(i), and 

§ 50.47(e). 

• Combined license and ESP 

applicants must continue to include 

emergency planning information in 

their site safety analysis report and 

FSAR; §§ 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 § 50.47 and appendix E to 10 CFR 

part 50, or the requirements in § 50.160. 

• Applicants choosing to comply 

with § 50.160 must describe how their 

emergency plans meet the requirements 

in § 50.160(b). A revision to § 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 § 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 § 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 § 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 § 50.160(b)(1)(iii). The 

NRC anticipates that performance 

objectives needed to demonstrate 


lotter on DSK11XQN23PROD with RULES3
80062 Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 / Rules and Regulations 

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 § 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, 

§ 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 

§ 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 

§ 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 § 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 § 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 


lotter on DSK11XQN23PROD with RULES3
Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 / Rules and Regulations 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 

§ 50.160(b)(1)(iii)(F)(1), ‘‘Radiological 

conditions,’’ § 50.160(b)(1)(iii)(F)(3), 

‘‘Core or vessel damage,’’ and 

§ 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 

§ 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 § 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: § 50.160(b)(1)(iv)(A) 

establishes planning activities for all 

applicants and licensees complying 

with § 50.160; and § 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, § 50.47(b) requires 

licensees to be capable of maintaining 

prompt communication among the 

response organizations and the public. 

In § 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 

§ 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 

§ 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 § 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 

§ 50.160(b)(1)(iv)(B)(4) to new 

§ 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 § 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 § 50.160(b)(1)(iv)(B)(11) 

to new § 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 § 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 § 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 § 50.160 


lotter on DSK11XQN23PROD with RULES3
80064 Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 / Rules and Regulations 

5See FEMA’s Emergency Management Agencies 

website https://www.fema.gov/emergencymanagement-agencies. 

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, § 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 

§ 50.160(b)(1)(iv)(B)(5) is renumbered to 

§ 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 

§ 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

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 § 50.47(c)(1)(iii) 

and further strengthened by the NRC’s 


lotter on DSK11XQN23PROD with RULES3
Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 / Rules and Regulations 80065 

6For further information on the National Incident 

Management System, see: https://www.fema.gov/ 

pdf/emergency/nims/nimsfaqs.pdf. 7For further information on the National 

Preparedness Goal, see: https://www.fema.gov/ 

national-preparedness-goal. 

8For further information on Core Capabilities, 

see: https://www.fema.gov/core-capabilities. 

9For further information on the National 

Preparedness System, see: https://www.fema.gov/ 

national-preparedness-system. 

10For further information on the National 

Planning Frameworks, see: https://www.fema.gov/ 

national-planning-frameworks. 

11For more information on the definition of 

‘‘whole community,’’ see: https://www.fema.gov/ 

whole-community#. 

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. 

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 § 50.47 in this rule clarify 

when § 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 § 50.160 or the 

approach to EP under § 50.47(b) and 

appendix E to 10 CFR part 50. This final 

rule includes conforming changes to 

§ 50.54(q). 

Existing § 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 

§ 50.47(b), and existing § 50.54(q)(3) and 

(4) describe the process for analyzing, 

submitting, and making changes to 

emergency plans. The NRC is revising 

§ 50.54(q)(2) through (4) to include 

cross-references to the requirements 

under § 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 

§ 50.160 or the requirements of 

appendix E to 10 CFR part 50 and, for 

nuclear power reactor licensees, the 

planning standards of § 50.47(b). The 

NRC is not making any changes to the 

emergency plan change process. 

Licensees choosing the performancebased approach to EP must evaluate 

changes to their emergency plans 

against the performance-based 

requirements under § 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 § 50.54(q)(1) to remove 

references to appendix E to 10 CFR part 

50 and § 50.47(b) because emergency 

planning functions are addressed under 

both these sections and under § 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, 

§ 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 § 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 § 50.72 ERDS 

activation requirement are not 

applicable to applicants and licensees 

choosing to comply with § 50.160. 

Applicants and licensees choosing 

§ 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 casespecific 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, § 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 


lotter on DSK11XQN23PROD with RULES3
80066 Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 / Rules and Regulations 

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, technologyinclusive 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 

§§ 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 designor 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 § 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 

§ 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 

§ 52.17(b)(2)(ii), or an ESP that proposes 

major features of the emergency plans 

and describes the EPZ, then § 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 § 50.33(g)(2) would need to 

show that one or both of the criteria in 

§ 50.33(g)(2)(i) are not met. For purposes 

of complying with § 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 

§ 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 

§ 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 

§ 50.160(b)(4). Applicants and licensees 

complying with § 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 § 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 


lotter on DSK11XQN23PROD with RULES3
Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 / Rules and Regulations 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 

§ 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 

§ 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 performancebased approach to EP to establish, 

implement, and maintain an EP program 

that meets the requirements of 

§ 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 § 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 § 52.103(g) is required to 

establish, implement, and maintain an 

EP program that meets the requirements 

of § 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, 

§ 50.54(q)(7) stipulates that facilities 

desiring to change their emergency 

plans to comply with the performancebased 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 

§§ 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 § 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 casespecific review of design- and sitespecific 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 performancebased 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 

§ 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 § 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 

§ 50.160(b) from the proposed rule to 

state that the reasonable assurance 

finding made under § 50.47(a)(1) 

necessary to issue an OL, COL, or ESP 

to an applicant complying with § 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 § 50.160. The NRC also revised 

§ 50.47(a)(1)(iv) to reflect that an 

applicant for an ESP that proposes 

major features of the emergency plan 


lotter on DSK11XQN23PROD with RULES3
80068 Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 / Rules and Regulations 

under § 52.17(b)(2)(i) can choose to 

comply with § 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 

§ 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 § 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 § 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 § 50.8, this final rule adds new 

§ 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 § 50.10, this final rule revises 

paragraph (a)(1)(vii) to include onsite 

emergency facilities necessary to 

comply with new § 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 § 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 § 50.160. 

Section 50.34 Contents of 

Applications; Technical Information 

In § 50.34, this final rule revises 

paragraph (a)(10) to require SMR, nonLWR, or NPUF CP applicants to 

describe in their PSARs the preliminary 

plans for coping with emergencies based 

on the requirements in either § 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 § 50.160 or 

appendix E to 10 CFR part 50. 

Section 50.47 Emergency Plans 

In § 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 § 50.47(a)(2), (b), and 

(c)(2) do not apply. 

Section 50.54 Conditions of Licenses 

In § 50.54, this final rule revises 

paragraph (q)(1)(iii) to remove the 

references to appendix E to 10 CFR part 

50 and § 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 § 50.160 or appendix E 

to 10 CFR part 50 and, for nuclear 

power reactor licensees, § 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 

§ 50.160, when making an emergency 

plan change that reduces plan 

effectiveness, need to specify the basis 

for concluding how their revised 


lotter on DSK11XQN23PROD with RULES3
Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 / Rules and Regulations 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 

§ 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 § 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 § 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-LightWater Reactors, and Non-power 

Production or Utilization Facilities,’’ 

after § 50.155 and new § 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 § 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 § 50.160, 

as applicable. 

Section 52.18 Standards for Review of 

Applications 

This final rule revises § 52.18 to make 

editorial changes and to include 

references to new § 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 § 50.160 or the 

requirements in appendix E to 10 CFR 

part 50 and § 50.47(b). 

Section 72.32 Emergency Plans 

In § 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 § 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 (§ 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 

§§ 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 § 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 


lotter on DSK11XQN23PROD with RULES3
80070 Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 / Rules and Regulations 

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 § 50.33(g) 

and the ingestion response planning 

requirements under § 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 

§ 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 § 50.33(g) and 

ingestion response planning 

requirement under § 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 licenseedefined 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: oira_submission@omb.eop.gov. 

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 §§ 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 

§ 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 


lotter on DSK11XQN23PROD with RULES3
Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 / Rules and Regulations 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 § 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. 

Document ADAMS accession No./web link/Federal Register 

citation 

EPA/520/1–75–001, ‘‘Manual of Protective Action Guides and Protective Actions for Nuclear Incidents,’’ September 1975.ML20203M064. 

NUREG–75/014, ‘‘Reactor Safety Study—An Assessment of Accident Risks in U.S. 

Commercial Nuclear Power Plants,’’ (WASH–1400), October 1975 (Appendices III–IV, 

Appendix V, Appendix VI, Appendices VII–X).

ML070610293, 

ML070530533, 

ML070600389, 

ML070600376. 

NUREG–0396, ‘‘Planning Basis for the Development of State and Local Government 

Radiological Emergency Response Plans in Support of Light Water Nuclear Power 

Plants,’’ December 1978.

ML051390356. 

RG 2.6, ‘‘Emergency Planning for Research Reactors,’’ January 1979 ............................. ML12184A008. 

‘‘10 CFR Parts 50 and 70, Emergency Planning,’’ Final Rule, August 19, 1980 ............... 45 FR 55402. 

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,’’ November 1980.

ML040420012. 

‘‘Emergency Planning and Preparedness,’’ Final Rule, July 13, 1982 ............................... 47 FR 30232. 

NUREG–0849, ‘‘Standard Review Plan for the Review and Evaluation of Emergency 

Plans for Research and Test Reactors,’’ October 1983.

ML062190191. 

‘‘Specific Exemptions; Clarification of Standards,’’ Final Rule, December 12, 1985 .......... 50 FR 50764. 

‘‘Regulation of Advanced Nuclear Power Plants, Statement of Policy,’’ July 8, 1986 ........ 51 FR 24643. 

NUREG–1226, ‘‘Development and Utilization of the NRC Policy Statement on the Regulation of Advanced Nuclear Power Plants,’’ June 1988.ML13253A431. 

‘‘Emergency Planning and Preparedness Requirements for Nuclear Power Plant Fuel 

Loading and Low-Power Testing,’’ Final Rule, September 23, 1988.

53 FR 36955. 

‘‘Early Site Permits; Standard Design Certifications; and Combined Licenses for Nuclear 

Power Plants,’’ Final Rule, April 18, 1989.

54 FR 15372. 

EPA–400–R–92–001, ‘‘Manual of Protection Action Guides and Protective Actions for 

Nuclear Incidents,’’ May 1992.

https://www.epa.gov/sites/production/files/2016-03/ 

documents/pags.pdf. 

SECY–93–092, ‘‘Issues Pertaining to the Advanced Reactor (PRISM, MHTGR, and 

PIUS) and CANDU 3 Designs and Their Relationship to Current Regulatory Requirements,’’ April 8, 1993.

ML040210725. 

SRM–SECY–93–092, ‘‘Staff Requirements—SECY–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.

ML003760774. 

NUREG–1537, Part 1, ‘‘Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Format and Content,’’ February 1996.ML042430055. 

NUREG–1537, Part 2, ‘‘Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Standard Review Plan and Acceptance Criteria,’’ 

February 1996.

ML042430048. 

SECY–97–020, ‘‘Results of Evaluation of Emergency Planning for Evolutionary and Advanced Reactors,’’ January 27, 1997.ML992920024. 

Homeland Security Presidential Directive 5, ‘‘Management of Domestic Incidents,’’ February 28, 2003.https://www.dhs.gov/publication/homeland-securitypresidential-directive-5. 

SECY–04–0236, ‘‘Southern Nuclear Operating Company’s Proposal to Establish a Common Emergency Operating Facility at its Corporate Headquarters,’’ December 23, 

2004.

ML042590576. 

SRM–SECY–04–0236, ‘‘Staff Requirements—SECY–04–0236—Southern Nuclear Operating Company’s Proposal to Establish a Common Emergency Operating Facility at its 

Corporate Headquarters,’’ February 23, 2005.

ML050550131. 

SECY–06–0200, ‘‘Results of the Review of Emergency Preparedness Regulations and 

Guidance,’’ September 20, 2006.

ML061910707. 

SRM–SECY–06–0200, ‘‘Staff Requirements—SECY–06–0200—Results of the Review 

of Emergency Preparedness Regulations and Guidance,’’ January 8, 2007.

ML070080411. 

NUREG–0800, ‘‘Standard Review Plan for the Review of Safety Analysis Reports for 

Nuclear Power Plants: LWR Edition,’’ Section 13.3, ‘‘Emergency Planning,’’ March 

2007.

ML063410307. 

NUREG–0800, Section 14.3.10, ‘‘Emergency Planning—Inspections, Tests, Analyses, 

and Acceptance Criteria,’’ March 2007.

ML070730206. 

‘‘Policy Statement on Regulation of Advanced Reactors,’’ October 14, 2008 .................... 73 FR 60612. 


lotter on DSK11XQN23PROD with RULES3
80072 Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 / Rules and Regulations 

Document ADAMS accession No./web link/Federal Register 

citation 

‘‘Summary of Workshop on Small and Medium-Sized Nuclear Reactors (SMRs),’’ October 22, 2009.ML092940138. 

SECY–10–0034, ‘‘Potential Policy, Licensing, and Key Technical Issues for Small Modular Reactor Designs,’’ March 28, 2010.ML093290268. 

NUREG–1520, ‘‘Standard Review Plan for the Review of a License Application for a 

Fuel Cycle Facility,’’ Revision 1, May 1, 2010.

ML101390110. 

‘‘Summary of July 28, 2010, Category 2 Meeting with Small Modular Reactor Design 

Representatives to Discuss Small Modular Reactor Key Licensing Issues (TAC NO. 

Q00269),’’ August 26, 2010.

ML102380209. 

Presidential Policy Directive/PPD–8, ‘‘National Preparedness,’’ March 30, 2011 .............. https://www.dhs.gov/presidential-policy-directive-8-national-preparedness. 

SECY–11–0152, ‘‘Development of an Emergency Planning and Preparedness Framework for Small Module Reactors,’’ October 28, 2011.ML112570439. 

‘‘Enhancements to Emergency Preparedness Regulations,’’ Final Rule, November 23, 

2011.

76 FR 72560. 

Interim Staff Guidance for NUREG–1537, ‘‘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.

ML12156A069. 

Final Interim Staff Guidance for NUREG–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.

ML12156A075. 

NEI 99–02, ‘‘Regulatory Assessment Performance Indicator Guideline,’’ Revision 7, August 13, 2013.ML13261A116. 

NEI White Paper, ‘‘White Paper: Proposed Methodology and Criteria Establishing the 

Technical Basis for Small Modular Reactor Emergency Planning Zone,’’ December 

23, 2013.

ML13364A345. 

SECY–14–0038, ‘‘Performance-Based Framework for Nuclear Power Plant Emergency 

Preparedness Oversight,’’ April 4, 2014.

ML13238A018. 

SECY–14–0066, ‘‘Request by Dominion Energy Kewaunee Inc., for Exemptions from 

Certain Emergency Planning Requirements,’’ June 27, 2014.

ML14072A257. 

SRM–SECY–14–0038, ‘‘Staff Requirements—SECY–14–0038—Performance-Based 

Framework for Nuclear Power Plant Emergency Preparedness Oversight,’’ September 

16, 2014.

ML14259A589. 

SECY–14–0118, ‘‘Request by Duke Energy Florida, Inc., for Exemptions from Certain 

Emergency Planning Requirements,’’ October 29, 2014.

ML14219A444. 

American National Standards Institute/American Society Standard (ANSI/ANS) 15.16— 

2015. ‘‘Emergency Planning for Research Reactors,’’ American Nuclear Society, La 

Grange Park, IL, February 2015.

https://webstore.ansi.org/standards/ansi/ansians

15162015. 

SECY–15–0077, ‘‘Options for Emergency Preparedness for Small Module Reactors and 

Other New Technologies,’’ May 29, 2015.

ML15037A176. 

‘‘Summary of June 7–8, 2015, Department of Energy and Nuclear Regulatory Commission Co-Hosted Workshop on Advanced Non-Light Water Reactors,’’ July 7, 2015.ML16188A226. 

NEI White Paper, ‘‘Proposed Emergency Preparedness Regulations and Guidance for 

Small Modular Reactor Facilities,’’ July 2015.

ML15194A275. 

SRM–SECY–15–0077, ‘‘Staff Requirements—SECY–15–0077—Options for Emergency 

Preparedness for Small Module Reactors and Other New Technologies,’’ August 4, 

2015.

ML15216A492. 

‘‘Summary of September 1–2, 2015, Nuclear Regulatory Commission and Department of 

Energy Co-Hosted Workshop on Advanced Non-Light Water Reactors,’’ October 1, 

2015.

ML15265A165. 

‘‘Variable Annual Fee Structure for Small Modular Reactors,’’ Proposed Rule, November 

4, 2015.

80 FR 68268. 

‘‘Memorandum of Understanding Between the Department of Homeland Security/Federal Emergency Management Agency and Nuclear Regulatory Commission Regarding 

Radiological Emergency Response, Planning, and Preparedness,’’ December 7, 2015.

ML15344A371. 

‘‘Variable Annual Fee Structure for Small Modular Reactors,’’ Final Rule, May 24, 2016 81 FR 32617. 

SECY–16–0069, ‘‘Rulemaking Plan on Emergency Preparedness for Small Module Reactors and Other New Technologies,’’ May 31, 2016.ML16020A388. 

Nuclear Innovation Alliance, ‘‘Enabling Nuclear Innovation: Strategies for Advanced Reactor Licensing,’’ June 7, 2016.https://docs.wixstatic.com/ugd/5b05b3_71d40115

45234838aa27005ab7d757f1.pdf. 

SRM–SECY–16–0069, ‘‘Staff Requirements—SECY–16–0069—Rulemaking Plan on 

Emergency Preparedness for Small Module Reactors and Other New Technologies,’’ 

June 22, 2016.

ML16174A166. 

RG 1.219, Revision 1, ‘‘Guidance on Making Changes to Emergency Plans for Nuclear 

Power Reactors,’’ July 2016.

ML16061A104. 

‘‘Summary of August 22, 2016, Public Meeting to Discuss a Performance-Based Approach to Emergency Preparedness for Small Modular Reactors and Other New 

Technologies,’’ September 15, 2016.

ML16257A510. 

‘‘NRC Vision and Strategy: Safely Achieving Effective and Efficient Non-Light Water Reactor Mission Readiness,’’ December 2016.ML16356A670. 


lotter on DSK11XQN23PROD with RULES3
Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 / Rules and Regulations 80073 

Document ADAMS accession No./web link/Federal Register 

citation 

EPA–400/R–17/001, ‘‘PAG Manual: Protective Action Guides and Planning Guidance for 

Radiological Incidents,’’ January 2017.

https://www.epa.gov/sites/production/files/2017-01/ 

documents/epa_pag_manual_final_revisions_01-11- 

2017_cover_disclaimer_8.pdf. 

‘‘Tribal Policy Statement,’’ January 9, 2017 ........................................................................ 82 FR 2402.

‘‘Emergency Preparedness for Small Modular Reactors and Other New Technologies,’’ 

Draft Regulatory Basis, April 13, 2017.

82 FR 17768. 

‘‘Summary of May 10, 2017, Public Meeting on the Draft Regulatory Basis for the Rulemaking for Emergency Preparedness for Small Modular Reactors and Other New 

Technologies,’’ May 24, 2017.

ML17139C860. 

RG 2.6, ‘‘Emergency Planning for Research and Test Reactors and Other Non-Power 

Production and Utilization Facilities,’’ September 2017.

ML17263A472. 

‘‘Emergency Preparedness for Small Modular Reactors and Other New Technologies,’’ 

Regulatory Basis, November 15, 2017.

82 FR 52862. 

‘‘Regulatory Improvements for Power Reactors Transitioning to Decommissioning Rulemaking,’’ Regulatory Basis, November 27, 2017.82 FR 55954. 

SECY–18–0055, ‘‘Proposed Rule: Regulatory Improvements for Production and Utilization Facilities Transitioning to Decommissioning,’’ May 22, 2018.ML18012A019. 

‘‘Generalized Dose Assessment Methodology for Informing Emergency Planning Zone 

Size Determinations,’’ June 2018.

ML18064A317. 

‘‘Required Analyses for Informing Emergency Planning Zone Size Determinations,’’ June 

2018.

ML18114A176. 

SRM–SECY–18–0103, ‘‘Staff Requirements—SECY–18–0103—Proposed Rule: Emergency Preparedness for Small Modular Reactors and Other New Technologies (RIN 

3150 AJ68; NRC–2015–0225),’’ December 17, 2019.

ML19351C729. 

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,’’ December 2019.

ML19347D139. 

RG 1.233, ‘‘Guidance for a Technology-Inclusive, Risk-Informed, and PerformanceBased Methodology to Inform the Licensing Basis and Content of Applications for Licenses, Certifications, and Approvals for Non-Light Water Reactors,’’ June 2020.ML20091L698. 

Summary of June 24, 2020, Public Meeting to Discuss the Proposed Emergency Preparedness for Small Modular Reactors and Other New Technologies Rule, July 14, 

2020.

ML20196L775 

‘‘Regulatory Analysis for the Final Rule: Emergency Preparedness for Small Modular 

Reactors and Other New Technologies,’’ January 2022.

ML23226A027. 

‘‘Environmental Assessment for the Final Rule—Emergency Preparedness for Small 

Modular Reactors and Other New Technologies,’’ November 2023.

ML23226A031. 

‘‘Supporting Statement for Information 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.

ML21200A185. 

‘‘Supporting Statement for Information 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.

ML21200A190. 

RG 1.242, ‘‘Performance-Based Emergency Preparedness for Small Modular Reactors, 

Non-Light-Water Reactors, and Non-Power Production or Utilization Facilities,’’ November 2023.

ML23226A036. 

‘‘NRC Response to Public Comments; Emergency Preparedness for Small Modular Reactors and Other New Technologies’’.ML23229A227. 

SECY–22–0001, ‘‘Final Rule: Emergency Preparedness for Small Modular Reactors and 

Other New Technologies,’’ January 3, 2022.

ML21200A059. 

SRM–M230814, ‘‘Affirmation Session—SECY–22–0001: Rulemaking: Final Rule: Emergency Preparedness for Small Modular Reactors and Other New Technologies,’’ August 14, 2023.ML23226A184, 

ML23226A218. 

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 


lotter on DSK11XQN23PROD with RULES3
80074 Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 / Rules and Regulations 

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 

■ 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. 

■ 2. In § 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: 

§ 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 

§ 50.21(a) or (c), or § 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 § 52.1 of this 

chapter, licensed under § 50.21 or 

§ 50.22 to produce heat energy up to 

1,000 megawatts thermal per module. 

* * * * * 

§ 50.8 [Amended] 

■ 3. In § 50.8, in paragraph (b), add the 

citation ‘‘50.160,’’ after the citation 

‘‘50.155,’’. 

■ 4. In § 50.10, revise paragraph 

(a)(1)(vii) to read as follows: 

§ 50.10 License required; limited work 

authorization. 

(a) * * * 

(1) * * * 

(vii) Onsite emergency facilities 

necessary to comply with either 

§ 50.160 or § 50.47 and appendix E to 

this part, as applicable. 

* * * * * 

■ 5. In § 50.33, revise paragraph (g) to 

read as follows: 

§ 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 § 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. 

* * * * * 4Emergency 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-lightwater reactor, or non-power production 

or utilization facility applicants 

complying with § 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 

§ 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 

§ 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 

§ 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 § 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 § 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. 

* * * * * 

■ 6. In § 50.34, revise paragraphs (a)(10) 

and (b)(6)(v) to read as follows: 


lotter on DSK11XQN23PROD with RULES3
Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 / Rules and Regulations 80075 

§ 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 § 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 § 50.160 or 

appendix E to this part. 

* * * * * 

■ 7. In § 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: 

§ 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 § 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 § 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 § 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 § 50.160 

or paragraph (b) of this section is wholly 

or substantially the result of the nonparticipation of State and/or local 

governments. 

* * * * * 

(e) Notwithstanding the requirements 

of paragraph (b) of this section and the 

provisions of § 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 § 50.54(gg), and a 

holder of a combined license under part 

52 of this chapter that is complying with 

the requirements of § 50.160 may not 

load fuel or operate except as provided 

in accordance with § 50.160(c)(2) and 

§ 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. 

■ 8. In § 50.54: 

■ a. Revise paragraphs (q)(1)(iii) and 

(q)(2) through (4); 

■ b. In paragraph (q)(5), remove the 

words ‘‘made after February 21, 2012’’; 

■ c. Add paragraph (q)(7); 

■ d. In paragraph (s)(2)(ii), in the first 

sentence: 

■ i. Remove the words ‘‘after April 1, 

1981,’’; 

■ ii. Remove the word ‘‘reactor’’ and 

add in its place the word ‘‘facility’’; and 

■ iii. Add the words ‘‘or cease 

operation’’ after the words ‘‘shut down’’; 

and 

■ e. Revise paragraphs (s)(3) and (gg)(1) 

introductory text. 

The revisions and addition read as 

follows: 

§ 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 § 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 § 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 

§ 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 

§ 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 

§ 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 § 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 § 50.160 or the 

requirements in appendix E to this part 

and, for nuclear power reactor licensees, 

the planning standards of § 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 


lotter on DSK11XQN23PROD with RULES3
80076 Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 / Rules and Regulations 

desiring to make such a change shall 

submit an application for an 

amendment to its license. In addition to 

the filing requirements of §§ 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 § 50.160 or the 

requirements in appendix E to this part 

and, for nuclear power reactor licensees, 

the planning standards of § 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 § 50.160 shall 

submit to the Commission, as specified 

in § 50.90, a license amendment request 

for implementing an emergency 

preparedness program with the 

associated plan modification necessary 

to meet the requirements of § 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 

§ 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 § 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 § 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 

§ 50.47 and appendix E to this part, or 

§ 50.160, as applicable. Review of the 

applicant’s emergency plans will 

include the following standards with 

offsite aspects: 

* * * * * 

■ 9. After § 50.155, add an undesignated 

center heading and § 50.160 to read as 

follows: 

Small Modular Reactors, Non-LightWater Reactors, and Non-Power 

Production or Utilization Facilities 

§ 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 § 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 § 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 


lotter on DSK11XQN23PROD with RULES3
Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 / Rules and Regulations 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 

§ 50.33(g)(2) meets the criteria in 

§ 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 § 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. 

■ 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

1EPZs 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-bycase 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. 2Regulatory 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 

■ 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. 

■ 12. In § 52.1, in paragraph (a), revise 

the definition of ‘‘Major feature of the 

emergency plans’’ to read as follows: 

§ 52.1 Definitions. 

(a) * * * 


lotter on DSK11XQN23PROD with RULES3
80078 Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 / Rules and Regulations 

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). 

* * * * * 

■ 13. In § 52.17, revise paragraphs 

(b)(2)(i) and (ii) to read as follows: 

§ 52.17 Contents of applications; technical 

information. 

* * * * * 

(b) * * * 

(2) * * * 

(i) Propose major features of the 

emergency plans, in accordance with 

either the requirements in § 50.160 of 

this chapter, or the requirements in 

appendix E to part 50 of this chapter 

and § 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 § 50.160 

of this chapter, or the requirements in 

appendix E to part 50 of this chapter 

and § 50.47(b) of this chapter. To the 

extent approval of emergency plans is 

sought, the application must contain the 

information required by § 50.33(g) and 

(j) of this chapter. 

* * * * * 

■ 14. Revise § 52.18 to read as follows: 

§ 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 § 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 § 52.17(b)(2)(i) are 

acceptable in accordance with either the 

requirements in § 50.160 of this chapter, 

or the requirements in appendix E to 

part 50 of this chapter and § 50.47(b) of 

this chapter, and whether any 

emergency plans submitted by the 

applicant under § 52.17(b)(2)(ii) provide 

reasonable assurance that adequate 

protective measures can and will be 

taken in the event of a radiological 

emergency. 

■ 15. In § 52.79, revise paragraph (a)(21) 

to read as follows: 

§ 52.79 Contents of applications; technical 

information in final safety analysis report. 

(a) * * * 

(21) Emergency plans complying with 

the requirements of § 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 § 50.160 of this chapter, or the 

requirements in appendix E to part 50 

of this chapter and § 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 

■ 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. 

■ 17. In § 72.32, revise paragraph (c)(2) 

to read as follows: 

§ 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 § 50.160 of this chapter, 

or the requirements in appendix E to 

part 50 of this chapter and § 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 


lotter on DSK11XQN23PROD with RULES3