[Federal Register Volume 85, Number 92 (Tuesday, May 12, 2020)]
[Proposed Rules]
[Pages 28436-28466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09666]



[[Page 28435]]

Vol. 85

Tuesday,

No. 92

May 12, 2020

Part V





 Nuclear Regulatory Commission





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10 CFR Parts 50 and 52





Emergency Preparedness for Small Modular Reactors and Other New 
Technologies; Proposed Rule

  Federal Register / Vol. 85 , No. 92 / Tuesday, May 12, 2020 / 
Proposed Rules  

[[Page 28436]]


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NUCLEAR REGULATORY COMMISSION

10 CFR Parts 50 and 52

[NRC-2015-0225]
RIN 3150-AJ68


Emergency Preparedness for Small Modular Reactors and Other New 
Technologies

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule and guidance; request for comment.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is proposing to 
amend its regulations to include new alternative emergency preparedness 
(EP) requirements for small modular reactors (SMRs) and other new 
technologies (ONTs), such as non-light-water reactors (non-LWRs) and 
certain non-power production or utilization facilities (NPUFs). The new 
EP requirements would acknowledge technological advancements and other 
differences from large LWRs that are inherent in SMRs and ONTs. 
Concurrently, the NRC is issuing for public comment draft Regulatory 
Guide (DG), DG-1350, ``Performance-Based Emergency Preparedness for 
Small Modular Reactors, Non-Light-Water Reactors, and Non-power 
Production or Utilization Facilities.'' The NRC plans to hold a public 
meeting to promote full understanding of the proposed rule and guidance 
and to facilitate public comment.

DATES: Submit comments by July 27, 2020. Comments received after this 
date will be considered if it is practical to do so, but the Commission 
is able to ensure consideration only for comments received before this 
date.

ADDRESSES: You may submit comments by any of the following methods 
(unless this document describes a different method for submitting 
comments on a specific subject):
     Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2015-0225. Address 
questions about NRC dockets to Carol Gallagher; telephone: 301-415-
3463; email: [email protected]. For technical questions contact 
the individuals listed in the FOR FURTHER INFORMATION CONTACT section 
of this document.
     Email comments to: [email protected]. If you do 
not receive an automatic email reply confirming receipt, then contact 
us at 301-415-1677.
     Mail comments to: Secretary, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, ATTN: Rulemakings and 
Adjudications Staff.
    For additional direction on obtaining information and submitting 
comments, see ``Obtaining Information and Submitting Comments'' in the 
SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Robert Beall, Office of Nuclear 
Material Safety and Safeguards; telephone: (301) 415-3874, email: 
[email protected]; or Eric Schrader, Office of Nuclear Security and 
Incident Response; telephone: 301-287-3789; email: 
[email protected]; both are staff of the U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001.

SUPPLEMENTARY INFORMATION: 

Executive Summary

A. Need for the Regulatory Action

    The current EP requirements and guidance, initially developed for 
large light-water reactors (LWRs) and for non-power reactors, also 
referred to as research and test reactors (RTRs), as defined in part 50 
of title 10 of the Code of Federal Regulations (10 CFR), ``Domestic 
Licensing of Production and Utilization Facilities,'' do not consider 
the advances in designs and safety research and their application to 
future operation of SMRs and ONTs. Through this proposed rule, the NRC 
is proposing to amend its regulations to create an alternative EP 
framework for SMRs and ONTs. The new alternative EP requirements and 
implementing guidance in DG-1350 would adopt a performance-based, 
technology-inclusive, risk-informed, and consequence-oriented approach. 
The new alternative EP requirements and guidance would adopt a scalable 
plume exposure pathway emergency planning zone (EPZ) approach and 
address ingestion response planning. The new alternative EP 
requirements and guidance would: (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 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 
smaller sized reactors' and non-LWRs' potential benefits associated 
with postulated accidents, including slower transient response times, 
and relatively small and slow release of fission products. This 
proposed rule and guidance could affect existing SMR and non-LWR 
applicants and licensees as well as SMRs, non-LWRs, and NPUFs that 
would be licensed after the effective date of the final rule. Those 
applicants and licensees would 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 proposed 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 rule, large LWRs 
are reactors that are licensed to produce greater than 1,000 megawatts 
thermal (MWt) power.
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    \1\ Emergency planning requirements for facilities licensed 
under 10 CFR part 70, ``Domestic Licensing of Special Nuclear 
Material,'' are set forth in Sec.  70.22(i).
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B. Major Provisions

    Major provisions of this proposed rule and guidance would include 
the addition of:
     A new alternative performance-based EP framework, 
including requirements for demonstrating effective response in drills 
and exercises for emergency and accident conditions;
     A hazard analysis of any NRC-licensed or non-licensed 
facility contiguous or nearby to an SMR or ONT, that considers any 
hazard that would adversely impact the implementation of emergency 
plans;
     A scalable approach for determining the size of the plume 
exposure pathway EPZ; and
     A requirement to describe ingestion response planning in 
the emergency plan, including the capabilities and resources available 
to prevent contaminated food and water from entering the ingestion 
pathway.

C. Costs and Benefits

    The NRC prepared a draft regulatory analysis to determine the 
expected quantitative costs and benefits of this proposed rule and 
associated guidance as well as qualitative factors to be considered in 
the NRC's rulemaking decision. The conclusion from the analysis is that 
this proposed rule and associated guidance would result in net averted 
costs to the industry and the NRC ranging from $5.89 million using a 7-
percent discount rate to $9.71 million using a 3-percent discount rate.
    The draft regulatory analysis also considered qualitative aspects, 
such as greater regulatory stability, predictability, and clarity to 
the licensing process. These benefits would

[[Page 28437]]

result from applicants and licensees not needing to use the exemption 
process to establish EP criteria commensurate with design- and site-
specific considerations. Another 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, please see the draft regulatory analysis 
(available in the NRC's Agencywide Documents Access and Management 
System (ADAMS) Accession No. ML18134A077).

Table of Contents

I. Obtaining Information and Submitting Comments
    A. Obtaining Information
    B. Submitting Comments
II. Background
III. Discussion
IV. Specific Requests for Comments
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 Proposed Finding of No Significant 
Impact
XII. Paperwork Reduction Act Statement
XIII. Criminal Penalties
XIV. Voluntary Consensus Standards
XV. Availability of Guidance
XVI. Public Meeting
XVII. Availability of Documents

I. Obtaining Information and Submitting Comments

A. Obtaining Information

    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.
     NRC's ADAMS: You may obtain publicly-available documents 
online in the ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``Begin Web-based 
ADAMS Search.'' For problems with ADAMS, please contact the NRC's 
Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-
4737, or by email to [email protected]. For the convenience of the 
reader, instructions about obtaining materials referenced in this 
document are provided in section XVII, ``Availability of Documents.''
     Attention: The Public Document Room (PDR), where you may 
examine and order copies of public documents is currently closed. You 
may submit your request to the PDR via email at [email protected] or 
call 1-800-397-4209 between 8:00 a.m. and 4:00 p.m. (EST), Monday 
through Friday, except Federal holidays.

B. Submitting Comments

    Please include Docket ID NRC-2015-0225 in your comment submission. 
To facilitate NRC review, please distinguish your comments between 
comments on the proposed rule and comments on the proposed guidance. 
The NRC cautions you not to include identifying or contact information 
that you do not want to be publicly disclosed in your comment 
submission. The NRC will post all comment submissions at https://www.regulations.gov as well as enter the comment submissions into 
ADAMS. The NRC does not routinely edit comment submissions to remove 
identifying or contact information. If you are requesting or 
aggregating comments from other persons for submission to the NRC, then 
you should inform those persons not to include identifying or contact 
information that they do not want to be publicly disclosed in their 
comment submission. Your request should state that the NRC does not 
routinely edit comment submissions to remove such information before 
making the comment submissions available to the public or entering the 
comment into ADAMS.

II. Background

    Current EP requirements and guidance, initially developed for large 
LWRs and non-power reactors, do not consider advances in designs and 
safety research and their applications to existing or future operation 
of SMRs and ONTs. Within the SUPPLEMENTARY INFORMATION section of this 
document, the NRC uses the term ``ONTs'' to refer to new technologies, 
such as non-LWRs and proposed medical radioisotope facilities that 
would be licensed under 10 CFR part 50. Further, within this document, 
the NRC uses the term ``existing'' or ``current'' when referring to 
existing applicants or licensees for an SMR or ONT facility. This 
proposed rule would also define ``non-power production or utilization 
facility'' to clarify the applicability of the proposed performance-
based EP framework. As used in this proposed rule, the term ``non-power 
production or utilization facility'' would be defined to have the same 
meaning as the definition used in SECY-19-0062, ``Final Rule: Non-power 
Production or Utilization Facility License Renewal'' (ADAMS Accession 
No. ML18031A000), dated June 17, 2019.\2\ The definition would include 
production or utilization facilities, licensed under Sec.  50.21(a), 
Sec.  50.21(c), or Sec.  50.22, as applicable, that are not nuclear 
power reactors or production facilities as defined under paragraphs (1) 
and (2) of the definition of Production facility in Sec.  50.2. In the 
context of this proposed rule, medical radioisotope facilities that 
would be licensed under 10 CFR part 50 would also be included within 
this definition of NPUF. The term ``non-power production or utilization 
facility'' is used in this proposed rule to distinguish between those 
medical radioisotope facilities that would be licensed as production or 
utilization facilities under 10 CFR part 50 and other facilities to be 
used for the production of medical radioisotopes that would be 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 that would be licensed 
under 10 CFR parts 30, 40, or 70 would be covered by 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 
proposed rule and associated draft guidance. As such, the scope of this 
proposed rule is limited to those ONT facilities (i.e., non-LWRs and 
medical radioisotope facilities) for which the NRC expects to receive 
license applications under 10 CFR part 50 or 10 CFR part 52, 
``Licenses, Certifications, and Approvals for Nuclear Power Plants.'' 
Therefore, those NPUFs that are not considered ONTs (i.e., currently 
operating non-power reactors) are not within the scope of this proposed 
rule. Currently operating non-power reactors will continue to implement 
existing emergency planning requirements and guidance.
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    \2\ Any changes made to the definition of ``non-power production 
or utilization facility'' based on Commission direction will be 
reflected in the final rule on EP for SMRs and ONTs.
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    In the staff requirements memorandum (SRM) to SECY-15-0077, 
``Options for Emergency Preparedness for Small Modular Reactors and 
Other New Technologies,'' dated August 4, 2015 (ADAMS Accession No. 
ML15216A492), the Commission approved the staff's recommendation to 
conduct rulemaking to address EP for SMRs and ONTs. In December 2016, 
the

[[Page 28438]]

NRC developed and published ``NRC Vision and Strategy: Safely Achieving 
Effective and Efficient Non-Light Water Reactor Mission Readiness'' 
(ADAMS Accession No. ML16356A670), with a goal to further develop the 
NRC's non-LWR regulatory, technical, and policy infrastructure in order 
to be ready to efficiently and effectively review potential licensing 
applications for non-LWR technologies. This proposed rule contributes 
to the NRC's overall plan to optimize non-LWR regulatory readiness. In 
particular, the NRC's objective for this proposed rule is to create 
alternative EP requirements that would: (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 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 
smaller sized reactors' and non-LWRs' potential benefits associated 
with postulated accidents, including slower transient response times, 
and relatively small and slow release of fission products.

A. Existing Emergency Preparedness Framework for Nuclear Power Reactors

    Appendix E, ``Emergency Planning and Preparedness for Production 
and Utilization Facilities,'' to 10 CFR part 50 identifies the specific 
items required to be included in emergency plans. Additionally, the 
regulation in Sec.  50.47, ``Emergency plans,'' provides EP 
requirements for nuclear power reactors, including planning standards 
for onsite and offsite emergency response plans. Other relevant 
regulations include paragraphs (q), (s), and (t) of Sec.  50.54, 
``Conditions of licenses.''
    Large LWRs use a variety of guidance documents in support of EP 
programs. The two most notable guidance documents for the development 
and maintenance of emergency plans are: NUREG-0654/FEMA-REP-1, Rev.1, 
``Criteria for Preparation and Evaluation of Radiological Emergency 
Response Plans and Preparedness in Support of Nuclear Power Plants'' 
(ADAMS Accession No. ML040420012), 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; and Regulatory Guide (RG) 1.219, 
Rev. 1, ``Guidance on Making Changes to Emergency Plans for Nuclear 
Power Reactors'' (ADAMS Accession No. ML16061A104), dated July 2016, 
which provides guidance for operating power reactor licensees 
implementing requirements in Sec.  50.54(q) for evaluating and making 
changes to emergency plans.
    This regulatory framework has defined the EP programs for large 
LWRs for several decades. These standards have been effectively used in 
practice and provided a basis to draw from in developing the proposed 
EP regulatory framework for SMRs and ONTs.

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, EP 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 RTRs that 
reflected the lower potential radiological hazards associated with 
these facilities. While RTRs and other NPUFs must meet the emergency 
planning requirements of Sec. Sec.  50.34(a)(10) and (b)(6)(v) and 
50.54(q) and appendix E to 10 CFR part 50, the requirements of Sec.  
50.47 do not apply to these facilities. 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 other 
facilities, stating that the size of EPZs and the degree to which 
compliance with sections I through V of appendix E to 10 CFR part 50 is 
necessary will be 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,'' will be 
used as guidance for the acceptability of RTR emergency response plans. 
Regulatory Guide 2.6 was initially issued in January 1979 (ADAMS 
Accession No. ML12184A008) 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 (ADAMS 
Accession No. ML17263A472). Consistent with the radiological risks 
associated with operating power levels between 5 watts thermal and 20 
MWt for currently operating RTRs, RG 2.6, Revision 2 endorses the use 
of the source term and power-level based emergency planning guidance 
contained in American National Standards Institute (ANSI) and American 
Nuclear Society (ANS) standard ANSI/ANS-15.16-2015, ``Emergency 
Planning for Research Reactors.'' Similarly, RG 2.6, Revision 2 
endorses the use of ANSI/ANS-15.16-2015 for other NPUFs. The ANSI/ANS-
15.16, originally developed in 1982, and updated in 2008 and 2015, 
provides specific criteria and guidance for RTRs to comply with the 
applicable requirements set forth in Sec. Sec.  50.34, ``Contents of 
applications; technical information,'' and 50.54, and appendix E to 10 
CFR part 50.
    In October 1983, the NRC issued NUREG-0849, ``Standard Review Plan 
for the Review and Evaluation of Emergency Plans for Research and Test 
Reactors'' (ADAMS Accession No. ML062190191). 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 to 800 meters from the 
operations boundary \3\ 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. In addition to NUREG-0849 and 
ANSI/ANS-15.16, Section 12.7, ``Emergency Planning,'' of the non-power 
reactor standard review plan, NUREG-1537, Parts 1 and 2, ``Guidelines 
for Preparing and Reviewing Applications for the Licensing of Non-power 
Reactors'' (ADAMS Accession Nos. ML042430055 and ML042430048) and the 
Interim Staff Guidance augmenting NUREG-1537, Parts 1 and 2, for the 
licensing of radioisotope production facilities and aqueous homogeneous 
reactors (ADAMS Accession Nos. ML12156A069 and ML12156A075) provide 
additional emergency planning considerations for NPUFs. For example, 
relevant radioisotope production facility emergency planning 
considerations (e.g., hazardous chemicals) contained in the Interim 
Staff Guidance augmenting NUREG-1537 are based on NUREG-1520, Revision 
1, ``Standard Review Plan for the Review of a License Application for a 
Fuel Cycle Facility'' (ADAMS Accession No. ML101390110).
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    \3\ As defined in ANSI/ANS-15.16-2015, ``operations boundary'' 
refers to the area within the site boundary such as the reactor 
building (or the nearest physical personnel barrier in cases where 
the reactor building is not a principal physical personnel barrier) 
where the reactor chief administrator has direct authority over all 
activities.
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    These criteria and guidance provide a basis for NPUF applicants and 
licensees to develop acceptable emergency

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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 a basis 
for developing the consequence-oriented approach to establishing EPZs 
and the planning commensurate with the radiological risk.

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 proposed rule.
Emerging Interest in Advanced Nuclear Reactor Technology
    Concurrent with large LWR deployment and design evolution, the 
United States and other countries have developed and promoted several 
different reactor designs that are either light-water SMRs with passive 
safety features or reactors that do not use light-water as a coolant. 
This latter category is commonly referred to as non-LWR technology. 
Advanced designs using non-LWR technology include liquid-metal-cooled 
reactors, gas-cooled reactors, and molten-salt-cooled reactors. These 
advanced designs' rated thermal power could range 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 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'' (ADAMS Accession No. ML13253A431) in June 1988 
to provide guidance on developing new regulatory requirements to 
support advanced reactor designs. With the issuance of this initial 
guidance came questions concerning EP requirements for such designs.
    In response, the NRC staff stated 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'' \4\ 
(ADAMS Accession No. ML040210725), dated April 8, 1993, that no change 
to existing EP regulations for advanced reactors was currently needed. 
The NRC staff noted that regulatory direction would be given at or 
before the start of the design certification phase of advanced reactors 
so that design implications for EP could be addressed in the licensing 
process.
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    \4\ ``PRISM,'' ``MHTGR,'' ``PIUS,'' and ``CANDU'' are 
abbreviations for Power Reactor Innovative Small Module, Modular 
High-Temperature Gas-Cooled Reactor, Process Inherent Ultimate 
Safety, and CANadian Deuterium-Uranium, respectively.
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    The Commission agreed, and stated in the SRM (ADAMS Accession No. 
ML003760774) 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'' (ADAMS 
Accession No. ML992920024), dated January 27, 1997, the NRC 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 
(ADAMS Accession No. ML042590576), the NRC staff noted the following:

    [A]s part of the top-down review of Emergency Preparedness, the 
staff has identified 10 CFR 50 Appendix E section E.8 and 10 CFR 
50.47(b)(3) as opportunities to enhance the emergency preparedness 
regulatory structure. The staff will propose rulemaking to remove 
``near-site'' from the regulations, as a more performance based 
requirement is appropriate. . . .

    The Commission agreed, highlighting the potential value of 
performance-based EP for LWRs in the SRM (ADAMS Accession No. 
ML050550131) for SECY-04-0236, dated February 23, 2005. The Commission 
directed that:

    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 (ADAMS Accession 
No. ML061910707), the staff sought Commission approval to explore the 
feasibility of a voluntary, performance-based EP regulatory regimen. 
Specifically, the staff stated:

    [A]s the EP program has matured and industry performance has 
improved, the staff recognized the benefits of a performance-based 
regulatory structure. Thus, the staff is proposing a new voluntary 
performance-based regulatory regimen. The staff has conceptualized 
the basis for a voluntary performance-based EP regulatory regimen. . 
. . This regimen could be adopted in lieu of the existing EP 
regulations contained in 10 CFR part 50. The current regimen tends 
to emphasize compliance with, and control over, emergency plans and 
facilities. The performance-based regimen would focus licensee 
efforts on actual performance competencies, rather than control of 
emergency plans and procedures. Regulatory oversight would focus on 
licensee performance, instead of licensee processes and procedures. 
Creating a performance-based EP regulatory regimen could achieve a

[[Page 28440]]

higher level of preparedness, as the regimen would focus on results 
and abilities rather than on means. The performance-based regimen 
would provide the NRC with enhanced oversight of the actual 
competencies important to protection of public health and safety 
while allowing licensees increased flexibility.

    In SECY-06-0200, the staff also outlined several high-level 
performance-based concepts for large LWRs related to performance goals, 
staffing, and performance indicators (PIs). In the SRM (ADAMS Accession 
No. ML070080411) for SECY-06-0200, dated January 8, 2007, the 
Commission approved the NRC staff's recommendation for the development 
of a rulemaking plan and guidance changes to enhance EP regulations and 
guidance. The Commission also approved the staff's request to begin 
activities to explore a voluntary performance-based EP regulatory 
concept.
    During the early development of a performance-based EP regulatory 
concept, the NRC published a ``Policy Statement on the Regulation of 
Advanced Reactors,'' dated October 14, 2008 (73 FR 60612). The policy 
statement expressed the Commission's expectation that advanced reactor 
designers would ensure that security and emergency response are 
considered alongside safety during the early stages of plant design.
    By 2014, the NRC had finalized its study and review of the 
potential to enhance the oversight of performance-based nuclear power 
plant EP programs as directed in the SRM for SECY-06-0200. In SECY-14-
0038, ``Performance-Based Framework for Nuclear Power Plant Emergency 
Preparedness Oversight'' (ADAMS Accession No. ML13238A018), dated April 
4, 2014, the NRC staff stated:

    A systematic review and revision of EP requirements to employ a 
more performance-based oversight regimen (regulation, inspection, 
and enforcement) has the potential to enhance many aspects of 
emergency response and oversight. A performance-based oversight 
regimen could simplify EP regulations and focus inspection more 
fully on response-related performance rather than the current focus 
on plan maintenance and compliance.

    Although the NRC staff asserted that the performance-based 
framework would simplify EP regulations and focus inspections more on 
response-related performance, the NRC 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 for implementing a performance-based framework and could 
introduce regulatory uncertainty. Additionally, the NRC staff 
recognized that existing EP programs provided reasonable assurance of 
adequate protection of public health and safety and therefore 
recommended maintaining the current EP regimen.
    In the SRM (ADAMS Accession No. ML14259A589) to SECY-14-0038, dated 
September 16, 2014, the Commission directed that:

    The staff should be vigilant in continuing to assess the NRC's 
emergency preparedness program and should not rule out the 
possibility of moving to a performance-based framework in the 
future. The Commission notes the potential benefit of a performance-
based emergency preparedness regimen for small modular reactors, and 
the staff should return to the Commission if it finds that 
conditions warrant rulemaking.
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 (ADAMS Accession No. ML093290268), 
the NRC 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. 
Additional information on these meetings can be found in the summaries 
for the October 8-9, 2009 and July 28, 2010 meetings (ADAMS Accession 
Nos. ML092940138 and ML102380209 respectively). 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 module, 
potentially forming the basis for smaller EPZs relative to large LWRs.
    The NRC 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 (ADAMS 
Accession No. ML112570439). The paper informed the Commission of the 
NRC staff's proposed actions to develop an emergency planning and 
preparedness framework for SMR facilities. In the document, the NRC 
staff stated its intent to develop a technology-neutral, dose-based, 
consequence-oriented EP framework for SMR sites that would take into 
account the various designs, modularity, and collocation of these 
facilities, 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 SMR-appropriate EPZs. 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 (ADAMS Accession No. ML13364A345), 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

[[Page 28441]]

stated in the paper, NEI's approach was rooted in the following:

    (1) The expectation of enhanced safety inherent in the design of 
SMRs (e.g., increased safety margin, reduced risk, smaller and 
slower fission product accident release, and reduced potential for 
dose consequences to population in the vicinity of the plant); (2) 
the applicable SECY-11-0152 concepts including utilization of 
existing emergency preparedness regulatory framework and dose 
savings criteria of NUREG-0396; and (3) the significant body of risk 
information available to inform the technical basis for SMR-
appropriate EPZ, including severe accident information developed 
since NUREG-0396 was published in 1978, and information from the 
design-specific and plant-specific probabilistic risk assessments 
(PRAs) which will support SMR design and licensing.

    The NEI 2013 White Paper addressed only SMRs with light-water-
cooled and moderated designs and the plume exposure pathway EPZ. It did 
not address other designs or the ingestion pathway EPZ (IPZ). The NRC 
has reviewed the White Paper and has discussed the development of the 
regulatory framework with NEI and stakeholders; however, the NRC has 
not endorsed the paper.
    In the enclosure to SECY-10-0034, the NRC 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 NRC 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'' (ADAMS Accession No. ML15037A176), dated May 29, 2015, 
the NRC staff proposed a consequence-oriented approach to establishing 
EP requirements commensurate with the potential consequences to public 
health and safety and the common defense and security at SMR and ONT 
facilities. The NRC staff stated that the need for EP is based on the 
projected offsite dose in the unlikely occurrence of a severe accident. 
In SRM-SECY-15-0077, the Commission approved the staff's recommendation 
to proceed with rulemaking, keeping a performance-based framework in 
mind as previously directed in SRM-SECY-14-0038. The Commission further 
directed that, for any SMR reviews conducted prior to the establishment 
of a regulation, the staff should be prepared to adapt an approach to 
EPZs for SMRs under the existing 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 for SMR facilities. In ``White Paper: Proposed Emergency 
Preparedness Regulations and Guidance for Small Modular Reactors 
Facilities'' (ADAMS Accession No. ML15194A276), dated July 2015, NEI 
provided proposed revisions to the planning standards set forth in 
Sec.  50.47 and appendix E to 10 CFR part 50 as well as associated EP 
guidance. The proposed revisions were developed by NEI to 
``constructively inform the staff's deliberations concerning the 
development of an SMR EP framework, and serve as a basis for future 
public meeting engagement.'' The NRC staff has considered NEI's 
recommendations in the development of this proposed rule.
    In addition to the NEI white papers, the NRC staff has had several 
interactions with the public concerning licensing issues related to 
SMRs and ONTs, including DOE-NRC Workshops on Advanced Non-Light-Water 
Reactors held on September 1-2, 2015 and June 7-8, 2016. The NRC staff 
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 the summaries 
available at ADAMS Accession Nos. ML15265A165 and ML16188A226.
Rulemaking Activity
    In response to SRM for SECY-15-0077, on May 31, 2016, the NRC staff 
submitted a rulemaking plan to the Commission (SECY-16-0069, 
``Rulemaking Plan on Emergency Preparedness for Small Modular Reactors 
and Other New Technologies'' (ADAMS Accession No. ML16020A388)) 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 approved the staff's 
rulemaking plan in SRM-SECY-16-0069 (ADAMS Accession No. ML16174A166).
    On August 22, 2016, the NRC staff held a Category 3 public meeting 
to request feedback from interested 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. Additional information about this public 
meeting is detailed in the meeting summary (ADAMS Accession No. 
ML16257A510). After considering the feedback received from the 
stakeholders in support of the performance-based approach to EP, the 
NRC staff developed a draft regulatory basis that included an option to 
proceed with rulemaking to implement this approach.
    On April 13, 2017, the NRC issued a draft regulatory basis for a 
75-day public comment period (82 FR 17768). In the draft regulatory 
basis, the NRC requested feedback from the public on questions related 
to the scope of the draft regulatory basis, performance-based approach, 
regulatory impacts, and cumulative effects of regulation (CER). In 
addition, the NRC held a public meeting on May 10, 2017, to discuss the 
draft regulatory basis with interested stakeholders. Additional 
information about this public meeting is detailed in the meeting 
summary (ADAMS Accession No. ML16257A510).
    The NRC received 57 comment submissions on the draft regulatory 
basis and the associated regulatory analysis, which contained 223 
individual comments related to EP. The commenters included individuals, 
environmental groups, industry groups, a Native American Tribal 
organization, States, and FEMA. The NRC reviewed all comments submitted 
on the draft regulatory basis, grouped the comments into categories by 
comment topic, and developed a resolution for each topic. Comments 
included topics such as: Consequence-based approach, co-location, dose 
assessment, EPZ and offsite EP, general rulemaking approach, siting of 
multi-module facilities, performance-based approach, regulatory 
analysis, scope of the draft regulatory basis, safety, and technology-
inclusive approach. The NRC considered those

[[Page 28442]]

comment submissions and discussions from the public meeting as it 
finalized the regulatory basis. The NRC published a notice in the 
Federal Register announcing the public availability of the regulatory 
basis on November 15, 2017 (82 FR 52862).

III. Discussion

Objective and Applicability

    The NRC's objective for this rulemaking is to create alternative EP 
requirements that would: (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 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 smaller sized reactors' and non-LWRs' 
potential benefits associated with postulated accidents, including 
slower transient response times, and relatively small and slow release 
of fission products. This proposed rule would apply to existing and 
future SMR and ONT facilities. These applicants and licensees would 
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 proposed rule 
does not include within its scope emergency planning, preparation, and 
response for large LWRs, which for the purposes of this proposed rule 
are those LWRs that are licensed to produce greater than 1,000 MWt 
power; fuel cycle facilities; or currently operating non-power 
reactors.
    In SRM-SECY-15-0077, the Commission approved the staff's 
recommendation to conduct rulemaking for SMRs and ONTs, including non-
LWRs and medical radioisotope facilities. The current operating fleet 
of power reactors has an established EP regulatory framework under 
Sec.  50.47 and appendix E to 10 CFR part 50. Emergency planning 
requirements for facilities licensed under 10 CFR part 70 are set forth 
in Sec.  70.22(i). The NRC established in appendix E to 10 CFR part 50 
emergency planning requirements for RTRs that reflect the lower 
potential radiological hazards associated with these facilities.
    The plume exposure pathway EPZ for the current operating fleet of 
nuclear power reactors consists of an area about 10 miles (16 km) in 
radius and the IPZ for such facilities consists of an area about 50 
miles (80 km) in radius. See Sec. Sec.  50.33(g) and 50.47(c). As 
discussed in the ``Background'' section of this document, in the early 
2000s, the NRC anticipated that future SMR and ONT applications would 
reflect a wide range of potential designs that have smaller source 
terms and incorporate EP considerations as part of the design. The 
Commission Policy Statement on the Regulation of Advanced Reactors (73 
FR 60612) stated that the Commission ``expects that advanced reactors 
will provide enhanced margins of safety and/or use simplified, 
inherent, passive, or other innovative means to accomplish their safety 
and security functions.'' Under the current EP framework, Sec. Sec.  
50.33(g) and 50.47(c)(2) provide that the size of plume exposure 
pathway EPZs and IPZs for gas-cooled nuclear reactors and for reactors 
with an authorized power level less than 250 MWt may be determined on a 
case-by-case basis. Section I.3 of appendix E to 10 CFR part 50 states 
that the EPZs for facilities other than power reactors may also be 
determined on a case-by-case basis. In addition, applicants and 
licensees for power reactors may also request that the size of the EPZs 
and IPZs for their facilities be determined on a case-by-case basis by 
seeking an exemption under Sec.  50.12, ``Specific exemptions,'' from 
the requirements in Sec.  50.47(c)(2) regardless of authorized power 
level. Furthermore, appendix E to 10 CFR part 50, provides the 
flexibility to determine other emergency planning considerations, such 
as organization, assessment actions, activation of emergency 
organization, emergency facilities, and equipment, on a case-by-case 
basis for certain facilities.
    The NRC initiated this proposed rule to seek a wide-range of public 
views and increase regulatory predictability and flexibility in the 
development of an alternative, generic approach that designers, 
vendors, and applicants may use to determine the appropriate EP 
requirements for SMRs and ONTs, for which emergency planning may 
otherwise be addressed on a case-by-case basis. In particular, this 
proposed rule would provide 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 
proposed 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 proposed rule would define the different types of 
affected facilities. The NRC would amend Sec.  50.2 to include the 
terms ``small modular reactor,'' ``non-light-water reactor,'' and 
``non-power production or utilization facility.'' In developing the 
proposed definition for ``small modular reactor,'' the NRC referred to 
a variety of existing definitions and policy documents. The following 
discussion describes these sources of information in more detail.
    In this proposed rule, the NRC has included a definition of ``non-
light-water reactor'' to cover other new technologies, including 
liquid-metal-cooled reactors, gas-cooled reactors, and molten-salt-
cooled reactors. Having a separate definition for these non-LWR 
technologies would clarify the applicability of the existing EP 
standards and requirements in 10 CFR part 50, which are specific to 
LWRs, and would maintain consistency between this proposed rule and the 
``Variable Annual Fee Structure for Small Modular Reactors'' final rule 
(81 FR 32617; May 24, 2016) (referred to herein as the ``SMR Fee 
Rule'').
    The NRC has evaluated the suitability of using the existing 
definition of ``small modular reactor'' in Sec.  171.5, ``Definitions'' 
for the purposes of this EP proposed rule. The Sec.  171.5 definition 
of ``small modular reactor'' means, for the purpose of calculating 
fees, the class of light-water power reactors having a licensed thermal 
power rating less than or equal to 1,000 MWt per module. This rating is 
based on the thermal power equivalent of a light-water SMR with an 
electrical power generating capacity of 300 megawatts electrical or 
less per module. Although similar, this proposed 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, the NRC determined that using the thermal power equivalent of 
electric power generating capacity would be fair because SMRs should 
pay annual fees that are commensurate with the economic benefit 
received from their license (81 FR 32617, 32623). Because electrical 
generating power capacity is not a criterion the NRC uses to determine 
EP requirements, this proposed rule's definition would focus on thermal 
power rating.

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

[[Page 28443]]

interactions and discussions with SMR designers and the DOE. In 
general, these issues result from the key differences between the new 
designs and the current-generation large LWRs, such as rated thermal 
power, moderator, coolant, and fuel design. In SECY-10-0034, the NRC 
described designs discussed in pre-application interactions with DOE 
and SMR designers. The rated thermal power of these designs ranged from 
30 MWt to 1,000 MWt. The designs included the use of helium gas, 
sodium, and light-water as coolants. While some SMR designs employ 
conventional LWR radiological barrier designs, some designs may employ 
a non-traditional containment approach.
    In addition to licensing issues associated with differences in 
designs, some of the licensing issues resulted from industry-proposed 
review approaches and industry-proposed modifications to current 
policies and practices, including standard review plans and design-
specific review 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 
appropriate 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 for 
applicants, licensees, and the NRC stemming from the applicant- or 
licensee-specific nature of exemption requests.
    This proposed rule would create a transparent alternative EP 
regulatory framework for SMR and ONT applicants and licensees that 
would continue to provide reasonable assurance that adequate protective 
measures can and will be implemented in a radiological emergency. The 
proposed alternative EP requirements would consider a wide-range of 
views and 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 proposed rule would also 
support the principles of good regulation, including openness, clarity, 
and reliability.

Proposed Changes

Technical Basis
    The NRC is proposing 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 proposed 
rule, and the following discussion addresses the technical basis for 
each.
Performance-Based Approach
    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 and supporting regulatory 
guidance 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 actions can and will 
be taken in a radiological emergency.
    The NRC anticipates that existing and future SMR and ONT 
applications will reflect a wide range of potential designs and source 
terms. Because the technology for certain SMR and ONT designs is still 
evolving, a performance-based approach could allow for more regulatory 
flexibility, provide a basis for appropriate EP through review of 
design- and site-specific accident scenarios, and minimize the need for 
exemption requests that would otherwise be anticipated under a 
prescriptive regulatory framework. In this context, a performance-based 
approach bases the adequacy of EP upon the NRC's identification of 
emergency response functions that affect the protection of public 
health and safety and the licensee's successful execution of those 
functions. The NRC's proposed performance-based framework, inspection 
and enforcement program, and design-specific review process would 
provide reasonable assurance that protective actions can and will be 
taken in the event of an emergency at an SMR or ONT facility. The NRC 
has previously explored the idea of a performance-based EP framework, 
as discussed in the ``Performance-Based Emergency Preparedness'' 
section of this document, and the Commission noted that a performance-
based approach was a potential benefit to regulating EP for SMRs. The 
performance-based approach could simplify EP regulations and focus 
inspections more fully on response-related performance. A graded 
approach to EP was also considered, which would take into account the 
magnitude of any credible hazard involved, the particular 
characteristics and status of a facility, and the balance between 
radiological and non-radiological hazards. A graded approach to EP has 
a longstanding regulatory history. The 16 EP planning standards for 
nuclear power reactors, outlined in Sec.  50.47(b), and the associated 
evaluation criteria in NUREG-0654/FEMA-REP-1, Revision 1, are one part 
of a continuum of planning standards for radiological EP. The existing 
regulations in Sec.  50.47(c)(2) for EPZ size determinations for gas-
cooled reactors and reactors with power levels less than 250 MW(t), the 
EP regulations for production and utilization facilities other than 
nuclear power reactors in appendix E to 10 CFR part 50, and the EP 
regulations for fuel cycle facilities in Sec.  70.22(i) and independent 
spent fuel storage installations (ISFSIs) in Sec.  72.32, ``Emergency 
Plan,'' are also part of a graded approach to EP that is commensurate 
with the relative radiological risk, source term, and potential 
hazards, among other considerations.
Technology-Inclusive Approach
    As previously mentioned, the NRC has licensed, reviewed, or had 
pre-application discussions with stakeholders supporting a range of 
technology types that are included in the scope of this proposed 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

[[Page 28444]]

with, or nearby to, NRC-licensed or non-licensed facilities could lead 
to a variety of accident frequencies, progression times, and potential 
consequences for SMRs or ONTs. To incorporate recent and potential 
existing or future technology advancements and reduce the need for 
future EP rulemaking, the NRC is therefore proposing 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.
    As described further in the ``Performance-Based Framework'' section 
of this document, the NRC's proposed 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 proposed Sec.  
50.160, ``Emergency preparedness for small modular reactors, non-light-
water reactors, and non-power production or utilization facilities,'' 
do not contain any technology-specific language. Rather, applicants and 
licensees would 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.
Risk-Informed and Consequence-Oriented Approaches to Emergency Planning
    The NRC is proposing a consequence-oriented approach to establish 
EP requirements for SMRs and ONTs. In this context, consequence-
oriented means the principle of basing decisions of the extent of EP 
required upon the level and severity of the consequences of a credible 
radiological accident. The decisions regarding EP should be based upon 
projected offsite dose from such accidents and the pre-determined plume 
exposure pathway EPZ for pre-planned protective actions. Emergency 
preparedness is risk-informed rather than risk-based, and therefore 
emergency planning is independent of accident probability.
    The NRC has 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'' (ADAMS Accession No. ML18012A019), 
dated May 22, 2018). This review identified that all of the existing 
types of NRC-licensed nuclear facilities use a consequence-oriented 
approach and take into account other considerations 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, EPA-400/R-17/001, was issued in January 2017. A 
similar consequence-oriented rationale also would be one option for 
establishing the EPZ for SMR or ONT designs.
    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'' (ADAMS 
Accession No. ML051390356), introduced the concept of generic EPZs as 
the basis for preplanned response actions. These 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 actions in the event of 
a reactor accident that would result in offsite dose consequences. 
Other considerations in the planning basis include the stipulation that 
no single specific accident sequence should be isolated as the one for 
which to plan because each accident could have different consequences, 
both in nature and degree. Planning should 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 (dose, 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 for large LWR accident scenarios in planning 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 their operation 
involve considerations different than those associated with nuclear 
power reactors.
    In this proposed rule, the NRC would establish a plume exposure 
pathway EPZ boundary that provides public protection from dose levels 
above a 10 millisieverts (mSv) [1 roentgen-equivalent man (rem)] total 
effective dose equivalent (TEDE) threshold. The primary purpose of the 
plume exposure pathway EPZ is to provide an area where predetermined 
protective actions are implemented, which result in dose savings and a 
reduction in early health effects. In determining this boundary, the 
applicant would consider plume exposure doses from a spectrum of 
credible accidents for the facility. The NRC expects that areas outside 
of the site's proposed plume exposure pathway EPZ would not exceed the 
dose threshold of 10 mSv (1 rem) TEDE based on site-specific 
meteorology for a spectrum of credible accidents for the facility. The 
proposed rule would apply the same dose standard for predetermined 
protective actions to SMRs or ONTs as is required of the current 
operating large LWRs. By maintaining this consistency, the regulations 
described in proposed

[[Page 28445]]

Sec.  50.33(g)(2) would afford the same level of protection of the 
public health and safety as the current regulatory framework.
    The principle of using dose savings to determine EPZ size has been 
used in the past when the NRC licensed several small reactors with a 
reduced EPZ size of 5 miles (8 km). These reactors include the Fort St. 
Vrain high-temperature gas-cooled reactor (HTGR) (842 MWt), the Big 
Rock Point boiling water reactor (BWR) (240 MWt), and the La Crosse BWR 
(165 MWt).
    With the expected safety enhancements in SMR designs and the 
potential for reduced accident source terms and fission product 
releases, the NRC is proposing that SMR applicants would develop 
reduced EPZ sizes commensurate with their accident source terms, 
fission product releases, and accident dose characteristics. Pre-
application conversations between the NRC and SMR designers have 
indicated that SMRs also could have reduced offsite dose consequences 
in the unlikely event of an accident.
    To support this proposed rule, the NRC conducted research about EPZ 
size determinations for SMRs and ONTs. Because of the uncertainty and 
potential variation in SMR or ONT designs, the NRC cannot conduct a 
comprehensive evaluation of source terms and spectra of accidents as 
part of this proposed rule. Instead, the research study, ``Generalized 
Dose Assessment Methodology for Informing Emergency Planning Zone Size 
Determinations'' (ADAMS Accession No. ML18064A317), 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. That 
review, and a subsequent set of recommended analyses documented in 
``Required Analyses for Informing Emergency Planning Zone Size 
Determinations'' (ADAMS Accession No. ML18114A176), dated June 2018, 
can be used in conjunction with the criterion that the EPZ should 
encompass an area such that public dose does not exceed 10 mSv (1 rem) 
TEDE over 96 hours from the release of radioactive materials resulting 
from a spectrum of credible accidents (design-basis accidents, less 
severe accidents, and less probable but more severe accidents) at the 
SMR or ONT facility. The information from these reports was used to 
develop the methodology described in Appendix A of DG-1350, 
``Performance-Based Emergency Preparedness for Small Modular Reactors, 
Non-Light Water Reactors, and Non-power Production or Utilization 
Facilities'' (ADAMS Accession No. ML18082A044).
    This proposed rule would require applicants to submit an analysis 
under proposed Sec.  50.33(g)(2) to justify the technical basis for the 
proposed plume exposure pathway EPZ size. The NRC would then evaluate 
each application on a case-specific basis. The ``Emergency Planning 
Zones'' section in this document contains additional discussion on the 
NRC's consequence-oriented approach to EPZ size determinations for an 
SMR or ONT facility.
    This proposed rule does not provide for a specific ingestion 
pathway planning zone. The NRC is proposing ingestion response planning 
requirements instead of an IPZ at a set distance as part of the 
performance-based framework. Ingestion response planning focuses 
planning efforts on identification of major onsite and offsite exposure 
pathways for ingestion of contaminated food and water. This proposed 
rule would require applicants and licensees who comply with Sec.  
50.160 to describe in their emergency plan the licensee, Federal, 
Tribal, State, and local resources for emergency response capabilities 
available to sample, assess, and implement a quarantine or embargo of 
food and water to protect against contaminated food and water entering 
the ingestion pathway. For those applicants and licensees using Sec.  
50.47(b) and appendix E to 10 CFR part 50, the IPZ requirements would 
remain unchanged.
    These emergency response capabilities are implemented either by the 
licensee within the site boundary or by Federal, Tribal, State, and 
local authorities in the intermediate or later-stage response to an 
accident involving the release of radioactive material. Although the 
sampling, assessing, and imposing of a quarantine or embargo are 
longer-term issues, some immediate, precautionary actions could be 
taken prior to a significant release occurring. For example, Tribal, 
State, and local authorities could instruct individual farmers to wash 
vegetables and fruits and to place livestock in fields, such as cows, 
goats, sheep, and so forth, on stored feed. Federal, Tribal, and State 
authorities frequently issue similar precautionary actions, or 
implement quarantines or embargos for non-radiological contamination of 
foods. Further, Federal resources are available upon request to Tribal, 
State, and local 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.
Performance-Based Framework
    This proposed rule would create a new section, Sec.  50.160, that 
would provide a performance-based EP framework for SMRs and ONTs, which 
would be an alternative to the current regulations. Under proposed 
Sec.  50.54(q)(2)(ii), licensees would be required to follow and 
maintain an emergency plan that meets the requirements in either Sec.  
50.160 or appendix E to 10 CFR part 50 and, except for NPUF licensees, 
the planning standards of Sec.  50.47(b). Proposed Sec. Sec.  50.34 and 
52.79, ``Contents of applications; technical information in final 
safety analysis report,'' would stipulate that SMR and ONT applicants 
would have the option to choose either approach. Proposed Sec.  50.160 
would include: (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 proposed provision applies, (3) requirements for 
considering credible hazards associated with contiguous or nearby NRC-
licensed and non-licensed industrial facilities, 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 
would be required under proposed Sec.  50.160(b)(1) to demonstrate 
effective response in drills and exercises, and describe in their 
emergency plans how they will maintain preparedness. To comply, 
emergency plans would need to include a description of how the 
emergency response functions in proposed Sec.  50.160(b)(1)(iii) and 
the planning activities in proposed Sec.  50.160(b)(1)(iv), if 
applicable, would 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 (ROP)).\5\ Under the proposed performance-based approach to EP, 
performance and results are the primary basis for regulatory decision-
making, and the applicant or licensee has the flexibility to determine 
how to meet the established performance criteria for an effective EP

[[Page 28446]]

program. The performance-based regimen would focus on actual 
performance competencies, rather than control of emergency plans and 
procedures. Regulatory oversight would focus on performance, instead of 
processes and procedures. The performance-based regimen would provide 
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.
---------------------------------------------------------------------------

    \5\ For further information on the ROP, see: https://www.nrc.gov/reactors/operating/oversight.html.
---------------------------------------------------------------------------

    The performance-based requirements in proposed Sec.  50.160 address 
the most risk-significant aspects of EP (e.g., classification, 
notification, protective action recommendation, mitigation), as well as 
several planning activities currently required under appendix E to 10 
CFR part 50. Compliance under the proposed framework would be 
demonstrated by performance during drills or exercises and the NRC's 
review of performance objectives and corrective actions. The NRC, in 
consultation with FEMA when the EPZ extends beyond the site boundary, 
would still make reasonable assurance determinations on emergency 
plans, but the determination would be based on demonstrations of 
required emergency response functions through drills and exercises and 
NRC inspections. Between drills and exercises, licensees would maintain 
a set of performance objectives to measure emergency response 
performance. See the ``Reasonable Assurance'' section of this document 
for a discussion of how the proposed approach would maintain reasonable 
assurance that adequate protective measures can and will be taken in 
the event of a radiological emergency.
Application Process
    Current applicants for a construction permit (CP), early site 
permit (ESP), operating license (OL), or combined license (COL) are 
required to provide emergency planning information as described under 
Sec.  50.33, Sec.  50.34, Sec.  52.17, ``Contents of applications; 
technical information,'' or Sec.  52.79. In particular, Sec.  
50.34(a)(10) requires applicants for CPs to describe within the 
preliminary safety analysis report (PSAR) their preliminary plans for 
coping with emergencies. Under Sec.  52.17(b), applicants for ESPs 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, applicants also have the option 
of proposing major features of emergency plans (under Sec.  
52.17(b)(2)(i)) or complete and integrated emergency plans (under Sec.  
52.17(b)(2)(ii)) for review and approval. Applicants for OLs and COLs, 
as well as ESP applicants choosing to provide emergency plans under 
Sec.  52.17(b)(2)(ii), must submit radiological emergency response 
plans of State and local government agencies wholly or partially within 
the plume exposure pathway EPZ and State governments wholly or 
partially within the IPZ under Sec.  50.33(g). Under Sec. Sec.  
50.34(b)(6)(v) and 52.79, OL and COL applicants also must include in 
their final safety analysis report (FSAR) their plans for coping with 
emergencies.
    Because SMR and ONT licensees would be given a choice between 
complying with either proposed Sec.  50.160 or the requirements in 
appendix E to 10 CFR part 50 and, except for NPUF licensees, the 
planning standards in Sec.  50.47, this proposed rule includes a number 
of conforming changes to clarify application requirements for 
applicants choosing the performance-based requirements.
     Construction permit and OL applicants would still need to 
include emergency planning information in their PSARs and FSARs, 
respectively, and proposed Sec.  50.34(a)(10) and (b)(6)(v) would 
clarify that the information should describe how the applicant would 
comply with either appendix E to 10 CFR part 50 or proposed Sec.  
50.160.
     Combined license and ESP applicants would need to continue 
to include emergency planning information in their site safety analysis 
report and FSAR; proposed Sec. Sec.  52.17(b)(2), 52.18, and 
52.79(a)(21) would clarify that the information should describe how the 
applicant would comply with either the applicable requirements in Sec.  
50.47 and appendix E to 10 CFR part 50, or the proposed requirements in 
Sec.  50.160.
     Applicants choosing to comply with proposed Sec.  50.160 
would need to describe how their emergency plans will meet the 
performance-based requirements in proposed Sec.  50.160(b). A proposed 
revision to Sec.  52.1, ``Definitions,'' would clarify 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 proposed Sec.  50.160(b).
     Proposed Sec.  50.33(g)(2)(i)(A) would clarify 
requirements to submit Tribal, State, and local emergency response 
plans for SMR, non-LWR, and NPUF applicants. Namely, if the application 
is for an OL or COL, or for an ESP that contains plans for coping with 
emergencies, and the plume exposure pathway EPZ extends beyond the site 
boundary (as defined in Sec.  20.1003, ``Definitions''), the applicant 
must submit Tribal, State, and local emergency response plans.
    The requirements in proposed Sec.  50.33(g)(2) also include 
submission of an analysis for determining the plume exposure pathway 
EPZ size, which is discussed in the ``Emergency Planning Zones'' 
section of this document.
Performance Objectives
    Applicants and licensees adopting the performance-based regulations 
would need to 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 proposed Sec.  
50.160(b)(1)(iii). The NRC anticipates that performance objectives 
needed to demonstrate compliance with performance-based requirements 
would vary by design. Therefore, future additional guidance may be 
developed by the NRC or by the industry related to performance 
objectives for specific designs or classes of designs.
    Proposed Sec.  50.160(b)(1)(ii) would require applicants and 
licensees 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 
would maintain records showing the implemented performance objectives 
and associated metrics during each calendar quarter for the previous 
eight calendar quarters. The NRC would monitor the performance 
objectives and metrics under the ROP to ensure that licensees are 
maintaining adequate emergency planning and preparedness. During 
evaluated exercises, the NRC would assess the performance of the 
licensee and review the ability of the licensee to take corrective 
actions in a timely manner before performance decreases below 
performance objective thresholds. In addition, licensees would need to 
identify downward trends in the implementation of performance 
objectives or indications that a performance objective has crossed a 
threshold as part of their corrective action program required under 
Sec.  50.160(b)(1)(iii)(H).
Drills and Exercises
    A key feature of this proposed rule would be the use of drills and 
exercises

[[Page 28447]]

to demonstrate that the applicant's and licensee's EP program is 
capable of carrying out an effective response in the event of emergency 
and accident conditions. Current regulations in appendix E to 10 CFR 
part 50, section IV.F and Sec.  50.47(b)(14) include requirements for 
periodic drills and exercises for nuclear power reactor licensees. 
Proposed Sec.  50.160(b)(1)(iii) would establish the emergency response 
functions to be demonstrated through drills and exercises. Unlike the 
existing drill and exercise requirements in appendix E to 10 CFR part 
50, the proposed performance-based requirements would not define the 
required frequency of drills and exercises or their scenarios. However, 
the NRC anticipates that applicants and licensees would adopt an 
exercise cycle of eight years during which licensees would vary the 
content of exercise scenarios to provide ERO members the opportunity to 
demonstrate proficiency in the key skills necessary to respond to 
several specific scenario elements. Applicants and licensees would be 
required to describe exercise scenario elements necessary to 
demonstrate the emergency response functions in their emergency plans. 
Under proposed Sec.  50.160(c), prior to operating the facility, the 
NRC also would require the applicant for an OL or a holder of a COL 
prior to the Commission's Sec.  52.103(g) finding to conduct an initial 
exercise to demonstrate the effectiveness of the EP program no later 
than 18 months before the issuance of the OL for the applicant or 18 
months before fuel loading for the COL holder.
    For facilities with EPZs that do not extend beyond the site 
boundary, OROs would not be required to participate in radiological 
drills and exercises. Participation would not be required because 
Tribal, State, and local government organizations would not need to 
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 Tribal, State, or local 
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 proposed Sec.  50.160(b)(1)(iii), the applicant's or 
licensee's emergency response team would need to have sufficient 
capability to demonstrate the following emergency response functions:
     Event classification and mitigation. The applicant or 
licensee would need to establish an emergency classification and action 
level scheme with established criteria for determining the need for 
notification of Tribal, State, and local agencies, and participation of 
those agencies 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 would 
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. The 
requirements of this section are not meant to apply to severe accident 
management guidelines, extensive damage mitigation guidelines, or other 
non-emergency plan implementing procedures or programs.
     Protective actions. The drill and exercise program would 
need to demonstrate that consequences to onsite personnel could be 
reduced through the effective use of protective actions. Applicants and 
licensees would need to demonstrate the ability to recommend protective 
actions to offsite authorities as conditions warrant.
     Communications. The drill and exercise program would need 
to demonstrate that control room staff are capable of making effective 
communications to the ERO, including emergency response personnel. 
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 
would need to notify and maintain communications with the fire brigade, 
rescue squad or medical dispatch, and law enforcement according to 
established agreements. As EP programs are developed, applicants and 
licensees would need to determine if notification to OROs is 
appropriate. If notification to OROs is necessary, then drills and 
exercises would need to demonstrate notifying the Tribal, State, and 
local officials of an emergency.
     Command and control. The drill or exercise would need to 
demonstrate continuity of operations through one or more shift changes 
of emergency response personnel, including the augmentation of the ERO. 
The applicant's or licensee's supporting organizational structure would 
need to have defined roles, responsibilities, and authorities, and the 
drill or exercise would need to show how key emergency response 
organization 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) would be maintained around the clock 
throughout the emergency.
     Staffing and operations. The drills or exercises would 
need to demonstrate effective emergency response with the level of 
staffing at the SMR or ONT as described in the emergency plan. There 
would need to be sufficient on-shift staff to perform all necessary 
tasks until augmenting staff arrive to provide assistance. This is of 
particular interest to the NRC because of the potential for reduced 
staffing levels at SMRs and ONTs, as compared to large LWRs. For 
example, some SMR and ONT designs may use multiple modules at one site 
with a single, centralized control room. Designers have indicated that 
they are considering designs that can operate with a staffing 
complement that is less than what is currently required of large LWRs 
by Sec.  50.54(m), which sets forth the minimum licensed operator 
staffing requirements. Under this proposed rule, drills and exercises 
would 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 would 
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 proposed drills or 
exercises, control room staff, on-shift personnel, and the emergency 
response team would 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; use protective 
equipment; and demonstrate implementation of onsite protective actions.
     Reentry. Reentry is the temporary movement of people into 
an area of actual or potential hazard. The applicant or licensee also 
would need to demonstrate general plans for reentry after an emergency 
through drills or exercises. The applicant or licensee would need to 
demonstrate reentry

[[Page 28448]]

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, including the outcomes of drills and 
exercises (or responses to actual emergencies), would be evaluated to 
identify areas for improvement in the EP program. The applicant or 
licensee would need to use a corrective action program to evaluate, 
track, and correct EP deficiencies. Deficiencies may include items such 
as errors in the emergency plan or implementing procedures, ERO 
weaknesses identified in drills or exercises, downward trends in the 
achievement of performance objectives or indications that a performance 
objective has crossed a threshold, or degraded conditions in emergency 
response facilities, systems, and equipment. Corrective actions may 
require a variety of actions, including remedial exercises to 
demonstrate that the deficiencies have been fully addressed.
Planning Activities
    In addition to an applicant's or licensee's performance 
demonstrations through drills and exercises, the NRC is proposing a set 
of required planning activities in Sec.  50.160(b)(1)(iv) to account 
for certain EP-related activities that are not readily observable or 
effectively measured through drills and exercises. This proposed rule 
includes two sets of planning activities: Sec.  50.160(b)(1)(iv)(A) 
would establish planning activities for all applicants and licensees 
complying with Sec.  50.160; and Sec.  50.160(b)(1)(iv)(B) would 
establish planning activities that would apply to applicants and 
licensees with a plume exposure pathway EPZ that extends beyond the 
site boundary.
    Currently, Sec.  50.47(b) requires licensees to be capable of 
maintaining prompt communication among the response organizations and 
the public. In proposed Sec.  50.160(b)(1)(iv)(A)(1), SMR and ONT 
applicants and licensees would be required to be capable of preparing 
and issuing information to the public during emergencies to protect 
public health and safety. The NRC is proposing in Sec.  
50.160(b)(1)(iv)(A)(2) that applicants and licensees also must be 
capable of implementing the NRC-approved emergency response plan in 
conjunction with the Licensee Safeguards Contingency Plan. In 
implementing the emergency response plan, licensees should coordinate 
security-related and emergency response activities to ensure an 
adequate and efficient response to a radiological event. In proposed 
Sec.  50.160(b)(1)(iv)(A)(3), the NRC would require applicants and 
licensees to have 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 would provide timely 
updates to the NRC on the implementation of the emergency plan during 
and after an emergency. Finally, proposed Sec.  50.160(b)(1)(iv)(A)(4) 
would require applicants and licensees to have the capability to 
establish emergency response facilities to support the emergency 
response functions required in Sec.  50.160(b). Applicants and 
licensees would 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 would need to include 
descriptions of the facilities' functional capabilities, activation 
times, staffing, and communication systems.
Offsite Radiological Emergency Preparedness Planning Activities
    Current requirements for offsite radiological emergency response 
plans are included in Sec.  50.47 and appendix E to 10 CFR part 50 and, 
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 
proposed Sec.  50.160 that establish a plume exposure pathway EPZ at 
the site boundary, the NRC would not mandate offsite radiological 
emergency planning activities. Proposed Sec.  50.160(b)(1)(iv)(B) would 
establish 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 would 
include:
     Contacts/arrangements with governmental agencies. 
Applicants and licensees would need to describe in emergency plans 
their contacts and arrangements with OROs for offsite radiological 
emergency response, including the roles of each organization in the 
ERO. Applicants and licensees would need to ensure regular coordination 
with these organizations, including review of emergency plan changes.
     Notification of OROs. Applicants and licensees would need 
to establish primary and backup means of notifying OROs and a message 
authentication scheme. The emergency plan would need to include the 
proposed time period within which notifications to OROs would be made.
     Protective measures. Applicants and licensees would need 
to maintain the capability to issue offsite protective action 
recommendations to OROs (e.g., evacuation, sheltering). The emergency 
plan would need to describe the procedures by which protective measures 
are implemented, maintained, and discontinued in their emergency plans.
     Offsite agency training. Applicants and licensees would 
need to provide site familiarization training to individuals whose 
assistance may be needed in the event of a radiological emergency, 
including personnel from offsite organizations.
     Evacuation time estimate study. Applicants and licensees 
would need to conduct an evacuation time estimate (ETE) study and 
maintain the ETE up-to-date. The methodologies described in existing 
NRC published or endorsed guidance should be used to prepare the ETE.
     Emergency response facilities. Applicants and licensees 
would 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 would 
need to be capable of making offsite dose assessments and communicating 
their results to OROs. The emergency plan would need to describe the 
methods and instruments available for conducting these assessments.
     Dissemination of public information. Applicants and 
licensees would 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 would need to describe the public alert 
and notification system.
     Reentry. Applicants and licensees would need to describe 
in their emergency plans coordination with OROs on offsite reentry 
plans including

[[Page 28449]]

the conditions necessary to allow reentry. 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 
would 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 
would need to describe in their emergency plans how offsite 
radiological emergency response is incorporated into their drill and 
exercises. Drill and exercise scenarios would need to incorporate 
offsite response, and applicants and licensees would need to coordinate 
with offsite organizations, including FEMA, for their participation in 
drills and exercises and implementation of corrective actions.
     Emergency plan maintenance. Applicants and licensees would 
need to maintain up-to-date the emergency plan, contacts and 
arrangements with OROs, procedures, and ETEs. Emergency plans would 
need to include a description of the periodic coordination with OROs.
    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 proposed rule, FEMA findings and 
determinations regarding reasonable assurance under proposed Sec.  
50.54(s)(3) would only be needed for a facility where the plume 
exposure pathway EPZ extends beyond the site boundary requiring 
dedicated offsite radiological EP plans for the facility.
    The NRC's proposal not to require offsite planning activities for 
facilities with plume exposure pathway EPZs at the site boundary would 
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 would 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 and local 
governments with technical advice related to the safety and security of 
any proposed SMR or ONT facility.
    In cases where the 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. As provided for in the Tenth Amendment to the U.S. Constitution 
and State constitutions and statutes, State and local governments are 
responsible for the overall protection of public health and safety in 
their localities when the Federal government does not have such 
authority. Each of the states has established an emergency management 
organization to facilitate the safeguarding of the life and property of 
its citizens.\6\ Based on the NRC's evaluation of a limited set of ORO 
capabilities in NUREG/CR-7248, ``Capabilities and Practices of Offsite 
Response Organizations for Protective Actions in the Intermediate Phase 
of a Radiological Emergency Response'' (ADAMS Accession No. 
ML18170A043), dated June 2018, the NRC has high confidence in the 
ability of OROs to implement appropriate response actions when 
necessary. The OROs' general emergency response capabilities are not 
unique to radiological emergency response. The NRC's confidence is 
further strengthened by the NRC's regulations in Sec.  50.47(c)(1)(iii) 
and the NRC's recognition of national-level efforts (e.g., National 
Incident Management System,\7\ National Preparedness Goal,\8\ Core 
Capabilities,\9\ National Preparedness System,\10\ National Planning 
Frameworks),\11\ in which the NRC participates, to improve the state of 
emergency planning at all levels of government and within the whole 
community.\12\ Consequently, for SMR and ONT facilities 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.
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    \6\ See FEMA's Emergency Management Agencies website https://www.fema.gov/emergency-management-agencies.
    \7\ For further information on the National Incident Management 
System, see: https://www.fema.gov/pdf/emergency/nims/nimsfaqs.pdf.
    \8\ For further information on the National Preparedness Goal, 
see: https://www.fema.gov/national-preparedness-goal.
    \9\ For further information on Core Capabilities, see: https://www.fema.gov/core-capabilities.
    \10\ For further information on the National Preparedness 
System, see: https://www.fema.gov/national-preparedness-system.
    \11\ For further information on the National Planning 
Frameworks, see: https://www.fema.gov/national-planning-frameworks.
    \12\ For more information on the definition of ``whole 
community,'' see: https://www.fema.gov/whole-community#.
---------------------------------------------------------------------------

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 
proposing 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 proposed Sec.  50.160 or the 
approach to EP under appendix E to 10 CFR part 50. The NRC's proposal 
includes a number of conforming changes to Sec.  50.54(q).
    Existing Sec.  50.54(q)(2) requires licensees to follow and 
maintain the effectiveness of an emergency plan that meets the planning 
standards in Sec.  50.47(b) and the requirements in appendix E to 10 
CFR part 50, and existing Sec.  50.54(q)(3) and (4) describe the 
process for analyzing, submitting, and making changes to emergency 
plans. The NRC is proposing to revise Sec.  50.54(q)(2) through (4) to 
include cross-references to the requirements under proposed Sec.  
50.160 for licensees choosing the performance-based approach and to 
clarify that licensees must follow and maintain an emergency plan that 
meets either the applicable requirements of Sec.  50.160 or the 
requirements of appendix E to 10 CFR part 50 and, except for NPUF 
licensees, the planning standards of Sec.  50.47(b). The NRC is not 
proposing any changes to the emergency plan change process.

[[Page 28450]]

Licensees choosing the performance-based approach to EP would need to 
evaluate changes to their emergency plans against the performance-based 
requirements under proposed Sec.  50.160 using the same reduction in 
effectiveness criteria as current licensees and would still need to 
submit changes that reduce the effectiveness of the plan to the NRC for 
approval prior to implementation. The definition of ``emergency 
planning function'' under proposed Sec.  50.54(q)(1) would be revised 
to remove references to appendix E and Sec.  50.47(b) because emergency 
planning functions would be addressed under both these sections and 
under the proposed Sec.  50.160, and the NRC does not consider the 
references essential to the definition.
    For any existing or future holder of an operating or combined 
license for an SMR or non-LWR, or any future holder of an operating 
license for an NPUF, proposed Sec.  50.54(q)(7) would stipulate that a 
licensee desiring to change its emergency plan to comply with the 
performance-based approach to EP would need to submit a license 
amendment request with the proposed changes to its emergency plan. The 
request would need to include an explanation of the schedule and 
analyses supporting the implementation of a performance-based EP 
program.
Emergency Response Data System
    Appendix E to 10 CFR part 50, section VI, ``Emergency Response Data 
System,'' outlines a set of system, testing, and implementation 
requirements for the emergency response data system (ERDS) for 
operating nuclear power reactor licensees, and Sec.  50.72, ``Immediate 
notification requirements for operating nuclear power reactors,'' 
includes requirements for activation of ERDS. In contrast, the 10 CFR 
part 50, appendix E ERDS requirement and Sec.  50.72 ERDS activation 
requirement would not be applicable to applicants and licensees 
choosing to comply with Sec.  50.160. Applicants and licensees choosing 
Sec.  50.160 would be required to describe in their emergency plans the 
data links with the NRC for use in emergencies. Specific parameters to 
be reported would be determined for the specific technology during the 
license application process under 10 CFR part 50 or 10 CFR part 52. The 
NRC would review each applicant's data transmission capabilities on a 
case-specific basis. The NRC is not proposing any changes to its ERDS 
regulations.
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 would require 
additional EP considerations relative to an independently sited 
facility. For example, SMRs or ONTs may need to be prepared for events 
associated with other contiguous or nearby facilities' proximate 
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 non-licensed 
facility. For example, a nuclear power facility could be sited 
contiguous or nearby to 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 or nearby to a non-licensed 
facility but, under each scenario, the hazards of the non-licensed 
facility must be factored into the EP program of the nuclear facility 
to ensure the protection of public health and safety, and the 
environment.
    For SMR or ONT applicants and licensees located contiguous or 
nearby to another facility, proposed Sec.  50.160(b)(2) would require 
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 would need 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 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 would 
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 would assess the combined 
radiological and industrial hazards at the site.
    The NRC is issuing DG-1350 for public comment with this proposed 
rule that includes guidance on hazard analyses for contiguous or nearby 
facilities.
Emergency Planning Zones
    The NRC is proposing a consequence-oriented, technology-inclusive 
approach to EPZ size determinations for SMRs and ONTs. This proposed 
approach is similar to the dose/distance rationale historically used by 
the NRC in part to determine EPZ size for production or utilization 
facilities. Under the existing regulations, SMRs or ONTs, depending on 
their capacity and technology, are either required to establish a 10-
mile (16-km) plume exposure pathway EPZ and a 50-mile (80-km) IPZ or 
follow the case-by-case EPZ size determination process under Sec. Sec.  
50.33(g), 50.47(c)(2), and section I.3. of appendix E to 10 CFR part 
50. Pre-application 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) and 50-
mile (80-km) EPZs 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 proposing an alternative 
scalable methodology for determining EPZ size on a case-specific basis. 
This methodology would be established in guidance (DG-1350) generically 
without design- or site-specific information regarding source term, 
fission products, or projected offsite dose. Applicants would 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

[[Page 28451]]

EPA PAGs. The NRC is proposing an EPZ size determination process that 
is consistent with this philosophy. Proposed Sec.  50.33(g)(2) would 
establish an EPZ size determination process for SMR, non-LWR, and NPUF 
applicants complying with Sec.  50.160. Small modular reactor and non-
LWR applicants for an OL, COL, CP, or ESP and NPUF applicants for a CP 
or OL would be required to submit the analysis used to establish their 
proposed plume exposure pathway EPZ size. Applicants would need to 
establish their EPZ as the area within which public dose, as defined in 
Sec.  20.1003, is projected to exceed 10 mSv (or 1 rem) TEDE over 96 
hours from the release of radioactive materials resulting from a 
spectrum of credible accidents for the facility. If the plume exposure 
pathway EPZ extends beyond the site boundary and if the application is 
for an SMR or non-LWR OL, COL, an ESP that contains plans for coping 
with emergencies under Sec.  52.17(b)(2)(ii), or an ESP that proposes 
major features of the emergency plans and describes the EPZ, then 
proposed Sec.  50.33(g)(2) would require 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. Proposed Sec.  50.160(b)(3) 
would require applicants and licensees to incorporate the boundaries 
and physical descriptions of the EPZ into their emergency plans.
    To support the technical basis for this proposed rule, the NRC 
conducted research studies (ADAMS Accession Nos. ML18064A317 and 
ML18114A176), dated June 2018 to support EPZ size determinations for 
SMRs and ONTs. Supported by the results of these studies, the NRC is 
including guidance in Appendix A to DG-1350 for determining the EPZ 
size based on the NRC staff's evaluation of a spectrum of accidents and 
the criterion in proposed Sec.  50.33(g)(2) that the plume exposure 
pathway EPZ should be established as the area in which public dose is 
projected to exceed 10 mSV (1 rem) TEDE over 96 hours from the release 
of a spectrum of credible accidents for the facility. In the DG, the 
NRC is providing general guidance and anticipates that industry will 
develop and implement detailed design-specific calculations for NRC 
review and approval. The NRC's guidance is not a regulatory requirement 
and applicants and licensees may use alternative approaches to meeting 
regulatory requirements as long as appropriately supported and 
justified.
    Upon receiving an OL, COL, ESP, or CP applicant's technical basis 
for proposed site-specific plume exposure pathway EPZ size, the NRC 
would review the design and licensing information to ensure that the 
information that the applicants provide 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 and the environment. 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 would consider an appropriate spectrum of accidents 
to provide a basis for judging the adequacy of features such as 
functional containment design and the need for offsite emergency 
planning. The NRC also would assess the need to provide site-specific 
guidance concerning the accident scenarios being considered.
    In addition to the proposed plume exposure pathway EPZ size 
determination process, the NRC is proposing to include ingestion 
response planning requirements under proposed Sec.  50.160(b)(4). 
Applicants and licensees complying with proposed Sec.  50.160 would be 
required to describe in their emergency plans the capabilities to 
protect contaminated food and water from entering the ingestion 
pathway. The capabilities described in the emergency plan would 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 hours 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 would reference capabilities of Federal, 
Tribal, State, and local Federal authorities.
    Three notable incidents documented by the Center for Disease 
Control and Prevention that demonstrate the capability to conduct 
large-scale quarantines are the multi-state 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 planning zone.
Implementation
    The NRC is proposing implementation schedules for existing and 
future applicants and licensees of facilities choosing to comply with 
proposed Sec.  50.160. Per the requirements of proposed Sec.  
50.160(c)(1), an applicant for an operating license issued under 10 CFR 
part 50 after the effective date of this proposed rule desiring to 
comply with the performance-based approach to EP and within the scope 
of that approach as stated in this proposed rule would be required to 
establish, implement, and maintain an EP program that meets the 
requirements of proposed Sec.  50.160(b) and conduct an initial 
exercise to demonstrate this compliance no later than 18 months before 
the issuance of an operating license for the first unit described in 
the license application. Per the requirements of Sec.  50.160(c)(2), a 
holder of a combined license issued under 10 CFR part 52 desiring to 
comply with the performance-based approach to EP before the Commission 
has made the finding under Sec.  52.103(g) would be required to 
establish, implement, and maintain an emergency preparedness program 
that meets the requirements of proposed Sec.  50.160(b), as described 
in the emergency plan and license, and conduct an initial exercise to 
demonstrate this compliance no later than 18 months before the 
scheduled date for initial loading of fuel.
    As discussed in the ``Changes to Emergency Plans'' section of this 
document, for existing or future SMRs or ONTs that hold operating or 
combined licenses, proposed Sec.  50.54(q)(7) would stipulate that 
facilities desiring to change their emergency plans to comply with the 
performance-based approach to EP, shall submit a license amendment 
request with these proposed changes.
Reasonable Assurance
    The NRC's authority to regulate the use of radioactive materials is 
set forth in the AEA and Title II of the Energy Reorganization Act of 
1974, as amended (ERA). Both the AEA and ERA confer broad regulatory 
powers to the Commission and specifically authorize it to issue 
regulations it deems necessary to fulfill its responsibilities under 
those statutes. Section 161.b of the AEA authorizes the Commission to 
establish by rule, regulation, or order such standards and instructions 
to

[[Page 28452]]

govern the possession and use of special nuclear material, source 
material, and byproduct material as the Commission may deem necessary 
or desirable to promote the common defense and security or to protect 
health or to minimize danger to life or property. Under Section 161.i 
of the AEA, the Commission may prescribe such regulations or orders, as 
it may deem necessary, to protect health and to minimize danger to life 
or property.
    The NRC's regulations include standards for both onsite and offsite 
emergency response plans. The Commission, based on its authority under 
the AEA, determined that these standards are necessary for operating 
power reactors to provide for public health and safety. The regulations 
in Sec. Sec.  50.47 and 50.54, prescribe how the NRC will make 
licensing decisions or take 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 will base 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 Tribal, State, and local 
emergency plans are adequate and whether there is reasonable assurance 
that they can be implemented.
    The proposed performance-based approach to EP under Sec.  50.160 
would provide for an adequate basis for an acceptable state of EP and 
ensure that coordination and applicable arrangements with offsite 
agencies are maintained (e.g., notification and assistance resources). 
Reasonable assurance will be maintained under the proposed performance-
based approach through: (1) Submission and case-specific review of 
design- and site-specific analyses to support the proposed plume 
exposure pathway EPZ size; (2) review of site-specific emergency plans 
to ensure compliance with the proposed 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 or non-licensed facilities; and (6) the NRC's inspection 
and enforcement program. Proposed Sec.  50.160(b) would state that the 
NRC would not issue an initial operating license to a licensee 
complying with proposed Sec.  50.160 unless a reasonable assurance 
finding is made.
    For applicants and licensees with plume exposure pathway EPZs 
beyond the site boundary, the NRC, in consultation with FEMA, would 
continue to make a determination of reasonable assurance based on the 
performance-based requirements, as demonstrated through drills and 
exercises. As described in the ``Offsite Radiological Emergency 
Preparedness Planning Activities'' section of this document, the NRC is 
proposing that FEMA findings and determinations regarding reasonable 
assurance under Sec.  50.54(s)(3) would not be needed for SMRs or ONTs 
with plume exposure pathway EPZs that do not extend beyond the site 
boundary. The NRC would continue to make reasonable assurance 
determinations regarding onsite EP requirements for these facilities, 
and every licensee must follow and maintain the effectiveness of its 
emergency plan if the NRC is to continue to find, under Sec.  
50.54(s)(2)(ii), that there is reasonable assurance that adequate 
protective measures can and will be taken in the event of a 
radiological emergency at that site.
Administrative and Clarifying Changes to the Regulations
    The NRC is proposing clarifying changes to the following 
paragraphs.
    1. Section 50.54(q)(4), which required after February 21, 2012, any 
changes to 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 proposing to delete ``after February 21, 2012'' and 
retain the remainder of the provision.
    2. Section 50.54(q)(5), which required licensees to submit a report 
of each change made without prior NRC approval, as allowed under Sec.  
50.54(q)(3), after February 21, 2012, including a summary of its 
analysis, within 30 days after the change is put into effect. The NRC 
is proposing to delete ``after February 21, 2012'' from this provision, 
as the date has expired, and retain the remainder of the provision.
    3. Section 50.54(s)(2)(ii), which allows the NRC to take 
enforcement action to shut down power reactors that do not provide 
reasonable assurance that adequate protective measures would be taken 
in the event of a radiological emergency after April 1, 1981. There is 
no longer a need for the date requirement of this provision because any 
future determinations made under Sec.  50.54(s) will occur after April 
1, 1981. The NRC is proposing to delete ``after April 1, 1981'' and 
retain the remainder of the provision.
    The NRC is proposing to revise these paragraphs in the interest of 
regulatory clarity. Eliminating these requirements would not relax 
currently effective regulatory requirements or cause any regulatory 
burden for existing or future licensees.

IV. Specific Requests for Comments

    The NRC is seeking public comment on this proposed rule. The NRC 
staff is particularly interested in comments and supporting rationale 
from the public on the following:
     Terminology used to describe the requirements: This 
proposed rule continues the practice from SECY-11-0152, ``Development 
of an Emergency Planning and Preparedness Framework for Small Modular 
Reactors,'' of describing the alternative framework for EP as 
``technology-neutral, dose-based, and consequence-oriented.'' The NRC 
recognizes, however, that the overarching term ``risk-informed'' as 
defined by the Commission in ``STAFF REQUIREMENTS--SECY-98-144--White 
Paper on Risk-Informed and Performance-Based Regulation'' (ADAMS 
Accession No. ML003753601), includes consideration of both the 
likelihood of a spectrum of events and their consequences. In the 
context of EP, the consequences of concern would be dose. The NRC is 
therefore considering aligning the discussion of the EP framework in 
this rule with its other risk-informed, performance-based regulations 
and considering eliminating the use of the descriptors ``dose-based'' 
and ``consequence-oriented,'' but intends no change to the meaning of 
the proposed regulations. Would such a change impact the clarity and 
predictability of the regulations?
     Scope of this proposed rule: This proposed rule would 
allow SMRs and ONTs to establish an alternative performance-based, 
consequence-oriented approach to EP. The NRC received a comment on its 
draft regulatory basis in 2017 that recommended that the NRC expand the 
scope of this proposed rule to include large LWRs. Large LWRs were not 
included by the NRC in the scope of this proposed rule because an EP 
licensing framework already exists for those reactors, and licensees 
for those plants have not presented a clear interest in changing that 
framework. Nonetheless, in light of the public comment on the draft 
regulatory basis, and although this proposed rule is written for SMRs 
and ONTs, the NRC is open to considering

[[Page 28453]]

a performance-based, consequence-oriented approach to EP for large 
LWRs, fuel cycle facilities, and currently operating NPUFs.
    Are the proposed ``non-light-water reactor,'' ``non-power 
production or utilization facility,'' and ``small modular reactor'' 
definitions in Sec.  50.2 sufficient to address EP for existing and 
anticipated technologies? Are there any unintended consequences of 
including each of these classes of facilities within the scope of this 
proposed rule? Please provide the basis for your response.
    Should the NRC consider a performance-based, consequence-oriented 
approach to EP for entities besides SMRs and ONTs (e.g., large LWRs, 
fuel cycle facilities, and currently operating NPUFs) in a future 
rulemaking? Please provide a basis for your response.
    If the NRC considers a performance-based, consequence-oriented 
approach to EP for entities other than SMRs and ONTs, what criteria 
should such entities be required to meet to use a performance-based, 
consequence-oriented approach to EP in a future rulemaking? Please 
provide a basis for your response.
    If the NRC does not consider a performance-based, consequence-
oriented approach to EP for entities other than SMRs and ONTs, should 
the NRC offer mechanisms (other than the existing exemption process) 
that would allow other entities to request NRC approval to use the EP 
framework proposed in this rulemaking? If so, what mechanisms? Please 
provide a basis for your response.
     Performance-based requirements: Under this proposed rule, 
applicants and licensees choosing to comply with the performance-based 
approach would need to demonstrate emergency response functions 
required under Sec.  50.160(b)(1)(iii) through the use of drills or 
exercises and performance objectives. Are there additional emergency 
response functions that the NRC should consider for incorporation in 
this proposed rulemaking? Please provide the basis for your answer.
     Drills or exercises: Under proposed Sec.  50.160(b)(1), 
applicants and licensees would need to develop a drill and exercise 
program to demonstrate compliance with performance-based requirements. 
Would an 8-year exercise cycle (as is currently required for large 
LWRs) be appropriate for SMRs or ONTs choosing to comply with the 
performance-based approach? If not, would an alternative cycle length 
be appropriate? Please provide the basis for your answer.
     Planning activities: The NRC is proposing four planning 
activities under Sec.  50.160(b)(1)(iv)(A) that all applicants and 
licensees choosing the performance-based approach to EP would need to 
comply with and 11 offsite planning activities under Sec.  
50.160(b)(1)(iv)(B) that are designed for applicants and licensees with 
an EPZ that extends beyond the site boundary. These planning activities 
identify certain EP-related activities that are not readily observable 
and cannot be effectively measured through drills and exercises. Are 
there any planning activities that should be added to or removed from 
the NRC's proposed list? Please provide the basis for your answer.
     Hazard analysis for contiguous or nearby facilities: The 
NRC is proposing to require applicants and licensees choosing a 
performance-based approach to EP to submit a hazard analysis under 
Sec.  50.160(b)(2). To what extent should this analysis be harmonized 
with or rely upon the analysis conducted under 10 CFR 100.20, ``Factors 
to be considered when evaluating sites,'' for man-related hazards? What 
kinds of facilities might be located contiguous or nearby to SMRs or 
ONTs? Should the NRC change the scope of the hazard analysis? If so, 
how should the scope of the hazard analysis change? Please provide the 
basis for your answer.
     Emergency planning zones: The NRC is proposing to require 
applicants and licensees choosing to comply with proposed Sec.  50.160 
to submit the analysis used to establish a site-specific plume exposure 
pathway EPZ size. The analysis for the proposed EPZ size would be 
reviewed on a case-specific basis by the NRC to ensure that design- and 
site-specific accident scenarios are appropriately incorporated and 
that reasonable assurance is maintained with the proposed EPZ size. 
Applicants and licensees would need to establish their plume exposure 
pathway EPZ as the area within which public dose is projected to exceed 
10 mSv (1 rem) TEDE over 96 hours from the release of radioactive 
materials resulting from a spectrum of credible accidents for the 
facility. Is the proposed 10 mSv (1 rem) criterion appropriate? Are 
there particular factors and technical considerations that need to be 
included in an EPZ size analysis? If the analysis demonstrates that the 
EPZ is within the facility's site boundary, would the need for a 
dedicated, Federal-mandated offsite radiological emergency preparedness 
program exist? If the applicant or licensee provides an adequate 
description of the existing Federal, Tribal, State, and local Federal 
capabilities to interdict contaminated food and water, would the need 
for an IPZ exist? Please provide the basis for your answer.
     Costs: The NRC recognizes that all power reactor 
applicants will develop a PRA to meet existing requirements and support 
development of their application. The NRC would allow applicants the 
option to further the use of PRA to support a risk-informed approach 
for the development of source terms. The NRC is seeking information on 
the incremental cost estimates for any additional PRA modeling 
necessary to generate the credible accident sequences and the 
development of the source terms used in determining a site-specific EPZ 
size.

V. Section-by-Section Analysis

    The following paragraphs describe the specific changes proposed by 
this proposed rule.

Section 50.2 Definitions

    In Sec.  50.2, this proposed rule would add the definitions for 
Non-light-water reactor, Non-power production or utilization facility, 
and Small modular reactor.

Section 50.8 Information Collection Requirements; OMB Approval

    In Sec.  50.8, this proposed rule would add new Sec.  50.160 to the 
list of approved information collection requirements contained in 10 
CFR part 50.

Section 50.10 License Required; Limited Work Authorization

    In Sec.  50.10, this proposed rule would revise paragraph 
(a)(1)(vii) to include onsite emergency facilities necessary to comply 
with new Sec.  50.160 requirements within the scope of items for which 
a construction permit or limited work authorization is necessary to 
commence construction.

Section 50.33 Contents of Applications; General Information

    In Sec.  50.33, this proposed rule would revise paragraph (g) to 
create new subparagraphs (g)(1) and (2). Paragraph (g)(1) would contain 
the original text of paragraph (g) and would add the qualifier ``except 
as provided in paragraph (g)(2) of this section.''
    Paragraph (g)(2) would establish an EPZ size determination process 
for SMR, non-LWR, and NPUF applicants complying with Sec.  50.160.

Section 50.34 Contents of Applications; Technical Information

    In Sec.  50.34, this proposed rule would revise paragraph (a)(10) 
to require SMR, non-LWR, or NPUF construction permit applicants to 
describe in their PSARs

[[Page 28454]]

the preliminary plans for coping with emergencies based on the 
requirements in either Sec.  50.160 or appendix E to 10 CFR part 50.
    This proposed rule also would revise paragraph (b)(6)(v) to require 
SMR, non-LWR, and NPUF applicants for an operating license to include 
in their FSARs their plans for coping with emergencies based on the 
requirements in either Sec.  50.160 or appendix E to 10 CFR part 50.

Section 50.47 Emergency Plans

    In Sec.  50.47, this proposed rule would make conforming changes to 
paragraph (b) and add new paragraph (f) denoting when the offsite 
emergency response plan requirements in paragraph (b) of this section 
do not apply.

Section 50.54 Conditions of Licenses

    In Sec.  50.54, this proposed rule would revise paragraph 
(q)(1)(iii) to remove the reference to appendix E to 10 CFR part 50 and 
Sec.  50.47(b).
    It would revise paragraph (q)(2) to include new subparagraphs (i) 
and (ii). Paragraph (i) would contain the original text of paragraph 
(q)(2) and would add the qualifier ``except as provided in paragraph 
(q)(2)(ii) of this section, and paragraph (ii) would allow SMR, non-
LWR, and NPUF licensees to follow and maintain the effectiveness of an 
emergency plan that meets the requirements of Sec.  50.160 or appendix 
E to 10 CFR part 50 and, except for NPUF licensees, Sec.  50.47(b).
    It also would revise paragraph (q)(3) to include new subparagraphs 
(i) and (ii). Paragraph (i) would contain the original text of 
paragraph (q)(3) and would add the qualifier ``except as provided in 
paragraph (q)(3)(ii) of this section'' and paragraph (ii) would specify 
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.
    Paragraph (q)(4) and (5) would be revised to remove the date 
February 21, 2012, and paragraph (q)(4) would be further revised to 
specify that licensees that choose to comply with the new requirements 
of Sec.  50.160, when making an emergency plan change that reduces plan 
effectiveness, would need to specify the basis for concluding how their 
revised emergency plans continue to meet the requirements of that 
section.
    This proposed rule would add new paragraph (q)(7) that would 
contain the details for submitting license amendment requests for SMR, 
non-LWR, or NPUF licensees implementing emergency preparedness programs 
with the associated plan modifications necessary to meet the 
requirements of new Sec.  50.160.
    Paragraph (s)(2)(ii) would be revised to remove the date April 1, 
1981, and to replace the word ``reactor'' with the word ``facility.''
    This proposed rule would revise paragraph (s)(3) by adding 
clarification at the beginning of the sentence that if the standards 
apply to offsite emergency response plans, or if the planning 
activities in new Sec.  50.160(b)(1)(iv)(B) apply, then the NRC would 
base its findings on a review of FEMA's findings and determinations.
    This proposed rule would also revise paragraph (gg)(1) to include 
the option for SMR, non-LWR, or NPUF applicants to use new Sec.  
50.160, as applicable.

Section 50.160 Emergency Preparedness for Small Modular Reactors, Non-
Light-Water Reactors, and Non-Power Production or Utilization 
Facilities

    This proposed rule would add new subpart, ``Small Modular Reactors, 
Non-Light-Water Reactors, and Non-power Production or Utilization 
Facilities,'' and new Sec.  50.160, which would contain alternative EP 
requirements for SMRs, non-LWRs, and NPUFs.

Appendix E to Part 50--Emergency Planning and Preparedness for 
Production and Utilization Facilities

    In appendix E to part 50, this proposed rule would 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.

Section 52.1 Definitions

    In Sec.  52.1, this proposed rule would revise the definition of 
Major feature of the emergency plans to include new Sec.  50.160, as 
applicable.

Section 52.17 Contents of Applications; Technical Information

    In Sec.  52.17, this proposed rule would revise paragraph (b)(2) to 
include new Sec.  50.160, as applicable.

Section 52.18 Standards for Review of Applications

    This proposed rule would revise Sec.  52.18 to include new Sec.  
50.160, as applicable.

Section 52.79 Contents of Applications; Technical Information in Final 
Safety Analysis Report

    In Sec.  52.79, this proposed rule would revise paragraph (a)(21) 
to require applicants for SMRs or non-LWRs to comply with either Sec.  
50.160 or Sec.  50.47 and appendix E to 10 CFR part 50.

VI. Regulatory Flexibility Certification

    As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 
605(b), the Commission certifies that this rule, if adopted, will not 
have a significant economic impact on a substantial number of small 
entities. This proposed 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 
(10 CFR 2.810).

VII. Regulatory Analysis

    The NRC has prepared a draft regulatory analysis on this proposed 
regulation. The analysis examines the costs and benefits of the 
alternatives considered by the NRC. The conclusion from the analysis is 
that this proposed rule and associated guidance would result in net 
savings to the industry and the NRC of $5.89 million using a 7-percent 
discount rate and $9.71 million using a 3-percent discount rate. The 
NRC requests public comment on the draft regulatory analysis. The draft 
regulatory analysis is available as indicated in the ``Availability of 
Documents'' section of this document. Comments on the draft regulatory 
analysis may be submitted to the NRC as indicated under the ADDRESSES 
caption of this document.

VIII. Backfitting and Issue Finality

    This proposed rule and implementing guidance would not be subject 
to the NRC's backfitting regulation at Sec.  50.109, ``Backfitting,'' 
or issue finality regulations in 10 CFR part 52. This proposed rule 
would contain new alternative requirements for SMR and ONT applicants 
and licensees. Because these alternative requirements would not be 
imposed upon applicants and licensees and would not prohibit applicants 
and licensees from following existing requirements, the proposed 
requirements would not constitute backfitting or a violation of issue 
finality.
    As described in section XV, ``Availability of Guidance,'' in this 
document, the NRC is issuing a draft regulatory guide (DG) that, if 
finalized, would provide guidance on the methods acceptable to the NRC 
for complying with aspects of this proposed rule. Issuance of the DG in 
final form would not constitute backfitting under Sec.  50.109 and 
would not otherwise violate issue finality under 10 CFR part 52. As 
discussed in the ``Implementation''

[[Page 28455]]

section of the DG, the NRC has no current intention to impose the DG on 
holders of an operating license or COL.
    Furthermore, in general, the backfitting provisions under 10 CFR 
part 50 and the issue finality provisions under 10 CFR part 52 do not 
apply to current or future applicants because neither the backfitting 
nor issue finality provisions were intended to apply to every NRC 
action that substantially changes the expectations of current and 
future applicants. Applicants have no reasonable expectation that 
future requirements will not change (``Early Site Permits; Standard 
Design Certifications; and Combined Licenses for Nuclear Power Plants; 
Final Rule,'' 54 FR 15372, at 15385-15386; April 18, 1989).
    The exceptions to this general principle include a 10 CFR part 50 
power reactor operating license applicant that references an NRC-issued 
construction permit, limited work authorization, or design 
certification rule with issue finality, or a 10 CFR part 52 applicant 
that references a 10 CFR part 52 license (e.g., an ESP), an NRC 
regulatory approval (e.g., a design certification rule), or both, with 
specified issue finality provisions. The NRC does not currently intend 
to impose the positions represented in the DG in a manner that would 
constitute backfitting or would be inconsistent with any issue finality 
provision of 10 CFR part 52. If, in the future, the NRC seeks to impose 
positions stated in the DG in a manner that would constitute 
backfitting or be inconsistent with an issue finality provision, the 
NRC would need to make the showing as set forth in Sec.  50.109 or 
address the regulatory criteria set forth in the applicable issue 
finality provision, as applicable, that would allow the NRC to impose 
the position.

IX. Cumulative Effects of Regulation

    The NRC is following its CER process by engaging with external 
stakeholders throughout this proposed rule and related regulatory 
activities. Public involvement has included: (1) A public meeting held 
on August 22, 2016, to request feedback from interested stakeholders on 
a potential performance-based approach for EP for SMRs and ONTs; (2) 
the publication of the draft regulatory basis for public comment (82 FR 
17768) on March 15, 2017; (3) a public meeting held on May 10, 2017, to 
facilitate public comments on the development of the final regulatory 
basis; (4) a public meeting held on June 14, 2018 to discuss 
initiatives within the industry and NRC related to the development and 
licensing of non-LWRs, including the status of the proposed rule; and 
(5) an Advisory Committee on Reactor Safeguards Subcommittee meeting 
held on August 22, 2018 to discuss the proposed rule.
    Another opportunity for public comment is provided to the public at 
this proposed rule stage. The NRC will be issuing the draft 
implementing guidance also for comment, along with this proposed rule 
to support more informed external stakeholder feedback. Further, the 
NRC will continue to hold public meetings throughout the rulemaking 
process. Section XV, ``Availability of Guidance,'' of this document 
describes how the public can access the draft implementing guidance for 
which the NRC seeks external stakeholder feedback.
    In addition to the questions on the implementation of this proposed 
rule presented in the ``Specific Requests for Comments'' section of 
this document, the NRC is requesting CER feedback on the following 
questions:
    1. In light of any current or projected CER challenges, does this 
proposed rule's effective date provide sufficient time to implement the 
new alternative proposed requirements, including changes to programs, 
procedures, and facilities?
    2. If CER challenges currently exist or are expected, what should 
be done to address them? For example, if more time is required for 
implementation of the new alternative requirements, what period of time 
is sufficient?
    3. Do other (NRC or other agency) regulatory actions (e.g., orders, 
generic communications, license amendment requests, inspection findings 
of a generic nature) influence the implementation of this proposed 
rule's requirements?
    4. Are there unintended consequences? Does this proposed rule 
create conditions that would be contrary to this proposed rule's 
purpose and objectives? If so, what are the unintended consequences, 
and how should they be addressed?
    5. Please comment on the NRC's cost and benefit estimates in the 
draft regulatory analysis that supports this proposed rule. The draft 
regulatory analysis is available as indicated under the ``Availability 
of Documents'' section of this document.

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 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 
31883). The NRC requests comment on this document with respect to the 
clarity and effectiveness of the language used.

XI. Environmental Assessment and Proposed Finding of No Significant 
Impact

    The Commission has determined under the National Environmental 
Policy Act of 1969, as amended, and the NRC's regulations in subpart A 
of 10 CFR part 51, that this proposed rule, if adopted, would not be a 
major Federal action significantly affecting the quality of the human 
environment, and an environmental impact statement is not required. The 
following sets forth the basis of this determination. This majority of 
the provisions in the proposed rule are administrative or procedural in 
nature and either would not affect the physical environment at all or 
would have no noticeable effects. Further, the NRC has evaluated 
proposed 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 proposed 
Sec.  50.33(g) and the ingestion response planning requirements under 
Sec.  50.160(b)(4), and determined that this proposed rule would not 
have a significant environmental impact for the following reasons. 
Under the existing EP requirements and these proposed alternative EP 
requirements, the dose criteria under which predetermined protective 
actions would be taken (e.g., evacuation, sheltering) would be similar 
under both rules, and therefore, the dose consequence to the public 
would be similar. The proposed ingestion response planning requirements 
under proposed Sec.  50.160(b)(4), while not requiring SMR and ONT 
applicants and licensees to establish an IPZ, would 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 proposed 
ingestion response planning requirements are similar to that of the 
existing EP requirements. For these reasons, the NRC concludes that the 
proposed EPZ requirement under Sec.  50.33(g) and ingestion response 
planning requirement under Sec.  50.160(b)(4) would not have a

[[Page 28456]]

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.
    Public stakeholders should note, however, that comments on any 
aspect of this environmental assessment may be submitted to the NRC as 
indicated under the ADDRESSES caption. The environmental assessment is 
available as indicated under the ``Availability of Documents'' section 
of this document.
    The NRC has sent a copy of the environmental assessment and this 
proposed rule to each of the FEMA, EPA, Tribal Representatives, and 
State Liaison Officers, and has requested comment.

XII. Paperwork Reduction Act

    This proposed rule contains new and amended collections of 
information subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501 et seq.). This proposed rule has been submitted to the Office of 
Management and Budget (OMB) for review and approval of the information 
collections.
    Type of submission, new or revision: Revision.
    The title of the information collection: 10 CFR parts 50 and 52, 
Emergency Preparedness for Small Modular Reactors and Other New 
Technologies: Proposed Rule
    The form number if applicable: Not Applicable.
    How often the collection is required or requested: Emergency plans 
are submitted once at time of application. Once an EP program is 
implemented, EP records are updated quarterly and reports are submitted 
every eight years for drills and exercises. Records of the approved EP 
program, and any changes, are kept for the life of the license. 
Quarterly records of the EP performance objectives and metrics are kept 
for eight quarters.
    Who will be required or asked to respond: SMR, non-LWR, and NPUF 
applicants and licensees.
    An estimate of the number of annual responses: Part 50: decrease of 
1 reporting response (the current number of recordkeepers remains the 
same does not change under the proposed rule). Part 52: the number of 
reporting responses remains the same (recordkeepers are captured under 
part 50).
    The estimated number of annual respondents: Reporting: Part 50 = 
one respondent; Part 52 = one respondent. Three recordkeepers will 
maintain records under the current and proposed rule.
    An estimate of the total number of hours needed annually to comply 
with the information collection requirement or request: Part 50: 
reduction of 2,407 hours (1,333 reporting + 1,074 recordkeeping). Part 
52: reduction of 740 reporting hours.
    Abstract: The proposed rule would provide SMR, non-LWR, and NPUF 
applicants or licensees that are regulated by 10 CFR part 50 or 10 CFR 
part 52, the alternative to submit for NRC approval a performance-based 
EP program to include a scalable EPZ and licensee-defined performance 
objectives and metrics data. If the EP program is approved by the NRC, 
the proposed rule would require the applicants or licensees to develop 
and maintain at the beginning of each calendar quarter a list of 
performance objectives for that calendar quarter. Each licensee would 
also maintain records showing the implemented performance objectives 
and associated metrics during each calendar quarter for the previous 
eight calendar quarters. The reports and recordkeeping requirements 
allow the NRC to evaluate the adequacy of the proposed EP program for 
approval and to assess the ongoing adequacy once implemented. The 
recordkeeping requirements allow the NRC to determine whether to take 
actions, such as to conduct inspections or to alert other licensees to 
prevent similar events that may have generic implications. The 
information is also used to update information in the NRC Emergency 
Operations Center used in support of an NRC response to an actual 
emergency, drill, or exercise.
    The proposed rule would allow applicants and licensees to reduce 
their emergency plan information collection requirements compared to 
the current framework based on the potential for smaller EPZs and the 
reduction in license amendments and exemptions. The submission of 
emergency plans to the NRC is required in order to allow the NRC to 
determine that the emergency plans and EP continue to provide 
reasonable assurance that adequate protective measures can and will be 
taken in the event of a radiological emergency.
    The NRC is seeking public comment on the potential impact of the 
information collection(s) contained in this proposed rule and on the 
following issues:
    1. Is the proposed information collection necessary for the proper 
performance of the functions of the NRC, including whether the 
information will have practical utility?
    2. Is the estimate of the burden of the proposed information 
collection accurate?
    3. Is there a way to enhance the quality, utility, and clarity of 
the information to be collected?
    4. How can the burden of the proposed information collection on 
respondents be minimized, including the use of automated collection 
techniques or other forms of information technology?
    A copy of the OMB clearance package is available in ADAMS under 
Accession No. ML18134A086. You may obtain information and comment 
submissions related to the OMB clearance package by searching on 
https://www.regulations.gov under Docket ID NRC-2015-0225.
    You may submit comments on any aspect of these proposed information 
collection(s), including suggestions for reducing the burden and on the 
above issues, by the following methods:
     Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2015-0225.
     Mail comments to: Information Services Branch: T6-A10M, 
U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by 
email to [email protected].
     Submit to OMB Directly: Written comments and 
recommendations for the proposed information collection should be sent 
within 60 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. You may find this particular information collection by 
selecting ``Currently Under Review--Open for Public Comments'' or by 
using the search function. Comments on the information collections will 
be publicly available in ADAMS and on Reginfo.gov.
    Submit comments by July 27, 2020. Comments received after this date 
will be considered if it is practical to do so, but the NRC is able to 
ensure consideration only for comments received on or before this date.

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. Criminal Penalties

    For the purposes of Section 223 of the AEA, the NRC is issuing this 
proposed rule that would amend or create Sec. Sec.  50.2, 50.8, 50.10, 
50.33, 50.34, 50.47, 50.54, 50.160, 52.1, 52.17, 52.18, 52.79, and 
appendix E to 10 CFR part 50 under one or more of Sections 161b, 161i, 
or 161o

[[Page 28457]]

of the AEA. Willful violations of the rule would be subject to criminal 
enforcement. Criminal penalties as they apply to regulations in 10 CFR 
parts 50 and 52 are discussed in Sec. Sec.  50.111 and 52.303.

XIV. Voluntary Consensus Standards

    The National Technology Transfer and Advancement Act of 1995, Pub. 
L. 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. The NRC did not endorse any consensus standards 
for use in this proposed rule. In this proposed rule, the NRC will 
revise regulations associated with emergency preparedness in 10 CFR 
parts 50 and 52. This action does not constitute the establishment of a 
standard that contains generally applicable requirements.

XV. Availability of Guidance

    The NRC is issuing for comment new draft guidance, DG-1350, 
``Performance-Based Emergency Preparedness for Small Modular Reactors, 
Non-Light-Water Reactors, and Non-power Production or Utilization 
Facilities,'' that will support implementation of the requirements in 
this proposed rule. The guidance is available in ADAMS under Accession 
No. ML18082A044. You may obtain information and comment submissions 
related to the draft 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 the regulations. As a guidance 
document, DG-1350 does not establish additional requirements, and 
applicants and licensees are able to propose alternative ways for 
demonstrating compliance with the requirements in proposed Sec.  
50.160.
    You may submit comments on this draft regulatory guidance by the 
methods provided in the ADDRESSES section of this document.

XVI. Public Meeting

    The NRC will conduct a public meeting to explain the changes in 
this proposed rule and to answer questions from the attendees to 
facilitate the development of public comments.
    The NRC will publish a notice of the location, time, and agenda of 
the meeting on http://www.regulations.gov and on the NRC's public 
meeting website within at least 10 calendar days before the meeting. 
Stakeholders should monitor the NRC's public meeting website for 
information about the public meeting at: https://www.nrc.gov/public-involve/public-meetings/index.cfm.

XVII. Availability of Documents

    The documents identified in the following table are available to 
interested persons through one or more of the following methods, as 
indicated.

------------------------------------------------------------------------
                                           ADAMS Accession No./web link/
                Document                     Federal Register citation
------------------------------------------------------------------------
Draft Regulatory Analysis, ``Emergency    ML18134A077.
 Preparedness for Small Modular Reactors
 and Other New Technologies Proposed
 Rule--Draft Regulatory Analysis''.
Draft Environmental Assessment,           ML18134A079.
 ``Emergency Preparedness for Small
 Modular Reactors and Other New
 Technologies''.
Draft Information Collection Clearance    ML18184A308.
 Package.                                 ML18184A309.
Draft Regulatory Guide DG-1350,           ML18082A044.
 ``Performance-Based Emergency
 Preparedness for Small Modular
 Reactors, Non-Light-Water Reactors, and
 Non-power Production or Utilization
 Facilities''.
NUREG-0396, ``Planning Basis for the      ML051390356.
 Development of State and Local
 Government Radiological Emergency
 Response Plans in Support of Light-
 water Nuclear Power Plans,'' December
 1978.
NUREG-0849, ``Standard Review Plan for    ML062190191.
 the Review and Evaluation of Emergency
 Plans for Research and Test Reactors,''
 October 1983.
NUREG-1537, Part 1, ``Guidelines for      ML042430055.
 Preparing and Reviewing Applications
 for the Licensing of Non-power
 Reactors, Format and Content,''
 February 1996.
NUREG-1537, Part 2, ``Guidelines for      ML042430048.
 Preparing and Reviewing Applications
 for the Licensing of Non-power
 Reactors, Standard Review Plan and
 Acceptance Criteria,'' February 1996.
Interim Staff Guidance for NUREG-1537,    ML12156A069.
 ``Final Interim Staff Guidance
 Augmenting NUREG-1537, Part 1,
 `Guidelines for Preparing and Reviewing
 Applications for the Licensing of Non-
 power Reactors, Format and Content' for
 Licensing Radioisotope Production
 Facilities and Aqueous Homogenous
 Reactors,'' October 12, 2012.
Final Interim Guidance for NUREG-1537,    ML12156A075.
 ``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.
NUREG-1520, ``Standard Review Plan for    ML101390110.
 the Review of a License Application for
 a Fuel Cycle Facility,'' Revision 1,
 May 1, 2010.
NUREG-1226, ``Development and             ML13253A431.
 Utilization of the NRC Policy Statement
 on the Regulation of Advanced Nuclear
 Power Plants,'' June 1988.
NUREG-0654/FEMA-REP-1, Revision 1,        ML040420012.
 ``Criteria for Preparation and
 Evaluation of Radiological Emergency
 Response Plans and Preparedness in
 Support of Nuclear Power Plants,''
 November 1980.
SECY-93-092, ``Issues Pertaining to the   ML040210725.
 Advanced Reactor (RISM, MHTGR, and
 PIUS) and CANDU 3 Designs and Their
 Relationship to Current Regulatory
 Requirements,'' April 8, 1993.
SECY-97-020, ``Results of Evaluation of   ML992920024.
 Emergency Planning for Evolutionary and
 Advanced Reactors,'' January 27, 1997.

[[Page 28458]]

 
SECY-04-0236, ``Southern Nuclear          ML042590576.
 Operation Company's Proposal to
 Establish a Common Emergency Operating
 Facility at its Corporate
 Headquarters,'' December 23, 2004.
SECY-06-0200, ``Results of the Review of  ML061910707.
 Emergency Preparedness Regulations and
 Guidance,'' September 20, 2006.
SECY-10-0034, ``Potential Policy,         ML093290268.
 Licensing, and Key Technical Issues for
 Small Modular Reactor Designs,'' March
 28, 2010.
SECY-11-0152, ``Development of an         ML112570439.
 Emergency Planning and Preparedness
 Framework for Small Module Reactors,''
 October 28, 2011.
SECY-14-0066, ``Request by Dominion       ML14072A257.
 Energy Kewaunee Inc., for Exemptions
 from Certain Emergency Planning
 Requirements,'' June 27, 2014.
SECY-14-0118, ``Request by Duke Energy    ML14219A444.
 Florida, Inc., for Exemptions from
 Certain Emergency Planning
 Requirements,'' October 29, 2014.
SECY-14-0038, ``Performance-Based         ML13238A018.
 Framework for Nuclear Power Plant
 Emergency Preparedness Oversight,''
 April 4, 2014.
SECY-15-0077, ``Options for Emergency     ML15037A176.
 Preparedness for Small Module Reactors
 and Other New Technologies,'' May 29,
 2015.
SECY-16-0069, ``Rulemaking Plan on        ML16020A388.
 Emergency Preparedness for Small Module
 Reactors and Other New Technologies,''
 May 31, 2016.
SRM-SECY-93-092, ``Staff Requirements--   ML003760774.
 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.
SRM-SECY-04-0236, ``Staff Requirements--  ML050550131.
 SECY-04-0236--Southern Nuclear
 Operating Company's Proposal to
 Establish a Common Emergency Operating
 Facility at its Corporate
 Headquarters,'' February 23, 2005.
SRM-SECY-06-0200, ``Staff Requirements--  ML070080411.
 Results of the Review of Emergency
 Preparedness Regulations and
 Guidance,'' January 8, 2007.
SRM-SECY-14-0038, ``Staff Requirements--  ML14259A589.
 SECY-14-0038--Performance-Based
 Framework for Nuclear Power Plant
 Emergency Preparedness Oversight,''
 September 16, 2014.
SRM-SECY-15-0077, ``Staff Requirements--  ML15216A492.
 SECY-15-0077--Options for Emergency
 Preparedness for Small Module Reactors
 and Other New Technologies,'' August 4,
 2015.
SRM-SECY-16-0069, ``Staff Requirements--  ML16174A166.
 Rulemaking Plan on Emergency
 Preparedness for Small Module Reactors
 and Other New Technologies,'' June 22,
 2016.
``Memorandum of Understanding Between     ML15333A371.
 the Department of Homeland Security/
 Federal Emergency Management Agency and
 Nuclear Regulatory Commission Regarding
 Radiological Emergency Response,
 Planning, and Preparedness,'' December
 7, 2015.
``Emergency Planning and Preparedness,''  47 FR 30232.
 Final Rule, July 13, 1982.
``NRC Vision and Strategy: Safely         ML16356A670.
 Achieving Effective and Efficient Non-
 Light-Water Reactor Mission
 Readiness,'' December 2016.
``Enhancements to Emergency Preparedness  76 FR 72559.
 Regulations,'' Final Rule, November 23,
 2011.
Regulatory Basis for Regulatory           82 FR 55954.
 Improvements for Power Reactors
 Transitioning to Decommissioning
 Rulemaking, November 27, 2017.
SECY-18-0055, ``Proposed Rule:            ML18012A019.
 Regulatory Improvements for Production
 and Utilization Facilities
 Transitioning to Decommissioning,'' May
 22, 2018.
Regulatory Guide (RG) 2.6, ``Emergency    ML12184A008.
 Planning for Research Reactors,''
 January 1979.
RG 2.6, ``Emergency Planning for          ML17263A472.
 Research and Test Reactors and Other
 Non-power Production and Utilization
 Facilities,'' September 2017.
``Specific Exemptions; Clarification of   50 FR 50764.
 Standards,'' December 12, 1985.
``Regulation of Advanced Nuclear Power    51 FR 24643.
 Plants, Statement of Policy,'' July 8,
 1986.
``Policy Statement on Regulation of       73 FR 60612.
 Advanced Reactors,'' October 14, 2008.
EP for Small Modular Reactors and Other   82 FR 17768.
 New Technologies, Draft Regulatory
 Basis, April 13, 2017.
EP for Small Modular Reactors and Other   82 FR 52862.
 New Technologies, Regulatory Basis,
 November 15, 2017.
Variable Annual Fee Structure for Small   80 FR 68268.
 Modular Reactors, Proposed Rule,
 November 4, 2015.
Variable Annual Fee Structure for Small   81 FR 32617.
 Modular Reactors, Final Rule, May 24,
 2016.
NEI White Paper, ``White Paper: Proposed  ML13364A345.
 Methodology and Criteria Establishing
 the Technical Basis for Small Modular
 Reactor Emergency Planning Zone,'' 2013.
NEI White Paper ``Proposed Emergency      ML15194A276.
 Preparedness Regulations and Guidance
 for Small Modular Reactors
 Facilities,'' July 2015.
``Summary of September 1-2, 2015,         ML15265A165.
 Nuclear Regulatory Commission and
 Department of Energy Co-Hosted Workshop
 on Advanced Non-Light-Water Reactors,''
 October 15, 2015.

[[Page 28459]]

 
``Summary of June 7-8, 2015, Department   ML16188A226.
 of Energy and Nuclear Regulatory
 Commission Co-Hosted Workshop on
 Advanced Non-Light-Water Reactors,''
 July 7, 2015.
EPA-520/1-75-001, ``Manual of Protective  https://nepis.epa.gov/Exe/
 Action Guides and Protective Actions      ZyPDF.cgi?Dockey=9101AK8V.PDF
 for Nuclear Incidents,'' September,       .
 1975.
EPA-400-R-92-001, ``Manual of Protection  https://www.epa.gov/sites/
 Action Guides and Protective Actions      production/files/2016-03/
 for Nuclear Incidents,'' May 1992.        documents/pags.pdf.
EPA-400/R-17/001, ``PAG Manual:           https://www.epa.gov/sites/
 Protective Action Guides and Planning     production/files/2017-01/
 Guidance for Radiological Incidents,''    documents/
 January 2017.                             epa_pag_manual_final_revision
                                           s_01-11-
                                           2017_cover_disclaimer_8.pdf.
NEI 99-02, ``Regulatory Assessment        ML13261A116.
 Performance Indicator Guideline,''
 Revision 7, August 13, 2013.
FEMA-NC MOU re: Radiological Emergency    ML15344A371.
 Response, Planning, and Preparedness,
 dated December 7, 2015.
``Generalized Dose Assessment             ML18064A317.
 Methodology for Informing Emergency
 Planning Zone Size Determinations,''
 June 2018.
``Required Analyses for Informing         ML18114A176.
 Emergency Planning Zone Size
 Determinations,'' June 2018.
Homeland Security Presidential Directive  https://www.dhs.gov/
 5, ``Management of Domestic               publication/homeland-security-
 Incidents,'' February 28, 2003.           presidential-directive-5.
Presidential Policy Directive (PPD)-8,    https://www.dhs.gov/
 ``National Preparedness,'' March 30,      presidential-policy-directive-
 2011.                                     8-national-preparedness.
Nuclear Innovation Alliance ``Enabling    https://docs.wixstatic.com/ugd/
 Nuclear Innovation: Strategies for        5b05b3_71d4011545234838aa2700
 Advanced Reactor Licensing,'' June 7,     5ab7d757f1.pdf.
 2016.
American National Standards Institute/    http://www.ans.org/store/item-
 American Society Standard (ANSI/ANS)      240305/.
 15.16--2015. ``Emergency Planning for
 Research Reactors,'' American Nuclear
 Society, La Grange Park, IL, February
 2015.
``Early Site Permits; Standard Design     54 FR 15372.
 Certifications; and Combined Licenses
 for Nuclear Power Plants, Final Rule,''
 April 18, 1989.
``Summary of August 22, 2016, Public      ML16257A510.
 Meeting to Discuss a Performance-Based
 Approach to Emergency Preparedness for
 Small Modular Reactors and Other New
 Technologies,'' September 15, 2016.
``Summary of May 10, 2017, Public         ML17139C860.
 Meeting on the Draft Regulatory Basis
 for the Rulemaking for Emergency
 Preparedness for Small Modular Reactors
 and Other New Technologies,'' May 24,
 2017.
NUREG/CR-7248, ``Capabilities and         ML18170A043.
 Practices of Offsite Response
 Organizations for Protective Actions in
 the Intermediate Phase of a
 Radiological Emergency,'' June 2018.
``10 CFR Parts 50 and 70, Emergency       45 FR 55402.
 Planning; Final Rule,'' August 19, 1980.
SECY-19-0062, ``Final Rule: Non-power     ML18031A000.
 Production or Utilization Facility
 License Renewal,'' June 17, 2019.
------------------------------------------------------------------------

    Throughout the development of this proposed rule, the NRC may post 
documents related to this rule, including public comments, on the 
Federal rulemaking website at https://www.regulations.gov under Docket 
ID NRC-2015-0225. The Federal rulemaking website allows you to receive 
alerts when changes or additions occur in a docket folder. To 
subscribe: (1) Navigate to the docket folder (NRC-2015-0225); (2) click 
the ``Sign up for Email Alerts'' link; and (3) enter your email address 
and select how frequently you would like to receive emails (daily, 
weekly, or monthly).

List of Subjects

10 CFR Part 50

    Administrative practice and procedure, Antitrust, Backfitting, 
Classified information, Criminal penalties, Education, Emergency 
planning, Fire prevention, Fire protection, Incorporation by reference, 
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, Incorporation by 
reference, 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.
    For the reasons set out in the preamble and under the authority of 
the Atomic Energy Act of 1954, as amended; the Energy Reorganization 
Act of 1974, as amended; and 5 U.S.C. 552 and 553, the NRC is proposing 
to adopt the following amendments to 10 CFR parts 50 and 52:

PART 50--DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION 
FACILITIES

0
1. The authority citation for part 50 continues to read as follows:

    Authority: Atomic Energy Act of 1954, secs. 11, 101, 102, 103, 
104, 105, 108, 122, 147, 149, 161, 181, 182, 183, 184, 185, 186, 
187, 189, 223, 234 (42 U.S.C. 2014, 2131, 2132, 2133, 2134, 2135, 
2138, 2152, 2167, 2169, 2201, 2231, 2232, 2233, 2234, 2235, 2236, 
2237, 2239, 2273, 2282); Energy Reorganization Act of 1974, secs. 
201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); Nuclear Waste 
Policy Act of 1982, sec. 306 (42 U.S.C. 10226); National 
Environmental Policy Act of 1969 (42 U.S.C. 4332); 44 U.S.C. 3504 
note; Sec. 109, Pub. L. 96-295, 94 Stat. 783.

0
2. In Sec.  50.2, add in alphabetical order the definitions for ``Non-
light-water reactor'', ``Non-power production or utilization 
facility'', and ``Small modular reactor'' to read as follows:


Sec.  50.2  Definitions.

* * * * *

[[Page 28460]]

    Non-light-water reactor means a nuclear power reactor using a 
coolant other than light water.
    Non-power production or utilization facility means a production or 
utilization facility, licensed under Sec.  50.21(a) and (c), or Sec.  
50.22, as applicable, that is not a nuclear power reactor or a 
production facility as defined under paragraphs (1) and (2) of the 
definition of Production facility in this section.
* * * * *
    Small modular reactor means a power reactor, licensed under Sec.  
50.21 or Sec.  50.22 to produce heat energy up to 1,000 megawatts-
thermal, which may be of modular design as defined in Sec.  52.1 of 
this chapter.
* * * * *


Sec.  50.8  [Amended]

0
3. In Sec.  50.8(b), add ``50.160'' after ``50.155''.
0
4. In Sec.  50.10, revise paragraph (a)(1)(vii) to read as follows:


Sec.  50.10  License required; limited work authorization.

    (a) * * *
    (1) * * *
    (vii) Onsite emergency facilities necessary to comply with either 
Sec.  50.160 or Sec.  50.47 and appendix E to this part, as applicable.
* * * * *
0
5. In Sec.  50.33, revise paragraph (g) to read as follows:


Sec.  50.33  Contents of applications; general information.

* * * * *
    (g)(1) Except as provided in paragraph (g)(2) of this section, if 
the application is for an operating license or combined license for a 
nuclear power reactor, or if the application is for an early site 
permit and contains plans for coping with emergencies under Sec.  
52.17(b)(2)(ii) of this chapter, the applicant shall submit 
radiological emergency response plans of State and local governmental 
entities in the United States that are wholly or partially within the 
plume exposure pathway emergency planning zone (EPZ),\4\ as well as the 
plans of State governments wholly or partially within the ingestion 
pathway EPZ.\5\ If the application is for an early site permit that, 
under 10 CFR 52.17(b)(2)(i), proposes major features of the emergency 
plans describing the EPZs, then the descriptions of the EPZs must meet 
the requirements of this paragraph. Generally, the plume exposure 
pathway EPZ for nuclear power reactors shall consist of an area about 
10 miles (16 km) in radius and the ingestion pathway EPZ shall consist 
of an area about 50 miles (80 km) in radius. The exact size and 
configuration of the EPZs surrounding a particular nuclear power 
reactor shall be determined in relation to the local emergency response 
needs and capabilities as they are affected by such conditions as 
demography, topography, land characteristics, access routes, and 
jurisdictional boundaries. The size of the EPZs also may be determined 
on a case-by-case basis for gas-cooled reactors and for reactors with 
an authorized power level less than 250 MW thermal. The plans for the 
ingestion pathway shall focus on such actions as are appropriate to 
protect the food ingestion pathway.
* * * * *
    \4\ Emergency planning zones (EPZs) are discussed in NUREG-0396, 
EPA 520/1-78-016, ``Planning Basis for the Development of State and 
Local Government Radiological Emergency Response Plans in Support of 
Light-Water Nuclear Power Plants,'' December 1978.
* * * * *
    \5\ If the State and local emergency response plans have been 
previously provided to the NRC for inclusion in the facility docket, 
the applicant need only provide the appropriate reference to meet 
this requirement.
* * * * *
    (2) Small modular reactor, non-light-water reactor, or non-power 
production or utilization facility applicants complying with Sec.  
50.160 who apply for a construction permit or an operating license 
under this part, or small modular reactor or non-light-water reactor 
applicants complying with Sec.  50.160 who apply for a combined license 
or an early site permit under part 52 of this chapter, must submit as 
part of the application the analysis used to establish the size of the 
plume exposure pathway EPZ. The plume exposure pathway EPZ is 
determined as the area within which public dose, as defined in Sec.  
20.1003 of this chapter, is projected to exceed 10 mSv [1 rem] total 
effective dose equivalent over 96 hours from the release of radioactive 
materials, resulting from a spectrum of credible accidents for the 
facility.
    (i) If the application is for an operating license or combined 
license or if the application is for an early site permit and contains 
plans for coping with emergencies under Sec.  52.17(b)(2)(ii) of this 
chapter, and if the plume exposure pathway EPZ extends beyond the site 
boundary:
    (A) The applicant shall submit radiological emergency response 
plans of Tribal, State, and local 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.
    (ii) If the application is for an early site permit that, under 
Sec.  52.17(b)(2)(i) of this chapter, proposes major features of the 
emergency plans and describes the EPZ, and if the EPZ extends beyond 
the site boundary, then the exact configuration of the plume exposure 
pathway EPZ surrounding the facility shall be determined in relation to 
the local emergency response needs and capabilities as they are 
affected by such conditions as demography, topography, land 
characteristics, access routes, and jurisdictional boundaries.
* * * * *
0
6. In Sec.  50.34, revise paragraphs (a)(10) and (b)(6)(v) to read as 
follows:


Sec.  50.34  Contents of applications; technical information.

    (a) * * *
    (10) A discussion of the applicant's preliminary plans for coping 
with emergencies based on:
    (i) Except as provided in paragraph (a)(10)(ii) of this section, 
the requirements in appendix E to this part.
    (ii) For a small modular reactor, a non-light-water reactor, or 
non-power production or utilization facility construction permit 
applicant, the requirements in either Sec.  50.160 or appendix E to 
this part.
* * * * *
    (b) * * *
    (6) * * *
    (v) Plans for coping with emergencies based on:
    (A) Except as provided in paragraph (b)(6)(v)(B) of this section, 
the requirements in appendix E to this part.
    (B) For a small modular reactor, a non-light-water reactor, or a 
non-power production or utilization facility operating license 
applicant, the requirements in either Sec.  50.160 or appendix E to 
this part.
* * * * *
0
7. In Sec.  50.47, revise paragraph (b) introductory text and add 
paragraph (f).
    The revision and addition read as follows:


Sec.  50.47  Emergency plans.

* * * * *
    (b) The onsite and, except as provided in paragraphs (d) and (f) of 
this section, offsite emergency response plans for

[[Page 28461]]

nuclear power reactors must meet the following standards:
* * * * *
    (f) Paragraphs (a)(2) and (b) of this section do not apply to 
offsite radiological emergency response plans if the licensee's 
emergency plan is not required to meet these planning standards or if 
the plume exposure pathway EPZ does not extend beyond the site 
boundary.
0
8. In Sec.  50.54:
0
 a. Revise paragraphs (q)(1)(iii) and (q)(2) through (4);
0
 b. In paragraph (q)(5), remove the words ``made after February 21, 
2012'';
0
c. Add paragraph (q)(7);
0
 d. In paragraph (s)(2)(ii), remove the words ``after April 1, 1981,'', 
remove the word ``reactor'' and add in its place the word ``facility'', 
and add the words ``or cease operation'' after the words ``shut down'';
0
e. In paragraph (s)(3), remove the words ``The NRC'' and add in their 
place the words ``If the planning standards for radiological emergency 
preparedness apply to offsite emergency response plans, or if the 
planning activities in Sec.  50.160(b)(1)(iv)(B) of this part apply, 
the NRC''; and
0
 f. Revise paragraph (gg)(1).
    The addition and revisions read as follows:


Sec.  50.54  Conditions of licenses.

* * * * *
    (q) * * *
    (1) * * *
    (iii) Emergency planning function means a capability or resource 
necessary to prepare for and respond to a radiological emergency.
* * * * *
    (2)(i) Except as provided in paragraph (q)(2)(ii) of this section, 
a holder of a license under this part, or a combined license under part 
52 of this chapter after the Commission makes the finding under Sec.  
52.103(g) of this chapter, shall follow and maintain the effectiveness 
of an emergency plan that meets the requirements in appendix E to this 
part and, for nuclear power reactor licensees, the planning standards 
of Sec.  50.47(b).
    (ii) A holder of a license under this part for a non-power 
production or utilization facility, a holder of a license under this 
part for a small modular reactor or a non-light-water reactor, or a 
holder of a combined license under part 52 of this chapter after the 
Commission makes the finding under Sec.  52.103(g) of this chapter for 
a small modular reactor or a non-light-water reactor, shall follow and 
maintain the effectiveness of an emergency plan that meets the 
requirements in either Sec.  50.160 or appendix E to this part and, 
except for a holder of a license under this part for a non-power 
production or utilization facility, the planning standards of Sec.  
50.47(b).
    (3)(i) Except as provided in paragraph (q)(3)(ii) of this section, 
the licensee may make changes to its emergency plan without NRC 
approval only if the licensee performs and retains an analysis 
demonstrating that the changes do not reduce the effectiveness of the 
plan and the plan, as changed, continues to meet the requirements in 
appendix E to this part and, for nuclear power reactor licensees, the 
planning standards of Sec.  50.47(b).
    (ii) A non-power production or utilization facility, small modular 
reactor, or non-light-water reactor licensee may make changes to its 
emergency plan without NRC approval only if the licensee performs and 
retains an analysis demonstrating that the changes do not reduce the 
effectiveness of the plan and the plan, as changed, continues to meet 
the requirements in either Sec.  50.160 or appendix E to this part and, 
except for a non-power production or utilization facility licensee, the 
planning standards of Sec.  50.47(b).
    (4) The changes to a licensee's emergency plan that reduce the 
effectiveness of the plan as defined in paragraph (q)(1)(iv) of this 
section may not be implemented without prior approval by the NRC. A 
licensee desiring to make such a change shall submit an application for 
an amendment to its license. In addition to the filing requirements of 
Sec. Sec.  50.90 and 50.91, the request must include all emergency plan 
pages affected by that change and must be accompanied by a forwarding 
letter identifying the change, the reason for the change, and the basis 
for concluding that the licensee's emergency plan, as revised, will 
continue to meet the requirements in either Sec.  50.160 or, appendix E 
to this part and, for nuclear power reactor licensees, the planning 
standards of Sec.  50.47(b).
    (5) The licensee shall retain a record of each change to the 
emergency plan made without prior NRC approval for a period of three 
years from the date of the change and shall submit, as specified in 
Sec.  50.4, a report of each such change made, including a summary of 
its analysis, within 30 days after the change is put in effect.
* * * * *
    (q)(7) Each holder of an operating license under this part or a 
combined license under 10 CFR part 52 for a small modular reactor or 
non-light-water reactor or each holder of an operating license under 
this part issued after [Date 30 Days After Date of Publication of the 
Final Rule in the Federal Register] for a non-power production or 
utilization facility that wishes to transition to Sec.  50.160 shall 
submit to the Commission, as specified in Sec.  50.90, a license 
amendment request for implementing an emergency preparedness program 
with the associated plan modification necessary to meet the 
requirements of Sec.  50.160(b). This submittal must include an 
explanation of the schedule and analyses supporting the implementation 
of the emergency preparedness program.
* * * * *
    (gg)(1) Notwithstanding 10 CFR 52.103, if, following the conduct of 
the exercise required by either paragraph IV.f.2.a of appendix E to 
this part or Sec.  50.160(c)(2), as applicable, FEMA identifies one or 
more deficiencies in the state of offsite emergency preparedness, the 
holder of a combined license under part 52 of this chapter may operate 
at up to 5 percent of rated thermal power only if the Commission finds 
that the state of onsite emergency preparedness provides reasonable 
assurance that adequate protective measures can and will be taken in 
the event of a radiological emergency. The NRC will base this finding 
on its assessment of the applicant's onsite emergency plans against the 
pertinent standards in either Sec.  50.47 and appendix E to this part 
or Sec.  50.160, as applicable. Review of the applicant's emergency 
plans will include the following standards with offsite aspects:
* * * * *
0
9. Add undesignated center heading ``Small Modular Reactors, Non-Light-
Water Reactors, and Non-power Production or Utilization Facilities: and 
Sec.  50.160 to read as follows:

Small Modular Reactors, Non-Light-Water Reactors, and Non-Power 
Production or Utilization Facilities


Sec.  50.160  Emergency preparedness for small modular reactors, non-
light water-reactors, and non-power production or utilization 
facilities.

    (a) Definitions. For the purpose of this section:
    (1) Site boundary means site boundary as defined in Sec.  20.1003 
of this chapter.
    (2) [Reserved]
    (b) Requirements. The emergency plan shall contain information 
needed to demonstrate compliance with the elements set forth in this 
paragraph. The NRC will not issue an initial operating license to a 
licensee unless a finding is

[[Page 28462]]

made by the NRC that there is reasonable assurance that adequate 
protective measures can and will be taken in the event of a 
radiological emergency. No finding under this section is necessary for 
issuance of a renewed power reactor operating license.
    (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 this 
paragraph.
    (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 response organization 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 
response organization 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 response 
organization 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 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) of this section.
    (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 local, 
State, Tribal and Federal 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) The site familiarization training for any offsite organization 
that may respond to the site in the event of an emergency;
    (5) An evacuation time estimate of the areas beyond the site 
boundary and within the EPZ;
    (6) The offsite facility and any backup facilities to coordinate 
the onsite response with the offsite response;
    (7) The means of making offsite dose projections and the means of 
communicating the offsite dose projections to the offsite response 
coordinating agencies;
    (8) 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;
    (9) The general plans and methods to allow entry into the EPZ 
during and after an emergency;
    (10) The drill and exercise program that tests and implements major 
portions of planning, preparations, and the coordinated response by the 
onsite response organizations with the offsite response organization 
within the EPZ without mandatory public participation; and
    (11) The 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.
    (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. 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 protect 
contaminated food and water from entering into the ingestion pathway.
    (c) Implementation. (1) An applicant for an operating license 
issued under

[[Page 28463]]

this part after [Date 30 Days After Date of Publication of the Final 
Rule in the Federal Register] 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 
no later than 18 months before the issuance of an operating license for 
the facility described in the license application.
    (2) A holder of a combined license issued under part 52 of this 
chapter before the Commission has made the finding under Sec.  
52.103(g) of this chapter, must establish, implement, and maintain an 
emergency preparedness program that meets the requirements of paragraph 
(b) of this section, as described in the approved emergency plan and 
license, and conduct an initial exercise to demonstrate this compliance 
no later than 18 months before the scheduled date for initial loading 
of fuel.
0
10. In appendix E to part 50, revise paragraph I.3. and footnote 2 to 
I.3 to read as follows:

APPENDIX E TO PART 50--EMERGENCY PLANNING AND PREPAREDNESS FOR 
PRODUCTION AND UTILIZATION FACILITIES

    I. * * *
0
3. The potential radiological hazards to the public associated with the 
operation of non-power production or utilization facilities licensed 
under 10 CFR part 50 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 as necessary will be determined on a case-
by-case basis.\2\
* * * * *
    \2\ Regulatory Guide 2.6, ``Emergency Planning for Research and 
Test Reactors and Other Non-power Production and Utilization 
Facilities,'' may be used as guidance for the acceptability of non-
power production or utilization facility emergency response plans.
* * * * *

PART 52--LICENSES, CERTIFICATIONS, AND APPROVALS FOR NUCLEAR POWER 
PLANTS

0
11. The authority citation for part 52 continues to read as follows:

    Authority: Atomic Energy Act of 1954, secs. 11, 101, 102, 103, 
104, 105, 108, 122, 147, 149, 161, 181, 182, 183, 184, 185, 186, 
187, 189, 223, 234 (42 U.S.C. 2014, 2131, 2132, 2133, 2134, 2135, 
2138, 2152, 2167, 2169, 2201, 2231, 2232, 2233, 2234, 2235, 2236, 
2237, 2239, 2273, 2282); Energy Reorganization Act of 1974, secs. 
201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); Nuclear Waste 
Policy Act of 1982, sec. 306 (42 U.S.C. 10226); National 
Environmental Policy Act of 1969 (42 U.S.C. 4332); 44 U.S.C. 3504 
note; Sec. 109, Pub. L. 96-295, 94 Stat. 783.

0
12. In Sec.  52.1, revise the definition of ``Major feature of the 
emergency plans'' to read as follows:


Sec.  52.1  Definitions.

* * * * *
    Major feature of the emergency plans means an aspect of those plans 
necessary to:
    (i) Address in whole or part either one or more of the 16 standards 
in 10 CFR 50.47(b) or the requirements of 10 CFR 50.160(b), as 
applicable; or
    (ii) Describe the emergency planning zones as required in 10 CFR 
50.33(g).
* * * * *
0
13. In Sec.  52.17, revise paragraph (b)(2) to read as follows:


Sec.  52.17  Contents of applications; technical information.

* * * * *
    (b) * * *
    (2) * * *
    (i) Propose major features of the emergency plans, in accordance 
with either the pertinent standards of Sec.  50.47 of this chapter and 
the requirements of appendix E to part 50 of this chapter, or Sec.  
50.160 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 applicable standards of Sec.  50.47 of this 
chapter and the requirements of appendix E to part 50 of this chapter, 
or Sec.  50.160 of this chapter. To the extent approval of emergency 
plans is sought, the application must contain the information required 
by Sec.  50.33(g) and (j) of this chapter.
* * * * *
0
14. Revise Sec.  52.18 to read as follows:


Sec.  52.18  Standards for review of applications.

    Applications filed under this subpart will be reviewed according to 
the applicable standards set out in 10 CFR part 50 and its appendices 
and 10 CFR part 100. In addition, the Commission shall prepare an 
environmental impact statement during review of the application, in 
accordance with the applicable provisions of 10 CFR part 51. The 
Commission shall determine, after consultation with Federal Emergency 
Management Agency, as applicable, whether the information required of 
the applicant by Sec.  52.17(b)(1) shows that there is not significant 
impediment to the development of emergency plans that cannot be 
mitigated or eliminated by measures proposed by the applicant, whether 
any major features of emergency plans submitted by the applicant under 
Sec.  52.17(b)(2)(i) are acceptable in accordance with either the 
applicable standards of Sec.  50.47 of this chapter and the 
requirements of appendix E to part 50 of this chapter, or Sec.  50.160 
of this chapter, and whether any emergency plans submitted by the 
applicant under Sec.  52.17(b)(2)(ii) provide reasonable assurance that 
adequate protective measures can and will be taken in the event of a 
radiological emergency.
0
15. In Sec.  52.79, revise paragraph (a)(21) to read as follows:


Sec.  52.79  Contents of applications; technical information in final 
safety analysis report.

    (a) * * *
    (21) Emergency plans complying with the requirements of Sec.  50.47 
of this chapter, and appendix E to part 50 of this chapter, or for a 
small modular reactor or a non-light-water reactor
    license applicant, the requirements in either Sec.  50.160 of this 
chapter or appendix E to part 50 of this chapter and Sec.  50.47 of 
this chapter;
* * * * *

    Dated at Rockville, Maryland, this 1st day of May, 2020.

    For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary to the Commission.

    Note:  The following Appendix will not appear in the Code of 
Federal Regulations.

Separate Views of Commissioner Baran

    For the last 40 years, NRC has required emergency planning zones, 
or EPZs, around nuclear power plants ``to assure that prompt and 
effective actions can be taken to protect the public in the

[[Page 28464]]

event of an accident.'' \1\ Every one of the 96 operating large light-
water reactors in the country has a plume exposure pathway EPZ that 
extends about 10 miles around the site with dedicated offsite 
radiological emergency plans and protective actions in place to avoid 
or reduce radiation dose to the public during an accident. An ingestion 
exposure pathway EPZ with a radius of 50 miles around each of these 
sites is designed to avoid or reduce dose from consuming food and water 
contaminated by a radiological release. The EPZs and dedicated 
radiological emergency plans are meant to provide multiple layers of 
protection--or defense-in-depth--against potential radiological 
exposure. Other NRC requirements are focused on preventing or 
mitigating a radioactive release. The emergency planning regulations 
are there to provide another layer of defense in case a release occurs 
despite those safety requirements. In other words, EPZs and 
radiological emergency planning are designed to address low-
probability, high-consequence events. The Federal Emergency Management 
Agency (FEMA) assesses the adequacy of the offsite emergency plans, and 
NRC regulations require licensees to hold offsite emergency 
preparedness drills at each plant at least once every 2 years to 
practice implementing the plans.\2\
---------------------------------------------------------------------------

    \1\ NUREG-0396, Planning Basis for the Development of State and 
Local Government Radiological Emergency Response Plans in Support of 
Light Water Nuclear Power Plants (1978) at 11.
    \2\ The regulations require a full set of emergency preparedness 
exercises to be conducted at each plant over an 8-year cycle.
---------------------------------------------------------------------------

    Under this proposed rule, emergency planning for small modular 
reactors (SMRs) and non-light-water reactors would be flimsy by 
comparison. Instead of a 10-mile plume exposure pathway EPZ, these 
reactors would have EPZs that encompass only areas where the projected 
dose from ``credible'' accidents could exceed 1 rem. An EPZ extending 
only to the site boundary is explicitly permitted under this 
methodology. In the case of a site-boundary EPZ, NRC would not require 
dedicated offsite radiological emergency planning and FEMA would have 
no role in evaluating the adequacy of a site's emergency plans. In 
addition, the proposed rule would eliminate the requirement for an 
ingestion exposure pathway EPZ and no longer require a specific drill 
frequency for emergency planning exercises. Overall, this proposed rule 
represents a radical departure from more than 40 years of radiological 
emergency planning.
    No new SMR or non-light-water reactor designs have yet been 
approved by NRC, and only one SMR design has been submitted for the 
staff's review. These new designs could potentially be safer than 
current large light-water-reactor designs. But that does not eliminate 
the need for EPZs and dedicated offsite emergency planning to provide 
defense-in-depth in case something goes wrong.
    Since 1978, when the concept of an EPZ was first developed, the 
size of an EPZ has never been exclusively based on the likelihood of an 
accident occurring. The joint NRC-EPA task force that introduced the 
EPZ concept specifically stated: ``Emergency planning is not based upon 
quantified probabilities of incidents or accidents.'' \3\ Its 
foundational task force report, referred to as NUREG-0396, explained 
that ``[r]adiological emergency planning is not based upon 
probabilities, but on public perceptions of the problem and what could 
be done to protect health and safety.'' \4\ This was not an isolated 
statement. The task force found that EPZ size should be ``derived from 
the characteristics of design basis and Class 9 accident 
consequences.'' \5\ Class 9 accidents were defined as those 
``considered to be so low in probability as not to require specific 
additional provisions in the design of a reactor facility,'' including 
total core melt scenarios ``in which the containment catastrophically 
fails and releases large quantities of radioactive materials directly 
to the atmosphere.'' \6\ Today, we refer to these as beyond-design-
basis accidents. NRC and EPA understood that these kinds of extreme 
accidents were unlikely, but they also knew that EPZs should be in 
place to provide defense-in-depth because ``the probability of an 
accident involving a significant release of radioactive material, 
although small, is not zero.'' \7\ The task force further concluded 
that nuclear accidents were unique in important ways. The report 
explained: ``the potential consequences of improbable but nevertheless 
severe power reactor accidents, while comparable in some sense to 
severe natural or man-made disasters which would trigger an ultimate 
protective measure such as evacuation, do require some specialized 
planning considerations.'' \8\
---------------------------------------------------------------------------

    \3\ Id. at I-2.
    \4\ Id.
    \5\ Id. at 16.
    \6\ Id. at 26, I-6.
    \7\ Id. at II-1.
    \8\ Id. at III-1, III-2.
---------------------------------------------------------------------------

    NRC's recognition of the important role emergency planning plays in 
providing defense-in-depth endured over the years. In the 1986 Safety 
Goals Policy Statement, even as the Commission focused on the 
quantitative risk of nuclear reactor accidents, the Commission 
recognized ``emergency planning as [an] integral part[ ] of the 
defense-in-depth concept associated with its accident prevention and 
mitigation philosophy.'' \9\ The Commission stated that ``emergency 
response capabilities are mandated to provide additional defense-in-
depth protection to the surrounding populations.'' \10\ Similarly, when 
the agency was working through non-light-water reactor issues in 1993, 
the NRC staff proposed ``no changes to the existing regulations 
governing EP for non-light-water reactor licensees,'' explaining that 
it ``views the inclusion of emergency preparedness by advanced reactor 
licensees as an essential element in NRC's `defense-in-depth' 
philosophy.'' \11\ Four years later, the staff emphasized the 
importance of getting the buy-in of federal, state, and local emergency 
response agencies for any emergency response changes relating to new, 
potentially safer reactor designs.\12\
---------------------------------------------------------------------------

    \9\ 51 FR 28044 (1986).
    \10\ Id.
    \11\ SECY-93-0092, Issues Pertaining to the Advanced Reactor 
(PRISM, MHTGR, and PIUS) and CANDU 3 Designs and Their Relationship 
to Current Regulatory Requirements at 13.
    \12\ SECY-97-0020, Results of Evaluation of Emergency Planning 
for Evolutionary and Advanced Reactors.
---------------------------------------------------------------------------

    But these considerations are sidelined with the proposed rule. 
Under the rule's EPZ sizing methodology, the quantitative dose formula 
exclusively determines the size of the EPZ. It is a purely 
quantitative, risk-based determination rather than a risk-informed 
decision that accounts for expert judgment, defense-in-depth, and 
public confidence. With this proposed rule, no one is exercising any 
human judgment about how large an EPZ should be. It is simply a 
mathematical calculation.
    The NRC staff acknowledges in the draft proposed rule that 
emergency planning is supposed to be ``risk-informed rather than risk-
based'' and ``independent of accident probability.'' \13\ After all, an 
existing plant's EPZ does not change every time a plant modification 
reduces the risk of an accident. A large light-water-reactor licensee 
does not (and should not) get a smaller EPZ because it installs an 
additional emergency diesel generator or stores FLEX equipment on site. 
But

[[Page 28465]]

the proposed rule embodies just that sort of exclusively quantitative 
approach. Instead of risk being one important factor considered in 
setting emergency planning requirements, it would become the only 
factor that matters. For any SMR or non-light-water reactor that met 
the dose criteria for a site boundary EPZ, there would be no dedicated 
off-site radiological emergency planning. That element of defense-in-
depth would be dropped completely.
---------------------------------------------------------------------------

    \13\ SECY-18-0103, Proposed Rule: Emergency Preparedness for 
Small Modular Reactors and Other New Technologies, Enclosure 1, 
Draft Proposed Rule at 30.
---------------------------------------------------------------------------

    FEMA has expressed major concerns about the NRC staff's approach. 
It disagrees that quantitative dose criteria should completely 
determine the size of an EPZ. Consistent with NUREG-0396, FEMA has 
expressed its support for ``a methodology for EPZ sizing that takes 
into account such `non-technical' criteria'' as public confidence.\14\
---------------------------------------------------------------------------

    \14\ Letter from Michael S. Casey, Director, Technological 
Hazards Division, FEMA to NRC (Aug. 24, 2019) (ML19240A938).
---------------------------------------------------------------------------

    Moreover, ``FEMA has consistently raised concerns about a 
methodology that allows for a site boundary EPZ for a commercial 
nuclear power plant.'' \15\ In the absence of an EPZ and dedicated 
offsite radiological emergency planning, emergency responders would be 
left with all-hazards planning. FEMA does not believe that all-hazards 
planning would be adequate in the event of an actual nuclear power 
plant accident. According to FEMA, ``Radiological [emergency planning] 
is not sufficiently addressed within the All Hazards framework--
radiological [emergency planning] is unique. In a Worst-Case Scenario, 
our [offsite response organizations] could be challenged to effectively 
protect the health and safety of the public using an ad hoc [emergency 
planning] construct.'' \16\ FEMA explains that ``[a]dvanced planning--
such as provided by an EPZ--reduces the complexity of the decision-
making process during an incident.'' \17\ And FEMA ``stress[es] that 
the proven best way to ensure offsite readiness is to develop, 
exercise, and assess [offsite response organization] radiological 
capabilities, as is now done throughout the offsite EPZ.'' \18\ While a 
radiological emergency plan could be ``scaled up'' to address a more 
severe accident than what was planned for, FEMA notes that it is 
``unrealistic'' to scale up ``non-existent plans'' and that the 
resulting ``lack of necessary equipment, and shortage of trained 
emergency personnel could have unfortunate consequences.'' \19\
---------------------------------------------------------------------------

    \15\ Id.
    \16\ Letter from Michael S. Casey, Director, Technological 
Hazards Division, FEMA to NRC (July 8, 2019) (ML19189A318).
    \17\ Id.
    \18\ Id.
    \19\ Letter from Michael S. Casey, Director, Technological 
Hazards Division, FEMA to NRC (Aug. 24, 2019) (ML19240A938).
---------------------------------------------------------------------------

    In short, all-hazards planning would not be as effective as 
dedicated radiological emergency planning in an actual radiological 
emergency. As a result, a site boundary EPZ with all-hazards planning 
would not provide the same level of protection for a community located 
near a reactor site as an offsite EPZ with dedicated radiological 
emergency planning. FEMA, therefore, ``believes that the NRC staff 
conclusion that the proposed methodology of offsite emergency 
preparedness maintains the same level of protection as a ten-mile EPZ 
is unsupported.'' \20\
---------------------------------------------------------------------------

    \20\ Id.
---------------------------------------------------------------------------

    We need to take FEMA's warnings seriously. FEMA has a key role in 
determining whether the emergency planning for a nuclear power plant 
site is adequate. Under NRC's regulations, a nuclear power plant 
license cannot be issued unless NRC makes a finding that the major 
features of the emergency plan meet the regulatory requirements. And 
NRC is supposed to base its finding on FEMA's determinations as to 
whether the offsite emergency plans are adequate and whether there is 
reasonable assurance that they can be implemented. In fact, under NRC's 
regulations, ``in any NRC licensing proceeding, a FEMA finding will 
constitute a rebuttable presumption on questions of adequacy and 
implementation capability.'' \21\ FEMA has this prominent role in our 
licensing process because of its well-known expertise in this area. 
Yet, under the proposed rule, FEMA would have no role in assessing the 
adequacy of offsite emergency plans and capabilities for reactors with 
a site boundary EPZ.\22\
---------------------------------------------------------------------------

    \21\ 10 CFR 50.47.
    \22\ See Draft Proposed Rule at 47 (``for SMRs and [other new 
technologies] within the scope of this proposed rule, FEMA findings 
and determinations regarding reasonable assurance . . . would only 
be needed for a facility where the plume exposure pathway EPZ 
extends beyond the site boundary requiring dedicated offsite 
radiological EP plans for the facility.'')
---------------------------------------------------------------------------

    In addition to the issues identified by FEMA, there are several 
other significant problems with the proposed rule.
    First, the logic of the proposed EPZ sizing methodology could be 
applied to the existing fleet of large light-water reactors to weaken 
the current level of protection. As the Advisory Committee on Reactor 
Safeguards noted:

    No technical basis is stated in the rule or the guidance for 
restricting the use of the new rule to SMRs and [other new 
technologies] with a limit on thermal power. The rule could apply to 
any reactor technology regardless of size. During our meetings, the 
staff acknowledged this point.\23\
---------------------------------------------------------------------------

    \23\ Letter from Michael Corradini, Chairman, ACRS to NRC (Oct. 
19, 2018) (ML18291B248).

    In fact, the proposed rule explicitly seeks comment on whether to 
apply this kind of approach to large light-water reactors.\24\ This 
opens the door to smaller EPZs and reduced emergency planning for the 
existing fleet of power reactors. If the proposed rule's formulaic 
approach is adopted, a precedent will be established for applying a 
purely risk-based methodology to EPZ sizing.
---------------------------------------------------------------------------

    \24\ Draft Proposed Rule at 60.
---------------------------------------------------------------------------

    Second, the proposed rule does not account for the possibility of 
accidents affecting more than one SMR module. Even though some SMR 
designs contemplate several reactors at one site, the EPZ sizing 
methodology addresses each reactor in isolation. This ignores a key 
lesson of the Fukushima accident--that severe natural disasters can 
simultaneously threaten multiple reactors at a site. Under the draft 
proposed rule, a SMR is defined as a power reactor that produces less 
than 1,000 megawatts-thermal. The combined heat energy produced by just 
two SMRs of this size could be larger than that of some existing large 
light-water reactors in the U.S. But, under the proposed rule, each 
module could individually qualify for a site boundary EPZ without 
consideration of the other.
    Third, unlike the existing regulations for large light-water 
reactors, the proposed rule ``would not define the required frequency 
of drills and exercises'' for emergency preparedness.\25\ As a result, 
SMR and non-light-water reactor licensees would not be required to 
conduct a full offsite emergency preparedness drill every 2 years. The 
NRC staff provides no basis for this weaker standard.
---------------------------------------------------------------------------

    \25\ Draft Proposed Rule at 39.
---------------------------------------------------------------------------

    Finally, the proposed rule would eliminate the ingestion pathway 
EPZ for SMRs and non-light-water reactors. The NRC staff argues that 
prior quarantines of spinach and eggs in response to E. Coli and 
salmonella infections ``demonstrate[] that a response to prevent 
ingestion of contaminated foods and water could be performed in an 
expeditious manner without a predetermined planning zone.'' \26\ No 
FEMA evaluation of this change is provided. Nor is there any discussion 
of the effectiveness of ad hoc responses to previous radiological 
releases.

[[Page 28466]]

Moreover, if the staff's unbounded rationale were adopted, it could 
ultimately lead to ingestion pathway EPZs being dropped for the 
existing fleet of large light-water reactors.
---------------------------------------------------------------------------

    \26\ Draft Proposed Rule at 55.
---------------------------------------------------------------------------

    For these reasons, I do not support finalizing the proposed rule in 
its current form. NRC needs a rule that provides regulatory certainty 
for potential applicants and recognizes that SMRs and non-light-water 
reactors will be different than traditional, large light-water 
reactors. It makes sense to have a graded approach that accounts for 
potential safety improvements in new designs. But the rule should not 
be purely risk-based, relying entirely on the results of a dose 
formula. Instead, NRC should issue a rule to establish the following 
emergency planning requirements for three categories of nuclear power 
plants.
    SMRs and non-light-water reactors with a thermal output of more 
than 20 megawatts would be eligible for a 2-mile EPZ, as long as they 
meet the dose standard at that distance. A 2-mile EPZ recognizes that 
these new technologies could be safer than large light-water reactors 
while ensuring that there will be dedicated offsite radiological 
emergency planning to provide defense-in-depth in the unlikely event of 
a severe accident. To account for future potential technological 
advances, an alternate EPZ smaller than 2 miles should be available if 
NRC, FEMA, and the host state all agree that the alternate EPZ would 
provide for an effective and adequate response in the event of a severe 
radiological emergency. The rule should include an EPZ sizing 
methodology that accounts for the possibility of accidents affecting 
more than one SMR module, provide for an appropriately-sized ingestion 
pathway EPZ, and maintain the existing requirements to conduct an 
offsite emergency preparedness drill every 2 years and the full suite 
of emergency preparedness exercises over an 8-year cycle.
    SMRs and non-light-water reactors with a thermal output of 20 
megawatts or less would be eligible for a site boundary EPZ, as long as 
they meet the dose standard at that distance. Reactors of this size, 
essentially micro-reactors, would present accident consequences 
comparable to existing research and test reactors, which are not 
subject to offsite emergency planning requirements.\27\
---------------------------------------------------------------------------

    \27\ The largest currently operating test reactor has a power 
level of 20 megawatts thermal.
---------------------------------------------------------------------------

    Large light-water reactors, as well as any SMRs or non-light-water 
reactors that do not meet the dose standard for a 2-mile EPZ, would 
continue to have a 10-mile EPZ.
    In my view, this approach strikes the right balance. It recognizes 
the potential for improved designs with lower risks, while maintaining 
defense-in-depth to protect the public. It builds on 40 years of 
experience with emergency planning rather than discarding it. During 
the comment period, a broad range of stakeholders will have an 
opportunity to offer their views on how this approach can be further 
refined in the rule.

[FR Doc. 2020-09666 Filed 5-11-20; 8:45 am]
 BILLING CODE 7590-01-P