[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
[[Page 28439]]
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.
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\5\ For further information on the ROP, see: https://www.nrc.gov/reactors/operating/oversight.html.
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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#.
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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.
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Modular Reactors and Other New
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Draft Information Collection Clearance ML18184A308.
Package. ML18184A309.
Draft Regulatory Guide DG-1350, ML18082A044.
``Performance-Based Emergency
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Reactors, Non-Light-Water Reactors, and
Non-power Production or Utilization
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Acceptance Criteria,'' February 1996.
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``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.
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Guidance,'' September 20, 2006.
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28, 2010.
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Framework for Nuclear Power Plant
Emergency Preparedness Oversight,''
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and Other New Technologies,'' May 29,
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Reactors and Other New Technologies,''
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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
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Facility at its Corporate
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SRM-SECY-06-0200, ``Staff Requirements-- ML070080411.
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Preparedness Regulations and
Guidance,'' January 8, 2007.
SRM-SECY-14-0038, ``Staff Requirements-- ML14259A589.
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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.
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the Department of Homeland Security/
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``NRC Vision and Strategy: Safely ML16356A670.
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``Enhancements to Emergency Preparedness 76 FR 72559.
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Improvements for Power Reactors
Transitioning to Decommissioning
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and Utilization Facilities
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22, 2018.
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Planning for Research Reactors,''
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RG 2.6, ``Emergency Planning for ML17263A472.
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``Policy Statement on Regulation of 73 FR 60612.
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New Technologies, Draft Regulatory
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New Technologies, Regulatory Basis,
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Variable Annual Fee Structure for Small 80 FR 68268.
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Variable Annual Fee Structure for Small 81 FR 32617.
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``Summary of June 7-8, 2015, Department ML16188A226.
of Energy and Nuclear Regulatory
Commission Co-Hosted Workshop on
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Planning Zone Size Determinations,''
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Meeting to Discuss a Performance-Based
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Technologies,'' September 15, 2016.
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and Other New Technologies,'' May 24,
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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
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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\
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\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.
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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\
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\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.
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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\
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\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.
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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.
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\13\ SECY-18-0103, Proposed Rule: Emergency Preparedness for
Small Modular Reactors and Other New Technologies, Enclosure 1,
Draft Proposed Rule at 30.
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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\
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\14\ Letter from Michael S. Casey, Director, Technological
Hazards Division, FEMA to NRC (Aug. 24, 2019) (ML19240A938).
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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\
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\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).
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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\
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\20\ Id.
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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\
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\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.'')
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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\
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\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.
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\24\ Draft Proposed Rule at 60.
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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.
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\25\ Draft Proposed Rule at 39.
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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.
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\26\ Draft Proposed Rule at 55.
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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\
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\27\ The largest currently operating test reactor has a power
level of 20 megawatts thermal.
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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