[Federal Register Volume 86, Number 105 (Thursday, June 3, 2021)]
[Rules and Regulations]
[Pages 29683-29685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11637]
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Rules and Regulations
Federal Register
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This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
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Federal Register / Vol. 86, No. 105 / Thursday, June 3, 2021 / Rules
and Regulations
[[Page 29683]]
NUCLEAR REGULATORY COMMISSION
10 CFR Chapter I
[NRC-2020-0262]
Evidence-Building and Evaluation Policy Statement
AGENCY: Nuclear Regulatory Commission.
ACTION: Policy statement; issuance.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing an
Evidence-Building and Evaluation Policy Statement that describes the
general standards that guide the NRC's ``evidence-building''
activities, consistent with the Foundations for Evidence-Based
Policymaking Act of 2018. The policy statement is intended to provide
agency personnel and stakeholders with a clear understanding of the
expectations related to the NRC's standards for evidence-building
activities, which includes analyses, research, assessments, and
evaluations performed by the agency for programmatic, operational,
regulatory, and policy decision making. These standards include rigor,
relevance and utility, transparency, collaboration, independence and
objectivity, and ethics.
DATES: This policy statement is effective on June 3, 2021.
ADDRESSES: Please refer to Docket ID NRC-2020-0262 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-2020-0262. Address
questions about NRC dockets to Dawn Forder; telephone: 301-415-3407;
email: [email protected]. For technical questions contact the
individual listed in the FOR FURTHER INFORMATION CONTACT section of
this document.
NRC's Agencywide Documents Access and Management System
(ADAMS): You may obtain publicly-available documents online in the
ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``Begin Web-based ADAMS
Search.'' For problems with ADAMS, please contact the NRC's Public
Document Room (PDR) reference staff at 1-800-397-4209, at 301-415-4737,
or by email to [email protected]. The final Evidence-Building and
Evaluation Policy Statement, in its entirety, is in the attachment to
this document.
Attention: The 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.
FOR FURTHER INFORMATION CONTACT: Matthew Meyer, Office of the Executive
Director for Operations, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001, telephone: 301-415-6198, email:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The Foundations for Evidence-Based Policymaking Act of 2018
(``Evidence Act'') became law on January 14, 2019 (Pub. L. 115-435), to
enhance evidence-building activities, make data more accessible, and
strengthen privacy protections.\1\ ``[T]he Evidence Act creates a new
paradigm by calling on agencies to significantly rethink how they
currently plan and organize evidence-building, data management, and
data access functions to ensure an integrated and direct connection to
data and evidence needs.'' \2\ The Evidence Act requires each agency to
name an Evaluation Officer. At the NRC, the Director of the Office of
Nuclear Regulatory Research holds this position and must ``establish
and implement an agency evaluation policy'' to fulfill a primary
function of this position.\3\ The agency evaluation policy ``should
guide the agency's activities throughout the evaluation lifecycle.''
\4\ The Office of Management and Budget (OMB) has provided guidance on
establishing an agency evaluation policy based on ``approaches that
Federal agencies have found useful.'' \5\ This guidance includes
``[e]nsuring that the agency evaluation policy incorporates the
evaluation standards'' recommended by OMB.\6\ OMB developed these
evaluation standards through an interagency council that ``reviewed an
extensive list of source documents to identify widely accepted
standards for evaluation.'' \7\ The interagency council identified the
following evaluation standards: relevance and utility, rigor,
independence and objectivity, transparency, and ethics.\8\
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\1\ Public Law 115-435, 132 Stat 5529 (2019).
\2\ Office of Management and Budget, M-19-23, ``Phase 1
Implementation of the Foundations for Evidence-Based Policymaking
Act of 2018: Learning Agendas, Personnel, and Planning Guidance,'' 2
(July 10, 2019).
\3\ 5 U.S.C. 313(d)(3).
\4\ Office of Management and Budget, M-20-12, ``Phase 4
Implementation of the Foundations for Evidence-Based Policymaking
Act of 2018: Program Evaluation Standards and Practices,'' Appendix
C (March 10, 2020) (M-20-12).
\5\ M-20-12, Appendix C.
\6\ Id.
\7\ Id. at 2.
\8\ Id. at 3-5.
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The Evidence Act focuses on the importance of sound evidence-
building, which includes evaluation, to make informed evidence-based
decisions. The evaluation standards developed by the interagency
council, including an additional standard developed by the NRC
(collaboration), are applicable to all of the NRC's evidence-building
activities.
Historically, the NRC has relied on high-quality evidence obtained
from external entities and through its own capacity. In recent years
the agency has begun evidence-building activities to support licensing
new or novel nuclear technologies, including advanced, non-light water
reactor designs; accident tolerant nuclear fuel; and digital
instrumentation and controls.\9\ Additionally, the NRC has increasingly
sought to rely on evidence-based metrics to improve internal agency
performance including budgeting and financial management.\10\ The NRC
has developed an evidence-building and evaluation policy statement to
enhance its existing evidence-building activities
[[Page 29684]]
through the activities directed in the Evidence Act. The NRC envisions
that this approach will strengthen the agency's oversight of existing
uses of nuclear technology, enhance the agency's readiness to license
and regulate new and novel nuclear technologies, and further the NRC's
ongoing efforts to improve its internal processes.
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\9\ Nuclear Regulatory Commission, NUREG-1350, 2019-2020
Information Digest, at 4 (August 2019).
\10\ Id. at 7.
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II. Public Comments
The NRC published the Proposed Evaluation Policy Statement in the
Federal Register for a 30-day comment period on December 8, 2020 (85 FR
79042). The NRC received a total of nine public comments.
These comments were generally supportive of the policy statement
and the NRC's commitment to ensuring that its regulatory decisions are
supported with evidence and sound technical bases. However, commenters
also requested that the NRC clarify the applicability of the policy
statement to evidence-building activities other than ``evaluation'' as
that term is defined in the Evidence Act (5 U.S.C. 311(3)), such as
licensing, inspection, rulemaking, generic communication, and other
regulatory activities (including backfitting analyses, and
environmental reviews performed under the National Environmental Policy
Act). The NRC agrees and has revised the proposed policy statement to
clarify that the general standards articulated in the policy statement
apply to all agency ``evidence-building'' activities. This includes not
only ``evaluations'' conducted to review the effectiveness and
efficiency of NRC programs, policies, and organizations, but other
types of evidence-building such as regulatory analyses, compliance
analyses, and performance assessments. A complete table of the comments
received on the proposed policy statement and NRC staff responses to
those comments is available in ADAMS under Accession No. ML21070A196.
III. Procedural Requirements
Congressional Review Act
This policy statement is not a rule as defined in the Congressional
Review Act (5 U.S.C. 801-808).
Paperwork Reduction Act
This Policy Statement does not contain new or amended information
collection requirements and, therefore, is not subject to the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
The text of the Evidence-Building and Evaluation Policy statement
is attached.
Dated: May 28, 2021.
For the Nuclear Regulatory Commission.
Wesley W. Held,
Acting Secretary of the Commission.
Note: The following attachment will not appear in the Code of
Federal Regulations:
Attachment--Evidence-Building and Evaluation Policy Statement
The purpose of this Evidence-Building and Evaluation Policy
Statement is to describe the general standards that govern the NRC's
planning and conduct of evidence-building. Evidence-building includes
activities such as analysis, assessment, research, and program
evaluation (evaluation).\11\ The Foundations for Evidence-Based
Policymaking Act of 2018 requires an agency evaluation policy to guide
the agency's evaluation activities throughout the evaluation lifecycle.
The NRC is committed to using evidence and scientific methods when
making evidence-based decisions.
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\11\ The Evidence Act defines ``evaluation'' as ``an assessment
using systematic data collection and analysis of one or more
programs, policies, and organizations intended to assess their
effectiveness and efficiency'' (5 U.S.C. 311(3)). ``Evaluation can
look beyond the program, policy, or organizational level to include
assessment of projects or interventions within a program'' (OMB M-
20-12).
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The NRC is an evidence-based organization with a culture of
continuous learning and improvement. The NRC's evidence-building
activities use objective technical analyses and assessments to document
decisions with explicitly stated rationale. Furthermore, the NRC
commits to implementing the standards of rigor; relevance and utility;
transparency; collaboration; independence and objectivity; and ethics
in the conduct of its evidence-building activities. This policy
statement describes these general standards.
The Commission, as a collegial body, formulates policies, develops
regulations governing nuclear reactor and nuclear material safety,
issues orders to licensees, and adjudicates legal matters. The
collegial decision-making process results in actions reflecting the
collective judgment of a group aided by professional and administrative
staff and advisory committees, such as the Advisory Committee on
Reactor Safeguards. Strict requirements govern the admission and
consideration of ``evidence'' when the Commission acts in its
adjudicatory capacity. This policy applies to the NRC's non-
adjudicatory functions.\12\
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\12\ The NRC's rules of practice and procedure in 10 CFR part 2
govern the Commission's adjudicatory process.
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The NRC's Principles of Good Regulation, which include
independence, efficiency, clarity, reliability, and openness, have
guided the agency's regulatory activities and decisions using evidence
and scientific methods. The principles focus on meeting the agency's
important safety and security mission while appropriately considering
the interests of stakeholders, including licensees; State, local, and
Tribal governments; nongovernmental organizations; and the public. The
agency's openness principle explicitly recognizes that the public must
be informed about and have an opportunity to participate in the
regulatory process.
Evidence-building is used to inform agency activities and actions,
such as licensing, oversight, budgeting, program improvement,
accountability, management, rulemaking, guidance development, and
policy development. The emphasis on evidence is meant to support
innovation, improvement, and learning. Examples of how the NRC carries
out evidence-building include (1) identifying, evaluating, and
resolving safety issues; (2) ensuring that an independent technical
basis exists to review licensee submittals; (3) evaluating operating
experience and results of risk assessments for safety implications; (4)
supporting the development and use of risk-informed regulatory
approaches; (5) conducting research with scientific integrity; and (6)
ensuring that licensing and oversight findings are supported by
evidence.
Evidence-Building Standards
The NRC uses the following standards when conducting evidence-
building activities.
1. Rigor--The NRC is committed to using rigorous evidence-building
methods by qualified staff with relevant education, skills, and
experience to ensure findings are appropriate and feasible within
statutory, budgetary, and other constraints.
Rigorous evidence-building requires inferences about cause and
effect to be well founded (internal validity); clarity about the
populations, settings, or circumstances to which results can be
generalized (external validity); and the use of measures that
accurately capture the intended information (measurement reliability
and validity). The NRC's evidence-building activities are conducted by
qualified staff with relevant education, skills, and experience for the
methods undertaken. The NRC's evidence-building activities use
appropriate designs and methods that adhere to widely accepted
scientific principles to answer key questions
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while balancing goals, scale, timeline, feasibility, and available
resources. Additionally, the NRC's Information Quality Program \13\
ensures that all information relied on by the NRC is subject to
rigorous quality standards.
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\13\ Management Directive 3.17, ``Information Quality Program,''
ensures that peer review is conducted on all influential scientific
information and highly influential scientific assessment that the
agency intends to disseminate.
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2. Relevance and Utility--The NRC ensures that evidence-building
activities are relevant and provide useful findings to inform agency
activities, actions, and stakeholders.
The NRC performs evidence-building activities to examine questions
of importance and serve the information needs of stakeholders. The NRC
presents findings that are clear, concise, actionable, and available
within a timeline that is appropriate to the questions under
consideration. The NRC's evidence-building priorities consider
legislative requirements; the NRC's strategic goals, objectives, and
strategies; and the interests and views of stakeholders.
3. Transparency--The NRC is committed to conducting evidence-
building activities in an open and transparent manner, which keeps
stakeholders informed.
The NRC's evidence-building activities are conducted openly and the
public must be informed about and have an opportunity to participate in
the NRC's regulatory process. As a regulator, the NRC listens to,
respects, and analyzes different views from its stakeholders. The NRC
ensures open channels of communication are maintained between internal
and external stakeholders, including Congress, other government
agencies, licensees, nongovernmental organizations, individual members
of the public, and international and domestic nuclear communities. The
NRC takes reasonable measures to make all information, including
information about the NRC's evidence-building activities (including
their purpose, objectives, design, findings, and methods), broadly
available and accessible. The NRC releases public evidence-building
findings in a timely manner and archives the data for secondary use by
stakeholders, as appropriate.
4. Collaboration--The NRC is committed to working collaboratively
when conducting evidence-building activities and draws on the expertise
of subject matter experts to ensure diversity in perspectives.
The NRC fosters a collaborative work environment that encourages
diverse views, alternative approaches, critical thinking, creative
problem solving, unbiased findings, and honest feedback. The NRC
emphasizes trust, respect, and open communication to promote a positive
work environment that maximizes the potential of all individuals, which
improves evidence building and evaluation activities. A collaborative
environment leverages expertise from subject matter experts and enables
peer reviews to ensure rigorous evidence-building. The NRC conducts
research and collaborates with organizations that develop consensus
standards to improve data and methods used in risk analysis. The NRC
collaborates with national laboratories, Agreement States, other
Federal agencies, universities, and international organizations.
5. Independence and Objectivity--As an independent Federal agency,
the NRC is committed to conducting evidence-building activities that
are independent and based on objective assessments and analysis of all
relevant information.
The NRC was established as an independent agency to regulate
civilian uses of radioactive material. The NRC's evidence-building
activities are independent and objective to maintain credibility and
integrity. The implementation of evidence-building activities,
including the selection and assignment of the staff, should be
appropriately insulated from factors that may affect objectivity,
impartiality, and professional judgment. Evidence-building is inclusive
and the NRC seeks input from a broad range of stakeholders in setting
priorities, identifying questions, and assessing the implications of
findings. The NRC strives for objectivity in the planning and conduct
of evidence-building activities.
6. Ethics--The NRC is committed to conducting evidence-building
activities that adhere to Government-wide ethics standards to protect
the public and maintain public trust.
The NRC's evidence-building activities comply with relevant legal
requirements and are conducted in a manner that is free from conflicts
of interest, undue influence, the appearance of bias, and safeguards
the dignity, rights, safety, and privacy of participants. The NRC
complies with Governmentwide ethics standards contained in Federal
statutes and regulations, which are intended to ensure that every
citizen can have confidence in the integrity of the Federal Government.
[FR Doc. 2021-11637 Filed 6-2-21; 8:45 am]
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