[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
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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

[[Page 29685]]

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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