Federal Register - June 3, 2021

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Source: Federal Register

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Federal Register / Vol. 86, No. 105 / Thursday, June 3, 2021 / Rules and Regulations
through the activities directed in the Evidence Act. The NRC envisions that this approach will strengthen the agencys oversight of existing uses of nuclear technology, enhance the agencys readiness to license and regulate new and novel nuclear technologies, and further the NRCs ongoing efforts to improve its internal processes.
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 NRCs 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. 3113, 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. 801808.

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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.

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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:

AttachmentEvidence-Building and Evaluation Policy Statement The purpose of this EvidenceBuilding and Evaluation Policy Statement is to describe the general standards that govern the NRCs planning and conduct of evidencebuilding. 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 agencys evaluation activities throughout the evaluation lifecycle. The NRC is committed to using evidence and scientific methods when making evidence-based decisions.
The NRC is an evidence-based organization with a culture of continuous learning and improvement.
The NRCs 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 evidencebuilding 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 decisionmaking 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 NRCs non-adjudicatory functions.12
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. 3113. Evaluation can look beyond the program, policy, or organizational level to include assessment of projects or interventions within a program OMB M2012.
12 The NRCs rules of practice and procedure in 10 CFR part 2 govern the Commissions adjudicatory process.

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The NRCs Principles of Good Regulation, which include independence, efficiency, clarity, reliability, and openness, have guided the agencys regulatory activities and decisions using evidence and scientific methods. The principles focus on meeting the agencys 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 agencys 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. RigorThe 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 NRCs evidence-building activities are conducted by qualified staff with relevant education, skills, and experience for the methods undertaken.
The NRCs evidence-building activities use appropriate designs and methods that adhere to widely accepted scientific principles to answer key questions
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Federal Register - June 3, 2021

TitoloFederal Register

PaeseStati Uniti

Data03/06/2021

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