Where Agencies Get Their Facts

Administrative agencies compile factual information from multiple sources during the regulatory development process. The factual material that appears in proposed rules, final rules, and supporting documents originates through various channels and undergoes documentation in the administrative record. This article describes the mechanisms through which factual information enters agency possession and becomes incorporated into regulatory materials.

Internal Agency Research and Data Collection

Agencies conduct their own research and data collection activities as part of regulatory development. Staff economists, scientists, engineers, and policy analysts generate studies, compile datasets, and produce technical reports that form part of the factual foundation for proposed regulations. These internal efforts may include economic modeling, risk assessments, cost-benefit calculations, and technical feasibility analyses.

Agencies maintain databases drawn from their regulatory and enforcement activities. Inspection records, compliance reports, incident databases, and monitoring data accumulated through an agency’s statutory responsibilities provide factual material about regulated industries and activities. Environmental Protection Agency air quality monitoring networks, Occupational Safety and Health Administration workplace injury records, and Food and Drug Administration adverse event reports exemplify agency-maintained data systems that supply factual information for rulemaking.

Some agencies operate research facilities or contract with national laboratories to conduct scientific investigations. The National Institute for Occupational Safety and Health conducts toxicology studies and workplace exposure research that informs OSHA regulations. The National Highway Traffic Safety Administration performs vehicle crash testing that generates data for motor vehicle safety standards.

External Studies and Published Research

Agencies incorporate findings from academic research, scientific literature, and technical publications into regulatory analysis. Peer-reviewed journal articles, conference proceedings, technical reports from universities and research institutions, and published datasets become part of the factual record when agencies cite them in regulatory documents.

The process of identifying relevant external research varies by agency and subject matter. Agency staff conduct literature reviews, monitor scientific publications in relevant fields, and track research developments related to regulatory topics. Citations to external studies appear in preambles to proposed and final rules, regulatory impact analyses, and technical support documents.

Agencies distinguish between different types of external research based on methodology, peer review status, and relevance to regulatory questions. Epidemiological studies, laboratory experiments, engineering analyses, economic research, and field observations each contribute different categories of factual information. The administrative record reflects which studies an agency examined and how those studies informed factual determinations.

Information Submitted During Notice and Comment

The notice-and-comment process generates substantial factual material. Commenters submit technical reports, scientific studies, economic analyses, industry data, and other factual information during the comment period. Trade associations provide data about industry practices and costs. Public interest organizations submit scientific studies and technical analyses. Individual companies supply information about their operations, technologies, and compliance capabilities.

Submitted information becomes part of the rulemaking docket. Agencies catalog comments and attachments in electronic dockets accessible through regulations.gov and agency-specific systems. The volume of submitted material varies considerably across rulemakings, ranging from dozens to thousands of submissions containing factual information.

Agencies document their consideration of submitted factual material in responses to comments. The preamble to a final rule typically addresses significant factual claims, data submissions, and technical arguments raised by commenters. This documentation reveals which submitted information the agency found relevant, credible, or persuasive in establishing factual predicates for regulatory decisions.

Stakeholder Meetings and Information Exchanges

Agencies obtain factual information through meetings with regulated entities, industry representatives, advocacy organizations, and technical experts. These interactions occur throughout the regulatory development process, both before and after publication of proposed rules. Participants in such meetings may present data, explain technical processes, describe industry practices, or provide other factual information.

Federal advisory committees provide another channel for factual information. Agencies establish advisory committees composed of technical experts, industry representatives, and other stakeholders to provide advice on regulatory matters. These committees review data, evaluate studies, and discuss factual questions relevant to regulatory development. Committee meetings, reports, and recommendations become part of the public record.

Ex parte communications rules govern certain interactions between agency staff and outside parties during rulemaking. Agencies maintain logs of meetings and substantive communications, documenting when factual information was conveyed outside the formal comment process.

Statutory and Regulatory Information Requirements

Some statutes require regulated entities to submit specific information to agencies. Manufacturers may be required to report production volumes, chemical compositions, safety testing results, or other data. These mandatory submissions provide agencies with factual information about regulated products, substances, or activities.

Agencies also issue information collection requests under the Paperwork Reduction Act. Surveys, questionnaires, and reporting requirements generate data that agencies use in regulatory analysis. The Office of Management and Budget reviews and approves these information collections, and agencies document the purpose and use of collected information.

Petitions for rulemaking submitted by outside parties often contain factual information supporting the petitioner’s request. While agencies are not required to initiate rulemaking in response to petitions, the factual material in petitions may inform subsequent regulatory development if the agency proceeds with rulemaking on the subject.

Documentation in Regulatory Materials

Factual information appears throughout the documents that comprise a rulemaking record. The preamble to a proposed or final rule describes the factual basis for regulatory requirements, citing studies, data, and other sources. Regulatory impact analyses contain detailed factual material about costs, benefits, economic impacts, and regulatory alternatives.

Technical support documents provide extended discussion of scientific, engineering, or technical factual matters. These documents compile and analyze data, explain methodologies, and present detailed factual findings that support regulatory provisions. Environmental impact statements prepared under the National Environmental Policy Act contain extensive factual information about environmental conditions and projected impacts.

Agencies distinguish between factual findings and policy judgments in regulatory documents. Factual statements describe conditions, relationships, or characteristics based on data and analysis. Policy judgments involve choices among regulatory alternatives, balancing of competing considerations, or determinations about regulatory stringency. The administrative record reflects this distinction through the structure and language of regulatory documents.

The Administrative Record

The administrative record comprises all materials the agency considered in developing a regulation. This includes internal agency documents, external studies, submitted comments, meeting records, and other factual materials. Courts reviewing agency regulations examine the administrative record to determine whether factual findings have support in the compiled materials.

Agencies compile and organize administrative records according to established procedures. The record includes both materials supporting the agency’s factual determinations and materials presenting contrary evidence or alternative interpretations. The completeness and organization of the administrative record affects the reviewability of agency factual findings.

The mechanisms described above establish how factual material enters agency possession and becomes incorporated into the regulatory record. These processes operate across federal agencies with variations reflecting different statutory frameworks, subject matter expertise, and regulatory contexts.