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Significant regulatory action is a term used to describe an agency rule that has had or might have a large impact on the economy, environment, public health, or state or local governments. These actions may also conflict with other rules or presidential priorities. The term was defined in 1993 byPresidentBill Clinton'sExecutive Order 12866. As part of its role in theregulatory review process, theOffice of Information and Regulatory Affairs (OIRA) determines which rules meet this definition are thus are subject to its review.^[1][2][3]

Background

Executive Order 12866, titled "Regulatory Planning and Review," is anexecutive order issued byPresidentBill Clinton in 1993 establishing principles and processes to govern federal agencyrulemaking, regulatory planning, andregulatory review. It was designed to guide presidential oversight of regulatory and administrative policy. This order authorizes theOffice of Information and Regulatory Affairs (OIRA) to review what it considers all new and preexisting significant regulatory actions and directs OIRA "to ensure that regulations are consistent with applicable law, the President's priorities, and the principles set forth in this Executive order, and that decisions made by one agency do not conflict with the policies or actions taken or planned by another agency." OIRA has 90 days (with a possible 30 day extension) to complete its review of a significant regulatory action; the rule in question cannot be published in theFederal Register until the office completes its review without recommendations or the review period expires.^[1][2][3]

PresidentJoe Biden (D) issuedExecutive Order 14094, titled "Modernizing Regulatory Review," on April 6, 2023, in an effort to revise the regulatory review process. The order changed the definition of a significant regulatory action to include any action with an annual effect of $200 million or more, as opposed to $100 million or more. It also directed the OIRA administrator to review all other significant rules (those regarding novel policy issues) and sought to classify agency rules in an effort to limit the number of actions that require review by OIRA.^[4][5] On January 20, 2025, PresidentDonald Trump (R) issuedExecutive Order 14148, revoking E.O. 14094.^[6]

PresidentDonald Trump (R) issuedExecutive Order 14215, titled "Ensuring Accountability for All Agencies," on February 18, 2025. This order modifiedExecutive Order 12866 by including mostindependent federal agencies in E.O. 12866's requirement that proposed rules be reviewed for significance by theOffice of Information and Regulatory Affairs (OIRA).^[7]

State-level significant regulatory action

The process for states to determine whether a rule is significant often differs from the federal process and varies by state. In some cases, executive review of state regulation is required, whereas other states may require legislative review or review by an independent agency. In some states, all rules must undergo the same degree of review. In other states, a review of regulatory action is triggered by the rule's significance, which is determined by an economic threshold or a significant small business impact.^[8]

Forty-eight states, as of a 2022 report by the Mercatus Center, have an impact analysis requirement. Some states have an economic threshold that is used to determine whether a rule is significant and requires an analysis, similar to the degree of economic significance at the federal level. The threshold for economic significance can vary by state, however, some states adopt the federal standards for determining what rules are significant.^[8]

Definition

E.O. 12866 defines a significant regulatory action as "any regulatory action that is likely to result in a rule that may:"^[1]

The termeconomically significant rule refers to regulatory actions meeting part (1) of the above definition. A regulatory action that is not economically significant but that meets some other part of the above definition, or is considered important by the agency proposing the rule, is referred to as another significant rule.^[10][11][12]

As part of theregulatory review process outlined by E.O. 12866, theOffice of Information and Regulatory Affairs is responsible for determining which regulatory actions meet this definition and thus are subject to its review.^[1][2]

Noteworthy events

Trump administration includes most independent federal agencies in E.O. 12866 review (2025)

On February 18, 2025, PresidentDonald Trump (R) issuedExecutive Order 14215. This order removed E.O. 12866's exception from OIRA significance review forindependent federal agencies, with the exception of the Board of Governors and Federal Open Market Committee of theFederal Reserve System.^[7]

Trump revokes Executive Order 14094 (2025)

On January 20, 2025, PresidentDonald Trump (R) issuedE.O. 14148, which revoked PresidentJoe Biden's earlierExecutive Order 14094.^[6] By revoking E.O. 14094, which had raised the monetary threshold for significance to $200 million or more, this action effectively restored the $100 million or more threshold established byExecutive Order 12866.

Biden administration issues highest number of section 3(f)(1) significant rules since Reagan (2024)

Federal agencies issued thirty-four section 3(f)(1) significant rules, formerly known as economically significant rules, in April—higher than any month since the Reagan administration, according to The George Washington University Regulatory Studies Center (GW RSC). A section 3(f)(1) significant rule refers to a regulatory action with an estimated annual economic impact of $200 million or more.

The Biden administration issued 32 other significant rules in April, bringing the total count of significant final rules to 66—more than any other month under the Biden administration.

Scholars from the GW RSC argue that the recent increase in regulatory actions is due to theCongressional Review Act’s (CRA) lookback period. The CRA authorizes Congress to review rulemaking activities by federal agencies and pass joint resolutions of disapproval to overturn a rule and block agencies from creating similar rules in the future. The lookback period refers to a period of time at the beginning of a new presidential administration in which rules published within the last 60 legislative days of the previous administration are eligible for consideration under the act.

Zhoudan Xie, a senior policy analyst for GW RSC, wrote, “If there is a presidential transition next year, the lookback period gives the incoming president and Congress a unique opportunity to overturn rules issued by the current administration. … Clearly, agencies are rushing to finalize rules with the early deadline in mind.” Xie wrote that the exact dates for the lookback period are uncertain and that the “estimate ranges from as early as May 22, 2024 to the beginning of August.”^[13]

Biden issues Executive Order 14094, raising monetary threshold for significant rules (2023)

PresidentJoe Biden (D) issued anExecutive Order 14094 on April 6, 2023, which made changes to the regulatory review process. The order raised the monetary threshold for classifying significant rules and sought to reduce the number of actions that require review by theOffice of Information and Regulatory Affairs (OIRA).

The executive order changed the definition of a significant regulatory action to include any action with an annual effect of $200 million or more, as opposed to $100 million or more. It also directed the OIRA administrator to review all other significant rules (those regarding novel policy issues) and sought to classify agency rules in an effort to limit the number of actions that require review by OIRA. The order also directed the Office of Management and Budget (OMB) to update regulatory analysis guidance Circular A-4 within one year, among other provisions.^[4][5]

Analysis of significant regulatory actions under the Trump administration (2017)

A study released on October 1, 2017, byClyde Wayne Crews Jr. of theCompetitive Enterprise Institute found that during the first nine months ofDonald Trump’s (R) presidency, his administration issued 116 significantfinal rules, a 58 percent reduction compared to the 274 significant rules finalized by the administration of PresidentBarack Obama (D) during the same nine-month period in 2016.^[14][15]

See also

• Executive Order 12866
• Truth in Regulating Act
• U.S. Office of Information and Regulatory Affairs
• U.S. Office of Management and Budget
• Major rule

External links

• Executive Order 12866
• RegInfo.gov
• Search Google News for this topic

Footnotes

v • e The Administrative State Main The Administrative State Project main page •Administrative State Project Index •Glossary of administrative state terms •Quotes about the administrative state •Administrative state •Rulemaking •Deference •Adjudication •Nondelegation doctrine •Ballotpedia's administrative state legislation tracker Pillars Agency control •Executive control •Judicial control •Legislative control •Public control Reporting Changes to the Federal Register •Completed OIRA review of federal administrative agency rules •Federal agency rules repealed under the Congressional Review Act •Historical additions to the Federal Register, 1936-2016 Laws Administrative Procedure Act •Antiquities Act •Civil Service Reform Act •Clayton Antitrust Act •Communications Act of 1934 •Congressional Review Act •Electronic Freedom of Information Act •Federal Food, Drug, and Cosmetic Act of 1938 •Federal Housekeeping Statute •Federal Reserve Act •Federal Trade Commission Act of 1914 •Freedom of Information Act •Government in the Sunshine Act •Independent Offices Appropriations Act of 1952 •Information Quality Act •Interstate Commerce Act •National Labor Relations Act •Paperwork Reduction Act •Pendleton Act •Privacy Act of 1974 •Regulatory Flexibility Act •REINS Act •REINS Act (Wisconsin) •Securities Act of 1933 •Securities Exchange Act of 1934 •Sherman Antitrust Act •Small Business Regulatory Enforcement Fairness Act •Truth in Regulating Act •Unfunded Mandates Reform Act Cases Abbott Laboratories v. Gardner •A.L.A. Schechter Poultry Corp. v. United States •Association of Data Processing Service Organizations v. Camp •Auer v. Robbins •Chevron v. Natural Resources Defense Council •Citizens to Preserve Overton Park v. Volpe •Federal Trade Commission (FTC) v. Standard Oil Company of California •Field v. Clark •Food and Drug Administration v. Brown and Williamson Tobacco Corporation •Humphrey's Executor v. United States •Immigration and Naturalization Service (INS) v. Chadha •J.W. Hampton Jr. & Company v. United States •Lucia v. SEC •Marshall v. Barlow's •Massachusetts v. Environmental Protection Agency •Mistretta v. United States •National Federation of Independent Business (NFIB) v. Sebelius •National Labor Relations Board v. Noel Canning Company •National Labor Relations Board v. Sears, Roebuck & Co. •Panama Refining Co. v. Ryan •Securities and Exchange Commission v. Chenery Corporation •Skidmore v. Swift & Co. •United States v. Lopez •United States v. Western Pacific Railroad Co. •Universal Camera Corporation v. National Labor Relations Board •Vermont Yankee Nuclear Power Corp. v. Natural Resources Defense Council •Wayman v. Southard •Weyerhaeuser Company v. United States Fish and Wildlife Service •Whitman v. American Trucking Associations •Wickard v. Filburn •Wiener v. United States Terms Adjudication (administrative state) •Administrative judge •Administrative law •Administrative law judge •Administrative state •Arbitrary-or-capricious test •Auer deference •Barrier to entry •Bootleggers and Baptists •Chevron deference (doctrine) •Civil servant •Civil service •Code of Federal Regulations •Codify (administrative state) •Comment period •Compliance costs •Congressional Record •Coordination (administrative state) •Deference (administrative state) •Direct and indirect costs (administrative state) •Enabling statute •Ex parte communication (administrative state) •Executive agency •Federal law •Federal Register •Federalism •Final rule •Formal rulemaking •Formalism (law) •Functionalism (law) •Guidance (administrative state) •Hybrid rulemaking •Incorporation by reference •Independent federal agency •Informal rulemaking •Joint resolution of disapproval (administrative state) •Major rule •Negotiated rulemaking •Nondelegation doctrine •OIRA prompt letter •Organic statute •Pragmatism (law) •Precautionary principle •Promulgate •Proposed rule •Publication rulemaking •Regulatory budget •Regulatory capture •Regulatory dark matter •Regulatory impact analysis •Regulatory policy officer •Regulatory reform officer •Regulatory review •Rent seeking •Retrospective regulatory review •Risk assessment (administrative state) •Rulemaking •Separation of powers •Significant regulatory action •Skidmore deference •Statutory authority •Substantive law and procedural law •Sue and settle •Sunset provision •Unified Agenda of Federal Regulatory and Deregulatory Actions •United States Code •United States Statutes at Large Bibliography "Administrative Law - The 20th Century Bequeaths an 'Illegitimate Exotic' in Full and Terrifying Flower" by Stephen P. Dresch (2000) "Confronting the Administrative Threat" by Philip Hamburger and Tony Mills (2017) "Constitutionalism after the New Deal" by Cass R. Sunstein (1987) Federalist No. 23 by Alexander Hamilton (1787) "From Administrative State to Constitutional Government" by Joseph Postell (2012) "Interring the Nondelegation Doctrine" by Eric A. Posner and Adrian Vermeule (2002) "Rulemaking as Legislating" by Kathryn Watts (2015) "The Checks & Balances of the Regulatory State" by Paul R. Verkuil (2016) "The Myth of the Nondelegation Doctrine" by Keith E. Whittington and Jason Iuliano (2017) "The Progressive Origins of the Administrative State: Wilson, Goodnow, and Landis" by Ronald J. Pestritto (2007) "The Rise and Rise of the Administrative State" by Gary Lawson (1994) "The Study of Administration" by Woodrow Wilson (1887) "The Threat to Liberty" by Steven F. Hayward (2017) "Why the Modern Administrative State Is Inconsistent with the Rule of Law" by Richard A. Epstein (2008) Agencies Administrative Conference of the United States •United States Civil Service Commission •U.S. Government Accountability Office •U.S. Office of Information and Regulatory Affairs •U.S. Office of Management and Budget