Executive Order 12866, signed by President Clinton on September 30, 1993, is the framework that governs how federal agencies write and review regulations. It requires executive branch agencies to run significant proposed rules through a central White House office, the Office of Information and Regulatory Affairs (OIRA), backed by a formal cost-benefit analysis showing that the rule’s benefits justify its costs. More than three decades and several amendments later, the order still sets the basic terms of federal regulatory review.1National Archives. Executive Order 12866 of September 30, 1993 Regulatory Planning and Review
The order also sets out regulatory principles agencies are supposed to follow: regulate only when there is a genuine need for government action, pick the approach that maximizes net benefits to society, impose the least burden consistent with the goal, and base decisions on the best available scientific and economic information.
Which Rules Get Reviewed
Not every rule triggers formal White House oversight. Only “significant regulatory actions” go through OIRA review. A rule qualifies if it meets any one of four criteria:
- It is expected to have an annual effect on the economy of $100 million or more, or to materially harm productivity, competition, jobs, the environment, public health, or state and local governments.
- It would create a serious inconsistency with an action taken or planned by another federal agency.
- It would materially change the budgetary impact of entitlements, grants, user fees, or loan programs.
- It raises novel legal or policy questions arising from new legal mandates, presidential priorities, or the principles in the order itself.
The $100 million economic threshold is the trigger that captures most rules entering formal review.2US EPA. Summary of Executive Order 12866 – Regulatory Planning and Review Between April 2023 and January 2025, Executive Order 14094 raised this figure to $200 million. That order was revoked in January 2025, restoring the original $100 million level.3The American Presidency Project. Executive Order 14094 – Modernizing Regulatory Review
The Regulatory Impact Analysis
An agency proposing an economically significant rule must prepare a Regulatory Impact Analysis before submitting the rule to OIRA. This document does the analytical heavy lifting, and a weak one is the most common reason rules get sent back.
The analysis has to define the problem the agency is trying to solve, explain why federal regulation is the right tool as opposed to state action, enforcement of existing laws, or doing nothing, and evaluate a range of alternatives including the alternative of not regulating.4Office of Information and Regulatory Affairs. Regulatory Impact Analysis – A Primer For each option, the agency must quantify expected costs and benefits both in physical terms (say, injuries prevented) and in dollars wherever feasible, working from the best available scientific and economic information.
The cost-benefit standard in EO 12866 is that benefits must justify costs, not necessarily outweigh them numerically. That distinction matters. It allows agencies to account for benefits that are hard to quantify in dollar terms, like environmental protection or human dignity, without being forced into a strict numerical comparison.
Agencies are also expected to consider distributional effects, meaning how a rule’s costs and benefits fall across different groups, income levels, and communities. A rule that produces large net benefits overall but concentrates costs on a small, disadvantaged group raises different questions than one that spreads costs evenly.
How OIRA Review Works
OIRA sits within the Office of Management and Budget and serves as the central reviewer for significant rules coming out of executive branch agencies.5The White House. Office of Information and Regulatory Affairs When an agency submits a draft rule, OIRA staff examine the proposal’s data, methodology, legal basis, and alignment with presidential priorities. The office also coordinates across departments so one agency’s rule doesn’t contradict another’s.6Department of Defense. OMB Approval Process
Review Timeline
The clock starts when the agency submits its draft rule and supporting analysis. For most significant rules, OIRA has 90 calendar days to complete its review. If the agency previously submitted the same rule and nothing material has changed, the timeline shrinks to 45 days. Preliminary actions like advance notices of proposed rulemaking get 10 working days.7U.S. Department of Health and Human Services. Executive Order 12866 – Regulatory Planning and Review
When the standard 90-day period isn’t enough, typically for highly technical or politically sensitive rules, the OMB Director can approve a single extension of up to 30 additional calendar days. The agency head can also request an extension. Beyond that, the order doesn’t provide for further delays, though reviews sometimes run past their deadlines in practice.
How Reviews End
OIRA closes out a review with one of several outcomes:
- Consistent without change. The rule is approved as submitted, and the agency can publish it in the Federal Register.
- Consistent with change. The rule is approved, but modifications were made during review. OIRA uses this label whether the changes originated from OIRA, another agency, or the sponsoring agency.
- Return letter. OIRA sends the rule back for further work. This doesn’t necessarily signal opposition; the analysis may just be insufficient or the alternatives inadequately explored. The letter must cite the specific provision of EO 12866 supporting the decision, and the agency head can push back in writing.
- Withdrawal. The sponsoring agency pulls the rule, either because OIRA’s concerns are too substantial to fix quickly or because circumstances have changed.
Return letters are relatively rare but carry consequences. An agency that receives one has to redo the analytical work before resubmitting.8The White House. Office of Information and Regulatory Affairs (OIRA) Q and As
What’s Outside the Order
Some categories of rules fall outside the order’s definition of “regulation” and never reach OIRA. These include rules involving military or foreign affairs functions (though procurement rules and regulations on importing or exporting non-defense goods are still covered), rules limited to an agency’s internal organization or personnel management, and rules issued through formal trial-like rulemaking procedures under the Administrative Procedure Act. The OIRA Administrator can exempt additional categories case by case.7U.S. Department of Health and Human Services. Executive Order 12866 – Regulatory Planning and Review
A bigger carve-out involves independent regulatory agencies such as the Securities and Exchange Commission, the Federal Communications Commission, the Federal Trade Commission, and the Federal Reserve. These bodies are headed by multi-member boards or commissions whose members serve staggered terms and can only be removed for cause, which gives them insulation from presidential control. The order excludes them from the definition of “agency” for purposes of OIRA review. They still have to participate in the Unified Regulatory Agenda and Regulatory Plan, but their rules don’t go through OIRA.
Public Disclosure
Once OIRA finishes review and the rule is published in the Federal Register, the agency must make public the version it originally submitted, identify any changes made during review, and specify which of those changes came at OIRA’s suggestion.2US EPA. Summary of Executive Order 12866 – Regulatory Planning and Review This creates a paper trail showing how White House review shaped the final rule.
OIRA must also disclose records of meetings with people outside the federal government during a rule’s review. Those records include the date, attendees, and substantive topics. If an industry group or advocacy organization met with OIRA reviewers while a rule was pending, the public can see that it happened and what was discussed. Meeting requests, confirmations, and cancellations are all logged.9Reginfo.gov. How To Guide for EO 12866 Meetings
The Unified Regulatory Agenda
EO 12866 requires every covered agency, independent agencies included, to publish a semiannual agenda of all regulations under development or review. This document, the Unified Agenda of Federal Regulatory and Deregulatory Actions, gives the public a forward-looking view of what rules are coming. Each fall, agencies also prepare a Regulatory Plan identifying their most important upcoming significant actions.10Federal Register. Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions
The Unified Agenda generally covers actions the agency expects to take within the next 12 months, though longer-timeline items can be included. It also lists rules completed or withdrawn since the last edition. For anyone tracking federal regulatory activity, it is the single most useful planning tool the system produces.
Agencies must additionally submit a program for periodic review of existing significant regulations to determine whether those rules should be modified or eliminated. Rules picked for retrospective review appear in the agency’s Regulatory Plan.11ACUS. Executive Order 12866 – Regulatory Planning and Review
Amendments and Current Status
EO 12866 has been amended repeatedly, but its core structure has survived every administration. Executive Orders 13258 and 13422 under President George W. Bush adjusted the review process. Executive Order 13563 under President Obama reaffirmed and supplemented the order, emphasizing public participation and retrospective review.12Reginfo.gov. Executive Order 12866 Regulatory Planning and Review
In April 2023, President Biden signed Executive Order 14094, which raised the significance threshold from $100 million to $200 million and added new requirements on distributional analysis. That order was revoked on January 20, 2025, by Executive Order 14148, restoring the $100 million figure. In February 2025, a separate executive order directed agencies to consult with Department of Government Efficiency team leads alongside OIRA when developing new regulations, and added factors for agencies to weigh, including whether a rule exceeds constitutional authority, imposes costs not outweighed by public benefits, or creates undue burdens on small businesses.13The White House. Ensuring Lawful Governance and Implementing the President’s Department of Government Efficiency Regulatory Initiative These additions layer on top of the EO 12866 framework rather than replacing it. The underlying process of agency submission, OIRA review, cost-benefit analysis, and public disclosure continues to operate as it has for more than three decades.