Rulemaking Requirements from the Executive Office of the President

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This section discusses the most significant presidential Executive Orders, Bulletins, and Memoranda, which pertain to the rulemaking process or federal regulation. Other executive orders and memoranda may be found in other sections, e.g., those relating to the Federal Advisory Committee Act.

Lead Agency:

Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget (OMB)

Executive Orders

Table of Executive Order Requirements

Executive Order (EO) Date and Administration of Issue Action Items Does the EO Contain a Statement Regarding Applicability to Independent Agencies?
EO 12630 - Governmental Actions and Interference with Constitutionally Protected Property Rights 1988 - Reagan General Principles. Each agency “shall be guided by” the principles set forth in the EO when “formulating or implementing policies that have takings implications.”

Safety. These principles include the point that “the mere assertion of a . . . safety purpose is insufficient to avoid a taking.”  They should be undertaken only for “real and substantial threats,” be designed to significantly advance safety, “and be no greater than is necessary.”

Criteria. To the extent permitted by law, agencies are required to comply with a set of criteria before undertaking covered actions that include an assessment identifying the risk, establishing that safety is substantially advanced and that restrictions are not disproportionate to the overall risk, and estimating the cost to the government if the action is found to be a taking. In the event of an emergency, the analysis can be done later.

Policies That Have Takings Implications. These include proposed and final rules that if implemented “could effect a taking” (e.g., licenses, permits, or other conditions or limitations on private property use).

Ensuring Compliance. OMB and the Department of Justice are responsible for ensuring compliance with the EO.

EO 12866 - Regulatory Planning and Review 1993 - Clinton See 12866 table See 12866 table
EO 12889 - Implementation of the North American Free Trade Agreement 1993 - Clinton Notice. Agencies subject to the APA must provide at least a 75-day comment period for “any proposed Federal technical regulation or any Federal sanitary or phytosanitary measure of general application.”


  1. NAFTA Implementation. Regulations ensuring that the NAFTA Implementation Act is appropriately implemented on the date NAFTA enters into force (pursuant to 19 U.S.C. §3314(a)).
  2. Perishable Goods. Technical regulations relating to perishable goods.
  3. Urgent Safety or Protection Rules. Technical regulations addressing an “urgent problem” relating to safety or to protection of human, animal, or plant life or health; the environment; or consumers.
  4. Urgent Sanitary or Phytosanitary Protection. Regulations addressing an “urgent problem” relating to sanitary or phytosanitary protection.


  1. Technical Regulations. These are defined in the Trade Agreements Act at 19 U.S.C. §2576 b(7).
  2. Sanitary or Phytosanitary Measures. These are defined at 19 U.S.C. §2575 b(7).
EO 12898 - Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations 1994 - Clinton Strategies. Each agency is required to develop a strategy that “identifies and addresses disproportionately high and adverse human health or environmental effects of its programs, policies, and activities on minority populations and low-income populations” and identify, among other things, rules that should be revised to meet the objectives of the Order.

Conduct. Each agency must ensure that its programs, policies, and activities that “substantially affect human health or the environment” do not exclude persons (including populations) from participating in or getting the benefits of, or subject them to discrimination under, such programs, policies, and activities.

Documents and Hearings. An agency’s public documents, notices, and hearings relating to human health and the environment must be “concise, understandable, and readily accessible.”

Yes. See § 6–604 for relevant text: "Independent agencies are requested to comply with the provisions of this order."
EO 12988 - Civil Justice Reform 1996- Clinton Within budgetary constraints and executive branch coordination requirements, agencies must review existing and new regulations to ensure they comply with specific requirements (e.g., “eliminate drafting errors and ambiguity” and “provide a clear legal standard for affected conduct rather than a general standard”) to improve regulatory drafting in order to reduce needless litigation. In conducting the reviews, agencies must “make every reasonable effort” to ensure that the rule meets specific objectives (e.g., specifies in clear language the preemptive or retroactive effect, if any). Agencies must determine that the rule meets the applicable standards or that it is unreasonable to meet one or more of those standards. Yes. See § 6 for relevant text: "The term 'agency' shall be defined as that term is defined in section 105 of title 5, United States Code."
EO 13045 - Protection of Children from Environmental Health Risks and Safety Risks 1997 - Clinton Policy. With respect to its rules, “to the extent permitted by law and appropriate, and consistent with the agency’s mission,” each agency must “address disproportionate risks to children that result from environmental health risks or safety risks.”

Analysis. For any substantive rulemaking action that “is likely to result in” an economically significant rule that concerns “an environmental health risk or safety risk that an agency has reason to believe may disproportionately affect children,” the agency must provide OMB/OIRA:

  1. Evaluation: “an evaluation of the environmental health or safety effects [attributable to products or substances that the child is likely to come in contact with or ingest] of the planned regulation on children.”
  2. Alternatives: “an explanation of why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the agency.”
Yes. See § 1–102 for relevant text: "Each independent regulatory agency is encouraged to participate in the implementatoin of this order and comply with its provisions."
EO 13132 - Federalism 1999 - Clinton See 13132 table   See 13132 table  
EO 13175 - Consultation and Coordination with Indian Tribal Governments 2000 - Clinton See 13175 table See 13175 table
EO 13211 - Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use 2001 - Bush Statement of Energy Effects. Agencies are required to prepare and submit to OIRA a Statement of Energy Effects for significant energy actions, to the extent permitted by law.

Significant Energy Action. A “significant energy action” is one that is “significant” under EO 12866 and is likely to have a significant adverse energy effect. Additionally, actions designated by the OIRA Administrator as “significant energy actions” are significant energy actions.

Contents of Statement. Agencies must provide a detailed statement of “any adverse effects on energy supply, distribution, or use (including a shortfall in supply, price increases, and increased use of foreign supplies)” for the action and reasonable alternatives and their effects.  

Publication. Agencies must publish the Statement or a summary in the related NPRM and final rule.

Yes. See § 4(b)(2) for relevant text: "'Agency' means any authority of the United States . . . other than those considered to be independent regulatory agencies . . . ."
EO 13272 - Proper Consideration of Small Entities in Agency Rulemaking 2002 - Bush Advocacy Review. Agencies must “notify” Advocacy of draft rules that may have a significant economic impact on a substantial number of small entities when the draft rule is submitted to OIRA under EO 12866 or, if submission to OIRA is not required, “at a reasonable time prior to publication of the rule.” Advocacy is authorized to submit comments on the draft rule.

Consideration of Advocacy Comments. Agencies must give “every appropriate consideration” to any Advocacy comments on a draft rule. If consistent with legal requirements, agencies must include in final rule preambles their response to any written Advocacy comments on the proposed rule, unless the agency head certifies that the public interest is not served by such action.

Agency Procedures. Agencies must issue written procedures ensuring that the potential impact of their draft rules on small businesses, small governmental jurisdictions, and small organizations are “properly considered.”

Yes. See § 4 for relevant text: "Terms defined in section 601 of title 5 . . . including the term 'agency,' shall have the same meaning in this order."
EO 13563 - Improving Regulation and Regulatory Review 2011 - Obama General Principles. This EO supplements and reaffirms EO 12866, stressing that, to the extent permitted by law, each agency must ensure that the benefits of its rulemaking actions justify their costs, tailor their regulations to impose the least burden, consider cumulative burdens, maximize net benefits, use performance objectives, and assess available alternatives.

Public Participation. Agencies must provide a “meaningful opportunity” for public comment (generally 60 days) through the internet, with “timely” and easy access to all “pertinent” documents. Prior to issuing NPRMs, agencies should seek “the views of those likely to be affected,” when “feasible and appropriate.”

Integration and Innovation. Each agency must promote “coordination, simplification, and harmonization” across agencies to reduce redundant, inconsistent, or overlapping rules. Agencies must also seek to achieve goals “designed to promote innovation.”

Flexible Approaches. Agencies must consider “approaches that reduce burdens and maintain flexibility and freedom of choice.”

Objectivity with regard to scientific information. Agencies must “ensure the objectivity of any scientific and technological information and processes” supporting their rulemaking.

Retrospective Analysis. Agencies must consider how best to promote retrospective analysis of rules. They must have a plan to “periodically review” their existing significant regulations to make them “more effective or less burdensome.”

Yes. See § 7(a) for relevant text: "For purposes of this order, 'agency' shall have the meaning set forth in section 3(b) of [EO] 12866."
EO 13579 - Regulation and Independent Regulatory Agencies 2011 - Obama Independent regulatory agencies should promote EO 13563's goal of protecting “public health, welfare, safety, and our environment while promoting economic growth, innovation, competitiveness, and job creation,” and should comply with the provisions of EO 13563. Independent regulatory agencies should conduct retrospective analyses of rules to determine if they are “outmoded, ineffective, insufficient, or excessively burdensome.” Each independent agency should publish their analyses online when possible, and develop a plan within 120 days of the EO's issuance to periodically review its regulations to determine if any should be “modified, streamlined, expanded, or repealed.” Yes. The EO is entirely geared toward independent agencies.
EO 13609 - Promoting International Regulatory Cooperation 2012 - Obama Every agency must include in its Regulatory Plan under EO 12866 (if required to submit one) a summary of international regulatory cooperation activities. All agencies must also ensure that regulations with international impacts are designated as such in the Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda), on, and on Additionally, agencies must consider reforming significant regulations that create “unnecessary differences” between U.S. and international regulatory systems. Agencies are also required to consider any regulatory approaches abroad that the U.S. has agreed to consider under a regulatory cooperation council work plan. Yes. See § 4(a): "'Agency' means any authority of the United States that is an 'agency' . . . other than those considered to be independent regulatory agencies, as defined in 44 U.S.C. 3502(5)"; and § 5: "Independent reegulatory agencies are encouraged to comply with the provisions of this order" for relevant text.
EO 13610 - Identifying and Reducing Regulatory Burdens 2012 - Obama Agencies are instructed to institutionalize regular reviews of their previously issued significant regulations and take additional steps to increase public participation in retrospective review of regulations. Agencies shall regularly (on the second Monday of January and July of each year) report on the status of their retrospective review efforts to OIRA. Reports should contain: progress on review, anticipated accomplishments, and proposed timelines. Agencies must make available to the public the final reports within three weeks from the date of submission of the draft report to OIRA. Yes. See § 5(b) for relevant text: "'[A]gency means any authority of the United States that is an 'agency' . . . other than those considered to be independent regulatory agencies, as defined in 44 U.S.C. 3502(5)."
EO 13725 - Steps to Increase Competition and Better Inform Consumers and Workers to Support Continued Growth of the American Economy 2016 - Obama Agencies must identify specific actions they can take to address “undue burdens” on competition, via pro-competitive rulemaking and regulations. Semiannual reports to the National Economic Council on actions meant to promote greater competition are also required.   Yes. See § 3(b) for relevant text: "Independent agencies are strongly encouraged to comply with the requirements of this order."
EO 14094 - Modernizing Regulatory Review 2023 - Biden Agencies should affirmatively promote public participation in rulemaking and proactively engage interested parties. Regulatory analysis should recognize distributive impacts and equity. No.

Other White House Bulletins and Memoranda


History of Presidential Oversight of Rulemaking and Regulation

Presidential oversight of regulation is not a recent innovation. It has been in effect, in one form or another, since 1971, and it accompanied a major expansion in the scope and complexity of federal regulation that occurred in the 1960s and 1970s when a number of important social and environmental regulatory statutes were enacted.

In June 1971, President Nixon established a “Quality of Life Review” program, under which all “significant” draft proposed and final rules were submitted to the Office of Management and Budget (OMB), which circulated them to other agencies for comment. Agencies were required to submit a summary of their proposals, a description of the alternatives that had been considered, and a cost comparison of alternatives. In practice, this program applied to rules pertaining to environmental quality, consumer protection, and occupational health and safety.

In 1974, President Ford issued an executive order requiring executive branch agencies to prepare an “inflation impact statement” for each “major” federal action. The order empowered the Director of OMB to administer the program, with authority to delegate functions to other agencies, including the Council on Wage and Price Stability (COWPS). Under the Inflation Impact Statement program, agencies were required to prepare an inflation impact statement (IIS) for “major” rules prior to publication of the notice of proposed rulemaking (NPRM), and then to forward a summary of the IIS to COWPS upon publication of the NPRM. COWPS would review the IIS and, in its discretion, offer informal criticism of the proposal or participate in the public proceedings on the rule.

President Carter continued presidential review of agency rules by means of Executive Order 12044, Improving Government Regulations, issued in 1978. Under the order, executive agencies were required to: (1) publish semi-annual agendas, describing and giving the legal bases for, any “significant” regulations under development by the agency; (2) establish procedures to identify “significant” rules, to evaluate their need, and to have the agency head assure that the “least burdensome of the acceptable alternatives” was proposed; and (3) prepare a “regulatory analysis” that examined the cost-effectiveness of alternative regulatory approaches for “major rules.”

President Carter also established a Regulatory Analysis Review Group to review the regulatory analyses prepared for a limited number of proposed “major” rules and to submit comments on the proposed rules during the public comment period. He created another rulemaking review body, the Regulatory Council, which was charged with coordinating agency rulemaking to avoid duplication of effort or conflicting policy in regulation of any area. These efforts to coordinate agency rulemaking were challenged unsuccessfully in several lawsuits.

President Reagan acted quickly after taking office to increase control over executive branch rulemaking. On February 17, 1981, the President issued an executive order on federal regulations designed “to reduce the burdens of existing and future regulations, increase agency accountability for regulatory actions, provide for presidential oversight of the regulatory process, minimize duplication and conflict of regulations, and insure well-reasoned regulations.” The new Executive Order 12291, Federal Regulation, replaced Executive Order 12044, which President Reagan said had “proven ineffective.”

Executive Order 12291 contained both substantive requirements and procedural steps to be followed in the development and promulgation of new rules. The Office of Information and Regulatory Affairs (OIRA) in OMB was given responsibility for implementing Executive Order 12291. OMB’s rulemaking review function is supplemented by the powers it was given in the Paperwork Reduction Act of 1980, by which Congress statutorily established OIRA to, among other things, review and approve or disapprove agency “information collection requests.”

The Office of Legal Counsel in the U.S. Department of Justice issued an opinion supporting the validity of Executive Order 12291. The opinion stated that the President’s authority to issue the order was based on his constitutional power to “take care that the laws be faithfully executed.” While concluding that any inquiry into Congressional intent in enacting specific rulemaking statutes “will usually support the legality of presidential supervision of rulemaking by Executive Branch agencies,” the opinion stated that presidential supervision of agency rulemaking “is more readily justified when it does not purport wholly to displace, but only to guide and limit, discretion which Congress had allocated to a particular subordinate official.”

Despite criticism of this new form of presidential review, President Reagan began his second term by expanding the program through Executive Order 12498, Regulatory Planning Process, which established a “regulatory planning process” with the purpose of helping to “ensure that each major step in the process of rule development is consistent with Administration policy.”

According to OMB, the problem with regulatory review under Executive Order 12291 was that such review “often came late in the regulatory process, after huge investments of agency time and resources, and often after agency staff commitments to constituents had made it extremely difficult to consider any legally acceptable, but previously ignored, regulatory alternative.” This resulted, OMB said, in the “bureaucracy often present[ing] agency heads with faits accompli.”

Executive Order 12498’s regulatory planning process was designed to avoid this problem. Under this procedure, the head of each agency was required to determine at the beginning of the regulatory process whether a proposed regulatory venture was “consistent with the goals of the Administration.” At the beginning of the year, Agency heads were to develop a plan for managing the agency’s most significant regulatory actions. OMB then reviewed the plan for consistency with the administration’s program and published the coordinated agency plans in a government-wide document. This document, entitled “Regulatory Program of the United States Government,” governed more than 20 major rulemaking agencies and was published each year during the second Reagan term and the Bush administration to inform Congress and the public of the government’s regulatory plans.

President Reagan, in 1987 and 1988, issued three additional executive orders, dealing with federalism, interference with property rights (which is still in effect), and the family. OMB was given a role in ensuring coordination of regulatory policy in these areas. President Bush basically continued the program of presidential review of agency rulemaking established by President Reagan, although due to congressional opposition to OIRA actions, President Bush’s nominee to head OIRA was not confirmed. To counter this weakening of OIRA’s authority, President Bush created the Council on Competitiveness, headed by Vice President Quayle, and gave it authority to intervene in major agency rulemakings. Several of the Council’s interventions provoked intense criticisms leading up to the 1992 elections.

The Clinton Executive Order—Executive Order 12866

With the election of President Clinton, one of his first actions was an attempt to reestablish some bipartisan consensus on rulemaking review. His nominee as OIRA Administrator was the first subcabinet nominee to be appointed. Following the example of the Reagan Administration, President Clinton then set out to redraft the extant Executive Order and produced Executive Order 12866, Regulatory Planning and Review, on September 30, 1993. This Executive Order, which remains operative, carries over many of the principles of Executive Order 12291 and Executive Order 12498 and made some significant modifications that simplified the process, made it more selective, and introduced more transparency into the OMB/agency consultations. In drafting this Executive Order, the Clinton Administration followed many of the suggestions in ACUS Recommendation 88-9.

The Executive Order begins with a lengthy “Statement of Regulatory Philosophy and Principles,” which are quite similar to those in Executive Order 12291 except that it specifies that measurement of costs and benefits should include both quantifiable and qualitative measures. As with previous Orders, Executive Order 12866 retains the traditional (since 1978) level of $100 million annual effect on the economy for those major rules (now referred to as “economically significant” rules) that must be accompanied by cost-benefit assessments when forwarded to OIRA as proposed and final rules.

Executive Order 12866 also retains the OIRA review process for other rules, although it only requires that “significant regulatory actions” be subject to review. This includes those $100 million rules plus others that have material adverse effects on “the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities.” It also includes rules that may materially alter the budgetary impact of benefit programs or the rights of recipients, that raise “novel legal or policy issues,” or are inconsistent or interfere with actions taken by another agency. The process established for identifying such “significant regulatory actions” relies on agency identification of them in the first instance, vetted by OIRA. Rules that are not so identified may be issued without OIRA review. This selectivity streamlined the review process considerably and made it possible to include, for the first time, a deadline (of 90 days, with one 30-day extension allowed) for completion of OIRA review. In the event of an unresolved dispute between OIRA and the agency, the Vice President is directed to make the decision (or recommend one to the President).

The review process set forth in the Executive Order made significant improvements in transparency. Following an ACUS recommendation closely, it provides that after the agency has concluded its rulemaking it should make available to the public all submissions to OIRA and identify all changes made in the rule, noting those made at the behest of OIRA. In addition, OIRA, for its part, must regularize the way it receives any outside communications concerning an agency rule that is subject to review. Only the Administrator or her designee may receive such communications. OIRA must forward any such communications to the agency within ten days, invite agency officials to any meetings held with outsiders, and maintain a public log of all such contacts. At the end of the proceeding OIRA must also make available all documents exchanged with the agency.

In place of the Reagan Executive Order 12498 on regulatory planning, the Clinton Order establishes its own yearly planning mechanism. It continues the semiannual publication of the Unified Agenda of Regulatory and Deregulatory Actions, which lists all proposed, pending, and completed regulatory and deregulatory actions. And it requires that the October Agenda contain each agency’s annual Regulatory Plans, which must be approved personally by the agency head. These plans must be forwarded to OIRA (and then on to affected agencies, the Vice President and a group of named high-level White House Advisors) by June 1 of each year. The plans are supposed to also include agency determinations on which existing rules are to be reviewed and reconsidered during the ensuing year and “preliminary estimates of the anticipated costs and benefits” of each rule planned for that calendar year. These actions do not represent any sharp break from the practices of previous administrations. However, Executive Order 12866 is a departure in one regard—for the first time the independent regulatory agencies are specifically directed to comply with the planning and agenda provisions (though not with the rule-review process).

The Clinton Executive Order was generally well received by most observers of the regulatory scene. Its basic approach has remained fundamentally unchanged since its issuance, and OIRA has worked out a stable and workable relationship with the agencies in administering it. The once rather vibrant legal and policy debate over the pros and cons of presidential review has gradually evolved into a fairly broad agreement that it is legal and, if properly administered, is essential to effective executive branch management. Nevertheless, there has been some serious criticism of OIRA’s failure to meet the deadlines set in the Order.

President Clinton also issued a presidential directive on plain language and number of other executive orders that remain in effect concerning: environmental justice in minority populations and low-income populations (Executive Order 12898), civil justice reform (Executive Order 12988), protection of children from environmental risks (Executive Order 13045), federalism (Executive Order 13132), and consultation with Indian Tribal Governments (Executive Order 13175).

President Bush continued the use of Executive Order 12866, although he did make several significant changes. In 2002, he made some small changes in Executive Order 13258, Amending Executive Order 12866 on Regulatory Planning and Review, basically removing the Vice President from the process. In January 2007, in Executive Order 13422, Further Amendment to Executive Order 12866 on Regulatory Planning and Review, he made more fundamental changes. Most significantly he added a requirement that “significant guidance documents” also be reviewed by OIRA in a way similar to significant regulatory actions. He also required that agencies identify in writing specific “market failures” that necessitate a rulemaking, that agency Regulatory Policy Officers be presidential appointees, that these officers must approve the Regulatory Plan, that aggregate costs and benefits for all rules must be included in the Regulatory Plan, and that agencies consider whether to use “formal” (“on the record”) rulemaking for “complex determinations.” However, as mentioned below, President Obama, upon assuming office, revoked the Bush changes and reinstated the original Clinton order. However, by later memorandum, the requirement that significant guidance documents be reviewed by OIRA was reinstated.

OIRA did issue a memorandum in September 2001 putting its own stamp on the Executive Order 12866 process. The memorandum describes the “general principles and procedures that will be applied by OMB in the implementation of Executive Order 12866 and related statutory and executive authority.”

Significantly, during the Bush Administration, OIRA also announced several new initiatives in its review process. First, it made extensive use of its website to publish its guidelines and other information pertaining to its review process and specific rule reviews. This continues today. Second, it began the practice of issuing public “return letters” that send rules back to the agency for reconsideration, “review letters” that comment on aspects of a particular rule review, and “prompt letters,” which are sent on OMB’s initiative and contain suggestions for new or stronger regulations. While these letters are still posted on, the Obama and the Trump Administrations have made little use of this practice.

More importantly, during the Bush Administration, OMB issued four far-reaching documents affecting the regulatory process that remain in effect today. In 2003 it issued a revised OMB Circular A-4, which provides guidance on the development of regulatory analyses. OMB also issued a more far-reaching and controversial Peer Review Bulletin in December 2004, which requires administrative agencies to conduct a peer review on all “influential regulatory information that the agency intends to disseminate.” Finally, in 2007, OMB issued an important new government-wide Bulletin on Good Guidance Practices. OMB also (along with the Office of Science and Technology Policy) issued a set of Updated Principles for Risk Analysis. In so doing it declined to finalize a Proposed Risk Assessment Bulletin that the two agencies had issued in January 2006, in favor of updating the Clinton Administration’s Principles issued in 1995. Finally, President Bush issued two other executive orders concerning regulations that remain in effect today: (1) analysis of adverse effects on energy supply, distribution, or use (Executive Order 13211) and (2) proper consideration of small entities in agency rulemaking (Executive Order 13272).

Developments in the Obama Administration

Shortly after taking office, President Obama revoked the Bush Amendments to Executive Order 12866 and directed the Director of OMB, in consultation with regulatory agencies, to produce a set of recommendations for a new executive order on federal regulatory review within 100 days, followed by an unusual request for public comments on the same subject. Almost 200 public comments were received.

After about a year of internal consideration, the White House finally settled on its approach to OMB review—basically to reaffirm Executive Order 12866—with Executive Order 13563, Improving Regulation and Regulatory Review on January 18, 2011. In Section 1(b), the Order stated: “This order is supplemental to and reaffirms the principles, structures, and definitions governing contemporary regulatory review that were established in Executive Order 12866.”

It did contain a few new mandates and points of emphasis. Most notably, agencies were urged (as appropriate and within legal constraints) to (1) consider “values that are difficult or impossible to quantify, including equity, human dignity, fairness, and distributive impacts”; (2) “afford the public a meaningful opportunity to comment through the Internet on any proposed regulation, with a comment period that should generally be at least 60 days”; (3) “provide, for both proposed and final rules, timely online access to the rulemaking docket on, including relevant scientific and technical findings, in an open format that can be easily searched and downloaded”; (4) for proposed rules, provide “an opportunity for public comment on all pertinent parts of the rulemaking docket, including relevant scientific and technical findings”; (5) seek public input from affected persons “[b]efore issuing a notice of proposed rulemaking”; (6) “identify and consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice”; (7) “promote retrospective analysis of rules that may be outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned”; and (8) “[w]ithin 120 days of the date of this order, . . . develop and submit to [OIRA] a preliminary plan” for periodically reviewing “its existing significant regulations to determine whether any such regulations should be modified, streamlined, expanded, or repealed so as to make the agency’s regulatory program more effective or less burdensome in achieving the regulatory objectives.”

The one action mandate in the new Executive Order was for agencies to develop plans for retrospective review of their existing regulations. On May 26, 2011, the OIRA Administrator announced the results of this effort. On July 11, 2011, President Obama issued Executive Order 13579, Regulation and Independent Regulatory Agencies, which extended the terms of Executive Order 13563 to independent regulatory agencies. On September 15, 2015, President Obama issued Executive Order 13707, Using Behavioral Science Insights to Better Serve the American People. Noting the value of insights from behavioral science to improve the “effectiveness and efficiency of Government.”

Developments in the Trump Administration

Shortly after taking office, President Trump issued Executive Order 13771, Reducing Regulation and Controlling Regulatory Costs, which requires agencies to identify at least two regulations to be repealed for every proposed or promulgated regulation. The cost of each new regulation must be fully offset by the repeal specified above, and the agency must provide an approximation of the total costs or savings associated with each new regulation or repealed regulation. All regulations must be included in the Unified Agenda, and during the federal budget process, the OMB Director must identify to agencies a total amount of incremental costs of regulations permitted for that fiscal year. The order directed the Director of OMB to provide agency heads with guidance addressing the processes for measuring regulatory costs, the costs of existing regulations, what qualifies as new and offsetting regulations, and situations that would require waivers of the order’s requirements. OIRA issued Guidance Implementing Executive Order 13771, Titled “Reducing Regulation and Controlling Regulatory Costs” to assist agencies in carrying out these requirements.

President Trump also issued Executive Order 13777, Enforcing the Regulatory Reform Agenda. This order requires the head of each agency to designate an official as its Regulatory Reform Officer (RRO) who would implement initiatives and policies including Executive Order 13771, Executive Order 12866, and Section 6 of Executive Order 13563 regarding retrospective review. All agencies must also form a Regulatory Reform Task Force made up of the RRO, the Regulatory Policy Officer, a representative from the central policy office, and three senior agency officials if the agency is listed in 31 U.S.C. § 901(b)(1) (the executive departments, EPA, and NASA), which “shall evaluate existing regulations . . . and make recommendations to the agency head regarding their repeal, replacement, or modification.” In making these determinations, the task forces should focus on regulations that (1) “eliminate jobs, or inhibit job creation;” (2) “are outdated, unnecessary, or ineffective;” (3) “impose costs that exceed benefits;” (4) “create serious inconsistency or otherwise interfere with regulatory initiatives and policies;” (5) “are inconsistent with the requirements of section 515 of the Treasury and General Government Appropriations Act, 2001, . . . in particular those regulations that rely in whole or in part on data, information, or methods that are not publicly available or that are insufficiently transparent to meet the standard for reproducibility; or” (6) “derive from or implement Executive Orders or other Presidential directives that have been subsequently rescinded or substantially modified.” The Executive Order also requires agency heads to prioritize regulations that the Regulatory Reform Task Force identifies as outdated, unnecessary, or ineffective when implementing regulatory offsets under Executive Order 13771.

Finally, President Trump issued Executive Order 13783, Promoting Energy Independence and Economic Growth, which directs agencies to review regulations that “potentially burden the development or use of domestically produced energy resources and appropriately suspend, revise, or rescind those that unduly burden the development of domestic energy resources.” This order also revoked Executive Order 13653, Preparing the United States for the Impact of Climate Change, and memoranda under the Obama Administration related to climate change.

Developments in the Biden Administration

Within his first two months in office, President Biden rescinded several of President Trump’s executive orders related to the rulemaking process. In addition, President Biden issued a memorandum titled Modernizing Regulatory Review. This memorandum explicitly reaffirms Executive Orders 12,866 and 13,563. Additionally, it directs the OMB Director to work with agencies to produce a set of recommendations that improves and modernizes regulatory review. The memorandum specifies that these recommendations should include concrete suggestions on how the regulatory review process can “promote public health and safety, economic growth, social welfare, racial justice, environmental stewardship, human dignity, equity, and the interests of future generations.” Furthermore, the memorandum specifies that the recommendations should, among other actions, include proposed reforms to Circular A-4 to promote these goals; suggest procedures that take into account distributional impacts in regulatory analyses; propose how OIRA can partner with agencies to “explore, promote, and undertake regulatory initiatives that are likely to yield significant benefits”; and determine an appropriate approach to the review of guidance documents.

On April 6, 2023, President Biden issued Executive Order 14094, Modernizing Regulatory Review, which reaffirmed and amended Executive Order 12,866 § 3(f)’s definition of “significant regulatory action” to require OIRA review for rulemakings having an annual effect on the economy of $200 million or more. It also reaffirmed the Biden Administration’s commitment to distributive analysis and equity, as well as proactive public engagement in rulemaking. In addition to the Executive Order, the Biden Administration also issued revisions to Circulars A-4 and A-94 for public comment, as well as a memorandum regarding implementation of the Executive Order. On July 19, 2023, OMB issued a memorandum for the heads of executive departments and agencies providing guidance for how to implement Executive Order 14094.


Congressional Documents

OMB/OIRA Documents

Reports to Congress on the Costs and Benefits of Regulations

Other OMB Documents

  • Regulatory Program of the United States Government (1987-1988) (and through 1990-91).
  • Report on Executive Order No. 12866, 59 Fed. Reg. 24276 (May 10, 1994).
  • More Benefits Fewer Burdens—Creating a Regulatory System that Works For the American People, A Report to the President on the Third Anniversary of Executive Order 12866 (1996).

ACUS Documents


CRS Documents

  • Maeve P. Carey, RL32240, The Federal Rulemaking Process: An Overview (June 17, 2013).
  • Maeve P. Carey, R41974, Cost-Benefit and Other Analysis Requirements in the Rulemaking Process (Dec. 9, 2014).
  • Vivian S. Chu & Daniel T. Shedd, R42720, Presidential Review of Independent Regulatory Commission Rulemaking: Legal Issues (Sept. 10, 2012).
  • Vivian S. Chu & Daniel T. Shedd, RS20846, Executive Orders: Issuance, Modification, and Revocation (Apr. 6, 2014).
  • Curtis Copeland, RL33862, Changes to the OMB Regulatory Review Process by Executive Order 13422 (Jan. 3, 2008).
  • Curtis Copeland, RL32397, Federal Rulemaking: The Role of the Office of Information and Regulatory Affairs (June 9, 2009).

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