Executive Order 12866 Regulatory Planning and Review October 1993
Ex. Ord. No. 12866, Sept. 30, 1993, 58 F.R. 51735, as amended by
Ex. Ord. No. 13258, Feb. 26, 2002, 67 F.R. 9385
American people deserve a regulatory system that works for
them, not against them: a regulatory system that protects and
improves their health, safety, environment, and well-being and
improves the performance of the economy without imposing
unacceptable or unreasonable costs on society; regulatory
policies that recognize that the
private sector and private markets are the best engine for economic growth; regulatory approaches that
role of State, local, and tribal governments; and regulations
that are effective, consistent, sensible, and understandable.
not have such a regulatory system today.
With this Executive order, the Federal Government begins a program to reform and make more efficient the regulatory process.
The objectives of this Executive order are to enhance planning
with respect to both new and existing regulations; to
reaffirm the primacy of Federal agencies in the regulatory
decision-making process; to restore the integrity and legitimacy
review and oversight; and to make the process more
accessible and open to the public.
In pursuing these objectives, the regulatory process shall be conducted so as to meet
requirements and with due regard to the discretion that has been entrusted to the Federal agencies.
Accordingly, by the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:
Section 1. Statement of Regulatory Philosophy and Principles.
(a) The Regulatory Philosophy. Federal agencies should promulgate only such
regulations as are required by law, are necessary to
interpret the law, or are made necessary by compelling public
need, such as
material failures of private markets to protect or improve
the health and safety of the public, the environment, or the
well-being of the American people.
In deciding whether and how to
regulate, agencies should assess all costs and benefits of
available regulatory alternatives, including the alternative of
not regulating. Costs and benefits shall be understood to include both
quantifiable measures (to the fullest extent that these can be
usefully estimated) and qualitative measures of costs and
are difficult to quantify, but nevertheless essential to
in choosing among alternative regulatory
approaches, agencies should select those approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts;
unless a statute requires another regulatory approach.
(b) The Principles of Regulation. To ensure that the agencies' regulatory programs are consistent with the philosophy set forth above, agencies should adhere to the following principles, to the
extent permitted by law and where applicable:
(1) Each agency shall identify the problem that it intends to address (including, where applicable, the failures of private markets or public institutions that warrant new agency action) as well as assess the significance of that problem.
(2) Each agency shall examine whether existing regulations (or other law) have created, or contributed to, the problem that a
is intended to correct and whether those regulations (or other law) should be modified to achieve the intended goal of regulation more effectively.
(3) Each agency shall identify and assess available alternatives to direct regulation, including providing economic incentives to encourage the desired behavior, such as user fees or marketable
permits, or providing information upon which choices can be made
by the public.
(4) In setting regulatory priorities, each agency shall consider,
to the extent reasonable, the degree and nature of the risks
various substances or activities within its jurisdiction.
(5) When an agency determines that a regulation is the best
available method of achieving the regulatory objective, it shall design its regulations in the most cost-effective manner to
regulatory objective. In
doing so, each agency shall consider incentives for innovation, consistency, predictability, the costs of enforcement and compliance (to the government, regulated entities, and the public), flexibility, distributive impacts, and equity.
(6) Each agency shall assess both the costs and the benefits of
the intended regulation and, recognizing that some costs and
benefits are difficult to quantify, propose or adopt a regulation
only upon a reasoned determination that the benefits of the
intended regulation justify its costs.
(7) Each agency shall base its decisions on the best reasonably
obtainable scientific, technical, economic, and other information
concerning the need for, and consequences of, the intended regulation.
(8) Each agency shall identify and assess alternative forms of
regulation and shall, to the extent feasible, specify performance
objectives, rather than specifying the behavior or manner of compliance that regulated entities must adopt.
(9) Wherever feasible, agencies shall seek views of appropriate
State, local, and tribal officials before imposing regulatory requirements that might significantly or uniquely affect those
governmental entities. Each
agency shall assess the effects of
Federal regulations on State, local, and tribal governments,
including specifically the availability of resources to carry out
those mandates, and seek to minimize those burdens that uniquely
affect such governmental entities, consistent with
achieving regulatory objectives.
In addition, as appropriate, agencies shall seek to harmonize Federal regulatory actions with related State, local, and tribal regulatory and other
(10) Each agency shall avoid regulations that are inconsistent,
incompatible, or duplicative with its other regulations or those
(11) Each agency shall tailor its regulations to impose the least
burden on society, including individuals, businesses of differing
sizes, and other entities (including small communities and governmental entities), consistent with obtaining the regulatory objectives, taking into account, among other things, and to the extent practicable, the costs of cumulative regulations.
(12) Each agency shall draft its regulations to be simple and easy to understand, with the goal of minimizing the potential for
uncertainty and litigation arising from such uncertainty.
. 2. Organization. An efficient regulatory planning and review
process is vital to ensure that the Federal Government's
best serves the American people.
(a) The Agencies. Because Federal agencies are the repositories
of significant substantive expertise and experience, they are responsible for developing regulations and assuring that the regulations are consistent with applicable law, the President's priorities, and the principles set forth in this Executive order.
(b) The Office of Management and Budget. Coordinated review of
agency rulemaking is necessary to ensure that regulations are consistent with applicable law, the President's priorities, and
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.
The Office of Management and
Budget (OMB) shall carry out that review function.
Within OMB, the Office of Information and Regulatory Affairs (OIRA) is the repository of expertise concerning regulatory issues, including methodologies and procedures that affect more than one agency,
order, and the President's regulatory policies.
To the extent
permitted by law, OMB shall provide guidance to agencies and assist the President and regulatory policy advisors to the President in regulatory planning and shall be the entity that reviews individual regulations, as provided by this Executive
(c) Assistance. In fulfilling his responsibilities under this Executive order, the President shall be assisted by the
advisors within the Executive Office of the President and by
such agency officials and personnel as the President may, from
time to time,
Section. 3. Definitions. For purposes of this Executive order:
(a) ''Advisors'' refers to such regulatory policy advisors to the
President as the President may from time to time consult,
including, among others: (1) the Director of OMB; (2) the Chair
member) of the Council of Economic Advisers; (3) the
Assistant to the President for Economic Policy; (4) the Assistant
to the President for Domestic Policy; (5) the Assistant to the
President for National Security Affairs; (6) the Director of the
Office of Science and Technology Policy; (7) the Deputy Assistant
to the President and Director for Intergovernmental Affairs; (8)
the Assistant to the President and Staff Secretary; (9) the
Assistant to the President and Chief of Staff to the Vice
President; (10) the Assistant to the President and Counsel to the
President; (11) the Chairman of the Council on Environmental
Quality and Director of the Office of Environmental Quality; (12)
the Assistant to the President for Homeland Security; and (13)
of OIRA, who also shall coordinate communications
relating to this Executive order among the agencies, OMB, the
and the Office of the Vice President.
(b) ''Agency,'' unless otherwise indicated, means any authority
of the United States that is an ''agency'' under 44 U.S.C.
than those considered to be independent regulatory agencies,
as defined in 44 U.S.C. 3502(10).
(c) ''Director'' means the Director of OMB.
(d) ''Regulation'' or ''rule'' means an agency statement of general applicability and future effect, which the agency intends to have the force and effect of law, that is designed to
or prescribe law or policy or to describe the procedure or practice requirements of an agency.
It does not, however, include:
(1) Regulations or rules issued in accordance with the formal
rulemaking provisions of 5 U.S.C. 556, 557;
(2) Regulations or rules that pertain to a military or foreign affairs function of the United States, other than procurement
regulations and regulations involving the import or export of
non-defense articles and services;
(3) Regulations or rules that are limited to agency organization,
management, or personnel matters; or
(4) Any other category of regulations exempted by the
Administrator of OIRA.
(e) ''Regulatory action'' means any substantive action by an
agency (normally published in the Federal Register) that promulgates or is expected to lead to the promulgation of a final rule or regulation, including notices of inquiry, advance notices of proposed rulemaking, and notices of proposed rulemaking.
(f) ''Significant regulatory action'' means any regulatory action that is likely to result in a rule that may:
(1) Have an annual effect on the economy of $100 million or more
or adversely affect in a material way the economy, a sector of
productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or
(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth
in this Executive order.
Sec. 4. Planning Mechanism. In order to have an effective
regulatory program, to provide for coordination of regulations,
consultation and the resolution of potential conflicts at an early stage, to involve the public and its State, local, and ribal officials in regulatory planning, and to ensure that new
regulations promote the President's priorities and the
principles set forth in this Executive order, these procedures
shall be followed, to the extent permitted by law:
(a) Agencies' Policy Meeting. Early in each year's planning cycle, the Director shall convene a meeting of the Advisors and
the heads of
agencies to seek a common understanding of priorities and to coordinate regulatory efforts to be accomplished in the
(b) Unified Regulatory Agenda. For purposes of this subsection,
the term ''agency'' or ''agencies'' shall also include those considered to be independent regulatory agencies, as defined in
3502(10). Each agency shall prepare an agenda of all
regulations under development or review, at a time and in a
by the Administrator of OIRA. The description of each
regulatory action shall contain, at a minimum, a regulation
identifier number, a brief summary of the action, the legal
authority for the action, any legal deadline for the action, and
the name and telephone number of a knowledgeable agency official.
Agencies may incorporate the information required under 5 U.S.C. 602 and (former) 41 U.S.C. 402 into these agendas.
(c) The Regulatory Plan. For purposes of this subsection, the
term ''agency'' or ''agencies'' shall also include those
be independent regulatory agencies, as defined in 44 U.S.C.
3502(10). (1) As part of the Unified Regulatory Agenda, beginning
in 1994, each agency shall prepare a Regulatory Plan (Plan) of
important significant regulatory actions that the agency reasonably expects to issue in proposed or final form in that fiscal year or thereafter. The
Plan shall be approved personally
by the agency head and shall contain at a minimum:
(A) A statement of the agency's regulatory objectives and
priorities and how they relate to the President's
(B) A summary of each planned significant regulatory action
including, to the extent possible, alternatives to be considered and preliminary estimates of the anticipated costs and benefits;
(C) A summary of the legal basis for each such action, including
whether any aspect of the action is required by statute or court order;
(D) A statement of the need for each such action and, if
applicable, how the action will reduce risks to public health, safety, or the environment, as well as how the magnitude of the
risk addressed by the action relates to other risks within the
jurisdiction of the agency;
(E) The agency's schedule for action, including a statement of
any applicable statutory or judicial deadlines; and
(F) The name, address, and telephone number of a person the
public may contact for additional information about the planned
(2) Each agency shall forward its Plan to OIRA by June 1st of
(3) Within 10 calendar days after OIRA has received an agency's
Plan, OIRA shall circulate it to other affected agencies and the
(4) An agency head who believes that a planned regulatory action
of another agency may conflict with its own policy or action
planned shall promptly notify, in writing, the Administrator of
OIRA, who shall forward that communication to the issuing agency
and the Advisors.
(5) If the Administrator of OIRA believes that a planned
regulatory action of an agency may be inconsistent with the
President's priorities or the principles set forth in this
Executive order or may be in conflict with any policy or action
taken or planned by another agency, the Administrator of OIRA
notify, in writing, the affected agencies and the
(6) The Director may consult with the heads of agencies with
respect to their Plans and, in appropriate instances, request
further consideration or inter-agency coordination.
(7) The Plans developed by the issuing agency shall be published
annually in the October publication of the Unified Regulatory
Agenda. This publication shall be made available to the Congress;
State, local, and tribal governments; and the public.
Any views on any
aspect of any agency Plan, including whether any planned
regulatory action might conflict with any other planned or
impose any unintended consequences on the public, or confer any unclaimed benefits on the public, should be directed
to the issuing
agency, with a copy to OIRA.
(d) Regulatory Working Group. Within 30 days of the date of this
Executive order, the Administrator of OIRA shall convene a Regulatory Working Group (''Working Group''), which shall consist of representatives of the heads of each agency that the Administrator determines to have significant domestic regulatory responsibility and the Advisors. The Administrator of OIRA shall chair the Working Group and shall periodically advise the
Director on the
activities of the Working Group. The Working Group shall serve as a forum to assist agencies in identifying and analyzing
important regulatory issues (including, among others (1) the
development of innovative regulatory techniques, (2) the methods,
efficacy, and utility of comparative risk assessment in
and (3) the development of short forms and other
streamlined regulatory approaches for small businesses and other
entities).The Working Group shall meet at least quarterly and may
meet as a whole or in subgroups of agencies with an interest in
particular issues or subject areas. To inform its discussions, the
Working Group may commission analytical studies and reports by
OIRA, the Administrative Conference of the United States, or any
(e) Conferences. The Administrator of OIRA shall meet quarterly
with representatives of State, local, and tribal governments to identify both existing and proposed regulations that may uniquely
or significantly affect those governmental entities.
of OIRA shall also convene, from time to time, conferences with representatives of businesses, nongovernmental
organizations, and the public to discuss regulatory issues of
Section . 5. Existing Regulations. In order to reduce the regulatory burden on the American people, their families, their communities, their State, local, and tribal governments, and their industries; to determine whether regulations promulgated by the executive branch of the Federal Government have become unjustified or unnecessary as a result of changed circumstances; to confirm that regulations are both compatible with each other and not duplicative or inappropriately burdensome in the aggregate; to ensure that all regulations are consistent with the President's priorities and the principles set forth in this Executive order, within applicable law; and to otherwise improve the effectiveness of existing regulations:
Within 90 days of the date of this Executive
order, each agency shall submit to OIRA a program, consistent
resources and regulatory priorities, under which the agency
will periodically review its existing significant regulations to
determine whether any such regulations should be modified or
eliminated so as to make the agency's regulatory program more
effective in achieving the regulatory objectives, less
in greater alignment with the President's priorities and the
principles set forth in this Executive order.
regulations selected for review shall be included in the agency's
annual Plan. The agency shall also identify any legislative
mandates that require the agency to promulgate or
continue to impose
regulations that the agency believes are unnecessary or
outdated by reason of changed circumstances.
(b) The Administrator of OIRA shall work with the Regulatory
Working Group and other interested entities to pursue the
objectives of this section.
State, local, and tribal governments
are specifically encouraged to assist in the identification of
regulations that impose significant or unique burdens on those
governmental entities and that appear to have outlived their
justification or be otherwise inconsistent with the public
(c) The Director, in consultation with the Advisors, may identify
for review by the appropriate agency or agencies other existing
regulations of an agency or groups of regulations of more than
one agency that
affect a particular group, industry, or sector of the
economy, or may identify legislative mandates that may be
appropriate for reconsideration by the Congress.
Sec. 6. Centralized Review of Regulations. The guidelines set
forth below shall apply to all regulatory actions, for both new
regulations, by agencies other than those agencies
specifically exempted by the Administrator of OIRA:
(a) Agency Responsibilities. (1) Each agency shall (consistent
with its own rules, regulations, or procedures) provide the
meaningful participation in the regulatory process.
before issuing a notice of proposed rulemaking, each
agency should, where appropriate, seek the involvement of those
intended to benefit from and those expected to be burdened by
any regulation (including, specifically, State, local, and tribal
officials). In addition, each agency should afford the public a
meaningful opportunity to comment on any proposed regulation,
which in most
cases should include a comment period of not less than 60 days. Each agency
also is directed to explore and, where
appropriate, use consensual mechanisms for developing
(2) Within 60 days of the date of this Executive order, each
agency head shall designate a Regulatory Policy Officer who shall
report to the agency head. The
Regulatory Policy Officer shall be
involved at each stage of the regulatory process to foster the
development of effective, innovative, and least burdensome
regulations and to further the principles set forth in this
(3) In addition to adhering to its own rules and procedures and
to the requirements of the Administrative Procedure Act (5 U.S.C.
551 et seq., 701 et seq.), the Regulatory Flexibility Act (5
U.S.C. 601 et
seq.), the Paperwork Reduction Act (44 U.S.C. 3501 et seq.),
and other applicable law, each agency shall develop its
in a timely fashion and adhere to the following procedures
with respect to a regulatory action:
(A) Each agency shall provide OIRA, at such times and in the
manner specified by the Administrator of OIRA, with a list of its
planned regulatory actions, indicating those which the agency
believes are significant regulatory actions within the meaning of
this Executive order. Absent
a material change in the development
of the planned regulatory action, those not designated as
significant will not be subject to review under this section
unless, within 10 working days of receipt of the list, the
Administrator of OIRA notifies the agency that OIRA has
a planned regulation is a significant regulatory action within
the meaning of this Executive order.
The Administrator of OIRA may
waive review of any planned regulatory action designated by the
agency as significant, in which case the agency need not further
comply with subsection (a)(3)(B) or subsection (a)(3)(C) of this
(B) For each matter identified as, or determined by the Administrator of OIRA to be, a significant regulatory action, the
issuing agency shall provide to OIRA:
(i) The text of the draft regulatory action, together with a
reasonably detailed description of the need for the regulatory
action and an explanation of how the regulatory action will meet
that need; and
(ii) An assessment of the potential costs and benefits of the
regulatory action, including an explanation of the manner in
regulatory action is consistent with a statutory mandate and,
to the extent permitted by law, promotes the President's
avoids undue interference with State, local, and tribal
governments in the exercise of their governmental functions.
(C) For those matters identified as, or determined by the
Administrator of OIRA to be, a significant regulatory action
scope of section 3(f)(1), the agency shall also provide to OIRA
the following additional information developed as part of the
agency's decision-making process (unless prohibited by law):
(i) An assessment, including the underlying analysis, of benefits
anticipated from the regulatory action (such as, but not limited
to, the promotion of the efficient functioning of the economy and
private markets, the enhancement of health and safety, the
protection of the natural environment, and the elimination or
reduction of discrimination or bias) together with, to the extent
feasible, a quantification of those benefits;
(ii) An assessment, including the underlying analysis, of costs
anticipated from the regulatory action (such as, but not limited
to, the direct cost both to the government in administering the
regulation and to businesses and others in complying with the
regulation, and any adverse effects on the efficient functioning
of the economy,
private markets (including productivity, employment,
and competitiveness), health, safety, and the natural
with, to the extent feasible, a quantification of those
(iii) An assessment, including the underlying analysis, of costs
and benefits of potentially effective and reasonably feasible
alternatives to the planned regulation, identified by the
agencies or the
public (including improving the current regulation and
reasonably viable nonregulatory actions), and an explanation why
the planned regulatory action is preferable to the identified
(D) In emergency situations or when an agency is obligated by law
to act more quickly than normal review procedures allow, the
notify OIRA as soon as possible and, to the extent
practicable, comply with subsections (a)(3)(B) and (C) of this
section. For those
regulatory actions that are governed by a
statutory or court-imposed deadline, the agency shall, to the
extent practicable, schedule rulemaking proceedings so as to
time for OIRA to conduct its review, as set forth below
in subsection (b)(2) through (4) of this section.
(E) After the regulatory action has been published in the Federal
Register or otherwise issued to the public, the agency shall:
(i) Make available to the public the information set forth in
subsections (a)(3)(B) and (C);
(ii) Identify for the public, in a complete, clear, and simple
manner, the substantive changes between the draft
submitted to OIRA for
review and the action subsequently announced; and
(iii) Identify for the public those changes in the regulatory
action that were made at the suggestion or recommendation of
(F) All information provided to the public by the agency shall be
in plain, understandable language.
(b) OIRA Responsibilities. The Administrator of OIRA shall
provide meaningful guidance and oversight so that each agency's
regulatory actions are consistent with applicable law, the
President's priorities, and the principles set forth in this
Executive order and do not conflict with the policies or actions
agency. OIRA shall, to the extent permitted by law, adhere
to the following guidelines:
(1) OIRA may review only actions identified by the agency or by
OIRA as significant regulatory actions under subsection (a)(3)(A)
of this section.
(2) OIRA shall waive review or notify the agency in writing of
the results of its review within the following time periods:
(A) For any notices of inquiry, advance notices of proposed
rulemaking, or other preliminary regulatory actions prior to a
Notice of Proposed Rulemaking, within 10 working days after the
date of submission of the draft action to OIRA;
(B) For all other regulatory actions, within 90 calendar days
after the date of submission of the information set forth in subsections (a)(3)(B) and (C) of this section, unless OIRA has previously reviewed this information and, since that review,
there has been
no material change in the facts and circumstances upon
which the regulatory action is based, in which case, OIRA shall
complete its review within 45 days; and
(C) The review process may be extended (1) once by no more than 30 calendar days upon the written approval of the Director and
(2) at the
request of the agency head.
(3) For each regulatory action that the Administrator of OIRA
returns to an agency for further consideration of some or all of
its provisions, the Administrator of OIRA shall provide the
a written explanation for such return, setting forth the
pertinent provision of this Executive order on which OIRA is
relying. If the
agency head disagrees with some or all of the
bases for the return, the agency head shall so inform the
Administrator of OIRA in writing.
(4) Except as otherwise provided by law or required by a Court,
in order to ensure greater openness, accessibility, and
accountability in the regulatory review process, OIRA shall be
governed by the following disclosure requirements:
(A) Only the Administrator of OIRA (or a particular designee)
shall receive oral communications initiated by persons not
employed by the
executive branch of the Federal Government regarding the
substance of a regulatory action under OIRA review;
(B) All substantive communications between OIRA personnel and persons not employed by the executive branch of the Federal Government regarding a regulatory action under review shall be governed by the following guidelines:
A representative from the
issuing agency shall be invited to any meeting between OIRA
personnel and such person(s);
(ii) OIRA shall forward to the issuing agency, within 10 working
days of receipt of the communication(s), all written
communications, regardless of format, between OIRA personnel and
any person who is not employed by the executive branch of the
Federal Government, and the dates and names of individuals
involved in all
substantive oral communications (including meetings to which
an agency representative was invited, but did not attend, and
telephone conversations between OIRA personnel and any such
(iii) OIRA shall publicly disclose relevant information about
such communication(s), as set forth below in subsection (b)(4)(C)
of this section.
(C) OIRA shall maintain a publicly available log that shall
contain, at a minimum, the following information pertinent to
regulatory actions under review:
(i) The status of all regulatory actions, including if (and if
so, when and by whom) Presidential consideration was requested;
(ii) A notation of all written communications forwarded to an
issuing agency under subsection (b)(4)(B)(ii) of this section;
(iii) The dates and names of individuals involved in all
substantive oral communications, including meetings and telephone conversations, between OIRA personnel and any person not employed by the executive branch of the Federal Government, and the
discussed during such communications.
(D) After the regulatory action has been published in the Federal Register or otherwise issued to the public, or after the agency has announced its decision not to publish or issue the regulatory action, OIRA shall make available to the public all documents exchanged between OIRA and the agency during the review by OIRA under this section.