The Federal Rulemaking Process: An
Overview
Curtis W. Copeland
Specialist in American National Government
February 22, 2011
Congressional Research Service
7-5700
www.crs.gov
RL32240
CRS Report for Congress
P
repared for Members and Committees of Congress
The Federal Rulemaking Process: An Overview
Summary
Federal regulation, like taxing and spending, is one of the basic tools of government used to
implement public policy. Although not as frequently examined as congressional or presidential
policy making, the process of developing and framing rules is viewed by some as central to the
definition and implementation of public policy in the United States. Regulations generally start
with an act of Congress, and are the means by which statutes are implemented and specific
requirements are established. The terms “rule” or “regulation” are often used interchangeably in
discussions of the federal regulatory process. The Administrative Procedure Act of 1946 defines a
rule as “the whole or part of an agency statement of general or particular applicability and future
effect designed to implement, interpret, or prescribe law or policy.” The procedures that federal
agencies are required to follow in writing regulations are called the rulemaking process, and are
the subject of this report.
During the past 60 to 65 years, Congress and various Presidents have developed an elaborate set
of procedures and requirements to guide the federal rulemaking process, often with the implicit or
explicit goal of reducing the amount of regulatory burden placed on the public. Statutory
rulemaking requirements applicable to a wide range of agencies include the Administrative
Procedure Act, the Regulatory Flexibility Act, the Paperwork Reduction Act, the Unfunded
Mandates Reform Act, and the Information Quality Act. These and other cross-cutting rulemaking
requirements often require some type of analysis on the part of the rulemaking agency before
issuing a covered rule, but also often give agencies substantial discretion regarding whether the
requirements are applicable. Other statutorily based rulemaking requirements are contained in
agency- or program-specific laws, which provide varying levels of discretion regarding the
substance of agencies’ rules and may impose (or exclude) additional analytical or procedural
requirements. The most important of the current set of presidential rulemaking requirements are
in Executive Order 12866, which establishes presidential review of covered agencies’ rulemaking
within the Office of Management and Budget’s Office of Information and Regulatory Affairs
(OIRA). The executive order requires covered agencies to submit their significant rules to OIRA
for review before they become final, and requires those rules to meet certain minimal standards.
Other executive orders and presidential directives delineate other specific rulemaking
requirements incumbent on covered agencies. However, these requirements also often provide
substantial discretion to agencies regarding whether, and if so how, they are applied.
The purpose of this report is to provide Congress with an overview of the federal rulemaking
process and a brief discussion of the major laws and executive orders that prescribe the
procedures agencies are to apply when promulgating regulations. This report will be updated
when new requirements are put in place or when the requirements in this report change.
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The Federal Rulemaking Process: An Overview
Contents
Introduction ................................................................................................................................ 1
Statutory Rulemaking Requirements ........................................................................................... 3
Federal Register Act.............................................................................................................. 5
Administrative Procedure Act................................................................................................ 5
Exceptions to the APA Notice Requirement ..................................................................... 6
National Environmental Policy Act ....................................................................................... 8
Paperwork Reduction Act...................................................................................................... 9
Regulatory Flexibility Act ................................................................................................... 11
Small Business Regulatory Enforcement Fairness Act ......................................................... 13
Congressional Review Act .................................................................................................. 15
Unfunded Mandates Reform Act ......................................................................................... 16
Information Quality Act ...................................................................................................... 18
Peer Review.................................................................................................................. 19
Other Statutory Provisions Related to Rulemaking .............................................................. 21
Federal Advisory Committee Act................................................................................... 21
Trade Agreements Act ................................................................................................... 21
Negotiated Rulemaking Act .......................................................................................... 22
National Technology Transfer and Advancement Act..................................................... 23
Regulatory Right-to-Know Act...................................................................................... 23
Government Paperwork Elimination Act ....................................................................... 24
E-Government Act ........................................................................................................ 24
Small Business Paperwork Relief Act............................................................................ 25
Executive Orders and Directives ............................................................................................... 25
Executive Order 12866 ....................................................................................................... 26
Executive Order 13422 ....................................................................................................... 28
Executive Order 13563 ....................................................................................................... 29
Other Executive Orders and Directives................................................................................ 30
Conclusion................................................................................................................................ 32
For Additional Information........................................................................................................ 33
Figures
Figure 1. Federal Rulemaking Process......................................................................................... 2
Contacts
Author Contact Information ...................................................................................................... 34
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The Federal Rulemaking Process: An Overview
Introduction
Federal regulation, like taxing and spending, is one of the basic tools of government used to
implement public policy. In fact, the development and framing of a rule has been described as
“the climactic act of the policy making process.”1 Another observer described the rulemaking
process as “absolutely central to the definition and implementation of public policy in the United
States,” and said that “no significant attempt to alter the direction of a public program can
succeed without effective management of the rulemaking process.”2 Regulations generally start
with an act of Congress, and are the means by which statutes are implemented and specific
requirements are established. Federal agencies usually issue more than 3,000 final rules each year
on topics ranging from the timing of bridge openings to the permissible levels of arsenic and
other contaminants in drinking water. The costs and benefits associated with all federal
regulations have been a subject of great controversy, with the costs estimated in the hundreds of
billions of dollars and the benefits estimates even higher. The costs federal regulations impose on
regulated entities to accomplish policy goals are not reflected in the federal budget process, and
some view these off-budget regulatory costs as greater than all federal domestic discretionary
spending. Estimates of the benefits of federal regulations are even higher.
The terms “rule” or “regulation” are often used interchangeably in discussions of the federal
regulatory process. The Administrative Procedure Act (APA) of 1946 defines a rule as “the whole
or part of an agency statement of general or particular applicability and future effect designed to
implement, interpret, or prescribe law or policy.”3 The process by which federal agencies develop,
amend, or repeal rules is called “rulemaking,” and is the subject of this report.
Figure 1 illustrates in a general manner the process that most federal agencies are generally
required to follow in writing or revising a significant rule. However, we should be quick to point
out that some aspects of Figure 1 do not apply to all rulemaking. For example, as discussed later
in this report, an agency may, in certain circumstances, issue a final rule without issuing a notice
of proposed rulemaking, thereby skipping several steps depicted in the figure. On the other hand,
some rules may be published for public comment more than once. Also, independent regulatory
agencies4 are not required to submit their rules to the Office of Management and Budget’s (OMB)
Office of Information and Regulatory Affairs (OIRA) for review, and no agency is required to do
so for rules that are not “significant.”
1 Colin Diver, “Regulatory Precision,” in Keith Hawkins and John Thomas, eds., Making Regulatory Policy
(Pittsburgh: University of Pittsburgh Press, 1989), p. 199.
2 Cornelius M. Kerwin, Rulemaking: How Government Agencies Write Law and Make Public Policy, 2nd ed.,
(Washington: CQ Press, 1999), p. ix.
3 5 U.S.C. §551 (4).
4 As used in this report, the term “independent regulatory agencies” refers to the boards and commissions identified as
such in the Paperwork Reduction Act (44 U.S.C. §3502(5)), including the Federal Communications Commission, the
Federal Energy Regulatory Commission, the Nuclear Regulatory Commission, and the Securities and Exchange
Commission. The term “independent agencies” refers to other agencies that answer directly to the President, but are not
part of Cabinet departments.
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The Federal Rulemaking Process: An Overview
Figure 1. Federal Rulemaking Process
Source: CRS.
* The Office of Management and Budget’s (OMB) office of Information and Regulatory Affairs (OIRA) reviews
only significant rules, and does not review any rules submitted by independent regulatory agencies.
Note at the top of Figure 1 that the rulemaking process begins when Congress passes a statute
either requiring or authorizing an agency to write and issue certain types of regulations. An
initiating event (e.g., a recommendation from an outside body or a catastrophic accident) can
prompt either legislation or regulation (where regulatory action has already been authorized). For
example, in response to lethal chemical releases by plants in Bhopal, India, and West Virginia,
Congress enacted section 313 of the Emergency Planning and Community Right-to-Know Act of
1986 (42 U.S.C. §§ 11001-11050, 11023). The act required the owners and operators of certain
types of facilities to report the amounts of various toxic chemicals that the facilities release to the
environment above certain thresholds, and requires the Environmental Protection Agency (EPA)
to make this information available to the public. EPA subsequently issued detailed regulations
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implementing these requirements and, using the authority provided to it through the statute, has
required reporting for more than 300 toxic substances in addition to those delineated in the law.
As this example illustrates, the authority to regulate rests with Congress, and is delegated,
through law, to an agency. The statutory basis for a regulation can vary greatly in terms of its
specificity, from (1) very broad grants of authority that state only the general intent of the
legislation and leave agencies with a great deal of discretion as to how that intent should be
implemented, to (2) very specific requirements delineating exactly what regulatory agencies
should do and how they should take action. Note also in Figure 1 the roles that Congress and the
courts can play at the end of the rulemaking process, which may result in a rule being returned to
an earlier point in the process or being vacated by the reviewing body. Congress may also play a
role at other stages in the process through its oversight and appropriations responsibilities.
Implicit within the steps depicted in Figure 1 is an elaborate set of procedures and requirements
that Congress and various Presidents have developed during the past 75 years to guide the federal
rulemaking process. Some of these rulemaking requirements apply to virtually all federal
agencies, some apply only to certain types of agencies, and others are agency-specific.
Collectively, these rulemaking provisions are voluminous and require a wide range of procedural,
consultative, and analytical actions on the part of rulemaking agencies. Some observers contend
that the requirements have resulted in the “ossification” of the rulemaking process, causing
agencies to take years to develop final rules.5 For example, the National Advisory Committee on
Occupational Safety and Health noted that it takes the Occupational Safety and Health
Administration (OSHA) within the Department of Labor an average of 10 years to develop and
promulgate a health or safety standard.6 On the other hand, while these congressional and
presidential rulemaking requirements are numerous, it is not clear whether they or some other
factors (e.g., lack of data, congressionally imposed delays, court challenges, etc.) are the primary
cause of the long time-frames that are sometimes required to develop and publish final rules.
Statutory Rulemaking Requirements
Statutory rulemaking requirements can be generally categorized into two groups—those that are
specific to an individual agency or program and those that are more cross-cutting in nature, and
therefore applicable to a wider range of agencies or programs. Agency- or program-specific
rulemaking requirements may be in authorizing or appropriating statutes, and can have a
significant or even determinative effect on an agency’s rules and rulemaking procedures. As noted
previously, these statutes sometimes specifically delineate what the agency’s rules should require.
For example, the Employee Retirement Income Security Act (29 U.S.C. § 1001 et seq.) gives the
Pension Benefit Guaranty Corporation no discretion in drafting rules that establish minimum
pension insurance premium rates, specifying to the dollar what those rates should be.7 Also, for a
5 See, for example, Thomas O. McGarity, “Some Thoughts on ‘Deossifying’ the Rulemaking Process, Duke Law
Journal, vol. 41 (June 1992), pp. 1385-1462; Richard J. Pierce, Jr., “Seven Ways to Deossify Agency Rulemaking,” 47
Administrative Law Review, vol. 47, winter 1995, pp. 59-93; Paul R. Verkuil, “Rulemaking Ossification—A Modest
Proposal,” Administrative Law Review, vol. 47 (summer 1995), pp. 453-459.
6 National Advisory Committee on Occupational Safety and Health, Report and Recommendations Related to OSHA’s
Standards Development Process (Washington: June 6, 2000).
7 For example, 29 U.S.C. §1306(a)(3)(A) states that the annual premium rate payable in the case of a single-employer
plan for basic benefits is “an amount equal to the sum of $19 plus the additional premium (if any) determined under
subparagraph (E) for each individual who is a participant in such plan during the plan year.”
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number of years the Department of Transportation (DOT) concluded that it had no discretion in
setting the average fuel economy standards for light trucks, and was required to keep the standard
at 20.7 miles per gallon.8 Agency-specific statutes may also impose specific procedural
requirements on their rulemaking processes (e.g., the conduct of public hearings, the publication
of a notice of proposed rulemaking by a particular date, or the coordination of rulemaking with
another agency).
In other cases, though, the statutes give rulemaking agencies substantial discretion in how rules
are developed and what they require. For example, the Agricultural Adjustment Act provides a
broad grant of rulemaking authority to the Secretary of Agriculture, stating only that agricultural
marketing should be “orderly” but providing little guidance regarding which crops should have
marketing orders or how to apportion the market among growers.9 More recently the Patient
Protection and Affordable Care Act (PPACA, P.L. 111-148) contained a number of provisions
giving federal agencies broad authority to issue “such regulations as may be necessary” to carry
out certain requirements in the law.10
Agency rulemaking is also often significantly influenced by court decisions interpreting these
agency- or program-specific statutory requirements. For example, in 1980 the Supreme Court
ruled that, before promulgating new health standards, OSHA must demonstrate that the particular
chemical to be regulated poses a “significant risk” under workplace conditions permitted by
current regulations.11 The court also said that OSHA must demonstrate that the new limit OSHA
proposes will substantially reduce that risk. This decision effectively requires OSHA to evaluate
the risks associated with exposure to a chemical and to determine that these risks are “significant”
before issuing a regulatory standard. Other court decisions have required OSHA rulemaking to
demonstrate the technical and economic feasibility of its requirements.12 Still other decisions have
required agencies to permit meaningful public participation in rulemaking and to fully explain
what they considered and why they did and did not take particular actions.13
The following discussion of statutory rulemaking requirements focuses solely on the cross-cutting
requirements that are applicable to more than one agency. The discussion provides descriptions of
some of the major rulemaking-related statutes and is not intended to be a catalogue of all such
requirements. Some of these rulemaking requirements have been in place for more than 70 years,
but most have been implemented within the past 30 years. Some of these statutory requirements
apply to Cabinet departments and independent agencies; others apply to those agencies as well as
the independent regulatory agencies.
8 DOT’s 1998 appropriations act stated that “(n)one of the funds in this Act shall be available to prepare, propose, or
promulgate any regulations ... in any model year that differs from the standards promulgated for such automobiles prior
to the enactment of this section.”
9 For an examination of the amount of regulatory discretion afforded in specific statutes, see U.S. General Accounting
Office, Regulatory Burden: Some Agencies’ Claims Regarding Lack of Rulemaking Discretion Have Merit,
GAO/GGD-99-20, Jan. 8, 1999.
10 For more information on PPACA rulemaking provisions, see CRS Report R41180, Rulemaking Requirements and
Authorities in the Patient Protection and Affordable Care Act (PPACA), by Curtis W. Copeland.
11 Industrial Union Department v. American Petroleum Institute, 448 U.S. 607 (1980).
12 See, for example, American Textile Mfrs. Inst., Inc. v. Donovan, 452 U.S. 490 (1981) and United Steelworkers v.
Marshall, 647 F.2d 1189 (D.C. Cir. 1980), cert. denied, 453 U.S. 913 (1981).
13 See, for example, Motor Vehicle Manufacturers Association v State Farm Mutual Automobile Insurance Co., 463
U.S. 29 (1983). The Supreme Court said the agency “must examine the relevant data and articulate a satisfactory
explanation of its action, including a ‘rational connection between the facts found and the choice made.’”
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Federal Register Act
With the surge of New Deal legislation enacted in the 1930s, Congress made federal agencies
responsible for issuing detailed regulations on a variety of complex social and economic issues.
However, no central regulatory publication system existed, so there was no efficient way for
citizens to know about regulations that affected them. Therefore, Congress enacted the Federal
Register Act, which became law in July 1935 (44 U.S.C. Chapter 15). The act established a
uniform system for handling agency regulations by requiring (1) the filing of documents with the
Office of the Federal Register, (2) the placement of documents on public inspection, (3)
publication of the documents in the Federal Register, and (4) (after a 1937 amendment)
permanent codification of rules in the Code of Federal Regulations. Publication of a rule in the
Federal Register provides official notice of its existence and contents. Other documents that are
generally published in the Federal Register include presidential proclamations and executive
orders, notices, and documents that the President or Congress require to be published.
Regulations for carrying out the Federal Register Act deal with, among other things, the format
and distribution of the Federal Register and how documents are prepared, transmitted, and
processed.14 The Office of the Federal Register is responsible for printing and distributing the
Federal Register, and the Office has published a guide and a drafting handbook explaining how
Federal Register documents are to be prepared. The Federal Register is published each business
day, and is now available electronically.15
Administrative Procedure Act
The most long-standing and broadly applicable federal rulemaking requirements are in the
Administrative Procedure Act (APA) of 1946 (5 U.S.C. § 551 et seq.). The APA was written to
bring regularity and predictability to agency decisionmaking, and provides for both formal and
informal rulemaking. Formal rulemaking is used in ratemaking proceedings and in certain other
cases when rules are required by statute to be made “on the record” after an opportunity for a
trial-type agency hearing. However, few statutes require such on-the-record hearings. Informal
rulemaking, also known as “notice and comment” rulemaking, is used much more frequently, and
is the focus of this section.16
In informal rulemaking, the APA generally requires that agencies (Cabinet departments and
independent agencies as well as independent regulatory agencies) publish a notice of proposed
rulemaking (NPRM) in the Federal Register.17 The notice must contain (1) a statement of the
time, place, and nature of public rulemaking proceedings; (2) reference to the legal authority
under which the rule is proposed; and (3) either the terms or substance of the proposed rule or a
14 1 C.F.R. ch. I, pts. 1-22.
15 Electronic access to the Federal Register is provided through a Government Printing Office website at
http://www.gpoaccess.gov/fr/index.html.
16 For more on formal and other types of rulemaking, as well as information on judicial review, see CRS Report
R41546, A Brief Overview of Rulemaking and Judicial Review, by Vanessa K. Burrows and Todd Garvey.
17 Some agencies begin the rulemaking process by publishing an “advance notice of proposed rulemaking in which the
agency notifies the public that it is considering an area for rulemaking and often requests comments on the appropriate
scope or topics of the rule. The APA does not require the use of advance notices, but some other statutes require it for
particular types of rules. Similarly, agencies may issue a “supplemental notice of proposed rulemaking” after an NPRM
is issued if they wish to obtain public comment on new factual proposals before issuing a final rule.
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description of the subjects and issues involved. After giving “interested persons” an opportunity
to comment on the proposed rule, and after considering the public comments, the agency may
then publish the final rule, incorporating a general statement of its basis and purpose. Although
the APA does not specify the length of this public comment period, agencies commonly allow at
least 30 days.18 Public comments as well as other supporting materials (e.g., hearing records or
agency regulatory studies but generally not internal memoranda) are placed in a rulemaking
“docket” which must be available for public inspection. Finally, the APA states that the final rule
cannot become effective until at least 30 days after its publication unless (1) the rule grants or
recognizes an exemption or relieves a restriction, (2) the rule is an interpretative rule or a
statement of policy, or (3) the agency determines that the rule should take effect sooner for good
cause, and publishes that determination with the rule.
The final rule cannot adopt a provision if the NPRM did not clearly provide notice to the public
that the agency was considering adopting it. If challenged in court under the APA, an agency
rulemaking can be held unlawful or set aside if it is found to be “arbitrary, capricious, an abuse of
discretion, or otherwise not in accordance with the law.”19 The court can also “compel agency
action unlawfully withheld or unreasonably delayed.” Amendment or revocation of an existing
rule generally requires the responsible agency to issue a new rule through the APA process.
Exceptions to the APA Notice Requirement
Although the APA generally requires agencies to publish NPRMs before promulgating a final
rule, the act provides exceptions to this requirement. For example, the APA states that the notice
and comment procedures generally do not apply when an agency finds, for “good cause,” that
those procedures are “impracticable, unnecessary, or contrary to the public interest.” When
agencies use the good cause exception, the act requires that they explicitly say so and provide a
rationale for the exception’s use when the rule is published in the Federal Register. The APA also
provides explicit exceptions to the NPRM requirement for certain categories of regulatory
actions, such as rules dealing with military or foreign affairs; agency management or personnel;
or public property, loans, grants, benefits, or contracts. Further, the APA says that the NPRM
requirements do not apply to interpretative rules; general statements of policy; or rules of agency
organization, procedure, or practice.20 However, these rules do have to be published in the
Federal Register.
The legislative history of the APA makes it clear that Congress did not believe that the act’s good
cause exception to the notice and comment requirements should be an “escape clause.” According
to the Senate committee’s report accompanying the APA, a “true and supported or supportable
finding of necessity or emergency must be made and published” when the agency uses the good
18 Executive Order 12866, discussed in detail later in this report, suggests that agencies allow the public at least 60 days
to comment for “significant” rules.
19 The APA judicial review provisions are codified at 5 U.S.C 701-706. For more information on the APA and judicial
review, see CRS Report R41546, A Brief Overview of Rulemaking and Judicial Review, by Vanessa K. Burrows and
Todd Garvey.
20 In addition to the APA exceptions, Congress sometimes includes specific exemptions from notice and comment
procedures in other statutes. For example, section 161(d) under title I of the Federal Agriculture Improvement and
Reform Act of 1996 (P.L. 104-127, 110 Stat. 934-935) instructed the Secretary of Agriculture and the Commodity
Credit Corporation to issue regulations not later than 90 days after the date of enactment of the title, without regard to
the notice and comment provisions of the APA.
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cause exception.21 The legislative history also indicates that Congress envisioned agencies using
the notice and comment procedures even in some cases in which the APA’s exceptions applied.
A federal agency’s invocation of the good cause exception (or other exceptions to notice and
comment procedures) is subject to judicial review. After having reviewed the totality of
circumstances, the courts can and sometimes do determine that an agency’s reliance on the good
cause exception was not authorized under the APA.22 The case law has generally reinforced the
view that the good cause exception should be “narrowly construed.”23
Two procedures for noncontroversial and expedited rulemaking were designed not to involve
NPRMs. “Direct final” rulemaking involves agency publication of a rule in the Federal Register
with a statement that the rule will be effective on a particular date unless an adverse comment is
received within a specified period of time (e.g., 30 days). However, if an adverse comment is
filed, the direct final rule is withdrawn and the agency may publish the rule as a proposed rule
under normal NPRM procedures. Direct final rulemaking can be viewed as a particular
application of the APA’s good cause exception in which agencies claim NPRMs are
“unnecessary.”24 Both Vice President Albert Gore’s National Performance Review and the
Administrative Conference of the United States encouraged agencies to use direct final
rulemaking for noncontroversial rules.25
The Administrative Conference also endorsed the use of what is known as “interim final”
rulemaking, in which an agency issues a final rule without an NPRM that is generally effective
immediately, but with a post-promulgation opportunity for the public to comment. If the public
comments persuade the agency that changes are needed in the interim final rule, the agency may
revise the rule by publishing a final rule reflecting those changes. Interim final rulemaking can be
viewed as another particular application of the good cause exception in the APA, but with the
addition of a comment period after the rule has become effective.26
Congress sometimes requires agencies to use interim final rulemaking, and may also specify the
length of the comment period. For example, Subsection (b)(2) of Section 1104 of the Patient
Protection and Affordable Care Act amended Section 1173 of the Social Security Act (at 42
U.S.C. § 1320d-2) and states, in part, that the Secretary “shall promulgate an interim final rule
21 Senate Committee on the Judiciary, “Administrative Procedure Act: Legislative History,” Senate Document 248, 79th
Congress, 2nd Session (1946).
22 For discussions of these court cases, see Ellen R. Jordan, “The Administrative Procedure Act’s ‘Good Cause’
Exemption,” Administrative Law Review, 36, spring 1984, pp. 113-178; and Catherine J. Lanctot, “The Good Cause
Exception: Danger to Notice and Comment Requirements Under the Administrative Procedure Act,” Georgetown Law
Journal, 68 (Feb. 1980), pp. 765-782.
23 See American Federation of Government Employees, AFL-CIO v. Block, 655 F.2d 1153, 1156 (D.C. Cir 1981); and
Mobay Chemical Corp. v. Gorsuch, (682 F.2d 419, 426 (3rd Cir.), cert. denied, 459 U.S. 988 (1982). In another case
(Action on Smoking and Health v. CAB, 713 F.2d 795, 800 [D.C. Cir 1983]), the court said that allowing broad use of
the good cause exception would “carve the heart out of the statute.”
24 For more, see Ronald M. Levin, “More on Direct Final Rulemaking: Streamlining, Not Corner Cutting,”
Administrative Law Review, 51 (summer 1999), pp. 757-766.
25 See Office of the Vice President, Improving Regulatory Systems: Accompanying Report of the National Performance
Review (Washington: Sept. 1993). The Administrative Conference was established by statute as an independent agency
to promote improvements in the efficiency, adequacy, and fairness of procedures by which federal agencies conduct
regulatory programs, administer grants and benefits, and perform related governmental functions.
26 For more, see Michael Asimow, “Interim Final Rules: Making Haste Slowly,” Administrative Law Review, 51
(summer 1999), pp. 703-755.
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applying any standard or operating rule recommended by the National Committee on Vital and
Health Statistics,” and “shall accept and consider public comments on any interim final rule
published under this subparagraph for 60 days after the date of such publication.”
In August 1998, the General Accounting Office reported that about half of the 4,658 final
regulatory actions published in the Federal Register during 1997 were published without
NPRMs.27 Seven agencies accounted for about 70% of both the final actions and the actions
without NPRMs. Most of the actions without NPRMs appeared to involve administrative or
technical issues with limited applicability. However, 11 of the 61 final rules published during
1997 that were “major” (e.g., having a $100 million impact on the economy) did not have
NPRMs. The agencies most commonly cited the APA’s good cause exception as their justification
for not publishing NPRMs, frequently noting the time-sensitive nature of the actions being taken.
The agencies also frequently used the categorical exceptions permitted in the APA (e.g., actions
involving agencies’ management or personnel). In some cases GAO concluded that the agencies’
explanations for why NPRMs were not used were not clear or understandable, with the agencies
sometimes making broad assertions that an NPRM would delay the issuance of rules that were, in
some general sense, in the public interest. For example, in one case the agency said that soliciting
public comments on the rule was “contrary to the public interest” because the rule authorized a
“new and creative method of financing the development of public housing.”28
National Environmental Policy Act
The National Environmental Policy Act (NEPA) of 1969 (42 U.S.C. §§ 4321-4347) was the first
statute to require an “impact statement” as a way to ensure that federal agencies give special
consideration to certain issues during the rulemaking process. NEPA requires all federal agencies
to include in every recommendation or report related to “major Federal actions significantly
affecting the quality of the human environment” a detailed statement on the environmental impact
of the proposed action. Initially, though, agencies make a threshold determination (known as an
“environmental assessment”) as to whether the rule or other action represents a significant impact
on the environment. If not, the agency issues a “finding of no significant impact.” If the agency
concludes that there is a significant impact, the agency then prepares a full “environmental impact
statement” describing the likely effects of the rule.
According to the act and its implementing regulations developed by the Council on
Environmental Quality, the environmental impact statement must delineate the direct, indirect,
and cumulative effects of the proposed action.29 Agencies are also required to include in the
statement (1) any adverse environmental effects that cannot be avoided should the proposal be
implemented, (2) alternatives to the proposed action, (3) the relationship between local short-term
uses of the environment and the maintenance and enhancement of long-term productivity, and (4)
any irreversible and irretrievable commitments of resources that would be involved if the
proposed action should be implemented. Before developing any such environmental impact
statement, NEPA requires the responsible federal official to consult with and obtain comments of
27 U.S. General Accounting Office, Federal Rulemaking: Agencies Often Published Final Actions Without Proposed
Rules, GAO/GGD-98-126, Aug. 31, 1998.
28 See Juan J. Lavilla, “The Good Cause Exemption to Notice and Comment Rulemaking Requirements Under the
Administrative Procedure Act,” The Administrative Law Journal, 3 (fall 1989), pp. 317-423 for another study on the
use of the good cause exception.
29 NEPA regulations are codified at 40 CFR Parts 1500-1508.
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any federal agency that has jurisdiction by law or special expertise with respect to any
environmental impact involved. Agencies must make copies of the statement and the comments
and views of appropriate federal, state, and local agencies available to the President, the Council
on Environmental Quality, and to the public. The adequacy of an agency’s environmental impact
statement is subject to judicial review.
In April 2002, the chairman of the Council on Environmental Quality established a task force
composed of federal agency employees to review NEPA implementation practices and
procedures. In September 2003, the task force issued a report containing more than 50
recommendations to expedite the NEPA review process.30 Among other things, the task force
recommended that new guidance be developed setting standards for the documentation needed to
support a determination that a rule would not have significant environmental effects. Also, several
pieces of legislation have been enacted since 2008 in an effort to streamline the NEPA process. 31
Paperwork Reduction Act
The Paperwork Reduction Act (PRA) (44 U.S.C. §§ 3501-3520) was originally enacted in 1980,
but was subsequently amended in 1986 and again in 1995. One of the purposes of the PRA is to
minimize the paperwork burden for individuals, small businesses, and others resulting from the
collection of information by or for the federal government. The act generally defines a “collection
of information” as the obtaining or disclosure of facts or opinions by or for an agency by 10 or
more nonfederal persons. Many information collections, recordkeeping requirements, and third-
party disclosures are contained in or are authorized by regulations as monitoring or enforcement
tools. In fact, these paperwork requirements are the essence of many agencies’ regulatory
provisions.32 The PRA requires agencies to justify any collection of information from the public
by establishing the need and intended use of the information, estimating the burden that the
collection will impose on respondents, and showing that the collection is the least burdensome
way to gather the information.
The original PRA established the Office of Information and Regulatory Affairs (OIRA) within the
Office of Management and Budget (OMB) to provide central agency leadership and oversight of
government-wide efforts to reduce unnecessary paperwork burden and improve the management
of information resources. Agencies must receive OIRA approval (signified by an OMB control
number displayed on the information collection) for each collection request before it is
implemented, and those approvals must be renewed at least every three years. Failure to obtain
OIRA approval for an active collection, or the lapse of that approval, represents a violation of the
act, and triggers the PRA’s public protection provision. Under that provision, no one can be
penalized for failing to comply with a collection of information subject to the act if the collection
30 NEPA Task Force, Report to the Council on Environmental Quality, Modernizing NEPA Implementation
(Washington: Sept. 2003).
31 For more information this legislation and on NEPA, see CRS Report RL33152, The National Environmental Policy
Act (NEPA): Background and Implementation, by Linda Luther.
32 For example, EPA’s Toxics Release Inventory (TRI) program is essentially a database created through collections of
information imposed on businesses to inform the public about chemical hazards in their communities. TRI reports
require businesses in certain industries to report the quantity of any of more than 600 chemicals entering each
environmental medium on site, transfers of the chemical in wastes to off-site locations, on-site treatment methods and
efficiency, and source reduction and recycling activities.
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does not display a valid OMB control number.33 OIRA can disapprove any collection of
information if it believes the collection is inconsistent with the requirements of the PRA.34
The PRA clearance process is described in the act and implementing regulations. For new
collections, no later than the publication of the NPRM, the issuing agency must submit the
proposed rule and any background information to OIRA. At the same time the agency is required
to publish a notice in the Federal Register stating that OIRA’s approval is being sought, thereby
providing the public with an opportunity to comment on the proposed collection. For any
collection of information that is not contained in a proposed rule, OIRA staff have up to 60 days
under the statute to review the proposed collection and ensure, among other things, that the
collection is statutorily authorized and necessary, and that the agency’s paperwork burden
estimate (most commonly measured in terms of “burden hours”) is reasonable.35 At the end of the
process the agency is notified of the disposition of the review. OIRA data indicates that the office
takes action on between 3,000 and 5,000 information collection requests (new approvals,
renewals, or revisions) each year.
The 1995 PRA reaffirmed the principles in the original act and gave significant new
responsibilities to OIRA and executive branch agencies. For example, the act currently requires
OIRA to “oversee the use of information resources to improve the efficiency and effectiveness of
governmental operations to serve agency missions.” The PRA also requires federal agencies to
establish a process, independent of program responsibility, to evaluate proposed collections of
information, manage information resources to reduce information collection burdens on the
public, and ensure that the public has timely and equitable access to information products and
services.
The coverage of the PRA is extremely broad, including actions by both Cabinet departments and
independent agencies as well as independent regulatory agencies, and covering virtually any type
of collection of information that these agencies “conduct or sponsor.”36 As a result of the 1995
amendments to the act, the PRA’s clearance requirements clearly cover collections of information
“requiring the disclosure to third parties or the public,” effectively overturning the Supreme
Court’s 1990 decision in Dole v. United Steelworkers of America (494 U.S. 26).
One of the key features of the PRA of 1995 was the requirement that OIRA, in consultation with
the agency heads, set annual government-wide goals for the reduction of information collection
burdens by at least 10% in fiscal years 1996 and 1997, and by at least 5% in each of the
succeeding four fiscal years. The act also required OIRA to establish agency burden reduction
goals each year representing “the maximum practicable opportunity in each agency.” At the end
33 For an up-to-date inventory of OMB-approved information collections, see http://www.reginfo.gov/public/do/
PRAMain.
34 Independent regulatory agencies can, by majority vote, void any OIRA disapproval of a proposed collection of
information.
35 An agency’s annual paperwork burden-hour estimate is a function of (1) the frequency of the information collection,
(2) the estimated number of respondents, and (3) amount of time that the agency estimates it takes each respondent to
complete the collection. For example, if an agency estimates that an information collection conducted twice each year
will take each of the estimated 10,000 respondents 10 hours to complete each time, the total annual burden hour
estimate for the collection is 200,000 burden hours (2 times 10,000 times 10).
36 The act’s definition of an agency excludes only the General Accounting Office, the Federal Election Commission,
the governments of the District of Columbia, U.S. territories and possessions, and government-owned contractor-
operated facilities.
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of FY1995 (just before the PRA of 1995 took effect) federal agencies estimated that their
information collections imposed about 7 billion burden hours on the public. Therefore, if all
federal agencies had been able to meet each of the government-wide goals, by September 30,
2001, the burden-hour estimate would have decreased about 35% to about 4.6 billion hours.
However, this reduction did not occur. In fact, as of September 30, 2002, the government-wide
burden estimate stood at more than 8.2 billion hours—a 17% increase since the PRA of 1995 took
effect. Nearly half of that increase occurred during FY2002 alone, and about 70% occurred
during fiscal years 2001 and 2002.37 The agencies contend that they are often unable to reduce
paperwork requirements without changes in the underlying statutes that require the information to
be collected.38 As of February 2011, there were more than 9,000 active agency information
collections, with a total burden-hour estimate of nearly 9.9 billion hours.
Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) of 1980 (5 U.S.C. §§ 601-612), requires federal agencies to
assess the impact of their forthcoming regulations on “small entities,” which the act defines as
including small businesses, small governmental jurisdictions, and certain small not-for-profit
organizations. Under the RFA, Cabinet departments and independent agencies as well as
independent regulatory agencies must prepare a regulatory flexibility analysis at the time
proposed and certain final rules are issued. The analysis for a proposed rule is referred to as an
“initial regulatory flexibility analysis” (IRFA) and the analysis for a final rule is referred to as a
“final regulatory flexibility analysis.” The RFA requires the analysis to describe, among other
things, (1) the reasons why the regulatory action is being considered; (2) the small entities to
which the proposed rule will apply and, where feasible, an estimate of their number; (3) the
projected reporting, recordkeeping, and other compliance requirements of the proposed rule; and
(4) any significant alternatives to the rule that would accomplish the statutory objectives while
minimizing the impact on small entities.39
However, these analytical requirements are not triggered if the head of the issuing agency
certifies that the proposed rule would not have a “significant economic impact on a substantial
number of small entities.” The RFA does not define “significant economic impact” or “substantial
number of small entities,” thereby giving federal agencies substantial discretion regarding when
the act’s analytical requirements are initiated. Also, the RFA’s analytical requirements do not
apply to final rules for which the agency does not publish a proposed rule.40
The RFA initially did not permit judicial review of agencies’ actions under the act. However,
amendments to the act in 1996 as part of the Small Business Regulatory Enforcement Fairness
Act (SBREFA) (110 Stat. 857, 5 U.S.C. § 601 note) permitted judicial review regarding, among
other things, agencies’ regulatory flexibility analyses for final rules and any certifications that
37 OMB is required to report to Congress on the implementation of the PRA, and does so through an annual
“information collection budget.” For the 2010 report, see http://www.whitehouse.gov/sites/default/files/omb/inforeg/
icb/icb_2010.pdf.
38 For more information on the PRA, see CRS Report R40636, Paperwork Reduction Act (PRA): OMB and Agency
Responsibilities and Burden Estimates, by Curtis W. Copeland and Vanessa K. Burrows.
39 See http://www.reginfo.gov/public/do/PRAMain for information collection totals.
40 Many agencies are apparently aware of this limitation; GAO estimated that in more than 500 final rules published in
1997 the agencies specifically stated that the RFA was not applicable or that a regulatory flexibility analysis was not
required because the action was not preceded by an NPRM. See GAO/GGD-98-126, p. 31.
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their rules will not have a significant impact on small entities. As a result, a small entity that is
adversely affected or aggrieved by an agency’s determination that its final rule would not have a
significant impact on small entities could seek judicial review of that determination within one
year of the date of the final agency action. In granting relief, a court may remand the rule to the
agency or defer enforcement against small entities. The addition of judicial review in 1996 is
generally viewed as a significant strengthening of the RFA, and is believed to have improved
agencies’ compliance with the act.41
The RFA also contains several other notable provisions. For example, section 602 requires each
federal agency to publish a “regulatory flexibility agenda” in the Federal Register each October
and April listing regulations that the agency expects to propose or promulgate which are likely to
have a significant economic impact on a substantial number of small entities.42 Section 610 of the
act requires agencies to review those rules that have or will have a significant impact within 10
years of their promulgation to determine whether they should be continued without change or
should be amended or rescinded to minimize their impact on small entities. Section 612 of the
RFA requires the Chief Counsel of the Small Business Administration’s (SBA) Office of
Advocacy to monitor and report at least annually on agencies’ compliance with the act. SBA’s
primary method of monitoring agencies’ compliance is to review and comment on proposed
regulations when they are published for notice and comment in the Federal Register. However,
the statute also specifically authorizes the Chief Counsel to appear as amicus curiae (i.e., “friend
of the court”) in any court action to review a rule.
The RFA also requires agencies to ensure that small entities have an opportunity to participate in
the rulemaking process, and the 1996 amendments to the act in SBREFA put in place special
requirements for proposed rules issued by the Environmental Protection Agency (EPA) and the
Occupational Safety and Health Administration (OSHA). The Dodd-Frank Wall Street Reform
and Consumer Protection Act (P.L. 111-203) required the new Consumer Financial Protection
Bureau (CFPB) to also hold such panels. EPA , OSHA, and CFPB are required to convene
“advocacy review panels” before publishing a regulatory flexibility analysis for a proposed rule.
Specifically, the agency issuing the regulation must notify the SBA Chief Counsel for Advocacy
and provide information on the draft rule’s potential impacts on small entities and the type of
small entities that might be affected. The Chief Counsel then must identify representatives of
affected small entities within 15 days of the notification. The review panel must consist of full-
time federal employees from the rulemaking agency, the Office of Management and Budget, and
SBA’s Chief Counsel for Advocacy. During the panel process, the panel must collect the advice
and recommendations of representatives of affected small entities about the potential impact of
the draft rule. The panel must report on the comments received and on the panel’s
recommendations no later than 60 days after the panel is convened, and the panel’s report must be
made public as part of the rulemaking record.43 The agency may or may not adopt the panel’s
recommendations.
41 U.S. Small Business Administration, 20 Years of the Regulatory Flexibility Act: Rulemaking in a Dynamic Economy
(Washington: 2000).
42 This requirement, as well as a similar requirement in Executive Order 12866, is generally met via entries in the
Unified Agenda of Federal Regulatory and Deregulatory Actions. The Unified Agenda is published twice each year in
the Federal Register by the Regulatory Information Service Center, and provides uniform reporting of data on
regulatory activities under development throughout the federal government.
43 For an examination of the first five advocacy review panels were implemented, see U.S. General Accounting Office,
Regulatory Reform: Implementation of the Small Business Advocacy Review Panel Requirements, GAO/GGD-98-36,
March 18, 1996.
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GAO has examined the implementation of the RFA several times within the past 10 to 15 years,
and a recurring theme in GAO’s reports is a lack of clarity in the act and a resulting variability in
the act’s implementation. For example, in 1991 GAO reported that each of the four federal
agencies that it reviewed had a different interpretation of key RFA provisions.44 In 1994 GAO
again reported that agencies’ compliance with the RFA varied widely from one agency to another
and that agencies were interpreting the statute differently.45 In a 1999 report on the
implementation of section 610 of the RFA and in a 2000 report on the implementation of the RFA
at the Environmental Protection Agency (EPA), GAO concluded that agencies had broad
discretion to determine what the statute required.46 In all of these reports, GAO suggested that
Congress consider clarifying the act’s requirements and/or give SBA or some other entity the
responsibility to develop criteria for whether and how agencies should conduct RFA analyses. In
2001, GAO testified that the promise of the RFA may never be realized until Congress or some
other entity defines what a “significant economic impact” and a “substantial number of small
entities” mean in a rulemaking setting.47 However, other observers have indicated that the
definitions of these terms should remain flexible because of significant differences in each
agency’s operating environment.
Periodically, legislation is introduced to amend the RFA. For example, in the 112th Congress, H.R.
527, the Regulatory Flexibility Improvements Act of 2011, would (among other things) clarify
and expand the rules covered by the act, and require the SBA Chief Counsel for Advocacy to
“issue rules governing agency compliance with this chapter.”48
Small Business Regulatory Enforcement Fairness Act
As noted in the previous section of this report, certain provisions in SBREFA amended the RFA to
permit judicial review and to permit small entities to participate in EPA and OSHA rulemaking
before a proposed rule with a significant impact on small entities is published. Other provisions in
SBREFA did not amend the RFA, but imposed new rulemaking-related requirements on federal
agencies.
For example, section 212 of SBREFA requires agencies to develop one or more compliance
guides for each final rule or group of related final rules for which the agency is required to
prepare a regulatory flexibility analysis. Specifically, section 212 requires the guides to (1) be
published, (2) be designated as “small entity compliance guides,” and (3) explain the actions a
small entity is required to take to comply with an associated final rule. However, the discretion
inherent in the RFA regarding when a regulatory flexibility analysis is required also applies to
whether compliance guides must be developed. Section 212 gives agencies broad discretion in
44 U.S. General Accounting Office, Regulatory Flexibility Act: Inherent Weaknesses May Limit Its Usefulness for Small
Governments, GAO/HRD-91-16, Jan. 11, 1991.
45 U.S. General Accounting Office, Regulatory Flexibility Act: Status of Agencies’ Compliance, GAO/GGD-94-105,
Apr. 27, 1994.
46 U.S. General Accounting Office, Regulatory Flexibility Act: Agencies’ Interpretations of Review Requirements Vary,
GAO/GGD-99-55, Apr. 2, 1999; U.S. General Accounting Office, Regulatory Flexibility Act: Implementation in EPA
Program Offices and Proposed Lead Rule, GAO/GGD-00-193. Sept. 20, 2000.
47 U.S. General Accounting Office, Regulatory Flexibility Act: Key Terms Still Need to Be Clarified, GAO-01-669T,
Apr. 24, 2001.
48 For more information about the RFA, see CRS Report RL34355, The Regulatory Flexibility Act: Implementation
Issues and Proposed Reforms, by Curtis W. Copeland.
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other areas as well. For example, it says agencies “may” prepare separate guides covering groups
or classes of similarly affected small entities, and “may” cooperate with associations of small
entities to develop and distribute the guides. Agencies are given “sole discretion” in the use of
plain language in the guides. The statute does not indicate when the guides must be developed or
how they must be “published.” In December 2001, GAO reported that section 212 of SBREFA
did not appear to have had much of an impact on agencies’ rulemaking activities, and its
implementation varied across and sometimes within agencies.49 Using the discretion that the
section provided, GAO said “an agency could legally exclude all of its rules from coverage by the
statute, designate a previously published document as its small entity compliance guide, or
develop and publish a guide with no input from small entities years after the covered rule takes
effect.” GAO recommended several changes it felt were needed to strengthen and clarify the
requirements in section 212.50
Section 213 of SBREFA required federal agencies regulating the activities of small entities to
establish a program for responding to inquiries concerning compliance with applicable statutes
and regulations. The section also says that in any civil or administrative action against a small
entity, such guidance “may be considered as evidence of the reasonableness or appropriateness of
any proposed fines, penalties or damages sought against such small entity.”
Section 222 of SBREFA amended the Small Business Act (15 U.S.C. § 631 et seq.) to require the
SBA Administrator to designate a “Small Business and Agriculture Regulatory Enforcement
Ombudsman,” who was directed to work with each agency to ensure that small business concerns
have an opportunity to comment on agencies’ enforcement actions. The ombudsman was directed
to annually evaluate and report on each agency’s enforcement activities, including a rating of the
“responsiveness to small business” of each agency’s regional and program offices. Section 222
also required the Administrator to establish a “Small Business Regulatory Fairness Board” in
each SBA regional office to report to and advise the ombudsman on “excessive enforcement
actions of agencies against small business concerns.
Section 223 of SBREFA requires agencies to provide small entities with some form of relief from
civil monetary penalties. Specifically, subsection 223(a) of the act required federal agencies
regulating the activities of small entities to establish a policy or program by end of March 1997
for the reduction and, under appropriate circumstances, the waiver of civil penalties by small
entities. In February 2001, GAO reported on the implementation of section 223 and concluded
that all of the agencies’ penalty reduction and waiver policies were within the broad discretion
afforded by the statute.51 However, GAO also reported that some of the policies covered only a
portion of the agencies’ enforcement actions involving small entities, and some treated small
entities no differently than large entities. The agencies’ policies also differed in terms of how key
terms such as “small entity” and “penalty reduction” were defined, and most were developed
before SBREFA took effect. GAO suggested several changes to the statute to strengthen agencies’
penalty relief policies and make them more consistent. For example, GAO suggested amending
the act to require agencies to maintain data on the number of enforcement actions involving small
49 U.S. General Accounting Office, Regulatory Reform: Compliance Guide Requirement Has Had Little Effect on
Agency Practices, GAO-02-172, Dec. 28, 2001.
50 In 2007, Congress enacted some changes to these requirements. See P.L. 110-28, Title VI, Subtitle B, sec. 7005.
Among other things, agencies must prepare compliance guides for any rule for which it must prepare a final regulatory
flexibility analysis, and must post the guides on their websites.
51 U.S. General Accounting Office, Regulatory Reform: Implementation of Selected Agencies’ Civil Penalty Relief
Policies for Small Entities, GAO-01-280, Feb. 20, 2001.
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entities and the amount of penalty relief provided. This recommendation was later implemented
with the passage of the Small Business Paperwork Relief Act of 2002 (P.L. 107-198, 116 Stat.
729), which required (among other things) that agencies develop and report such information to
selected congressional committees.
Congressional Review Act
The statutory provision commonly known as the Congressional Review Act (CRA) (5 U.S.C. §§
801-808) was included as part of SBREFA as enacted in March 1996, and established expedited
procedures by which Congress may disapprove agencies’ rules by enacting a joint resolution of
disapproval.52 Under the CRA, before any final rule can become effective it must be filed with
each house of Congress and GAO.53 The act also requires federal agencies to submit to GAO and
make available to each house of Congress a copy of any cost-benefit analysis prepared for the
rule and a report on the agency’s actions related to the RFA and any other relevant act or
executive order. The definition of a “rule” under the CRA is very broad, and the act applies to
rules issued by Cabinet departments and independent agencies as well as independent regulatory
agencies.
If OIRA considers the issuing agency’s rule to be “major” (e.g., has a $100 million effect on the
economy), the agency generally must delay the rule’s effective date by 60 days after the date of
publication in the Federal Register or submission to Congress and GAO, whichever is later.
Within 15 calendar days of receiving a major rule, GAO is required to provide Congress with a
report on the rule assessing the issuing agency’s compliance with the procedural steps required by
the various acts and executive orders applicable to the rulemaking process.54 Although the CRA
establishes these special requirements for major rules, the CRA procedures for disapproving
regulations apply to all rules, whether or not they are declared to be major.
Within 60 days after Congress receives an agency’s rule, excluding periods when Congress is in
recess or adjournment, a Member of Congress can introduce a resolution of disapproval that, if
adopted by both Houses and enacted into law, can nullify the rule, even if it has already gone into
effect. Congressional disapproval under the CRA also prevents the agency from proposing to
issue a “substantially similar” rule without subsequent statutory authorization, but this provision
is not intended to vitiate altogether the agency’s power to establish regulations in the area in
question.
The CRA provides that Senate action on a disapproval resolution under the act must occur within
60 days of session after the regulation is submitted, and makes available during that period an
expedited procedure intended to ensure that the Senate can take up and vote on the measure
before the period expires. The act establishes no such expedited procedure for the House. If
Congress adjourns less than 60 days of session after a rule is submitted, a new 60 day period for
disapproval under the act begins on the 15th legislative day of the next session. If a disapproval
resolution is rejected by either house of Congress, the rule can take effect immediately (or as
provided by other governing law or rule).
52 For a detailed discussion of CRA procedures, see CRS Report RL31160, Disapproval of Regulations by Congress:
Procedure Under the Congressional Review Act, by Richard S. Beth.
53 Nevertheless, some rules have not been submitted. See CRS Report R40997, Congressional Review Act: Rules Not
Submitted to GAO and Congress, by Curtis W. Copeland.
54 To view these reports, see http://www.gao.gov/decisions/majrule/majrule.php.
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Federal agencies have submitted more than 50,000 rules to GAO (and presumably, Congress)
since the CRA took effect in March 1996, including more than 1,000 major rules. However, only
one rule had been overturned through CRA’s procedures—OSHA’s ergonomics standard in March
2001 (P.L. 107-5). Many reasons have been suggested for why the CRA has not been used more
often,55 but chief among them may be the fact that, if the President vetoes a resolution of
disapproval (which is likely if the underlying rule is developed during his administration), then
enactment of the resolution would require approval of a two-thirds majority in both houses of
Congress. The rejection of the ergonomics rule was the result of a specific set of circumstances
created by a transition in party control of the presidency. The majority party in both houses of
Congress was the same as the party of the incoming President (George W. Bush). When the new
Congress convened in 2001 and adopted a resolution disapproving the rule published under the
outgoing President (William J. Clinton), the incoming President did not veto the resolution.
Congress may be most able to use the CRA to disapprove rules in similar, transition-related
circumstances.56
Congress can also stop agency rulemaking or regulatory enforcement through provisions added to
agency appropriations legislation. There appear to be four types of such appropriations
provisions: (1) restrictions on the finalization of particular proposed rules, (2) restrictions on
regulatory activity within certain areas, (3) implementation or enforcement restrictions, and (4)
conditional restrictions (e.g., preventing implementation of a rule until certain actions are taken).
Some of these kinds of provisions have been included in appropriations bills for many years in a
row. The reasons behind these restrictions vary, with some appearing to be based on economic
considerations, some requiring or preventing the implementation of rules issued at the end of a
presidential administration, and some included for various other reasons. Such provisions are
generally applicable only for the period of time and the agencies covered by the relevant
appropriations bill, but (depending on how they are worded) can be more broadly applicable.
Also, to the extent that agencies have independent sources of funding (e.g., user fees) or
implement their regulations through state or local governments, some of the limitations may not
be as restrictive as they seem.57
Unfunded Mandates Reform Act
The Unfunded Mandates Reform Act (UMRA) of 1995 was enacted in an effort to reduce the
costs associated with federal imposition of responsibilities, duties, and regulations upon state,
local, and tribal governments and the private sector without providing the funding appropriate to
the costs imposed by those responsibilities. Title I of UMRA established new procedures
designed to ensure that Congress fully considers the potential effects of unfunded federal
55 A related CRS analysis of the implementation of the CRA describes several possible impediments to the law’s use.
See CRS Report RL30116, Congressional Review of Agency Rulemaking: An Update and Assessment of The
Congressional Review Act after a Decade, by Morton Rosenberg. See also Morton Rosenberg, “Whatever Happened to
Congressional Review of Agency Rulemaking?: A Brief Overview, Assessment, and Proposal for Reform,”
Administrative Law Review, vol. 51, fall 1999, pp. 1051-1092.
56 See, for example, Susan E. Dudley, “Reversing Midnight Regulations,” Regulation, vol. 24 (Spring 2001), p. 9, who
noted that the “veto threat is diminished [after a transition], since the president whose administration issued the
regulations is no longer in office.” For a discussion of which rules may be carried over and disapproved after a
transition, see CRS Report RL34633, Congressional Review Act: Disapproval of Rules in a Subsequent Session of
Congress, by Curtis W. Copeland and Richard S. Beth.
57 For more information, see CRS Report RL34354, Congressional Influence on Rulemaking and Regulation Through
Appropriations Restrictions, by Curtis W. Copeland.
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mandates before imposing them in legislation. Among other things, the procedures call for the
Congressional Budget Office to provide statements to authorizing committees about whether
reported bills contain mandates and, if so, the cost of those mandates.58
Title II of UMRA (2 U.S.C. §§ 1532-1538) contains requirements imposed on covered federal
agencies during the rulemaking process. Specifically, the act requires Cabinet departments and
independent agencies (but not independent regulatory agencies) to, among other things:
• prepare a written statement containing specific descriptions and estimates for any
proposed rule or any final rule for which a proposed rule was published that
includes any federal mandate that may result in the expenditure of $100 million
or more in any year by state, local, or tribal governments, in the aggregate, or the
private sector. One of the items required in the written statement is a qualitative
and quantitative assessment of the anticipated costs and benefits of the mandate
(Section 202);
• identify and consider a reasonable number of regulatory alternatives and select
the least costly, most cost-effective, or least burdensome alternative (or explain
why that alternative was not selected) for each rule for which a written statement
is prepared (Section 205);
• develop a plan in which agencies provide notice of regulatory requirements to
potentially affected small governments (Section 203); and
• develop an effective process to permit elected officers of state, local, and tribal
governments (or their designees) to provide input in the development of
regulatory proposals containing significant intergovernmental mandates (Section
204).
OIRA has primary responsibility for monitoring agency compliance with title II of UMRA, and
issued guidance in March 1995 on the implementation of the title that generally repeated the
requirements of the statute. OIRA also publishes an annual report on the implementation of title
II.59
In February 1998, GAO reported that, because of the way the statute was written, title II of
UMRA had little effect on agencies’ rulemaking actions during its first two years of
implementation.60 First, many of the act’s requirements did not appear to apply to most of the
“economically significant” rules (e.g., rules with a $100 million impact on the economy) that
were promulgated during this period. For example, if a final rule did not have an associated
NPRM or imposed a mandate as a condition of federal financial assistance, the written statement
requirement in section 202 of UMRA does not apply. Second, UMRA does not require agencies
to take the actions specified if the agencies determine that they are duplicative of other actions or
58 For an overview of UMRA, see CRS Report R40957, Unfunded Mandates Reform Act: History, Impact, and Issues,
by Robert Jay Dilger and Richard S. Beth.
59 In recent years, OIRA’s annual report on UMRA has been combined with its report on the costs and benefits of
federal regulations. See, for example, Office of Management and Budget, Office of Information and Regulatory
Affairs, 2010 Report to Congress on the Benefits and Costs of Federal Regulations and Unfunded Mandates on State,
Local, and Tribal Entities, available at http://www.whitehouse.gov/sites/default/files/omb/legislative/reports/
2010_Benefit_Cost_Report.pdf.
60 U.S. General Accounting Office, Unfunded Mandates: Reform Act Has Had Little Effect on Agencies’ Rulemaking
Actions, GAO/GGD-98-30, Feb. 4, 1998.
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that accurate estimates of the effect of their rules are not feasible. Third, even when UMRA is
triggered, it often requires agencies to take actions that are identical or similar to actions that they
were already required to take. For example, UMRA’s requirements in sections 202 and 205 for
the conduct of cost-benefit analysis and identification of regulatory alternatives are similar to the
requirements that were already in place under Executive Order 12866, which was issued more
than a year before UMRA was enacted. (See below for a discussion of “Executive Order 12866.”)
The consultation requirements in section 204 are traceable to the notice and comment
requirements in the APA, and are almost identical to the requirements in Executive Order 12875,
which was issued more than a year before UMRA.
In May 2004, GAO again reported that UMRA’s written statement requirements did not apply to
most major or economically significant final rules issued in 2001 and 2002 (only 9 of 122).61
However, GAO also said that some of the rules not triggering UMRA’s requirements “appeared to
have potential financial impacts on affected nonfederal parties similar to those of the actions that
were identified as containing mandates at or above the act’s thresholds.” In March 2005, GAO
reported that parties from various sectors (businesses, public interest groups, academia, and
others) most commonly cited UMRA’s numerous definitions, exclusions, and exceptions as
problematic and in need of improvement.62 In February 2011, GAO reiterated these conclusions,
noting that there are 14 reasons why a rule would not be considered a “mandate” under UMRA.63
Information Quality Act
Section 515 of the Treasury and General Government Appropriations Act for Fiscal Year 2001,
generally known as the “Data Quality Act” or the “Information Quality Act” (IQA) amended the
Paperwork Reduction Act and directed OMB to issue government-wide guidelines that “provide
policy and procedural guidance to Federal agencies for ensuring and maximizing the quality,
objectivity, utility, and integrity of information (including statistical information) disseminated by
Federal agencies.”64 The IQA also instructed agencies (both Cabinet departments and independent
agencies as well as independent regulatory agencies) to issue their own guidelines not more than
one year after the issuance of OMB’s government-wide guidelines, and to establish administrative
mechanisms allowing affected persons to seek and obtain correction of information maintained
and disseminated by the agency. Finally, the act required agencies to report periodically to the
Director of OMB on the number and nature of complaints received and how such complaints
were handled by the agency. The first agency reports were due by January 1, 2004.
In response to a separate congressional requirement, in April 2004, OMB provided Congress with
a report on the implementation of the IQA during FY2003.65 The report said that agencies
61 U.S. General Accounting Office, Unfunded Mandates: Analysis of Reform Act Coverage, GAO-04-637, May 12,
2004.
62 U.S. Government Accountability Office, Unfunded Mandates: Views Vary About Reform Act’s Strengths,
Weaknesses, and Options for Improvement, GAO-05-454, March 31, 2005.
63 Testimony of Denise M. Fantone, Director, Strategic Issues, U.S. Government Accountability Office, before the
Subcommittee on Technology, Information Policy, Intergovernmental Relations and Procurement Reform, House
Committee on Oversight of Government Management, available at http://www.gao.gov/products/GAO-11-385T.
64 OMB published those government-wide guidelines in interim form on September 28, 2001, and in updated final form
on February 22, 2002. See Office of Management and Budget, “Guidelines for Ensuring and Maximizing the Quality,
Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies; Republication,” Federal Register,
vol. 67, no. 36, Feb. 22, 2002, p. 8452.
65 For a copy of this report, see http://www.whitehouse.gov/omb/inforeg/fy03_info_quality_rpt.pdf.
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received only about 35 substantive correction requests during the year, and said it was “premature
to make broad statements about both the impact of the correction request process and the overall
responsiveness of the agencies.” Many other correction requests listed in the report were on
minor issues or involved matters that had been dealt with before the IQA was enacted. OMB
indicated that the correction requests came from all segments of society, and said there was no
evidence that the IQA had affected the pace of rulemaking. However, OMB Watch (a public
interest group) said OMB’s report was “seriously flawed” in that it understated the number of
correction requests and did not disclose that nearly three-quarters of the requests were from
industry.66
The IQA builds upon existing agency responsibilities to assure the quality of information
collected, used, or disseminated to the public. Proponents of the act contend that the law and the
OMB and agency guidelines will improve the quality of agency science and regulation, and force
agencies to regulate based on the best science available. Some of these proponents also maintain
that the act will help agencies defend their regulations against lawsuits and reduce the number of
lawsuits filed. They also point out that in any requests for correction of information, the IQA
places the burden of proof on the affected parties making the request; they must demonstrate that
a specific dissemination does not meet the standards of either the OMB guidelines or the agency-
specific guidelines. However, opponents of the act and the guidelines contend the IQA may have
a chilling effect on agency distribution and use of scientific information. These opponents foresee
a flood of information quality challenges, correction requests, and court suits on a wide range of
scientific issues, which may tie up agency resources and significantly delay health, safety, and
environmental regulations. Opponents have also noted that since “quality” is a subjective term
and some regulations are based on “best available data,” regulations could be arbitrarily rejected
under this new law.
A major test of the IQA concerned whether agencies’ denials of information correction requests
are subject to judicial review. In March 2006, the U.S. Court of Appeals for the Fourth Circuit
ruled that the act does not permit judicial review.67 Two district courts had previously reached a
similar conclusion,68 and the Department of Justice had issued a brief stating that the IQA does
not permit judicial review.69
Peer Review
In a development closely related to the issue of information quality, in September 2003, OMB
published a proposed bulletin on “Peer Review and Information Quality” that would have, if
66 For a copy of this report, see http://www.ombwatch.org/infor/dataqualityreport.pdr.
67 Salt Institute; Chamber of Commerce of the United States of America v. Michael O. Leavitt, Secretary of Health and
Human Services, No. 05-1097, Mar. 6, 2006.
68 In re: Operation of the Missouri River Sys. Litig., No. 03-MD-1555 at 49 (D. Minn. June 21, 2004) (order granting
motions for summary judgment); and Salt Institute and the Chamber of Commerce of the United States of America v.
Tommy G. Thompson, Secretary, U.S. Department of Health and Human Services, Civil Action No. 04-359, Nov. 15,
2004. In the Salt Institute case, the court ruled that there is no private right of action under the IQA, saying that the
“language in the IQA reflects Congress’s intent that any challenges to the quality of information disseminated by
federal agencies should take place in administrative proceedings before federal agencies and not the courts.” The court
also said that judicial review under the APA was not available because the agency’s actions did not constitute a “final
agency action,” and because the agency decisions were within the discretion provided to the agency by law.
69 For more information on the IQA, see CRS Report RL32532, The Information Quality Act: OMB’s Guidance and
Initial Implementation, by Curtis W. Copeland.
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made final, provided a standardized process by which all significant regulatory information
would be peer reviewed.70 The authorities that OMB cited for this action were the IQA, the
Paperwork Reduction Act, and Executive Order 12866. “Regulatory information” was defined in
the bulletin as any scientific or technical study that “might” be used by federal, state, local, or
international regulatory bodies.
Specifically, the bulletin proposed requiring each federal agency (each executive agency and
independent regulatory agency) to take three actions: (1) have all “significant regulatory
information” that it intends to disseminate peer reviewed (with information defined as
“significant” if OMB determines that it will have a clear and substantial impact on important
public policies or private sector decisions); (2) have “especially significant regulatory
information” subject to the above requirements peer reviewed according to even higher standards
(with information deemed “especially significant” if, among other things, it supports a regulatory
action with a $100 million or more impact on the economy or “is relevant to an Administration
policy priority”); and (3) provide OMB at least once each year with information about upcoming
significant regulatory disseminations and the agency’s plans for conducting peer reviews. The
proposed bulletin also said agencies that are likely to disseminate “significant” or “especially
significant” regulatory information must supplement or amend their information quality
guidelines to incorporate the requirements of the proposed peer review bulletin for “significant”
and “especially significant” information. The proposed bulletin indicated that OMB could waive
the requirements for peer review if an agency made “a compelling case” that a waiver is
necessary (e.g., an imminent health hazard or homeland security threat). OMB received 187
comments from the public and other agencies on its proposed peer review bulletin, with some
supporting its issuance in final and others calling for its withdrawal and reconsideration. On April
15, 2004, OMB published a revised bulletin, and again asked the public for comments.71
On December 15, 2004, OMB published a final version of the peer review bulletin on its
website.72 The final bulletin was published in the Federal Register on January 14, 2005.73 OMB
said this version reflects “minor revisions” made in response to more than 50 comments from the
public on the revised bulletin. For example, the final bulletin requires agencies to disclose the
names of peer reviewers to the public and adds an annual reporting requirement to allow OMB to
track how agencies are using the bulletin. However, agencies are still afforded substantial
discretion to determine when and what type of peer review is required. OMB also retains
substantial discretion in certain areas.
OMB and supporters of the peer review bulletin indicate that peer review standards across the
government are currently inconsistent, and that more consistent use of peer review can increase
the technical quality and credibility of regulatory science.74 They also assert that peer review can
70 Office of Management and Budget, Executive Office of the President, “Proposed Bulletin on Peer Review and
Information Quality,” Federal Register, vol. 68, no. 178, Sept. 15, 2003, p. 54023.
71 For a copy of the revised peer review bulletin, see http://www.whitehouse.gov/omb/inforeg/peer_review041404.pdf.
For a summary of the public and agency comments provided regarding the first bulletin, see
http://www.whitehouse.gov/omb/inforeg/peer_review_comment.pdf. Copies of the comments can be viewed at
http://www.whitehouse.gov/omb/inforeg/2003iq/iq_list.html.
72 Office of Management and Budget, Final Information Quality Bulletin for Peer Review, Dec. 15, 2004, available at
http://www.whitehouse.gov/omb/inforeg/peer2004/peer_bulletin.pdf.
73 Office of Management and Budget, Final Information Quality Bulletin for Peer Review, 70 Federal Register 2664
(Jan. 14, 2005).
74 In a Sept. 20, 2001, memorandum to the President’s Management Council, the OIRA Administrator previously
(continued...)
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protect science-based regulations from political criticism and litigation. Opponents view the
bulletin as an effort to inject political considerations into the world of science and to use the
uncertainty that inevitably surrounds science as an excuse to delay new rules that could cost
regulated entities millions or even billions of dollars. They also expressed concerns regarding the
need for the bulletin and OMB’s authority to issue it.75
Other Statutory Provisions Related to Rulemaking
Other statutory provisions have been enacted over the years that, while generally not imposing
new rulemaking requirements per se, can affect the rulemaking process.
Federal Advisory Committee Act
Several statutes either require or permit the use of advisory committees in the federal rulemaking
process. An advisory committee may be composed of experts in the regulatory field involved,
representatives of the interest groups affected by the rule, and related federal or state agencies,
and may help set the agency’s rulemaking agenda or may simply serve as a sounding board for
agency ideas. The enactment of the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C.
App. II) established requirements to ensure that agencies using advisory committees receive
impartial and relevant expertise. Specifically, FACA requires that the advice provided by advisory
committees be objective and accessible to the public. With certain exceptions, each advisory
committee meeting is presumptively open to the public. Adequate advance notice of the meetings
must be published in the Federal Register, and all papers, records, and minutes of the meetings
must generally be made available to the public. FACA also requires that the advisory committees
be fairly balanced in regard to the points of view of affected interests and the functions
performed. The act defines an advisory committee as any committee or similar group (1)
established or used to obtain advice or recommendation for one or more federal agencies or the
President and (2) that is not composed wholly of full-time federal officers or employees.76
Trade Agreements Act
The Trade Agreements Act of 1979 (19 U.S.C. §§ 2531-2533) prohibits agencies from setting
regulatory standards that create “unnecessary obstacles to foreign commerce” of the United
States. The act specifically states that legitimate domestic objectives such as safety or health are
not considered unnecessary obstacles. The statute also requires, where appropriate, the use of
performance standards rather than design standards and the consideration of international
standards as the basis of domestic standards.
(...continued)
indicated that, during its reviews of agencies’ draft rules under Executive Order 12866, it would give a “measure of
deference” to regulatory analyses that had been peer reviewed.
75 For more information, see CRS Report RL32680, Peer Review: OMB’s Proposed, Revised, and Final Bulletins, by
Curtis W. Copeland and Eric A. Fischer.
76 For more information, see CRS Report R40520, Federal Advisory Committees: An Overview, by Wendy R.
Ginsberg.
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Negotiated Rulemaking Act
The Negotiated Rulemaking Act of 1990 (5 U.S.C. §§ 561-570a), as amended and permanently
authorized in 1996 (110 Stat. 3870), seeks to overcome what some observers describe as an
adversarial relationship between agencies and affected interest groups that often accompanies
agency rulemaking. The concept of negotiated rulemaking (sometimes referred to as regulatory
negotiation or “reg-neg”) emerged in the 1980s as a supplement to the traditional procedure for
developing regulations. Negotiated rulemaking does not replace procedures necessary under the
APA. Instead, the act encourages (but does not require) agencies to consider convening a
negotiated rulemaking committee before developing and issuing a proposed regulation under the
APA. The committee, composed of representatives of the agency and the various interest groups
that would be affected by the proposed regulation, addresses areas of concern in the hope that it
can reach agreement on the contents of a proposed regulation. The agency can, if it agrees, then
issue the agreement as a proposed rule, and eventually a final rule under existing APA
requirements. The expectation is that any rule drafted through negotiated rulemaking would be
easier to implement and less likely to be the subject of subsequent litigation. However, any
proposal agreed to by the negotiated rulemaking committee is not binding on the agency or other
parties.
The major provisions of the act require that (1) a negotiated rulemaking committee consist of at
least one member of the agency and no more than 25 members, unless the head of the agency
determines that more are needed; (2) the agency select an impartial “facilitator” to chair meetings,
subject to the approval of the committee by consensus; (3) an agreement on any negotiated
rulemaking must be unanimous, unless the negotiated rulemaking committee agrees to other
conditions; and (4) the head of an agency, when deciding whether to establish a negotiated
rulemaking committee, assure that (a) there are a limited number of identifiable interests that will
be significantly affected by the rule; (b) there is a reasonable chance that a committee can be
convened with a balanced representation of interested parties willing to negotiate in good faith;
and (c) there is a reasonable likelihood that a committee will reach a consensus on the proposed
rule within a fixed period of time.
An agency may pay reasonable travel and per diem expenses, and reasonable compensation to
negotiating committee members under certain conditions. The agency must comply with FACA in
establishing and administering the committee. Agency procedural actions related to establishing,
assisting, or terminating the committee are not subject to judicial review, but any judicial review
available regarding the rule resulting from negotiated rulemaking is unaffected.77 Although the
use of negotiated rulemaking was expected to improve rulemaking timeliness and reduce
litigation, one examination of agencies’ efforts in this area indicated that those expectations were
not being fulfilled.78 However, another study indicated that negotiated rulemaking can improve
participants’ perception of the final rule and of the overall rulemaking process.79
77 For a complete discussion of negotiated rulemaking, see Administrative Conference of the United States, Negotiated
Rulemaking Sourcebook (Sept. 1995).
78 Cary Coglianese, “Assessing Consensus: The Promise and Performance of Negotiated Rulemaking,” Duke
University Law Journal, vol. 46 (1997), pp. 1255-1349.
79 Laura I. Langbein and Cornelius M. Kerwin, “Regulatory Negotiation versus Conventional Rulemaking: Claims,
Counterclaims, and Empirical Evidence,” Journal of Public Administration Research and Theory, vol. 10 (2000), pp.
599-632.
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Although the Negotiated Rulemaking Act gives agencies substantial discretion as to whether the
approach should be employed in rulemaking, Congress has sometimes mandated its use by
rulemaking agencies and established specific procedures and time frames to follow. For example,
Section 5602 of the Patient Protection and Affordable Care Act requires the Secretary of Health
and Human Services to use negotiated rulemaking to establish a “comprehensive methodology
and criteria for designation of ... (A) medically underserved populations in accordance with
section 330(b)(3) of the Public Health Service Act (42 U.S.C. § 254b(b)(3)),” and “(B) health
professions shortage areas under section 332 of the Public Health Service Act (42 U.S.C. §
254e).”80
National Technology Transfer and Advancement Act
Section 12(d) of the National Technology Transfer and Advancement Act (15 U.S.C. § 272 note),
adopted in March 1996, generally requires federal agencies to “use technical standards that are
developed or adopted by voluntary consensus standards bodies” to carry out policy objectives
unless doing so is “inconsistent with applicable law or otherwise impractical.” Agencies are also
required to consult with and (if in the public interest and compatible with agency missions,
authority, priorities, and resources) participate with voluntary, private sector, consensus bodies.
This provision essentially codified policies already in existence in OMB Circular A-119, and also
established reporting requirements and authorized the National Institute of Standards and
Technology (NIST) within the Department of Commerce to coordinate agencies’ conformity
assessment activities. According to NIST, federal agencies use consensus standards in hundreds
of federal procurement or regulatory programs (e.g., requiring certification from Underwriters
Laboratories that a product is safe or requiring individuals in certain professions meet specific
educational or competency standards).81
Regulatory Right-to-Know Act
Section 624 of the Treasury and General Government Appropriations Act, 2001 (31 U.S.C. §
1105 note), sometimes referred to as the “Regulatory Right-to-Know Act,” requires OMB to
prepare and submit with the budget an “accounting statement and associated report” containing
an estimate of the total costs and benefits (including quantifiable and nonquantifiable effects) of
federal rules and paperwork, to the extent feasible, (1) in the aggregate, (2) by agency and agency
program, and (3) by major rule. The accounting statement is also to contain an analysis of impacts
of federal regulation on state, local, and tribal governments, small businesses, wages, and
economic growth. The statute requires an accounting statement and report for calendar year 2002
“and each year thereafter.”82 To prepare the report, OMB relies heavily on agencies’ estimates of
costs and benefits for individual rules published during the previous 10 years. However, if an
agency quantified but did not monetize its estimates, OMB monetizes them using “standard”
80 For more information, see CRS Report RL32452, Negotiated Rulemaking, by Curtis W. Copeland.
81 For a discussion of federal policies relating to certification and consensus standards, see U.S. General Accounting
Office, Certification Requirements: New Guidance Should Encourage Transparency in Agency Decisionmaking,
GAO/GGD-99-170, Sept. 24, 1999.
82 The accounting statement requirement had been included in appropriations bills for several previous years on a year-
to-year basis.
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assumptions. In its reports, OMB attempts to capture the agencies’ nonquantified benefits and
costs in “other information” columns, but OMB’s monetized estimates exclude these effects.83
Government Paperwork Elimination Act
In 1998, Congress enacted the Government Paperwork Elimination Act (GPEA) (44 U.S.C. §
3504 note), which required that by October 21, 2003, federal agencies provide the public, when
practicable, with the option of submitting, maintaining, and disclosing information electronically,
instead of on paper. GPEA makes OMB responsible for ensuring that federal agencies meet the
act’s implementation deadline. Although GPEA does not specifically mention rulemaking, both
OMB and rulemaking agencies have indicated that its requirements have provided an impetus for
developing information technology-based approaches to rulemaking that involves information
collection and, more generally, to regulatory management.
E-Government Act
The E-Government Act of 2002 (44 U.S.C.A. § 3601 note) was designed to enhance the
management and promotion of electronic government services and processes, and contains
requirements affecting the rulemaking process. Specifically, section 206 of the act requires
agencies, to the extent practicable, to:
• ensure that a publicly accessible website includes all information about that
agency that is required to be published in the Federal Register,
• accept public comments on proposed rules “by electronic means,” and
• ensure that a publicly accessible federal website contains “electronic dockets” for
proposed rules containing all comments submitted on the rules as well as “other
materials that by agency rule or practice are included in the rulemaking docket
under (the APA), whether or not submitted electronically.”
The E-Government Act also requires agencies to conduct a “privacy impact assessment” before
initiating a new collection of information that uses information technology and contains
individually identifying information. In addition, the act established an Office of Electronic
Government within OMB, headed by an Administrator appointed by the President. It requires the
Administrator of that office to work with the Administrator of OIRA in establishing the strategic
direction of the e-government program, and to oversee its implementation.
In January 2003, the Bush Administration launched the “Regulations.gov” website—the first
module of its own “e-rulemaking” initiative that would accomplish many of the objectives of the
E-Government Act. The website permits the public to identify proposed rules that are open for
comment government-wide, and permits the public to comment electronically on those rules.84
The second module of the e-rulemaking initiative is intended to create one or more electronic
dockets for proposed and final rules. The Environmental Protection Agency (EPA) is the lead
agency for the e-rulemaking initiative.
83 See http://www.whitehouse.gov/omb/inforeg_regpol_reports_congress/ for a compilation of these reports.
84 For a comparison of the Regulations.gov website with individual agency systems, see U.S. General Accounting
Office, Electronic Rulemaking: Efforts to Facilitate Public Participation Can Be Improved, GAO-03-90, Sept. 17,
2003.
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E-rulemaking has been described as a way to increase democratic legitimacy, improve regulatory
policy decisions, decrease administrative costs, and increase regulatory compliance. However, the
implementation of e-rulemaking in the federal government has been controversial. Although the
migration of agencies into the government-wide docket was originally planned for 2004, that
migration was not completed until 2008. Congress has objected to how e-rulemaking and several
other e-government projects have been funded (through appropriations transfers or
reimbursements to the projects’ “managing partner” agencies), and has voiced other concerns
about the overall management and appropriateness of the initiatives. Questions have also been
raised regarding the e-rulemaking initiative’s centralized structure, its costs (more than $53
million spent through FY2008) and expected financial benefits, the functionality of some of the
applications being used, and its effect on public participation in the rulemaking process.
The reasons why the federal e-rulemaking initiative had such a difficult first five years are many,
but one appears to be the lack of direct, consistent funding. From FY2003 through FY2007,
Congress appropriated less than $20 million to the E-Government Fund for all e-government
projects—much less than the $345 million authorized in the E-Government Act for that period.
Congress has also required approval by the Appropriations Committees before any transfers or
reimbursements of appropriations are made. Although some have suggested that better
communication is needed between Congress and the executive branch, the conflicts may reflect
basic differences of opinion between the two branches regarding control of federal operations and
how the branches should interact. A long-term issue is whether e-rulemaking should continue to
be housed in EPA.85
Small Business Paperwork Relief Act
In June 2002, Congress enacted and the President signed the Small Business Paperwork Relief
Act of 2002 (P.L. 107-198). The act amended the Paperwork Reduction Act to, among other
things, require each agency to establish a single point of contact to act as a liaison for small
business concerns with regard to information collection and paperwork issues. It also directed
agencies to make a special effort to reduce information collection burdens for small businesses
with fewer than 25 employees. OMB was directed to publish in the Federal Register and make
available on the Internet an annual list of the compliance assistance resources available to small
businesses.86 The act also required agencies to report to Congress on the amount of penalty relief
provided to small businesses, and established a task force to study the feasibility of streamlining
information collection requirements on small businesses.
Executive Orders and Directives
During the past 20 years, each President has issued executive orders and/or presidential directives
designed to guide the federal rulemaking process, often with the goal of reducing regulatory
burden. Although independent regulatory agencies are generally not covered by these
requirements, they are often encouraged to follow them. By far the most important of the current
85 For more information, see CRS Report RL34210, Electronic Rulemaking in the Federal Government, by Curtis W.
Copeland.
86 These lists of compliance assistance resources are available on the OMB website at http://www.whitehouse.gov/omb/
inforeg/infocoll.html#sbpra and on the SBA website at http://www.sba.gov/ombudsman/compliance/
complianceassist.html.
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executive rulemaking requirements is Executive Order 12866,87 which describes both the
principles and the process by which presidential regulatory review currently takes place.
Executive Order 12866
Centralized review of agencies’ regulations within the Executive Office of the President has been
part of the federal rulemaking process for more than 30 years. Although each of his three
predecessors had some type of review process, the most significant development in the evolution
of presidential review of rulemaking occurred in 1981, when President Reagan issued Executive
Order 12291. The executive order established a set of general requirements for rulemaking, and
required federal agencies (other than independent regulatory agencies) to send a copy of each
draft proposed and final rule to OMB before publication in the Federal Register. It also required
covered agencies to prepare a regulatory impact analysis for each “major” rule (e.g., those with a
$100 million impact on the economy). As a result of this order, OIRA’s responsibilities were
greatly expanded from paperwork reviews to examinations of the substance of covered agencies
rules—between 2,000 and 3,000 reviews per year. In 1985, President Reagan expanded OIRA’s
influence further by issuing Executive Order 12498, which required covered agencies (all except
independent regulatory agencies) to submit a regulatory plan to OMB for review each year that
covered all of their significant regulatory actions underway or planned.
On September 30, 1993, President Clinton issued Executive Order 12866, which revoked
Executive Orders 12291 and 12498 and established a new process for OIRA review of rules.88
Like its predecessors, the new executive order limited OIRA’s reviews to proposed and final rules
published by agencies other than independent regulatory agencies. However, it also limited OIRA
reviews to actions identified by the rulemaking agency or OIRA as “significant” regulatory
actions, defined as those that were “economically significant” (e.g., those with a $100 million
impact on the economy) or that (1) were inconsistent or interfered with an action taken or planned
by another agency; (2) materially altered the budgetary impact of entitlements, grants, user fees,
or loan programs; or (3) raised novel legal or policy issues. As a result, the number of rules that
OIRA reviewed dropped from between 2,000 and 3,000 per year to between 500 and 700 per
year.
Executive Order 12866 also differs from its predecessors in other respects. For example, the order
requires that OIRA generally complete its reviews of proposed and final rules within 90 calendar
days. It also requires both rulemaking agencies and OIRA to disclose certain information about
how the regulatory reviews were conducted. For example, agencies are to identify for the public
(1) the substantive changes made to rules between the draft submitted to OIRA for review and the
action subsequently announced, and (2) changes made at the suggestion or recommendation of
OIRA. OIRA is required to, among other things, provide agencies with a copy of all
communications between OIRA personnel and parties outside of the executive branch, and to
maintain a public log of all regulatory actions under review and of all of the documents provided
to the agencies.89
87 Executive Order 12866, “Regulatory Planning and Review,” 58 Federal Register 51735, Oct. 4, 1993.
88 Although issued on September 30, 1993, the executive order was not printed in the Federal Register until several
days later. See The President, “Executive Order 12866—Regulatory Planning and Review,” Federal Register, vol. 58,
no. 190 (Oct. 4, 1993).
89 For a current list of regulations under OIRA review or reviews completed within the past 30 days, see
http://www.whitehouse.gov/omb/inforeg/regpol-regs_under12866.html.
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For each significant draft rule, the executive order requires the issuing agency to provide to OIRA
the text of the draft rule, a description of why the rule is needed, and a general assessment of the
rule’s costs and benefits. For draft rules that are “economically significant,” the executive order
requires a detailed cost-benefit analysis, including an assessment of the costs and benefits of
“potentially effective and reasonably feasible alternatives to the planned regulation.” One of the
“principles of regulation” in the order is that agencies shall “propose or adopt a regulation only
upon a reasoned determination that the benefits of the intended regulation justify its costs.” The
order also says that when setting regulatory priorities, “each agency shall consider, to the extent
reasonable, the degree and nature of the risks posed by various substances or activities within its
jurisdiction.” The executive order’s “regulatory philosophy” states that unless a statute requires
another regulatory approach, “in choosing among alternative regulatory approaches, agencies
should select those approaches that maximize net benefits.”90
During the formal Executive Order 12866 review process, OIRA analyzes the draft rule in light of
the principles of the executive order and discusses the rule with staff and officials at the
rulemaking agency. OIRA may also discuss the draft rule with other agencies with whom
interagency coordination will be necessary, and may meet or otherwise communicate with
interested stakeholders outside of the federal government.91 At the end of the review OIRA either
concludes that the draft rule is consistent with the principles of the executive order (the majority
of the cases) or returns the rule to the agency “for further consideration.” In some cases agencies
withdraw their draft rules during OIRA’s review. If the draft is a proposed rule, the agency may
then publish an NPRM. If the draft is a final rule, the agency may then publish a final rule and
allow the rule to take effect. OIRA staff also sometimes review draft rules informally before their
formal submission under the executive order—particularly when there is a statutory or legal
deadline or when a rule has a large impact on society.
OIRA’s formal review process has not changed substantially since Executive Order 12866 was
issued in 1993.92 However, GAO reported in September 2003 that there had been several changes
in OIRA policies and practices since the current OIRA Administrator (Dr. John Graham) took
office in July 2001, including (1) increased use of public letters explaining why OIRA returned
rules to agencies for their consideration and suggesting regulatory action, (2) increased emphasis
on cost-benefit analysis and peer review of agencies’ rules, (3) stricter adherence to the 90-day
time limit for OIRA review, (4) improvements in the transparency of the OIRA review process,
and (5) an increase in the size and skills of OIRA’s staff.93 Underlying many of these changes is a
shift in how OIRA administrators view the office’s role in the rulemaking process—from
“counselor” to the agencies to regulatory “gatekeeper.” GAO also concluded that, certain changes
90 In January 1996, OIRA published a document that described “best practices” for preparing the economic analyses
called for by the executive order. This document was revised and issued as guidance in 2000. In September 2003, OMB
and the Council of Economic Advisors finalized new guidance for agencies on regulatory analysis, refining and
replacing the 1996 “best practices” document. For a copy of this guidance, see http://www.whitehouse.gov/omb/
circulars/a004/a-4.pdf.
91 OIRA has indicated that it will try and accommodate any request for a meeting with parties outside of the federal
government. OIRA discloses these contacts on its website at http://www.whitehouse.gov/omb/oira/meetings.html. A
representative from the agency issuing the rule must be invited to any such meeting.
92 Executive Order 13258 reassigned certain responsibilities from the Vice President to the President’s chief of staff,
but otherwise did not change the OIRA review process. See The President, “Executive Order 13258—Amending
Executive Order 12866 on Regulatory Planning and Review,” Federal Register, vol. 67, no. 40, Feb. 28, 2002, p. 9385.
93 U.S. General Accounting Office, Rulemaking: OMB’s Role in Reviews of Agencies’ Draft Rules and the
Transparency of Those Reviews, GAO-03-929, Sept. 22, 2003.
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notwithstanding, the OIRA review process was still not very transparent to the public, and
recommended several changes in OIRA’s disclosure policies.
GAO and others have also examined agencies’ analyses of economically significant rules under
the executive order.94 For example, in 1998 GAO reported that some of the 20 economic analyses
that it examined from five agencies did not incorporate all of the best practices set forth in OMB’s
guidance.95 Five of the analyses did not discuss alternatives to the proposed regulatory action and,
in many cases, it was not clear why the agencies used certain assumptions. Also, five of the
analyses did not discuss uncertainty associated with the agencies’ estimates of benefits and/or
costs or document the agencies’ reasons for not doing so.
Executive Order 12866 also includes several other notable requirements. For example, section 5
of the order requires agencies to periodically review their existing significant regulations to
determine whether they should be modified or eliminated. In March 1995, President Clinton
reemphasized this requirement by directing each agency to conduct a page-by-page review of all
existing regulations. In June 1995, the President announced that 16,000 pages had been
eliminated from the Code of Federal Regulations. GAO reported on this review effort in October
1997, noting that the page elimination totals that four agencies reported did not take into account
pages that had been added while the eliminations took place.96 GAO also reported that about half
of the actions taken appeared to have no effect on the burden felt by regulated entities, would
have little effect, or could increase regulatory burden.
Executive Order 13422
On January 18, 2007, President George W. Bush issued Executive Order 13422, making the most
significant amendments to Executive Order 12866 since it was published. The changes made by
this new executive order were controversial, characterized by some as a “power grab” by the
White House that undermines public protections and lessens congressional authority and by
others as “a paragon of common sense and good government.” The most important changes made
by Executive Order 13422 fell into five general categories: (1) a requirement that agencies
identify in writing the specific market failure or problem that warrants a new regulation, (2) a
requirement that each agency head designate a presidential appointee within the agency as a
“regulatory policy officer” who can control upcoming rulemaking activity in that agency, (3) a
requirement that agencies provide their best estimates of the cumulative regulatory costs and
benefits of rules they expect to publish in the coming year, (4) an expansion of OIRA review to
include significant guidance documents,97 and (5) a provision permitting agencies to consider
whether to use more formal rulemaking procedures in certain cases. 98
94 See, for example, Richard D. Morgenstern, ed., Economic Analyses at EPA: Assessing Regulatory Impact
(Washington: Resources for the Future, 1997); and Robert W. Hahn, ed., Risks, Costs, and Lives Saved: Getting Better
Results from Regulation (Washington: AEI Press, 1996).
95 U.S. General Accounting Office, Regulatory Reform: Agencies Could Improve Development, Documentation, and
Clarity of Regulatory Economic Analyses, GAO/RCED-98-142, May 26, 1998.
96 U.S. General Accounting Office, Regulatory Reform: Agencies’ Efforts to Eliminate and Revise Rules Yield Mixed
Results, GAO/GGD-98-3, Oct. 2, 1997.
97 On the same day that E.O. 13422 was issued, OMB also issued a “Final Bulletin for Agency Good Guidance
Practices” that mirrored, in many respects, the provisions in this section of the executive order. Unlike the order,
however, the bulletin requires agencies to include certain standard elements in their significant guidance documents, to
list those documents on the agencies’ websites, and to publish a notice in the Federal Register soliciting public
(continued...)
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In the first half of 2007, two House subcommittees held three oversight hearings on the order. A
provision was added to the appropriations measure funding OMB for FY2008 that would have
prevented the implementation of the executive order, but the measure was eliminated from the
final version of the legislation. On January 30, 2009, President Barack Obama issued Executive
Order 13497, which (among other things) revoked Executive Order 13422.99 As a result,
Executive Order 12866 was returned to the form when it was issued in September 1993.
Executive Order 13563
On January 18, 2011, President Obama issued Executive Order 13563 on “Improving Regulation
and Regulatory Review.”100 Section 1(b) of the new order states that “This order is supplemental
to and reaffirms the principles, structures, and definitions governing contemporary regulatory
review that were established in Executive Order 12866 of September 30, 1993.” Although similar
to the 1993 order in many respects, Executive Order 13563 contains some new provisions. For
example, Section 2(b) of the order states that agencies should generally provide “timely online
access to the rulemaking docket on regulations.gov, including relevant scientific and technical
findings, in an open format that can be easily searched and downloaded. For proposed rules, such
access shall include, to the extent feasible and permitted by law, an opportunity for public
comment on all pertinent parts of the rulemaking docket, including relevant scientific and
technical findings.”
Perhaps most notably, Section 6(b) of the new order requires agencies to initiate retrospective
reviews of their existing rules. Specifically, it states,
Within 120 days of the date of this order, each agency shall develop and submit to the Office
of Information and Regulatory Affairs a preliminary plan, consistent with law and its
resources and regulatory priorities, under which the agency will periodically review 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.
Section 5(a) of Executive Order 12866 had previously required agencies to submit a plan for
retrospective reviews to OIRA, so this provision appears to require agencies to update those
plans. On February 2, 2011, the OIRA Administrator issued guidance to federal agencies on the
implementation of the executive order, including these retrospective reviews.101
(...continued)
comments on economically significant documents. To view a copy of this bulletin, see http://www.whitehouse.gov/
omb/memoranda/fy2007/m07-07.pdf; and Office of Management and Budget, “Final Bulletin for Agency Good
Guidance Practices,” 72 Federal Register 3432, January 25, 2007.
98 For more information, see CRS Report RL33862, Changes to the OMB Regulatory Review Process by Executive
Order 13422, by Curtis W. Copeland.
99 Executive Order 13497, “Revocation of Certain Executive Orders Concerning Regulatory Planning and Review,” 74
Federal Register 6113, February 4, 2009.
100 Executive Order 13563, “Improving Regulation and Regulatory Review,” 76 Federal Register 3821, January 21,
2011.
101 See http://www.whitehouse.gov/sites/default/files/omb/memoranda/2011/m11-10.pdf.
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Other Executive Orders and Directives
Agencies other than independent regulatory agencies must also be aware of an array of other
rulemaking requirements contained in executive orders and presidential directives. For example:
• Executive Order 13132 on “Federalism” requires covered federal agencies to
“have an accountable process to ensure meaningful and timely input by State and
local officials in the development of regulatory policies that have federalism
implications.”102 The order defines “federalism implications” as “substantial
direct effects on the States, on the relationship between the national government
and the States, or on the distribution of power and responsibilities among the
various levels of government.” Federal agencies are prohibited from
promulgating any regulation with unfunded federalism implications unless they
have (1) consulted with state and local officials early in the development of the
proposed rule, and (2) prepared a “federalism summary impact statement”
consisting of a description of the prior consultation with state and local officials,
a summary of their concerns and the agency’s position regarding the need to
issue the rule, and a statement of the extent to which the officials’ concerns have
been met. The order gives agencies substantial discretion regarding its
implementation. For example, it does not define what type of regulatory action
constitutes “substantial direct effects,” and says the consultation and impact
statement requirements apply “to the extent practicable.”103
• Executive Order 12630 on constitutionally protected property rights says each
agency “shall be guided by” certain principles when formulating or implementing
policies that have “takings” implications.104 For example, the order says that
private property should be taken only for “real and substantial threats,” and “be
no greater than is necessary.”105
• Executive Order 12889 on the North American Free Trade Agreement generally
requires agencies subject to the APA to provide at least a 75-day comment period
for any “proposed Federal technical regulation or any Federal sanitary or
phytosanitary measure of general application.”106
• Executive Order 12898 on environmental justice says (among other things) that
each agency must 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
102 Executive Order 13132, “Federalism,” 64 Federal Register 43255, Aug. 10, 1999.
103 Executive Order 12612, the previous executive order on federalism, also gave federal agencies broad discretion to
determine the applicability of its requirements. GAO examined the implementation of this order and concluded that its
analytical requirements were rarely implemented. See U.S. General Accounting Office, Federalism: Previous
Initiatives Have Had Little Effect on Agency Rulemaking, GAO/T-GGD-99-3, June 30, 1999.
104 Executive Order 12630, “Governmental Actions and Interference with Constitutionally Protected Property Rights,”
53 Federal Register 8859, Mar. 18, 1988.
105 For an analysis of how this executive order has been implemented, see U.S. General Accounting Office, Regulatory
Takings: Implementation of Executive Order on Government Actions Affecting Private Property Use, GAO-03-1015,
Sept. 19, 2003.
106 Executive Order 12889, “Implementation of the North American Free Trade Agreement,” 58 Federal Register
69681, Dec. 30, 1993.
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populations.107 It also says that environmental human health research should
include diverse segments of the population in epidemiological and clinical
studies, and that agencies should identify rules that should be revised to meet the
objectives of the order.
• Executive Order 12988 on civil justice reform generally requires agencies
reviewing existing and new regulations to ensure that they comply with specific
requirements (e.g., “eliminate drafting errors and ambiguity” and “provide a clear
legal standard for affected conduct”) to improve regulatory drafting in order to
minimize litigation.108 Agencies formulating proposed regulations are directed to
“make every reasonable effort” to ensure that they, among other things, specify in
clear language any preemptive or retroactive effects, and the effect on existing
law.
• Executive Order 13045 on protection of children from environmental health risks
and safety risks says that 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 may disproportionately affect children, the agency must
provide OIRA with (1) an evaluation of the environmental or safety effects on
children and (2) an explanation of why the planned regulation is preferable to
other potentially effective and reasonably feasible alternatives.109
• Executive Order 13175 on consultation and coordination with Indian tribal
governments generally prohibits agencies from promulgating any regulation not
required by law that has tribal implications and imposes substantial direct costs
on tribal governments unless the necessary funds are provided or the agency
consults with tribal officials and provides a “tribal summary impact statement”
describing those consultations.110 Similar consultation and impact statement
requirements apply to rules that preempt tribal laws.
• Executive Order 13211 on energy impacts requires agencies (to the extent
permitted by law) to prepare and submit to OMB a “statement of energy effects”
for significant energy actions.111 The statement, published in the NPRM and the
final rule, is to include a detailed statement of “any adverse effects on energy
supply, distribution, or use” for the action and reasonable alternatives and their
effects.
• Executive Order 13272 on small entities generally requires federal agencies to
issue (by February 2003) written procedures and policies to ensure proper
consideration during the rulemaking process of the impacts of their draft rules on
small entities.112 The order also requires agencies to notify the SBA Chief
107 Executive Order 12898, “Federal Actions to Address Environmental Justice in Minority Populations and Low-
Income Populations,” 59 Federal Register 7629, Feb. 16, 1994.
108 Executive Order 12988, “Civil Justice Reform,” 61 Federal Register 4729, Feb. 7, 1996.
109 Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks,” 62 Federal
Register 19885, Apr. 23, 1997.
110 Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments,” 65 Federal Register
67249, Nov. 9, 2000.
111 Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or
Use,” 66 Federal Register 28355, May 22, 2001.
112 Executive Order 13272, “Proper Consideration of Small Entities in Agency Rulemaking,” 67 Federal Register
(continued...)
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Counsel for Advocacy of any draft rules that may have a significant economic
impact on a substantial number of small entities, and to give “every appropriate
consideration” to any comments the Chief Counsel provides.
In addition to executive orders, presidential memoranda or directives can also affect the
rulemaking process. For example:
• a March 4, 1995, presidential memorandum directed federal agencies to (among
other things) focus their regulatory programs on results, not process, and expand
their use of negotiated rulemaking.
• an April 21, 1995, memorandum directed agencies to waive or reduce penalties in
certain circumstances, and to reduce the frequency of reports the public is
required to provide to the government.
• a June 1, 1998, presidential directive required agencies to use plain language in
proposed and final rulemaking documents.
Conclusion
During the past 60 to 65 years, Congress and various Presidents have made numerous attempts to
add structure, economy, efficiency, accountability, and greater public access and transparency to
the regulatory process. In this regard, Congress has enacted laws such as the Administrative
Procedure Act, the Regulatory Flexibility Act, the Paperwork Reduction Act, and the Unfunded
Mandates Reform Act that require some type of procedure, review, and/or analysis of draft rules
by the rulemaking agencies themselves or by outside parties. Presidential rulemaking
requirements have often focused on coordination of agencies’ regulatory efforts with the
President’s priorities and attempts to improve the quality of regulations through cost-benefit
analysis, risk assessment analysis, and the consideration of specific factors in the rulemaking
process (e.g., environmental justice, children, and property rights). Underlying many of these
congressional and presidential requirements is an attempt to ensure that certain interests or issues
are considered during the rulemaking process and/or to minimize the burden associated with
federal regulations.
However, these rulemaking requirements impose burdens of their own on rulemaking agencies,
and clearly are a factor (although it is unclear whether they are the most important factor) in the
length of time it takes agencies to issue rules. Federal agencies must be aware of the cross-cutting
and the program-specific statutory and executive requirements underlying their regulations and
must craft rules that are consistent with those requirements—or run the risk of having their rules
returned to them by OIRA or rejected by Congress or the courts. Several of these statutes and
orders indicate that their requirements may be integrated with or satisfied by the requirements in
other statutes or orders. For example, the Regulatory Flexibility Act states that federal agencies
can develop their regulatory agendas and perform their regulatory flexibility analyses “in
conjunction with or as a part of any other agenda or analysis required by any other law.” Some
observers believe that integration and consolidation of all these requirements could improve the
rulemaking process. In 1993 the Administrative Conference of the United States noted that the
(...continued)
53461, Aug. 16, 2002.
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simple requirements in the Administrative Procedure Act for informal rulemaking had been
“overlain with an increasing number of constraints,” including those imposed by Congress,
Presidents, and the courts. The Administrative Conference recommended a “coordinated
framework of proposals aimed at promoting efficient and effective rulemaking.” Since then, the
number of rulemaking requirements has increased.
On the other hand, many of these statutory and executive order provisions provide the agencies
substantial discretion regarding when and how the rulemaking requirements are to be applied. For
example, because the Regulatory Flexibility Act does not define the term “significant impact on a
substantial number of small entities,” agencies have a great deal of latitude to determine when a
regulatory flexibility analysis is required. Similarly, Executive Order 13132 does not define the
term “significant federalism implications,” so agencies have substantial discretion in deciding
whether the analytical requirements of the order have been triggered. Other rulemaking
requirements are written in such a way that they actually apply to only a small number of rules.
For example, title II of the Unfunded Mandates Reform Act does not apply to any rules published
by independent regulatory agencies or any rules for which an agency determines there is “good
cause” not to publish a notice of proposed rulemaking. Other rules are exempt from UMRA if
they are conditions of federal financial assistance or enforce constitutional rights.
The discretion and exceptions built into these rulemaking statutes and orders diminish their
impact, and allow agencies knowledgeable of their provisions to avoid many of the analyses and
procedures they seem to require. For example, on hundreds of occasions, agencies have stated in
the preambles to their rules that because they believed there was “good cause” not to issue a
notice of proposed rulemaking, the requirements of the RFA and/or UMRA do not apply.
Agencies also have standard language that they insert into preambles certifying that their rules do
not require regulatory flexibility analyses or UMRA written statements. And if agencies are not
required to prepare regulatory flexibility analyses for their proposed rules, they are also exempt
from the SBREFA requirements to prepare small entity compliance guides and (in the case of
OSHA, EPA, and CFPB) to convene advocacy review panels.
Because of the inevitability of regulation and its associated burden, efforts to either tighten
existing requirements or impose new ones are likely to continue. A clear understanding of the
existing requirements and how they have been implemented may inform any such future efforts.
For Additional Information
Kerwin, Cornelius M., Rulemaking: How Government Agencies Write Law and Make Policy,
Third Edition (Washington: CQ Press, 2003).
Lubbers, Jeffrey S., ed., A Guide To Federal Agency Rulemaking, Fourth Edition (Chicago: ABA
Publishing, 2006).
In addition, information regarding a variety of regulatory issues is available at the following
websites:
Center for Progressive Regulation
http://www.progressiveregulation.org
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Center for Regulatory Effectiveness
http://www.thecre.com
Competitive Enterprise Institute
http://www.cei.org
Government Accountability Office (GAO, formerly the General Accounting Office)
http://www.gao.gov
Government Printing Office (GPO)
http://www.gpoaccess.gov/nara/index.html
Office of Management and Budget
http://www.whitehouse.gov/omb
OMB Watch
http://www.ombwatch.org
Regulations.gov
http://www.regulations.gov
Regulatory Information Service Center
http://www.reginfo.gov
Author Contact Information
Curtis W. Copeland
Specialist in American National Government
cwcopeland@crs.loc.gov, 7-0632
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