Federal Rulemaking: The Role of the Office of Information and Regulatory Affairs

Prepared for Members and Committees of Congress

The Paperwork Reduction Act of 1980 created the Office of Information and Regulatory Affairs
(OIRA) within the Office of Management and Budget (OMB). Executive Order 12291, issued by
President Reagan in 1981, gave OIRA the responsibility to review the substance of agencies’
regulatory actions before publication in the Federal Register. The office’s regulatory review role
was initially highly controversial, and it has been criticized at different times as being both too
active and too passive regarding agencies’ rules. Although OIRA has a number of specific
statutory responsibilities (e.g., paperwork review and regulatory accounting), as a component of
OMB it is part of the Executive Office of the President, and helps ensure that covered agencies’
rules reflect the President’s policies and priorities.
OIRA’s current regulatory review responsibilities are detailed in Executive Order 12866, which
was issued by President Clinton in 1993. The office reviews significant draft rules from agencies
(other than independent regulatory agencies) at both the proposed and final rulemaking stages,
and also informally reviews certain rules before they are formally submitted. For rules that are
“economically significant” (most commonly defined as those having a $100 million impact on the
economy), OIRA also reviews the economic analyses. Since 1994, OIRA has reviewed between
500 and 700 significant proposed and final rules each year, and can clear the rules with or without
changes, return the rules to the agencies for reconsideration, or encourage the agencies to
withdraw them. The executive order also requires OIRA or the rulemaking agencies to disclose
certain elements of the review process to the public, including the changes made at OIRA’s
recommendation. A September 2003 report by the General Accounting Office indicated that
OIRA had a significant effect on more than a third of the 85 rules in the study, but OIRA’s most
common effect was to suggest changes to explanatory language in the preambles to the rules. At
the start of the George W. Bush Administration, OIRA made a number of changes to its review
process, including increased use of return letters, added emphasis on economic analysis to
support the rules, and improvements in the transparency of the office’s review process. Overall, in
contrast to the “counselor” role it played during the Clinton Administration, OIRA appeared to
have returned to the “gatekeeper” role that it had during its first 12 years of existence. Possible
legislative issues involving OIRA include codification of the office’s review function and
principles, increasing or decreasing the office’s funding and staffing, adding review of rules from
independent regulatory agencies, and improvements in the transparency of OIRA’s review
This report will be updated if there are changes in OIRA’s regulatory review responsibilities. For
information, see CRS Report RL33862, Changes to the OMB Regulatory Review Process by
Executive Order 13422, by Curtis W. Copeland; CRS Report RL32240, The Federal Rulemaking
Process: An Overview, by Curtis W. Copeland; and CRS Report RL32356, Federal Regulatory
Reform: An Overview, by Curtis W. Copeland.

The Establishment of Regulatory Review in OIRA........................................................................1
OIRA and Reagan Executive Orders on Regulatory Review....................................................2
Comparison to Previous Regulatory Review Efforts................................................................5
Early Views Regarding OIRA Reviews....................................................................................6
OIRA and the George H. W. Bush Administration....................................................................8
Regulatory Review Under Executive Order 12866.........................................................................9
Specific Provisions in the Executive Order...............................................................................9
OIRA’s Formal Review Process.........................................................................................11
OIRA’s Informal Reviews.................................................................................................14
Effects of OIRA’s Reviews............................................................................................................15
GAO’s Analysis of OIRA’s Effects.........................................................................................16
OIRA’s Impact on Rules...................................................................................................17
Regulated Entities’ Contacts with OIRA..........................................................................18
Changes in OIRA’s Policies and Practices During the George W. Bush Administration..............18
Return of the “Gatekeeper” Role............................................................................................18
Increased (and Decreased) Use of Return Letters...................................................................19
Advent (and Decline) of Prompt Letters.................................................................................20
Increased Emphasis on Economic Analysis............................................................................20
Increased Transparency...........................................................................................................21
Changes in OIRA Staffing.......................................................................................................22
Changes to OIRA Review by Executive Order 13422..................................................................22
OIRA’s Other Responsibilities......................................................................................................23
OIRA and the Future of Presidential Regulatory Review.............................................................26
Possible Legislative Issues......................................................................................................27
Statutory Authority for Regulatory Review......................................................................27
Funding and Staffing.........................................................................................................28
Addition of Independent Agencies’ Rules.........................................................................28
Transparency of Reviews..................................................................................................29
Reversal of Executive Order 13422..................................................................................30
Figure 1. The Number of Rules That OIRA Reviewed Dropped Under Executive Order
12866, Issued in 1993.................................................................................................................10
Figure 2. OIRA Reviews Draft Proposed and Final Rules............................................................12
Table 1. Most Rules That OIRA Reviewed Were Coded in Database as Changed or Not
Change d ...................................................................................................................................... 13

Author Contact Information..........................................................................................................30

he Office of Information and Regulatory Affairs (OIRA) is one of several statutory offices 1
within the Office of Management and Budget (OMB), and can play a significant—if not
determinative—role in the rulemaking process for most federal agencies. In addition to its T

many other responsibilities, OIRA currently reviews the substance of between 500 and 700
significant proposed and final rules each year before agencies publish them in the Federal 2
Register, and can clear the rules with or without change, return them to the agencies for
reconsideration, or encourage the agencies to withdraw the rules. Between 70 and 100 of the rules
that OIRA reviews each year are each considered “economically significant” or “major” (e.g.,
have a $100 million impact on the economy). The office was created by Congress and has a
number of specific statutory responsibilities, but also helps ensure that agencies’ rules reflect the
President’s policies and priorities.
OIRA’s role in the federal rulemaking process has been highly controversial in all four of the
presidential administrations in which it has been in existence, but some of the criticisms directed
at the office have varied over time. In some administrations, OIRA has been accused of
controlling the agenda of the rulemaking agencies too much, directing them to change substantive
provisions in draft rules or even stopping proposed regulatory actions that it believes are poorly
crafted or unnecessary. At other times, though, OIRA has been accused of not exerting enough
authority over the agencies’ rules. Other, more persistent criticisms have focused on the lack of
transparency of OIRA’s regulatory reviews to the public and the sometimes unseen influence that
regulated entities and other nongovernmental organizations can have on agencies’ rules through
those reviews.
This report describes how OIRA reviews covered agencies’ draft rules, OIRA’s effects on the
rules, and changes in OIRA’s procedures and policies in recent years. Much of that discussion is
drawn from a September 2003 report on OIRA by the General Accounting Office (GAO, now the 3
Government Accountability Office). First, though, this report will provide a brief history of
presidential regulatory review and describe how OIRA’s review process was established. Finally,
the report describes several potential legislative issues regarding OIRA’s regulatory review

OIRA was created within OMB by Section 3503 of the Paperwork Reduction Act (PRA) of 1980 4
(44 U.S.C. Chapter 35). The PRA provided that OIRA would be headed by an administrator, and

1 The other statutory offices, which are collectively referred to as the “management side of OMB, are the Office of
Federal Financial Management, the Office of Federal Procurement Policy, and the Office of Electronic Government
and Information Technology. OMBs resource management offices, which review agencies budget submissions, are
sometimes collectively referred to as OMBsbudget side.
2 The Administrative Procedure Act of 1946 (5 U.S.C. 551 et seq.). generally requires agencies to publish a notice of
proposed rulemaking in the Federal Register, permit the public to comment on the proposed rule, and then publish a
final rule addressing the comments provided. For an overview of many of the statutes and executive orders governing
federal rulemaking, see CRS Report RL32240, The Federal Rulemaking Process: An Overview, by Curtis W.
3 U.S. General Accounting Office, Rulemaking: OMBs Role in Reviews of Agencies’ Draft Rules and the
Transparency of Those Reviews, GAO-03-929, Sept. 22, 2003.
4 For a discussion of the PRA, see CRS Report RL30590, Paperwork Reduction Act Reauthorization and Government
Information Management Issues, by Harold C. Relyea.

designated the OIRA administrator as the “principal advisor to the Director on Federal
information policy.” The act also said that the Director of OMB “shall delegate to the (OIRA)
Administrator the authority to administer all functions under this chapter.” Specific areas of
responsibility in the PRA that were assigned to the Director (and later delegated to OIRA)
included information policy, information collection request clearance and paperwork control,
statistical policy and coordination, records management, privacy, and automatic data processing 5
and telecommunications. With regard to paperwork reduction, the act generally prohibited
agencies from conducting or sponsoring a collection of information until they had submitted their
proposed information collection requests to OIRA and the office had approved those requests.
The PRA’s requirements cover rules issued by virtually all agencies, including Cabinet 6
departments, independent agencies, and independent regulatory agencies and commissions.
Although the PRA gave OIRA substantive responsibilities in many areas, the bulk of the office’s
day-to-day activities under the act were initially focused on reviewing and approving agencies’
proposed information collection requests. OIRA had 77 staff members when the PRA took effect
in 1981, of which about half were involved in reviewing agencies’ information collection
requests. That year, OIRA took nearly 5,000 paperwork review actions—approving new and
revised collections, extending existing collections, and reinstating expired collections. The
office’s paperwork clearance workload since then has generally been between 4,000 and 6,000
actions each year, although the number of OIRA staff overall and those reviewing proposed 7
collections has declined substantially. Many federal regulations have an information collection
component, but the PRA did not authorize OIRA to review or comment on the non-paperwork 8
elements of those regulations, or on regulations without an information collection component.
In 1980, President Reagan was elected on a platform critical of government’s role in society in
general and of federal regulations in particular. Shortly after taking office, he established a
“Presidential Task Force on Regulatory Relief,” headed by Vice President George H. W. Bush and
composed of Cabinet officers (although the bulk of the task force’s work was reportedly
performed by OMB staff). The task force’s responsibilities included (1) monitoring the
establishment of OMB’s responsibility to coordinate and review new rules, (2) the development
of legislative changes to regulatory statutes, and (3) the revision of existing regulations. In

5 The PRA was later amended in 1986 and again in 1995, and the list of OIRAs duties changed somewhat. For
example, the 1986 amendments sharpened the management focus of the act and changed “information policy to
information resources management.” As discussed later in this report, the 1986 amendment also required the
administrator of OIRA to be appointed by the President, subject to advice and consent of the Senate.
6 As used in this report, the term “independent regulatory agencies” refers to agencies established to be independent of
the President, including the Federal Communications Commission, the Securities and Exchange Commission, and the
Consumer Product Safety Commission. The term “independent agencies” refers to agencies that are independent of
Cabinet departments but not independent regulatory agencies (e.g., the Environmental Protection Agency and the
Office of Personnel Management).
7 For example, by 1989, OIRAs overall staffing had declined to fewer than 60 employees, of whom OIRA estimated
35 were reviewing information collection requests. By 1997, OIRA staffing declined 48 employees, of whom 22 were
reviewing paperwork requests. See U.S. General Accounting Office, Regulatory Management: Implementation of
Selected OMB Responsibilities Under the Paperwork Reduction Act, GAO/GGD-98-120, July 9, 1998.
8 In some cases, though, the paperwork requirement may be the essence of the regulation. For example, EPAs Toxics
Release Inventory (TRI) program is essentially a database created through collections of information imposed on
businesses in order to inform the public about chemical hazards in their communities.

relation to this last responsibility, the task force ultimately identified a total of 119 rules for
alteration or cancellation by the issuing agencies, nearly half of which had been issued by the
Department of Transportation or the Environmental Protection Agency. Although the task force
said that implementation of the changes it recommended would save more than $150 billion over
the next 10 years, critics charged that this estimate ignored the benefits associated with the rules
on what they referred to as the administration’s regulatory “hit list.” The task force’s legislative
efforts were less successful, failing to get Congress to enact revisions to clean air and water laws
or to enact broad regulatory reform legislation that would have limited agencies’ rulemaking 9
In February 1981—less than one month after taking office—President Reagan issued Executive 10
Order 12291 on “Federal Regulation,” which greatly increased both the scope and importance 11
of OIRA’s responsibilities. Specifically, the executive order generally required covered agencies
(Cabinet departments and independent agencies, but not independent regulatory agencies) to:
• refrain from taking regulatory action “unless the potential benefits to society for
the regulation outweigh the potential costs to society,” select regulatory
objectives to maximize net benefits to society, and select the regulatory
alternative that involves the least net cost to society;
• prepare a “regulatory impact analysis” for each “major” rule, which was defined
as any regulation likely to result in (among other things) an annual effect on the
economy of $100 million. Those analyses were required to contain a description
of the potential benefits and costs of the rule, a description of alternative
approaches that could achieve the regulatory goal at lower cost (and why they
weren’t selected), and a determination of the net benefits of the rule. The issuing
agency was to make the initial determination of whether a rule was “major,” but
the executive order gave OMB the authority to require a rule to be considered
major; and
• send a copy of each draft proposed and final rule to OMB before publication in
the Federal Register. The order authorized OMB to review “any preliminary or
final regulatory impact analysis, notice of proposed rulemaking, or final rule
based on the requirements of this Order.” Non-major rules were required to be
submitted to OMB at least 10 days before publication, but major rules had to be
submitted as much as 60 days in advance.
Executive Order 12291 authorized the director of OMB to review any draft proposed or final rule
or regulatory impact analysis “based on the requirements of this Order.” The executive order
indicated that the review should be completed within 60 days, but allowed the director to extend
that period whenever necessary. It also authorized the director to exempt classes of regulations 12
from any or all of the order’s requirements, and generally required agencies to “refrain” from

9 The task force was disbanded in August 1983 after issuing a final report.
10 Executive Order 12291, “Federal Regulation,46 Federal Register 13193, Feb. 19, 1981.
11 For a description of the effects of this order, see Erik D. Olson,The Quiet Shift of Power: Office of Management &
Budget Supervision of Environmental Protection Agency Rulemaking Under Executive Order 12291, Virginia
Journal of Natural Resources Law, vol. 4 (Fall 1984), pp. 1-80.
12 The exemptions that OMB granted fell into four broad categories: (1) rules that were essentially nonregulatory in
nature, (2) rules that delegated regulatory authority to the States, (3) rules that generally affected individual entities and
that did not involve broader policy issues, and (4) rules for which a delay of even a few days could have imposed

publishing any final rules until they had responded to OMB’s comments. The executive order
made OMB’s authority to review agencies’ draft rules subject to the overall direction of the 13
presidential task force on regulatory relief.
Although the executive order did not specifically mention OIRA, shortly after its issuance the
Reagan Administration decided to integrate OMB’s regulatory review responsibilities under the
executive order with the responsibilities given to OMB (and ultimately to OIRA) by the PRA. As
a result, OIRA’s responsibilities for substantive review of rules under the executive order were
added to the office’s substantial responsibilities under the PRA. In 1981, OIRA reviewed the
substance of nearly 2,800 rules under Executive Order 12291—in addition to the nearly 5,000
paperwork review actions it took that year.
In 1985, President Reagan extended OIRA’s influence over rulemaking even further by issuing
Executive Order 12498, which required Cabinet department and independent agencies (but not
independent regulatory agencies) to submit a “regulatory program” to OMB for review each year 14
that covered all of their significant regulatory actions underway or planned. Previously,
Executive Order 12291 required each of those agencies to publish semiannual “regulatory
agendas” of proposed regulations that the agency “has issued or expects to issue,” and any 15
existing rule that was under review. These agendas were required to contain a schedule for
completing action on any major rule for which the agency had published a notice of proposed
rulemaking. The new executive order went further, saying that, except in “unusual
circumstances,” OMB could return any rule submitted for review under Executive Order 12291 to
the issuing agency for “reconsideration” if it was not in the agency’s regulatory program for that
year, or was “materially different” from what was described in the program.
In other words, OIRA could return a draft rule to an issuing agency if the office did not have
advance notice of the rule’s submission, even if the rule was otherwise consistent with the 16
requirements in Executive Order 12291. The regulatory agenda and program requirements in
these executive orders also permitted OIRA to become aware of forthcoming agency actions well
in advance of the submission of a draft proposed rule, thereby permitting the office to stop or alter
an objectionable rule before the rulemaking process developed momentum. Although Reagan
Administration officials compared this planning process to the process used to develop the
President’s budget, critics noted that the budget process has a final step that the regulatory process
lacks—review and approval by Congress.

substantial costs and that were unlikely to involve significant policy issues. OMB granted about 30 exemptions, most of
which were established in 1981 or 1982.
13 Although the task force was chaired by Vice President Bush, the executive director was the administrator of OIRA.
Other members included the Director of OMB, the Attorney General, and the Secretaries of Commerce, Labor, and the
14 Executive Order 12498, “Regulatory Planning Process,” 50 Federal Register 1036, Jan. 8, 1985.
15 As discussed later in this report, President Carter first required the use of these agendas in 1978.
16 An OIRA representative said that although the office had this authority it never used it, noting that would have been
difficult to defend the return of an agencys rule for purely procedural reasons.

The establishment of this regulatory review function within OIRA was a significant development
both in the office’s history and in the overall movement to reform the federal regulatory process.
In another sense, though, Executive Orders 12291 and 12498 represented the continuation of
presidential review of rules, not the start of such reviews. Some form of centralized review of
agencies’ regulations within the Executive Office of the President has been part of the rulemaking
process since the early 1970’s. For example:
• In 1971, President Nixon established a “Quality of Life Review” program in
which executive departments and independent agencies submitted all
“significant” draft proposed and final rules pertaining to “environmental quality,
consumer protection, and occupational and public health and safety” to OMB, 17
which then circulated them to other agencies for comment. In their submissions,
agencies were to provide a summary of their proposals, including their principal
objectives, the alternatives that they considered, and a comparison of the
expected benefits and cost of those alternatives. Agencies were also required to
submit a schedule showing estimated dates of proposed and final significant
• In 1974, President Ford issued Executive Order 11821, which required agencies 18
to prepare an “inflation impact statement” for each “major” proposed rule. The
statement was a certification that the inflationary impact of the rule had been
evaluated in accordance with criteria and procedures developed by OMB. The
executive order directed OMB to develop criteria for the identification of major
rules that may have a significant impact on inflation, but specified that the office
must consider costs, effects on productivity, effects on competition, and effects
on supplies of important products and services. Before a major rule was
published in the Federal Register, the issuing agency was required to submit the
associated impact statement to the Council on Wage and Price Stability (CWPS).
CWPS would then either provide comments directly to the agency or participate
in the regular rulemaking comment process.
• In 1978, President Carter issued Executive Order 12044, which (among other
things) required agencies to publish semiannual agendas of any significant rules
under development or review, and to prepare a regulatory analysis for at least all 19
rules with a $100 million impact on the economy. The analysis was to contain a
succinct statement of the problem, a description of the alternative approaches
considered, and the “economic consequences” of those alternatives. OMB was
instructed to “assure the effective implementation of this Order,” but was not
given specific review responsibilities. President Carter also established (1) a
“Regulatory Analysis Review Group” (RARG) to review the analyses prepared
for certain major rules and to submit comments during the comment period, and

17 This requirement was formally established through an October 1971 memorandum from then-OMB Director George
Schultz. According to some observers, the requirements were routinely imposed only on the Environmental Protection
18 Executive Order 11821, “Inflation Impact Statements,” 39 Federal Register 41501, Nov. 29, 1974. The order also
required such statements for agency-proposed major legislation.
19 Executive Order 12044, “Improving Government Regulations,” 43 Federal Register 12661, Mar. 24, 1978.

(2) a “Regulatory Council” to coordinate agencies’ actions to avoid conflicting
requirements and duplication of effort.
In several ways, though, the analytical and review requirements in Executive Order 12291 were
significantly different from these previous efforts. For example, the requirement in the new
executive order that agencies choose the least costly approach to a particular regulatory objective
went further than the requirement in President Carter’s Executive Order 12044, which simply
required agencies to analyze and consider alternative regulatory approaches. Also, whereas the
regulatory oversight functions were divided among many offices (OMB, CWPS, RARG, and the
regulatory council) during the Carter Administration, Executive Order 12291 consolidated these 20
functions within OIRA. Another major difference was the amount of influence that OIRA had
compared to its predecessors. Under previous executive orders, CWPS and RARG had primarily
an advisory role. In contrast, under Executive Order 12291, OIRA could overrule agency
determinations regarding whether the rule was “major” (and therefore required a regulatory
impact analysis), and could delay the regulation until the agency had adequately responded to its
concerns (e.g., if it believed the agency had not considered all reasonable alternatives, that its
analysis was not sound, or that it was contrary to administration policy). OIRA’s significant
influence on rulemaking was underscored by its organizational position within OMB—the agency
that reviews and approves the rulemaking agencies’ budget requests. Finally, and perhaps most
importantly, the nature and transparency of the review process was significantly different under
Executive Order 12291. Under the Carter Administration’s approach, RARG and CWPS prepared
and filed comments on agencies’ regulatory proposals during the formal public comment period,
after they were published in the Federal Register. In the case of RARG filings, a draft of the
comments was circulated to all RARG members, and the comments and any dissents were placed
on the public record at the close of the comment period. In contrast, OIRA’s reviews occurred
before the rules were published for comment, and Executive Order 12291 did not require that
OIRA’s comments on the draft rule be disclosed. This pre-publication review process made
OIRA’s regulatory reviews under Executive Order 12291 qualitatively different than its
The expansion of OIRA’s authority in the rulemaking process via Executive Orders 12291 and
12498 was highly controversial. Although some believed that the authority did not go far enough
(e.g., did not cover independent regulatory agencies), most of the concerns were that the
expansion had gone too far. For example, a number of the concerns raised by Members of
Congress, public interest groups, and others focused on whether OIRA’s role violated the
constitutional separation of powers and the effect that OIRA’s review had on public participation 21
and the timeliness of agencies’ rules. Some believed that OIRA’s new authority displaced the
discretionary authority of agency decision makers in violation of congressional delegations of
rulemaking authority, and that the President exceeded his authority in issuing the executive
orders. Others indicated that OIRA did not have the technical expertise needed to instruct

20 George Eads, “Harnessing Regulation: The Evolving Role of White House Oversight,” Regulation, vol. 5 (May/June
1981), pp. 19-26.
21 U.S. Congress, House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations, Role of
OMB in Regulation, 97th Cong., 1st sess., June 18, 1981 (Washington: GPO, 1981). See also Morton Rosenberg,
Beyond the Limits of Executive Power: Presidential Control of Agency Rulemaking Under Executive Order 12291,”
Michigan Law Review, vol. 80 (Dec. 1981), pp. 193-247.

agencies about the content of their rules. Still other concerns focused on OIRA’s ability to carry
out its many responsibilities. In 1983, GAO concluded that the expansion of OIRA’s
responsibilities under Executive Order 12291 had adversely affected the office’s ability to carry
out its PRA responsibilities, and recommended that Congress consider amending the act to 22
prohibit OIRA from carrying out other responsibilities like regulatory review.
Many of the early concerns about OIRA focused on the lack of transparency of the regulatory
reviews, and specifically questioned whether OIRA had become a clandestine conduit for outside
influence in the rulemaking process. Critics pointed out that in the first few months after the
executive order was issued, OIRA met with representatives from dozens of businesses and
associations seeking regulatory relief and returned dozens of rules to the agencies for 23
reconsideration. In response to these concerns, the OMB Director issued a memorandum in June
1981 stating that any factual material provided to OIRA regarding proposed rules should also be
sent to the relevant rulemaking agency. The memorandum did not, however, apply to information
provided to OIRA orally, and did not require that OIRA’s meetings with outside parties be
disclosed to the public.
OIRA’s role in the rulemaking process remained controversial for the next several years. In 1983,
Congress was so dissatisfied with OIRA’s performance in the areas of regulatory and paperwork
review that it permitted the office’s appropriation authority to expire (although the office’s
statutory authority under the PRA was not affected and it continued to receive an appropriation 24
via OMB). In 1985, five House committee chairmen filed a friend-of-the-court brief in a lawsuit
brought against the Department of Labor regarding the department’s decision (reportedly at the
behest of OMB) not to pursue a proposed standard concerning exposure to ethylene oxide, a
sterilizing chemical widely used in hospitals and suspected of causing cancer. The chairmen
claimed that OMB’s actions represented a usurpation of congressional authority.
Congress reauthorized OIRA in 1986, but only after making the administrator subject to Senate
confirmation. By 1986, Congress began considering legislation to restrict OIRA’s regulatory
review role and to block OIRA’s budget request. In an attempt to head off that legislation, in June
1986 the OIRA administrator issued a memorandum for the heads of departments and agencies
subject to Executive Order 12291 describing new OIRA procedures to improve the transparency
of the review process. For example, the memorandum said that only the administrator or the
deputy administrator could communicate with outside parties regarding rules submitted for
review, and that OIRA would make available to the public all written materials received from
outside parties. OIRA also said that it would, upon written request after a rule had been published,
make available all written correspondence between OIRA and the agency head regarding the draft 25
submitted for review.
In 1987 the National Academy of Public Administration published a report on presidential
management of agency rulemaking that summarized the criticisms of the OIRA review process as

22 U.S. General Accounting Office, Implementing the Paperwork Reduction Act: Some Progress, But Many Problems
Remain, GAO/GGD-83-35, April 20, 1983.
23 Letter from James C. Miller III, administrator of OIRA, to the Honorable John D. Dingell, Chairman, Subcommittee
on Oversight and Investigations, House Committee on Energy and Commerce, April 28, 1981.
24 OIRAs authorization for appropriation also expired in 2001, and (as of the date of this report) has not been
25 For further information on this policy, see Judith Havemann, “No Shade-Drawn Dealings for OMB; Congress Gets
Disclosure of Regulation-Review Procedures,” Washington Post, June 17, 1986, p. A-21.

well as the positions of its proponents.26 The report also described a number of issues in
regulatory review and offered recommendations for improvement. For example, the report
recommended that “regulatory management be accepted as an essential element of presidential
management.” It also recommended that regulatory agencies “log, summarize, and include in the
rulemaking record all communications from outside parties, OMB, or other executive or
legislative branch officials concerning the merits of proposed regulations.”
In 1988, the Administrative Conference of the United States also examined the issue of
presidential review of agency rulemaking and concluded that the reviews could improve 27
coordination and resolve conflicts among agencies. The Administrative Conference also said,
though, that presidential review “does not displace responsibilities placed in the agency by law
nor authorize the use of factors not otherwise permitted by law.” The Conference recommended
public disclosure of proposed and final agency rules submitted to OIRA under the executive
order, communications from OMB relating to the substance of rules, and communications with 28
outside parties, and also recommended that the reviews be completed in a “timely fashion.”
President George H. W. Bush continued the implementation of Executive Orders 12291 and

12498 during his administration, but external events significantly affected OIRA’s operation and,

more generally, the federal rulemaking process. In 1989, President Bush’s nominee to head OIRA
was not confirmed. Later, in response to published accounts that the burden of regulation was
once again increasing, President Bush established the President’s “Council on Competitiveness”
(also known as the Competitiveness Council) to review regulations issued by agencies. Chaired
by Vice President Quayle, the council oversaw and was supported by OIRA, and reviewed
particular rules that it believed would have a significant impact on the economy or particular
industries. According to OIRA representatives, the council signified continued White House-level
interest in the regulatory arena, and also represented a continuation of the type of role played by
the Presidential Task Force on Regulatory Relief during the Reagan Administration.
Many of the Competitiveness Council’s actions were highly controversial, with critics assailing
both the effects of those actions (e.g., rolling back environmental or other requirements) and the 29
secrecy in which the council acted. The council attempted to maintain strict secrecy regarding 30
both its deliberations and those in the private sector with whom it communicated or consulted.
Critics decried what they believed to be “backdoor rulemaking” by the Competitiveness Council,
but the council continued its operations until the end of the Bush Administration in 1993.

26 National Academy of Public Administration, Presidential Management of Rulemaking in Regulatory Agencies (Jan.
27 Administrative Conference of the United States, Presidential Review of Agency Rulemaking, Conference
Recommendation 88-9 (1988). The Administrative Conference was established in 1968 to provide advice regarding
procedural improvements in federal programs, and was eliminated by Congress in 1995.
28 The National Academy of Public Administration and the American Bar Association have also recognized the
potential value of presidential regulatory review. They also recommended reforms such as improved transparency and
better communication between OIRA and agency staff.
29 Christine Triano and Nancy Watzman, All the Vice President’s Men: How the Quayle Council on Competitiveness
Secretly Undermines Health, Safety, and Environmental Programs (Washington: OMB Watch/Public Citizen, 1991).
30 See Bob Woodward and David Broder,Quayles Quest: Curb Rules, LeaveNo Fingerprints,” Washington Post,
Jan. 9, 1992, p. A1.

Meanwhile, OIRA continued its operations under Executive Order 12291, reviewing between

2,100 and 2,500 rules each year from 1989 through 1992.

In September 1993, President Clinton issued Executive Order 12866 on “Regulatory Planning
and Review,” which revoked Executive Orders 12291 and 12498 and abolished the Council on 31
Competitiveness. Although different from its predecessors in many respects, Executive Order
12866 (which is still in effect) continued the general framework of presidential review of
rulemaking. For example, it requires covered agencies (again, Cabinet departments and
independent agencies but not independent regulatory agencies) to submit their proposed and final
rules to OMB before publishing them in the Federal Register. The order also requires agencies to
prepare cost-benefit analyses for their “economically significant” rules (essentially the same as
“major” rules under Executive Order 12291). As discussed in detail below, however, Executive
Order 12866 established a somewhat new regulatory philosophy and a new set of rulemaking
principles, limited OIRA’s reviews to certain types of rules, and established transparency
requirements that included but went beyond those that had been put in place by the
administrator’s June 1986 memorandum. Section 2(b) of the order assigns responsibility for
review of agency rulemaking to OMB, and specifically names OIRA as “the repository of
expertise concerning regulatory issues.” The order also named the Vice President as principal 32
advisor to the President on regulatory policy, planning, and review.
In its statement of regulatory philosophy, Executive Order 12866 says, among other things, that
agencies should assess all costs and benefits of available regulatory alternatives, including both
quantitative and qualitative measures. It also provides that agencies should select regulatory
approaches that maximize net benefits (unless a statute requires another approach). Where
permissible and applicable, the order states that agencies should adhere to a set of principles when
developing rules, including (1) consideration of the degree and nature of risk posed when setting
regulatory priorities, (2) adoption of regulations only upon a “reasoned determination that the
benefits of the intended regulation justify its costs,” and (3) tailoring regulations to impose the
least burden on society needed to achieve the regulatory objectives. Some of the stated objectives
of the order are “to reaffirm the primacy of Federal agencies in the regulatory decision-making
process; to restore the integrity and legitimacy of regulatory review and oversight; and to make
the process more accessible and open to the public.” According to OIRA representatives, the
“primacy” of the agencies provision signaled a significant change in regulatory philosophy,
vesting greater control of the rulemaking process with regulatory agencies and taking away
authority from OIRA. Also, the requirement that the benefits of a regulation “justify” its costs
was a noticeably lower threshold than the requirement in Executive Order 12291 that the benefits
“outweigh” the costs.

31 Executive Order 12866, “Regulatory Planning and Review,” 58 Federal Register 51735, Oct. 4, 1993. For an
electronic copy of this executive order, see http://www.whitehouse.gov/omb/inforeg/eo12866.pdf.
32 Executive Order 13258, issued in February 2002, amended Executive Order 12866 and reassigned all roles originally
assigned to the Vice President to the Presidents chief of staff. For a copy of this executive order, see

Section 6 of Executive Order 12866 established agency and OIRA responsibilities in the
centralized review of regulations. In contrast to the broad scope of review under Executive Order
12291, the new order limited OIRA reviews to actions identified by the rulemaking agency or
OIRA as “significant” regulatory actions, which are defined in section 2(f) of the order as the
“Any regulatory action that is likely to result in a rule that may (1) have an annual effect on
the economy of $100 million or more or adversely affect in a material way the economy, a
sector of the economy, productivity, competition, jobs, the environment, public health or
safety, or State, local, or tribal governments or communities; (2) create a serious
inconsistency or otherwise interfere with an action taken or planned by another agency; (3)
materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or
the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues
arising out of legal mandates, the President’s priorities, or the principles set forth in the
Executive order.”
As Figure 1 shows, by focusing OIRA’s reviews on significant rules, the number of draft
proposed and final rules that OIRA examined fell from between 2,000 and 3,000 per year under
the Executive Order 12291 to between 500 and about 700 rules per year under Executive Order


Figure 1. The Number of Rules That OIRA Reviewed Dropped Under Executive
Order 12866, Issued in 1993
Source: http://www.reginfo.gov/public/do/eoCountsSearchInit?action=init
Executive Order 12866 also differs from its predecessors in other respects. For example, the order
generally requires that OIRA complete its review of proposed and final rules within 90 calendar 33
days, and requires both the agencies and OIRA to disclose certain information about how the
regulatory reviews were conducted. Specifically, agencies are required to identify for the public

33 Section 6(b)(2) of the executive order states that OIRA shall waive review or notify the agency in writing of the
results of its review, generally within 90 calendar days after a draft rule has been submitted. Nevertheless, in some
cases, OIRA does not complete its review within 90 days. For example, as of January 8, 2008, one Department of
Commerce rule (on “Right Whale Ship Strike Reduction”) had been under review at OIRA for 322 days.

(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 provide agencies with a copy of all written communications between
OIRA personnel and parties outside of the executive branch, and a list of the dates and names of
individuals involved in substantive oral communications. The order also instructs OIRA to
maintain a public log of all regulatory actions under review and of all of the above-mentioned 34
documents provided to the agencies.
As Figure 2 shows, OIRA reviews agencies’ draft rules at both the proposed and final stages of 35
rulemaking. In each phase, the review process starts when the rulemaking agency formally
submits a regulatory review package to OIRA consisting of the rule, any supporting materials,
and a transmittal form. The OIRA docket librarian then logs the receipt of the review package and
forwards it to the appropriate desk officer. In some cases, agencies withdraw their rules from
OIRA during the review period and the rules may or may not be subsequently resubmitted. At the
end of the review period, OIRA either returns the draft rule to the agency “for reconsideration” or
OIRA concludes that the rule is consistent with the executive order. OIRA codes the rule in its
database as “consistent with change” if there had been any changes to the rule, regardless of the
source or extent of the change. OIRA codes rules in its database as “consistent with no change”
only if they are exactly the same at the end of the review period as the original submission. If the
draft rule is a proposed rule and is judged by OIRA to be consistent with the executive order, the
agency may then publish a notice of proposed rulemaking in the Federal Register, obtain
comments during the specified comment period, review the comments received, and make any
changes to the rule that it believes are necessary to respond to those comments. (Executive Order
12866 says that this comment period should, in most cases, be at least 60 days for significant
rules reviewed by OIRA.) If the draft is a final rule, the agency may publish the rule after OIRA
concludes its review and the rule will generally take effect either at that point or at some later date
specified by the agency.

34 For a discussion of the differences between the transparency requirements under Executive Order 12291 and
Executive Order 12866, see William D. Araiza,Judicial and Legislative Checks on Ex Parte OMB Influence Over
Rulemaking,” Administrative Law Review, 54 (Spring 2002), 611-630, and Peter M. Shane,Political Accountability in
a System of Checks and Balances: The Case of Presidential Review of Rulemaking, Arkansas Law Review, 48 (1995),
35 OIRA may also formally or informally review other rulemaking documents before proposed rules (e.g., advance
notices of proposed rulemaking).

Figure 2. OIRA Reviews Draft Proposed and Final Rules
Source: GAO
In most of the years since Executive Order 12866 was issued, more than 90% of the rules that
OIRA reviewed were coded in the database as either “consistent with change” or “consistent
without change.” (See Table 1.) Only a small percentage of rules were withdrawn, and even
fewer were returned to the agencies. The proportion of rules coded as “changed” has varied
somewhat over time, but the last several years of the Clinton Administration (1997 through 2000)
were fairly similar to the most recent non-transition years of the George W. Bush Administration
(2002 through 2005). The data indicate that there were a relatively large number of rules that
were withdrawn and returned in 2001 compared to other years. The withdrawn rules reflect
actions taken at the start of the George W. Bush Administration pursuant to a memorandum issued
by Assistant to the President and Chief of Staff Andrew H. Card, which generally directed
Cabinet departments and independent agencies to (1) not send proposed or final rules to the
Office of the Federal Register, (2) withdraw from the Office rules that had not yet been published
in the Federal Register, and (3) postpone for 60 days the effective date of rules that had been 36
published but had not yet taken effect. As discussed in greater detail later in this report, OIRA
returned a number of rules to the agencies for reconsideration shortly after a new administrator
was appointed in 2001.

36 Executive Office of the President, White House Office, “Regulatory Review Plan, 66 Federal Register 7702, Jan.
24, 2001. To view a copy of this memorandum, see http://www.whitehouse.gov/omb/inforeg/regreview_plan.pdf. For a
discussion of the rules whose effective dates were postponed, see U.S. General Accounting Office, Regulatory Review:
Delay of Effective Dates of Final Rules Subject to the Administration’s Jan. 20, 2001, Memorandum, GAO-02-370R,
Feb. 2002.

Table 1. Most Rules That OIRA Reviewed Were Coded in Database as Changed or
Not Changed
Percentage of rules OIRA reviewed that were coded:
Year Consistent Consistent
with change without change Withdrawn Returned Other
1994 37.3 53.4 4.3 0.2 4.9
1995 39.0 53.1 5.2 0.5 2.3
1996 51.5 41.4 5.1 0.0 2.0
1997 56.0 37.4 5.1 0.8 0.6
1998 59.3 36.1 3.1 0.0 1.4
1999 62.2 31.5 3.1 0.0 3.2
2000 60.4 34.3 3.9 0.0 1.4
2001 45.6 28.1 22.0 2.6 1.7
2002 54.3 31.7 7.6 0.7 5.6
2003 60.3 30.1 6.9 0.3 2.2
2004 62.7 29.8 6.5 0.2 0.8
2005 65.4 27.0 6.6 0.2 1.0
2006 69.2 26.5 3.7 0.0 0.7
2007 72.3 21.1 6.3 0.2 0.2
Source: OIRA.
Note: “Other” includes rules that were sent improperly, emergency rules, and rules with a statutory or judicial
deadline. Numbers do not total to 100.0 due to rounding.
The type of review that OIRA conducts under Executive Order 12866 sometimes depends on the
type of draft rule submitted. For example, if the draft rule contains a collection of information
covered by the PRA, the desk officer would also review it for compliance with that act. If the
draft rule is “economically significant” (e.g., has an annual impact on the economy of at least
$100 million), the executive order requires agencies to prepare an economic analysis describing,
among other things, the alternatives that the agency considered and the costs and benefits of those 37
alternatives. For those economically significant rules, OIRA desk officers are to review the
economic analyses using the office’s guidance on how to prepare regulatory analyses under the 38
executive order.
An attachment to a September 20, 2001, memorandum to the President’s Management Council
described the general principles and procedures that OIRA reportedly uses in the implementation 39
of Executive Order 12866. For example, the attachment indicated that the office would, where

37 Section 3(f) of the executive order also defines an economically significant rule as adversely affectingin a material
way, the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or
State, local, or tribal governments or communities.”
38 This guidance was issued as OMB Circular A-4 in September 2003. For a copy of this guidance, see
39 For a copy of this September 20, 2001 memorandum and the attachment, see http://www.whitehouse.gov/omb/

appropriate, (1) include an evaluation of whether the agency has conducted an adequate risk
assessment, (2) give “a measure of deference” to regulatory impact analyses and other supporting
technical documents that have been peer reviewed in accordance with specified procedures, (3)
ensure that regulatory clearance packages satisfy the requirements in other executive orders (e.g.,
include the certifications required by Executive Order 13132 on “Federalism” and Executive
Order 13175 on “Consultation and Coordination with Indian and Tribal Governments”), (4)
consult with the Small Business Administration (SBA) and the SBA Chief Counsel for Advocacy,
and (5) ensure that agencies evaluate the possible impact of the draft rule on the programs of
other federal agencies.
There is usually some type of communication during the review process (often via e-mail or
telephone) between the OIRA desk officer and the rulemaking agency regarding specific issues in
the draft rule. Briefings and meetings are sometimes held between OIRA and the agency during
the review process, with OIRA branch chiefs, the deputy administrator, or the administrator
involved in some of these meetings. According to OIRA representatives, the desk officers always
consult with the resource management officers on the budget side of OMB as part of their
reviews, and reviews of draft rules are not completed until those resource management officers
sign off. If the draft rule is economically significant, the desk officer would also consult with a
government economist to help review the required economic analysis. For other rules the desk
officer might consult with other OIRA staff on issues involving statistics and surveys, information
technology and systems, or privacy issues. In certain cases, OIRA may circulate a draft rule to
other parts of the Executive Office of the President (e.g., the Office of Science and Technology
Policy or the Council on Environmental Quality) or other agencies (e.g. the Departments of
Energy, the Interior, or Transportation for certain Environmental Protection Agency rules).
Executive Order 12866 requires OIRA to complete its regulatory reviews within certain time
frames—(1) within 10 working days of submission for any preliminary actions prior to a notice of
proposed rulemaking (e.g., a notice of inquiry or an advance notice of proposed rulemaking) or
(2) within 90 calendar days of submission for all other regulatory actions (or 45 days if OIRA had
previously reviewed the material). In some instances, however, agency officials said OIRA will
ask the rulemaking agency to withdraw the rule and resubmit it, restarting the review period. The
executive order does not permit OIRA to “approve” or “disapprove” a draft rule; it is up to the
agency to decide whether to proceed with publication of a rule after it had been returned, or to
accept OIRA’s suggested changes. OIRA representatives said it is often an iterative process in
which the agencies and OIRA negotiate issues and clarify terms. Nevertheless, agencies very
rarely publish rules that OIRA returns or ignore substantive OIRA “suggestions.” In some
instances, agency officials will formally or informally appeal OIRA determinations to the White
Figure 2 also shows that, for some rules, there is an additional phase of “informal review” before
the rule is officially submitted to OIRA. In its December 2001 report on the costs and benefits of
federal regulations, OIRA stated that the office’s original review process “was designed as an 40
end-of-the-pipeline check against poorly conceived regulations.” OIRA also said, however, that

40 Office of Management and Budget, Making Sense of Regulation: 2001 Report to Congress on the Cost and Benefits
of Regulations and Unfunded Mandates on State, Local and Tribal Entities, Dec. 2001, available at

by the time an agency formally submits a rule to OIRA for review there may be “strong
institutional momentum” behind the proposal and, as a result, the agency may be reluctant to
address certain issues that OIRA analysts might raise. Therefore, OIRA indicated “there is value
in promoting a role for OIRA’s analytic perspective earlier in the process, before the agency
becomes too entrenched.” OIRA went on to state the following:
“A common yet informal practice is for agencies to share preliminary drafts of rules and/or
analyses with OIRA desk officers prior to formal decision making at the agency. This
practice is useful for agencies since they have the opportunity to educate OIRA desk officers
in a more patient way, before the formal 90-day review clock at OMB begins to tick. The
practice is also useful for OIRA analysts because they have the opportunity to flag serious
problems early enough to facilitate correction before the agency’s position is irreversible.”
OIRA cannot informally review each of the hundreds of significant proposed and final rules that
are submitted to the office each year. Informal reviews are most common when there is a
statutory or legal deadline for a rule or when the rule is extremely large and requires discussion
with not only OMB but also other federal agencies. The Environmental Protection Agency (EPA)
and the Departments of Agriculture, Health and Human Services, and Transportation often issue
those types of rules, and therefore are more likely to have their rules reviewed informally before
formal submission.
OIRA has informally reviewed agencies’ draft rules since its review function was established in
1981, but informal reviews reportedly became more common when Executive Order 12866 was
adopted in 1993 and OIRA’s reviews were focused on “significant” rules. There have been some
indications, though, that OIRA has increased its use of informal reviews even further in recent
years. For example, in its March 2002 draft report to Congress on the costs and benefits of federal
regulation, OIRA said “agencies are beginning to invite OIRA staff into earlier phases of
regulatory development in order to prevent returns late in the rulemaking process. It is at these
early stages where OIRA’s analytic approach can most improve on the quality of regulatory
analyses and the substance of rules.” Separately, in 2002, the OIRA administrator said “an
increasing number of agencies are becoming more receptive to early discussions with OMB, at 41
least on highly significant rulemakings.”
The administrator also indicated that agencies’ “receptivity” to informal reviews may be
enhanced by the possibility of a returned rule. For example, in early 2002 he said that OIRA was
trying “to create an incentive for agencies to come to us when they know they have something
that in the final analysis is going to be something we’re going to be looking at carefully. And I
think that agencies that wait until the last minute and then come to us—well, in a sense, they’re 42
rolling the dice.”

Although a great deal has been written about OIRA’s reviews of agencies’ draft rules, few studies
have systematically tried to determine the extent to which those reviews result in substantive

41 Dr. John D. Graham, remarks prepared for the American Hospital Association, July 17, 2002. For a copy of this
speech, see http://www.whitehouse.gov/omb/inforeg/graham_ama071702.html.
42 Rebecca Adams, “Regulating the Rulemakers: John Graham at OIRA,” CQ Weekly, Feb. 23, 2002, pp. 520-526.

changes to the rules. One such study (using data prior to the advent of Executive Order 12988)
concluded that OIRA’s reviews resulted in the rejection of some regulations that would have been
economically inefficient, but did not appear to have improved the cost-effectiveness (e.g., costs-43
per-life saved) of many of the rules. Other studies have used OIRA’s database showing the
number of rules that were coded as “consistent with change” and “consistent without change” in
an attempt to determine the significance of OIRA’s effects on agencies’ rules and whether those 44
effects have changed over time. As mentioned previously, however, the “consistent with
change” code includes changes made at the initiation of the agencies as well as changes suggested
by OIRA. Also, the code does not differentiate between minor editorial changes and changes that
radically alter the effect of the rule. “Returns” and “withdrawals” in OIRA’s database also need
careful interpretation. A return may be for purely administrative reasons, not for substantive
OIRA objections. Conversely, a withdrawal of a rule by an agency may have been initiated by
OIRA. In order to use these data effectively, researchers should examine the associated
documentation in the agencies’ and OIRA’s rulemaking dockets.
GAO published such an analysis in September 2003, supplementing information from OMB’s 45
database with information in the dockets and interviews with agency officials. GAO reported
that from July 1, 2001, through June 30, 2002, OIRA completed 642 reviews of agencies’ draft
proposed and final rules. Of these,
• About 33% (214) were coded in the database as “consistent with no change,”
indicating that OIRA considered the rules consistent with the executive order as
• About 50% (322) were coded as “consistent with change,” indicating that the
rules had changed after being submitted to OIRA, and that OIRA subsequently
concluded that the rule was consistent with the executive order’s requirements.
• About 8% (50) were coded as “withdrawn” by the agency.
• About 3% (21) were coded as “returned” to the agency by OIRA.
• About 5% (35) had some other disposition (e.g., “sent improperly,” “emergency,”
or “statutory or judicial deadline”).
In order to make its review manageable, GAO focused on 85 of those rules that were coded as
changed, withdrawn, or returned and that were submitted to OIRA by nine selected health, safety,
or environmental agencies or offices: the Animal and Plant Health Inspection Service within the
Department of Agriculture; the Food and Drug Administration within the Department of Health
and Human Services; the Occupational Health and Safety Administration within the Department
of Labor; the Federal Aviation Administration (FAA), the Federal Motor Carrier Safety
Administration, and the National Highway Traffic Safety Administration (NHTSA) with the

43 Scott Farrow, Improving Regulatory Performance: Does Executive Office Oversight Matter? (Pittsburgh: Carnegie
Mellon University, July 26, 2000).
44 See, for example, Steven Croley, “White House Review of Agency Rulemaking: An Empirical Investigation,
University of Chicago Law Review, vol. 70 (Summer 2003), pp. 821-885.
45 U.S. General Accounting Office, Rulemaking: OMBs Role in Reviews of Agencies’ Draft Rules and the
Transparency of Those Reviews, GAO-03-929, Sept. 22, 2003.

Department of Transportation (DOT); and the offices of air and radiation, water, and solid waste
and emergency response within EPA. Seventy-one of the 85 rules had been coded “consistent
with change,” nine were coded as “returned,” and five were coded as “withdrawn.”
GAO’s analysis of the underlying documents indicated that OIRA had a significant effect on at
least 25 of the 85 draft rules. Specifically:
• Of the 71 “changed” rules, GAO concluded that OIRA had suggested significant
changes to 17 of them—changes that affected the scope, impact, or estimated
costs or benefits of the rules as originally submitted. In general, the focus of
OIRA’s suggested changes appeared to be on reducing regulatory burden (and, in
some cases, the expected benefits as well). Fourteen of the 17 significantly
changed rules were from EPA’s office of air and radiation or its office of water.
For example, at OIRA’s recommendation, EPA removed manganese from a list of
hazardous wastes, deleted certain types of engines from coverage of a rule setting
emissions standards, and delayed the compliance dates for two other types of
emissions. Of the remaining 54 “changed” rules, the most significant changes
made at OIRA’s suggestion involved adding explanatory language to the
preambles of the rules and asking for comment on particular provisions. In 20 of
the 54 rules, OIRA suggested only minor editorial changes (e.g., correcting
spelling errors or citations) or made no suggestions at all.
• Of the nine rules that had been returned to the agencies by OIRA, two were
returned because they had been improperly submitted, not because of substantive
defect. OIRA returned the remaining seven rules because of concerns about the
agencies’ regulatory analyses or a perceived lack of coordination between
rulemaking agencies. For example, OIRA returned one EPA rule because the
agency did not provide a quantitative analysis of costs and benefits, and returned
a NHTSA rule because OIRA did not believe that the agency had demonstrated
that it had selected the best available alternative. Five of the seven rules returned
for substantive reasons had been submitted by the FAA.
• Of the five rules that were withdrawn, GAO determined that only one had been
withdrawn at OIRA’s suggestion. The other four rules were withdrawn solely at
the agencies’ initiative or as a result of a mutual decision by the agencies and
If anything, GAO’s analysis understates the influence that OIRA has on agencies’ rules because
its findings were often limited to the documentation that was available. If OIRA suggested a
change to a rule before it was formally submitted to OIRA (e.g., during informal review), GAO’s
analysis would not reflect those changes. In fact, the rule might not have even been in the
universe of rules that GAO examined (i.e., those coded as changed, returned, or withdrawn during
OIRA’s formal review). Other forms of OIRA influence may be even more indirect and harder to
document. For example, some agencies have indicated that they do not even propose certain
regulatory provisions because they believe that OIRA would find them objectionable.

GAO also reported that regulated entities directly contacted OIRA either before or during its 46
review process regarding 11 of the 25 rules that OIRA significantly affected. Eight of those 11
cases involved EPA rules, and the nature of the contacts ranged from meetings with OIRA
representatives to letters sent to OIRA. In 7 of the 11 cases, GAO concluded that what OIRA
ultimately recommended to the rulemaking agencies was similar to what these regulated parties
recommended to OIRA—in some cases, using similar language to that used by the regulated
entities. For example, during OIRA’s review of an EPA rule on identification and listing of
hazardous waste, industry representatives met with and sent letters to OIRA opposing the listing
of manganese as a hazardous waste constituent. (The industry representatives had made
essentially the same argument to EPA during the public comment phase, but EPA did not agree.)
The main focus of OIRA’s comments to EPA at the conclusion of its review was that final action
on listing manganese as a hazardous contaminant should be deferred. Notwithstanding the
congruence between the comments of the regulated entities and OIRA’s comments, GAO said it
was impossible to determine the extent to which this or other suggestions made by the regulated
entities might have influenced OIRA’s actions, if at all.

The formal process by which OIRA reviews agencies’ draft rules has changed little since 47
Executive Order 12866 was issued in 1993. There have, however, been several subtle yet
notable changes in OIRA policies and practices in recent years—particularly after Dr. John D.
Graham became OIRA administrator in July 2001. In October 2002, Administrator Graham said
“the changes we are making at OMB in pursuit of smarter regulation are not headline grabbers:
No far-reaching legislative initiatives, no rhetoric-laden executive orders, and no campaigns of
regulatory relief. Yet we are making some changes that we believe will have a long-lasting impact 48
on the regulatory state.”
As noted previously, during the Reagan Administration, OIRA was often criticized for acting as a
regulatory gatekeeper, actively overseeing and recommending changes to agencies’ rules. During
the Clinton Administration, however, the opposite concerns were expressed. A number of
observers criticized OIRA for not overseeing the actions of the rulemaking agencies more
aggressively. In September 1996, the then-administrator of OIRA testified that “we have
consciously changed the way we relate to the agencies,” and described OIRA’s relationship with

46 Environmental and public interest groups also contacted OIRA regarding three of the rules.
47 There has been only one amendment to Executive Order 12866 since it was issued. As mentioned earlier in this
report, Executive Order 13258 reassigned all roles originally assigned to the Vice President in Executive Order 12866
(e.g., to be principal advisor to the President on regulatory policy, planning, and review) to the Presidents chief of
48 John D. Graham, “Presidential Oversight of the Regulatory State: Can It Work?,” speech at the Heinz School,
Carnegie Mellon University, Oct. 4, 2002.

the rulemaking agencies as “collegial” and “constructive.”49 She also said she agreed with an
article that said OIRA functioned during that period “more as a counselor during the review 50
process than as an enforcer of the executive order.”
OIRA during the George W. Bush Administration has returned to the role it had during the
Reagan Administration, even describing itself in an annual report as the “gatekeeper for new 51
rulemakings.” OIRA Administrator Graham said one of the office’s functions is “to protect
people from poorly designed rules,” and said OIRA review is a way to “combat the tunnel vision
that plagues the thinking of single-mission regulators.” He has also compared OIRA’s review of
agencies’ rules to OMB’s role in reviewing agencies’ budget requests. This return to the
gatekeeper perspective of OIRA’s role has implications for an array of OIRA’s functions, and
underlays many of the other changes described below.
As noted previously in Table 1, during the Clinton Administration, OIRA only rarely returned
rules to the agencies for reconsideration. Specifically, according to OIRA’s database, of the more
than 4,000 rules that OIRA reviewed from 1994 through 2000, OIRA returned only seven rules to
the agencies—three in 1995 and four in 1997. OIRA administrators during that period said they
viewed the use of return letters as evidence of the failure of the collaborative review process,
since OIRA and the agencies were part of the same presidential Administration.
In contrast, OIRA Administrator Graham referred to return letters as the office’s “ultimate
weapon,” and viewed them as a way to make clear that the office is serious about the review
process. In the first eight months after he took office in July 2001, OIRA returned 21 draft rules to
the agencies for reconsideration. DOT had the most rules returned during 2001 and 2002 (eight),
followed by the Social Security Administration (five) and the Department of Veterans Affairs 52
(four). The letters commonly indicated that OIRA returned the rules because of concerns about
the agencies’ analyses (e.g., whether the agencies had considered all reasonable alternatives or
had selected the alternative that would yield the greatest net benefits).
Subsequently, however, the pace of OIRA’s return letters slowed. Although the average number of
rules that OIRA reviewed each month stayed about the same, in the period from March 2002 until
January 2008, OIRA returned a total of seven draft rules to the agencies—a dramatic decline from 53
the 21 returns during Administrator Graham’s first eight months in office. OIRA officials
attributed the decline in return letters to the improved quality of agencies’ regulatory submissions
after the initial flurry of returns.

49 U.S. Congress, Senate Committee on Governmental Affairs, Subcommittee on Financial Management and
Accountability, Oversight of Regulatory Review Activities of the Office of Information and Regulatory Affairs, 104th nd
Cong., 2 sess., Sept. 25, 1996 (Washington: GPO, 1997).
50 William Niskanen, “Clinton’s Regulatory Record: Policies, Process, and Outcomes,” Regulation, vol. 19 (1996), pp.
51 Office of Management and Budget, Stimulating Smarter Regulation: 2002 Report to Congress on the Costs and
Benefits of Federal Regulations and Unfunded Mandates on State, Local, and Tribal Entities, Dec. 2002, available at
52 Copies of OIRAs return letters are available on OMB’s website at http://www.whitehouse.gov/omb/inforeg/
53 Two of the five returns during this period involved the same DOT rule.

OIRA has traditionally been a reactive force in the rulemaking process, commenting on draft
proposed and final rules that are generated by the agencies. Although OIRA occasionally
suggested regulatory topics to the agencies during previous administrations, the practice was
relatively uncommon and the discussions were not made public. In contrast, OIRA Administrator
Graham was more publicly proactive, sending several agencies “prompt letters” (and posting
them on the OIRA website) suggesting that they develop regulations in a particular area or 54
encouraging the agencies’ ongoing efforts. For example, one such letter encouraged NHTSA to
give greater priority to modifying its frontal occupant protection standard, and another letter
suggested that OSHA make the promotion of automatic external heart defibrillators a higher
priority. Other prompt letters recommended that the agencies better focus certain research or
programs. Between September 2001 and December 2003, OIRA sent a total of 13 prompt letters
to regulatory agencies, and several of the agencies took action in response to the letters. Since
then, however, the number of prompt letters diminished substantially. Only two prompt letters
were issued in 2004, none in 2005, one in 2006, and none in 2007.
Although OIRA has always encouraged agencies to provide well-developed economic analyses
for their draft rules, Administrator Graham expressed greater interest in this issue than his
predecessors. Also, according to agency officials, there has been a perceptible “stepping up the
bar” in the amount of support required for their rules, with OIRA reportedly more often looking
for regulatory benefits to be quantified and a cost-benefit analysis for every regulatory option that
the agency considered, not just the option selected.
In September 2003, OIRA published revised guidelines for economic analysis under the executive 55
order—updating “best practices” guidance issued in January 1996. The new guidelines were
generally similar to the earlier guidance, but differed in several key areas—e.g., encouraging
agencies to (1) perform both cost-effectiveness and cost-benefit analyses in support of their major 56
rules, (2) use multiple discount rates when the benefits and costs of rules are expected to occur 57
in different time periods, and (3) use a formal probability analysis of benefits and costs when a
rule is expected to have more than a $1 billion impact on the economy (unless the effects of the
rule are clear).
Although OIRA has said that regulations based on economic analysis are more likely to be better
than those that are not, it has also signaled that these analyses are sometimes difficult or

54 Copies of these prompt letters are available on OMBs website at http://www.whitehouse.gov/omb/inforeg/
55 As noted earlier in this report, this guidance (OMB Circular A-4) is available at http://www.whitehouse.gov/omb/
56 Cost-benefit analysis involves the systematic identification of all costs and benefits associated with a forthcoming
regulation. Cost-effectiveness analysis seeks to determine how a given goal can be achieved at the least cost. In contrast
to cost-benefit analysis, the concern in cost-effectiveness analysis is not with weighing the merits of the goal, but with
identifying and analyzing the costs of alternatives to reach that goal (e.g., dollars per life saved).
57 Discounting can have a significant effect on the present value of future health benefits. For example, in a February
2003 speech the OIRA administrator noted that the present value of 1,000 lives saved 50 years in the future is only 34
lives in present value when evaluated at a 7 % discount rate.

impossible for certain types of rules. In November 2005, OIRA Administrator Graham said
“[h]omeland security regulations account for about half of our major-rule costs in 2004 but we do 58
not yet have a feasible way to fully quantify benefits.” He also said that cost-benefit analysis
may not be appropriate for homeland security rules, and that a more practical “soft” test was 59
being used for them. Some have questioned why assessments of homeland security rules should 60
be treated differently than health, safety, and environmental rules.
As noted previously, many of the longstanding concerns about OIRA’s role in the rulemaking
process have centered on the perceived lack of transparency of its reviews. Executive Order
12866 attempted to address some of those concerns, requiring (among other things) that agencies
disclose after the publication of a rule the changes made to the rule during OIRA’s review and the
changes made at the suggestion or recommendation of OIRA. The executive order requires OIRA
to maintain a publicly available log disclosing the status of all regulatory actions under review
and the names and dates of those involved in substantive oral communications (e.g., meetings,
telephone calls) between OIRA staff and parties outside of the executive branch. These
requirements notwithstanding, concerns about the lack of transparency continued. For example,
even after issuance of the executive order, OIRA disclosed contacts with outside parties only if
they occurred during the office’s formal review period, not if they occurred during its informal
In October 2001, the OIRA administrator published a memorandum to OIRA staff on the office’s
website that extended the executive order’s disclosure requirements in several areas. For example,
the memorandum said that OIRA would disclose substantive meetings and other contacts with
outside parties about a rule under review even if OIRA was only informally reviewing the rule.
OIRA also said it would disclose substantive telephone calls with outside parties that were
initiated by the administrator, not just calls initiated by outside parties. OIRA has also posted on 61
its website lists of regulations currently under review, reviews concluded in the previous 30 6263
days, and its contacts with outside parties. Although these changes have improved the
transparency of OIRA’s reviews, as discussed later in this report, the effects of OIRA’s reviews
(particularly informal reviews) are not always apparent.

58 John Graham, “The Smart-Regulation Agenda: Progress and Challenges, speech before the AEI-Brookings Joint
Center for Regulatory Studies, Nov. 7, 2005.
59 Nancy Ognanovich, “Head of OMB Regulatory Office Says Analyzing Homeland Security Rules Difficult,” BNA
Daily Report for Executives, Nov. 8, 2005, p. A39.
60 For example, former OIRA administrator Sally Katzen saidwhen it matters to them to get rules out quickly, they
wink and blink. But in the areas of public health and safety, where they have longstanding relations with the business
communities involved, they’re insistent on satisfying these standards,” in Rebecca Adams, “Graham Leaves OIRA
With a Full Job Jar,” CQ Weekly, Jan 23, 2006, p. 226.
61 See http://www.whitehouse.gov/omb/library/OMBREGSP.html.
62 See http://www.whitehouse.gov/omb/library/OMBREGSC.html.
63 A list of OIRAs meetings with outside parties can be found at http://www.whitehouse.gov/omb/oira/meetings.html.
A list of its oral communications can be found at http://www.whitehouse.gov/omb/oira/oral_communications.html.

When OIRA was created in FY1981, the office had a “full-time equivalent” (FTE) ceiling of 90
staff members. By 1997, OIRA’s FTE allocation had declined to 47—a nearly 50% reduction.
Although Executive Order 12866 (issued in late 1993) permitted OIRA to focus its resources on
“significant” rules, this decline in OIRA staffing also occurred during a period in which
regulatory agencies’ staffing and budgetary levels were increasing and OIRA was given a number
of new statutory responsibilities. Specifically, as discussed later in this report, OIRA was
expected to perform various duties under the Unfunded Mandates Reform Act of 1995, the Small
Business Regulatory Enforcement Fairness Act of 1996, and the Regulatory Right-to-Know Act
of 2001.
Starting in 2001, OIRA’s staffing authorization began to increase; by 2002 , it stood at 55 FTEs.
Between 2001 and 2003, OIRA hired five new staff members in such fields as epidemiology, risk
assessment, engineering, and health economics. OIRA indicated that these new hires reflected the
increasing importance of science-based regulation in federal agencies, and would enable OIRA to
ask penetrating technical questions about agency proposals.

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 in 1993. The changes
made by this new executive order are controversial, characterized by some as a “power grab” by 64
the White House that undermines public protections and lessens congressional authority, and by 65
others as “a paragon of common sense and good government.”
The most important changes made to Executive Order 12866 by Executive Order 13422 fall 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,
and (5) a provision permitting agencies to consider whether to use more formal rulemaking
procedures in certain cases.
A separate CRS report discusses each of these changes, noting areas that are unclear and the
potential implications of the changes; provides background information on presidential review of
rules; discusses three congressional hearings on the executive order in 2007; and notes 66
congressional efforts to block the implementation of the order. It concludes by pointing out that

64 Public Citizen,New Executive Order Is Latest White House Power Grab, available at http://www.citizen.org/
pressroom/release.cfm?ID=2361. See also Margaret Kriz, “Thumbing His Nose,” National Journal, July 28, 2007, pp.
65 Attributed to William Kovacs, Vice President of Environment, Energy, and Regulatory Affairs, U.S. Chamber of
Commerce, in John Sullivan, “White House Sets Out New Requirements for Agencies Developing Rules, Guidance,
Daily Report for Executives, Jan. 19, 2007, p. A-31.
66 CRS Report RL33862, Changes to the OMB Regulatory Review Process by Executive Order 13422, by Curtis W.

the significance of the changes made to the review process by Executive Order 13422 may
become clear only through their implementation. The changes made by this executive order
represent a clear expansion of presidential authority over rulemaking agencies. In that regard,
Executive Order 13422 can be viewed as part of a broader statement of presidential authority
presented throughout the Bush Administration.

In addition to its regulatory review responsibilities under Executive Order 12866 and its multiple
responsibilities under the Paperwork Reduction Act (paperwork review, information resources
management, statistical policy and coordination, records management, privacy and security, and
information technology), Congress has assigned OIRA a number of other specific functions
related to the rulemaking and regulatory process. For example:
• The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1532-1538) generally
requires agencies to prepare written statements describing the effects of their
rules that are subject to the act’s requirements. The act requires the director of
OMB to collect those written statements and provide them to the Congressional
Budget Office, to establish pilot programs to test innovative regulatory
approaches, and to prepare an annual report on the implementation of the act. The 67
OMB director has delegated these responsibilities to OIRA.
• The Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) (5
U.S.C. 601 note) required EPA and OSHA to convene “advocacy review panels”
before publishing proposed rules expected to have a significant economic impact 68
on a substantial number of small entities. The act specifically requires the
review panel to include full-time employees from OIRA as well as other
• SBREFA also contains provisions commonly referred to as the “Congressional
Review Act,” which (among other things) requires agencies to delay the effective
date of “major” rules, and requires GAO to submit a report on those rules within
15 days of their issuance. SBREFA defines a major rule as one that the OIRA
administrator concludes has resulted or is likely to result in (among other things) 69
a $100 million annual effect on the economy.
• Section 515 of the Treasury and General Government Appropriations Act for
Fiscal Year 2001 (44 U.S.C. 3504 (d)(1) and 3516), generally known as the “Data
Quality Act” or the “Information Quality Act,” directed OMB to take several
actions (all of which were delegated to OIRA). Specifically, the act required
OMB to issue governmentwide 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)

67 For a more complete discussion of UMRA, see CRS Report RS20058, Unfunded Mandates Reform Act Summarized,
by Keith Bea and Richard S. Beth.
68 This requirement is codified at 5 U.S.C. 609.
69 For a more complete discussion of the Congressional Review Act, see CRS Report RL30116, Congressional Review
of Agency Rulemaking: An Update and Assessment of The Congressional Review Act after a Decade, by Morton

disseminated by Federal agencies.” OMB published those guidelines in final 70
form on February 22, 2002. The act also required agencies to develop their own
guidelines (which were reviewed by OMB), and to report to OMB on the number
and nature of complaints received and how such complaints were handled by the
• Section 624 of the Treasury and General Government Appropriations Act, 2001,
(31 U.S.C. 1105 note), sometimes known as the “Regulatory Right-to-Know
Act,” requires OMB to prepare and submit with the budget an annual
“accounting statement and associated report” containing an estimate of the 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 required
to contain an analysis of impacts of federal regulation on state, local, and tribal
governments, small businesses, wages, and economic growth. Similar one-year
requirements were in previous appropriations acts.
• The same legislation requires OMB to include “recommendations for reform” in
its cost-benefit reports. Rather than rely on its own expertise, OIRA decided to
solicit suggestions from the public. For example, in March 2002, OIRA asked the
public for recommendations to eliminate or modify existing rules as well as to
expand or extend existing programs. In response, OIRA received more than 300
suggestions, which OIRA turned over to the appropriate agencies for
prioritization. In February 2004, OIRA asked the public for suggested reforms of
rules affecting the manufacturing sector. OIRA said it was focusing on
manufacturing because of the relatively large impact that regulations have on that 71
• The Small Business Paperwork Relief Act of 2002 (P.L. 107-198) requires OMB
to annually publish, in the Federal Register and on the Internet, a list of
compliance assistance resources available to small businesses. The act also
requires OMB to convene and chair a task force to study the feasibility of
streamlining paperwork requirements on small businesses. The task force was
required to file an initial report by the end of June 2003, and is required to file a
second report by the end of June 2004.
• The E-Government Act of 2002 (P.L. 107-347) requires the OIRA administrator
to work with the administrator of the Office of Electronic Government to
establish the strategic direction of the governmentwide e-government program

70 Office of Management and Budget, “Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and
Integrity of Information Disseminated by Federal Agencies; Notice; Republication, 67 Federal Register 8451, Feb. 22,
71 A similar requirement forrecommendations for reform was included in section 628(a)(3) of the FY2000 Treasury
and General Government Appropriations Act. OIRA received 71 suggestions from the public in response to its call for
suggestions on specific regulations that could be rescinded or changed that would increase net benefits to the public,”
most of which came from the Mercatus Center at George Mason University. OIRA reviewed these suggestions and
identified 23 as ahigh priority for review. Eight of the 23 high priority recommendations involved EPA rules, and
five involved rules from the Department of Labor. Although business groups generally applauded this effort,
environmentalists and public interest groups characterized it as the development of ahit list” of rules that the Bush
Administration wanted to eliminate.

and to oversee its implementation. OIRA has been particularly active in the
Administration’s e-rulemaking initiative.
• In the Treasury and General Government Appropriations Act, 2002 (P.L. 107-67),
Congress stated that about $6.3 million of OMB’s $70.7 million appropriation
was for OIRA, but stipulated that nearly $1.6 million of that amount should not
be obligated until OMB “submits a report to the Committees on Appropriations
that provides an assessment of the total costs and benefits of implementing 72
Executive Order No. 13166.”
• The conference report for OMB’s appropriation for FY2004 (to accompany H.R.
2673) directed OIRA to submit a report to the House and Senate Committees on
Appropriations by June 1, 2004, on “whether agencies have been properly
responsive to public requests for correction of information pursuant to the (Data 73
Quality Act).”
Congress also sometimes limits OIRA’s actions through riders on OMB’s appropriation. For
example, since 1983, language has been included in OMB’s appropriation stating that none of the
funds appropriated to OMB could be used for the purpose of reviewing any agricultural
marketing orders issued by the Department of Agriculture. Marketing orders, which cover dozens
of commodities from lemons to milk, basically keep prices up by regulating supplies, and had
been targeted for elimination or amendment by President Reagan’s task force on regulatory relief
in the early 1980s. In response, Members of Congress have inserted this restriction in each
subsequent appropriation bill, asserting that the Department of Agriculture, not OMB, has
statutory authority in this area.
In other cases, OIRA has taken on additional responsibilities, sometimes basing its actions on
previous statutory or executive order authorities. For example:
• In December 2004, OIRA published a final bulletin establishing government-
wide guidance aimed at enhancing the practice of peer review of government 74
science documents. The bulletin applied to all “influential scientific
information” and “highly influential scientific assessments.” The final version of
the bulletin gave agencies significantly greater discretion to decide when
information required peer review than the September 2003 proposed bulletin, but
OIRA retained significant authority in certain areas (e.g., when information is
“highly influential” and requires more stringent peer review).
• In November 2005, OMB published a proposed bulletin “Good Guidance
Practices,” saying that it was concerned that agency guidance documents “may
not receive the benefit of careful consideration accorded under the procedures for 75
regulatory development and review. OMB did not cite any specific statutes or
executive orders as authorizing the issuance of the bulletin, but did indicate that it

72 Executive Order 13166, “Improving Access to Services for Persons With Limited English Proficiency, 65 Federal
Register 50121, Aug. 16, 2000. For a copy of the report, see http://www.whitehouse.gov/omb/inforeg/lepfinal3-14.pdf.
73 OIRA submitted this report in April 2004. For a copy of the report, see http://www.whitehouse.gov/omb/inforeg/
74 To view a copy of this bulletin, see http://www.whitehouse.gov/omb/memoranda/fy2005/m05-03.pdf.
75 To view a copy of this document, see http://www.whitehouse.gov/omb/inforeg/good_guid/

was “responsible both for promoting good management practices and for
overseeing and coordinating the Administration’s regulatory policy.” The bulletin
would require agencies to develop written procedures for the approval of
significant guidance documents, and to publish “economically significant”
documents in the Federal Register and invite comments.
• In January 2006, OIRA published a proposed bulletin on agency risk assessment
practices for public comment and peer review by the National Academy of 76
Sciences. The legal authorities cited for the bulletin included the Information
Quality Act and “OMB’s general authorities to oversee the quality of agency
analyses, information and regulatory actions.” The bulletin described a series of
general risk assessment and reporting standards, and also laid out a set of “special
standards for influential risk assessments.” It requires agencies to certify that
each covered risk assessment has complied with the bulletin’s requirements, but
allows agency heads to waiver or defer some or all of its requirements.

For more than 25 years, OIRA has played a central role in the federal rulemaking process.
Although some argued early in OIRA’s history that the office’s regulatory review role was
unconstitutional, few observers continue to hold that view. No court has directly addressed the
constitutionality of the OIRA regulatory review process, but in 1981 (the year that OIRA was
created) the D.C. Circuit said the following:
The court recognizes the basic need of the President and his White House staff to monitor the
consistency of agency regulations with Administration policy. He and his advisors surely
must be briefed fully and frequently about rules in the making, and their contributions to
policymaking considered. The executive power under our Constitution, after all, is not 77
shared—it rests exclusively with the President.
OIRA is located within the Executive Office of the President and is the President’s direct
representative in the governmentwide rulemaking process. As Executive Order 12866 states,
OIRA is the “repository of expertise on regulatory issues” within the Executive Branch, and is
uniquely positioned both within OMB (with its budgetary influence) and within the federal
rulemaking process (reviewing and commenting on rules just before they are published in the
Federal Register) to enable it to exert maximum influence.
Variations in how OIRA operates—as a gatekeeper or a counselor—are largely a function of the
wishes of the President that the office serves. For example, in a June 2001 article in Harvard Law
Review, Elena Kagan posited that, while it is generally acknowledged that President Reagan used
OIRA’s review function as a tool to control the policy and political agenda in an anti-regulatory 78
manner, President Clinton did much the same thing to accomplish pro-regulatory objectives.

76 To view a copy of this bulletin, see http://www.whitehouse.gov/omb/inforeg/
77 Sierra Club v. Costle, 657 F.2d 298 (D.C. Cir. 1981).
78 Elana Kagan, “Presidential Administration,” Harvard Law Review, vol. 18 (June 2001), pp. 2245-2385.

She said he did so by exercising directive authority and asserting personal ownership over a range
of agency actions, thereby making them “presidential” in nature. She also characterized this
emergence of enhanced methods of presidential control over the regulatory state—what she
termed the “presidentialization of administration”—as “the most important development in the
last two decades in administrative process.”
Other observers, however, view OIRA (like other executive branch agencies) as having more of a
shared allegiance between the President and the Congress. They point out that OIRA was created
by Congress, and has been given a number of statutory responsibilities through the PRA and other
laws. Nevertheless, even supporters of a strong legislative perspective recognize that OIRA is part
of the Executive Office of the President, and that Congress gave OIRA its responsibilities because 79
of its strategic position within that office. With both statutory and executive order
responsibilities, OIRA embodies a broader tension between Congress and the President for
control of administrative agencies.
Although major differences of opinion exist among observers of the federal rulemaking process
regarding the appropriateness of OIRA’s regulatory review role, the broad reach and influence of
the office’s is undebatable. Rulemaking agencies formally challenge OIRA’s returns and
“suggestions” for change only rarely, and sometimes refrain from even submitting draft rules for
review if they believe they will be opposed by OIRA. Regulated entities also recognize OIRA’s
influence, and seem to view the office as a “court of second resort” if they are unable to influence
regulatory agencies to their position directly.
Congress also recognizes the importance that OIRA plays in the rulemaking process, and usually
holds several hearings each year examining OIRA’s implementation of its responsibilities
pursuant to various statutes and executive orders. Proposals for changes to OIRA’s authority and
responsibilities have focused on such issues as (1) providing a statutory underpinning for
regulatory reviews, (2) increasing or decreasing the office’s funding and staffing, (3) including
independent agencies’ rules under the office’s regulatory review function, and (4) improving the
transparency of OIRA’s regulatory review processes.
As noted previously, Congress has enacted legislation expanding OIRA’s statutory
responsibilities, and has considered (but not enacted) legislation that would provide a statutory th
basis for OIRA’s regulatory review function. For example, in the 106 Congress, section 632 of
S. 746 (the “Regulatory Improvement Act of 1999”) would have required the President (via OMB
and OIRA) to “establish a process for the review and coordination of Federal agency regulatory
actions.” The proposed legislation also would have placed in statute many of the transparency
requirements in Executive Order 12866.

79 For example, David H. Rosenbloom, in Building a Legislative-Centered Public Administration (Tuscaloosa, AL: The
University of Alabama Press, 2001) states that “where coordinated government-wide clearance is required to achieve
Congress policy objectives, there may be few or no alternatives (to paperwork and regulatory review within OMB).”

Congress has also considered legislation that would affect OIRA as part of broader OMB th
changes. For example, during the 107 Congress, proposed legislation was introduced (H.R. 616)
that would have established an Office of Management within the Executive Office of the
President and redesignated OMB as the Office of the Federal Budget. As part of that process,
OIRA and other offices within OMB would have been abolished and their functions and
authorities transferred to the new Office of Management. Neither of these bills was enacted.
OIRA does not have a specific line item in the budget, so its funding is part of OMB’s
appropriation. Similarly, OIRA’s staffing levels are allocated from OMB’s totals. Although OIRA
staffing has increased in recent years, as of May 2004, OIRA had fewer staff than it had when its
regulatory review function was first established in 1981. Currently, about 30 OIRA desk officers
and branch chiefs review about 3,000 agency information collection requests each year and
between 500 and 700 significant rules each year. At various times in its history, certain Members
of Congress have attempted to reduce funding for OIRA in order to signal congressional 80
displeasure with the office’s actions. Other observers, however, believe that OIRA’s funding
should be increased, not reduced, arguing that a relatively small amount of additional resources 81
for OIRA could yield substantial benefits.
At other times, proposed legislation has been introduced designating how OIRA staff should be th
used. For example, in the 108 Congress, a provision in H.R. 2432 as originally introduced would
have required the OMB Director to “assign, at a minimum, the equivalent of at least 2 full time
staffers to review the Federal information collection burden on the public imposed by the Internal
Revenue Service.” The Internal Revenue Service accounts for more than 80% of the estimated
paperwork burden, but OIRA indicated that it devoted less than one FTE to reviewing the
agency’s paperwork requests (because much of the burden is mandated by statute). The Bush
Administration objected to this specific direction of OIRA staff, so the sponsors of the bill agreed
to delete this requirement before it was approved by the House of Representatives in May 2004.
Although several of the statutes that OIRA helps to administer include rules issued by
independent regulatory agencies (e.g., the PRA, the Regulatory Flexibility Act, the Congressional
Review Act, and the Data Quality Act), the executive orders that have established regulatory 82
review within OIRA have explicitly excluded rules issued by those agencies. Some observers
have suggested that this limitation be lifted, arguing that independent regulatory agencies issue
regulations that have a significant impact on the economy (about $230 billion per year according

80 For example, as noted previously, in OMB’s appropriation for 2002, Congress stipulated that nearly $1.6 million
should not be obligated until OMB submitted a report assessing the total costs and benefits of implementing Executive
Order No. 13166. Also, in the conference report for OMBs FY2004 appropriation (under the headingOffice of
Information and Regulatory Affairs”), the conferees directed that $1 million “be withheld from obligation until
resolution of existing programmatic concerns by House conferees are addressed and the House and Senate Committee
on Appropriations approve of such obligations.”
81 See, for example, Robert W. Hahn and Robert E. Litan, Why Congress Should Increase Funding for OMB Review of
Regulations, AEI-Brookings Joint Center for Regulatory Studies, Policy Matter 03-33, Oct. 2003.
82 For purposes of regulatory review, both Executive Order 12291 and Executive Order 12866 defined a covered
“agency” as excluding those agencies specified in 44 U.S.C. 3502(10).

to OIRA) but their rules often contain little quantitative information on regulatory costs and 83
benefits. Those opposed to this expansion in OIRA’s duties point out that independent
regulatory agencies were established to be relatively independent of the President, and inclusion
of their rules under OIRA’s would be counter to this purpose. In response, proponents argue that
independent regulatory agencies’ rules are already reviewed for purposes such as paperwork
clearance and ensuring that data quality requirements are met, so examining the substance of the
rules is just an extension of those reviews.
One consistent area of concern to some observers has been the lack of transparency of the OIRA
review process to the public. Notwithstanding recent improvements, they argue that it is difficult
for the public to know with any degree of certainty what changes OIRA has suggested to
agencies’ draft rules, what contacts OIRA has made with regulated entities and other outside
parties regarding those rules, or whether documents were exchanged between OIRA and the
agencies. In its September 2003 report, GAO said that the documentation that agencies are
required to provide showing the changes made at OIRA’s suggestion or recommendation were not
always available and, when done, were not always clear or consistent. GAO also said that the
transparency requirements incumbent on OIRA were not always clear, and recommended several
improvements. For example:
• Although OIRA indicated that it can have its greatest impact on agencies’ rules
during informal reviews before review packages are formally submitted, OIRA
indicated that agencies only had to disclose the changes made at OIRA’s
suggestion during formal review (some of which were as short as one day). GAO
recommended that OIRA define this requirement in the executive order to
include informal reviews, just as it did with regard to the requirements involving
the office’s communications with outside parties.
• As noted previously, the “consistent with change” code in OIRA’s database does
not differentiate between OIRA- or agency-initiated changes, or changes that
were major or minor in nature. GAO recommended that the database be changed
to more clearly indicate which rules were substantively changed at OIRA’s
• GAO also recommended refinements to the executive order’s requirements
applicable to OIRA (e.g., more clearly indicating on its website the regulatory
actions being discussed at meetings with outside parties and the affiliations of the
participants) and the requirements applicable to the agencies (e.g., defining the
types of “substantive” changes that agencies should disclose).
In commenting on GAO’s report, the administrator of OIRA said that the office planned to review
its implementation of the executive order’s transparency requirements and would work to
improve the clarity of its meeting log. The administrator did not, however, believe that changes
made during informal OIRA reviews should be disclosed—even though he said that OIRA can
have its greatest influence during informal reviews. Disclosure of these informal review changes

83 See, for example, the Center for Regulatory Effectiveness, A Blueprint for OMB Review of Independent Agency
Regulations, Mar. 2002. The previously mentioned bill (S. 746) that proposed to establish in law presidential review of
rules would have included rules issued by independent regulatory agencies.

could be required through an administrative directive issued by the OIRA administrator or,
alternatively, through legislation.
On June 27, 2007, during House floor consideration of H.R. 2829, the Financial Services and
General Government (FSGG) Appropriations Act, 2008 (which funds OMB, among other
agencies), Representative Brad Miller and Representative Linda Sanchez offered a “general
provision” amendment stating that “None of the funds made available by this Act may be used to
implement Executive Order 13422.” The amendment was agreed to as Section 901 of H.R. 2829
as passed by the House.
In the wake of this action, on July 12, 2007, the Director of OMB sent a letter to the chairmen and
ranking members of the House and Senate Appropriations Committees stating that “If the
President were presented with a bill that contained a restriction on the implementation of
Executive Order 13422, the President’s Senior Advisors would recommend that he veto the bill.”
The Director urged the rejection of any provision that would interfere in any way with the
implementation of the executive order “because it involves a matter that directly affects the
operation of [OMB] and involves the President’s authority to manage the Executive Branch.”
As reported by the Senate Subcommittee on Financial Services, the FSGG appropriations bill
contained a provision stating that no funds in the measure could be used to implement either
Executive Order 13422 or an OMB bulletin on guidance documents. However, one of the
“manager’s package” amendments to the legislation that was adopted when the bill was reported
by the full Senate Appropriations Committee on July 12, 2007, deleted this provision from the
legislation. The FSGG appropriations bill was later folded into the Consolidated Appropriations
Act for FY2008 (H.R. 2764), and President Bush signed the bill into law on December 26, 2007
(P.L. 110-161). The legislation did not contain any language regarding Executive Order 13422. It
is possible that some Members of Congress may again try to limit the implementation of the
executive order in funding legislation for FY2009.
Curtis W. Copeland
Specialist in American National Government
cwcopeland@crs.loc.gov, 7-0632