Rulemaking: OMB's Role in Reviews of Agencies' Draft Rules and	 
the Transparency of Those Reviews (22-SEP-03, GAO-03-929).	 
                                                                 
Under Executive Order 12866, the Office of Management and	 
Budget's Office of Information and Regulatory Affairs (OIRA)	 
reviews hundreds of agency rules each year before they are	 
published in the Federal Register. Those reviews can have a	 
significant effect on a broad array of public policies. GAO was  
asked to (1) describe OIRA's review process and any changes in	 
its policies or processes in recent years, (2) provide detailed  
information about rules submitted by nine health, safety, or	 
environmental agencies that were returned, withdrawn, or changed 
at OIRA's suggestion, and (3) describe how OIRA decided that	 
certain existing rules merited high priority review.		 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-03-929 					        
    ACCNO:   A08755						        
  TITLE:     Rulemaking: OMB's Role in Reviews of Agencies' Draft     
Rules and the Transparency of Those Reviews			 
     DATE:   09/22/2003 
  SUBJECT:   Federal agencies					 
	     Federal regulations				 
	     Regulatory agencies				 
	     Policy evaluation					 
	     Policies and procedures				 

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GAO-03-929

United States General Accounting Office

GAO

                       Report to Congressional Requesters

September 2003

RULEMAKING

  OMB's Role in Reviews of Agencies' Draft Rules and the Transparency of Those
                                    Reviews

                                       a

GAO-03-929

Highlights of GAO-03-929, a report to congressional requesters

Under Executive Order 12866, the Office of Management and Budget's Office
of Information and Regulatory Affairs (OIRA) reviews hundreds of agency
rules each year before they are published in the Federal Register. Those
reviews can have a significant effect on a broad array of public policies.
GAO was asked to (1) describe OIRA's review process and any changes in its
policies or processes in recent years, (2) provide detailed information
about rules submitted by nine health, safety, or environmental agencies
that were returned, withdrawn, or changed at OIRA's suggestion, and (3)
describe how OIRA decided that certain existing rules merited high
priority review.

GAO recommends that the OMB Director build on recent improvements that
have been made in the transparency of the OIRA review process. In
particular, GAO recommends that agencies be instructed to document
substantive changes made at OIRA's suggestion to draft rules submitted for
review whenever they occur, not just changes that OIRA recommended during
formal reviews.

OMB said the factual foundations of our report were well grounded but
disagreed with most of our recommendations, saying that the report had not
demonstrated the need or desirability of changing the agency's existing
level of transparency.

www.gao.gov/cgi-bin/getrpt?GAO-03-929.

To view the full product, including the scope and methodology, click on
the link above. For more information, contact Victor Rezendes at (202)
512-6806, or [email protected].

September 2003

RULEMAKING

OMB's Role in Reviews of Agencies' Draft Rules and the Transparency of Those
Reviews

The formal process by which OIRA reviews agencies' proposed and final
rules is essentially unchanged since Executive Order 12866 was issued in
1993. However, there have been several changes in OIRA's policies in
recent years, including increased use of public letters explaining why
rules were returned to the agencies and prompting the development of new
rules, increased emphasis on economic analysis, stricter adherence to the
90-day time limit for OIRA review, and improvements in the transparency of
the OIRA review process (although some elements of that process are still
unclear). Underlying many of these changes is a shift in how recent OIRA
administrators view the office's role in the rulemaking process-from
"counselor" to "gatekeeper." OIRA sometimes reviews drafts of rules before
they are formally submitted, and OIRA has said it can have its greatest
influence on agencies' rules during this informal review period. However,
OIRA contends that agencies need only document the changes made to rules
during what are sometimes very brief formal review periods.

Because about 400 rules were changed, returned, or withdrawn during the
1-year period that GAO examined, the review focused on 85 rules from the
nine health, safety, or environmental agencies with five or more such
rules. OIRA significantly affected 25 of those 85 rules. The Environmental
Protection Agency's rules were most often significantly changed, and
almost all of the returned rules were from the Department of
Transportation. OIRA's suggestions appeared to have at least some effect
on almost all of the 25 rules' potential costs and benefits or the
agencies' estimates of those costs and benefits. Outside parties contacted
OIRA before or during its formal review regarding 11 of the 25 rules that
OIRA significantly affected. In 7 of these 11 cases, at least some of
OIRA's recommendations were similar to those of the outside parties, but
we could not determine whether those contacts influenced OIRA's actions.
The agencies' docket files did not always provide clear and complete
documentation of the changes made during OIRA's review or at OIRA's
suggestion, as required by the executive order. However, some agencies
clearly documented these changes, sometimes including changes suggested
during OIRA's informal reviews.

OIRA did not publicly disclose how it determined that 23 of the 71 rules
nominated by the public for change or elimination in 2001 merited high
priority review. As explained to GAO, OIRA desk officers made the initial
determinations regarding issues with which they were familiar, subject to
the approval by OIRA management. The Mercatus Center at George Mason
University made most of the nominations overall and in the high priority
group. Regulatory agencies or OIRA have at least begun to address the
issues raised in many of the 23 suggestions. OIRA's 2002 nomination and
review process was different from the 2001 process in several respects
(e.g., broader request for reforms, more responses from more commentors,
prioritization of the suggestions being made by the agencies, and clearer
discussion of process and criteria).

Contents

                                    Letter 1

     Executive Summary                     Purpose                        3 3 
                                         Background                         3 
                                      Results in Brief                      5 
                                     Principal Findings                     7 
                            Recommendations for Executive Action           14 
                             Agency Comments and Our Evaluation            16 
         Chapter 1                       Background                     17 17 
                             Objectives, Scope, and Methodology            26 

Chapter 2
Some of OIRA's
Regulatory Review
Policies Have Changed

OIRA Regulatory Review Process 29 Changes in Regulatory Review Policies 38

Chapter 3
OIRA's Effects on Rules
Submitted for
Executive Order
Review Varied

69 OIRA Significantly Affected About One-Third of the Rules That the
Selected Agencies Submitted for Review 69 OIRA Affected the Costs and
Benefits or Estimates in Some Rules 84 Outside Parties Contacted OIRA
Regarding about Half of the Rules OIRA Significantly Affected 89
Documentation of OIRA's Reviews Varied, but Some Agencies' Practices
Improved Transparency 94

Chapter 4 103

Mercatus Center Nominated Most Rules Selected forMany Rules Nominated High
Priority Review in 2001 Report 103 for Reform Are Being How High Priority
Review Selections Were Made 106 Changed Status of Rules Selected for High
Priority Review 107

Second Round of Nominations Was Different 108

                                    Contents

Chapter 5 110

Conclusions 110
Conclusions and Recommendations 115
Recommendations Agency Comments and Our Evaluation 116

Appendixes                                                             
                Appendix I:      Objectives, Scope, and Methodology       121 
                                             Objectives                   121 
                                        Scope and Methodology             122 
                                             Limitations                  130 
                                Summary Information on Selected Rules     
               Appendix II:               Submitted to OIRA               
                            for Executive Order Review between July 2001  
                                              and June                    
                                                2002                      132 
                                    Explanation of Table Contents         132 
                            Case Studies on Significantly Affected Rules  
              Appendix III:                 With Evidence                 
                             That OIRA Was Contacted by External Parties  188 
                            Control of Emissions from Nonroad Large Spark 188 
                                               Engines                    
                            Proposed Nonconformance Penalties for 2004    
                            and Later Model Year                          
                              Emission Standards for Heavy-duty Diesel    
                                             Engines and                  
                                     Heavy-duty Diesel Vehicles           189 
                            Identification and Listing of Hazardous Waste 191 
                                             (Manganese)                  
                            Minimizing Adverse Environmental Impact from  
                                            Cooling Water                 
                                 Intake Structures at New Facilities      194 
                              National Pollutant Discharge Elimination    
                                       System (Existing Intake            
                                             Structures)                  196 
                            Effluent Limitation Guidelines and New Source 
                                             Performance                  
                                 Standards for the Construction and       199 
                                        Development Category              
                            Effluent Limitations Guidelines for the Iron  
                            and Steel Manufacturing                       
                                        Point Source Category             201 
                                  Tire Pressure Monitoring Systems        202 
                                  Part 145 Review: Repair Stations        205 
              Appendix IV:     Status of 23 High Priority Review Rules    207 
                            Comments from the Office of the Information   
                Appendix V: and Regulatory                                
                                               Affairs                    212 

Tables Table 1:	Selected Agencies' Regulatory Submissions by
Outcome 71

                                    Contents

Table 2:	Nature of Changes Made at the Suggestion or Recommendation of
OIRA 75

Table 3:	Rules from FAA and EPA's Office of Air and Radiation and Office
of Water Were Most Often Significantly Affected by OIRA Review 82

Table 4: OIRA Was Only Slightly More Likely to Significantly Affect
Economically Significant Rules 83 Table 5: Agencies' Compliance with
Executive Order 12866 Documentation Requirements Was Mixed 97 Table 6: The
Mercatus Center Suggested Most of the 23 "High-Priority Review" Rules 105
Table 7: Findings and Determinations for Rules Changed after Submission to
OIRA 136 Table 8: Findings and Determinations for Rules Returned to Agency
after Submission to OIRA 178 Table 9: Findings and Determinations for
Rules Withdrawn after Submission to OIRA 183

Table 10: Status of the 23 High Priority Review Suggestions Identified in
OIRA's December 2001 Report on the Costs and Benefits of Federal
Regulations 207

Figures	Figure 1: Figure 2: Figure 3:

Figure 4: Figure 5:

Figure 6:

Figure 7:

Figure 8: Figure 9:

OIRA Is One of the Statutory Offices within OMB
Organization of OIRA
Number of Rules That OIRA Reviewed Dropped Under
Executive Order 12866
The OIRA Regulatory Review Process
OIRA Returned More Rules to Agencies in Calendar Year
2001 Than in the 7 Previous Years Combined
OIRA Returned Only Two Rules Between February 2002
and May 2003
The Number of OIRA Reviews Lasting More Than 90 Days
Dropped Sharply in 2002
OIRA Recently Reversed a 20-year Decline in Staffing
EPA Air and Water Rules Were More Often Significantly
Changed at the Suggestion of OIRA

                                     18 19

                                     24 30

                                       42

                                       44

                                     46 60

                                       76

                                       90

Figure 10: Outside Parties Most Often Contacted OIRA Regarding EPA Rules

Contents

Abbreviations

APA Administrative Procedure Act
APHIS Animal and Plant Health Inspection Service
ARSA Aeronautical Repair Station Association
BLM Bureau of Land Management
CEA Council of Economic Advisors
CEED Center for Energy and Economic Development
CFR Code of Federal Regulations
CWD chronic wasting disease
DOE Department of Energy
DOI Department of the Interior
DOL Department of Labor
DOT Department of Transportation
EEAC Equal Employment Advisory Council
EEOC Equal Employment Opportunity Commission
EPA Environmental Protection Agency
EPF Employment Policy Foundation
FAA Federal Aviation Administration
FDA Food and Drug Administration
FMCSA Federal Motor Carriers Safety Administration
FTE full-time equivalent
HHS Department of Health and Human Services
ICR information collection request
MACT maximum achievable control technology
MGD million gallons per day
MOU memorandum of understanding
NCP nonconformance penalty
NHTSA National Highway Traffic Safety Administration
NMMA National Marine Manufacturers Association
OFCCP Office of Federal Contract Compliance Programs
OIRA Office of Information and Regulatory Affairs
OMB Office of Management and Budget
OSHA Occupational Safety and Health Administration
PRA Paperwork Reduction Act
RCRA Resource Conservation and Recovery Act
RFG reformulated gasoline
RIN regulation information number
SBA Small Business Administration
SDWA Safe Drinking Water Act
TPMS tire pressure monitoring system
TSS total suspended solids

USDA Department of Agriculture
VSL value of a statistical life
VSLY value of a statistical life year
WRAP Western Regional Air Partnership

This is a work of the U.S. government and is not subject to copyright
protection in the United States. It may be reproduced and distributed in
its entirety without further permission from GAO. However, because this
work may contain copyrighted images or other material, permission from the
copyright holder may be necessary if you wish to reproduce this material
separately.

A

United States General Accounting Office Washington, D.C. 20548

September 22, 2003

The Honorable Richard J. Durbin

Ranking Minority Member

Subcommittee on Oversight of Government Management, Restructuring, and the
District of Columbia Committee on Governmental Affairs United States
Senate

The Honorable Joseph I. Lieberman Ranking Minority Member Committee on
Governmental Affairs United States Senate

In response to your request, this report on the regulatory review process
of the Office of Management and Budget's (OMB) Office of Information and
Regulatory Affairs (OIRA) (1) describes OIRA's review process and any
changes in its policies or processes in recent years, (2) provides
detailed information about rules submitted by nine health, safety, or
environmental agencies that were returned, withdrawn, or changed at OIRA's
suggestion, and (3) describes how OIRA decided that certain rules merited
"high priority" review. We include recommendations to the Director of OMB
to improve the transparency of the OIRA review process.

As we agreed with your office, unless you publicly announce the contents
of this report earlier, we will not distribute it until 30 days from the
date of this letter. We will then send copies to the Director of OMB and
will provide copies to others on request. It will also be available at no
charge on GAO's Web site at http://www.gao.gov.

If you have any questions concerning this report, please call me or Curtis
Copeland at (202) 512-6806. Key contributors to this report were Ben
Atwater, Tim Bober, and Joseph Santiago.

Victor S. Rezendes
Managing Director, Strategic Issues

Executive Summary

Purpose	The Office of Information and Regulatory Affairs (OIRA) within the
Office of Management and Budget (OMB) is a relatively small office
(currently, 55 full-time equivalents), but it can have a significant-if
not determinative- effect on a broad array of federal regulations that
agencies issue to enact statutes and establish specific requirements.
Under Executive Order 12866, OIRA reviews hundreds of significant proposed
and final rules from all federal agencies (other than independent
regulatory agencies) before they are published in the Federal Register. As
a result of OIRA's review, many draft rules are changed before
publication, withdrawn before a review is completed, or returned to the
agencies because, in OIRA's opinion, certain aspects of the rule need to
be reconsidered.

Despite its importance, OIRA's regulatory review function generally is not
well documented or well understood. Therefore, the Ranking Minority
Members of the Senate Committee on Governmental Affairs and its
Subcommittee on Oversight of Government Management, the Federal Workforce,
and the District of Columbia requested that we examine and report on
certain aspects of OIRA's operations. Specifically, we were asked to (1)
describe OIRA's current regulatory review policies and processes and
determine whether, and if so how, those policies have changed in recent
years, (2) provide detailed information about the effects of OIRA's
reviews of rules submitted by nine health, safety, and environmental
agencies that were returned to the agencies for reconsideration, withdrawn
at OIRA's request, or significantly changed in response to OIRA's reviews
during a 1-year period, and (3) describe how OIRA determined that certain
existing rules listed in its reports to Congress on the costs and benefits
of federal regulations merited high priority review for potential
modification or rescission. We also examined the transparency of the
OIRA's review process. To address these objectives, we interviewed OIRA
representatives, former OIRA officials, agency officials, and others
knowledgeable about the OIRA review process. We also examined
documentation at both OIRA and regulatory agencies to determine the effect
of OIRA's reviews. Specific elements of our methodology are discussed in
the sections below.

Background	The Paperwork Reduction Act of 1980 established OIRA to provide
central agency leadership and oversight of governmentwide efforts to
reduce unnecessary paperwork burden and manage information resources. In
1981, OIRA's responsibilities expanded when Executive Order 12291
authorized it to review all proposed and final regulations from
nonindependent regulatory agencies-between 2,000 and 3,000 rules each

Executive Summary

year. OIRA's regulatory review function under this executive order was
highly controversial, with concerns raised about its effects on separation
of powers, public participation, transparency, and the timeliness of
agencies' rulemaking efforts. In September 1993, Executive Order 12866
replaced Executive Order 12291 and made several changes to OIRA's
regulatory review function. For example, Executive Order 12866 limits
OIRA's regulatory reviews to nonindependent agencies' "significant
regulatory actions" (e.g., rules expected to have an annual effect of $100
million or more on the economy or raising other coordination, budgetary,
or policy issues). As a result, the number of OIRA reviews declined to
about 500 to 700 each year. The executive order also generally requires
OIRA to complete its review within 90 days after an agency formally
submits a draft regulation, and contains several "transparency" provisions
that require both OIRA and the agencies to disclose certain information
about the review process. For example, section 6 of the order requires
agencies to publicly identify the substantive changes made to rules during
OIRA's review and at OIRA's suggestion or recommendation. It also requires
OIRA to disclose all of the documents exchanged between the agencies and
OIRA during the review process. The executive order and related OIRA
guidance also identify some regulatory principles and analytical practices
(e.g., considering the costs and benefits of a proposed regulation and
assessing alternative approaches) that help to guide OIRA's reviews of
agencies' draft regulatory actions.

In January 1998, we reported on the implementation of the transparency
requirements in Executive Order 12866 that are applicable to rulemaking
agencies.1 We concluded that complete documentation of all substantive
changes made in the rules, and of all the changes that OIRA had suggested,
was available to the public for only about one-quarter of the 122 rules
that we reviewed. The agencies' rulemaking dockets had only some or no
documentation for the remaining rules, and we could not always determine
whether OIRA had made available all relevant documents exchanged between
the agencies and OIRA. We recommended that the Director of OMB provide the
agencies with guidance on how to implement these transparency
requirements. OMB disagreed with our recommendations in this area and did
not implement them.

1U.S. General Accounting Office, Regulatory Reform: Changes Made to
Agencies' Rules Are Not Always Clearly Documented, GAO/GGD-98-31
(Washington, D.C.: Jan. 8, 1998).

                               Executive Summary

Results in Brief	OIRA's formal review process is essentially unchanged
since Executive Order 12866 was issued in 1993. However, there have been
several changes in OIRA policies and practices in recent years,
particularly since the current OIRA Administrator took office in July
2001. Those changes, some of which the Administrator said would "have a
long-lasting impact on the regulatory state," include increased use of
public letters explaining why OIRA returned rules to the agencies for
their reconsideration (return letters) and suggesting regulatory action
(prompt letters), increased emphasis on benefit-cost analysis and peer
review, stricter adherence to the 90-day time limit for OIRA review,
improvements in the transparency of the OIRA review process, and an
increase in the size and skills of OIRA's staff. However, some of these
changes are not as significant a departure from previous practice as they
initially appear. Underlying many of the changes in OIRA's policies is a
shift in how the Administrator (and, ultimately, the President) views
OIRA's role in the regulatory process-less of a "counselor" to the
agencies and more of a "gatekeeper." Prior to the formal executive order
review process, OIRA sometimes informally reviews agencies' draft rules,
and OIRA has said it can have a significant influence on the rules during
this informal review period.

OIRA's database indicated that about 400 draft rules were changed,
returned, or withdrawn from OIRA during the 1-year period from July 2001
through June 2002. Therefore, we focused our examination of the effects of
OIRA's review on 85 changed, returned, or withdrawn rules that had been
submitted by the nine health, safety, or environmental agencies with 5 or
more such rules.2 We concluded that OIRA had significantly affected 25 of
the 85 rules by suggesting changes that revised the scope, impact, or
costs and benefits of the rules, returning the rules for reconsideration
by the agency, or, in one case, requesting that the agency withdraw the
rule from review. The Environmental Protection Agency's (EPA) rules were
most often significantly changed, and almost all of the returned rules
were from the Department of Transportation (DOT), as was the rule
withdrawn at OIRA's request. Many of OIRA's actions in these cases
appeared to have been prompted by concerns about the cost and cost
effectiveness of the regulatory options that agencies selected, in keeping
with general

2Our unit of analysis was technically the submission of a rule to OIRA for
Executive Order 12866 review, rather than the rule itself, because some of
the rules were reviewed by OIRA more than once (e.g., submitted, reviewed,
and withdrawn, then resubmitted, reviewed again, and published). However,
for simplicity we refer to these executive order submissions as rules in
this report.

Executive Summary

principles established by Executive Order 12866 and related OIRA guidance.
In almost all of the 25 rules that were significantly affected, OIRA's
actions appeared to have at least some effect on the potential costs and
benefits associated with the rule or prompted revisions to the agency's
estimates of those costs and benefits. As permitted by the executive
order, outside parties contacted OIRA before or during the formal review
period regarding 11 of these 25 rules.3 Although OIRA's positions
regarding 7 of the 11 rules were similar in some respects to those
expressed by the outside parties, it is impossible to determine the extent
to which those contacts might have influenced OIRA's actions, if at all.
OIRA might have reached the same conclusions in the absence of those
contacts. The transparency of the agencies' and OIRA's actions during
these 85 reviews varied, with the docket files for between 45 percent and
62 percent of the rules providing clear and complete documentation of all
elements expected under the two relevant portions of the executive order.
However, a few agencies exhibited exemplary transparency practices.

In May 2001, OIRA asked the public to nominate rules that it believed
should be modified or rescinded. OIRA decided that 23 of the 71
nominations that it received merited high priority review, but did not
publicly disclose how those determinations were made. Representatives of
OIRA told us that the agency's desk officers initially determined which
nominations should be placed in the high priority category, subject to the
approval by OIRA management, with the final decisions made by the
Administrator. Forty-four of the 71 nominations were from the Mercatus
Center at George Mason University, as were 14 of the 23 high priority
nominations.4 As of May 2003, regulatory agencies or OIRA had addressed or
begun to address the issues raised in many of these 23 suggestions. In
March 2002 OIRA again solicited public comments on regulations in need of
reform. However, this effort was different from the 2001 process in
several respects (e.g., broader request for reforms, more responses from
more commentors, no ranking of the suggestions being made by the agencies,
nominations to strengthen rules, and clearer discussion of process and
criteria).

3OIRA defines outside parties as "persons not employed by the executive
branch."

4The Mercatus Center is an education, research, and outreach organization
affiliated with George Mason University. The Center's Regulatory Studies
Program includes a public interest comment project, which analyzes
agencies' regulatory proposals during the public comment process, before
the rules become final. The Regulatory Studies Program is headed by Dr.
Wendy Lee Gramm, Administrator of OIRA from 1985 to 1988.

                               Executive Summary

Although both OIRA and some of the rulemaking agencies have improved the
transparency of the regulatory review process, our review indicated that
some elements of the process remain unclear. For example, neither OIRA nor
the agencies are required to disclose why rules are withdrawn from review,
and the descriptions that OIRA discloses about its contacts with outside
parties is often not very helpful. In particular, OIRA representatives
said neither they nor the rulemaking agencies are required to disclose the
changes made to rules while they are under informal review-the period in
which OIRA said it can have its greatest effect. This interpretation of
this aspect of the executive order's transparency requirements restricts
those requirements to the formal review period, which can be as short as 1
day.

  Principal Findings

    OIRA's Regulatory Review Process and Changes in Policies/Practices

OIRA's formal regulatory review process begins when the rulemaking agency
sends a draft proposed or final rule and other parts of the review package
to OIRA. OIRA desk officers do not use a standard "checklist" in their
reviews, but most OIRA regulatory reviews are similar in that all rules
must be consistent with applicable law, the President's priorities, and
the principles in Executive Order 12866, and must not conflict with the
policies or practices of other agencies. OIRA regulatory reviews differ
somewhat depending on the content of the draft rules. For example, if the
rule contains a collection of information under the Paperwork Reduction
Act, the desk officer would also review the rule for compliance with that
act. If the draft rule is "economically significant," the desk officer
would review the agency's economic analysis. There is usually some form of
communication between OIRA and the agency during the review, most commonly
by e-mail or telephone. OIRA desk officers always consult with and obtain
the consent of the appropriate resource management officer on the budget
side of OMB before approving a rule. OIRA may also consult with others
within the Executive Office of the President or other agencies, managing
an interagency review process.

In some cases, OIRA also reviews drafts of agencies' rules before formal
submission (e.g., large rules with statutory or judicial deadlines and/or
that require discussions with other agencies). OIRA indicated that these
informal reviews are increasing, and that reviews before formal submission
can have a substantial effect on the agencies' regulatory analysis and the

                               Executive Summary

substance of the rules-before the agencies' positions become too
entrenched. OIRA also informally consulted with agencies and reviewed
agencies' draft rules before formal submission during previous
administrations.

OIRA representatives told us that the formal process the office uses to
review draft rules has been essentially the same since Executive Order
12866 was established in 1993. However, several notable changes in OIRA's
policies and practices have occurred since the current Administrator took
office in July 2001, including (1) an overall resurgence in the
"gatekeeper" role that OIRA played shortly after it was established, (2)
increased use of return letters, (3) greater emphasis on economic analysis
and the issuance of new draft guidelines on economic analysis, (4), fewer
reviews extending beyond the 90-day limit, (5) the use of "prompt" letters
that suggest regulatory priorities to the agencies, (6) improvements in
the transparency of OIRA's regulatory review process (e.g., electronic
access to information about rules under review and fuller disclosure of
OIRA's contacts with outside parties), and (7) expansion of the size and
expertise of OIRA staff. In some cases, though, the changes are less
different from previous practices than they initially appear. For example,
in the first 8 months after the Administrator took office, OIRA returned
21 of the nearly 400 rules it reviewed to the agencies-more returns than
in the previous 7 years combined. However, in the subsequent 15 months
OIRA returned only 2 of the more than 850 rules that it reviewed. Also,
OIRA prompted agencies to initiate rulemaking in particular areas during
previous administrations- albeit not through public letters.

    OIRA's Effect on Changed, Withdrawn, and Returned Rules

Because of the large number of draft rules that had been changed,
withdrawn, or returned to the agencies from July 1, 2001, through June 30,
2002, we focused our analysis on the rules that were submitted by health,
safety, or environmental agencies or offices with five or more rules that
were changed, withdrawn, or returned during this 1-year period.5 This
resulted in the selection of 85 rules from 9 agencies: the Animal and
Plant Health Inspection Service (APHIS) within the Department of
Agriculture;

5Most of other agencies that submitted five or more such rules submitted
rules that involved transfer payments (e.g., reimbursement rates to
doctors' medical services in rules submitted by the Centers for Medicare
and Medicaid Services within the Department of Health and Human Services).

Executive Summary

the Food and Drug Administration (FDA) within the Department of Health and
Human Services; the Occupational Safety and Health Administration (OSHA)
within the Department of Labor; the Federal Aviation Administration (FAA),
Federal Motor Carrier Safety Administration (FMCSA), and National Highway
Traffic Safety Administration (NHTSA) within DOT; and the Offices of Air
and Radiation, Solid Waste and Emergency Response, and Water within EPA.

We concluded that OIRA's review had a significant effect on 25 of the 85
draft rules. In 17 of the 25 rules, OIRA recommended the revision,
elimination, or delay of certain provisions in the draft regulatory text,
the addition or revision of regulatory alternatives that provided more
flexible and/or less costly compliance options, or the revision of
agencies' cost and/or benefit estimates for the rules. EPA submitted 14 of
the 17 rules that were significantly changed at OIRA's suggestion. For
example, at OIRA's suggestion, EPA took the following actions:

o 	Eliminated manganese from a list of hazardous constituents in a final
rule on the identification and listing of hazardous wastes (see app. II,
ID 56).

o 	Delayed the compliance date for states to report two types of emissions
in a final rule on consolidated emissions reporting (ID 50).

o 	Made compliance requirements more flexible in a proposed rule on
pollutant discharge elimination systems for large cooling water intake
structures at existing power generating facilities by allowing options for
a site-specific approach to minimizing environmental harm (ID 68).

o 	Revised the benefit-cost and cost-effectiveness estimates in a proposed
rule on emissions from spark ignition marine vessels and highway
motorcycles (ID 54).

OIRA returned 7 of the 25 rules to the agencies for reconsideration (6 of
which had been submitted by DOT). For example, OIRA returned a NHTSA final
rule on tire pressure monitoring systems because, in the office's opinion,
the agency's analysis did not adequately demonstrate that NHTSA

Executive Summary

had selected the best available regulatory alternative (ID 78).6 OIRA
returned a proposed FAA rule on certification of pilots, aircraft, and
repairmen for the operation of light sport aircraft because it believed
that the agency's regulatory analysis did not sufficiently justify the
rule (ID 73). OIRA also requested that an FAA rule be withdrawn by the
agency. Overall, we determined that rules submitted by three of the
agencies (FAA, EPA's Office of Air and Radiation, and EPA's Office of
Water) were much more often significantly affected by OIRA's review than
rules submitted by the other six agencies in our study.

In 22 of the 25 rules that OIRA significantly affected, the changes
appeared to have an effect on either the costs and/or benefits of the
rules or the agencies' estimates of those costs and/or benefits. For
example, in the above-mentioned EPA rule on cooling water intake
structures, the approach that OIRA recommended was expected to have
somewhat lower benefits than the approach EPA proposed but was estimated
to cost significantly less, thereby yielding much larger net benefits. In
the tire pressure monitoring system rule, NHTSA inserted (at OIRA's
suggestion) additional estimates of some costs and benefits of regulatory
alternatives and added information about benefits that might be realized
with different regulatory alternatives.

In 34 of the 60 rules that OIRA did not significantly affect, the changes
that OIRA suggested primarily involved revisions to the language in the
preambles of the draft rules (e.g., expanding or clarifying agencies
explanations of certain issues) or suggestions that the agencies request
public comments on particular issues. Although we did not consider these
types of changes to be "significant," they were substantive in that they
made the rules easier to understand and/or could affect the final versions
of the rules. OIRA suggested only minor editorial changes or no changes to
20 rules and returned 2 others for procedural rather than substantive
reasons. Four rules were withdrawn from OIRA's review solely at the
agencies' initiative or because of a "mutual decision" made by the
agencies and OIRA.

6NHTSA revised the final rule to address OIRA's concerns. However, the
U.S. Court of Appeals recently held that the rule was contrary to the
intent of the tire safety legislation and arbitrary and capricious under
the Administrative Procedure Act. Public Citizen, Inc.

v. Mineta, No. 02-4237 (2d Cir. Aug. 6, 2003).

                               Executive Summary

Materials in the OIRA docket or the rulemaking agencies' dockets indicated
that outside parties (most commonly representatives of regulated entities)
had contacted OIRA regarding 11 of the 25 rules that OIRA significantly
affected (including 8 of the 15 rules submitted by EPA that were
significantly affected). In 7 of the 11 rules, at least some of the
actions that OIRA recommended were similar to those suggested to OIRA by
outside parties. For example:

o 	In the above-mentioned rule on cooling water intake structures, OIRA's
suggested revisions of the regulatory language regarding the use of a
site-specific approach to minimizing environmental harm were similar to
those previously recommended by representatives of the electric industry
during their contacts with OIRA (ID 68).

o 	In letters and meetings with OIRA, representatives from steel
manufacturers and a chemical company opposed the listing of manganese as a
hazardous waste constituent in an EPA final rule (ID 56). Subsequently,
the main focus of OIRA's suggested changes to this rule was the deferral
of final action on all parts of the rule identifying manganese as a
hazardous constituent.

However, it is impossible to determine whether OIRA's contacts with those
outside parties affected its conclusions; OIRA may have reached the same
conclusions without those contacts. In the four other cases, OIRA's
recommended actions did not appear to be similar to those suggested by
outside parties. OIRA generally disclosed its contacts with outside
parties; we identified only four such contacts regarding the rules in our
review that OIRA had not disclosed. However, because our knowledge of such
contacts is generally limited to what OIRA or the agencies disclose, we
cannot be sure that there were not other contacts that did not come to our
attention.

    Rules and Regulatory Programs Selected for High Priority Review

Congress has required OMB to submit "recommendations for reform" with its
recent reports on the costs and benefits of federal regulations. In May
2001, OIRA asked the public to suggest "specific regulations that could be
rescinded or changed that would increase net benefits to the public." Of
the 71 nominations that OIRA received, 44 were from the Mercatus Center at
George Mason University. OIRA reviewed the suggestions and selected 23 of
them for high priority review-including 14 of the 44 Mercatus nominations.
In its December 2001 final report, OIRA said the high priority designation
indicated that it was inclined to agree with the

Executive Summary

recommendation. However, OIRA did not indicate in the report how it made
that determination. OIRA representatives described the process to us as a
"bottom up" exercise, with desk officers making the initial determinations
and the final decisions being made by the OIRA Administrator. Five of the
23 rules designated for high priority review had been issued at the end of
the Clinton Administration, and 13 had been issued by EPA or were
environmental in nature.

As of May 2003, most of these 23 high-priority review items were at least
in the process of being addressed by either the rulemaking agencies or
OIRA. For example:

o 	One of the nominations focused on a Department of Energy (DOE) rule
issued in January 2001 that would have raised the energy efficiency of new
central air conditioners by 30 percent. In May 2002, DOE withdrew the rule
and issued a new rule raising the efficiency level by 20 percent.

o 	An EPA July 2000 final rule regarding allowable amounts of pollution in
water ("total maximum daily load") was also the subject of a suggested
change. In March 2003, EPA published a final rule withdrawing the July
2000 rule. By May 2003, a draft of a new proposed rule was undergoing
informal interagency review.

However, in a few cases the agencies and/or OIRA decided not to take any
action or had not made a decision regarding the rules in question.

In March 2002, OIRA again asked the public to nominate rules for reform,
and received suggestions involving 267 regulations and 49 guidance
documents from approximately 1,700 individuals, trade associations,
nonprofit organizations, and others. In contrast to the first round, OIRA
asked the public to nominate not only regulations that could be rescinded
or changed, but also rules that could be expanded. Also, OIRA did not
designate certain nominated rules for high priority review. Instead, OIRA
forwarded the nominations to the appropriate agencies for their review and
prioritization, and suggested that the agencies rely on three criteria:
efficiency, fairness, and practicality. Although most of the nominations
sought modifications that would increase regulatory flexibility or rescind
rules, more than a quarter of them suggested making rules more stringent
or developing new rules.

                               Executive Summary

    Improvements Notwithstanding, OIRA's Review Process Is Still Not Well
    Documented or Clear

OIRA and some of the agencies whose rules we examined have taken several
steps to improve the transparency of the regulatory review process and its
outcomes since our last review. For example, OIRA's disclosure of its
contacts with outside parties is now triggered by the start of informal
review, not just formal reviews, and OIRA is now providing electronic
access to review information. Also, some agencies' dockets now more
clearly indicated the changes made to their rules than was the case during
our previous review 5 years ago, and some agencies' practices in this area
were exemplary (FDA, FMCSA, and EPA's Office of Water).

However, the agencies still varied in the extent to which the transparency
requirements in Executive Order 12866 were satisfied. Where the
requirements were applicable, the agencies clearly identified the
substantive changes made between the draft submitted for review and the
action subsequently announced in only about 45 percent of the rules. The
agencies clearly identified the changes made at OIRA's suggestion or
recommendation in about 62 percent of these rules. FAA had no such
documentation available, and OSHA said it did not keep the information in
its docket to ensure that it is not part of the official rulemaking record
if a lawsuit is filed. Other agencies had copies of e-mails between them
and OIRA discussing changes that had been made to the rules, but we could
not tell whether these e-mails represented all or just some of the changes
that had been made.

Also, several aspects of the OIRA review process remain unclear, and could
be improved to better allow the public to understand the effects of OIRA's
reviews. For example:

o 	There is no requirement that either OIRA or the agencies explain why
rules are withdrawn before OIRA completes its review.

o 	Although the executive order requires OIRA to disclose its contacts
with outside parties regarding rules under review, the information that
OIRA provides in its publicly available meeting log often does not allow
the public to know what rule is being discussed or what parties were
represented.

o 	The executive order requires OIRA to disclose "all documents exchanged"
between the office and the rulemaking agency during the review, but OIRA
said it would not do so regarding exchanges between the agencies and OIRA
staff at the level where most such exchanges occur.

                               Executive Summary

o 	The "consistent with change" category in OIRA's public database does
not indicate whether the changes made to agencies' rules during the formal
review process had been suggested by OIRA or the agencies, or whether the
changes were substantive or editorial in nature.

o 	The agencies differed considerably regarding what types of changes made
to their rules were "substantive" and therefore needed to be documented.
For example, documentation for some rules included changes made to both
the regulatory text and the agencies' explanations of their rules, while
other documentation only included changes to the regulatory text.

o 	OIRA said informal submission of a draft rule for review triggers the
office's disclosure requirements regarding its contacts with outside
parties, but OIRA representatives said it does not trigger the
requirements that the office and the rulemaking agency disclose the
changes made during the review-even though OIRA has said it can have a
significant influence on agencies' draft rules during this informal review
period. OIRA indicated that the transparency requirements only apply to
the formal review period-which can be as short as 1 day- even though OIRA
may have been reviewing substantive drafts of agencies' rule weeks or even
months in advance of the formal review period.

In some cases, the agencies or OIRA included materials in their files
(e.g., substantive changes made during OIRA's informal review) that, while
not required by the executive order as interpreted by OIRA, provided
valuable insights regarding OIRA's effect on the development of those
rules. Although OIRA indicated that disclosure of substantive changes made
to agencies rules during informal review could have a "chilling effect" on
OIRA-agency interactions, we saw no evidence of that effect in those
instances where the substantive changes were already being disclosed.
However, we recognize that OIRA and the agencies should be able to discuss
regulatory matters in general without having to document and disclose
those communications.

Recommendations for We recommend that the Director of the Office of
Management and Budget:

Executive Action  o 	Define the transparency requirements applicable to
the agencies and OIRA in section 6 of Executive Order 12866 in such a way
that they include not only the formal review period, but also the informal
review

Executive Summary

period when OIRA says it can have its most important impact on agencies'
rules. Doing so would make the trigger for the transparency requirements
applicable to OIRA's and the agencies' interaction consistent with the
trigger for the transparency requirements applicable to OIRA regarding its
communications with outside parties.

o 	Change OIRA's database to clearly differentiate within the "consistent
with change" outcome category which rules were substantively changed at
OIRA's suggestion or recommendation and which were changed in other ways
and for other reasons.

o 	Improve the implementation of the transparency requirements in the
executive order that are applicable to OIRA. Specifically, the
Administrator should take the following actions:

o 	More clearly indicate in the meeting log which regulatory action was
being discussed and the affiliations of the participants in those
meetings.

o 	Because most of the documents that are exchanged while rules are under
review at OIRA are exchanged between agency staff and OIRA desk officers,
OIRA should reexamine its current policy that only documents exchanged by
OIRA branch chiefs and above need to be disclosed.

o 	Establish procedures whereby either OIRA or the agencies disclose the
reasons why rules are withdrawn from OIRA review.

o 	Improve the implementation of the transparency requirements in the
executive order that are applicable to rulemaking agencies. Specifically,
the Administrator should take the following actions:

o 	Define the types of "substantive" changes during the OIRA review
process that agencies should disclose as including not only changes made
to the regulatory text but also other, noneditorial changes that could
ultimately affect the rules' application (e.g., explanations supporting
the choice of one alternative over another and solicitations of comments
on the estimated benefits and costs of regulatory options).

o 	Instruct agencies to put information about changes made in a rule after
submission for OIRA's review and those made at OIRA's

                               Executive Summary

suggestion or recommendation in the agencies' public rulemaking dockets,
and to do so within a reasonable period after the rules have been
published.

o 	Encourage agencies to use "best practice" methods of documentation that
clearly describe those changes (e.g., like those used by FDA, EPA's Office
of Water, or FMCSA).

  Agency Comments and Our Evaluation

On August 8, 2003, we provided a draft of this report to the Director of
the Office of Management and Budget for his review and comment. On
September 2, 2003, the Administrator of OIRA provided written comments on
the draft report. (See app. V for a copy of these comments.) The
Administrator said OIRA believed the "factual foundations of the report
are well grounded," and was pleased that the report noted improvements in
the timeliness of OIRA's reviews and the transparency of the review
process. He indicated that OIRA agreed with our recommendation to improve
the clarity of the office's meeting log, but said OIRA did not agree with
all of the recommendations in the draft report. He said the report had not
demonstrated the need or desirability of changing the agency's existing
"unprecedented" level of transparency, and cited several specific
examples. However, we continue to believe that improvements can and should
be made to improve the transparency of the OIRA review process. The
difficulties that we experienced during this review clearly demonstrated
that OIRA's reviews are not always transparent to the public. (See chapter
5 for a fuller description of OMB's comments and our evaluation.)

Chapter 1

Introduction

Federal regulation, like taxing and spending, is one of the basic tools of
government used to implement public policy. Regulations generally start
with an act of Congress and are the means by which statutes are enacted in
specific requirements are established. Federal agencies issue more than
4,000 regulatory actions each year on topics ranging from the timing of
bridge openings to the permissible levels of contaminants in drinking
water. The costs and benefits associated with all federal regulations has
been a subject of great controversy, with the costs estimated in the
hundreds of billions of dollars and the benefits estimates even higher.
During the past 50 to 60 years, Congress and various presidents have
developed an elaborate set of procedures and requirements to guide the
federal rulemaking process. One of the most important yet least understood
of these requirements is the provision that federal agencies (other than
independent regulatory agencies) submit their draft rules to the Office of
Information and Regulatory Affairs (OIRA) within the Office of Management
and Budget (OMB) for review before being published in the Federal
Register. Although a relatively small office (about 55 full-time
equivalent or "FTE" positions), OIRA reviews can have a significant-if not
determinative-effect on federal rulemaking and, therefore, public policy.

Because OIRA's regulatory review function is not well understood, the
Ranking Minority Members of the Senate Committee on Governmental Affairs
and its Subcommittee on Oversight of Government Management, the Federal
Workforce, and the District of Columbia requested that we examine and
report on certain aspects of its operation. Specifically, they requested
that we (1) describe OIRA's current regulatory review policies and
processes and determine whether, and if so how, those policies have
changed in recent years, (2) provide information about health, safety, and
environmental rules from nine selected agencies that were returned to the
agencies for reconsideration, withdrawn at OIRA's request, or
significantly changed in response to OIRA's reviews during a 1-year
period, and (3) describe how OIRA determined that certain existing rules
listed in its reports to Congress on the costs and benefits of federal
regulations merited high priority review for potential modification or
rescission.

Background	OMB is part of the Executive Office of the President, along
with such agencies as the Council of Economic Advisors (CEA), the Council
on Environmental Quality, and the Office of Science and Technology Policy.
These agencies help develop and implement the policies and programs of the
President. As figure 1 shows, OIRA is one of the statutory offices within
OMB-which are sometimes collectively referred to as the

                                   Chapter 1

"management" side of OMB. Other OMB offices include the resource
management offices, which review agencies' budget submissions and are
sometimes collectively referred to as OMB's "budget" side.1

           Figure 1: OIRA Is One of the Statutory Offices within OMB

Source: GAO.

The Administrator of OIRA is appointed by the President, subject to the
advice and consent of the Senate. As figure 2 illustrates, OIRA currently
has four branches: (1) Information Policy and Technology, (2) Statistical
and Science Policy, (3) Health, Transportation, and General Government,
and (4) Natural Resources, Energy, and Agriculture. Of these, the last two
branches are primarily responsible for reviewing agencies' draft proposed
and final regulations under Executive Order 12866. However, as discussed
later in this report, the other branches as well as other parts of OMB and
the Executive Office of the President may be consulted during their
reviews.

1For a discussion of these offices, see U.S. General Accounting Office,
Office of Management and Budget: Changes Resulting From the OMB 2000
Reorganization, GAO/GGD/AIMD-96-50 (Washington, D.C.: Dec. 29, 1995).

                                   Chapter 1

                         Figure 2: Organization of OIRA

Source: GAO.

                 The Rulemaking Process and Presidential Review

The basic process by which federal agencies develop and issue regulations
is spelled out in the Administrative Procedure Act of 1946, as amended
(APA), codified at 5 U.S.C. section 553. Among other things, the APA
generally requires agencies to (1) publish a notice of proposed rulemaking
in the Federal Register, (2) allow interested persons an opportunity to
participate in the rulemaking process by providing "written data, views,
or arguments," and (3) publish the final rule 30 days before it becomes
effective. However, the APA allows agencies to issue final rules without a
previous notice of proposed rulemaking in certain cases.2

The Paperwork Reduction Act (PRA) of 1980 established OIRA to provide
central agency leadership and oversight of governmentwide efforts to
reduce unnecessary paperwork burden and improve the management of
information resources. Specifically, the act required OIRA to review and
approve agencies' proposed collections of information before the agencies
could collect information from the public. In recent years, OIRA has

2We previously reported that about half of all final rules published
during 1997 were published without a notice of proposed rulemaking. See
U.S. General Accounting Office, Federal Rulemaking: Agencies Often
Published Final Actions Without Proposed Rules, GAO/GGD-98-126
(Washington, D.C.: Aug. 31, 1998).

Chapter 1

reviewed between 3,000 and 5,000 proposed collections of information each
year under the PRA. Although many federal regulations have an information
collection component, the PRA did not specifically authorize OIRA to
review or comment on the substance of those regulations.

Nevertheless, centralized review of agencies' regulations within the
Executive Office of the President has been part of the rulemaking process
for more than 30 years. For example:

o 	In 1971, President Nixon established a "Quality of Life Review" program
in which agencies submitted all significant draft proposed and final rules
to OMB, which then circulated them to other agencies for comment. In their
submissions, agencies provided a summary of their proposals, a description
of the alternatives that they considered, and the cost of those
alternatives.

o 	In 1974, President Ford issued Executive Order 11821, which required
agencies to prepare an "inflation impact statement" for each "major"
proposed rule before publication in the Federal Register, and to send a
summary of those statements to the Council on Wage and Price Stability
when the rule was published. The council would then review the statement
and either provide comments to the agency or participate in the comment
process.

o 	In 1978, President Carter issued Executive Order 12044, which (among
other things) required agencies to publish semiannual agendas of any
significant rules under development and to prepare a regulatory analysis
that examined the cost-effectiveness (i.e., the least cost of achieving
the objective) of alternative regulatory approaches for major rules.
President Carter also established (1) a "regulatory analysis review group"
to review the analyses prepared for certain major rules and to submit
comments during the comment period, and (2) a "regulatory council" to
coordinate agencies' actions to avoid conflicting requirements and
duplication of effort.

Perhaps the most significant development in this evolution of presidential
review of rulemaking occurred in 1981 when President Reagan issued

Chapter 1

Executive Order 12291.3 The executive order replaced Executive Order 12044
and established a set of general requirements for rulemaking-e.g., that
(to the extent permitted by law) (1) the potential benefits of a
regulatory action must outweigh the potential costs to society, (2)
regulatory objectives should maximize net benefits to society, and (3)
agencies should select the regulatory alternative involving the least net
cost to society. The order also required federal agencies (other than
independent regulatory agencies) to send a copy of each draft proposed and
final rule to OMB before publication in the Federal Register. In addition,
it required covered agencies to prepare a regulatory impact analysis for
each "major" rule, and 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."4 As a result of this order,
OIRA's responsibilities were greatly expanded from paperwork reviews to
examinations of the substance of covered agencies' proposed and final
rules-between 2,000 and 3,000 reviews per year.5 In 1985, President Reagan
extended OIRA's influence even further by issuing Executive Order 12498,
which required nonindependent agencies to submit a regulatory plan to OMB
for review each year that covered all of their significant regulatory
actions underway or planned.

The expansion of OIRA's role in the rulemaking process as a result of
these executive orders was not without controversy. Concerns were raised
by members of Congress, public interest groups, and others regarding a
variety of issues, including whether OIRA's role violated constitutional
separation of powers, and the effect that OIRA's review had on public
participation under the APA and the timeliness of agencies' rulemaking.
(Neither the order nor OIRA guidance placed any time limits on OIRA's
reviews.) Concerns were also raised regarding the transparency of OIRA's
reviews, specifically whether OIRA had become a clandestine conduit for

3See, for example, 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, 4 (Fall 1984), 1-80.

4The order defined a "major rule" as any regulation likely to result in
(1) an annual effect on the economy of $100 million or more, (2) a major
increase in costs or prices for consumers or others, or (3) significant
adverse effects on competition, employment, investment, productivity,
innovation, or international competitiveness.

5For a discussion of OIRA's review process under this order, see U.S.
General Accounting Office, Regulatory Review: Information on OMB's Review
Process, GAO/GGD-89-101FS (Washington, D.C.: July 14, 1989).

Chapter 1

outside influence in the rulemaking process. In response to those
criticisms, in June 1986, the OIRA Administrator issued a memorandum for
the heads of departments and agencies subject to the executive orders
describing OIRA procedures to improve the transparency of the 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, make available all written correspondence
between OIRA and the agency head regarding a draft 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 regulatory review effort as well as the positions
of its proponents.6 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 coordination and resolve conflicts among
agencies. However, the conference also said 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 outside parties, and also
recommended that the reviews be completed in a "timely fashion."7

6National Academy of Public Administration, Presidential Management of
Rulemaking in Regulatory Agencies (January 1987).

7The National Academy of Public Administration and the American Bar
Association have also recognized the potential value of presidential
regulatory review. However, they too recommended reforms such as improved
transparency and better communication between OIRA and agency staff.

                                   Chapter 1

Executive Order 12866	On September 30, 1993, President Clinton issued
Executive Order 12866 on "Regulatory Planning and Review," which revoked
Executive Orders 12291 and 12498 and established a new regulatory
philosophy and set of principles, as well as a new process for OIRA
review. In its statement of regulatory philosophy, the executive order
states, 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 agencies should adhere to a set of principles, 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." 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 principle advisor to the
President on regulatory policy, planning, and review.

Section 6 of Executive Order 12866 established agency and OIRA
responsibilities in the centralized review of regulations. Like its
predecessor, the new executive order limits OIRA reviews to rules
published by agencies other than independent regulatory agencies. However,
in contrast to the broad scope of review under Executive Order 11291, the
new order limits OIRA reviews to actions identified by the rulemaking
agency or OIRA as "significant" regulatory actions, which are defined in
section 3(f) of the order as the following:

"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."

                                   Chapter 1

As figure 3 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 700 rules per year under Executive Order 12866.

Figure 3: Number of Rules That OIRA Reviewed Dropped Under Executive Order
12866

Number of rules reviewed 3,000

2,790

2,500

2,000

1,500

1,000

500

0

Year

                                 Source: OIRA.

Executive Order 12866 also differs from its predecessor in other respects.
For example, the order required that OIRA generally complete its review of
proposed and final rules within 90 calendar days. It also requires both
the agencies and OIRA to disclose certain information about how the
regulatory reviews were conducted. For example, agencies are required to
identify for the public (1) the substantive changes made to rules between
the draft submitted to OIRA for review and the action subsequently
announced and (2) changes made at the suggestion or recommendation of
OIRA. OIRA is required to 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. OIRA is also instructed to maintain a

                                   Chapter 1

public log of all regulatory actions under review and of all of the
above-mentioned documents provided to the agencies.8

In October 1993, the OIRA Administrator issued guidance to the heads of
executive department and agencies regarding the implementation of
Executive Order 12866. The section of that guidance on "Openness and
Public Accountability" that discussed the order's transparency
requirements indicated that the requirement that agencies identify for the
public the changes made at the suggestion or recommendation of OIRA only
applies to changes made after draft rules are formally submitted to OIRA
for review. In January 1996, OIRA published a document that described
"best practices" for preparing the economic analysis of significant
regulatory actions called for by the executive order. This document was
revised and issued as guidance in 2000, and is described in greater detail
in chapter 2 of this report.

  Prior Report on Transparency Requirements

In January 1998, we reported on the implementation of some of the
transparency requirements in Executive Order 12866 within selected
agencies.9 We concluded that the agencies had complete documentation of
changes made during OIRA's review for only about 26 percent of the 122
regulatory actions that we reviewed. The agencies had complete
documentation of the changes that OIRA suggested or recommended for only
about 24 percent of the rules. In other cases the agencies had some
documentation that changes had been made, but it was not clear whether all
such changes had been documented. In addition, the documentation that we
were able to locate was sometimes not available to the public or hard to
find. In our report, we recommended that OIRA provide agencies with
guidance on how to implement the transparency requirements in the
executive order. Specifically, we said the guidance should require the
agencies to include a single document in the public rulemaking docket for
each regulatory action that (1) identified all substantive changes made
during OIRA's review and at the suggestion or recommendation of OIRA or

8For 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), 161-214.

9GAO/GGD-98-31.

                                   Chapter 1

(2) states that no changes were made.10 We also said that the guidance
should point to best practices in some agencies to suggest how other
agencies could organize their dockets to best facilitate public access and
disclosure. OIRA disagreed with our recommendations and did not implement
them.

  Objectives, Scope, and Methodology

The overall objective of this assignment was to determine how OIRA
conducts its regulatory reviews. The requesters indicated that little was
known about those reviews, the effects that outside parties have on OIRA
decision making, or the impact of OIRA decisions on the American public.
Our specific objectives were the following:

o 	Describe OIRA's current regulatory review policies and processes and
determine whether, and if so how, those policies and processes have
changed in recent years.

o 	Identify the rules issued by selected agencies that were reviewed by
OIRA between July 1, 2001, through June 30, 2002, and that were either
significantly changed at OIRA's direction, returned by OIRA for further
consideration by the agencies, or withdrawn by the agencies at OIRA's
suggestion. For each such rule, (a) describe the changes made by OIRA, the
reasons why the rule was returned or withdrawn, and any subsequent
activity regarding the rule, (b) describe, to the extent possible, the
effects of the changes, returns, and withdrawals on the rule's original
benefits and costs, and (c) determine whether there are any indications
that the actions OIRA took were traceable to suggestions offered by
regulated entities or outside parties and, if so, whether OIRA publicly
disclosed their involvement. We also examined OIRA's and the agencies'
application of the transparency requirements in the executive order and
related guidance.

o 	Describe how OIRA determined that certain existing rules listed in its
reports to Congress on the costs and benefits of federal regulations
merited high priority review. Specifically, determine (a) which
organizations or persons suggested that these rules be reviewed, (b) what
process OIRA used to select and prioritize the rules, (c) the extent

10As used in this report, a rulemaking "docket" is the official repository
for documents or information related to an agency's rulemaking activities
and may include any public comments received and other information used by
agency decisionmakers.

Chapter 1

to which OIRA publicly disclosed its selection and priority-setting
process, and (d) the current status of those rules.

A detailed discussion of our methodology and scope limitations is provided
in appendix I. In brief, we defined OIRA's "current" regulatory review
policies and processes as those in place as of June 2002 or later. To
describe those policies and processes and any changes in recent years, we
reviewed relevant documents (e.g., executive orders, legislation, and OMB
guidance) and interviewed current OIRA and agency staff, two former OIRA
Administrators, and knowledgeable officials and staff from external groups
that are actively involved in observing and commenting on the federal
regulatory process.

We focused our efforts in the second objective on those rules submitted
for OIRA review that met the following criteria: (a) the rule was
submitted to OIRA as a proposed, interim final, or final rule, (b) OMB
completed its review of the rule between July 1, 2001, and June 30, 2002,
(c) the rule was returned to the rulemaking agency by OIRA, withdrawn from
OIRA's review by the agency, or changed after submission for OIRA's
review, and (d) it was included among the set of health, safety, or
environmental rules from those agencies or subagencies that OIRA's
Executive Order Review database indicated had five or more rules returned,
withdrawn, or changed during the period in scope for this objective. A
total of 85 rules from nine agencies-the Animal Plant and Health
Inspection Service (APHIS); Food and Drug Administration (FDA);
Occupational Safety and Health Administration (OSHA); Department of
Transportation's (DOT) Federal Aviation Administration (FAA); Federal
Motor Carrier Safety Administration (FMCSA); and National Highway Traffic
Safety Administration (NHTSA); and the Environmental Protection Agency's
(EPA) Office of Air and Radiation, Office of Solid Waste and Emergency
Response, and Office of Water-met these criteria.11 We also reviewed
documents in both agencies' and OIRA's rulemaking dockets, and interviewed
OIRA and agency officials to obtain information about the regulatory
review process for the individual rules included in our scope.

11These nine agencies submitted a total of 102 proposed, final, or interim
final rules to OIRA during this 1-year period. Another EPA rule that met
these criteria was dropped from our review because, although OIRA had
cleared the submitted rule with changes, it has not yet been publicly
announced due to homeland security issues.

Chapter 1

Our work to address the third objective focused on the particular rules
identified for high priority review in the 2001 and 2002 versions of OMB's
annual report to Congress on the costs and benefits of federal
regulations. We reviewed any available documentation describing the
process that OIRA used to select certain rules for high priority review.
We also interviewed OIRA representatives and representatives of other
relevant agencies and organizations to determine how the classifications
were made and why the particular selected rules were designated as high
priority.

The specific limitations to our engagement are identified with each of our
findings. In general, our findings were sometimes limited to the
documentation that was available. Some types of OIRA's influence on rules
may not be reflected in the documentation we relied on in this review. For
example, in a previous review DOT officials told us that they will not
even propose certain regulatory provisions because they know that OIRA
will not find them acceptable.12 Also, we cannot be sure that we have
identified all changes to the selected rules that were made at the
direction or suggestion of OIRA (e.g., changes made during informal OIRA
reviews that were not documented), nor can we be sure that we identified
all the effects of such changes on the rules or all instances in which an
outside party may have influenced OIRA's actions. We conducted our review
from July 2002 through May 2003 at the headquarters offices of the
above-mentioned agencies in accordance with generally accepted government
auditing standards. We verified data elements that we used from OIRA's
database and found only minor differences between that database and
information in OIRA's and agencies' files. Therefore, we concluded that
the data were sufficiently reliable for purposes of our report. We
provided a draft of this report to OMB for comment. The comments that we
received, and our evaluation of those comments, are reflected in the
"Agency Comments and Our Evaluation" section of chapter 5 of this report.

12U.S. General Accounting Office, Regulatory Reform: Implementation of the
Regulatory Review Executive Order, GAO/T-GGD-96-185 (Washington, D.C.:
Sept. 25, 1996).

Chapter 2

Some of OIRA's Regulatory Review Policies Have Changed

Our first objective was to describe OIRA's current regulatory review
policies and processes and determine whether, and if so how, those
policies and processes have changed in recent years. We determined that
OIRA's formal regulatory review process under Executive Order 12866
sometimes also includes informal reviews before the official submission of
draft rules by the agencies. Both types of reviews focus on the draft
rules' adherence to applicable laws, executive orders, guidance documents,
and the President's policies. The OIRA review process is essentially
unchanged since the office began reviewing rules in 1981. The most
significant changes occurred in 1993 with the issuance of Executive Order
12866. However, there have been several other changes in policies and
emphasis in recent years, particularly since the current OIRA
Administrator took office in July 2001. Those changes include increased
use of return letters and the advent of "prompt" letters, increased
emphasis on benefit-cost analysis and peer review, stricter adherence to
the 90-day period for OIRA review, improvements in the transparency of the
OIRA review process, and an increase in the size and skills of OIRA staff.
However, some of these changes are not as significant a departure from
previous practice as they initially appear. Underlying many of these
changes is a shift in how the Administrator views OIRA's role in the
regulatory process.

                                OIRA Regulatory
                                 Review Process

As noted in chapter 1 of this report, Executive Order 12866 limits OIRA's
regulatory reviews to significant rules that are initiated by agencies
other than independent regulatory agencies.1 The executive order also
establishes certain requirements regarding how those reviews are conducted
(e.g., generally requiring the reviews to be completed within 90 calendar
days after the rule is submitted to OIRA). Although the overall process
that OIRA uses to review covered agencies' draft rules is described in the
executive order or other OIRA publications, the specific details about how
the office conducts its reviews are not well understood. One rulemaking
agency official described the review process to us as a "black box" into
which agencies submit rules that later come out intact, changed,
withdrawn, or returned.

1Representatives of OIRA told us that the agency occasionally reviews
other material, such as agencies' guidance documents or notices, reports
and budget information shared with OIRA by resource management officers on
the budget side of OMB, and draft legislation. However, these materials
are not covered by the executive order's review requirements.

        Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

As figure 4 shows, OIRA reviews agencies' draft rules at both the proposed
and final stages of rulemaking.2 In each phase, the rulemaking agency
formally submits a regulatory review package to OIRA (consisting of the
rule, any supporting materials, and a transmittal form) and OIRA initiates
a review. During the review process, OIRA analyzes the draft rule in light
of the principles of Executive Order 12866, and discusses the package with
staff and officials at the rulemaking agency, and, if the occasion
warrants, with other agencies with whom interagency coordination will be
necessary. In the course of that process, the draft rule that is submitted
by the agency often changes. In some cases, agencies withdraw the draft
rule from OIRA during the review period and the rule may or may not be
subsequently resubmitted to OIRA.

                  Figure 4: The OIRA Regulatory Review Process

Source: GAO.

2OIRA also reviews some rules at the Advance Notice of Proposed Rulemaking
stage.

        Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

At the end of the review period, OIRA either concludes that the draft rule
is consistent with the principles of the executive order (which occurs in
the vast majority of cases) or returns the rule to the agency "for further
consideration."3 If a draft rule that was determined to be consistent with
the executive order had been modified in the course of the review, the
rule is coded in the OIRA database as "consistent with change" (regardless
of the source or extent of the change). If no changes have been made to
the draft rule during the review, the rule is coded as "consistent without
change." OIRA only codes rules as "consistent with no change" if they are
exactly the same at the end of the review period as the original
submission. Even editorial changes made at the rulemaking agency's
initiative can cause a rule to be coded "consistent with change."

If the draft is a proposed rule, upon completion of OIRA's review the
agency may then publish a notice of proposed rulemaking and, in accordance
with the APA, obtain comments during the specified period (usually at
least 30 days), review the comments received, and make any changes to the
rule that it believes are necessary to respond to those comments. If the
draft is a final rule, the agency may publish the final rule after OIRA
concludes its review and the rule will take effect either at that point or
at some later date specified by the agency. OIRA representatives
emphasized that the office does not "approve" or "disapprove" draft rules.
They noted that the rulemaking agency has been vested with authority by
Congress to issue regulations, and said OIRA's review of draft rules under
Executive Order 12866 does not displace that authority. They said any
changes that are made to draft rules as a result of that review are made
by the rulemaking agency, not OIRA.

Figure 4 also illustrates that for some rules there are two distinct
phases of OIRA's review: (1) a formal review period after the rule is
officially submitted to OIRA and (2) an informal review period before
submission of the rule.

Formal Review	According to OIRA representatives, the formal regulatory
review process begins when the rulemaking agency sends the draft rule to
the OIRA docket librarian (either electronically or hand carried), who
logs the receipt of the

3As discussed in detail later in this report, more than 70 percent of
draft rules submitted to OIRA in recent years have been coded as either
"consistent with change" or "consistent with no change." At most, only
about 3 percent of the rules were coded as "returned."

Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

rule and forwards it to the appropriate desk officer. The representatives
said that OIRA desk officers do not use a standard "checklist" to review
agencies' rules, but indicated that most reviews are similar in certain
respects. Section 6 of Executive Order 12866 states that the OIRA
Administrator is to provide meaningful guidance and oversight "so that
each agency's regulatory actions are consistent with applicable law, the
President's priorities, and the principles set forth in this Executive
order, and do not conflict with the policies or actions of another
agency." The laws applicable to specific regulations vary, but always
include the specific statutory authority under which each regulation is
being developed (e.g., the Clean Air Act or the Occupational Safety and
Health Act) as well as a variety of crosscutting regulatory statutes
(e.g., the APA and the Regulatory Flexibility Act).

The principles in Executive Order 12866 that are intended to guide covered
agencies' rulemaking practices (and therefore guide OIRA's review
practices as well) include the following:

o  Identify and assess available alternatives to direct regulation;

o 	design regulations in the most cost-effective manner to achieve the
regulatory objective;

o 	assess both the costs and benefits of the intended regulation, and
propose or adopt a regulation only upon a reasoned determination that the
benefits of the intended regulation justify its costs;

o 	base decisions on the best reasonably obtainable scientific, technical,
economic, and other information;

o  identify and assess alternative forms of regulation; and

o  tailor regulations to impose the least burden on society.

In addition, the executive order's "regulatory philosophy" provides that
"in deciding whether and how to regulate, agencies should assess all costs
and benefits of available regulatory alternatives, including the
alternative of not regulating." It goes on to state that, unless a statute
requires another regulatory approach, "in choosing among alternative
regulatory approaches, agencies should select those approaches that
maximize net benefits."

Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

The type of review that OIRA conducts sometimes depends on the type of
draft rule submitted. For example, if the draft rule contains a collection
of information covered by the Paperwork Reduction Act, OIRA
representatives said that the desk officer would also review it for
compliance with the act. (They indicated that conducting both reviews
simultaneously can be more difficult if different offices within the
rulemaking agencies are responsible for the rule and the information
collection.) 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 alternatives. For those economically significant
rules, the desk officers review the economic analyses using the "best
practices" document developed in January 1996 and the related guidance
document issued in 2000. (These documents are described in more detail
later in this report.)

In addition to Executive Order 12866, there are several memoranda and
guidance documents from OMB and/or the OIRA Administrator that provide
additional details regarding the content of OIRA's regulatory reviews. For
example, on September 20, 2001, the OIRA Administrator sent a memorandum
to the President's Management Council on "Presidential Review of Agency
Rulemaking by OIRA." An attachment to the memorandum described "the
general principles and procedures that will be applied by OMB in the
implementation of E.O. 12866 and related statutory and executive
authority." For example, the attachment indicated that the office would,
where appropriate, (1) include an evaluation of whether the agency has, in
assessing exposure to a risk or environmental hazard, 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,4 (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 Tribal Governments"), (4) consult with the Small
Business Administration (SBA) and the SBA Chief Counsel for

4For example, the memorandum indicated that peer reviewers should (1) be
selected primarily on the basis of necessary technical expertise, (2)
disclose to agencies any prior positions on the issues at hand, and (3)
disclose to agencies their sources of personal and institutional funding.

Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

Advocacy, and (5) evaluate the possible impact of the draft rule on the
programs of other federal agencies. (Several of these elements are
discussed more fully later in this chapter, including OMB's guidance on
economic analysis.)

OIRA representatives said that there is usually some type of communication
(often via e-mail or telephone) between the desk officer and the
rulemaking agency regarding specific issues in the draft rule. The
representatives said briefings and meetings are sometimes held between
OIRA and the agency during the review process, with branch chiefs, the
Deputy Administrator, and/or the Administrator involved in some of these
meetings.5 They also said that 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. (In fact, they said that the resource
management offices might take the lead in the review for rules involving
the "transfer" of federal funds within society.) If the draft rule is
economically significant, they said the desk officer would also consult
with an economist to help review the required economic analysis. For other
rules the OIRA representatives said 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. SBA for rules
having an impact on small businesses, or DOE, DOT, the Department of
Agriculture, and the Department of the Interior for certain EPA rules). In
those cases, OIRA may not only review the rule itself, but also manage an
interagency review process.

Executive Order 12866 generally 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 and there had been no material changes in the facts or
circumstances upon

5OIRA representatives said the Administrator's personal involvement in a
review depends on a variety of factors, such as whether the rule involves
an issue of interest to him or whether it is likely to be controversial.

Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

which the regulatory action was based). At the conclusion of its review,
they said OIRA notifies the issuing agency by telephone. At that point,
the agency may publish the rule in the Federal Register.

As noted previously, a draft rule that has been reviewed and judged
consistent with the executive order may be coded in the office's database
as "consistent with no change" (meaning that OIRA considered the draft
rule as submitted to be consistent with all applicable requirements) or
"consistent with change" (which means that the draft rule was changed at
either the issuing agency's initiation or at the suggestion of OIRA, and
that OIRA then considered the changed rule to be consistent with all
applicable requirements). If the rule is returned to the issuing agency
for reconsideration, the executive order requires OIRA to provide a
written explanation for the return. Section 7 of Executive Order 12866
originally required the President or the Vice President to resolve any
disagreements or conflicts between or among agency heads or between OMB
and any agency that cannot be resolved by the OIRA Administrator. However,
in February 2002, Executive Order 13258 reassigned the Vice President's
responsibilities in this area to the President's chief of staff.

Executive Order 12866 also requires OIRA to take certain actions to ensure
greater openness, accessibility, and accountability in the regulatory
review process. For example, the order says that a representative from the
agency issuing the regulation must be invited to any meeting between OIRA
personnel and persons not employed by the executive branch of the federal
government regarding a rule under executive order review.6 It also
requires OIRA to forward to the issuing agency within 10 working days any
written communications between such outside contacts and OIRA personnel,
as well as the dates and names of such outside contacts involved in
substantive oral communications with OIRA staff. Other requirements
include public disclosure of such written and oral communications, and the
maintenance of a publicly available log containing, among other things,
the status of all regulatory actions. After the regulatory action has been
published in the Federal Register or otherwise issued (or after the agency
announces it will not publish or issue the action), the executive order
requires OIRA to make available to the public "all documents exchanged

6The agency officials that we talked with during our review generally
indicated that they attended these meetings but sometimes did not
participate. However, DOT considers these meetings "ex parte
communications," and generally does not attend. (In fact, DOT has a
written policy of not attending these meetings.)

        Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

between OIRA and the agency during the review." The executive order
established other transparency requirements for rulemaking agencies (e.g.,
requiring them to identify substantive changes made to draft rules during
OIRA's review and at the suggestion or recommendation of OIRA).

Informal Review	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 end-of-the-pipeline check against poorly conceived
regulations."7 However, OIRA also stated that 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 final
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."

However, because of its size, OIRA cannot informally review each of the
hundreds of significant proposed and final rules that are submitted to the
office each year. OIRA representatives told us that a variety of factors
could trigger informal discussions about a forthcoming rule. For example,
they said informal reviews are sometimes used when there is a statutory or
legal deadline for a rule or when the rule has a large impact on society
and requires discussion with not only OMB but also other federal agencies.
Therefore, they said informal review is more likely regarding rules issued
by certain agencies (e.g., EPA, DOT, the Department of Agriculture, and
the Department of Health and Human Services) that issue those types of
rules. OIRA representatives also said there is an important distinction
between informal consultations between OIRA and agency staff that may
occur at any time and informal reviews that occur when OIRA is provided a
substantive draft of a rule.

7Office 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," (December 2001).

Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

There have been some indications that OIRA has increased its use of
informal reviews 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." Similarly, the Administrator said "we are trying to transform OIRA
from an end-of-the-pipeline organization to one that also engages in early
promotion of good policies and prevention of bad ones." He also said "an
increasing number of agencies are becoming more receptive to early
discussions with OMB, at least on highly significant rulemakings." As OIRA
noted, that receptivity may be enhanced by the threat of a returned rule.
In early 2002, the Administrator said 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 rolling the dice."8
Perhaps the clearest manifestation of OIRA's early involvement in
rulemaking occurred in 2002, when OIRA and EPA began what EPA described as
an "unusual collaboration," working closely together to develop a rule
curbing pollution from diesel-powered nonroad vehicles. EPA also indicated
that it would collaborate with OIRA on the design of an "innovative
regulatory analysis" for the rule.

However, OIRA informally consulted with agencies and reviewed agencies'
draft rules before formal submission during previous administrations as
well. For example, in September 1996, the then-OIRA Administrator
testified that her office is sometimes "involved earlier and more deeply
in an agency rulemaking-before the agency has completed all of its own
evaluation and its internal and/or interagency coordination, and has
become invested in its decision." An OIRA representative told us that
informal reviews probably had been conducted since OIRA began reviewing
rules, but became more common when Executive Order 12866 was adopted in
1993 and OIRA's reviews were focused on "significant" rules. He said
because these more complex rules can take years to develop, it makes sense
for agencies to involve OMB earlier in the process

8Rebecca Adams, "Regulating the Rule-Makers: John Graham at OIRA," CQ
Weekly, 60 (Feb. 23, 2002), 520-526.

        Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

so that policy disagreements can be discussed before substantial amounts
of staff work is conducted.

  Changes in Regulatory Review Policies

According to OIRA representatives, the process that OIRA uses to review
draft rules has been essentially the same since that process was
established in 1981. OIRA representatives indicated that the review
process had changed less in recent years than the changes that occurred
with the advent of Executive Order 12866 in 1993 (e.g., the focus on
"significant" rules, the 90-day clock, and the transparency requirements).
In presentations before various groups, the OIRA Administrator has said
that the office is "pursuing the agenda of quality regulation under the
terms of the Clinton-Gore executive order, which we believe...is based on
sound principles and procedures."

However, there have been several subtle yet notable changes in OIRA
policies and practices in recent years-particularly since the current OIRA
Administrator took office in July 2001. In October 2002, the Administrator
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 on the regulatory state."

Some of OIRA's review policies and practices that the Administrator and
others have identified as significant changes are clear departures from
the policies evident in previous administrations. However, other recent
OIRA policies and practices are only incrementally different from those
evident in previous administrations or have caveats that must be
recognized in their implementation.

    OIRA as Regulatory "Gatekeeper"

Overall, there has been a notable change in how recent Administrators (and
perhaps more generally, how recent administrations) have viewed OIRA's
role in the rulemaking process and its relationships with rulemaking
agencies-in essence, whether OIRA should play a more collaborative,
consultative role in relation to the agencies, or whether OIRA should take
on more of a "gatekeeper" role. This change in philosophy has implications
for virtually all of OIRA's responsibilities, and may be a precipitating
factor for many of the other changes identified in this section of our
report.

Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

Perhaps the clearest indications of this change in philosophy are in the
public statements of recent Administrators. For example, in a May 1994
report to the President on the first 6 months of Executive Order 12866,
the Administrator of OIRA at the time said the relationship between OIRA
and the agencies had "vastly improved" and that "rule writers and rule
reviewers were learning to work together as partners rather than as
adversaries." Officials we spoke with in 1996 at both EPA and DOT
confirmed this perception. In testimony before the Senate Committee on
Governmental Affairs in September 1996, the Administrator said, "we have
consciously changed the way we relate to the agencies" and described that
change as a "paradigm shift" from the relationship during previous
administrations. She described OIRA's relationship with rulemaking
agencies as "collegial" and "constructive," and said OIRA was "not in the
business of playing `gotcha' with them."9 She cited an article that she
said accurately described OIRA's approach as a "consensual process," and
that said OIRA functioned "more as a counselor during the review process
than as an enforcer of the executive order."10 She also emphasized that
this collaborative approach yielded better results than a more
confrontational OIRA-agency relationship.

Another former OIRA Administrator voiced similar sentiments during our
review. He said that during his and his predecessor's tenure in the
mid-to-late 1990s OIRA acted in a spirit of partnership with agencies
submitting regulations for review. He also said that although agencies
were not allowed to do whatever they wanted, OIRA did not dictate how
regulations should be written and worked with the agencies to ensure
transparency and fairness in the rulemaking process.

The current Administrator has characterized OIRA's role and relationship
with the agencies in quite different terms. For example, in its December
2002 report on the costs and benefits of federal regulations, OIRA
described itself as the "gatekeeper for new rulemakings."11 In a speech,
the current Administrator described OIRA's regulatory review process as "a

9Testimony before the Senate Committee on Governmental Affairs, September
25, 1996.

10William Niskanen, "Clinton's Regulatory Record: Policies, Process, and
Outcomes," Regulation (1996), 27-28.

11Office 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," (December 2002).

Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

form of consumer protection to protect people from poorly designed rules."
He went on to say that OMB's process of centralized oversight "is a device
to strengthen the hands of scientists, engineers and economists within the
agencies-they now know that regulatory proposals cannot survive OMB review
without careful supporting analysis." He also said OMB review is a device
"to combat the tunnel vision that plagues the thinking of single-mission
regulators." The Administrator has also compared OIRA's role in reviewing
agencies' proposed regulations to OMB's role in reviewing agencies' budget
requests:

"Now, no one would suggest that agencies should be permitted to negotiate
their `on-budget' resources from Congress, without any OMB review.
Likewise, Presidents realize that regulatory expenditures, while off
budget, require fiscal restraint for the same reasons that the size of
public budgets need to be restrained. If the President restrains the
federal budget without restraining regulation, regulatory advocates may
simply respond by urging Congress to shift regulatory costs from the
federal budget to states and the private sector. In other words, the
President cannot manage the Nation's fiscal health without managing the
regulatory state."

Comments from both the current and former OIRA Administrators suggest that
the change in the philosophy underlying OIRA's regulatory review function
may be, at least in part, a function of the change in the presidency that
the office serves. A previous Administrator emphasized that OIRA is part
of the Executive Office of the President, and the President is the
office's chief client. Therefore, she said, a change in the presidency has
a profound effect on how OIRA operates. She also said each new
Administrator of OIRA-and ultimately each new administration- represents a
reaction to the previous Administrator and administration. Just as the
Clinton administration's OIRA was a reaction to the administrations that
preceded it, she said the current Bush administration's OIRA is a reaction
to the Clinton period. Similarly, in March 2002, the current OIRA
Administrator said "Presidents use the powers of OMB regarding agency
action to advance Administration priorities and policy objectives... We
should remember that OMB is an office within the

        Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

Executive Office of the President and its actions necessarily reflect
Presidential priorities."12

    Increased Use of Return Letters

One clear indication of the emergence of OIRA's "gatekeeper" role is the
office's increased use of return letters since 2001. During the first 7
full calendar years that Executive Order 12866 was in place (1994 through
2000), OIRA generally reviewed between 500 and 700 rules each year but
returned very few of them to the agencies-three rules in 1995 and four in
1997. (See fig. 5.) However, although the total number of rules reviewed
each year remained about the same, the number of rules returned to the
agencies increased dramatically in 2001. In fact, OIRA returned almost
three times as many rules that year (18 rules) than in the 7 previous
years combined. All of the returns during calendar year 2001 occurred
after the current Administrator took office in July 2001. In calendar
years 2001 and 2002 combined, OIRA returned a total of 23 rules to the
agencies.

12Others have also noted the salience of presidential priorities in OIRA's
operations. See, for example, Susan E. Dudley and Angela Antonelli,
"Congress and the Clinton OMB: Unwilling Partners in Regulatory
Oversight?," Regulation (Fall 1997), 17-23. The authors noted "OIRA is
supposed to simultaneously provide independent and objective analysis, and
report to the president on the progress of executive policies and
programs. When those functions conflict, the presidential agenda will most
certainly prevail over independent and objective analysis."

Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

Figure 5: OIRA Returned More Rules to Agencies in Calendar Year 2001 Than
in the 7 Previous Years Combined

20 Number of draft regulatory actions returned to agency

18

15

10

5

0 1994 1995 1996 1997 1998 1999 2000 2001 2002 Calendar year

Source: OMB.

DOT had the most rules returned during 2001 and 2002 (eight), followed by
the Social Security Administration (five), the Department of Veterans
Affairs (four), and the Department of Housing and Urban Development (two).
The Department of Agriculture, the Office of Personnel Management, EPA,
and SBA each received one return letter. In the letters, OIRA commonly
said that it returned the rules because of concerns about the agencies'
analytic approach-such as whether the agency had considered all reasonable
regulatory alternatives, or had selected the alternative that would
produce the greatest net benefits. In its December 2002 report on the
costs and benefits of regulations, OIRA reported that 10 of the 22 rules
returned by October 2002 had been resubmitted and approved for
publication.

Recent OIRA Administrators have taken very different positions regarding
the use of return letters, reflecting the philosophical differences
between the administrations in OIRA's relationship with the agencies and
explaining the dramatic change in the use of returns. For example, two
former OIRA Administrators during the previous administration told us that
the objective of the review process was to achieve an end result that was
mutually agreeable, and that they viewed return letters as evidence of a
failure of the collaborative review process. One of the former

Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

Administrators noted that the agencies and OIRA are parts of the same
administration "team," so any public failure to agree on how a rule should
be written could only be seen as a breakdown of that process.

In contrast, the current OIRA Administrator said in one of his speeches
that the office is using a "carrot and stick" strategy in its efforts to
encourage better regulatory analysis, and that the "stick" has been the
revival of the return letter. In its March 2002 draft report on the costs
and benefits of federal regulations, OIRA noted that no rules had been
returned to the agencies for reconsideration during the previous
administration's final 3 years, and said "the degree of OIRA's actual
effectiveness can be questioned when it declines to use its authority to
return rules." OIRA noted that under the current administration the office
had revived the return letter, "making clear that OMB is serious about the
quality of new rulemakings."

However, OIRA's increased use of return letters appears to have been short
lived. As figure 6 shows, the sharp increase in the use of return letters
was primarily in the current Administrator's first 8 months in office
(July 2001 through February 2002). During that period, OIRA returned 21 of
the 415 rules that it reviewed to the agencies. More than half (11) of the
21 rules that OIRA returned during this period were sent to the agencies
in a single month-September 2001. However, during the following 15-month
period (from March 2002 through May 2003), OIRA returned to the agencies
only 2 of the 863 rules that it reviewed-about the same pace as during the
previous administration.

        Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

Figure 6: OIRA Returned Only Two Rules Between February 2002 and May 2003

            12 Number of draft regulatory actions returned to agency

                                       11

Some of the officials from rulemaking agencies who regularly interact with
OIRA also told us that there is a greater expectation now than several
years ago that the agencies' economic analyses (both benefit-cost and
cost-effectiveness) will be thorough. Officials from one agency described
it as a "more relentless emphasis" on benefit-cost analysis, and said OIRA
is expecting the agencies to devote more money and effort to refining
their analyses to develop rules that are more cost effective. Officials in
another agency said there had been a perceptible "stepping up the bar"
regarding what is expected in agencies' analyses. They also said that OIRA
is looking for greater quantification of benefits and more justification
and breakdown

                                      10 8

                                       6

                                       4

                                       2

                                  0 Month/year

                                  Source: OMB.

In its December 2002 report on the costs and benefits of federal
regulations, OIRA indicated that the decline in the number of returns
since February 2002 was a reflection of the improved quality of regulatory
packages. OIRA also said that an even more important factor was the
"earlier interaction between OIRA and agency staffs during 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
the quality of regulatory analyses and the substance of rules."

    Greater Emphasis on Economic Analysis

        Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

of marginal benefits of every line item in the agency's rules, and that
OIRA now expects agencies to do a benefit-cost analysis for all regulatory
options, not just for the option that the agency selected.

OIRA representatives pointed out that their office has always pushed for
agencies to do a better job with their analyses. However, they confirmed
that the current Administrator is somewhat more interested in having the
agencies do better analyses than previous Administrators. In fact, they
said the current Administrator said early in his tenure that he would
return a rule if the analysis needed work, even if the rule itself was
acceptable.

    Emphasis on 90-day Period for Review

Another clear change in OIRA regulatory review policy since the current
OIRA Administrator took office has been a stricter adherence to the time
frames for OIRA review. As mentioned earlier in this report, Executive
Order 12866 generally requires OIRA to complete its regulatory reviews
within 90 calendar days of submission for all draft proposed and final
rules. The executive order allows the review period to be extended once
upon the written permission of the OMB Director and at the request of the
rulemaking agency.13 According to a former OIRA Administrator, the 90-day
time limit in the executive order was put in place because of "strident
complaints" about the length of reviews during the previous
administrations' implementation of Executive Order 12291 in the 1980's and
early 1990's. However, she said the time limit created an unintended
"perverse incentive" for the agencies to respond to OMB suggestions late
in the 90-day period, and then suggest that the rule be approved because
of the time limit. As a result, she said, review periods were often
extended beyond the 90-day limit.

As figure 7 indicates, during each of the calendar years 1999, 2000, and
2001, more than 100 OIRA reviews exceeded the 90-day limit (115, 159, and
149, respectively). However, during calendar year 2002 (the current
Administrator's first full year in office) only 9 reviews lasted longer
than 90 days. According to an OIRA representative, virtually all of the
extensions of the review periods in each of these 4 years were done at the
request of the agency issuing the rule. (However, officials from one
agency and a

13The executive order actually says review periods can be extended only if
the agency requests an extension and the OMB Director provides written
permission. However, an OIRA representative said that extensions have been
provided if either condition is met.

Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

previous OIRA Administrator told us that OIRA sometimes asked the agency
to request an extension.)

Figure 7: The Number of OIRA Reviews Lasting More Than 90 Days Dropped
Sharply in 2002

170 Number of OIRA reviews over 90 days
160 159
150
140
130
120
110
100

90

80

70

60

50

40

30

20

10

0 1999 2000 2001 2002 Calendar year

Source: OMB.

The dramatic decline in the number of reviews lasting more than 90 days is
traceable to clear differences in philosophy between Administrators
regarding the importance of this requirement. For example, in September
1997 the OIRA Administrator at the time testified that "when two or more
agencies are at loggerheads over a regulatory issue, it may well take more
than 90, or even 120, days to obtain needed data and analyses, to conduct
the appropriate evaluation, and to arrange for the policy officials in the
interested agencies to come to agreement." For that and other reasons she
opposed draft legislation that would have imposed a statutory time limit
on OIRA reviews. Another OIRA Administrator during the previous
administration told us during our review that he considered it more
important to "get the rule right" rather than rigidly adhere to a 90-day
time limitation. Several of the agency officials that we contacted during
this review confirmed that view, saying that during the previous
administration OIRA often worked with the agencies after the 90-day
deadline had passed in order to resolve comments or questions. In
contrast, in May 2002 the

Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

current OIRA Administrator said "agencies have sometimes been forced to
wait 6 months, a year, or even longer to get an answer from OMB. We have
changed that practice. I have instructed my staff that no rule will stay
longer than 90 days at OMB without my personal authorization." According
to OIRA's December 2002 report on the costs and benefits of regulations,
the office now regards the 90-day review limit as "a performance indicator
for a strong regulatory gatekeeper." OIRA representatives confirmed that
close adherence to the 90-day clock is new, and said that OIRA management
tracks all rules that have been under formal review for more than 60 days.
They also said that a benefit of stricter adherence to the 90-day review
limit is that it forces officials to make decisions sooner, thereby moving
the review along more quickly.

Officials from several rulemaking agencies also told us that OIRA staff
currently seem much more focused on the 90-day clock than during the
previous administration. In fact, concerns about adherence to this fixed
review period might have precipitated some of the return letters that have
been more common during the current administration. For example, in the
September 14, 2001, return letter to DOT, the OIRA Administrator said
"(s)ince the resolution of the concerns will take some additional time, I
am returning the draft final rule on flight data recorders to the
Department for your reconsideration." The return letters for this rule and
for one other rule were sent to the agencies shortly after the rules'
90-day review periods had ended. An OIRA representative told us that the
90-day clock may play a role in some returns, but not always.

Officials in other agencies also said that rules are sometimes returned or
withdrawn at OIRA's request when time is running out on the 90-day clock
and it is recognized that more time is needed to resolve issues "off the
clock" or during a separate 90-day period. Representatives of OIRA told us
they do not request that agencies withdraw rules, and emphasized that it
is the agencies-not OIRA-that ultimately make withdrawal decisions. They
also said agencies sometimes withdraw rules as a negotiating strategy.

Although an increased emphasis on the 90-day time limit is clearly an area
of change in recent years, the formal review period itself may be somewhat
of an artificial construct if OIRA and the agency had been substantively
discussing the rule and/or exchanging drafts of the rule before formal
submission. For example, on December 10, 2001, EPA formally submitted a
draft rule to OIRA on proposed nonconformance penalties for heavy-duty
diesel engines. OIRA's database indicates that it completed its review 10

        Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

days later on December 20, 2001. However, public documents indicate that
EPA and OIRA met with outside parties in early October 2001 and
mid-November 2001 to discuss the rule, and that EPA informally submitted a
version of the draft rule and its economic analysis to OIRA in late
October 2001-weeks before the 10-day formal review period began. (See GAO
ID 53 in app. II of this report.) OIRA records indicate that the formal
review period for an EPA Clean Water Act rule in which OIRA made
significant changes was even shorter-1 day. (See GAO ID 69 in app. II of
this report.)

Use of Prompt Letters	Another change in OIRA policies and practices has
been the development of a new form of communication with the agencies-the
"prompt letter." In its December 2002 report on the costs and benefits of
federal regulations, OIRA stated that the office had historically been a
reactive force in the regulatory process, responding to proposed and final
rules that were generated by federal agencies. However, the report went on
to say that OIRA had recently begun "taking a more proactive role in
suggesting regulatory priorities for agency consideration," and the prompt
letter is the format by which those suggestions are brought to the
agencies' attention.

By the end of May 2003, OIRA had sent nine prompt letters to regulatory
agencies.14 Several of the initial prompt letters recommended that the
agencies consider taking regulatory actions regarding particular issues.
Notably, the letters did not always suggest that the agency publish a rule
on the issue, sometimes recognized that the agency had already begun
taking action, and generally left the final decision to the agency
regarding what action to take. For example:

o 	In September 2001, OIRA sent a letter to the Department of Health and
Human Services suggesting that FDA publish a final rule requiring that the
amount of trans fatty acid present in food be included in a product's
label. However, OIRA said the agency should review the comments received
on its proposed rule and proceed to final rulemaking "if appropriate."

14OIRA listed two items on the "prompt letters" page of its Web site that
did not appear to be prompt letters-a June 2002 EPA press release
regarding an EPA-OIRA collaboration and a January 2003 memorandum to the
heads of selected independent agencies asking them to consider
recommendations for reform that OIRA had received from the public.

Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

o 	Also in September 2001, OIRA sent a letter to OSHA requesting that the
agency "consider whether promotion of (automatic external heart
defibrillators) should be elevated to a priority." However, OIRA said it
understood that OSHA had limited resources and other constraints, and was
simply asking the agency to consider the matter.

o 	In December 2001, OIRA sent a letter to DOT encouraging NHTSA to give
greater priority to modifying its frontal occupant protection standard by
establishing a high-speed, frontal offset crash test. OIRA recognized that
the agency had already signaled its intent to move forward with this
standard, and also recognized NHTSA's resource constraints and other
legislative mandates.

o 	In May 2002, OIRA sent a letter to the Office of Federal Housing
Enterprise Oversight recommending that the office consider developing a
rule strengthening the corporate governance of Fannie Mae and Freddie Mac,
and to require them to make certain public disclosures.

o 	In May 2003, OIRA sent a letter to the Departments of Agriculture and
Health and Human Services requesting them to "further incorporate the
large body of recent public health evidence linking food consumption
patterns to health and disease" as the departments revise their dietary
guidelines and update the "Food Guide Pyramid." Specifically, OIRA
recommended that the revisions "emphasize the benefits of reducing foods
high in trans fatty acids and increasing consumption of foods rich in
omega-3 fatty acid."

Other OIRA prompt letters were even less focused on rulemaking or
guidance, instead recommending that the agencies better focus certain
research or programs. For example, in December 2001 OIRA sent a letter to
EPA highlighting "some critical research needs that can help target
environmental-protection investments to the most important sources of
(fine particulate matter) and thereby better inform cost-benefit studies
of future air pollution control policies." OIRA recognized that EPA
already devoted a substantial share of its research budget on particulate
matter, but suggested that the research focus on three particular issues.
Similarly, in February 2003, OIRA sent a letter to the Department of
Energy raising several issues regarding a particular energy modeling
system, and suggested changes in that system that would, in OIRA's view,
better enable the agency to assess the potential of hybrid-electric and
diesel powered vehicles.

Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

In March 2002 the OIRA Administrator said that the prompt letters issued
as of that date "have emerged primarily from discussions with my
professional staff," but encouraged the public to submit ideas for
prompts. In another speech he said the use of prompt letters "enables OMB
to publicly identify areas where agencies might improve regulatory
policies." He also said that prompt letters differ from the more
definitive presidential directive in that the letters represent a "public
request that is intended to stimulate agency and public deliberation," and
emphasized that "final decisions about priorities remain with the
agencies."

Although OIRA's use of public prompt letters is new, the concept of OIRA
(or, more generally, the President) making regulatory suggestions to the
agencies is not.15 One former OIRA Administrator told us that every
administration has had certain areas of regulatory emphasis and has
communicated those ideas to rulemaking agencies in a variety of ways. She
said that if OIRA wanted the agencies to initiate rulemaking in a
particular area, "we could get the agencies' attention without using a
letter." Similarly, another former OIRA Administrator said that during his
tenure if OIRA thought an agency should regulate in a particular area, he
would call an agency official and talk about the issue rather than sending
a public prompt letter than could embarrass the agency. Officials in one
agency also indicated that these types of communications had existed
previously-albeit not publicly. As indicated in the following quote from
its December 2002 report on the costs and benefits of federal regulation,
OIRA identified the public nature of the prompt letter as a distinguishing
feature:

"An important feature of the prompt letter can be its public nature, aimed
at stimulating agency, public and congressional interest in a potential
regulatory or informational priority. Although prompt letters could be
treated as confidential pre-decisional communications, OIRA believes that
it was wiser to make these prompt letters publicly available in order to
focus congressional and public scrutiny on the important underlying
issues."

An OIRA branch chief told us that the office still does, on occasion, call
an agency on the telephone and suggest areas for regulation. He said the
strategy used (telephone versus prompt letter) depends on a variety of

15See Elena Kagan, "Presidential Administration," Harvard Law Review, 114
(2001): 2,245-2,385, who asserted that recent presidents have increasingly
made agencies' regulatory activity into an extension of their own policy
and political agendas. She said President Clinton did so primarily by
"exercising directive authority over these agencies," using formal
directives to the heads of executive agencies to "set the terms of
administrative action and prevent deviation from his proposed course."

        Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

circumstances, but noted that prompt letters are more "transparent" and
may have more impact than a telephone call.

Several of the agencies have taken some type of action in response to the
OIRA prompt letters, and other actions were planned. For example, in
December 2001 OSHA issued a technical information bulletin regarding the
use of defibrillators in the workplace. In July 2003, FDA published a
final rule on trans-fatty acids. NHTSA said that it planned to issue a
notice of proposed rulemaking on offset crash testing in 2003.

Post-Review Letters	In 2001 and 2002, OIRA sent a total of five
"post-review letters" to rulemaking agencies and posted those letters on
its Web site. As of May 2003, no post-review letters had been sent since
August 2002. OIRA representatives said that although individual branch
chiefs or desk officers had previously provided staff-level comments to
rulemaking agencies at the conclusion of reviews, the use of a public
letter signed by the Administrator to convey those comments represented a
change in OIRA policy.

In some of the post-review letters, OIRA expressed concerns about the
rulemaking agencies' analyses and the cost-effectiveness of the rules that
were similar in many respects to the concerns that the office had
expressed in the previously mentioned return letters. For example, after
OIRA completed its review of EPA's draft proposed rule on "Control of
Emissions from Nonroad Large Spark-Ignition Engines and Recreational
Engines (Marine and Land-Based)" in September 2001, the OIRA Administrator
sent a letter to EPA noting that he was "concerned that the regulatory
analysis is not sufficient to support a reasoned determination on the
appropriate regulation of these sources." Specifically, he said that the
analysis did not "provide a benefit/cost analysis integral to the
decision-making process" and did not evaluate any alternatives as required
by the Unfunded Mandates Reform Act of 1995 and Executive Order 12866. The
Administrator said he expected improvements to the analysis to be
submitted before the final rule was submitted, and said EPA and OIRA
should schedule "quarterly meetings to review the progress in developing a
refined analysis."

However, in other post-review letters, OIRA expressed other types of
comments. For example:

o 	In an October 2001 letter regarding an FAA draft proposed rule on
"Traffic Alert and Collision Avoidance Systems," the OIRA Administrator

        Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

recognized that despite the rule's high cost compared to its benefits, the
agency had "limited alternatives available under the statute." In that
regard, he indicated that the department and the agency should share with
Congress "any information made available by the public that bears on the
reasonableness of implementing the statute." He also encouraged FAA to
carefully assess the impact of the rule on small entities and the
financial health of the industry "in light of recent events."

o 	In a June 2002 letter regarding a NHTSA final rule on tire pressure
monitoring systems, the OIRA Administrator expressed his appreciation for
the "significant improvements NHTSA made in the regulatory analysis," and
encouraged the agency to conduct a study examining the relative frequency
of different causes of crashes.

o 	In an August 2002 letter regarding a Department of Housing and Urban
Development rule on improving the process for obtaining mortgages, the
OIRA Administrator encouraged the department to continue its work to
improve and simplify the proposed forms, and suggested that the department
"further strengthen the economic and regulatory flexibility analyses."

A former OIRA Administrator told us that the office's current use of
public post-review letters represents a change in policy from the previous
administration. She said that during the previous administration OIRA
might have spoken with an agency about what it should be doing before a
proposed rule was resubmitted, but OIRA would not have put those comments
in writing. She described the previous process as "non-public post review
comments," and said written material was too confrontational.

                           Transparency Improvements

On numerous occasions, the current OIRA Administrator has identified
improvements in the transparency of the office's regulatory review process
as a key area of change, and has described the establishment of a climate
of openness at OIRA as his "first priority." The Administrator said the
information that OIRA discloses about its reviews is intended to "diminish
the culture of secrecy and mystery that has surrounded my Office since it
was launched early in the Reagan Administration," and said that "more
openness at OMB about regulatory review will enhance public appreciation
of the value and legitimacy of a centralized analytical approach to
regulatory policy." He also described the transparency of OIRA's
regulatory review process as "critical to our ability to improve the
nation's regulatory

        Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

system," and said "only if it is clear how the OMB review process works
and what it does will Congress and the public understand our role and the
reasons behind our decisions." He also said "we see openness not simply as
a canon of good government but as a strategy to transform the public
debate about regulation to one of substance...rather than process."
Similarly, in May 2002 the OMB Director said that one way to establish
public confidence in the "consumer protection" mission of OMB is "maximum
openness."

Disclosure of Contacts with In October 2001, the OIRA Administrator sent a
memorandum to OIRA staff

Outside Parties	(and published it on the office's Web site) that, among
other things, delineated OIRA's disclosure procedures regarding
substantive communications with outside parties (i.e., persons not
employed by the executive branch) while rules were under review. Many of
the procedures listed were the same as or clarifications of the disclosure
requirements in Executive Order 12866. For example, like the executive
order, the memorandum said that (1) only the Administrator or a particular
designee can receive substantive telephone calls from outside parties, (2)
a representative from the issuing agency must be invited to any meeting
between OIRA personnel and outside parties, and (3) OIRA must send to the
regulatory agency all written communications between OIRA personnel and
outside parties within 10 days.

However, the Administrator's October 2001 memorandum also extended the
executive order's disclosure requirements in certain areas. For example,
the memorandum said that OIRA would disclose substantive telephone calls
with outside parties about a rule under review if the calls are initiated
by the Administrator, not just the calls that the Administrator receives
from outside parties. Also, the memorandum said that OIRA considers a rule
to be under review for purposes of OIRA's disclosure requirements
regarding outside parties not just during the formal review process, but
before formal submission of the review package (i.e., during the
previously mentioned informal review period) if OIRA has started a
"substantive discussion with the agency concerning the provisions of a
draft rule or OIRA has received the rule in draft." As a result of this
change in policy, for the first time OIRA began disclosing letters,
telephone conversations, and meetings that occurred during the informal
review period. In its 2001 report on the costs and benefits of federal
regulations, OIRA described why the office believed that these outside
contacts before a rule is formally submitted should be disclosed.

Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

"Interested outside parties have gradually learned about this informal
process of agency-OIRA discussion and thus attempts are made to provide
information to agency and OIRA analysts. In order to protect the integrity
of OIRA and the administrative record, an informal practice has developed
that communications between OIRA and outside parties are treated as
`covered by E.O. 12866' as soon as a rulemaking has proceeded to a point
where OIRA desk officers have received from agencies copies of preliminary
draft regulatory text or analysis."

However, OIRA representatives that we contacted during this review
emphasized that a rule is not considered under review with regard to these
disclosure requirements if OIRA and an agency are in general consultation
about an issue, but the consultation has not become "substantive" and/or
the agency has not submitted a substantive draft of a rule for informal
review. Therefore, at that "preinformal review" stage of the process, OIRA
can communicate with outside parties about the issue and not have to
disclose those communications.

The October 2001 memorandum also announced that much of the information
generated through the disclosure requirements would be available to the
public on the agency's Web site, including summary information on
meetings, phone calls, and other oral communications with outside parties
and a list of the written correspondence that OIRA had received from
outside parties. The memorandum said that other information previously
available in hard copy and/or in the OIRA docket library would also be
posted to the Web site (e.g., monthly regulatory review lists and
statistics and the text of written outside communications).16 Improving
access to information about OIRA's review process by putting the
information on the office's Web site has been widely hailed as a
significant improvement in the transparency of the regulatory review
process.17

However, we concluded that some of the information that OIRA provides on
its Web site regarding its communications with outside parties is not very
informative. As a result, it is sometimes difficult to understand what

16The October 2001 transparency memorandum indicates that covered
telephone calls and correspondence must be logged and/or sent to the
rulemaking agency within 10 working days. An OIRA representative told us
that meetings are typically logged within 3 or 4 days. He also said that
materials provided to OIRA at meetings are only available in hard copy in
the OIRA docket, not electronically.

17An OIRA representative told us that the office had not made this
information available electronically during previous administrations
because of resource constraints.

Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

rule a meeting was about or the affiliations of the meeting participants.
For example, during our review the OIRA Web site provided the following
descriptions:

o 	On February 3, 2003, an OIRA desk officer had a meeting with a person
whose affiliation was listed as "Albemarle" regarding an EPA issue
identified as "N-Propyl Bromid (nPB)."

o 	On October 24, 2002, OIRA leadership and staff met with four
individuals regarding a Centers for Medicare and Medicaid Services issue
identified as "Outpatient."

o 	On June 27, 2002, the Administrator and other OIRA staff met with
several individuals whose affiliations were listed as "TPLG," "American
Association," "Powell Golstein," and "Hunton & Williams" regarding a
Centers for Medicare and Medicaid Services issue identified as "Inherent
Reasonableness."

o 	On April 26, 2002, OIRA and OMB leadership and staff met with several
individuals regarding a General Services Administration issue identified
as "DOT Gov Rule: 3090-AH41." Two of the non-OMB participants'
affiliations were listed as "NASCIO" and "PTI."

The OIRA Web site included a column for each meeting in which the client
being represented by an outside party could be identified. However, we
found that this column was usually blank. An OIRA representative told us
that he recognized that OIRA could sometimes do a better job describing
the rule being discussed at meetings as well as the affiliations of the
meeting participants, and said that he had already notified OIRA staff
that the information posted on executive order meetings should be clearer
regarding these issues (e.g., no abbreviations when identifying the
affiliations of outside parties).

OIRA's practice of providing minimal information to the public about its
meetings with outside parties stands in contrast to the more formal,
APA-driven practices of certain agencies that we reviewed. For example, on
October 26, 2001, the OIRA Administrator and three OIRA staff members met
with representatives of the automobile industry regarding a NHTSA tire
pressure monitoring proposed rule. Two representatives from NHTSA were
also present. The OIRA web page listed the names and affiliations of those
present. However, the DOT electronic docket contained a memorandum
providing that information and also described the positions

        Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

taken by the various parties at the meeting. The memorandum indicated it
was prepared pursuant to DOT Order 2100.2, which requires that DOT
agencies prepare a report on meetings with outside parties for the
rulemaking docket. The DOT order also says "a mere recitation that on X
day a meeting was held with listed persons to discuss a named general
subject is inadequate."

Disclosure of OIRA-Agency The Administrator's October 2001 memorandum also
briefly discussed the

Interactions

requirements in Executive Order 12866 regarding disclosure of OIRA's
interactions with the rulemaking agencies. For example, it stated that
OIRA would, upon request, provide certain materials to the public after a
reviewed rule had been published, including the draft as originally
submitted, any material submitted by the agency during the review, pages
where changes occurred in the course of review, and correspondence between
OIRA and the agency that had been exchanged during the review.

However, OIRA representatives told us that the term "during the review" in
this context has a different meaning from the term "under review" with
regard to OIRA's contacts with outside parties. As mentioned previously,
OIRA considers a rule under review whenever informal review begins, and
said it would disclose all contacts with outside parties after that date.
In contrast, OIRA considers the period "during the review" in relation to
its contacts with the rulemaking agencies to include only a rule's formal
review period. Therefore, whereas OIRA discloses its contacts with outside
parties during informal reviews, it does not disclose its contacts with
rulemaking agencies during this period.

Similarly, OIRA representatives also said that the transparency
requirements in the executive order that are applicable to the agencies
are not triggered by informal reviews. As noted previously, the executive
order requires agencies to identify for the public (1) "the substantive
changes between the draft submitted to OIRA for review and the action
subsequently announced," and (2) "those changes in the regulatory action
that were made at the suggestion or recommendation of OIRA." The OIRA
representatives said they considered the second of these requirements to
be a subset of the first, and that the term "the draft submitted to OIRA
for review" refers to the draft rule submitted for formal review, not any
drafts submitted for informal review.

Therefore, under this interpretation of the executive order, an agency
could submit a draft rule to OIRA for informal review, make changes in
response to multiple OIRA suggestions and recommendations, and neither the

        Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

agency nor OIRA would have to disclose those changes to the public. If the
rule was not subsequently changed during the formal review period, OIRA
would code the rule in its database as "consistent with no change" and the
public would never know that OIRA had influenced its development.

OIRA representatives told us that drafts of a rule that are informally
submitted to OIRA do not represent the agency's official position, and
therefore should not be disclosed to the public even after the rule is
published. They also said that postpublication disclosure of
communications between OIRA and the agency that occur prior to formal rule
submission could have a "chilling effect" on those communications in the
future. Similarly, in its 2002 report on the costs and benefits of
regulations, OIRA said it believes "that its interactions with agencies
prior to formal regulatory review are pre-decisional communications that
should generally be insulated from public disclosure in order to
facilitate valuable deliberative exchanges." However, in the same report,
OIRA said "it is at these early stages where OIRA's analytic approach can
most improve the quality of regulatory analyses and the substance of
rules."

During our review we found evidence that some of these OIRA-agency
communications are being disclosed. OIRA's and the agencies' dockets for
several of the rules that we examined in chapter 3 of this report
contained e-mails and faxes between OIRA and the agency about rules under
informal review. Those documents proved very helpful to us in determining
what changes had been made to agencies' rules at the suggestion of OIRA.

Other Caveats	There are also other caveats to the OIRA-agency transparency
requirements in the executive order and the Administrator's October 2001
memorandum. For example, OIRA representatives told us that the requirement
in the executive order that OIRA make available to the public "all
documents exchanged between OIRA and the agency" issuing the regulation
applies only to exchanges made by OIRA staff at the branch chief-level and
above. Therefore, any e-mails, faxes, or other documents exchanged between
OIRA desk officers and staff in regulatory agencies about rules under
review do not have to be disclosed.18 OIRA said that this

18However, in practice we found evidence that such communications are, at
least in some cases, disclosed. OIRA's docket for several of the rules
that we examined in chapter 3 of this report contained e-mails and faxes
between the OIRA desk officer and agency staff about rules under review.

        Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

"branch chiefs and above" distinction had been the office's policy during
the previous administration as well.

Other OIRA-agency interactions are not covered by any transparency
requirements. For example, if OIRA returns a rule to an agency for
reconsideration, the executive order requires the Administrator to provide
the agency with a written explanation for the return. The return letter is
then made available to the public. After OIRA concludes its review and a
rule is published, the executive order requires the agency to disclose to
the public the substantive changes made during OIRA's review and those
made at OIRA's suggestion or recommendation. However, if an agency
withdraws a rule from OIRA during its review-either at its own initiative
or at the recommendation of OIRA-neither the agency nor OIRA is required
to disclose the reason.19

    OIRA's "Open Door" Policy on Meetings with Outside Parties

In its December 2002 report on the costs and benefits of federal
regulations, OIRA said that it had adopted an "open door approach to
meeting with outside parties." In explanation, OIRA representative told us
that if a party outside of the federal government wanted to meet with OIRA
about a rule under review or a matter of general regulatory policy, OIRA
would always try and accommodate that request. OIRA representatives
emphasized that these meetings are initiated by the outside parties, not
OIRA. However, a former OIRA Administrator told us that she did not
believe that this "open door" policy was new, and said OIRA had meetings
with outside interest groups "all of the time" during her tenure in the
mid-1990s.

Information on the OIRA Web site indicated that from October 2001 through
March 2003, OIRA had more than 100 meetings with outside parties. Of
these, at least 85 were with representatives of regulated entities
(primarily private companies); environmental and other public interest

19Agency officials told us that if a rule is withdrawn after having been
formally proposed, an agency may publish a "withdrawal" notice in the
Federal Register. If the rule is withdrawn before being proposed, they
said the only documentation may be a notation in the "completed action"
section of the Unified Agenda of Federal Regulatory and Deregulatory
Actions. However, OIRA's involvement may not be revealed in either form of
documentation.

        Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

groups were involved in 8 meetings.20 OIRA representatives said that one
possible explanation for the apparent imbalance in those with whom OIRA
meets is that there are more regulated entities that are directly affected
by agencies' regulations than public interest groups who have a more
general interest in the issues. However, another possible explanation is
that, while OIRA has said that it will meet with any organization that
wants to meet with it about a rule under review, representatives of
several public interest groups told us some such groups have made a policy
decision to not request meetings with OIRA. They said they take this
position because their groups do not believe that OIRA is the proper locus
of authority or decision making with regard to rulemaking issues.

    Hiring of Additional Staff Specialists

OIRA has also changed the office's human capital strategy in recent years,
increasing both the number of staff and adding new types of expertise. As
figure 8 shows, when OIRA was created in fiscal year 1981 the office had
an FTE ceiling of 90 staff members. By 1997, the number of FTEs allocated
to OIRA declined to 47-a nearly 50 percent reduction since 1981. OIRA
noted in its December 2002 report on the costs and benefits of regulations
that the decline in OIRA staffing during this period was more pronounced
than the decline in OMB as a whole, and occurred at a time when OIRA was
given new statutory responsibilities (e.g., concerning unfunded mandates,
small business, regulatory accounting, and information policy) and when
regulatory agencies' staffing and budgetary levels were increasing. Also
during this period, though, with the advent of Executive Order 12866 in
late 1993, the number of rules that OIRA reviewed went from between 2,000
and 3,000 per year to between 500 and 700 per year.

20The other meetings were with representatives of state, local, or tribal
governments (11 meetings), Members of Congress (2 meetings), or
individuals/organizations that could not be readily identified (8
meetings).

        Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

         Figure 8: OIRA Recently Reversed a 20-year Decline in Staffing

90 80 70 60 50 40 30 20 10 0

Source: OMB.

As the figure shows, OIRA's staffing authorization began to increase in
2001, and by 2002 the office had 55 authorized FTEs. 21 Between 2001 and
2003, OIRA had hired five new "specialist" or "expert" staff members who
were intended to provide new science and engineering expertise to OIRA:

o 	A risk assessor who received her Ph.D. in environmental
health/molecular toxicology from the University of Washington and who most
recently had been a science and technology fellow at EPA's National Center
for Environmental Assessment.

o 	An epidemiologist who received her Ph.D. in geography (resources
management) from Clark University and who had worked on exposure
assessment issues at EPA and was an environmental professor and researcher
at the schools of health at Johns Hopkins University and Harvard
University.

21OIRA's FTE total includes a number of positions that are not regularly
involved in the review of rules under Executive Order 12866, including
staff within the Information Policy and Technology branch and the
Statistical and Science Policy branch, and administrative staff within the
office. As of July 2003, 22 full-time OIRA analysts were primarily
responsible for the regulatory and paperwork reviews of all federal
agencies.

Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

o 	An engineer who received his Ph.D. in health policy from Harvard
University and a Masters of Science from the Massachusetts Institute of
Technology in civil and environmental engineering and technology and
policy. He previously worked at Resources for the Future and the
consulting firm Industrial Economics Incorporated.

o 	A health economist who received her Ph.D. in health policy from Harvard
University and a Master of Science degree in earth systems from Stanford
University. She formerly worked at the American Enterprise Institute.

o 	An economist who received his Ph.D. in economics from the University of
North Carolina at Chapel Hill and who formerly worked at FDA's Center for
Food Safety and Applied Nutrition.

In its December 2002 report on regulatory costs and benefits, OIRA said
these hires would facilitate collaboration with staff in the Office of
Science and Technology Policy and would "enable us to develop a more
diversified pool of expertise to ask penetrating technical questions about
agency proposals." In an October 2002 speech, the Administrator said that
these new hires also reflected "the increasing importance of science-based
regulation in the federal agencies." He also indicated that his vision for
how OIRA should be staffed is similar to that outlined in a 1993 book by
Stephen Breyer (later appointed to the Supreme Court), who suggested the
creation of a small, technically-trained group within OMB that offered its
members a special civil service career path-similar to that of the French
Conseil d' Etat.22 Breyer also indicated that this group might assume
OIRA's mandate to review agencies' proposed rules, "augmented by its
missions to rationalize risk regulation and seek tradeoffs." The OIRA
Administrator said "although I am not sure that the British or French
civil service are exactly the right analogies, I do have in mind a
talented and analytically keen staff who know how markets work, how
government works, and respect the role of expertise and values in solving
national problems."

Both former OIRA Administrators with whom we spoke supported increasing
the number of OIRA staff. However, both also indicated that they never
felt that OIRA was lacking in technical expertise and that they could
always tap into the resources available in other parts of the

22Stephen Breyer, Breaking the Vicious Circle: Toward Effective Risk
Regulation (Cambridge, Mass.: Harvard University Press, 1993).

        Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

Executive Office of the President (e.g., the Office of Science and
Technology Policy or the Council of Economic Advisors) or other agencies
if the need arose. An OIRA branch chief said the office still utilizes
staff from other agencies from time to time, in addition to using its new
"in house" expertise.

    Relationship With SBA Office of Advocacy

In March 2002, the OIRA Administrator and the SBA chief counsel for
advocacy signed a memorandum of understanding (MOU) committing OIRA and
the Office of Advocacy to work together to ensure that federal agencies
comply with the Regulatory Flexibility Act.23 As part of OIRA's regulatory
reviews, the MOU requires OIRA to consider whether agencies should have
prepared regulatory flexibility analyses under the act. If the Office of
Advocacy has concerns about an agency's analysis, the MOU requires OIRA to
provide a copy of the draft rule to that office. Also, the MOU says that
OIRA would help the Office of Advocacy develop guidance for agencies to
follow in complying with the act. In May 2003 testimony before the House
Committee on Small Business, the OIRA Administrator said that this
agreement would enhance OIRA's and SBA's ability to ensure that agencies
are meeting their Regulatory Flexibility Act responsibilities.

However, in that same testimony the Administrator said that the memorandum
of understanding would "formalize OIRA's long-standing practice of
involving the Office of Advocacy in our review of agency regulations." In
response to recommendations in our March 1994 report on the administration
of the Regulatory Flexibility Act, the SBA chief counsel for advocacy said
that she would send OMB a copy of any written notifications of
noncompliance with the act that she sends to the agencies during the
rulemaking process.24 She and the Deputy Administrator of OIRA said they
would work together to develop criteria and procedures for determining
agency compliance with the act. The Deputy Administrator also said that if
the chief counsel notified OMB about an agency's compliance with the
Regulatory Flexibility Act, OMB would discuss the issue with the agency
before concluding its review of any final regulations.

23In August 2002, the President signed Executive Order 13272, which also
urged agencies to give proper consideration to small entities in their
rulemaking.

24U.S. General Accounting Office, Regulatory Flexibility Act: Status of
Agencies' Compliance, GAO/GGD-94-105 (Washington, D.C.: Apr. 27, 1994).

        Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

    Proposed New Guidelines on Economic Analysis

One of the more controversial elements of OIRA's regulatory review
function involves its examination of agencies' regulatory impact analyses
that are required in support of the 70 to 110 rules that the office has
reviewed in recent years that are "economically significant" (e.g., have a
$100 million impact on the economy). As of May 2003, OIRA's approach to
these reviews had not officially changed. However, OIRA had initiated a
process that may ultimately result in alterations to its current
procedures.

In January 1996, OIRA published a document entitled "Economic Analysis of
Federal Regulations Under Executive Order 12866." Developed by a group
established by the OIRA Administrator and cochaired by a member of the
Council of Economic Advisers (CEA), the document described "best
practices" for preparing the economic analysis of significant regulatory
actions called for by the executive order.25 In general, the guidance
states that the agencies' analyses should contain three elements: (1) a
statement of the need for the proposed action, (2) an examination of
alternative approaches, and (3) an analysis of benefits and costs. Within
each of these areas, the guidance provides additional information. For
example, in the discussion of benefits and costs, the guidance addresses
such issues as discounting (when benefits and costs occur at different
times), the treatment of risk and uncertainty, and general methods for
valuing health and safety benefits (e.g., the monetary valuation of
reductions in the risk of illness, injury, and premature death). Each of
these issues can have a major effect on agencies' estimates of benefits
and costs. For example, in a February 2003 speech the OIRA Administrator
noted that the present value of 1,000 lives saved 50 years from now is 608
when evaluated at 1 percent discount rate, 228 when evaluated at 3
percent, and 34 when evaluated at 7 percent.26

In its December 2002 final report on the costs and benefits of federal
regulations, OIRA noted that it had initiated "a process of refinement" to
the guidance. In its February 2003 draft report, OIRA said the review was
again cochaired by the Administrator and a member of the CEA, and
published proposed revised guidelines for comment. OIRA said the key
changes in the proposed guidelines included the following:

25The 1996 best practices document was modified and issued as guidance in
2000.

26"Valuing Health: An OMB Perspective," speech given before the Conference
on Valuing Health Outcomes: An Assessment of Approaches (Feb. 13, 2003).

Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

o 	The proposal encourages agencies to perform both cost-effectiveness and
benefit-cost analyses in support of major rules, where feasible, because
the two techniques offer regulators somewhat different but useful
perspectives. In the previously mentioned February 2003 speech, the
Administrator described cost-effectiveness analysis as a "bang for the
buck" exercise in which the payoff is measured in health units rather than
dollars. However, since cost-effectiveness analysis only provides relative
comparisons, he said benefit-cost analysis is still needed to determine
whether the benefits of any particular alternative justify the costs.
Also, the Administrator said that OMB believes that multiple effectiveness
measures based on different value assumptions and research designs should
be encouraged (which he said can lead to inconsistency). To promote more
consistency, he said OMB would sponsor interagency discussions about the
most promising and practical effectiveness measures. Also, he said OMB
would request that agencies provide it with their original data on
mortality and morbidity to allow OMB to compare across agencies using
similar assumptions and methods (as an aid to performance-based
budgeting).

o 	When the benefits and costs of rules are expected to occur in different
periods, the proposal recommends that agencies report the results of their
analyses using multiple discount rates. Historically, OMB has recommended
a uniform 7 percent rate of discount for these rules. Now, the proposal
recommends that the results be computed at both 3 percent and 7 percent
for rules with impacts primarily within this generation. However, for
rules with intergenerational impacts, the proposal permits additional
sensitivity analysis with rates as low as 1 percent.

o 	For rules that are expected to have a more than $1 billion impact on
the economy, the proposal calls for agencies to employ formal probability
analysis of benefits and costs (rather than a single number) unless the
benefits and costs are known with a high degree of certainty. The
Administrator said that information on probabilities is crucial when
agencies must decide whether to act now, based on imperfect science, or
whether to collect additional information prior to rulemaking-
particularly in relation to "low-probability, high-consequence events such
as the events of September 11th."

The February 2003 draft guidelines also noted that two widely used
techniques were being used to assign a monetary value to projected
reductions in premature mortality-(1) the value of a statistical life
(VSL)

        Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

and (2) the value of a statistical life year (VSLY). The guidelines
pointed out a number of technical issues associated with the appropriate
use of these measures, and said "in all instances...agencies should
consider providing estimates of both VSL and VSLY, while recognizing the
developing states of knowledge in this area." Subsequently, AARP and other
organizations expressed concern that use of the VSLY approach could lead
to an undervaluing of the lives of older adults. On May 30, 2003, the OIRA
Administrator sent a memorandum to the President's Management Council that
again recommended that agency benefit-cost analysts present both VSL and
VSLY methods. However, the Administrator cautioned that a "simple VSLY
method" (i.e., assuming that saving 10 life years is 10 times more
valuable than saving 1 life year) "could underestimate benefits
significantly when applied to rules that primarily or significantly
benefit senior citizens." He went on to say that, "when benefit estimates
based on the VSLY method are presented, as OMB has encouraged since 1996,
I recommend that agencies present analyses with larger VSLY estimates for
senior citizens."27

In February 2003, OIRA released the draft guidelines for public comment.
After the comment period, OIRA said that it planned to conduct an
interagency review of the draft guidelines. Until this process is
complete, OIRA said that it would continue to use the 1996 best practices
guidance document. However, as noted earlier in this chapter, some agency
officials told us that OIRA already expects agencies' cost-benefit
analyses to be more thorough than they were required to be several years
ago.

    New Guidelines on Risk Assessment

Some (but by no means all) of OIRA's regulatory reviews evaluate whether
an agency's assessment of the exposure to a risk or environmental hazard
was properly conducted. Risk assessment is a complex but valuable set of
tools for federal regulatory agencies, helping them to identify issues of
potential concern, select regulatory options, and estimate the range of a
forthcoming regulation's benefits. As we noted in our August 2001 report,
the statutory and legal context in which risk assessments are conducted
determine the general focus and goals of an agency's risk assessment
activities, and also may shape how those assessments are supposed to be

27The Administrator noted that EPA's most recent VSLY estimates were
$434,000 per life-year saved for persons over age 65 and $172,000 per life
year saved for those under age 65.

Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

conducted.28 Therefore, different agencies (and different offices within
those agencies) may have distinctive concerns regarding chemical risks.
OIRA's January 1996 "best practices" guidance contains a section on risk
assessment, stating in general terms the qualities of a good assessment.
For example, it says that assessments "should present results representing
a range of plausible scenarios, together with any information that can
help in providing a qualitative judgment of which scenarios are more
scientifically plausible." It also says that risk assessments "must
provide some estimates of the probability distribution of risks with and
without the regulation" and, where possible, "some estimates of central
tendency (e.g., mean and median) must be provided in addition to ranges,
variances, specified low-end and high-end percentile estimates, and other
characteristics of the distribution."

In 1996, Congress adopted a basic standard of quality for the use of
science in health decisions under the Safe Drinking Water Act (SDWA).
Specifically, Congress provided that if an agency's decision under the
statute was based on science, it should use "(i) the best available,
peer-reviewed science and supporting studies conducted in accordance with
sound and objective scientific practices, and (ii) data collected by
accepted methods or best available methods (if the reliability of the
method and the nature of the decision justifies the use of data)."
Congress also adopted a standard for the dissemination of public
information involving risks under SDWA, providing that agencies should
"ensure that the presentation of information on (risk) effects is
comprehensive, informative, and understandable." In addition, Congress
required that agencies should, to the extent practicable, specify and make
available to the public in a supporting document information on (1) each
population addressed by any estimate of applicable risk effects, (2) the
expected risk or central estimate of risk for the affected populations,
(3) each appropriate upper-bound or lower-bound estimate of risk, (4) each
significant uncertainty identified in the process of the risk assessment
(and any studies that would help resolve the uncertainty), and (5)
relevant peer-reviewed studies regarding the estimated risk effects.

In his September 2001 memorandum on presidential review of agency
rulemaking, the OIRA Administrator proposed expanding the applicability of
these requirements to statutes other than SDWA. Specifically, he

28U.S. General Accounting Office, Chemical Risk Assessment: Selected
Federal Agencies' Procedures, Assumptions, and Policies, GAO-01-810
(Washington, D.C.: Aug. 6, 2001).

        Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

recommended that each agency consider adopting or adapting these standards
for judging the quality of scientific information that it uses about risk.
These recommendations were subsequently contained in information quality
guidelines intended to ensure and maximize the quality, objectivity,
utility, and integrity of a wide range of information disseminated by
federal agencies.29 The Administrator said that under these guidelines
"the public will be provided an opportunity to challenge any health risk
information disseminated by a federal agency that does not adhere to the
OMB and agency guidelines. Agencies will be expected to provide a prompt
and objective response to these challenges." An OIRA representative said
the office considered the SDWA risk assessment standards "reasonable" and
a "model" approach the could be used in regulations under other statutes
(unless, of course, those other statutes prohibited that approach).

    Deference to Peer Reviewed Regulatory Analyses

In his September 2001 memorandum on "Presidential Review of Agency
Rulemaking by OIRA," the OIRA Administrator said OMB recommended that
agencies subject regulatory impact analyses and other supporting documents
to independent, external peer review. He also delineated certain peer
review practices that OMB recommended, including (1) selection of
reviewers primarily on the basis of necessary technical expertise, (2)
disclosure of reviewers' prior positions on the issues at hand as well as
sources of personal and institutional funding, and (3) implementation of
the review in an open and rigorous manner. In the previously mentioned
information quality guidelines, OMB noted that if peer review is used to
help satisfy the "objectivity" standard, the review process should meet
these criteria. The OIRA Administrator has described EPA's 2001 decision
on arsenic as an example of a quality, peer-reviewed study.

Although OIRA did not require greater use of peer review by rulemaking
agencies in this September 2001 memorandum, the Administrator said that
OIRA would "be giving a measure of deference" to agencies' analyses that
were developed in conjunction with certain peer review principles.30 In
one of his speeches he said that this deference to peer reviewed studies
was

29For a copy of these guidelines, see 67 Fed. Reg. 8452 (Feb. 22, 2002).

30Shortly before the publication of this report, on August 29, 2003, OIRA
proposed a standard analytical process by which all "significant
regulatory information" that federal agencies intend to disseminate would
be peer reviewed.

Chapter 2 Some of OIRA's Regulatory Review Policies Have Changed

intended to serve as an incentive to improved regulatory analysis-the
"carrot" portion of the "carrot and stick" approach mentioned previously.

However, two former OIRA Administrator indicated that similar deference
was given during the previous administration to peer reviewed regulatory
analyses, and that the current administration's initiative in this area
reflected a change in the degree to which deference is given rather than a
substantial change of direction. On the other hand, they also said the
current policy is more explicit than the previous administration's
approach.

Chapter 3

OIRA's Effects on Rules Submitted for Executive Order Review Varied

OIRA had a significant effect on 25 of the 85 draft proposed and final
rules from nine selected agencies that it reviewed between July 1, 2001,
and June 30, 2002; 17 of the rules were significantly changed by OIRA, 7
were returned to the agencies for reconsideration, and 1 was withdrawn by
the agency at OIRA's request.1 Almost all of the rules that were
significantly changed at OIRA's suggestion were from EPA. Almost all of
the returned rules were from DOT, as was the rule withdrawn at OIRA's
request. Many of OIRA's actions in these cases were prompted by concerns
about the quality of the agencies' regulatory analyses and/or whether the
agencies had selected the most cost-effective regulatory option. For 22 of
the 25 rules, OIRA's actions appeared to have at least some effect on the
costs and benefits associated with the rule or to have prompted revisions
in the agency's estimates of those costs and benefits. There was evidence
that outside parties had contacted OIRA before or during OIRA's formal
review period regarding about half of the significantly changed rules, two
of the returned rules, and the rule withdrawn at OIRA's request. Although
OIRA's positions regarding these rules were sometimes similar to those
expressed by outside parties, it is impossible to determine the extent to
which those contacts might have influenced OIRA's actions, if at all. ORIA
might have reached the same conclusions in the absence of those contacts.
Some of the agencies did not clearly identify all of the changes made to
their rules during OIRA's review or at OIRA's suggestion-as required by
Executive Order 12866. However, other agencies clearly identified those
changes.

  OIRA Significantly Affected About One-Third of the Rules That the Selected
  Agencies Submitted for Review

Our second objective was to provide detailed information on rules that
were significantly changed by OIRA, withdrawn at OIRA's initiative, or
returned to the agencies for reconsideration. According to the OIRA
database, from July 1, 2001, through June 30, 2002, OIRA completed 642
reviews of agencies' draft regulatory actions submitted under Executive
Order 12866. The dispositions of these reviews were as follows:

o 	About 33 percent (214) were coded in the database as "consistent with
no change," indicating that OIRA considered the rules consistent with the
executive order as submitted.

1Our unit of analysis was technically the submission of a rule to OIRA for
Executive Order 12866 review, rather than the rule itself, because some of
the rules were reviewed by OIRA more than once. However, for simplicity we
refer to these executive order submissions as rules in this report.

Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review
Varied

o 	About 50 percent (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.

o  About 8 percent (50) were coded as "withdrawn" by the agency.

o  About 3 percent (21) were coded as "returned" to the agency by OIRA.

o 	About 5 percent (35) had some other disposition (e.g., "sent
improperly," "emergency," or "statutory or judicial deadline").

Because the number of changed, returned, or withdrawn rules governmentwide
during this time frame was so large (393), we focused this part of our
review on 85 proposed and final rules with those dispositions that were
submitted to OIRA by nine selected agencies or offices: 2

o 	The Animal and Plant Health Inspection Service within the Department of
Agriculture.

o 	The Food and Drug Administration within the Department of Health and
Human Services.

o 	The Occupational Safety and Health Administration within the Department
of Labor.

o 	The Federal Aviation Administration, the Federal Motor Carrier Safety
Administration, and the National Highway Traffic Safety Administration
within the Department of Transportation.

o 	The Offices of Air and Radiation, Solid Waste and Emergency Response,
and Water within EPA.

We selected these agencies and offices because the OIRA database indicated
they had the most rules that were changed, withdrawn, or returned during
the relevant 1-year period.

2See appendix I for a more detailed description of our objectives, scope,
and methodology, and appendix II for information about each of the 85
submissions.

 Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review Varied

Table 1 shows the number of rules with each type of OIRA disposition
within each of the selected agencies or offices. We generally did not
question the rule dispositions used in the OIRA database. However, we
included one rule from EPA's Office of Air and Radiation in the
"consistent with change" category that had been coded as a "deadline case"
in the database because publicly available information indicated that the
rule had been changed in response to OIRA's review (ID 41).3 It is unclear
whether other rules with "deadline case" outcome codes in the database
were also changed by OIRA, or why other rules that we reviewed with legal
deadlines were not coded as deadline cases.4 Also, we dropped one rule
from EPA's Office of Solid Waste and Emergency Response that was coded
"consistent with change" because it had not been published in the Federal
Register at the time of our review.

         Table 1: Selected Agencies' Regulatory Submissions by Outcome

                              Number of rules reviewed between July 1,  
                                   2001, and June 30, 2002, that        
            Agency               were coded in the OIRA database as     Total 
                                                       Withdrawn by the 
                             Consistent with change Returned to agency  
                                               agency                   
             APHIS                                               12 0 1 
              FDA                                                 7 0 2 
             OSHA                                                 5 0 0 
            DOT-FAA                                               5 6 1 
           DOT-FMCSA                                              6 0 0 
           DOT-NHTSA                                              5 1 1 
     EPA Office of Air and                                       14 1 0 
           Radiation                                                    
EPA Office of Solid Waste                                      9 0 0 
    and Emergency Response                                              
      EPA Office of Water                                         8 1 0 
             Total                                               71 9 5    85 

Source:OIRA's database.

3See, for example, Arthur Allen, "Where the Snowmobiles Roam," Washington
Post Magazine (Aug. 18, 2002).

4OIRA's database has a separate field, separate from the field on reviews'
outcomes, that identifies submissions with legal deadlines. Twenty-two of
the 85 rules that we reviewed were coded in OIRA's database as having a
statutory or judicial deadline.

Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review
Varied

Note: Data in each category reflect the number of proposed, final, and
interim final rules that OIRA reviewed between July 1, 2001, and June 30,
2002, but do not include other types of regulatory actions submitted to
OIRA during this period (e.g., notices, prerules, or emergency rules). As
discussed later in this report, the nine returned rules included two
improper submissions-one from FAA and one from the EPA Office of Air and
Radiation.

Although the OIRA database was useful in focusing our review on certain
agencies and rules, the categories used in that database are broader than
the specific types of rules targeted in this section of our report-those
that were significantly affected by OIRA.

o 	The "consistent with change" category includes all rules that were
changed between their formal submission to OIRA for review and their
issuance by the agency, regardless of the source or the significance of
the changes made-not just those that were significantly changed at OIRA's
request. For example, even if the only change made to a rule during OIRA's
review was the correction of a legal citation made by the submitting
agency, the rule would be coded in the database as "consistent with
change."

o 	The "returned" category includes all returns, not just those that were
substantively "returned for reconsideration." Therefore, if OIRA returned
a rule solely because it was not subject to OIRA review (e.g., was
improperly submitted), it would be coded in the database as a "returned"
rule.

o 	The "withdrawn" category includes all rules withdrawn by the agencies
during OIRA's review, not just those that were withdrawn at the initiation
of OIRA. Therefore, if an agency erroneously submitted a rule to OIRA and
withdrew it solely at the agency's initiative, the rule would be coded in
the OIRA database as "withdrawn."

Because of the breadth of these categories, we had to gather additional
information on each of the 85 changed, returned or withdrawn rules to
determine which ones had been significantly affected by OIRA and,
therefore, met our more specific criteria.

Ultimately, we determined that 25 of the 85 rules from these agencies were
significantly affected by OIRA's review. Specifically, we concluded that
17 of the 71 rules that were coded as "changed" in the database were
significantly affected by OIRA. Seven of the nine rules coded as
"returned" were returned by OIRA for substantive reasons. One of the five
"withdrawn" rules was returned at the initiation of OIRA.

 Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review Varied

    OIRA Did Not Significantly Affect Many of the "Changed" Rules

We used a variety of information sources (e.g., agency and OIRA docket
materials and interviews with agency officials) to place each of the 71
rules coded as "consistent with change" into one of three categories:

1.	Significant changes-i.e., rules in which the most significant changes
attributed to OIRA's or OMB's suggestions affected the scope, impact, or
estimated costs and benefits of the rules as originally submitted to
OIRA.5 Usually, these significant changes were made to the regulatory
language that would ultimately appear in the Code of Federal Regulations.

2.	Other material changes-i.e., rules in which the most significant
changes attributed to OIRA's or OMB's suggestions resulted in the addition
or deletion of material in the explanatory preamble section of the rule.
For example, OIRA may have recommended that agencies provide better
explanations for certain rulemaking actions and/or suggested that agencies
ask the public to comment on particular aspects of the rules.

3.	Minor or no OIRA/OMB changes-i.e., rules in which the most significant
changes attributed to OIRA's or OMB's suggestions resulted in editorial or
other minor revisions, or rules in which changes occurred prior to
publication but not at the suggestion of OIRA or OMB. Where no changes
were made at OIRA's or OMB's suggestion, the changes that caused the rule
to be coded "consistent with change" could have been initiated by the
regulatory agency itself or by another federal agency (e.g., the Office of
the Federal Register).6

We placed each of the rules that we examined into the appropriate category
based on the most significant changes attributed to either OIRA or OMB-
even if the regulatory agencies initiated more significant changes to
their rules during the period of OIRA's review than did OIRA.7

5The agencies sometimes attributed suggested changes to OMB and sometimes
specifically to OIRA. In a few instances, OMB staff outside of OIRA
suggested the changes.

6Because the executive order does not require agencies to document
nonsubstantive changes, three of the rules we included in this category
were ones in which it was clear all the changes were minor, but the source
of the changes (i.e., whether they were made at the suggestion of
OMB/OIRA) could not be identified.

Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review
Varied

Table 2 presents the results of our analysis by agency. We concluded that
17 of the 71 rules coded as "consistent with change" in the OIRA database
(about 24 percent) were significantly changed as a result of OIRA's
suggestion or recommendation, 34 of the rules had other material changes
attributable to requests by OIRA, and 20 rules had only minor changes or
no changes at OIRA's suggestion or recommendation. Fourteen of the 17
significantly changed rules were from EPA-all but one of which were from
the agency's Offices of Air and Radiation or Water. Three other rules had
significant changes attributed to suggestions from OIRA or OMB-two APHIS
rules regarding indemnity payments for the destruction of diseased animals
and one NHTSA rule on tire pressure monitoring systems. (See app. II for
the coding and detailed descriptions of the changes made to each of the 71
rules.)

7For example, after submitting its rule on emission standards for surface
coating of metal furniture to OIRA, EPA reanalyzed data from the covered
industry and revised the emission limits to be less stringent than those
originally proposed-what we would have considered a "significant" change
if suggested by OIRA (ID 47). However, because the most significant
OIRA-suggested change was the addition of text to the preamble clarifying
the agency's analysis and requesting comments on a particular provision,
we coded this rule as having had "other material changes."

Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review
Varied

Table 2: Nature of Changes Made at the Suggestion or Recommendation of
OIRA

                                                          Total rules changed 
                      Number of rules by most significant after submission to 
                                                 level of 
            Agency        change suggested by OIRA                       OIRA 
                                   Other                  
                         Significant material Minor or no 
                                  changes changes changes 
             APHIS                                  2 9 1 
               FDA                                  0 6 1 
              OSHA                                  0 2 3 
           DOT-FAA                                  0 2 3 
              DOT-                                  0 3 3 
             FMCSA                                        
              DOT-                                  1 2 2 
             NHTSA                                        
        EPA Office                                  7 4 3 
        of Air and                                        
         Radiation                                        

                      EPA Office       1              4                     4 
                        of Solid                               
                       Waste and                               
                       Emergency                               
                        Response                               

EPA Office 6 2 0 of Water

Total 17 34 20

Source: GAO analysis.

As figure 9 illustrates, rules from EPA's Office of Air and Radiation and
Office of Water were more often significantly changed at the suggestion of
OIRA than rules from the other agencies and offices that we examined.

 Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review Varied

Types of Significant Changes Made at OIRA's Suggestion/Recommendation

Figure 9: EPA Air and Water Rules Were More Often Significantly Changed at
the Suggestion of OIRA

16 Number of changed submissions

14

12

10

8

6

4

2

0 APHIS FDA OSHA DOT-FAA DOT-DOT-EPA-AR EPA-EPA-FMCSA NHTSA OSWER
WaterAgency

Significant changes

Other material changes

Minor or no changes

Source: GAO.

In 6 of the 14 EPA rules that were significantly changed, the primary
effect of OIRA's suggestions or recommendations was to delay or eliminate
certain regulatory provisions that were included in the draft rules as
submitted to OIRA. For example:

o 	In response to OIRA concerns about the information collection request
associated with an EPA Office of Air and Radiation final rule on
consolidated emissions reporting, EPA delayed the compliance date for
states to report on two types of emissions (ID 50).

o 	OIRA's suggestions also prompted the deletion of provisions covering
marine and highway motorcycle engines from an EPA Office of Air and

Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review
Varied

Radiation proposed rule on emissions from nonroad large spark-ignition
engines and recreational engines (ID 41).8

o 	EPA eliminated manganese from a list of hazardous constituents in an
Office of Solid Waste and Emergency Response final rule on the
identification and list of hazardous wastes in response to comments from
OIRA (ID 56).

In four other significantly changed EPA rules, OIRA suggestions encouraged
the agency to change, add, or select regulatory alternatives that
generally provided more flexible and/or less costly compliance options to
regulated entities. For example:

o 	OIRA suggestions led to changes in an EPA Office of Water proposed rule
on pollutant discharge elimination systems for large cooling water intake
structures at existing power generating facilities that (1) lowered the
performance standard in the rule, (2) made compliance requirements more
flexible by allowing options for a site-specific approach to minimizing
environmental harm, and (3) broadened a restoration option whereby firms
may repair environmental harm rather than comply with the designated
performance standard (ID 68). OIRA believed that these options were not
only less burdensome, but also would yield greater net benefits.

o 	In a related EPA Office of Water final rule on minimizing environmental
impact from cooling water intake structures at new facilities,
OIRA-suggested changes included (1) the addition of criteria that would
allow more facilities to qualify for lower performance standards, (2) a
changed requirement so that facilities only needed to use screens to
minimize impingement mortality of fish and shellfish if certain criteria
were met, and (3) the addition of an exception to intake flow requirements
regarding cooling water intake structures located in a lake or reservoir
(ID 65).

In three other EPA rules and the NHTSA tire pressure monitoring systems
rule, OIRA suggested significant changes to the agencies' regulatory
impact analysis. For example:

  8The marine and motorcycle engines provisions later resurfaced as a separate
                                 rule (ID 54).

 Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review Varied

Rules With "Other Material Changes" Attributable to OIRA

o 	OIRA suggestions prompted EPA to make changes regarding the discount
rates and fuel prices that the agency used to estimate the potential costs
of a proposed rule on nonconformance penalties and emission standards for
heavy-duty diesel engines and vehicles (ID 53).

o 	Similarly, OIRA comments led EPA to revise the cost-benefit and
cost-effectiveness estimates in a proposed rule on emissions from spark
ignition marine vessels and highway motorcycles (ID 54).

In both of the APHIS rules with significant changes attributed to requests
from OMB, the changes reduced the potential total cost to the federal
government of paying indemnities to owners of animals destroyed or for
other measures taken to avoid the spread of certain communicable diseases
among animals (IDs 9 and 12).

We concluded that in 34 (about 48 percent) of the 71 "consistent with
change" rules, regulatory agencies made "other material changes" in
response to OIRA's suggestions or recommendations. Typically, these
changes augmented an agency's explanation of certain provisions in the
rule, clarified the agency's basis for decisions made about regulatory
options or assumptions, better explained the potential impact of different
options, or requested public comments and data on regulatory options or
costs. For example, in response to OIRA's suggestions or recommendations:

o 	APHIS revised the preamble to a rule that updated plant pest
regulations to (1) clarify that the proposed regulations would not cover
genetically modified organisms, (2) acknowledge there is a continuum of
risk related to regulated organisms, (3) solicit comments about the
adequacy of criteria APHIS used to identify organisms for inclusion, and
(4) solicit comments on the data elements that would have to be addressed
in a proposed notification system (ID 6).

o 	FDA added or revised information to the preamble of a final rule on
notification and recordkeeping requirements for exports to clarify its
responses to public comments on the proposed rule (ID 13).

o 	OSHA revised the preamble to a rule on procedures for handling
discrimination complaints (1) to add information and request public
comment regarding the whistle-blower model that OSHA chose and (2) to
clarify that certain procedures would be triggered at the "request of the
named person" (the person alleged to have violated the act) (ID 21).

 Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review Varied

o 	EPA's Office of Air and Radiation revised the preamble of its proposed
rule on national emission standards for hazardous air pollutants from
surface coating of metal furniture to request public comments on (1) its
conclusion that the creation of subcategories in the rule was not
warranted and (2) whether there were alternative means of monitoring
performance for add-on controls at source facilities that would be as
effective and less expensive than the proposed requirements (ID 47).

Rules in Which OIRA Suggested OIRA suggested only editorial or other minor
changes, or no changes at all,

Minor Changes or No Changes	in 20 (about 28 percent) of the 71 rules coded
in the OIRA database as "consistent with change." These minor changes
included rearranging existing text for clarity, correcting spelling
errors, making word choice changes, and adding or correcting procedural
language, such as where to submit public comments on the rules being
published. For example:

o 	The only two changes that OIRA suggested in a FMCSA rule on
certification of safety auditors, investigators, and inspectors were to
delete a redundant sentence and to correct the number cited for a relevant
executive order (ID 33).

o 	In an EPA proposed rule on a national ambient air quality standard for
ozone, OIRA suggested rewording three similar statements in the preamble
regarding EPA's views about "using plausible but highly uncertain
assumptions" (ID 42).

o 	The only change made at OIRA's suggestion in an EPA hazardous waste
management rule concerning cathode ray tubes and mercury-containing
equipment was to revise a request for comments on extending the
"speculative accumulation time of used, broken CRTs" to "two or more
years" instead of just "two years" (ID 62).

As noted previously, although we concluded that OIRA suggested only minor
changes or no changes to these rules, some of them appeared to have been
significantly changed during the period of OIRA's review at the initiative
of the agencies.

Most of the Rules That OIRA Two of the nine rules from the selected
agencies that were coded as Returned Were for "returned" in the OIRA
database were returned because they were Reconsideration improperly
submitted for review. The other seven rules were returned to

the issuing agencies for reconsideration-five rules from FAA, one from

NHTSA, and one from EPA.

Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review
Varied

In each of these seven cases, OIRA sent the rulemaking agency a "return
letter" describing its rationale for returning the rule. The letters
indicated that the returns for reconsideration were most often triggered
by OIRA concerns about the quality of agencies' regulatory analyses or the
cost-effectiveness of the proposed regulatory options. For example:

o 	OIRA said it returned a proposed FAA rule on certification of pilots,
aircraft, and repairmen for the operation of light sport aircraft because
it believed that the regulatory analysis did not sufficiently justify the
rule (ID 73).

o 	OIRA returned another FAA draft final rule after raising questions and
concerns about the relative cost-effectiveness of requiring additional
flight data recorder parameters (ID 77).

o 	OIRA returned a NHTSA final rule on tire pressure monitoring systems
because, in OIRA's opinion, NHTSA's analysis did not adequately
demonstrate that the agency had selected the best available alternative
(ID 78).

o 	OIRA returned an EPA rule on water quality standards for Indian country
because, among other issues, EPA did not provide a quantitative analysis
of the costs and benefits that could result from this regulatory action
(ID 80).

In other cases, OIRA cited coordination issues as its rationale for the
returns. For example, in one rule OIRA suggested to FAA that a concurrent
review of the aging aircraft and corrosion control plan rules could assist
in determining the most cost-effective way to detect and correct problems
affecting aging aircraft safety (IDs 76 and 74). In another FAA rule on
Part 145 repair stations, OIRA cited concerns from the Department of State
regarding the effect of the rule on international treaties (ID 72).
(However, FAA officials told us during our review that FAA and the
Department of State had resolved these concerns prior to the rule's
submission to OIRA, so the rule might have been returned because of a
misunderstanding.)9 Another factor that seems to have influenced at least
some of the returns was the 90-day limit for OIRA's reviews. In return
letters for three rules, OIRA specifically mentioned the need for
additional time to resolve some

9FAA resubmitted the rule, with no revisions, on the same day that it was
returned. Ten days later, OIRA completed its review of the resubmitted
version "consistent with no change."

 Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review Varied

of its issues and comments as part of the explanation for returning draft
rules for reconsideration.

As of May 2003, five of the seven rules that OIRA returned for
reconsideration by the rulemaking agencies had been resubmitted by the
agencies, completed another review by OIRA, and were published in the
Federal Register. Publication of one other rule-FAA's proposed revision of
digital flight data recorder regulations-was still pending, according to
FAA officials, but EPA had not resubmitted its proposed rule on federal
water quality standards for Indian country to OIRA.

    Agencies, Not OIRA, Initiated Most Withdrawals

Neither OIRA nor the regulatory agencies are required to document why
rules are withdrawn from OIRA's review. Therefore, we relied primarily on
testimonial evidence from agency officials to determine whether the five
rules within the scope of our review had been withdrawn at the suggestion
of OIRA or OMB. We determined that only one of the five rules appeared to
have been withdrawn at OIRA's initiative-FAA's Part 145 Review rule on
repair stations (ID 84). FAA's docket included a chronology of
developments regarding this rule with an entry stating that OIRA
instructed the agency to withdraw the rule. FAA officials explained that
OIRA suggested this withdrawal due to "concerns from industry and the
State Department."10 (As noted previously, OIRA representatives told us
they do not request that agencies withdraw rules, and emphasized that it
is the agencies-not OIRA-that ultimately make withdrawal decisions.
However, they also said that agencies sometimes withdraw rules as a
negotiating strategy.)

Agency officials characterized two of the withdrawals as "mutual
decisions" made by their agencies and OIRA. In one of these cases, an
APHIS rule on importation of clementines from Spain, an agency official
said that the rule was withdrawn pending the close of a comment period on
a related document published by the agency, because keeping the rule at
OIRA until then would have taken OIRA's review period beyond 90 days (ID
81). (It was resubmitted about a month later and subsequently coded
"consistent with change.") In the other case, an FDA rule on records and
reports concerning new animal drugs, the agency officials characterized
the mutual decision as a compromise to address the fact that the old

10This was the same rule that was subsequently resubmitted, returned to
FAA by OIRA, resubmitted yet again, and ultimately completed OIRA review
with no changes.

 Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review Varied

proposed rule was "stale" (ID 82). (The rule was later published as an
"interim final" rule to permit additional public comment without having to
restart the rulemaking at the proposed rule stage.) The remaining two
rules-an FDA proposed rule concerning dietary ingredients and supplements
and a NHTSA rule on light truck fuel economy standards- were withdrawn
solely at the initiative of the agency or its executive department (IDs 83
and 85). All five of the withdrawn rules that we examined were
subsequently resubmitted to OIRA by the agencies and were later
characterized by the office as consistent with the executive order.

Rules from FAA and EPA's As table 3 shows, when the results for all the
changed, returned, or Office of Air and Radiation withdrawn rules are
combined, it is clear that the rules submitted by FAA and Office of Water
Were and EPA's Office of Air and Radiation and Office of Water were most
often

significantly affected by OIRA's review. During the period covered by
ourMore Often Significantly review, about 56 percent of the rules from
these agencies (20 of 36) wereAffected by OIRA significantly affected. In
contrast, only about 10 percent of the rules from

the remaining six agencies (5 of 49) were significantly affected by OIRA's

review.

Table 3: Rules from FAA and EPA's Office of Air and Radiation and Office
of Water Were Most Often Significantly Affected by OIRA Review

        Rules submitted to OIRA for executive order review Agency Total

Significantly affected by OIRA Number Percent

                                   APHIS    13             2 
                                     FDA     9             0 
                                    OSHA     5             0 
                                 DOT-FAA    12             6 
                               DOT-FMCSA     6             0                0 
                               DOT-NHTSA     7             2               29 
                   EPA-Office of Air and    15             7               47 
                               Radiation                     
               EPA-Office of Solid Waste     9             1               11 
                  and Emergency Response                     
                     EPA-Office of Water     9             7               78 
                                   Total    85        25                   29 
                   Source: GAO analysis.                     
                                 Page 82                           GAO-03-929 

Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review
Varied

OIRA representatives suggested that the differences in the extent to which
OIRA significantly affected agencies' rules might actually be a function
of differences in the importance or impact of the rules submitted-not
whether they are from one agency or another. The representatives said that
OIRA typically spends more time and effort reviewing economically
significant rules that are likely to have the biggest impact on society.
Therefore, they indicated that agencies like EPA that produce a number of
economically significant rules were more likely to have their rules
significantly affected by OIRA's review than agencies like FDA that did
not submit as many economically significant rules.

As table 4 shows, 14 of the 85 rules that we examined were economically
significant. We concluded that 5 of those 14 rules (36 percent) had been
significantly affected by OIRA's review. In comparison, we concluded that
20 of the 71 rules that were not economically significant (28 percent) had
been significantly affected by OIRA's review. Therefore, although OIRA was
slightly more likely to have had a major effect on economically
significant rules than other rules, the difference was not statistically
significant.11

Table 4: OIRA Was Only Slightly More Likely to Significantly Affect
Economically Significant Rules

Rules submitted to OIRA for executive order review

Significantly affected by OIRA

Type of rule

Total Number Percent

                            Economically         14                         5 
                             significant                    
                        Not economically         71                        20 
                             significant                    
                                   Total         85                        25 

Source: GAO analysis.

11We performed a statistical analysis using Fisher's exact test to
determine if there was a statistically significant association between
whether the rules reviewed by OIRA were economically significant and
whether the rules were significantly affected by OIRA. The test results (p
= 0.43) did not support a hypothesis that a statistically significant
association exists.

 Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review Varied

Notably, all six of the FAA rules that OIRA significantly affected were
not economically significant. Of the 14 EPA Office of Air and Radiation
and Office of Water rules that OIRA significantly affected, only 3 were
economically significant.

  OIRA Affected the Costs and Benefits or Estimates in Some Rules

In 22 of the 25 rules that we concluded had been significantly affected by
OIRA's suggestions or recommendations, OIRA appeared to have influenced
either (1) the expected costs and/or benefits of the rules and/or (2) the
agencies' estimates of those costs and/or benefits. The focus of OIRA's
changes in most of these cases appeared to be on reducing the costs and
regulatory burdens, improving the cost-effectiveness of the rules, and/or
yielding greater net benefits. This focus is consistent with the emphasis
in Executive Order 12866 and the related "best practices" document and
guidance on improving regulatory net benefits and cost-effectiveness and
minimizing the cost burden of regulation.

    OIRA-Suggested Changes That Appeared to Have Affected Costs and Benefits

In at least 12 rules, OIRA or OMB suggested changes to the regulatory text
that could reasonably be expected to affect the potential costs and/or
benefits of the regulations. Sometimes there was direct evidence in the
docket materials of those effects. For example:

o 	In an EPA Office of Water proposed rule on pollutant discharge
elimination systems for large cooling water intake structures at existing
power generating facilities, OIRA recommended that the agency select a
regulatory alternative that it believed would yield substantially greater
net benefits (ID 68). The approach that EPA originally proposed would have
cost an estimated $610 million per year, with estimated benefits of $890
million per year, yielding net benefits of $280 million. However, OIRA
recommended that EPA select another approach that, while having estimated
benefits of $735 million, was expected to cost only $280 million, yielding
net benefits of $455 million.

o 	In another example, an APHIS rule regarding foot-and-mouth disease, OMB
suggested changes in the indemnity payments that were, in turn, reflected
in the agency's revised estimates of the rule's costs and benefits (ID
12).

However, in most of the cases in which OIRA suggested changes to
regulatory text, the documentary evidence of how those changes affected

Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review
Varied

the rules' costs and/or benefits was more limited and less clear. In some
cases the rules at issue were not "economically significant," so the
regulatory agencies were not required to prepare formal quantitative
assessments of the rules' expected costs or benefits. In another case, the
agency prepared those assessments but did not include complete copies of
the original and revised versions of the cost and benefit estimates in the
regulatory dockets. Therefore, we were unable to compare the agencies'
estimates to determine the effect of the OIRA-suggested changes in the
regulatory text.

Nevertheless, even in the absence of such documentation, we believe that
it is reasonable to assume in at least some cases that the OIRA-suggested
elimination or delay of certain regulatory provisions in the text of draft
rules as submitted to OIRA would also eliminate or delay the expected
costs and/or benefits associated with those provisions. The following are
examples of OIRA suggested changes in regulatory text that appeared to
affect the rules' expected costs and/or benefits:

o 	APHIS revised the regulatory text in a proposed rule on payment of
indemnity for animals affected by foot-and-mouth disease to eliminate
compensation coverage for certain voluntary actions taken by owners of
animals, thereby reducing potential costs to the federal government (ID
12). However, according to an APHIS official (and as explained in the
preamble of the proposed rule), not providing compensation for the care
and feeding of "official vaccinates" that could be used as a "fire wall"
around infected animals to help prevent the spread of the disease, and
eliminating compensation for cleaning and disinfecting non-susceptible
animals that could spread the disease even if they cannot themselves
become infected, could impede eradication efforts, thus reducing overall
benefits to society.12

o 	EPA changed the regulatory text in a final rule regarding cooling water
intake structures at new facilities to provide regulated entities the
flexibility to use more alternatives or exceptions to compliance with the
rule's requirements and standards (ID 65). These changes could reasonably
be expected to reduce at least some of the regulated entities' costs of
compliance with those requirements and standards, without any documented
change in benefits.

12Official vaccinates are livestock vaccinated as part of a foot-and-mouth
eradication program.

 Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review Varied

o 	EPA deferred final action on adding manganese to the list of hazardous
waste constituents, thereby also deferring the potential costs and
benefits of designating manganese as a hazardous waste constituent, with
an unknown effect on net benefits (ID 56).

o 	EPA delayed compliance dates in two provisions of a proposed rule
setting national emission standards for hazardous air pollutants from
surface coating of wood building products, thereby producing corresponding
delays in the costs and benefits expected for the rule (ID 51).

    OIRA-Suggested Changes that Affected Agencies' Estimates of Costs and
    Benefits

In 14 rules (including some of the ones described above with regulatory
text changes), OIRA specifically commented on and requested changes in the
agencies' analyses of the economic impacts of the draft regulations. Six
of the seven rules that OIRA returned to agencies for reconsideration fell
into this category. Although OIRA sometimes suggested revisions in
existing estimates and calculations, OIRA more often suggested changes
that added or clarified information and analysis presented on a draft
rule's economic impacts. For example:

o 	EPA responded to OIRA comments and suggestions by revising cost-benefit
and cost-effectiveness estimates for a proposed rule regarding emissions
from spark-ignition marine vessels and highway motorcycles (ID 54). As a
result of the changes, the estimated annual costs to manufacturers were
reduced by $4 million and the estimated annual fuel savings to the public
were increased by $4.3 million.

o 	OIRA returned an FAA proposed rule on certification of pilots,
aircraft, and repairmen for the operation of light sport aircraft with a
request that the agency prepare additional revised analyses of the
potential impacts (ID 73). OIRA's comments focused on the analytical
baseline FAA had used and the regulatory alternatives presented. Among
other things, OIRA suggested that, as part of an improved analysis of
alternatives, FAA could consider means of improved compliance and
enforcement of regulations currently in place.

o 	At OIRA's suggestion, NHTSA inserted additional estimates of some costs
and benefits of regulatory alternatives (e.g., adding estimates of the
total estimated costs of the proposed alternatives, where the original
draft only provided estimates of average cost per vehicle), added
additional information about the potential range of injuries and deaths

 Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review Varied

prevented and other benefits that might be realized with different
regulatory alternatives, and identified unquantified benefits and costs
that might be associated with its proposed rule on tire pressure
monitoring systems (ID 36).

    A Focus on Costs, Cost-Effectiveness, and Net Benefits

In general, the focus of OIRA's changes in most of these cases appeared to
be on reducing costs and regulatory burdens, improving the
cost-effectiveness of the rules, or maximizing the rules' net benefits.
For example, OIRA returned six rules for reconsideration because of
concerns that the agencies' analyses had not adequately captured all
economic effects of the rules or presented regulatory options that OIRA
did not believe were cost-effective. In the changed rules, reducing costs
or improving cost-effectiveness was sometimes accomplished by suggesting
additional, more flexible regulatory options, but it was not always clear
whether reductions in costs would necessarily be accompanied by increases
in net benefits to society. For example, in response to an OIRA
suggestion, EPA eliminated a regulatory provision requiring a minimum net
reduction if steel facilities used a voluntary pollutant trading mechanism
called a "water bubble (ID 71)." EPA's original draft rule noted that the
mechanism had been structured in a way to produce an additional benefit
because the amount of the pollutant discharges pursuant to the bubble had
to be 10-percent to 15-percent less than the discharges otherwise
authorized by the rule without the bubble. However, eliminating this
minimum net reduction requirement might encourage more regulated entities
to use this voluntary mechanism to comply with the standards of the rule
at lower cost. The potential change in net benefits to society is
therefore not clear.

Although attention to the cost side of economic effects was most prevalent
in OIRA's comments and suggestions, in at least four cases OIRA also
suggested specific changes in agencies' estimated benefits of their rules.
OIRA suggested several changes regarding the benefits estimates of NHTSA's
proposed tire pressure monitoring system rule, in particular inserting
additional information about benefit estimates, such as the range of
injuries and deaths prevented, stopping distance effects, and average tire
life increases (ID 36). OIRA also suggested adding a discussion on the
effect of human factors on the benefits of tire pressure monitoring
systems. When OIRA returned NHTSA's draft final rule on tire pressure
monitoring systems, the office stated that the technical foundation for
NHTSA's estimates of safety benefits needed to be better explained and
subjected to sensitivity analysis (ID 78). OIRA also questioned some of
EPA's estimates

Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review
Varied

of the environmental impacts associated with a proposed rule on emissions
from nonroad large spark-ignition engines and recreational engines (ID
41). In an indemnity program to address chronic wasting disease (CWD) in
cervids (antler-bearing animals, such as elk and deer), OIRA asked APHIS
to avoid citing as a benefit the avoidance of disease in humans caused by
CWD because this possibility was considered remote by a Harvard risk
analysis (ID 9).

There were also cases in which OIRA did not directly affect the expected
costs or benefits of a rule but nevertheless suggested changes to an
agency's discussion of the rule's costs and benefits. In 19 such rules
that were changed after submission, OIRA suggested clarification or
revision of the information presented in the rule about estimated costs
and benefits or how they were calculated, solicited comments on a
regulatory agency's cost-benefit estimates, or requested comments on ways
to make a regulation more cost-effective or less costly and burdensome.
(At least 2 of the 22 rules that we identified as having costs and/or
benefits directly affected by OIRA's actions also had such clarifications
or requests for comments inserted at OIRA's suggestion.)

Again, many of OIRA's comments and suggested changes were focused on the
costs of the proposed regulatory actions, although in these cases OIRA's
suggestions most often helped to clarify the potential costs of regulatory
alternatives or how an agency had estimated those costs. In at least seven
rules, OIRA specifically suggested that agencies solicit public comments
and data on the potential costs and burdens of proposed regulations or
suggestions for alternative regulatory options that would be more
cost-effective or less burdensome. By focusing attention and soliciting
comments on cost and burden issues, particularly at the proposed rule
stage, these revisions to preamble language might prompt changes in the
costs and benefits of the rules in future iterations of the rules.

Appendix II includes more detailed information on the extent to which
OIRA's regulatory reviews had an effect on the potential costs and
benefits of individual rules within the scope of our report.

 Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review Varied

  Outside Parties Contacted OIRA Regarding about Half of the Rules OIRA
  Significantly Affected

Another part of this objective was to determine whether there was any
evidence that the actions that OIRA took (e.g., to suggest significant
changes to rules or to return them to the agencies for reconsideration)
were traceable to suggestions offered by regulated entities or other
parties outside of the federal government. It is not possible to
independently determine what motivated OIRA's actions with regard to any
of the rules that it reviewed. However, we did identify a number of
instances in which outside parties directly contacted OIRA regarding rules
that OIRA later significantly affected. Those direct contacts took the
form of either a meeting with OIRA representatives or a letter sent to
OIRA before or during the period of OIRA's review.13 We also identified
similarities between the actions that OIRA suggested or recommended to the
agencies and those advocated to OIRA by outside parties through those
direct contacts.

Outside parties directly contacted OIRA regarding 11 of the 25 rules that
OIRA significantly affected-8 of the rules that were significantly changed
as a result of OIRA's suggestions or recommendations, 2 of the rules that
OIRA returned to the agencies for reconsideration, and the 1 withdrawal
that was made at OIRA's request. As figure 10 shows, 8 of these 11 rules
were from EPA, FAA submitted 2 of the rules, and 1 was a NHTSA
submission.14 In all 11 cases, representatives of regulated entities were
involved in those contacts with OIRA. In 3 of the 11 cases, environmental
and other public interest groups also contacted OIRA about the rules.

13In some OIRA files, we found evidence that OIRA had reviewed copies of
substantive comments on previous versions of the draft rule currently
under review. Because these were public docket materials previously
submitted to the regulatory agencies, not OIRA, we did not consider them
as evidence of direct contact with OIRA by external parties. Also, there
was evidence that external parties contacted OIRA after the formal review
period regarding two other substantively changed submissions, but such
postreview contacts could not have affected the outcome of OIRA's reviews
in those cases.

14The two FAA submissions were actually the same Part 145 repair station
regulation. One of the submissions resulted in a withdrawal and one
resulted in a return (IDs 84 and 72, respectively).

Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review
Varied

Figure 10: Outside Parties Most Often Contacted OIRA Regarding EPA Rules

No contact by outside parties

Contact on EPA rule

Contact on FAA rule

Contact on NHTSA rule

Source: GAO.

In 7 of the 11 cases where there was direct contact with OIRA by outside
parties, at least some of the actions that OIRA recommended or took
appeared to be similar to those suggested to OIRA by regulated parties.
(OIRA did not recommend changes that were similar to all of the changes
suggested by the regulated entities.) Environmental or other public
interest groups had also directly contacted OIRA in 3 of these 7 cases,
but OIRA's actions did not appear to be similar to the suggestions offered
by those groups. Examples of the 7 cases include the following:

o 	As a result of its review of an EPA Office of Water rule on cooling
water intake structures at existing power-generating facilities, OIRA
suggested changes that lowered the draft performance standard and added
compliance flexibility to the rule by allowing, among other things,
options for a site-specific approach to minimizing environmental harm (ID
68). Some of OIRA's suggested revisions of the regulatory language were
similar to those proposed by representatives of the electric industry-in
particular, the site-specific approach-during their contacts with OIRA
regarding this rule. (The representatives of the electric industry also
proposed other changes to this rule that OIRA did not recommend to EPA.)
Representatives of an environmental interest group also contacted OIRA
regarding this rule, advocating that EPA's regulations be based on
nationally uniform standards and not on case-by-case, site-specific
determinations.

Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review
Varied

o 	During its review of an EPA final rule on identification and listing of
hazardous waste, industry representatives from steel manufacturers and a
chemical company sent letters and met with OIRA opposing the listing of
manganese as a hazardous waste constituent due to concerns about the costs
that the rule would impose on certain facilities (ID 56). Industry
representatives had raised similar points in the public comments they
submitted during the proposed rule stage of this rulemaking, but EPA was
not persuaded to revise its draft of the final rule after considering
those comments. The main focus of OIRA's extensive changes in this rule
was the deferral of final action on all parts of the draft rule that would
have identified manganese as a hazardous contaminant, as in the original
proposed rule and EPA's draft final rule.

o 	In a draft final rule on tire pressure monitoring systems, NHTSA
included provisions that would eventually have mandated use of direct
sensing technologies, rather than indirect technologies, for such systems
(ID 78).15 Representatives of automobile manufacturers contacted OIRA to
raise concerns that "the structure of the final rule will have the effect
of eliminating indirect tire pressure monitoring systems as a compliance
option." They also argued that there was no evidence that safety benefits
would be noticeably different between systems using indirect and direct
sensing technologies. OIRA returned this rule to NHTSA for
reconsideration, citing as its reason that the agency's analysis did not
adequately demonstrate that NHTSA had selected the best available option
and raising concerns regarding NHTSA's analysis of the safety impacts of
regulatory alternatives. OIRA subsequently completed a review (consistent
with no change) of NHTSA's resubmitted version of the rule (with a revised
analysis of safety issues, costs, and benefits of direct and indirect
system alternatives) that allowed either type of sensing technology
through a phase-in period and deferred until 2005 a decision on which
performance standards would be effective after 2006.

However, it is impossible to determine the extent to which the suggestions
made by the regulated parties might have influenced OIRA's actions, if at
all. OIRA might have independently reached the same conclusions or had

15Direct tire pressure monitoring systems have a tire pressure sensor in
each tire that transmits pressure information to a receiver. Indirect
systems do not have tire pressure sensors. Current indirect systems rely
on the wheel speed sensors in an anti-lock braking system to detect and
compare differences in the rotational speed of a vehicle's wheels, which
can correlate to differences in tire pressure.

Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review
Varied

the same concerns even if the regulated entities had not contacted OIRA.
An OMB representative told us that in many of these meetings outside
parties have raised issues that had already been expressed in public
comments, meetings between the outside parties and the regulatory
agencies, trade papers, news articles, and other venues-all of which might
have been reviewed by OIRA.

On the other hand, in 4 of the 11 cases in which regulated parties
directly contacted OIRA, OIRA's actions or suggestions to the agencies did
not appear to be similar to the actions or suggestions that the regulated
parties advocated. Examples of these cases include the following:

o 	Representatives of the steel industry contacted OIRA regarding an EPA
final rule on effluent limitations guidelines, pretreatment standards, and
new source performance standards for the iron and steel manufacturing
point source category (ID 71). In the letter requesting a meeting with the
OIRA Administrator, the steel industry representatives asserted that EPA's
revised effluent limitation guidelines were not technically, economically,
or legally justified, and also raised concerns about specific aspects of
EPA's benefit-cost analysis. The only substantive change that OIRA
suggested in this rule, however, was to eliminate a preexisting "minimum
net reduction" provision in regulations that applied if facilities used a
"water bubble" alternative mechanism for trading pollutants.

o 	Similarly, representatives from a number of regulated parties requested
that OIRA return FAA's draft final rule on part 145 repair stations to the
agency with instructions to prepare a supplemental notice of proposed
rulemaking and essentially restart most of the rulemaking process (IDs 84
and 72). However, OIRA's actions to have the agency withdraw the rule and,
later, to return the rule to the agency for reconsideration cited issues
unrelated to those voiced by the regulated entities. When FAA resubmitted
the same draft rule a third time, OIRA completed its review of the rule
with an outcome of "consistent with no change." An industry representative
that we interviewed said that the industry groups ultimately did not get
the changes in the rule that they wanted from OIRA.

Appendix III contains case studies that provide more detailed information
about each of the rules for which we found evidence that outside parties
had contacted OIRA.

 Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review Varied

OIRA Generally Disclosed Outside Contacts

As noted in chapter 2 of this report, Executive Order 12866 requires OIRA
to maintain a publicly available log containing the dates and names of
those involved in substantive oral communications (e.g., telephone calls
or meetings) between OIRA personnel and outside parties and the subject
matter discussed. We used the OIRA list of substantive outside
communications to help us identify the information presented above and
examined other material to identify those contacts, including agencies'
rulemaking dockets.

Overall, we identified only two meetings that OIRA had with outside
parties and two letters to OIRA from outside parties regarding the rules
in our review that OIRA had not disclosed at the time of our review:

o 	The OIRA docket contained a letter indicating that OIRA had met in
October 2001 with representatives from the iron and steel industry in
relation to an EPA draft rule that would have added manganese to a list of
hazardous waste constituents (ID 56). However, when we examined OIRA's
meeting log in early 2003 there was no record of this meeting. (OIRA
subsequently added this meeting to its on-line meeting log.)

o 	A July 2001 letter sent to OIRA in relation to the FAA part 145 rule
was included as part of a regulated entity's testimony before a
congressional committee (IDs 84 and 72). However, OIRA's docket did not
contain a copy of this correspondence at the time of our review. (OIRA
subsequently added this letter to its docket.)

o 	EPA's docket included a February 2002 letter from the Center for Energy
and Economic Development to the OIRA Administrator regarding revisions to
a regional haze rule (ID 48).16 However, we did not find a copy of this
letter in OIRA's docket. EPA's docket for this rule also included a copy
of an e-mail message from OIRA to EPA noting that a meeting at OMB had
been scheduled at the Center's request for February 5, 2002. However, we
did not find documentation for this meeting during our review of OIRA's
dockets and logs. (OIRA's docket did contain a copy of a letter from
another outside party regarding this rule.)

16The Center for Energy and Economic Development is a nonprofit
organization formed by coal-producing companies, railroads, a number of
electric utilities, and related organizations.

 Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review Varied

However, we have no way of knowing whether there were other meetings with
outside parties or other letters from those parties about rules in our
review that did not come to our attention. Our knowledge of such meetings
or correspondence is generally limited to what OIRA or the agencies
disclose in their files. OIRA representatives told us that some of the
letters mailed to OIRA after the events of September 11, 2001, and the
anthrax letters in October 2001 may not have been delivered, and said they
were committed to disclosing all outside contacts regarding rules under
review.

Documentation of Agencies varied in the extent to which they satisfied the
documentation

requirements in Executive Order 12866, but most of the agencies
satisfiedOIRA's Reviews Varied, those requirements for most of their
rules. However, having materials inbut Some Agencies' the agencies'
rulemaking dockets does not necessarily mean that OIRA's Practices
Improved effects on the rules were fully transparent. The executive order
also

requires OIRA to disclose certain information about its review process,
andTransparency we concluded that OIRA generally satisfied those
requirements regarding the rules that we reviewed.

    Agencies Varied in Extent to Which Documentation Requirements Were Satisfied

One of the stated purposes of Executive Order 12866 is to make the federal
rulemaking process more accessible and open to the public. Toward that
end, the executive order places certain public disclosure and
documentation requirements on regulatory agencies or OIRA. However, some
types of actions are not covered by these requirements and, therefore, do
not have to be disclosed or documented by either party. Also, in some
cases the executive order does not clearly indicate what must be disclosed
or documented.

In general, the applicability and nature of the disclosure and
documentation requirements in the executive order depends on the outcome
of OIRA's review. If an agency withdraws a rule from OIRA's review,
neither the agency nor OIRA are required to disclose the reason. However,
if OIRA returns a rule to an agency for reconsideration, section 6(b)(3)
of the executive order requires the OIRA Administrator to provide the
issuing agency with a written explanation delineating the pertinent
section of the order on which OIRA is relying. For rules that OIRA reviews
and are subsequently published in the Federal Register, the executive
order requires agencies to make the rule and any cost or benefit
information prepared available to the public. Two other sections of the
order establish

Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review
Varied

specific documentation requirements regarding changes made to rules
submitted to OIRA for review:

o 	Section 6(a)(3)(E)(ii) of the order states that agencies must "identify
for the public, in a complete, clear, and simple manner, the substantive
changes between the draft submitted to OIRA for review and the action
subsequently announced." However, neither the executive order nor OIRA's
October 1993 guidance on its implementation defines what the term
"substantive changes" means.

o 	Section 6(a)(3)(E)(iii) of the order requires agencies to "identify for
the public those changes in the regulatory action that were made at the
suggestion or recommendation of OIRA."

OIRA's October 1993 guidance on the implementation of the order considers
the second requirement to be a subset of the first. Therefore, under this
interpretation, the agencies are only required to identify the changes
made at OIRA's suggestion or recommendation after formal submission of the
rule to OIRA-not during any informal review period that precedes formal
submission. OIRA also took this position in response to recommendations in
our 1998 report on the implementation of these transparency requirements
and during this review. This distinction is important because, in some of
the 25 rules that we concluded had been significantly changed at OIRA's
suggestion or recommendation, OIRA suggested significant changes prior to
formal submission of the rule to OIRA. Also, some of the rules that were
reviewed informally for weeks or months had very short formal review
periods-in some cases as little as a few days.

To determine agencies' compliance with these documentation requirements,
we considered the required information to have been "identified for the
public" if it was available in the agencies' public docket for the
relevant rule. We coded the level of documentation in the agencies'
dockets for each changed rule into one of four categories, reflecting
whether (1) all changes were clearly documented, (2) changes were
identified but it was not clear that all changes had been documented or at
whose initiative, (3) no changes were documented in the agencies' public
rulemaking docket, or (4) the Executive Order 12866 documentation
requirements were not applicable.17 The first requirement is not
applicable when there were no changes made to the rule during OIRA's
review that the agencies considered "substantive." Even if there were
substantive changes made during OIRA's review, the second requirement is
not applicable if

Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review
Varied

those changes were not made at the suggestion or recommendation of OIRA.
We made our determinations regarding agencies' compliance with these
requirements solely on the basis of the information that would be
available to a member of the public if he/she had reviewed the docket for
a given rule.18 Furthermore, because the executive order places
responsibility to document changes on the agencies rather than OIRA, our
determinations only reflect material available in the regulatory agencies'
dockets, not materials in OIRA's public files.19 Table 5 presents the
results of our analysis of agencies' compliance with both documentation
requirements in the executive order.

17We conducted a similar exercise in our previous GAO report on this
subject. See GAO/GGD-98-31.

18In many cases, the agencies prepared supplementary memoranda or
summaries for us that provided additional information and explanations
regarding the changes made in various rules. In those cases, we used the
supplementary information to address other elements of our review-such as
the nature of changes attributed to OIRA-but did not consider the
materials specifically prepared for our review to be public documents
within the dockets.

19It is notable that these dockets sometimes contained information that
the agencies were not required to disclose under OIRA's interpretation of
the executive order-and that information frequently provided valuable
insights to our determinations regarding the nature of OIRA's changes. For
example, the agencies sometimes disclosed changes that were not
"substantive," and sometimes disclosed changes that OIRA made to rules
before they were formally submitted to OIRA.

 Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review Varied

Table 5: Agencies' Compliance with Executive Order 12866 Documentation
Requirements Was Mixed

                                                                        Total 
                                                                    number of 
                                            Changes made at OIRA's            
                                                suggestion or         changed
      Agency     Changes made during OIRA       recommendation          rules 
                       review period                                
                         Not clear                Not clear         
                      All that all No          All that all No      
                  changes changes changes  changes changes changes  
                          clearly had been         clearly had been 
                            identified Not           identified Not 
                 identified identified in  identified identified in 
                 docket applicable         docket applicable        
       APHIS                       1 8 0 3                  4 5 0 3 
        FDA                        7 0 0 0                  6 0 0 1 
       OSHA                        0 0 4 1                  0 0 2 3 
      DOT/FAA                      0 0 2 3                  0 0 2 3 
     DOT/FMSCA                     4 0 0 2                  2 0 0 4 
     DOT/NHTSA                     0 1 0 4                  1 0 0 4 
EPA Office of                   1 9 1 3                  2 7 1 4 
      Air and                                                       
     Radiation                                                      

     EPA Office of      2      3      0      4      5      0      0      4    
      Solid Waste                                                      
          and                                                          
       Emergency                                                       
        Response                                                       

EPA Office of 800 0800 0 Water

Total 2321 7202812 526

Source: GAO analysis.

For the rules where the requirements were applicable, the results were
mixed. As discussed in more detail later in this report, some agencies
(FDA, FMCSA, and EPA's Office of Water) provided clear documentation in
their rulemaking dockets of all of the changes made to their rules during
OIRA's review and at OIRA's suggestion or recommendation. In contrast,
other agencies (FAA and OSHA) did not have any documentation of the
changes made in their dockets. FAA officials told us that their agency had
not been documenting changes made during OIRA's review, but would do so in
the future and put the documentation in the agency's rulemaking docket.20
OSHA officials said the documentation was available from the Office of the
Solicitor, and said that if a member of the public wanted information on
changes made during OIRA's review it would be provided upon specific
request. (OSHA officials said that they keep the information

 Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review Varied

in the Office of the Solicitor in order to ensure that the OIRA-directed
change documentation is not part of the official rulemaking record if a
lawsuit is filed.) However, because there is nothing in the OSHA
rulemaking docket to identify that documentation of OIRA changes exists or
is available, a member of the public interested in finding this
information would have to know to specifically request the relevant
documentation from the Office of the Solicitor.

For the remaining agencies (APHIS, NHTSA, and EPA's Offices of Air and
Radiation and Solid Waste and Emergency Response), it was unclear that the
documentation available in the dockets covered all of the relevant changes
to their rules. For example, these agencies sometimes included in their
dockets copies of e-mails between OIRA and the agencies discussing changes
that had been made to the draft rule. However, we could not tell whether
these e-mails represented all or only some of the changes that had been
made. In other cases, agencies documented changes made, but it was not
clear if any of the changes had been at the suggestion or recommendation
of OIRA. Agency officials later told us that, in these cases, the
documentation that we found represented all of the changes that had been
made to the rules during OIRA's review or at OIRA's initiative. Therefore,
it may be that the lack of clarity regarding these agencies' adherence to
the documentation requirements in the executive order reflected unclear or
inadequate labeling and attribution of the sources of changes, rather than
the absence of documentation.

    Agencies Varied in How Changes to Draft Rules Were Documented

Executive Order 12866 does not specify how agencies should document the
changes made to draft rules after their submission to OIRA, nor is there
any governmentwide guidance that directs agencies how to do so. OIRA
representatives told us that it is up to each agency to decide how its
rulemaking dockets are kept and how they satisfy the executive order's
requirements. Not surprisingly, therefore, the regulatory agencies in our
review had different methods of documenting changes to the rules that OIRA
reviewed under Executive Order 12866. In the cases of DOT and EPA, which
each had three agencies or program offices in our review, the
documentation practices also varied across their agencies and offices.

20As table 5 shows, the executive order's documentation requirements were
not applicable in three of the five FAA changed rules we reviewed because
only minor (nonsubstantive) changes had been made to those rules.

 Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review Varied

How Changes Were Identified	For example, there were clear differences
among the agencies in how they "identified for the public" the changes
made to draft rules after their submission to OIRA and at the suggestion
or recommendation of OIRA.

o 	The most common method was the inclusion in the public rulemaking
docket of a marked-up copy of the rule (or selected pages thereof) as
submitted to OIRA or after the review was completed showing the changes
made during the review process. In some cases these marked-up copies were
done by hand, but in other cases a "redline/strikeout" version was
prepared electronically, printed, and placed in the public docket.
Agencies with this type of documentation included FMCSA, NHTSA, and EPA's
Office of Solid Waste and Emergency Response. In addition to a marked-up
version of its rules, FDA also included a standard cover form that
identified the information placed in the dockets to address each part of
the executive order's documentation requirements.

o 	Some agencies' documentation included the above marked-up versions of
the rules and/or copies of e-mail messages of faxes between OIRA and the
regulatory agencies reflecting the changes that were being made to the
rules. Agencies with this type of documentation included EPA's Office of
Air and Radiation and APHIS.

o 	For all but one of the dockets prepared by EPA's Office of Water, the
office included a detailed memorandum addressing each of the executive
order's documentation requirements, summarizing the development and review
of the rule and identifying all substantive changes made and those made at
the suggestion of OIRA.21

How Sources of Changes Were The regulatory agencies also differed in how
they identified the source of

Identified	the changes (e.g., whether the changes had been made at the
suggestion of OIRA or at the agency's initiative). Most commonly, the
agencies noted the source of the changes in the margins of their marked-up
versions of at least some of the rules (e.g., APHIS, FDA, and FMCSA). In
those cases where e-mails or faxes were used for documentation, the
sources of the changes were usually apparent from those documents (e.g.,
EPA's Office of Air and

21 The other Office of Water docket included an annotated
"redline/strikeout" version of the revised rule. The Corps of Engineers
prepared the docket for one rule jointly issued by the Corps and EPA's
Office of Water and similarly included an annotated "redline/strikeout"
version of the revised rule.

 Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review Varied

Radiation). If the agency prepared a summary memorandum (e.g., EPA's
Office of Water), the sources were usually identified in that memorandum.
However, in some cases the agencies did not clearly indicate which of the
changes that they identified were from OIRA and which were from the
agencies.

Other Differences in Other areas in which the agencies' documentation
practices differed Documentation included the following:

o 	Officials in some of the agencies (e.g., APHIS, FDA, and NHTSA)
indicated that the only changes to their rules that they considered
"substantive" were those that affected the impact or text of the rule as
it appeared in the Code of Federal Regulations (although the executive
order does not specify that only changes to regulatory text are
substantive). However, in practice most of these agencies documented both
regulatory text changes and other changes to the preambles of their rules
(particularly those that we previously identified as "other material
changes" in which OIRA suggested that the agency clarify or solicit
comments on a particular issue). Other agencies documented all changes to
their rules, even those that were editorial or otherwise minor in nature.

o 	Some agencies documented changes made to their rules by OIRA prior to
formal submission (e.g., EPA Office of Air and Radiation), while others
did not.

o 	Some of the agencies documented when there had been no substantive
changes made to their rules (e.g., EPA Office of Air and Radiation), while
others did not (e.g., FAA and NHTSA).

    Some Agencies Demonstrated "Best Practices"

Overall, we often found it difficult to identify the changes that had been
made to agencies' rules during OIRA's review and/or at the suggestion or
recommendation of OIRA by reviewing material in the agencies' rulemaking
dockets. As noted previously, one agency (FAA) had done nothing at the
time of our review to document these changes, and another agency (OSHA)
placed its documentation in the Office of the Solicitor, not the agency's
rulemaking docket. (Therefore, a member of the public would have to know
to ask for the materials from that office.) Other agencies did not
document any changes if the changes were not, in their opinion,
"substantive." In another case the agency simply provided a copy of the
rule as submitted to OIRA and a copy of the rule as published in the
Federal

Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review
Varied

Register, with no indication of what had changed in the text. In still
other cases, the changes were indicated in a "redline/strikeout" version
of the rule, but the photocopied redline version was so indistinct that it
was difficult to identify or attribute all of the changes. The agencies
appeared to do a better job of documenting the changes that had been
initiated by OIRA than in clearly identifying whether other substantive
changes had been made to the rules by the agencies or other parties after
submission to OIRA. For several of the rules, the agencies added material
to the public dockets shortly before we arrived or after we told the
agencies we could not find documentation for certain rules that had been
changed. For example, FMCSA added documentation of changes made to a rule
that OIRA had finished reviewing in May 2002 after we asked about the rule
during a meeting with FMCSA officials in February 2003. Executive Order
12866 does not specify when agencies must "identify for the public" the
changes made during OIRA's review.

In marked contrast, the documentation practices used by some of the
agencies and offices in our review-FDA, FMCSA and EPA's Office of
Water-represented what we consider to be "best practices" that not only
met the minimal requirements of the Executive Order 12866 but also made
clear how the rules had changed during OIRA's review and which changes
were made at OIRA's suggestion.

o 	EPA's Office of Water usually did this through detailed memoranda
prepared for the docket specifically to address the executive order's
requirements. For example, in the Office of Water's rule on proposed
changes to meat and poultry effluent limitations guidelines and standards,
EPA included a detailed cover memorandum specifically addressing the
executive order's requirements (ID 67). The memorandum not only identified
all of the substantive changes made at OIRA's suggestion, it also
identified the substantive EPA changes made independent of other
reviewers. Also, the memorandum identified nonsubstantive changes that had
been suggested by OMB and others (e.g., SBA and the Department of
Agriculture). Copies of relevant documents were attached to the memorandum
as well as copies of suggested changes that were sent to the agency by the
OIRA desk officer.

o 	FMCSA often provided a "redline/strikeout" version of the revised rule
after OIRA's review, clearly annotating the changes that had been made to
the rule between submission of the manuscript to OIRA and its publication,
as well as the source of each change. For example, in

Chapter 3 OIRA's Effects on Rules Submitted for Executive Order Review
Varied

several places in the agency's interim final rule regarding a safety
monitoring system and compliance initiative for Mexico-domiciled motor
carriers operating in the United States, FMCSA identified changes that had
been made at the request of OIRA, at the request of the Office of the
Federal Register, or at FMCSA's initiative after the submission of a
previous version of the rule to OIRA (ID 32).

o 	FDA used a standard one-page cover form with attached copies of the
rule in which the agency had marked the changes made to the rule and
annotated the sources of those changes. The FDA form, as well as some
similar forms we found in EPA's dockets, had the additional benefit of
allowing agency officials to affirmatively indicate whether there were
substantive changes made to a rule during OIRA's review and, separately,
whether there were changes made at the suggestion or recommendation of
OIRA. For example, in the agency's draft final rule on food additives, FDA
included the cover memorandum and a copy of the rule as submitted to OIRA
with hand-written annotations of FDA and OIRA changes (ID 17). In
addition, FDA included a copy of its responses to detailed OMB questions
about the final rule.

Chapter 4

Many Rules Nominated for Reform Are Being Changed

Our third objective was to describe how OIRA determined that certain
existing rules merited high priority review. With regard to OIRA's 2001
review effort, our specific objectives were to determine (a) which
organizations or persons suggested that the rules be reviewed, (b) what
process OIRA used to select and prioritize the nominations, (c) the extent
to which OIRA publicly disclosed its selection and priority-setting
process, and (d) the current status of those rules. We also compared that
review effort to a second review that OIRA initiated in 2002.

In summary, OIRA received 71 nominations from the public in response to
its May 2001 request for suggestions of rules that should be modified or
rescinded. Of these, 44 nominations were from the Mercatus Center at
George Mason University. OIRA selected 23 of the 71 nominations for high
priority review-14 of which were originally nominated by the Mercatus
Center. The only other organizations that nominated more than one of the
suggestions that OIRA so designated were the Equal Employment Advisory
Council and the Employment Policy Foundation (two suggestions each).
Representatives of OIRA told us that the office's desk officers initially
determined which issues merited high priority review, subject to the
approval by OIRA management. Although OIRA fully disclosed the source of
each of the nominations that it received and defined the priority
categories that it used, the office did not publicly describe how it
decided which nominations merited high priority review. As of May 2003,
regulatory agencies or OIRA have at least begun to address the issues
raised in many of the suggestions. In March 2002 OIRA again solicited
public comments on regulations in need of reform, and in response received
more than 300 suggestions. However, this time OIRA forwarded the
suggestions to the relevant federal agencies for review and
prioritization. In general, OIRA explained the process used for this
second round of nominations more clearly and completely than was done for
the first round.

Mercatus Center Section 628(a)(3) of the fiscal year 2000 Treasury and
General Government

Appropriations Act required OMB to submit "recommendations for
reform"Nominated Most Rules with its report on the costs and benefits of
federal regulations. In the Selected for portion of its May 2001 draft
report responding to this requirement, OIRA High Priority Review in said
it did not have enough information to make recommendations for the

reform of specific regulations or regulatory programs, and asked for2001
Report recommendations and comments on rules and regulatory programs that
could be "of concern to the public." Specifically, OIRA said the
following:

Chapter 4
Many Rules Nominated for Reform Are Being
Changed

"We would like to receive suggestions on specific regulations that could
be rescinded or changed that would increase net benefits to the public by
either reducing costs and/or increasing benefits. We would appreciate if
commenters identified regulations that are obsolete or outmoded, and could
be rescinded or updated."

OIRA asked that commenters provide their suggestions in a particular
format (e.g., name of regulation, agency regulating, citation, and
description of problem) and invited commenters to suggest "any other
reforms to the regulatory development and oversight processes that would
improve regulatory outcomes."

In its December 2001 final report, OIRA said it received 71 suggestions in
response to its request from 33 commentators involving 17 agencies. In an
appendix to the report listing the suggestions, OIRA indicated that 44 of
them came from the Mercatus Center at George Mason University. The report
also indicated that OIRA had completed an initial review of the
suggestions and placed them into one of three categories: (1) "high
priority," meaning that OIRA was inclined to agree with and look into the
suggestion, (2) "medium priority," meaning that OIRA needed more
information about the suggestion, or (3) "low priority," meaning that OIRA
was not convinced that the suggestion had merit. OIRA listed 23 of the
suggestions in the first category, and said a "prompt letter" might be
sent to the responsible agency for its "deliberation and response." Eight
of the 23 high priority suggestions involved regulations from EPA, 5
suggestions involved regulations from the Department of Labor (DOL), and 2
each from the Departments of Health and Human Services (HHS), Agriculture
(USDA), and the Interior (DOI). Five of the 23 suggestions involved rules
that had been issued at the end of the Clinton administration and delayed
by a January 20, 2001, memorandum from Assistant to the President and
Chief of Staff Andrew H. Card, Jr. (Card memorandum) directing federal
agencies to, among other things, postpone the effective dates of certain
regulations for 60 days.1 As table 6 shows, 13 of the 23 recommendations
came from the Mercatus Center, and one was a joint recommendation from
Mercatus and the Association of Metropolitan Water Agencies.

1For a discussion of this memorandum and the rules delayed, see U.S.
General Accounting Office, Regulatory Review: Delay of Effective Dates of
Final Rules Subject to the Administration's January 20, 2001, Memorandum,
GAO/02-370R (Washington, D.C.: Feb. 15, 2002).

Chapter 4
Many Rules Nominated for Reform Are Being
Changed

Table 6: The Mercatus Center Suggested Most of the 23 "High-Priority
Review" Rules

Commenter Regulation at issue Agency issuing regulation

Mercatus Center	Central air conditioner and heat Department of Energy pump
energy conservation standards

Mercatus Center	Standards for privacy of individually HHS identifiable
health information

                Mercatus Center Food labeling: trans fatty  HHS/Food and Drug 
                                acids in                   
                                        nutrition labeling     Administration 
                Mercatus Center            Hardrock mining DOI/Bureau of Land 
                                                                   Management 

Mercatus Center	Snowmobile use in Rocky Mountain DOI/National Park Service
National Park

Mercatus Center Davis-Bacon Act "helpers" regulation 	DOL/ Employment
Standards Administration

Mercatus Center Hours of service of drivers 	DOT/Federal Motor Carrier
Safety Administration

Mercatus Center Total maximum daily loads EPA

Mercatus Center	Economic incentive program EPA guidance

Mercatus Center	New source review 90-day review EPA background paper

Mercatus Center	Concentrated animal feeding EPA operations effluent
guidelines

Mercatus Center/ Arsenic in drinking water EPA
Association of
Metropolitan Water
Agencies

Mercatus Center	Roadless area conservation (draft USDA/ Forest Service
environmental impact statement)

Mercatus Center Forest Service planning rules USDA/Forest Service

Notre Dame Title IV regulations under the Higher Department of Education
University Education Act

Equal Employment Office of Federal Contract DOL/OFCCP Advisory Council
Compliance Programs' (OFCCP)

equal opportunity survey

Equal Employment Uniform Guidelines on Employee Equal Employment Advisory
Council Selection Procedures Opportunity Commission

Employment Policy Procedures for certification of DOL/Employment and
Foundation (EPF) employment based immigration and Training Administration
guest worker applications

LPA, Inc.	Overtime compensation under the DOL/Wage and Hour Fair Labor
Standards Act Division

                                   Chapter 4
                   Many Rules Nominated for Reform Are Being
                                    Changed

(Continued From Previous Page)

Commenter Regulation at issue Agency issuing regulation

EPF/National Partnership for Women and Families Record keeping and
notification regulations under the Family and Medical Leave Act DOL/Wage
and Hour Division American Mixture and derived from rule under EPA

Chemistry Council	the Resource Conservation and Recovery Act

City of Austin	Drinking water regulations under the EPA Safe Drinking
Water Act

American Notification of substantial risk under EPA Petroleum Institute
the Toxic Substances Control Act

Source: OMB.

In its December 2002 report, OIRA noted that several commenters questioned
the 2001 comment process because the Mercatus Center provided a majority
of the recommendations for reform. OIRA said it believed that, if there
was a problem with that process, "it was not that the Mercatus Center was
too active but that other potential commenters were silent." An OIRA
representative told us during this review that the Mercatus Center had
systematically tried to analyze and comment on a wide range of rules, and
it simply submitted the analyses that it had done. A Mercatus Center
official told us that the center had submitted nominations regarding all
of the rules on which it had commented since 1997.2

  How High Priority Review Selections Were Made

Although OIRA identified the source and ranking of each of the suggestions
that it received, the office did not fully explain in its report to
Congress how it decided that 23 of the suggestions merited high priority
review. During our review, OIRA representatives told us that those
determinations were made through a very informal, "bottom-up" process,
with OIRA staff initially looking at the nominations with which they were
most familiar and making some preliminary decisions that were then
reviewed by the branch chiefs and others. They said the OIRA Administrator
made the final decision regarding which rules should be in the high
priority category.

2She said that the Mercatus Center actually submitted a total of 58
suggestions for reform. However, several of the suggestions were about the
same rule, so OIRA's report only listed the 44 comments that were about
different rules.

                                   Chapter 4
                   Many Rules Nominated for Reform Are Being
                                    Changed

In its December 2002 final report, OIRA noted that 8 of the 23
high-priority nominations listed in the December 2001 report addressed EPA
rules, and another 5 addressed rules that could be considered
environmental in nature. However, OIRA said "an examination of OIRA's
decision-making process reveals no implicit or explicit intent to target
environmental rules for scrutiny. In fact, the distribution of nominated
rules by agency reflects the concerns raised by public comments, not the
interests of OIRA." OIRA noted that only 13 of 33 environmental rules that
were nominated were rated as a high priority for review and said some of
these 13 rules had already been established as an administration priority
for review.

  Status of Rules Selected for High Priority Review

As of May 2003, the status of the rules that were the subject of the 23
high-priority suggestions varied. OIRA said in its December 2002 final
report that, in some cases, the agencies had "convinced us that reform is
unnecessary or not appropriate at this time." For example, OIRA noted that
EPA had decided not to modify its rule on arsenic in drinking water, and
DOL had decided that changes in the Davis-Bacon regulations were not
appropriate at that time. However, as the following examples illustrate,
in many cases the responsible agencies took action on the suggestions or
were in the process of taking action:

o 	One of the nominations focused on a Department of Energy rule issued in
January 2001 that would have required that the energy efficiency of new
central air conditioners be increased by 30 percent. The commenter said
that the department did not adequately consider differences among
consumers and may have overstated projected energy savings. In May 2002,
DOE withdrew the rule and issued a new rule requiring a 20 percent
increase in energy efficiency. The new rule's effective date was August
2002.

o 	EPA's July 2000 final rule regarding allowable amounts of pollution in
water ("total maximum daily load") was also the subject of a suggested
change. Specifically, the commenter said the revisions to the program in
that rule were overly prescriptive and could prove costly to the states.
In October 2001, EPA published a notice delaying the effective date of the
rule until April 2003. In March 2003, EPA published a final rule
withdrawing the July 2000 rule. By May 2003, a draft of a new proposed
rule was undergoing informal interagency review.

o 	Another commenter questioned the assumptions underlying a May 2000
proposed rule that would alter the hours of service for motor carrier

                                   Chapter 4
                   Many Rules Nominated for Reform Are Being
                                    Changed

drivers (e.g., trucks and buses). In April 2003, FMCSA published the final
rule that changed the scope and the requirements from the proposal. For
example, the final rule exempts buses from its coverage. Most of the final
rule's provisions were scheduled to take effect in June 2003.

o 	One commenter expressed concerns about Department of Education
regulations under Title IV of the Higher Education Act, indicating that
the rules were redundant and placed "inappropriate administrative burdens
on institutions of higher learning." In November 2002, the department
published a final rule amending regulations under the Higher Education
Act, and said the amendments were designed to "reduce administrative
burden for program participants, and to provide them with greater
flexibility to serve students and borrowers." The rules were generally
scheduled to take effect in July 2003.

In these and many other cases, it is impossible to know whether the
changes that the agencies made and were making to rules were initiated or
affected by their designation as an item for high priority review.
However, OIRA representatives noted that some of the changes that agencies
were making to their rules began as a consequence of the administration's
Card memorandum review in January 2001-not their later designation as an
item for high priority review. Appendix IV provides information on the
status of each of the 23 high priority rules as of May 2003.

  Second Round of Nominations Was Different

Section 624 of the Treasury and General Government Appropriations Act of
2001, also known as the "Regulatory Right-to-Know Act," required OIRA to
include "recommendations for reform" in its cost-benefit report each year.
Therefore, in its March 2002 draft report, OIRA repeated its solicitation
of public comments on regulations or regulatory programs in need of
reform. However, OIRA's second effort to identify rules for further review
differed from its 2001 effort in the following respects.

o 	In the 2001 effort, OIRA asked the public to identify "regulations that
could be rescinded or changed that would increase net benefits to the
public by either reducing costs and/or increasing benefits." However, in
the 2002 effort OIRA asked the public to nominate reforms to specific
rules that would increase net benefits to the public, including not just
the elimination or modification of existing rules but also "extending or
expanding existing regulatory programs." OIRA also specifically

Chapter 4
Many Rules Nominated for Reform Are Being
Changed

requested comments on regulations affecting small businesses, and invited
comments on agencies' practices regarding guidance documents.

o 	Whereas OIRA received only 71 nominations in 2001, primarily from one
commentor, in the December 2002 report OIRA said it received comments on
267 regulations and 49 guidance documents from approximately 1,700
individuals, firms, trade organizations, and others. Many of the 23 items
that OIRA designated for high priority review during the 2001 process were
again nominated. Although most of the nominations sought modifications
that would increase regulatory flexibility or rescind rules, more than a
quarter of them suggested making rules more stringent or developing new
rules.

o 	In the first effort, OIRA reviewed the nominations and decided which
ones merited high priority review. In the second effort, OIRA indicated
that the agencies would be responsible for initially reviewing and
prioritizing the suggested items. OIRA said it did so because of the large
volume of nominations, and because the agencies could bring to bear "their
extensive knowledge and resources, which will provide a basis for
selecting reform priorities in consultation with OIRA."

o 	As noted previously, OIRA did not fully explain in its report to
Congress regarding the 2001 review how it decided which rules merited high
priority review. However, in the December 2002 report OIRA discussed in
some detail how it processed the nominations and suggested three criteria
that the agencies should use to conduct their evaluations: (1) efficiency
(reforms that can maximize net benefits, including improvements to the
economy, environment, and public health and safety), (2) fairness
(nominations with the potential for desirable distributive impacts and
process considerations), and (3) practicality (nominations that are more
important than others and that can be implemented under existing statutory
authority).

OIRA asked the Small Business Administration's Office of Advocacy to
review all of the nominations and identify those that it believes could
reduce unjustified regulatory burdens on small businesses. OIRA asked that
agencies complete their initial review of the nominations and discuss them
with OIRA by the end of February 2003. An OIRA representative told us that
the office met with the agencies that had the most nominated rules (i.e,
EPA, HHS, DOT, and DOL) in January and February 2003 and emphasized that
the final decisions on which suggestions to pursue would be up to the
agencies.

Chapter 5

                        Conclusions and Recommendations

Conclusions	OIRA has been reviewing agencies' draft rules for more than 20
years, and those reviews have become an established and important part of
the federal rulemaking process. While OIRA reviews clearly have an
analytical component (e.g., ensuring compliance with legal and procedural
requirements and conformance with principles of economic analysis), they
are also a way to ensure that the agencies' regulatory programs are
consistent with administration priorities (within applicable legislative
constraints). OIRA is part of the Executive Office of the President, and
the President is OIRA's chief client. Because it represents the President
and because it reviews hundreds of significant rules each year from dozens
of federal agencies, OIRA can have a major influence on the direction of a
wide range of public policies.

Our review documented OIRA's direct influence with regard to more than two
dozen rules in which it suggested significant changes that were ultimately
adopted by the rulemaking agencies. OIRA's presence in the rulemaking
process may also have a subtler, more indirect effect on agencies'
decision making-discouraging them from submitting rules that OIRA is
unlikely to find acceptable and encouraging them to make the case for the
regulations that they do submit more carefully. However, the OIRA
regulatory review process is not well understood or documented, and the
effect that OIRA's reviews have on individual rules is not always easy to
determine.

  Agency and OIRA Documentation Not Always Clear

Concerns about the effect that OIRA was having on agencies' rules led to
the adoption of transparency requirements in section 6 of Executive Order
12866. For nearly 10 years the executive order has required agencies to
identify for the public the substantive changes in regulatory actions that
were made between the drafts submitted to OIRA and the actions
subsequently announced, and to identify the changes made to the drafts at
the suggestion or recommendation of OIRA. Some of the agencies that we
focused on in our review (EPA's Office of Water, FDA, and FMCSA) had what
we considered to be "best practices" of documenting these changes,
although their methods of documentation varied considerably. However, in
other agencies the documentation of the changes made to their rules was
either unavailable or unclear, making it difficult for us to determine
what effect OIRA's review had on their rules. For example:

o 	Some agencies did not comply with the executive order's transparency
requirements at all (FAA) or did not put the required information in the

Chapter 5 Conclusions and Recommendations

agencies' public dockets (OSHA). In a few cases, the agencies did not put
the information in the dockets until months after the rules had been
published (i.e., not until we asked for the files as part of this review).
The agencies correctly noted that neither the executive order nor OIRA
guidance establishes a time limit by which the documentation had to be
provided.

o 	In many cases, it was unclear whether the documentation that the
agencies provided was complete (e.g., the agencies provided multiple
drafts, "change pages," and/or memoranda identifying alterations that had
been made to their rules, but there was no indication that the changes
identified represented all of the substantive changes made to the rules).

o 	In some cases, it was unclear which changes that the agencies
identified were suggested by OIRA and which were suggested by others
(e.g., the rulemaking agencies themselves).

o 	In other cases, it appeared that the agencies focused their efforts on
documenting changes that had been suggested by OIRA but did not clearly
document whether others had initiated substantive changes in the rules
during the OIRA review period.

o 	The agencies also differed in what they considered a "substantive"
change that required documentation. Some of the agencies identified all
changes made to their rules during OIRA's review, regardless how small.
However, other agencies said they only considered changes to the text of
the rule as it appears in the Code of Federal Regulations to be
"substantive." Our review indicated that some changes made to the
preambles of the agencies' rules (e.g., suggestions that agencies solicit
comments on particular issues) could affect their application, and
therefore appeared to us to be "substantive."

The executive order also places certain transparency requirements on OIRA.
For example, the order requires OIRA to disclose any substantive
communications it has with outside parties regarding rules under review,
and the status of all regulatory actions under review. After a regulatory
action that it reviewed has been issued, OIRA is required to disclose all
documents exchanged between OIRA and the agency during the review.
However, in some cases the documentation that OIRA provided regarding the
rules it reviewed did not clearly illustrate what occurred. For example,

Chapter 5 Conclusions and Recommendations

o 	OIRA's descriptions of its contacts with outside parties sometimes did
not clearly indicate what rule was being discussed or what organizations
those parties represented.

o 	OIRA's coding of some of the outcomes of its reviews made our review
more difficult. In particular, the "consistent with change" code included
any type of change made to a rule, regardless of its significance or
source. As a result, an agency's action to correct a legal citation or a
misspelling is coded the same as a significant change to the text of a
rule that was suggested by OIRA. Also, OIRA's use of an outcome code of
"deadline case" for some rules provided no information on whether the
reviews of such rules were completed with or without changes. The
usefulness of that outcome code is also questionable, given that OIRA's
database already has a separate field to identify rules with legal
deadlines.

o 	As interpreted by OIRA, the requirement that OIRA disclose documents
exchanged with the agencies only applies to documents exchanged by staff
at the branch chief level and above. Therefore, under this interpretation,
OIRA is not required to disclose any documents that are e-mailed or faxed
between OIRA desk officers and regulatory agency personnel-the level at
which such exchanges are most likely to occur. Nevertheless, during our
review we sometimes discovered staff-level e-mails and other documentation
in the agencies' or OIRA's dockets, and that information was very useful
in explaining what had happened to rules undergoing OIRA review. We have
no way of knowing how often other documents were exchanged at the staff
level and not disclosed.

There also appears to be a gap in the transparency requirements applicable
to OIRA regulatory reviews. If OIRA returns a rule to the rulemaking
agency for reconsideration, the executive order requires OIRA to explain
in writing why the rule was returned. If a rule is substantively changed
while under review at OIRA, the executive order requires the agency to
identify those changes for the public. However, neither the rulemaking
agencies nor OIRA are required to disclose why rules are withdrawn from
review. Our review indicated that withdrawals can be initiated by the
agencies, can be requested by OIRA, or can be a joint decision. If a rule
is withdrawn and not subsequently published, the agencies may not create a
docket into which any explanation for the withdrawal could be disclosed.
Therefore, in those instances, OIRA may be the most logical site for any
withdrawal disclosure-just as it is for returns. If the withdrawn rule is
subsequently

                   Chapter 5 Conclusions and Recommendations

published, the agencies could document the reasons for the withdrawals in
the rulemaking docket.

  Opportunity to Build on Improvements in Transparency

The current OIRA Administrator has made several notable improvements in
the transparency of the office's regulatory reviews. For example, by
placing information about the rules under review and OIRA's contacts with
outside parties on the office's Web site, the Administrator has made that
information much more accessible to the public than it had been
previously. Also, recognizing that outside parties were increasingly
contacting OIRA during the informal review periods that sometimes precede
formal submission, the Administrator changed the trigger for the
disclosure requirements applicable to OIRA's interactions with outside
parties from the start of the formal review period to the start of any
informal review period. As a result, OIRA now discloses substantive
communications (e.g., phone calls, meetings, and correspondence) with
outside parties involving specific rules that occur any time after OIRA
receives a draft rule from the agency or begins substantive discussions
with an agency about the provisions of a draft rule. Disclosing the
office's interactions with outside parties at this stage of the rulemaking
process can go a long way toward eliminating what the Administrator
referred to as "the culture of secrecy and mystery" that has surrounded
OIRA for more than 20 years.

However, another result of this change in policy is that the trigger for
the transparency requirements applicable to OIRA regarding its interaction
with outside parties (the start of informal review) is now inconsistent
with the trigger for the transparency requirements applicable to OIRA and
the agencies regarding their interactions with each other (the start of
formal review). We agree with the Administrator that it is useful and
important that the public know about OIRA contacts with outside parties
while rules are undergoing informal review. However, we also believe that
it is at least as important for the public to know whether substantive
changes were made to agencies' draft rules during this period, and in
particular, whether those changes were suggested by OIRA.

The transparency requirements in Executive Order 12866 were intended to
allow the public to understand what changes had been made to agencies'
rules during OIRA's review and at OIRA's suggestion. During our review we
discovered that formal OIRA review periods can be as short as 1 day, but
informal review periods can go on for weeks or even months in advance of
formal reviews. Therefore, restricting the transparency requirements in

Chapter 5 Conclusions and Recommendations

Executive Order 12866 only to a brief period of formal review seems
antithetical to the intent of those requirements. We also discovered that
agencies sometimes provided the public with documentation of changes
occurring during informal OIRA reviews-even though they were not required
to do so. In several cases that documentation helped us to identify
significant changes that had been suggested by OIRA and to better
understand how the published rule was developed. Based on that
documentation and other evidence that was available, we concluded that
OIRA's reviews appeared to have had a significant effect on 25 of the 85
rules that we examined. However, because neither OIRA nor the rulemaking
agencies are required to document the changes during informal review, we
do not know whether there were other "consistent with change" rules (or
even rules coded as "consistent with no change") that were significantly
altered at the suggestion of OIRA.

In several speeches during the past 2 years the OIRA Administrator has
emphasized the importance of transparency, describing the establishment of
a climate of openness at OIRA as his "first priority" and stating that
"more openness at OMB about regulatory review will enhance public
appreciation of the value and legitimacy of a centralized analytical
approach to regulatory policy." Also, on more than one occasion, OIRA has
said that it can have its most significant effect on agencies' draft rules
before they are formally submitted to OIRA for review. Therefore, it is
not clear why OIRA believes that the executive order's transparency
requirements should not cover the part of the review period when the most
important changes can occur. Real transparency about the effects of OIRA's
reviews would require either OIRA or the rulemaking agencies to disclose
the changes made to agencies' draft rules during informal review. Under
OIRA's current interpretation of the executive order's requirements, the
public might never know about some of the most significant changes that
are made to agencies' rules.

We recognize that there are limits to what should be disclosed regarding
OIRA's interactions with the rulemaking agencies. OIRA and the agencies
should be able to discuss regulatory matters in general without having to
document and disclose those communications. However, if the published
version of a rule reflects substantive changes that OIRA recommended to
the draft rule, even if those changes were recommended during informal
review, we believe that the agencies should document the changes so that
the public can understand how the rule was developed. We also recognize
that it may not always be clear when informal reviews begin (e.g., when
"substantive" discussions with agencies have begun regarding draft rules).

                   Chapter 5 Conclusions and Recommendations

However, OIRA must make that determination now regarding the disclosure of
its contacts with outside parties. Also, although OIRA representatives
indicated that postpublication disclosure of communications between OIRA
and the agency that occur prior to formal rule submission could have a
"chilling effect" on those communications in the future, that effect does
not appear to have taken place in those agencies that already disclose
those communications. Further, our interactions with the agencies and OIRA
during this review indicated that a requirement that substantive changes
be disclosed during any part of OIRA's review would not pose practical
difficulties for either party. Both OIRA and the agencies know what
substantive changes are made to agencies' rules during the review period
(whether formal or informal) and the source of those changes.

Although the current Administrator has substantively improved the ability
of the public to understand the OIRA regulatory review process, we believe
that there are several additional initiatives that OIRA can undertake to
further improve the transparency of the review process without sacrificing
the confidentiality of OIRA-agency consultations.

Recommendations We recommend that the Director of the Office of Management
and Budget:

o 	Define the transparency requirements applicable to the agencies and
OIRA in section 6 of Executive Order 12866 in such a way that they include
not only the formal review period but also the informal review period when
OIRA says it can have its most important impact on agencies' rules. Doing
so would make the trigger for the transparency requirements applicable to
OIRA's and the agencies' interaction consistent with the trigger for the
transparency requirements applicable to OIRA regarding its communications
with outside parties.

o 	Change OIRA's database to clearly differentiate within the "consistent
with change" outcome category which rules were substantively changed at
OIRA's suggestion or recommendation and which rules were changed in other
ways and for other reasons.

o 	Improve the implementation of the transparency requirements in the
executive order that are applicable to OIRA. Specifically, the
Administrator should take the following actions:

                   Chapter 5 Conclusions and Recommendations

o 	More clearly indicate in the OIRA meeting log which regulatory action
was discussed and the affiliations of the participants in those meetings.

o 	Because most of the documents that are exchanged while rules are under
review at OIRA are exchanged between agency staff and OIRA desk officers,
OIRA should reexamine its current policy that only documents exchanged by
OIRA branch chiefs and above need to be disclosed.

o 	Establish procedures whereby either OIRA or the agencies disclose the
reasons why rules are withdrawn from review.

o 	Improve the implementation of the transparency requirements in the
executive order that are applicable to agencies. Specifically, the
Administrator should:

o 	Define the types of "substantive" changes during the OIRA review
process that agencies should disclose as including not only changes made
to the regulatory text but also other, noneditorial changes that could
ultimately affect the rules' application (e.g., explanations supporting
the choice of one alternative over another and suggestions that agencies
solicit comments on the estimated benefits and costs of regulatory
options).

o 	Instruct agencies to put information about changes made to rules after
submission for OIRA's review and at OIRA's suggestion or recommendation in
the agencies' public rulemaking dockets, and to do so within a reasonable
period after the rules have been published.

o 	Encourage all agencies to use "best practice" methods of documentation
that clearly describe the changes made to agencies' rules (e.g., like
those practices used by FDA, EPA's Office of Water, or FMCSA).

Agency Comments and 	On August 8, 2003, we provided a draft of this report
to the Director of OMB for his review and comment. We also provided a
draft to APHIS, FDA, DOL,

Our Evaluation	DOT, and EPA for technical review. We received several
technical suggestions from these agencies, which we incorporated as
appropriate. For example, at the request of certain agencies, some of the
entries in appendix II now provide both the title of the rule as submitted
to OIRA and

Chapter 5 Conclusions and Recommendations

the title as published in the Federal Register. We also made minor changes
to the body of the report clarifying why certain rules were changed or
withdrawn.

On September 2, 2003, the Administrator of OIRA provided written comments
on the draft report. (See app. V for a copy of these comments.) The
Administrator said OIRA believed the "factual foundations of the report
are well grounded," and was particularly pleased that the report noted
improvements in the timeliness of OIRA's reviews and the transparency of
the review process. He also said that OIRA plans to review its
implementation of the transparency requirements and, in particular, would
work to improve the clarity of its meeting log. However, the Administrator
said OIRA did not agree with all of the recommendations in the draft
report, and did not believe that the report had demonstrated the need or
desirability of changing the agency's existing "unprecedented" level of
transparency. He then discussed several specific issues, describing why he
disagreed with the recommendations. The bullets below summarize his
concerns and present our response.

o 	The Administrator said that OIRA did not believe that disclosure of
"deliberations" that occur during informal review of rules would improve
the rulemaking process. He also said that Congress and the courts have
recognized the importance of confidentiality during the deliberative
process and said it would not be appropriate for OIRA to waive the
"deliberative privilege" for rulemaking agencies. However, we did not
recommend that OIRA's deliberations with the agencies be disclosed. Our
recommendation was that, after a rule has been published in the Federal
Register, agencies disclose any substantive changes made to draft
rules-whether those changes were made during the formal review process or
an informal review. As we said in the draft report, real transparency
regarding the substantive changes made to agencies' draft rules during
OIRA's review requires disclosure of those changes whenever they occurred.
Excluding the portion of the review process when OIRA has said it can have
its most significant effect seems to seriously call into question the
transparency of that process. The desirability of such disclosure was
clearly demonstrated during our review when agencies disclosed substantive
changes made to their rules during informal review at the suggestion or
recommendation of OIRA. Those disclosures greatly facilitated our
understanding of the extent to which OIRA affected the rules at issue.

Chapter 5 Conclusions and Recommendations

o 	The Administrator said that the draft report does not explain why
changes are needed to the "longstanding practice" of limiting the
disclosure of documents exchanged during the review process to only
documents that were exchanged at the OIRA branch chief level and above. In
our draft report, we recommended that OIRA reexamine that policy because
our review of OIRA's and the rulemaking agencies' files indicated that
most of the documents exchanged occurred below the branch chief level.
Therefore, only requiring disclosure of documents exchanged at a level at
which they rarely are exchanged seems inconsistent with the spirit of
transparency.

o 	The Administrator indicated that the draft report does not explain why
agencies or OIRA should disclose why rules are withdrawn from review,
again noting that nondisclosure has been a "longstanding practice." He
also indicated that rules are withdrawn at the request of the rulemaking
agency and that OIRA does not believe it is appropriate for it to "waive
the deliberative privilege" by disclosing why rules are withdrawn.
However, as we noted in our report, the executive order already requires
disclosure regarding rules that are changed or returned to the agencies.
Withdrawals are the only substantive action that can be taken without
explanation or documentation. Further, our review indicated that OIRA
sometimes initiates these withdrawals (even though they were technically
"requested" by the agencies).

o 	The Administrator noted that the draft report recommended that OIRA
differentiate within the "consistent with change" category in its database
those rules that were substantively changed at OIRA's suggestion or
recommendation and those rules that were changed in other ways and for
other reasons. He then referred to the former Administrator's response to
our 1998 report, indicating that OIRA continues to believe that it is
better to provide the public with copies of the draft regulations reviewed
by OIRA than to clearly delineate which changes were substantive. First of
all, we did not address the issue of the "consistent with change" category
in our 1998 report. Further, we concluded during this review that it is
extremely difficult to determine what changes had been made in different
versions of draft rules that sometimes were hundreds of pages in
length-much less to determine which of those changes were substantive. The
executive order requires rulemaking agencies to identify for the public
the substantive changes made to draft rules "in a complete, clear, and
simple manner." It does not place the responsibility on the public to
identify changes made to agency rules. Also, simply providing copies of
the rules as they entered

Chapter 5 Conclusions and Recommendations

and exited OIRA does not necessarily identify changes made at OIRA's
suggestion or recommendation.

o 	Finally, the Administrator indicated that he disagreed with our
recommendation that OIRA encourage agencies to use "best practices" in
disclosing changes made to their rules and said that OIRA would defer to
the agencies on this issue (as it did during the previous administration).
He also said OIRA expected that many of the differences in agencies'
documentation practices that we identified should be eliminated by the
administration's e-rulemaking initiative (which would consolidate each
agency's public docket into a single governmentwide docket).1 Our
examination of agencies' rulemaking dockets during this review indicated
that the documentation of changes made during OIRA's review was often
confusing and, at times, totally absent. Also, section 2(b) of the
executive order states "to the extent permitted by law, OMB shall provide
guidance to agencies" and that OIRA "is the repository of expertise
concerning regulatory issues, including methodologies and procedures that
affect more than one agency." Therefore, we believe that OIRA has a
responsibility under the executive order to instruct agencies regarding
the order's transparency requirements (just as it has done with regard to
other issues). Further, the consolidation of the agencies' dockets in the
administration's erulemaking initiative will not address the deficiencies
that we observed regarding the contents of some of those dockets. The
confusing documentation (or the absence of documentation) will just be
more accessible to the public.

Overall, we continue to believe that improvements can and should be made
to improve the transparency of the OIRA review process. We recognize and
applaud the improvements that the current Administrator has made in this
area. However, the difficulties that we experienced during this review
clearly demonstrated that OIRA's reviews are not always transparent to the
public. Weaknesses were apparent regarding both the coverage and the
implementation of the requirements placed on both OIRA and the rulemaking
agencies. Our review also indicated that, when OIRA and the rulemaking
agencies disclosed changes and communications beyond what

1For an examination of the first module of this initiative, see U.S.
General Accounting Office, Electronic Rulemaking: Efforts to Facilitate
Public Participation Can Be Improved, GAO-03-901 (Washington, D.C.: Sept.
17, 2003).

Chapter 5 Conclusions and Recommendations

is currently required, those practices greatly enhanced our (and the
public's) ability to understand how rules are made.

Appendix I

                       Objectives, Scope, and Methodology

This appendix presents more detailed information about our reporting
objectives, the scope and methods used to address each of the objectives
and subobjectives, and the most significant limitations of our findings
and analyses.

Objectives	The general purpose of this engagement was to examine and
report on how the Office of Management and Budget's Office of Information
and Regulatory Affairs (OIRA) conducts its regulatory review function and
the outcomes of those reviews. Specifically, we were asked to:

1.

2.

3.

Describe OIRA's current regulatory review policies and processes and
determine whether, and if so how, those policies and processes have
changed in recent years.

Identify the rules issued by selected agencies that were reviewed by OIRA
between July 1, 2001, and June 30, 2002, and that were either
significantly changed at OIRA's direction, returned by OIRA for further
consideration by the agencies, or withdrawn by the agencies at OIRA's
suggestion. For each such rule, (a) describe the changes made by OIRA, the
reasons why the rule was returned or withdrawn, and any subsequent
activity regarding the rule, (b) describe, to the extent possible, the
effects of the changes, returns, and withdrawals on the rule's original
benefits and costs, and (c) determine whether there are any indications
that the actions OIRA took were traceable to suggestions offered by
regulated entities or outside parties and, if so, whether OIRA publicly
disclosed their involvement.1 We also examined OIRA's and the agencies'
application of the transparency requirements in Executive Order 12866 and
related guidance.

Describe how OIRA determined that certain existing rules listed in its
reports to Congress on the costs and benefits of federal regulations
merited high priority review. With regard to OIRA's 2001 report, our
specific objectives were to determine (a) which organizations or persons
suggested that the rules be reviewed, (b) what process OIRA used to select
and prioritize the nominations, (c) the extent to which OIRA publicly
disclosed its selection and priority-setting process, and (d) the current
status of those rules. Another specific objective was to

1OIRA defines outside parties as "persons not employed by the executive
branch."

                                   Appendix I
                       Objectives, Scope, and Methodology

compare that 2001 effort to the process OIRA used regarding a second round
of nominations for OIRA's 2002 report.

  Scope and Methodology

Objective 1	Under the first objective, our primary focus was on describing
OIRA's regulatory review policies and processes in place as of June 2002
or later. To determine whether and to what extent those policies and
processes have changed in recent years, we focused mainly on identifying
changes that may have occurred since the previous administration. However,
to provide additional context on the evolution of the OIRA review
processes, we also identified the major changes that have occurred since
OIRA began carrying out a regulatory review function in 1981.

To describe the policies and processes used by OIRA to conduct regulatory
reviews, we reviewed relevant primary documents, such as executive orders,
legislation, OMB guidance, and memoranda, speeches, and documents from the
OIRA administrator describing aspects of the review process. We also
reviewed other historical and secondary documents that provided background
and context on the framework for OIRA's regulatory reviews. We interviewed
current and former OIRA officials to provide additional information on the
changes, if any, in the agency's regulatory review policies and processes.
We supplemented the documentary and testimonial evidence obtained from
OIRA with interviews and document reviews at selected regulatory agencies
that are subject to OIRA's regulatory reviews.

For this objective, and the other two objectives, we also interviewed
officials and staff from outside (nonfederal) groups representing public
interest groups and regulated entities that are actively involved in
observing and commenting on the federal regulatory process. Participants
in these meetings included representatives of the American Bakers
Association, American Road and Transportation Builders Association, Center
for Regulatory Effectiveness, Exxon/Mobil, Mercatus Center, National
Association of Home Builders, National Association of Manufacturers,
National Federation of Independent Business Research Foundation, Natural
Resources Defense Council, National Roofing

                                   Appendix I
                       Objectives, Scope, and Methodology

Contractors Association, OMB Watch, Public Citizen, and United States
Chamber of Commerce.

Objective 2	With regard to the second objective, we used OIRA's Executive
Order Review database to identify the draft regulatory actions that
agencies had submitted for OIRA's review during the 1-year time period
(July 1, 2001, through June 30, 2002) specified in the congressional
request. Because a given draft regulatory action could have been submitted
for OIRA's review more than once before final publication or disposition,
our unit of analysis was each separate submission to OIRA, which is what
OIRA's database reflects, rather than each rule. However, to simplify
reporting, we refer to these submissions as rules in this report.

Out of the total of 642 draft items submitted for OIRA's review during the
1-year time period, we identified 393 draft rules from 81 agencies and
offices for which OIRA's database had coded the outcome of the review as
"returned," "withdrawn," or "consistent with change." Because we could not
devote the time and resources that would have been necessary to search
dockets for all of these rules at all of the agencies, we limited our
efforts to selected rules and agencies, focusing on the agencies with the
largest numbers of affected rules, as discussed and agreed to in
consultation with the requesters. Specifically, we agreed to focus our
efforts on the rules submitted for OIRA regulatory reviews that met the
following criteria:

o 	The submission to OIRA was a draft health, safety, or environmental
rule.

o 	The rule was submitted to OIRA as a proposed, interim final, or final
rule (i.e., we did not include other items, such as prerules and white
papers, that agencies also sometimes submitted for OIRA's review).

o 	OIRA completed its review of the rule between July 1, 2001, and June
30, 2002.

o 	The rule was returned to the rulemaking agency by OIRA, withdrawn from
OIRA's review by the agency, or changed after its submission to OIRA.

Appendix I
Objectives, Scope, and Methodology

o 	The rule was from an agency or subagency that OIRA's Executive Order
Review database indicated had five or more rules returned, withdrawn, or
changed during the time period in scope for this objective.

We identified 85 draft regulatory actions that met these criteria. The 85
rules were submitted for OIRA's review from nine agencies-the Animal Plant
and Health Inspection Service (APHIS), the Food and Drug Administration
(FDA), the Occupational Safety and Health Administration (OSHA), the
Department of Transportation's (DOT) Federal Aviation Administration
(FAA), Federal Motor Carrier Safety Administration (FMCSA), and National
Highway Traffic Safety Administration (NHTSA), and the Environmental
Protection Agency's (EPA) Office of Air and Radiation, Office of Solid
Waste and Emergency Response, and Office of Water. We generally did not
question the rule dispositions used in the OIRA database. However, we
included one rule from EPA's Office of Air and Radiation in the
"consistent with change" category that had been coded as a "deadline case"
in the database because publicly available information indicated that the
rule had been changed in response to OIRA's review.2 It is unclear whether
other rules with "deadline case" outcome codes in the database were also
changed by OIRA, or why other rules that we reviewed with statutory or
legal deadlines were not coded as deadline cases.3 We also dropped one
rule from EPA's Office of Solid Waste and Emergency Response that had a
"consistent with change" outcome code in OIRA's database because it had
not been published in the Federal Register at the time of our review. (See
app. II for information on each of the selected submissions.)

We were asked to address three specific topics regarding the selected
rules: (1) the nature of the changes attributed to OIRA or the reasons
that rules were withdrawn or returned at OIRA's initiation, (2) the effect
of OIRA's actions on the costs and/or benefits of the rules, and (3)
contact with OIRA by external parties regarding these rules. Because
Executive Order 12866 also imposes certain documentation requirements on
agencies and OIRA regarding OIRA's regulatory review process, we also
addressed compliance with those requirements as a fourth part of our
analysis of the 85 rules.

2See, for example, Arthur Allen, "Where the Snowmobiles Roam," Washington
Post Magazine (Aug. 18, 2002).

3OIRA's database has a separate field, separate from the field on reviews'
outcomes, that identifies submissions with legal deadlines. Twenty-two of
the 85 rules that we reviewed were coded in OIRA's database as having a
statutory or judicial deadline.

                                   Appendix I
                       Objectives, Scope, and Methodology

In general, to address these four areas we reviewed the available
documents in both agency and OIRA rule dockets. We also interviewed
officials at the agencies and OIRA to obtain information about the
regulatory review process for the individual rules included in our scope.
We then used an iterative process to develop summary findings and
determinations on each rule. Multiple reviewers from our team
independently examined and coded the information and materials that had
been collected. We then held a series of meetings to discuss and reach
consensus on the coding and description of results for each rule. We
vetted these preliminary results with OIRA and the agencies to address
outstanding questions and obtain their feedback on the accuracy of our
findings and determinations. We incorporated their comments as appropriate
before developing our official draft report for formal agency comments.
The analysis and coding process for each of the four areas also had some
unique aspects, as described below.

Nature and significance of The review outcome categories used in the OIRA
database are broader than

OIRA's effects on rules	the specific types of rules targeted by our second
objective-those that were significantly affected by OIRA. Therefore, we
had to gather additional information on each of the 71 changed, 9
returned, and 5 withdrawn rules to determine which ones had been
significantly affected by OIRA and, therefore, met our more specific
criteria.

First, we used a variety of information sources (e.g., agency and OIRA
docket materials and interviews with agency officials) to place each of
the 71 rules that had been changed after submission to OIRA into one of
three categories, based on the most significant changes attributed to
either OIRA or OMB.4 Our three coding categories were:

1.	Significant changes-This category included rules in which the most
significant changes attributed to OIRA or OMB affected the scope, impact,
or estimated costs and benefits of the rules as originally submitted to
OIRA. Usually, these significant changes were made to the regulatory
language that would ultimately appear in the Code of Federal Regulations.

4The agencies sometimes attributed changes to OMB and sometimes
specifically to OIRA. In a few instances, OMB staff outside of OIRA
suggested the changes. There were also rules in which the regulatory
agencies initiated more significant changes during the period of OIRA's
review than did OIRA.

                                   Appendix I
                       Objectives, Scope, and Methodology

2.

3.

Other material changes-This category covered rules in which the most
significant changes attributed to OIRA or OMB resulted in the addition or
deletion of material in the explanatory preamble section of the rule. For
example, OIRA may have recommended that agencies provide better
explanations for certain rulemaking actions and/or suggested that agencies
ask the public to comment on particular aspects of the rules.

Minor or no OIRA/OMB changes-We used this category to identify rules in
which the most significant changes attributed to OIRA's or OMB's
suggestions resulted in editorial or other minor revisions, or rules in
which changes occurred prior to publication but not at the suggestion of
OIRA or OMB. Where no OIRA/OMB changes were made, the changes that caused
the rule to be coded "consistent with change" in OIRA's database could
have been initiated by the regulatory agency itself or by another federal
agency (e.g., the Office of the Federal Register). Because the executive
order does not require agencies to document nonsubstantive changes, three
of the rules we included in this category were ones in which it was clear
that all the changes were minor, but the source of the changes (i.e.,
whether they were made at the suggestion of OIRA/OMB) could not be
identified.

Identifying returned rules significantly affected by OIRA and OIRA's
rationale for the returns was more straightforward. When OIRA returns a
rule to an agency for reconsideration, section 6(b)(3) of Executive Order
12866 requires the OIRA Administrator to provide the issuing agency with a
written explanation delineating the pertinent section of the order on
which OIRA is relying. OIRA has posted copies of its return letters,
including those relevant to rules within the scope of our engagement, on
the OMB Web site. OIRA identified other rules that were returned for
nonsubstantive reasons as "improper submissions" in its database.

There are no documentation requirements on agencies or OIRA covering
withdrawn rules, so we relied primarily on testimonial evidence from
agency officials to determine whether OIRA, rather than the submitting
agency, had initiated the withdrawal. In one case, however, a withdrawn
rule from FAA that was subsequently resubmitted to OIRA and published, the
agency docket included a written chronology for the rulemaking process
that attributed the withdrawal to OIRA's action.

Effect of OIRA's reviews on costs We considered two types of actions
attributed to OIRA or OMB as potential and benefits evidence that OIRA
directly affected the costs and/or benefits of the rule

                                   Appendix I
                       Objectives, Scope, and Methodology

compared to those expected under the draft version of the rule submitted
for OIRA's review. These were when (1) OIRA or OMB suggested changes to a
draft rule's regulatory text that could reasonably be expected to affect
the potential costs and/or benefits of the regulations (e.g., changing the
proposed federal share of an indemnity payment) and (2) OIRA specifically
commented on and requested changes in the agencies' analyses of the
economic impacts of the draft regulations. With regard to the first type
of action, we believed that it was reasonable to assume that
OIRA-suggested elimination or delay of certain regulatory provisions in
the text of draft rules as submitted to OIRA would also eliminate or delay
the expected costs and/or benefits associated with those provisions. We
also identified and reported on other changes suggested by OIRA that,
while not directly affecting regulatory provisions or cost-benefit
estimates, otherwise revised, clarified, or requested comments on issues
relevant to the agencies' discussion of potential costs and/or benefits of
a rule. We consulted with our Chief Economist in making our determinations
and describing the potential effects of OIRA's actions.

Evidence of outside contacts Another part of this objective was to
determine whether there was any

regarding rules under OIRA evidence that the actions that OIRA took (e.g.,
to suggest significant

review	changes to rules or to return them to the agencies for
reconsideration) were traceable to suggestions offered by regulated
entities or other parties outside of the federal government. It is not
possible to independently determine what motivated OIRA's actions with
regard to any of the rules that it reviewed. However, as part of our
review, we checked whether OIRA had direct contact with such outside
parties regarding rules that OIRA significantly affected. We defined
"direct contact" as taking the form of either oral communications with
OIRA (meetings or phone calls) or written communications (correspondence)
sent directly to OIRA officials before or during the period of OIRA's
review. In some OIRA files, we found evidence that OIRA had reviewed
copies of substantive comments on previous versions of the draft rule
currently under review. Because these were public docket materials
previously submitted to the regulatory agencies, not OIRA, we did not
consider them as evidence of direct contact with OIRA by outside parties.
If there was evidence that outside parties had contacted OIRA, we also
examined whether there were similarities between the actions that OIRA
suggested or recommended to the agencies and those advocated to OIRA by
external parties through those direct contacts.

Transparency of agencies' and Our primary focus with regard to agencies'
compliance with OIRA's documentation of reviews documentation requirements
of Executive Order 12866 was on determining

Appendix I
Objectives, Scope, and Methodology

whether the agencies had publicly documented changes made in rules between
submission for OIRA's review and publication in the Federal Register.
Section 6(a)(3)(E)(ii) of the order states that agencies must "identify
for the public, in a complete, clear, and simple manner, the substantive
changes between the draft submitted to OIRA for review and the action
subsequently announced." However, neither the executive order nor OIRA's
October 1993 guidance on its implementation defines what the term
"substantive changes" means. Section 6(a)(3)(E)(iii) of the order requires
agencies to "identify for the public those changes in the regulatory
action that were made at the suggestion or recommendation of OIRA." OIRA's
October 1993 guidance on the implementation of the order considers the
second requirement to be a subset of the first. Therefore, under this
interpretation, the agencies are only required to disclose the changes
made at OIRA's suggestion or recommendation after formal submission of the
rule to OIRA-not during any informal review period that precedes formal
submission.

To determine agencies' compliance with these documentation requirements,
we considered the required information to have been "identified for the
public" if it was available in the agencies' public docket for the
relevant rule. We coded the level of documentation in the agencies'
dockets for each changed rule into one of four categories, reflecting
whether (1) all changes were clearly documented, (2) changes were
identified but it was not clear that all changes had been documented or at
whose initiative, (3) no changes were documented in the public docket, or
(4) the Executive Order 12866 documentation requirements were not
applicable.5 The first requirement is not applicable when there were no
changes made to the rule during OIRA's review that the agencies considered
"substantive." Even if there were substantive changes made during OIRA's
review, the second requirement is not applicable if those changes were not
made at the suggestion or recommendation of OIRA. We made our
determinations regarding agencies' compliance with these requirements
solely on the basis of the information that would be available to a member
of the public if he/she had reviewed the docket for a given rule.6
Further, because the executive order places responsibility to document
changes on the agencies rather than OIRA, our determinations only reflect
material available in the regulatory agencies' dockets, not

5 We conducted a similar exercise in our previous GAO report on this
subject. See GAO/GGD-98-31.

                                   Appendix I
                       Objectives, Scope, and Methodology

materials in OIRA's public files.7 However, we did use information from
the OIRA files to identify rule changes that agencies should have
documented.

Our primary focus with regard to OIRA's compliance with documentation
requirements was to see if (1) when returning rules to agencies for
reconsideration, the OIRA Administrator provided the issuing agency with a
written explanation delineating the pertinent section of the order on
which OIRA relied in returning the rule, as required by section 6(b)(3) of
the executive order, and (2) OIRA had documented written and oral
communications with outside parties regarding rules under review by OIRA,
as required by section 6(b)(4) of the order. To address the first item, we
confirmed that OIRA had prepared a return letter for each of the rules it
returned to agencies for reconsideration of substantive issues. To address
the second item, we reviewed OIRA's docket files, meeting logs (both the
paper-based and on-line versions), and phone logs. We also checked other
potential sources of information on contacts with outside parties
regarding the 85 rules, especially the agencies' regulatory docket files
on these rules.

Objective 3	Our work to address the third objective focused on the
particular rules, and OIRA's processes for selecting and ranking those
rules, identified for high priority review in the 2001 and 2002 versions
of OMB's annual report to Congress on the costs and benefits of federal
regulations. In order to address the third objective, we reviewed any
available documentation describing the process that OIRA used to select
certain rules for high priority review. We also interviewed OIRA officials
and officials in other relevant agencies and organizations to determine
how the classifications were made, and reasons why the particular selected
rules were designated as high priority.

6 In many cases, the agencies prepared supplementary memos or summaries
for us that provided additional information and explanations regarding the
changes made in various rules. In those cases, we used the supplementary
information to address other elements of our review-such as the nature of
changes attributed to OIRA-but did not consider the materials specifically
prepared for our review to be public documents within the dockets.

7It is notable that these dockets sometimes contained information that the
agencies were not technically required to disclose-and that information
frequently provided valuable insights to our determinations regarding the
gravity of OIRA's changes. For example, the agencies sometimes disclosed
changes that were not "substantive," and sometimes disclosed changes that
OIRA made to rules before they were formally submitted to OIRA.

                                   Appendix I
                       Objectives, Scope, and Methodology

Limitations The most important limitations to our engagement were related to the
                        second objective. In particular:

o 	Our analysis of individual rules submitted for OIRA's review was
limited to the 85 rules and 9 agencies or offices that met specific
selection criteria. We did not review all 393 rules from all 81 agencies
or offices that OIRA's database indicated had rules changed, returned, or
withdrawn during the 1-year period from July 1, 2001, through June 30,
2002.

o 	Some types of OIRA's influence on rules may not be reflected in the
documentation we relied on in this review. For example, DOT officials told
us in 1996 that they will not even propose certain regulatory provisions
because they know that OIRA will not find them acceptable. Also, the
documentation that we reviewed generally did not reflect the
OIRA-suggested changes that were not adopted by the agencies.

o 	We cannot be sure that we have identified all changes to the selected
rules that were made at the suggestion or recommendation of OIRA (e.g.,
changes made as a result of informal OIRA reviews that were not
documented). Neither can we be sure to have identified all the effects of
such changes on the rules or all instances in which an external party may
have influenced OIRA's actions.

o 	Given the available documentation, we were not able to clearly
attribute all changes or actions taken regarding the selected rules to
OIRA or to the actions or influence of outside parties. We cannot
attribute any cause-effect relationships in those instances where both
OIRA's comments or changes regarding a particular rule and the suggestions
of an external party on that same rule were similar. Likewise, any
identified changes in the benefits and costs of selected rules after
OIRA's reviews may not be attributable in whole or in part to changes made
at OIRA's suggestion.

o 	Characterizing the nature of changes made to the rules, particularly
the extent to which they are "significant," is inherently subjective. We
attempted to mitigate this limitation by (1) establishing criteria to
generally categorize the nature of changes, (2) using multiple reviewers
for each rule, and (3) obtaining views of agency and OIRA officials on
whether we had accurately identified and characterized the nature of
OIRA's effect on each rule.

Appendix I
Objectives, Scope, and Methodology

o 	Our knowledge of OIRA contacts by outside parties, such meetings or
correspondence, was generally limited to what OIRA or the agencies
disclosed in their files. Although in one case we found documented
evidence of such contact through materials posted by a trade group-
evidence that did not appear in either the OIRA or agency files-we do not
know whether there were other meetings with outside parties or other
letters from those parties about rules in our review that did not come to
our attention.

Appendix II

Summary Information on Selected Rules Submitted to OIRA for Executive Order
Review between July 2001 and June 2002

This appendix contains three tables that summarize GAO's findings and
determinations regarding 85 health, safety, or environmental rules
submitted for OIRA's review by nine selected agencies (APHIS, FDA, OSHA,
DOT-FAA, DOT-FMCSA, DOT-NHTSA, EPA-Office of Air and Radiation, EPA-Office
of Solid Waste and Emergency Response, and EPA-Office of Water) that we
examined to address our second reporting objective. The three tables
present information on, respectively, rules that were changed after being
submitted for OIRA's review (table 7), rules that OIRA returned to the
agencies (table 8), and rules that were withdrawn after having been
submitted for OIRA's review (table 9).

Explanation of Table 	The following paragraphs identify the analytical
contents of each table and provide definitions of the codes we used. In
general, for each analytical

Contents	category, we used a process of separate coding by each GAO team
member, followed by a discussion to reconcile any differences and reach
consensus on the most appropriate code. We then shared our preliminary
findings and determinations with OIRA and the regulatory agencies to
obtain a "fact check" on the descriptive information and also solicited
their comments or clarifications regarding our coding determinations.

Table 7: Summary of Findings and Determinations for Changed Rules

o 	GAO ID - This column provides a unique GAO case identification number
for each executive order submission to OIRA that we reviewed to address
our second reporting objective. Note that our unit of analysis was the
submission of a draft regulation for OIRA's review, not the rule itself.
Therefore, a given draft regulation could have been submitted to OIRA more
than once with more than one outcome. In such cases, each separate
submission that fell within the scope of our review would appear under a
different GAO ID.

o 	Executive order review submission - This column provides general
information about the draft regulation submitted for OIRA's review. As
noted above, our unit of analysis was the submission to OIRA, so the
titles presented here are those that appear in OIRA's data base on the
submissions it has received, not the titles of the rules as published in
the Federal Register. We also identify the draft rule's Regulation
Identifier Number (RIN),1 its type (proposed, final, or interim final
rule), the time

Appendix II
Summary Information on Selected Rules
Submitted to OIRA for Executive Order
Review between July 2001 and June 2002

period for OIRA's formal review of the rule, and when and where the
cleared version of the rule was published in the Federal Register.2

o 	Nature of OMB/OIRA changes - This column represents GAO's
interpretation of the nature of the changes suggested by OMB or OIRA, in
particular whether the changes made to the rule in response to OMB or OIRA
significantly affected the draft rule. We used any available information
to categorize and describe the changes attributed to OMB or OIRA (e.g.,
agency docket materials, OIRA files, interviews with agency officials, and
any memos or e-mails on the changes that agency officials specifically
prepared to address this GAO engagement). We characterized the nature of
the changes for each of the changed rules using three categories, with a
code assigned to each rule for the most significant level of change
observed. The three categories were:

1. Significant changes - We used this category for rules in which changes
attributed to OMB or OIRA resulted in a revision to the scope, impact, or
estimated costs and benefits of the rule compared to the draft version
originally submitted to OIRA. Most often, these were rules in which
changes were made to the regulatory language of the draft regulation
(i.e., amendments to the Code of Federal Regulations).

2.	Other material changes - We used this category for changes that did not
have as significant an effect as "significant changes," but did result in
adding or deleting material to the original text. Most often, these
changes were in the preambles of the rules, rather than the regulatory
text, and involved clarifying an agency's explanation of certain
provisions in the rule, clarifying the agency's basis for decisions made
about regulatory options or assumptions, better explaining the potential
impact of different options, and requesting public comments and/or data on
regulatory options or costs.

1 The RIN is assigned by the Regulatory Information Service Center to
identify each rulemaking cycle listed in The Regulatory Plan and the
Unified Agenda of federal agencies, as directed by Executive Order 12866.
Also, OMB has asked agencies to include RINs in the headings of their Rule
and Proposed Rule documents when publishing them in the Federal Register
to make it easier for the public and agency officials to track the
publication history of regulatory actions throughout their development.

2 In addition to the date of publication, we provide the location of the
published rule using the Federal Register's standard format (e.g., 66 FR
55530 indicates that the rule was published starting on page 55530 of
volume 66).

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

3.	Minor editorial changes or no OMB or OIRA changes - This category was
used both for rules with changes that, at best, represented editorial
corrections and revisions (e.g., rearranging existing text, correcting
spelling, word choice changes, and adding or correcting boilerplate
language, such as where to submit comments) and rules in which no changes
were made at the suggestion or recommendation of OMB or OIRA.

o 	Evidence that OMB/OIRA changes affected the potential costs or benefits
of the submitted rule - We usually only assigned a "yes" code under this
topic if documentation of OMB or OIRA changes to a rule specifically
showed that cost-benefit, cost-effectiveness, Paperwork Reduction Act
burden estimates, or similar information on regulatory impacts had been
edited or changed at the suggestion of OMB or OIRA. However, in the case
of rules with substantive changes (additions or deletions) in the
regulatory language, we assumed that adding or deleting entire provisions
would have at least some effect on the potential costs or benefits of the
rule, compared to the draft version submitted to OIRA.

o 	Evidence that outside parties contacted or met with OMB/OIRA regarding
the submitted rule - A "yes" code under this topic indicates that we found
documentation that an outside (nonfederal government) party or parties had
directly contacted OMB or OIRA regarding a particular rule before or
during OIRA's formal review period for that rule. Direct contacts were
either through a meeting or correspondence.3 Most often, this evidence
came from OIRA's files and logs, but sometimes the documentation came from
a regulatory agency's docket on that rule.

Table 8: Summary of  o  GAO ID and Executive Order Review Submission -
(Columns as Findings and described under table 7, except that information
about the publication Determinations for of the rule, if applicable,
appears under a separate column on Returned Rules subsequent activity.)

3We also checked OIRA's phone logs regarding calls related to Executive
Order 12866 reviews, but found no evidence of such calls before or during
OIRA's formal review periods of the rules within our scope.

Appendix II
Summary Information on Selected Rules
Submitted to OIRA for Executive Order
Review between July 2001 and June 2002

o 	Reason for OIRA's return of the rule - For each rule, we summarized the
information presented in OIRA's return letter or, for the "improper"
submissions with no return letters, cited the classification from OIRA's
regulatory review database. In some cases, we supplemented these
descriptions with additional information provided by regulatory agency
officials.

o 	Evidence that outside parties contacted or met with OIRA regarding this
submission - (As described under table 7.)

o 	Evidence of subsequent activity regarding this submission - Our focus
under this topic was identifying information regarding resubmission and
publication of the rule after OIRA had returned it. If an agency provided
information that the rule has not yet been resubmitted and/or published,
we also report that.

Table 9: Summary of Findings and Determinations for Withdrawn Rules

o 	GAO ID and Executive Order Review Submission - (As described under
table 7, except that information about the publication of the rule, if
applicable, appears under a separate column on subsequent activity.)

o 	Reasons for withdrawal of the submitted rule - For each rule, we report
the explanation provided by the regulatory agency and/or OIRA regarding
the withdrawal of the rule. Our primary focus under this item, per our
congressional request, was on identifying whether the rule had been
withdrawn at the suggestion of OIRA.

o 	Evidence that outside parties contacted or met with OIRA regarding this
submission - (As described under table 7.)

o 	Evidence of subsequent activity regarding this submission - (As
described under table 8.)

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

Table 7: Findings and Determinations for Rules Changed after Submission to OIRA

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

APHIS Mexican Hass Avocado Import Program

Proposed rule

RIN 0579-AB27

OIRA review period: 06/13/2001 to 07/05/2001

Published 07/13/2001 (66 FR 36892) Other material changes

Information was added to the preamble regarding several topics-e.g., a
previous amendment to Hass avocado regulations, an APHIS review of the
Hass avocado import program, a study on fruit flies, responses to
commenter concerns, and a new section summarizing the regulatory impact
analysis. Also, there were minor rewording changes throughout. An APHIS
official characterized most OIRA changes to the rule as minor editorial
comments but said that other changes strengthened the agency's explanation
for the rule. There were no substantive changes to the regulatory
language.

                                     No No

Karnal Bunt; Compensation for the 1999-2000 and Subsequent Crop Seasons

Final rule

RIN 0579-AA83

OIRA review period: 07/26/2001 to 07/31/2001

Published 08/06/2001 (66 FR 40839) Minor editoral changes or no changes No
No

Changes were limited to minor clarifications and a sentence change in the
Paperwork Reduction Act section in the preamble. There were no changes in
the regulatory language.

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

Importation Prohibitions Because of Bovine Spongiform Encephalopathy (BSE)

Interim final rule

RIN 0579-AB26

OIRA review period: 04/18/2001 to 07/27/2001

Published 08/14/2001 (66 FR 42595) Other material changes No No

A section was added to the preamble noting that APHIS would obtain BSE
risk factor data from trading partners and, if significant risk was
indicated, APHIS would take action to restrict animal product imports from
the risky areas.

Scrapie in Sheep and Goats; Interstate Movement Restrictions and Indemnity
Program

(Listed in OIRA's database as: Interstate Movement of Sheep and Goats From
States That Do Not Quarantine Scrapie-Infected and Source Flocks)

Final rule

RIN 0579-AA90

OIRA review period: 04/18/2001 to 08/07/2001

Published 08/21/2001 (66 FR 43964) Other material changes

OMB suggested several changes to the preamble that added or clarified
descriptions of issues such as (a) the increase in paperwork burden caused
by this rule, (b) how to calculate animal and human health risks
associated with scrapie, and (c) how to estimate the effectiveness of
indemnity as an incentive. OMB also suggested that APHIS clarify how much
of the rule's activities could be funded from currently projected agency
budgets and how much would require additional funds. According to APHIS,
these additional discussions caused no significant changes to the scope of
the rule or the benefits it provided. The regulatory language was not
changed.

No No

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

Phytosanitary Certificates for Imported Fruits and Vegetables

Proposed rule

RIN 0579-AB18

OIRA review period: 03/21/2001 to 08/15/2001

Published 08/29/2001 (66 FR 45637) Other material changes

In a memo prepared for GAO, APHIS identified eight specific changes that
OMB requested, all in the preamble. These changes mainly provided more
specific information, additional examples, and expanded discussions about
the economic impacts of this rule.

No

The actual costs and benefits did not appear to change as a result of the
revisions made at the request of OMB, but the revisions did provide more
information on and support for APHIS' analysis of the economic impacts of
the rule.

                                       No

Plant Pest Regulations; Update of Current Provisions

Proposed rule

RIN 0579-AA80

OIRA review period: 03/21/2001 to 09/26/2001

Published 10/09/2001 (66 FR 51340) Other material changes

APHIS identified five main changes that OMB requested to the preamble of
the rule, such as adding explanations and soliciting comments and
alternatives on certain issues, all focused on improving the clarity of
the rule. There were no changes to the regulatory language.

No No

Although the paperwork burden estimates were revised downward in the final
version, there is no indication that OIRA was the source of the revisions.

7        Mexican Hass    Other material changes    No          No          
                 Avocado                                 
       Import Program                                    
                          Numerous changes were made            However, OIRA 
                                    to the                            focused 
         Final rule         preamble of the rule,        many of its comments 
                             especially regarding        
                         responses to public comments           on suggesting 
                                    on the                          revisions 
        RIN 0579-AB27         proposed rule and          or expansions of the 
                             explanations of the         
                           agency's actions. APHIS         APHIS responses to 
                                characterized            
     OIRA review period: these as changes to make the      public comments on 
                                  final rule                              the 
        10/23/2001 to    "more defensible and              proposed rule, and 
                         internally consistent."                          the 
         10/29/2001      There were no changes to the    OIRA docket included 
                                  regulatory             
                                  language.                 copies of adverse 
     Published                                             comments submitted 
     11/01/2001                                                            on 
        (66 FR 55530)                                      the proposed rule. 

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

Interstate Movement of Swine Within a Production System

Final rule

RIN 0579-AB28

OIRA review period: 09/25/2001 to 12/11/2001

Published 12/20/2001 (66 FR 65598) Other material changes No No

There were inserts in the Federalism and Paperwork Reduction Act sections
of the preamble. Inserts in the Paperwork Reduction Act section added
information about changes made from proposed rule in terms of paperwork
and information collection requirements.

Chronic Wasting Disease in Cervids; Payment of Indemnity

(Listed in OIRA's database as: Chronic Wasting Disease in Elk; Interstate
Movement Restrictions and Payment of Indemnity)

Interim final rule

RIN 0579-AB35

OIRA review period: 01/07/2002 to 02/04/2002

Published 02/08/2002 (67 FR 5925) Significant changes

The most significant change made at the suggestion of OMB affected the
cost-sharing formula, limiting the federal indemnity payment to 95
percent. Other changes made in response to OMB were related to cost,
benefit, and risk data. Both the preamble and the CFR section of the rule
were affected by OMB-suggested changes.

Yes

OMB changed the 100-percent reimbursement that APHIS had proposed for the
indemnity to be 95 percent. OMB also asked APHIS to avoid citing the
possible avoidance of a human disease caused by chronic wasting disease as
a benefit of this rule because this possibility was considered remote by a
Harvard risk analysis.

                                       No

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

Animals Destroyed Because of Tuberculosis; Payment of Indemnity

Interim final rule

RIN 0579-AB29

OIRA review period: 11/13/2001 to 02/11/2002

Published 02/20/2002 (67 FR 7583) Other material changes No No

Changes were made to the preamble for clarification, particularly
regarding APHIS's cost-sharing policy. However, no changes were made to
the regulatory language in the CFR amendments section of the rule.

Infectious Salmon Anemia; Payment of Indemnity

Interim final rule

RIN 0579-AB37

OIRA review period: 03/08/2002 to 04/02/2002

Published 04/11/2002 (67 FR 17605) Other material changes

OMB requested changes related to future (post-2002) funding for the
infectious salmon anemia indemnity and a control and eradication program
(e.g., clarifying that the administration was examining how the costs of
program activities, including the payment of indemnity, are shared among
the federal government and others and, therefore, that in the future the
indemnity rate provided under this rule might change). OMB further
requested that APHIS make clear that all potential indemnity payments were
subject to the availability of funding.

(An APHIS official also noted that, before the formal review period for
this action, OIRA and APHIS agreed to make the federal share of the
indemnity 60 percent. Whether this share is any different from what would
have been stated in the rule without OIRA's input is not known.)

Unclear No

The preamble changes suggest that indemnity rates and program funding in a
second indemnity/program year might change.

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

Foot-and-Mouth Disease; Payment of Indemnity

(Listed in OIRA's database as: Foot-and-Mouth Disease, Pleuropneumonia,
Rinderpest, and Certain Other Communicable Diseases of Livestock or
Poultry; Payment of Indemnity)

Proposed rule

RIN 0579-AB34

OIRA review period: 01/17/2002 to 04/16/2002

Published 05/01/2002 (67 FR 21934) Significant changes

The most substantive changes attributed to OMB affected the regulatory
language in the Code of Federal Regulations (CFR) amendments
section-specifically, eliminating language in the original version of the
rule that would have provided compensation for care and feeding of
"official vaccinates" (livestock vaccinated as part of a foot-and-mouth
eradication program) and compensation "relating to cleaning and
disinfecting non-susceptible animals." OMB suggested other changes in the
preamble that generally provided additional justifications for the rule
and added explanations in the Regulatory Flexibility Act and Executive
Order 12866 sections. OMB also requested substantial changes to the
economic analysis and APHIS's approach in evaluating the proposed rule's
impact.

Yes

APHIS made substantial changes to the economic analysis in response to
OIRA's suggestion. Further, limiting compensation by not covering the care
and feeding of official vaccinates or the cleaning and disinfection of
non-susceptible animals lowered the potential costs to the government of
the indemnity program.

However, according to an APHIS official (and as explained in the preamble
of the proposed rule), removing these compensation provisions could impede
eradication efforts and, thus, reduce overall benefits to society. This is
because official vaccinates may be used as a "fire wall" to prevent the
spread of the disease beyond infected animals, and owners would not be
compensated for the costs of maintaining the vaccinated animals for the
time that might be necessary, and because non-susceptible animals could
spread foot-and-mouth disease even if they cannot themselves become
infected.

                                       No

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

FDA Exports; Notification and Recordkeeping Requirements

Final rule

RIN 0910-AB16

OIRA review period: 08/28/2001 to 11/27/2001

Published 12/19/2001 (66 FR 65429) Other material changes No No

Some of the OMB-suggested changes in the preamble added or revised
information to clarify FDA's responses to public comments on the proposed
rule. There were no changes to the regulatory language in the CFR section
of the rule.

Additional Criteria and Procedures for Classifying Over-the-Counter Drugs
as Generally Recognized as Safe and Effective and Not Misbranded

Final rule

RIN 0910-AA01

OIRA review period: 09/27/2001 to 12/21/2001

Published 01/23/2002 (67 FR 3060) Other material changes

Most changes were minor editorial revisions in the preamble, but some more
substantive changes included (a) repeating information from the analysis
of impacts section at the end of the rule on page 2, (b) inserting
clarifying material about the General Agreement on Tariffs and Trade and
the World Trade Organization to a response to comments on the proposed
rule, and (c) inserting a sentence to note that, over the next several
years, FDA expects to be able to accept electronic submissions. There were
no changes in the regulatory language of the CFR section.

No No

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

Records and Reports Concerning Experience with Approved New Animal Drugs;
Interim Final Rule

(Listed in OIRA's database at time of GAO's review as: New Animal Drug
Approval Process; Implementation of Title I of the Generic Animal Drug and
Patent Term Restoration Act (GADPTRA))

Interim final rule

RIN 0910-AA02

OIRA review period: 11/29/2001 to 01/08/2002

Published 02/04/2002 (67 FR 5046) Other material changes

Some of the changes to the preamble that were attributed to OMB added new
clarifying information or examples to the original text. OMB also revised
some of the text on the estimated reporting and recordkeeping burdens,
specifically characterizing two sections of the rule as posing new
information collection requirements over the existing requirements. The
changes attributed to OMB in the regulatory language of the CFR section
appeared to be mainly editorial in nature, although the language in one
provision on reporting requirements was changed from "must" to "should."
(Note: this rule was previously withdrawn. See GAO ID 82.)

Unclear No

Updated information on the estimated reporting and recordkeeping burdens
was included in the revised version of the rule (replacing data from 1999
fiscal year submission reports with data from 2000 fiscal year reports),
but the source of this change is not clear in the documentation. FDA,
rather than OIRA, might have initiated this change.

Requirements for Submission of Labeling for Human Prescription Drugs and
Biologics in Electronic Format

Proposed rule

RIN 0910-AB91

OIRA review period: 12/14/2001 to 03/05/2002

Published 05/03/2002 (67 FR 22367) Other material changes

The changes made in response to OIRA included (a) how electronic
signatures would be handled and how this would be described in the rule
and (b) the treatment and description of the onetime capital costs
associated with the reporting burden for this rule. There were also some
clarifying changes to the proposed regulatory language in the CFR section.

No No

Although the OIRA changes affected the categorization and description of
the costs of this rule-identifying them as onetime capital costs
associated with the reporting burdens of this proposal, where FDA's
original text had said there were no capital costs associated with this
information collection-this re-categorization did not change FDA's
estimate of total costs.

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

Food Additives: Food Contact Substances Notification System

Final rule

RIN 0910-AB94

OIRA review period: 02/19/2002 to 05/14/2002

Published 05/21/2002 (67 FR 35724) Minor editoral changes or no changes

Only a few minor changes were attributed to OMB, such as rewording an
introductory paragraph regarding comments received on the proposed rule
and inserting one sentence in an illustration of how FDA expected its
review of notifications to proceed in the future. The Executive Order
12866 statement in the rule was also revised to note that it was a
significant regulatory action that was reviewed by OMB, rather than the
original statement that it was not. All of these changes were in the
preamble; OMB requested no changes in the regulatory language.

(However, a substantive FDA change is reflected in the documentation.)

                                     No No

Efficacy Evidence Needed for Products To Be Used Against Toxic Substances
When Human Studies Are Unethical or Unfeasible

Final rule

RIN 0910-AC05

OIRA review period: 03/07/2002 to 05/21/2002

Published 05/31/2002 (67 FR 37988) Other material changes

Additional material was inserted in the preamble to better explain the
legal authority and rationale for taking this regulatory action. Other
changes were made to FDA's response to some public comments on the
proposed version of this rule. However, no changes were made to the
regulatory language.

No No

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

Investigational New Drugs; Export Requirements for Unapproved New Drug
Products

Proposed rule

RIN 0910-AA61

OIRA review period: 03/07/2002 to 05/29/2002

Published 06/19/2002 (67 FR 41642) Other material changes

The only changes attributed to OMB were (a) expanding the citations of
relevant legal authority in the background section of the preamble and (b)
updating references to a previous Federal Register notice with a related
record keeping requirement-and noting that this particular rule,
therefore, would not contain any new record keeping requirements. There
were no changes at OMB's request in the regulatory language.

                                     No No

OSHA Occupational Injury and Illness Recording and Reporting Requirements

Final rule

RIN 1218-AC00

OIRA review period: 09/24/2001 to 10/04/2001

Published 10/12/2001 (66 FR 52031) Minor editoral changes or no changes

OIRA did not suggest or recommend any substantive changes to this rule.

(However, OSHA initiated a substantive change to delay the effective date
of Section 1904.29(b)(7)(vi), and new language was included in the
preamble and regulatory text to accomplish this change.)

No No

No changes were suggested by OIRA.

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

Procedures for Handling of Discrimination Complaints Under Section 519 of
the Wendal H. Ford Aviation Investment and Reform Act for the 21st Century

Interim final

RIN 1218-AB99

OIRA review period: 12/21/2001 to 03/20/2002

Published 04/01/2002 (67 FR 15454) Other material changes

Three sets of changes were attributed to OIRA. In the preamble of the
rule, the changes included (a) adding information and a request for public
comment regarding the whistle-blower model that OSHA chose for this rule
and (b) identifying this rule as a significant regulatory action
(originally labeled "not significant" by OSHA). In the CFR section,
language was added to three provisions to clarify that certain procedures
would be triggered at the "request of the named person" (the person
alleged to have violated the act).

                                     No No

Safety Standards for Signs, Signals, and Barricades

Final rule

RIN 1218-AB88

OIRA review period: 12/31/2001 to 03/07/2002

Published 04/15/2002 (67 FR 18145) Minor editoral changes or no changes No
No

The only changes attributed to OMB affected two sentences regarding EO
12866 in the preamble-identifying this as a significant regulatory action
that was reviewed by OMB, but also noting that the rule was not an
economically significant action within the meaning of the executive order.

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

Occupational Injury and Illness Recording and Reporting Requirements;
Occupational Hearing Loss

Final rule

RIN 1218-AC06

Economically significant

OIRA review period: 05/24/2002 to 06/25/2002

Published 07/01/2002 (67 FR 44037) Other material changes

OIRA requested an additional explanation of OSHA's method of estimating
the number of recordable hearing loss cases. OSHA added a section in the
preamble in response to OIRA's request.

No No

However, the substantive insert in the preamble explained OSHA's
estimation of recordable hearing loss cases.

Occupational Injury and Illness Recording and Reporting Requirements

Proposed rule

RIN 1218-AC06

Economically significant

OIRA review period: 05/24/2002 to 06/25/2002

Published 07/01/2002 (67 FR 44124) Minor editoral changes or no changes

OIRA did not suggest or recommend any substantive changes to this rule.

(OSHA initiated the only substantive change made to the rule after it was
submitted for OIRA's review, deleting a section on state occupational
safety and health plans in the preamble. A section on state plans was
later reinserted in the version of the rule that was published in the
Federal Register. Documentation in the OIRA file for this rule showed that
OSHA had informed OIRA before reinserting the state plans section before
publication.)

No No

No changes were suggested by OIRA.

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

DOT-FAA Fees for FAA Services for Certain Flights

Final rule

RIN 2120-AG17

OIRA review period: 08/01/2001 to 08/06/2001

Published 08/20/2001 (66 FR 43680) Minor editoral changes or no changes No
No

No substantive changes were made to this rule.

Flight Operational Quality Assurance Program

Final rule

RIN 2120-AF04

OIRA review period: 07/30/2001 to 08/28/2001

Published 10/31/2001 (66 FR 55042) Minor editoral changes or no changes No
No

The only changes made to this rule were minor editorial revisions, such as
changing section headings.

Traffic Alert Collision Avoidance System

Proposed rule

RIN 2120-AG90

OIRA review period: 08/01/2001 to 10/18/2001

Published 11/01/2001 (66 FR 55506) Other material changes

FAA officials provided evidence that indicates that OIRA suggested
clarification to the cost-benefit section to be more explicit on how the
benefits were determined. Direct questions from OIRA indicate that OIRA
wanted the regulation evaluation to be more explicit regarding the rule's
likely benefits. According to FAA officials, changes made to the rule were
not major, although the rule did receive a postreview letter.

No No

(However, OIRA did suggest that DOT develop a more transparent analysis of
the benefits of the proposal.)

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

Certification of Pilots, Aircraft, and Repairmen for the Operation of
Light Sport Aircraft

Proposed rule

RIN 2120-AH19

OIRA review period: 12/17/2001 to 01/03/2002

Published 02/05/2002 (67 FR 5368) Other material changes

In response to issues raised by OIRA, FAA added a footnote to this rule
that explained consumer surplus benefits and also clarified that specific
accident data were not counted more than once. FAA officials characterized
these changes as clarifications.

(Note that a previous version of this rule was returned by OIRA to FAA for
reconsideration [see GAO ID 73 in the table on returned rules].)

No No

(However, in response to OIRA's review, FAA added information to clarify
and explain some of the information on benefits discussed in the rule.)

Reduced Vertical Separation Minimum in Domestic United States Airspace

Proposed rule

RIN 2120-AH63 (in the published rule) RIN 2120-AH68 (in OIRA's list of
reviewed rules)

OIRA review period: 04/12/2002 to 05/03/2002

Published 05/10/2002 (67 FR 31920) Minor editoral changes or no changes

According to FAA officials, only one paragraph was changed in the
regulatory evaluation, and FAA officials could not determine whether that
change was due to OIRA's suggestion. Further, the one change to the rule
was not substantive; it broke out components of a cost estimate without
changing the estimate itself.

No No

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

DOT-FMCSA Revision of Regulations and Application Form for
Mexican-Domiciled Motor Carriers to Operate in U.S. Municipalities and
Commercial Zones on the U.S.-Mexico Border

Final rule

RIN 2126-AA33

OIRA review period: 01/15/2002 to 03/01/2002

Published 03/19/2002 (67 FR 12652) Minor editoral changes or no changes

FMCSA considered the OIRA-suggested changes to be primarily editorial or
clarifying in nature and not substantive (such as substituting numbers for
percentages in a discussion of the cost-effectiveness of this rule).
However, there were substantive changes made by FMCSA.

No No

(However, FMCSA made changes to the burden-hour estimates for the
information collection associated with this rule.)

Application by Certain Mexican Motor Carriers to Operate Beyond U.S.
Municipalities and Commercial Zones on the U.S.-Mexico Border

Interim final rule

RIN 2126-AA34

OIRA review period: 01/15/2002 to 03/1/2002

Published 03/19/2002 (67 FR 12702) Other material changes

OIRA suggested some revisions or clarifications to descriptions in the
preamble and regulatory language of this rule, including noting the
applicability of immigration law, revising the rationale in some of
FMCSA's explanations or responses to public comments, and clarifying that,
under the North American Free Trade Agreement Annex, Mexican-domiciled
motor carriers may not provide point-to-point transportation services,
including express delivery services, within the United States, other than
international cargo. Other OIRA-suggested changes were largely minor
editorial changes, such as correcting the title of an application form and
substituting numbers for percentages in a discussion of the
cost-effectiveness of this rule.

No No

(However, FMCSA initiated changes to the Paperwork Reduction Act section
of the preamble after submission of the draft to OIRA. FMCSA's changes
slightly reduced the estimated burden of the information collection
associated with this rule.)

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

Safety Monitoring System and Compliance Initiative for Mexico-Domiciled
Motor Carriers Operating in the United States

Interim final rule

RIN 2126-AA35

OIRA review period: 01/15/2002 to 03/1/2002

Published 03/19/2002 (67 FR 12758) Other material changes

Although most of the changes OIRA suggested were minor (e.g., word
choice), one change in the preamble appeared to be material. At OIRA's
suggestion, FMCSA added Appendix A to Part 385 for clarification. This new
appendix informed Mexico-domiciled motor carriers of the evaluation
criteria that FMCSA would use to ensure compliance with the requirements
of this rule. A statement in the original draft that the statute requires
an examination of each Mexico-domiciled carrier's drivers upon entry was
also revised to say that the examination of drivers resulting from the
statute provision would allow inspection of each Mexico carrier's drivers
upon entry. Changes to the CFR that were attributed to OIRA appeared to be
minor, editorial changes (e.g., replacing "oversight program" with
"monitoring system"), as well as rewording and reordering of sentences.

                                     No No

Certification of Safety Auditors, Safety Investigators, and Safety
Inspectors

Interim final rule

RIN 2126-AA64

OIRA review period: 01/15/2002 to 03/01/2002

Published 03/19/2002 (67 FR 12776) Minor editoral changes or no changes

The two changes attributed to OIRA were not substantive as they dealt with
minor corrections to the rule. One of the suggested changes deleted a
redundant statement, and the other corrected the citation of a relevant
executive order (changing the citation from Executive Order 12866 to
Executive Order 13211).

No No

OIRA did not suggest or recommend any substantive changes to this rule.

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

Parts and Accessories Necessary for Safe Operation; Certification of
Compliance with Federal Motor Vehicle Safety Standards (FMVSS)

Proposed rule

RIN 2126-AA69

OIRA review period: 01/15/2002 to 03/01/2002

Published 03/19/2002 (67 FR 12782) Minor editoral changes or no changes No
No

The only change that was attributed as being made at the request of OIRA
was the deletion of a redundant statement in the preamble- regarding the
boilerplate section on the National Environmental Policy Act.

35 New Entrant Safety Other material changes No                            
      Assurance Process                                                       
                 The changes attributed to requests by OIRA Although the OIRA 
      Interim final rule in the draft rule or the regulatory evaluation       
      changes added several                                                   
             included (1) requesting comments on the requests for comments on 
      RIN 2126-AA59 resource cost to the economy of denying the potential     
      economic                                                                
      permanent registration, the effect on safety of effects and benefits of 
                                                                         this 
      Economically significant denying registration, and the assumptions rule 
                                                      and also clarified that 
                        FMCSA made regarding crash rate FMCSA would reimburse 
      OIRA review period: reductions, (2) attributing designation that states 
                                                          80 percent of costs 
          04/12/2002 to this was an economically significant rule to incurred 
                                                            conducting safety 
       05/06/2002 OMB rather than FMCSA, and (3) adding a audits, the changes 
                                                                      did not 
              statement on reimbursement to states of the affect the costs or 
                                                                     benefits 
      Published 05/13/2002 costs incurred in conducting safety audits (80 of  
      the rule.                                                               
      (67 FR 31978) percent). There were no changes to the                    
                               regulatory language.                           

                                       No

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

DOT-NHTSA Tire Pressure Monitoring Systems

Proposed rule

RIN 2127-AI33

Economically significant

OIRA review period: 07/05/2001 to 07/23/2001

Published 07/26/2001 (66 FR 38982) Significant changes

Changes identified in the material found in the NHTSA docket indicate that
OIRA suggested changes to discussions of cost and benefit estimates in the
proposed rule, in particular (a) adding statements to the preamble
regarding unquantified benefits and costs that might exist, (b) adding
estimates of total estimated costs of the two regulatory alternatives in
the proposal (original draft only provided estimates of average cost per
vehicle), (c) inserting additional information about the calculation of
some benefit estimates (e.g., range of injuries and deaths prevented,
stopping distance effects, and average tire life increases), and (d)
adding a discussion regarding the effect of human factors on the benefits
of tire pressure monitoring systems. Many of the OIRA-suggested inserts
included a request for public comments. At OIRA's suggestion, NHTSA also
deleted draft material about potential unquantified environmental
benefits.

Yes No

At OIRA's suggestion, statements were added that unquantified benefits and
costs may exist due to this rule, and public comments were requested on
this issue. OIRA also suggested the insertion of (a) additional estimates
of some costs and benefits, (b) added clarification or explanation of some
economic effects, and (c) requests for public comments on benefits and
costs of the proposed regulatory alternatives.

Light Truck Average Fuel Economy Standard Model Year 2004

Proposed rule

2127-AI68

Economically significant

OIRA review period: 01/10/2002 to 01/17/2002

Published 01/24/2002 (67 FR 3470) Other material changes No No

OIRA suggested the addition of an Energy Impact section. Although NHTSA
did not consider the addition of this section to be a substantive change,
it met our criteria for classifying the nature of the change in this rule
to be an "other material change."

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

Federal Motor Vehicle Improved Tire Safety Standards

Proposed rule

RIN 2127-AI54

Economically significant

OIRA review period: 12/17/2001 to 02/22/2002

Published 03/05/2002 (67 FR 10050) Minor editoral changes or no changes No
No

NHTSA officials could not recall any changes, substantive or
nonsubstantive, to this rule during OIRA's review.

Automotive Fuel Economy Manufacturing Incentives for Dual Fuel Vehicles

Proposed rule

RIN 2127-AI41

Economically significant

OIRA review period: 12/19/2001 to 02/22/2002

Published 03/11/2002 (67 FR 10873) Other material changes

Additional information was added to the introduction and background
sections of the preamble referring to the Energy Task Force and additional
public comments. There were also minor editorial changes throughout the
revised draft.

Although NHTSA did not consider OIRA's suggested changes to be
substantive, we classified the changes made to this rule as an "other
material change" to Other material changesbe consistent with our coding of
the level of changes observed in other rules.

                                     No No

Federal Motor Vehicle Safety Standards; Child Restraint Systems

Proposed rule

RIN 2127-AI34

OIRA review period: 02/26/2002 to 04/08/2002

Published 05/01/2002 (67 FR 21806) Minor editoral changes or no changes No
No

NHTSA officials confirmed that OIRA only suggested editorial changes on
two or three pages.

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

EPA-Office of Air and Radiation

Control of Emissions From Nonroad Large Spark-Ignition Engines and
Recreational Engines (Marine and Land-Based)

Proposed rule

RIN 2060-AI11

Economically significant

OIRA review period: 08/01/2001 to 09/14/2001

Published 10/05/2001 (66 FR 51098) Significant changes Yes

There were substantive comments and Deleting some of the changes from OMB
on the preamble, CFR regulatory scope from the section, and regulatory
support document for original version of this this rule. The most
substantive issue/change rule-covering regulation was "OMB's desire to not
move forward with of highway motorcycles the marine and highway motorcycle
portions and marine engines- of the proposal." would reduce the potential

total costs and benefits of the rule as originally submitted for OMB's
review.

(Note, however, that EPA then covered those engines in a separate rule-see
GAO ID 54.)

Yes

Many outside parties contacted OIRA regarding this rule, including
representatives of several environmental organizations (Natural Trails and
Waters Coalition, PIRG, Sierra Club, Bluewater Network, National Parks
Conservation Association - meeting held 08/29/2001); the National Marine
Maritime Association (meeting held 08/31/2001); the snowmobile industry
(Polaris Industries, Arctic Cat, Bombadier, and International Snowmobile
Manufacturers Association - meeting held 09/06/2001); and the Motorcycle
Riders Association (letter of 09/14/2001; meeting held 10/25/2001).

(Representatives of the Vice President's Office, the White House Council
of Economic Advisors, and the Small Business Administration also attended
these meetings.)

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

National Ambient Air Quality Standard for Ozone; Proposed Response to
Remand

Proposed rule

RIN 2060-ZA11

Economically significant

OIRA review period: 08/27/2001 to 10/25/2001

Published 11/14/2001 (66 FR 57268) Minor editoral changes or no changes

There were only three minor changes in the preamble attributed to OMB. All
three changes appeared to be rewording (rather than deleting or adding
information) of statements in the submitted version regarding EPA's views
about effects "using plausible but highly uncertain assumptions."

                                     No No

Regulation to Establish New Date Receipt of Summer Grade Reformulated
Gasoline at Terminals

Proposed rule

RIN 2060-AJ79

OIRA review period: 10/24/2001 to 11/16/2001

Published 12/03/2001 (66 FR 60163) Other material changes

Changes were made to the preamble, CFR section, and regulatory support
document, although the CFR changes would probably not be considered
substantive even using a "possibly substantive" definition. In the
preamble, material was added regarding (a) the dates when terminals can
receive summer grade reformulated gasoline (RFG), (b) explanations of the
costs of producing more summer grade and less winter grade RFG, (c) an
explanation of the requirement to petition EPA for approval to transfer
dirty blendstocks (with a request for comment on the issue), (d)
classification of this rule as a significant regulatory action under EO
12866, and (e) reporting burden comments from the National Petrochemical
and Refiners Association in response to a related EPA information
collection request. Original material regarding requirements for
transferring blendstocks was deleted from the preamble. In the CFR section
the only changes were incorporation by reference of a standard test method
and some minor edits. The technical support document was changed to
specify dates when terminals are required to receive summer grade RFG and
to add explanatory details on the costs of producing more summer grade
RFG.

No No

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

National Emission Standards for Hazardous Air Pollutants: Organic Liquid
Distribution (Non-Gasoline)

Proposed rule

RIN 2060-AH41

OIRA review period: 06/18/2001 to 09/19/2001

Published 04/02/2002 (67 FR 15674) Other material changes

Changes attributed to OMB in the preamble of the rule included (a) a new
section regarding Executive Order 13211, discussing energy effects of the
rule, (b) new language reflecting the rule's impact on organic liquid
distribution sources, and (c) a request for comments from the public
regarding the accuracy of EPA's cost impact estimates. There were also
minor editorial changes throughout the preamble. There were no changes to
the regulatory language in the CFR section of the proposed rule.

                                     No No

National Emission Standards for Hazardous Air Pollutants: Miscellaneous
Organic Chemical Manufacturing and Miscellaneous Coating Manufacturing

Proposed rule

RIN 2060-AE82

OIRA review period: 06/18/2001 to 09/21/2001

Published 04/04/2002 (67 FR 16154) Minor editoral changes or no changes

EPA docket materials appeared to identify many changes suggested by the
Small Business Administration's (SBA) Office of Advocacy, but the only
evidence of a change suggested by OMB was an e-mail message suggesting a
rewrite of two explanatory sentences in the preamble.

(A side-by-side comparison of the submitted and cleared versions of this
rule in OIRA's files indicated that there were many changes but without
attribution of the sources of those changes.)

No No

Although there was no evidence of OMB/OIRA contacts with outside parties
during the formal review period for this proposal, the EPA docket files
did document a presentation by industry representatives to OMB and SBA's
Office of Advocacy (not attended by EPA) in August 2000.

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

NESHAP: Petroleum Refineries; Catalytic Cracking Units, Catalytic
Reforming Units and Sulfur Recovery Units

Final rule

RIN 2060-AF28

OIRA review period: 08/29/2001 to 11/27/2001

Published 04/11/2002 (67 FR 17762) Minor editoral changes or no changes No
No

The EPA docket had an OMB review cover sheet indicating "no substantive
changes." The person in charge of developing this rule confirmed that
OMB's review resulted in only a few very minor editorial changes.

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

National Emission Standards for Hazardous Air Pollutants; Surface Coating
of Metal Furniture (Surface Coating)

Proposed rule

RIN 2060-AG55

OIRA review period: 06/18/2001 to 10/24/2001

Published 04/24/2002 (67 FR 20206) Other material changes

Changes in the preamble to address OMB comments primarily inserted
material for clarification and to request comments. For example, language
was added to ask for comments on EPA's maximum achievable control
technology (MACT) floor, EPA's conclusion that the creation of
subcategories was not warranted for these standards, EPA's decision to
reject regulatory options more stringent than the MACT floor, and whether
there were alternative means of monitoring performance for add-on controls
at source facilities that would be as effective and less expensive than
the proposed requirements. In response to OMB's comments, EPA also asked
that commenters provide information in support of their comments. More
detailed explanations were added regarding (a) the subcategories issue,
(b) a requirement to determine the mass of organic hazardous air
pollutants in coatings, thinners, and cleaning materials, (c) monitoring
systems, and (d) the explanation of the equation for calculating hazardous
air pollutant emissions.

Changes in the CFR section to address OMB comments included modifying (a)
the applicability section of the rule to clarify applicability where a
potential overlap may exist with EPA's wood furniture rule and (b) the
equation for calculating hazardous air pollutant emissions.

(Note that there was also a substantive change regarding the proposed
emission limits-which, in turn, affected the estimated costs and benefits
of the rule-but the materials in EPA's docket indicated that the change
was due to EPA's own reanalysis of emissions data received from firms.)

No No

(Substantive changes to the potential costs and benefits of the rule were
not attributed to a change suggested by OMB but rather to a change EPA
made to the proposed emission limits after reanalysis of emissions data
submitted by facilities. The revised limits were less stringent than
originally proposed, leading to lower costs and lower projected emission
reductions.)

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

Revisions to Regional Haze Rule to Incorporate Sulfur Dioxide Milestones
and Backstop Emissions Trading Program for Nine Western States and
Eligible Indian Tribes

Proposed rule

RIN 2060-AJ50

OIRA review period: 11/29/2001 to 02/22/2002

Published 05/06/2002 (67 FR 30418) Other material changes

There were only a few changes in the preamble-for example, deleting some
requests for comments and an explanatory section on why EPA was deferring
to the Western Regional Air Partnership's (WRAP) judgment on the issue of
critical mass and inserting a footnote in response to issues raised in a
meeting with the Center for Energy and Economic Development (CEED). There
were no changes in the CFR section.

(WRAP is a collaborative effort of tribal governments, state governments,
and various federal agencies to implement the Grand Canyon Visibility
Transport Commission's recommendations and develop tools to comply with
EPA's regional haze regulations. CEED is a national, nonprofit
organization formed by the nation's coal-producing companies, railroads, a
number of electric utilities, equipment manufacturers, and related
organizations that advocates on behalf of the long-term viability of
coal-based electricity generation in America.)

No Yes

WRAP and CEED sent letters to OIRA on this rule, and CEED requested an EO
12866 meeting with OMB on the rule. The EPA docket included a copy of a
02/05/2002 CEED letter to Dr. Graham (not found in the OIRA files) and an
e-mail from OIRA to EPA noting that a meeting had been scheduled at CEED's
request on that date (no record found in OIRA's files). A 02/15/2002
letter from WRAP to Dr. Graham appeared in OIRA's docket.

Control of Emissions of Air Pollution From New Marine Compression Ignition
Engines At or Above 30 Liters/Cylinder

Proposed rule

RIN 2060-AJ89

OIRA review period: 04/15/2002 to 04/30/2002

Published 05/29/2002 (67 FR 37548) Significant changes

Docket materials indicated that EPA moved from proposing to considering
second tier emission standards. Specifically, OIRA edits systematically
suggested changing language regarding certain emission [Tier 2] standards
from statements "proposing" the adoption of these standards to statements
that EPA was only "considering" adoption of the standards.

Unclear

Material in the OIRA files indicated that, although the regulatory support
document was amended, the revisions did not affect the estimates of costs
and benefits for this proposed rule. However, it seems that a shift from
actually proposing to just considering adoption of particular emission
standards should have had some effect on the rule's potential costs and
benefits.

                                       No

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

Consolidated Emissions Reporting Rule

Final rule

RIN 2060-AH25

OIRA review period: 08/27/2001 to 11/26/2001

Published 06/10/2002 (67 FR 39602) Significant changes

Per review of the Paperwork Reduction Act portion of this rule, OMB raised
concerns about one portion of the Information Collection Request (ICR). In
response, EPA elected to delay compliance with that portion of the ICR,
rather than delay the compliance date of the rule. With this change,
states would not have to commence reporting point source emissions for two
types of emissions until 06/01/2004, or later, if EPA fails to publish an
approved revised ICR.

Unclear No

Delaying commencement of reporting for one subsection of the rule might
have a marginal effect on the projected costs and benefits of states'
reporting on emissions.

National Emission Standards for Hazardous Air Pollutants; Surface Coating
for Wood Building Products

Proposed rule

RIN 2060-AH02

OIRA review period: 09/07/2001 to 12/07/2001

Published 06/21/2002 (67 FR 42400) Significant changes

Changes were made in both the preamble and CFR sections of the proposal.
The most substantive change attributed to a request from OMB was in the
CFR section-delaying the compliance dates in two provisions from 2 years
to 3 years after the date of publication of the final rule.

At OMB's request, language also was inserted throughout the preamble
requesting specific comments on various aspects of products and activities
EPA selected for coverage in this rule. Requests were also inserted for
data on potential costs and burdens of the rule and how they might differ
by subcategories of emission sources.

Yes No

The most substantive change in the proposed regulatory language would
delay compliance dates for two of the rule's provisions.

(Note also that some of the changes in the preamble raised questions and
solicited comments about the cost-effectiveness of elements of this
proposal.)

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

Proposed Rule for Compliance Program Fees for Light-Duty Vehicles and
Engines; Heavy-Duty Vehicles and Engines; and Nonroad Engines and
Motorcycles

Proposed rule

RIN 2060-AJ62

OIRA review period: 02/01/2002 to 04/22/2002

Published 08/07/2002 (67 FR 51402) Significant changes

Lengthy inserts were made to the preamble and the regulatory language in
the CFR section. The most substantive change appeared to be the insertion
of an entire new section on how to qualify for reduced fees within the
regulatory provisions of the CFR section. The changes that appeared to be
most substantive in the preamble included: (a) inserting requests for
comments regarding many aspects of the proposed fee system (e.g., on
minimum fees, alternative ways to adjust fees for inflation, various
process questions, and EPA's cost analysis), (b) adding material on
special provision fee payments and applications for certain types of
manufacturers (and deleting the previous version of the basis for fee
schedules), (c) adding clarifying material defining how to calculate a
vehicle's average retail value, and (d) adding a Paperwork Reduction Act
section.

No No

The changes primarily affected the explanations of fee payments and
application processes, including clarification of how to qualify for
reduced fees, but did not change EPA's estimated costs of the proposed
rule.

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

Proposed Non-Conformance Penalties for 2004 and Later Model Year Emission
Standards for Heavy-Duty Diesel Engines and Heavy-Duty Diesel Vehicles

Proposed rule

RIN 2060-AJ73

OIRA review period: 12/10/2001 to 12/20/2001

Published 08/08/2002 (67 FR 51464) Significant changes

The most significant comments and edits conveyed from OIRA to EPA on this
rule addressed: (a) rewriting a section about an additional adjustment to
"level the playing field" and the assumptions used by EPA (OIRA's position
was that this secondary adjustment was not necessary), (b) discount rate
(OIRA's position was that, per OMB Circular A-94, it was more appropriate
to use a discount rate of 7 percent consistently throughout the rule and
regulatory impact analysis-in some instances EPA had used a 3 percent
discount rate, citing a recommendation by EPA's Science Advisory Board),
(c) fuel prices (OIRA's position was that the estimated fuel price EPA
used in its draft was excessive, and OIRA suggested that EPA instead use a
3-to 5-year average of nationwide fuel prices), (d) significance of this
proposed rule (OIRA's position was that the proposed rule was significant
and potentially economically significant in light of the estimated
nonconformance penalties), and (e) cost estimation (OIRA's position was
that the basis for the cost estimates was unclear, among other issues, and
OIRA suggested that EPA clarify and explicitly discuss its estimation
method).

(The proposed rule as published solicited comments on use of discount rate
other than 7 percent and on using a 5-year average of fuel prices. In the
final rule, EPA based its analysis on use of a 7 percent discount rate and
a 5-year average for the price of fuel.)

Unclear

Overall, the actual economic impact of the rule (and any changes made to
it) is unclear because the use of nonconformance penalties by
manufacturers is optional. According to EPA, manufacturers are likely to
choose whether or not to use nonconformance penalties based on their
ability to comply with emissions standards. Nevertheless, changes
regarding the discount rate and fuel price could have an effect on the
potential costs and benefits of this rule. (A higher discount rate reduces
the present value of future costs and benefits compared to more immediate
costs and benefits.) In particular, the discount rate changes appeared to
result in a slight decrease in the penalty amounts cited in the rule once
the discount rate is changed to 7 percent. (As noted in the revised
version of the Technical Support Document section, "Penalty Sensitivity to
Discount Rate" the net effect of using a smaller discount rate would
generally be penalties that were higher.)

Yes

OIRA was contacted before the formal review period by industry
representatives from Cummins Inc. (letters to OIRA on 09/13/2001,
10/12/2001, and 11/07/2001; meeting with OIRA on 10/01/2001) and
Caterpillar Inc. (letter on 10/25/2001 and meeting on 11/14/2001), but
there was no evidence of outside contacts within the formal review period
for this proposed rule.

(There were also many other documents on outside contacts in the dockets
for this rulemaking, but they were dated during OIRA's formal review
period for the final version of the rule.)

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

Control of Emissions from Spark Ignition Marine Vessels and Highway
Motorcycles

Proposed rule

RIN 2060-AJ90

OIRA review period: 01/16/2002 to 04/16/2002

Published 08/14/2002 (67 FR 53050) Significant changes

There were substantive changes in the preamble and the regulatory support
document, along with minor editorial changes. However, there did not
appear to be any substantive changes in the regulatory language of the CFR
section.

Substantive changes were made in the regulatory support document regarding
some of the cost-benefit, and cost-effectiveness estimates (e.g., cost per
motorcycle, cost increases, and fuel savings rates). In the preamble, the
sections on regulatory flexibility alternatives and the Paperwork
Reduction Act were expanded, while original language was deleted regarding
(a) previous standards accomplishing little more than a phase-out of
two-stroke engines, (b) the contributions of motorcycles and marine
engines to total U.S. emissions, (c) use of catalysts and safety concerns
for marine engines, (d) a request for comment on whether banking or
trading emission credits should be incorporated into the program, (e)
total increased costs per motorcycle, (f) a statement that fuel savings
offset cost of emission controls, and (g) a conclusion regarding cost per
ton of emission reduction.

Yes

The docket materials identified changes in cost-benefit and
cost-effectiveness estimates for this rule. In aggregate, the estimated
annual cost to manufacturers was reduced by $4 million per year and the
estimated annual fuel savings was increased by $4.3 million per year.

Yes

Although there was no evidence of direct contact from outside parties
during the formal review period for this rule, OMB had meetings with and
received letters from several groups (representing both industry and
environmental interests) on a previous related rule-GAO ID 41, from which
this rule was spun off.

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

                EPA-Office of Solid Waste and Emergency Response

Hazardous Waste Management System; Standardized Permit Corrective Action;
and Financial Responsibility for RCRA Hazardous Waste Management
Facilities

Proposed rule

RIN 2050-AE44

OIRA review period: 05/10/2001 to 07/19/2001

Published 10/12/2001 (66 FR 52192) Other material changes

Among the revisions attributed to OMB in the preamble were (a) adding
several inserts requesting comments on various aspects of the rule (e.g.,
on ways to reduce the burden and cost of the permitting process), (b)
adding a statement that storage of hazardous waste military munitions
should continue under the individual permitting program, (c) deleting a
short section proposing that "the regulatory agency may itself choose to
initiate your conversion to a standardized permit," (d) adding an
explanation of current regulatory responsibilities if a generator sends
waste off-site for land disposal, (e) adding several paragraphs explaining
the option of not requiring a closure plan, (f) deleting much of a
paragraph discussing differences between closure cost estimates prepared
using EPA's methodology and the estimates from owners and operators (but
leaving in a request for actual cost data and a discussion of six options
EPA considered for developing cost estimates), (g) adding a reference to
an estimation option that has a larger reduction of burden associated with
cost estimating but tends to produce higher cost estimates, and (h) adding
a paragraph regarding the level of detail required for compliance audits.
In the CFR section, the only material change was adding language to
clarify which parts of Title 40 CFR section 124.10 apply to the Resource
Conservation and Recovery Act (RCRA) standardized permit. There were also
minor editorial changes throughout the revised rule.

No No

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

Identification and Listing of Hazardous Waste; Addition of Manganese to
Appendix VIII; Inorganic Chemical Manufacturing Waste; and CERCLA
Hazardous Substance Designation and Reportable Quantities

Final rule

RIN 2050-AE49

OIRA review period: 09/26/2001 to 10/31/2001

Published 11/20/2001 (66 FR 58258) Significant changes

Substantive changes were made throughout the preamble and CFR section of
the notice in response to OMB's comments. Specifically, the rule as
cleared by OMB deferred final action on all elements of the original
proposal related to the waste constituent manganese (e.g., adding
manganese as a regulated hazardous constituent).

Yes

Deferring regulatory action on manganese would also defer potential costs
and benefits of the regulatory actions originally proposed by EPA.

Yes

OIRA was contacted by industry representatives from the Steel
Manufacturers Association and American Iron and Steel Institute (sent
letters 09/28/2001 and 10/19/2001; met with OIRA 10/16/2001), Cookson
Group (sent letters 09/26/2001 and 10/18/2001), and Eastman (sent letter
10/08/2001).

The OIRA files also indicated that OIRA reviewed materials sent by some of
these groups to the RCRA Information Center. Cookson Group also requested
a meeting with OIRA.

Resource Conservation and Recovery Act Burden Reduction Initiative; Office
of Solid Waste Burden Reduction Project

Proposed rule

RIN 2050-AE50

OIRA review period: 08/02/2001 to 10/15/2001

Published 01/17/2002 (67 FR 2518) Minor editoral changes or no changes No
No

EPA told us they made no substantive changes to the rule. The sensitivity
analysis requested by OMB also did not result in any changes to the rule.

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

Amendments to the Corrective Action Management Unit [CAMU] Rule

Final rule

RIN 2050-AE77

OIRA review period: 11/14/2001 to 12/19/2001

Published 01/22/2002 (67 FR 2962) Other material changes

The changes attributed to OMB in the redline/strikeout document were all
in the preamble of the rule. In addition to several minor editorial
changes (e.g., correcting spelling), changes attributed to OMB included
(a) adding a couple of sentences to a paragraph discussing differences
between generic minimum national design and operation standards for
disposal units and requirements for site-specific clean-ups, (b) rewording
and clarifying some statements and responses to public comments regarding
a proposed "discretionary kickout provision," (c) clarifying in one
sentence, as stated previously in the same section, that the final
regulation covers both listed and characteristic wastes, and (d) deleting
some of the text explaining why EPA was not further extending the comment
period.

(Note that the most substantive change from the original draft to the
published version of the rule-adding a new provision about allowing
disposal of "CAMU-eligible wastes" in off-site hazardous waste
landfills-was not attributed to OMB.)

                                     No No

NESHAPS: Standards for Hazardous Air Pollutants for Hazardous Waste
Combustors

Interim final rule

RIN 2050-AE79

OIRA review period: 01/09/2002 to 01/18/2002

Published 02/13/2002 (67 FR 6792) Minor editoral changes or no changes No
No

The only changes marked were in the preamble, and all appeared to be
minor. There were no changes in the CFR section of the rule.

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

NESHAPS: Standards for Hazardous Air Pollutants for Hazardous Waste
Combustors

Final rule

RIN 2050-AE79

OIRA review period: 01/09/2002 to 01/18/2002

Published 02/14/2002 (67 FR 6968) Minor editoral changes or no changes No
No

The only two changes clearly marked in the redline/strikeout document were
in the preamble and appeared to be minor. There were no changes in the CFR
section of the rule.

Gasification of Hazardous Oil-Bearing Secondary Materials from the
Petroleum Refining Industry to Produce Synthesis Gas Fuel

Proposed rule

RIN 2050-AE78

OIRA review period: 10/17/2001 to 01/15/2002

Published 03/25/2002 (67 FR 13684) Other material changes

There were changes on most of the pages in the revised version of the
rule. All of the substantive changes were in the preamble, including
sizeable insertions of text that provided explanatory information not in
the original version of the rule. In particular, there were lengthy
inserts requesting comments on a variety of issues and options and also
new text regarding the potential economic impacts. There were also many
minor editorial changes throughout the preamble and some rewording in the
CFR section.

No No

The changes regarding potential economic impacts just provided more
explanation of the potential benefits of this rule. The estimated costs
and benefits did not change.

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

Hazardous Waste Management System; Modification of the Hazardous Waste
Program; Cathode Ray Tubes and Mercury-Containing Equipment

Proposed rule

RIN 2050-AE52

OIRA review period: 12/21/2001 to 02/13/2002

Published 06/12/2002 (67 FR 40508) Minor editoral changes or no changes

According to EPA, the only change made at the suggestion of OMB was that
EPA solicited comments on extending the speculative accumulation time of
used, broken CRTs to "two or more years" instead of just "two years." A
line-by-line comparison of the revised and original versions of the rule
in the OIRA docket confirmed only minor changes in the preamble and no
changes evident in the CFR section of this rule.

No No

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

Oil Pollution Prevention Regulation: Non-Transportation-Related Onshore
and Offshore Facilities; Revisions

Final rule

RIN 2050-AC62

OIRA review period: 04/27/2001 to 10/15/2001

Published 07/17/2002 (67 FR 47042) Other material changes

The following changes were attributed to OMB in the preamble of the rule:
(a) added two sentences to note that EPA will continue to evaluate and
intends to request additional data and comments on the issue of modifying
secondary containment requirements for small electrical and other types of
equipment that use oil for operating purposes, (b) deleted a total of 10
sentences in a section about discretionary provisions in the rule-all
appeared to be related to wording changes or additional clarifications in
response to comments, (c) expanded a paragraph regarding appropriate
methods of secondary containment (e.g., factors to consider in determining
whether to install double-walled piping), (d) added a few sentences to a
paragraph in which EPA withdrew a proposed 72-hour impermeability standard
that was in the proposed rule, (e) added two sentences explaining an
editorial change made to one of the rule's provisions (deleting
unnecessary words), and (f) added sentences in a response to public
comments to note that EPA will continue to evaluate whether provisions for
secondary containment found in section 112.7(h)(1) should be modified or
revised and that EPA intends to publish a notice asking for additional
data and comment on this issue. The only two changed sentences in the CFR
section appeared to reflect minor editorial wording changes.

No No

(However, the docket materials did show that EPA provided OIRA
supplemental cost analyses as part of the revised version of the rule.)

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

                              EPA-Office of Water

National Primary Drinking Water Regulations: Arsenic and Clarifications to
Compliance and New Source Contaminant Monitoring

Proposed rule

RIN 2040-AB75

OIRA review period: 06/22/2001 to 07/13/2001

Published 07/19/2001 (66 FR 37617) Other material changes

The significant OMB changes identified by the EPA memo were all in the
preamble. (There was no regulatory language associated with this
proposal.) EPA made changes to the following seven aspects of the preamble
as a result of discussions with OMB: (1) changed questions in the requests
for comments to be identical to the language used in the charges to the
three review panels, (2) expanded the description of uncertainties in risk
analysis, (3) included information specific to the recommendations from
the Science Advisory Board on treatment technologies and from a Science
Advisory Board advisory committee on latency and income adjustments, (4)
expanded the description of latency and other income adjustments, (5)
included several clearly worded references to the health date relating
primarily to arsenic research at levels above 50 parts per billion (ppb),
and the extent to which that affects uncertainties associated with
benefits of reducing arsenic below 50 ppb, (6) made editorial changes to
the small system section to clearly indicate that EPA identified
affordable technologies, so small system variances will not be an option,
and (7) included additional wording about providing a small government
agency plan under section 203 of the Unfunded Mandates Reform Act.)

No No

(However, the OMB docket did include copies of letters and comments dated
prior to the publication of the previous related rulemaking on
01/22/2001.)

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

Minimizing Adverse Environmental Impact From Cooling Water Intake
Structures at New Facilities Under Section 316(b) of the Clean Water Act,
Phase I

Final rule

RIN 2040-AC34

OIRA review period: 09/10/2001 to 11/08/2001

Published 12/18/2001 (66 FR 65256) Significant changes

Five major changes to the rule were attributed to OIRA, all of which
appeared to provide greater flexibility and more alternatives to
compliance with requirements and standards in the original draft of the
rule. OIRA's five main changes were to (a) add criteria that would allow
more facilities to qualify for lower performance standards, (b) change
requirements so that facilities withdrawing between 2 million gallons per
day (MGD) and 10 MGD did not have to reduce intake flow to a minimum level
commensurate with that attained by a closed-cycle recirculating cooling
water system, (c) change a requirement so that facilities only needed to
use screens to minimize impingement mortality of fish and shellfish if
certain criteria were met, (d) add an exception to intake flow
requirements regarding cooling water intake structures located in a lake
or reservoir, and (e) add "restoration measures" as a compliance
alternative under the "Track II" compliance alternative so that intake
structure operators may implement measures that "result in increases in
fish and shellfish."

Yes

OIRA's changes would likely reduce the costs of the rule by providing
regulated entities more flexibility and alternatives to compliance with
the original standards and requirements of the rule. Their effect on
potential benefits is not clear. Changes to the cost estimates were
evident in the published version of the rule.

Yes

OMB met with Riverkeeper on 09/27/2001, and with representatives from
Edison Electric Institute and EOP Group) on 10/29/2001.

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

National Primary Drinking Water Regulations: Long-Term 1 Enhanced Surface
Water Treatment Rule

Final rule

RIN 2040-AD18

OIRA review period: 06/13/2001 to 09/24/2001

Published 01/14/2002 (67 FR 1812) Significant changes

Although the EPA docket memo first stated that OMB had no significant
comments on this rule, it went on to a long discussion about two major
policy issues raised by OMB concerning (a) special primacy requirements
for states and (b) the valuation of the cost of Cryptospirdiosis used in
the economic analysis accompanying the final rule. The memo noted that
both of these issues were elevated to Dr. Graham (OIRA) and Tracy Mehan
(EPA Office of Water). OMB agreed to remove their objections to the
special primacy requirements in this rule, but indicated intent to raise
this issue in subsequent Safe Drinking Water Act regulatory packages. To
address OMB's concerns about the valuation issue, the Office of Water and
OMB agreed to expand this rule's benefit range by using two
cost-of-illness values instead of one. The memo stated that other OMB
comments were editorial in nature.

(Note that the redline/strikeout document also shows many other changes in
the preamble. It was not clear whether these were changes that were not
made at the suggestion of OMB or whether the author of EPA's Executive
Order 12866 compliance memo did not consider changes to the preamble to be
substantive.)

Yes No

In response to OMB's concern about EPA's valuation of the cost of
Cryptospirdiosis used in the economic analysis, OMB and the Office of
Water agreed to expand the rule's benefit range by using two
cost-of-illness values instead of one. This second COI estimate that was
added was lower and only valued lost work time and medical costs
associated with Cryptospirdiosis. The other estimate remained the same as
EPA's original and valued all loss categories included in the original
published study used by EPA (valuing losses for medical costs, work time,
productivity, and leisure time).

Effluent Guidelines and Standards for the Meat Products Point Source
Category (Revisions)

Proposed rule

RIN 2040-AD56

OIRA review period: 12/21/2001 to 01/28/2002

Published 02/25/2002 (67 FR 8582) Other material changes

OMB and SBA suggested changes in two sections of the preamble of the
proposed rule. In response to those suggestions, EPA: (a) revised the
pretreatment discussion in the preamble to restate the results from EPA's
preliminary data collection on meat and poultry product indirect
dischargers and related POTW interference events and (b) added a lengthy
paragraph in response to OMB's and SBA's request to provide a more
thorough explanation of how EPA developed four different production size
classifications for each meat and poultry product subcategory.

No No

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

National Pollutant Discharge Elimination System: Proposed Regulations to
Establish Requirements for Large Cooling Water Intake Structure at
Existing Power Generating Facilities

Proposed rule

RIN 2040-AD62

Economically significant

OIRA review period: 12/28/2001 to 02/28/2002

Published 04/09/2002 (67 FR 17122) Significant changes

EPA identified major changes made at the suggestion or recommendation of
OIRA in both the preamble and CFR sections of the proposed rule. Overall,
these OIRA changes lowered the performance standard in the rule and made
compliance requirements more flexible by allowing, among other things,
options for a site-specific approach to minimizing environmental harm. The
changes also broadened a restoration option, whereby firms may restore
environmental harm rather than comply with the designated performance
standard.

Many changes to the proposed rule language in eight sections of the
proposed CFR amendments were attributed to OIRA. The most extensive
changes were to sections 125.94 (10 of 14 major changes in this section
were attributed to OIRA) and 125.95 (previously 125.96 - all 7 major
changes identified in this section were attributed to OIRA). For example
OIRA suggested removing a requirement that facilities in estuaries and
tidal waters withdrawing greater than 1 percent of the tidal excursion
volume, and oceans withdrawing greater than 500 MGD meet performance
standards for reducing mortality and entrainment based on reducing flow
commensurate with a closed-cycle, recirculating cooling system and
replaced it with a requirement for all facilities in estuaries, tidal
rivers, and oceans (regardless of flow) to reduce both impingement
mortality and entrainment based on the performance of fish return systems
and fine mesh screens. OIRA also suggested broadening the scope of
restoration measures to allow use under all compliance alternatives,
adding language that allows restoration measures to be used in lieu of
design and construction technologies and operational measures to meet
performance requirements of the rule.

Yes

OIRA recommended that EPA select a regulatory alternative that OIRA
believed would yield substantially greater net benefits. The approach that
EPA originally proposed would have cost an estimated $610 million per
year, with estimated benefits of $890 million per year, yielding net
benefits of $280 million. However, OIRA recommended that EPA select
another approach that, while having estimated benefits of $735 million,
was expected to cost only $280 million, yielding net benefits of $455
million.

Yes

Industry groups, such as Edison Electric Institute, EOP Group, and
Cinergy, sent letters and provided materials to OIRA. Representatives of
those groups and Public Service Electric and Gas, TXU, Progress Energy,
Teco Energy, Constellation Energy Group, Allegheny Energy, Minnesota
Power, and Migrant Corp. met with OIRA on 02/08/2002. Riverkeeper (an
environmental interest group) met with OMB on 02/07/2002.

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

Final Revisions to the Clean Water Act Regulatory Definition of "Fill
Material" and "Discharge of Fill Material"

Final rule

RIN 2040-AD51

OIRA review period: 05/01/2002 to 05/02/2002

Published 05/09/2002 (67 FR 31129)

(Note that this was a joint rulemaking of the Department of the Army's
Corps of Engineers and EPA.)

Significant changes

The most substantive change attributed to OIRA in the preamble and
regulatory language of the rule revised the definition of fill material as
follows - "The term fill material does not include trash,or garbage, or
similar materials unless such materials are to be used to create any
structure or infrastructure in waters of the United States, such as an
artificial reef or berm. (According to an EPA official, the impact of the
change was to make the definition clearer so that fill material permit
applicants could not ask to use trash or garbage as fill material in
creating a structure or infrastructure.) Many of the other OIRA-suggested
changes revised discussions of relevant court actions and decisions
related to this rulemaking.

Unclear No

Revising original regulatory There was no evidence

language to exclude the of contact before or

possible use of trash, during OIRA's formal

garbage, or similar review. However, in a

materials as fill material for joint letter dated

some purposes might 05/03/2002, one day

affect potential costs and after OIRA cleared this

environmental benefits.	rule, 10 environmental groups-American Rivers,
Clean Water Action, Earthjustice, Friends of the Earth, League of
Conservation Voters, Mineral Policy Center, National Audubon Society,
National Wildlife Federation, Natural Resources Defense Council, and the
Sierra Club-contacted Dr. Graham regarding this rule.

(The OIRA files also included a newspaper article that referred to a
meeting between the National Mining Association andOMB on 04/06/2001.
However, meeting records we reviewed indicated only that EPA attended a
meeting with the National Mining Association on that date; there was no
mention of whether anyone from OMB also participated.)

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

70 Effluent Limitation Significant changes Unclear                         
      Guidelines and New                                                      
       Source Performance There were substantive changes in both the The memo 
                                                              in EPA's docket 
      Standards for the proposed regulatory options in the CFR regarding OIRA 
      changes                                                                 
      Construction and amendments and the preamble discussion of did not      
      directly address                                                        
      Development Category those regulatory options. At the suggestion        
      whether there were                                                      
             or recommendation of OIRA, the proposed changes in the potential 
      Proposed rule regulation no longer included the storm water costs and   
      benefits of the                                                         
           management or postconstruction regulatory rule. The EPA docket did 
      RIN 2040-AD42 options from the original draft. Also, the not include    
      sufficient                                                              
       active construction options were changed to information to allow for a 
      Economically significant identify and discuss the following three       
      detailed comparison of                                                  
              regulatory options: (1) inspection and revised cost and benefit 
           OIRA review period: certification of construction site erosion and 
                                                    data. However, the nature 
        03/01/2002 to sediment controls, for sites one acre or of the changes 
                                                                  made to the 
           05/15/2002 larger, (2) codification of the Construction regulatory 
                                                               options should 
                   General permit plus inspection and have had some effect on 
      Published 06/24/2002 certification requirements, for sites five acres   
      the proposed rule's                                                     
      (67 FR 42644) or larger, and (3) no regulation. The potential costs and 
              revisions to the regulatory proposal required benefits.         
                     corresponding revisions to the preamble.                 

Yes

The OIRA files on this rulemaking included a document from the ELG Working
Group (a coalition of interested trade associations) entitled "Issues
Raised By The Construction and Development Effluent Limitations Guidelines
Working Group Before the White House Office of Management and Budget
Office of Information and Regulatory Affairs" (dated 02/04/2002 - about 1
month prior to the formal review period).

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                         (Continued From Previous Page)

Evidence that OMB/OIRA Evidence that outside Executive order review Nature
of most significant OMB/OIRA changes affected costs parties contacted GAO
ID submission changes or benefits OMB/OIRA

Effluent Limitations Guidelines, Pretreatment Standards, and New Source
Performance Standards for the Iron and Steel Manufacturing Point Source
Category

Final rule

RIN 2040-AC90

OIRA review period: 03/29/2002 to 04/30/2002

Published 10/17/2002 (67 FR 64216) Significant changes Unclear

At the suggestion of OMB, EPA revised the As described in the existing
regulation and supporting preamble regulation that this rule was
discussion for the "water bubble" provision (a amending, the water
voluntary regulatory flexibility mechanism to bubble provision had a allow
for trading of identical pollutants at any minimum net reduction single
steel facility with multiple compliance provision-if a facility used
points). This change eliminated an existing this tool, the amount of the
minimum net reduction provision that had pollutant discharges applied if
facilities used the water bubble pursuant to the bubble had alternative.
to be 10 percent to 15

percent less than the discharges otherwise authorized by the rule without
the bubble. At the suggestion of OMB, the revised final rule eliminated
this minimum net reduction provision.

However, the net effect on costs and benefits of this rule are unclear.
While this change eliminated a requirement for additional reductions in
pollutant discharges if the water bubble tool is used, it also provided
greater flexibility for facilities to use this tool to achieve the overall
pollutant reductions required by 40 CFR 420 at the least cost.

Yes

Representatives of industry groups contacted OIRA prior to OIRA's formal
review period for this rulemaking. On 03/04/2002, representatives of the
Steel Manufacturers Association and the Specialty Steel Industry of North
America sent a letter to Dr. Graham with comments anda request for a
meeting. On 03/19/2002, OIRA held a meeting with steel industry
representatives (including those who requested the meeting on March 4).

(Note also that the OIRA files on its review of this rule indicated that
OIRA had reviewed the substantive comments from the proposed rule stage.
The water bubble provision was the subject of some of the public comments
on the proposed rule, with industry groups generally supportive of
expansions of the water bubble flexibilities and environmental groups
supportive of restrictions on the water bubble.)

Source: GAO analysis.

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

    Table 8: Findings and Determinations for Rules Returned to Agency after
                               Submission to OIRA

                                                                Evidence of   
                                         Evidence that outside     subsequent 
                                                       parties       activity 
          Executive order                contacted or met with regarding this 
              review                                      OIRA 
GAO ID   submission     Reason for       regarding this       submission   
                          OIRA's return       submission       

DOT-FAA Part 145 Review: Repair Stations

Final rule

RIN 2120-AC38

OIRA review period: 07/13/2001 to 07/20/2001 OIRA cited concerns from
other federal agencies and unease about complicating relations with other
countries in its rationale for returning the rule.

DOT officials confirmed that the Department of State voiced concerns about
the wording of certain provisions. However, they pointed out that FAA had
worked out wording changes with the Department of State prior to
submitting the rule for OIRA's review. They believed that OIRA's request
that FAA withdraw the rule (see GAO ID 84) and OIRA's subsequent return of
the resubmitted rule (this case) were based on an OIRA misunderstanding
that the Department of State's concerns had not been addressed.

Yes

On 07/09/2001-2 days before FAA withdrew the original submission of this
rule-the Aeronautical Repair Station Association, the Airline Suppliers
Association and other business representatives sent a letter to the OMB
Director with a copy to OIRA asking that OIRA send the rule back to FAA
with instructions to prepare a Supplemental Notice of Proposed Rulemaking.

On 07/26/2001-about 1 week after OIRA returned the rule to FAA and FAA
resubmitted to rule to OIRA-OIRA met with representatives from the
Aeronautical Repair Station Association, Aerospace Industries Association,
Air Transport Association of America, Aircraft Electronics Association,
Aircraft Owners and Pilots Association, Airline Suppliers Association,
General Aviation Manufacturers Association, National Air Carrier
Association, National Air Transport Association, Professional Aviation
Maintenance Association, The Boeing Company, General Electric Aircraft
Engines, Goodrich, Honeywell, Rockwell Collins, and United Technologies
Corporation.

There were a series of activities regarding this rule both before and
after this return. On 07/02/2001, FAA submitted a draft of this rule for
OIRA's review. On 07/11/2001, FAA withdrew the rule (at OIRA's suggestion
according to FAA officials.) (This withdrawal is covered by GAO ID 84.)

On 07/13/2001, FAA resubmitted the rule for OIRA's review, and OIRA
returned it on 07/20/2001 (the sequence covered by this particular case).
That same day FAA resubmitted the rule to OIRA.

On 07/30/2001, OIRA completed its review of the rule (with the outcome
coded "consistent with no change"). The rule was published on 08/06/2001
(66 FR 41088).

Appendix II
Summary Information on Selected Rules
Submitted to OIRA for Executive Order
Review between July 2001 and June 2002

                                                                Evidence of   
                                         Evidence that outside     subsequent 
                                                       parties       activity 
          Executive order                contacted or met with regarding this 
              review                                      OIRA 
GAO ID   submission     Reason for       regarding this       submission   
                          OIRA's return       submission       

Certification of Pilots, Aircraft and Repairmen for the Operation of Light
Sport Aircraft

Proposed rule

RIN 2120-AH19

OIRA review period: 07/06/2001 to 08/09/2001 OIRA returned this rule
because of concerns that the regulatory analysis did not adequately
support the rule. OIRA noted that FAA used a baseline with which to
compare the rule that assumed that, in the absence of this rule, FAA would
propose a more stringent set of standards than in the proposal. Although
OIRA had no objection to FAA analyzing an alternative that was more
stringent than the proposal, OIRA believed that the benefits of the
proposal should be compared with a status quo that did not include the
artificial "baseline" assumption of increased stringency. OIRA also
suggested that, as part of an improved analysis of alternatives, FAA could
also consider means of improved compliance and enforcement of regulations
currently in place.

Given these concerns, OIRA suggested that DOT publish an advanced notice
of proposed rulemaking before publishing the specific proposal and
returned the rule to DOT for reconsideration.

No 	FAA reexamined its regulatory evaluation and resubmitted the rule to
OIRA on 12/17/2001.

OIRA completed its review of the resubmitted rule on 01/03/2002 (outcome
code "consistent with change") (see GAO ID 28).

The proposed rule was published on 02/05/2002 (67 FR 5368).

Corrosion Control Plan

Proposed rule

RIN 2120-AE92

OIRA review period: 03/02/2001 to 09/18/2001 OIRA returned this rule
because of concerns about the agency's regulatory analysis, primarily
related to the cost-benefit analysis. Many of these same concerns applied
to the analysis of a related FAA rule on aging aircraft. (See related rule
at GAO ID 76.) Although FAA responded to some of these concerns in a
revised regulatory evaluation on 07/27/2001, OIRA suggested that a
concurrent review of this rule and the aging aircraft rule would help
resolve OIRA's concerns and assist in determining the most cost-effective
way to detect and correct problems affecting the safety of aging aircraft.
Because resolution of these concerns would take additional time, OIRA
returned the two rules to DOT and FAA for reconsideration.

No 	On 06/18/2002, FAA resubmitted this rule to OIRA.

On 09/16/2002, OIRA completed its review of the resubmitted rule (outcome
code "consistent with no change").

The proposed rule was published on 10/03/2002 (67 FR 62142).

Appendix II
Summary Information on Selected Rules
Submitted to OIRA for Executive Order
Review between July 2001 and June 2002

                                                                Evidence of   
                                         Evidence that outside     subsequent 
                                                       parties       activity 
          Executive order                contacted or met with regarding this 
              review                                      OIRA 
GAO ID   submission     Reason for       regarding this       submission   
                          OIRA's return       submission       

Retrofit of Improved Seats in Air Carrier Transport Category Airplanes

Proposed rule

RIN 2120-AC84

OIRA review period: 05/14/2002 to 05/16/2002 According to the OIRA
database, this rule was returned to FAA because it was an improper
submission.

However, FAA officials disputed that characterization. They stated that
OIRA "had a slew of questions" to which FAA gave a 12-page response. They
said that, after the return and an exchange of OIRA suggestions and FAA's
response, FAA added language to further explain the plan for improving the
seat certification process.

No 	On 06/17/2002, FAA resubmitted this rule for OIRA's review.

OIRA completed its review of the resubmitted version on 09/24/2002
(outcome code "consistent with change").

The proposed rule was published on 10/04/2002 (67 FR 62294).

Aging Airplane Safety

Final rule

RIN 2120-AE42

OIRA review period: 07/27/2001 to 09/18/2001 OIRA returned this rule due
to concerns about the regulatory analysis. Many of these same concerns
applied to the analysis of a related FAA corrosion control plan rule (GAO
ID 74). Although FAA responded to some of these concerns in a revised
regulatory evaluation on 07/27/2001, OIRA believed that a concurrent
review of this rule and the corrosion control plan rule would help resolve
OIRA's concerns and assist in determining the most cost-effective way to
detect and correct problems affecting the safety of aging aircraft.
Because resolution of these concerns would take additional time, OIRA
returned the two rules to DOT-FAA for reconsideration.

No 	On 06/18/2002, FAA resubmitted this rule to OIRA.

On 09/24/2002, OIRA completed its review (outcome code "consistent with
change"). According to FAA, the changes were to issue this as an interim
final rule with a request for comment, instead of as a final rule, and to
expand the benefit analysis in the regulatory evaluation.

The interim final rule was published on 12/06/2002 (67 FR 72726).

Appendix II
Summary Information on Selected Rules
Submitted to OIRA for Executive Order
Review between July 2001 and June 2002

                                                                Evidence of   
                                         Evidence that outside     subsequent 
                                                       parties       activity 
          Executive order                contacted or met with regarding this 
              review                                      OIRA 
GAO ID   submission     Reason for       regarding this       submission   
                          OIRA's return       submission       

Revision of Digital Flight OIRA returned this rule due to concerns No The
final rule is still

Data Recorder Regulations about the relative cost-effectiveness of
pending, according to

     for Boeing 737 Airplanes requiring additional flight data recorder FAA
                                   officials.

and for Part 125 Operators parameters, in light of additional steps that
would be proposed in a related Final rule notice of proposed rulemaking on
general flight recorder improvements. RIN 2120-AG87

OIRA review period: 06/14/2001 to 09/18/2001 DOT-NHTSA Tire Pressure
Monitoring Systems

Final rule

RIN 2127-AI33

Economically significant

OIRA review period: 12/17/2001 to 02/12/2002 OIRA returned this rule
because it did not believe the analysis performed by NHTSA adequately
demonstrated that the agency selected the best available alternative.

Specifically, OIRA returned the rule for reconsideration of two analytic
concerns related to safety. First, OIRA identified a regulatory
alternative that NHTSA had not explicitly analyzed-considering the impact
of regulatory alternatives on the availability of anti-lock brake systems.
Second, OIRA said that the technical foundation for NHTSA's estimates of
safety benefits needed to be better explained and subjected to sensitivity
analysis.

Yes, prior to the formal review period

On 10/26/2001, OIRA and DOT officials met with representatives of the
Alliance of Automobile Manufacturers and various member companies,
including Daimler-Chrysler, Ford, Toyota, and VW of America.

(There was also a meeting after the formal review period - on 02/21/2002 -
with the Rubber Manufacturers' Association.)

On 05/28/2002, NHTSA submitted a final rule to OIRA that contained the
changes suggested by OIRA in the return letter.

OIRA completed its review of the rule on 05/29/2002 (outcome code
"consistent with no change").

The final rule was published on 06/05/2002 (67 FR 38704).

The U.S. Court of Appeals recently held that the rule was contrary to the
intent of the tire safety legislation and arbitrary and capricious under
the APA. Public Citizen, Inc. v. Mineta, No. 02-4237 (2d Cir. Aug. 6,
2003).

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

                                                                Evidence of   
                                         Evidence that outside     subsequent 
                                                       parties       activity 
          Executive order                contacted or met with regarding this 
              review                                      OIRA 
GAO ID   submission     Reason for       regarding this       submission   
                          OIRA's return       submission       

EPA-Office of Air and Radiation

FY 2000 Report to Congress on EPA's Implementation of the Waste Isolation
Pilot Plant Land Withdrawal Act

Proposed rule

RIN 2060-ZA12

OIRA review period: 09/13/2001 to 10/17/2001 OIRA returned this item
because it was No N/A an improper submission.

                              EPA-Office of Water

Federal Water Quality Standards for Indian Country and Other Provisions
Regarding Federal Water Quality Standards

Proposed rule

RIN 2040-AD46

OIRA review period: 06/29/2001 to 10/02/2001 OIRA's return letter cited a
number of concerns about this rule. In particular, the return letter noted
that EPA did not provide a quantitative analysis of the costs and benefits
that would result from this action. OIRA pointed out that the preamble
identified nearly 300 point sources on tribal lands that would be directly
affected by the rule and that there might be substantial numbers of
nonpoint sources and point sources upstream of tribal lands that could
also be affected. OIRA therefore stated that the rule could benefit from
further analysis of costs and benefits in order to support informed public
comment. OIRA was also concerned with EPA's conclusion that this proposed
rule did not have federalism implications. OIRA noted that some of the
impacts of this rule on states were likely to be significant (e.g.,
affecting state permitting activities in upstream waters), but the rule
did not appear to contain any requirements for consultation with states.
OIRA was also concerned that the rule appeared to establish for the first
time EPA jurisdiction over waters whose Indian country status is in
dispute. No No

According to an EPA official, EPA has not resubmitted this rule to OIRA.

Source: GAO analysis.

                                  Appendix II
                     Summary Information on Selected Rules
                     Submitted to OIRA for Executive Order
                     Review between July 2001 and June 2002

  Table 9: Findings and Determinations for Rules Withdrawn after Submission to
                                      OIRA

                   Did the agency                      Evidence   
                                                         that     
                    withdraw this                      outside    
                                                       parties    
                  submission at the                  contacted or Evidence of 
                                                     met          
                                                      with OIRA    subsequent 
                    suggestion or                                    activity 
GAO Executive  recommendation of Reason for        regarding    regarding  
         order                      withdrawal of        this        this     
       review                        the submitted                            
ID  submission       OIRA?             rule        submission  submission

APHIS Importation of The withdrawal was

Clementines From characterized by APHIS

Spain as a mutual decision by APHIS and OIRA. Proposed rule

RIN 0579-AB40

OIRA review period: 04/26/2002 to 05/21/2002 According to APHIS, OIRA No
APHIS resubmitted the

and APHIS mutually rule to OIRA on

decided to withdraw this 06/28/2002.

rule to avoid violating the

90-day limit on reviews OIRA completed

under Executive Order review of the rule on

12866. 	07/05/2002 (outcome code "consistent with change"). According to
APHIS, OIRA had some changes to better explainthe basis for the rule and
to address concerns by Spanish clementine exporters. APHIS also noted that
some changes were made to the regulatory language in response to the U.S.
Trade Representative's Office.

The rule was published on 07/11/2002 (67 FR 45922).

Appendix II
Summary Information on Selected Rules
Submitted to OIRA for Executive Order
Review between July 2001 and June 2002

                   Did the agency                      Evidence   
                                                         that     
                    withdraw this                      outside    
                                                       parties    
                  submission at the                  contacted or Evidence of 
                                                     met          
                                                      with OIRA    subsequent 
                    suggestion or                                    activity 
GAO Executive  recommendation of Reason for        regarding    regarding  
         order                      withdrawal of        this        this     
       review                        the submitted                            
ID  submission       OIRA?             rule        submission  submission

FDA

Records and Reports FDA characterized the
Concerning withdrawal as a mutual
Experience with decision by FDA and
Approved New Animal OIRA.
Drugs; Final Rule

(Listed in OIRA's
database at time of
GAO's review as:
Records and Reports
Concerning
Experience with
Approved New Animal
Drugs; Implementing of
Title I of the Generic
Animal Drug and
Patient [sic] Term
Restoration Act)

Final rule

RIN 0910-AA02

OIRA review period:
08/28/2001 to
11/26/2001

According to FDA, OIRA and FDA made a mutual decision to withdraw the
original final rule and reissue it as an interim final rule. Issuing this
rule as an interim final rule with an opportunity for public comment was a
compromise decision to address OMB's concerns regarding the length of time
since publication of the proposed rule (12/17/1991) while not further
delaying the rule by reproposing it.

No 	FDA resubmitted the rule to OIRA on 11/29/2001.

OIRA completed review of the rule on 01/08/2002 (outcome code "consistent
with change"). According to FDA, OIRA had some clarifying comments, but
these were not substantive (see GAO ID 15 in this appendix for additional
details).

An interim final rule was published on 02/04/2002 (67 FR 5046). (The
interim final rule was published again on 07/31/2002, delaying the
effective date indefinitely in order to address Paperwork Reduction Act of
1995 requirements and comments received on the interim final rule.)

Appendix II
Summary Information on Selected Rules
Submitted to OIRA for Executive Order
Review between July 2001 and June 2002

                   Did the agency                      Evidence   
                                                         that     
                    withdraw this                      outside    
                                                       parties    
                  submission at the                  contacted or Evidence of 
                                                     met          
                                                      with OIRA    subsequent 
                    suggestion or                                    activity 
GAO Executive  recommendation of Reason for        regarding    regarding  
         order                      withdrawal of        this        this     
       review                        the submitted                            
ID  submission       OIRA?             rule        submission  submission

Current Good Manufacturing Practice in Manufacturing, Packing, or Holding
Dietary Ingredients and Dietary Supplements

Proposed rule

RIN 0910-AB88

Economically significant

OIRA review period: 03/28/2001 to 12/19/2001 No

The Department of Health and Human Services (HHS) withdrew the rule.

According to FDA, this rule previously had been submitted to OIRA for
review but was initially withdrawn in response to the Card memo. Although
FDA then resubmitted this rule to OIRA in March 2001, new policy makers in
HHS wanted to reconsider the rule. Therefore, HHS decided to again
withdraw the rule from OIRA's review.

No 	FDA resubmitted a version of this rule to OIRA on 10/04/2002.

OIRA completed review of the resubmitted rule on 01/16/2003 (outcome code
"consistent with change").

The proposed rule was published on 03/13/2003 (68 FR 12158).

Appendix II
Summary Information on Selected Rules
Submitted to OIRA for Executive Order
Review between July 2001 and June 2002

                   Did the agency                      Evidence   
                                                         that     
                    withdraw this                      outside    
                                                       parties    
                  submission at the                  contacted or Evidence of 
                                                     met          
                                                      with OIRA    subsequent 
                    suggestion or                                    activity 
GAO Executive  recommendation of Reason for        regarding    regarding  
         order                      withdrawal of        this        this     
       review                        the submitted                            
ID  submission       OIRA?             rule        submission  submission

DOT-FAA

Part 145 Review: Yes Repair Stations According to FAA, the Final rule
agency withdrew the rule at OIRA's RIN 2120-AC38 suggestion.

OIRA review period: 07/02/2001 to 07/11/2001

FAA officials stated that Yes

OIRA suggested the

withdrawal due to "concerns On 07/09/2001- 2

from industry and the State days before the

department."	withdrawal-the Aeronautical Repair Station Association, the
Airline Suppliers Association, and other business representatives sent a
letter to OMB Director with a copy to OIRA asking that it send the rule
back to FAA with instructions to prepare a Supplemental Notice of Proposed
Rulemaking.

(On 07/26/2001- after the withdrawal and also after OIRA's 07/20/2001
return of this draft rule-OIRA met with these business representatives.)

(See chronology presented under GAO ID 72, which covers the version of
this rule that was returned by OIRA for reconsideration by DOT-FAA.)

Appendix II
Summary Information on Selected Rules
Submitted to OIRA for Executive Order
Review between July 2001 and June 2002

                   Did the agency                      Evidence   
                                                         that     
                    withdraw this                      outside    
                                                       parties    
                  submission at the                  contacted or Evidence of 
                                                     met          
                                                      with OIRA    subsequent 
                    suggestion or                                    activity 
GAO Executive  recommendation of Reason for        regarding    regarding  
         order                      withdrawal of        this        this     
       review                        the submitted                            
ID  submission       OIRA?             rule        submission  submission

                                   DOT-NHTSA

      Light Truck      No         According to NHTSA    No  NHTSA resubmitted 
          Average                                                           a 
    Fuel Economy                officials, they              proposed rule to 
                                withdrew the                             OIRA 
Standard Model NHTSA         rule because the agency      on 01/10/2002.   
             Year withdrew the                             
        2004          rule.     did not want to            
                                promulgate                 
                                fuel economy standards       OIRA completed   
     Final rule                 under the congressional         review of the 
                                                                     proposed 
                                freeze imposed when the    rule on 01/17/2002 
RIN 2127-AI68                rule was drafted, as it      (outcome code    
                                appeared that the           "consistent with  
                                freeze                     
    Economically                would soon be lifted        change" - see GAO 
                                (as it                                     ID 
    significant                   was on 12/18/2001).              37 in this 
                                                                 appendix for 
                                                                   additional 
                                                                information). 
      OIRA review                                          
          period:                                          
11/29/2001 to                                            The proposed rule 
                                                                          was 
     12/12/2001                                               published on    
                                                                01/24/2002. A 
                                                                        final 
                                                           rule was published 
                                                                           on 
                                                            04/04/2002 (67 FR 
                                                                16052).       

                             Source: GAO analysis.

Appendix III

Case Studies on Significantly Affected Rules With Evidence That OIRA Was
Contacted by External Parties

The case studies described in this appendix include significantly affected
rules that also had evidence of external party contact with OIRA during
the review process. For each case, a description of the rule as submitted
to OIRA, external party contact with OIRA, and changes ultimately made at
OIRA's suggestion are included.

Control of Emissions GAO ID 41

Agency: EPA

  from Nonroad Large RIN: 2060-AI11

Spark Engines 	Rulemaking stage at time of review: Proposed Date submitted
to OMB for review: August 1, 2001 Date OMB review completed: September 14,
2001 Result of review: Consistent with change

Rule as Submitted to OIRA	On August 2, 2001, OIRA formally received a
draft rule from EPA that proposed emission standards for several groups of
nonroad engines. These engines include large spark-ignition engines, such
as those used in forklifts and airport tugs; recreational vehicles using
spark-ignition engines, such as off-highway motorcycles, all-terrain
vehicles, and snowmobiles; and recreational marine diesel and highway
motorcycle engines.

    Outside Parties' Contacts with OIRA

In communications with OIRA, marine and highway motorcycle industry
representatives objected to being covered by the proposed rule standards.
The Motorcycle Riders Foundation sent a letter (dated September 14, 2001)
to the OIRA Administrator stating that EPA should defer the proposed
rule's coverage of highway motorcycles. According to the letter, "there is
no court-ordered deadline for this part of the regulation, and the EPA
isn't otherwise under pressure to rush to regulation." The National Marine
Manufacturers Association (NMMA) expressed similar concerns. A memo
summarizing a meeting with OIRA and EPA on August 31, 2001, indicated that
"the key issues raised by NMMA were a federal commitment to delay action
on exhaust standards coupled with working with NMMA, Coast Guard and
California on catalyst technology."

Changes Made to Rule at A redline/strikeout version of the rule in EPA's
docket containing "edits

OIRA's Suggestion	representing discussions between EPA and OMB on
September 14" reflects deletions of language covering marine vessels with
spark engines and

                                  Appendix III
                  Case Studies on Significantly Affected Rules
                    With Evidence That OIRA Was Contacted by
                                External Parties

highway motorcycles. Language in the published proposed rule states: "We
intended to include in this proposal emission standards for two additional
vehicle categories: new exhaust emission standards for highway motorcycles
and new evaporative emission standards for marine vessels powered by
spark-ignition engines. Proposals for these two categories are not
included in the September 14 deadline mandated by the courts, as is the
case for the remaining contents that appear in today's proposed rule. We
are committed to issue proposals regarding these categories within the
next two to three months."

The proposed rule was published in the Federal Register October 5, 2001.
The marine and highway motorcycle portions of the proposal were covered in
a later proposed rulemaking, which was published in the Federal Register
August 14, 2002.

  Proposed Nonconformance Penalties for 2004 and Later Model Year Emission
  Standards for Heavy-duty Diesel Engines and Heavy-duty Diesel Vehicles

GAO ID 53
Agency: EPA
RIN: 2060-AJ73
Rulemaking stage at time of review: Proposed
Date submitted to OMB for review: December 10, 2001
Date OMB review completed: December 20, 2001
Result of Reviews: Consistent With Change

Rule as Submitted to OIRA	On at least four occasions EPA sent versions of
the proposed rule preamble to OIRA previous to OIRA's formal review
period. The exchanges began October 30, 2001, and OIRA's official review
period was logged as beginning December 10, 2001. In the first draft rule
sent to OIRA, EPA proposed that nonconformance penalties (NCP) be made
available for the 2004 and later model year nonmethane hydrocarbons and
nitrogen oxides standard for heavy-duty diesel engines and vehicles.
According to the proposal, the availability of NCPs allows a manufacturer
of heavy-duty engines or heavy-duty vehicles whose engines or vehicles
fail to conform with certain applicable emission standards, but do not
exceed a designated upper limit, to be issued a certificate of conformity
upon payment of a monetary penalty. In the technical support document
accompanying the rule

                                  Appendix III
                  Case Studies on Significantly Affected Rules
                    With Evidence That OIRA Was Contacted by
                                External Parties

preamble, EPA originally used a 3 percent discount rate in calculating
certain compliance and fuel costs which were then used in calculating NCP
amounts.

    Outside Parties' Contacts with OIRA

Regulated parties sent comments to OIRA and met with OIRA officials on
several occasions before OIRA's official review of this rule began. From
what is available in the OIRA meeting logs, some of the discussions
concerned whether the rule would advantage or disadvantage certain engine
manufacturers. (Available documents do not indicate that regulated parties
suggested OIRA's primary revision to the rule-an increase in the discount
rate used in the regulatory impact analysis.) OIRA's contact with external
parties regarding the proposed version of this rule is described below.

On September 13, 2001, Cummins Inc. sent a letter to the OIRA
Administrator requesting a meeting "to discuss an important regulation
which has very serious competitive ramifications for our Company - the
2004 Nonconformance Penalty for Heavy Duty Engines." On October 1, 2001,
OIRA, EPA, DOE met with Cummins Inc. to discuss the rule. Several days
later (on October 12, 2001) Cummins Inc. sent a letter to the OIRA
Administrator thanking him for the October 1, 2001, meeting and requested
that the rule not harm engine manufacturers that produce compliant
engines. On October 25, 2001, another engine manufacturer (Caterpillar)
requested a meeting with OIRA regarding the heavy-duty diesel engine rule;
the meeting was held November 14, 2001. On November 7, 2001 Cummins sent
additional comments on the rule to the OIRA Administrator urging
"expeditious review" of the rule.

Changes Made to Rule at OIRA's Suggestion

OIRA initiated an increase (from 3 percent to 7 percent) in the discount
rate used in parts of the regulatory impact analysis for this rule. Some
members of EPA's Environmental Economics Advisory Council recommended use
of the 3 percent rate. OIRA's suggested change lowered the NCPs levied in
the rule from the amounts originally proposed by EPA.

Most of OIRA's suggested changes to the discount rate occurred before
OIRA's official review period. However, EPA did not completely switch to
the 7 percent discount rate before the official review period began. In a
draft submitted December 4, 2001, (about one week before OIRA's official
review period began), the 3 percent discounted values remained and a table
was added showing certain values if a 7 percent discount rate were used.

                                  Appendix III
                  Case Studies on Significantly Affected Rules
                    With Evidence That OIRA Was Contacted by
                                External Parties

Additional language also requested comment on which discount rate would be
more appropriate.

OIRA's rationale for increasing the discount rate is offered in the
following correspondence with EPA: "We believe that it is more appropriate
to use a discount rate of 7% (see OMB circular A-94) consistently
throughout the rule, representing the opportunity cost of capital. Since
the EPA NCP Cost Survey instructs respondents to discount by 3% and report
net present value estimates for the fixed costs, hardware cost, warranty
cost, and maintenance/operating cost, please discuss the necessary
adjustments used in presenting NPB estimates, in the first version of the
proposal, for these cost categories using the 7% discount rate." The
rationale for a 7 percent discount rate is also included in a separate fax
sent to EPA. By the time the proposed rule was published in the Federal
Register, all discount rate discussion in the rule used a 7 percent rate.
However, the following language is included in the rule regarding
potential use of a different rate for portions of the impact analysis and
an example of nonconformance penalty parameters using a 3 percent discount
rate is included in the technical support document:

"... there is evidence in other contexts that users might apply a
different discount rate than seven percent when considering future
operating costs during a purchase decision. We request comment on whether
there is evidence to support the application of such an alternative
discount rate to operating costs in the various segments of the heavy duty
engine market. Your comments in support of an alternative discount rate (a
higher or lower value) should include a discussion of the supporting
economic and business rationale for the alternative rate. We have included
an example of the impact on the NCP parameters from using a smaller
discount rate (three percent) in the draft Technical Support Document for
this proposal."

Identification and GAO ID 56

Agency: EPA

  Listing of Hazardous RIN: 2050-AE49

Waste (Manganese)	Rulemaking stage at time of review: Final Date submitted
to OMB for review: September 26, 2001 Date OMB review completed: October
31, 2001 Result of review: Consistent with change

Rule as Submitted to OIRA	On September 26, 2001, EPA submitted a draft
final rule to OIRA for review listing manganese and two other wastes
generated from inorganic chemical manufacturing processes as "hazardous
constituents." EPA said in the

                                  Appendix III
                  Case Studies on Significantly Affected Rules
                    With Evidence That OIRA Was Contacted by
                                External Parties

draft rule that it was adding manganese to the list "based on scientific
studies demonstrating that manganese has toxic effects on humans." The
agency said manganese had long been known to cause neurological effects in
occupational settings, a "continuum of dysfunction" with low levels of
exposure, and a danger to individuals with a hepatic insufficiency. EPA
also cited evidence from epidemiological studies that point to negative
health impacts of low-level exposure to manganese in drinking water. After
considering public comments on the proposed rule, the agency refuted
commenters' claims that manganese is not hazardous and said "we continue
to believe that manganese is toxic and clearly poses significant risk to
human health." EPA also said that, "based on consultations with
individuals knowledgeable in hazardous waste treatment and corrective
action, a review of the chemical properties of manganese, and review of
Resource Conservation and Recovery Act (RCRA) regulations, the Agency does
not believe that there are significant, incremental costs or economic
impacts associated with adding manganese to [the list of hazardous
constituents]."

    Outside Parties' Contacts with OIRA

Also on September 26, 2001, legal counsel for the Cookson Group (an
international materials technology organization) sent a letter to OIRA
stating that the cost of the final rule to Cookson would be significantly
higher than EPA estimated. The letter indicated that Cookson was obligated
to manage and dispose of slag materials at a Laredo, Texas smelter that it
once owned, and that the rule would classify this slag as hazardous
waste-thereby costing the company an additional $29 million to $36
million. The letter also indicated that the "Laredo slag constitutes well
over 90 percent of the material that will likely be subject to this
rulemaking over the next 30 years." Later, on October 18, 2001, the
counsel for the Cookson Group sent another letter to OMB requesting a
meeting to discuss the "significant impact of the [rule] on Cookson at a
former facility in Laredo, TX, which impact was not known to and
considered by EPA when formulating the rule."

On September 28, 2001, counsel for the Steel Manufacturers Association and
the American Iron and Steel Institute requested a meeting with the OIRA
Administrator to discuss "the failure of [EPA] to conduct any analysis of
the impact of the proposal on the steel industry, the country's largest
consumer and user of manganese." On October 16, 2001, OIRA and EPA
officials met with the organizations' counsels. Three days later, the
counsel sent a letter to an OIRA official thanking him for the meeting and
stating

                                  Appendix III
                  Case Studies on Significantly Affected Rules
                    With Evidence That OIRA Was Contacted by
                                External Parties

that listing manganese as hazardous could harm the steel industry due to
increased costs for treating manganese-contaminated waste.1

On October 8, 2001, the Eastman chemical company sent a letter to the OIRA
Administrator stating that the company "strongly opposes adding manganese
to [the listing of hazardous constituents] because of its very low
toxicity and the substantial costs it would impose on facilities outside
the inorganic chemicals industry, with no resultant environmental or
health benefits."

Changes Made to Rule at OIRA's Suggestion

On October 31, 2001, OIRA's review of the rule ended, and the rule was
coded as "consistent with change." A memo dated the same day was placed in
the EPA docket submitting a "redline/strikeout" version of the rule
showing the changes made "in response to comments from OMB." All language
in the rule related to listing manganese as hazardous had been deleted.
The following language was inserted in the text.

"We received numerous comments related to the risk associated with
manganese and the economic impact to many industries, including the steel
industry, of adding manganese to the Universal Treatment Standards
requirements and to 40 CFR 261. Appendix VIII. Although we continue to
believe that manganese poses significant issues that ultimately should be
resolved, the court ordered schedule under which we are operating provides
us with no flexibility to take additional time to explore these topics
more fully. As a result, we have chosen to defer final action on
[manganese]."

The final rule was published in the Federal Register on November 20, 2001.
As of May 30, 2003 EPA had not published a rule regarding manganese.

1This letter was not in the EPA docket for the rule, but did appear in the
OIRA docket.

                                  Appendix III
                  Case Studies on Significantly Affected Rules
                    With Evidence That OIRA Was Contacted by
                                External Parties

Minimizing Adverse GAO ID 65

Agency: EPA

  Environmental Impact RIN: 2040-AC34

from Cooling Water Rulemaking stage at time of review: Final

Intake Structures at 	Date submitted to OMB for review: September 10, 2001
Date OMB review completed: November 8, 2001

New Facilities Result of review: Consistent with change

Rule as Submitted to OIRA	The draft version of the rule submitted to OIRA
on September 10, 2001, implemented section 316 (b) of the Clean Water Act
for new facilities (primarily electric power plants) that use water
withdrawn from rivers, streams, lakes, reservoirs, estuaries, oceans or
other waters of the U.S. for cooling purposes. The draft rule established
national technology-based performance requirements applicable to the
location, design, construction, and capacity of cooling water intake
structures at new facilities. The national requirements also established
the best technology available (referred to as a "closed-cycle
recirculating cooling water system") for minimizing adverse environmental
impacts associated with the use of these structures. The primary adverse
environmental impact due to these structures is casualties among aquatic
life forms (e.g., fish and shellfish).

The draft rule used a two-track approach to achieve technology based
performance requirements. Track I established national intake capacity and
velocity requirements as well as location- and capacity-based requirements
to reduce intake flows to certain levels. This performance standard was to
be commensurate with that produced by a closed-cycle recirculating cooling
water system. Track II allowed permit applicants to conduct site-specific
studies to demonstrate that alternatives to Track I would result in the
same level of reduction of impingement and entrainment at the cooling
water intake structure as would be achieved under Track I.

Outside Parties' Contacts Riverkeeper met with OIRA and EPA officials on
September 27, 2001,

with OIRA	regarding the rule and advocated "dry-cooling" as the technology
basis for the final rule.

On October 29, 2001, industry representatives (from EOP Group and Edison
Electric Institute) met with OIRA and EPA officials. The industry

                                  Appendix III
                  Case Studies on Significantly Affected Rules
                    With Evidence That OIRA Was Contacted by
                                External Parties

representatives recommended that the final rule: (1) use the level of harm
reduction in impingement and entrainment as the "point of departure to
compare Track I and II," (2) allow different impingement and entrainment
performance if the system minimizes total adverse environmental impacts,
(3) eliminate the proposal for additional design and construction
technologies, (4) allow alternative systems if achieving the Track I
system performance is not a cost-effective reduction in adverse
environmental impacts.

Changes Made to Rule at OIRA's Suggestion

Five substantive changes were made to the rule due to OIRA's suggestions.

o 	As originally written, EPA allowed facilities to qualify for
alternative performance requirements that were less stringent than those
required by the rule. OIRA suggested adding one additional criterion
allowing qualification for less stringency if full compliance "would
result in significant adverse impacts on local air quality, significant
adverse impacts on local water resources not addressed under Section
125.84 (d) (1) (i), or significant adverse impacts on local energy
markets." This additional criterion could have the effect of allowing more
facilities to qualify for lower performance standards.

o 	As originally written, facilities withdrawing between 2 million gallons
per day (MGD) and 10 MGD had to meet the performance requirements imposed
on facilities with higher MGD withdrawal amounts. OIRA suggested changing
the requirements so that facilities withdrawing between 2 MGD and 10 MGD
did not have to reduce intake flow to a minimum level commensurate with
that attained by a closed-cycle recirculating cooling water system.
However, all other specifications remained applicable (e.g.,
through-screen intake velocities and total design intake flow requirements
remained the same despite the OIRA change).

o 	As originally written, intake structures were required to use screens
in order to minimize impingement mortality of fish and shellfish. OIRA
suggested changing the requirement so that the facilities only needed to
use the screens if certain criteria were met (e.g., if there are
threatened or endangered species or habitat for these species within the
hydraulic zone of the intake structure, if species of interest to fishery
management agencies pass through the hydraulic zone, or if the primary
performance requirements of the rule would not sufficiently ease stress on
protected species or habitat.)

                                  Appendix III
                  Case Studies on Significantly Affected Rules
                    With Evidence That OIRA Was Contacted by
                                External Parties

o 	As originally written, one of the intake flow requirements specified by
EPA stated that "for cooling water intake structures located in a lake or
reservoir, the total design intake flow must not alter the natural thermal
stratification or turnover pattern of the source water." OIRA suggested
adding an exception to this requirement by inserting the following
language: "...except in cases where the disruption is determined to be
beneficial to the management of fisheries for fish and shellfish by any
fishery management agency (ies)."

o 	As originally written, EPA offered "Track II" compliance measures that
allowed facility operators to comply with the performance standard of the
rule through means other than a closed-cycle recirculating cooling water
system. OIRA suggested adding "restoration measures" as a compliance
alternative under the "Track II" compliance alternative so that intake
structure operators may implement measures that "result in increases in
fish and shellfish."

The final rule was published in the Federal Register December 18, 2001.
Subsequently, on December 26, 2002, EPA published a direct final rule in
order to make "minor changes to EPA's final rule published December 18,
2001." However, on March 24, 2003, EPA withdrew the direct final rule "due
to adverse comments."

National Pollutant GAO ID 68

Agency: EPA

Discharge Elimination RIN: 2040-AD62

System (Existing Rulemaking stage at time of review: Proposed

Intake Structures)	Date submitted to OMB for review: December 28, 2001
Date OMB review completed: February 28, 2002 Result of review: Consistent
with change

Rule as Submitted to OIRA	The proposed rule would have implemented section
316(b) of the Clean Water Act for certain existing power producing
facilities that employ a cooling water intake structure and that withdraw
50 million gallons per day or more of water from rivers, streams, lakes,
reservoirs, estuaries, oceans, or other waters of the U.S. for cooling
purposes. According to the legislative history, section 316(b) "requires
the location, design, construction, and capacity of cooling water intake
structures of steam-

                                  Appendix III
                  Case Studies on Significantly Affected Rules
                    With Evidence That OIRA Was Contacted by
                                External Parties

electric generating plants to reflect the best technology available for
minimizing any adverse environmental impacts."

As submitted to OIRA on December 28, 2001, the draft proposed rule
required that large facilities in estuaries and tidal rivers meet a
uniform, national performance standard commensurate with a closed-cycle,
recirculating cooling system that would reduce impingement mortality and
entrainment.

    Outside Parties' Contacts with OIRA

On January 15, 2002, EPA provided OIRA with a copy of slides from a
presentation that the Public Service Electric and Gas (PSEG) Company made
to EPA on January 3, 2002, regarding the section 316(b) rulemaking. The
slides recommend a "streamlined site-specific approach" for the rule
instead of uniform, national standards.

On January 23, 2002, Riverkeeper (an environmental group) sent a letter to
the OIRA Administrator requesting a meeting on the rule. February 7, 2002,
OIRA and EPA officials met with officials from Riverkeeper, who said
Congress mandated that best technology available standards be nationally
uniform and technology based-not set on a cases-by-case basis or related
to the quality of the water involved. They also said that the use of
site-specific best technology available determinations had perpetuated
"the most destructive `once-through' technology." Finally, they argued
that leaving best technology available determinations to a case-by-case,
site-specific determination "puts a tremendous burden on State regulatory
agencies, as well as environmental and citizens groups."

On January 28, 2002, OIRA received an e-mail indicating "PSEG has prepared
draft language for implementing Section 316(b) on a site-specific basis."
The draft posited that permittees could demonstrate compliance with
section 316(b) in any of three ways: (1) a demonstration based on a prior
Section 316(b) determination, (2) a demonstration based on a site-specific
evaluation of the best technologies or other measures for minimizing
adverse effects, or (3) a demonstration to determine the presence of any
adverse environmental effects. The draft concluded by saying that
"voluntary restoration or conservation measures may be used, in
conjunction with or instead of technologies, to demonstrate that a
[cooling water intake structure] is not causing (adverse environmental
impact)." On January 31, 2002, OIRA received a fax from the EOP Group (a
consulting company) containing identical draft section 316(b) regulations
"for Site-Specific Permit Renewal Options for Existing Sources."

                                  Appendix III
                  Case Studies on Significantly Affected Rules
                    With Evidence That OIRA Was Contacted by
                                External Parties

In February 2002, the Edison Electric Institute prepared a paper
advocating a site-specific approach to regulating intake structures that
are managed by states. (We discovered the document in the OIRA docket for
the rule, although it is not clear how the paper was submitted to OIRA).

On January 31, 2002, Cinergy Corporation sent a letter to the OIRA
Administrator requesting a meeting with him on the proposed rule. The
Edison Electric Institute sent a similar letter on February 4, 2002. On
February 8, 2002, OIRA and EPA officials met with officials from a number
of regulated parties, including "TXU" (meaning unclear), Cinergy, Public
Service Enterprise Group, Edison Electric Institute, Progress Energy, Teco
Energy, Constellation Energy Group, Allegany Energy, Minnesota Power, and
Mirant Corporation. Documents submitted at the meeting advocate a
"site-specific approach" as "the best means for ensuring cost-effective
environmental protection." The documents also indicated that the uniform
technology standards "would be based upon performance standards that could
only be met by retrofitting to closed cycle cooling for some or all power
plants covered under the Phase II rule." In addition, the documents
indicated that retrofitting 40 percent of existing open cycle capacity
would cost $40 billion, that wide-scale construction outages could affect
regional power supplies, and increased air emissions could result from
lower-efficiency closed-cycle systems.

On February 27, 2002, OIRA received a fax from the EOP Group forwarding
letters that EPA had received from the states and others on the section
316(b) rule. The letters were signed by representatives from the
Pennsylvania Department of Environmental Protection, the Marine Mammal
Commission, the Texas Natural Resource Conservation Commission, the Office
of the Governor of the State of North Carolina, and the Illinois
Environmental Protection Agency.

Changes Made to Rule at OIRA's Suggestion

On February 14, 2002, EPA submitted a summary of the revised regulatory
proposal to OMB. The summary stated that permittees could chose one of
three alternatives for establishing the best technology for minimizing
adverse environmental impact at its facility-(1) demonstrate that existing
technologies and measures meet regulatory performance standards, (2)
demonstrate that technologies and measures selected by the permittee will
meet performance standards, and (3) demonstrate that a site-specific
determination of best technology available is appropriate. The summary
went on to say that restoration could be used in lieu of or in combination
with intake technologies and operational measures if the results could be

                                  Appendix III
                  Case Studies on Significantly Affected Rules
                    With Evidence That OIRA Was Contacted by
                                External Parties

shown to be comparable to the results obtained from compliance with the
regulatory standards.

In its summary of changes made during interagency review, one of the
changes that EPA identified as having been suggested by OIRA was "added
new regulatory framework that provides three compliance alternatives for
the Phase II existing facility rule."

On February 28, 2002, OIRA approved the rule as revised. The rule was
published in the Federal Register on April 9, 2002.

Effluent Limitation GAO ID 70

Agency: EPA

Guidelines and New RIN: 2040-AD42

Source Performance Rulemaking stage at time of review: Proposed

Standards for the 	Date submitted to OMB for review: March 1, 2002 Date
OMB review completed: May 15, 2002

Construction and Result of review: Consistent with change

  Development Category

Rule as Submitted to OIRA	As originally submitted to OIRA, the draft
proposed rule would have established effluent limitations for 150,000
construction firms. The draft contained a number of regulatory options to
control discharges from active construction sites of one acre or larger
(temporary erosion and sediment controls applicable to construction sites
while land is being disturbed - three options) and long-term storm water
discharges (postconstruction, long-term storm water management options
intended as permanent storm water controls - three options). EPA's
preferred option combination contained two major provisions. For active
construction sites, it would have codified EPA's current construction
general permit, along with a design goal of 80 percent reduction in total
suspended solids (TSS) discharged from sites and a series of enhanced
inspection and certification requirements to improve compliance.2 EPA's
preferred option for management of postconstruction storm water run-off
would have established a design goal of an 80 percent reduction in TSS
discharge from

2TSS are characterized by EPA as conventional pollutants. The primary TSS
of concern in this rulemaking is sediment.

                                  Appendix III
                  Case Studies on Significantly Affected Rules
                    With Evidence That OIRA Was Contacted by
                                External Parties

finished projects and a requirement to maintain peak runoff levels at
pre-construction levels.

Outside Parties' Contacts ELG Working Group (an industry association) met
with OIRA and EPA on

with OIRA	February 4, 2002 and argued that additional storm water
regulations for the construction and development industry are "unnecessary
and unwarranted" because construction and development activities "have
been subject to federal, state and often local regulations for controlling
storm water discharges since 1990." In a document prepared for the
meeting, the ELG Working Group suggested that the federal government
should encourage state and local flexibility to address water quality
issues.

Changes Made to Rule at OIRA's Suggestion

In a memo regarding interagency review, dated May 22, 2002 with no author
listed, changes to the rule while under OIRA review are identified,
including a change that dropped the postconstruction requirements from the
proposed rule. The memo stated that "given the requirement to address
postconstruction runoff in the Phase I and Phase II municipal stormwater
program, EPA determined that it would be more appropriate to support local
communities in developing tailored programs that could better reflect
regional and local conditions, and be better integrated into broader local
planning efforts."

According to a June 10, 2002, memo (the memo author was not identified),
the agency made several changes to the proposed regulation at the
suggestion or recommendation of OIRA. The proposed regulation no longer
included the storm water management, or postconstruction, regulatory
options. Also, the active construction options changed. These changes
consisted of identifying and discussing three regulatory options: (1)
inspection and certification of construction site erosion and sediment
controls, for sites one acre or larger, (2) codification of the
Construction General Permit, plus inspection and certification
requirements, for sites five acres or larger, and (3) no regulation. These
revisions to the regulatory proposal required corresponding revisions to
the preamble.

On June 24, 2002, the proposed rule was published in the Federal Register.

                                  Appendix III
                  Case Studies on Significantly Affected Rules
                    With Evidence That OIRA Was Contacted by
                                External Parties

Effluent Limitations GAO ID 71

Agency: EPA

  Guidelines for the Iron RIN: 2040-AC90

and Steel Rulemaking stage at time of review: Final

Manufacturing Point 	Date submitted to OMB for review: March 29, 2002 Date
OMB review completed: April 30, 2002

Source Category Result of review: Consistent with change

Rule as Submitted to OIRA	The draft rule as submitted to OIRA for review
revised technology-based effluent limitations guidelines and standards for
certain wastewater discharges associated with metallurgical cokemaking,
sintering, and ironmaking operations. In its original form, the rule would
have retained an existing minimum net reduction provision in regulations
regarding use of a "water bubble" mechanism. According to the rule
preamble, the "water bubble" is a regulatory flexibility mechanism that
allows trading of identical pollutants at any single steel facility with
multiple compliance points to realize cost savings and/or to facilitate
compliance. Under the existing regulations, facilities that used the water
bubble mechanism were required to reduce the amount of their pollutant
discharges pursuant to the bubble to 10 percent to 15 percent less than
the discharges otherwise authorized by the regulations without use of the
bubble. This additional reduction was referred to as the "minimum net
reduction" provision throughout the rule.

    Outside Parties' Contacts with OIRA

Counsel for Steel Manufacturers Association and Specialty Steel Industry
of North America met with OIRA and EPA officials to discuss this
rulemaking on March 19, 2002. In the letter requesting a meeting, the
industry counsel argued that "revised effluent limitation guidelines are
not technically, economically, or legally justified." The counsel further
specified aspects of EPA's cost-benefit analysis that were believed to be
flawed, said that the actual cost-benefit ratio for this rule was at least
100:1, and asserted that the rule would be the "most cost-ineffective ELG
[effluent limitation guideline] ever promulgated."

Changes Made to Rule at 	The major change in this final rule that was
attributed to a request from OIRA eliminated the existing minimum net
reduction provision that applied if facilities used a "water bubble"
alternative. Because of the elimination of

    OIRA's Suggestion

                                  Appendix III
                  Case Studies on Significantly Affected Rules
                    With Evidence That OIRA Was Contacted by
                                External Parties

this minimum net reduction provision, facilities that trade pollutants in
accordance with the water bubble mechanism are not required to reduce
pollutant discharges to be 10 percent to 15 percent less than the
discharges otherwise authorized by the rule without use of the water
bubble (as had been required by the existing provision). This water bubble
provision was the subject of public comments on EPA's proposed rule, with
industry groups generally supportive of the water bubble flexibilities and
environmental groups advocating restrictions on the water bubble. The OIRA
files on its review of this draft final rule indicated that OIRA had
reviewed the substantive comments EPA received on the proposed rule.

On October 17, 2002, the final rule was published in the Federal Register.

Tire Pressure GAO ID 78

Agency: DOT-National Highway Traffic Safety Administration (NHTSA)

  Monitoring Systems RIN: 2127-AI33

Rulemaking stage at time of review: Final
Date submitted to OMB for review: December 17, 2001
Date OMB review completed: February 12, 2002
Result of Review: Returned

Rule as Submitted to OIRA	As submitted to OIRA for review, the draft final
rule would have established a standard under which all new vehicles would
be required to have a tire pressure monitoring system (TPMS). The rule
would have allowed automobile manufacturers to use either of two types of
systems until October 31, 2006 -a "direct" system that measures the
pressure in each tire or an "indirect" system that uses a vehicle's
antilock brake system to sense tire pressure differences by monitoring the
speed of tire revolution. However, after October 31, 2006, the rule would
have required manufacturers to use only the direct monitoring systems.

Outside Parties' Contacts On October 26, 2001-3 months after the Notice of
Proposed Rulemaking

with OIRA	was published in the Federal Register and almost 2 months before
the draft final rule was submitted to OIRA for review-OIRA and NHTSA
officials met with representatives from the Alliance of Automobile
Manufacturers and representatives from individual auto manufacturers
(Toyota, Ford, Volkswagen, and Daimler Chrysler). According to a summary
of the meeting prepared by NHTSA and placed in the DOT docket, most of the

                                  Appendix III
                  Case Studies on Significantly Affected Rules
                    With Evidence That OIRA Was Contacted by
                                External Parties

comments presented by the industry representatives were similar to those
in their filed written comments concerning such issues as legislative
intent, assumptions about costs and benefits, the validity of test data on
stopping distance, the number of vehicles operating with more than one
significantly underinflated tire, and the safety benefits of antilock
braking systems. In its March 23, 2001, comments on the proposed rule, the
Alliance of Automobile Manufacturers said it "believes that both
wheel-speed based [indirect] and pressure-sensor based [direct] TPMS have
merit, and should be permitted under pending requirements. Our proposal
will allow the further development of both types of systems."

On October 31, 2001, the Alliance sent letter to the OIRA Administrator
reiterating views regarding the draft final rule. The Alliance expressed
concern that the structure of the final rule would have the effect of
eliminating indirect tire pressure monitoring systems as a compliance
option. According to the letter:

"The Alliance has seen no evidence in the rulemaking record to suggest
that real world safety benefits that may accrue from tire pressure
monitoring systems will be noticeably different between systems using
indirect and direct sensing technologies. Absent such evidence, the
Alliance believes that the final rule should be carefully structured to
allow, at a minimum, current systems employing either type of sensing
technology - indirect or direct - to be used as compliance options. As
additional field experience is developed through the implementation of
this mandate, NHTSA may in the future exercise its long-standing authority
to initiate rulemaking to enhance the performance requirements for tire
pressure monitoring systems as may be warranted by valid engineering and
performance data. The rule should also be structured to assure the timely
and orderly implementation by providing a reasonable phase-in period."

OIRA officials also met with representatives from the Rubber Manufacturers
Association regarding the rule on February 21, 2002-9 days after OIRA
returned the rule for reconsideration. However, because NHTSA officials
did not attend the meeting because of agency policy, there is no summary
of the meeting available. An e-mail attached to the OIRA meeting log
stated that, according to an OIRA branch chief, "this is not an (Executive
Order 12866) meeting, since the rule is no longer here for review."
Nevertheless, OIRA listed the meeting on its Web site.

Changes Made to Rule at According to the February 12, 2002, return letter,
OIRA said "NHTSA needs

OIRA's Suggestion	to provide a stronger analysis of the safety issues and
benefits, including a formal analysis of a regulatory alternative that
would permit indirect systems after the phase-in period. Moreover, NHTSA
could analyze an option that would defer a decision about the ultimate
fate of indirect

Appendix III
Case Studies on Significantly Affected Rules
With Evidence That OIRA Was Contacted by
External Parties

systems for several more years, until the potential impact on installation
of anti-lock brake systems is better understood."

According to a July 24, 2002, NHTSA memo, the agency changed the draft
rule at OIRA's suggestion to "permit vehicle manufacturers to use current
indirect TPMSs as their means of complying with the standard." The new
draft final rule established two compliance options for a period beginning
November 1, 2003, and ending October 31, 2006. During this period,
automobile manufacturers would be allowed to use either direct or indirect
TPMSs. Meanwhile, NHTSA said that it would conduct additional studies and
would leave the rulemaking docket open for the submission of new data and
analysis. NHTSA said the second part of the rule will be issued by March
1, 2005, and will set performance standards to become effective November
1, 2006. Depending on the data developed during the first period, the
performance standards issued in 2005 could require direct monitoring
systems (as in the draft final rule as submitted to OIRA), or they could
reach some other determination (e.g., continue to allow the use of
indirect systems).

On May 28, 2002, NHTSA resubmitted the draft final rule for OIRA review.
The next day, OIRA approved the rule "consistent with no change." On June
5, 2002, the final rule was published in the Federal Register.3

3 The U.S. Court of Appeals recently held that the rule was contrary to
the intent of the tire safety legislation and arbitrary and capricious
under the APA. Public Citizen, Inc. v. Mineta, No. 02-4237 (2d Cir. Aug.
6, 2003).

                                  Appendix III
                  Case Studies on Significantly Affected Rules
                    With Evidence That OIRA Was Contacted by
                                External Parties

  Part 145 Review: Repair Stations

GAO IDs 84 and 72
Agency: DOT-FAA
RIN: 2120-AC38
Rulemaking stage at time of review: Final
Dates submitted to OMB for review: July 2, 2001; resubmitted July 13,
2001;
resubmitted July 20, 2001
Dates OMB review completed: July 11, 2001 (withdrawn); July 20, 2001
(returned); July 30, 2001 (consistent with no change)
Result of Reviews: Withdrawn, returned, consistent with no change

Rule as Submitted to OIRA	As submitted to OIRA on July 2, 2001, the rule
updated and revised the regulations for repair stations. Specifically, the
rule reorganized the requirements applicable to repair stations to reduce
duplication of regulatory language and eliminate obsolete information. In
addition, the rule established new definitions applicable to repair
stations and updated requirements relating to repair station
certification; housing, facilities, equipment, materials, and data;
personnel; and operations. The rule also eliminated, where practicable,
distinctions between repair stations based on geographical location.

    Outside Parties' Contacts with OIRA

On July 9, 2001, the Aeronautical Repair Station Association (ARSA) and
other industry representatives sent a letter to the Director of OMB (with
copies to the Deputy Administrator of OIRA and other OIRA officials and
staff) requesting that OIRA send the Part 145 rule back to FAA "with
instructions to prepare a Supplemental Notice of Proposed Rulemaking
(SNPRM) to address all of the issues needed to modernize Part 145."

On July 26, 2001, ARSA and other industry representatives met with OIRA
officials and an official from the Department of Commerce (but no one from
FAA) to discuss the Part 145 rule. (DOT officials told us that they
generally do not attend meetings with industry representatives at OMB.) In
their presentation to OIRA, the industry representatives repeated their
request that a supplemental notice of proposed rulemaking be issued
instead of the final rule. They also requested that guidance material be
issued at the same time that the final rule is issued and that a more
realistic compliance date be set.

                                  Appendix III
                  Case Studies on Significantly Affected Rules
                    With Evidence That OIRA Was Contacted by
                                External Parties

    Actions Taken at OIRA's Suggestion

On July 11, 2001, FAA withdrew the rule from OIRA review. An FAA
chronology of the rulemaking process stated that OMB "asked FAA to
withdraw the final (rule)." That same day, counsel to ARSA testified
before the House Subcommittee on Aviation on the FAA rulemaking process,
and attached the above-mentioned July 9, 2001, letter to his statement.
During our review, the counsel told us that he did not know whether OIRA
had requested that FAA withdraw the Part 145 rule, but said any such
action on OIRA's part "had nothing to do with us."

On July 13, 2001, FAA resubmitted the rule to OIRA for review. FAA
officials told us that the resubmitted rule was identical to the rule
submitted to OIRA on July 2, 2001. On July 20, 2001, OIRA returned the
rule to FAA for reconsideration. In his return letter, the Deputy
Administrator of OIRA said that the Department of State and the Office of
the United States Trade Representative indicated that certain language in
the rule could be read by other governments as a "needs test" for foreign
repair stations that would "raise a significant issue of our compliance
with applicable international trade agreements." However, FAA officials
told us that they had already addressed the Department of State's
concerns. Therefore, they said FAA resubmitted the rule to OIRA (unchanged
from its previous submission) on the same day as the return letter-July
20, 2001.

On July 30, 2001, OIRA approved the rule as "consistent with no change,"
and did not suggest that FAA make the changes that the industry
representatives recommended. On August 8, 2001, FAA published the final
rule in the Federal Register.

Appendix IV

                    Status of 23 High Priority Review Rules

In its May 2001 draft report on the costs and benefits of federal
regulations, the Office of Information and Regulatory Affairs (OIRA)
within the Office of Management and Budget requested that the public
provide it with "suggestions on specific regulations that could be
rescinded or changed that would increase net benefits to the public by
either reducing costs and/or increasing benefits." In its December 2001
final report, OIRA said it had received 71 suggestions in response to its
request. The report also indicated that OIRA had completed an initial
review of the suggestions and placed each of the suggestions into one of
three categories: (1) "high priority," meaning that OIRA was inclined to
agree with and look into the suggestion, (2) "medium priority," meaning
that OIRA needed more information about the suggestion, or (3) "low
priority," meaning that OIRA was not convinced that the suggestion had
merit. OIRA listed 23 of the suggestions in the first category, and said a
"prompt letter" might be sent to the responsible agency for its
"deliberation and response."

In its December 2002 report, OIRA reported on the status of these 23 high
priority suggestions. We used that information and supplemented it with
additional information from published sources to determine the status of
each of the regulations or issues that were the subject of the 23
suggestions as of May 2003. We then asked OIRA to review our descriptions
and provide us with any additional information available. The consolidated
information is presented in the table below for each of the 23
suggestions.

Table 10: Status of the 23 High Priority Review Suggestions Identified in
OIRA's December 2001 Report on the Costs and Benefits of Federal
Regulations

Regulation/issue and concern (as reported by OIRA) Status

The Mercatus Center said that the Department As published in January 2001,
a Department of Energy final rule would have required of Energy's analysis
for its central air that the energy efficiency of new central air
conditioners and heat pumps be increased conditioner and heat pump energy
by 30 percent by January 2006. However, in May 2002, the department
withdrew the conservation standards did not adequately rule and issued a
new final rule raising minimum energy efficiency by 20 percent. The
consider key differences among consumers department said the withdrawn
rule, which never became effective, was "not and may overstate projected
energy savings. economically justified under the Energy Policy and
Conservation Act."

The Mercatus Center said Department of In August 2002, the department
published final revisions to a December 2000 medical Health and Human
Services (HHS) rule on privacy rule, clarifying some aspects and modifying
others. For example, instead of standards for privacy of individually
identifiable mandating that direct treatment providers obtain prior
written consent to use protected health information imposed a costly
approach health information before treating a patient, the final rule
required them to make a good to medical privacy protections while failing
to faith effort to obtain a patient's written acknowledgement that the
patient received a offer tangible benefits. notice of privacy rights and
practices. The department said the changes were intended

to, in part, relieve "unintended administrative burdens created by the
Privacy Rule."

                                  Appendix IV
                    Status of 23 High Priority Review Rules

                         (Continued From Previous Page)

Regulation/issue and concern (as reported by OIRA) Status

The Mercatus Center said that the Food and In September 2001, the OIRA
administrator sent HHS a prompt letter on the trans fatty
Drug Administration's (FDA) proposed rule on acid content of foods,
encouraging the agency to give the issue greater priority. FDA
trans fatty acids in nutrition labeling misled the submitted the draft
final rule to OIRA for review in May 2003.
public by treating trans fats as a subset of
saturated fat.

The Mercatus Center said the costs of the In March 2001, BLM published a
proposed rule to suspend the hardrock mining Department of the Interior's
(DOI) Bureau of regulations that took effect in January 2001. In October
2001, BLM published a final Land Management (BLM) rule on hardrock rule
removing certain provisions and returning others to those in effect before
January mining outweighed the benefits. 2001. For example, the final rule
removed a provision granting federal land managers

more authority to deny hardrock mining permits and deleted enhanced
performance standards for groundwater and site remediation. BLM said the
new rule "balances the nation's need to maintain reliable sources of
strategic and industrial minerals, while ensuring protection of the
environment and natural resources on public lands."

The Mercatus Center said that DOI's National In its December 2002 report,
OIRA stated that the January 2001 DOI proposed rule on

Park Service's rule prohibiting snowmobile use at issue in this suggestion
was undergoing internal departmental review. As of May

in Rocky Mountain National Park did not allow 2003 no final rule had been
issued. However, in response to a lawsuit involving a

for different types of users to enjoy the park. 	separate January 2001
final rule that restricted snowmobile use in other parks in the Rocky
Mountains, the National Park Service initiated an environmental impact
statement that, when completed in February 2003, suggested allowing the
use of snowmobiles with access restrictions and limitations on the types
of engines. In March 2003, the Park Service approved a record of decision
selecting that alternative. Legislation has been introduced in both the
House and the Senate that would, if enacted, reinstate the ban on
snowmobile use in the parks.

The Mercatus Center said the Department of In November 2000, DOL published
a final rule allowing contractors on federal and
Labor's (DOL) regulations on "helpers" under federally assisted
construction projects to use "helpers" when that practice prevails in a
the Davis-Bacon Act should attempt to conform locality. In December 2002,
OIRA noted in its final report on the costs and benefits of
to private sector practices. Specifically, regulations that DOL decided
that changes to the Davis-Bacon regulations were not
Mercatus questioned the department's appropriate at that time.
definition of a "helper," which it said "constrains
private sector practices and innovation."

The Mercatus Center said the Department of In May 2000, DOT's Federal
Motor Carrier Safety Administration (FMCSA) published a
Transportation (DOT) did not present data proposed rule to alter the hours
of service for truck and other motor carrier drivers. The
supporting its conclusions in its rule on the agency received more than
50,000 comments on the proposal, which it later
hours of service of drivers that driver fatigue characterized as
"generally unfavorable." The fiscal year 2002 appropriations bill
contributes to highway fatalities or that its prohibited the department
from moving to a final rule that year. In April 2003, FMCSA
proposal would address those issues. published a final rule that changed
the scope and certain requirements from the

proposal. For example, the final rule exempted buses from its coverage.

The Mercatus Center said that revisions to the EPA's July 2000 final rule
on the program was intended to resolve issues concerning the Environmental
Protection Agency's (EPA) total identification of impaired waterbodies and
to address other issues. However, in an maximum daily loads program were
overly amendment to a fiscal year 2000 appropriations bill, Congress
prohibited EPA from prescriptive and could cost the states billions of
implementing the rule. In October 2001 EPA published a notice delaying the
effective dollars. date of the agency's July 2000 rule until April 2003.
In March 2003, EPA published a

final rule withdrawing the July 2000 rule. According to OIRA, as of May
2003, a draft of

a new proposed rule was undergoing informal interagency review.

The Mercatus Center recommended changes In its December 2002 report, OIRA
said it would "consider further review of the
to EPA's guidance on states' use of economic guidance after the States
have further experience with the current guidelines."
incentive programs to achieve air quality
standards.

                                  Appendix IV
                    Status of 23 High Priority Review Rules

                         (Continued From Previous Page)

Regulation/issue and concern (as reported by OIRA) Status

The Mercatus Center said that EPA's new In December 2002, EPA published a
final rule revising the Clean Air Act's new source source review program
was a deterrent to review program that provides industrial facilities with
alternatives to the program's investment in new oil refinery and power
requirements to install modern pollution controls whenever they make major
generation capacity, and that even relatively modifications that
significantly increase emissions. EPA asserts that the rule will modest
modifications that improve remove obstacles to investments in cleaner and
more efficient processes, and provide environmental performance could
trigger the greater certainty and administrative flexibility. Certain
environmental groups and state reviews. and local governments petitioned
EPA to reconsider specific aspects of the rule, and

EPA has agreed to reconsider and take public comment on several of the
issues raised by these parties. Also in December 2002, EPA published a
proposed rule that would revise an exemption from the rule for projects
involving routine maintenance, repair, and replacement.

The Mercatus Center said that while In January 2001, EPA published a
proposed rule changing the Clean Water Act concentrated animal feeding
operations are a permitting requirements for concentrated animal feeding
operations and strengthening problem in some areas, the benefits of a the
effluent guidelines for those facilities. In February 2003, EPA published
a final rule national rule establishing effluent guidelines do that OIRA
said had been significantly scaled back from the proposal, but would still
not justify the costs. more than triple the number of operations that
would have to obtain permits. However,

environmental groups said the new rule weakened the existing standard and
said they

were considering a lawsuit.

The Mercatus Center and the Association of EPA's January 2001 final rule
lowered the allowable level of arsenic in drinking water Metropolitan
Water Agencies said the benefits from 50 parts per billion to 10 parts per
billion. In May 2001, EPA delayed the rule's of EPA's rule on arsenic in
drinking water did implementation to review the science and cost factors
associated with changing the not justify the costs. standard. In September
2001, the National Academy of Sciences published a report

indicating that low levels of arsenic can result in higher incidences of
cancer. In October 2001, EPA announced that it would publish a final
standard at the 10 parts per billion level.

The Mercatus Center said that the Department A January 2001 Forest Service
final rule prohibited road construction, reconstruction, of Agriculture's
Forest Service rule on roadless and timber harvesting in inventoried
roadless areas on nearly 60 million acres of area conservation would cause
unnecessary National Forest System land. In May 2001, the Idaho District
Court granted a economic and environmental costs. preliminary injunction
enjoining the Forest Service from implementing all aspects of the rule.
According to OIRA, in December 2002, the U.S. Court of Appeals for the
Ninth Circuit lifted the injunction and remanded the decision to the
District Court. As of May 2003 its decision was pending. Also, in July
2003, the Wyoming District Court granted a permanent injunction enjoining
the Forest Service from implementing this rule. The Mercatus Center said
the Forest Service's In December 2002, the Forest Service published a rule
proposing changes to its planning procedures polarize the public and
November 2000 rule on forest planning. A review conducted at the direction
of the are a drain on Forest Service resources. Office of the Secretary
concluded that the 2000 rule was "neither straightforward nor

easy to implement," and "did not clarify the programmatic nature of land
and resource planning." The new proposed rule would, among other things,
allow federal land managers to disregard previously established scientific
requirements for wildlife protection and expedite the environmental review
process when developing plans. According to OIRA, a final rule is expected
in the fall of 2003.

Notre Dame University said the Department of In November 2002, the
Department of Education published a final rule amending the Education's
regulations under title IV of the department's regulations under the
Higher Education Act and other statutes. According Higher Education Act
are redundant and place to the department, the amendments were designed to
"reduce administrative burden for inappropriate administrative burden on
program participants, and to provide them with greater flexibility to
serve students and institutions of higher education. borrowers."

                                  Appendix IV
                    Status of 23 High Priority Review Rules

                         (Continued From Previous Page)

Regulation/issue and concern (as reported by OIRA) Status

The Equal Employment Advisory Council said In January 2003, the Employment
Standards Administration within DOL announced a that DOL's Office of
Federal Contract "preclearance consultation program" in which the public
was allowed to provide Compliance Programs' (OFCCP) equal comment on the
equal opportunity survey. Comments were due by the end of March
opportunity survey is excessively burdensome 2003. The announcement
indicated that OFCCP had engaged an outside contractor to and ineffective
in targeting contractors for study the survey submissions, and that the
study would be completed in 2004. In compliance audits. addition, OFCCP
requested a 2-year extension to its authorization for the survey under

           the Paperwork Reduction Act (until the end of March 2005).

The EEAC said the Equal Employment DOL said it and the other signatories
to the Uniform Guidelines (EEOC, the Department
Opportunity Commission's (EEOC) Uniform of Justice, and the Office of
Personnel Management) have been meeting for more than 3
Guidelines on Employee Selection Procedures years on the applicant
redefinition issue, particularly as it relates to recordkeeping and
should establish a standard definition of a "job reporting requirements.
The department also said that reauthorization responsibility
applicant" that does not impose undue burden rests with EEOC in
consultation with the other signatory agencies, and said OMB has
on employers to solicit race and gender requested resolution of this issue
by the end of September 2003.
information.

The Employment Policy Foundation (EPF) said In May 2002, the Employment
and Training Administration within DOL published a
that regulations affecting most employment-proposed rule that would, among
other things, amend its regulations governing the filing
based immigration cause needless effort and and processing of labor
certification applications for the permanent employment of
delays, and recommended replacing the aliens in the United States. In
December 2002, OIRA indicated that DOL was in the
certification process with a simpler attestation process of addressing
comments and finalizing the rule.
procedure.

LPA, Inc. said DOL requirements regarding OIRA indicated in its December
2002 report that DOL was considering whether
overtime compensation are a disincentive for revisions to these
regulations would be appropriate.
providing bonuses.

EPF and the National Partnership for Women In December 2002, OIRA said
that DOL was considering whether revisions to these and Families said
record keeping and regulations would be appropriate. In February 2003, the
Employment Standards notification regulations under the Family
Administration within DOL announced that it was conducting a preclearance
Medical Leave Act are burdensome and consultation program (allowing the
public and federal agencies to comment) regarding ambiguous. information
collections under the Family and Medical Leave Act. The department said it

was particularly interested in, among other things, "whether the proposed
collection of information is necessary for the proper performance of the
functions of the agency."

The American Chemistry Council said that In April 2003, EPA published a
proposed rule adding two chemicals-benzene and 2-
EPA's "mixture and derived from" rule under ethoxyelthanol-to the list of
solvents that can be mixed with wastewater without
the Resource Conservation and Recovery Act causing it to be defined as
hazardous waste. The proposed rule also would provide
is necessarily inclusive, and recommended flexibility in the way
compliance is determined, and would make additional listed
exempting certain waste streams resulting hazardous wastes eligible for
the de minimus exemption.
from the treatment of hazardous waste from
the requirements.

The City of Austin said EPA needed to improve In its December 2002 report,
OIRA indicated that it was addressing the issues raised in
its cost-benefit estimates for drinking water this suggestion in its new
analytic guidance. (See chapter 2 of this report for a
regulations under the Safe Drinking Water Act discussion of that
guidance.)
in three areas (overly conservative
assumptions, inappropriate discount rates, and
inadequate consideration of latency) and
should change the way fatal risk reduction is
valued.

                                  Appendix IV
                    Status of 23 High Priority Review Rules

                         (Continued From Previous Page)

Regulation/issue and concern (as reported by OIRA) Status

The American Petroleum Institute said EPA In its December 2002 report,
OIRA said EPA was considering several options to
needed to make several changes to its address this issue and said EPA had
established a new web page that contains
requirements regarding the notification of guidance, previous submissions,
and new submissions posed within 2 weeks of receipt.
substantial risk under section 8(e) of the Toxic OIRA also said that EPA
was working on a package that would make policy
Substances Control Act (e.g., limit reporting to clarifications.
information that truly meets the statutory
standard of substantial risk).

            Source: OIRA and GAO analysis of published information.

Appendix V

Comments from the Office of the Information and Regulatory Affairs

Appendix V
Comments from the Office of the Information
and Regulatory Affairs

Appendix V
Comments from the Office of the Information
and Regulatory Affairs

Appendix V
Comments from the Office of the Information
and Regulatory Affairs

Appendix V
Comments from the Office of the Information
and Regulatory Affairs

(450138)

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