United States General Accounting Office

GAO Report to the Committee on

Governmental Affairs, U.S. Senate

January 1998 REGULATORY

REFORM

Changes Made to

Agencies’ Rules Are

Not Always Clearly

Documented

GAO/GGD-98-31

GAO United States

General Accounting Office

Washington, D.C. 20548

General Government Division

B-276296 

January 8, 1998

The Honorable Fred Thompson

Chairman

The Honorable John Glenn

Ranking Minority Member

Committee on Governmental Affairs

United States Senate

The number of federal regulations and their effect on the American

economy have grown dramatically during the past 30 years. With that

growth has come an increased concern about the manner in which those

regulations are developed by federal agencies. Executive Order 12866 on

“Regulatory Planning and Review,” which was issued on September 30,

1993, describes the process by which proposed significant1

 rules of

regulatory agencies (other than those considered to be independent

regulatory agencies) are to be reviewed by the Office of Management and

Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA).2

One of the stated purposes of Executive Order 12866 is to make the

federal rulemaking process “more accessible and open to the public.” In

furtherance of that objective, the order includes requirements to improve

the “transparency” of the process. Specifically, the order requires that

agencies identify for the public in a complete, clear, and simple manner

the substantive changes that are made to rules while under review at OIRA

and, as a separate requirement, the changes that are made at the

suggestion or recommendation of OIRA. The order also requires OIRA to

make available to the public at the conclusion of the rulemaking process

all documents exchanged between OIRA and the agency during the review

process.

In September 1996, we testified on the implementation of Executive Order

12866.3

 This report responds to your request that we update and look more

deeply into an issue addressed in that testimony—the transparency of the

regulatory review process. You specifically asked that we focus our review

1

Significant rules are defined by Executive Order 12866 as ones that may (1) have an annual effect of

$100 million or more on the economy or have other economic effects; (2) create a serious

inconsistency or interfere with an action planned or taken by another agency; (3) materially alter the

budgetary impact of entitlements, grants, user fees, or loan programs or alter the rights and obligations

of recipients thereof; or (4) raise novel legal or policy issues.

2

Throughout this report we use OIRA, instead of OMB, when discussing OMB responsibilities that have

been delegated to OIRA.

3

Regulatory Reform: Implementation of the Regulatory Review Executive Order (GAO/T-GGD-96-185,

Sept. 25, 1996).

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on OIRA and four regulatory agencies: the Departments of Housing and

Urban Development (HUD) and Transportation (DOT), the Department of

Labor’s Occupational Safety and Health Administration (OSHA), and the

Environmental Protection Agency (EPA). The objectives of our review were

to determine whether (1) the regulatory agencies had identified for the

public the substantive changes made to their regulations between the draft

submitted to OIRA and the regulatory actions4

 subsequently announced,

(2) the regulatory agencies had identified for the public the changes made

to their regulations at the suggestion or recommendation of OIRA, and

(3) OIRA had made available to the public all documents exchanged

between OIRA and the selected agencies during OIRA’s review. To answer

these questions, we focused on regulatory actions related to significant

rules that were developed by the four agencies and that were reviewed by

OIRA before publication as final rules between January 1, 1996, and

March 1, 1997.

Results in Brief EPA, DOT, HUD, and OSHA had complete documentation available to the

public of all of the substantive changes made to their rules between the

draft submitted to OIRA and the actions subsequently announced for about

26 percent of the 122 regulatory actions that we reviewed. For about

30 percent of the regulatory actions, the agencies had some

documentation available to the public indicating that changes had been

made to the rules while at OIRA, but the information did not indicate

whether all such changes had been documented. For the remaining

44 percent of the regulatory actions, the agencies had no documentation

available to the public of changes made during OIRA’s review. Because

Executive Order 12866 does not specifically require agencies to document

that no changes were made to rules while they were under review at OIRA,

the absence of documentation does not necessarily mean that the agencies

were not complying with the order. However, it was unclear whether the

absence of documentation meant that no changes had been made to the

rules or whether changes had been made but they had not been recorded.

The agencies had complete documentation available to the public of all of

the changes that OIRA had suggested or recommended for about 24 percent

of the 122 regulatory actions. For about 17 percent of the regulatory

actions, the agencies had some documentation available to the public

indicating that OIRA had suggested changes to the rules, but the

information did not indicate whether all such changes had been

4

In Executive Order 12866 and this report, proposed rules and final rules are each considered separate

“regulatory actions.” The order requires that, after the completion of each such action, the agencies

document changes that were made to the rules.

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documented. For the remaining 59 percent of the actions, the agencies had

no documentation available to the public indicating whether changes had

been made at the suggestion or recommendation of OIRA. For some of

these actions, the agencies had documentation available indicating that

changes had been made to the rules during the rulemaking process, but it

was unclear whether any of the changes were at OIRA’s suggestion. Again,

the absence of documentation does not mean that the agencies were not

complying with the order. However, it was unclear whether the absence of

documentation meant that changes had not been made at OIRA’s suggestion

or whether documentation of such changes was missing.

Even those rules for which the agencies had complete documentation of

all changes made while they were at OIRA and at the suggestion of OIRA, the

documents were not always available to the public or easy to locate. Some

agencies did not include this information in their public rulemaking

dockets. Other agencies had the information in their dockets but the

dockets had no indexes; therefore, the public would have to review the

entire docket to find any documentation of rule changes. In contrast, some

agencies’ dockets were well-organized, with a consistently structured

index for all rules and specific sections for information related to OIRA’s

review. Several agencies had also begun to automate their dockets so that

both indexes and eventually the entire rulemaking record could be

accessed electronically by the public.

We could not identify all of the documents that had been exchanged

between the agencies and OIRA during the regulatory review process, so we

could not determine whether OIRA had made all such documents available

to the public. OIRA officials said that most of OIRA’s interactions with the

agencies during the regulatory review process are by telephone or in

face-to-face meetings, not by exchanging documents. They said that any

documents that are exchanged are usually drafts of the rules themselves

and any related economic analyses. Nearly all of the draft rules and

analyses that the agencies’ dockets indicated had been sent to OIRA were in

OIRA’s public files, but memorandums and other documents that the

agencies’ dockets indicated had been exchanged were often not in the OIRA

files.

Background Executive Order 12291, which was issued by President Reagan in 1981,

authorized OMB to review all proposed and final federal regulations, except

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those of independent regulatory agencies.5 The order also required OMB to

monitor agencies’ compliance with the order’s requirements and to

coordinate its implementation. OIRA’s reviews under this order were highly

controversial, with critics contending that OIRA exerted too much control

over the development of rules and that decisions were being made without

appropriate public scrutiny.

Executive Order 12866 revoked Executive Order 12291 but continued the

basic framework of the regulatory review process. It also reaffirmed the

legitimacy of OIRA’s centralized review function and its responsibility for

providing guidance to the agencies.6

 However, Executive Order 12866 also

made changes to address criticisms of the regulatory program under

Executive Order 12291. In its recent draft report to Congress on the costs

and benefits of federal regulations, OMB said that one of these changes was

“to increase the openness and accountability of the review process.”7

Specifically, section 6 of Executive Order 12866 requires OIRA to “make

available to the public all documents exchanged between OIRA and the

agency during the review by OIRA under this section.” Section 6 of the

order also requires agencies to (1) “[i]dentify for the public, in a complete,

clear, and simple manner, the substantive changes between the draft

submitted to OIRA for review and the action subsequently announced” and

(2) “[i]dentify for the public those changes in the regulatory action that

were made at the suggestion or recommendation of OIRA.” The order does

not require agencies to document when no changes are made during OIRA’s

review or at the suggestion or recommendation of OIRA.

In October 1993, the OIRA Administrator issued guidance to the heads of

executive departments 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 essentially repeated those requirements without elaboration.

In previous reports on the implementation of Executive Order 12866, OIRA

has cited increased openness and accountability as a major success of the

executive order. Also, at the September 1996 hearing on the

implementation of the order, the OIRA Administrator said the following:

5

For a description of and statistics relating to OIRA’s review process under Executive Order 12291, see

Regulatory Review: Information on OMB’s Review Process (GAO/GGD-89-101FS, July 14, 1989).

6

Section 2(b) of Executive Order 12866 states that, “[t]o 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 . . . .”

7

Draft Report to Congress on the Costs and Benefits of Federal Regulations, OMB, Federal Register,

Vol. 62, No. 140, July 22, 1997.

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“Executive Order 12866 created a more open and accountable review process. The order

called for more public involvement, and it specifically delineated who is responsible for

what and when, so that interested parties would know the status and results of the

Executive review. I have since heard no complaints about accountability and

transparency—and I take that as a success.”

However, in response to our testimony at the same hearing that EPA and

DOT frequently had not documented the changes made to their rules that

had been suggested or recommended by OIRA, the Administrator

acknowledged that agencies had not “been scrupulously attentive” to that

requirement in the order.

S. 981, the proposed “Regulatory Improvement Act of 1997,” includes

several provisions to strengthen and clarify the executive order’s

requirements for public disclosure of and access to information on

regulatory review actions. One section of the bill requires agencies to

include in the rulemaking record (1) a document identifying in a complete,

clear, and simple manner, the substantive changes between the draft

submitted to OIRA and the rule subsequently announced; (2) a document

identifying changes in the rule made at the suggestion or recommendation

of OIRA; and (3) all written communications exchanged between OIRA and

agencies during the review. The bill differs from the order in that it

requires (1) agencies (not OIRA) to include in the rulemaking record all

written communications (not “documents”) exchanged between OIRA and

the agencies8

 and (2) agencies to identify changes made to rules while they

were at OIRA and changes made at the suggestion of OIRA in a single

document.9

Objectives, Scope,

and Methodology

Our first two objectives were to determine whether EPA, DOT, HUD, and OSHA

had (1) identified for the public the substantive changes between the draft

submitted to OIRA for review and the regulatory action subsequently

announced and (2) identified for the public those changes in the regulatory

action that were made at the suggestion or recommendation of OIRA. Our

third objective was to determine whether OIRA had made available to the

public all documents exchanged between OIRA and the agency during the

review process.

8

“Written communications” may or may not be broader than “documents.” Executive Order 12866 does

not indicate whether “documents” includes all types of “written communications.”

9

For our comments on certain provisions in this bill, see Regulatory Reform: Comments on S.

981—The Regulatory Improvement Act of 1997 (GAO/T-GGD/RCED-97-250, Sept. 12, 1997).

Page 5 GAO/GGD-98-31 Regulatory Reform
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We included in our review all of the four agencies’ regulations that were

reviewed by OIRA before publication as final rules between January 1, 1996,

and March 1, 1997. We obtained a list of all such rules and any related

notices of proposed rulemaking from the Regulatory Information Service

Center (RISC).10 We deleted from the list all rules that were withdrawn by

the agencies and all proposed rules that were reviewed by OIRA before

Executive Order 12866 was issued on September 30, 1993.11 The proposed

rules and final rules comprised the universe of regulatory actions that we

reviewed. Table 1 shows the number of proposed rules, final rules, and the

total number of regulatory actions that we examined in each agency.

Table 1: The Number of Proposed

Rules, Final Rules, and Total

Regulatory Actions for Each Agency

Agency Proposed rules Final rules Total

HUD 2 23 25

OSHA 1 2 3

DOT 12 27 39

EPA 25 30 55

Total 40 82 122

Source: RISC.

We asked officials in each agency how to locate the information that is

required by Executive Order 12866 for these rules. In almost all cases, the

agencies said that the information was in their public rulemaking dockets.12

 We then reviewed those dockets and other agency files to determine the

extent to which documentation of changes made while under review at

OIRA met the requirements of executive order. The order says that the

agencies must “identify for the public, in a complete, clear, and simple

manner, the substantive changes made” between the draft submitted to

OIRA for review and the regulatory action subsequently announced.

However, the order does not define these terms or provide criteria for

determining whether agencies have complied with these provisions.

10RISC is part of the General Services Administration and works closely with OMB to provide

information to the president, Congress, and the public about federal regulations. Its primary role is to

coordinate the development of the Unified Agenda of Federal Regulatory and Deregulatory Actions,

which is a comprehensive listing of proposed and final regulations. RISC maintains a database that

includes information on all regulatory actions reviewed by OIRA.

11We excluded rules that were withdrawn by the agencies because Executive Order 12866 only requires

agencies to make information about changes to regulatory actions available to the public if they are

published in the Federal Register or otherwise issued to the public.

12As will be discussed later in this report, one agency indicated that the required information was not

in its public rulemaking docket, but was “available to the public.” In this report, we refer to these few

instances of documentation that were “available” as being in the rulemaking docket.

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To describe differences in the extent of documentation available to the

public in the agencies’ files, we coded each regulatory action into one of

the following three categories: (1) complete documentation, which could

be a “redline/strikeout” version of the rule showing all changes made

during the review, a memorandum to the file listing all of the changes, or a

memorandum indicating that there were no such changes; (2) some

documentation, which means we found indications of changes that had

been made during OIRA’s review (e.g., memorandums or redline/strikeout

versions), but the files did not indicate whether all such changes had been

documented; and (3) no documentation, which means that there were no

changes made during the review or that changes were made, but were not

documented. The last two descriptive categories do not necessarily

indicate whether the agencies have complied with the executive order.

However, the categories do provide a relative sense of how transparent a

regulatory review is to the interested public. If the agencies’ files indicated

that all changes had been documented, we did not verify that assertion.

We followed the same general procedure to describe the extent to which

the agencies had documented for the public the changes made to the

regulatory actions at the suggestion or recommendation of OIRA. The OIRA

Administrator’s October 1993 guidance on the implementation of

Executive Order 12866 indicated that the changes made to a regulatory

action at the suggestion or recommendation of OIRA were a subset of

changes made during the period of OIRA’s review. However, in this review

we examined the implementation of these requirements separately

because changes made at OIRA’s suggestion or recommendation are not

necessarily a subset of changes made during the period of OIRA’s review.

Both OIRA and agency officials have said that OIRA frequently comments on

draft rules before they are formally submitted for review. Changes made to

rules as a result of those comments would not be the same as changes

made “between the draft submitted to OIRA for review and the regulatory

action subsequently announced.” Therefore, in this part of the review we

looked for documentation of changes that were made at the suggestion or

recommendation of OIRA whenever they occurred.

We also noted the extent to which the agencies’ documents for the

regulatory actions that we reviewed were actually accessible to the public

in the agencies’ public dockets or elsewhere. Both EPA and DOT had a

number of public dockets, generally corresponding with different subunits

in the agencies. For example, within DOT we examined files in the dockets

of eight departmental units: the Federal Aviation Administration (FAA), the

Federal Railroad Administration (FRA), the Federal Highway

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Administration (FHWA), the Maritime Administration (MARAD), the National

Highway Traffic Safety Administration (NHTSA), the Research and Special

Programs Administration (RSPA), the United States Coast Guard (USCG),

and the Office of the Secretary of Transportation (OST). In HUD, there was

one public docket covering all of the rules in our review. In OSHA, the

information for our review was not part of the public docket, but was

provided by agency officials.

As part of the second objective, we also examined EPA and DOT actions

after September 1996 to document changes suggested by OIRA. In our

September 1996 testimony, we reported that EPA and DOT frequently had

not documented changes to their rules that OIRA had suggested or

recommended. As a result of that testimony, both EPA and DOT issued

guidance to certain employees emphasizing the executive order’s

requirement for documenting such changes. We examined EPA and DOT

actions after the hearing to determine whether the agencies’ staff were

better documenting OIRA-suggested changes. We also determined whether

OIRA had taken any actions after the hearing to require agencies to

document changes made at OIRA’s suggestion.

Regarding the third objective, which was to determine whether OIRA had

made available to the public all of the documents exchanged between OIRA

and the agencies during the reviews by OIRA, we first noted any evidence in

the agencies’ files that documents had been exchanged between the

agencies and OIRA during the rulemaking process. In this review, we

defined “documents” to include not only drafts of the rule sent to OIRA, but

also letters, faxes, memorandums of telephone conversations, and

decision memorandums. We then examined OIRA’s public files for each

final action for which the agencies’ files indicated documents had been

exchanged. In addition, we reviewed OIRA’s files for selected other final

actions for which the agencies’ files did not indicate that documents had

been exchanged. These actions were selected to obtain dispersion across

the agencies and, when combined with the files we were already

examining, to review at least one-half of the 82 final regulatory actions. We

did not examine OIRA files for any of the related proposed rules because

OIRA had already sent most of these older files out to be archived. We

coded each of the actions on the basis of whether (1) OIRA and agency files

had the same documents, (2) OIRA files did not have documents that we

found in the agency files, (3) OIRA files had documents that were not in the

agency files, or (4) both OIRA and the agency had documents not found in

the other’s files.

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We conducted this review between March and December 1997 in the

Washington, D.C., headquarters offices of each of the four regulatory

agencies and OIRA in accordance with generally accepted government

auditing standards. We provided a draft of this report to the Director of

OMB and the Secretaries of HUD, Labor, and DOT, and the Administrator of

EPA for their review and comment. Their comments are reflected in the

agency comments section of this report.

Agencies Often Did

Not Document

Whether Changes

Were Made to Rules

While at OIRA

Executive Order 12866 directs agencies to “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.” The 4 agencies had complete documentation of the changes

for about 26 percent of the 122 regulatory actions that we reviewed. The

agencies had some documentation of changes made during OIRA’s review

for another 30 percent of the actions, but the files did not indicate whether

all such changes had been documented. The remaining 44 percent of the

actions had no documentation available to the public indicating whether

changes were made to the draft rule submitted to OIRA.

We considered agencies to have completely documented the changes

made to the rules during OIRA’s review if the docket included

memorandums to the file listing all of the changes made, drafts of the rules

indicating all changes that had been made, or agency certifications that no

changes had been made. For example, OSHA’s records for its two final rules

contained a memorandum to the file that summarized telephone contacts

and a meeting between OSHA and OIRA during the review, and all of the

changes that were made to the rule resulting from these contacts. The

memorandum also indicated whether the changes were in the body of the

regulation or in its preamble, and identified some changes as simply minor

word adjustments. Some of the DOT dockets, particularly those in FAA and

OST, contained a certification signed by a senior agency official indicating

that no changes had been made to the rules.

The dockets for the regulatory actions that had only some documentation

contained memorandums and other records in the files indicating that

certain changes had been made to the rules in question, but it was unclear

whether all of the changes made during OIRA’s review had been recorded.

For example, in EPA’s Air and Radiation docket three documents identified

changes that had been made to one of the final rules as a result of

communications with OIRA at different phases of the review process.

However, it was not clear whether these three documents reflected all of

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the changes that had been made to the rule during OIRA’s review, or

whether other changes had been made but not documented.

The dockets for other regulatory actions had no documentation of changes

made during OIRA’s review. For example, NHTSA’s public rulemaking docket

contained a great deal of information related to the development of the

four NHTSA rules included in our review. However, the docket did not

contain any documents indicating that the rules had been submitted to

OIRA, or that changes had been made during or as a result of OIRA’s review.

Some of the HUD files contained documents that had been submitted to

OIRA, but did not indicate whether any changes were made to the rules.

As figure 1 shows, some differences existed among the four agencies in

the degree to which they had documented changes made to rules during

OIRA’s review. Although all four of the agencies had at least some

documentation for over one-half of their regulatory actions, the agencies

differed in the degree to which the documentation was complete. Two of

the agencies (DOT and EPA) had no documentation for about one-half of

their regulatory actions. The remaining agencies (HUD and OSHA) had no

documentation for about one-third of their regulatory actions.

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Figure 1: Differences Among Agencies

in Documentation of Changes During

OIRA’s Review

OSHA HUD DOT EPA

0

20

40

60

80

100

33

12

41

22

33

52

10

33 33

36

49

46

Percentage of regulatory actions

Complete documentation

Some documentation

No documentation

N = 3 N = 25 N = 39 N = 55

Note: Numbers may not add to 100 percent because of rounding.

Source: GAO analysis.

Agencies Often Did

Not Document

Whether Changes

Were Made to Rules at

the Suggestion or

Recommendation of

OIRA

Executive Order 12866 also directs agencies to identify changes to each

regulatory action made at the suggestion or recommendation of OIRA.

About 24 percent of the regulatory actions that we examined in the four

agencies had complete documentation of these changes. Another

17 percent of the actions had some documentation of changes that had

been made to the rules, but the files did not indicate whether all such

changes had been made at OIRA’s suggestion or whether all OIRA-suggested

changes had been documented. The remaining 59 percent of the regulatory

actions had no documentation of changes that had been suggested or

recommended by OIRA.

The manner in which the agencies completely documented the changes

made to the rules at OIRA’s suggestion included memorandums to the file

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listing all such changes, drafts of the rules indicating all changes made

because of OIRA, and agency certifications that no OIRA-directed changes

had been made. For example, the public docket for the two FRA actions

that we examined had memorandums to the file detailing changes made to

the draft “pursuant to meetings of appropriate OMB staff and FRA staff.” One

of the HUD regulatory actions had a clear, simple memorandum to the file

documenting not only the changes the agency made to the rule at the

suggestion of OIRA, but also OIRA-suggested changes that the agency

decided not to make. For an FAA final regulatory action, changes were

noted in a redline/strikeout copy of the rule that identified them as “OMB

changes.” An accompanying certification form indicated that all

information required by the order was included, so we considered the

documentation to be complete.

Agencies’ public rulemaking dockets for other regulatory actions had

some documentation of OIRA-suggested changes. For some of these

actions, the dockets indicated that changes had been made to the rules in

question, but it was unclear which specific changes could be traced to

OIRA. In other cases, it was unclear whether all OIRA-suggested changes had

been documented. For example, OSHA’s file for its methylene chloride final

rule contained 10 documents indicating that a number of issues had been

raised during the months that the rule had been reviewed at OIRA. Some of

the documents indicated that specific changes had been made to the rule

at OIRA’s suggestion, but the files did not indicate whether these

documents reflected all of the changes that OIRA had suggested or

recommended. Other documents indicated that OIRA had suggested certain

changes to the rule, but it was unclear whether those changes had been

made.

As figure 2 shows, the agencies differed somewhat in the degree to which

they documented OIRA-suggested changes. Also, a comparison of figures 1

and 2 indicates that HUD, DOT, and EPA were less likely to have any

documentation of OIRA-suggested changes than documentation of changes

made during OIRA’s review.

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Figure 2: Differences Among Agencies

in Documentation of Changes Made at

the Suggestion or Recommendation of

OIRA

OSHA HUD DOT EPA

0

20

40

60

80

100

33

8

36

22

33

24

10

18

33

68

54

60

Complete documentation

Some documentation

No documentation

N = 3 N = 25 N = 39 N = 55

Percentage of regulatory actions

Note: Numbers may not add to 100 percent because of rounding.

Source: GAO analysis.

EPA and DOT

Documentation of

OIRA-Suggested Changes

Improved Little After

Congressional Hearing

In our September 1996 testimony on the implementation of Executive

Order 12866, we reported that only a few of the rules that we examined at

EPA and DOT had information in the agencies’ public rulemaking dockets

that clearly indicated what changes had been made to the rules at the

suggestion or recommendation of OIRA. As a result of our review, both

agencies sent guidance to certain staff instructing them to better

document OIRA-suggested changes to their rules. In September 1996, EPA’s

Director of Regulatory Management and Information sent a memorandum

to the agency’s steering committee representatives and regional regulatory

contacts instructing them to ensure that the order’s transparency

requirements were satisfied for all rules then under development. He

suggested using redline/strikeout versions of the draft rule to satisfy these

requirements.

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In a November 1996 memorandum, DOT’s Assistant General Counsel for

Regulation and Enforcement reminded regulatory officers throughout the

Department of their responsibilities under section 6 of Executive Order

12866 to identify for the public the drafts of rulemaking actions provided

to OIRA and the substantive changes between the draft submitted to OIRA

for review and the action subsequently announced. The memorandum also

said that a signed, standard form certifying that these executive order

requirements had been met would have to accompany any rules accepted

in the rulemaking docket from OST. Those completing the form were

required to indicate that the rule was not reviewed by OIRA, that no

substantive changes had been made after the rule was submitted, or that

the required information was attached. Although the certification form

was required only for OST rules, the Assistant General Counsel suggested

that other units within DOT use the same form.

We examined documentation for EPA and DOT regulatory actions both

before and after the September 1996 hearing to determine whether the

agencies had better complied with Executive Order 12866 requirements on

documenting OIRA-suggested changes. From January through September

1996, OIRA reviewed 18 EPA and 15 DOT final rules. In the period between

October 1996 and March 1997, OIRA reviewed 12 EPA and 12 DOT final rules.

As shown in table 2, the percentage of EPA rules with no documentation in

the rulemaking dockets decreased in the later period, and the percentage

of rules with some (but not complete) documentation increased. The

percentage of DOT rules with no documentation also decreased, but the

percentage with complete documentation increased. Although DOT did not

issue its guidance until November 1996, use of the certification form

suggested in that the guidance resulted in more rules with complete

documentation in the later period.

Table 2: Percentage of EPA and DOT

Final Rules Reviewed Before and After

September 30, 1996, That Had

Complete, Some, and No

Documentation

EPA DOT

Documentation

Before

9/30/97

After

9/30/97

Before

9/30/97

After

9/30/97

Complete 28% 17% 27% 42%

Some 11 33 13 8

None 61 50 60 50

Total 100% 100% 100% 100%

Source: GAO analysis.

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The rulemaking docket for all but one of the six FAA rules that we reviewed

had the certification form that the DOT Assistant General Counsel for

Regulation and Enforcement had suggested to indicate compliance with

Executive Order 12866. However, in each case these certifications were

added to the rulemaking dockets the day of or the day before our review

of those dockets. Therefore, it appeared that the certifications were added

for our benefit, not as a result of DOT’s guidance.

OIRA Has Not Issued

Guidance on Transparency

Requirements Since the

September 1996 Hearing

As of December 1, 1997, OIRA had not taken any action since the

September 1996 hearing to require agencies to document changes made

pursuant to OIRA’s suggestion or recommendation. In fact, the OIRA

Administrator has indicated that she does not support this transparency

requirement. For example, in testimony before the Senate Governmental

Affairs Committee on September 12, 1997, the OIRA Administrator said she

opposed including a similar provision in S. 981 because “[b]ased on my

four-and-a-half years overseeing the regulatory review process, I strongly

believe that this provision is counterproductive to everything we have

sought to achieve in carrying out meaningful review.” She also said that “in

our review process, it is very often not entirely clear who suggests or

recommends a change in a regulation” and that having this requirement

may “result in resistance to change lest the ‘record’ reflect a series of

‘gotchas’ by OMB.”

Information About

Changes in

Regulations Was

Sometimes Not

Readily Available to

the Public

One purpose of Executive Order 12866’s transparency requirements is to

make information about the rulemaking process available to the public.

However, some documents clearly identifying changes made during the

OIRA review or at the suggestion of OIRA were not in the public rulemaking

dockets. More frequently, however, documents describing changes to the

rules were in the public dockets, but they were difficult to locate because

the dockets either did not have indexes or had indexes that were difficult

to use without special expertise.

Some Documents Were

Not in the Public Dockets

Some documents identifying changes made during OIRA’s review or at the

suggestion of OIRA existed, but they were not available to the public. For

example, two of the seven USCG regulatory actions that were included in

our review had some documentation of changes made during OIRA’s review

or at the suggestion or recommendation of OIRA in the agency’s rulemaking

docket. However, it was unclear whether all such changes had been

documented. Although, USCG had prepared detailed summaries for agency

Page 15 GAO/GGD-98-31 Regulatory Reform
B-276296 

decisionmakers of all of the changes made during OIRA’s review, USCG

officials said these summaries were internal communications and,

therefore, not available to the public.

OSHA had complete documentation of the changes made at the suggestion

of OIRA for one of its three regulatory actions included in our review, and

had some documentation for another action. However, OSHA maintained

the information in files separate from the public rulemaking docket to

ensure that it did not become part of the official rulemaking record and,

therefore, subject to litigation. OSHA officials said that they would make the

documentation available to the public upon request. However, for

individuals to request the information, they must first know that the

documents exist.

Some Documents Were

Difficult to Find in the

Public Dockets

The agencies’ public rulemaking dockets varied in the degree to which

they could be easily used to find the information about changes in

regulatory actions that Executive Order 12866 requires be identified for

the public. The information in the dockets for some of the rules was quite

voluminous, with numerous documents added to the files during the years

in which the rules were being developed. Furthermore, many of the

dockets did not have an index to the documents in the files, making it

difficult to locate the information mandated by the order within those

files. For example, the docket for 1 rule at FRA contained 19 folders of

material related to the development of the rule, some of which were nearly

a foot thick. FRA did not have a public index to this or other files in its

docket, although the agency did have an internal listing of the contents of

these folders. FRA officials said the agency’s internal index would become

a part of a public, electronic index when the agency moves onto a DOT

automated system that was under development at the time of our review.

Several other dockets, including those at FAA, USCG, and HUD, did not have

indexes for their rulemaking records.

Even in the dockets that had indexes to the documents in the files, the

indexes were not always very useful in identifying documents related to

the OIRA review. Some of the agencies’ indexes (e.g., NHTSA’s index) were

simply chronological lists of documents in the files. Although a

chronological list is better than no list at all, these lists were often

extensive, and the documents in the list were not always clearly identified.

For example, in EPA’s Toxic Substances Control Act (TSCA) docket, the file

index for one of the rules in our review identified communications

between EPA and OIRA staff by the name of the OIRA staff member who was

Page 16 GAO/GGD-98-31 Regulatory Reform
B-276296 

responsible for the review (e.g., “Memo from John Doe”). Therefore, a user

of this index would have to know that “John Doe” was the name of an OIRA

staff member to use the index to identify the documents reflecting

OIRA-suggested changes.

In contrast, other agencies have implemented procedures and practices

that make locating and using information in their dockets much easier for

the public. For example, EPA’s Air and Radiation docket had a consistently

structured index for all of its rules, with specific sections in which

information related to OIRA’s reviews could be found. OST also had a

consistently structured index for rules in its dockets and had automated

its docket so that both the indexes and the full text of many documents on

the rulemaking process could be accessed electronically. Using the

automated index greatly facilitated our access to information about

documents in the rulemaking dockets. DOT officials told us that the

automated system will eventually be extended across the entire

Department and that all DOT dockets will be available on the Internet. EPA

has also taken some steps to automate its dockets.

OIRA Made Some

Documents

Exchanged During the

Review Process

Available to the Public

Executive Order 12866 requires OIRA, at the conclusion of each regulatory

action, to make available to the public all documents exchanged between

OIRA and regulatory agencies during the review process. To determine

whether OIRA had complied with this requirement, we first had to

determine what documents had been exchanged between OIRA and the

agencies during the review. Therefore, during our examination of the

regulatory agencies’ files in relation to the first two transparency

requirements, we also noted any evidence of documents that had been

exchanged.

Relatively few of the agencies’ files contained any indication that

documents had been exchanged between the agencies and OIRA. This could

indicate that documents are usually not exchanged during the review

process or that documents are exchanged, but they are often not recorded

in the agency files (because the order does not require the agencies to do

so). OIRA officials said that there are relatively few documents exchanged

during the review process, other than the rules themselves and any related

economic analyses. Officials in one agency told us that most of OIRA’s

interactions with the agency during the review process are by telephone or

in face-to-face meetings, not by exchanging documents.

Page 17 GAO/GGD-98-31 Regulatory Reform
B-276296 

Because we could not be sure that we had identified all of the documents

that had been exchanged between the agencies and OIRA during the

regulatory review process, we could not conclusively determine the extent

to which OIRA had made such documents available to the public. However,

the agencies’ files seemed to support the OIRA’s observations that the

documents exchanged are most commonly the draft rules and draft

economic analyses. Other documents that the agencies’ files indicated had

been exchanged included letters, faxes, and memorandums documenting

telephone calls or meetings with OIRA staff summarizing the issues

discussed, questions raised, and positions taken by the agencies and OIRA.

We examined OIRA’s public files for (1) each final action for which the

agencies’ files indicated documents had been exchanged and (2) selected

other final actions for which the agencies’ files did not indicate that

documents had been exchanged. In total, we reviewed the files for 42 of

the 82 final regulatory actions that we examined in the agencies. For 25 of

these 42 actions, the OIRA files had the same documents that the agencies’

files indicated had been exchanged or had more documents that had been

exchanged than the agencies’ files had indicated. For 17 of the 42 actions,

the OIRA files did not have certain documents that the agencies files said

had been exchanged (although in 7 of these cases, the OIRA files also had

documents that were not in the agencies’ files). The OIRA files nearly

always contained the draft rules that the agencies’ files indicated had been

exchanged. However, OIRA less frequently had the other types of

documents that the agencies’ files indicated had been exchanged (e.g.,

letters, faxes, and memorandums).

Conclusions Executive Order 12866 requires federal agencies to make the regulatory

review process more transparent by identifying for the public “in a

complete, clear, and simple manner” the substantive changes made to

regulatory actions while under review at OIRA, and to identify the changes

made at the suggestion or recommendation of OIRA. We believe that these

public disclosure requirements, combined with the administration’s

assertion of their effectiveness, can result in a public perception that

information on changes made to regulations while at OIRA and at the

suggestion of OIRA is readily available. However, our review of the

information available to the public at four agencies indicated that this was

usually not the case.

The public rulemaking dockets for many of the 122 regulatory actions that

we examined did not contain complete documentation of the changes

Page 18 GAO/GGD-98-31 Regulatory Reform
B-276296 

made during OIRA’s review or at OIRA’s suggestion. Some of the files in

those dockets indicated that certain OIRA-suggested changes had been

made to the rules in question, but these files did not indicate whether all

such changes had been documented. Other files contained no

documentation of changes made during OIRA’s review or at OIRA’s

suggestion. It was unclear whether this absence of documentation meant

that no changes had been made to the rules or that the changes were

made, but they had not been documented. Some agencies had prepared or

collected documentation of these changes, but the documents were not in

the public rulemaking dockets. Some of the files in the dockets were

extremely voluminous, and, without indexes to the documents in those

files, it was difficult to locate the information that the order requires be

made available to the public.

On the other hand, about 26 percent of the 122 regulatory actions that we

reviewed in the 4 agencies had complete documentation available to the

public of the changes made to rules while at OIRA, and about 24 percent

had documentation of changes made at OIRA’s suggestion. Some of the

dockets were well-organized, with clear indexes indicating where changes

made during OIRA’s review and at OIRA’s suggestion could be found. Several

agencies had begun to automate their dockets so that both indexes and

eventually the entire rulemaking record could be accessed electronically

by the public. These best practices illustrate both how agencies can satisfy

the order’s transparency requirements, and how they can organize their

dockets to facilitate public access and disclosure.

As the agency charged with providing guidance and central review of the

regulatory process, OIRA is in a position to tell the regulatory agencies how

to improve the transparency of the regulatory review process. However,

OIRA’s October 1993 guidance on this issue essentially repeated the

requirements of the executive order. OIRA did not issue any further

guidance on this issue after we noted in September 1996 that EPA and DOT

frequently had not documented changes made to rules at OIRA’s suggestion.

One resource that OIRA could use in the development of additional

guidance on the order’s transparency requirements could be the best

practices that we found in some of the agencies that we reviewed.

OIRA’s October 1993 guidance indicated that the changes made at the

suggestion or recommendation of OIRA are a subset of the changes made

during the period of OIRA’s formal review. However, OIRA frequently

comments on draft rules before they are formally submitted for review.

Page 19 GAO/GGD-98-31 Regulatory Reform
B-276296 

Under OIRA’s current guidance, any changes made to the rules as a result of

these comments would not need to be documented for the public.

S. 981 contains public disclosure requirements that, if enacted into law,

would provide a statutory foundation for the public’s right to regulatory

review information. We believe that the bill’s requirement that rule

changes be described in a single document is a good idea because it would

make understanding regulatory changes much easier for the public.

However, even if a statute is not enacted, the agencies would still benefit

from guidance on how to improve the transparency of the regulatory

review process under the order.

Recommendation We recommend that the Administrator of OIRA provide the agencies with

guidance on how to implement Executive Order 12866 transparency

requirements. The guidance should require agencies to include a single

document in the public docket for each regulatory action that (1) identifies

all substantive changes made during OIRA’s review and at the suggestion or

recommendation of OIRA or (2) states that no changes were made during

OIRA’s review or at OIRA’s suggestion or recommendation. The guidance

should also indicate that agencies should document changes made at

OIRA’s suggestion whenever they occur, not just during the period of OIRA’s

formal review. Finally, the guidance should point to best practices in some

agencies to suggest how other agencies can organize their dockets to best

facilitate public access and disclosure.

Agency Comments

and Our Evaluation

We sent a draft of this report for review and comment to the Director of

OMB; the Secretaries of HUD, Labor, and DOT; and the Administrator of EPA.

HUD officials said they had no comments on the draft report. The other

agencies provided the following comments.

EPA, DOT, and OSHA

Comments

On October 30, 1997, EPA’s Director of the Office of Regulatory

Management and Evaluation told us that he believed the draft report was

factually correct for EPA rules and highlighted the need for improved

agency compliance with the docketing requirements of Executive Order

12866. He said that EPA will re-examine the content and implementation of

its initial guidance and will issue new guidance or implementation

methods to improve compliance with the requirements.

Page 20 GAO/GGD-98-31 Regulatory Reform
B-276296 

Also on October 30, 1997, we discussed the draft report with DOT officials,

including the Assistant General Counsel for Regulation and Enforcement.

The Assistant General Counsel suggested that we make several changes in

the final report. Specifically, he said the report should more clearly

• state that Executive Order 12866 does not require agencies to document

instances where no changes were made to rules during OIRA review, and

that the absence of documentation of changes made to a rule does not

mean that an agency had not complied with the order’s transparency

requirements;

• note that the November 1996 guidance he issued regarding certification of

compliance with the executive order applied only to OST and was

suggested guidance for the rest of DOT; and

• reflect the extent of DOT’s efforts to develop best practices for improving

transparency of regulatory decisionmaking, particularly in the area of

automation.

DOT officials also suggested that we modify our recommendation to state

that the OIRA guidance should specifically require agencies to document for

the record when no changes were made during the OIRA review or at the

suggestion or recommendation of OIRA. We agreed with all of these

suggestions and made the appropriate changes in this report.

On November 4, 1997, we met with OSHA officials, including OSHA’s Director

of Regulatory Analysis, to discuss the draft report. We noted that we had

changed the draft to address a question raised earlier by an OSHA official.

This official had pointed out that one of the OSHA-proposed rules included

in our review had been reviewed by OIRA before the issuance of Executive

Order 12866 and should not have been subject to the requirements of the

order. We deleted this proposed rule from our analysis, thereby reducing

the number of OSHA regulatory actions from four to three. We also deleted

6 proposed rules in DOT that had been reviewed by OIRA before the issuance

of the order, thereby reducing the number of DOT regulatory actions from

45 to 39. We then recalculated all related statistics and figures to account

for these changes. (None of the HUD or EPA proposed rules was reviewed

by OIRA before the issuance of the order.) OSHA officials also suggested that

we provide additional clarification regarding our criteria for distinguishing

between actions characterized as having “complete documentation” and

those having “some documentation.” In this report, we clarified the

definition of “some documentation,” emphasizing that the term referred to

those agencies’ files that did not indicate whether all changes had been

documented.

Page 21 GAO/GGD-98-31 Regulatory Reform
B-276296 

Finally, OSHA officials said that we should make our recommendation more

specific to indicate that the OIRA guidance should require agencies to

document all changes made during the OIRA review and at the suggestion

or recommendation of OIRA in a single, summary memorandum to the file.

We agreed with this suggestion and made appropriate changes to the

recommendation.

OMB Comments On November 10, 1997, we received a letter commenting on the draft

report from the Administrator of OIRA. (See app. I for a reprint of those

comments.) The Administrator said that OIRA staff were not surprised by

and agreed with several of the issues raised in the draft report. For

example, she said that she was not surprised that there may not be a

“one-to-one equivalence” between agencies’ files and OIRA files because of

differences in Executive Order 12866 requirements between the agencies

and OIRA. She said that OIRA’s database indicated that no changes were

made to about 40 percent of the regulatory actions in the four agencies,

which she suggested was why documentation did not exist in about

40 percent of the actions that we reviewed (because, as she confirmed, the

order itself does not require documentation of no changes). She also said

that providing an interested individual with a copy of the draft rule

submitted for review and the draft on which OIRA concluded its review was

an effective way to permit that individual to identify changes made to the

draft rule.

However, the Administrator also indicated that OIRA disagreed with the

draft report in at least three respects. First, she said that OIRA disagreed

with the draft report’s recommendation that OIRA issue guidance to

agencies on how to organize their rulemaking dockets to best facilitate

public access and disclosure. She said agencies have developed their own

methods of organizing their rulemaking dockets and “it is not the role of

OMB to advise other agencies on general matters of administrative

practice.” Second, she said that OMB interprets some of the transparency

requirements in the order differently than we did. We believe that the

order requires agencies to document OIRA-suggested changes whenever

they occur. The Administrator said that the order requires agencies to

document only OIRA-suggested changes made during the formal period of

OIRA’s review, not any changes made at OIRA’s suggestion before that

period. Third, the Administrator said that she believes that the requirement

that agencies document the changes made at the suggestion of OIRA is

“counterproductive,” and that it is irrelevant who gets the “credit” for

suggesting changes.

Page 22 GAO/GGD-98-31 Regulatory Reform
B-276296 

The OIRA Administrator’s statement, in response to our recommendation,

that it is not OMB’s role to advise agencies on general matters of

administrative practice seems to run counter to the requirements placed

on the agency in Executive Order 12866. Section 2(b) of the order states

that “[t]o 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 . . . .” Furthermore, as the Administrator pointed

out, OIRA has already provided agencies with general guidance on the

implementation of the order, including the transparency requirements.

Therefore, we retained our recommendation, and, as suggested by DOT and

OSHA, made it more specific by suggesting that the guidance require

agencies to include a single document in the public docket for each

regulatory action that (1) identifies all substantive changes made during

OIRA’s review and at the suggestion or recommendation of OIRA or

(2) states that no changes were made during OIRA’s review or at OIRA’s

suggestion or recommendation.

Executive Order 12866 requires that agencies identify for the public (1) the

substantive changes that are made to rules while under review at OIRA and

(2) the changes that are made at the suggestion or recommendation of

OIRA. We believe the Administrator’s view that the second of these

transparency requirements only applies to suggestions or

recommendations made during the period of OIRA’s formal review reflects

a narrow interpretation of the order, and is inconsistent with the intent of

the order’s transparency requirements. In her letter, the Administrator said

that OIRA tries to consult with agencies “early and often” in the rulemaking

process because OIRA can become “deeply” involved in important agency

rules “before an agency has become invested in its decision.” However, her

interpretation of the order that agencies do not have to document any

changes made at OIRA’s suggestion or recommendation during this period

would result in agencies’ failing to document OIRA’s early involvement in

the rulemaking process. The transparency requirements were included in

the order because of concerns during previous administrations that the

public could not determine what changes OIRA was making to agencies’

rules. Limiting the disclosure of OIRA-suggested or OIRA-recommended

changes only to those made during the relatively narrow window of OIRA’s

formal review, and specifically excluding changes made during a period in

which the Administrator said OIRA can have its greatest impact, is not

consistent with the order’s transparency objective.

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Furthermore, the OIRA Administrator’s comment that “an interested

individual” can identify changes made to a draft rule by comparing drafts

of the rule seems to change the focus of responsibility as it is stated in

Executive Order 12866. The order requires agencies to identify for the

public changes made to draft rules. It does not place the responsibility on

the public to identify changes made to agency rules. Also, comparison of a

draft rule submitted for review with the draft on which OIRA concluded

review would not indicate which of the changes were made at OIRA’s

suggestion, which is a specific requirement of the order.

Finally, the Administrator’s position that the order’s requirement that

agencies document the changes made at OIRA’s suggestion is

“counterproductive” is unpersuasive for several reasons. First, this

transparency requirement was put in place because of criticisms that OIRA

exerted too much control over the development of rules and that decisions

were being made without appropriate public scrutiny. Therefore, the

purpose of this requirement is to allow the public to be able to understand

why certain changes were made during the rulemaking process; it has

nothing to do with who gets the “credit” for those changes. Second, the

Administrator cites no evidence of a counterproductive effect of the

requirement that agencies document OIRA-suggested changes. Even if

evidence of negative effects were presented, those effects would need to

be weighed against the transparency and public disclosure that the

requirement permits. Finally, if the Administrator believes that this

requirement is counterproductive and will result in resistance to change,

she could recommend that the President revise the executive order and

delete this requirement. Four years after the issuance of the order and the

imposition of this requirement, the Administrator has not done so. In

response to this comment, we clarified our interpretation of the order’s

requirements in the body of the report and specified that OIRA’s guidance

should indicate that agencies should document changes made at OIRA’s

suggestion whenever they occur.

We are sending copies of this report to the Director of OMB; the Secretaries

of HUD, Labor, and DOT; and the Administrator of EPA. We are also sending

this report to the Chairmen and Ranking Minority Members of (1) the

House Committee on Government Reform and Oversight; (2) that

Committee’s Subcommittee on National Economic Growth, Natural

Resources, and Regulatory Affairs; and (3) the House Committee on the

Judiciary, Subcommittee on Commercial and Administrative Law. We will

make copies available to others on request.

Page 24 GAO/GGD-98-31 Regulatory Reform
B-276296 

Major contributors to this report are listed in appendix II. Please contact

me on (202) 512-8676 if you or your staff have any questions concerning

this report.

L. Nye Stevens

Director, Federal Management

 and Workforce Issues

Page 25 GAO/GGD-98-31 Regulatory Reform
Appendix I 

Comments From the Office of Management

and Budget

Page 26 GAO/GGD-98-31 Regulatory Reform
Appendix I 

Comments From the Office of Management

and Budget

Page 27 GAO/GGD-98-31 Regulatory Reform
Appendix I 

Comments From the Office of Management

and Budget

Page 28 GAO/GGD-98-31 Regulatory Reform
Appendix I 

Comments From the Office of Management

and Budget

Page 29 GAO/GGD-98-31 Regulatory Reform
Appendix I 

Comments From the Office of Management

and Budget

Page 30 GAO/GGD-98-31 Regulatory Reform
Appendix I 

Comments From the Office of Management

and Budget

Page 31 GAO/GGD-98-31 Regulatory Reform
Appendix II 

Major Contributors to This Report

General Government

Division, Washington,

D.C.

Curtis Copeland, Assistant Director, (202) 512-8101

Elizabeth Powell, Senior Evaluator

Thomas Beall, Technical Advisor

Office of the General

Counsel, Washington,

D.C.

Alan Belkin, Assistant General Counsel

Susan Michal-Smith, Senior Attorney

(410190) Page 32 GAO/GGD-98-31 Regulatory Reform
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