In addition to the requirements under the APA, an  agency may also need to comply with requirements imposed by other  statutes. Agencies Have Limited Data on the Time and Resources Used to Address Regulatory Requirements in Their Rulemaking Processes

All agencies’ rulemaking processes share three basic steps or phases:  initiation of rulemaking actions, development of proposed rules, and  development of final rules. During initiation, agency officials identify issues that may potentially result  in a rulemaking. During the course of our review, only DOT provided us with data that  showed it routinely tracked these milestones. SEC did not have such systematic tracking and reporting of its scheduled  and actual regulatory milestones. As noted above,  internal control standards call for relevant, reliable and timely  information. Similarly, there is limited information available regarding contract costs. Many of the Rules GAO Reviewed Triggered Few of the Broadly Applicable Rulemaking Requirements

When issuing major rules, agencies must generally comply with the APA  and a number of other broadly applicable procedural and analytical  requirements specified in law. Officials from case-study agencies identified two long-standing analytical  and procedural requirements, the PRA regarding information collections  and the RFA regarding analysis of rules’ effects on small entities, as having  had more significant effects on time and resources than the more recent  requirements. However,  the documentation could be improved for greater transparency. As we also found in 2003, agencies sometimes included more information  about OIRA’s review than required, and we found such information useful  to more clearly explain what had occurred. Agencies’ labeling practices also sometimes made it difficult to find the  relevant documentation about OIRA’s reviews. OIRA Implemented Only One of Eight Prior GAO Recommendations to Improve Transparency of the Regulatory Review Process

In our 2003 report on the OMB/OIRA regulatory review process, we made  eight recommendations to the Director of OMB to improve the  transparency of the process. 4. Our study of broadly applicable requirements illustrated the difficulties of  evaluating the effects of regulatory requirements on the rulemaking  process with limited data. However, in  comments on our draft report, EPA and FDA subsequently provided some  documentation and data on their tracking and reporting of milestones. If the current administration retains Executive Order 12866, or establishes  similar transparency requirements, we recommend that the Director of  OMB, through the Administrator of OIRA, take the following four actions  to more consistently implement the order’s requirement to provide  information to the public “in a complete, clear, and simple manner”:    define in guidance what types of changes made as a result of the OIRA  review process are substantive and need to be publicly identified,  instruct agencies to clearly attribute those changes “made at the  suggestion or recommendation of OIRA,”    direct agencies to clearly state in final rules whether they made  substantive changes as a result of the OIRA reviews, and    standardize how agencies label documentation of these changes in public  rulemaking dockets. Specifically, it provides that “no agency shall promulgate any regulation  that has federalism implications,  that imposes substantial direct  compliance costs on state and local governments,” unless the agency   (1) has consulted with state and local officials early in the process,   (2) submitted to OMB copies of any written communications from such  officials, and (3) published in the preamble of the rule “a federalism  summary impact statement” describing the consultations, “a summary of  the nature of  concerns and the agency’s position  supporting the need to issue the regulations, and a statement of the extent  to which the concerns of State and local officials have been met.”

		Executive Order 13175 – Consultation and Coordination with Indian Tribal Governments

This executive order provides that “no agency shall promulgate any  regulation that has tribal implications” unless the agency (1) has consulted  with tribal officials early in the process, (2) submitted to OMB copies of  any written communications from such officials, and (3) published in the  preamble of the rule “a tribal summary impact statement” describing the  consultations, “a summary of the nature of their concerns and the agency’s  position supporting the need to issue the regulation, and a statement of the  extent to which the concerns of tribal officials have been met.” On issues  relating to tribal self-government, tribal trust resources, or Indian tribal  treaty and other rights, each agency should explore and, where  appropriate, use consensual mechanisms for developing regulations,  including negotiated rulemaking. Appendix II: Case Studies of 16 Selected Rules

This appendix provides case studies on 16 final rules published between  January 2006 and May 2008 that we reviewed for this report. The body of each case study includes  identifying information, a brief summary or synopsis of the rule, a  discussion of the regulatory requirements addressed in the final rule, a  summary of the changes to the rule resulting from reviews of the draft rule  by the Office of Management and Budget’s (OMB) Office of Information  and Regulatory Affairs (OIRA) (if applicable), and a timeline of important  events in the course of the rulemaking. Changes Resulting from OIRA Review

There was a significant change to the regulatory text. March 14, 2006: OIRA staff met with outside parties to discuss this rule. Regulatory Management: Implementation of Selected OMB  Responsibilities Under the Paperwork Reduction Act.
Why GAO Did This Study

Regulation is one of the principal tools that the government uses to implement public policy. As part of the rulemaking process federal agencies must comply with an increasing number of procedural and analytical requirements. GAO was asked to examine how broadly applicable rulemaking requirements cumulatively have affected (1) agencies' rulemaking processes, in particular including effects of requirements added to the process since 2003, and (2) transparency of the Office of Information and Regulatory Affairs (OIRA) regulatory review process. To address these objectives, GAO reviewed selected rules issued between January 2006 and May 2008 and associated dockets and also interviewed knowledgeable agency and OIRA officials.

What GAO Found

The agencies GAO reviewed had little data on the time and resources used to comply with regulatory requirements making it difficult to evaluate the effects of these requirements on rulemaking. All the agencies set milestones for regulatory development. During our review, only the Department of Transportation (DOT) provided data showing that it tracked and reported on milestones, but EPA and FDA provided similar information in their agency comments. The agencies GAO reviewed also could provide little systematic data on the resources they used--such as staff hours, contract costs, and other expenses--in developing rules. DOT and SEC have attempted to identify staff time expended on individual rules but are encountering difficulties generating usable and reliable data. Despite the challenges they have encountered in attempting to track time and resources in rulemaking, agency officials identified potential benefits to the management of their processes if they had such information to evaluate. Systematic tracking and reporting by agencies on their schedules and milestones would also be consistent with internal control standards. Our review of 139 major rules including 16 case-study rules revealed that most triggered analytical requirements under the Paperwork Reduction Act (PRA), Regulatory Flexibility Act (RFA), and Executive Order 12866, but few other requirements. Agency officials reported that requirements added to the rulemaking process by the Office of Management and Budget (OMB) since 2003 sometimes required a learning period when first implemented, but their agencies either already performed the added requirements or recognized the revisions as best practices. The officials instead identified long-standing requirements of the PRA and the RFA as generally requiring a more significant investment of resources. Based on the limited information available, the average time needed to complete a rulemaking across our 16 case-study rules was about 4 years, with a range from about 1 year to nearly 14 years, but there was considerable variation among agencies and rules. OIRA's reviews of agencies' draft rules often resulted in changes. Of 12 case-study rules subject to OIRA review, 10 resulted in changes, about half of which included changes to the regulatory text. Agencies used various methods to document OIRA's reviews, which generally met disclosure requirements, but the transparency of this documentation could be improved. In particular, some prior issues persist, such as uneven attribution of changes made during the OIRA review period and differing interpretations regarding which changes are "substantive" and thus require documentation. Out of eight prior GAO recommendations to improve the transparency OIRA has implemented only one--to clarify information posted about meetings with outside parties regarding draft rules under OIRA review.