The terms “rule” or “regulation” are often used interchangeably in discussions of the federal regulatory process. The Administrative Procedure Act (APA) of 1946 defines a rule as “the whole or part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy.”² The process by which federal agencies develop, amend, or repeal rules is called “rulemaking,” and is the subject of this report.

Figure H-1 illustrates in a general manner the process that most federal agencies are generally required to follow in writing or revising a significant rule. However, we should be quick to point out that some aspects of Figure H-1 do not apply to all rulemaking. For example, as discussed later in this report, an agency may, in certain circumstances, issue a final rule without issuing a notice of proposed rulemaking, thereby skipping several steps depicted in the figure. On the other hand, some rules may be published for public comment more than once. Also, independent regulatory agencies³ are not required to submit their rules to the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) for review, and no agency is required to do so for rules that are not “significant.”

Note at the top of Figure H-1 that the rulemaking process begins when Congress passes a statute either requiring or authorizing an agency to write and issue certain types of regulations. An initiating event (e.g., a recommendation from an outside body or a catastrophic accident) can prompt either legislation or regulation (where regulatory action has already been authorized). For example, in response to lethal chemical releases by plants in Bhopal, India, and West Virginia, Congress enacted section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 (42 USC §§ 11001-11050, 11023). The act required the owners and operators of certain types of facilities to report the amounts of various toxic chemicals that the facilities release to the environment above certain thresholds, and requires the Environmental Protection Agency (EPA) to make this information available to the public. EPA subsequently issued detailed regulations implementing these requirements and, using the authority provided to it through the statute, has required reporting for more than 300 toxic substances in addition to those delineated in the law.

As this example illustrates, the authority to regulate rests with Congress, and is delegated, through law, to an agency. The statutory basis for