Federal regulation, like taxing and spending, is one of the basic tools of government used to implement public policy. In fact, the development and framing of a rule has been described as "the climactic act of the policy making process." Another observer described the rulemaking process as "a ubiquitous presence in virtually all government programs.... The crucial intermediate process of rulemaking stands between the enactment of a law by Congress and the realization of the goals that both Congress and the people it represents seek to achieve by that law." Regulations generally start with an act of Congress, and are one of the means through which statutes are implemented and specific requirements are established. Federal agencies usually issue more than 3,000 final rules each year on topics ranging from the timing of bridge openings to the permissible levels of arsenic and other contaminants in drinking water. The costs and benefits associated with all federal regulations have been a subject of great controversy, with the costs estimated in the hundreds of billions of dollars and the benefits estimates generally even higher. 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." The process by which federal agencies develop, amend, or repeal rules is called "rulemaking," and is the subject of this report. Figure 1 illustrates the basic process that most federal agencies are generally required to follow in writing or revising a significant rule. However, some aspects of Figure 1 do not apply to all rules. 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 agencies 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 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 U.S.C. §§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 it 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 a regulation can vary greatly in terms of its specificity, from (1) very broad grants of authority that state only the general intent of the legislation and leave agencies with a great deal of discretion as to how that intent should be implemented, to (2) very specific requirements delineating exactly what regulatory agencies should do and how they should take action. Note also in Figure 1 the roles that Congress and the courts can play at the end of the rulemaking process, which may result in a rule being returned to an earlier point in the process or being vacated by the reviewing body. Congress may also play a role at other stages in the process through its oversight and appropriations responsibilities. Implicit within the steps depicted in Figure 1 is an elaborate set of procedures and requirements that Congress and various Presidents have developed during the past 60 to 70 years to guide the federal rulemaking process. Some of these rulemaking requirements apply to virtually all federal agencies, some apply only to certain types of agencies, and others are agency-specific. Collectively, these rulemaking provisions are voluminous and require a wide range of procedural, consultative, and analytical actions on the part of rulemaking agencies. Some observers contend that the requirements have resulted in the "ossification" of the rulemaking process, causing agencies to take years to develop final rules. For example, the National Advisory Committee on Occupational Safety and Health noted that it takes the Occupational Safety and Health Administration (OSHA) within the Department of Labor an average of 10 years to develop and promulgate a health or safety standard. On the other hand, while these congressional and presidential rulemaking requirements are numerous, it is not clear whether they or some other factors (e.g., lack of data, congressionally imposed delays, court challenges, etc.) are the primary cause of the long time-frames that are sometimes required to develop and publish final rules. Statutory rulemaking requirements can be generally categorized into two groups—those that are specific to an individual agency or program and those that are more cross-cutting in nature and therefore apply to a wider range of agencies or programs. Agency- or program-specific rulemaking requirements may be in authorizing or appropriating statutes, and can have a significant or even determinative effect on an agency's rules and rulemaking procedures. As noted previously, these statutes sometimes specifically delineate what the agency's rules should require. For example, the Employee Retirement Income Security Act (29 U.S.C. §1001 et seq. ) gives the Pension Benefit Guaranty Corporation no discretion in drafting rules that establish minimum pension insurance premium rates, specifying to the dollar what those rates should be. Also, for a number of years the Department of Transportation (DOT) concluded that it had no discretion in setting the average fuel economy standards for light trucks, and was required to keep the standard at 20.7 miles per gallon. Agency-specific statutes may also impose specific procedural requirements on their rulemaking processes (e.g., the conduct of public hearings, the publication of a notice of proposed rulemaking by a particular date, or the coordination of rulemaking with another agency). In other cases, however, statutes may give rulemaking agencies substantial discretion in how rules are developed and what they require. For example, the Agricultural Adjustment Act provides a broad grant of rulemaking authority to the Secretary of Agriculture, stating only that agricultural marketing should be "orderly" but providing little guidance regarding which crops should have marketing orders or how to apportion the market among growers. More recently, the Patient Protection and Affordable Care Act (ACA, P.L. 111-148 ) contained a number of provisions giving federal agencies broad authority to issue "such regulations as may be necessary" to carry out certain requirements in the law. Agency rulemaking is also often significantly influenced by court decisions interpreting these agency- or program-specific statutory requirements. For example, in 1980, the Supreme Court ruled that, before promulgating new health standards, OSHA must demonstrate that the particular chemical to be regulated poses a "significant risk" under workplace conditions permitted by current regulations. The court also said that OSHA must demonstrate that the new limit OSHA proposes will substantially reduce that risk. This decision effectively requires OSHA to evaluate the risks associated with exposure to a chemical and to determine that these risks are "significant" before issuing a regulatory standard. Other court decisions have required OSHA rulemaking to demonstrate the technical and economic feasibility of its requirements. Still other decisions have required agencies to permit meaningful public participation in rulemaking and to fully explain what they considered and why they did and did not take particular actions. The following discussion of statutory rulemaking requirements focuses solely on the cross-cutting requirements that are applicable to more than one agency. The discussion provides descriptions of some of the major rulemaking-related statutes and is not intended to be a catalogue of all such requirements. Some of these rulemaking requirements have been in place for more than 70 years, but most have been implemented within the past 30 years. Some of these statutory requirements apply to Cabinet departments and independent agencies; others apply to those agencies as well as the independent regulatory agencies. With the surge of New Deal legislation enacted in the 1930s, Congress made federal agencies responsible for issuing detailed regulations on a variety of complex social and economic issues. However, no central regulatory publication system existed, so there was no efficient way for citizens to know about regulations that affected them. Therefore, Congress enacted the Federal Register Act, which became law in July 1935 (44 U.S.C. Chapter 15). The act established a uniform system for handling agency regulations by requiring (1) the filing of documents with the Office of the Federal Register, (2) the placement of documents on public inspection, (3) publication of the documents in the Federal Register , and (4) (after a 1937 amendment) permanent codification of rules in the Code of Federal Regulations . Publication of a rule in the Federal Register provides official notice of its existence and contents. Other documents that are generally published in the Federal Register include presidential proclamations and executive orders, notices, and documents that the President or Congress requires to be published. Regulations for carrying out the Federal Register Act deal with, among other things, the format and distribution of the Federal Register and how documents are prepared, transmitted, and processed. The Office of the Federal Register is responsible for printing and distributing the Federal Register , and the Office has published a guide and a drafting handbook explaining how Federal Register documents are to be prepared. The Federal Register is published each business day, and is now available electronically.