The process of issuing and enforcing regulations is one of the basic tools of government, and the process has generated considerable controversy. Some individuals and organizations have called for increasing regulation of businesses and other nonfederal entities to achieve certain goals, such as fairer competition, cleaner water, or safer consumer products and services. Others have recommended drastic reductions in federal regulatory activity and/or the imposition of constraints on how agencies develop or implement regulations, often because of the burden associated with regulatory compliance and questions about whether the regulations are actually achieving their stated purposes. A number of studies have attempted to analyze the effect of federal regulations on businesses or the economy as a whole, with some analysts claiming that federal regulations cost the economy hundreds of billions of dollars each year. Although these estimates are frequently cited, measurement of the effects of regulation on the economy is imprecise and controversial. Also, relatively little is known about the impact of all regulations on individual businesses or even how many regulations apply to a business. This type of information about the impact of regulations on individual businesses would provide a better understanding of the impact of regulations on the economy as a whole. Regulations generally start with an act of Congress and serve as the means by which statutes are implemented and specific requirements are established. These requirements tell people and businesses what must be done to comply with the law. The statutory basis for a regulation can vary dramatically, 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 what regulatory agencies should do and how they should do it. The Agricultural Adjustment Act is an example of a broad grant of authority, delegating to the Secretary of Agriculture wide discretion to make agricultural marketing “orderly.” The statute provides little guidance on which crops should have marketing orders or how to apportion the market among growers. The toxic air provisions of the Clean Air Act Amendments of 1990 are examples of very specific statutory requirements. The provisions specified that the Environmental Protection Agency (EPA) establish standards, on the basis of the best existing pollution control technologies, for major sources of 189 of the most prevalent and hazardous air pollutants. The provisions also established three interim milestones and a final milestone for setting the standards and specified certain consequences if EPA missed a milestone for any source category. Likewise, in the Safe Drinking Water Act Amendments of 1986, Congress specified 83 contaminants for which EPA was to promulgate standards within 3 years. The act also required EPA to regulate drinking water contaminants to be as close as technically feasible to a level at which no known or anticipated health effects occur. The federal government has long regulated economic activity, often through independent regulatory agencies established separate from traditional federal departments and agencies. Social regulation in such areas as environmental quality, workplace safety, and consumer protection is a relatively recent phenomenon. Beginning in the 1960s, a number of major new statutes were enacted in those areas, including amendments to the Clean Air Act (CAA) and the Clean Water Act (CWA), the Toxic Substances Control Act (TSCA), the Resource Conservation and Recovery Act (RCRA), the Occupational Safety and Health Act, the Truth in Lending Act, and the Consumer Product Safety Act. Those and other acts, as well as executive orders, also created new regulatory agencies, such as EPA, the Occupational Safety and Health Administration (OSHA), the National Highway Traffic Safety Administration, and the Consumer Product Safety Commission. By the 1980s, an array of federal regulations were in place that affected many decisions made by American businesses. Concerns then began to be raised about whether the benefits these regulations and regulatory agencies were attempting to achieve were worth the costs associated with compliance. Concerns were also being raised about the cumulative effect of all federal regulations on individual businesses. The basic rulemaking process is spelled out in section 553 of the Administrative Procedure Act, which, among other things, generally requires agencies to (1) publish notice of a proposed rulemaking in the Federal Register; (2) allow interested persons an opportunity to participate in the rulemaking by providing “written data, views, or arguments”; and (3) publish the rule 30 days before it becomes effective. Other procedural rulemaking requirements have been added through general statutes, executive orders, and judicial decisions. For example, certain executive orders since 1981 have required agencies (other than those considered to be independent regulatory agencies) to submit at least their significant regulations to the Office of Management and Budget (OMB) for its review before publication in the Federal Register. Because of the numerous processes involved, federal rulemaking can take years to complete. Once completed, federal regulations are compiled in the Code of Federal Regulations (CFR). Numerous attempts have been made legislatively and by the executive branch to reform federal regulatory processes. For example, Congress enacted the following two regulatory reform initiatives in 1980: (1) the Paperwork Reduction Act and (2) the Regulatory Flexibility Act. As its name implies, the Paperwork Reduction Act attempted to minimize the paperwork and reporting burdens agencies impose on nonfederal entities. The act also established the Office of Information and Regulatory Affairs (OIRA) within OMB to review and approve all agency information collection activities. The Regulatory Flexibility Act required agencies to assess the impact of their regulations on small entities (e.g., businesses and governments) and to publish their plans for new regulations. We have reported on the effects these laws have had on agencies’ regulatory programs and recommended improvements to their design and implementation. During the 104th Congress, numerous legislative initiatives have been introduced that attempted to reform the regulatory process and/or reduce businesses’ regulatory burden. As of July 1996, at least three major governmentwide reform initiatives had been enacted. The Unfunded Mandates Reform Act of 1995 established a mechanism for advising Congress of the nature and size of federal mandates in proposed legislation or regulations to allow congressional consideration of the appropriateness of such mandates on state, local, or tribal governments or the private sector. As part of that process, agencies are required to assess the anticipated costs and benefits of federal mandates. The Paperwork Reduction Act of 1995 reaffirmed the principles of the 1980 Act, required OIRA to establish governmentwide and agency-specific paperwork reduction goals, redefined key terms such as “collection of information,” and required agencies to establish their own paperwork review and clearance function. The Small Business Regulatory Enforcement Fairness Act of 1996 made several changes in regulatory procedures, including (1) amending the Regulatory Flexibility Act to allow for judicial review of agency decisions, (2) requiring the publication of “small entity compliance guides” to explain the actions a small business or other small entity must take to comply with a rule or a group of rules, and (3) establishing a congressional review process through which Congress can disapprove of final agency regulations. Some Members of Congress viewed this review process as necessary because they believed some agencies had issued regulations that went beyond the intent of Congress when it passed the underlying statutes. Every president in recent years also has taken steps intended to reduce the burden of federal regulations. In 1981, President Reagan issued Executive Order 12291, which gave OMB the authority to review all new regulations for consistency with administration policies. The order also required agencies to prepare a “regulatory impact analysis” for each major rule, describing the costs, benefits, and alternatives to the rule. In 1985, President Reagan issued Executive Order 12498, which required agencies subject to Executive Order 12291 to submit a list of significant regulatory actions they expected to propose during the upcoming year to OMB for clearance. The President also established a Task Force on Regulatory Relief, headed by then Vice President Bush. In turn, President Bush named his Vice President to head the Competitiveness Council, which was charged with advocating regulatory relief for business. In 1992, President Bush sent a memorandum to all federal departments and agencies calling for a 90-day moratorium on new proposed or final rules. During the moratorium, agencies were “. . . to identify and accelerate action on initiatives that will eliminate any unnecessary regulatory burden or otherwise promote economic growth.” The Clinton administration has also made a number of attempts to reform the federal regulatory process. Issued in September 1993, Executive Order 12866 revoked Executive Orders 12291 and 12498 and, among other things, established a number of “principles of regulation” (e.g., use the best scientific, technical, economic, or other information; specify performance objectives, not behaviors; make regulations simple and easy to understand; and use cost-benefit analysis and risk assessment) and reaffirmed the role of OMB in the regulatory review process (although only for “significant” rules). Vice President Gore’s National Performance Review also made a number of recommendations to improve the regulatory process, including (1) encouraging innovative regulatory approaches and negotiated rulemaking; (2) streamlining agency rulemaking procedures; and (3) ranking the seriousness of environmental, health, or safety risks. In March 1995, the President reiterated his interest in regulatory reform, calling on all agencies to (1) conduct a page-by-page review of all their regulations and eliminate or revise those outdated or in need of reform; (2) change the performance measures of agencies and regulators to focus on results, not process and punishment; (3) convene groups of regulators and the people affected by their regulations around the country and create “grassroots partnerships”; and (4) expand their efforts to promote consensual rulemaking. During 1995 and early 1996, the President also announced regulatory reform initiatives aimed at certain agencies or issues (e.g., the environment, pensions, and cancer drugs) and announced other reforms applicable to all federal agencies. For example, agencies were asked to halve many of their reporting requirements, reduce penalties for self-disclosed violations of certain regulations, and allow companies to change processes for certain low-risk manufacturing operations without agency preapproval.