Guidance Documents and Regulatory Beneficiaries

Federal agencies rely heavily on guidance documents, and their volume is massive. The Environmental Protection Agency and the Occupational Safety and Health Administration recently catalogued over 2000 and 1600 such documents, respectively, issued between 1996 and 1999. These documents can range from routine matters, such as how employees should maintain correspondence files, to broad policies on program standards, implementation, and enforcement. Documents in the latter category include Education Department policies on Title IX implementation, Environmental Protection Agency policies on hazardous waste cleanup, the Food and Drug Administration\u27s policies on food safety and broadcast advertising of pharmaceuticals, and many more.Although these documents often resemble informal rules, agencies generally avoid Administrative Procedure Act notice-and-comment requirements because guidance documents arguably qualify under the statutory exceptions for general policy statements, interpretative rules, or both. These policies now typically are express in disclaiming any binding effect upon regulated entities or upon the agency itself, a response to some recent judicial decisions requiring notice-and-comment rulemaking for a guidance accorded binding effect, as well as to congressional concern about uncertainty. Nonetheless, a guidance document often evokes a significant change in behavior by those the agency regulates.And if the document includes an interpretation of law, that interpretation may also receive limited Mead/Skidmore deference in court. Finally, despite the lack of formal legal binding effect, agencies are increasingly stating they will usually conform to positions taken in guidance documents