Federal regulations are specific details directives or requirements with the force of law enacted by the federal agencies necessary to enforce the legislative acts passed by Congress. The Clean Air Act, the Food and Drug Act, the Civil Rights Act are all examples of landmark legislation requiring months, even years of highly publicized planning, debate, compromise and reconciliation in Congress. Yet the work of creating the vast and ever-growing volumes of federal regulations, the real laws behind the acts, happens largely unnoticed in the offices of the government agencies rather than the halls of Congress.
Regulatory Federal Agencies
Agencies, like the FDA, EPA, OSHA and at least 50 others, are called "regulatory" agencies, because they are empowered to create and enforce rules - regulations - that carry the full force of a law. Individuals, businesses, and private and public organizations can be fined, sanctioned, forced to close, and even jailed for violating federal regulations. The oldest Federal regulatory agency still in existence is the Office of the Comptroller of the Currency, established in 1863 to charter and regulate national banks.
The Federal Rulemaking Process
The process of creating and enacting federal regulations is generally referred to as the "rulemaking" process.
First, Congress passes a law designed to address a social or economic need or problem. The appropriate regulatory agency then creates regulations necessary to implement the law. For example, the Food and Drug Administration creates its regulations under the authority of the Food Drug and Cosmetics Act, the Controlled Substances Act and several other acts created by Congress over the years. Acts such as these are known as "enabling legislation," because the literally enable the regulatory agencies to create the regulations required to administer enforce them.
The "Rules" of Rulemaking
Regulatory agencies create regulations according to rules and processes defined by another law known as the Administration Procedure Act (APA).
The APA defines a "rule" or "regulation" as...
"[T]he whole or a part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or describing the organization, procedure, or practice requirements of an agency.
The APA defines "rulemaking" as…
"[A]gency action which regulates the future conduct of either groups of persons or a single person; it is essentially legislative in nature, not only because it operates in the future but because it is primarily concerned with policy considerations."
Under the APA, the agencies must publish all proposed new regulations in the Federal Register at least 30 days before they take effect, and they must provide a way for interested parties to comment, offer amendments, or to object to the regulation.
Some regulations require only publication and an opportunity for comments to become effective. Others require publication and one or more formal public hearings. The enabling legislations states which process is to be used in creating the regulations. Regulations requiring hearings can take several months to become final.
New regulations or amendments to existing regulations are known as "proposed rules." Notices of public hearings or requests for comments on proposed rules are published in the Federal Register, on the Web sites of the regulatory agencies and in many newspapers and other publications. The notices will include information on how to submit comments, or participate in public hearings on the proposed rule.