National Legislative Office

The Federal Rulemaking Process

How Federal Regulations Are Created

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.

... and, the process of "rulemaking" is defined 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 legislation 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.

In addition, the complete text of all proposed rules is published in the Federal Register and typically posted on the promulgating agency's Web site.

Once a regulation takes effect, it becomes a "final rule" and is printed in the Federal Register, the Code of Federal Regulations (CFR) and usually posted on the Web site of the regulatory agency. For example, the Occupational Health and Safety Administration (OSHA) lists all of the agencies' final rules on the OSHA Regulations & Compliance Links page of its Web site.