Notice-and-Comment Rulemaking

Notice-and-comment rulemaking, also called informal rulemaking, is the default process U.S. federal agencies use to issue regulations under Section 553 of the Administrative Procedure Act (APA) of 1946. It is the procedural backbone of the modern regulatory state, governing everything from EPA air quality standards to FDA food labeling requirements.

The process has three core steps:

• Notice: The agency publishes a Notice of Proposed Rulemaking (NPRM) in the Federal Register, including the text or substance of the proposed rule, its legal authority, and the relevant time and place for proceedings.
• Comment: The agency provides interested persons—individuals, companies, NGOs, state governments, foreign entities—an opportunity to submit written data, views, or arguments. Comment periods are typically 30 to 60 days, though significant rules often receive longer windows.
• Final rule: The agency publishes the final rule along with a "concise general statement of its basis and purpose," which courts have interpreted to require a reasoned response to significant comments.

Certain categories are exempt under §553, including military and foreign affairs functions, interpretive rules, general statements of policy, and matters of agency organization or personnel. Agencies may also invoke a "good cause" exception when notice and comment would be impracticable, unnecessary, or contrary to the public interest.

Judicial review under the APA's §706 allows courts to set aside rules that are "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law." The Supreme Court's decision in Motor Vehicle Manufacturers Association v. State Farm (1983) established the "hard look" doctrine requiring agencies to examine relevant data and articulate a satisfactory explanation. Following Loper Bright Enterprises v. Raimondo (2024), which overturned Chevron deference, courts now exercise independent judgment on questions of statutory interpretation underlying agency rules, increasing the litigation stakes of the rulemaking record.

Formal rulemaking under §§556–557, which requires trial-type hearings, is rare and used only when a statute specifically demands rules be made "on the record after opportunity for an agency hearing."