The federal rulemaking process is the set of procedures agencies must follow under the Administrative Procedure Act before a regulation can bind the public: publish a proposed rule, invite comments, respond to them in writing, and wait out a delay before the rule takes effect. Layered on top are review by the Office of Management and Budget, a window for Congress to disapprove the rule, and the possibility of a court striking it down. Every step exists so the reasoning behind a regulation is visible enough to challenge.
Where a Rule Starts: The Proposed Rule
Most regulations begin with a Notice of Proposed Rulemaking published in the Federal Register. Section 553(b) of the APA requires that notice to include the legal authority the agency is relying on, the text or substance of the proposal, and the time and nature of the public proceeding.1Office of the Law Revision Counsel. 5 U.S.C. 553 – Rule Making Each notice carries a docket number and points to a plain-language summary on Regulations.gov.
The statute does not force agencies to publish their underlying research, but preambles usually run long. Agencies include economic analysis, scientific data, and policy rationale because vague proposals invite legal challenges, and because courts expect a well-developed record. That preamble is where you find out what the agency is actually trying to accomplish and what assumptions it is making.
How to Submit a Comment That Matters
Once the notice is published, anyone can submit written comments through Regulations.gov, the official federal platform for regulatory participation.2Regulations.gov. How You Can Effectively Participate in the Regulatory Process Through Public Comment Executive Order 12866 directs agencies to allow at least 60 days for comment on significant regulations. The APA itself sets no minimum.
Substance is what changes rules. The agency is legally obligated to consider every relevant comment and to respond to significant ones when it publishes the final rule. A comment that identifies flawed assumptions, unintended consequences, or missing data can reshape the regulation. A comment that says only “I oppose this rule” carries almost no weight. Everything submitted becomes part of the public record and is available for judicial review, so specificity, evidence, and clear stakes are what make a comment count.
The Final Rule and the 30-Day Delay
After the comment window closes, the agency drafts the final regulation. It must include a concise statement of the rule’s basis and purpose, explaining how public input was handled.1Office of the Law Revision Counsel. 5 U.S.C. 553 – Rule Making That statement is not a formality; courts read it to decide whether the agency engaged with the comments or went through the motions.
The final rule cannot depart so far from the proposal that affected parties never had a fair chance to weigh in. Under the “logical outgrowth” doctrine, a reader of the original notice should have been able to anticipate the kind of changes the agency ends up making. If the final version goes further than that, the agency must publish a supplemental notice and reopen comments.3Department of Transportation. Logical Outgrowth Memorandum Courts have summarized the point bluntly: “something is not a logical outgrowth of nothing.”
A substantive final rule must be published at least 30 days before it takes effect.4Office of the Law Revision Counsel. 5 U.S. Code 553 – Rule Making That delay gives regulated parties time to come into compliance. Three exceptions apply: rules that grant an exemption or relieve a restriction can take effect sooner, interpretive rules and policy statements are not bound by the 30 days, and an agency can shorten the delay for good cause if it explains why in the published rule.
When Agencies Can Skip Notice and Comment
Not every regulation goes through the full process. Section 553(a) exempts rules involving military or foreign affairs functions, and rules dealing with internal agency management, personnel, public property, loans, grants, benefits, or government contracts.1Office of the Law Revision Counsel. 5 U.S.C. 553 – Rule Making Interpretive rules, which explain how an agency reads existing law without creating new obligations, are also exempt, along with general statements of policy. If a rule labeled interpretive actually creates new binding requirements, courts will treat it as a legislative rule that should have gone through the full process.
The “good cause” exception lets an agency skip notice and comment when the normal process would be impracticable, unnecessary, or contrary to the public interest. The agency must explain the justification in the preamble, and courts scrutinize those explanations closely. An imminent safety threat can qualify. Simple impatience with public comment does not.
Formal and Negotiated Rulemaking
Two variations on the standard process show up in specific circumstances. When a statute requires rules to be made “on the record after opportunity for an agency hearing,” the agency must use formal rulemaking under 5 U.S.C. sections 556 and 557.5Office of the Law Revision Counsel. 5 U.S.C. 556 – Hearings; Presiding Employees; Powers and Duties; Burden of Proof; Evidence; Record as Basis of Decision That means a trial-like proceeding before an administrative law judge, with evidence, testimony, and cross-examination as needed for full disclosure of the facts. The agency’s final decision must rest exclusively on the hearing record. Formal rulemaking is slow and expensive, so Congress rarely requires it.
Negotiated rulemaking, authorized by 5 U.S.C. sections 561 through 570, runs in the opposite direction.6Office of the Law Revision Counsel. 5 U.S.C. Chapter 5 Subchapter III – Negotiated Rulemaking Procedure The agency brings stakeholders together before a proposal is drafted. A convener identifies affected interests, including residents of rural areas, and reports on whether negotiation is feasible.7Office of the Law Revision Counsel. 5 U.S.C. 563 – Determination of Need for Negotiated Rulemaking Committee If the committee reaches consensus, that agreement becomes the foundation of the agency’s formal proposal, which still runs through the standard notice-and-comment process.
Petitioning an Agency to Make or Change a Rule
Rulemaking does not always start with the agency. Under 5 U.S.C. section 553(e), any interested person can petition a federal agency to issue a new rule, amend an existing one, or repeal one entirely.1Office of the Law Revision Counsel. 5 U.S.C. 553 – Rule Making The APA guarantees the right to ask; each agency publishes its own procedures for how petitions should be formatted and filed.
If the agency denies a petition, it must give prompt notice and a brief explanation. Agencies are expected to respond within a reasonable time, though the APA sets no specific deadline. When an agency sits on a petition indefinitely, the petitioner may be able to challenge the delay in court as unreasonably withheld agency action.
Oversight After the Agency Signs Off
OIRA Review
Before most significant regulations reach the Federal Register, they pass through the Office of Information and Regulatory Affairs inside the Office of Management and Budget. Executive Order 12866, issued in 1993, requires agencies to submit any regulation likely to have an annual economic effect of $100 million or more for OIRA review. OIRA weighs consistency with presidential priorities, whether costs and benefits have been adequately justified, and whether the rule conflicts with other agencies’ plans.
Executive Order 14219, issued in February 2025, keeps the EO 12866 framework in place and adds consultation requirements. Agencies must now consult with designated efficiency team leads and the OIRA Administrator, weighing whether a rule exceeds statutory authority, imposes costs that outweigh public benefits, or unduly burdens small businesses.8Federal Register. Executive Order 14219 – Ensuring Lawful Governance
Congressional Review
The Congressional Review Act, at 5 U.S.C. sections 801 through 808, gives Congress a fast-track path to block a regulation after it is finalized.9Office of the Law Revision Counsel. 5 U.S.C. Chapter 8 – Congressional Review of Agency Rulemaking Agencies must submit every final rule to both chambers of Congress and the Government Accountability Office before it can take effect. A rule qualifies as “major” if OIRA determines it will likely have an annual economic effect of $100 million or more, cause a major increase in costs or prices, or produce significant adverse effects on competition, employment, or investment.10Office of the Law Revision Counsel. 5 U.S.C. 804 – Definitions Major rules generally cannot take effect for 60 days.
To overturn a rule, a member of Congress must introduce a joint resolution of disapproval within 60 legislative days of receiving the agency’s report.11Office of the Law Revision Counsel. 5 U.S. Code 802 – Congressional Disapproval Procedure The CRA adds Senate shortcuts, including a discharge petition needing only 30 signatures and a 10-hour cap on floor debate. The resolution is legislation, so the president must sign it. Most successful CRA resolutions therefore follow a change in administration. If the resolution passes and is signed, the rule has no legal force, and the agency is barred from reissuing a substantially similar regulation without new congressional authorization.
Judicial Review
Under 5 U.S.C. section 706, a court can strike down an agency rule as arbitrary and capricious, in excess of statutory authority, unconstitutional, or procedurally defective.12Office of the Law Revision Counsel. 5 U.S.C. 706 – Scope of Review For formal rulemaking, the standard is “substantial evidence” on the hearing record. For informal rulemaking, the “arbitrary and capricious” standard asks whether the agency examined the relevant data, considered important aspects of the problem, and offered a satisfactory explanation.
Recent Limits on Agency Authority
Two Supreme Court decisions have reshaped what agencies can do with ambiguous statutes. In Loper Bright Enterprises v. Raimondo (2024), the Court overruled the Chevron doctrine, holding that the APA requires courts to exercise their own independent judgment on whether an agency has acted within its statutory authority.13Supreme Court of the United States. Loper Bright Enterprises v. Raimondo Courts may still consider an agency’s interpretation as informative, particularly on matters of factual expertise, but the interpretation cannot bind the court.
The major questions doctrine, established in West Virginia v. EPA (2022), requires “clear congressional authorization” whenever an agency claims authority over decisions of vast economic and political significance.14Supreme Court of the United States. West Virginia v. EPA A plausible reading of a statute is not enough. The larger the regulatory action, the clearer the statutory permission has to be.