Congress writes laws in general terms and often directs an agency to fill in the details, such as setting a safety standard or defining who qualifies for a program. Each year agencies issue thousands of rules, most of them routine, along with a smaller number of major rules with large economic effects. The process for making them is designed to be public, reasoned, and reviewable.
This guide follows a regulation from its statutory roots through proposal, comment, review, and finalization, and explains how rules are challenged, overturned, and changed.
After reviewing comments, the agency revises the rule, sends significant rules back to the White House for review, and publishes the final rule in the Federal Register with a preamble responding to major comments. Most rules take effect at least 30 days later, and major rules at least 60 days later. The rule is then added to the Code of Federal Regulations. In some cases agencies skip comment for good cause and issue interim final rules, taking comments afterward.
Under the Congressional Review Act of 1996, Congress can overturn a new rule with a joint resolution passed by simple majorities in both chambers and signed by the President, and the agency may not reissue a substantially similar rule. The law is used most often early in a new administration against rules issued at the end of the previous one, and it was used more in 2025 than in any earlier year. Affected parties can also sue, arguing a rule exceeds the agency's authority or is arbitrary and capricious. Since Loper Bright in 2024, courts decide the meaning of statutes for themselves, and the major questions doctrine requires clear authorization for rules of vast significance.
A new administration cannot simply erase a final rule. It must go through notice and comment to amend or repeal it and explain the change, or persuade Congress or a court to act. Presidents often freeze pending rules on their first day, and many have ordered agencies to cut regulations, from regulatory budgets in 2017 to a 2025 order requiring ten rules to be repealed for each new one. Supporters say these efforts cut costly red tape, while critics say they weaken protections for health, safety, and the environment.
Every regulation must rest on authority granted by Congress, and an agency that exceeds that authority acts unlawfully. The Administrative Procedure Act of 1946 sets the basic procedures. Rules often begin with a new law, a court decision, a petition from the public, or a presidential priority. Agencies list planned rules twice a year in the Unified Agenda, and they may first publish an advance notice to gather ideas before drafting.
Anyone, from individuals to companies, advocacy groups, states, and other agencies, can submit comments, usually through regulations.gov, during a comment period that typically lasts 30 to 60 days and is sometimes extended. Agencies must consider the comments, but the process is not a vote. Detailed comments with data and legal arguments carry the most weight, and well-organized interests often dominate. Agencies may also hold hearings or consult advisory committees.
The agency drafts a notice of proposed rulemaking explaining what it wants to do, its legal authority, and the evidence behind it. If the rule is significant, generally because its economic effect is at least 100 million dollars a year or it raises novel policy issues, it goes to the Office of Information and Regulatory Affairs for review, usually with a cost-benefit analysis. Other laws require agencies to consider effects on small businesses and paperwork burdens. The proposal is then published in the Federal Register.
See where rulemaking fits in the administrative state explained, compare it with presidential directives in executive orders explained, or learn to participate in how to comment on a federal regulation.