Most federal law that affects daily life is written by agencies rather than by Congress, through a procedure that constrains how they may do it. The process is public by design and its steps determine whether a rule survives challenge.
Authority comes from a statute
An agency cannot regulate on its own initiative. Congress passes a statute directing or permitting the agency to issue rules within a defined area.
The breadth of that grant sets the outer limit. A rule reaching beyond what the statute authorizes can be struck down regardless of how well it was drafted.
Disputes about the scope of delegated authority are among the most common grounds on which major regulations are challenged in court.
The proposal must be published
An agency issues a notice of proposed rulemaking in the Federal Register, setting out the proposed text, the legal basis and the reasoning behind it.
The notice must be specific enough that interested parties can understand and respond to what is actually being proposed.
A final rule that departs too far from what was proposed can be invalidated, on the reasoning that the public never had a chance to comment on the version adopted.
Comments have to be considered
Anyone may file a comment during the open period, and agencies receive everything from individual letters to lengthy technical submissions from industry and advocacy organizations.
The agency is required to consider significant comments and to explain in the final rule why it accepted or rejected the substantive objections raised.
Volume alone carries little weight. A single comment identifying a flaw in the agency's analysis matters more than many identical form submissions.
Review happens before publication
Economically significant rules pass through centralized review within the executive branch, where costs, benefits and alternatives are examined.
That review can delay a rule substantially or send it back for revision, and it operates outside the public comment record.
Once finalized, the rule is published with an effective date and is codified in the Code of Federal Regulations alongside existing regulations.
Congress and the courts retain checks
Final rules are submitted to Congress, which has a defined window to disapprove a rule through an expedited procedure requiring presidential signature.
Courts review rules for whether the agency stayed within its authority, followed the procedure and gave a reasoned explanation supported by the record.
A rule overturned for inadequate explanation is not necessarily dead. The agency can often redo the analysis and issue the rule again with a better-supported record.
Repealing an existing rule generally requires the same procedure that created it. An agency cannot simply stop enforcing a regulation without going through notice and comment again.