Federal regulations are made by executive-branch agencies working under authority Congress has granted them by statute. The basic path for how federal regulations are made runs in a straight line: Congress passes a law telling an agency to regulate a subject, the agency drafts a proposed rule and publishes it in the Federal Register, the public gets a window to comment, the White House reviews significant rules, and the agency then issues a final rule that carries the same legal force as the statute behind it. Every binding requirement on workplace safety, air quality, financial reporting, or food labeling reaches you through some version of that sequence.
Where an Agency Gets the Power to Regulate
An agency can only write regulations if Congress first passes a law giving it permission. That law, usually called an enabling statute, either creates the agency or assigns a task to an existing one, and it sets the boundaries of what the agency can regulate. The Environmental Protection Agency exists because Congress passed statutes directing it to set pollution limits. Without a specific grant of power, no agency has legal standing to impose requirements on anyone.
The Constitution limits how much lawmaking power Congress can hand off. Under the nondelegation doctrine, Congress must provide what courts call an “intelligible principle” to guide the agency’s decisions. The Supreme Court established that standard in 1928, holding that Congress may authorize another body to set specific requirements as long as the legislation lays down a principle the agency is directed to follow.1Library of Congress. J.W. Hampton, Jr. and Co. v. United States, 276 U.S. 394 (1928) In practice, the Court has almost always found the bar met, upholding delegations in securities regulation, environmental protection, and workplace safety.
The Major Questions Doctrine
Even when a statute appears to grant broad authority, the Supreme Court has drawn a line around issues of vast economic or political significance. In West Virginia v. EPA (2022), the Court held that when an agency claims the power to make decisions with sweeping nationwide consequences, it must point to clear congressional authorization for that specific authority.2Supreme Court of the United States. West Virginia v. EPA, 597 U.S. 697 (2022) Congress, in other words, does not hide transformative powers in vague or ancillary provisions. If an agency wants to restructure a major sector of the economy, the statute needs to say so plainly.
The Notice-and-Comment Rulemaking Process
Most federal regulations are made through a procedure called notice-and-comment rulemaking, established by the Administrative Procedure Act (APA).3Office of the Law Revision Counsel. 5 U.S.C. Chapter 5 – Administrative Procedure Three steps make up the core: the agency proposes a rule, the public responds, and the agency issues a final version that accounts for that feedback.
Step 1: The Proposed Rule
The process starts when an agency publishes a Notice of Proposed Rulemaking (NPRM) in the Federal Register. The notice must identify the legal authority for the rule, describe the subjects and issues involved, and include either the proposed text or a summary of what the agency plans to require. The NPRM also has to link to a plain-language summary on Regulations.gov, the centralized federal portal where anyone can read the proposal and its supporting documents.4Office of the Law Revision Counsel. 5 U.S.C. 553 – Rule Making
Step 2: Public Comments
After publication, the agency must give the public an opportunity to submit written comments, data, and arguments.3Office of the Law Revision Counsel. 5 U.S.C. Chapter 5 – Administrative Procedure The APA sets no fixed minimum for how long the comment window stays open, but most agencies provide at least 30 days, and significant rules typically get 60 days or more. Anyone can participate: individuals, businesses, trade groups, other government agencies, or advocacy organizations.
Step 3: The Final Rule
The agency then reviews every comment and may revise the rule before publishing a final version. The final rule must include a statement of basis and purpose explaining the agency’s reasoning.4Office of the Law Revision Counsel. 5 U.S.C. 553 – Rule Making The agency does not have to adopt every suggestion, but it cannot ignore significant issues raised during the comment period. Under the Supreme Court’s decision in Motor Vehicle Manufacturers Association v. State Farm, a final rule can be struck down if the agency failed to examine the relevant data or provide a satisfactory explanation for its choices.5Justia. Motor Vehicle Manufacturers Association v. State Farm Mutual, 463 U.S. 29 (1983) Once finalized, the rule generally cannot take effect for at least 30 days.
When Agencies Skip the Comment Period
Not every rule goes through this route. The APA exempts interpretive rules, general policy statements, and internal procedural rules.4Office of the Law Revision Counsel. 5 U.S.C. 553 – Rule Making Agencies can also invoke a “good cause” exception when they determine that going through the full process would be impracticable, unnecessary, or contrary to the public interest. When an agency uses this exception, it must publish a written explanation of why it skipped the normal steps.6Administrative Conference of the United States. Public Engagement in Agency Rulemaking Under the Good Cause Exemption In urgent situations, agencies sometimes publish an “interim final rule” that takes effect immediately while simultaneously accepting comments, allowing later revision based on public feedback.
White House Review Through OIRA
Before a significant regulation is published, the agency must submit it for review to the Office of Information and Regulatory Affairs (OIRA), a small but influential office within the White House budget office. Executive Order 12866 defines a “significant regulatory action” as one likely to have an annual economic effect of $200 million or more, adversely affect a sector of the economy, conflict with another agency’s plans, or raise novel legal or policy issues.7Federal Register. Modernizing Regulatory Review For rules meeting the economic threshold, the agency must provide OIRA with a cost-benefit analysis that quantifies the expected benefits and costs, along with an assessment of alternatives.8National Archives. Executive Order 12866 – Regulatory Planning and Review
OIRA generally has 90 days to complete its review and can push back on rules it considers poorly justified or inconsistent with the President’s priorities. After the rule is published, the agency must identify any changes made at OIRA’s suggestion, keeping the review process at least partially transparent.9U.S. Environmental Protection Agency. Summary of Executive Order 12866 – Regulatory Planning and Review
The Congressional Review Act Check
Congress built its own safety valve through the Congressional Review Act (CRA). Before any rule takes effect, the agency must send a copy to both chambers of Congress and to the Government Accountability Office.10Office of the Law Revision Counsel. 5 U.S.C. 801 – Congressional Review If OIRA classifies the rule as “major,” meaning it has an annual economic impact of $100 million or more, significantly increases costs, or adversely affects competition, the rule cannot take effect for 60 days.11Office of the Law Revision Counsel. 5 U.S.C. 804 – Definitions During that window, Congress can pass a joint resolution of disapproval to block the rule entirely. If the President vetoes that resolution, Congress can attempt an override, but the practical effect is that the CRA works most easily during a change in administration, when a new President is willing to sign disapproval resolutions targeting the prior administration’s final batch of regulations.
A rule blocked under the CRA carries an extra consequence: the agency cannot reissue a substantially similar rule unless Congress later passes a new law specifically authorizing it.10Office of the Law Revision Counsel. 5 U.S.C. 801 – Congressional Review
Where the Finished Rule Shows Up
Two government publications hold the output of the rulemaking process. The Federal Register is the daily journal that records proposed rules, final rules, executive orders, and agency notices as they happen. Every regulatory action appears in the order it is filed, which makes it essential for tracking what’s new but impractical for looking up all the current rules on a single topic.
The Code of Federal Regulations (CFR) organizes every general and permanent rule currently in force into 50 titles arranged by subject area. Title 21 covers food and drugs; Title 29 covers labor. If you need to know every active requirement for a particular industry, the CFR is where you look rather than sifting through years of daily Federal Register entries.12Office of the Law Revision Counsel. 5 U.S.C. 551 – Definitions
The electronic Code of Federal Regulations (eCFR) at ecfr.gov is updated daily and is generally current within two business days of any change. It is the fastest way to check whether a regulation has been amended recently, though the Office of the Federal Register advises users to verify effective dates against the original Federal Register document.13eCFR. Understanding the eCFR The eCFR does not include temporary rules or regulations that last less than one year.
How You Can Push Back on a Rule
The comment period is the first and easiest way to influence a rule while it is being made. Written comments submitted through Regulations.gov become part of the rulemaking record, and the agency has to address significant points in its final statement of basis and purpose.
Once a rule is final, the remaining option is judicial review. The APA grants the right to challenge an agency action to any person who has suffered a “legal wrong” or is “adversely affected or aggrieved” by it.14Office of the Law Revision Counsel. 5 U.S.C. 702 – Right of Review A general policy disagreement is not enough. You need to show the regulation directly harms you or your business.
A federal court reviewing a rule applies the standards in 5 U.S.C. ยง 706. It will set aside a rule that is arbitrary or capricious, exceeds the agency’s statutory authority, violates the Constitution, or was adopted without following required procedures.15Office of the Law Revision Counsel. 5 U.S.C. 706 – Scope of Review The arbitrary-and-capricious standard is the most commonly invoked. Courts apply it by checking whether the agency examined the relevant data, considered reasonable alternatives, and explained its reasoning in a way that connects the evidence to the final decision.5Justia. Motor Vehicle Manufacturers Association v. State Farm Mutual, 463 U.S. 29 (1983)
For forty years, courts reviewing an agency’s interpretation of its own statute followed a framework called Chevron deference: if the statute was ambiguous, the court would accept the agency’s reading as long as it was reasonable. That changed in 2024. In Loper Bright Enterprises v. Raimondo, the Supreme Court overruled Chevron and held that courts must exercise their own independent judgment when deciding whether an agency has acted within its statutory authority.16Justia. Loper Bright Enterprises v. Raimondo, 603 U.S. ___ (2024) Courts can still consider an agency’s interpretation as informative, especially when it rests on factual expertise within the agency’s specialty, but the interpretation cannot bind the court.17Supreme Court of the United States. Loper Bright Enterprises v. Raimondo, 603 U.S. ___ (2024) Combined with the major questions doctrine, the end of Chevron deference means regulations that rest on creative readings of old statutes are far more vulnerable to challenge than they were a few years ago, and agencies drafting new rules now have to tie their authority much more tightly to specific statutory text.