Federal Agency Rulemaking Explained, How Rules Get Made and How Courts Can Stop Them

Federal rulemaking is the process through which U.S. government agencies create, amend, or repeal legally binding regulations under authority granted by Congress through the Administrative Procedure Act of 1946 (APA), 5 U.S.C. § 551 et seq. These rules carry the same legal weight as statutes passed by Congress and affect virtually every area of American life — from workplace safety to drug approvals to student loan eligibility.

Quick Facts: Federal Agency Rulemaking

Field	Detail
Legal Term	Federal Rulemaking
Governing Law	Administrative Procedure Act (APA), 5 U.S.C. § 551 et seq.
Applies To	All executive branch agencies and most independent regulatory agencies
Public Comment Right	Yes — required before any final rule takes effect
Where Rules Are Published	The Federal Register (federalregister.gov)
Compiled In	Code of Federal Regulations (CFR)
Standard Court Review	Arbitrary and capricious (5 U.S.C. § 706)
Federal or State	Federal — states have parallel systems
Last Updated	May 20, 2026

What Federal Agencies Actually Are — and Where Their Power Comes From

Congress cannot do everything itself. It passes broad laws — the Clean Air Act, the Affordable Care Act, the Higher Education Act — but those laws often need detailed rules to actually work in practice. So Congress delegates the job of filling in the specifics to specialized agencies: the EPA, the FDA, the Department of Education, OSHA, the SEC, and hundreds of others.

Each agency’s power comes directly from the statute Congress passed. That matters enormously. An agency can only make rules within the boundaries of what Congress authorized. If an agency writes a rule that goes beyond what its authorizing statute allows, a court can strike it down — and in recent years, courts have done exactly that more often and more aggressively than at any point in modern history.

The APA is the rulebook all federal agencies must follow. It sets the procedures for making rules, gives the public the right to participate, and tells courts how to review agency actions. Without the APA, agencies could write and enforce rules with no public input and essentially no accountability. For a broader look at how administrative law shapes consumer rights, see our guide to consumer rights and federal regulatory law at AllAboutLawyer.com.

How Federal Agencies Make Rules: The Notice-and-Comment Process

The standard rulemaking process — called “notice-and-comment rulemaking” or “informal rulemaking” under APA § 553 — follows a clear sequence. Most major federal rules go through every step.

Step 1 — The agency drafts a proposed rule. Before publishing anything publicly, the agency researches the problem, considers alternatives, and writes a proposed regulation. Significant rules also go through review by the Office of Information and Regulatory Affairs (OIRA) at the White House, which screens for economic impact and policy alignment.

Step 2 — The agency publishes a Notice of Proposed Rulemaking (NPRM) in the Federal Register. The Federal Register is the official daily journal of the U.S. government, published every business day. The NPRM must include the text or subject of the proposed rule, the legal authority the agency is relying on, and an invitation for public comment.

Related article: North Carolina’s Lawsuit Over Nursing Student Loans, What Healthcare Students Need to Know Right Now

Step 3 — The public comment period opens — typically at least 30 days. Anyone — individuals, companies, advocacy groups, state governments — can submit written comments on the proposed rule through regulations.gov. This is not just a formality. Agencies are legally required to read and respond to all “significant” comments. Comments that raise substantive issues can change or kill a proposed rule.

Step 4 — The agency reviews comments and writes the final rule. The agency must explain how it considered the public comments, justify its choices, and connect its decision to the evidence in the record. This written justification matters enormously — it is what courts examine when someone challenges the rule later.

Step 5 — The agency publishes the final rule in the Federal Register. The rule cannot take effect for at least 30 days after publication, giving affected parties time to prepare. Congress also has a window to review major rules under the Congressional Review Act and can pass a resolution to overturn them.

Step 6 — The rule goes into effect and is compiled in the Code of Federal Regulations (CFR). The CFR is organized by subject area — Title 29 covers labor, Title 21 covers food and drugs, Title 34 covers education — and is updated annually.

There are exceptions. Agencies can sometimes skip the notice-and-comment process for “good cause” — in genuine emergencies — or for interpretive rules and policy statements that do not change legal rights. But for any rule that creates binding legal obligations on the public, the full process is required.

Three Ways Courts Strike Down Federal Agency Rules

When a federal agency publishes a final rule, affected parties can sue to block it. The lawsuit is filed in federal district court (or in some cases directly in a federal court of appeals, depending on the statute). The court reviews the rule under the APA. Courts use three main grounds to invalidate agency rules — and the legal landscape shifted dramatically in 2022 and 2024.

Ground 1 — Arbitrary and Capricious (5 U.S.C. § 706(2)(A))

This is the most common ground for striking down a rule. A court will invalidate a rule if the agency failed to examine the relevant evidence, offered no rational explanation for its choice, ignored important aspects of the problem, or reached a conclusion that runs counter to the evidence in the record. The Supreme Court established the core test in Motor Vehicle Manufacturers Association v. State Farm Mutual Auto Insurance Co. (1983): an agency must “examine the relevant data and articulate a satisfactory explanation for its action.”

In plain English: the agency has to show its work. If it cannot connect its conclusions to its evidence, the rule goes down. This is also the standard that applies when an agency changes course from a prior position — courts look harder at rule reversals than at new rules.

Ground 2 — Exceeding Statutory Authority (The Major Questions Doctrine)

Even when an agency follows every procedural step correctly, it can still lose in court if the rule goes beyond what Congress authorized. In West Virginia v. EPA, 597 U.S. 697 (2022), the Supreme Court established what it called the major questions doctrine: when an agency claims authority to decide something of vast economic and political significance, it must point to clear congressional authorization — not just a general grant of regulatory power.

The EPA had claimed authority to effectively restructure the entire U.S. electricity grid by shifting power generation from coal to renewable sources. The Court said that was not the kind of authority Congress implicitly handed over through general language in the Clean Air Act. If Congress wanted agencies to make decisions of that magnitude, it needed to say so explicitly.

Think of it this way: Congress gives agencies keys to certain rooms. The major questions doctrine says agencies cannot use those keys to enter rooms Congress never intended them to open, especially when the stakes are enormous.

Ground 3 — The Post-Chevron World: Courts Now Decide What Laws Mean

For 40 years, courts used a framework called Chevron deference — from Chevron U.S.A. v. Natural Resources Defense Council (1984) — that told judges to defer to an agency’s reasonable interpretation of an ambiguous statute it administered. If the law was unclear and the agency’s reading was reasonable, the agency won.

The Supreme Court ended Chevron deference entirely in Loper Bright Enterprises v. Raimondo, 144 S. Ct. 2244 (2024). In a 6-3 decision, the Court held that under the APA, courts must exercise their own independent judgment about what a statute means. Agencies no longer get the benefit of the doubt when a law is ambiguous. Courts now decide the “best reading” of the statute themselves — and if the agency’s rule does not match that best reading, the rule can be struck down. This directly applies to the NC nursing student loan lawsuit: the states are arguing the Department of Education’s rule does not match the best reading of the One Big Beautiful Bill Act, and after Loper Bright, the court — not the agency — gets to decide if they are right.

Frequently Asked Questions

Is a federal agency rule the same as a law passed by Congress? 

No, but they carry the same legal force. Congress passes statutes — the broad law. Agencies create regulations — the detailed rules that implement the statutes. Both are legally binding, but regulations can be challenged in court more easily than statutes, because agencies must stay within the boundaries Congress set.

What is the Federal Register and do I need to read it? 

The Federal Register is the official daily journal where the federal government publishes proposed and final rules, executive orders, and agency notices. You do not need to read it regularly, but it is where you can find proposed rules and submit public comments during the comment period. It is available free at federalregister.gov.

Do I need a lawyer to challenge a federal agency rule?

 Challenges to federal rules are complex administrative law cases that almost always require an attorney with expertise in the APA and judicial review. Organizations, businesses, and states typically bring these cases. An individual can sometimes challenge a rule that directly harms them — standing requires a concrete, specific injury — but this is not a DIY process.

What law governs federal rulemaking in the U.S.? 

The Administrative Procedure Act, 5 U.S.C. § 551 et seq., governs how all federal agencies make rules and how courts review them. Every notice-and-comment rulemaking, every public comment period, and every court challenge to a federal rule flows through the APA.

What is the difference between a proposed rule and a final rule?

 A proposed rule is a draft that an agency publishes in the Federal Register to collect public comment. It has no legal force. A final rule is published after the agency reviews comments and is legally binding once its effective date arrives — typically 30 days after publication.

Can Congress undo a federal agency rule? 

Yes — through the Congressional Review Act (CRA), Congress can pass a joint resolution of disapproval to overturn a final agency rule within a set review period. The president must sign it (or Congress must override a veto). Congress used the CRA to overturn 16 Obama-era rules in 2017 and has used it selectively since.

Sources & References

• Administrative Procedure Act, 5 U.S.C. § 551 et seq.: law.cornell.edu
• Congressional Research Service, “An Overview of Federal Regulations and the Rulemaking Process”: congress.gov
• Congressional Research Service, “Judicial Review Under the Administrative Procedure Act”: congress.gov
• U.S. Government Accountability Office, “Federal Rulemaking”: gao.gov
• Loper Bright Enterprises v. Raimondo, 144 S. Ct. 2244 (2024): supremecourt.gov
• West Virginia v. EPA, 597 U.S. 697 (2022): supremecourt.gov
• Federal Register: federalregister.gov

Prepared by the AllAboutLawyer.com Editorial Team and reviewed for factual accuracy against official legal sources, APA statutory text, and Supreme Court opinions on May 20, 2026. Last Updated: May 20, 2026

Disclaimer: This article is for general informational and educational purposes only and does not constitute legal advice. Laws and court decisions are subject to change. For advice about your specific situation, consult a qualified attorney.