How the Federal Government Makes the Rules That Govern Your Life

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Every product you buy, every breath of air you take, every dollar you invest—federal regulations shape them all.

From car safety standards to environmental protections to financial regulations, government agencies create thousands of rules each year that directly impact American lives. But how do these rules actually get made?

The process isn’t as mysterious as it might seem. Federal agencies follow specific procedures laid out in a 1946 law called the Administrative Procedure Act.

This law created two main paths for making regulations: the common “notice and comment” process that most agencies use, and a much rarer “formal rulemaking” process that looks more like a court trial.

Here’s how both systems work, why they matter, and how you can participate.

What Are Federal Rules and Why Do Agencies Make Them?

Rules vs. Laws: The Difference That Matters

Federal rules and regulations aren’t suggestions—they’re legally binding requirements that can affect everyone from individual consumers to massive corporations. The Administrative Procedure Act defines a “rule” as any agency statement that implements, interprets, or prescribes law or policy with future effect.

When Congress passes a law saying the air should be cleaner, that’s just the beginning. The Environmental Protection Agency then creates specific rules setting exactly how much pollution each industry can emit. Congress might say workplaces should be safer, but the Occupational Safety and Health Administration writes the detailed rules about hard hats, safety barriers, and chemical exposure limits.

These rules cover an enormous range: food safety standards, drug approval processes, aviation safety requirements, banking regulations, immigration procedures, and thousands of other areas. They establish specific requirements, grant rights, and impose obligations that carry the full force of law.

Why Congress Delegates Rule-Making Power

Congress could theoretically write every detailed regulation itself, but that would be impossible. Lawmakers lack the time, resources, and specialized knowledge needed to regulate complex technical issues. How many members of Congress understand the intricacies of pharmaceutical manufacturing or aircraft engine design?

Instead, Congress passes broad laws and delegates authority to agencies with relevant expertise. The Food and Drug Administration employs scientists who understand drug interactions. The Federal Aviation Administration has engineers who know aircraft systems. The Securities and Exchange Commission has economists who understand financial markets.

This delegation system is practical, but it also means that unelected officials make decisions with the force of law. That’s why the Administrative Procedure Act requires public participation and transparent decision-making processes.

Agencies initiate rulemaking for several reasons. Sometimes Congress specifically directs them to create rules. Other times, agencies identify problems on their own—like emerging health risks or unfair business practices. Changes in technology, new scientific understanding, or evolving social needs can also prompt new regulations.

The public can also petition agencies to create, change, or eliminate rules. These petitions don’t always succeed, but they sometimes trigger the rulemaking process.

The Administrative Procedure Act: The Rule Book for Rules

The Administrative Procedure Act became law in 1946 and remains the foundation of federal rulemaking. You can read the full text through resources like Cornell Legal Information Institute and the National Archives.

The APA tries to balance two competing needs: allowing agencies to work efficiently using their expertise, while ensuring public accountability and participation in decisions that affect citizens’ lives. The law creates different procedural tracks depending on the type and importance of the rule being made.

Most federal rules go through “informal” notice and comment rulemaking. A much smaller number require “formal” rulemaking with trial-like hearings. The specific process depends on what Congress wrote in the original law authorizing the agency to make that type of rule.

Notice and Comment Rulemaking: How Most Federal Rules Get Made

The vast majority of federal regulations—probably over 95%—are created through notice and comment rulemaking. Despite being called “informal,” this process follows strict legal requirements that agencies ignore at their peril.

What Notice and Comment Really Means

Notice and comment rulemaking requires agencies to:

• Publish a detailed proposal explaining what they want to do and why
• Give the public time to submit written feedback
• Consider all the comments they receive
• Explain their final decision and respond to major concerns raised by commenters

This might sound simple, but each step involves complex legal requirements. Courts regularly throw out agency rules when agencies fail to follow these procedures properly.

The Legal Framework: APA Section 553

Section 553 of the Administrative Procedure Act lays out the basic requirements for informal rulemaking. The key elements include:

Notice: Agencies must publish a general notice of proposed rulemaking in the Federal Register.

Public Participation: Interested people must have an opportunity to submit written data, views, or arguments.

Statement of Basis and Purpose: The final rule must include a concise explanation of its basis and purpose.

Effective Date: Most rules can’t take effect for at least 30 days after publication, giving people time to prepare for compliance.

This framework is flexible enough to handle everything from technical aviation safety rules to broad environmental policies, while still ensuring public input and reasoned agency decisions.

Step One: The Proposal

What Goes Into a Notice of Proposed Rulemaking

The process typically starts when an agency publishes a Notice of Proposed Rulemaking (NPRM). This document serves as the agency’s formal announcement that it’s considering a new rule or changes to existing regulations.

A good NPRM includes several key components:

The Problem: What specific issue is the agency trying to solve? Why is current law or regulation inadequate?

Legal Authority: Which law gives the agency power to make this rule? Agencies can only regulate within the bounds of authority Congress has given them.

Proposed Solution: What exactly would the new rule require? This might be the full text of proposed regulations or a detailed description of what the agency has in mind.

Supporting Analysis: What data, studies, or reasoning support the agency’s approach? How did officials decide this was the best solution?

Questions for the Public: What specific issues does the agency want feedback on? Where is the agency uncertain or looking for additional information?

How to Comment: Practical details about submitting feedback, including deadlines and submission methods.

The quality of an NPRM directly affects the quality of public participation. Vague or highly technical proposals that don’t clearly explain the agency’s reasoning make it hard for people to provide useful feedback. The best NPRMs transparently lay out the problem, the proposed solution, the supporting rationale, and specific areas where public input would be most valuable.

Where to Find Proposed Rules

All NPRMs are published in the Federal Register, the government’s official daily publication. The Federal Register includes proposed rules, final rules, agency notices, and presidential documents.

Most agencies also post their proposals on Regulations.gov, a centralized website designed to make it easier for the public to find and comment on regulatory actions. The E-Government Act of 2002 requires agencies to post plain-language summaries of most proposed rules on this site.

Regulations.gov represents a major improvement over the historically user-unfriendly Federal Register. The website allows you to search by agency, topic, or keyword, and provides a single place to submit comments on most federal rules.

Step Two: Public Comments

How to Submit Comments

Once an agency publishes an NPRM, the public comment period opens. This is your main opportunity to influence the final rule.

Comment periods typically last 30 to 60 days, though they can be longer for complex rules or shorter in urgent situations. The NPRM will specify the deadline and acceptable submission methods.

Most agencies now prefer electronic comments submitted through Regulations.gov or their own websites. Some still accept comments by mail, though this is less common. All comments generally become part of the public record and are available for anyone to read.

Electronic comment systems have made it much easier for people to participate in rulemaking. You can submit a comment from your phone in minutes rather than printing, mailing, and waiting for delivery. However, this convenience has also enabled mass comment campaigns where thousands of people submit identical form letters.

While these campaigns can signal broad public sentiment, agencies often find unique, well-reasoned comments more useful for actually improving rules. A thoughtful comment that identifies a specific problem or suggests a practical alternative can have more impact than 10,000 identical form letters.

Why Your Comments Actually Matter

Public comments aren’t just for show. Agencies are legally required to consider relevant feedback when developing final rules. While they don’t have to adopt every suggestion, they must demonstrate that they’ve reviewed and thought about the input they received.

Comments can have real impact on final regulations by:

• Providing agencies with data, insights, and real-world perspectives they might not have considered
• Identifying potential unintended consequences or practical problems with proposals
• Suggesting alternative approaches that could achieve the agency’s goals more effectively
• Pointing out errors or gaps in the agency’s analysis
• Offering specific examples of how the rule would affect different groups or situations

Robust public participation generally leads to better rules. When agencies engage seriously with public feedback, the resulting regulations are often more workable, better understood by affected parties, and less likely to face successful legal challenges.

The legal requirement for agencies to consider and respond to significant comments creates a form of public dialogue. Agencies must publicly justify their policy choices in light of the feedback they receive, transforming rulemaking from a purely top-down process into something more deliberative.

What Makes Comments Effective

Not all comments carry equal weight. To maximize your impact, consider these strategies often recommended by agencies:

Be Specific: Clearly state your position and explain your reasoning. Reference specific parts of the proposed rule if possible.

Provide Evidence: Support your points with facts, data, scientific evidence, personal experiences, or logical arguments. Explain why you believe something, don’t just state opinions.

Explain Real-World Impact: Describe how the proposed rule would affect you, your community, your business, or the environment. Concrete examples are often more persuasive than abstract arguments.

Offer Alternatives: If you disagree with a proposal, suggest specific, workable alternatives that could address the agency’s concerns while mitigating your own.

Focus on Substance: Address the merits of the proposed rule rather than just expressing general support or opposition.

Stay Organized: If you have multiple points, organize them clearly with headings or bullet points.

Be Professional: Maintain a respectful tone. Clear, concise arguments are usually more effective than emotional appeals.

Comments that provide new information, identify flaws in agency analysis, or propose well-reasoned alternatives carry particular weight because they contribute directly to the official “rulemaking record.” This record forms the basis for agency decisions and subsequent court review.

Step Three: The Final Rule

How Agencies Review Comments

After the comment period closes, agency staff review and analyze all submitted comments. For major rules, this can be a massive undertaking involving thousands or even hundreds of thousands of submissions.

Staff typically categorize comments, identify common themes, and assess the merits of various points raised. This process requires significant time and resources, especially for controversial rules that attract large volumes of input.

The thoroughness of comment review, while often invisible to the public, is crucial for rulemaking integrity. Rushed or superficial review can result in valuable insights being overlooked and significant public concerns going unaddressed. This can weaken the final rule or the justification supporting it.

Explaining the Decision

When agencies issue final rules, the Administrative Procedure Act requires them to include “a concise general statement of [the rule’s] basis and purpose.” This statement, typically found in the preamble to the rule, serves as the agency’s official explanation.

The preamble generally:

• Summarizes key provisions of the final rule
• Discusses significant issues raised in public comments
• Explains how the agency responded to feedback—whether it agreed, disagreed, or modified the proposal, and why
• Articulates the factual, legal, and policy grounds supporting the final rule

This statement isn’t just informational—it’s legally critical. It’s the primary way agencies demonstrate they’ve engaged in reasoned decision-making and considered public input. For people who submitted comments, this is where they can see whether and how their concerns were addressed.

The statement also becomes central to any court challenge of the rule. Courts scrutinize it to determine whether the agency provided a coherent explanation and adequately addressed important comments and contrary evidence. An inadequate statement increases the likelihood that a court will find the rule “arbitrary and capricious” and therefore unlawful.

Publication and Implementation

Final rules are published in the Federal Register with their explanatory preambles. This publication provides official legal notice of the rule’s content and adoption.

Most rules can’t take effect for at least 30 days after publication, giving affected parties time to understand new requirements and prepare for compliance. This reflects a basic fairness principle—people shouldn’t be suddenly subject to new legal obligations without reasonable notice.

There are exceptions to the 30-day rule for certain types of regulations, such as those that grant exemptions or relieve restrictions, or when agencies find “good cause” for immediate implementation, such as in emergencies.

Variations on the Standard Process

While the NPRM-comment-final rule sequence is standard, agencies sometimes use additional procedures to enhance public participation or respond to changing circumstances.

Advance Notice of Proposed Rulemaking

Sometimes agencies publish an Advance Notice of Proposed Rulemaking (ANPRM) before issuing an NPRM. ANPRMs are used to gather preliminary information and input at very early stages of the rulemaking process.

Agencies might use ANPRMs when they’re trying to define the scope of a problem, identify potential regulatory approaches, gather data, or narrow down alternatives before committing to a specific proposal. While ANPRMs add time to the process upfront, early engagement can lead to more focused and well-developed proposals later.

Supplemental Notices

If an agency decides to make substantial changes to its proposal after reviewing public comments, it may issue a Supplemental Notice of Proposed Rulemaking (SNPRM). This is particularly important if the changes weren’t a “logical outgrowth” of the original proposal—meaning the public couldn’t have reasonably anticipated the revisions.

SNPRMs present revised proposals and offer new opportunities for public comment on the modifications. This ensures fairness and allows public input on significant changes before final rules are issued. While SNPRMs extend rulemaking timelines, they’re crucial for maintaining due process when proposals evolve significantly.

Interim Final Rules

In certain circumstances, agencies may issue Interim Final Rules (IFRs) that become effective immediately without prior public comment. This approach is typically reserved for urgent situations like public health emergencies or when the APA’s “good cause” exception applies—meaning prior notice and comment would be “impracticable, unnecessary, or contrary to the public interest.”

Agencies issuing IFRs usually solicit comments after the rule takes effect. They then review this feedback and may revise the rule, make it permanent as-is, or withdraw it. IFRs represent a significant departure from standard participatory processes, prioritizing speed over initial public input, so their use requires careful justification.

When Notice and Comment Doesn’t Apply

The APA exempts certain categories of rules from notice and comment requirements:

Military or Foreign Affairs: Rules involving military or foreign affairs functions of the United States.

Internal Management: Matters relating to agency management, personnel, public property, loans, grants, benefits, or contracts. However, agencies sometimes voluntarily use notice and comment for these matters.

Interpretive Rules and Policy Statements: These clarify existing law without creating new obligations or announce tentative agency intentions without establishing binding norms.

Good Cause Exception: Agencies may skip notice and comment if they find “good cause” that such procedures are “impracticable, unnecessary, or contrary to the public interest.” Agencies must explain their reasoning when invoking this exception.

These exceptions exist for practical reasons, but their application can be controversial. The “good cause” exception is intended for limited circumstances and courts typically interpret it narrowly. If agencies interpret it too broadly, they could improperly bypass public input on rules that genuinely warrant it.

The distinction between exempt “interpretive rules” and “legislative rules” (which create new law and require notice and comment) can be quite nuanced and is frequently disputed in court. Citizens should be aware that agencies must justify their use of exceptions and that rule characterizations can have significant procedural consequences.

Formal Rulemaking: The Rare Trial-Like Process

Formal rulemaking is much less common than notice and comment procedures, but it’s important to understand because it represents a fundamentally different approach to making regulations.

What Makes Formal Rulemaking Different

Formal rulemaking involves trial-like hearings presided over by Administrative Law Judges (ALJs) or other designated agency officials. Interested parties present evidence, offer testimony under oath, cross-examine witnesses, and make legal arguments. The agency’s final rule must be based exclusively on evidence in the formal record compiled during these proceedings.

This process is significantly more complex, time-consuming, and resource-intensive than informal rulemaking. The demanding procedural requirements reflect a congressional judgment that certain types of rules warrant a more rigorous, court-like approach to fact-finding, even if it comes at considerable cost in terms of agency resources and speed.

Legal Requirements: APA Sections 556 and 557

While Section 553 sets out general rulemaking requirements, the detailed procedures for formal hearings are found in APA Sections 556 and 557. These sections detail rules for presiding officers, evidence presentation, official records, burdens of proof, and the basis for agency decisions.

The internal architecture of the APA creates a two-track system. When an agency’s authorizing statute mandates that a rule be made “on the record after opportunity for an agency hearing,” this specific language triggers the trial-like procedures of Sections 556 and 557. Without these “magic words,” agencies typically use informal notice and comment procedures.

The Critical Trigger: “On the Record”

Formal rulemaking is required only when the specific law authorizing an agency to make rules explicitly states that the rule must be made “on the record after opportunity for an agency hearing.” This precise phrasing acts as the trigger for formal procedures.

The interpretation of this language was significantly shaped by the Supreme Court’s 1973 decision in United States v. Florida East Coast Railway Co. The Court held that trial-like procedures are triggered only when the authorizing statute expressly requires rules to be made “on the record.” Simply requiring a “hearing” without the crucial “on the record” language was insufficient.

This strict interpretation dramatically limited formal rulemaking. Since many statutes authorize hearings but omit the precise “on the record” language, the practical effect was to cement informal notice and comment as the dominant method of federal rulemaking.

Inside a Formal Rulemaking Hearing

The Trial-Like Process

Formal rulemaking hearings closely resemble court trials. They’re adversarial processes where interested parties present their cases through oral and documentary evidence. Witnesses provide testimony under oath, and parties often have rights to cross-examine opposing witnesses.

This contrasts sharply with informal rulemaking, where public input is primarily through written comments. Any public meetings in informal rulemaking are usually legislative-style information-gathering sessions, not trial-type proceedings for testing facts.

The adversarial nature of formal hearings, particularly cross-examination opportunities, is designed to rigorously test evidence and factual assertions. This can be crucial for rules depending on complex scientific, technical, or economic data. However, this rigor makes formal rulemaking extremely time-consuming and expensive for both agencies and participating parties.

Some FDA formal rulemaking proceedings in the 1970s took more than ten years to complete. This procedural burden can lead to “ossification” where agencies become reluctant to use formal procedures, even when thorough fact-finding might be beneficial.

Administrative Law Judges

Formal hearings are typically presided over by Administrative Law Judges (ALJs), officials within agencies who are appointed to conduct formal proceedings and function as impartial adjudicators. ALJs have authority to:

• Administer oaths and affirmations
• Issue authorized subpoenas
• Rule on evidence and receive relevant testimony
• Take depositions
• Regulate hearing procedures
• Hold settlement conferences
• Make or recommend decisions

ALJs are intended to be independent decision-makers, particularly in conducting hearings and making initial decisions. This independence helps ensure fairness in formal proceedings and prevents improper influence from agency preferences or information not subjected to hearing scrutiny.

Building the Official Record

A core principle of formal rulemaking is that agency decisions must be based exclusively on evidence presented and officially included in the formal “record” created during hearings. APA Section 556(e) states that “the transcript of testimony and exhibits, together with all papers and requests filed in the proceeding, constitutes the exclusive record for decision.”

This “on the record” requirement ensures that agency decisions are grounded in verifiable evidence that all parties had opportunities to examine and contest. If evidence isn’t properly introduced into the official record during hearings, it generally can’t be considered when formulating final rules.

This contrasts with informal rulemaking, where agencies can draw upon broader information sources while adequately explaining their reasoning. The “closed record” nature of formal rulemaking provides a clear basis for judicial review but makes the hearing stage critically important for ensuring all pertinent facts and arguments are thoroughly documented.

Restrictions on Private Communications

In formal rulemaking, ex parte communications—off-the-record communications about rule merits between interested outsiders and agency decision-makers—are generally prohibited or strictly limited. This prohibition protects the fairness and integrity of the trial-like process and ensures decisions are based solely on the public record developed during hearings.

This reflects the adjudicative character of formal rulemaking. Just as it would be unfair for one party in a trial to communicate privately with the judge about the case, allowing such private influence in formal rulemaking would undermine hearing fairness and the principle that decisions must be based only on openly presented evidence.

This differs from informal rulemaking, where ex parte communications are often permitted if disclosed and placed in the public docket to maintain transparency.

When Formal Rulemaking Is Used

Formal rulemaking is rare in the federal government, employed only when specific statutes explicitly mandate it. Examples include:

• Certain ratemaking proceedings by regulatory agencies (setting rates for utilities or transportation)
• Rules concerning food additives under the Federal Food, Drug, and Cosmetic Act
• Historically, FDA used formal procedures for food standards, drug safety and efficacy rules, and color additive safety determinations

The domains where Congress has mandated formal procedures often involve very high stakes for public health and safety, or complex economic regulations where precise factual determinations are critical and potentially contested. Congress appears to have calculated that the costs and burdens of formal procedures are justified by the paramount need for robust, evidence-based, and fair decisions in these areas.

Comparing the Two Systems

This comparison shows that “rulemaking” isn’t a single, uniform activity. The procedural rights afforded to the public, the nature of their engagement, the basis for agency decisions, and even court review standards differ dramatically depending on which process is used.

For example, the opportunity to directly question agency experts or opposing witnesses through cross-examination exists typically only in formal rulemaking—a process far less common than notice-and-comment procedures relying on written submissions.

Your Role in the Process

Public participation isn’t just a procedural step—it’s fundamental to democratic governance, especially when agencies exercise delegated legislative power.

Why Participation Matters

Meaningful public engagement offers numerous benefits:

Better Rules: Diverse knowledge, experiences, data, and perspectives can lead to more practical, effective, and well-informed regulations. Citizens, businesses, and organizations often have on-the-ground insights that agency staff lack.

Transparency and Accountability: Open rulemaking processes make agency actions more transparent and hold agencies accountable for their decisions.

Public Trust: When people have genuine opportunities to be heard and see their input taken seriously, it fosters greater trust in government and increases perceived legitimacy of resulting regulations.

Identifying Problems: Public comment helps agencies identify potential negative impacts or unforeseen consequences before rules are finalized.

Fairness: Public participation aims to give stakeholders—including individuals, interest groups, and communities—opportunities to influence decisions affecting their lives.

The EPA’s Public Participation Guide emphasizes that public participation is “a process, not a single event” and should involve both informing the public and obtaining input where it can genuinely shape decisions.

Effective participation extends beyond simply providing comment opportunities. It encompasses agencies’ responsibility to actively listen, make information accessible, and design processes enabling diverse voices to be meaningfully engaged. This may involve proactive outreach to underrepresented communities, providing materials in understandable language, and ensuring participation mechanisms are user-friendly.

Finding Information About Rules

The Federal Register

The Federal Register is the official daily publication for federal agency rules, proposed rules, and notices, plus executive orders and other presidential documents. It’s the primary source for finding out what the federal government is proposing and what final actions it’s taking.

GovInfo, managed by the U.S. Government Publishing Office, also provides Federal Register access.

While the Federal Register is comprehensive and official, its volume and technical nature can be daunting. Online versions have significantly improved searchability and user interface compared to print versions, but underlying documents often remain complex.

Key Online Resources

Regulations.gov: This government-wide portal is the primary online destination for finding proposed federal regulations and submitting electronic comments. Most agencies use Regulations.gov to post NPRMs, supporting analyses, and receive public comments.

Agency Websites: Individual federal agency websites often have dedicated rulemaking sections providing access to specific dockets, proposed and final rules, guidance documents, and participation information.

USAFacts.org: This non-partisan, not-for-profit organization provides accessible data and reports on U.S. government finances, demographics, and policy outcomes based on publicly available government data. While not directly listing rulemaking dockets, it offers context about government actions and potential regulatory impacts.

Administrative Conference of the United States (ACUS): This independent federal agency studies and makes recommendations for improving administrative processes, including rulemaking. ACUS reports and publications offer insights into complex procedural issues and best practices in administrative law.

The proliferation of online resources has democratized access to rulemaking information, empowering citizens to become more informed and engaged. However, this information abundance creates a need for information literacy skills to distinguish between official primary sources and secondary commentary, news analyses, and advocacy positions.

After Rules Are Made: Court Review

The rulemaking process doesn’t necessarily end when agencies publish final rules. The Administrative Procedure Act provides for judicial review, meaning agency rules can often be challenged in federal court.

Can Rules Be Challenged?

Generally, final agency rules can be challenged in federal court by individuals or entities who are “suffering legal wrong because of agency action, or adversely affected or aggrieved by agency action within the meaning of a relevant statute” (APA §702). This right serves as a critical accountability mechanism, ensuring agencies act within legal authority, follow proper procedures, and make rational, evidence-supported decisions.

The availability of judicial review incentivizes agencies to adhere carefully to APA procedural requirements and develop strong, well-reasoned justifications for their rules. Agencies know their final rules can be subjected to legal scrutiny, and overturned rules can result in wasted resources, policy setbacks, and credibility damage.

How Courts Review Rules

When federal courts review agency rules, they don’t substitute their own judgment for agency expertise, particularly on technical matters or policy choices. Instead, courts apply specific “standards of review” established by the APA to determine if agency action was lawful.

Arbitrary and Capricious Standard

The most common standard, primarily applied to informal rulemaking rules, examines whether agencies:

• Relied on factors Congress didn’t intend them to consider
• Failed to consider important aspects of problems
• Offered explanations that run counter to evidence or are implausible
• Failed to examine relevant data and articulate satisfactory connections between facts and choices

The “arbitrary and capricious” standard is deferential to agencies but requires them to demonstrate reasoned decision-making.

Substantial Evidence Standard

Applied to agency findings in cases subject to formal hearing requirements, “substantial evidence” means “more than a mere scintilla”—”such relevant evidence as a reasonable mind might accept as adequate to support a conclusion.” Courts review entire formal hearing records to determine if agency factual findings are reasonably supported.

Both standards reflect careful judicial balance, providing meaningful oversight to ensure agencies operate lawfully and rationally while respecting specialized knowledge and policy-making authority Congress has delegated to administrative agencies. Judicial review primarily scrutinizes how agencies arrive at decisions rather than substituting courts’ policy preferences, as long as agency choices are legally sound and rationally supported by the administrative record.

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