How Regulatory Agencies Make Rules That Affect You

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Regulatory agencies are powerful institutions that shape nearly every aspect of modern life. From the food you eat to the air you breathe, from the safety of your workplace to the security of your financial investments, regulatory agencies create and enforce rules that protect public health, ensure fairness, and maintain order across countless industries. Understanding how these agencies develop regulations is essential for anyone who wants to participate in the democratic process and influence the policies that affect their daily lives.

The rulemaking process is a complex but transparent system designed to balance the need for effective regulation with the principles of public participation and accountability. The Administrative Procedure Act (APA) governs the process by which federal agencies develop and issue regulations. This foundational law, enacted in 1946, serves as what some legal scholars consider a sort of “constitution” for U.S. administrative law.

What Are Regulatory Agencies and Why Do They Matter?

Regulatory agencies are governmental bodies authorized by Congress to implement and enforce specific laws. These agencies exist at federal, state, and local levels, each with distinct responsibilities and jurisdictions. The APA applies to both the federal executive departments and the independent agencies. Examples include the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), the Occupational Safety and Health Administration (OSHA), and the Securities and Exchange Commission (SEC).

The scope of regulatory influence is vast. Agencies make decisions about environmental protections, transportation infrastructure, health insurance, food safety, housing standards, and internet access. These decisions directly impact individuals, businesses, and entire communities. Because of this broad reach, understanding how agencies create rules is crucial for effective civic engagement.

The APA describes rulemaking as the “agency process for formulating, amending, or repealing a rule,” and a “rule” is defined expansively to include any “agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy.” When properly issued, these rules carry the force and effect of law, binding both the regulated parties and the agencies themselves.

The Administrative Procedure Act represents a fundamental safeguard in American administrative law. The APA creates a framework for regulating agencies and their roles. This framework addresses concerns about the separation of powers and prevents unchecked authority within particular areas of government.

According to the Attorney General’s Manual on the Administrative Procedure Act, the basic purposes of the law include requiring agencies to keep the public informed of their organization, procedures, and rules; providing for public participation in the rulemaking process; and establishing uniform standards for the conduct of formal rulemaking and adjudication.

Key Components of the APA

The APA includes requirements for publishing notices of proposed and final rulemaking in the Federal Register, and provides opportunities for the public to comment on notices of proposed rulemaking. Additionally, the APA requires most rules to have a 30-day delayed effective date. This delay ensures that regulated parties have adequate time to prepare for compliance with new requirements.

Beyond rulemaking procedures, the APA addresses other agency actions such as issuance of policy statements, licenses, and permits, and provides standards for judicial review if a person has been adversely affected or aggrieved by an agency action. This comprehensive approach ensures accountability throughout the administrative process.

Types of Rulemaking Procedures

Not all rules are created through the same process. The APA details the rarely used procedures for formal rules as well as the requirements for informal rulemaking, under which the vast majority of agency rules are issued. Understanding these different approaches helps clarify how agencies operate in various contexts.

Informal Rulemaking (Notice-and-Comment)

The informal rulemaking process is therefore also referred to as “notice and comment” rulemaking. This is by far the most common method agencies use to create new regulations. The process involves several key steps that ensure transparency and public participation.

First, the agency must give a notice of a proposed rulemaking, published in the Federal Register. The Federal Register “is the official daily publication for rules, proposed rules, and notices of Federal agencies and organizations, as well as executive orders and other presidential documents.”

The notice of proposed rulemaking must include: 1) a statement of the time, place, and nature of public rulemaking proceedings; 2) reference to the legal authority under which the rule is proposed; 3) either the terms or substance of the proposed rule or a description of the subjects and issues involved; and 4) the Internet address of a summary of not more than 100 words in length of the proposed rule, in plain language.

After publication, the agency must give interested persons an opportunity to participate in the rulemaking through submission of written data, views, or arguments with or without opportunity for oral presentation. This public comment period is a cornerstone of democratic rulemaking.

Formal Rulemaking

Although rules are typically promulgated through the informal rulemaking process, in limited circumstances, federal agencies must follow formal rulemaking requirements, which are only triggered when Congress explicitly requires that the rulemaking proceed “on the record.”

When formal rulemaking is required, the process becomes much more elaborate. Agencies must engage in trial-like procedures, providing parties with opportunities to present their cases through oral or documentary evidence and conduct cross-examination. These proceedings are presided over by an agency official or Administrative Law Judge.

Other Rulemaking Methods

Federal agencies may promulgate rules through various methods including formal rulemaking, informal (notice-and-comment or § 553) rulemaking, hybrid rulemaking, direct final rulemaking, and negotiated rulemaking.

Negotiated rulemaking represents a collaborative approach where agencies consult with interested persons and groups during the developmental stages. The goal is to increase administrative efficiency and decrease subsequent opposition by engaging stakeholders early in the process, allowing the agency and involved interests to reach consensus before publishing a proposed rule.

The Rulemaking Process: Step by Step

Understanding the detailed steps of rulemaking helps demystify how regulations come into being and reveals multiple opportunities for public engagement.

Step 1: Identifying the Need for Regulation

The rulemaking process begins when an agency identifies a need for new regulations or changes to existing ones. This need may arise from various sources: congressional mandates, court decisions, petitions from the public or industry groups, emerging health or safety concerns, technological changes, or the agency’s own research and monitoring activities.

Agencies often conduct preliminary research and analysis during this stage, gathering data, consulting with experts, and assessing the scope of the problem they aim to address. While agencies generally have discretion during this preliminary stage, some circumstances require early stakeholder involvement, particularly when proposed actions involve complex or numerous proposals.

Step 2: Developing the Proposed Rule

Once the need is established, agency staff begin drafting the proposed rule. This involves extensive research, economic analysis, and consultation with technical experts. Agencies must ensure that their proposed rules align with their statutory authority and consider potential impacts on various stakeholders.

During development, agencies often prepare supporting documents including regulatory impact analyses, cost-benefit assessments, and explanations of the legal basis for the proposed action. These materials help the public understand the rationale behind the proposed rule and provide context for meaningful comment.

Step 3: Publishing the Notice of Proposed Rulemaking

An agency issues a Notice of Proposed Rulemaking (NPR), published in the Federal Register, to describe and solicit public comments on a proposed regulatory action. This publication marks the official beginning of the public comment period and triggers various procedural requirements.

Rules and regulations issued or proposed by federal administrative agencies are published chronologically in the Federal Register. Once finalized, promulgated rules and regulations are then organized by topic in a separate publication called the Code of Federal Regulations.

Step 4: The Public Comment Period

The public comment period is perhaps the most critical phase for citizen participation. There is no minimum period specified for the comment period to remain open, and it often varies with the complexity of the rule. Most comment periods last between 30 and 60 days, and some are re-opened if the agency believes that there was insufficient time for the public to respond.

For significant regulatory actions, longer comment periods are recommended. For “significant regulatory actions” as defined in Executive Order 12,866, as supplemented by Executive Order 13,563, agencies should use a comment period of at least 60 days.

Absolutely anyone can submit a public comment on an agency’s proposed regulation. You do not have to be an academic, expert, or even someone who knows all of the ins and outs of the policy at hand. This accessibility ensures that diverse perspectives inform the regulatory process.

Step 5: Reviewing and Responding to Comments

After the comment period closes, agencies face the substantial task of reviewing all submitted comments. Once the commenting period has ended, agencies commence reviewing submitted comments. Staff and/or contractors hired by the agency sort and split comments using several approaches.

They identify comments that were submitted as part of larger writing or form letter campaigns and group them together. They also divide lengthier comments into parts and match them with the sections of a rule that would change if the agency were to adopt the comments’ recommendations. This process allows staff members, who are responsible for specific sections of a rule according to their expertise, to more readily respond to relevant comments.

Agencies must consider all “relevant matter presented” during the comment period, and they must respond in some form to all comments received. However, they are not required to take any specific action with regard to the rule itself.

Agencies take public comments seriously, and particularly respond to new data and analyses raised in public comments that weren’t included in the agency’s original analyses during rule development. This responsiveness ensures that regulations benefit from the collective knowledge and experience of affected parties.

Step 6: Publishing the Final Rule

If the agency decides to issue a final rule, it develops the regulatory text along with a preamble explaining the rule’s basis and purpose and responding to all significant issues raised in the comments. The agency concludes the rulemaking by publishing the final rule and preamble in the Federal Register.

The notice must specify the rule’s effective date, which must be at least 30 days after publication in the Federal Register. For major rules as defined in the Congressional Review Act, the effective date must be at least 60 days after publication.

The publication of the final rule must include analyses of any relevant data or other materials submitted by the public and a justification of the form of the final rule in light of the comments the agency received. This requirement ensures transparency and accountability in the final decision-making process.

Public Participation: Your Voice in the Process

Public participation is not merely a procedural formality—it is a fundamental component of democratic governance that can meaningfully influence regulatory outcomes. Understanding how to participate effectively empowers citizens to shape the rules that govern their lives.

Why Public Comments Matter

Agencies are legally required to consider all substantive comments before finalizing a rule. While this does not mean every comment will lead to change, agencies must consider thoughtful, evidence-based feedback they receive. This legal obligation means that well-crafted comments can genuinely influence regulatory outcomes.

It’s important to understand that the number of comments alone does not determine an agency’s decision. Quality matters more than quantity. Comments that provide new data, identify unintended consequences, offer practical alternatives, or present perspectives the agency had not considered are particularly influential.

How to Find Opportunities to Comment

Several resources help the public identify opportunities to comment on proposed regulations. The Federal Register, published every weekday, includes all proposed rules open for public comment. Additionally, Regulations.gov serves as a centralized portal where the public can search for proposed regulations, access supporting documents, and submit comments electronically.

Many advocacy organizations, trade associations, and professional groups monitor regulatory developments in their areas of interest and alert their members to comment opportunities. Subscribing to email alerts through Regulations.gov or following specific agencies can help you stay informed about regulations that matter to you.

Writing Effective Comments

Effective public comments share several characteristics. They clearly state a position early in the comment, provide specific reasoning and evidence to support that position, and address the substance of the proposed rule rather than making general statements.

Comments that include personal experiences grounded in facts and evidence can be particularly powerful. They demonstrate real-world impacts and help agencies understand how their proposals will affect actual people and businesses. Technical comments that provide new data, identify errors in the agency’s analysis, or suggest specific alternative approaches are also highly valued.

Comments can be brief or extensive, can address specific aspects of a proposed rule or the entire proposal, and can support or oppose the agency’s approach. The key is to provide substantive input that helps the agency make a more informed decision.

Submitting Your Comment

Most federal agencies accept comments through Regulations.gov, though some may also accept comments via email, fax, or postal mail. When submitting through Regulations.gov, you’ll need to provide basic identifying information including your name, city, state, and country. This information typically becomes part of the public record.

You can submit comments directly in a text box on the website or upload a document. The system accepts common file formats including Microsoft Word and PDF files. Be mindful of the comment deadline, as late submissions may not be considered.

Oversight and Additional Requirements

Beyond the basic APA requirements, additional layers of oversight and analysis apply to many regulatory actions, particularly those with significant economic or social impacts.

Executive Branch Review

By virtue of their constitutional role, U.S. presidents can try to influence specific regulatory proposals before their finalization. Within the Executive Office of the President is the Office of Information and Regulatory Affairs (OIRA), a federal subagency led by a presidential appointee that is widely viewed as working on the president’s behalf during the regulatory review process.

Executive orders, particularly Executive Order 12866 and Executive Order 13563, establish additional requirements for executive branch agencies. These orders require agencies to assess costs and benefits of significant regulatory actions, consider regulatory alternatives, and coordinate with other agencies to avoid conflicting or duplicative regulations.

Regulatory Impact Analysis

For economically significant rules—generally those with an annual effect on the economy of $100 million or more—agencies must prepare detailed regulatory impact analyses. These analyses examine the costs and benefits of the proposed rule and reasonable alternatives, helping ensure that regulations are cost-effective and necessary.

Regulatory impact analyses typically include assessments of direct costs to regulated entities, indirect costs to consumers or other parties, benefits in terms of health, safety, environmental protection or other goals, and distributional effects on different groups or sectors.

The Regulatory Flexibility Act

The Regulatory Flexibility Act requires agencies to consider the impact of their rules on small businesses, small governmental jurisdictions, and small nonprofit organizations. When a rule will have a significant economic impact on a substantial number of small entities, agencies must prepare a regulatory flexibility analysis exploring less burdensome alternatives.

Congressional Oversight

Congress maintains several mechanisms for overseeing agency rulemaking. The Congressional Review Act allows Congress to review and potentially disapprove major rules through a special expedited procedure. Additionally, congressional committees regularly hold hearings on agency regulations and can influence rulemaking through appropriations riders or new legislation.

Exceptions to Notice-and-Comment Requirements

While notice-and-comment rulemaking is the default procedure, the APA recognizes certain exceptions where these requirements do not apply. Understanding these exceptions helps explain why some agency actions proceed without public comment periods.

Statutory Exceptions

The APA exempts certain categories of rules from notice-and-comment requirements. These include rules involving military or foreign affairs functions, matters relating to agency management or personnel, and rules concerning public property, loans, grants, benefits, or contracts. Courts interpret these exceptions narrowly to preserve public participation opportunities.

Procedural and Interpretive Rules

Agencies can issue procedural rules, interpretive rules, and general statements of policy without following notice-and-comment procedures. Procedural rules govern an agency’s internal operations without substantially affecting regulated parties. Interpretive rules explain how an agency understands existing statutes or regulations without creating new legal obligations. General policy statements announce an agency’s tentative intentions without binding the agency or regulated parties.

The distinction between these exempt categories and legislative rules that require notice and comment can be subtle and is often contested in court. Courts apply functional tests to determine whether a rule creates new rights or obligations, in which case notice and comment is required.

Good Cause Exception

The APA allows agencies to skip notice-and-comment procedures when they find “good cause” that these procedures are “impracticable, unnecessary, or contrary to the public interest.” Agencies must explain their good cause determination, and courts review these explanations skeptically to prevent abuse of this exception.

Good cause might exist in emergency situations requiring immediate action, when the rule is a minor technical amendment unlikely to generate meaningful comment, or when notice and comment would defeat the rule’s purpose (such as rules addressing tax loopholes that would be exploited if publicly announced in advance).

Implementation and Enforcement

Once a rule becomes effective, agencies shift from rulemaking to implementation and enforcement. This phase determines whether regulations achieve their intended purposes and how they affect regulated parties in practice.

Compliance Assistance

Many agencies provide guidance to help regulated parties understand and comply with new requirements. This assistance may include interpretive guidance documents, compliance manuals, training sessions, webinars, and direct consultation with agency staff. While these guidance documents do not have the force of law, they help clarify regulatory expectations and promote consistent compliance.

Monitoring and Inspections

Agencies use various methods to monitor compliance with their regulations. These may include routine inspections, required reporting by regulated entities, complaint investigations, and data analysis. The frequency and intensity of monitoring typically depend on the risks involved and the resources available to the agency.

Enforcement Actions

When agencies identify violations, they have several enforcement tools available. These range from informal measures like warning letters and compliance conferences to formal actions including administrative penalties, civil lawsuits, and in some cases, criminal prosecutions. Many agencies follow graduated enforcement approaches, reserving severe penalties for serious or repeated violations while using education and assistance for minor or first-time violations.

Petitions for Reconsideration

After a rule is finalized, interested parties can petition the agency to reconsider or amend the rule. These petitions must typically present new information or arguments not previously considered. While agencies are not required to grant these petitions, they must respond to them, and sometimes petitions lead to new rulemaking proceedings to modify problematic provisions.

Judicial Review of Agency Rules

The courts play a crucial role in ensuring that agencies follow proper procedures and act within their legal authority when making rules. Understanding judicial review helps explain the checks and balances that constrain agency power.

Standing and Timing

To challenge a rule in court, a party must have standing—meaning they must show that the rule causes them concrete injury that a court decision could remedy. Challenges to rules are typically brought after the rule is finalized but before it is enforced, though some challenges arise in the context of enforcement actions.

Procedural Review

Courts review whether agencies followed required procedures, including providing adequate notice, allowing meaningful opportunity for comment, and responding to significant comments. Procedural violations can lead courts to vacate rules and require agencies to repeat the rulemaking process correctly.

Substantive Review

Courts also review the substance of agency rules under the “arbitrary and capricious” standard. This deferential standard asks whether the agency examined relevant data, articulated a rational connection between facts and the decision made, and considered important aspects of the problem. Courts do not substitute their judgment for the agency’s but ensure that the agency’s decision-making process was reasonable and well-supported.

Chevron Deference

When reviewing an agency’s interpretation of an ambiguous statute it administers, courts traditionally applied Chevron deference, upholding reasonable agency interpretations even if the court might have interpreted the statute differently. This doctrine recognized agencies’ expertise and the political accountability of executive branch decision-making. However, the application and scope of Chevron deference has evolved over time and remains an important area of administrative law.

State and Local Rulemaking

While this article focuses primarily on federal rulemaking, state and local agencies also create regulations that significantly affect daily life. Many states have adopted their own administrative procedure acts modeled on the federal APA, though with variations reflecting state-specific concerns and priorities.

State Administrative Procedure Acts

State APAs generally require notice and comment procedures similar to federal requirements, though details vary. Some states require longer comment periods, mandatory public hearings, or more extensive economic impact analyses than federal law requires. Understanding your state’s specific procedures is important for effective participation in state-level rulemaking.

Local Regulations

Local governments—cities, counties, and special districts—also create regulations affecting land use, building codes, public health, and many other areas. Local rulemaking procedures vary widely depending on local charters, state law requirements, and local traditions. Many local governments hold public hearings before adopting new regulations, providing opportunities for community input.

Current Challenges and Reforms

The regulatory system faces ongoing challenges and debates about how to improve its effectiveness, efficiency, and democratic legitimacy.

Regulatory Delay

The rulemaking process can be time-consuming, sometimes taking years from initial proposal to final rule. This delay can be problematic when urgent action is needed to address emerging threats or when regulated parties face prolonged uncertainty. Efforts to streamline rulemaking must balance speed with the need for thorough analysis and meaningful public participation.

Complexity and Accessibility

Regulatory proposals and supporting analyses can be highly technical and difficult for non-experts to understand. This complexity can limit effective public participation, particularly by individuals and small organizations lacking resources to hire experts. Agencies increasingly use plain language summaries and other tools to make regulatory information more accessible, but challenges remain.

Digital Participation

The shift to electronic rulemaking through platforms like Regulations.gov has made participation more convenient in many ways, but also raises questions about digital divides and the quality of online comments. Agencies continue to refine their approaches to electronic rulemaking to maximize both accessibility and the usefulness of public input.

Regulatory Reform Proposals

Various proposals seek to reform the regulatory process. Some advocate for stricter cost-benefit requirements, sunset provisions requiring periodic review of existing rules, or enhanced congressional oversight. Others emphasize improving public participation, increasing transparency, or ensuring that regulations adequately protect public health and safety. These debates reflect different views about the proper role and scope of regulation in society.

The Importance of Informed Participation

Regulatory agencies make decisions every day that affect public health, safety, economic opportunity, and quality of life. The rulemaking process provides structured opportunities for public participation in these decisions, but effective participation requires understanding how the system works.

By learning about the rulemaking process, identifying regulations that matter to you, and submitting thoughtful comments, you can help ensure that regulations reflect diverse perspectives and real-world impacts. Whether you’re a business owner concerned about compliance costs, a community advocate focused on environmental protection, a worker interested in safety standards, or simply a citizen who wants government to work better, your voice can make a difference in the regulatory process.

The Administrative Procedure Act and the notice-and-comment process it establishes represent a remarkable achievement in democratic governance—a system that requires powerful government agencies to explain their decisions, listen to affected parties, and justify their actions based on evidence and reasoned analysis. While the system is not perfect, it provides meaningful opportunities for participation and accountability that are essential to legitimate governance in a complex modern society.

Resources for Further Engagement

Several resources can help you stay informed about regulatory developments and participate effectively in the rulemaking process:

  • Regulations.gov – The primary portal for finding proposed federal rules and submitting comments online
  • Federal Register – The official daily publication containing all proposed and final federal rules
  • Agency websites – Most agencies maintain dedicated rulemaking pages with information about current and planned regulatory actions
  • Unified Agenda of Federal Regulatory and Deregulatory Actions – A semi-annual publication listing regulations that agencies are developing or reviewing
  • Congressional Research Service reports – Detailed analyses of administrative law topics available through Congress.gov
  • Public interest organizations – Many advocacy groups monitor regulatory developments in specific areas and provide alerts and analysis to their members

Key Takeaways

Understanding how regulatory agencies make rules empowers you to participate in decisions that affect your life. The rulemaking process, governed by the Administrative Procedure Act, requires agencies to provide public notice of proposed rules, accept and consider public comments, and explain their final decisions. This transparent process ensures accountability and allows diverse voices to influence regulatory outcomes.

Public participation is not merely symbolic—agencies are legally required to consider substantive comments, and well-crafted input can genuinely influence regulatory decisions. Whether you’re concerned about specific regulations affecting your industry, community, or personal interests, or simply want to understand how government works, engaging with the rulemaking process is an important form of civic participation.

The regulatory system balances multiple goals: protecting public health and safety, promoting economic efficiency, ensuring fairness, and maintaining democratic accountability. While debates continue about how best to achieve these goals, the fundamental framework of notice-and-comment rulemaking provides a foundation for informed, participatory governance that serves the public interest.

For more information about administrative law and the rulemaking process, visit the Administrative Conference of the United States, which provides extensive resources and recommendations for improving federal administrative procedures. You can also explore Regulations.gov to find current opportunities to comment on proposed federal rules, or review the Federal Register for comprehensive information about all federal regulatory actions.