Table of Contents
Government agencies serve as the backbone of regulatory governance in the United States, creating and enforcing rules that touch nearly every aspect of modern life. From the food we eat to the air we breathe, from workplace safety standards to financial protections, federal regulations shape the landscape of public health, safety, and welfare. Understanding how these agencies develop regulations is essential for citizens, businesses, and organizations seeking to navigate the complex world of administrative law and participate meaningfully in the democratic process.
The Foundation of Federal Rulemaking
The Administrative Procedure Act (APA) governs the process by which federal agencies develop and issue regulations. Enacted in 1946, this landmark legislation established a framework designed to ensure transparency, accountability, and public participation in the regulatory process. Rulemaking is the “agency process for formulating, amending, or repealing a rule,” and it represents one of the most significant ways that federal agencies exercise their delegated authority.
By delegating authority to administrative agencies to write and enforce regulations that have the force and effect of law, Congress provides federal agencies with considerable power. This delegation occurs because Congress recognizes that it cannot possibly address every technical detail required to implement complex public policies. Instead, Congress passes statutes that establish broad policy objectives and then authorizes agencies with specialized expertise to fill in the details through rulemaking.
Why Congress Delegates Rulemaking Authority
The delegation of rulemaking authority to administrative agencies serves several important purposes. This can be useful for Congress, which is responsible for establishing policy in a wide range of issue areas and does not necessarily have the same depth of expertise that agencies may have. Agencies employ scientists, engineers, economists, and other specialists who possess the technical knowledge necessary to develop detailed regulations in their respective fields.
Delegating authority to agencies can enable Congress to focus on “big picture” issues rather than spending its time and resources debating all the technical details required to fully implement a complex public policy. This division of labor allows for more efficient governance, with Congress setting policy direction and agencies handling implementation specifics.
However, this delegation also comes with important checks and balances. Even after delegating rulemaking authority to agencies, Congress retains its general legislative power, which gives it the ability to conduct oversight, modify or repeal regulations, and amend agencies’ underlying statutory authority. This ensures that agencies remain accountable to elected representatives and, by extension, to the American people.
Understanding Notice-and-Comment Rulemaking
Most regulations are created via a rulemaking procedure described in §553 of the APA that is referred to as “informal rulemaking” or “notice-and comment rulemaking.” In general, this process consists of 3 basic steps. This procedure has become the standard method for federal agencies to create new rules and modify existing ones, balancing the need for expert decision-making with democratic participation.
Informal rulemaking is the most common process through which administrative agencies make rules. It is also referred to as notice-and-comment rulemaking. The term “informal” distinguishes this process from formal rulemaking, which requires trial-like hearings and is rarely used today.
Step One: Notice of Proposed Rulemaking
The rulemaking process begins when an agency identifies a need for regulation. This need might arise from a congressional mandate, a petition from the public, emerging scientific evidence, or the agency’s own assessment of issues within its jurisdiction. Once the agency decides to pursue rulemaking, it must provide public notice of its intentions.
Section 553 of the APA requires that an agency generally must first provide notice that it intends to promulgate a rule. An agency does this by publishing a notice of proposed rulemaking in the Federal Register. The Federal Register is the daily publication for Rules, Proposed Rules, and Notices of the Federal Government. This publication serves as the official journal of the federal government, ensuring that proposed regulations receive wide dissemination.
The notice must provide (1) the time, place, and nature of the rulemaking proceedings; (2) a reference to the legal authority under which the rule is proposed; and (3) either the terms or subject of the proposed rule. These requirements ensure that interested parties have sufficient information to understand what the agency proposes and to prepare meaningful comments.
This also usually includes a “preamble” describing the purpose of the rule and what the agency hopes to accomplish by its promulgation. The preamble provides crucial context, explaining the problem the agency seeks to address, the regulatory approach it has chosen, and the expected benefits and costs of the proposed rule.
Step Two: Public Comment Period
After publishing the notice of proposed rulemaking, agencies must allow time for public input. The agency must then allow “interested persons an opportunity” to comment on the proposed rule. This comment period represents a critical opportunity for democratic participation in the regulatory process.
Federal law requires government agencies to allow at least 30 days after publication for the public to submit “written data, views, or arguments” regarding a proposed rule. However, many agencies provide longer comment periods, particularly for complex or controversial rules. 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 or that the agency did not receive as much feedback as it would like.
Many agencies give several options for submitting comments, including U.S. mail, private courier, email, and the official federal electronic comment portal: Regulations.gov. This electronic portal has revolutionized public participation, making it easier than ever for citizens to engage with the rulemaking process. Anyone can submit comments—from individual citizens to large corporations, from advocacy organizations to state and local governments.
The comments submitted during this period can vary widely in scope and sophistication. These comments can be simple or contain detailed arguments. Some commenters might submit brief statements of support or opposition, while others provide extensive technical analyses, economic data, or legal arguments. All comments become part of the official rulemaking record and must be considered by the agency.
Step Three: Final Rule Publication
After the comment period closes, agencies face the important task of reviewing and responding to the input they received. Agencies must consider all “relevant matter presented” during the comment period, and they must respond in some form to all comments received. They are not, however, required to take any specific action with regard to the rule itself.
The agency is not required to include in the final rule a response to every comment received. Instead, the agency is obligated only to respond to what the courts have characterized as “significant” comments. This requirement ensures that agencies take public input seriously while recognizing that they cannot address every individual submission in detail.
After receiving comments, the agency must publish a Notice of Final Rulemaking in the Federal Register. This notice must again state the reasons why the agency is creating or amending the rule and respond to comments received during the public comment period. The final rule publication includes both the regulatory text that will be codified in the Code of Federal Regulations and a preamble explaining the agency’s decisions.
The APA requires most rules to have a 30-day delayed effective date. This delay gives regulated parties time to prepare for compliance with the new requirements. However, agencies can implement rules immediately in certain circumstances, such as when they provide benefits or when delay would be contrary to the public interest.
The Pre-Rulemaking Phase
While the formal notice-and-comment process represents the core of rulemaking, significant work occurs before an agency publishes a proposed rule. Understanding this pre-rulemaking phase provides insight into how regulatory ideas develop and mature.
Identifying the Need for Regulation
Agencies identify potential rulemaking topics through various channels. Congressional statutes often mandate that agencies develop regulations by specific deadlines. Court decisions may require agencies to address regulatory gaps or revise existing rules. Petitions from members of the public can also trigger rulemaking proceedings.
If an agency receives a “Petition for Rulemaking” from a member of the public, it may decide to announce the petition in the Federal Register to solicit additional input. This mechanism allows citizens and organizations to formally request that agencies consider new regulations or modify existing ones.
Agencies also conduct their own research and monitoring to identify emerging issues. information through unstructured processes and informal conversations with people and organizations interested in the issues. This informal information gathering helps agencies understand stakeholder perspectives and potential regulatory approaches before committing to a formal proposal.
Advance Notice of Proposed Rulemaking
For particularly complex or novel regulatory issues, agencies sometimes publish an Advance Notice of Proposed Rulemaking (ANPRM) before developing a formal proposal. An agency might publish a preliminary notice, in which it describes its objective and initial findings, in order to obtain input from interested parties before drafting the proposed rule.
This additional step allows agencies to test ideas, gather data, and understand stakeholder concerns before investing significant resources in drafting a detailed proposed rule. It can lead to better-informed regulations and help agencies avoid proposing rules that would face insurmountable practical or legal obstacles.
Regulatory Planning and Agenda
Agencies are required to publish a “Regulatory Plan” once a year in the fall and an “Agenda of Regulatory and Deregulatory Actions” in the spring and fall. These documents provide transparency about agencies’ regulatory priorities and upcoming actions, allowing interested parties to anticipate and prepare for potential rulemakings.
The Unified Agenda, as it is commonly known, lists regulations under development, including those in the pre-rule stage, those at the proposed rule stage, and those at the final rule stage. This advance notice helps businesses plan for compliance, allows advocacy groups to prepare comments, and enables Congress to conduct oversight of agency activities.
Alternative Rulemaking Procedures
While notice-and-comment rulemaking represents the standard approach, agencies sometimes use alternative procedures depending on statutory requirements or the nature of the regulation.
Formal Rulemaking
Formal rulemaking, which requires a hearing on the record with the presentation of evidence, similar to a courtroom proceeding; and informal rulemaking, which requires notice to the public and the opportunity to comment on the proposed rule. Formal rulemaking typically takes place when specifically required by the statute authorizing the rule.
Formal rulemaking is appropriate in two cases: (1) where a statute provides that rules are “required to be made on the record after opportunity for an agency hearing”; and (2) in rulemakings that involve adjudicative facts, or facts specific to the rights of an individual. This process is much more time-consuming and expensive than informal rulemaking, which is why Congress rarely requires it and agencies avoid it when possible.
Hybrid Rulemaking
In providing rulemaking authority to an agency, Congress may direct the agency to follow specific procedural requirements in addition to those required by the informal rulemaking procedures of the APA. These hybrid procedures typically fall somewhere between informal and formal rulemaking, adding requirements such as oral hearings or limited cross-examination opportunities while stopping short of full trial-type proceedings.
Direct Final Rulemaking
For non-controversial rules that are expected to receive broad support, agencies sometimes use direct final rulemaking. In this process, the agency publishes a rule as final but states that it will withdraw the rule if it receives adverse comments. If adverse comments are submitted, the agency is required to withdraw the direct final rule before the effective date. The agency may re-start the process by publishing a conventional proposed rule or decide to end the rulemaking process entirely.
Negotiated Rulemaking
The Negotiated Rulemaking Act of 1990 outlines the framework for the procedure, and Congress occasionally mandates its use when passing a law. However, due to the difficulty of incorporating the views of diverse groups of stakeholders, agencies do not often pursue negotiated rulemaking. This approach brings together representatives of affected interests to negotiate the terms of a proposed rule before it is formally published, potentially reducing conflict and improving the quality of regulations.
Exceptions to Notice-and-Comment Requirements
The APA recognizes that not all agency actions require the full notice-and-comment process. Several exceptions allow agencies to bypass these procedures in specific circumstances.
Categorical Exceptions
The APA identifies several exceptions to the notice and comment requirements: Rules relating to “military or foreign affairs function[s]”; Rules relating to “agency management or personnel”; Rules relating to “public property, loans, grants, benefits, or contracts”; Interpretive rules, meaning rules that interpret an existing statute or rule; These exceptions recognize that certain types of rules either do not significantly affect the public or involve matters where public comment would be impractical or inappropriate.
Interpretive rules and policy statements deserve special mention. These documents explain how an agency understands existing law or how it intends to exercise its discretion, but they do not create new legal obligations. Because they do not have the binding force of legislative rules, they are exempt from notice-and-comment requirements.
Good Cause Exception
When the agency finds for good cause that the notice and comment process is impracticable, unnecessary, or contrary to the public interest. This exception allows agencies to act quickly in emergencies or other situations where delay would cause harm. However, courts scrutinize invocations of this exception carefully to prevent abuse.
The agency’s own delay cannot bring about good cause that the notice and comment process is impracticable, unnecessary, or contrary to the public interest. This prevents agencies from creating artificial urgency through poor planning and then using that urgency to bypass public participation requirements.
The Role of Public Participation
Public participation stands as one of the cornerstones of the American regulatory system. The notice-and-comment process provides multiple opportunities for citizens, businesses, advocacy groups, and other stakeholders to influence regulatory outcomes.
Who Can Participate
The rulemaking process is remarkably open and democratic. Anyone can submit comments on a proposed rulemaking. This includes individuals, businesses of all sizes, trade associations, labor unions, public interest groups, state and local governments, foreign governments, and international organizations. No special standing or qualification is required—if you have an interest in a proposed rule, you have the right to comment.
How to Submit Effective Comments
While anyone can comment, the quality and substance of comments matter. Agencies must respond to “significant” comments, which typically means comments that raise important issues, provide relevant data or analysis, or identify potential problems with the proposed approach. Effective comments often include:
- Specific references to provisions of the proposed rule
- Clear explanations of how the rule would affect the commenter
- Data, studies, or other evidence supporting the commenter’s position
- Concrete suggestions for improving the rule
- Identification of unintended consequences or implementation challenges
Comments that simply express general support or opposition without providing reasoning or evidence are less likely to influence the final rule, though agencies must still consider them as part of the record.
The Rulemaking Docket
The rulemaking docket is the electronic file in which the Commission places all of the rulemaking documents it issues (e.g., the NPRM, any extensions of comment periods, and final rules), supporting documents that it prepares, and public comments, replies, and ex parte presentations related to the rulemaking. This docket provides transparency, allowing anyone to see what information the agency considered and what arguments different parties made.
The public nature of the docket serves multiple purposes. It allows commenters to see what others have said and potentially respond to those arguments. It provides a record for judicial review if the final rule is challenged in court. And it promotes accountability by making the agency’s decision-making process visible to the public and to Congress.
Regulatory Analysis and Review
Before finalizing major regulations, agencies must conduct various analyses to assess the impacts and justify their decisions. These analytical requirements add rigor to the rulemaking process and help ensure that regulations are well-considered and cost-effective.
Cost-Benefit Analysis
Executive orders issued by presidents of both parties have required agencies to conduct cost-benefit analyses for economically significant regulations. In addition, the agency may be required to analyze a proposed rule’s impact on: small businesses; state, local and tribal governments; families; federalism. It may also need to analyze issues of just compensation and unfunded mandates.
These analyses require agencies to quantify, to the extent possible, both the costs and benefits of proposed regulations. Costs might include compliance expenses for businesses, administrative costs for government, and economic impacts such as reduced employment or higher prices. Benefits might include lives saved, illnesses prevented, environmental improvements, or economic efficiencies gained.
Office of Information and Regulatory Affairs Review
For significant regulations, agencies must submit their proposed and final rules to the Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget for review. This centralized review process ensures coordination across the executive branch and provides an additional check on regulatory quality.
After a rule is drafted, it undergoes the centralized review process described in Section III. Once this process is complete, the rule is published in the Federal Register as a notice of proposed rulemaking (NPRM). OIRA review can result in changes to proposed rules, though the extent and nature of these changes are not always transparent to the public.
Small Business Impact Analysis
The Regulatory Flexibility Act requires agencies to consider the impact of regulations on small businesses and, when possible, to adopt regulatory approaches that minimize burdens on small entities. This might involve exempting small businesses from certain requirements, providing longer compliance deadlines, or adopting performance standards rather than prescriptive requirements.
Implementation and Enforcement of Final Rules
Once a rule is finalized and published, it becomes part of the Code of Federal Regulations and has the force and effect of law. However, the agency’s work does not end with publication—effective implementation and enforcement are crucial to achieving regulatory objectives.
Codification in the Code of Federal Regulations
Rules that are immediately effective are integrated into the “Electronic Code of Federal Regulations” (e-CFR) database (ecfr.gpoaccess.gov). Rules with delayed effective dates are placed in amendment files and linked from the main e-CFR database. The e-CFR is an unofficial, but authoritative editorial compilation published by the Office of the Federal Register and GPO.
The Code of Federal Regulations is organized by subject matter into 50 titles, each covering a broad area of regulation. Within each title, regulations are further divided into chapters, parts, and sections. This systematic organization makes it easier for regulated parties to find applicable requirements and understand their obligations.
Compliance and Enforcement Mechanisms
Agencies employ various tools to ensure compliance with regulations. These may include:
- Inspections and audits: Many agencies conduct regular inspections of regulated facilities or review records to verify compliance
- Reporting requirements: Regulations often require entities to submit periodic reports demonstrating compliance
- Certification programs: Some regulatory schemes require certification or licensing before entities can engage in regulated activities
- Civil penalties: Agencies can impose monetary fines for violations, with amounts often calibrated to the severity of the violation
- Criminal prosecution: For serious violations, agencies may refer cases to the Department of Justice for criminal prosecution
- Injunctive relief: Agencies can seek court orders requiring violators to cease unlawful conduct or take corrective action
Effective enforcement requires adequate resources, clear standards, and consistent application. Agencies must balance the need to deter violations with the recognition that some violations may be inadvertent or technical in nature.
Guidance Documents and Compliance Assistance
To help regulated parties understand and comply with regulations, agencies often issue guidance documents, frequently asked questions, and other compliance assistance materials. These documents do not have the force of law but provide helpful explanations of how agencies interpret and apply regulations.
Many agencies also operate compliance assistance programs, offering training, technical assistance, and consultation services to help businesses and other regulated entities meet their obligations. These programs recognize that voluntary compliance is often more effective and efficient than enforcement actions.
Judicial Review of Agency Rules
The rulemaking process does not necessarily end when an agency publishes a final rule. Parties adversely affected by regulations can challenge them in federal court, providing an important check on agency power.
Grounds for Judicial Review
A court may vacate an agency rule if the agency acted (1) arbitrarily or capriciously, (2) in excess of statutory authority, (3) contrary to a constitutional right, or (4) in violation of procedures required by statute. These standards ensure that agencies act within their legal authority and follow proper procedures while giving them appropriate deference on matters within their expertise.
The “arbitrary and capricious” standard is the most common basis for challenging rules. Under this standard, courts examine whether the agency considered relevant factors, explained its reasoning, and made a rational connection between the facts found and the choices made. Courts will not substitute their judgment for the agency’s, but they will ensure that the agency engaged in reasoned decision-making.
The Importance of the Rulemaking Record
When reviewing agency rules, courts typically limit themselves to the administrative record—the documents, comments, and analyses that were before the agency when it made its decision. This makes the rulemaking record crucial. Agencies must ensure that the record contains adequate support for their decisions and that they have responded to significant comments and concerns raised during the public comment period.
Remedies for Unlawful Rules
If a court finds that an agency violated the APA or other legal requirements, it may vacate the rule entirely, vacate specific provisions, or remand the rule to the agency for further consideration. Under the APA, a court may compel any agency action that is unreasonably delayed or unlawfully withheld. This provision allows parties to sue agencies that fail to complete required rulemakings within reasonable timeframes.
Congressional Oversight and the Congressional Review Act
Congress maintains several mechanisms for overseeing agency rulemaking and, when necessary, reversing regulatory decisions.
The Congressional Review Act
The Congressional Review Act (CRA) allows Congress to overturn agency rules through a resolution of disapproval. Under this statute, agencies must submit final rules to Congress before they can take effect. Congress then has a limited time period to pass a resolution disapproving the rule. If such a resolution passes both houses and is signed by the President (or if Congress overrides a presidential veto), the rule is nullified and the agency is prohibited from issuing a substantially similar rule without new statutory authorization.
The CRA provides a streamlined process with special procedural rules that make it easier to bring disapproval resolutions to a vote. However, it is used relatively rarely, as it requires agreement between both houses of Congress and the President (or sufficient votes to override a veto).
Other Oversight Mechanisms
Beyond the CRA, Congress exercises oversight through hearings, investigations, and budget controls. Congressional committees regularly hold hearings on agency rulemakings, questioning agency officials about their decisions and the evidence supporting them. Congress can also use appropriations riders to prohibit agencies from using funds to implement or enforce specific regulations.
Ultimately, Congress can amend the underlying statutes that authorize regulations, either to overturn specific rules or to change the framework within which agencies operate. This legislative power provides the most fundamental check on agency rulemaking.
Challenges and Criticisms of the Rulemaking Process
While the notice-and-comment process has served as the foundation of federal rulemaking for over 75 years, it faces various challenges and criticisms.
Concerns About Regulatory Capture
Some critics worry that well-resourced industry groups have disproportionate influence over rulemaking outcomes. These groups can afford to submit extensive comments, hire expert consultants, and maintain ongoing relationships with agency officials. This may give them advantages over less-organized public interest groups or individual citizens.
However, the transparency of the rulemaking process provides some protection against capture. All comments become part of the public record, and agencies must explain their decisions in ways that respond to the full range of input received. Courts review agency decisions to ensure they are not arbitrary or based on improper considerations.
Delays and Ossification
The rulemaking process can be time-consuming, sometimes taking years from initial proposal to final rule. The multiple layers of analysis, review, and public comment, while valuable for ensuring quality and legitimacy, can slow agency responses to emerging problems. Some scholars worry about “ossification” of the rulemaking process—the concern that procedural requirements have become so burdensome that agencies avoid rulemaking even when new regulations would be beneficial.
Accountability Concerns
Unlike Members of Congress, agency personnel and officials who write regulations are not directly accountable to the electorate. This raises questions about democratic legitimacy. However, agencies are accountable through multiple channels: presidential appointment and removal of agency heads, congressional oversight and appropriations, and judicial review of agency actions.
The Future of Rulemaking
As technology evolves and society faces new challenges, the rulemaking process continues to adapt.
Digital Participation
The rise of electronic comment submission through Regulations.gov has dramatically increased public participation in rulemaking. Thousands or even millions of comments can be submitted on controversial rules, though this raises questions about how agencies can meaningfully review and respond to such large volumes of input. Some agencies are experimenting with data analytics and artificial intelligence tools to help process and categorize comments.
Regulatory Innovation
Agencies are exploring new approaches to regulation that may be more flexible and adaptive than traditional prescriptive rules. Performance-based standards, regulatory sandboxes, and adaptive management approaches allow for experimentation and learning while still protecting public interests.
Transparency and Open Government
Initiatives to increase government transparency have led to greater public access to rulemaking information. Agencies increasingly make supporting documents, data, and analyses available online. Some agencies hold public meetings or webinars to explain proposed rules and answer questions, supplementing the traditional written comment process.
Practical Tips for Engaging with the Rulemaking Process
For citizens, businesses, and organizations interested in participating in rulemaking, several practical steps can increase the effectiveness of their engagement.
Stay Informed About Upcoming Rules
Monitor the Unified Agenda and agency websites to learn about upcoming rulemakings in areas of interest. Subscribe to agency email lists or RSS feeds to receive notifications about new proposed rules. Trade associations, advocacy groups, and professional organizations often track relevant rulemakings and alert their members.
Submit Substantive Comments
Focus on providing specific, evidence-based input rather than general statements of support or opposition. Explain how the proposed rule would affect you or your organization. Provide data, studies, or examples that support your position. Suggest concrete alternatives or modifications if you believe the proposed approach is flawed.
Engage Early in the Process
If an agency publishes an Advance Notice of Proposed Rulemaking or holds pre-proposal meetings, participate at this early stage. Input provided before the agency has committed to a specific approach may have more influence than comments submitted after a detailed proposal has been developed.
Build Coalitions
Consider coordinating with others who share your interests. Coalition comments that represent multiple organizations or constituencies may receive more attention than individual submissions. However, agencies also value diverse perspectives, so there is room for both coalition comments and individual submissions.
Follow Through
After submitting comments, monitor the docket to see what others have said and whether the agency requests additional information. When the final rule is published, review the preamble to see how the agency responded to your comments. If you believe the final rule is unlawful, consider whether legal challenge is appropriate.
Resources for Learning More
Numerous resources are available for those seeking to deepen their understanding of the rulemaking process:
- Regulations.gov: The official portal for finding and commenting on federal regulations
- Federal Register: The daily publication containing proposed and final rules, available at www.federalregister.gov
- Office of the Federal Register: Provides guides and resources explaining the rulemaking process
- Administrative Conference of the United States: An independent federal agency that studies administrative procedures and recommends improvements
- Congressional Research Service reports: Provide detailed analysis of rulemaking procedures and issues
Many law schools, think tanks, and advocacy organizations also publish guides, toolkits, and analyses related to rulemaking. Agency websites typically include information about their specific rulemaking procedures and opportunities for public participation.
Conclusion
The federal rulemaking process represents a remarkable achievement in administrative governance, balancing the need for expert decision-making with democratic accountability and public participation. Through the notice-and-comment process established by the Administrative Procedure Act, agencies develop detailed regulations that implement congressional mandates while providing opportunities for all interested parties to contribute their knowledge and perspectives.
Understanding how agencies make rules empowers citizens to participate more effectively in the democratic process. Whether you are a business owner concerned about compliance costs, an advocate for public health or environmental protection, or simply a citizen interested in how government works, the rulemaking process offers meaningful opportunities to influence decisions that affect daily life.
While the system faces challenges—from concerns about delay and complexity to questions about accountability and influence—it has proven remarkably durable and adaptable. As new technologies emerge and society confronts novel challenges, the fundamental principles of transparency, public participation, and reasoned decision-making that underlie the rulemaking process remain as important as ever.
By engaging with the rulemaking process, submitting thoughtful comments, and holding agencies accountable for their decisions, citizens can help ensure that federal regulations serve the public interest and reflect the diverse perspectives and values of American society. The rulemaking process is not merely a technical exercise in administrative law—it is a vital component of democratic governance that deserves our attention, participation, and continued refinement.