Federal Rulemaking 101

This explainer breaks down the mechanisms by which federal agencies are granted authority, issue regulations, and respond to public comments.

Date

Nov. 6, 2026

Publication

Explainer

Reading time

8 minutes

Introduction

Widespread deregulation under the second Trump administration has illuminated the role of federal agencies in implementing environmental policy. Agencies like the US Environmental Protection Agency (EPA), US Department of Energy, and US Department of the Interior set pollution limits, issue water-quality standards, and make decisions about federal lands. Staffed by experts, agencies are essential pieces of the policymaking process, translating congressional directives into real-world action.

Agencies are not staffed or run by elected officials, but through the regulatory process, agencies play a substantial role in governance. The power of agencies is heavily structured by a process outlined in § 553 of the Administrative Procedure Act of 1946, and an agency’s capacity to make and act on decisions relies on the functions the legislative branch delegates to that agency.

This explainer breaks down the mechanisms by which federal agencies are granted authority, issue regulations, and respond to public comments.

What Gives Federal Agencies Authority to Issue and Rescind Regulations?

When Congress passes legislation, it is not often practical to include the specifics needed to implement each law. One reason for this low specificity is that executing a law often requires expert knowledge of complex science or other technical elements which may be outside the scope of legislative offices. To ensure that laws are implemented properly, Congress regularly passes certain responsibilities to the executive branch, leaning on agencies to fill in details and create actionable plans to fulfill congressional intent.

For example, Congress stated in the Clean Air Act Amendments of 1970 that, to protect the right to healthy air quality, the government must set standards to decide how much pollution may be legally present in the air Americans breathe. However, Congress did not state exactly which pollutants must be regulated, nor to what level. Instead, it authorized EPA to identify pollutants that pose a risk to public health and decide what amounts of these substances may be present in the ambient air. In the text of the Clean Air Act, Congress explained what EPA must do to justify regulating a pollutant, thereby giving the agency authority to promulgate regulations under the act. The 1984 US Supreme Court decision Chevron USA, Inc. v. Natural Resources Defense Council, Inc. established judicial deference to agencies for interpreting Congressional intent. This precedent was overturned in the 2024 Supreme Court case Loper Bright Enterprises v. Raimondo.

In some cases, after the initial agency rulemaking required to implement a law, future regulation may also be needed to fulfill legislative requirements (e.g., the Clean Air Act requires regular reconsideration of air-pollutant lists), update rules according to new scientific data, respond to citizen lawsuits or petitions, or carry out executive directives (such as President Donald Trump’s executive order which instructed agencies to rescind 10 regulations for each new regulation they issue).

Steps to Informal Rulemaking

After Congress grants authority, agencies begin the steps to publish a rule, most commonly through the informal notice-and-comment process. (The formal rulemaking process requires a public hearing and occurs very rarely, typically when a statute explicitly calls for it.) The notice-and-comment rulemaking process is codified by the Administrative Procedure Act (APA) and has remained largely unchanged since the law’s passage in 1946. An executive order by President Ronald Reagan in 1981 centralized the regulatory review process under the Office of Management and Budget and required benefit-cost analyses for all major rules. The Congressional Review Act (CRA) in 1996 streamlined the process through which Congress can disapprove a final rule.

If a Rule Is Significant: The Office of Information and Regulatory Affairs Reviews a Proposed Rule

If a regulatory action is deemed significant by the rulemaking agency or the Office of Management and Budget’s Office of Information and Regulatory Affairs (OIRA), the agency must receive clearance from OIRA before it can publish a proposed rule. This requirement was established by Executive Order 12866, “Regulatory Planning and Review,” and applies to rules which are anticipated to result in one of the following:

  • an annual effect of either benefits or costs of at least $100 million
  • material and adverse effects on the environment or public health
  • inconsistencies with another agency’s actions
  • alterations of the benefits given to funding recipients
  • new policy issues

Under Executive Order 12866, OIRA review is intended to ensure that the benefits of a rule outweigh its costs, the action aligns with the priorities of the presidential administration, and the rule will not interfere with the functions of other agencies. OIRA chooses to approve the rule as submitted, clear the rule with recommended modifications, or suggest or mandate that the agency withdraw the rule. Aside from acting as the prime reviewer, OIRA also coordinates an interagency process to review regulations. Formal disapproval occurs very rarely; typically between zero and two agency rules are rejected by OIRA each year out of hundreds submitted for review.

Step 1. The Proposed Rule is Published and Opened for Public Comment

The first step of rulemaking mandated in the APA is that the agency must publish a notice of proposed rulemaking. The notice includes a summary description of the intended regulatory action, typically accompanied by specific questions about options or policy approaches the agency would like feedback on. Economically significant proposed rules (those that have an annual impact equal to or more than $100 million per year) also include a regulatory impact analysis, which provides estimates of the benefits and costs of the proposal. The notice is published in the Federal Register, a website that collects documents released daily by agencies and the Executive Office of the President.

Once an agency publishes the notice of proposed rulemaking, the public comment period begins. Anyone—including individuals and organizations, American citizens and noncitizens—may post a comment to the notice, either through an online submission or by mailing a comment to the agency’s office. The public comment period typically lasts 30, 60, or 90 days, and is sometimes extended in response to requests from commenters for more time to formulate comments.

A public hearing may also be scheduled, where commenters deliver oral responses to the proposed rule or discuss contentious related topics. Public hearings can be scheduled at an agency’s discretion and are sometimes mandated by law—such as when EPA issues changes to water quality standards under the Clean Water Act.

The notice of proposed rulemaking may be preceded by an optional advanced notice of proposed rulemaking, which solicits public feedback during the process of developing the proposed rule. The advanced notice allows for early integration of public and expert opinion in the decisionmaking process.

Step 2. The Agency Reviews Comments and Revises the Rule

After the public comment period closes, the agency is required to review all comments posted on the notice of proposed rulemaking and respond to those considered significant. The APA mandates that an agency incorporate a summary of issues raised by public comments in its final ruling. The agency’s response to significant public comments is included within the preamble of the final rule itself and sometimes elaborated on in a separate, public document.

If a Rule Is Significant: OIRA Reviews the Final Rule

After the agency has finalized the text of a significant rule, it will once again submit the rule to OIRA for review. This stage of review includes ensuring that the rule remains within the scope of its initial proposal and that the agency has adequately responded to public input. OIRA has 90 days to clear or withdraw a rule at this stage, but does have the option for an extension.

Step 3. The Agency Publishes the Final Rule

The final version of the rule is published in the Federal Register and set to go into effect after a certain period of time (no less than 30 days) to allow for affected individuals and organizations to prepare for the new regulation. In cases where the rule is making an exemption—for example, if the US Food and Drug Administration is lifting a ban on a food additive that was proven to be safe for consumption—or changing how an agency interprets a law without imposing a substantive obligation on affected parties, the rule may go into effect more quickly.

Step 4. Congress Has the Opportunity to Provide Oversight on the Final Rule

The CRA gives Congress the authority to review final regulations published by agencies. Within 60 session days of the submission of the final rule to the Federal Register, any member of Congress may propose a joint resolution of disapproval. The resolution is forwarded to the relevant congressional committee before proceeding through both chambers, like an item of legislation. In the Senate, such resolutions have rules to expedite their consideration, and the resolutions are not subject to the filibuster.

If the joint resolution of disapproval passes both the House and the Senate with a majority vote, the president has the opportunity to either sign or veto the resolution. If it is signed, the rule is invalidated and repealed or does not go into effect. A two-thirds majority vote in the Senate is required to override a veto. Once Congress passes a resolution of disapproval for a rule and it is signed by the president, the agency that issued it is permanently prohibited from ever promulgating a rule that is “substantially the same form” in the future, absent new congressional authorization.

The CRA was invoked only once between its passage in 1996 and President Trump’s first election in 2016. However, during Trump’s first term, Republicans in Congress used the CRA 16 times to invalidate Obama administration rules and policies. During President Joe Biden’s term, Congress invoked the CRA three times, marking the first time a Democratic president signed a joint resolution of disapproval.

During the first year of President Trump’s second term in office, Congress disapproved 22 agency rules using the CRA. The applicability of the CRA to some of these agency actions, such as the rejection of the federal waiver allowing California to issue strict vehicle emissions standards, was contested by the Government Accountability Office and instigated several lawsuits.

Step 5. The Final Rule Is Opened to Citizen Petitions for Modification or Repeal

After an agency submits a final rule and that rule has gone into effect, individuals and organizations may still interact with the agency through citizen petitions. The APA mandates that agencies recognize the right of any “interested persons” to petition an agency to issue, repeal, or modify a regulation.

Agencies do not have a standardized procedure for dealing with citizen petitions, so the process of handling these requests varies based on the governing body. As with public comments, an agency is required to consider all received petitions and respond with an explanation of its decision, even if it is to inform the petitioner that their request has been denied. Denials of citizen petitions may be challenged in court, giving the judicial system an opportunity to weigh in on whether the agency is obligated to make or rescind a rule.

A notable use of this citizen power occurred in 1999, when a group of organizations petitioned for EPA to regulate greenhouse gas emissions by new motor vehicles under the Clean Air Act. When EPA denied the petition, stating that the statute did not allow regulations focused on climate change and that insufficient evidence links greenhouse gases to warming global temperatures, the petitioners brought a lawsuit against EPA. Several states joined the ensuing legal battle, which traveled all the way to the US Supreme Court, where the 2003 Massachusetts v. EPA decision compelled EPA to institute the first federal regulations targeting greenhouse gas emissions.

After the Final Rule: Legal and Policy Response

After rules go into effect, they may be challenged on legal grounds or prompt federal, state, or local policy response. Controversial regulations are often followed by lawsuits from industry stakeholders, interest groups, and state governments for a variety of reasons. New pollution limits, for example, may prompt affected industries to sue if they can argue that the regulation forces the adoption of technology beyond the scope of the underlying statute, while removing effluent limits might cause state attorneys general to sue for damage to the environment from standards that were not sufficiently protective under the law. If judicial review finds a rule to be in conflict with (or an overreach of) an agency’s statutory authority, the rule will be overturned.

In cases of deregulation, the resulting void in federal rules may be filled in by policy at state and local levels. This infilling can create a patchwork of regulations, where the same action faces different consequences depending on the state.

How Are Research Institutions like Resources for the Future Involved in the Rulemaking Process?

Research institutions such as Resources for the Future (RFF) play multiple roles in the construction of, response to, and analysis of federal regulations. By providing analysis of policy, including estimates of the benefits and costs of regulation, RFF helps agencies craft informed and effective rules. For example, an effort led by RFF and the University of California, Berkeley, helped decisionmakers quantify the damage to the environment and public health done by greenhouse gas emissions.

RFF research can also identify policy priorities. RFF experts testify before Congress during the process of drafting and passing bills and participate directly in the rulemaking process by submitting comments to proposed rules posted in the Federal Register.

RFF frequently produces analyses of regulation and the models used to justify agency action, including through its If/Then series, which provides timely and accessible resources to understand the likely impacts of policy actions.

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