1. What is rulemaking?

    What is rulemaking? Learn about the process that helps make the law--and that you have the right to be part of.

Rulemaking is the process federal agencies use to make new regulations. These regulations (also called "rules") affect everything from the air we breathe and the food we eat, to the vehicles we drive and the roads we drive them on, to our health care and financial security. Congress passes the broad statutes that govern us, but most of the details are left to federal agencies to figure out through the rulemaking process.

Rulemaking can have different twists and turns, but this is the basic process for most important rules:

Getting legal authority

The lifecycle of a new regulation begins when Congress passes a statute giving the agency power to make rules to solve certain problems or reach certain goals.

Sometimes, the statute tells the agency exactly what those rules should say, and how quickly they have to be made. Or It might limit what the agency can do by requiring, or prohibiting, certain kinds of solutions.

Drafting the proposal

Many different people in the agency are likely to work on drafting the new regulation, including experts on the topic, economists, and lawyers. While the draft is being worked on, agency staff often get informal input from groups who will be affected. The agency might also hold public hearings. Or it might get the advice of a group of experts and stakeholders known as an "advisory committee."

Sometimes, the agency publishes an "Advance Notice of Proposed Rulemaking" (ANPRM) that outlines what it's working on and identifies important questions or areas where it needs more information. The idea is to get initial feedback and information from the public to help in drafting the proposal.

Predicting likely effects

The agency must also analyze the new regulation's likely impact. In the “Regulatory Impact Analysis” (RIA), the agency has to predict the total costs and benefits of the rule to those who would be directly affected by it and to society generally (usually, over a ten-year period).

The agency must also analyze likely impacts on the environment, small business and local governments, and privacy. The agency may hire outside consultants to write these analyses.

Drafting the explanation

Agency staff will draft a long explanation to go with the proposed new regulation. This explanation usually includes

    • what the agency is trying to do
    • why it thinks it has the legal authority to do this
    • the background of the proposal, including any steps that Congress, the agency itself, or other agencies have taken already
    • the studies, data or other information the agency has been using to draft the proposal
    • any questions the agency still has or additional information it wants
    • alternative approaches it is considering, or has rejected
    • a summary of the RIA and other analyses

    This explanation, together with the actual language of the proposed rule, is the draft Notice of Proposed Rulemaking (NPRM, or NPR for some agencies).

    White House review

    For most agencies, the draft NPRM and analyses must be sent for review to the Office of Information and Regulatory Affairs (OIRA) in the White House Office of Management and Budget (OMB). OIRA is supposed to make sure that the RIA reasonably estimates the costs and benefit. It also decides whether the proposed new regulation matches the President’s policy views.

    OIRA might ask for input from other agencies who work on related areas or problems. Often, it asks the agency to provide more information, revise the RIA, or make changes in the draft rule itself or the explanation.

    Some agencies (called "independent" agencies) don't have to get OIRA approval during rulemaking. You can see a list of independent agencies here.

    Publishing the proposal

    Once OIRA approves the NPRM (or, for an independent agency, once the draft NPRM is finished), the agency publishes it in the Federal Register. This is the place where the federal government gives people official notice of important new developments.

    Opportunity for public comment

    After the NPRM is published, the public has a certain period of time to comment on the proposed regulation, the agency's explanation, or the RIA and other analyses. A typical comment period is 60 days, but it could be shorter or much longer.

    During this time, any individual, group, corporation, or other organization can submit questions, concerns, ideas, data, and alternate proposals.

    Considering the comments

    The agency must consider every comment it receives. It will pay particular attention to comments that

      • contain new information or a new perspective
      • respond to specific questions the agency asked in the NPRM
      • offer different ideas on how the agency can accomplish the goals Congress told it to accomplish

      To learn more about writing comments that count, see What's effective commenting?

      Deciding what to do

      Once the agency has read and considered all the comments, it decides whether to go ahead with a final rule. The agency might adopt a final rule identical, or very similar, to the initial proposal, or it might make changes based on the comments. It might even decide to stop the rulemaking altogether.

      This process can take a few months, or even years.

      White House review (again)

      If the agency had to the send the draft NPRM to OIRA, it will also have to let OIRA review the final rule it wants to adopt.

      Publishing the final rule and explanation

      If the agency has decided to go ahead, it must publish the new regulation in the Federal Register. It must include a long explanation

      • describing the comments it received from the public
      • responding to major criticisms, concerns or questions commenters had
      • explaining why it decided on the particular rule it has published
      • discussing why alternative approaches wouldn't have been as good

      Opportunity for Congressional review

      New regulations generally can't take effect until at least 30 days after they have been published in the Federal Register. For major rules, there is a 60-day wait so that Congress has a chance to decide whether to prohibit the new regulation.

      A majority of both the House and the Senate must vote to keep a new regulation from taking effect and the President must agree. If the President does not agree, two-thirds of the members of both the House and the Senate must vote to prohibit the regulation.

      Possible challenge in court

      If someone affected by the new regulation believes that the agency

      • exceeded the power Congress gave it
      • failed to consider something important raised in the comments
      • made an unreasonable decision

      he/she may ask the federal courts to overturn the rule. It's very common for important rules to be challenged in court, sometimes by many different groups.


      Once a rule is final and becomes effective, it has as much legal authority as a statute. Violating it can result in fines, loss of licenses or certificates, and sometimes even jail.

      Especially with long, complicated regulations, the agency may have to explain what certain parts mean or what it will treat as a violation of the rule. These explanations are called "guidance." Agencies are supposed to make guidance documents available to the public on their websites.

      Changing a regulation

      In general, to change or repeal a regulation on the books, the agency must use the same process it used to make the rule in the first place.

      Anyone can petition the agency to change or repeal any rule.