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Developing Regulations: From Start to Finish

When EPA identifies the potential need for a regulation, we form a workgroup to learn more. The workgroup is led by the EPA office that will be writing the regulation (i.e., the "lead office") and includes members from other parts of the Agency with related interests or responsibilities. The workgroup may work for months - employing expert scientists, economists, and other analysts - before an appropriate course of action is decided upon. The process generally goes like this:

1. Receive Commencement Approval. Before a workgroup starts to write a regulation, EPA's Regulatory Policy Officer (RPO) must authorize them to start work. EPA's RPO is the Deputy Administrator. Every federal agency must designate an RPO, as required by Executive Order 13422 (PDF) (3 pp, 600K, About PDF).

2. Analyze the Problem. The workgroup begins by developing a work plan that will guide the regulatory development process. This plan is called an Analytic Blueprint and outlines the major questions that must be answered, the data needed, the experts who should be consulted, the anticipated costs, and other rulemaking needs. EPA's senior management provides guidance on the Analytic Blueprint early in the process at a meeting called Early Guidance. After the Early Guidance meeting, the workgroup uses its Analytic Blueprint to begin studying the problem. We may draw information from EPA's research, scientific literature, other government agencies, or other researchers in the United States and abroad.

3. Identify Options. The workgroup then considers the available options for addressing the problem. This may require evaluating environmental technologies, changes in environmental management practices, and incentives that can motivate better environmental performance. The workgroup also takes related issues into account at this stage, such as the impact of various options on small businesses, on children's health, or on state and local governments. Sometimes the workgroup might find there is no need for regulation.

4. Publish a Proposal & Request Public Comments. If the preliminary analysis recommends the need for regulation, the workgroup drafts a proposed regulation for publication in the Federal Register. Experts from EPA, other federal agencies, advisory groups, and more help inform the proposed regulation.

The draft publication is called a Notice of Proposed Rulemaking (NPRM). A law called the Administrative Procedure Act (5USC Ch. 5) generally requires EPA (and other federal regulatory agencies) to request comments from the public before finalizing the regulation. The public comment period typically lasts 60 to 90 days. Federal Register notices related to the environment are available online from many Web sites, including this site.

At the same time we publish an NPRM, EPA will sometimes publish an Information Collection Request (ICR). The Paperwork Reduction Act (PDF) (23 pp, 122K, About PDF) requires all agencies to ensure that their regulations do not impose an undue paperwork burden on individuals, businesses, and others. Therefore, we seek approval of an ICR when our proposed regulations might require more than 10 members of the public to report similar information back to us. The public can comment on these ICRs just as they can the NPRMs. See EPA's ICR Web site for more information.

5. Review Public Comments. Next, the workgroup reviews and evaluates all the comments received. Depending on the regulation, these comments may range from recommendations for minimal change to extensive rewriting. The workgroup carefully weighs and evaluates the comments before developing a draft final regulation for review and approval by EPA senior management. All public comments and our responses are posted in the regulation's docket. (Learn more about how to comment and how to access dockets.)

6. Issue Regulation. After approval by senior management, the EPA Administrator or his delegee reviews the final regulation and decides whether it should be issued. If the Administrator decides to issue the regulation, it is published in the Federal Register. Effective dates vary. A regulation may be effective on the day it is published, for example, or it may be effective a year later. These dates are specified in every regulation. Congress may decide to overturn a regulation after the Administrator has issued it, but it rarely does.

7. Analyze Our Regulations. When a final regulation is issued, our work has just begun. After promulgation, we work with regulated businesses, governments, and non-profits to help them comply with the requirements. In some cases, enforcement actions are necessary. And, we analyze our regulations to make sure they are effective.

Occasionally there are additional steps in this process. For instance, the workgroup might decide to draft a notice seeking public comment and information before the proposal is even developed. This pre-proposal is called an Advanced Notice of Proposed Rulemaking and is also published in the Federal Register. Sometimes the workgroup receives new data from the public during a comment period, in which case we might publish in the Federal Register a Notice of Data Availability (NODA) so interested parties can learn more and submit additional comments. Finally, the workgroup might decide to take a new direction after receiving new data, which in some cases results in a Supplemental Notice of Proposed Rulemaking.

EPA has a central staff within the Administrator's Office to support all the regulations under development. The Office of Regulatory Policy and Management supports and monitors the status of regulatory workgroups, helps with Federal Register publication, and ensures that EPA is following the various laws and Executive Orders that govern how regulations are written.

Working with Other Federal Partners

Because EPA is part of the Executive Branch, we solicit the input of other federal departments and agencies when our regulations relate to their work. The White House's Office of Management and Budget (OMB) ensures rules are consistent with the Administration's environmental priorities and policies, and coordinates review by other federal agencies that might have an interest in the issue.

Generally, OMB coordinates reviews of regulations that could impose more than $100 million in annual costs on society, present controversial legal or policy issues, or require multi-agency input. Executive Order (EO) 12866 (PDF) (10 pp, 36K, About PDF) governs how the OMB review process operates. You may view the current and past regulations under EO12866 review at RegInfo.gov.

Cover of the Code of Federal Regulations, the book where all of EPA's regulations are published and codified.

Where to Look for Regulations

We publish all of our proposed regulations, final regulations, and notices in the Federal Register. All general and permanent regulations are then codified in the Code of Federal Regulations (CFR), which is maintained for all federal departments and agencies by the Government Printing Office (GPO). Known as the CFR, this compilation of government regulations is divided into 50 titles that represent topics of federal authority, such as education, transportation, and agriculture. Environmental regulations are mainly in Title 40: Protection of the Environment.

 

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