Legal Definitions - informal rulemaking

Informal Rulemaking, also widely known as notice-and-comment rulemaking, is the most common method used by administrative agencies in the United States to create new regulations or modify existing ones. This process is designed to be transparent and allow for public participation, ensuring that agency rules are well-considered and reflect diverse perspectives.

The procedures for informal rulemaking are outlined in the Administrative Procedure Act (APA). When an agency decides to create a new rule, it typically follows these steps:

• Public Notice: The agency first publishes a "notice of proposed rulemaking" in the Federal Register, which is the official daily publication for rules, proposed rules, and notices of federal agencies. This notice informs the public about the proposed rule, its purpose, and the legal authority for its creation.
• Comment Period: After publishing the notice, the agency opens a period, usually at least 30 days, during which interested individuals, organizations, and businesses can submit written comments on the proposed rule. These comments can express support, opposition, suggest changes, or provide data and arguments for the agency to consider.
• Consideration of Comments: The agency is legally required to review and consider all relevant comments received during the comment period. While the agency doesn't have to adopt every suggestion, it must genuinely take the feedback into account.
• Final Rule Publication: After considering the comments, the agency publishes the final rule in the Federal Register. This publication includes a "concise general statement of their basis and purpose," explaining the rationale behind the rule and how the agency addressed significant comments received. The final rule then becomes legally binding.

Examples of Informal Rulemaking:

• Environmental Protection Agency (EPA) Setting New Emissions Standards: Imagine the EPA proposes a new regulation to reduce greenhouse gas emissions from power plants. The agency would first publish a detailed notice in the Federal Register, explaining the proposed emission limits, the scientific basis for them, and the expected environmental benefits. Environmental advocacy groups, energy companies, utility providers, and even individual citizens would then submit comments. Some might argue for stricter limits, while others might raise concerns about economic impact or technological feasibility. The EPA would review these diverse comments, potentially adjusting the proposed limits or implementation timelines based on the feedback. Finally, the agency would publish the definitive new emissions standards, along with a statement explaining its decision and how it considered the public input.

  This illustrates informal rulemaking because the EPA provided public notice of a proposed rule, allowed a period for interested parties to submit comments, considered those comments, and then published a final, legally binding regulation with an explanation of its basis.

• Food and Drug Administration (FDA) Updating Food Labeling Requirements: Suppose the FDA decides to update the nutritional information required on packaged food labels to include a new category, such as "added sugars." The FDA would publish a proposed rule outlining the specific changes to labeling requirements, including formatting and definitions. Food manufacturers, consumer health organizations, dietitians, and even sugar industry representatives would submit comments. Manufacturers might comment on the cost and logistics of reprinting labels, while health groups might advocate for clearer presentation of information. The FDA would analyze these comments, perhaps refining the implementation timeline or clarifying certain definitions. Ultimately, the FDA would publish the final updated labeling requirements in the Federal Register, along with a statement explaining the public health benefits and how industry concerns were addressed.

  This demonstrates informal rulemaking as the FDA initiated a regulatory change with public notice, solicited and reviewed public comments from various stakeholders, and then issued a final rule accompanied by a statement of its rationale.