Legal Definitions - formal rulemaking

Formal rulemaking is a specific and highly structured process that U.S. administrative agencies must follow when creating new regulations or amending existing ones. It is a more rigorous and formal procedure than the common "notice and comment" rulemaking, designed to ensure a thorough and transparent examination of facts and arguments before a rule is finalized.

This heightened level of procedural requirement is mandated by the Administrative Procedure Act (APA) and is only triggered when a statute passed by Congress explicitly states that an agency's rules must be made "on the record after opportunity for an agency hearing." Without this precise language in the authorizing statute, agencies typically use less formal methods.

When formal rulemaking is required, the process closely resembles a court trial or an adjudication. An Administrative Law Judge (ALJ) presides over the proceedings, much like a judge in a courtroom. During these hearings:

• The agency provides public notice of the proposed rule.
• Interested parties, such as businesses, consumer groups, or experts, are given the opportunity to present evidence, call witnesses, and cross-examine opposing witnesses under oath.
• The ALJ manages the hearing, rules on evidence, and ensures due process.
• Based on the evidence presented "on the record," the ALJ makes findings and recommendations, which often form the basis of the final rule.
• The agency then issues the final rule, which is published in the Code of Federal Regulations.

This extensive process ensures that the final rule is based on a comprehensive and formally established factual record, making it more robust against legal challenges.

Examples of Formal Rulemaking

• Setting New Environmental Standards: Imagine Congress passes a law requiring the Environmental Protection Agency (EPA) to establish new national emission limits for a specific industrial pollutant, but the law explicitly states that these limits must be determined "on the record after opportunity for an agency hearing."

  How it illustrates: In this scenario, the EPA could not simply propose a rule and collect written comments. Instead, it would have to conduct formal hearings where scientists, industry representatives, and environmental advocates present expert testimony, data, and arguments under oath before an ALJ. The ALJ would then evaluate all the evidence presented during these trial-like proceedings to make findings that would directly inform the final emission standards.

• Regulating a Novel Medical Device: Suppose a new statute directs the Food and Drug Administration (FDA) to create safety and efficacy regulations for a groundbreaking type of implantable medical device, and the statute specifically mandates that these regulations be developed "on the record after a hearing."

  How it illustrates: The FDA would be compelled to hold formal hearings. During these hearings, medical device manufacturers, doctors, patient advocacy groups, and independent researchers would present scientific evidence, clinical trial data, and expert opinions. An ALJ would preside, ensuring a fair process for presenting and challenging information, and the final regulations for the device would be based on the comprehensive factual record established during these formal proceedings.

• Establishing New Aviation Safety Protocols: Consider a situation where Congress passes legislation requiring the Federal Aviation Administration (FAA) to develop new air traffic control protocols for drone operations in congested airspace, and the law specifies that these rules must be made "on the record after opportunity for an agency hearing."

  How it illustrates: The FAA would need to conduct formal hearings where drone manufacturers, commercial operators, private pilots, and air traffic controllers present evidence regarding safety risks, technological capabilities, and operational feasibility. An ALJ would oversee the presentation of this evidence, allowing for cross-examination and the creation of a detailed record. The final air traffic control protocols would then be formulated based on the findings derived from this formal, evidentiary hearing process.