Food Regulation. Neal D. Fortin

with a right to access agency information.

      1.4.1 The Administrative Procedure Act

      The federal APA (5 U.S.C. § 551 et seq.) provides for basic procedural safeguards in the federal regulatory system, and establishes and defines judicial review authority over the federal regulatory agencies. A major thrust of the APA is to ensure due process in the rulemaking and adjudication by administrative agencies.

      In simplest terms, due process means fairness. The three most basic elements of due process are that those affected by the regulatory process are guaranteed notice, an opportunity to be heard, and a record for use in judicial appeals. The major statutory requirements of procedural fairness in the federal APA are paralleled in state administrative procedure acts.

      1.4.2 Rulemaking

      Rulemaking involves the development of administrative rules or regulations for future enforcement. Generally, regulations specify the technical details that are necessary to comply with a law’s much broader requirements. For example, the FD&C Act, section 403, states in part, “A food shall be deemed to be misbranded (a) If (1) its labeling is false or misleading in any particular … .” Regulations are promulgated by the FDA to define specific information required on a label to avoid being false or misleading in any particular.

      The APA specifies minimum procedural safeguards that agencies must follow when engaged in rulemaking. Notice of any proposed rule must be published by the proposing agency in the Federal Register. The agency must allow interested parties time to submit comments. In some instances, public hearings must be conducted with an official record and formal rules. Public comments must be reviewed and considered by the agency before final adoption of a regulation. The agency must explain why it did or did not incorporate suggestions in the final regulation. Final regulations must be published at least thirty days before they are to take effect, so as to allow an opportunity both for legal challenge and for adjustments necessary for compliance with the regulation. Note, however, that unless Congress specifies otherwise, federal agencies have some discretion under these procedural rules.

      1.4.3 Adjudication

      Judging noncompliance and imposing penalties for violation of regulations may also be a part of an agency’s responsibility (if so authorized by statute). Agency adjudication is an agency hearing, somewhat similar to a judicial proceeding, but typically conducted before an agency official acting in the capacity of an administrative law judge (or hearing referee). Agency adjudication is less formal than most judicial proceedings. An adjudicatory hearing deals with specific parties and facts; it establishes what happened and prescribes what is to be done, including determining penalties. For example, a state agriculture department might conduct an adjudication proceeding in which it first establishes the facts as to whether a food establishment violated applicable sanitation standards and then whether revocation of the establishment’s license is warranted.

Thus, an administrative agency can serve as the lawmaker, the prosecutor, and the judge, all rolled into one. This does not necessarily violate the principle of separation of powers. The rationale is that administrative agencies have narrow areas of technical expertise, they are controlled by numerous procedural requirements, and these decisions always may be appealed to the court system. Due process and the APA specify that agencies, when engaged in adjudication, must provide a person notice of the case against him or her, and a meaningful opportunity to present their case. In some cases, the determination must be made by trial‐type proceeding.³⁵

While court challenges of agency adjudications are not uncommon, it should be noted that those challenges are usually based on procedural, rather than substantive grounds. The courts are enormously deferential to an agency’s expertise, and are unlikely to interfere with the substantive decisions made by an agency.³⁶ Procedural challenges are much more likely to be successful, and also provide greater advantage for negotiated settlements or delays in the implementation of the agency’s decision. For example, a grocery store may challenge an agency’s decision to revoke their license due to insanitary conditions. However, the challenge is far less likely to be successful on the basis that the agency was incorrect in its professional judgment that the store was insanitary (a substantive challenge), as opposed to the challenge that the agency failed to consider all pertinent evidence in the record because it failed to properly notify the establishment (procedural challenges). A court is far less likely to overturn the agency’s decision on the seriousness of the insanitation than to find there was a procedural deficiency.

      1.4.4 Judicial Review

      Administrative agency activity must also be consistent with the Constitution and relevant statutes. Judicial review of administrative agency activity oversees this consistency. Standards for judicial review of agency actions are outlined in the APA, which defines the basis and scope of judicial intervention and review. Generally, the courts will not consider whether an agency acted wisely, but only whether the agency acted as follows:

       Stayed within its constitutional and statutory authority.

       Properly interpreted the applicable law.

       Conducted a fair proceeding.

       Avoided arbitrary or capricious action.

       Reached a decision supported by substantial evidence in the record.

However, the Supreme Court has also ruled that the courts are to review agency decisions with a searching and careful inquiry to determine “whether the decision was based on consideration of the relevant factors and whether there has been a clear error of judgment.”³⁷ This “Hard Look” doctrine leaves reviewing courts with considerable latitude for overseeing the actions of administrative agencies.

      1.4.5 Federal Advisory Committee Act (FACA)

      FACA requires that certain kinds of groups whose advice is relied upon by the government be chartered as advisory committees. Advisory committees must be constituted to provide balance and to avoid a conflict of interest. Committee meetings must also be held in public with an opportunity for comment from those outside the committee.

As science‐based programs, the food‐regulation agencies often rely on committees for scientific advice. Therefore, affected parties may find it important to have a say in the deliberations and recommendations of these advisory committees. For example, USDA and HHS select members for the Dietary Guidelines Advisory Committee, which issues the nation’s nutritional and dietary guidelines. These recommendations are the foundation for the nutritional standards in all federal food assistance programs, including school lunches and food stamps, and are used in developing the food guides and nutritional classes. Various groups have contested the makeup of the committee for lack of balance and for conflicts of interest. Because food companies are regular sponsors for educational activities of nutrition professional associations as well as nutrition research, finding nutrition academics without some connection to the food industry is difficult.³⁸

      NOTES AND QUESTIONS

      1 1.2 FACA. Why would the composition of the various advisory committees be so important that Congress would write a law requiring balance?

      2 1.3 Conflicts of interest. What type of conflicts of interest might arise in the composition of the Dietary Guidelines Advisory Committee?

      3 1.4 Advisory Committees. The FDA relies on expert advisory committees heavily for therapeutic products approvals. To a lesser extent, they are used for food. FD&C Act