Food Regulation. Neal D. Fortin

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СКАЧАТЬ to refer to this exclusive state power, the broad powers traditionally possessed by governments and exercised to protect the health, safety, welfare, and general well‐being of the citizenry.²⁵ Authority to make food inspection laws and health laws are part of the traditional police powers.

Nevertheless, often the federal government may regulate an activity that falls under the police power category because it also falls under federal authority via another power, such as the power to regulate interstate commerce. For example, the federal government could not regulate the minimum cold‐holding temperatures of foods for health and safety reasons, but it may do so for the purpose of regulating interstate commerce.

In theory, this limitation on the federal government reach is considerable. In practice, due to the interconnected nature of the food supply, most food businesses would be considered to have an effect on interstate commerce. For instance, use of a single ingredient that was shipped in interstate commerce in a multi‐ingredient food would create federal jurisdiction and fall within the scope of the FD&C Act.²⁶

The end result of federalism is the states’ independent power creates more regional differences in the law and regulation than would occur if there were a single national legal standard. In addition, states are free to legislate and regulate any arena that has not been preempted by federal law.²⁷ However, any additional restriction passed by a state must not place an unreasonable burden on interstate commerce.

      Accordingly, firms shipping into various states must be careful that they meet both federal and state requirements. This patchwork of different laws has been criticized as being of burden to firms shipping to several states.

While troublesome from a commercial standpoint, this decentralization of power was intentional to prevent against tyranny. There is also the benefit of different localities having the opportunity to propose laws that best serve the needs of their community. For instance, coastal states often have closer scrutiny for seafood harvests than states without fisheries.²⁸

The experience of trying out new ideas and conducting these regulatory experiments in local settings may yield useful information for future efforts to solve problems that face all communities.²⁹ For example, because sulfites can be dangerous to sensitive individuals, Michigan requires the labeling of sulfite use on salad bars.³⁰ California, a major producer of canned food, adopted the first regulation for mandated thermal processing controls for canned food in 1920.³¹ California’s updated low‐acid canning regulation eventually served as the model for the FDA low‐acid canning regulation promulgated in 1973.

At the beginning of the twentieth century, increased distribution of milk to growing population centers resulted in outbreaks of milk‐borne diseases. The city of Chicago passed the first mandatory milk pasteurization law in 1908. In 1947, Michigan became the first state to require milk pasteurization.³² Other states soon followed, but federal regulation did not prohibit unpasteurized milk until 1987.³³

Consistent with the principles of federalism and of state’s rights, courts have generally held that states may enact and enforce food laws that are different from the federal law so long as the state laws are not inconsistent with the federal law and do not unreasonably burden interstate commerce. “Inconsistent” generally means direct or indirect conflict between state and federal law.³⁴

      To prevent the problems from inconsistency, cooperative and educational efforts at uniformity have been an important part of the legal landscape in food law. For example, the FDA issues a model Food Code for retail food establishment, and the Association of Food and Drug Officials (AFDO) issues a model FD&C Act. When the models or the federal laws are perceived as adequate by state governments, usually the states will adopt the model or federal regulations essentially word for word into state law.

1.4 AGENCY PROCEDURAL REGULATION

      The chief executive (the president or governor) bears the ultimate responsibility for executing the laws enacted by the legislative branch of government. This responsibility is carried out by the administrative agencies that are part of the executive branch of government.

      In addition to following the requirements of the Constitution and the enabling statutes, administrative agencies must comply with a number of procedural statutes. Three of these are the especially important:

       Administrative Procedure Act (APA), which specifies requirements for rulemaking (the process by which federal agencies make regulations) and agency adjudication.

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

       Freedom of Information Act (FOIA), which provides the public 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 СКАЧАТЬ