Identify pertinent food regulations.
While the primary responsibility for enforcing federal regulations for the safety of the food supply is within the realm of the U.S. Department of Agriculture (FSIS) and the U.S. Department of Health and Human Service’s Food and Drug Administration (FDA), there are no less than 12 separate agencies that oversee various aspects of food safety.
U.S. Department of Agriculture
The USDA is responsible for regulating red meat, poultry, and certain egg products. There are four divisions within the USDA that address food safety. These divisions are: Office of Risk Assessment and Cost-Benefit Analysis (ORACBA), Marketing and Regulatory Programs (MRP), Research, Education, and Economics (REE), and Food Safety and Inspection Service (FSIS). The following are key legislation that the USDA enforces.
Federal Meat Inspection Act in 1967. FSIS carries out mandatory inspections of plants that slaughter livestock. Currently, there are more than 75,000 inspectors who must be present at all meat plants while processing. The inspector has the power to withdraw, which stops processing operations, condemn foods, and obtain plan records. The agency follows the products throughout processing to assure wholesomeness and proper labeling. Under this Act, cattle, sheep, swine, goats, horses, mules, and other equines are to be visually inspected by a federal inspector before slaughter. The carcasses and organs are subject to a post-mortem inspection including inspections during the preparation of meat products. FSIS also imposes detailed facility, equipment, and sanitation requirements FSIS inspectors are responsible for checking compliance with these requirements. FMIA also lists circumstances under which meat articles will be considered adulterated and unfit for human consumption. FMIA also sets out specific situations in which misbranding occurs, such as use of false or misleading labels, use of an incorrect product name, or lack of a label identifying one food as an imitation of another food. FMIA also contains provisions for both criminal penalties and civil sanctions.
Poultry Products Inspection Act of 1957. FSIS carries out mandatory inspections of plants that slaughter poultry. Poultry is defined to include chickens, turkeys, ducks, geese, and guineas and poultry product is defined as the carcass or part or any product made from poultry. The inspection may include examination of poultry before slaughter to determine if it plainly shows any disease or condition that should cause it to be condemned. This Act also defines adulteration in the same manner as FMIA. There are 12 specific situations in which misbranding occurs with regard to any poultry product. These are identical to those itemized in FMIA. Prior approval of labels to be used with poultry and poultry products is also required, as under FMIA.
Egg Products Inspection Act of 1970. FSIS carries out mandatory inspections of plants that process shell eggs or liquid, dried, or frozen egg products. The agency follows the products throughout processing to assure wholesomeness and proper labeling. This Act makes it illegal to buy, sell, or transport eggs or egg products for use as human food that are not inspected and labeled under the provisions of the ACT. Egg is defined to include eggs of the domesticated chicken, turkey, duck, goose, or guinea.. Egg product means any dried, frozen, or liquid eggs with or without added ingredients but does not include products that contain eggs in only a relatively small proportion or which have not historically been considered products of the egg food industry. Adulteration, misbranding/labeling are also addressed.
Voluntary Inspection Program. A processor of exotic animals, such as reindeer, elk, deer, antelope, bison, and water buffalo, may apply for approval as an official exotic animal establishment and if approved, receive (Fee-based) inspection services. A voluntary inspection program for rabbits slaughtered for human food operates in a similar manner.
Department of Health and Human Service
Food and Drug Administration. This agency is responsible for the safety of all other food not regulated by the USDA. Food is defined to include articles used for food or drink for man or animal, chewing gum, and any food components. This mandate covers the inspection of food plants and the establishment of standards for composition, quality, and safety of food and food additives, as well as economic standards to assure consumer confidence in labeling.
There are four divisions within the FDA that address food safety. These divisions are: Center for Food Safety and Applied Nutrition (CFSAN), the Center for Veterinary Medicine (CVM), National Center for Toxicological Research (NCTR), and Office of Regulatory Affairs (ORA).
The FDA also determines the types of food in which an additive can be used; the maximum quantity of the additive that can be used; and the information that must appear on the label. The following are key legislation that the FDA enforces:
Federal Food Drug and Cosmetic Act. FFDCA prohibits the entry into interstate commerce of adulterated or misbranded food. The term adulterated includes products that are defective, unsafe, filthy or produced under unsanitary conditions. The term misbranded includes statements, designs, or pictures in labeling that are false or misleading, and failure to provide required information in labeling. Compliance with this Act is secured through periodic inspections of facilities and products, analysis of samples, educational activities, and legal proceedings. Adulterated or misbranded products may be voluntarily destroyed or recalled from the market by the shipper or may be seized by U.S. Marshals on orders obtained by the FDA from Federal district courts. While the legal requirements that must be met are the same for imported and domestic products, the enforcement procedures are necessarily different. Imported products regulated by the FDA are subject to inspection at the time of entry through U.S. Customs. Shipments found not to comply with the laws and regulations are subject to detention. They must be brought into compliance, destroyed, or re-exported. The statute permits use without prior agency approval of a substance with a long history of use and if it is considered generally recognized as safe (GRAS). A listing of substances that are generally recognized as safe can be found in 21 CFR Parts 182 (substances generally recognized as safe), 184 (direct food substances affirmed as generally recognized as safe), and 186 (indirect food substances affirmed as generally recognized as safe). This information is available online at: http://www.gpoaccess.gov/cfr/index.html
Food Code. This code is a model for safeguarding public health and ensuring food is unadulterated and honestly presented when offered to the consumer. The Code establishes definitions; sets standards for management and personnel, food operations, and equipment and facilities; and provides for food establishment plan review, permit issuance, inspection, employee restriction, and permit suspension. Individual local, state, and federal governmental jurisdictions are encouraged to adopt the Code as the basis for their regulatory guidelines governing foodservice, retail food stores, and food vending operations.
Low Acid Foods Registration and Process Filing. All commercial processors of heat processed low-acid canned foods and acidified foods are required to register their establishments and file processing information for all such products with the FDA. This is required for both U.S. establishments and those in other countries that export such food to the U.S. Full text of this requirement can be found in 21 CFR 108, 113, and 114 which are located at:
Another agency within the Department of Health and Human Services that addresses food safety issues is the Centers for Disease Control and Prevention (CDC). The CDC is responsible for tracking foodborne illness incidents and outbreaks. For more information about the CDC go to their Web site at: www.cdc.gov
Environmental Protection Agency
There are three divisions within the Environmental Protection Agency (EPA) that address food safety. These divisions are: Office of Prevention, Pesticides, and Toxic Substances (OPPTS), Office of Research and Development (ORD), and Office of Enforcement and Compliance Assistance). The following key legislation is enforced by the EPA:
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Sets pesticide residue tolerances or legal limits on the amount of residue that can be found in or on particular foods. The FDA and USDA enforce those tolerances on their portions of the food supply. Tolerance levels have been set for over 9,000 pesticides.
Department of Commerce
There is one division within the Department of Commerce that addresses food safety. This division is the National Oceanic and Atmospheric Administration (NOAA). This division oversees the management of fisheries in the U.S. and is responsible for seafood quality and grading. NOAA Fisheries operates a voluntary inspection program for fish in conjunction with FDA. In 1995, FDA issued its final rule on HACCP plans that must be in place for seafood processors and a guidance documents that consists of recommendations to aid seafood processors in developing their own HACCP plans. NOAA Fisheries has its own authority for the promulgation of grade standards, inspection, and certification of fish and shellfish.
Department of Treasury
There are two divisions within the Department of Treasury that address food safety. These divisions are: Bureau of Alcohol, Tobacco, and Firearms (BATF) and Customs.
Federal Trade Commission
The Federal Trade Commission (FTC) shares jurisdiction with FDA and USDA over claims made by food manufacturers. In 1954, a memorandum of understanding outlined that the regulation of food advertising would be primarily in the hands of FTC, while FDA would have the primary responsibility of regulating food labeling. The FTD’s statutory authority with regard to food advertising is broad. In general, FTC requires that any objective claim made in advertising must be supported by a reasonable basis of substantiation that the advertisers has in its possession at the time the claim is first made.
SOURCE: Looney, J.W., P.G. Crandall, and A.K. Poole. 2001. The Matrix of Food Safety Regulations. Food Technology 55(4):60-76.