The Development of National Food Safety Policy
At least a dozen federal agencies implementing more than 35 statues make up the federal food safety system (Roberts 2001). Major roles in carrying out food safety regulatory activities are played by four agencies: the Food and Drug Administration (FDA) of the Department of Health and Human Services (DHHS); the Food Safety and Inspection Service (FSIS) of the US Department of Agriculture (USDA); the Environmental Protection Agency (EPA); the National Marine Fisheries Service (NMFS) of the Department of Commerce; and the Center for Disease Control (CDC). Other agencies play smaller roles in regulating specific products.
Food and Drug Administration (FDA)
The first national food safety law, the Federal Food and Drugs Act of 1906, added regulatory functions to the Bureau of Chemistry. It prohibited interstate commerce in misbranded and adulterated foods, drinks, and drugs (Federal Food and Drugs Act 1906). There were numerous regulations, amendments, and US Supreme Court rulings on adulteration, misbranding, false and misleading claims, and food additives.
In 1933 FDA recommended a complete revision of the 1906 Act. After 5 years, the Federal Food, Drug, and Cosmetic Act (FD&C) of 1938 was passed, essentially replacing the 1906 Act. The origins of the current food-safety system are in the FD&C Act, which established FDA as the controlling federal authority for food safety (Hygiene in Food Processing 2003; Roberts 2001). The act corrected manipulations in food packaging and quality, and it mandated legally enforceable food standards. Tolerances for certain poisonous substances in food products, including pesticide residues, were set. The law formally authorized factory inspections, and allowed FDA to issue injunctions in order to enforce standards (Federal Food, Drug and Cosmetic Act 1938).
The Act re-defined “food,” “adulteration,” and “misbranding,” and defined “food additives” and “added substances.” Food was defined as “(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article” (Federal Food, Drug and Cosmetic Act 1938).
The Act set forth multiple, independent definitions of adulteration, meaning that a product needed to violate only one of the definitions in order to be considered adulterated. The primary definition for adulterated foods is as follows:
“[A product] bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health” (Federal Food, Drug and Cosmetic Act 1938).
Adulteration was also extended to the conditions of the raw materials, production and processing facilities and procedures, packaging materials. Any insanitary conditions along the products creation could violate these definitions, branding the food as adulterated and in violation of the Act, even if the product was proven to be safe for consumers.
Labeling was defined as, “all labels and other written, printed, or graphic matters (1) upon any article or any of its containers or wrappers, or (2) accompanying such article” (Federal Food, Drug and Cosmetic Act 1938). Misbranding was defined as, “[a product’s] labeling is false or misleading in any particular” (Federal Food, Drug and Cosmetic Act 1938). These definitions include any books, pamphlets, or other literary media (not including advertisements) that was explicitly sold with the product and made claims about its qualities. Misbranding is independent of adulteration, and FDA could take action against any product in violation of one or both of these categories.
Food additives were defined as, “any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food” (Federal Food, Drug and Cosmetic Act 1938). The Act sets forth exemptions for substances which are treated under different regulations, including pesticide chemicals and their residue, color additives, substances previously approved under other statutes, new animal drugs, and dietary supplements (as defined later in the Act). The statute directs that food additives are to be presumed unsafe (and prohibited) until they have been proven to be safe(Federal Food, Drug and Cosmetic Act 1938).
Some of the exceptions to the food additives definition are termed “added substances,” and while not explicitly defined in the Act, are referred to in several sections. Such substances are prohibited, “except where such substance is required in the production thereof or cannot be avoided by good manufacturing practice” (Federal Food, Drug and Cosmetic Act 1938). Because added substances often cannot be avoided in food, such as the presence of man-made pollutants in fish, the FDA is required to “promulgate regulations limiting the quantity therein or thereon to such extent as [is] necessary for the protection of public health” (Federal Food, Drug and Cosmetic Act 1938). The tolerances set by FDA addressed these added substances.
There have been many amendments to the FD&C Act since its passage. The 1948 Miller Amendment affirmed that the FD&C Act applied to goods moving in interstate commerce (Roberts 2001). The 1953 Factory Inspection Amendment clarified the Act, giving FDA the authority to inspect a processing plant without a warrant and without the permission of the owner. FDA was also required to give manufacturers written reports of conditions observed during inspections and analyses of factory samples (Hygiene in Food Processing 2003). Following Congressional hearings in the early 1950’s, a series of laws addressing pesticide residues and food and color additives gave FDA tighter control over chemicals entering the food supply and required manufacturers to establish their safety (Swann). The 1954 Pesticide Residue Amendment detailed the procedures for setting safety limits for pesticide residues on raw agricultural commodities. Under the 1958 Food Additives Amendment manufacturers of new food additives were required to establish the safety of the additives. FDA was also given premarket review and approval authority over chemical additives to food. The Delaney clause prohibited the approval of any food additive shown to induce cancer in humans or animals. The 1960 Color Additive Amendment required manufacturers to establish the safety of color additives in foods (Roberts 2001). In 1996, Congress replaced the Delaney clause with a single standard for both fresh and processed foods, allowing pesticides that pose only a negligible risk (Meadows 2006). After the events of September 11, 2001 Congress passed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, establishing new requirements for registration of possession, use, and transfer of “Select Agents and Toxins” that could pose a threat to human, animal, and plant safety and health (Public Health Security and Bioterrorism Preparedness and Response Act of 2002 2002).
After a 1968 departmental reorganization, FDA became responsible for assuring safe milk supplies (through cooperation with state and local milk control authorities); safe shellfish supplies and processing; sanitation in food service facilities (e.g. restaurants); safe food, water, and sanitation in interstate travel facilities (trains, planes, buses, ships, interstate highways); and providing poison control centers with information on treatment (Janssen 1981).
The Nutrition Labeling and Education Act (1990) required all packaged foods to bear nutrition labeling and all health claims for foods to be consistent with terms defined by HHS. Packaged foods now required per-serving nutrition labeling, and an easily understood list of the most important nutrients. Specific conditions must be met to use terms such as “low fat.” The law preempted states’ requirements for food standards (Bill Summary & Status: Nutritional Labeling and Education Act of 1990 1990). The Food Allergy Labeling and Consumer Protection Act in 2004 further required the labeling of all food that contains any proteins derived from peanuts, soybeans, cow’s milk, eggs, fish, crustacean shellfish, tree nuts, and wheat (Swann).
United States Department of Agriculture (USDA)
When passed, the Federal Meat Inspection Act (FMIA) of 1906 ensured that meat and meat products produced and sold within the US were not adulterated and properly labeled and packaged. The FMIA established mandatory on-site inspections by government inspectors of livestock before and after slaughter, and set explicit sanitary standards for slaughterhouses. Animal carcasses and processed products could not be shipped from the processing plant until they had been inspected by a USDA inspector. It also allowed USDA to issue grants of inspection and monitor slaughter and processing operations, enabling the Department to enforce its requirements (Federal Meat Inspection Act 1906).
With the passage of the Agricultural Marketing Act in 1946, the scope of USDA’s authority was expanded to inspect, certify, and identify the class, quality and condition of agricultural products. Grading and quality identification activities were separated from inspection activities and assigned to the Agricultural Marketing Service (AMS) in 1981 (Institute of Medicine and National Research Council 1998).
In 1957, Congress passed the Poultry Products Inspection Act (PPIA), which imposed requirements on poultry product handling and processing that mirrored requirements of the FMIA. It required any poultry products that moved in interstate commerce to be continuously inspected—before and after slaughter, and before processing—that plant facilities be sanitary, and that product labels be accurate and truthful (Poultry Products Inspection Act 1957).
States remained responsible for inspection of meat and poultry sold in the state where they were produced, but USDA monitored the process. The 1967 Wholesome Meat Act and the 1968 Wholesome Poultry Products Act set a minimum sanitation requirement by which State inspection programs must be “at least equal in rigor to” their federal counterparts. If the state chose to end its inspection program or could not maintain the standard, the FSIS must assume responsibility for inspection (Hygiene in Food Processing 2003). Additionally, these acts established concurrent jurisdiction over adulterated meat products between USDA and FDA (Food Safety and Inspection Service).
The 1970 Egg Products Inspection Act gave USDA jurisdiction over egg safety, requiring continuous inspection of the processing of frozen, liquid, and dried egg products. Egg hatcheries and packers were also put under discontinuous inspections (Egg Products Inspection Act 1970). In 1995, FSIS received the sole responsibility for egg inspection within the USDA, but FDA maintained regulatory authority over intact-shell eggs (Institute of Medicine and National Research Council 1998; Hygiene in Food Processing 2003).
During the 1960s, the National Aeronautics and Space Administration (NASA), US Army Natick Laboratories, and the Pillsbury Company began to develop foods for the space program. They introduced the Hazard Analysis Critical Control Point (HACCP) System in 1971, which focused on preventing hazards that could cause food-borne illness by applying controls at each step of the process from raw material to the finished product (Roberts 2001). Following the recommendation of a National Academy of Sciences committee, FDA passed the Seafood HACCP Regulations in 1995, requiring all seafood processors to implement HACCP systems (Institute of Medicine and National Research Council 1998). In 1996 USDA published the Pathogen Reduction: HACCP System rule, requiring HACCP Systems and Sanitation Standard Operating Procedures in FSIS inspected establishments. All establishments were required to develop a HACCP plan to ensure the safety of their product (The Final Rule on Pathogen Reduction and Hazard Analysis and Critical Control Point (HACCP) Systems 1996; Food Safety and Inspection Service). Implementation of HACCP systems was the responsibility of food producers, processors, and distributors. The role of government was to ensure that HACCP programs were properly implemented by evaluation of HACCP plans and inspection of records of monitoring of critical control points (Institute of Medicine and National Research Council 1998).
Other Agencies
Agencies other than the FDA and USDA that had roles in food safety and regulation included EPA, NMFS in the Department of Commerce, and CDC. Other government agencies also had smaller regulatory responsibilities.
EPA regulates two aspects indirectly linked to food safety: regulating pesticide use and ensuring clean air and water, all of which may threaten the safety of the food supply. PFederal pesticide regulation originated in the 1910 Federal Insecticide Act, which was passed to ensure the quality of pesticides bought by consumers and was enforced by USDA. In 1947, the Federal Insecticide, Fungicide and Rodenticide Act extended the 1910 Act to regulate pesticide usage in food production. The FD&C Act established FDA tolerances for pesticide residues in food. When EPA was established in 1970, it took over FDA’s responsibility for setting pesticide tolerances (Stephen J. Toth 1996). The Food Quality Protection Act (FQPA) of 1996 amended the FD&C Act, strengthening regulation of pesticides by FDA and EPA. It required that EPA consider a new, stronger safety standard, which included considering exposure to the pesticide from all non-occupational sources (food, drinking water, residential use) (Roberts 2001). EPA was also responsible for the safe use of food detergents and sanitizers to protect the public from exposure through food (Institute of Medicine and National Research Council 1998).
Federal regulation of the nation’s drinking water began in 1914 when the Public Health Service (PHS) imposed bacteriological standards for drinking water. These standards were revised in 1925, 1946, and 1962, and eventually adopted by all 50 states. The 1974 Safe Drinking Water Act (SDWA) established national, enforceable health standards for contaminants in drinking water. Prior to the SDWA, EPA water regulations focused on regulating pollution in waterways. In 1986 SDWA was amended by the Surface Water Treatment Rule, which required public water systems to filter and disinfect all surface water supplies. The Safe Drinking Water Act of 1996 extended protection of drinking water from source to tap, and required notifying the public about contaminants in tap water (Roberts 2001; Office of Water 2000). FDA regulates bottled water under separate regulations (Institute of Medicine and National Research Council 1998).
Mandatory regulation of seafood processing was under FDA, but excluded fishing vessels, common carriers, and retail establishments. Under the 1946 Agricultural Marketing Act, NMFS conducted a voluntary seafood and seafood product inspection and grading program for the industry, including establishments not inspected by FDA. NMFS also conducted research on seafood safety (National Oceanic and Atmospheric Administration).
CDC, in conjunction with states and local health departments, undertook surveillance and investigations of illnesses associated with food consumption in support of USDA and FDA regulations. CDC conducted field investigations of food-borne diseases only at the request of state health departments. FDA and FSIS were called into investigations when the safety of a food in their jurisdiction was questioned (Medicine and Council 1998).
Several other federal agencies had smaller regulatory responsibilities. For example, the Department of the Treasury’s Bureau of Alcohol, Tobacco, and Firearms was responsible for overseeing the production, distribution, and labeling of alcoholic beverages, except for wines containing less than seven percent alcohol, which were the responsibility of the FDA. The department’s Custom Service assisted other agencies in ensuring the safety and quality of imported foods through services such as collecting samples (Roberts 2001).
