Food Safety – An Overview
The United States food regulatory system has developed piecemeal over the last century, generating new rules and regulations in response to emerging food problems. As a result, responsibilities for specific food safety concerns are allocated to various government agencies. A key to effective regulation within this complex and fragmented system is interagency cooperation and cooperation between these agencies and public and private stakeholders.
Although this overview focuses on federal regulation of food safety, it is important to note that state regulatory agencies also play an important role in food safety regulation, especially in enforcement. Most notably, state regulatory agencies are primarily responsible for food sanitation and safe food handling by food retailers, foodservice providers, and food-vending operations.
The United States food supply system encompasses a multi-faceted production and delivery system of food products. Essential system components include the production, processing, preparing, packaging, labeling, distribution, and, of course, consumption of food. At each of these stages, food products may be exposed to various levels of risk.
This food system is also becoming increasingly more global, as many of these system components occur outside the boundaries of the United States and involve a wide variety of small to large players. Much of this international development is driven by consumers who increasingly demand various types of food year-round. A global food supply system renders governance difficult where national regulatory regimes approach regulation differently and where these regimes are limited in ensuring the safety of food produced and processed beyond United States borders. Hence, the oversight and inspection of imported food products has emerged as an important issue for policy makers.
Additional factors that challenge the efficacy of the United States food safety regulatory regime include evolving public attitudes towards food safety, changes in food production and technology, concerns about the changing nature of foodborne illnesses, threats of food terrorism, and the growth of private standards in the food industry.
While the United States is generally regarded as having the safest food supply in the world, foodborne illness caused by the consumption of contaminated foods or beverages is still a compelling public health problem. The Centers for Disease Control and Prevention (CDC) estimates that foodborne diseases annually cause 48 million illnesses, 128,000 hospitalizations, and 3,000 deaths (for more information, see the CDC Estimates for Foodborne Illness). The United States Department of Agriculture (USDA) estimates that the economic burden of the pathogens responsible for 95% of the illnesses and deaths from foodborne illnesses was about $17.6 billion in 2018 dollars (for more information, see the USDA Cost Estimates for Foodborne Illnesses). Compounding the problem is the constantly changing nature of foodborne illness. While improvements in food safety such as pasteurization and proper canning have all but eliminated some diseases, new foodborne infections have emerged. Today there are more than 250 different foodborne diseases caused by a variety of bacteria, viruses, and parasites (for more information, see the CDC Foodborne Germs and Illnesses).
Foodborne illness outbreaks are becoming increasingly widespread and complicated. Years ago, an outbreak of foodborne illness was confined to a local community, generally caused by meat at a reception or a potluck dinner. Our food system has grown from a localized system with isolated food safety incidents to a global system where food safety incidents can affect people worldwide. Changes in food transportation, preparation, storage, and consumption cause foodborne illness outbreaks to affect a widespread range of people living across the nation. Further, these cases of illness occur over longer periods of time. The safety of imported food raises additional concern (for more information, see the Biosecurity Reading Room). Foodborne illness outbreaks, some of which are highly publicized incidents, have resulted in public outcry for more stringent measures to safeguard food supplies.
Development of Federal Food Safety Regulations
Before the twentieth century, food safety regulation was generally a matter of state and local concern. Public support for passage of federal food safety law grew as food safety problems in the food industry were exposed. The first food laws in the United States were spurred by two important events: Dr. Wiley’s poison squad and the publication of Upton Sinclair’s The Jungle. In 1902, Congress appropriated funds for a study regarding the use of untested chemicals as food preservatives conducted by Harvey Wiley M.D., the chief chemist of the USDA’s Bureau of Chemistry. Dr. Wiley recruited volunteers for his “poison squad” who would eat foods containing the new chemical preservatives. Based on the sicknesses exhibited by members of the poison squad after consuming large quantities of chemical preservatives, Dr. Wiley concluded that chemical preservatives should only be used in foods when necessary, that the onus of safety should be on the producer of foods, and that consumers should be informed of food ingredients on food labels. Additionally, the 1905 publication of Upton Sinclair’s The Jungle portrayed nauseating practices and unsanitary conditions in the meat-packing industry that captured the public’s attention.
In 1906, President Theodore Roosevelt signed both the Pure Food and Drugs Act and the Federal Meat Inspection Act (FMIA) into law. Passage of these two statutes began the modern era of United States food regulation by prohibiting the introduction of adulterated, poisonous, or deleterious food into interstate commerce. There was no pre-market approval system for food ingredients or drugs under these statutes, which only allowed government action after products were out in the market. The acts did prohibit the introduction of misbranded and adulterated foods, drinks, and drugs in interstate commerce; prohibited the addition of color additives to conceal inferiority; and prohibited the use of “poisonous” colors in confectionary. In 1913, the first labeling amendment, The Gould Amendment, was added to the Pure Food and Drugs Act. The Gould Amendment required that a food package plainly mark its contents on the outside of the food package. In 1924, the Supreme Court ruled against deceptive labeling on apple cider vinegar; bringing to a halt deceptive labeling practices that allowed producers to misrepresent product identities under distinctive names (such as “BRED-SPRED” – a fruit jelly like substance that contained no fruit) (United States v. Ninety-Five Barrels More or Less Alleged Apple Cider Vinegar, 265 U.S. 438, 44 S. Ct. 529, 68 L. Ed. 1094 (1924)).
In 1930, the Bureau of Chemistry became the Food and Drug Administration (FDA). In 1933, the FDA introduced a bill to senate recommending a complete revision of the 1906 Food and Drug Act, but the bill did not pass. However, in 1937, elixir of sulfanilamide, which contained poisonous diethylene glycol (anti-freeze), killed 107 persons, many of whom were children. This tragedy spurred legislative action, and in 1938 Congress strengthened federal food safety regulatory authority with the passage of the Federal Food, Drug, and Cosmetic Act (FDCA). The 1938 Act also created standards of identity, quality, and fill of container that are the subject of much discussion today. Similarly, the Poultry Products Inspection Act (PPIA), which is similar to the FMIA, was enacted in 1957 in response to a rapidly expanding market for processed poultry products.
Food laws continued to evolve based upon the concerns and issues of the times. In response to concerns over synthetic food additives, pesticides, and cancer, the Food Additives Amendment to the FDCA was enacted in 1958, requiring the evaluation of food additives to establish safety. In 1960, the Color Additive Amendment to the FDCA was enacted, which required manufacturers to establish the safety of color additives in foods, drugs, and cosmetics. In 1966, the Fair Packaging and Labeling Act required products marketed on a retail basis to consumers in interstate commerce to be honestly and informatively labeled. Following well-publicized outbreaks of botulism food poisoning in canned foods in 1973, the FDA issued Low-Acid Food Processing Regulations. In 1978, in response to chloride deficiency in about 130 infants, the FDCA was amended by passage of the Infant Formula Act of 1980 requiring manufacturers to follow strict safety, quality, and analytical regulations.
Throughout the 1980’s, a growing interest developed in the effect of nutrition on health. At the same time, the food processing industry continued a trend of producing food nationally rather than locally. Various states implemented non-uniform laws to regulate health and nutrition claims, which the national industry asserted interfered with interstate commerce. In 1990, Congress responded by enacting the Nutrition Labeling and Education Act (NLEA) that requires nearly all packaged foods to bear nutritional labeling and requires nutritional and health claims for foods to be consistent with the terms defined by the FDA. NLEA preempts state requirements on food standards, nutritional labeling, and health claims. For more information, see the Food Labeling Reading Room.
In 1993, an outbreak of E. coli 0157:H7 in the Pacific Northwest caused 400 illnesses and four deaths. In response to public demands for safer ground beef products, the Food Safety Inspection Service (FSIS), an agency within the USDA, issued a rule implementing Hazard Analysis and Critical Control Point Systems (HACCP). The rule focuses on the prevention and reduction of microbial pathogens on raw products that can cause illness and applies to meat and poultry plants in the United States. By 2004, HACCP was required by the USDA in all meat and poultry processing plants and by the FDA in juice and seafood producing facilities.
Consistent with historical patterns of response to food crises, the federal government responded to the threat of food terrorism following September 11, 2001, by enacting new food laws to be applied within the established food regulatory system. The emerging regulation is largely encompassed in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). The Bioterrorism Act requires registration of food facilities, the establishment and maintenance of records, and prior notice of importation of food. The Bioterrorism Act also grants additional enforcement authority to the FDA.
In response to increasing incidents of food borne illness in the early 2000’s, President Barak Obama signed the Food Safety Modernization Act (FSMA) (P.L. 111-353) into law in 2011. The FSMA is considered the first major piece of federal legislation addressing food safety since 1938. The FSMA gives the FDA new authorities to regulate the way food is grown, harvested, and processed. The FSMA also allows the FDA to focus more on preventing food safety problems rather than primarily reacting to problems after they occur. Under FSMA, food facilities are required to implement a Food Safety Plan after conducting a Hazard Analysis of Risk-Based Preventive Controls (HARPC). This type of approach is very similar to the HACCP model employed by the FSIS in that it is a risk-based approach to the prevention of food safety outbreaks. Further, the FSMA provides the FDA with greater regulatory authority; namely the authority to issue a mandatory recall when a company fails to voluntarily recall unsafe food after being asked to by the FDA.
With the enactment of the FSMA, the FDA established science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. These standards, known as the FSMA final rule on Produce Safety (PSR), require covered farms to take appropriate measures to minimize the risk of serious adverse health consequences or death from the use of, or exposure to, covered produce. The PSR applies where there is a covered farm that raises covered produce under a covered activity. The PSR establishes safety standards regarding the following components of covered farms: (1) the use of water intended to or likely to contact covered produce; (2) the use of any chemical, biological, or physical material intentionally added to soil to improve the condition of soil, known as soil amendments; (3) the growing, harvesting, packing and holding of sprouts; (4) the potential for domesticated or wild animals to contaminate covered produce; (5) the potential for personnel and visitors to contaminate covered product; (6) worker health and hygiene; (7) personnel qualification and training; (8) the construction, maintenance, cleaning and sanitizing requirements for equipment; and (9) growing, harvesting, packing, and holding activities.
Role of Federal Agencies
Within the food safety statutory framework are several administrating federal agencies, each with specific responsibilities related to the safety of the nation’s food supply. Although a total of thirteen federal agencies play ancillary or supporting roles in the regulation of food safety, the FDA and the FSIS have most of the regulatory responsibility. The FSIS generally regulates all meat, poultry, and egg products, as well as catfish, while the FDA regulates almost all other foods and beverages.
The FDA is an agency within the Secretary of Health and Human Services (HHS). The FDCA grants food regulatory authority to the HSS, which has delegated its authority to the FDA. Accordingly, the FDA has jurisdiction over all “food” under the FDCA. The FSIS has food-safety and inspection jurisdiction over products containing more than “small amounts” of meat, poultry, and processed egg products under the PPIA and FMIA (see exact percentages below) Another example of an agency with food safety responsibility is the Environmental Protection Agency (EPA), which under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), establishes tolerances for pesticide residues in or on raw agricultural commodities and processed food products. For a discussion of the FIFRA, visit the Pesticides Reading Room.
The respective regulatory approaches of the FSIS and FDA are markedly divergent. Under FSIS jurisdiction, meat and poultry products must be approved prior to marketing. In contrast, food products under the FDA’s jurisdiction can be marketed without prior approval. The FSIS conducts continuous inspection at meat packing plants and requires trained inspectors to be on duty to examine meat animals both before and after slaughter. FSIS also inspects products prior to shipment to consumers. In contrast, the FDA inspects facilities on average once every three to five years. The FDA’s food safety budget and workforce are much smaller than those available to the FSIS.
Determining whether the FDA or the FSIS has jurisdiction over certain food facilities and food products can be tricky. Whether the FDA or the FSIS has regulatory authority depends upon the percentage of meat contained in a food product. The FDA has jurisdiction over products containing less than 2% cooked poultry meat and less than 10% of a combination of cooked poultry skins, giblets, fat, and poultry meat (limited to less than 2%). The USDA has jurisdiction over products containing 2% or more cooked poultry and 10% or more cooked poultry skins, giblets, fat, and poultry meat. Similarly, the FDA has jurisdiction over products containing less than 3% raw meat (other than poultry), less than 2% cooked meat, or less than 30% fat, tallow, or meat extract. The USDA has jurisdiction over products containing more than 3% raw meat, 2% or more cooked meat, or 30% or more fat, tallow, or meat extract.
Section 11016 of the Food, Energy, and Conservation Act of 2008, commonly referred to as the 2008 Farm Bill (P.L. 110-246), makes catfish subject to mandatory inspection under the FMIA as an “amenable species.” Other types of seafood were not included although report language suggests that the Secretary has authority under FMIA to bring in other types of seafood. In addition, the USDA is required to implement a voluntary grading system for catfish similar to other voluntary grading systems currently in effect. The Agricultural Act of 2014, commonly referred to as the 2014 Farm Bill (P.L. 113-79) continued USDA inspections of catfish despite early opposition to allegedly duplicative FDA and USDA inspection programs.
Since common issues concerning food safety regulation may involve the jurisdiction and expertise of more than one agency, the FDA, USDA, and other federal agencies coordinate their activities. The most common mechanism used to facilitate interagency coordination on food safety is the Memorandum of Understanding (MOU). More than fifty interagency agreements have been entered into by the federal agencies to govern their combined food safety oversight responsibilities. An FDA-FSIS working group has also met to explore changing rules about product categorization and agency jurisdiction to resolve some of the overlaps in authority. Federal and state agencies also coordinate in an effort to protect the food supply. This coordination extends to industry, where trade associations composed of food producers, processors, ingredient suppliers, retailers, and service establishments form model policies and support programs to help members enhance food safety and meet regulatory requirements. Other groups, such as consumer organizations, professional organizations, and academic organizations, play important roles in promoting food safety, researching food safety technology, and in training and education.
Section 11015 of the 2008 Farm Bill amended the PPIA and the FMIA to allow state-inspected plants to opt-in to a program that would allow these plants to ship across state lines. Under this program, a federal coordinator would supervise state inspectors in the plant. To be eligible, a plant cannot have more than 25 employees, with the exception that plants with 25-35 employees were eligible for the first three years after enactment. Products inspected under this program would display the federal inspection seal.
Despite these efforts of cooperation and coordination, the multi-agency delegation of food safety responsibilities has been criticized by many who advocate a single food safety agency. Many believe that a unified food safety agency with responsibility for the safety of the entire United States food supply is preferable over the existing multi-agency system. On the other hand, supporters of the existing United States food regulatory system point out that the system is strong and flexible because of the coordinated interactions among authorities. Supporters believe that these complementary and interdependent food safety missions create a comprehensive and effective system. Many are also concerned that the disparate regulatory culture, particularly at the FDA and FSIS, would make merging resources and personnel problematic.
Food Safety Standards
As a general matter, federal laws incorporate food safety into the definition of “adulteration.” The basic legal standard for what constitutes adulterated food is the same under the FDCA, PPIA, and FMIA. Generally speaking, food is adulterated if it contains a harmful substance that may pose a safety risk; it contains an added harmful substance that is acquired during production or cannot be reasonably avoided and exceeds applicable tolerance levels; it contains a substance that has been intentionally added to the food but that has not been approved or otherwise sanctioned for use by a regulatory agency or one of the food safety statutes; or it has been handled under unsanitary conditions, creating a risk of contamination with a substance that may pose a safety threat.
The regulatory driver for food safety standards for both the FSIS and the FDA has been a collective group of regulations called “good manufacturing practices” (GMPs). GMPs are standards that were adopted as regulations for food processing and handling following consultations with industry, experts, the public, and other interested parties, and after rigorous notice and comment periods. GMPs are preventative guidelines for plant and facility operations and serve as integral parts of HCCPS plans. With the 2011 signing of the FSMA, the FDA solicited public comments and updated the GMPs to Current Good Manufacturing Practices to help with the creation of mandatory HARPC food safety plans. GMPs serve as the backdrop to a strong food safety plan.
Food Additives and GRAS
Given the growth in processed foods, the Food Additives Amendment of 1958 occupies a critical place in the regulation of food safety. The term “food additive” includes any substance that is intended or may be reasonably expected to become a component of a food or would otherwise affect the characteristic of any food. The amendment sought to define the circumstances under which new added substances or food additives could be legally used. Food that contains an unapproved ingredient or an approved ingredient in quantities that exceed specified limits is adulterated. The Food Additives Amendment requires pre-market review of a food additive that depends on a showing that the proposed additive will be safe under the specific conditions of its use. The procedure for obtaining pre-market approval requires the submission of safety data including animal studies, toxicological studies, and other such evidence of safety by the proponent of the additive.
By congressional design, the 1958 Food Additives Amendment does not apply to all intentional or unintentional additives. The Amendment specifically excludes substances that are classified as generally recognized as safe (GRAS). GRAS exemptions are granted for substances that are generally recognized, among experts qualified by scientific training and experience to evaluate their safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or through experience based on common use in food) to be safe under the conditions of their intended use. For new food additives, the GRAS exemption represents the single most important provision of the Amendments. Companies can avoid the FDA’s costly food additive approval process through a process called GRAS self-determination. The GRAS self-determination process allows companies to determine for themselves that the conditions of use of a new ingredient in food products is generally recognized as safe. Self-determination of GRAS status permits the immediate marketing of a food additive.. GRAS is not recognized, however, as an exemption to the definition of a color additive.
Enforcement of Food Safety Standards
The array of enforcement tools available to the FDA and the FSIS include warning letters, adverse publicity, injunctions, product retention, seizure, criminal prosecution, and recall. These sanctions are not mutually exclusive and may build upon one another. Both the FDA and the FSIS depend on state and local government agencies to assist them in carrying out their food enforcement responsibilities. There is a considerable amount of overlap in food enforcement authority between the states and the FDA and the FSIS. .
The recall of food is considered the most important tool in the enforcement of food safety regulations. With the addition of the FSMA of 2011, the FDA now has the statutory authority to order companies to recall food, while all recalls administered by the FSIS remain voluntary. For companies under the regulatory jurisdiction of the FSIS, the implicit threat of regulatory action, liability, and adverse liability make recall the only practical option for a company experiencing food safety problems.
The FSMA dramatically increased the FDA’s legislative mandate over food safety, primarily by shifting from reactionary food safety to more preventative methods. The law requires: food production facilities to conduct a hazard-based risk assessment and develop risk based preventative controls; the development of science-based safety standards for fruits and vegetables; increased inspection frequency for all facilities through greater state and local agency partnerships; and improved traceability for domestic and imported food products to respond to a foodborne illness outbreak more effectively. Additional regulations were also placed on food importers, requiring verification that their international suppliers are complying with domestic food safety laws and providing the FDA with the authority to deny entry for products arriving from facilities or countries that have denied FDA access.
Section 11017 of the 2008 Farm Bill requires any establishment subject to FSIS inspection (producers of meat, poultry, egg, and catfish products) to promptly notify the USDA if it has reason to believe that a misbranded or adulterated meat or poultry product has entered commerce. FSIS inspected establishments are also required to develop and maintain recall plans for inspectors to copy and review.
Because FSIS inspection is mandatory for products under its oversight, the FSIS can impose a serious sanction against a firm by withdrawal of inspection. Loss of inspection results in putting the establishment out of business. Because the FSIS must seek withdrawal of the grant of federal inspection from a company through an administrative proceeding, this enforcement tool is sought infrequently.
Criminal prosecution against corporations and individuals for violations of food regulations is the ultimate enforcement tool for the FDA and the FSIS. Offenses may be prosecuted as misdemeanors or felonies, and penalties may involve fines or imprisonment. The legal standard for individual criminal liability under the FDCA is set forth in United States v. Park, 421 U.S. 658 (1975). The U.S. Supreme Court held that the FDCA is a strict liability law with respect to responsible corporate officials, meaning that corporate officials can be responsible irrespective of whether he or she had actual knowledge of the violative condition.
New technologies have generated considerable controversy pertaining to the safety of food. One such technology is biotechnology, which is the manipulation of the genetic material of living seeds or embryos, usually before they reach the farm. The United States approach to the regulation of these genetically modified (GM) products is termed “substantial equivalence.” Under substantial equivalence, the attributes of new GM products are compared to conventional products that have been consumed for many years. New crop varieties produced through biotechnology – if they are “substantially equivalent” – are treated the same as their conventional counterparts. For information on biotechnology, visit the Biotechnology Reading Room.
Another new technology is irradiation, a processing treatment in which foods are exposed to ionizing energy after harvest or slaughter. A variety of foods have been approved for irradiation in the United States for numerous purposes including mold control, sprout inhibition, eradication of parasites, increasing shelf life, sterilization, and reduction of bacterial pathogens. For meat irradiation, separate approval is required from both the FDA and the USDA.
International Standards and Food Imports
Food safety regulation also intersects with developing international standards. The Codex Alimentarius Commission was created in 1962 by two United Nations organizations, the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Codex is the major international mechanism for encouraging fair international trade in food while promoting the health and economic interests of consumers. Within the United States, officials from the USDA and the FDA work to coordinate Codex activities.
Given the dramatic growth in recent years of food imported into the United States, high profile cases of food safety problems with imported food has proved especially vexing to authorities. Although all food products imported into the United States must meet the same safety standards as domestically produced foods, international trade rules permit a foreign country to apply its own differing regulatory authorities and institutional systems in meeting such standards under an internationally recognized concept known as “equivalence.”
Under the PPIA and FMIA, the FSIS is responsible for determining the equivalence of other countries’ meat and poultry safeguards. A foreign plant cannot ship products to the United States unless the FSIS has certified that its country has a program that provides a level of protection that is at least equivalent to the United States system. In addition, the FSIS operates a reinspection program at United States border entry points.
Under the FDCA, the FDA can refuse entry to any food import if it “appears,” based on a physical examination or otherwise, to be adulterated, misbranded, or in violation of the law. In exercising its oversight, the agency relies on a system of prior notifications by importers and document reviewers at points of entry. The FDA’s ability to operate within other countries is more limited than that of the FSIS. The FDA can, and does, periodically visit foreign facilities to inspect their operations, but usually in response to a concern and only with the permission of the foreign government. Regardless of whether it might have the legal authority to do so, the FDA asserts that it lacks the staff and funding to increase its presence overseas. For more information on international issues, please refer to the International Trade Reading Room.
A growing number of food retailers in the global food supply chain are adopting private food safety standards that often exceed the safety standards mandated by federal and state law. These standards govern the safety and quality of the production of food product via contract and third-party certification. The implications of these private standards on food safety and the interplay between these standards and federal and state law are unknown at this point.