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.
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 laws 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. Harvey Wiley’s poison squad and the publication of Upton Sinclair’s The Jungle.
In 1902, Congress appropriated funds to the United States Department of Agriculture’s (USDA’s) Bureau of Chemistry, the predecessor of the Food and Drug Administration (FDA), to study chemicals that were commonly used as food preservatives and additives at the time. Such chemicals included formaldehyde, arsenic, chalk, salicylic acid, and Borax. Dr. Harvey Wiley was the chief chemist of the Bureau of Chemistry and oversaw the study. Dr. Wiley recruited volunteers who became known as the “poison squad” and the recruits were to eat three meals a day prepared by Dr. Wiley’s team. Dr. Wiley and his team tested one chemical at a time and would observe the effects of that chemical on the poison squad. Among the poison squad, there was a control group who received meals not contaminated with the chemical being tested. Dr. Wiley published the findings after testing each chemical and many Americans became appalled by the affects the food they were eating could have on their health. In his findings, 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. During the same time Dr. Wiley was publishing his findings, Upton Sinclair published his novel, The Jungle, which portrayed nauseating practices and unsanitary conditions in the meat-packing industry that captured the public’s attention.
Dr. Wiley’s studies and Upton Sinclair’s book both captured the attention of politicians. In 1906, Congress passed, and President Theodore Roosevelt signed into law, both the Pure Food and Drugs Act and the Federal Meat Inspection Act (FMIA). Passage of these two statutes began the modern era of United States food regulation. Neither the Pure Food and Drugs Act nor the FMIA established a pre-market approval system for food ingredients or drugs. These laws only allowed government action after products were on the market. The laws prohibited 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. Because these laws separated meat safety and food safety regulation among different federal regulatory bodies, we still today have a jurisdictional split in meat and food safety regulation. The Pure Foods and Drugs Act was administered by the predecessor of what is today the FDA, and the FMIA was originally administered by the predecessor of what is today the Food Safety and Inspection Service (FSIS).
In 1930, the Bureau of Chemistry was reorganized, and a portion of the former agency became what is today known as the FDA. In 1933, the FDA recommended the Senate pass a bill to completely revise 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 people, many of which were children. This tragedy spurred Congress to act, and in 1938 Congress passed the Federal Food, Drug, and Cosmetic Act (FDCA). The 1938 FDCA created standards of identity, quality standards, and fill of container standards, many of which are still in effect today. Similarly, Congress passed the Poultry Products Inspection Act (PPIA), which is similar to the FMIA, 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 1958 Congress enacted the Food Additives Amendments to the FDCA in response to concerns over synthetic food. These amendments required food manufacturers to evaluate food additives to establish safety and led the FDA to promulgate its Generally Recognized as Safe (GRAS) regulations. In 1960, Congress enacted the Color Additive Amendment to the FDCA, which required manufacturers to establish the safety of color additives in foods, drugs, and cosmetics. In 1966, the Fair Packaging and Labeling Act required manufacturers to honestly and informatively label products marketed on a retail basis to consumers in interstate commerce. In 1973, Following well-publicized outbreaks of botulism food poisoning in canned foods, the FDA issued Low-Acid Food Processing Regulations. In 1978, in response to chloride deficiency in about 130 infants, Congress amended the FDCA and passed the Infant Formula Act of 1980 which required manufacturers to follow strict safety, quality, and analytical regulations.
By the 1980’s, the food industry was dominated by only a few key national and global players, and there was not much as a local food industry. However, throughout the United States there were non-uniform laws regulating health and nutrition claims. The large food companies began arguing that these laws interfered with interstate commerce. In 1990, Congress responded and enacted the Nutrition Labeling and Education Act (NLEA) which 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, FSIS 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 FSIS 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. In 2002, Congress passed the Public Health Security and Bioterrorism Preparedness and Response Act (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, in 2011, President Barak Obama signed the Food Safety Modernization Act (FSMA) (P.L. 111-353) into law. FSMA is considered the first major piece of federal legislation addressing food safety since 1938. FSMA gives the FDA authority to regulate the way food is grown, harvested, and processed. 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 FSIS in that it is a risk-based approach to the prevention of food safety outbreaks. Further, 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 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.
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 FSIS have most of the regulatory responsibility.
FSIS is housed within the United States Department of Agriculture and has food-safety and inspection jurisdiction over products containing more than “small amounts” of meat, poultry, and processed egg products under the FMIA, PPIA, and Egg Products Inspection Act (EPIA). FSIS also has jurisdiction over catfish, which since the 2008 Farm Bill, is regulated under the FMIA. Meanwhile, the FDA is an agency within the Department of Health and Human Services (HHS) and regulates almost all other foods and beverages. Accordingly, the FDA has jurisdiction over all “food” under the FDCA. Although the FDCA grants FDA primary regulatory authority over foods that are not regulated by the FMIA, PPIA, and EPIA, it also grants the Environmental Protection Agency (EPA) some authority over the pesticides used in food production. For a discussion on EPA’s food regulatory authority, visit the Pesticides Reading Room.
The respective regulatory approaches of FSIS and FDA are markedly divergent. Under FSIS jurisdiction, FSIS must inspect all meat and poultry products before they enter interstate commerce. 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. FSIS also must pre-approve all labels placed on meat and poultry products that will be sold across state lines. In contrast, FDA inspects facilities on average once every three to five years and FDA regulated food manufacturers may market their food without prior FDA approval. As a result of these regulatory differences, FDA’s food safety budget and workforce are much smaller than those available to the FSIS even though FDA regulates around 80% of the food supply.
Determining whether the FDA or 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%). FSIS 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. FSIS has jurisdiction over products containing more than 3% raw meat, 2% or more cooked meat, or 30% or more fat, tallow, or meat extract.
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 is through memoranda of understanding (MOUs). Federal agencies have entered into more than fifty interagency agreements 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 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.
Despite these efforts of cooperation and coordination, some have criticized the multi-agency delegation of food safety responsibilities and advocate for a single food safety agency. 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. There are also concerns 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, FMIA, PPIA, and EPIA. Generally speaking, food is adulterated if it (1) contains a harmful substance that may pose a safety risk; (2) contains an added harmful substance that is acquired during production or cannot be reasonably avoided and exceeds applicable tolerance levels; (3) contains a substance that has been intentionally added to the food but has not been approved or otherwise sanctioned for use by a regulatory agency or one of the food safety statutes; or (4) 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 FSIS and the FDA are a collective group of regulations called “good manufacturing practices” (GMPs). GMPs are preventative guidelines for plant and facility operations and serve as integral parts of HCCPS plans. The goal of GMPs is to ensure that food manufacturers are taking the precautions necessary to avoid adulteration.
Food Additives and GRAS
As defined in the 1958 Food Additives Amendment to the FDCA, the term “food additive” refers to 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 food manufacturers could legally add new substances or additives to food. Under the amendment, food is adulterated if it contains an unapproved ingredient or an approved ingredient in quantities that exceed specified limits. The Food Additives Amendment requires pre-market review of a food additive that requires the petitioning food manufacturer to prove that the proposed additive will be safe under the specific conditions of its use. The procedure for obtaining pre-market approval requires petitioners to submit to FDA safety data including animal studies, toxicological studies, and other evidence of safety.
However, if the scientific information about a substance’s safety is widely known, then the food manufacturer can much more easily use the additive. The amendment specifically excludes substances that are classified as generally recognized as safe (GRAS) from the pre-market approval process. FDA classifies a substance as GRAS if it is generally recognized, among experts qualified with scientific training and experience to evaluate food safety, to be safe under the conditions of the substance’s intended use. Under the amendment, FDA may classify substances used in food prior to January 1, 1958, as GRAS based on experience data, or data showing that the additive has not posed a risk in the past. The GRAS determination process offers companies the opportunity to avoid the FDA’s food additive pre-market approval process through and partake in GRAS self-determination. The GRAS self-determination process allows companies to determine for themselves that the conditions of use of a new ingredient in a food product is GRAS, and the company does not need to notify FDA of the determination. Self-determination of GRAS status permits the immediate marketing of a food additive. It is important to note that under FDA’s regulations, color additives are not considered food additives and therefore are not regulated under the GRAS determination process.
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). 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.
Despite these statistics and facts, not all foodborne illness causing pathogens are considered adulterants under the FDCA, FMIA, PPIA, and EPIA. Additionally, the FDA and FSIS evaluate whether a pathogen is an adulterant differently. To learn more about these differences, read former Staff Attorney Jana Caracciolo’s article series The Adulterating Foodborne Pathogens, here and here.
Enforcement of Food Safety Standards
The array of enforcement tools available to the FDA and 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 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 FSIS.
The recall of food is considered the most important tool in the enforcement of food safety regulations. Under FSMA, the FDA has the statutory authority to order companies to recall food, while all recalls administered by FSIS remain voluntary. For companies under the regulatory jurisdiction of FSIS, the implicit threat of regulatory action, liability, and adverse liability make recall the practical option for a company experiencing food safety problems.
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; FDA to develop science-based safety standards for fruits and vegetables; FDA to increase inspection frequency for all facilities through greater state and local agency partnerships; and FDA to improve traceability for domestic and imported food products to respond to foodborne illness outbreaks more effectively. FSMA also placed additional regulations on food importers. It requires food importers to verify that their international suppliers are complying with domestic food safety laws. FMSA also granted the FDA the authority to deny entry for products arriving from facilities or countries that have denied the FDA access.
Although FSMA only applied to the FDA, Congress has also improved FSIS’s food safety authority over time. 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 FSIS 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, FSIS can impose a serious sanction against a firm by withdrawing inspection. Without inspection, the establishment is not able to sell any of the meat, poultry, or egg products it produces. However, FSIS must seek withdrawal of the grant of federal inspection through an administrative proceeding, therefore, 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 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.
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 have 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 FMIA and PPIA, 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, 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 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 products 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.