Introduction and Background
Humans must have food to survive. In the United States and other countries, the system of obtaining food was highly localized before the twentieth century. With the development of new technologies and improved transportation, food production and distribution systems became national in scope and more complex. The current food system stretches from producers to consumers and is international in scope. Ensuring its quantity, nutritional adequacy, and safety has become more complicated, and requires major government and private-sector efforts.
Food safety encompasses a wide spectrum of issues-not only the avoidance of foodborne pathogens, chemical toxicants, and physical hazards, but also issues such as nutrition, food quality, labeling, and education. The system for regulating the food supply in the United States involves all levels of government from federal to local. The present legal framework is comprised of many inconsistent statutes and regulations, and implementing authority is spread among at least 12 federal agencies1 (Appendix A). Such a fragmented structure requires heroic efforts at cooperation, communication, and coordination (federal agencies have reported more than 50 interagency agreements), but duplication of efforts and regulatory gaps are common. Food safety problems that transcend
the jurisdictional boundaries of two or more agencies are often not reported in the most expeditious manner. The General Accounting Office (GAO) reports that the National Marine Fisheries Service (NMFS), which operates a voluntary seafood inspection program, failed to notify the Food and Drug Administration (FDA), the agency with regulatory responsibility for corrective action, of 198 plants that failed NMFS inspection between 1988 and 1991 (GAO, 1992).
Recent outbreaks involving such items as Guatemalan raspberries, hamburger, ice cream, and cereal have raised concern over the adequacy of the current system to ensure the safety of the US food supply. The GAO, public interest groups, and several members of Congress have suggested the consolidation of the existing federal food safety structure into a single food safety agency (GAO, 1997). (See Appendix B for a 1998 Congressional Research Service analysis of several proposals.) In addition, the Institute of Food Technologists (IFT) recently developed Guiding Principles for Optimum Food Safety Oversight and Regulation in the United States, which describes attributes of an effective food safety system (IFT, 1998). These principles have been endorsed by 13 professional, scientific societies.
To improve the safety of the US food supply, in early 1997 President Clinton directed the Secretary of Agriculture, the Secretary of Health and Human Services, and the Administrator of the Environmental Protection Agency to develop a food safety initiative. Food Safety from Farm to Table: A National Food-Safety Initiative (Appendix C) seeks to address hazards that present the greatest risk, make the best use of public and private resources, increase collaboration between public and private organizations, and improve coordination in the government. Recently, President Clinton announced a plan to create a Joint Institute for Food Safety Research that will develop a coordinated strategy for conducting food safety research consistent with the above national initiative (Office of the President, 1998).
CHANGES IN THE US FOOD SYSTEM AND THEIR EFFECTS ON FOOD SAFETY
The US food supply is abundant and affordable and it is acknowledged by many to pose an acceptable level of risk. The food system has evolved from one that provided consumers with minimally processed basic commodities for home meal preparation to today's availability of highly processed products that are ready-to-eat or require minimal preparation. Food preservation processes have changed dramatically from traditional salting, curing, drying, and heating. Today's products are the result of many technological developments such as pasteurization, irradiation, and genetic engineering. Likewise, food distribution systems have changed greatly. The broad introduction of refrigerated railcars and trucks, freezers, and air transport created a national and now global food
system. These changes allow out-of-season availability, convenience, variety, and improved sensory attributes.
The size and complexity of the US food system raise many safety issues, for example:
- The emergence of new foodborne pathogens such as Escherichia coli 0157:H7 and the re-emergence of previously identified pathogens such as Salmonella have resulted in new microbiological hazards.
- Advances in science and technology that allow the development of genetically modified foods and the construction of modified macronutrients require new ways of evaluating the safety of substances added to the food supply, and this need will increase.
- Heightened consumer interest in raw or minimally processed fruits and vegetables, partly in response to dietary recommendations, has created a year-round demand for fresh produce, which can be met out-of-season only through increased imports (GAO, 1998). This increased produce volume requires additional attention to possible contamination of domestic as well as imported fruits and vegetables.
- Americans eat fewer home-prepared meals than ever before, in response to changes in the US workforce and to developments in food processing and food service that offer greater convenience and variety in available foods (FMI, 1998b). The potential for contamination increases as food is handled by more people.
- As technology has advanced, a smaller number of food facilities provide food to larger numbers of US consumers, increasing the extent of harm that can arise from a single incident.
- The remarkable success of modern medicine in extending the lifespan and increasing the quality of life for many people has placed new demands on the food system and on those responsible for guarding its safety. Increasing numbers of people have immune systems that are compromised because of age, illness, or medical treatment. These people are highly susceptible to illness and death from microbial pathogens, and might be more sensitive to new food ingredients and recently identified natural components of the diet.
- Increasing consumption of fortified foods and dietary supplements, including herbals, has raised new questions about the safety of ''natural" substances not normally in the diet, or normally part of the diet but at much lower concentrations, and about the health effects of consuming high concentrations of nutrients ordinarily considered safe.
Thus, the developments that have provided the American consumer with a wide array of food products have also introduced risks. Government has attempted to address such developments by adding structures and processes without always considering their effects on other aspects of the system. As a
result, inefficiencies and apparent conflicts within the system have arisen. Some have been corrected (for example, pesticides have been exempted from the Delaney clause's ban on carcinogens2), but others remain. For example, inspectors from multiple agencies oversee parallel and nearly identical processes in the same food processing facility.
The current food safety system has evolved piecemeal over almost a century in response to changes in the food supply and to changes in the biophysical and social environments in which the system operates. The present system is not the product of planning, and it is often not equipped to anticipate changes. But the situation is not just haphazard; changes in risks have made the system outmoded. The role and organization of government entities have remained largely unchanged, and the food safety system has fallen behind today's needs.
SCOPE OF THE FOOD SAFETY PROBLEM
Over the years, as the agriculture and marketing systems have evolved to provide food to a growing and increasingly sophisticated population, complex processes built on advances in science and technology have been developed to evaluate and manage the risks associated with the food supply. In spite of well-established systems that control many food risks, serious hazards to public health remain. Although estimates vary greatly, there is agreement that foodborne illness is a serious problem. In the United States, an estimated 81 million cases of foodborne illness may occur each year (Archer and Kvenberg, 1985), resulting in as many as 9,000 deaths (CAST, 1994). The estimated annual medical costs and productivity losses due to seven major foodborne pathogens range from $6.6 billion to $37.1 billion (Buzby and Roberts, 1997).
The responsibility for managing foodborne risks is shared throughout the system because the wholesomeness and safety of a food are influenced by all the people and processes that handle or transform it from production to consumption (Sobal et al., in press). Federal, state, and local governments play major roles in managing risks to protect the public from hazards in the food supply. Regulatory agencies are empowered to prescribe rules, standards, and processes to control risks; to develop and maintain research programs to apply contemporary science and technology to safety decisions; to monitor risks in the food supply; and to provide information and education to all components of the food system. In authorizing and funding efforts to ensure the safety of the food supply, the government must balance the interests of diverse groups and allocate finite resources among competing needs.
Faulty handling of a product at any point in the system can transform a safe product into one that can cause serious harm. Producers, shippers, importers, processors, wholesalers, retailers, handlers, and consumers all influence the health risks associated with food products. Consumers play a particularly important role in the control of microbiological risks, both in their food handling practices and in their demand for an effective, efficient food safety system.
Food safety issues also involve the interplay of domestic and international legal, political, scientific, social, and economic forces. Intense debates about desired levels of protection and about the appropriateness of different control measures can arise as parties discuss the scientific bases for risk decisions, public expectations, and relative costs and benefits of intervention in different ways and in different components of the food system.
Science must play a vital role in food safety decisions through risk assessment, that is, the identification of hazards and the determination of the likelihood and severity of risk under given conditions of exposure (IOM, 1997). Hazards are biological, chemical, or physical substances that can cause adverse consequences. Hazards associated with food include microbiological pathogens, naturally occurring toxins, allergens, intentional and unintentional additives, modified food components, agricultural chemicals, environmental contaminants, animal drug residues, and excessive consumption of some dietary supplements. In addition, certain methods of food preparation in the home can contribute to increasing some of these hazards. However, a hazard does not pose a risk in the absence of exposure. The susceptibility of the consumer and the magnitude of exposure determine whether those hazards cause immunological changes, genetic and developmental changes, cancer, or death.
Hazard identification is the basis for estimating risk. A food safety risk is the probability of harm to health resulting from a food-related hazard at a particular exposure to a specified person or group. It is important to recognize that safety is an intellectual concept, not an inherent biological property of a substance; safety has been defined as the judgment of an acceptable level of risk. Thus, "safe food" involves a subjective evaluation of social issues and values, as well as a scientific assessment of risk (Lowrance, 1976; Miller, 1997).
HISTORY OF US FOOD SAFETY REGULATION
In the United States, regulation of food safety was largely the responsibility of state and local officials until the first decade of the twentieth century. Nineteenth century legal theorists questioned whether the US Constitution gave Congress the authority to legislate matters of health and safety. The emergence of a national market for food, combined with shocking stories of practices in the food industry, spurred the federal government to reassess its responsibility to ensure food safety. In response, in 1906 Congress passed the Meat Inspection
Act and the Pure Food and Drugs Act, the first national laws designed to protect consumers against foodborne illness.
Although those seminal laws provide the basic legal and institutional framework for the federal regulation of food safety that we observe today, they are very different in their implementation and responsibilities. Their core was similar: each prohibited the shipment in interstate commerce of food that met any of several definitions of "adulteration." Those definitions, or proscriptions, targeted products that were spoiled, contaminated with filth, derived from diseased animals, or contained unsafe substances. In short, both laws sought to prevent the sale of food that could offend consumers or cause them to become ill.
The original Meat Inspection Act and Pure Food and Drugs Act focused on different sectors of the food market and, from the beginning, supported different approaches to ensuring compliance. The Meat Inspection Act, which has been administered by the US Department of Agriculture (USDA) since its inception, requires continuous on-site factory inspections by government inspectors using sight, smell, and touch to detect problems. The USDA also administers the 1957 Poultry Products Inspection Act, which requires continuous inspection of poultry and poultry products and the 1970 Egg Product Inspection Act, which requires continuous inspection of the processing of liquid, frozen, and dried egg products. Animal carcasses and processed products cannot be shipped from the processing plant until they have been inspected and deemed to be unadulterated by the USDA inspector.
The 1906 Pure Food and Drugs Act was administered by the USDA Bureau of Chemistry, which was renamed the Food and Drug Administration (FDA) in 1930. In 1940, FDA was transferred to the Federal Security Agency, and in 1953 it became a separate entity in the Department of Health, Education, and Welfare, later retitled the Department of Health and Human Services. FDA, with a more varied and ever-expanding industry to regulate, has used a sampling strategy in which far fewer inspectors pay periodic visits to settings where food is produced, processed, or stored to verify compliance with its requirements or to uncover and punish violations. In 1958, when Congress enacted the Food Additives Amendment to the Food, Drug, and Cosmetic Act of 1938, the FDA was given premarket review and approval authority over chemical additives to foods.
The meat and poultry inspection system still requires sight, smell, and touch inspections, which are ineffective in addressing the current issues of food safety. Expert opinion that USDA inspection procedures do not adequately address the microbiological problems associated with meat and poultry (NAS, 1987; 1990) led to the adoption of a new approach to inspection using the Hazard Analysis Critical Control Point (HACCP) system (NAS, 1985). In contrast to the reactive characteristics of traditional food safety strategies, the HACCP system focuses on preventing hazards that could cause foodborne illness by applying science-based controls at each step of the process from raw material to finished product.
Following the recommendation of a National Academy of Sciences committee, FDA adopted the HACCP approach for seafood inspection in December 1995, and USDA began the implementation of HACCP for meat and poultry inspection in January 1997 with completion of the implementation by January 2000 (FDA, 1995; FSIS, 1996b, 1998).
Agencies other than USDA and FDA-such as the National Marine Fisheries Service (NMFS) in the Department of Commerce, the Environmental Protection Agency (EPA), the Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH)-also have roles in food safety. NMFS conducts a voluntary seafood inspection and grading program and does research on seafood safety. The EPA Office of Prevention, Pesticides, and Toxic Substances is responsible for risk assessment, product approvals, tolerance setting, and research on pesticide residues in or on human food and animal feed. State health departments in conjunction with CDC are responsible for the surveillance and investigation of illnesses related to foods, and NIH conducts research related to foodborne disease. Many state and local agencies are also involved in food safety regulation and inspection.
With so many agencies involved in food safety, decisions and priorities often focus on specific issues rather than strategies, and they are not always well-integrated. The system that has evolved in the federal government for regulating food safety is complex, fragmented, and cumbersome.
THE COMMITTEE AND ITS CHARGE
Congress (HR 2160 Conference Report) directed USDA's Agricultural Research Service to contract with the National Academy of Sciences to conduct a study on the scientific and organizational needs of an effective food safety system. The Academy appointed an ad hoc Food Safety Oversight Commission composed of selected members of the Institute of Medicine's Food and Nutrition Board, the National Research Council's (NRC) Board on Agriculture, and the NRC Commission on Life Science's Board on Environmental Studies and Toxicology; in turn, the ad hoc commission convened the Committee to Ensure Safe Food from Production to Consumption.
The committee was charged with determining the scientific basis of an effective food safety system; assessing the effectiveness of the current US system to ensure safe food; identifying scientific and organizational needs and gaps in the current system at the federal level; and providing recommendations to move toward the scientific foundation and organizational structure of a more effective food safety system for present and future generations. If organizational changes were recommended, a subsequent study on implementing the recommendations was to follow, if requested. Given the constraints on time and funding, the committee focused on the role of the federal government in ensuring safe food.
The committee is aware that safe food is and always will be a moving target with respect to both changing hazards and changing degrees of acceptance of risk. This report is not and cannot be a comprehensive, all-inclusive discussion of these issues and adoption of its recommendations will not end the effort to make food safer. It is not possible to foresee how risk acceptance will change or how the problems will change in decades to come, but federal food safety efforts must be designed effectively to deal with what is known and what is not known.