2
The Current US Food Safety System

Every organization and every person involved with the food chain from farm and sea to table shares responsibility for the safety of food. Our "food safety system" includes producers, processors, shippers, retailers, food preparers, and, ultimately, consumers. The government plays an important role by establishing standards and overseeing their enforcement. Supporting roles are played by trade and consumer organizations that inform policy and by professional organizations and academic institutions that engage in research and education. Great responsibility lies with consumers who must be cognizant of the level of safety associated with the foods they purchase and who must handle these foods accordingly. The food safety system in this country is complex and multilevel. It is also essentially uncoordinated. As a consequence, the government's role is also complex, fragmented, and in many ways uncoordinated.

The committee heard testimony from diverse groups asserting that the US food supply is among the safest in the world (Appendix D), yet found little evidence to either support or contradict this assertion. In fact, surveillance and reporting systems are insufficient in scope, resources, and statutory authority to generate reliable current measures of foodborne illness, much less to establish trends.

This chapter describes the main features of the current food safety system, including regulation, surveillance, research and development, consumer education, and international dimensions. This overview does not provide a detailed description of the system, but it does illustrate where current



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2 The Current US Food Safety System Every organization and every person involved with the food chain from farm and sea to table shares responsibility for the safety of food. Our "food safety system" includes producers, processors, shippers, retailers, food preparers, and, ultimately, consumers. The government plays an important role by establishing standards and overseeing their enforcement. Supporting roles are played by trade and consumer organizations that inform policy and by professional organizations and academic institutions that engage in research and education. Great responsibility lies with consumers who must be cognizant of the level of safety associated with the foods they purchase and who must handle these foods accordingly. The food safety system in this country is complex and multilevel. It is also essentially uncoordinated. As a consequence, the government's role is also complex, fragmented, and in many ways uncoordinated. The committee heard testimony from diverse groups asserting that the US food supply is among the safest in the world (Appendix D), yet found little evidence to either support or contradict this assertion. In fact, surveillance and reporting systems are insufficient in scope, resources, and statutory authority to generate reliable current measures of foodborne illness, much less to establish trends. This chapter describes the main features of the current food safety system, including regulation, surveillance, research and development, consumer education, and international dimensions. This overview does not provide a detailed description of the system, but it does illustrate where current

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responsibilities and allocations of resources exist and how the system currently functions. REGULATION Federal Regulatory Programs At least a dozen federal agencies implementing more than 35 statutes make up the federal part of the food safety system. Twenty-eight House and Senate committees provide oversight of these statutes. The primary Congressional committees responsible for food safety are the Agriculture Committee and Commerce Committee in the House; the Agriculture, Nutrition, and Forestry Committee and the Labor and Human Resources Committee in the Senate; and the House and Senate Agriculture, Rural Development, and Related Agencies Appropriating Subcommittees. Four agencies play major roles in carrying out food safety regulatory activities: the Food and Drug Administration (FDA), which is part 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); and the National Marine Fisheries Service (NMFS) of the Department of Commerce. More than 50 interagency agreements have been developed to tie the activities of the various agencies together. FDA has jurisdiction over domestic and imported foods that are marketed in interstate commerce, except for meat and poultry products. FDA's Center for Food Safety and Applied Nutrition (CFSAN) seeks to ensure that these foods are safe, sanitary, nutritious, wholesome, and honestly and adequately labeled. CFSAN exercises jurisdiction over food processing plants and has responsibility for approval and surveillance of food-animal drugs, feed additives and of all food additives (including coloring agents, preservatives, food packaging, sanitizers, and boiler water additives) that can become part of food. CFSAN enforces tolerances for pesticide residues that are set by EPA and shares with FSIS responsibilities for egg products (FDA, personal communication to committee, March 1998). The FDA's statutes give CFSAN jurisdiction over restaurants, but it has always ceded this responsibility to states and localities. The agency provides leadership for state regulation of retail and institutional food service through the development of a model Food Code, which it recommends be adopted by states and localities (DHHS, 1995; 1997a). FDA has oversight responsibility for an estimated 53,000 domestic food establishments (Rawson and Vogt, 1998). In fiscal year 1997, FDA devoted 2,728 staff-years to food safety activities (Lisa Siegel, FDA, personal communication to committee, July 1998). Food safety consumes about 23.5 percent of FDA's budget each year (OMB, 1998). In 1997, that amounted to approximately $203 million for food safety surveillance, risk assessment,

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research, inspection, and education out of the total FDA budget of $997 million (Appendix E; Lisa Siegel, FDA, personal communication to committee, July 1998). The largest share of FDA's budget is devoted to its nonfood responsibilities including drugs, cosmetics, and medical devices. The agency's culture and its public image have been dominated by its drug approval mission. FSIS seeks to ensure that meat and poultry products for human consumption are safe, wholesome, and correctly marked, labeled, and packaged if they move into interstate or international commerce. By the mid-1990s, roughly 7,400 FSIS inspectors were responsible for inspecting 6,200 meat and poultry slaughtering and processing plants by continuous carcass-by-carcass inspection during slaughter as well as by full daily inspection during processing (FSIS, 1996b). FSIS shares responsibility with FDA for the safety of intact-shell eggs and processed egg products. Because of the statutorily mandated continuous inspection requirements, FSIS's inspection budget is about four times that of FDA (Appendix E; Thomas Billy, FSIS, personal communication to committee, March 1998). Food scientists believe that inspection of each animal carcass is no longer the best or most cost-effective means of preventing foodborne diseases, but this effort is required by statute and so is fully funded. The sensory evaluation inspection methods used in FSIS inspections were appropriate when adopted 70 years ago, when major concerns included gross contamination, evidence of animal disease, and other problems that are no longer acute concerns. Those methods are not appropriate or adequate to detect the major microbial and chemical hazards of current concern. Because of the FDA-USDA jurisdictional split along commodity lines, some food products that might be perceived by consumers as similar are regulated differently, depending on content. The most cited example is pizza, which is regulated by FDA unless topped with 2 percent or more of cooked meat or poultry, in which case it is USDA-regulated (FSIS, 1996a; 9 CFR 319.600). This means that inspection at pizza production facilities must be conducted simultaneously under two sets of guidelines by two different inspectors from separate agencies. EPA licenses all pesticide products distributed in the United States and establishes tolerances for pesticide residues in or on food commodities and animal feed. EPA is responsible for the safe use of pesticides, as well as food plant detergents and sanitizers, to protect people who work with and around them and to protect the general public from exposure through air, water, and home and garden applications, as well as food uses. EPA is also responsible for protecting against other environmental chemical and microbial contaminants in air and water that might threaten the safety of the food supply (EPA, personal communication to committee, May 1998). In both programs, EPA works with state and local officials. NMFS conducts a voluntary seafood inspection and grading program which is primarily a food quality activity. Seafood is the only major food source that is both "caught in the wild" and raised domestically. Seafood is an international commodity for which quality and safety standards vary widely from country to

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country. Inspection of processing is a challenge because much of it takes place at sea (NMFS, personal communication to committee, March 1998). Mandatory regulation of seafood processing is under FDA, and applies to all seafood related entities in FDA's establishment inventory, including exporters, all foreign processors that export to the United States, and importers. However, fishing vessels, common carriers, and retail establishments are excluded. The Agricultural Marketing Service (AMS), Grain Inspection, Packers, and Stockyards Administration (GIPSA), and Animal and Plant Health Inspection Service (APHIS) of the USDA oversee the USDA's marketing and regulatory programs. Together they play indirect roles in food safety and more direct roles in marketing, surveillance, data collection, and quality assurance (USDA, personal communication to committee, May 1998). The Centers for Disease Control and Prevention (CDC) of DHHS engages in surveillance and investigation of illnesses associated with food consumption in support of the USDA and FDA regulatory missions (Morris Potter, CDC, personal communication to committee, March 1998). The Federal Trade Commission, through regulation of food advertising, plays an indirect role in food safety regulation. Several other federal agencies have smaller but important regulatory responsibilities in food safety. For example, the Department of the Treasury's Bureau of Alcohol, Tobacco, and Firearms is responsible for overseeing the production, distribution, and labeling of alcoholic beverages, except for wines containing less than 7 percent alcohol, which are the responsibility of FDA. The department's Customs Service assists other agencies in ensuring the safety and quality of imported foods through such services as collecting samples. State and Local Regulatory Systems State and local health departments are responsible for surveillance at the state and local level and the extent to which these activities are carried out varies widely by jurisdiction. States and territories have separate departments of health and of agriculture. In addition, many counties and many cities have parallel agencies. In total, more than 3,000 state and local agencies have food safety responsibilities for retail food establishments (DHHS, 1997a). In many jurisdictions, there is a split between agriculture and health department authority that mirrors, in many respects, the split in federal food safety jurisdictions. In most state and local jurisdictions, for example, the health department has authority over restaurants, but the agriculture department has authority over supermarkets. Thus, a restaurant in a supermarket might be under agriculture department authority, whereas a stand-alone restaurant in the same chain will fall under the authority of the health department. Like FDA and USDA, health and agriculture departments in the same jurisdiction are generally governed by different statutes, use different methods and standards, and have different cultures that affect their regulatory stance.

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States are responsible for the inspection of meat and poultry sold in the state where they are produced, but FSIS monitors the process. The 1967 Wholesome Meat Act and the 1968 Wholesome Poultry Products Act require state inspection programs to be ''at least equal to" the federal inspection programs. If a state chooses to end its inspection programs or cannot maintain the "at least equal to" standard, FSIS must assume responsibility for inspection. In a few states, state employees carry out inspections in some federal plants under federal-state cooperative inspection agreements. FDA's Food Code provides scientific standards and guidelines that states and localities may adopt for food safety in restaurants and institutional food settings (DHHS, 1995; 1997a). The code includes temperature standards for cooking, cooling, refrigerating, reheating, and holding food. It also recommends that inspectors visit restaurants every six months. Each state or locality may choose to adopt any or all of the code in its laws or regulations. Although there appears to be some recent progress toward more widespread adoption of this model code (FDA, personal communication to committee, June 1998), there is much variation among jurisdictions in standards currently being applied to restaurants and other food establishments, according to one recent survey (DeWaal and Dahl, 1997). In contrast with the FDA Food Code, which has had varied acceptance, the Public Health Service 1924 Standard Milk Ordinance has been adopted by all 50 states, the District of Columbia, and US trust territories. This model was created collaboratively by public and private entities to assist states and municipalities in initiating and maintaining effective programs for the prevention of milkborne disease. Now known as the Grade A Pasteurized Milk Ordinance, it is the standard used in the voluntary cooperative state-PHS program for certification of interstate milk shippers. Revisions are considered every two years on the basis of recommendations of the National Conference on Interstate Milk Shipments. The ordinance is incorporated by reference into federal specifications for procurement of milk and milk products, and it is used as the sanitary regulation for milk and milk products served on interstate carriers. The ordinance is recognized by public health agencies, the milk industry, and many others as a national standard for milk sanitation, although exemptions allow for the sale of raw milk in some states (International Dairy Foods Association, personal communication to committee, April 1998). HACCP Systems Many parts of the current food safety assurance system are in the early stages of transition to Hazard Analysis Critical Control Point (HACCP) programs. The leadership of FSIS, FDA, and industry in making this fundamental change to a hazard prevention system is commendable. It is widely accepted by the scientific community that use of HACCP systems in food production, processing, distribution, and preparation is the best known approach

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to enhancing the safety of foods. If HACCP programs are fully implemented, they will substantially increase the effectiveness of the system. HACCP programs use a systematic approach to identify microbiological, chemical, and physical hazards in the food supply, and establish critical control points that eliminate or control such hazards (NRC, 1985). The control must effectively address the identified hazard and the effectiveness of the control point must be validated. This approach appears to be much more effective in ensuring the safety of foods than traditional visual inspection practices. The HACCP system institutes methods to control food safety hazards, whereas traditional inspection and testing procedures are not designed to detect and control contaminants that are sporadically distributed throughout foods and are not visible. In 1995, the FDA issued its final rule on HACCP for seafood, requiring all seafood processors to conduct a hazard analysis to determine whether food safety hazards are reasonably likely to occur (FDA, 1995). If no hazards are identified, no HACCP plan is needed, but reassessments are required whenever procedures are changed significantly. Written HACCP plans for seafood must be specific to each location and type of seafood product. In response to the need to train members of the seafood industry in HACCP techniques, the National Seafood HACCP Alliance for Training and Education was created. This organization provides information on HACCP training courses, as well as sample HACCP models for various seafood products. The Pathogen Reduction and HACCP system regulation of USDA establishes requirements in an effort to reduce the occurrence and numbers of pathogens on meat and poultry products and reduce the incidence of foodborne illness associated with consuming these products. Regulatory performance standards for pathogen reduction and end-product testing to determine whether the HACCP system meets those standards are basic to the USDA's approach to HACCP. In January 1998, 312 large (over 500 employees) meat and poultry processing plants were required by FSIS to implement HACCP systems. About 6,100 medium and small (10 to 500 employees) processing plants will be required to implement HACCP systems within two years (FSIS, 1996b; FSIS, 1997; FSIS 1998). During the first three months of implementation of HACCP based inspection by large meat and poultry processors, enforcement actions against 13 plants were taken by FSIS to address system failures and improper implementation or misunderstanding of HACCP procedures by processors or inspectors (FSIS, 1998). In response to the need to train members of the meat and poultry industry, the international meat and poultry HACCP alliance was formed at Texas A&M University. The alliance is composed of industry associations and is affiliated with federal agencies, universities, and professional organizations. Implementation of HACCP is the responsibility of food producers, processors, distributors, and consumers. The role of government is to ensure that HACCP programs are properly implemented throughout the food supply

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continuum by evaluation of HACCP plans and inspection of records indicating monitoring of critical control points. Implementation of this innovative approach requires a major educational effort and cultural change among federal inspectors. Adequate resources have not been provided to enable the implementation of HACCP-based inspection effectively, efficiently, and without disruption. Voluntary Efforts Trade Associations Trade associations are formed, in part, to give members a unified voice on various issues of common interest, such as marketing, technical issues, and regulation. Trade associations have been established at the national, state, and regional levels for the following: Food producers.  Examples include the United Fresh Fruit and Vegetable Association, the National Pork Producers Council (NPPC), the National Cattlemen's Beef Association (NCBA), the Animal Health Institute, and the United Egg Producers. Food processors. Examples include the National Food Processors Association (NFPA), the Grocery Manufacturers of America (GMA), the National Fisheries Institute, the American Meat Institute (AMI), and the International Dairy Foods Association. Food ingredient suppliers. Examples include the International Food Additive Council and the Sugar Association. Food retailers. An example is the Food Marketing Institute (FMI). Food service establishments. Examples include the National Restaurant Association (NRA) and the American School Food Service Association. Many trade associations have model policies and regulatory support programs to help members enhance food safety and meet regulatory requirements. The NFPA has developed model manuals on managing food product recalls, threats of tampering, and other crises; the manuals can be adapted to a company's needs. Videos and individual training programs are also available to members. The NFPA laboratories historically have helped members and FDA work out questions on the safety of canned and other processed foods (Rhona Applebaum, NFPA, personal communication to committee, April 1998). An industry initiative in the early 1970s led to the low-acid canned foods regulations.

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Consumer Groups Consumer organizations play important roles in the promotion of food safety, including its regulatory aspects. Some of these organizations-such as Consumers Union, the Consumer Federation of America, and the National Consumers League-were formed for general consumer protection purposes. Others-such as the Center for Science in the Public Interest (CSPI), Safe Tables Our Priority, and Public Voice for Food and Health Policy-coalesced primarily around issues of food safety and quality. As opinion leaders, these groups focus public attention on issues of concern, often seeking improved regulatory efforts and outcomes. Some of them, most notably Consumers Union and CSPI, have the scientific, financial, and public information resources to engage in product testing and surveillance and to disseminate their test results. For example, a story about the microbiological safety of poultry, published by Consumers Union in Consumer Reports in March 1998, received wide media coverage and effectively focused public attention on food safety concerns. Professional Organizations Professional organizations offer expertise to assist both research and regulatory processes. Because members are typically professionals working in all areas of a discipline (industry, government, and academe), these organizations also can offer a more balanced view of issues than might be obtained from experts in any one sector alone. Examples of these organizations include the Institute of Food Technologists (IFT); the American Society for Microbiology; the International Association of Milk, Food, and Environmental Sanitarians; and the Association of Food and Drug Officials. These organizations deliberate and comment on proposals concerning food safety technical and regulatory issues, develop and publish model codes, provide training to industry, sponsor symposia and seminars at annual meetings, publish authoritative technical journals (for example, Food Technology and the Journal of Food Protection), and publish valuable reference books. A recent example is a document that IFT submitted to the committee, Guiding Principles for Optimum Food Safety Oversight and Regulation in the United States (IFT, 1998). Academe Universities are actively involved in the food safety system in many ways. Training and continuing education for professionals are key roles played by academe. Specifically designed courses educate inspectors in the health hazards associated with foods, in inspection procedures for identifying foodborne hazards, and in methods used to eliminate these hazards. These programs have been conducted at Texas A&M University for FSIS inspectors and at several

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other cooperating universities for FDA inspectors. Universities also train state and local regulatory professionals and provide periodic programs on food safety to update producers, processors, retailers, nutritionists, and health professionals. Through outreach and public information programs, universities help the mass media and consumers understand and act on food safety concerns. FDA has cooperative research programs at the Joint Institute for Food Safety and Applied Nutrition at the University of Maryland and at the National Center for Food Safety and Technology at the Illinois Institute of Technology. These programs provide research data necessary to support changes in food safety regulations. For example, proper risk assessment for exposure to a mycotoxin requires knowledge about the stability of mycotoxins during food processing. Recycling is generally to be encouraged, but research on food packaging made from recycled materials would first be necessary to determine the safety of such practices, because nonfood products might have migrated into the recycled materials. Liability Failures of food safety can be costly for the food industry. Injured consumers might recover compensation if they are able to trace their illness to a particular food (which is not always possible). In most states, injured consumers benefit from the doctrine of strict product liability and do not have to prove any fault on the part of the producer or distributor if a food causes harm. Indeed, tainted food cases were largely responsible for the development and expansion of strict liability doctrine. Although the doctrine of strict liability (or recovery without proof of fault on the part of the seller) is controversial in some contexts, it has not elicited any substantial outcry with respect to food-related harms. Because it might be difficult to show that one's illness was in fact food related and to trace it to a particular product, the risk of having to pay damages to consumers for harm is probably not a major incentive for food safety. However, sellers of food that is, or is said to be unsafe, face huge public relations risks, which often prove to be more effective in "regulating" industry. The public is quick to shun whole categories of food products alleged to be tainted, as sellers of cranberries (the pesticide scare of 1959), apples (the Alar scare in 1989), and strawberries (the California Cyclospora scare, which turned out to be caused by raspberries, of 1996), verify. Because many unprocessed food commodities do not carry brand names, a food safety failure can harm careful as well as careless producers. Brand name food producers recognize that a recall or problem with any of their products will have a negative effect throughout their product lines. Most large food companies therefore try to work with suppliers and retailers to ensure that their products are kept safe beyond their immediate premises; the brand name is what the consumer sees.

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SURVEILLANCE Human and Animal Disease Surveillance for human foodborne diseases is primarily the responsibility of state and local health departments, which are required or authorized to collect and investigate reports of communicable diseases. Although specific reporting requirements vary by state, such common and serious bacterial foodborne pathogens as Salmonella, Shigella, Campylobacter, and E. coli 0157:H7 are reportable in most states. In addition, recognized outbreaks of foodborne disease are reportable in most states regardless of cause. Investigations are conducted to identify cases of illness, determine their sources, and control outbreaks. Responsibility for the primary investigation of individual cases or outbreaks may lie with local and state health departments. This system results in regional disparities in the probability of detecting outbreaks and may affect the thoroughness of an investigation. On a national level, the CDC collects data from the states on the occurrence of specific pathogens such as Salmonella, Shigella, Campylobacter, and E. coli, and collects summary data on foodborne disease outbreaks investigated by local and state health departments. CDC conducts field investigations of foodborne diseases only at the request of state health departments. CDC also plays a role in coordinating investigations of multistate or international outbreaks. The FDA and FSIS are called into investigations when the safety of a food in their jurisdictions is questioned. The FDA and FSIS are charged with ensuring that foods implicated in a foodborne illness outbreak and traveling in interstate commerce are removed from the market. Most recalls of food products regulated by FDA and FSIS, whether requested by the agency or initiated by the private entity, are carried out voluntarily by the businesses that manufacture, distribute, or sell these products. By statute they must use different methods to achieve that charge; FSIS uses its recall authority and FDA requests voluntary recalls of hazardous food by industry. The Food Safety from Farm to Table: National Food-Safety Initiative (Appendix C) includes plans to develop elements of an improved foodborne-disease surveillance system. Although it is intended to eventually provide a "new early warning system for foodborne disease surveillance," it takes only the first steps toward such a system. The first component of the system is the Active Foodborne Disease Surveillance System, known as FoodNet. This is a collaborative effort among the CDC, FDA, USDA, and states participating in CDC's Emerging Infections Program. FoodNet is designed to conduct population-based active surveillance of seven bacterial foodborne pathogens (Salmonella, Shigella, Campylobacter, E. coli 0157: H7, Listeria, Yersinia, and Vibrio) and determine-through a series of surveys of laboratories, physicians, and the population-the magnitude of diarrheal illnesses and the proportion of these illnesses that are attributable to foods. FoodNet provides one model for

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studying emerging infections; however, its current focus is limited to these seven routinely identifiable pathogens (Appendix C). A second major activity of the National Food Safety Initiative is the National Molecular Surveillance Network, or PulseNet, established by CDC in collaboration with state laboratories of public health. In 1996, standard protocols for subtyping E. coli 0157:H7 with pulsed-field gel electrophoresis (PFGE) were developed to more accurately identify routes of pathogen transmission. PFGE technology allows public health laboratories in different regions of the United States to share information through a national computer network. Epidemiologists can now trace and detect foodborne pathogens up to five times faster than previous surveillance methods (DHHS, 1998). FSIS surveillance activities include monitoring programs for Listeria monocytogenes in cooked and ready-to-eat meat and poultry products; E. coli 0157:H7 in raw ground beef products, imported products, and food in retail establishments; and Salmonella in egg products. In addition, FSIS conducts "swab tests on premises" to detect antibiotics in meat and poultry and "calf antibiotic and sulfa tests." These systems are being replaced with a new surveillance tool, the ''fast antimicrobial-screen test." The FSIS also operates a nationwide "residue violation information system" to check for drug, pesticide, and other chemical residues in slaughtered livestock and poultry and in processed eggs. FDA's Center for Veterinary Medicine has a new monitoring system to determine trends in antimicrobial resistance and changes in susceptibility. Samples from diagnostic laboratories, slaughter plants, farms, and public health settings are taken and compared for relative differences (Stephen Sundlof, Center for Veterinary Medicine, FDA, personal communication to committee, March 1998). The National Animal Health Monitoring System (NAHMS) program, under the auspices of APHIS, is designed to serve as a comprehensive system to measure the incidence of and determine the trends in and economic burden of diseases in food producing animals on local, state, and national bases. The NAHMS is administered by the Center for Epidemiology and Animal Health and is closely associated with surveys and data from food animal commodity groups and state departments of agriculture. USDA requires that certain animal diseases be reported, and each state also has its own listing of reportable diseases. USDA operates a national diagnostic laboratory reference center in two locations-the National Veterinary Services Laboratory in Ames, Iowa, and the Foreign Animal Disease Diagnostic Laboratory at Plum Island, New York. These centers monitor disease-eradication programs, some imported animal products, and reported occurrences of animal diseases across the country. A national infrastructure of animal health diagnostic laboratories across the country, associated with colleges of veterinary medicine or state departments of agriculture, provides an additional avenue for animal disease surveillance that is not federally mandated. These laboratories

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Cultural factors also play a role in public responses to food safety issues. Public acceptance of a risk and demands for protection have been described as related to values and views associated with such things as freedom of choice, government regulation, understanding of technology, credibility of science, preference for homemade or natural foods, and attribution of risks to fate (Dale and Wildavsky, 1991; Douglas, 1985; Douglas and Wildavsky, 1982; Fitchen, 1987; NRC, 1989). BOX 2-1. Public Perceptions About Food Risks Alan Levy, chief of the FDA's Consumer Studies Branch of the Office of Scientific Analysis and Support, sees a striking difference between consumer concerns and consumer behavior when it comes to safe food handling. From 1988 to 1993, research results showed consumer concern about food safety increased, while unsafe food handling practice by consumers also increased. Levy suggests several reasons for this "disconnect." For the last 30 years, he says, a dominant theme has been that we have the safest food supply in the world. Consumers have internalized this message and believe that a few remaining problems can be fixed by government controls, so that personal behavior has little effect. Failures that occur in processing plants and restaurants are likely to be far more newsworthy than sporadic cases of illness, and some consumers might not recognize problems caused by their own actions in their own homes. Focus group studies of the dangers of Vibrio vulnificus and the consumption of raw oysters reveals that many people were knowledgeable about the risks, considered themselves "experts," and felt that they knew how to control the risks. Even people who are fairly knowledgeable about food safety issues often have serious misconceptions about foodborne illness and its consequences. If the public does not see this as a serious problem, there will be little sense of urgency to change behavior. One way to break through ''is to give people a better picture of the magnitude of food safety problems and challenge people's understanding of themselves as experts." Levy says new data from the FoodNet surveillance system "may be the best way to challenge people's understanding of themselves as experts." SOURCE: Adapted from Changing Strategies: Changing Behavior June 12-13, 1997. (USDA, FDA, CDC) Consumer food handling practices are a critical control point in the management of food safety issues, especially hazards from pathogenic microorganisms. Yet many consumers in the United States fail to follow recommended practices, as indicated by surveys in which 26 percent of

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respondents reported not washing cutting boards after cutting raw meat, 50 percent said that they ate raw or undercooked eggs, 23 percent reported eating raw clams or oysters, and 23 percent reported eating undercooked hamburgers (Appendix C). Lack of knowledge of safe food handling practices can contribute to risky practices, and traditional rules about safe food handling practices are incomplete with respect to some food safety hazards, such as risks posed by eating a raw egg or a rare hamburger. A 1996 study found that 98 percent of respondents knew that meat and poultry could contain harmful bacteria and 75 percent knew that harmful bacteria could be present in dairy and egg products. However, fewer than half the respondents knew that harmful bacteria could be present on fruits and vegetables. In spite of this, a 1997 survey found that 88 percent of Americans believed they were taking precautionary steps in food handling practices to prevent foodborne illness (Partnership for Food Safety Education, 1997a). Recent research indicates that general misconceptions might explain the failure of many consumers to practice safe food handling: they believe that foodborne illness is limited to fairly mild gastrointestinal distress that is experienced shortly after eating, that food safety problems can be seen or smelled, and foodborne illness is viewed as something that happens to others and not to them (Partnership for Food Safety Education, 1997a). Aggressive efforts are essential to promote awareness of the risks from foodborne illness and to increase the public's use of safe food handling practices. Representatives who spoke to the committee agreed with the importance of this task: "I want my child to come home from school and remind me to follow food safety practices in the home the same way my nieces and nephews instruct me on why and how I should recycle my trash" (Rhona Applebaum, NFPA, personal communication to committee, April 1998). Partnerships between government agencies and trade associations, professional organizations, and public interest groups are significant initial steps in instituting an aggressive campaign to promote consumers' understanding of actions to reduce foodborne risks. The Partnership for Food Safety Education developed the "Fight BAC" campaign, an ambitious and far-reaching education effort to educate the public about safe food handling (Partnership for Food Safety Education, 1997b). The campaign uses graphics and a public service announcement to promote four key principles for safe food handling: wash hands and surfaces often, prevent cross-contamination, cook foods to proper temperatures, and refrigerate foods promptly. The campaign builds on past efforts of government agencies and other groups to promote safe food handling practices by the public.

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Adoption and use of those recommended practices will not be easily achieved. Individual behaviors are influenced by experience and by views of other important people in one's life, as well as by information received from experts. People are selective in their attention to risks, and their beliefs often change only slowly. Awareness of food risks and knowledge about recommended practices might not be reflected in behavior changes and risk reduction. Safe food handling practices involve everyday behaviors that have many different dimensions and involve multiple resources, such as equipment, time, and skills. Changing those practices is more complicated than changing consumer preferences from one brand of a product to another, as is the aim in product advertising. Changing behaviors related to food handling is more complex than changing some other health behaviors, such as seatbelt use. The time, attention, energy, and resources needed for the ambitious goal of reshaping the public's food handling practices must be recognized. Adequate resources and sustained program efforts over several years will be needed. Many causes compete for the public's attention, and professionals and community-based volunteers who are called on to assist in the campaign have competing demands on their time. A recent statement by Dr. C. Everett Koop in an independent panel report on food safety education emphasizes the vital importance of the goal: "Putting the country's resources behind public education on safe food handling is not only logical, it is absolutely essential. Now is the time to give this investment in basic information and public awareness the attention it deserves." (Partnership for Food Safety Education, 1997a). THE ROLE OF MEDIA-GOVERNMENT PARTNERSHIPS IN FOOD SAFETY EDUCATION The popular media—television, print, and radio—have long been the primary channels for communicating food-related science to the public and they play a major role in shaping public attitudes toward food safety. Media interest in this subject continues to grow. One three-month survey of coverage of diet, nutrition, and food safety issues by 38 local and national news outlets found that discussions of foodborne illness accounted for about 10 percent of all topical discussions, nearly twice the figure in 1995 (IFIC, 1998). Although increased media coverage of foodborne illness might be beneficial in drawing attention to serious issues, it can also contribute to consumer fear and result in misunderstandings about real and perceived risks. Experts are sometimes misquoted, information can be misinterpreted or presented out of context, and hype-prone headlines can quickly give a benign article an alarming spin. To the public, perception is reality; thus regulatory agencies and government officials cannot afford to avoid media contact or to remain silent when food safety debates emerge, regardless of whether the perceived danger is real or imagined.

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RESEARCH AND DEVELOPMENT Federal Research Activities Most federal research on food safety is conducted or administered by the following agencies: USDA: Agricultural Research Service (ARS), Cooperative State Research, Education and Extension Service (CSREES), and the Economic Research Service; DHHS: FDA and National Institutes of Health (NIH); Department of Commerce: NMFS; EPA; and, The Department of Defense. Food safety is a comparatively small part of the total research and development efforts of these agencies. Food safety is not at the top of the research agenda in any of the agencies, whether measured by budget share, staff, or management emphasis. Although definitive data are difficult to obtain, it appears that food safety does not dominate the agenda or the culture of the agencies; therefore food safety research is often difficult to defend and support, and it suffers during periods of shrinking budgets or crises that affect other items on the agenda. Other federal agencies-such as CDC, APHIS, AMS, GIPSA, and FSIS—cooperate in research projects that use their infrastructure for data or sample collection. They also affect research through the development of improved diagnostic procedures, recognition of new problems, and through their surveillance and epidemiological activities. The fragmented character and complexity of federal food safety research foster a culture of competition rather than collaboration among the agencies and scientists involved. It would require extraordinary efforts to develop and coordinate a federal food safety research agenda given the current organizational structure. The agencies recently established several interagency bodies or activities to coordinate research, for example, the ARS-FSIS annual workshop; a risk assessment consortium of FDA, USDA, EPA, and the University of Maryland; the USDA-university workshop on "Enhancing Cooperation in Food Safety Research and Education;" the FSIS Food Safety Research Working Group; and the National Science and Technology Council under the Office of Science and Technology Policy made up of representatives of FSIS, CSREES, ARS, FDA, CDC, and EPA. These efforts at coordination appear to have grown out of the increasing national concern about food safety. Both increased research and increased coordination of research are important components of the Food Safety from Farm to Table: National Food-Safety Initiative (Appendix C). Research priorities and implementation strategies for common goals tend to be determined from an agency perspective rather than as part of an integrated

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national program. For example, the need for increased surveillance of and epidemiological research on human illness and human pathogens in farm animals is generally recognized. In response, CDC, USDA, and FDA are cooperating with several states to establish a national infrastructure (FoodNet) for household-level studies of human illness. The USDA's APHIS has a national infrastructure for conducting epidemiological studies of animal health, which has been used for on-farm surveillance and field studies on pathogens. This APHIS responsibility has now been assigned to FSIS, and the funding has been reduced. The FSIS strategy is to contract with other federal and state agencies for on-farm epidemiological studies that can be conducted without a national infrastructure. USDA was attempting to consolidate its food safety efforts, but it has reduced its critical capacity and scientific base in this field. FSIS does not have research authority. ARS, a research agency, has the intramural character and top-down management structure to respond quickly to some of the changing needs of FSIS by redirecting, expanding, or sustaining projects or programs. FSIS formally communicates its research needs and priorities to ARS once a year. In addition, scientists and management from the two agencies jointly review work in progress and plans for the future at an annual workshop. USDA separates its intramural (ARS and ERS) and extramural (CSREES) research into different agencies even though most other departments combine intramural and extramural programs. The extramural programs support networks of scientists at universities throughout the nation. These networks leverage federally funded research with the intellectual and physical resources of the universities and with state and private research funds. Some university research is investigator-initiated in response to federal programs (such as those of NIH and the CSREES National Research Initiative) designed to bring science to food safety research. Some is in the form of grants or contracts structured to meet the immediate research needs of regulatory agencies. Much of the university research funded by state or private funds is targeted at specific state, regional, or commodity problems that have national importance. Not all research related to food safety is identified as such. For example, although NIH does not have a research program directed specifically at food safety, it conducts research on foodborne diseases within the overall NIH mission of research to understand disease processes in humans and devise intervention strategies to improve human health. NIH has provided much of the basic knowledge about the microorganisms that cause foodborne diseases. That basic knowledge provides openings for NIH, other agencies, and industry to conduct research and to develop diagnostic tests or other control strategies. Thus, NIH research on microorganisms provides many of the strategic underpinnings for much of the targeted food safety research conducted by other organizations. In the aggregate, the NIH budget for research related to food safety is slightly below the USDA food safety research budget (Appendix E). In contrast with USDA, the NIH extramural program is larger than the intramural

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one. NIH research is not well-integrated with research at regulatory agencies that are assigned specific authority for food safety. University research is largely supported by private industry, under grants or contracts with private companies or commodity to conduct intramural research on food safety. The outcomes of the research are, for the most part, proprietary and are not available to federal agencies or the public. Although information from the research is not usually distributed as widely as that generated by public funds, the industrial research is a large and essential component of the national food safety research effort. Application of New Technology The current system is slow to adopt new technologies that can improve food safety due to potential for harm if inadequately evaluated. For example, approval of irradiation was complicated by the 1958 congressional decision that irradiation be regulated as a food additive (rather than as a process) in spite of the lack of evidence that irradiation added anything to the product (Olson, 1998). Subsequent extensive research in both the United States and other countries documented that irradiation is a safe and effective means of reducing the risk of exposure to foodborne pathogens, and contributed to the development of procedures for the irradiation of foods. FDA approved the use of this technology for spices in 1982, for controlling porkborne trichinosis in 1985, and for poultry in 1990. It established the maximal doses of radiation that could be used in these applications and required that irradiated products be so labeled. FSIS established rules for implementing irradiation technology after FDA granted its approval for pork and poultry. These approvals also established the minimal dose of radiation that could be used, specified the design of the required label, and established requirements for record-keeping and inspection. There has been little demand for irradiated pork and poultry in the ensuing years. In the absence of any economic incentives for the industry to adopt the technology, there has been comparatively little education of consumers or producers about the process, and some individuals and groups have objected to any educational activities that might be seen as promoting the use of irradiation (FMI, 1998b). In 1997, FDA approved irradiation of beef and more intensive use of irradiation for pork and poultry, and FSIS is establishing procedures to implement the technology in these applications. Once the procedures are established by FSIS, adoption of the technology will depend on consumer acceptance and other economic incentives to the industry. Among the economic incentives for industry to adopt and promote irradiation are the destruction of E. coli 0157:H7, an adulterant of ground beef and other foods that can result in product recalls, and extension of the shelf-life of products. These effects also benefit consumers. Consumer acceptance and demand are increasing somewhat; broad implementation will require substantial new investments in irradiation facilities and further development of FDA-

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approved packaging materials. However, it seems unlikely that irradiation of foods will increase markedly unless there is a change in the magnitude of educational effort on the principles, efficacy, and safety of irradiation. INTERNATIONAL DIMENSIONS Any assessment of the US food safety system must consider the effects of activities outside the United States. Food is vital everywhere; countries other than the United States also take measures to protect the safety of food consumed domestically. The dramatic increase in international food trade means that the diet in most countries includes food produced abroad. This can be enriching, both culturally and nutritionally, but it presents increasing challenges for regulators in the United States and elsewhere. Threats to food safety do not respect international boundaries, so all countries exporting to the United States must be included in a food safety system that assures that risks associated with imported foods do not undermine the safety of domestically produced foods. Although cultural and legal differences among countries are significant issues when considering the adoption of measures from other countries, the efforts of close trading partners to the United States can be instructive. The scientific bases for food safety decision-making are generally published in the open literature and available internationally. The responses of foreign countries to threats faced in the United States might yield useful lessons for US regulators. The committee heard about and reviewed recent efforts by other governments to reform their food safety systems in response to recent concerns about disease transmission and food contamination (Appendix D). Food Safety Efforts of Other Countries Canada, Australia, and New Zealand have recently undertaken efforts to reform decentralized and fragmented food safety systems. The European Community and the United Kingdom have both taken preliminary steps toward centralizing their food safety efforts. Although the incentives for these efforts vary from country to country, there appear to be some common purposes, which include providing a single, consolidated focus for food safety efforts to enhance efficiency and reduce costs, responding to contemporary scientific developments, making use of external expertise, and fostering foreign markets for domestic food products. Steps have been taken largely to promote the interests of producers, processors, and regulators rather than the public health, but some health benefits will accrue.

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Canada In 1997, the Canadian government consolidated all federally mandated food inspection and quarantine services into a single federal food inspection agency, the Canadian Food Inspection Agency (CFIA). The goals of CFIA are to harmonize standards among federal, provincial, and municipal governments; to improve import and export controls and efficiency; and to enhance the international competitiveness of Canadian industry and products. As of April 1998, the agency was developing an integrated inspection system, streamlined food inspection, and a plant and animal health strategy for the entire food chain from input materials through production to retail sale and consumer use (CFIA, 1997, 1998). It has delegated the inspection activity to local governments. Other Countries and Cooperatives In July 1996, Australia and New Zealand established the Australian New Zealand Food Authority to develop and implement uniform food standards for the two countries. The European Commission has established the Food and Veterinary Office to monitor food hygiene, veterinary health, and plant health legislation within the European Union, and has embraced risk-assessment procedures to establish control priorities. In the United Kingdom, where food safety responsibility is divided between the Department of Health and the Ministry of Agriculture, Fisheries and Food, the government in January 1998 proposed the establishment of an independent Food Standards Agency (MAFF, 1998). Increasing trade in food has also produced opportunities for international cooperation in the evaluation of and response to food safety challenges. The Codex Alimentarius is perhaps the best known inter-governmental effort (FAO/WHO, 1997). Although the Codex is driven by a powerful desire to achieve uniform regulatory standards in the interests of trade, it also contributes to an elevation of food safety standards in many countries. In doing so, the Codex and similar efforts assist US regulators in keeping imported food relatively safe. US Regulation of Imported Foods The continuing internationalization of the US food supply poses a singular challenge. As food imports into the United States have increased dramatically in the last generation, questions have been raised about the government's ability to ensure the safety of imported foods (GAO, 1998). The production, processing, and shipment of food produced in the United States can, in theory, be subject to government monitoring from field to dinner table, but imported food is not subject to such oversight.

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Theoretically, Congress could forbid the importation not only of food that does not meet all domestic standards but also of food whose production is not subject to oversight by US officials in the same fashion as if it were produced domestically. Such a policy would require exporting countries to allow regular inspections by US inspectors; this would be politically unlikely and very expensive. Accordingly, the United States has adopted different strategies for protecting the safety of imported food. Both FDA and USDA take the position, as their laws require, that imported food meet the same standards of labeling, composition, and safety as domestically produced food. That goal seems obvious, but it is not easily achieved. However, a recent General Accounting Office (GAO) report found that FDA and USDA have adopted rather different approaches (GAO, 1998). FDA relies primarily on physical inspection and chemical analysis of imported food under its jurisdiction, using a sampling system that results in examination of 3 percent of all imported lots (GAO, 1998). It also relies on its knowledge of, or agreements reached with, the regulatory systems of the countries providing imports, focusing more port-of-entry attention on foods from countries where food safety controls are thought to fall short of US requirements. FDA is authorized to refuse admission to foods that appear to be adulterated, misbranded, or manufactured under unsanitary conditions; FDA may request that US Customs provide samples for inspection. FDA, with host-country agreement, occasionally undertakes some overseas inspections of production and processing facilities. GAO questions whether FDA is ensuring that imported foods meet domestic safety standards. Domestic food inspections by FDA have become less frequent in the last decade, just as its examinations of imported shipments have not kept pace with the growth of imports. More important, many pathogens and chemical contaminants that pose health risks are not readily detectable with the means available to FDA at the port-of-entry. USDA follows a rather different approach. An exporting country can seek official certification of its domestic control system for meat and poultry as "equivalent" to that of the United States. Certification of equivalence is based on an on-site review of its performance. In cooperation with US Customs, USDA refuses imports of meat and poultry from any country whose domestic regulatory system is not judged "equivalent" to its own. Once a country's system is determined to be equivalent (which requires that it include the same sort of carcass-by-carcass examination that historically has characterized USDA's inspection approach), imports are accepted without inspection of individual shipments. About 40 countries are approved to export meat products and five to export poultry products to the United States (9 CFR 327.2(b); 381.196(b)). The different systems of scrutiny of imports used by FDA and USDA largely mirror their different approaches to domestically produced food as is required since they must document domestic equivalence. History and statutory mandate, rather than scientific rationale, lead USDA to demand carcass-by-

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carcass inspection domestically. FDA, with its smaller budget, aspires to examine imports thoroughly but cannot do so. Neither approach is based on a rigorous assessment of risk. The major outbreak of foodborne illness traced to raspberries from Guatemala could not have been prevented by port-of-entry inspection, even if an inspection had taken place. International competition and the desire for export markets are primary factors leading to changes in food safety systems. As free trade agreements have been signed, trade disputes have increasingly focused on technical standards and inspection requirements. Other countries have been forced to revise domestic standards to establish equivalence with trading partners. The United States may also need to be concerned about the relationship of our food safety system to international trade. One important concern is that our system be scientifically grounded so that its requirements are recognized as legitimate protections of safety rather than as trade barriers. This report does not address issues of the safety of foods and food products exported, but exports are a major component of many food companies. Thus, new approaches must improve food safety at home and meet requirements abroad. Summary Findings: The Current US System for Food Safety Has many of the attributes of an effective system; is a complex, interrelated activity involving government at all levels, the food industry from farm and sea to table, universities, the media, and the consumer; is moving toward a more science-based approach with HACCP and with risk-based assessment; is limited by statute in implementing practices and enforcement that are based in science; and is fragmented by having 12 primary federal agencies involved in key functions of safety: monitoring, surveillance, inspection, enforcement, outbreak management, research, and education.

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