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1 Historical Perspective on the Use of Food Safety Criteria and Performance Standards The public health system in the United States traces its origins to the latter part of the nineteenth and early twentieth centuries, with its development parallel- ing the shift of the U.S. population from rural to urban settings. In the mid- nineteenth century there were concerns that life expectancy was decreasing in the rapidly growing cities (Huts and Merrill, 1991), leading to demands for govern- ment intervention to control epidemics of disease and to assure that the food and water provided by others was safe (Huts and Merrill, 1991~. Before the 1870s, except for a few staples such as flour, almost all of the food consumed in the United States was either made in the home or purchased from neighbors; gradu- ally, however, more and more food came from factories or was shipped long distances to market, so that consumers were unaware of the source of the food, the ways in which it had been processed and handled, or even what it contained (Alsberg, 1970; Roe, 1956~. At the same time, "competition in sales and in the development of products created incentives for illegal profits through the debase- ment of manufactured foods and the mislabeling of those products" (Roe, 1956~. In the late eighteenth and nineteenth centuries, medical science equated dirt with disease, and consequently early public health regulatory efforts placed a strong emphasis on sanitation and elimination of "filth" (Chapin,1970~. This was reflected in the Massachusetts Health Act of 1797, in which towns were in- structed to establish a health committee and appoint a health officer whose sole prescribed duty was "to remove all filth of any kind whatever . . . whenever such filth shall, in their judgment, endanger the lives or the health of the inhabitants thereof" (Chapin, 1970~. 13

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4 SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD By the end of the nineteenth century, there was increasing recognition that infectious diseases resulted from the action of microorganisms. Sternberg, in 1880, published the first American book on bacteriology, and during the next 30 to 40 years a series of landmark studies were conducted linking specific infec- tious agents to epidemics of disease and documenting routes by which these agents might be transmitted (Gorham, 1970~. Among others, an outbreak of typhoid fever at Wesleyan University in Middletown, Connecticut, in 1894 pro- vided the first clear evidence of transmission of typhoid fever in the United States by contamination of oysters (Clem, 1994~. However, despite the explosion in microbiological knowledge, public health officials continued to focus much of their effort on elimination of "filth, foul odors, and the decomposition and fer- mentation of animal and vegetable matter" in keeping with the generally accepted concept that "disease breeds in filth" (Gorham, 1970~. It was in this social and scientific context that Upton Sinclair published The Jungle, a scathing commentary on the industrial society that portrayed numerous abuses in the slaughter industry. Responding to this book and associated public concerns, in 1906 Congress passed the Federal Meat Inspection Act, which pro- vided for the inspection of slaughter facilities in order to prevent the introduction of dead, diseased, disabled, and dying animals into the food supply. In keeping with the prevailing public health views, the scientific basis for this act was firmly planted in the filth theory of disease; the act did not mention specific pathogens. Inspectors used their sight, touch, and smell (organoleptic inspection) to detect and exclude filth and dead and decaying animals from slaughter. As dead, dis- eased, disabled, and dying animals became increasingly less of a problem, pre- vention of fecal contamination became a major focus of the inspection system. This was accompanied by increasing government regimentation of the entire slaughter process to optimize the opportunities for inspectors to detect filth, fecal contamination, or evidence of disease in slaughtered animals. In this same time period, there was also increasing federal attention given to issues of food adulteration and mislabeling. As summarized by Roe (1956), Professor E.F. Ladd, then Food Commissioner of North Dakota, reported in a magazine article in 1905 that he "was unable to find any chicken or turkey in products designated as 'potted chicken' or 'potted turkey'." He noted a wide use of chemical preservatives, such as boric acid, and extensive use of coal-tar dyes in foods. He found that about 70 percent of the chocolate and cocoa on the market was adulterated with cocoa shell or other substitutes. Reported sales of "Vermont maple syrup" exceeded the production capacity of Vermont by about tenfold. Investigation of adulteration of food and drugs by the Division (then Bureau) of Chemistry of the U.S. Department of Agriculture (USDA) (the predecessor of today's Food and Drug Administration [FDAj), under the leadership of Dr. Harvey W. Wiley, led to widespread publicity about the adulteration of common foodstuffs. Wiley's so-called "poison squad" of 12 USDA employees used themselves as subjects to test the safety of widely-used food preservatives

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USE OF FOOD SAFETY CRITERIA AND PERFORMANCE STANDARDS 15 between 1902 and 1904, engendering significant public concern (Huts and Merrill, 1991~. These concerns culminated in 1906 with the passage of the Federal Food and Drugs Act, which contained prohibitions against misbranding and adultera- tion. As in meat and poultry inspection, the regulatory focus was on chemical contaminants and filth, rather than exclusion of specific pathogens. Even in the 1938 Food, Drug, and Cosmetic Act, which broadened and expanded the 1906 act, a food was defined as adulterated if it contained a poisonous or deleterious substance; if it consisted in whole or in part of any filthy, putrid, or decomposed substance; if it had been prepared, packed, or held under unsanitary conditions; if it was the product of a diseased animal or one dead before slaughter; or if its container was composed of any poisonous or deleterious substance (Slocum, 1956~. It was in shellfish, with their recognized association with typhoid fever, that microbiological criteria first began to play a major role in food protection (Clem, 1994~. With an increasing appreciation of the linkage between typhoid fever, raw shellfish consumption, and fecal contamination of harvest waters, efforts were focused at an early point on development of bacteriological methods for defining contamination. In 1909 the American Public Health Association appointed a committee to develop a "standard" bacteriological technique for screening oysters and other shellfish, which recommended use of a tube dilution method for the presence of Escherichia coli. In an effort to gain data on levels of contamination, USDA's Bureau of Chemistry conducted an extensive bacteriological study along the Atlantic and Gulf coasts between 1908 and 1910. While individual states began to implement increasingly stringent shellfish sanitation programs in the decade that followed, it required a major, multi-state outbreak of typhoid fever in 1924 to mobilize public opinion and drive public health action at a national level. The Surgeon General of the United States called a conference of health officials on February 19, 1925, to deal with this issue. Among other resolutions, the conference recommended that "The product [raw oysters] must conform to an established bacterial standard and must meet Federal, State, and local laws and regulations relative to salinity, water content, and food proportion, and must conform to the pure food laws standard" (Clem, 1994~. This recommendation generated a great deal of controversy based on concerns that ranged from the public health importance of bacteriological findings to technical issues related to appropriate cut-off levels for indicator organisms. However, the following two decades saw the development of increasing scientific consensus on appropriate scientific methods and criteria for bacteriological screening of harvest waters, a consensus that formed the basis for the bacteriological criteria currently used by the National Shellfish Sanitation Program for certification of shellfish and shell- fish-growing waters. The latter part of the twentieth century saw the establishment of another major regulatory agency, the U.S. Environmental Protection Agency (EPA), which is responsible for the licensing and registration of pesticides and sets limits

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6 SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD on pesticide residues in food. It also oversees drinking water quality and safety. In contrast to FDA and USDA, and reflecting the time at which the agency was established, the basic EPA regulatory framework was constructed on a much more up-to-date science base, which recognized the existence of both chemical and microbiological contaminants. For certain pathogenic microorganisms, such as Cryptosporidium and Giardia lamblia, EPA has set a maximum contaminant level goal of zero, reflecting the fact that any amount of these pathogens in drinking water may pose a risk to health. EPA also sets enforceable regulatory limits in the form of required treatment techniques, maximum contaminant levels, or both. These regulatory standards are required by law to achieve levels as close as feasible to the maximum contaminant level goal, taking into account the best available treatment technology and costs of treatment (EPA, 2002a, 2002b). While there are differences in the science base on which the regulatory structure is based, a common theme through all of these regulations is the recog- nition of the need for "performance standards" to provide clear articulation of what is and is not acceptable in the process or system being regulated. For the meat and poultry industry, it is exclusion of dead, diseased, disabled, and dying animals from the food supply; for processed foods, it is exclusion of adulterants and correct labeling; for oysters, it is the absence of high levels of fecal bacteria in harvest waters; while for EPA it is the presence of specific chemical or micro- biological hazards. The need for such standards in the food industry goes to the heart of regulatory theory, which recognizes the necessity for the government to establish standards as a counterbalance to private economic incentives. In the absence of government standards, companies willing to spend funds to assure protection of the public health are disadvantaged by the need to compete with companies unwilling to do so, because the latter could sell their products at a lower price. Some consumers might be willing to spend more on a "better" or "safer" product; poorer consumers, of course, would be unable to do so and would bear greater food safety risks than more affluent consumers. Price differ- entials for safer products would not be possible in many parts of the food market- place, however, as most foodstuffs are sold as unbranded commodities at the beginning of the food chain, and often (as with most meat, poultry, and produce) at the retail level. Thus, even if society were willing to rely upon the market to encourage food safety, it is unlikely to be an effective producer of safety because of the commodity nature of most food transactions, as well as the difficulty of connecting foodborne illness with particular eating occasions or individual foods. For the same reasons, personal injury litigation provides only a weak incentive for food companies to improve their food safety efforts, because there is a low probability that they will be sued for foodborne illness, the damages they would pay are likely to be small, and there is a low probability that such litigation would have negative public relations consequences (Buzby and Frenzen, 1999~. Current food safety regulatory standards in the United States have developed over the last century through the accumulation of new food safety legislation and

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USE OF FOOD SAFETY CRITERIA AND PERFORMANCE STANDARDS 17 the standard-setting activities of the regulatory agencies, including FDA, USDA, EPA, and the National Marine Fisheries Service. By legislation, Congress has set generic standards for naturally occurring toxins (deemed unlawful if "ordinarily injurious"), added "poisonous or deleterious" substances (deemed unlawful if they "may render" the food injurious), and intentional food additives, animal drugs, and pesticide residues (deemed safe if there is a "reasonable certainty of no harms. While applying these and other generic food safety standards, the regula- tory agencies have set more specific food safety standards. These include toler- ances (which set legal limits) on the presence of chemicals in food, prohibitions on specific microbial pathogens in specific foods, standards for process control, and standards defining the acceptable outcome of a food process for reducing pathogenic contamination. All of these are performance standards in the sense that they define what must be achieved in controlling risk factors for food safety. They have been set over a period of years and under diverse circumstances by USDA, FDA, and EPA based on a host of scientific, legal, and practical constraints. THE IMPACT OF CHANGING SCIENTIFIC AND SOCIETAL CONDITIONS ON STANDARDS The U.S. food regulatory system is a patchwork of standards developed across a century that has seen dramatic changes in society and science. While the standards established in the early part of the twentieth century were highly successful in accomplishing the objectives to which they were targeted, their success, and our increasing scientific sophistication, has led to the recognition of new problems that cannot be adequately addressed using existing standards. This is highlighted by two examples: 1. Use offecal coliform indicators for shellfish. As discussed earlier, fecal coliform standards for shellfish harvest waters were implemented as a response to public health concerns about the spread of typhoid fever through raw molluscan shellfish. These standards have been successful in minimizing the risk of illness due to pathogens present in fecal material, and their original intent to prevent recurrent outbreaks of oyster-associated typhoid fever has clearly been achieved. At this time, the leading causes of shellfish-associated illness and death in this country are bacteria of the Vibrio species, which can cause diarrhea! disease and potentially fatal bloodstream infections in susceptible hosts (Altekruse et al., 2000; Hlady and Klontz, 1996; IOM, 1991~. Vibrionaceae are free-living marine bacteria; in one study of the Chesapeake Bay, V. vulnificus (the species responsible for most oyster-associated deaths annually) alone accounted for 8 per- cent of the total culturable heterotrophic bacteria in the samples (Wright et al., 1996~. Because of their free-living status, Vibrionaceae are not associated with fecal contamination, and, consequently, the fecal coliform microbial performance standard has not been effective in reducing the rate of Vibrio-associated illness.

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8 SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD 2. Use of organoleptic inspection for poultry. As noted earlier, organoleptic inspection was initiated to prevent the introduction of dead, diseased, disabled, or dying animals into the food supply. In this sense, it has been highly effective: flocks coming to slaughter tend to be highly homogeneous and free of disease, and animals that die before slaughter never make it into the slaughterhouses. Today Campylobacter is the leading cause of poultry-associated foodborne ill- ness. Campylobacter species are part of the colonizing intestinal flora of normal, healthy chickens; exclusion of dead, diseased, disabled, and dying birds does not control this problem. Organoleptic inspection focuses on the identification of birds contaminated with feces; these birds are subsequently removed from the processing line for reprocessing. However, although visible fecal contamination is a relatively rare event, in some studies Campylobacter has been isolated from over 80 percent of chicken parts available at retail sale (NRC, 1987~. As it is virtually impossible for organoleptic inspection techniques to identify products bearing "invisible" microbial contamination by a specific pathogen such as Campylobacter, it is unrealistic to expect that organoleptic standards will have an important impact on reducing the incidence of Campylobacter infections in humans. FRAGMENTATION OF THE CURRENT REGULATORY SYSTEM The report Ensuring Safe Food from Production to Consumption (IOM/ NRC, 1998) adequately described the fragmentation of the current food safety regulatory system. At least a dozen federal agencies administer more than 35 statutes and are overseen by 28 congressional committees. Four federal agencies (FDA, part of the Department of Health and Human Services; the Food Safety and Inspection Service (FSIS), part of USDA; EPA; and the National Marine Fisheries Service, part of the U.S. Department of Commerce) play the major roles. State and local health departments play important roles as well; as at the federal level, many jurisdictions have multiple agencies involved in assuring food safety. Jurisdiction over a particular food, or a particular problem, depends not only upon geography, but also upon the type of food product involved and the level of the food chain at which the problem is found. The regulatory system is fragmented because of the statutes that created the food safety agencies and authorize their activities. As noted earlier, the system arose in response to public concerns. The statutory framework for the federal food regulatory system has its antecedents in legislation written originally in 1906; major revisions created the Federal Food, Drug, and Cosmetic Act in 1938 and the Wholesome Meat Act in 1967. As early as 1949, a federal advisory committee recommended significant reorganization of the food safety system (TOM/NRC, 1998), but no significant structural reform has ever occurred. This statutory framework for government food safety regulation poses a significant set

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USE OF FOOD SAFETY CRITERIA AND PERFORMANCE STANDARDS 19 of challenges and has had a clear negative impact on implementation and enforcement of modern, science-based performance standards by the regulatory agencies. For example, in the case of Supreme Beef Processors v. USDA 275 F.3d 432 (5th Cir. 2001), a federal appeals court decided that USDA did not have statutory authority to withdraw its inspectors from a meat processing and grinding plant- an action that would shut it down even though the plant had failed to meet the Salmonella performance standard on three consecutive occasions. Because Salmonella is present in a substantial percentage of raw meat and poultry prod- ucts, it is not considered an adulterant. Its presence in raw meat, therefore, does not prevent the meat from passing inspection and being marked by USDA as "inspected and passed." Nor is the presence of Salmonella deemed to render a product "injurious to health," because normal cooking will destroy the pathogen (275 F. 3d at 439~. The relevant statute, the Federal Meat Inspection Act, pro- vides that a meat product is adulterated if it has been prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health (21 U.S.C. 601(m)~4~. As noted earlier, this language reflects the prevailing scientific theories from 100 years ago, which equated filth with disease. This contrasts with our current un- derstanding that infectious diseases are caused by specific pathogenic microor- ganisms (such as Salmonella) that may be transferred to, and multiply in, a product as it moves through the continuum of slaughter and processing. It also fails to reflect our understanding that such microorganisms can be readily trans- ferred from a raw product to other foods in a kitchen, thereby serving as a cause of foodborne illness even if the product that introduced the microorganism into the kitchen is subsequently cooked. USDA's performance standard for Salmonella in beef was set to provide a proxy for the presence or absence of other pathogens. USDA has authority to shut down a plant for insanitation, but USDA did not allege unsanitary conditions at the Supreme Beef plant. Rather, it challenged the Salmonella level in the ground beef that the plant produced. The court concluded that USDA's statute cannot be used "to regulate characteristics of the raw mate- rials that exist" before the meat product is brought into the inspected plant: "The performance standard is invalid because it regulates the procurement of raw materials" (275 F. 3d at 441~. From the perspective of the consumer, it is irrelevant when or how a patho- gen gets into the food supply. The fact that Salmonella (or E. cold 0157:H7 or other pathogens) is introduced into a product at slaughter rather than during grinding does not negate its public health impact. The Ensuring Safe Food from Production to Consumption (TOM/NRC, 1998) report recommends modifying the federal statutory framework for food safety to eliminate fragmentation and enable the creation and enforcement of science-based standards.

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20 SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD DEVELOPMENT OF NEW REGULATORY APPROACHES The need for new types of inspection approaches and new performance standards to deal with current food safety problems has been emphasized in a series of reports by government and private organizations. The key reports include: . . . Meat and Poultry Inspection: The Scientific Basis of the Nation's Pro- gram (NRC, 1985b). This report recommended that FSIS focus on patho- genic organisms and that all official establishments adopt Hazard Analysis and Critical Control Point (HACCP) systems to control pathogens and other hazards. An Evaluation of the Role of Microbiological Criteria for Foods and Food Ingredients (NRC, 1985a). This report recommended the imple- mentation of microbiological guidance as part of HACCP systems, although criteria containing specific limits for pathogens were considered impractical in some instances. Poultry Inspection: The Basis for a Risk-Assessment Approach (NRC, 1987~. This report looked specifically at poultry slaughter and processing. It highlighted the lack of efficacy of the current organoleptic inspection system in reducing foodborne illness and recommended implementation of a HACCP-based regulatory system. Cattle Inspection (IOM, 1990~. This report also emphasized the lack of a scientific basis for organoleptic inspection and proposed implementation of a HACCP-based system. Seafood Safety (IOM, 1991~. This report summarized current problems and regulatory approaches for control of seafood-associated illness. Again, a HACCP-based approach was recommended as a possible basis for regu- latory intervention. "Food Safety: Risk-Based Inspections and Microbial Monitoring Needed for Meat and Poultry" (Herman, 1994~. In his testimony before a House subcommittee, Harman, speaking for the General Accounting Office, stated that "A HACCP system is generally considered the best approach currently available to ensure safe foods because it focuses on preventing contamination rather than detecting contamination once it has occurred." Hazard Analysis and Critical Control Point System and Guidelines for its Application (CAC,1997~. This report recommended that countries incor- porate HACCP principles into their food industries. "Hazard Analysis and Critical Control Point Principles and Application Guidelines" (NACMCF, 1998~. These principles endorsed the HACCP system as an effective and rational approach to the assurance of food safety.

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USE OF FOOD SAFETY CRITERIA AND PERFORMANCE STANDARDS 21 A consistent theme in these reports is the importance of encouraging indus- try to move toward the adoption of a HACCP system. HACCP is a preventive system for food safety process control that was originally developed as a contract specification by the National Aeronautics and Space Administration (NASA) in cooperation with the U.S. Army's Natick Laboratory, and subsequently imple- mented by Pillsbury as HACCP under the direction of Dr. Howard Bauman (Lachance, 1997~. The initial purpose of the concept was to minimize the risk of foodborne disease during space flights, but it has subsequently been adopted in many industries. The HACCP method addressed NASA's need for absolute free- dom from potentially catastrophic disease-producing bacteria and toxins in food delivered to astronauts. Since the 1980s, the HACCP method has been adopted by other agencies in the United States and abroad. HACCP involves seven prin- ciples (see Chapter 3) that must be backed by sound scientific knowledge (e.g., published microbiological studies on time and temperature factors for controlling foodborne pathogens). . As noted repeatedly in the reports cited above, HACCP provides an attrac- tive framework by which companies can minimize the risk of illness associated with their products. The problem comes, however, in integrating HACCP con- cepts into a regulatory system. The food safety standards of an earlier age were "command and control" in nature; for example, no fecal contamination of car- casses and inspectors standing in each plant with a rulebook written by the government to enforce the regulation. The past decade has seen development of a variety of creative approaches to integrate regulatory controls with HACCP. Within this process, however, there have been several problem areas: The need to match the inherent flexibility of HACCP with a similarly flexible regulatory system that encourages plants to analyze and monitor their own hazard profile and respond accordingly. That is, it must be determined how to move away from the old command and control ap- proach while maintaining sufficient regulatory control to protect the public health. How to deal with the recognized fact that science is constantly changing. Plans and regulatory approaches that are based on the best available sci- ence one year may be totally outdated by the following decade (or the following year); both HACCP and the associated regulatory controls must have the flexibility to deal with these changes. Many small- and medium- sized food-processing facilities lack the level of scientific expertise that would allow them not only to stay abreast of changes, but also to apply the implications of the changes to industrial operations. These facilities have difficulty applying the concepts of HACCP without significant guidance. A certain amount of structure is required and often desired by these com- panies; however, by providing this structure, some of the flexibility theo- retically afforded by these concepts is lost. Finding a balance that allows

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22 SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD for flexibility but acknowledges the scientific limitations of many food processors will continue to be a challenge. The lack of a generally accepted approach to setting regulatory controls and performance standards that result in a reduction of human disease. Subsequent sections highlight the status of current regulatory approaches and the ways in which regulatory standards have been and are being established today in the context of an increasing emphasis on the use of HACCP as a means of minimizing risk of foodborne illness. The key elements in the development of one such regulatory system, the USDA Pathogen Reduction (PR)/HACCP Final Rule, are provided in detail below. Example of the Development of a New Regulatory Approach In 1994 FSIS began a review and revision of existing food safety regulations for meat and poultry that led to the publication of the PR/HACCP rule (FSIS, 1996~. While numerous National Academies' and other expert committees and groups had recommended changes in the regulatory system, an outbreak this time, the E. cold 0157:H7 outbreak from hamburgers in restaurants in the western United States was again the major driving force for regulatory change. The primary objective of the new regulation was to reduce meat- and poultry-associ- ated foodborne illness. In keeping with the prior National Academies' and other expert reports, HACCP served as the core of the new regulatory structure. In brief, the PR/HACCP rule requires all meat and poultry slaughter and processing establishments to design and implement a HACCP system, with the schedule of implementation dependent on plant size. The exact elements of the HACCP plan are not specified in order to: encourage companies to carefully evaluate the particular public health hazards associated with each specific prod- uct line and plant; provide companies with the freedom to develop innovative methods for control of these hazards; and provide companies with the flexibility to identify Critical Control Points that would have maximal utility in the control of potential hazards in their products. It was fully anticipated that generic HACCP plans would rapidly emerge; however, it was also hoped that, in even the smallest plants, generic plans would be carefully evaluated, and plant owners would take advantage of the flexibility inherent in the system to develop new and creative approaches to control foodborne pathogens. To encourage such innovation, implementation of the PR/ HACCP rule was accompanied by ongoing efforts to reduce the regulatory con- trol that FSIS had previously maintained on all aspects of slaughter and process- ing, including the traditional tight control over any change in plant design or operation. There was also recognition that many of the major foodborne patho- gens were colonizers of the animal intestinal tract, and, consequently, there was

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USE OF FOOD SAFETY CRITERIA AND PERFORMANCE STANDARDS 23 value in monitoring (and minimizing) fecal contamination of carcasses. As such, the PR/HACCP rule required that, as part of their HACCP program, plants imple- ment a microbiological monitoring program for generic E. cold as a marker for fecal contamination in carcasses at slaughter operations (FSIS, 1996~. While efforts were being made to encourage flexibility and innovation through implementation of HACCP, there was also recognition that there had to be some type of regulatory "floor" to clearly define minimal acceptable levels of performance. As the goal of these regulatory changes was to reduce the incidence of meat- and poultry-associated foodborne illness, it was felt that such standards should focus on the effectiveness of a plant's HACCP program in reducing con- tamination of product with specific, known pathogens. At the time the PR/HACCP rule was being prepared, Salmonella species were recognized as having the great- est economic impact among the known bacterial foodborne pathogens. Salmonella was also present in all product classes that were being regulated, and it could be readily isolated using a well-established laboratory methodology available for its identification. Based on these considerations, the decision was made to establish a Salmonella performance standard. Given the low levels and uneven nature of contamination on a carcass and the ability of pathogenic microorganisms to rapidly multiply at the appropriate temperatures, and recognizing some of the technical issues involved in trying to quantify Salmonella on a single carcass, the percentage of carcasses contami- nated was used as the basis for the standard. The decision was made to set the initial standard at a level equal to the current national mean for that product class (e.g., in studies conducted in the early l990s, 25 percent of broiler chickens were found to be contaminated with Salmonella; consequently, the Salmonella perfor- mance standard for plants was set at 25 percent contamination). The concept was that the new standards would create accountability for all slaughter plants to target and control Salmonella and require plants performing worse than the national mean to at least bring their incidence of contamination down to that level. USDA intended that, as the incidence of contamination and the national mean declined, the Salmonella performance standard would be reduced accord- ingly, thereby inducing further reductions in Salmonella within the demonstrated capability of the industry, as reflected in the new national mean. In addition to monitoring Salmonella contamination at individual plants (and in keeping with recommendations in prior National Academies reports), the Centers for Disease Control and Prevention, working with FSIS and FDA, set up a national sentinel surveillance system for foodborne illnesses to provide data to assess the effectiveness of the PR/HACCP rule in reducing the national incidence of foodborne illness (see Chapter 2~. As described in subsequent chapters, this system, later named FoodNet, has served as a key element in monitoring foodborne disease incidence in the United States.

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24 SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD Significance of Zero Tolerance Regulators often confront the notion that they should have "zero tolerance" for anything (such as pathogens in the food supply) that is deemed to pose a risk to public health or safety. The term zero tolerance resonates with the public, which is appropriately seeking assurance of the safety of the products it con- sumes. Sometimes regulators use the term zero tolerance in reference to a patho- gen or environmental contaminant to indicate that whenever a particular problem is found, strict regulatory action will be taken. The term zero tolerance is commonly used in the media in respect to issues of science, including food safety, but also in many other contexts. For example, zero tolerance has been used to comment about drug-law enforcement, drug-testing policies in sports (Goldberg, 2000; Mann, 2000), crime (Gembrowski, 2000), and security violations (Pincus,2000~. Businesses frequently note their zero tolerance of offensive behavior (for example, eBay has zero tolerance for illegal items auctioned on its site [Harmon, 1999], and AOL has a policy of zero tolerance for hate messagesinits chat rooms end message boards [Farhi, 20011~. Zerotoler- ance is a powerful term, with the intended connotation of the complete absence of the hazard or inappropriate behavior at issue, and it is popularly perceived as assurance of protection against or at least official intolerance of that hazard or behavior. Laws and regulations, in contrast, use the term zero tolerance (or a tolerance of zero) sparingly. It does not appear in either Title 7 (Agriculture) or Title 21 (Food and Drugs) of the U.S. Code. It appears in the U.S. Code only in reference to binge drinking on college campuses in 20 U.S.C. 101 lh~b)~3), and behavioral guidelines for members of the Job Corps in 29 U.S.C. 2892(b)~2), 2899(d)~7~. It appears in sections of the Code of Federal Regulations that concern food and drugs only in respect to new animal drugs used in animal feed for which no residue (zero tolerance) is allowed to be found in the animal after slaughter (21 C.F.R. 558.3, general rule; see, e.g., 21 C.F.R. 172.820, 556.110, 556.120, 556.140~. That is, if any residue of these drugs is found, the user is in violation. In addition, there are some food safety regulations that use zero as a standard (e.g., zero percent prevalence of cattle affected with bovine tuberculosis), without including the zero tolerance phrase. Nevertheless, zero tolerance appears in Federal Register discussions of regu- latory policies by both USDA and FDA. Sometimes zero tolerance is rejected because, for example, there can be no zero tolerance policy for genetic contami- nation in organic foods because it would be "impossible to achieve" (AMS, 2000) or because zero tolerance for ingesta in poultry is too costly to achieve (USDA, 2002~. In other situations it is determined to be the appropriate policy: zero tolerance, defined as "no detectable level of viable pathogens," for Listeria monocytogenes in ready-to-eat products (FSIS, 2001) or zero tolerance for visible fecal material (FSIS, 2000~.

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USE OF FOOD SAFETY CRITERIA AND PERFORMANCE STANDARDS 25 Scientists are often dismayed by the use of this term because they recognize the inability to ensure, in most situations, the complete absence of pathogens and contaminants and the limitations of any feasible sampling plan to check for their total absence. The issue is not a new one; the National Academy of Sciences issued a report in November 1965 (NRC, 1965) on no residue and zero tolerance as they relate to the registration of pesticides, the setting of tolerances for pesti- cides, and FDA enforcement of pesticide residues in foods. This report consid- ered the development of increasingly sensitive analytical methods for residue detection, the problem of background levels of pesticide residues not related to immediate applications to food products, and the scientific and administrative barriers to employing zero tolerance for pesticide regulation. However, scientists do recognize that a preference for zero "is influenced by the wish to emphasize that absence is the desired objective (although it cannot be guaranteed) and by the knowledge that once pathogens are found, the finding cannot be ignored" (ICMSF, 2002~. The venous uses of and limits for this term, therefore, must be properly analyzed. The committee has adopted for its purposes the following definition of zero tolerance: Lay audience perception of the absence of a hazard that cannot be scientifically assured, but is operationally defined as the absence of a hazard in a specified amount of food as determined by a specific method. This definition reflects two points that may seem to be in conflict, but are actually reconcilable: 1. Some people perceive zero tolerance as meaning the absence of a hazard. 2. The absence of a hazard cannot be scientifically assured. However, in regulatory practice the concept requires the absence of the hazard in a specified amount of food as determined by a specific method and sam- pling protocol. If the hazard is found, regulators will take action. With agreement that zero tolerance is a regulatory and lay concept that specifies an ideal, but that science can strive for but never meet that ideal, dis- agreements over the use of the term should be minimized. REFERENCES Alsberg CL. 1970. Progress in federal food control. In: Ravenel MP, ed. A Half Century of Health. New York: Arno Press and the New York Times. Pp. 211-220. Altekruse SF, Bishop RD, Baldy LM, Thompson SG, Wilson SA, Ray BJ, Griffin PM. 2000. Vibrio gastroenteritis in the U.S. Gulf of Mexico region: The role of raw oysters. Epidemiol Infect 124:489-495.

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