Despite the warnings, Mr. Espy accepted a variety of favors from lobbyists for Tyson Foods, then the world's largest chicken-processing company (and now the largest producer of beef as well). Early in 1994, federal investigators accused Mr. Espy of violating the Meat Inspection Act by accepting-or permitting a companion to accept-airline travel, tickets to sporting events, a small scholarship, and other gifts worth about $12,000 from Tyson Foods, plus similar gifts from other meat and poultry companies. The results of that investigation forced Mr. Espy to resign from his position as USDA secretary, and a later investigation by a special prosecutor led to his indictment by a federal grand jury. Eventually, Mr. Espy was acquitted of all charges, largely because the prosecutor could not convince a jury that the gifts were intended intended to influence the USDA. Although it is difficult to imagine what other purpose the gifts might have served, the Supreme Court also ruled that Mr. Espy was entitled to accept them because they were not directly linked to regulatory matters. to influence the USDA. Although it is difficult to imagine what other purpose the gifts might have served, the Supreme Court also ruled that Mr. Espy was entitled to accept them because they were not directly linked to regulatory matters.33 Federal prosecutors also accused Mr. Espy's chief of staff, Ronald Blackley, of interfering with USDA attempts to regulate poultry safety. A USDA staff member told a reporter that Mr. Blackley had been surprised to learn that the agency was working on poultry rules: "He said to take [them] out of the computer. . . . We were a little shell shocked . . . wondering if we had all heard what we thought we'd heard. We put a stop to all poultry activity."32 At the time, the scandal made the USDA's ongoing efforts to improve poultry safety much more difficult. Some critics charged that the department's proposed rules for poultry inspection were simply "an effort to prove that . . . Espy was not beholden to poultry interests."34 When the agency decided not to go forward with the plan, officials had to deny that they had made this decision just to please the poultry industry. The Espy scandal, neither the first nor the last of its kind, was unusual only in that the favors were so visible and the issues so important. This particular USDA secretary had the opportunity and the ability to convert his department's century-old inspection system to one better equipped to deal with microbial pathogens. Tyson Foods' donation of tickets to sporting events demonstrated that even small favors produce substantial benefits if given at the right time, in this case just when the USDA was trying to get poultry producers to test for When the agency decided not to go forward with the plan, officials had to deny that they had made this decision just to please the poultry industry. The Espy scandal, neither the first nor the last of its kind, was unusual only in that the favors were so visible and the issues so important. This particular USDA secretary had the opportunity and the ability to convert his department's century-old inspection system to one better equipped to deal with microbial pathogens. Tyson Foods' donation of tickets to sporting events demonstrated that even small favors produce substantial benefits if given at the right time, in this case just when the USDA was trying to get poultry producers to test for Salmonella Salmonella and other pathogens. If nothing else, it worked greatly to Tyson Foods' advantage to keep Mr. Espy preoccupied with responses to legal challenges from a special prosecutor. As if the political nature of this situation were not transparent enough, one of President Clinton's last acts in office was to grant presidential pardons to Mr. Blackley and six food company executives and lobbyists who had been convicted of attempting to corrupt Mr. Espy. Reportedly, the White House and other pathogens. If nothing else, it worked greatly to Tyson Foods' advantage to keep Mr. Espy preoccupied with responses to legal challenges from a special prosecutor. As if the political nature of this situation were not transparent enough, one of President Clinton's last acts in office was to grant presidential pardons to Mr. Blackley and six food company executives and lobbyists who had been convicted of attempting to corrupt Mr. Espy. Reportedly, the White House invited invited defense lawyers to request the pardons, and granted them just hours before George W. Bush took office as president in January 2001. defense lawyers to request the pardons, and granted them just hours before George W. Bush took office as president in January 2001.35 USDA REQUIRES PATHOGEN TESTING: E. COLI E. COLI O157:H7 IN GROUND BEEF, 1994 O157:H7 IN GROUND BEEF, 1994.
By the early 1990s, USDA officials had argued for two decades that the decision in APHA APHA v. v. Butz Butz meant that the department did not have legal authority to set limits on microbial contaminants in meat and poultry because pathogens like meant that the department did not have legal authority to set limits on microbial contaminants in meat and poultry because pathogens like Salmonella Salmonella were "inherent" in raw meat. As late as 1993, the administrator of USDA's Food Safety and Inspection Service (FSIS), H. Russell Cross, explained to a congressional committee: "At the present time, meat and poultry inspection laws do not define raw meat and poultry containing bacteria as adulterated." were "inherent" in raw meat. As late as 1993, the administrator of USDA's Food Safety and Inspection Service (FSIS), H. Russell Cross, explained to a congressional committee: "At the present time, meat and poultry inspection laws do not define raw meat and poultry containing bacteria as adulterated."36 As noted earlier, the USDA could have interpreted As noted earlier, the USDA could have interpreted APHA APHA v. v. Butz Butz as giving the department considerable latitude to do whatever seemed necessary to protect the public, including setting performance standards-allowance limits verified by testing-for pathogens in meat. While Mr. Espy's legal difficulties were front-page news, he chose Michael Taylor to become administrator of FSIS. Mr. Taylor, a lawyer, moved to the USDA from the FDA; there, his previous employment with Monsanto raised conflict-of-interest questions about his role in setting policy for regulation of genetically modified foods (see as giving the department considerable latitude to do whatever seemed necessary to protect the public, including setting performance standards-allowance limits verified by testing-for pathogens in meat. While Mr. Espy's legal difficulties were front-page news, he chose Michael Taylor to become administrator of FSIS. Mr. Taylor, a lawyer, moved to the USDA from the FDA; there, his previous employment with Monsanto raised conflict-of-interest questions about his role in setting policy for regulation of genetically modified foods (see chapter 7 chapter 7). His actions at the USDA raised no such questions. In late September 1994, six weeks after assuming leadership of FSIS, Mr. Taylor gave his first public speech in his new job to an annual convention of the American Meat Institute. He said that it was high time for everyone involved in meat production and processing "to be driven as much by public health goals as by productivity concerns." FSIS intended to take advantage of "the tools of microbiology to ensure that preventive controls are in place to reduce the risk of harmful contamination and to verify that those controls are working." He announced that FSIS would soon propose regulations requiring installation of science-based HACCP systems in every meat and poultry plant. "Raw ground beef contaminated with E. coli E. coli O157:H7," he said, "poses a serious risk to public health, and contaminated lots should be excluded from commerce." The USDA intended to require the destruction or reprocessing of contaminated meat and "we expect companies who encounter contaminated lots of raw ground beef . . . to take similar action." O157:H7," he said, "poses a serious risk to public health, and contaminated lots should be excluded from commerce." The USDA intended to require the destruction or reprocessing of contaminated meat and "we expect companies who encounter contaminated lots of raw ground beef . . . to take similar action."37 If that challenge was not enough to bring his audience to rapt attention, he explained that FSIS would be taking these actions on the basis of the department's revised interpretation of APHA APHA v. v. Butz: Butz: To clarify an important legal point, we consider raw ground beef that is contaminated with E. coli E. coli O157:H7 to be adulterated within the meaning of the Federal Meat Inspection Act. We are prepared to use the Act's enforcement tools, as necessary, to exclude adulterated product from commerce. Finally, we plan to conduct targeted sampling and testing of raw ground beef at plants and in the marketplace for possible contamination with O157:H7 to be adulterated within the meaning of the Federal Meat Inspection Act. We are prepared to use the Act's enforcement tools, as necessary, to exclude adulterated product from commerce. Finally, we plan to conduct targeted sampling and testing of raw ground beef at plants and in the marketplace for possible contamination with E. coli E. coli O157:H7. This sampling program . . . will serve as an example and an incentive for those commercial enterprises that produce, process, and market raw ground beef to control their processes and conduct their own tests. O157:H7. This sampling program . . . will serve as an example and an incentive for those commercial enterprises that produce, process, and market raw ground beef to control their processes and conduct their own tests.37 Furthermore, because E. coli E. coli O157:H7 is infectious at very low doses, FSIS would consider O157:H7 is infectious at very low doses, FSIS would consider any any level of contamination of ground beef with these bacteria to be unsafe, adulterated, and subject to enforcement action. The agency, however, would restrict this "sample, test, and destroy" approach to just this one pathogen, level of contamination of ground beef with these bacteria to be unsafe, adulterated, and subject to enforcement action. The agency, however, would restrict this "sample, test, and destroy" approach to just this one pathogen, E. coli E. coli O157:H7, and to just this one product: ground beef. O157:H7, and to just this one product: ground beef.38 Food safety advocates admire Mr. Taylor for his courage in delivering this speech to an audience expected to be unsympathetic if not downright hostile. They also appreciate his skill in shifting USDA food safety policies to those more favorable to public health, especially at a time when the department's leadership was in such deep trouble. Indeed, he needed courage. His speech caused consternation in the cattle, meatpacking, and grocery industries. Meat producers and processors understood that if the USDA considered E. coli E. coli O157:H7 an "adulterant," they would break the law if they sold foods containing this pathogen. They would be vulnerable to criminal prosecution. As a representative of the American Meat Institute told the press, "the new USDA policy has the perhaps unintended consequence of creating rampant, irresponsible, criminal litigation." O157:H7 an "adulterant," they would break the law if they sold foods containing this pathogen. They would be vulnerable to criminal prosecution. As a representative of the American Meat Institute told the press, "the new USDA policy has the perhaps unintended consequence of creating rampant, irresponsible, criminal litigation."39 Industry lawyers instructed their clients not to do their own testing of ground beef for Industry lawyers instructed their clients not to do their own testing of ground beef for E. coli E. coli O157:H7 because finding it would expose them to legal liability. Rosemary Mucklow, then the executive director of the Western States Meat Association, said, "How can FSIS treat O157:H7 because finding it would expose them to legal liability. Rosemary Mucklow, then the executive director of the Western States Meat Association, said, "How can FSIS treat E. coli E. coli in hamburger meat as an adulterant subject to enforcement strategies, while not applying the same standard to salmonella in broilers. . . . Automated chicken lines allow birds to leave the plant as Inspected for Whole-someness with . . . grossly unacceptable defects. . . . Such gross policy interpretation favoring the poultry industry and disfavoring the beef industry is a travesty indeed." in hamburger meat as an adulterant subject to enforcement strategies, while not applying the same standard to salmonella in broilers. . . . Automated chicken lines allow birds to leave the plant as Inspected for Whole-someness with . . . grossly unacceptable defects. . . . Such gross policy interpretation favoring the poultry industry and disfavoring the beef industry is a travesty indeed."40 We will encounter further commentary from Ms. Mucklow later in these pages. We will encounter further commentary from Ms. Mucklow later in these pages.
In the meantime, the American Meat Institute-which had opposed the safe-food-handling labels-now used them to complain that the proposed testing program would cause cause food safety problems. Microbial testing would "mislead consumers with promises of a safer food supply, and as a result they may relax their own cooking and handling standards." food safety problems. Microbial testing would "mislead consumers with promises of a safer food supply, and as a result they may relax their own cooking and handling standards."4 The Food Marketing Institute also shifted responsibility to consumers in its argument against the initiative: "It is essential that nothing dilute the consumer message that the proper cooking of meat eliminates food-borne pathogens." The Food Marketing Institute also shifted responsibility to consumers in its argument against the initiative: "It is essential that nothing dilute the consumer message that the proper cooking of meat eliminates food-borne pathogens."41 The two trade associations and five others quickly filed suit to block the pathogen testing plan, based on this wonderfully convoluted argument: because the USDA had done nothing to control The two trade associations and five others quickly filed suit to block the pathogen testing plan, based on this wonderfully convoluted argument: because the USDA had done nothing to control E. coli E. coli O157:H7 since the first outbreak in 1982, the present situation could hardly be considered an emergency. This transparently self-serving argument prompted the O157:H7 since the first outbreak in 1982, the present situation could hardly be considered an emergency. This transparently self-serving argument prompted the New York Times New York Times to note the industry's "odd way" of promoting public health: "Trying to give their obstructionist lawsuit a respectable veneer, the plaintiffs voice concern that the spot-inspection program could mislead consumers into relaxing their own safe handling and cooking practices. . . . It is not consumers the lawsuit seeks to protect but the industry's right to sell tainted beef." to note the industry's "odd way" of promoting public health: "Trying to give their obstructionist lawsuit a respectable veneer, the plaintiffs voice concern that the spot-inspection program could mislead consumers into relaxing their own safe handling and cooking practices. . . . It is not consumers the lawsuit seeks to protect but the industry's right to sell tainted beef."42 Among the many ironic aspects of this dispute, the trade associations' lawsuit turned out to be heard by the very same Texas district court judge, James Nowlin, who had ruled against the USDA's proposals to require food-handling labels on procedural grounds just a year earlier. This time, the court surprised observers by ruling in favor of the USDA. Its rationale: because ordinary cooking temperatures could not kill E. coli E. coli O157:H7, the USDA had good reason to consider these bacteria as adulterants and test for them. This decision at last permitted the USDA to redesign its ancient food inspection system and start testing for this one harmful pathogen. Industry groups, however, saw the decision as mandating a program that "fails to protect consumers, wastes tax dollars and violates the law," and they vowed to "maintain our course of legal action to stop it." O157:H7, the USDA had good reason to consider these bacteria as adulterants and test for them. This decision at last permitted the USDA to redesign its ancient food inspection system and start testing for this one harmful pathogen. Industry groups, however, saw the decision as mandating a program that "fails to protect consumers, wastes tax dollars and violates the law," and they vowed to "maintain our course of legal action to stop it."43 The trade associations' lawsuit had one additional-and unanticipated-consequence. It mobilized the families of children killed by E. coli E. coli O157:H7 to form their own group-Safe Tables Our Priority (STOP)-to lobby for more rigorous meat regulations. The group picketed a meeting of the American Meat Institute and held a press conference to accuse meat producers of obstructing safety efforts: "My 6-year-old son Alex deserves to be alive today. . . . I hold the meat institute personally responsible" and "It's time to stop blaming consumers for not cooking and give them a clean product." O157:H7 to form their own group-Safe Tables Our Priority (STOP)-to lobby for more rigorous meat regulations. The group picketed a meeting of the American Meat Institute and held a press conference to accuse meat producers of obstructing safety efforts: "My 6-year-old son Alex deserves to be alive today. . . . I hold the meat institute personally responsible" and "It's time to stop blaming consumers for not cooking and give them a clean product."44 Another consumer group, the Safe Food Coalition, proposed a "simple household solution" to the problem of the industry's intransigent refusal to test for Another consumer group, the Safe Food Coalition, proposed a "simple household solution" to the problem of the industry's intransigent refusal to test for E. coli E. coli O157:H7 and its persistent avoidance of accountability: obtain proof of responsibility. "Tired of being a victim? . . . Weary of subjecting your family to a game of Russian Roulette every time you buy a package of hamburger meat? . . . [When] unpacking groceries, tuck the supermarket receipt and a small lump of hamburger in a ziplock bag. Toss this in the freezer. . . . In five seconds, at virtually no cost, you've got accountability. . . . This simple act gives control back to you and tells industry loud and clearly that we're not going to take it any more." O157:H7 and its persistent avoidance of accountability: obtain proof of responsibility. "Tired of being a victim? . . . Weary of subjecting your family to a game of Russian Roulette every time you buy a package of hamburger meat? . . . [When] unpacking groceries, tuck the supermarket receipt and a small lump of hamburger in a ziplock bag. Toss this in the freezer. . . . In five seconds, at virtually no cost, you've got accountability. . . . This simple act gives control back to you and tells industry loud and clearly that we're not going to take it any more."45 In this instance, the political context permitted the USDA to hold its position and test one product (ground meat) for one pathogen (E. coli O157:H7). When the department attempted to extend testing requirements to other forms of meat and other pathogens, it again met with fierce resistance, as O157:H7). When the department attempted to extend testing requirements to other forms of meat and other pathogens, it again met with fierce resistance, as chapter 3 chapter 3 will reveal. will reveal.
USDA POISED TO PROPOSE HACCP, 1994.
By the early 1990s, the long history of collusion between meat producers, Congress, and the USDA seemed to have entered a new phase in which public interests held greater influence. Meat producers' protection of the century-old inspection system no longer seemed credible. Although the industry contended that testing for microbes is unnecessary because so few samples are contaminated, this argument ignored a key point: even a small level of contamination can do great harm when the number of animals is large. For example, if just 0.2% of cattle are contaminated with E. coli E. coli O157:H7, 74,000 beef carcasses might be infected and, therefore, hundreds of thousands of pounds of hamburger. O157:H7, 74,000 beef carcasses might be infected and, therefore, hundreds of thousands of pounds of hamburger.46 For this reason alone, the pathogen reduction component of HACCP (which necessarily includes performance standards and testing for microbes) seems thoroughly warranted. For this reason alone, the pathogen reduction component of HACCP (which necessarily includes performance standards and testing for microbes) seems thoroughly warranted.
USDA's historical reluctance to change its inspection and pathogen control systems derives directly from the agency's conflicting mandates: to ensure the safety and quality of foods under its jurisdiction and, at the same time, to promote their marketing and consumption. The long-term collusion between the department and the meat industry impedes progress. Over the years, the breakdown of the agricultural establishment, the emergence of new food pathogens like E. coli E. coli O157:H7, and the appointment of USDA officials interested in the health effects (as well as the economic effects) of agricultural products, paved the way for more vigorous efforts to institute HACCP with performance standards for controlling pathogens. O157:H7, and the appointment of USDA officials interested in the health effects (as well as the economic effects) of agricultural products, paved the way for more vigorous efforts to institute HACCP with performance standards for controlling pathogens.
In the 20 years between 1974 and 1994, resistance to HACCP with pathogen reduction came from many sources: federal agencies unwilling to confront powerful constituents, industry groups willing to accept HACCP only without government oversight (especially of pathogen levels), consumer groups suspicious of the industry's commitment to safety standards and the government's ability to enforce them, and inspectors unwilling to change the nature of their work. By 1994, advocates feared that more lives of children would need to be sacrificed before Congress, the USDA, and the industry would take action to keep dangerous bacteria out of meat. Even the threat of financial liability did not seem severe enough to induce industry action. The institution of HACCP rules appeared inevitable to all but the most determined segments of the meat industry, but whether the rules would include requirements for pathogen performance standards and testing remained open for debate. Chapter 3 Chapter 3 explains how that debate developed. explains how that debate developed.
CHAPTER 3.
ATTEMPTING CONTROL OF FOOD PATHOGENS, 19942002
DESPITE THE BARRIERS DISCUSSED IN CHAPTER 2 CHAPTER 2 AND THE AND THE objections raised by businesses likely to be affected by the new regulations, government agencies were eventually able to institute HACCP (Hazard Analysis and Critical Control Point) systems designed to prevent harmful microbes from getting into food. This chapter describes how that happened, mainly with respect to HACCP controls for beef. Beef industry protests were more vehement and often more effective than those of other industries, and interactions of beef trade associations with the U.S. Department of Agriculture (USDA) and with Congress left more visible traces. Because most outbreaks of microbial illness derive from foods regulated by the Food and Drug Administration (FDA), this chapter also explains how the FDA tried to require the industries under its jurisdiction to institute HACCP plans, how those industries opposed the plans, and how that agency's systems-once in place-operated in practice. Opponents of HACCP often framed their objections in scientific terms: because cooking kills most food microbes, government intervention is unnecessary. When outbreaks did occur, food producers, processors, and retailers accused each other of causing them, and all blamed government inspectors and consumers. We will see that food companies were not alone in their objections to HACCP requirements. Meat inspectors opposed the new regulations because HAACP changed their work from examining animals to examining paper. In addition, some food safety advocates agreed with the inspectors' contention that HACCP gave too much control of production to industry and allowed foxes to guard chickens, as it were. objections raised by businesses likely to be affected by the new regulations, government agencies were eventually able to institute HACCP (Hazard Analysis and Critical Control Point) systems designed to prevent harmful microbes from getting into food. This chapter describes how that happened, mainly with respect to HACCP controls for beef. Beef industry protests were more vehement and often more effective than those of other industries, and interactions of beef trade associations with the U.S. Department of Agriculture (USDA) and with Congress left more visible traces. Because most outbreaks of microbial illness derive from foods regulated by the Food and Drug Administration (FDA), this chapter also explains how the FDA tried to require the industries under its jurisdiction to institute HACCP plans, how those industries opposed the plans, and how that agency's systems-once in place-operated in practice. Opponents of HACCP often framed their objections in scientific terms: because cooking kills most food microbes, government intervention is unnecessary. When outbreaks did occur, food producers, processors, and retailers accused each other of causing them, and all blamed government inspectors and consumers. We will see that food companies were not alone in their objections to HACCP requirements. Meat inspectors opposed the new regulations because HAACP changed their work from examining animals to examining paper. In addition, some food safety advocates agreed with the inspectors' contention that HACCP gave too much control of production to industry and allowed foxes to guard chickens, as it were.
To gain some insight into the basis of this conflict, I wanted to observe a HACCP system in action. Shortly after the USDA's final HACCP rules for meat went into effect in the late 1990s, the owner of a meatpacking plant in New York State agreed to let me visit as long as I did not identify the plant by name.
His company cooks meats under HACCP plans similar to the USDA model illustrated in figure 5 figure 5 ( (page 69), and his plant illustrates both the strengths and weaknesses of HACCP systems. Production practices followed the prescribed plan to the letter (a strength), but HACCP plans require mountains of paperwork and the attention of a full-time employee (at considerable added expense). Because some of the products include vegetable as well as meat ingredients, they fall under the regulatory requirements of three agencies: the FDA, the USDA, and New York State. Inspections vary in frequency-the USDA daily, New York State four times a year, and the FDA once a year-and are conducted according to the unique rules and reporting requirements of each agency. In practice, the multiple authorities mean that plant officials must fill out three distinct sets of reporting forms (a time-consuming and expensive nuisance). The on-site USDA inspector I met at the plant checked temperature records but seemed entirely uninterested in the production process (a serious weakness, as I will explain). One plant employee confided to me-shades of Upton Sinclair-that "someone could be butchering a dog in front of them [the inspectors], and they wouldn't have a clue."
Because the first of the three critical control points was to measure the temperature of products after they were cooked (see figure 5 figure 5), the managers learned that the ovens were not heating properly. They identified a succession of faults in the engineering of the ovens and tinkered with them until the problem was fixed (a strength). After the products were cooked, however, they were immediately transferred to open racks in a refrigeration room and chilled-uncovered-by cold air blasted in from a ceiling unit. The temperature of the products dropped quickly, as required by the plan (a strength). Unfortunately, the plan did not account for the ability of harmful bacteria like Listeria Listeria to flourish at cold temperatures in the cooling system and to contaminate the uncovered products to flourish at cold temperatures in the cooling system and to contaminate the uncovered products after after they were cooked (a weakness). The plant managers seemed unaware of the potential hazard. Because they followed the HACCP plan so scrupulously, they did not think the uncovered products posed problems (a further weakness). Within weeks of my visit, the company had to recall thousands of pounds of products because some had been found to be contaminated with they were cooked (a weakness). The plant managers seemed unaware of the potential hazard. Because they followed the HACCP plan so scrupulously, they did not think the uncovered products posed problems (a further weakness). Within weeks of my visit, the company had to recall thousands of pounds of products because some had been found to be contaminated with Listeria Listeria.
From this experience, it seemed obvious that HACCP plans can prevent contamination but that diligence in following them is not enough; the plans also must be thoughtfully designed and overseen, and verified by testing. The role of the on-site USDA inspector was particularly striking. He was not involved in promoting the plant's microbial safety. As a 20-year USDA veteran, he had been trained to inspect animals, not paperwork, and was unaware of the peculiar characteristics of newly emergent bacterial pathogens. He seemed much in the tradition of the inspector described in The Jungle The Jungle a century earlier, as we have already seen. a century earlier, as we have already seen.
With this understanding of HACCP systems in action, we can now return to the political battles of the mid-1990s that eventually enabled federal agencies to require some industries to follow HACCP plans. By late 1994, with the legal obstacles out of the way, federal agencies could begin the formal-and glacially tedious-rule-making process to require HACCP controls for one food industry or another: proposing rules in the Federal Register; Federal Register; requesting, collecting, and dealing with public comments; rewriting the proposals; and, eventually, issuing final rules that would go into effect some years later. The USDA proposed rules for meat and poultry, and the FDA proposed rules for some of the foods under its jurisdiction. The two agencies approached the task in quite different ways, particularly in their decisions about whether HACCP plans, performance standards, and requirements for pathogen testing should be required or voluntary. The FDA was the first to place its notices in the requesting, collecting, and dealing with public comments; rewriting the proposals; and, eventually, issuing final rules that would go into effect some years later. The USDA proposed rules for meat and poultry, and the FDA proposed rules for some of the foods under its jurisdiction. The two agencies approached the task in quite different ways, particularly in their decisions about whether HACCP plans, performance standards, and requirements for pathogen testing should be required or voluntary. The FDA was the first to place its notices in the Federal Register Federal Register, and we begin with this agency's approach to HACCP rules.
THE FDA TRIES HACCP, ONE FOOD AT A TIME.
Although up to 80% of outbreaks are caused by foods regulated by the FDA, this agency has had a difficult time figuring out what to do about them. The FDA first proposed to develop HACCP controls for seafood in January 1994 and, in late summer of 1994, asked for public comment on whether and how HACCP might be extended to "land foods." In approaching HACCP regulation in this manner, the FDA was responding not only to the need to control pathogens but also to its own internal difficulties. The resource constraints on the FDA's food safety program seemed unlikely to improve. It also seemed unlikely that the agency would ever be able to inspect, sample, and analyze more than a tiny fraction of the foods for which it was responsible. In deciding how to regulate food safety without funds or personnel, the FDA floated a trial balloon: Although the agency has reached no final conclusions about how its regulatory programs should be revised to make food as safe as possible, FDA has tentatively concluded that the improvements in the agency's current food safety assurance program should be based on a state-of-the-art, preventive approach known as HACCP. . . . The agency has tentatively chosen a HACCP approach because HACCP addresses the root causes of food safety problems in production, storage, transportation, etc., and is preventive.1 The FDA was careful to note that it expected to engage in further conversations with industry and other groups and that it planned to work closely with the USDA to make sure the rules of the two agencies were consistent. It asked for public comment on whether HACCP should be mandatory for all of the food industries under its jurisdiction or just for certain segments of those industries. It also asked for input on how mandatory HACCP plans might apply to the entire chain of food distribution, from production to retail sale.
As a further reflection of this cautious approach, the FDA asked companies to volunteer volunteer to develop pilot HACCP systems. The idea was to study the plans and use them as a basis for deciding how to proceed further. As it turned out, several firms agreed to be guinea pigs for this purpose: Alto Dairy, Campbell Soup, ConAgra, EarthGrains (Sara Lee), Pillsbury (General Mills), and Ralston Foods. Their pilot plans-which involved products such as cheese, frozen dough, breakfast cereals, salad dressing, fresh and pasteurized juices, bread, and flour-demonstrated that HACCP controls worked well to help companies identify safety problems and correct them. This was only to be expected given Pillsbury's experience 30 years earlier. Furthermore, the companies reported a decline in the frequency of product recalls (also to be expected with reduced contamination), along with unanticipated benefits in improved production efficiency, employee "ownership" and participation, and customer satisfaction. None of the volunteers, however, included microbial testing as a component of their plans. The pilot plans demonstrated that HACCP would reduce pathogens and be good for business but also suggested that companies would not test for harmful bacteria unless forced to do so. to develop pilot HACCP systems. The idea was to study the plans and use them as a basis for deciding how to proceed further. As it turned out, several firms agreed to be guinea pigs for this purpose: Alto Dairy, Campbell Soup, ConAgra, EarthGrains (Sara Lee), Pillsbury (General Mills), and Ralston Foods. Their pilot plans-which involved products such as cheese, frozen dough, breakfast cereals, salad dressing, fresh and pasteurized juices, bread, and flour-demonstrated that HACCP controls worked well to help companies identify safety problems and correct them. This was only to be expected given Pillsbury's experience 30 years earlier. Furthermore, the companies reported a decline in the frequency of product recalls (also to be expected with reduced contamination), along with unanticipated benefits in improved production efficiency, employee "ownership" and participation, and customer satisfaction. None of the volunteers, however, included microbial testing as a component of their plans. The pilot plans demonstrated that HACCP would reduce pathogens and be good for business but also suggested that companies would not test for harmful bacteria unless forced to do so.2 While these studies were underway, the FDA proposed HACCP rules for a few additional foods that seemed especially hazardous. It began with HACCP for seafood and shellfish (proposed in 1994 to take effect in 1997), for raw sprouts and eggs (to take effect in 1999), and, as discussed below, for fresh juices (2000). The FDA also initiated another voluntary HACCP experiment, this time for dairy products, and it proposed safe-handling instructions for eggs: "Eggs may contain harmful bacteria known to cause serious illness, especially in children, the elderly, and persons with weakened immune systems. For your protection: Keep eggs refrigerated; cook eggs until yolks are firm; and cook foods containing eggs thoroughly."3 But by 2009, the FDA required HACCP only for seafood. For all its other foods, HACCP was But by 2009, the FDA required HACCP only for seafood. For all its other foods, HACCP was voluntary voluntary. The FDA's food-by-food approach to HACCP, its lack of requirements for microbial testing, and its scarcity of inspectors left industries with many opportunities to avoid installing such plans or adhering to them. For example, only 44% of seafood processing firms had implemented HACCP plans by 1999, and more than half of all inspections revealed serious problems with the plans five years after their implementation. By 2001, the shellfish industry's chief safety strategy-education of consumers-had failed to reduce the illnesses and deaths caused by eating raw products, and neither the industry nor its FDA regulators had imposed preventive measures. This experience reinforced suspicions that voluntary approaches would not work.4 USDA'S POLITICAL BATTLES In contrast, and rather a surprise in view of its past history, the USDA moved quickly to introduce HACCP under the more consumer-friendly leadership appointed by President Bill Clinton. By the mid-1990s, some segments of the meat industry were asking the department to institute HACCP regulations, if for no other reason than to reassure the public that meat was safe. The Food Safety and Inspection Service (FSIS) began to develop HACCP rules for meat and poultry through a method previously unimaginable for this agency: it openly consulted stakeholders. The FSIS held information briefings, scientific conferences, public hearings, federal and state conferences, agency meetings, and a professional forum to listen to points of view. Its 1995 proposed rules differed from those of the FDA in several critical respects, most notably in their emphasis on requirements for pathogen testing. Indeed, the department called the plan Pathogen Reduction: HACCP Pathogen Reduction: HACCP-a critical distinction. The USDA plan established performance standards and required the companies to prove by daily sampling and testing that pathogenic contaminants did not exceed levels specified in the standards.5 True to form, some meat industry groups objected. An official of the Armour company, for example, told a congressional committee that HACCP was an imperfect system that did not address the real problem-consumer education: "There is a concern that HACCP has been oversold and public expectations may be unrealistically high. In particular, HACCP cannot guarantee the absence of enteric pathogens on raw meat or poultry. . . . Food safety is a shared responsibility involving industry, Government, and consumers. Public education on safe handling of foods continues to be a key factor in preventing foodborne illness."6 Untrue to form, the American Meat Institute petitioned the USDA to require HACCP for all meat and poultry plants: "We believe so strongly in HACCP's benefits for meat and poultry safety that we think it should be mandated for our segment of the industry." This group's unexpected support of HACCP is explained by its assumption-erroneous, as it happened-that industry industry inspectors would replace those of USDA. Later, when meat industry associations realized the implications of pathogen testing-that products found contaminated would be considered adulterated and unfit to sell-they tried to block the proposals. Meat producers and processors much preferred a "virtual" safety system: HACCP without pathogen reduction and entirely voluntary compliance. inspectors would replace those of USDA. Later, when meat industry associations realized the implications of pathogen testing-that products found contaminated would be considered adulterated and unfit to sell-they tried to block the proposals. Meat producers and processors much preferred a "virtual" safety system: HACCP without pathogen reduction and entirely voluntary compliance.7 Congress Demands "Negotiated Rulemaking," 1995 Before proposed regulations become final and go into effect, they are supposed to be held open for a specified period of time for public comment. The comment period for the proposed Pathogen Reduction: HACCP rules occurred at a time when especially conservative Republicans had taken control of Congress and were attempting to reduce regulatory burdens on industry. Meat and poultry lobbyists took advantage of this favorable situation to urge Congress to block the proposed rules. They used the usual argument: home cooks are responsible for most episodes of foodborne illness, and oversight of industry is unnecessary. Despite the false premise (most outbreaks derive from foods prepared outside the home), the lobbying succeeded in several respects. First, Congress extended the comment period to give the industry more time to organize opposition. Next, industry lobbyists convinced some members of Congress to amend the appropriations bill to delete funding for HACCP implementation. Finally, while discussions of this funding amendment were in progress, the lobbyists also convinced Congress to order the USDA to participate in "negotiated rulemaking," a process that would require the department to work closely with meat producers to make the regulations mutually acceptable. To observers offended by the idea that the industry would define its own regulations, the purpose of negotiated rule-making seemed clear-to postpone or eliminate HACCP. Representative George Brown (Dem-CA), explained: "The House Agriculture Committee would like to write more industry-friendly legislation and cut the USDA regulations off at the pass."8 The congressman who introduced the anti-HACCP funding amendment, James Walsh (Rep-NY), chaired the appropriations subcommittee for agriculture. Mr. Walsh seemed to be acting on behalf of the meat industry-a lawyer for the National Meat Association had participated in drafting his amendment.9 In a further action, Senator Robert Dole (Rep-KS), then majority leader and already campaigning for president, introduced a regulatory reform bill that would require federal agencies to review new regulations likely to cost industry more than $50 million annually, and to demonstrate that the benefits of such regulations would outweigh their costs. One purpose of the Dole bill was to stop government from regulating food safety. It contained provisions to (1) eliminate rules for pathogen testing, (2) postpone seafood inspection, (3) repeal the Delaney clause in the Food, Drug, and Cosmetic Act (which precluded use of carcinogenic food additives), (4) permit use of some carcinogenic pesticides, and (5) privatize approvals of food additives. In a further action, Senator Robert Dole (Rep-KS), then majority leader and already campaigning for president, introduced a regulatory reform bill that would require federal agencies to review new regulations likely to cost industry more than $50 million annually, and to demonstrate that the benefits of such regulations would outweigh their costs. One purpose of the Dole bill was to stop government from regulating food safety. It contained provisions to (1) eliminate rules for pathogen testing, (2) postpone seafood inspection, (3) repeal the Delaney clause in the Food, Drug, and Cosmetic Act (which precluded use of carcinogenic food additives), (4) permit use of some carcinogenic pesticides, and (5) privatize approvals of food additives.
Such blatantly consumer-unfriendly legislation was ripe for satire, and figure 7 figure 7 presents one such pointed commentary, in this case, from political cartoonist Garry Trudeau. Consumer advocate Ralph Nader observed that the Dole bill represented nothing less than a "big business takeover of the U.S. government in its health and safety responsibilities." Nevertheless, after contentious debate, the Senate passed various amendments to the Dole bill as part of the Republicans' Contract with America. As if to soften the bill's evident purpose, one such amendment expressed "the sense of the Senate that nothing in the bill is intended to delay the timely promulgation of any regulations that would meet a human health or safety threat." presents one such pointed commentary, in this case, from political cartoonist Garry Trudeau. Consumer advocate Ralph Nader observed that the Dole bill represented nothing less than a "big business takeover of the U.S. government in its health and safety responsibilities." Nevertheless, after contentious debate, the Senate passed various amendments to the Dole bill as part of the Republicans' Contract with America. As if to soften the bill's evident purpose, one such amendment expressed "the sense of the Senate that nothing in the bill is intended to delay the timely promulgation of any regulations that would meet a human health or safety threat."10 Mr. Walsh's industry-driven appropriations amendment was also under consideration, but the New York Times New York Times urged opposition: "By voting to defeat Mr. Walsh's amendment today, the Appropriations Committee would send a welcome signal that it cares more about protecting constituents' health than about pleasing the meat and poultry industries." Consumer advocates from the Washington, DCbased Center for Science in the Public Interest (CSPI) wrote that the Walsh proposal was "just a smoke screen to give businesses free rein to do business as usual-even if that means killing innocent children." urged opposition: "By voting to defeat Mr. Walsh's amendment today, the Appropriations Committee would send a welcome signal that it cares more about protecting constituents' health than about pleasing the meat and poultry industries." Consumer advocates from the Washington, DCbased Center for Science in the Public Interest (CSPI) wrote that the Walsh proposal was "just a smoke screen to give businesses free rein to do business as usual-even if that means killing innocent children."11 Late in June, the House committee passed the Walsh amendment, making it clear that it was doing so to give "meat packers a chance to win relief from new food-safety regulations."12 This meant that if the Senate also passed the amendment, the USDA would not be able to issue HACCP rules until it completed its "negotiated rulemaking" conversations with meat and poultry processors. This possibility inspired further editorial comment in the This meant that if the Senate also passed the amendment, the USDA would not be able to issue HACCP rules until it completed its "negotiated rulemaking" conversations with meat and poultry processors. This possibility inspired further editorial comment in the New York Times New York Times: [image]
FIGURE 7. The political cartoonist Garry Trudeau had this to say about Senator Robert Dole's attempt to deregulate the meat industry. Mr. Dole was expected to run for president in the next election. (Doonesbury, August 20, 1995, 1995 G.B. Trudeau. Reprinted with permission of Universal Press Syndicate. All rights reserved.) Two things will happen to anyone who takes a close look at the way meat is processed and inspected in this country: they will wonder how it is that even more people are not made sick by tainted meat, and they will get sick to their stomachs themselves. . . . Naturally, the meat industry and its stooges in the Republican Party have ganged up on the Agriculture Department (and the American consumer) to make sure the new inspection system never sees the light of day. . . . [Negotiating rulemaking] is like negotiating prison rules with convicts. . . . Children will continue to die in excruciating pain because the meat they ate was contaminated, and because unscrupulous Republicans in Congress fought aggressively to keep it that way.13 At this point, Mr. Walsh suddenly withdrew his amendment, attributing this surprising retreat to a revelation that Congress could in fact work out its differences with the USDA: "We got the personal commitment of the secretary to create the dialogue we sought."14 Alternative explanations seem more likely, however. Pressure from advocacy groups was surely a factor, especially a campaign organized by the families of children who became ill or died after eating contaminated hamburger. Advocates took credit for the amendment's withdrawal as a "resounding victory for public health and an unmasking defeat of good ol' boy politics." This last was a reference to press accounts that Mr. Walsh had accepted $66,000 in donations from meat and agricultural interests. Alternative explanations seem more likely, however. Pressure from advocacy groups was surely a factor, especially a campaign organized by the families of children who became ill or died after eating contaminated hamburger. Advocates took credit for the amendment's withdrawal as a "resounding victory for public health and an unmasking defeat of good ol' boy politics." This last was a reference to press accounts that Mr. Walsh had accepted $66,000 in donations from meat and agricultural interests.15 It also seems likely that members of Congress, not wanting to be viewed as destroyers of public health and killers of innocent children, suggested that Mr. Walsh would face a difficult floor fight if he pursued his anti-HACCP agenda. Ultimately, the Dole bill also failed to pass. Thus, one unanticipated-and positive-result of Mr. Walsh's amendment was to unite food safety advocates and encourage them to press for an independent food agency that would not be subject to such crass political pressures, an issue discussed in greater detail in It also seems likely that members of Congress, not wanting to be viewed as destroyers of public health and killers of innocent children, suggested that Mr. Walsh would face a difficult floor fight if he pursued his anti-HACCP agenda. Ultimately, the Dole bill also failed to pass. Thus, one unanticipated-and positive-result of Mr. Walsh's amendment was to unite food safety advocates and encourage them to press for an independent food agency that would not be subject to such crass political pressures, an issue discussed in greater detail in chapter 4 chapter 4.16 The Last Attempts to Derail HACCP, 19951996 With the demise of the Walsh amendment, the USDA released the nearly 200 pages of "final" rules for Pathogen Reduction: HACCP for meat and poultry products. As with the earlier drafts, these would need to be made available for public comment before going into effect in July 1996. The rules required large firms to develop, install, and implement HACCP plans by the beginning of 1998, small firms by 1999, and very small firms by 2000. To help companies figure out how to proceed, the department created 13 model plans and provided detailed instructions for developing and using them (figure 5 in in chapter 2 chapter 2 is based on one such model). is based on one such model).17 The published Pathogen Reduction: HACCP rules revealed that political pressures succeeded in achieving at least one compromise. Although the USDA originally wanted meat and poultry companies to be responsible for The published Pathogen Reduction: HACCP rules revealed that political pressures succeeded in achieving at least one compromise. Although the USDA originally wanted meat and poultry companies to be responsible for Salmonella Salmonella testing, it now said that federal inspectors would test for testing, it now said that federal inspectors would test for Salmonella Salmonella "on an unannounced basis." Companies would have to test for the "on an unannounced basis." Companies would have to test for the generic generic form of form of E. coli E. coli (as a marker of fecal contamination) in just a small number of samples: 1 out of every 300 beef carcasses, 1,000 hogs, 3,000 turkeys, and 22,000 chickens. (as a marker of fecal contamination) in just a small number of samples: 1 out of every 300 beef carcasses, 1,000 hogs, 3,000 turkeys, and 22,000 chickens.5 This time, meat processors used the comment period to press Congress to eliminate requirements for Salmonella Salmonella testing. Their congressional sympathizers introduced an amendment to the Farm Bill that would create an "independent" oversight panel of food, meat, and poultry scientists with broad powers to review FSIS decisions on HACCP procedures, standards, and practices. The amendment required the USDA to submit proposed rules to the panel and then allow 90 days for public comment. At the very least, this plan would further delay the regulations. The policy director of the House Agriculture Committee explained that the purpose of the panel was testing. Their congressional sympathizers introduced an amendment to the Farm Bill that would create an "independent" oversight panel of food, meat, and poultry scientists with broad powers to review FSIS decisions on HACCP procedures, standards, and practices. The amendment required the USDA to submit proposed rules to the panel and then allow 90 days for public comment. At the very least, this plan would further delay the regulations. The policy director of the House Agriculture Committee explained that the purpose of the panel was scientific: scientific: "The H.A.C.C.P. rule is purported to be science-based, but it seemed clear that some of the regulatory decisions have no scientific validity. The regulations should never have gotten to this stage." "The H.A.C.C.P. rule is purported to be science-based, but it seemed clear that some of the regulatory decisions have no scientific validity. The regulations should never have gotten to this stage."18 Reporters, however, viewed the panel as yet another political tactic to allow the meat industry to avoid having to test for pathogens. Eventually, this amendment failed to get enough votes to be included in the final bill. Reporters, however, viewed the panel as yet another political tactic to allow the meat industry to avoid having to test for pathogens. Eventually, this amendment failed to get enough votes to be included in the final bill.
Sorting out the political forces for and against Pathogen Reduction: HACCP is especially complicated because USDA inspectors also opposed the regulations. They had experienced a huge increase in "tasks not performed" just since the year before, meaning that their workloads had increased to the point where they could not complete assignments. One inspector, for example, complained that he was supposed to inspect 16 meat plants within a six-hour period. Once HACCP went into effect, workloads would be reduced (a benefit), but the inspectors did not like the idea that their jobs would change from inspecting animals and meat products-useless for preventing microbial contamination as that might be-to inspecting paperwork. The on-site USDA inspector at the meatpacking plant I visited, thoroughly disenchanted with having to deal with that paperwork, was counting the days until he could retire. Old-time inspectors quipped that because HACCP minimizes risk but can never assure absolute safety, its initials really should stand for "Have a Cup of Coffee and Pray."19 The General Accounting Office (GAO), however, continued to press for HACCP, also invoking science as the rationale. For years it had been issuing reports urging Congress to require oversight of food safety based on science (meaning assessment of hazards at critical points and evaluation by microbial testing) rather than sensory perception (poke-and-sniff). GAO officials complained that federal agencies repeatedly ignored their warnings and were still inspecting foods by obsolete systems that could not possibly address modern microbial hazards.20 In the case of meat and poultry regulation, reason eventually won out over politics, the benefits of HACCP prevailed, and the USDA issued its final set of regulations in July 1996-an election year in which the political climate had shifted to one more friendly to consumer interests. Perhaps as a sign of that change, the White House Office of Management and Budget (OMB), which typically opposed expansion of government regulations, praised the new rules: "For years, we have had the Government doing the work, the inspectors in the plants, and you hear stories of cursory checks and that's it. . . . This is an attempt to get away from Government micromanaging the process and instead saying to the regulated entity, 'you figure out how to do it, you're responsible, and we'll do some testing to make sure there are performance standards.' "21 An alternative reason for the OMB's blessing may have been financial. USDA economists calculated that the economic benefits of Pathogen Reduction: HACCP would outweigh its costs even under the most conservative estimates. Although the new rules were expected to cost industry more than a billion dollars over a 20-year period, the economic benefits to society would exceed that amount even if just 5% of foodborne illnesses could be prevented. Economists thought that if HACCP could achieve a 90% reduction in illnesses caused by just the six most common food pathogens, the 20-year savings in medical costs and lost productivity would be $170 billion or more.22 Furthermore, the meat and poultry industries would share financial benefits in the form of reduced recalls and liability, enhanced consumer confidence, and robust sales. Furthermore, the meat and poultry industries would share financial benefits in the form of reduced recalls and liability, enhanced consumer confidence, and robust sales.
By mid-1996, the HACCP schedule was in place. The E. coli E. coli O157:H7 testing of ground meat proposed in 1994 was due to start in January 1997. Large companies were to install Pathogen Reduction: HACCP plans by January 1998, and smaller companies by January 2000. From then on, all meat and poultry companies were to follow such plans and test for generic O157:H7 testing of ground meat proposed in 1994 was due to start in January 1997. Large companies were to install Pathogen Reduction: HACCP plans by January 1998, and smaller companies by January 2000. From then on, all meat and poultry companies were to follow such plans and test for generic E. coli E. coli, endure USDA testing of ground meat for E. coli E. coli O157:H7 and spot-checking for O157:H7 and spot-checking for Salmonella Salmonella, and meet performance standards for pathogen reduction. Food safety would depend on how carefully they designed and implemented the plans, and how well the USDA enforced them. For most foods regulated by the FDA, however, HACCP remained voluntary. As we will now see, events soon revealed serious gaps in the regulations, and indicated additional needs: for extension of HACCP rules to all food products at all stages of production, for federal authority to recall contaminated products, and for ways of countering the culture of entrenched resistance to government oversight so prevalent in the meat industry.
THE PRODUCT GAP: ODWALLA APPLE JUICE, 1996.
In October 1996, an outbreak of E. coli E. coli O157:H7 made it clear that O157:H7 made it clear that all all foods needed to be produced under Pathogen Reduction: HACCP because lapses could be catastrophic, not only for the victims, but also-temporarily, if not permanently-for the companies responsible for them. This outbreak put about 70 people in hospitals, made 14 children dreadfully ill, and resulted in the death of one child. foods needed to be produced under Pathogen Reduction: HACCP because lapses could be catastrophic, not only for the victims, but also-temporarily, if not permanently-for the companies responsible for them. This outbreak put about 70 people in hospitals, made 14 children dreadfully ill, and resulted in the death of one child.23 The unexpected feature of the outbreak was its source: apple juice. Investigators used genetic techniques and diet histories to trace the infections to freshly bottled apple juice produced by Odwalla, a California company specializing in "natural" foods. The company included windfall apples, those that had fallen off the trees onto the ground, among the lots pressed to make the juice, and investigators suspected that the fallen apples must have come in contact with animal manure containing E. coli E. coli O157:H7. Although apple juice is naturally acidic, its acids are not strong enough to kill this hardy microbe. Odwalla did not pasteurize its juices; its managers believed that temperatures high enough to kill most bacteria would alter the flavor of the juice and reduce vitamin content (which pasteurization does, but only slightly). The managers also believed-gravely in error-that the acidity of the solutions used to wash the apples and of the juice itself would kill harmful bacteria. O157:H7. Although apple juice is naturally acidic, its acids are not strong enough to kill this hardy microbe. Odwalla did not pasteurize its juices; its managers believed that temperatures high enough to kill most bacteria would alter the flavor of the juice and reduce vitamin content (which pasteurization does, but only slightly). The managers also believed-gravely in error-that the acidity of the solutions used to wash the apples and of the juice itself would kill harmful bacteria.24 Investigators made other disheartening observations. Just before the outbreak, the company had relaxed its standards for accepting blemished fruit. It overruled warnings from its own in-house inspector not to use the batch of apples responsible for the outbreak without special precautions. At the time, Odwalla was expanding rapidly and having difficulty meeting production demands. Its stock price was declining. These pressures also contributed to the company's failure to follow its own established procedures.25 To their great credit, Odwalla officials quickly took full responsibility for the failure of their safety systems and issued a recall. They paid medical expenses for the people who had become ill and an indemnity of about $250,000 to the family that had lost a child. Eventually, they settled more than a dozen civil suits at a cost of more than $12 million-just for the families of the five children who had been most injured. They also paid in other ways. In the first criminal conviction recorded in a large-scale outbreak of foodborne illness, Odwalla officials pleaded guilty to violating federal food safety laws, paid a $1.5 million fine, and were placed on probation for five years.26 Odwalla's corporate policy includes an explicit statement of social responsibility to employees and customers. Its officials immediately admitted wrongdoing and wrote checks. They also took action to improve production practices. Odwalla now flash-pasteurizes its juices (high temperature, short time), uses a HACCP plan, and actively promotes its quality-control efforts. These actions restored consumer confidence. By 1999, sales had almost returned to former levels, and by 2001 the company was comfortably profitable. The actions also restored investor confidence. In 2000, Odwalla merged with Fresh Samantha, another fresh juice company. A year later, ironically, this producer of fresh, "healthy" juices was purchased by Coca-Cola, the world's largest soft drink company, in a deal said to be worth $181 million.27 Among the many lessons of the Odwalla outbreak is the vulnerability of the nation's supply of fruit and vegetables to cross-contamination from infected animals, pointing even more forcefully to the need to prevent foodborne illness at its source. The Odwalla incident induced the FDA to demand a warning label on unpasteurized juices. Manufacturers would have to prove that their production practices achieved a "5-log" (100,000-fold) reduction in the number of dangerous contaminants in their juice products. Otherwise, juice labels would have to display this statement: "WARNING: This product has not been pasteurized and, therefore, may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems."28 Makers of unpasteurized juices, however, objected to the warning requirement. They argued that health risks posed by apple cider are too low to need a warning label: such labels are discriminatory (the FDA requires no such warnings for fruit, eggs, melons, or seafood); and the statement is frightening, confusing, and misleading. As the chairman of Odwalla explained: "The regulation issue is a 'very sensitive' one for the natural-food industry. Fresh food, and especially fresh produce, is very hard to regulate."29 Despite industry complaints, the FDA required the warning statement, and also issued HACCP regulations for domestic and imported juices in 2001. Despite industry complaints, the FDA required the warning statement, and also issued HACCP regulations for domestic and imported juices in 2001.30 The Odwalla outbreak provided convincing proof that unpasteurized and uncooked "natural" foods could contain the same pathogens as meat and poultry if they had the bad luck to come in contact with contaminated animal manure or meat. For the industry, the lessons were mixed. If food companies failed to reduce pathogens, their liability costs could be substantial-in money, time, legal penalties, and reputation-but these problems could be temporary and soon overcome. From a regulatory perspective, the Odwalla outbreak illustrated the universal need for Pathogen Reduction: HACCP, but an additional lesson was that the FDA was only likely to require such plans for the foods it regulated when confronted with disaster.
THE RECALL GAP: HUDSON FOODS, 1997.
The Odwalla outbreak also had implications for the livestock industry. Although beef industry officials were relieved to learn that fruit and vegetables could also be sources of E. coli E. coli O157:H7, meat products continued to cause outbreaks and unfavorable press. The USDA responded to the Odwalla outbreak by extending its generic O157:H7, meat products continued to cause outbreaks and unfavorable press. The USDA responded to the Odwalla outbreak by extending its generic E. coli E. coli testing requirements to include meat from goats, ducks, geese, and other animals but, in accordance with provisions of the old laws governing such matters, only after the animals had arrived at slaughterhouses. testing requirements to include meat from goats, ducks, geese, and other animals but, in accordance with provisions of the old laws governing such matters, only after the animals had arrived at slaughterhouses.31 Limitations on USDA authority became even more evident as a result of yet another E. coli E. coli O157:H7 outbreak, this one beginning in July 1997 as a case of bloody diarrhea in a supermarket employee who brought ground meat home from his store. The employee remembered eating a lightly cooked hamburger from a lot that was still stored in his freezer. Investigators quickly traced other patties from that lot to a Nebraska plant owned by Hudson Foods. Eventually, 16 people became ill as a result of eating meat processed at the Hudson plant. O157:H7 outbreak, this one beginning in July 1997 as a case of bloody diarrhea in a supermarket employee who brought ground meat home from his store. The employee remembered eating a lightly cooked hamburger from a lot that was still stored in his freezer. Investigators quickly traced other patties from that lot to a Nebraska plant owned by Hudson Foods. Eventually, 16 people became ill as a result of eating meat processed at the Hudson plant.32 At first, Hudson Foods officials told investigators that the contaminated lot included 3,400 pounds of meat that had been "reworked" into 20,000 pounds of hamburger the next day. They explained that their usual practice was to mix any meat left over from one day's production into the next day's batch of hamburger. This meant that if leftover meat contained harmful bacteria, the contaminated meat could get mixed into the next day's production. Plant officials neglected to tell USDA investigators that meat continued to be reworked from one day to the next, meaning that once a contaminated lot of meat got into the system, it would be mixed sequentially into all subsequent lots. Thus, the plant could not guarantee that any any subsequent lot would be free of harmful bacteria. Because the Meat Inspection Act does not authorize the USDA to recall contaminated products, the department's only recourse was to withdraw inspectors, thereby forcing the plant to close. Faced with this possibility, Hudson began a "voluntary" recall that eventually included 25 million pounds of potentially contaminated meat. subsequent lot would be free of harmful bacteria. Because the Meat Inspection Act does not authorize the USDA to recall contaminated products, the department's only recourse was to withdraw inspectors, thereby forcing the plant to close. Faced with this possibility, Hudson began a "voluntary" recall that eventually included 25 million pounds of potentially contaminated meat.33 Meat industry officials complained that the forced recall was excessive in relation to the actual problem, as none of the 16 victims had died. Instead, they thought the USDA should pay more attention to practices in slaughterhouses and retail stores. A Nebraska Chamber of Commerce official defended Hudson Foods: "There's always somebody out there trying to downgrade the meat industry. . . . I'm sure the people-veggies, is that what they call them-I bet they're rejoicing right now."34 At the end of August, Burger King placed full-page ads in major newspapers announcing that its franchises would no longer use Hudson's meat: "Although there was absolutely no indication that any of the beef Hudson Foods supplied to us was unsafe, we issued the recall anyway, because the trust and confidence you need to have in us every time you visit one of our restaurants is more important than any loss of business." Because Burger King flame-broils its hamburgers to temperatures much higher than those needed to kill bacteria, the business press criticized its action as "impossible to explain in scientific terms. . . . The company's fulminations about E. coli E. coli are thus pure public relations." are thus pure public relations."35 Hudson's bad luck was to receive a shipment of contaminated meat from one of its seven supplier slaughterhouses. Any other processing plant could have had the same problem, as all all of them typically rework leftover ground meat or poultry into the next day's production, and do so day after day. On this basis, an American Meat Institute official blamed the USDA for the problem because its on-site inspectors did not challenge the reworking: "To my knowledge . . . the USDA doesn't consider that to be an unsafe practice or against any regulations." of them typically rework leftover ground meat or poultry into the next day's production, and do so day after day. On this basis, an American Meat Institute official blamed the USDA for the problem because its on-site inspectors did not challenge the reworking: "To my knowledge . . . the USDA doesn't consider that to be an unsafe practice or against any regulations."36 This critique may have been accurate under the circumstances, but it did not speak to the need to prevent contamination at an earlier stage of production or to give USDA the authority to recall contaminated products. This critique may have been accurate under the circumstances, but it did not speak to the need to prevent contamination at an earlier stage of production or to give USDA the authority to recall contaminated products.
In September, the USDA reported that hamburger meat from the Hudson plant was contaminated on more dates than previously thought but the company had failed to disclose that information: "The department was originally told by Hudson that only 20,000 pounds of meat was involved and had to find out from other sources that far more was at stake." For misleading the USDA, a federal grand jury indicted Hudson and two of its employees, a decision considered unfair by Hudson Foods officials. The former chairman of the company told a reporter: "The overreaction of the U.S.D.A. in Washington in this incident destroyed my company's good name." Late in 1999, a federal jury in Nebraska agreed, and found Hudson officials not guilty not guilty of lying to government inspectors. Hudson closed the plant after the outbreak, but it was soon bought by Tyson Foods and reopened. As noted earlier, Tyson Foods was then the largest producer of chickens in the world and was soon to become the largest producer of beef as well. Of the 25 million pounds of hamburger recalled, 10 million pounds were recovered, an amount significantly of lying to government inspectors. Hudson closed the plant after the outbreak, but it was soon bought by Tyson Foods and reopened. As noted earlier, Tyson Foods was then the largest producer of chickens in the world and was soon to become the largest producer of beef as well. Of the 25 million pounds of hamburger recalled, 10 million pounds were recovered, an amount significantly higher higher than for most recalls. For example, a late 1990s recall of than for most recalls. For example, a late 1990s recall of E. coli E. coli O157:H7-contaminated hamburger from Beef America recovered only 400 of 443,656 pounds. Furthermore, the average percentage of product recovered in recalls fell from 40% in 1997 to 17% in 2000. O157:H7-contaminated hamburger from Beef America recovered only 400 of 443,656 pounds. Furthermore, the average percentage of product recovered in recalls fell from 40% in 1997 to 17% in 2000.37 In 2002, ConAgra "voluntarily" recalled 19 million pounds of ground beef after 19 people became ill with E. coli E. coli O157:H7 infections. The company produced the meat over a period of three months at a plant cited frequently for violations of safety codes. This incident provided further evidence that the USDA enforcement program was not working. A leaked GAO investigation of such matters was said to conclude that the USDA was taking more than a year (average: 566 days) to enforce standards in plants with high rates of O157:H7 infections. The company produced the meat over a period of three months at a plant cited frequently for violations of safety codes. This incident provided further evidence that the USDA enforcement program was not working. A leaked GAO investigation of such matters was said to conclude that the USDA was taking more than a year (average: 566 days) to enforce standards in plants with high rates of Salmonella Salmonella contamination, and some members of Congress complained about the USDA's "sluggish" pace of investigating deadly outbreaks. contamination, and some members of Congress complained about the USDA's "sluggish" pace of investigating deadly outbreaks.38 For food safety advocates, the contamination at the Hudson and ConAgra plants, and the USDA's inability to recall unsafe meat, illustrated the "linked failure of federal food safety programs and mismanagement by [the] food industry."39 For USDA officials, it provided further evidence of the need for recall authority. As one official told a reporter during the Hudson controversy: For USDA officials, it provided further evidence of the need for recall authority. As one official told a reporter during the Hudson controversy: This enforcement gap gets downright absurd. . . . We can use fines to protect farmers and ranchers from unfair trading practices. Abuse a circus elephant, sell a cat without a license, market a potato that's too small, keep bad records on watermelons, fail to report to the union committee-fine, fine, fine, fine, fine. Yet if you produce unsafe food-the only one of these items that puts people's lives at stake-there is no civil penalty.40 On the other hand, the meat industry interpreted the Hudson recall as a further example of excessively intrusive federal rules: "The statutory authority sought by the USDA is not necessary and would be contrary to sound public policy. . . . Frankly, to take away a company's limited right to discuss with the agency the scope and depth of its recall would likely lead to less co-ordination and more litigation."19 And Rosemary Mucklow of the National Meat Association charged that the ConAgra recall "may be an effort that is not justified" because the meat had already been in circulation for three months. And Rosemary Mucklow of the National Meat Association charged that the ConAgra recall "may be an effort that is not justified" because the meat had already been in circulation for three months.38 For the industry, the Hudson recall provided another opportunity for finger-pointing. Retailers such as Burger King blamed Hudson, while Hudson blamed the slaughterhouses and USDA inspectors. Everyone blamed the unregulated cattlemen, and not without reason. Investigations of cattle-rearing practices found For the industry, the Hudson recall provided another opportunity for finger-pointing. Retailers such as Burger King blamed Hudson, while Hudson blamed the slaughterhouses and USDA inspectors. Everyone blamed the unregulated cattlemen, and not without reason. Investigations of cattle-rearing practices found E. coli E. coli O157:H7 in feeding troughs, where the bacteria can survive in sediments for four months or more; in one instance, 40% of the troughs had not been cleaned in a year. O157:H7 in feeding troughs, where the bacteria can survive in sediments for four months or more; in one instance, 40% of the troughs had not been cleaned in a year.41 The bacteria also survive in manure for months, and many animals are found to be shedding them at the time of slaughter. The bacteria also survive in manure for months, and many animals are found to be shedding them at the time of slaughter.42 Despite these and other safety concerns, nobody in Congress or the administration wants to take on the cattlemen, leaving food safety advocates in the USDA without much in the way of political support for controlling pathogens on farms and feedlots, let alone in slaughterhouses, packing plants, or grocery stores. Despite these and other safety concerns, nobody in Congress or the administration wants to take on the cattlemen, leaving food safety advocates in the USDA without much in the way of political support for controlling pathogens on farms and feedlots, let alone in slaughterhouses, packing plants, or grocery stores.
THE TESTING GAP: "NONINTACT" BEEF, 1999 Chapter 2 described how, as a result of the Jack in the Box outbreak, the USDA identified ground beef contaminated with described how, as a result of the Jack in the Box outbreak, the USDA identified ground beef contaminated with E. coli E. coli O157:H7 as a public health risk, declared such beef "adulterated" under the terms of the Meat Inspection Act, and required the industry to reprocess or destroy it. It also described how the meat industry went to court to oppose-unsuccessfully, in that case-the USDA's 1994 imposition of a sampling and testing program for just this one pathogen ( O157:H7 as a public health risk, declared such beef "adulterated" under the terms of the Meat Inspection Act, and required the industry to reprocess or destroy it. It also described how the meat industry went to court to oppose-unsuccessfully, in that case-the USDA's 1994 imposition of a sampling and testing program for just this one pathogen (E. coli O157:H7) in just this one product (ground meat). Five years later, the USDA said it wanted to extend the definition of "adulterated" beyond just ground beef to include other forms of "nonintact" meat-meat that has been pounded, tenderized, or injected. Such procedures can introduce bacteria into the interior of the meat where they are unlikely to be cooked to as high a temperature as bacteria that contaminate outer surfaces. The USDA, however, continued to restrict its definition of "adulterated" to O157:H7) in just this one product (ground meat). Five years later, the USDA said it wanted to extend the definition of "adulterated" beyond just ground beef to include other forms of "nonintact" meat-meat that has been pounded, tenderized, or injected. Such procedures can introduce bacteria into the interior of the meat where they are unlikely to be cooked to as high a temperature as bacteria that contaminate outer surfaces. The USDA, however, continued to restrict its definition of "adulterated" to E. coli E. coli O157:H7. It excluded O157:H7. It excluded Listeria Listeria or or Salmonella Salmonella from this definition because these organisms are more easily killed during cooking. The department was not concerned about intact meat such as steak or chops because cooking or searing raises their surface temperatures high enough to kill bacteria. from this definition because these organisms are more easily killed during cooking. The department was not concerned about intact meat such as steak or chops because cooking or searing raises their surface temperatures high enough to kill bacteria.43 Although USDA officials said they would not test nonintact meat other than ground beef and veal, industry officials did not believe them and reacted with "shock, disbelief, and anger," viewing the new policy as nothing more than an attempt to divert public attention from current political concerns. According to Rosemary Mucklow, who by then had become executive director of the National Meat Association: "This will be an extraordinarily confusing issue. . . . This is just another step in this administration's obfuscation of the impeachment activities." Although USDA officials said they would not test nonintact meat other than ground beef and veal, industry officials did not believe them and reacted with "shock, disbelief, and anger," viewing the new policy as nothing more than an attempt to divert public attention from current political concerns. According to Rosemary Mucklow, who by then had become executive director of the National Meat Association: "This will be an extraordinarily confusing issue. . . . This is just another step in this administration's obfuscation of the impeachment activities."44 Ms. Mucklow's connection of E. coli E. coli O157:H7 testing to the then-current scandal involving President Clinton and a young White House intern, Monica Lewinsky, might seem a stretch for any group less relentless and self-serving than the beef industry. USDA Secretary Dan Glickman said he was "deeply and personally offended by this statement. USDA's efforts to improve food safety are grounded in science and a steadfast commitment to protecting public health." O157:H7 testing to the then-current scandal involving President Clinton and a young White House intern, Monica Lewinsky, might seem a stretch for any group less relentless and self-serving than the beef industry. USDA Secretary Dan Glickman said he was "deeply and personally offended by this statement. USDA's efforts to improve food safety are grounded in science and a steadfast commitment to protecting public health."45 The industry, however, continued to oppose the USDA's plans to test for The industry, however, continued to oppose the USDA's plans to test for E. coli E. coli O157:H7. Indeed, some thought that extending the testing requirements might backfire because companies would have an even stronger disincentive to do their own testing: "Given the serious financial ramifications of a positive test-the product would have to be recalled and then cooked or destroyed-it could be in the industry's best interest not to know." O157:H7. Indeed, some thought that extending the testing requirements might backfire because companies would have an even stronger disincentive to do their own testing: "Given the serious financial ramifications of a positive test-the product would have to be recalled and then cooked or destroyed-it could be in the industry's best interest not to know."38 Over the next year or so, the USDA opened the nonintact beef policy for public comment, held a public meeting, issued a position paper on E. coli E. coli O157:H7 testing, and dealt with opposing opinions in O157:H7 testing, and dealt with opposing opinions in Federal Register Federal Register notices. The meat industry's position on pathogen testing remained fixed: microbes are inherent in raw meat, testing would put companies out of business, and testing is ineffective. Instead, meat officials argued, the USDA should gather more data on risk before taking action, and consumers and farmers should take more responsibility for food safety. Furthermore, they said, the policy discriminates against beef because pork and poultry are similarly contaminated. notices. The meat industry's position on pathogen testing remained fixed: microbes are inherent in raw meat, testing would put companies out of business, and testing is ineffective. Instead, meat officials argued, the USDA should gather more data on risk before taking action, and consumers and farmers should take more responsibility for food safety. Furthermore, they said, the policy discriminates against beef because pork and poultry are similarly contaminated.46 Overall, the reactions to this proposal demonstrated that the beef industry was determined to oppose any expansion of pathogen testing, no matter how limited or beneficial to the public. Overall, the reactions to this proposal demonstrated that the beef industry was determined to oppose any expansion of pathogen testing, no matter how limited or beneficial to the public.
THE LEGAL GAP:.
LAWSUITS AGAINST PATHOGEN REDUCTION: HACCP.
As the consequences of Pathogen Reduction: HACCP for recall or destruction of contaminated products became increasingly evident, the beef industry went to court to force the USDA to adhere to the intent of the 1906 Meat Inspection Act: protect the public against sick animals, not bacteria. Two cases in the late 1990s illustrate the degree to which the industry would invoke that law, leaving to consumers the responsibility for avoiding bacterial contaminants.
Supreme Beef v. v. USDA USDA The lawsuit brought by Supreme Beef Processors in Dallas illustrates how the industry used the courts to block the USDA's imposition of Salmonella Salmonella testing. When HACCP regulations for small meat-processing firms went into effect in 1999, companies had to meet this performance standard: testing must find no more than 7.5% of sample products to contain (give "positive" results for) testing. When HACCP regulations for small meat-processing firms went into effect in 1999, companies had to meet this performance standard: testing must find no more than 7.5% of sample products to contain (give "positive" results for) Salmonella Salmonella. During that first year, 20% or so of Supreme Beef's ground beef tested positive on two occasions. When a third round of testing also showed that the company's meat exceeded the 7.5% standard, the USDA withdrew its inspectors and forced the plant to close. The USDA must have been especially concerned because this company supplied nearly half the ground beef distributed to schools participating in the national school lunch program. Supreme Beef immediately sued the USDA. The department, it charged, had acted in an "arbitrary and capricious" manner because it did not have legal authority to regulate Salmonella Salmonella. The suit also charged that because cooking kills Salmonella Salmonella, these bacteria do not threaten public safety and cannot be considered adulterants.
Four meat trade associations supported the suit for the usual finger-pointing reasons. Rosemary Mucklow of the National Meat Association told reporters: "Supreme Beef . . . is experiencing the consequences of a requirement that we think has some serious problems. It would have been better if U.S.D.A. had tried to work it out" and "Poor sanitation at ground-beef plants is seldom to blame for salmonella contamination. . . . It would be more effective to enforce performance standards at packing plants or feedlots and farms."47 The USDA, as Ms. Mucklow surely must have known, has no enforcement authority over feedlots and farms. The USDA, as Ms. Mucklow surely must have known, has no enforcement authority over feedlots and farms.
At this point, a U.S. District Court judge in Dallas, A. Joe Fish, ruled that the USDA did not have the authority to close the Supreme Beef plant since doing so could irreparably harm the company. Instead, he issued an injunction against the USDA, forcing its inspectors to continue stamping the meat "USDA Inspected and Passed." The USDA dealt with this frustrating setback in its ability to enforce Pathogen Reduction: HACCP by canceling the department's school lunch contract with Supreme Beef.48 Furthermore, the USDA continued to test Supreme Beef's ground meat for E. coli E. coli O157:H7. Just two weeks after the Dallas court decision, USDA tests identified this pathogen in one sample of ground beef and again forced a "voluntary" recall, this time of 180,000 pounds. To the USDA, this finding proved that Supreme Beef's safety procedures were faulty and its lawsuit unjustified. The company, however, maintained that this recall was unrelated to the previous one because O157:H7. Just two weeks after the Dallas court decision, USDA tests identified this pathogen in one sample of ground beef and again forced a "voluntary" recall, this time of 180,000 pounds. To the USDA, this finding proved that Supreme Beef's safety procedures were faulty and its lawsuit unjustified. The company, however, maintained that this recall was unrelated to the previous one because Salmonella Salmonella "has nothing to do with the safety of the meat we produce." "has nothing to do with the safety of the meat we produce."49 In May 2000, the same Dallas judge (A. Joe Fish) who had supported Supreme Beef's position on In May 2000, the same Dallas judge (A. Joe Fish) who had supported Supreme Beef's position on Salmonella Salmonella testing, extended his ruling to other plants in northern Texas; they also would not need to test for testing, extended his ruling to other plants in northern Texas; they also would not need to test for Salmonella Salmonella. The New York Times New York Times found this ruling startling: found this ruling startling: Under the judge's strange reasoning, a plant that produces Supreme Beef's dismal salmonella test results might still be perfectly clean. The judge was troubled by the idea of penalizing a plant when the meat may already have been contaminated when it arrived there. . . . As a matter of logic and science, the excessive presence of dangerous salmonella in any meat turned out by a plant should be deemed evidence that conditions at the plant are unsanitary.50 In the months following those decisions, Supreme Beef again failed its Salmonella Salmonella tests but could not be forced to close because of the court ruling. The president of the company, Steve Spiritas, characterized USDA's actions as an "all-out assault by the federal government on our small business." He charged USDA with "manipulating the testing results, suppressing critical information, . . . [and] using bullying tactics to support a position that a federal court has told it has no legal, logical, or scientific basis." tests but could not be forced to close because of the court ruling. The president of the company, Steve Spiritas, characterized USDA's actions as an "all-out assault by the federal government on our small business." He charged USDA with "manipulating the testing results, suppressing critical information, . . . [and] using bullying tactics to support a position that a federal court has told it has no legal, logical, or scientific basis."51 He also pointed out that meat supplied to Supreme Beef bore the stamp "USDA Inspected and Passed," meaning that USDA had certified its safety. He also pointed out that meat supplied to Supreme Beef bore the stamp "USDA Inspected and Passed," meaning that USDA had certified its safety.
Some legislators attempted to introduce bills granting USDA the authority to impose limits on Salmonella Salmonella, but these bills failed to pass. The USDA tried other approaches; it cited Supreme Beef for violating sanitation standards and initiated daily daily testing of ground meat for testing of ground meat for E. coli E. coli O157:H7. These actions caused Mr. Spiritas to complain that his small business was being held to unreasonable, discriminatory, and retaliatory standards. Eventually, he gave up, declared bankruptcy, and threatened to sue the USDA for its harassing tactics. The USDA tried to have the case declared moot because of the bankruptcy, but the courts denied this request. Supreme Beef, with the support of the National Meat Association and other meat industry groups, continued to pursue the case, as so much was at stake. If the USDA could shut down plants producing meat contaminated with O157:H7. These actions caused Mr. Spiritas to complain that his small business was being held to unreasonable, discriminatory, and retaliatory standards. Eventually, he gave up, declared bankruptcy, and threatened to sue the USDA for its harassing tactics. The USDA tried to have the case declared moot because of the bankruptcy, but the courts denied this request. Supreme Beef, with the support of the National Meat Association and other meat industry groups, continued to pursue the case, as so much was at stake. If the USDA could shut down plants producing meat contaminated with Salmonella Salmonella, as much as half half the meat supply would be considered adulterated and subject to recall or destruction. the meat supply would be considered adulterated and subject to recall or destruction.52 In December 2001, a three-judge federal appeals court in New Orleans ruled that the USDA's Salmonella Salmonella performance standards conflicted with the "plain language" of the 1906 law, which defined adulterated meat as "prepared, packed, or held under insanitary [ performance standards conflicted with the "plain language" of the 1906 law, which defined adulterated meat as "prepared, packed, or held under insanitary [sic] conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health." The court referred to the 1974 decision in APHA APHA v. v. Butz Butz to argue that " to argue that "Salmonella, present in a substantial proportion of meat and poultry products, is not an adulterant per se per se. . . . This is because normal cooking practices for meat and poultry destroy the Salmonella Salmonella organism." organism."53 This ruling essentially overturned the pathogen reduction portion of HACCP. The beef industry welcomed the decision: "Using a relatively infrequently encountered pathogen such as salmonella as an indicator organism that can objectively measure a processing plant's performance is not scientifically warranted. . . . Supreme's brave lawsuit and the court's ruling against imposition of these flawed standards stands as a shining moment for the meat industry, a momentary triumph of reason over regulation." This ruling essentially overturned the pathogen reduction portion of HACCP. The beef industry welcomed the decision: "Using a relatively infrequently encountered pathogen such as salmonella as an indicator organism that can objectively measure a processing plant's performance is not scientifically warranted. . . . Supreme's brave lawsuit and the court's ruling against imposition of these flawed standards stands as a shining moment for the meat industry, a momentary triumph of reason over regulation."54 Less self-interested observers, however, did not see it that way. The New York Times New York Times called the court's decision "misguided" and its logic "seriously flawed," saying, "It ignores both the government's broad discretion under the law to police unsanitary conditions in meat plants and the serious danger, unresolved by proper cooking, that arises when contaminated raw meat and poultry come in contact with cutting boards, utensils and other foods, such as fruits and vegetables." called the court's decision "misguided" and its logic "seriously flawed," saying, "It ignores both the government's broad discretion under the law to police unsanitary conditions in meat plants and the serious danger, unresolved by proper cooking, that arises when contaminated raw meat and poultry come in contact with cutting boards, utensils and other foods, such as fruits and vegetables."55 The USDA's response to the decision was to announce that it planned to continue to conduct microbial testing to ensure food safety. The court's ruling eliminated our ability to take enforcement action based solely on salmonella standards. The ruling doesn't prevent the department from using salmonella standards to verify a plant's ability to address food safety hazards. Salmonella standards alert us that there may be a problem in a plant and that the whole plant needs to be examined, not just one piece of meat.56 Food safetyconscious senators and representatives introduced bills to give the USDA greater authority to regulate meat safety but, as noted by the New York Times New York Times, "These proposals have so far attracted no Republican co-sponsors. Even more troubling, the noises from the Agriculture Department suggest that the administration is more interested in satisfying industry's wish for lax regulation than in restoring the government's power to shut unsanitary plants. The Supreme Beef Processors decision has left a hole in the inspection system, putting consumers everywhere at increased risk."57 Lending further support to this charge, the USDA announced that it would not appeal the ruling, enforce Salmonella Salmonella standards, or ask Congress to intervene. Under the administration of President George W. Bush, USDA officials appeared to be withdrawing support of HACCP, despite its evident effectiveness. Instead, the USDA would continue to test for standards, or ask Congress to intervene. Under the administration of President George W. Bush, USDA officials appeared to be withdrawing support of HACCP, despite its evident effectiveness. Instead, the USDA would continue to test for Salmonella Salmonella, but would use the results only as a basis for further inspections-not for closing plants or recalling products. These decisions "disappointed consumer advocates and [drew] praise from industry."58 In response, Senator Tom Harkin (Dem-IA) introduced legislation that in effect would In response, Senator Tom Harkin (Dem-IA) introduced legislation that in effect would order order USDA to follow its own rules for microbial contaminants. He said that he hoped the USDA had "not ceded the fight for safer food to the meat and poultry industry. . . . We must make it clear, once and for all, that the U.S.D.A. has the authority to set and enforce standards to reduce pathogens." USDA to follow its own rules for microbial contaminants. He said that he hoped the USDA had "not ceded the fight for safer food to the meat and poultry industry. . . . We must make it clear, once and for all, that the U.S.D.A. has the authority to set and enforce standards to reduce pathogens."59 Whatever the outcome of such cases or legislation, they thoroughly expose the politics of food safety and the glaring gaps in federal regulatory authority. Whatever the outcome of such cases or legislation, they thoroughly expose the politics of food safety and the glaring gaps in federal regulatory authority.
USDA Inspectors versus "HACCP-Based Inspection Models"
In June 1997, the USDA asked for comments on how the department might develop new ways of inspecting meat in slaughterhouses and processing plants "in a HACCP environment." Inspectors were still examining every carcass, but the department thought they would be better employed checking for fecal contamination, sampling for microbial pathogens, and monitoring meat that left the plant. The department proposed to try out a HACCP-Based Inspection Models Project (HIMP) that would substitute such activities for examination of every meat and poultry carcass coming off the production line.60 This time, the objections came from federal meat and poultry inspectors. The inspectors, their union (the American Federation of Government Employees), and a consumer advocacy group, the Community Nutrition Institute (CNI), sued the USDA to prevent the department from trying to do anything other than the carcass-by-carcass inspection required by the 1906 law. The inspectors' motivation is best expressed by the mission statement given on the union's Web site: "The-Inspector.com has been established in support of the thousands of dedicated Food & Consumer Safety Inspectors, working on the front lines of the meat, poultry & egg products industries, usually under miserable conditions, safeguarding the American food supply." At the time (it has since been sold), the Community Nutrition Institute published This time, the objections came from federal meat and poultry inspectors. The inspectors, their union (the American Federation of Government Employees), and a consumer advocacy group, the Community Nutrition Institute (CNI), sued the USDA to prevent the department from trying to do anything other than the carcass-by-carcass inspection required by the 1906 law. The inspectors' motivation is best expressed by the mission statement given on the union's Web site: "The-Inspector.com has been established in support of the thousands of dedicated Food & Consumer Safety Inspectors, working on the front lines of the meat, poultry & egg products industries, usually under miserable conditions, safeguarding the American food supply." At the time (it has since been sold), the Community Nutrition Institute published Nutrition Week Nutrition Week, a newsletter that tracked current events in food and nutrition. Both were run by Rodney Leonard, long an outspoken advocate of improved food safety. Mr. Leonard's otherwise inexplicable role as a plaintiff in this anti-HACCP lawsuit reflected his view that the meat industry could not be trusted to conduct its own inspections or testing and that this responsibility properly belonged to government. A U.S. appeals court agreed. It chided the USDA for attempting to reinterpret the Meat Inspection Act.
The government does not deny that in the ninety or so years since passage of the [1906 Act] . . . "inspection" has been taken to mean an organoleptic examination of the carcass, an inspection, that is, using the senses. Now the government has discovered another meaning. A "federal employee has performed an inspection of a carcass," the government tells us, "when he has watched a plant employee conduct the kind of examination, organoleptic or otherwise, that is necessary to determine whether the carcass is fit for human consumption." . . . In other words, the government believes that federal employees fulfill their statutory duty to inspect by watching others perform the task. One might as well say that umpires are pitchers because they carefully watch others throw baseballs.61 The decision against USDA left the future of HACCP uncertain. Nutrition Week Nutrition Week called it "a great victory for consumers. . . . USDA is no longer allowed to abdicate its responsibility for food safety," and quoted a representative of the inspectors' union: "The court found what we have maintained for years-allowing industry to inspect itself is a violation of the law." called it "a great victory for consumers. . . . USDA is no longer allowed to abdicate its responsibility for food safety," and quoted a representative of the inspectors' union: "The court found what we have maintained for years-allowing industry to inspect itself is a violation of the law."62 USDA responded by modifying the pilot system so that inspectors would continue to monitor carcasses. In January 2001, a federal court permitted the USDA to implement the proposed revisions, but the plaintiffs said they would appeal that decision. They argued that USDA's changes were insufficient and that the true purpose of the new system was to deregulate the meat industry. USDA responded by modifying the pilot system so that inspectors would continue to monitor carcasses. In January 2001, a federal court permitted the USDA to implement the proposed revisions, but the plaintiffs said they would appeal that decision. They argued that USDA's changes were insufficient and that the true purpose of the new system was to deregulate the meat industry.63 While the court case was in progress, Congress asked the General Accounting Office (GAO) to evaluate the effectiveness of the model inspection system. After a nine-month investigation that involved close examination of records from II model inspection projects in chicken plants, interviews with numerous participants, a survey of more than 200 inspectors, and visits to similar projects in Canada and Australia, the GAO produced a lengthy report of its findings in December 2001. Its conclusion: "a risk-based inspection system-such as the one that USDA is pilot-testing at chicken plants and is starting at hog plants-has merit in concept and is consistent with the existing risk-based framework for HACCP." GAO investigators, however, thought that the design of the projects was so flawed that it was impossible to determine whether the new system performed as well as the one it was supposed to replace. In particular, they noted that the results of Salmonella Salmonella testing were worse at nearly half the plants using the modified inspection system. Nevertheless, they said, testing were worse at nearly half the plants using the modified inspection system. Nevertheless, they said, This report reiterates our previous recommendation for legislative revisions aimed at reducing the potential for further legal challenges by providing USDA with a clear authority to modify its inspection system. . . . We continue to believe that . . . Congress should consider revising the Meat and Poultry Acts . . . to provide FSIS with the flexibility and discretion to target its inspection resources for the most serious food safety risks. Such revisions would eliminate the requirements that USDA has traditionally implemented through continuous carcass-by-carcass government inspection and replace them with a risk-based inspection system that includes government oversight and verification.64 In response, the USDA said, "No food safety or non-food safety defects are acceptable to FSIS. While no system is perfect, the models project is an effort to reduce and eliminate defects that pass through traditional inspection."65 Although further court action allowed the USDA to continue to test alternative inspection methods, studies continued to reveal serious flaws in food safety at the plants using the model systems. The USDA's own studies showed that 13 of 16 plants had higher rates of Salmonella Salmonella contamination under the new system (but lower rates of problems with contamination under the new system (but lower rates of problems with E. coli E. coli O157:H7). O157:H7).66 The most obvious interpretation of such dismal results is that neither the plants nor the USDA nor its inspectors were sufficiently committed to doing what is necessary to protect the public and reduce foodborne illness. The most obvious interpretation of such dismal results is that neither the plants nor the USDA nor its inspectors were sufficiently committed to doing what is necessary to protect the public and reduce foodborne illness.
No matter how the model projects and court cases eventually resolve, they reveal how strongly HACCP conflicts with entrenched views. Inspectors worry about protecting their jobs; some consumer groups distrust the industry's willingness to develop and monitor HACCP controls appropriately; the USDA is caught between Congress, the industry, and the courts; and each component of the meat and poultry food chain-producers, processors, retailers, and consumers-believes that responsibility for food safety belongs elsewhere. If nothing else, the legal battles over HACCP implementation make it clear that nothing less than a complete overhaul of the existing food safety system can fix the problems and provide adequate oversight.
THE CULTURE GAP: MEAT INDUSTRY VERSUS INSPECTORS.
The persistence of some segments of the meat industry in opposing pathogen testing can be explained by economic interests, of course, but also by the cultural tradition of individualistic, antigovernment attitudes reflected in images of cowboys riding herd on cattle in remote areas of the West. The industry culture also reflects what the meat industry itself is about-the slaughter of animals for food. As Upton Sinclair so graphically explained, much of the work of this industry is "stupefying and brutalizing." Despite reforms, more recent observers like Eric Schlosser continue to find this work repetitive, filthy, and terribly dangerous.67 Although meat producers and inspectors both oppose one or another aspect of USDA regulations, their common opposition does not unite them. On the contrary, the inspectors despise the industry for supporting self-inspection (albeit without testing for pathogens), and the industry does little to discourage-worse, actively encourages-open hostility, not only to the USDA regulations, but also to the individual inspectors who enforce them. In June 2000, in an extreme example of such hostility, the owner of the Santos Linguisa sausage factory in San Leandro, California, opened fire on four state and federal meat inspectors, wounding three of them; he then reloaded and killed three of them execution style with shots to the head. HACCP requirements for the plant had taken effect that January, and inspectors subsequently identified repeated failings of temperature control points and other problems. The plant's owner, Stuart Alexander, was known to have threatened the meat inspectors. He posted their photographs in the plant and displayed this sign outside its walls: "To all our great customers, the U.S.D.A. is coming into our plant harassing my employees and me, making it impossible to make our great product. Gee, if all meat plants could be in business for 79 years without one complaint, the meat inspectors would not have jobs. Therefore, we are taking legal action against them." Evidence presented to a grand jury included a video of the shootings and electronic mail messages from Mr. Alexander. One example: "I'm taking action against these government slime balls. . . . They messed with the wrong guy this time, baby."68 This incident, isolated as it was, appeared to be just the tip of the cowboy-culture iceberg. Meat inspectors told USDA officials that "threats from business owners upset over citations or what they perceive as unfair investigations are commonplace. . . . It's intimidating when you go into an office of some individual who is violating the codes and he has a pistol sitting on his desk." Verbal abuse was normal normal in the course of their duties, they said. At one meeting, 40% said they had been threatened, and 10% said they had been physically attacked-sometimes with knives or guns. in the course of their duties, they said. At one meeting, 40% said they had been threatened, and 10% said they had been physically attacked-sometimes with knives or guns.69 In the wake of the shootings, an Internet newsletter for meat processors published a series of articles on the industry's relationships with inspectors. The articles reported humorous accounts of the incident ("Jokes about the murders sprang up like poison mushrooms") and quoted a ground beef producer in New York City, referring to an article about the shootings on his wall: " 'Oh, we have that there as a joke. . . . Those guys-meaning the inspectors-can really aggravate you.' 'I tell my inspectors they're next,' laughed another." The articles noted that inspectors had the power to make life miserable for companies: "Some inspectors-not all, of course, but some-seem to take advantage of this power with particular relish. . . . Worse, the retribution may be endemic to the federal inspection program. . . . Administrators at FSIS seem powerless-or too weak-willed-to stop it." In the wake of the shootings, an Internet newsletter for meat processors published a series of articles on the industry's relationships with inspectors. The articles reported humorous accounts of the incident ("Jokes about the murders sprang up like poison mushrooms") and quoted a ground beef producer in New York City, referring to an article about the shootings on his wall: " 'Oh, we have that there as a joke. . . . Those guys-meaning the inspectors-can really aggravate you.' 'I tell my inspectors they're next,' laughed another." The articles noted that inspectors had the power to make life miserable for companies: "Some inspectors-not all, of course, but some-seem to take advantage of this power with particular relish. . . . Worse, the retribution may be endemic to the federal inspection program. . . . Administrators at FSIS seem powerless-or too weak-willed-to stop it."70 USDA officials asked meat industry leaders to tone down the hostile rhetoric, called a series of meetings on workplace conflict and violence, issued directives on how to handle violent incidents, and encouraged employees to report incidents to a hotline. The number of hotline reports increased from 62 in 1999 to 161 in 2001 and affected every inspection district. Overall, the USDA documented 252 incidents of workplace violence against inspectors in 2001.71 Changing such ingrained patterns of hostility among meat industry employees will not be easy. The laws require what everyone agrees is a "unique regulatory framework. . . . In no other industry are regulators required to be continuously present in order for the regulated facility to operate," and "a certain segment of the population harbors strong animosity toward authority in general and the federal government in particular."72 The primary activity of the meat industry is the killing of animals for food, and some level of "stupefying, brutalizing" callousness is only to be expected. The primary activity of the meat industry is the killing of animals for food, and some level of "stupefying, brutalizing" callousness is only to be expected.
From the incidents discussed in chapters 2 chapters 2 and and 3 3, we see that the politics of food safety early in the twenty-first century involves multiple elements. Microbial outbreaks are due to new and more dangerous organisms that affect an increasing number of foods. Federal agencies issue regulations for reducing pathogens for some-but nowhere near all-foods vulnerable to contamination. Government oversight remains mired in century-old laws, fragmented between two agencies with conflicting missions and rules. Both agencies lack adequate resources, political will, and industry support. The regulated industries resist pathogen controls as impositions, blame government or consumers for safety problems, and tolerate occasional legal liability as a reasonable price for conducting business as usual-even if doing so results in completely avoidable illness and death. As we will see in the next chapter, food companies much prefer consumer education or food irradiation to Pathogen Reduction: HACCP, and they continue to oppose any genuine strengthening of a federal role in food safety.
CHAPTER 4.
ACHIEVING SAFE FOOD.
ALTERNATIVES.
AS CITIZENS, WE NEED TO UNDERSTAND THAT PRODUCING SAFE food is not impossibly difficult. Food scientists proved years ago that HACCP systems prevented foodborne illness in outer space. Those systems should work just as well on earth. Sweden, Denmark, and the Netherlands have reduced foodborne illnesses by instituting control systems at every stage of production, starting on the farm. They set testing standards to reduce pathogens, limit antibiotics in animal feed, prevent infections in transported animals, test for microbes at slaughterhouses and supermarkets, and provide incentives to the industry to comply with safety rules. Our government could also take such actions. That it does not is a result of an entrenched political system that allows federal regulators to avoid enforcing their own rules, and food companies to deny responsibility and blame each other, the regulators, or the public whenever outbreaks occur. Rather than collaborating to reduce foodborne pathogens, the agencies and companies shift attention to consumer education as the best way to ensure safe food. Failing that, they call for foods to be irradiated or pasteurized. This chapter examines the education, irradiation, and pasteurization alternatives along with two others: using the courts to impose legal liability for foodborne illness, and reorganizing government to consolidate and improve oversight of food safety. food is not impossibly difficult. Food scientists proved years ago that HACCP systems prevented foodborne illness in outer space. Those systems should work just as well on earth. Sweden, Denmark, and the Netherlands have reduced foodborne illnesses by instituting control systems at every stage of production, starting on the farm. They set testing standards to reduce pathogens, limit antibiotics in animal feed, prevent infections in transported animals, test for microbes at slaughterhouses and supermarkets, and provide incentives to the industry to comply with safety rules. Our government could also take such actions. That it does not is a result of an entrenched political system that allows federal regulators to avoid enforcing their own rules, and food companies to deny responsibility and blame each other, the regulators, or the public whenever outbreaks occur. Rather than collaborating to reduce foodborne pathogens, the agencies and companies shift attention to consumer education as the best way to ensure safe food. Failing that, they call for foods to be irradiated or pasteurized. This chapter examines the education, irradiation, and pasteurization alternatives along with two others: using the courts to impose legal liability for foodborne illness, and reorganizing government to consolidate and improve oversight of food safety.
Before addressing these alternatives, we need to deal with one further issue: food imports. Pathogen Reduction: HACCP applies to domestic food production. The countries from which we import fruits, vegetables, and other foods do not necessarily follow such rules. Because food imports are influenced (if not governed) by international trade agreements, methods to ensure food safety must also take such agreements into consideration.
IMPORTING SAFE FOOD: THE POLITICS OF FOOD TRADE.
We live in a global economy with a global food supply. If we insist on having fresh strawberries and tomatoes in January (beyond those grown in our southern states), we have to buy them from countries with warmer climates. In 2000, the United States imported fresh and processed foods worth nearly $49 billion (including about $8 billion worth of fruits, vegetables, and juices), many of them from places with lower standards of water quality and sanitation. Imported foods have caused notable outbreaks: Hepatitis A from Mexican strawberries, Vibrio Vibrio from Thai coconut pudding, from Thai coconut pudding, E. coli E. coli O157:H7 from French semisoft cheeses, O157:H7 from French semisoft cheeses, Staphylococcus Staphylococcus from Chinese canned mushrooms. That we do not experience more episodes of illness is nothing less than miraculous, a tribute more to our healthy immune systems, the benefits of cooking and food preservation, and plain good luck than to federal oversight. from Chinese canned mushrooms. That we do not experience more episodes of illness is nothing less than miraculous, a tribute more to our healthy immune systems, the benefits of cooking and food preservation, and plain good luck than to federal oversight.1 Any system for grappling with the safety of imported food must deal with the usual two agencies, neither with anywhere near the resources required for this task. The USDA samples about 20% of imported meat and poultry products and rejects those from countries that do not meet our safety standards; it holds the "right of equivalency." In contrast, the FDA does not have this right and cannot reject imported foods that fail to meet our standards. This enforcement gap is not for lack of trying. FDA Commissioner David Kessler specifically requested the right of equivalency in 1993, and the General Accounting Office (GAO) called on Congress to grant it in 1998. Until recently, the FDA inspected less than 1% of the imported foods under its jurisdiction, down from 8% in 1992. In response to concerns about "homeland security," the level doubled-to 2%-in 2002. The FDA's challenge is daunting: in the late 1990s, it employed just 113 inspectors to examine 3 million food shipments flowing through 309 ports of entry to the United States. Yet at the Laredo, Texas, crossing point alone, 1.3 million trucks from Mexico enter the country each year. In 1997, Congress allotted $41 million to improve food inspection across the entire entire nation. At the same time, it granted $230 million for narcotics control, just for the Southwest border with Mexico. Food safety has never been a Congressional priority and, as we will see in the concluding chapter, it still is not. nation. At the same time, it granted $230 million for narcotics control, just for the Southwest border with Mexico. Food safety has never been a Congressional priority and, as we will see in the concluding chapter, it still is not.2 Trade works both ways; we exported about $54 billion worth of food products in 2000. Food exports represent 20% of the value of U.S. agricultural production and about one-third of our total harvest. The ability to sell agricultural products abroad is a critically important factor in our economy. If Congress gave the FDA the authority to reject foods from countries with lower safety standards, countries with higher standards might refuse to accept our our products. The result: trade problems. Other countries, after all, can exercise their own rights of equivalency. In 2002, for example, Russia temporarily banned imports of U.S. poultry, saying the chickens carried influenza, had been treated with antibiotics, and were contaminated with products. The result: trade problems. Other countries, after all, can exercise their own rights of equivalency. In 2002, for example, Russia temporarily banned imports of U.S. poultry, saying the chickens carried influenza, had been treated with antibiotics, and were contaminated with Salmonella Salmonella. The ban affected nearly one-quarter of the more than 1 million tons of frozen chicken (worth $640 million) expected to be exported to Russia that year. U.S. officials argued that the Russians were more worried about protecting their own chicken production than about safety. Trade negotiators worked for three weeks to resolve the dispute.3 Regardless of the agencies' need for more inspection resources, any additional regulatory authority over imported foods might backfire if trading partners refused our exports. Regardless of the agencies' need for more inspection resources, any additional regulatory authority over imported foods might backfire if trading partners refused our exports.4 Hence, politics. Hence, politics.
International trade issues related to food safety are resolved through a commission of the United Nations known as Codex Alimentarius (Latin for "food code"). The commission's purpose is to "promote the elaboration and establishment of definitions and requirements for foods, to assist in their harmonization and, in doing so, to facilitate international trade."5 With respect to food safety, this goal places the commission in potential conflict of interest; the Codex promotes safe food on the one hand, but trade on the other. As it turns out, trade issues almost always take precedence, perhaps because of the commission's composition. Among the nearly 2,600 individuals who participated in Codex meetings in the early 1990s, for example, 25% represented industry while only 1% represented public interest groups (the others were government officials). Among delegates from the United States at that time, nearly half (49%) were drawn from industry. With respect to food safety, this goal places the commission in potential conflict of interest; the Codex promotes safe food on the one hand, but trade on the other. As it turns out, trade issues almost always take precedence, perhaps because of the commission's composition. Among the nearly 2,600 individuals who participated in Codex meetings in the early 1990s, for example, 25% represented industry while only 1% represented public interest groups (the others were government officials). Among delegates from the United States at that time, nearly half (49%) were drawn from industry.6 That imbalance continues. That imbalance continues.
The Codex commission asserts that its safety standards are science based. If so, it can-and does-demand that members view its requirements as legitimate protections rather than trade barriers. In practice, the commission's efforts to "harmonize" the differing food safety regulations of member nations appear as pressures to lower lower standards: "Members shall ensure that any sanitary and phytosanitary measure is applied only to the extent necessary to protect human, animal, or plant life or health, is based on scientific principles and is not maintained without sufficient scientific evidence." standards: "Members shall ensure that any sanitary and phytosanitary measure is applied only to the extent necessary to protect human, animal, or plant life or health, is based on scientific principles and is not maintained without sufficient scientific evidence."5 Because scientific proof of safety is difficult to attain, and the results of most (if not all) scientific studies are subject to interpretation, the Codex criteria leave much room for trade disagreements in which science is invoked in the self-interest of one country or another. Because scientific proof of safety is difficult to attain, and the results of most (if not all) scientific studies are subject to interpretation, the Codex criteria leave much room for trade disagreements in which science is invoked in the self-interest of one country or another.
A 1997 U.S. outbreak of Cyclospora Cyclospora attributed to Guatemalan raspberries illustrates how difficult it can be to sort out such disputes. Until the mid-1980s, Guatemala did not grow raspberries. Then, during the country's campaign against leftist guerrillas, the U.S. Agency for International Development promoted development of "nontraditional agriculture" and encouraged farmers to grow exotic foods for North Americans as cash crops rather than continuing to grow corn and beans for themselves. Production grew rapidly. In 1992, Guatemala produced less than 4,000 pounds of the berries, but in 1996 it shipped 700,000 pounds. attributed to Guatemalan raspberries illustrates how difficult it can be to sort out such disputes. Until the mid-1980s, Guatemala did not grow raspberries. Then, during the country's campaign against leftist guerrillas, the U.S. Agency for International Development promoted development of "nontraditional agriculture" and encouraged farmers to grow exotic foods for North Americans as cash crops rather than continuing to grow corn and beans for themselves. Production grew rapidly. In 1992, Guatemala produced less than 4,000 pounds of the berries, but in 1996 it shipped 700,000 pounds.
Guatemalan raspberries become ripe and are ready to ship in April and May, when there is no competing source. Spring rains, however, encourage the growth of Cyclospora Cyclospora, a common cause of diarrhea among Guatemalan children and of illness among raspberry pickers. During the outbreak in the United States, investigators from the Centers for Disease Control and Prevention (CDC) found Cyclospora Cyclospora in the feces of people who had eaten Guatemalan raspberries. They did not, however, find the bacteria in the raspberries. Nevertheless, as a measure of prudence, they advised the public not to eat Guatemalan raspberries. Guatemalan growers were understandably distressed by unproven assumptions that their raspberries had caused the outbreak. They voluntarily suspended shipments but also "kicked the C.D.C.'s field investigator off their farms [and] denounced the American scientists as snipers fighting a trade war on behalf of the growers' California competitors." Reports quoted a spokesman for the berry growers: "Last year the guerrillas were in the fields asking my workers about their conditions . . . and this year it was the C.D.C. The C.D.C. is killing us. They kill us every time they open their mouths." The growers charged the United States with unfair trade practices: "Cyclospora? . . . They can't find it. . . . Protectionist forces find bugs or whatever to protect their market. It's a commercial war." in the feces of people who had eaten Guatemalan raspberries. They did not, however, find the bacteria in the raspberries. Nevertheless, as a measure of prudence, they advised the public not to eat Guatemalan raspberries. Guatemalan growers were understandably distressed by unproven assumptions that their raspberries had caused the outbreak. They voluntarily suspended shipments but also "kicked the C.D.C.'s field investigator off their farms [and] denounced the American scientists as snipers fighting a trade war on behalf of the growers' California competitors." Reports quoted a spokesman for the berry growers: "Last year the guerrillas were in the fields asking my workers about their conditions . . . and this year it was the C.D.C. The C.D.C. is killing us. They kill us every time they open their mouths." The growers charged the United States with unfair trade practices: "Cyclospora? . . . They can't find it. . . . Protectionist forces find bugs or whatever to protect their market. It's a commercial war."7 To add to such complexities, some countries do have food safety standards higher than ours, which is one reason they resist imports of our genetically modified soybeans and corn, as discussed in part 2 part 2 of this book. As we will see, such disputes fall under the purview of the multinational World Trade Organization, a higher-level international entity that takes precedence over the Codex Commission. As is often the case with food safety, the ability of U.S. regulatory agencies to ensure the safety of imported foods is influenced by politics-in this case, global politics. With that said, we can now return to the measures we might take-as individuals and as a society-to promote food safety at every stage of production, from farm to table. of this book. As we will see, such disputes fall under the purview of the multinational World Trade Organization, a higher-level international entity that takes precedence over the Codex Commission. As is often the case with food safety, the ability of U.S. regulatory agencies to ensure the safety of imported foods is influenced by politics-in this case, global politics. With that said, we can now return to the measures we might take-as individuals and as a society-to promote food safety at every stage of production, from farm to table.
ALTERNATIVE #1: EDUCATE.
When it comes to food safety, the public bears all of the health risks. But does that mean that we also must bear the entire burden of preventive measures? Of course, home cooks should follow basic principles of food safety, especially because doing so is not difficult and is almost always effective. Cooking kills most microbial pathogens, and cooked food remains relatively free of them when refrigerated or stored properly. Surveys, however, frequently find that home cooking practices violate the FDA's manual of food safety rules, the Food Code Food Code. This should be no surprise; hardly anyone has heard of it. Furthermore, the code is easy to violate; one merely needs to wipe a counter with an old sponge, use a dish towel more than once, store fresh and cooked foods on the same refrigerator shelf, or forget to wash hands. Even so, home code violations cause much less illness than those made by out-of-home food preparers who did not follow food safety rules.8 Nevertheless, addressing food safety in the home is now a primary goal of national public health policy. In 1980, when the Department of Health and Human Services (DHHS) established its first ten-year plan to improve health practices, officials estimated that nearly 75% of food-borne infections originated in restaurants, institutional food services, or processing plants. The plan mentioned washing hands and proper food handling as useful educational measures for workers in the food industry. Ten years later, DHHS assigned home cooks their own food safety objective: "Increase to at least 75 percent the proportion of households in which principal food preparers routinely refrain from leaving perishable food out of the refrigerator for over two hours and wash cutting boards and utensils with soap after contact with raw meat and poultry. (Baseline: for refrigeration of perishable foods, 70 percent; for washing cutting boards with soap, 66 percent; and for washing utensils with soap, 55 percent, in 1988)."9 This meant that by the year 2000, 75% of home cooks should be routinely washing cutting boards with soap, as compared to 66% in 1988. The 1988 baseline figures indicated that a sizable proportion of the population This meant that by the year 2000, 75% of home cooks should be routinely washing cutting boards with soap, as compared to 66% in 1988. The 1988 baseline figures indicated that a sizable proportion of the population already already followed safe food-handling practices fairly often-or at least said they did. followed safe food-handling practices fairly often-or at least said they did.
In 2000, with foodborne infections increasing in frequency and severity, DHHS assigned an entire section to food safety in its ten-year plan for 2010. The overall goal, to reduce foodborne illnesses reduce foodborne illnesses, includes three objectives dealing with pathogens-reduce infections, reduce outbreaks, and prevent antibiotic-resistant Salmonella Salmonella. Another objective calls for an increase to 79% in "the proportion of consumers who follow key food safety practices." Because baseline data from a 1998 survey confirmed that 72% of consumers already did so, the goal recognizes that home code violations are not the principal cause of outbreaks. For this reason, DHHS added a "developmental" objective-one for which no baseline information is available-to "improve food employee behaviors and food preparation practices that directly relate to foodborne illnesses in retail food establishments."10 Taken together, these objectives continue to place the responsibility for food safety on food handlers, not on food producers or processors. Taken together, these objectives continue to place the responsibility for food safety on food handlers, not on food producers or processors.
The phrase key food safety practices key food safety practices refers to elements of an education campaign jointly organized by the USDA and DHHS through an entity called the Partnership for Food Safety Education, an "ambitious public-private partnership created to reduce the incidence of foodborne illness by educating Americans about safe food handling practices." refers to elements of an education campaign jointly organized by the USDA and DHHS through an entity called the Partnership for Food Safety Education, an "ambitious public-private partnership created to reduce the incidence of foodborne illness by educating Americans about safe food handling practices."11 Additional members include the U.S. Department of Education, an association of food and drug officials, seven food trade associations, two consumer organizations, and one individual-the outspoken food safety advocate Carol Tucker Foreman, a partnership entity unto herself. Additional members include the U.S. Department of Education, an association of food and drug officials, seven food trade associations, two consumer organizations, and one individual-the outspoken food safety advocate Carol Tucker Foreman, a partnership entity unto herself.
Because Ms. Foreman appears again in these pages, she deserves a more formal introduction. In 1999, she became distinguished fellow and director of the Food Policy Institute of the Consumer Federation of America, but her previous career reflects the revolving door between jobs in government, industry, and the public interest sector. From 1973 to 1977, she directed the Consumer Federation. Under the administration of President Jimmy Carter, she served as USDA assistant secretary for Food and Consumer Services, where she was a strong advocate of consumer-friendly policies in dietary guidance, food assistance, and food safety. Subsequently, she founded the Safe Food Coalition, which advocated overhaul of the USDA's meat and poultry inspection system. For 18 years, she headed a Washington, DCbased consulting practice that included corporations such as Monsanto, the agricultural biotechnology company, among its clients. Because she lobbied on behalf of Monsanto in its successful attempt to win FDA approval of a bioengineered cow growth hormone (see chapter 6 chapter 6), some groups question her reliability as a food safety advocate.12 On the issue of food safety, her record speaks for itself; her forceful lobbying for Pathogen Reduction: HACCP has been unwavering, as will soon be evident. On the issue of food safety, her record speaks for itself; her forceful lobbying for Pathogen Reduction: HACCP has been unwavering, as will soon be evident.
[image]
FIGURE 8. The Partnership for Food Safety's Fight BAC! campaign. This public-private partnership places the burden of food safety responsibility on the public rather than focusing on food production, processing, or service, which are more prevalent sources of food-borne illness.
To return to the partnership: its principal contribution to food safety education is a campaign called Fight BAC! Keep Food Safe from Bacteria. Fight BAC! promotes the four food safety actions described in table 9 table 9 ( (page 75) and illustrated in figure 8 figure 8: clean, separate, cook, and chill.13 The partnership produces this illustration and related materials-brochures, posters, public service announcements, and refrigerator magnets-in English and Spanish. The partnership produces this illustration and related materials-brochures, posters, public service announcements, and refrigerator magnets-in English and Spanish.
In addition to its role in the partnership, USDA's Food Safety and Inspection Service (FSIS) offers its own Food Safety Education (FSE) programs. These encourage consumers to cook ground beef to temperatures high enough to kill harmful bacteria and to use cooking thermometers to check such critical control points. Its materials emphasize the scientific nature of such practices: "A unique aspect to the FSE programs is their basis in sound science, as well as education theory and market research. The safe handling advice consumers get from FSIS educational programs and the USDA Meat and Poultry Hotline is based on the latest scientific information available."14 Large food corporations also promote home food safety. ConAgra, for example, developed a campaign in 2000, "Home Food Safety . . . It's in Your Hands," in partnership with the American Dietetic Association. Large food corporations also promote home food safety. ConAgra, for example, developed a campaign in 2000, "Home Food Safety . . . It's in Your Hands," in partnership with the American Dietetic Association.15 Although the advice given in such campaigns makes perfect sense, the education alternative hardly appears adequate to deal with problems of food safety, especially when focused exclusively or primarily on consumers. Scientifically based or not, the educational programs of the partnership, the USDA, and food corporations are directed toward a minor source of foodborne illness at the very end of the food chain. If anything, food producers, processors, and servers are the groups most in need of education about food safety. If, for example, meat and poultry producers better understood their role in the safety of the food supply, they might be less hostile and more receptive to the value of Pathogen Reduction: HACCP. They might understand why it is so important to institute healthier working conditions and more comprehensive training programs for employees. As noted earlier, food handlers typically earn the minimum wage, receive no sick leave or health benefits, and may not have obtained much education. Many workers in meat and poultry processing plants are illegal immigrants with even less access than others to such benefits.16 These labor issues affect food safety because they lead to unsafe handling practices such as washing hands infrequently, staying on the job while sick, and failing to obtain treatment for intestinal infections. Education of employees would help, but education alone is not enough to ensure safe food. If we as a society are serious about preventing foodborne illness, we need to make certain that everyone who handles food is educated, is paid adequately, and, when needed, obtains sick leave and health care. These labor issues affect food safety because they lead to unsafe handling practices such as washing hands infrequently, staying on the job while sick, and failing to obtain treatment for intestinal infections. Education of employees would help, but education alone is not enough to ensure safe food. If we as a society are serious about preventing foodborne illness, we need to make certain that everyone who handles food is educated, is paid adequately, and, when needed, obtains sick leave and health care.
ALTERNATIVE #2: IRRADIATE.
Because regulatory approaches to food safety are endlessly obstructed, and educational approaches do not address underlying causes, the food industry and some health officials urge more immediate action: irradiate foods to kill pathogens. Here is how Dr. Michael Osterholm, a leading national expert on foodborne illness, explains the meaning of the Hudson ground beef recall discussed in chapter 3 chapter 3: The current recall reinforces the impression that government can fully protect us against contamination of our food supply, and that when problems do occur, they'll quickly be fixed. The truth is quite the opposite. . . . Routine testing of the product will not provide us with a reliable way to detect every single episode of contamination. . . . There is one major step we, as a society, can take toward producing safer food. The answer is irradiation.17 Dr. Osterholm and many others fully agree that irradiation kills unwanted microbes. It uses the elements cobalt-60 and cesium-137 or electric current as sources of gamma rays, x-rays, or electron beams to bombard foods. These rays disrupt the genetic material (DNA) of cells in proportion to the intensity of the source element and the length of exposure. Lower or shorter bouts of radiation reduce the number of microbes on a food; higher and longer exposures can kill all of them.
Contrary to the belief of some critics, irradiation does not cause the foods themselves to become radioactive, and its physical effects on food are not so different from those induced by cooking (which also disrupts cell structures). High-intensity irradiation induces minor losses of nutrients as well as slight changes in color, flavor, and odor, particularly in fatty meats. Whether these changes matter depends on point of view. Proponents of irradiation view taste disadvantages as minor in comparison to the ravages of E. coli E. coli O157:H7. From the perspective of science-based risk assessment, the benefits of food irradiation far outweigh taste considerations. O157:H7. From the perspective of science-based risk assessment, the benefits of food irradiation far outweigh taste considerations.18 The sterility induced by irradiation, however, is usually incomplete and temporary. The foods must be irradiated in intact packages; once the packages are opened or damaged, foods can become recontaminated. Thus, irradiated foods must be handled like fresh foods and may need to be refrigerated to retard bacterial growth. Even so, this process confers substantial advantages to food producers and processors. They no longer need to be concerned about preventing preventing contamination, because irradiation takes care of whatever pathogens are present. It also extends shelf life; irradiated strawberries, for example, can last 22 days on the shelf instead of the usual 3 to 5 days. contamination, because irradiation takes care of whatever pathogens are present. It also extends shelf life; irradiated strawberries, for example, can last 22 days on the shelf instead of the usual 3 to 5 days.19 Despite such advantages, the process is highly controversial and has been slow to gain acceptance. The very idea of irradiation induces dread and outrage, not least because it involves radiation, a foreign and personally uncontrollable technology. It also cannot guarantee sterility, and it treats rather than prevents safety problems. At best, irradiation is an end-stage technological fix.
The controversy is best understood in historical context. During World War II, the U.S. Army discovered that irradiated ground beef stayed fresh longer. Companies developed methods for commercial use by the late 1950S, but a congressional act in 1958 classified irradiation as, of all things, a food additive. This meant that companies had to prove the safety of irradiated foods before the FDA would authorize their sale. Because the companies thought the public would not accept such foods, they did not bother to press for approval.
In the early 1960S, the FDA began to authorize irradiation for limited use, one food at a time: first wheat and wheat flour; then spices, dried vegetable seasonings, pork, and chicken products for the general public; and then steak and turkey for astronauts. In turn, the USDA authorized irradiation for pork, poultry, and beef. Both agencies work to expand this list. In 2002, for example, the USDA proposed to permit Hawaii to export irradiated peppers, eggplants, mangoes, pineapples, squash, and tomatoes to the mainland.20 Overall, more than 35 countries have approved irradiation as a means to preserve more than 50 different kinds of foods. Numerous national and international organizations have endorsed the process, among them health and food technology associations and-most enthusiastically-groups representing irradiation companies. Overall, more than 35 countries have approved irradiation as a means to preserve more than 50 different kinds of foods. Numerous national and international organizations have endorsed the process, among them health and food technology associations and-most enthusiastically-groups representing irradiation companies.
In the United States, the FDA requires irradiated foods to be labeled "treated with (or by) radiation" and to display the international symbol of irradiation-the radura-printed in green. As shown in figure 9 figure 9, the radura symbol resembles the logo of the Environmental Protection Agency (EPA) and is meant to reassure the public that irradiated foods are ecologically correct, or "green." As we will see, supporters of irradiation say that any disclosure of the process is contrary to the public interest, and they consistently demand more favorable labeling requirements or-preferably-none at all.
Because fears of public disapproval inhibited development of the irradiation industry, the first multipurpose commercial food plant did not open until 1991. In 1994, Isomedix, a New Jersey company with 16 plants that irradiate medical devices and food packaging materials, petitioned the FDA to authorize irradiation of raw beef and lamb. Cattlemen strongly supported the petition and discussed the matter with their friends in Congress. Congress, in turn, pressured the USDA and FDA to come to a rapid decision. In 1997, during the period when USDA Secretary Dan Glickman was attempting to convince the Senate agriculture committee that his department should be allowed to issue mandatory recalls of contaminated meat, the senators "reacted skeptically, saying the plan would impose unnecessary new regulations when the focus should be on emerging technology like irradiation."21 that irradiate medical devices and food packaging materials, petitioned the FDA to authorize irradiation of raw beef and lamb. Cattlemen strongly supported the petition and discussed the matter with their friends in Congress. Congress, in turn, pressured the USDA and FDA to come to a rapid decision. In 1997, during the period when USDA Secretary Dan Glickman was attempting to convince the Senate agriculture committee that his department should be allowed to issue mandatory recalls of contaminated meat, the senators "reacted skeptically, saying the plan would impose unnecessary new regulations when the focus should be on emerging technology like irradiation." that irradiate medical devices and food packaging materials, petitioned the FDA to authorize irradiation of raw beef and lamb. Cattlemen strongly supported the petition and discussed the matter with their friends in Congress. Congress, in turn, pressured the USDA and FDA to come to a rapid decision. In 1997, during the period when USDA Secretary Dan Glickman was attempting to convince the Senate agriculture committee that his department should be allowed to issue mandatory recalls of contaminated meat, the senators "reacted skeptically, saying the plan would impose unnecessary new regulations when the focus should be on emerging technology like irradiation."21 [image]
FIGURE 9. The friendly radura symbol of irradiation used on food package labels is shown on the left. Perhaps by coincidence, its color (green) and design resemble the logo of the U.S. Environmental Protection Agency, shown at right.
Other groups also advocated approval of irradiation, charging that opposition to it was antiscientific. For example, Elizabeth Whelan of the industry-supported American Council on Science and Health (ACSH), proposed a much friendlier euphemism for the process in an article in the Wall Street Journal: Wall Street Journal: Pasteurization through irradiation is safe and effective and is used in other countries and in the U.S. for pork, poultry, and other foods. . . . Antitechnology advocates . . . are circulating unfounded claims that irradiation poses a health hazard. . . . It is time for all of us to stop responding to the scaremongers. We must listen, instead, to scientists, who are unanimous in their conclusion that food irradiation-not more government regulation-will make America's food supply even safer.22 The Produce Marketing Association, an industry trade group, also supported irradiation for reasons of both science and and values, in this case the value of "consumer choice": "Sound science must be the basis for decisions about all food issues. . . . Irradiation has been deemed to be a safe and viable technology . . . providing consumers the choice in the marketplace." Such statements, as we have seen, mistakenly equate safety (a scientific concept) with acceptability (a social concept). Meat industry officials, while lobbying for approval of irradiation, wanted to make sure that using it would not increase their accountability for foodborne illness: "Irradiation . . . is particularly important for ground beef . . . but the ultimate responsibility for food safety still rests with the food handler and preparer." values, in this case the value of "consumer choice": "Sound science must be the basis for decisions about all food issues. . . . Irradiation has been deemed to be a safe and viable technology . . . providing consumers the choice in the marketplace." Such statements, as we have seen, mistakenly equate safety (a scientific concept) with acceptability (a social concept). Meat industry officials, while lobbying for approval of irradiation, wanted to make sure that using it would not increase their accountability for foodborne illness: "Irradiation . . . is particularly important for ground beef . . . but the ultimate responsibility for food safety still rests with the food handler and preparer."23 The FDA delayed approval of irradiation for beef and lamb, not only because its approval processes are always slow, but also because its staff still needed to evaluate the effects of the process on meat from sheep as well as cattle and on fresh cuts as well as those that had been refrigerated and frozen. While the FDA was plugging along on its proposals for these rules, Congress passed the Food and Drug Administration Modernization Act of 1997 which, among other things, restricted the agency's ability to regulate irradiated foods: "No provision . . . shall be construed to require on the label or labeling of a food a separate radiation disclosure statement that is more prominent than the declaration of ingredients," and "FDA must act on petition within 60 days of enactment or provide to House and Senate an explanation of the process followed . . . and the reasons action on the petition was delayed."24 Congress, therefore, insisted that the FDA allow food labels to disclose irradiation in very small type and approve irradiation requests within months rather than years. Congress, therefore, insisted that the FDA allow food labels to disclose irradiation in very small type and approve irradiation requests within months rather than years.
Under that kind of pressure, the FDA immediately authorized irradiation of beef and lamb, explaining that the process "will not present a toxicological hazard, will not present a microbiological hazard, and will not adversely affect the nutritional adequacy of such products." The American Meat Institute hailed the approval as "a victory for consumers and the red meat industry."25 Rodney Leonard of the Community Nutrition Institute (CNI) offered a different opinion. Although he firmly opposed HACCP (as noted in Rodney Leonard of the Community Nutrition Institute (CNI) offered a different opinion. Although he firmly opposed HACCP (as noted in chapter 3 chapter 3), he also opposed irradiation: In addition to blaming the victim, government and industry are proposing a quick fix-food irradiation-to a problem of official neglect and industry abuse. . . . Bombarding contaminated foods with gamma rays will not improve public health, however, because it does not remove the feces of cattle and poultry. . . . The treatment is the only measure which government and industry can adopt which will not require the food supply to be cleaned up.26 Food safety advocate Carol Tucker Foreman succinctly reinforced this last point in a comment to Consumer Reports: Consumer Reports: "After all, sterilized poop is still poop." "After all, sterilized poop is still poop."26 Despite such opposition, pressures to hide irradiation from consumers continued. In 2002, Congress passed the Farm Security and Rural Investment Act, mostly to authorize $190 billion in price supports for basic farm commodities, but also to equate irradiation (a radiation process) with pasteurization (usually understood as a heat process). The act requires the FDA to allow food labels to use pasteurized pasteurized for any process that reduces pathogens in meat and poultry and to substitute this term for irradiation. This creative idea originated with Tom Harkin (Dem-IA), chair of the Senate agriculture committee, and a representative of the state housing the nation's largest irradiation plant for ground beef. for any process that reduces pathogens in meat and poultry and to substitute this term for irradiation. This creative idea originated with Tom Harkin (Dem-IA), chair of the Senate agriculture committee, and a representative of the state housing the nation's largest irradiation plant for ground beef.27 Even with such legislation, it is not clear whether the public will accept irradiated foods. Some experts believe that people will simply refuse to buy irradiated products; this possibility makes food producers so nervous that they all "want to be second to try it." Even with such legislation, it is not clear whether the public will accept irradiated foods. Some experts believe that people will simply refuse to buy irradiated products; this possibility makes food producers so nervous that they all "want to be second to try it."28 Some companies deliberately appeal to distrust of irradiation by advertising their products as nonirradiated. Fears of consumer resistance easily explain why the industry and its supporters pressed so forcefully for more attractive euphemisms such as "ionizing pasteurization" or "cold pasteurization." Will euphemisms convince people to buy irradiated products? Surveys reveal that at least half of consumers do not like Some companies deliberately appeal to distrust of irradiation by advertising their products as nonirradiated. Fears of consumer resistance easily explain why the industry and its supporters pressed so forcefully for more attractive euphemisms such as "ionizing pasteurization" or "cold pasteurization." Will euphemisms convince people to buy irradiated products? Surveys reveal that at least half of consumers do not like any any term for irradiation. term for irradiation.29 Other surveys, however, report the public to be relatively unconcerned about this process, leading its proponents to reassure the food industry that consumers will readily accept irradiated foods. One report to industry (costing $75 a copy) promises readers that most consumers think irradiation will prevent foodborne illness and reduce disease risk (8590%) and that most would buy irradiated products even if they were labeled as such (80%). The report quotes the president of the Food Marketing Institute: "Food irradiation is one safety tool whose time has come! . . . As an industry, we must also have the courage to support irradiated food products in the marketplace. . . . We must not let those who are afraid to let consumers make their own judgments use misinformation and scare tactics to win arguments they would lose on the scientific merits of the issues."30 Cost considerations, however, are likely to influence levels of outrage about this method, as may euphemistic labels so small as to be unnoticeable. Food technologists believe that when informed of the benefits of irradiation, the public will buy treated foods even if they cost more, as they most certainly will. Irradiation is expensive because of the equipment, the labels, and the transport from centralized facilities; the higher costs will be passed along to consumers. In 1997, USDA economists estimated that the cost to the beef industry alone could range from $28 million to $89 million annually, or from about 1.6 cents to 5 cents a pound. Although the costs to society of foodborne illness greatly exceed such amounts, and the additional price seems too small to make any difference to individual consumers, market comparisons suggest that a 10% premium for irradiated products would cause the proportion of people who might choose them to drop from 43% to 19%.31 This experiment is now underway. As irradiated foods increasingly enter the marketplace, the degree of acceptance by industry and the public will soon become evident. Furthermore, irradiation companies are using the anthrax scare of fall 2001 (discussed in the concluding chapter) to "do something they've been unable to do themselves: sell consumers on their controversial germ-zapping technology."32 Even if consumers do opt to buy irradiated foods, the process is unlikely to solve food safety problems. On this point, I defer to Rodney Leonard: Even if consumers do opt to buy irradiated foods, the process is unlikely to solve food safety problems. On this point, I defer to Rodney Leonard: All irradiation will do is add partially decontaminated fecal matter to the American diet, a practice that is likely to cause food poisoning cases to skyrocket when bacteria develop the survival tactics to resist irradiation. All past efforts to "eradicate" microbial organisms . . . have succeeded only in creating new generations of super bugs, and irradiation will be no different. . . . The solution to the food safety problem is to produce safe food The solution to the food safety problem is to produce safe food (emphasis added). (emphasis added).33 Like many other food safety matters, irradiation raises issues of societal values that extend beyond the scientific. To questions about costs and benefits must be added others about the safety of those employees who work with and transport hazardous radioactive materials, and the environmental effects of discarding surplus sources of gamma rays. From a value-based perspective, irradiation is a techno-fix: a short-term corrective to a late-stage contamination problem that should be addressed much earlier in the chain of production.
ALTERNATIVE #3: PASTEURIZE.
Technical solutions to food safety problems are linked, as we have seen, to conflicts between science and other kinds of value systems. The Odwalla company's corporate policy valued "fresh" and "natural," and it took a lethal outbreak to convince its managers to apply basic principles of microbiology to production processes; the company now pasteurizes its juices (in the old sense of the term). Many of my friends who are chefs or specialty food producers strongly believe that the sensory and cultural values of traditional raw or undercooked foods far outweigh the small risk of acquiring a foodborne infection. Raw (unpasteurized) milk-and cheeses made from it-have become rallying points for such views. For years, raw milk foods have caused rare but occasionally lethal outbreaks of Listeria, Salmonella, E. coli Listeria, Salmonella, E. coli O157:H7, and other pathogens. The catalog of foodborne outbreaks maintained by the Center for Science in the Public Interest (CSPI) reported just 11 from raw milk and 8 from cheeses made with raw milk during the 11-year period from 1990 to 2001. O157:H7, and other pathogens. The catalog of foodborne outbreaks maintained by the Center for Science in the Public Interest (CSPI) reported just 11 from raw milk and 8 from cheeses made with raw milk during the 11-year period from 1990 to 2001.34 These numbers seem excessively high to the people who became ill from eating the foods, to the families of those who died, and to safety officials who want such foods pasteurized. The number of outbreaks appears minor, however, to people who prize such foods for their taste subtleties and cultural traditions and who believe that such benefits outweigh what seems like an occasional risk. In the case of raw milk foods, the choice is voluntary, and the foods generate little dread or outrage. These numbers seem excessively high to the people who became ill from eating the foods, to the families of those who died, and to safety officials who want such foods pasteurized. The number of outbreaks appears minor, however, to people who prize such foods for their taste subtleties and cultural traditions and who believe that such benefits outweigh what seems like an occasional risk. In the case of raw milk foods, the choice is voluntary, and the foods generate little dread or outrage.
The risks are not equally distributed, however. Raw milk and soft cheeses such as the Mexican queso fresco queso fresco are implicated most often; these are particularly dangerous when contaminated with are implicated most often; these are particularly dangerous when contaminated with Salmonella Salmonella or other bacteria resistant to multiple antibiotics. or other bacteria resistant to multiple antibiotics.35 Harder domestic and foreign imported cheeses also have caused outbreaks and such incidents-rare though they may be-invariably elicit demands for mandatory pasteurization and restricted import of raw milk cheeses. As explained by an Oregon food safety expert, Dr. William Keene: Harder domestic and foreign imported cheeses also have caused outbreaks and such incidents-rare though they may be-invariably elicit demands for mandatory pasteurization and restricted import of raw milk cheeses. As explained by an Oregon food safety expert, Dr. William Keene: Even after almost 100 years of effort, medical and public health experts have been unable to eliminate raw milk consumption. Raw milk has been and continues to be a staple in the epidemiological literature, linked to a long list of diseases. . . . There is no mystery about why raw milk is a common vehicle for salmonellosis and other enteric infections; after all, dairy milk is essentially a suspension of fecal and other microorganisms in a nutrient broth. Without pasteurization or other processing to kill pathogens, consumption of raw milk is a high-risk behavior.36 Dr. Keene points out that the aging and drying processes required to make many kinds of cheeses will kill most pathogens, but soft cheeses are "well documented hazards." Defenders of raw milk cheeses, who would be appalled by his characterization of dairy milk as a broth of fecal bacteria, seize on the protective benefits of the aging and drying processes. They argue that problems caused by raw milk cheeses are due to flagrant lapses in good manufacturing practices such as leaving raw milk unrefrigerated overnight or washing the equipment with water from a backyard garden hose (as was the case with the queso fresco queso fresco harboring antibiotic-resistant harboring antibiotic-resistant Salmonella Salmonella). Furthermore, requiring milk to be pasteurized might have prevented the queso fresco queso fresco outbreak, but pasteurized milk also can become contaminated if it is handled carelessly. outbreak, but pasteurized milk also can become contaminated if it is handled carelessly.37 The CSPI outbreak catalog lists just as many incidents due to pasteurized milk or cheeses (or to products of unspecified pasteurization status) as to those attributed to raw milk products. Foods made from raw milk still carry a higher risk, however, as fewer of them are on the market. The CSPI outbreak catalog lists just as many incidents due to pasteurized milk or cheeses (or to products of unspecified pasteurization status) as to those attributed to raw milk products. Foods made from raw milk still carry a higher risk, however, as fewer of them are on the market.
The American Cheese Society, a trade group representing the makers of specialty "artisanal" cheeses, advises its members to institute Pathogen Reduction: HACCP. With HACCP plans seemingly taking care of the science, the society also opposes mandatory pasteurization for reasons of values-democracy and individual rights: The American Cheese Society supports the continued democratic option to use both pasteurized and unpasteurized milk to produce America's cheeses. . . . We support the rights of individuals in all countries to enjoy their own great cheese historically made with unpasteurized milks. . . . We believe that mandatory pasteurization places an unnecessary hardship on those cheesemakers dedicated to safe and healthy practices. . . . We will ensure that our cheesemakers' options to use pasteurized and unpasteurized milks are both heard and understood.38 I like the cheeses produced by the members of this society, and I enthusiastically support the work of artisanal cheese makers. Many of them make superb products, whether from unpasteurized or pasteurized milk. I am happier eating them, however, when I know that the maker of the cheese is following a carefully designed Pathogen Reduction: HACCP plan that includes microbial standards verified by testing. No matter how rarely an unpasteurized cheese causes an outbreak, its makers and consumers are taking a gamble-and one with unknown odds.
Good manufacturing practices can reduce the odds to practically nothing, however. On a trip to Italy in 2002, I visited a producer of handmade pecorino and ricotta cheeses derived from raw sheep's milk (latte crudo). The owner employed a full-time microbiologist to test every batch of cheese for Salmonella, Listeria, E. coli Salmonella, Listeria, E. coli O157:H7, and several other potential pathogens. He also insisted that his milk suppliers do such testing, and aged his cheeses beyond the time the FDA requires for imports. With this level of care, raw milk cheese raises minimal safety concerns. O157:H7, and several other potential pathogens. He also insisted that his milk suppliers do such testing, and aged his cheeses beyond the time the FDA requires for imports. With this level of care, raw milk cheese raises minimal safety concerns.
To generalize from this example: Pathogen Reduction: HACCP should reduce foodborne illness when manufacturers follow the plan and monitor pathogen levels in the products. Failure to do so can cause severe illness in consumers (and severe liability for manufacturers). It may be true that only an occasional child gets sick or dies from eating contaminated food, but that event becomes a personal tragedy rather than a statistical matter if the child is yours yours. Whether eating raw foods is worth the risk is a matter of personal values when-and only when-all parties understand and take responsibility for what is at stake. Education of consumers or techno-fixes cannot protect against illness when the problems originate at the production or processing level, which is why Pathogen Reduction: HACCP and monitoring of performance standards are essential for producers of all foods, artisanal as well as corporate.
ALTERNATIVE #4: LITIGATE.
It might seem reasonable to think that the cost of outbreak judgments in the tens of millions of dollars would be enough to make companies leap to put effective HACCP plans in place, required or not. That they fail to do so is in part a result of the shared responsibility for food safety among producers, processors, retailers, food service providers, and the public. USDA officials explain the behavior of meat and poultry producers in these terms: When consumers cannot trace an illness to any particular food or even be certain it was caused by food, food retailers and restaurateurs are not held accountable by their customers for selling pathogen-contaminated products and they, in turn, do not hold their wholesale suppliers accountable. This lack of marketplace accountability for foodborne illness means that meat and poultry producers may have little incentive to incur costs for more than minimal pathogen and other hazard controls.39 As we have seen, criminal charges in food-poisoning cases are rare, especially in comparison to the number of cases of illness and outbreaks. In 2000, about 20 of the nation's 6,000 meat processors pleaded guilty to violations of meat inspection regulations. In 2001, the Sara Lee company admitted to charges that it sold Listeria Listeria-contaminated meat responsible for the deaths of at least 15 people in 1998. Furthermore, the penalties can be quite light. In 2002, one of the owners of a Texas salvage food operation was fined $2,000, ordered to pay a $100 fee, and placed on probation for three years (including 120 days of home confinement) for selling rodent-contaminated meat.40 The typical corporate culture of "it's not my fault" is one reason for the lack of accountability, but another is the difficulty of assigning direct responsibility for an outbreak to one or another link in the chain of food production and consumption. A 1999 outbreak of E. coli E. coli O157:H7 illustrates this problem. The outbreak occurred among people who attended a state fair in upstate New York. Investigators recorded more than 1,000 cases of illness, 65 hospitalizations, and two deaths, one of a child and the other of an elderly man. They traced the source to drinking water from a well at the fairgrounds. A recent deluge of heavy rains had flooded the fairgrounds and allowed contaminated water, first thought to have come from manure from nearby barns, to leak into the well. Later, they discovered a nearby sewage pit that belonged to a fairgrounds dormitory run by a Cornell Cooperative Extension 4-H program. The well water was not chlorinated. In a situation like this, who is liable? Contributing to the outbreak were the fairgrounds, the cow barns, the dormitory, and the rain (an "act of God"). Eventually, suits were filed against Cornell Cooperative Extension on behalf of some of the sick children. O157:H7 illustrates this problem. The outbreak occurred among people who attended a state fair in upstate New York. Investigators recorded more than 1,000 cases of illness, 65 hospitalizations, and two deaths, one of a child and the other of an elderly man. They traced the source to drinking water from a well at the fairgrounds. A recent deluge of heavy rains had flooded the fairgrounds and allowed contaminated water, first thought to have come from manure from nearby barns, to leak into the well. Later, they discovered a nearby sewage pit that belonged to a fairgrounds dormitory run by a Cornell Cooperative Extension 4-H program. The well water was not chlorinated. In a situation like this, who is liable? Contributing to the outbreak were the fairgrounds, the cow barns, the dormitory, and the rain (an "act of God"). Eventually, suits were filed against Cornell Cooperative Extension on behalf of some of the sick children.41 Even if liability could be assigned easily, it is not clear that damage payments would be much of an incentive to food producers to be more careful. In a 1998 report on food safety, a committee of the National Research Council (NRC) pointed out that the risk of bad public relations is likely to be a much greater motivating force, as "the public is quick to shun whole categories of food products alleged to be tainted."42 This reaction certainly was true of the Jack in the Box and Odwalla outbreaks, but in these cases it was short-lived. Both companies recovered customers and sales. Filing lawsuits is an expensive proposition-in time and emotion-for the victims of outbreaks and is another end-stage solution to a problem that should have been prevented in the first place. This reaction certainly was true of the Jack in the Box and Odwalla outbreaks, but in these cases it was short-lived. Both companies recovered customers and sales. Filing lawsuits is an expensive proposition-in time and emotion-for the victims of outbreaks and is another end-stage solution to a problem that should have been prevented in the first place.
ALTERNATIVE #5: REORGANIZE.
Political problems require political solutions, which is why people without a vested interest in the current system-and some who have such an interest-support an entirely different approach to food safety: creation of a single independent government oversight agency. The idea is hardly new. A White House nutrition conference implied this need in 1969, and the National Research Council explicitly recommended creating such an agency in 1979. In 1988, the Food Marketing Institute, a conservative trade organization representing retailers and wholesalers, proposed that "the government's role can be accomplished if authority and responsibility for food safety are assigned to a single federal government agency. . . . It is vital that those agencies that currently have food safety responsibility be given sufficient resources to do the job properly and to ensure public confidence."43 The congressional watchdog agency, the General Accounting Office (GAO), has urged creation of a single food agency for years, despite the evident political barriers. In 1992, for example, the GAO told Congress that in a food safety system as entrenched as this one, "reaching agreement on such a major structural change would be difficult, at best."44 Nevertheless, it continued to press Congress on this point. In 1993, it said, "In our view, creating a single food safety agency is the most effective way for the federal government to resolve long-standing problems, deal with emerging food safety issues, and ensure the safety of our country's food supply." Nevertheless, it continued to press Congress on this point. In 1993, it said, "In our view, creating a single food safety agency is the most effective way for the federal government to resolve long-standing problems, deal with emerging food safety issues, and ensure the safety of our country's food supply."45 In 1999, the GAO again said: In 1999, the GAO again said: During the past 25 years, we . . . made numerous recommendations for change. While many of these recommendations have been acted upon, improvement efforts have fallen short, largely because the separate agencies continue to operate under the different regulatory approaches implicit in their basic authorities. Consequently, it is unlikely that fundamental, lasting improvements in food safety will occur until systematic legislative and structural changes are made to the entire food safety system.46 Despite such urgings from impartial investigators, Congress has failed to follow this advice. Government agencies, rather than taking whatever steps they can to unify the system, tend to protect their own resources. In 1993, for example, FDA commissioner Dr. David Kessler agreed on the need for a comprehensive food safety policy but insisted that his his agency take the lead in federal safety efforts and that any new initiatives should be designed to strengthen the FDA's role in this area. agency take the lead in federal safety efforts and that any new initiatives should be designed to strengthen the FDA's role in this area.47 As a result of political pressures, federal leadership on food safety appears unfocused. In 1997, President Clinton announced a budget of $43 million for early detection and prevention of foodborne microbial outbreaks; of that amount, more than half would go to the FDA for seafood inspection. Instead of a single agency, he created the Food Safety Initiative-a joint effort led by the chief administrators of USDA, DHHS (the FDA's parent agency), and the Environmental Protection Agency (EPA). He asked these officials to work with industry and consumer groups to recommend improvements in food safety research, inspection, and education.48 As is customary in such situations, the group issued a report-this one designed to improve the As is customary in such situations, the group issued a report-this one designed to improve the separate separate programs of each agency. Its one concession to joint efforts: a proposal for a plan to "make the best use of each agency's limited resources, with no mention of a single food agency." programs of each agency. Its one concession to joint efforts: a proposal for a plan to "make the best use of each agency's limited resources, with no mention of a single food agency."49 Later that year, Senator Richard Durbin (Dem-IL) introduced legislation to replace the current system with an independent food safety and inspection agency, but his bill did not get very far. President Clinton asked Congress for a $101 million increase in spending for the Food Safety Initiative to bring the total federal expenditure for this purpose to $817 million. This, he said, would "take the agencies that deal with food inspection from the 19th century to the 21st century."50 Relatively small as these amounts might be, Congress did not want to grant them. Agriculture committee members said that until the day federal agencies could define precisely how much it would cost to reduce foodborne illness, "they won't get any more money. . . . Some of the Food and Drug Administration's duties [should] be delegated to states and local governments." Relatively small as these amounts might be, Congress did not want to grant them. Agriculture committee members said that until the day federal agencies could define precisely how much it would cost to reduce foodborne illness, "they won't get any more money. . . . Some of the Food and Drug Administration's duties [should] be delegated to states and local governments."51 GAO investigators continued to press two points: (1) the USDA wasted most of its food safety budget on archaic inspections of slaughtered carcasses, and (2) the Food Safety Initiative failed to address fundamental weaknesses in coordination. Such arguments proved irrelevant when Congress provided only limited funding that year. GAO investigators continued to press two points: (1) the USDA wasted most of its food safety budget on archaic inspections of slaughtered carcasses, and (2) the Food Safety Initiative failed to address fundamental weaknesses in coordination. Such arguments proved irrelevant when Congress provided only limited funding that year.52 In 1998, the National Research Council (NRC) issued Ensuring Safe Food Ensuring Safe Food, a report commissioned by Congress at a reported cost of $420,000. The NRC committee must have been uneasy about how its work might be received, because it repeatedly emphasized the report's scientific underpinnings. Its purposes, said the committee, are to "determine the scientific scientific basis of an effective food safety system," "identify basis of an effective food safety system," "identify scientific scientific needs and gaps," and "[recommend] needs and gaps," and "[recommend] scientific scientific and organizational changes in federal food safety activity needed to ensure an effective and organizational changes in federal food safety activity needed to ensure an effective science science-based food safety system" (emphasis added).42 Although Rodney Leonard described this report as "one of the most expensive term papers ever written," Although Rodney Leonard described this report as "one of the most expensive term papers ever written,"53 the committee's scientific defensiveness is understandable, as it took considerable courage to recommend the committee's scientific defensiveness is understandable, as it took considerable courage to recommend a unified and central framework for managing federal food safety programs, one that is headed by a single official and which has the responsibility and control of resources for all federal food safety activities. . . . This recommendation envisions an identifiable, high-ranking, presidentially appointed head, who would direct and coordinate federal activities and speak to the nation, giving federal food safety efforts a single voice. The structure created, and the person heading it, should have control over the resources Congress allocates to the food safety effort; the structure should also have a firm foundation in statute and thus not be temporary and easily changed by political agendas or executive directives. . . . The most viable means of achieving these goals would be to create a single, unified agency headed by a single administrator.42 In arguing for one accountable official, the NRC deliberately rejected two other leadership options, one of them a joint coordinating committee like the one in charge of the Food Safety Initiative. President Clinton, however, ignored this advice. Instead of appointing a czar czar, he did something even less likely to be effective. He appointed a troika troika-a President's Council on Food Safety led by three people: the secretaries of USDA and DHHS and a high-level science advisor. A spokesman for the National Food Processors Association seemed delighted that the program would not be led by a single person holding considerable power and said, apparently without irony: "When you have a czar, that would probably create a new bureaucracy. . . . It is important to keep politics out of food safety."54 In its formal announcement of a National Food Safety Initiative, the troika produced this cheerfully optimistic vision statement: Consumers can be confident that food is safe, healthy, and affordable. We work within a seamless food safety system that uses farm-to-table preventive strategies and integrated research, surveillance, inspection, and enforcement. We are vigilant to new and emergent threats and consider the needs of vulnerable populations. We use science- and risk-based approaches along with public/private partnerships. Food is safe because everyone understands and accepts their responsibilities.55 To support this vision, Congress allocated a budget of $370 million for the entire entire surveillance, coordination, inspection, risk-assessment, education, and research components of the initiative for fiscal year 2000. This figure amounted to about $1.50 per person and was about the same size as the advertising budget of Burger King that year. One full year after release of the NRC report, officials of the FDA and USDA seemed in no hurry to make progress on its recommendations. Instead, the troika of the Council on Food Safety, now joined by the secretary of commerce as a surveillance, coordination, inspection, risk-assessment, education, and research components of the initiative for fiscal year 2000. This figure amounted to about $1.50 per person and was about the same size as the advertising budget of Burger King that year. One full year after release of the NRC report, officials of the FDA and USDA seemed in no hurry to make progress on its recommendations. Instead, the troika of the Council on Food Safety, now joined by the secretary of commerce as a fourth fourth member, was at work on yet another report. When released early in 2000, the report made no specific recommendation for structural change but instead suggested a range of options for consideration: (1) tweaking the current system so that it would speak with a "single voice"; (2) tweaking it to make one agency (but not necessarily the same one) responsible for chairing the council, leading the efforts, or overseeing everything having to do with specific food products such as pizza or sandwiches; (3) giving one unit within each agency full responsibility for all of that agency's food safety functions; or (4) creating a stand-alone, cabinet-level food safety agency. member, was at work on yet another report. When released early in 2000, the report made no specific recommendation for structural change but instead suggested a range of options for consideration: (1) tweaking the current system so that it would speak with a "single voice"; (2) tweaking it to make one agency (but not necessarily the same one) responsible for chairing the council, leading the efforts, or overseeing everything having to do with specific food products such as pizza or sandwiches; (3) giving one unit within each agency full responsibility for all of that agency's food safety functions; or (4) creating a stand-alone, cabinet-level food safety agency.56 Perhaps because the council listed the single agency as the last option, food industry groups praised its science-based approach and its lack of enthusiasm for erecting "a monolithic super bureaucracy that would do little to reduce the risk of foodborne diseases."57 To food safety advocates, however, the plan was nothing but "platitudes"-federal agencies protecting themselves-because it provided no timelines, deadlines, or budgets. In defending the plan, an FDA official said that he understood why people might view the agency's insistence on science-based approaches to regulation a "stall," as the FDA would always need more data on which to base decisions. Nevertheless, he said, the FDA intended to make the plan "real." To food safety advocates, however, the plan was nothing but "platitudes"-federal agencies protecting themselves-because it provided no timelines, deadlines, or budgets. In defending the plan, an FDA official said that he understood why people might view the agency's insistence on science-based approaches to regulation a "stall," as the FDA would always need more data on which to base decisions. Nevertheless, he said, the FDA intended to make the plan "real."58 The council's strategic plan, released a year later, in January 2001, analyzed the various options and unsurprisingly concluded that improvements in coordination and consolidation were necessary but not sufficient to improve oversight. Although a stand-alone agency could eliminate perceptions of bias or competing missions, it "might create new problems and inefficiencies in the oversight of dietary supplements and other food-related issues not included in the new agency." Thus, the council recommended "efforts to strengthen agency coordination . . . and the development of comprehensive, unifying legislation, followed by the development of a corresponding organizational reform plan by allowing risk-based risk-based allocation of resources and utilization of allocation of resources and utilization of science-based science-based regulation, enforcement, and education" (emphasis added). regulation, enforcement, and education" (emphasis added).56 The strong emphasis on a science-based regulatory approach-always requiring more studies and more reports-provided little ground for optimism that reforms would come soon. The strong emphasis on a science-based regulatory approach-always requiring more studies and more reports-provided little ground for optimism that reforms would come soon.
As soon as President George W. Bush took office in January 2001, he issued a number of antiregulatory executive orders, including one delaying the USDA's imposition of performance standards for Salmonella Salmonella and and Listeria Listeria in meat and poultry. The American Meat Institute used the delay to argue for a complete review of the rules, while consumer groups urged the newly appointed USDA Secretary, Ann Veneman, to move them forward. One month later, the USDA released the rules, reportedly because Secretary Veneman convinced the White House to grant an exception to the executive order. Industry groups were not pleased and complained that the rules were unfair because they singled out meat and poultry for testing when other foods were equally contaminated. in meat and poultry. The American Meat Institute used the delay to argue for a complete review of the rules, while consumer groups urged the newly appointed USDA Secretary, Ann Veneman, to move them forward. One month later, the USDA released the rules, reportedly because Secretary Veneman convinced the White House to grant an exception to the executive order. Industry groups were not pleased and complained that the rules were unfair because they singled out meat and poultry for testing when other foods were equally contaminated.59 Nevertheless, weaknesses in the system remained evident. In March, newspapers reported frequent violations of safety procedures in meat-producing plants in New York and New Jersey; they also headlined flagrant lapses in retail meat inspection throughout the Northeast. These reports only added to concerns about meat safety, then driven by the highly publicized epidemics of mad cow disease and foot-and-mouth disease among cattle in Great Britain and Europe. Together, the problems amounted to what the New York Nevertheless, weaknesses in the system remained evident. In March, newspapers reported frequent violations of safety procedures in meat-producing plants in New York and New Jersey; they also headlined flagrant lapses in retail meat inspection throughout the Northeast. These reports only added to concerns about meat safety, then driven by the highly publicized epidemics of mad cow disease and foot-and-mouth disease among cattle in Great Britain and Europe. Together, the problems amounted to what the New York Daily News Daily News characterized as a "Meat Mess" worthy of front-page attention, as shown in characterized as a "Meat Mess" worthy of front-page attention, as shown in figure 10 figure 10.
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FIGURE 10. New York City's Daily News Daily News of March 24, 2001, summed up the complicated local, national, and international politics of meat safety in two words: "Meat Mess." ( 2001 New York of March 24, 2001, summed up the complicated local, national, and international politics of meat safety in two words: "Meat Mess." ( 2001 New York Daily News Daily News L.P. Reprinted with permission.) L.P. Reprinted with permission.) Adding to this mess, the administrator of USDA's Agricultural Marketing Service announced that testing for Salmonella Salmonella in beef served in the federal school lunch program (the cause of the problems with Supreme Beef discussed in the previous chapter) was no longer necessary and schools could now serve in beef served in the federal school lunch program (the cause of the problems with Supreme Beef discussed in the previous chapter) was no longer necessary and schools could now serve irradiated irradiated beef instead. This suggestion elicited surprised comments from Senator Richard Durbin (Dem-IL), who viewed it as another attempt by corporations to circumvent safety regulations under an administration so friendly to industry that it had already reduced standards for the levels of arsenic permitted in drinking water: "The school lunch program is a very sacred budget in our program, and a lot of senators and congressmen don't feel it's a political issue. . . . First, it was arsenic in drinking water. Now it's salmonella in school lunches. Where will it end?" Apparently, the suggestion also surprised USDA Secretary Veneman. The next day, she said that she had not approved the change and would withdraw it, a turnaround that caused Senator Durbin to comment, "Someone in the department got caught with their hand in the hamburger." beef instead. This suggestion elicited surprised comments from Senator Richard Durbin (Dem-IL), who viewed it as another attempt by corporations to circumvent safety regulations under an administration so friendly to industry that it had already reduced standards for the levels of arsenic permitted in drinking water: "The school lunch program is a very sacred budget in our program, and a lot of senators and congressmen don't feel it's a political issue. . . . First, it was arsenic in drinking water. Now it's salmonella in school lunches. Where will it end?" Apparently, the suggestion also surprised USDA Secretary Veneman. The next day, she said that she had not approved the change and would withdraw it, a turnaround that caused Senator Durbin to comment, "Someone in the department got caught with their hand in the hamburger."60 This incident revealed the alarming increase in outbreaks of foodborne disease among school children eating contaminated meat served in school lunch programs. The Chicago Tribune Chicago Tribune identified dozens of such outbreaks, some of them affecting thousands of students; it attributed them to inadequate cooking of badly contaminated frozen meat shipped from careless and uncaring packers. The packers did the usual denying and blaming, along with one unusually creative response: "The real problem . . . is America's strict food safety laws. The more we battle these so-called pathogens, the more problems we're creating. . . . Our immune systems here are in pathetic shape. . . . We're not able to deal with elevated levels of bacteria that people in other parts of the world can deal with because we are in such a sterile environment." identified dozens of such outbreaks, some of them affecting thousands of students; it attributed them to inadequate cooking of badly contaminated frozen meat shipped from careless and uncaring packers. The packers did the usual denying and blaming, along with one unusually creative response: "The real problem . . . is America's strict food safety laws. The more we battle these so-called pathogens, the more problems we're creating. . . . Our immune systems here are in pathetic shape. . . . We're not able to deal with elevated levels of bacteria that people in other parts of the world can deal with because we are in such a sterile environment."61 The The Tribune's Tribune's disturbing reports made it clear that state inspectors could not be counted on to do their jobs adequately, thereby strengthening the case for stronger federal oversight. disturbing reports made it clear that state inspectors could not be counted on to do their jobs adequately, thereby strengthening the case for stronger federal oversight.
The GAO supported this case a few months later when it told Congress that at least 292 outbreaks from school meals-affecting more than 16,000 children-had occurred since 1990. Such outbreaks were clearly increasing, but no federal agency monitors the safety of school meals or issues special security measures to protect school children. The GAO said that closing this safety gap would require "addressing the overarching problems that affect the nation's federal food safety system as a whole."62 In 1992, Michael Taylor (the former USDA administrator introduced in In 1992, Michael Taylor (the former USDA administrator introduced in chapter 2 chapter 2) proposed specific legislative actions that might be taken to achieve that goal.63 Table 10 Table 10 summarizes some of his suggestions, along with some others derived from the ideas discussed in these chapters. summarizes some of his suggestions, along with some others derived from the ideas discussed in these chapters.
TABLE 10. Suggestions for legislative actions to ensure safe food Congress should provide the mandate, authority, and funding necessary to achieve: * A single agency accountable for providing consistent and coordinated oversight of food safety, from farm to table * Revision of the 1906 safety inspection laws to permit oversight of microbial pathogens * Institution of Pathogen Reduction: HACCP, with performance standards verified by pathogen testing, at every step of food production * A national food safety plan that sets priorities, adopts strategies, ensures accountability, and monitors progress * Recall authority, access to records, and penalties for lapses in safety procedures * Uniform food safety standards for states, consistent with federal policies * Standards for imported foods equivalent to those for domestic foods * Food safety to take precedence over commercial considerations in trade disputes * Universal food safety education for commercial food handlers * A national system for monitoring cases and outbreaks of foodborne disease and their causes * Research on methods to control microbial contamination and illness, and on prevention strategies
SOURCE: Some of these suggestions are adapted from Taylor MR. Some of these suggestions are adapted from Taylor MR. Food Technology Food Technology 2002;56(5):190194. 2002;56(5):190194.
CONCLUSION: THE GLOBAL POLITICS OF FOOD SAFETY.
At the beginning of the twenty-first century, efforts to prevent microbial contamination of the food supply continue to be held hostage to industries obstructing intervention, agencies competing for scarce resources, inspectors defending obsolete job descriptions, courts defending obsolete laws, and a Congress more anxious to protect the sources of campaign contributions than the health of the public. While many food safety problems have improved since the era of The Jungle The Jungle, the solution to others continues to face formidable political opposition.
Although this chapter has focused on U.S. food safety matters, it begins and ends by recognizing that domestic food safety-like many other political matters-cannot be discussed in isolation from its international dimensions. The safety of the foods we import depends not only on the quality standards set by our trading partners but also on international decisions that might seem only peripherally related to the food supply. Thus, an additional alternative surely should be to insist that the United Nations agencies dealing with trade issues-the Codex Commission and, as discussed in the next part of this book, the World Trade Organization-consider health and safety first in making rules about trade barriers.
As mentioned at the beginning of this chapter, several European countries have reduced outbreaks of foodborne disease by instituting control measures similar to Pathogen Reduction: HACCP. In response to food catastrophes such as mad cow disease in Great Britain and foot-and-mouth disease in cattle throughout Europe, countries such as Canada, Denmark, Ireland, and Great Britain have taken steps to consolidate their food safety activities into single agencies. The European Union has also created a unified Food Safety Authority.64 The reasons for taking this approach vary from one country to another and may well be designed to promote the interests of food companies and regulators rather than those of the public, as all seem driven primarily by the need for greater efficiency and reduced cost. The reasons for taking this approach vary from one country to another and may well be designed to promote the interests of food companies and regulators rather than those of the public, as all seem driven primarily by the need for greater efficiency and reduced cost.65 Although it is too soon to know whether they will also reduce episodes of foodborne illness, these experiments are of great interest. They hold the promise of solving coordination problems as well as providing the strength and flexibility to deal with emerging food safety challenges such as bioterrorism. Although it is too soon to know whether they will also reduce episodes of foodborne illness, these experiments are of great interest. They hold the promise of solving coordination problems as well as providing the strength and flexibility to deal with emerging food safety challenges such as bioterrorism.
International concerns also dominate discussions of food biotechnology, as countries throughout the world grapple with decisions about whether to accept genetically modified food crops produced in the United States. In part 2 part 2, we will see that the debates over such foods depend to some extent on safety considerations but relate even more to societal implications. Whether an independent food agency might be more effective in dealing with this broader range of considerations will be taken up in the concluding chapter, as will some thoughts on how the various stakeholders-government, food producers, and consumers-might make food safety issues less political and more focused on health.