Safe Food: The Politics of Food Safety (17 page)

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
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
explains how that debate developed.

DESPITE THE BARRIERS DISCUSSED IN
CHAPTER 2
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.

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
(
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
), 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
to flourish at cold temperatures in the cooling system and to contaminate the uncovered products
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
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
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;
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
, and we begin with this agency’s approach to HACCP rules.

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
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
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

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
—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