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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.

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