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By Root 1167 0

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