The passage of any new legislation is bound to bring on a lengthy period of adjustment. When that legislation is as broad and sweeping as the Food Safety Modernization Act (FSMA), the period of adjustment can last years. In our last column, we addressed the new federal requirement, which begins in June 2012, that food companies adopt written food safety plans, alternatively referred to as Hazard Analysis and Critical Control Point (HACCP) plans. While the initiative may appear relatively simple and straightforward, in practice it may prove difficult for the Food and Drug Administration (FDA) to enforce the new requirements uniformly and fairly. We wanted to take a moment to highlight some of the momentous challenges associated with the eventual implementation of the FDA’s new food safety rules.
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The concept of HACCP was developed in the 1960s by Pillsbury and NASA in a project aimed at keeping astronauts’ food pathogen-free. Microbiological testing, they knew, was only effective to a point. So, they collaborated on a program aimed at understanding where and how failures in food safety occur. The result was HACCP, a program designed to seek out and identify the processing points where food safety risks could be reduced to the greatest extent possible. In the 1990s, the FDA mandated HACCP for seafood production, and the program was eventually required in meat and poultry establishments by the Department of Agriculture’s Food Safety and Inspection Service.
The program has been largely successful in the meat industry and has led to a pronounced reduction in the number of foodborne illness outbreaks. As with any regulatory initiative, however, HACCP requires continuous refinement as science, technology, and consumer attitudes mature. And, while recognizing HACCP’s far-reaching success in the meat industry, it is important to note that the meat industry produces a fairly limited set of distinct products and that all beef slaughter operations, by nature of the processes used, follow relatively similar HACCP programs. The risks are finite and can be addressed from one plant to another with identical—or at least similar—interventions. Thus, within the meat industry, establishing uniformity in enforcement and compliance, while never easy, has at least proven somewhat manageable.
The FDA, unfortunately, has a much more complicated scenario to manage. Under the new requirements, every food processor will have to identify, categorize, then formally address a unique set of hazards. In other words, the HACCP program at a factory that makes frozen waffles is going to be fundamentally different than the one for a processor making yogurt, crackers, seasonings, or egg salad sandwiches. There are tens of thousands of food processors in the U.S. making hundreds of thousands of products.
So, how will the FDA ultimately approach the development and implementation of an inspection apparatus that deals uniformly and fairly with tens of thousands of companies producing hundreds of thousands of distinct food products? This, of course, is the million- (or, perhaps, billion-) dollar question, a question that should be flagged and debated today, as opposed to next year when compliance—however that term is ultimately defined by the FDA—will be required.
The FDA and the food industry have time to address many of the challenges of reaching the FSMA’s goals, and I have no doubt they can do so successfully. Companies and business owners, however, need to pitch in as well.
In a perfect world, the FDA could simply publish guidance materials outlining a single HACCP methodology, with a single set of compliance standards that could be applied uniformly to every manufacturing facility and food product. This scenario would prove impossible, however. As noted, there are simply too many different food companies producing too many dissimilar food products, and there is no such thing as a one-size-fits-all science-based HACCP program.