“Does this step require a preventive control?” This single box, found in most template hazard analyses, requires a yes or no answer. For all the food safety benefits that Hazard Analysis and Critical Control Points (HACCP) and preventive controls have brought us, maybe thinking of risk in a binary yes/no fashion has done us a disservice. Public health would be better served if companies put the most effort toward managing their greatest risks, deeply understanding the factors that contribute to the risk, allocating resources appropriately to prevent the risks and their root causes, and truly evaluating the effects of those efforts. This article continues the conversation around preventive, proactive approaches to managing food safety that began decades ago. While the conversation has conceptually evolved to promote risk-based thinking and risk-based preventive controls, these are premised on the assessment of risk, which takes skills and resources that may not always be available to each company. And interestingly, neither the U.S. Food and Drug Administration (FDA) Preventive Controls rule [technically called “Current Good Manufacturing Practices (GMPs), Hazard Analysis, and Risk-Based Preventive Controls for Human (or Animal) Food”] nor the FDA Produce Safety rule (technically called “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption”) includes a definition of “risk.”
The concept and implementation of HACCP-based thinking was as revolutionary as the space age that it accompanied.1 The fundamental shift from a reactive system to a preventive one demonstrably improved food safety. Moving the industry away from testing food to determine safety and toward preventing contamination in the first place was monumental. Implementing a preventive approach requires a systematic evaluation of hazards, and associated risk, at each point in the supply chain. Food manufacturers (the first supply chain segment to voluntarily transition to HACCP) had to truly understand and be able to document their production practices and had to demonstrate their understanding of the various hazards—biological, chemical, and physical—that could be introduced or were expected to be controlled at each step. No longer was it sufficient to simply make a food and hope it wouldn’t hurt people. In many ways, HACCP spawned the food safety discipline. A properly done hazard analysis required the expertise of scientists who understood the various types of hazards, the severity of illness or injury should those hazards be associated with the food, and the likelihood that the hazards would occur. Thus, HACCP and its evolution to preventive controls have been hailed as promoting a risk-based approach to food safety.