The preventive controls final rules require that a facility verify that hazards are being controlled and take corrective action to prevent contamination; and product testing and environmental monitoring are examples of steps a firm may take. A facility’s decision to conduct product testing, and to establish the frequency of such testing, will reflect a risk-based approach consistent with its hazard analysis. Consequently, the FDA expects that facilities that produce foods that have frequently been associated with outbreaks of foodborne illness or pathogen contamination, or produce ready-to-eat foods for which an effective preventive control cannot be implemented, would establish product testing programs more often than facilities that do not produce such foods.
Similarly, a facility that identifies an environmental pathogen as a hazard requiring a preventive control, for example, sanitation controls, would conduct environmental monitoring. Such a facility would decide what, if any, role product testing would play as a verification activity or as part of a corrective action as a result of positive findings from environmental monitoring, based on the facility, the food, the nature of the preventive control, and the role of the preventive control in the facility’s food safety system.
