Validation Targets – Setting Limits with Limited Data

The Technical Committee on Food Microbiology of the North American Branch of the International Life Sciences Institute collaborated with the American Peanut Council to convene a workshop to develop a framework for managing risk in low-moisture food commodities where large data sets are unavailable. Participants were charged with answering key questions: What are appropriate statistical and scientific methods for setting log reduction targets with limited pathogen prevalence and concentration data? What are suitable quantities of data needed for determining appropriate log reduction targets? Is the requirement of a 5-log reduction in the absence of data to establish a target log reduction is appropriate? What targeted log reduction would protect public health? The report concluded that the judgment about sufficient data is not solely scientific, but is instead a science-informed policy decision. The report noted that modeling efforts should proceed with sampling efforts, allowing one to compare various assumptions about prevalence and concentration and how they are combined. Report authors were comfortable with the use of a 5-log reduction for controlling risk in products like peanuts when the level of contamination of the raw ingredients is low (<1 CFU/g) and the process well controlled, even when limited data are available. The relevant stakeholders may eventually conclude that as additional data, assumptions, and models are developed, alternatives to a 5-log reduction might also result in the desired level of protection.