Integrating Concepts: a Case Study Using Enterobacter sakazakii in Infant Formula

This chapter reviews the risk assessment activities that have been performed on Enterobacter sakazakii and focuses on the relations between the various concepts. Other food products besides powdered infant formula (PIF), such as breast milk, starch, and commercially sterilized liquid infant formula, have been described as potentially causing E. sakazakii infections. One of the potential control measures to reduce the risk of E. sakazakii is setting microbiological criteria (MC) for PIF. When a microbial criterion is in place, batches of product need to be sampled at the end of manufacturing, e.g., at packaging, prior to storage. The risk assessment model (RAModel) predicts the number of illnesses due to E. sakazakii per million infant-days, resulting from feeding reconstituted PIF, and compares this number with the numbers resulting from a baseline scenario. Risk communication from users to risk managers is also required. To be able to weigh the various options for control measures, it is imperative that the actual preparation and handling practices become known. Risk assessors can then use the RAModel to compare the options, based on better assumptions regarding temperature, holding times, and cooling rates. Consequently risk managers may be able to design and implement control measures that will effectively reduce the risk, but at the same time take into account all the relevant factors to make sure that the control measures will be feasible and acceptable and can be applied for those infants who are currently most at risk.