Abstract

Listeriosis is an invasive illness typically caused by the ingestion of foods contaminated with Listeria monocytogenes. In 2015, an outbreak of listeriosis was linked to ice cream products produced on a specific production line at Facility X. The United States Food and Drug Administration (FDA) obtained samples representing several lots of three products manufactured on that line from May 2014 through January 2015. Two of these products, A and B, while not linked to any reported illnesses, were analyzed to determine the frequency of contamination and the contamination level for risk assessment and dose-response analyses. These enumerations were performed utilizing a Most Probable Number (MPN) method, with a lower detection limit of 0.03 MPN/g, on 344 samples of Product A and 95 samples of Product B. Ten lots of Product A were analyzed and 77% of the samples tested were found to be positive for L. monocytogenes. Five lots of Product B were analyzed and 46% of the tested samples were found to be positive. Additionally, the level of contamination of positive Product B samples was always less than 1 MPN/g. The contamination levels of both products, overall, were low with median values of 0.1 MPN/g and 0.02 MPN/g for Products A and B, respectively. A majority of Product A samples (52%) were contaminated at levels of less than 1 MPN/g and only one sample was above 100 MPN/g. Whole genome sequencing (WGS) of L. monocytogenes isolated from ice cream samples produced in the line suggested minor strain differences related to product type, possibly due to differences in the food matrices and/or differences in the manufacturing equipment. Overall, the data showed a consistent low level of contamination in products produced from a single production line over a nine month period.

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