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FDA's Cheese and Cheese Products Compliance Program guideline criteria for non-toxigenic Escherichia coli: A retrospective analysis of impacts on domestic and imported cheeses

Limoges, Marie, Donnelly, Catherine
Food control 2019 v.106 pp. 106730
Escherichia coli, European Union, Food and Drug Administration, Listeria monocytogenes, Salmonella, cheeses, compliance, food safety, guidelines, most probable number technique, pathogens, retrospective studies, safety assessment, trade
The U.S. Food and Drug Administration's (FDA) 2015 Domestic and Imported Cheese and Cheese Products Compliance Program Guidelines (CPG) (U.S. FDA, 2015) consider cheeses to be adulterated if non-toxigenic Escherichia coli levels of greater than 10 most probable number per gram (MPN/g) and less than 100 MPN/g are found in 3 or more of 5 subsamples. It is unclear if, or how, these standards impact food safety, and the extent to which these standards affect domestic and imported cheese commerce. We conducted a retrospective analysis of microbiological data from FDA's Domestic and Imported Cheese Compliance Program for cheese samples collected between January 1, 2004 and December 31, 2006. Out of 3,007 cheese samples tested by the FDA for non-toxigenic E. coli, 76% (2,300) of samples contained E. coli levels that exceeded 10/g. Of these samples, 68% (2,047) exceeded 2009 regulatory guidelines of 100/g. In comparison, only 7.7% (232) of tested cheese samples exceeded European Union (EU) standards (<1,000 E. coli/g) and 170 (5.7%) of samples exceeded the 1998 CPG criteria (<10,000 E. coli/g). Mexican-style soft, semi-soft, and soft ripened cheeses were the cheese types most impacted by application of the 2015 non-toxigenic E. coli standards. At E. coli levels of 10/g and 100/g, there was no statistically significant association with the presence of Listeria monocytogenes or Salmonella. However, associations between S. aureus levels of 10,000 cfu/g and presence of Salmonella and L. monocytogenes were statistically significant, indicating that EU regulations targeting S. aureus as the pathogen of concern may be more appropriate for cheese safety assessment.