ERP Micro December 2019

a ATCC = American Type Culture collection (Manassas, VA) b OPHD = Oregon Public Health Division (Portland, OR) c PSU = E . coli Reference Center (Penn State University, University Park, PA) d "ES" is the identification for individual E . coli strains in MilliporeSigma culture collection (Bellevue, WA) e FDA = Food and Drug Administration (White Oak, MD) f USDA-ARS = U.S. Department of Agriculture - Agricultural Research Service (Beltsville, MD) g GDS EHEC = Assurance GDS for E . coli O157:H7 Tq ( eae ) h '+' is GDS assay positive and '-' is GDS assay negative. These PCR results match the previously characterized biochemical and genetic profiles. Matrix Studies No natural contamination was detected in the screening of the product; therefore, the matrix was artificially contaminated with E. coli O157:H7 (see Preparation of Inoculum and Test Portions , above). As per criteria outlined in Appendix J of the Official Methods of Analysis Manual , fractional positive results were obtained for both confirmation methods of the 18 h enrichment for the GDS EHEC method (see Test Portion Analysis , above). A summary of the PPMX sample processing method comparison result PODs are presented in Table D and Table E , below.

Page 24 of 34