Microsoft Word - Draft OMB Meeting Agenda-April 11 2019

OMAMAN-30 D/ PTM Validation Report 081501 OMA ERP - June 2016 ERP Use Only

OMB Meeting 4-11-2019 Pre-read Materials

438

1 2 3 4 5 6 7 8

For the low inoculation level of the MDA2 - Listeria monocytogenes assay, there were 4 presumptive positives and 5 confirmed positives following the USDA/FSIS MLG 8.09 reference method confirmation procedure, resulting in 1 false negative. There were 6 observed positives for the reference method. For the high inoculation level, there were 5 presumptive positives and 5 confirmed positives following the USDA/FSIS MLG 8.09 reference method confirmation procedure. There were 5 confirmed positives following the reference method. Detailed results of

the POD analyses are presented in Tables 10 and 14.

9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46

Stainless Steel (enriched in 225 mL)

Results were identical after 24 and 26 hours of sample enrichment. For the low inoculation level of the MDA2 - Listeria monocytogenes assay, there were 5 presumptive positives and 5 confirmed positives following the USDA/FSIS MLG 8.09 reference method confirmation procedure. There were 8 observed positives for the reference method. For the high inoculation level, there were 5 presumptive positives and 5 confirmed positives following the USDA/FSIS MLG 8.09 reference method confirmation procedure. There were 5 confirmed positives following the reference method.Detailed results of the POD analyses are presented in Tables 11

and 15.

Sealed Concrete (enriched in 100 mL)

24-hour primary enrichment - For the low inoculation level of the MDA2 – Listeriamonocytogenes assay, there were 15 presumptive positives and 15 confirmed positives following the USDA/FSIS MLG 8.09 reference method confirmation procedure. There were 11 observed positives for the reference method. For the high inoculation level, there were 5 presumptive positives and 5 confirmed positives following the USDA/FSIS MLG 8.09 reference method confirmation procedure. There were 5 confirmed positives following the reference method.Detailed results of the POD analyses are presented in Tables 11 and 15. 26-hour primary enrichment - For the low inoculation level of the MDA2 – Listeriamonocytogenes assay, there were 16 presumptive positives and 15 confirmed positives following the USDA/FSIS MLG 8.09 reference method confirmation procedure, resulting in 1 false positive. There were 11 observed positives for the reference method. For the high inoculation level, there were 5 presumptive positives and 5 confirmed positives following the USDA/FSIS MLG 8.09 reference method confirmation procedure. There were 5 confirmed positives following the reference method.Detailed results of the POD analyses are presented in

AOAC Research Institute Expert Review Panel Use Only

Tables 11 and 15.

Plastic (enriched in 10 mL)

Results were identical after 24 and 26 hours of sample enrichment. For the low inoculation level of the MDA2 - Listeria monocytogenes assay, there were 12 presumptive positives and 12 confirmed positives following the USDA/FSIS MLG 8.09 reference method confirmation procedure. There were 10 observed positives for the reference method. For the high inoculation level, there were 5 presumptive positives and 5 confirmed positives following the USDA/FSIS MLG 8.09 reference method confirmation procedure. There were 5 confirmed positives

04/05/2019