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

449

Table 4a: Independent Study - Matrices and Inoculating Organisms (Continued)

1 2

Inoculating Organism (Culture Condition) L. monocytogenes ATCC 19118 & 10x Enterococcus faecium ATCC 19434

MDA2 Testing Time Points

# of Replicates

Reference Method (Enrichment)

Matrix

Target Inoculum Level

0 CFU/1” x 1” (5 cm2)

5

USDA/FSIS MLG 8.09 (UVM)

24 and 26 hours

Stainless Steel

~50 CFU/1” x 1” (5 cm2)

20

0 CFU/4” x 4” (100 cm2)

5

3 4

1 ATCC - American Type Culture Collection 2 CWD - University of Vermont

3 FSL - Cornell University 5 * Natural contamination was present during the background screen: 2 separate lots evaluated (20 replicates each) 6 7 8 9 10 Table 4b: Internal Study - Matrices and Inoculating Organisms 11 Matrix Inoculating Organism (Culture Condition) Target Inoculum Level # of Replicates MDA2 Testing Time Points

Reference Method (Enrichment) USDA/FSIS MLG 8.09 (UVM) ISO 11290-1/A1 (Half/Demi Fraser)

0 CFU/Test Portion

5

Raw chicken leg pieces

L. monocytogenes Ad 1 668

0.2-2 CFU/Test Portion 2-5 CFU/Test Portion

20

28 hours

5 5 5 5 5 5

0 CFU/Test Portion

Bagged raw spinach

L. monocytogenes Ad 543

24 hours

0.2-2 CFU/Test Portion 2-5 CFU/Test Portion 0 CFU/Test Portion 0.2-2 CFU/Test Portion 2-5 CFU/Test Portion

20

FDA/BAM Chapter 10 (BLEB)

Cold smoked salmon

L. monocytogenes Ad 670

20

24 hours

0 CFU/Test Portion

Cold smoked salmon

ISO 11290-1/A1 (Half/Demi Fraser)

L. monocytogenes Ad 670

24 hours

0.2-2 CFU/Test Portion 2-5 CFU/Test Portion

20

5

12 13

AOAC Research Institute Expert Review Panel Use Only

1 Ad – Adria Developpement Culture Collection

04/05/2019