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

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1400 Harrison Ave Cincinnati, OH 45214

Reviewers

Yvonne Salfinger

Consultant Denver, CO

Michael Brodsky Brodsky Consultants 73 Donnamora Crescent Thornhill, Ontario L3T 4K6

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Canada

Reviewer

Tony Hitchins FDA-Retired Rockville, MD

Scope of Method

a) Target organism . — Listeria monocytogenes

b) Matrices . — Beef hot dogs (25 g), deli turkey (125 g), queso fresco (25 g), vanilla ice cream (25 g), 4% milk fat cottage cheese (25 g), 3% chocolate whole milk (25 mL), whole melon, romaine lettuce (25 g), bagged raw spinach (25 g), cold smoked salmon (25 g), raw chicken leg pieces (25 g), sealed concrete (sponge enriched in 100 mL, 4” x 4”), plastic (Enviroswab enriched in 10 mL, 1” x 1”), stainless steel (sponge enriched in 225 mL, 4” x 4”). c) Summary of Validated Performance Claims . — Performance equivalent to that of the U.S. Food and Drug Administration Bacteriological Analytical Manual (FDA/BAM) Chapter 10 [1] for whole melon, cold smoked salmon, romaine lettuce; the U.S. Department of Agriculture Food Safety and Inspection Service Microbiology Laboratory Guidebook (USDA-FSIS/MLG) 8.09 [2] for beef hot dogs, deli turkey, raw chicken leg pieces, sealed concrete, plastic and stainless steel and AOAC 993.12 [3] for queso fresco, vanilla ice cream, 4% milk fat cottage cheese, 3% chocolate whole milk and theISO 11290-1/A1 [4]for cold

AOAC Research Institute Expert Review Panel Use Only

smoked salmon and bagged raw spinach.

Definitions

a) Probability of Detection (POD).— The proportion of positive analytical outcomes for a qualitative method for a given matrix at a given analyte level or concentration. POD is concentration dependent. Several POD measures can be calculated; POD R (reference method

POD), POD C

(confirmed candidate method POD), POD CP

(candidate method presumptive

result POD) and POD CC

(candidate method confirmation result POD).

04/05/2019