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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3. AOAC Official Method 993.12 Listeria monocytogenes in Milk and Dairy Products: Selective Enrichment and Isolation Method, First Action 1993, Final Action 1996. (Accessed January

2015)

4. ISO 11290-1/A1 (2004) - Microbiology of food and animal feeding stuffs - Horizontal method for the detection and enumeration of Listeria monocytogenes - Part 1: detection of

Listeria monocytogenes in foods

5. U.S. Food and Drug Administration, and U.S. Food Safety and Inspection Service. 2003. Quantitative Assessment of the Relative Risk to Public Health from Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-Eat Foods. Available in Docket No. 1999N-1168, Vols. 23 through 28, and at Quantitative Assessment of Relative Risk to Public Health from Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-Eat 6. Doyle ME, Mazzotta AS, Wang T, Wiseman DW, and Scott VN. 2001. Heat resistance of Listeria monocytogenes . Journal of Food Protection 64 (3): 410-429. 7. ISO 18593. Microbiology of food and animal feeding stuffs – Horizontal methods for sampling techniques from surfaces using contact plates and swabs. 8. AOAC Research Institute Performance Tested Methods SM Program validation outline protocol: Comparative Evaluation of the 3M ™ Molecular Detection Assay Listeria monocytogenes 2 and of the 3M ™ Molecular Detection Assay Listeria 2 (February 2015) Foods

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9. U. S. Food and Drug Administration Bacteriological Analytical Manual , Chapter 3 Aerobic

Plate Count ( January 2001) (Accessed January 2015)

http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm063346.m

10. Least Cost Formulations, Ltd., MPN Calculator Version 1.6 www.lcfltd.com/customer/LCFMPNCalculator.exe(Accessed January 2015) 11. AOAC International, Evaluation of the VITEK 2 Gram Positive (GP) Microbial Identification Test Card: Collaborative Study , Journal of AOAC International, 95, 1425

AOAC Research Institute Expert Review Panel Use Only

(2012)

12. Wehling, P., LaBudde, R., Brunelle, S., Nelson, M. Probability of Detection (POD) as a Statistical Model for the Validation of Qualitative Methods. Journal of AOAC

International, Vol. 94, No. 1, 2011.

13. Least Cost Formulations, Ltd., AOAC Binary Data Interlaboratory Study Workbook Version 2.2 (2011) -http://lcfltd.com/aoac/aoac-binary-v2-2.xls(Accessed January 2015) 14. Official Methods of Analysis of AOAC INTERNATIONAL (2012) 19th Ed., Appendix J: AOAC INTERNATIONAL Methods Committee Guidelines for Validation of Microbiological Methods for Food and Environmental Surfaces, AOAC INTERNATIONAL, Gaithersburg, MD,http://http://www.eoma.aoac.org/app_j.pdf (Accessed January 2015)

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