Microsoft Word - Draft OMB Meeting Agenda-April 11 2019

B ird et al .: J ournal of aoaC i nternational V ol . 99, n o . 4, 2016 997

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Ben Bastin and Alison Deshields, Q Laboratories Inc., Cincinnati, OH Heidi Wright, AEMTEK, Inc., Fremont CA Jesse Miller, Bryan Schindler, Eric Budge, Zach Geurin, Alex Repeck, and Courtney Gies, NSF International, Ann Arbor, MI Tonya Bonilla, Cynthia Zook, and Christina Barnes, 3M Food Safety, St. Paul, MN We would like to extend a special thanks to the following team members at Q Laboratories, Inc. for their efforts during the collaborative study: M. Joseph Benzinger, Jr, Allison Mastalerz, Megan Boyle, Jonathan Clifton, T. Shane Wilson, Meghan Daniel, and Nicole Klass. (1) Centers for Disease Control and Prevention (2015) Salmonella , http://www.cdc.gov/salmonella/general/index.html (accessed on November 2015) (2) Public Health Agency of Canada (2011) Salmonella Enterica spp., http://www.phac-aspc.gc.ca/lab-bio/res/psds-ftss/ salmonella-ent-eng.php (accessed on March 2016) (3) U.S. Food and Drug Administration (2015) Recalls Withdrawals , http://www.fda.gov/animalveterinary/safetyhealth/ recallswithdrawals (accessed on November 2015) (4) U.S. Department of Agriculture, Food Safety and Inspection Service (2015) Current Recalls and Alerts , http://www.fsis .usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/ current-recalls-and-alerts (accessed on November 2015) (5) ISO 6579 (2002) Microbiology of food and animal feeding stuffs – Horizontal method for the detection of Salmonella spp., Annex B, International Organization for Standardization, Geneva, Switzerland (6) Official Methods of Analysis (2012) 19th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, Appendix J, http:// www.eoma.aoac.org/app_j.pdf (accessed on September 2015) (7) U.S. Department of Agriculture, Food Safety and Inspection Service (2014) Microbiology Laboratory Guidebook , http:// www.fsis.usda.gov/wps/wcm/connect/700c05fe-06a2-492a- a6e1-3357f7701f52/MLG-4.pdf?MOD=AJPERES (accessed on September 2015) (8) U.S. Food and Drug Administration (2014) Bacteriological Analytical Manual , http://www.fda.gov/Food/ FoodScienceResearch/LaboratoryMethods/ucm070149.htm (accessed on September 2015) (9) Official Methods of Analysis (2012) 19th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, Method 990.12 , www .eoma.aoac.org (accessed on September 2015) (10) Least Cost Formulations, Ltd. MPN Calculator – Version 1.6, www.lcfltd.com/customer/LCFMPNCalculator.exe (accessed on September 2015) (11) Crowley, E., Bird, P., Fisher, K., Goetz, K., Boyle, M., Benzinger, M.J., Jr, Juenger, M., Agin, J., Goins, D., & Johnson, R. (2012) J. AOAC Int. 95 , 778–785 (12) Harris, L., & Humber, J. (1993) J. AOAC Int. 76 , 822–830 (13) Wehling, P., LaBudde, R., Brunelle, S., & Nelson, M. (2011) J. AOAC Int. 94 , 335–347 (14) Least Cost Formulations, Ltd (2011) AOAC Binary Data Interlaboratory Study Workbook, http://lcfltd.com/aoac/aoac- binary-v2-3.xls (accessed on September 2015) (15) ISO 18593 (2004) Microbiology of food and animal feeding References

butter, the isolates recovered from Laboratory 3 serotyped as the same strain as the inoculating organism, indicating that cross-contamination of the sample occurred. Due to the fact that cross-contamination occurred, the data were excluded from statistical analysis. For the statistical analysis of each matrix, all laboratory data that were submitted were included, with the exception of Laboratories 7 and 3 for the creamy peanut butter. Laboratory 7 indicated difficulties in the lysis procedure during its analysis of the creamy peanut butter test portions. After discussions with Laboratory 7, it was identified that an incorrect temperature was used during the lysis procedure. The incorrect temperature was obtained using an inappropriate thermometer for the 3M heat lysis block insert, which resulted in the combination of sample and lysis buffer in the lysis tubes to boil over during the heat lysis process. Due to the fact that samples were not heated at the proper temperature and that cross-contamination of the samples may have occurred, data from Laboratory 7 was not included in the statistical analysis. Overall, the data generated during this evaluation demonstrate reproducibility of the new method. For each matrix, the POD statistical analysis indicated that no statistically significant difference between the candidate method and the reference method or between the presumptive and confirmed results of the candidate method was obtained. It is recommended that the 3M MDA 2 – Salmonella method be adopted as Official First Action status for the detection of Salmonella in selected foods: raw ground beef (73% lean), raw ground chicken, chicken carcass rinse, chicken carcass sponge, pasteurized liquid whole egg, cooked breaded chicken, instant nonfat dry milk, black pepper, cocoa powder, raw whole shrimp, raw bagged spinach, creamy peanut butter, dry dog food, pasteurized processed American cheese, and sealed concrete, stainless steel, and sealed ceramic tile environmental surfaces. We would like to extend a sincere thank you to the following collaborators for their dedicated participation in this study: Robert Brooks, ATC Microbiology, LLC, North Little Rock, AR Joel Blumfield, EDL Labs, Inc., Purvis, MS Adam Hankins, McCoy & McCoy Laboratories, Inc., Madisonville, KY Jerry Lynn Pickett, Joseph Reynolds, and Jamie Casimir, Tyson WBAAnalytical, Springdale, AR Leslie Thompson, VANGUARD SCIENCES, North Sioux City, SD Luci Hardrath, AgSource Laboratories, Marshfield, WI Jean Schoeni and Mikiko Tillottson, Covance, Inc., Madison, WI Alexandra Calle and David Campos, Texas Tech University, Lubbock, TX Maria Mendres and Kenneth Naylor, Now Health Group, Bloomingdale, IL Brian Kupski and Nicole Cuthbert, Silliker, Food Science Center, Crete, IL Recommendations Acknowledgments

ERP Use Only

stuffs – Horizontal methods for sampling techniques from surfaces using contact plates and swabs, International Organization for Standardization, Geneva, Switzerland

04/05/2019