RI-ERP-FINALACTION-Recommendations

OMA 2015.13: Collaborative Study Protocol Expert Review Panel Use Only September, 2017

differences in mean log counts are not of practical difference. A practical difference is typically defined as a mean log difference ≤0.2 logs.That these statistically significant differences occur when the mean log differences are very small is due to the reproducibility of the method and good experimental technique rather than large numerical changes For the lot to lot/stability study, each time point was compared to Time 0 by a paired T test analysis. A P-Value of 0.022 was obtained with the test samples stored at room temperature at the 3 month pull point.While this is statistically significantly different, the difference in mean log recovery was 0.18 logs and therefore not practically different as defined above. Another instance where a similar significant difference was observed with an insignificant mean log recovery (0.13 logs) was with the samples stored for seven months, 4°C. All other test points showed no difference relative to the 0 time point. The method was awarded the PTM certification number 121403 on December 29, 2015. 1.3 Study Directors for Collaborative Study Robert P. Jechorek Patrick Bird & Erin Crowley Study Co-Director Study Co-Directors 3M Food Safety Department Q Laboratories, Inc. 3M Center, Building 260-6B-01 1400 Harrison Avenue St. Paul, MN 55144 Cincinnati, Ohio 45214 Phone: 651-733-9764 Phone : 513-471-1300 Fax: 651-733-5819 Fax : 513-471-5600 Email: rpjechorek@mmm.com Email: pbird@qlaboratories.com ecrowley@qlaboratories.com Collaborators A total of 17 collaborators have been solicited to participate in this study. A minimum of 8 laboratories, with acceptable data, will be needed for the successful completion of this study. Qualified laboratories currently using the 3M ™ Petrifilm ™ Plates or othersthat are thoroughly trained by a 3M representative, will act as collaborators for this study. A sample letter to collaborators can be found in Appendix 8.1. This letter will be sent to each collaborator prior to the start of the study. 3. Collaborative Study Design 1.1. This collaborative study is designed according to the AOAC INTERNATIONAL Methods Committee Guidelines for Validation of Microbiological Methods for AOAC Research Institute Expert Review Panel Use Only 2.