ERP Micro December 2019

AOAC RESEARCH INSTITUTE Expert Review Panel Chair Report for Microbiology for Foods and Environmental Surfaces Page 3 of 6

EXPERT REVIEW PANEL, METHOD BACKGROUND, AND CONCLUSIONS

Criteria for Vetting Methods to be considered: AOAC convened the Official Methods of Analysis SM (OMA) Expert Review Panel for Microbiology for Foods and Environmental Surfaces on Tuesday, June 26, 2018 from 11:00am – 4:00pm at AOAC INTERNATIONAL located at 2275 Research Blvd, Suite 300, Rockville, MD 20850 USA. The purpose of the meeting was to review the collaborative study manuscripts of OMAMAN-43: Evaluation of the MC-Media Pad™ Yeast and Mold Device for the Enumeration of Yeast and Mold: Collaborative Study (Charlotte Lindhardt, Merck KGaA, Frankfurter Str. 250, 64293 Darmstadt Germany, and Patrick Bird, Q Laboratories, 1400 Harrison Avenue, Cincinnati, OH 45214) for AOAC First Action Official Methods status. The ERP also reviewed the modification of AOAC Official Method 2017.09: Confirmation and Identification of Salmonella species, Cronobacter species, and Other Gram-Negative Organisms Bruker MALDI Biotyper Method, First Action 2017 (Daniele Sohier and Markus Kostrzewa, Bruker Daltonics, Fahrenheitstraße 4, Bremen, 28359 GERMANY). Candidate method, OMAMAN-43, was reviewed as a collaborative study and against the collaborative study protocol to verify that the method is scientifically valid and that the applicability is supported in the manuscript. Supplemental information was provided to the reviewers which included the collaborative study manuscript, protocol, method user guide/instructions for use, method safety checklist and the AOAC® Performance Tested Method SM 111401 report and modification. The ERP members used the AOAC First Action Method Review form to submit their comments. AOAC OFFICIAL METHOD 2017.09 was submitted and reviewed as a proposed modification to an existing First Action Official Method . The modification was a matrix extension to include Campylobacter spp. (in addition to Confirmation and Identification of Salmonella spp., and Cronobacter spp., and Other Gram-Negative Organisms by the Bruker MALDI Biotyper Method). The AOAC method review form will be to verify if this method is scientifically valid and that the applicability is supported in the manuscript. Supplemental information was provided to the reviewers which included the revised collaborative study manuscript, pre-collaborative study report, and the original method. The ERP members used the AOAC Method Review form to submit their comments. Criteria for Vetting Experts and Selection Process: The current Expert Review Panel (ERP) consisting of ten (10) experts and one (1) alternate were submitted for consideration by the Official Methods Board to evaluate candidate methods for microbiology methods as per the Expert Review Panel (ERP) Policies and Procedures. The candidates were highly recommended by the Microbiology Community, have participated in various AOAC activities, including but limited to, Method Centric Committees that were formed under the legacy OMA pathway, and were vetted by the Official Methods Board. The experts are Wendy McMahon (Co-Chair), Michael Brodsky (Co-Chair), Maya Achen, Patrice Arbault, Mark Carter, Peyman Fatemi, Maria Christina Fernandez, Tom Hammack/Yi Chen (alternate), Tony Hitchins, and Yvonne Salfinger. ERP Orientation: All ERP members have completed the mandatory AOAC Expert Review Panel Orientation Webinar. Expert Review Panel Meeting Quorum The meeting of the Expert Review Panel was held in person. A quorum is the presence of seven (7) members or 2/3 of the total vetted ERP, whichever is greater. Eight (8) members, out of the ten (10) voting members and