RI-ERP-FINALACTION-Recommendations

OMA 2015.13: Expert Review Panel Report (09/2015) Expert Review Panel Use Only September, 2017

AOAC RESEARCH INSTITUTE Expert Review Panel Chair Report for Microbiology for Foods and Environmental Surfaces Page 6 of 8

In regards to multiple and unique test portion sizes, and alternate enrichments, the ERP discussed that the information be considered on a case by case basis. However, it was noted that this information should be captured for future use and the tracking of exceptions regarding sample sizes, etc, should be noted. If r PTM AND OMA testing? Example: The method developer wants to claim 375g. The ERP discussed that the use of the 5 new Listeria species in the inclusivity studies, the ERP suggested that it should be included in the study, wherever available. The ERP discussed available information regarding the use of the alternative collaborative study design for expensive equipment. It was noted that ISO 16140 and AOAC Appendix I: AOAC INTERNATIONAL Methods Committee Guidelines for Validation of Biological Threat Agent Methods and/or Procedures, both allow for up to three collaborators in the same laboratory, as long as it is independent with separate sample sets. However, AOAC Appendix D: Guidelines for Collaborative Study Procedures to Validate Characteristics of a Method of Analysis allows for up to five collaborators. V. Discuss Final Action Requirements for First Action Official Methods (if applicable) The ERP discussed and reviewed the information received from the method author for the AOAC First Action methods that are or have approached their 2-year tracking period. The method authors were present to answer questions and comments from the ERP. The ERP is required to make a recommendation on AOAC Official First Action methods, 2 years after adoption, to the AOAC Official Methods Board regarding Final Action status. By consensus of the ERP the following motions were noted. 1) AOAC Official Method 2012.02: Gram-Positive Bacteria Identification Kit Name: VITEK® 2 Gram Positive (GP) Biochemical Identification Method Company: bioMérieux Method Status: First Action 2012 Motion by McMahon; Second by Fernandez, to recommend 2012.02 for AOAC Final Action status. Consensus demonstrated by: 8 in favor, 0 opposed, and 0 abstentions. Motion Passed. 2) AOAC Official Method 2013.01: Salmonella in a Variety of Foods Kit Name: VIDAS ® UP Salmonella (SPT) Method Company: bioMérieux Method Status: First Action 2013 Motion by McMahon; Second by Fatemi, to recommend 2013.01 for AOAC Final Action status. Consensus demonstrated by: 8 in favor, 0 opposed, and 0 abstentions. Motion Passed. 3) AOAC Official Method 2013.02 : Salmonella Species in a Variety of Foods and Environmental Surfaces Kit Name: BAX ® System Real-Time PCR Assay for Salmonella Motion by Brodsky; Second by Arbault, to recommend 2013.02 for AOAC Final Action status. Consensus demonstrated by: 7 in favor, 0 opposed, and 1 abstention. Motion Passed. AOAC Research Institute ERP Use Only Company: DuPont Nutrition & Health Method Status: AOAC First Action 2013