Microsoft Word - Candidates for 2018 ERP of the Year

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MOTION: Motion by Hitchins; Second by Salfinger, to have the method developer provide single laboratory validation for at least 1 of the 3 spices with the false negative result. Consensus demonstrated by: 8 in favor, 1 opposed, and 1 abstention. Motion Passed. Negative votes were overridden by 2/3 of voting ERP members. IV. Discuss Final Action Requirements for First Action Official Methods (if applicable) The ERP will discuss, review any additional information (i.e., additional collaborative study data, proficiency testing, and other feedback), track AOAC Official First Action methods for 2 years after adoption, and make recommendations to the Official Methods Board regarding Final Action status. AOAC staff presented the AOAC First Action Official Method to Final Action Feedback Mechanism for Method Use and Performance Evaluation fo r proprietary/sole source AOAC Official Method SM (OMA). 3 In accordance to Appendix G: Procedures and Guidelines for the Use of AOAC Voluntary Consensus Standards to Evaluate Characteristics of a Method of Analysis the following criteria must be submitted for AOAC Final Action Official Method consideration regarding the following aspects of the method: method applicability, safety concerns, reference materials, single-laboratory validation, reproducibility/uncertainty and probability of detection, additional feedback from users of method, and ERP additional required information (if applicable). AOAC is continuously seeking performance feedback from the method authors, method developers, and method end users. AOAC staff will revise the feedback form to reflect yes/no questions with options to explain if the answer was marked “no”. V. Discussion on ERP Review of Methods for OMA and PTM Programs ERP members discussed their roles as ERP members and as Expert Reviewers for the PTM program and how to become more actively involved in the review processes earlier. The ERP members agreed that everyone will be copied on PTM/OMA harmonized collaborative study protocol reviews, in addition to the assigned (1) AOAC Expert, and (2) ERP members. VI. Harmonization and Implementation Deborah McKenzie presented the current harmonization activities of the AOAC Research Institute and the AOAC International Stakeholder Panel for Alternative Methods (ISPAM). It was also noted that there will be a symposium at the AOAC Annual Meeting & Exposition in Los Angeles, California on the harmonization programs and how they can work together; this includes MicroVal, Afnor, and NMKL. The ERP was tasked to consider scenarios and a path forward for harmonization, implementation of the use of Broad Range of Foods vs. Variety of Foods claims, and to consider the acceptance criteria for validation studies for ISO 16140. VII. Action Items 1) Due to the discrepancies of whether or not additional data is required, the ERP will revisit the following AOAC First Action Official Methods:

a. AOAC Official Method 2013.02: Salmonella Species in a Variety of Foods and Environmental Surfaces (BAX® System Real-Time PCR Assay for Salmonella) b. AOAC Official Method 2014.06: Listeria species in Selected Foods and Environmental Surfaces (3M™ Molecular Detection Assay (MDA) Listeria Method)

3 Attachment 2: First to Final Action Feedback Instructions

03/12/2018