AOAC ERP Gluten Assays - March 2019

AOAC RESEARCH INSTITUTE Expert Review Panel Chair Report for Gluten Assays Page 3 of 5

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 Gluten Assays on Monday, September 19, 2016 from 4:00pm to 6:00pm in meeting room San Antonio B during the AOAC INTERNATIONAL Annual Meeting and Exposition being held at the Sheraton Dallas Hotel located at 400 N. Olive Street, Dallas, TX 75201 USA. The purpose of the meeting was to review AOAC Official Method 2012.01: Gliadin as a Measure of Gluten in Foods Containing Wheat, Rye, and Barley, Enzyme Immunoassay Method Based on a Specific Monoclonal Antibody to the Potentially Celiac Toxic Amino Acid Prolamine Sequences, First Action 2012 and AOAC Official Method 2014.03:Gluten in Rice Flour and Rice-Based Food Products G12 Sandwich ELISA, First Action 2014 for AOAC Final Action Official Methods status consideration. The study director for OMA 2012.01 was Dr. Markus Lacorn and Thomas Weiss from R-Biopharm AG, located at An der neuen Bergstraße 17, 64297 Darmstadt, Germany. Dr. Markus Lacorn and Patricia Meindhardt were present during the Expert Review Panel session. Michael Prinster from Romer Labs, located at 1301 Stylemaster Drive, Union, MO 63084-1156, USA was also present and is the study director for OMA 2014.03 . The candidate method was reviewed and supplemental information was also provided to the reviewers which included the method, method feedback and relevant JAOAC articles. Criteria for Vetting Experts and Selection Process: The following nine (9) candidates and one (1) alternate member were submitted for consideration by the Official Methods Board to evaluate candidate methods for gluten assays as per the Expert Review Panel (ERP) Policies and Procedures. The following candidates are highly recommended by the Food Allergens Community and other Food Allergen experts. Many of the following candidates have participated in various AOAC activities, including but limited to, members of Committee H, and expert reviewers for the AOAC Research Institute’s PTM Program. The members are Shang Jing Pan (Co-Chair), Terry Koerner (Co-Chair), Sneh Bhandari, Joe Boison, Clyde Don, Eric Garber/ Girdhari Sharma (Alternate), Bert Popping, Paul Wehling, and Jupiter Yeung. 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. Nine (9) out of the nine (9) members/one (1) alternate, were present and therefore met a quorum to conduct the meeting. Standard Method Performance Requirements (SMPRs): N/A Conclusion: The ERP reviewed OMA 2012.01 and have recommended this method to the AOAC Official Methods Board for AOAC Final Action consideration. OMAN 2014.03 was tabled until the next Expert Review Panel meeting. The decisions have been captured and reflected in the meeting minutes. Subsequent ERP Activities: ERP Chair to complete the AOAC Final Action checklist and submit to the AOAC Official Methods Board.

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