OMB Meeting Book - Jan. 11, 2018

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 onWednesday, March 15, 2017 from 4:30pm to 6:30pm during the AOAC INTERNATIONAL Mid-Year Meeting that was held at Gaithersburg Marriott Washingtonian Center, located at 9751 Washingtonian Boulevard, Gaithersburg, Maryland 20878 USA. The purpose of the meeting was to review AOAC Official Method 2014.03: Gluten in Rice Flour and Rice-Based Food Products, First Action 2014 for AOAC Final Action Official Methods status consideration and to review the proposed modification to AOAC Official Method 2012.01: Gliadin as a Measure of Gluten in Rice and Corn Based Foods, Final Action 2017 . The study director for OMA 2014.03 was Michael Prinster from Romer Labs, located at 1301 Stylemaster Drive, Union, MO 63084-1156, USA who was present during the Expert Review Panel session. The candidate method (OMA 2014.03) was reviewed and supplemental information was also provided to the reviewers which included the method, method feedback and relevant JAOAC articles. The study director for OMA 2012.01, Dr. Markus Lacorn from R-Biopharm AG, located at An der neuen Bergstraße 17, 64297 Darmstadt, Germany and Patricia Meindhardt were present during the Expert Review Panel session. The candidate method (OMA 2012.01) was review and supplemental information was provided to the reviewers which included a copy of the revised and original method with the data collected to support the proposed modification. Criteria for Vetting Experts and Selection Process: The following eight (8) 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 Terry Koerner (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. Eight (8) out of the eight (8) 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 2014.03 and have recommended this method to the AOAC Official Methods Board for AOAC Final Action consideration. The ERP also approved the proposed modification of OMA 2012.01. 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. Deborah McKenzie of AOAC, will follow -up with the community and interested parties regarding the submission of single laboratory validations and collaborative study validations to be reviewed by this specific ERP.