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AOAC RESEARCH INSTITUTE  Expert Review Panel Chair Report for Food Allergens ‐ Gluten  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 Food Allergens – Gluten on  Wednesday, September 30, 2015 during the AOAC Annual Meeting and Exposition held at the Westin Bonaventure  Hotel, 404 South Figueroa Street, Los Angeles, California 90071.  The purpose of the meeting was to review and evaluate OMAMAN‐20:  R‐Biopharm, Qualitative Detection of  Gluten on Surfaces and In Processed and Non‐Processed Products by R5 Immuno‐Chromatographic Dip Stick that  was tabled during the Expert Review Panel meeting held on March 19, 2015 during the AOAC Mid‐Year Meeting.   The co‐study directors for OMAMAN‐20 were 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.   The candidate method (OMAMAN‐20) was reviewed and  supplemental information was also provided to the reviewers which included the collaborative study manuscript,  method safety checklist, method user guide, material safety data sheet for cocktail solution, material safety data  sheet for sample diluent, in‐house validation – revised, method evaluation card, responses to Expert Review Panel  comments, and responses to statistical review comments.  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 food allergens (gluten) 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), Terrence Koerner (Co‐Chair), Sneh Bhandari, Joe Boison,  Clyde Don, Eric Garber/ Girdhari Sharma (Alternate), Bert Popping, Paul Wehling, and Jupiter Yeung. Please note  that Todd Marrow has resigned from this Expert Review Panel.   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 nine (9) members/one (1) alternate, were  present and therefore met a quorum to conduct the meeting.   Conclusion: The ERP reviewed OMAMAN‐20:  R‐Biopharm, Qualitative Detection of Gluten on Surfaces and In Processed and  Non‐Processed Products by R5 Immuno‐Chromatographic Dip Stick and have adopted this method for AOAC First  Action Official Method status by consensus. The decisions have been captured and reflected in the meeting  minutes.   Subsequent ERP Activities: ERP members are required to track the performance of the recently approved First Action method for a 2 year  period effective as of September 30, 2015.    Standard Method Performance Requirements (SMPRs):  N/A 

03/12/2018