Candidates for 2016 ERP of the Year

ERP PROFILE SUMMARIES

MEETING MINUTES

I. Welcome and Introductions The Expert Review Panel Co-Chair Terry Koerner welcomed Expert Review Panel members, initiated introductions, and discussed with the panel the goal of the meeting. II. Review of AOAC Volunteer Policies & Expert Review Panel Process Overview and Guidelines Deborah McKenzie presented a brief overview of AOAC Volunteer Policies, Volunteer Acceptance Agreement and Expert Review Panel Policies and Procedures which included Volunteer Conflicts of Interest, Policy on the Use of the Association, Name, Initials, Identifying Insignia, Letterhead, and Business Cards, Antitrust Policy Statement and Guidelines, and the Volunteer Acceptance Form (VAF). All members of the ERP were required to submit and sign the Volunteer Acceptance Form. In addition, she also presented an overview of the ERP process including meeting logistics, consensus, First Action to Final Action requirements, and documentation. Review of Methods All ERP members presented a review and discussed the proposed collaborative study manuscript for OMAMAN-19: R-Biopharm, Competitive Enzyme Immunoassay Based on the R5 Monoclonal Antibody to Determine Partially Hydrolysed Gluten in Foods Containing Wheat, Rye, and Barley. The method author Dr. Markus Lacorn and Patricia Meinhardt of R-Biopharm were present and able to address questions and concerns of the ERP members. A summary of comments were provided to the ERP members and the method author. 1 By consensus, the ERP presented the following motions for OMAMAN-19. MOTION: Motion by Wehling; Second by Boison, to move OMAMAN-19 to AOAC First Action Official Methods status. Consensus demonstrated by: (Unanimous) in favor, 0 opposed, and 0 abstentions. Motion Passed. MOTION: Motion by Garber; Second by Wehling, First to Final action requirements for OMAMAN-19 require single laboratory validation data showing at and below 20 mg/kg. Consensus demonstrated by: (Unanimous) in favor, 0 opposed, and 0 abstentions. Motion Passed. All ERP members presented a review and discussed the proposed collaborative study manuscript for OMAMAN-20: R-Biopharm, Qualitative Detection of Gluten on Surfaces and In Processed and Non-Processed Products by R5 Immuno-Chromatographic Dip Stick. The method author Dr. Markus Lacorn of R-Biopharm was present and able to address questions and concerns of the ERP members. A summary of comments were provided to the ERP members and the method author. 2 By consensus, the ERP presented the following motions for OMAMAN-20. MOTION: Motion by Don; Second by Yeung, to table the discussion and decision on OMAMAN-20 pending R- Biopharm’s response to the ERP comments. Consensus demonstrated by: (Unanimous) in favor, 0 opposed, and 0 abstentions. Motion Passed. IV. Discuss Final Action Requirements for First Action Official Methods (if applicable) No further action was discussed at this time. The First to Final Action requirements set for OMAMAN-19 were noted in the meeting minutes above. III.

V.

Adjournment: Meeting adjourned at 5:22pm

1 Attachment 1: Summary of Expert Reviewer Comments for OMAMAN-19 2 Attachment 2: Summary of Expert Reviewer Comments for OMAMAN-20

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