Candidates for 2016 ERP of the Year

ERP PROFILE SUMMARIES

MEETING MINUTES

I. Welcome and Introductions The Expert Review Panel Chair Shang-Jing (Jean) Pan welcomed Expert Review Panel members, initiated introductions, and discussed with the panel the goal of the meeting. II. Review of AOAC Volunteer Policies 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. III. Expert Review Panel Process Overview and Guidelines Deborah McKenzie presented a quick overview of the Expert Review panel process including meeting logistics, consensus, First Action to Final Action requirements, and documentation. IV. Review of Methods All ERP members presented a review and discussed the proposed collaborative study manuscript for The purpose of the meeting was to review and evaluate 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 of R-Biopharm was present and able to address questions and concerns of the ERP members. A summary of comments was provided to the ERP members. 1 In addition, Sean Tinkey, the Executive Director President of R-Biopharm was also present. The following comments noted below are the recommendations of the Expert Review Panel members who were present. 1) This sentence: “RIDASCREEN ® Gliadin competitive is used for the analysis of fermented and hydrolyzed food (e.g. beer, starch syrup, starch, malt extract, sourdough, soy sauce) which are declared as “gluten- free”.” Must be moved above the Principle section of the OMA. 2) Change “celiac toxic sequence QQPFP” to “immuno-stimulatory” and provide additional clarification. 3) Bracket all mentions of “prolamins” with gluten measurement. a. Add additional statement to tables in reference to both prolamins and gluten. 4) Accuracy and recovery statistics should have a paragraph explaining the nature of the sour dough samples specifically and also generally the difficulty estimating trueness in general. a. Provide paragraph regarding the hordein digest. How much of the extraction is the hordein? Indicate % hordein 5) Insist level at 20 for gluten collaborative study. 6) Concentration range? Bracket level at or below 20. – Additional work? 7) Remove: “The celiac activity of oats is still under discussion, and the Codex standard notes that the allowable level for oats in foods not contaminated with wheat, rye or barley may be determined at the national level(1).” 8) Remove: “besides intact prolamins,”

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

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