OMB Meeting Book - Jan. 11, 2018

AOAC RESEARCH INSTITUTE Expert Review Panel Chair Report for Gluten Assays Page 4 of 5

MEETING MINUTES

I. Welcome and Introductions The Expert Review Panel Chair Terry Koerner (Health Canada) and Jonathan Goodwin (AOAC Interim Executive Director) welcomed the 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. III. Review of Methods The Expert Review Panel Co-Chair Dr. Terry Koerner discussed the methods to be reviewed and the ERP members presented a review and discussed AOAC OMA 2014.03 Gluten in Rice Flour and Rice-Based Food Products, First Action 2014. The method author, organization representative, Michael Prinster of Romer Labs was present and able to address questions and concerns of the ERP members. By consensus, the ERP presented the following motions for OMA 2014.03. 1 MOTION: Motion by Popping; Second by Don, to move 2014.03 for AOAC Final Action consideration status. Consensus demonstrated by: (Unanimous) in favor, 0 opposed, and 0 abstentions. Motion Passed. The ERP members presented a review and discussed the proposed modification 2 of AOAC Official Method 2012.01: Gliadin as a Measure of Gluten in Rice and Corn Based Foods, Final Action 2017. The method author Dr. Markus Lacorn of R-Biopharm was present and able to address questions and concerns of the ERP members. Background of the proposed modification: The AOAC validated ELISA assay RIDASCREEN® Gliadin R7001 (OMA first action 2012.01) use a washing buffer which contains thimerosal (also known as thiomersal), a mercury containing preserving agent. Since the use and/or the disposal of mercury-containing liquids is heavily regulated in many countries or even prohibited in some countries and in order to protect the environment, R-Biopharm AG would like to substitute thimerosal in the washing buffer by the mercury-free preserving agent bronidox L. The experiments showed that there is no significant difference in stability and functionality between the buffer with thimerosal and with bronidox L. Most importantly, the mean obtained concentrations for the used control samples did not show a significant difference between thimerosal and bronidox L containing wash buffer. By consensus, the ERP presented the following motions for OMA 2012.01. MOTION: Motion by Boison; Second by Koerner, to recommend the modification of the wash solution to be considered a Minor Modification and will not affect the AOAC Final Action status. Consensus demonstrated by: (Unanimous) in favor, 0 opposed, and 0 abstentions. Motion Passed.

1 Attachment 1: Method Author Presentation for AOAC OMA 2014.03 2 Attachment 2: Method Author Documentation for the Modification of AOAC OMA 2012.01 Attachment 3: AOAC ERP Presentation of Motions