OMB First to Final Action Recommendation Checklist 11-12-18

ERP - GLUTEN ASSAYS: AOAC 2015.05 FAR

AOAC RESEARCH INSTITUTE AOAC OFFICIAL METHODS OF ANALYSIS (OMA)

OMAMAN-20: R-Biopharm, Qualitative Detection of Gluten on Surfaces and In Processed and Non- Processed Products by R5 Immuno-Chromatographic Dip Stick Study Director: Dr. Markus Lacorn & Thomas Weiss, R-Biopharm AG, An der neuen Bergstraße 17, 64297 Darmstadt, Germany threshold level of 20 mg/Kg. The reproducibility of the assay has been evaluated in corn sample and processed samples like cookies and corn snacks. The assay provides positive results above 2.5 mg/kg in non-processed foods and above 4 mg/kg in processed foods. The positive results are produced if a surface contains more than 1to 2 mcg gliadin/100 cm2. . The R5 dipstick has been in the market for a long time. It’s applicability to food matrices are recognized. However, food surfaces application appears to be an afterthought. No validation data were presented or reported elsewhere. As mentioned in the manuscript, a positive band can have non-uniform color intensity due to in-homogenous distribution of gluten on the dipstick sample pad. This may be a sampling protocol flaw and may give an inconsistent result. NA

ER 7 ER 8

Page 4 of 13

47