AOAC Gluten Qualitative Validation Guidance-FINAL (July 2023)

Gluten Public Comments (Responses)

Response to Public Comments – Original comments in black text, responses in red text. Table of contents Why do we have Scope and Applicability? For me both are quite comparable and can be merged in one chapter. Per WG discussion at the 2023 AOAC Midyear Meeting, the formatting and headers of the document will be decided by AOAC upon publication. ------------------------------------------------------------------------------------------------------------------------------------------ Scope Although we discussed the Scope at the beginning, considering all the new terms introduced into the guidance; perhaps the Scope should be revisited? Not least to ensure it is read by the widest group of stakeholders and not just method developers, as this would help educate those working in the field. Therefore, along the lines of: “The purpose of this document is to provide AOAC International (AOAC) guidelines for method developers conducting validation studies of immunoassay-based food allergen analysis methods, e.g., for submission for AOAC Official Methods of Analysis (OMA) status and/or Performance Tested Methods (PTM) certification. This document is not intended to describe requirements for laboratories using commercial immunoassay methods for food allergen analysis , though for these laboratories it would assist their understanding of the consensus-based approach, the terminology used and what information they can expect to receive from method developers. The bold section above, amended to reference gluten, has been added to the end of the first paragraph of the Scope. ------------------------------------------------------------------------------------------------------------------------------------------ Applicability "The current document lacks clarity regarding oats as a gluten free food. Many nations that allow gluten free claims allow oats in gluten free foods so long as gluten contamination from wheat, barley, or rye is equal to or below 20mg/kg (depending on the specific regulation by country). Additionally, oats have been excluded from the definition of gluten in previous AOAC documents (SMPR 2017.021). In light of the important role of oats in the diet of Celiacs, we propose this text for the Applicability section as follows: These guidelines are intended to be applicable to the validation of candidate qualitative methods for the detection of gluten from wheat, barley, rye, their crossbreeds, and/or their derivatives. Many nations that allow gluten free claims allow oats in gluten free foods so long as gluten contamination from wheat, barley, or rye is equal to or below 20 mg/kg (depending on the specific regulation by country). These guidelines apply to proprietary and non-proprietary methods, including those that may be submitted to AOAC for OMA status or PTM certification. Unforeseen circumstances may necessitate divergence from these guidelines in certain cases, and these must be reviewed by AOAC or another appropriate agency (other than the method developer). The AOAC PTM Program requires a method developer (single-laboratory) validation (SLV), and an independent laboratory study. The AOAC OMA Program requires an SLV (also known as the pre-collaborative study) and a collaborative study to achieve Final Action status. A harmonized PTM-OMA Program can be followed in which PTM certification is sought and, if successful, serves as the SLV phase of the OMA Program."