AOAC GFA Stakeholder Program Meeting Book (March 15, 2023)

4.1.3 Matrix / POD study For each gluten source-matrix combination, the developer must analyze a blank (no gluten) sample, one sample per each CDC, one sample at half of the lowest CDC, and one sample at least 1.5 times the highest CDC, prepared as described in Annex B. If the sample at half the lowest CDC produces a POD of 0%, an additional sample must be prepared and analyzed with a concentration midway between the half-lowest CDC sample and lowest CDC sample. If the sample at half the lowest CDC produces a POD of 100%, an additional sample must be prepared and analyzed with a concentration midway between the blank (no gluten) sample and the half-lowest-CDC sample. For environmental swabbing assays and CIP/rinse water validations, the developer will treat each surface and/or CIP/rinse water solution as a separate matrix, and analyze the prepared gluten source-matrix materials as described above. Perform (20) biological replicate tests of each gluten source-matrix-spike level sample. For environmental swabbing, perform (20) replicates of each gluten source-matrix-spike level sample on each surface claimed. The samples at and above the CDC must produce a POD of 0.95 or higher. The blank samples must produce a POD of 0.05 or lower. Page 6 – use of term “sample” without modifier” – In the paragraph beginning “For each gluten source- matrix combination…” the term “sample” is used several times. These should all have modifier of Lab sample, Analytical sample or test portion to reduce confusion – many might actually be better as “test material.” I’m worried someone may misinterpret these as meaning “test portion” and think they only need to run one test portion per level. I assume each of these “samples” will require multiple test portions?

Page 6: “biological replicate” – I would prefer to say “Perform analysis on twenty (20) test portions from each gluten source/matrix/level test material.”

Page 7 – “blank samples” should be “blank test materials”

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