7-27-2022_Draft-Agenda -ERP-CASPChemCont Methods

Requirements using the Reference Materials stated in the SMPR? If not, then specify what is missing and how this impacts demonstration of performance of the method. Yes (CRMs used) 3. Is there information demonstrating that the method performs within the SMPR Method Performance REquirements table specifications for all analytes in the SMPR applicability statement? If not, please specify what is missing and whether or not the method's applicability should be modified. Not is all aspects: 1) Applicable range was was note clearly defined or stated for any analytes. 2) LOD determination method of determination was not detailed. 3) Measurement uncertainty was not detemined and method of determination was not detailed. One sentance was provided with, I think, the formula they intended to use for standard uncertainty calculation. I did not see how this related to data and no values provided. 4) I am unclear about recovery data for aflatoxins B2, G1 and G2 for "betwee-day" recovery experiments so i can not determine if they meet the SMPR requirement 60-120%. The method determines the concentration of each analyte separately but it appears recovery was summed for the 4 aflatoxins so recoveries for B2, G1 and G2 were not provided. 5) summaries of data were provided but raw data like concentration values or recoveries for each replicate was not provided 1. Based on the supporting information, were there any additional steps in the evaluation of the method that indicated the need for any additional precautionary statements in the method? No 2. Does the method contain system suitability tests or controls as specified by the SMPR? If not, please indicate if there is a need for such tests or controls and which ones. No. I did not see any indication of sytem suitability tests or controls were used other than checking matrices for incurred aflatoxins. needed: 1) reagent blank(s) 2) process blank 3) spike recovery check per sample preparation batch - at lowest level and, ideally at a mid concentration point 4) calibration curve is serial dilution which does not allow you to find errors in initial standard preparation (error is carried through curve). A check standard(s) either from independent preparation ideally from a second lot or second source. 3. Is there information demonstrating that the method system suitability tests and controls as specified in the SMPR worked appropriately and as expected? If no, please specify. no 4. Based on the supporting information, is the method written clearly and concisely? If no, please specify the needed revisions. Not is all aspects: 1) in section A. Principle: says toxins are eluted with 100% methanol but later is written elution occurs with methanol then water. 2) ppb is used. This is ambiguous and should be changed to per g or per mL units 3 IV. General Submission Package IV. General Submission Package