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

III. Review of Information in Support of the Method III. Review of Supporting Information 1. Are the definitions specified in the SMPR used and applied appropriately in the supporting documentation (manuscripts, method studies, etc...)? If not, please explain the differences and if the method is impacted by the difference. Yes. I am speaking of the SLV study as published in "Food Additives and Contaminants". In particular, inter- and intra-day operative conditions have been described in detail, as expected. 2. Is there information demonstrating that the method meets the SMPR Method Performance 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. The “protocol” document states that there are not available reference materials. On the other hand, the use of spiking protocol allows the method to meet the SMPR Method Performance Requirements by means of in-house reference materials. 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. With reference to the already published SLV document, all supporting data (recovery, LOQ, LOD, RSDr) are shown in Tables 5, 6, and 7. In particular, please note the remarkable performance with relation to LOQ and LOD when speaking of ochratoxin, aflatoxin B1, and total aflatoxins. IV. General Submission Package IV. General Submission Package 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. Yes. According to the SMPR (System Suitability Tests and/or Analytical Quality Control), suitable methods will include blank check samples and check standards at the lowest point and midrange point of the analytical range. Appropriate tests have been carried out as demonstrated in Tables 3 to 6. 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. Yes. Suitable methods have to include blank check samples and check standards at the lowest point and midrange point of the analytical range. Appropriate tests have been carried out as demonstrated in the “Results and Discussion” section of SLV, and in Tables 3 to 6. 4. Based on the supporting information, is the method written clearly and concisely? If no, please specify the needed revisions. The method (in the SLV document) is written clearly and concisely. However, it needs to be formatted according to AOAC Guidelines. 5. Based on the supporting information, what are the pros/strengths of the method? Generally speaking, good specificity with sensitivity, recovery, and precision. Excellent performance when speaking of LOQ and LoD results. It is a good and simple routine method for screening of cannabis and cannabis products.

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