AOAC CASP SMPRs for Comment

1 DRAFT AOAC SMPR 2019.XXX; Version 4; July 7, 2019

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Method Name:

Standard Method Performance Requirements for Detection of Aspergillus in

Cannabis and Cannabis Products

Intended Use : 8 9 1. Purpose: AOAC Standard Method Performance Requirements SM (SMPRs) describe the minimum 10 recommended performance characteristics to be used during the evaluation of a method. The 11 evaluation may be an on-site verification, a single-laboratory validation, or a multi-site collaborative 12 study. SMPRs are written and adopted by AOAC stakeholder panels composed of representatives from 13 industry, regulatory organizations, contract laboratories, test kit manufacturers, and academic 14 institutions. AOAC SMPRs are used by AOAC expert review panels in their evaluation of validation 15 study data for method being considered for Performance Tested Methods SM or AOAC Official Methods 16 of Analysis SM and can be used as acceptance criteria for verification at user laboratories. [Refer to 17 Appendix F: Guidelines for Standard Method Performance Requirements , Official Methods of Analysis 18 of AOAC INTERNATIONAL (2019) 21 st Ed., AOAC INTERNATIONAL, Rockville, MD, USA.] Consensus-based Reference method.

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2. Applicability :

Candidate methods used to detect Aspergillus ( Aspergillus niger, Aspergillus fumigatus, Aspergillus flavus, and Aspergillus terreus) in cannabis (plants/flowers) and/or cannabis products (concentrates, infused edibles and infused non-edibles). Candidate methods may be validated for specific matrices, categories or broader claims. See Table 3 for matrix/category claim acceptance criteria.

3. Analytical Technique :

Any analytical technique that meets the method performance requirements is acceptable.

4. Definitions : 30 31 Acceptable minimum detection level (AMDL) . —The predetermined minimum level of an analyte, as 32 specified by an expert committee, which must be detected by the candidate method with an estimated 33 5% lower confidence limit on the probability of detection (POD) of 0.95 or higher. The AMDL is 34 dependent on the intended use. [ISO 16140-1:2016: Microbiology of the food chain—Method 35 validation—Part 1: Vocabulary] 36 37 Candidate Method . — The method submitted for validation [Appendix J: AOAC INTERNATIONAL 38 Methods Committee Guidelines for Validation of Microbiological Methods for Food and Environmental 39 Surfaces , Official Methods of Analysis of AOAC INTERNATIONAL , (2019) 21 st Ed., AOAC INTERNATIONAL, 40 Rockville, MD, USA] 41 42 Candidate Method Presumptive Result . —Preliminary result for a test portion produced by following a 43 candidate method’s instructions for use. 44 45 Candidate Method Confirmed Result . —Final result obtained for a test portion after cultural 46 confirmation of a candidate method.

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