AOAC CASP Meeting

MICROBIAL TESTING METHOD CHALLENGES

Consistent Challenges from State to State

Questions and Possible Solutions

• Varying sample sizes

• Statistical relevance

• 1 g (US) 10 g or 25 g (Canada)

• Too few, too small, and not random • What is representative?

• Short Laboratory Turnaround Times • Time and cost associated • Proper training and education

• Microbial Testing Methods:

• Traditional plating (1-2 wks) • Rapid plating (2-4 days) • Molecular Methods (1-3 days)

• Enumerable product types released to the market • How to handle the ever-growing infused products

• Matrix Challenges: • Flower

• Oil/concentrates • Edibles

• Lack of standardized industry testing conventions: • Assay verification • Assay validation • Certified reference materials

• Lack of standardized industry testing conventions: • Regulators need to be clear when stating what will be accepted for assay verification • Certified reference materials need to be validated prior to being sent out as a PTM test • Start working with federal agencies on standards

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STANDARDIZED TESTING, VERIFICATION AND VALIDATION OF METHODS AND MATERIALS

Problem

• There is wide variability, from laboratory to laboratory, in terms of analytical chemistry results (Bonn-Miller et al 2017) and microbiological testing results (unpublished observation). • This is leading to cultivators and distributors shopping around from lab to lab to “pass” products. Causes of Problem Possible Solutions Lack of standard methods • We are starting to address this here at AOAC CASP working groups Sample Inhomogeneity • This will vary depending on the matrix type. • Flower and Edibles might be difficult to get truly homogenous samples, but oils and concentrates might be more consistent. • Test multiple aliquots and average the results for statistical significance Lack of Appropriate Standards • The National Institute of Standards and Technology (NIST), issues reference materials for industry. • Challenges federally for cannabis but with hemp legalized we might begin to see changes. • How do we engage in this process? Sample Preparation Variability • Set a standard across the states for sample preparation and how to homogenize that would align with micro and molecular techniques.

Human Error

• Can be limited with proper training and education

Lack of Proper Training

• Educational courses are being discussed and developed through AOAC • The burden will fall on the testing labs as well as the assay development companies

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