AOAC CASP Meeting

Responsible Microbial Testing Policy in Cannabis – Challenges and Future Outlook

AOAC CASP Meeting September 7, 2019

Benjamin A Katchman, PhD. Principal Scientist, PathogenDx

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PRESENTATION OUTLINE

• Regulatory Challenges: • Validation and/or verification of State regulations for microbial assays

• Rapid regulatory changes and limited resources • Regulators and laboratories working together • Evidence based regulations • Challenges for Assay Designers and Laboratories: • Standardized Testing Materials • Broad matrices and broad organisms

• How to standardize reference material prior to federal oversight? • Method Acceptance, Verification and Validation • Currently most labs have discordant methods and cut-offs leading to wide variability in pass/ failure rates even on the same samples • Unclear verification guidance from state to state • Education and Training (Research) • Training on microbiology and molecular biology techniques

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