AOAC CASP Meeting

IN THE ABSENCE OF THE FDA/USDA……… CANNABIS REGULATIONS ARE BEING CREATED STATE BY STATE

Wide variability in microbial testing regulations, verification and validation from state to state, both qualitative and quantitative.

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What are the Minimum Standards for Safety?

• Different states have set different standards for public safety • Guidelines taken from – USP,USDA botanicals, tobacco, AHP, APHL etc. are not necessarily in line with cannabis research • Microbial regulations vary greatly due to this lack of research • Research into proper microbial regulations • What are the correct microbial failure levels? • Should those be the same for all matrix types? • What research has been done to demonstrate the levels that should constitute a fail? • How can labs and regulators work together to answer these questions? • Establish consistent standards to protect consumers no matter their zip code! • Strive to create standards that are recognized and accepted by all states • Standardizing regulations state by state will help when the Federal Government steps into Cannabis

Material

Total Aerobic

Bile Tolerant Gram Negative

Total Yeast and Mold

Absence of Specific Organism in 1 g or mL S. aureus, and P. aeruginosa E. coli in 10 g; Salmonella spp. in 25 g E. coli in NMT 10; Salmonella spp. E. coli in 1 g; Salmonella spp. in 10 g E. coli and Salmonella spp. in 10 g

Dry Powder Inhalation (USP 111)

NMT 10 2

Absent

NMT 10 1

Dried, unprocessed herbs in dietary supplement (AHPA)

10 7

10 5

10 4

Plant material for internal use (WHO)

10 5

10 3

10 3

Finished botanical product ( Ph. Eur.)

10 4

10 2

10 2

Dried or powdered botanicals (USP)

10 5

10 3

10 3

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