Standards Quality Assurance 2 Cindy Orser Ph D

+ Standards & Quality Assurance 2 Cindy Orser Ph. D

+ 3 What are Standards? n Standards ensure product functionality and comparability n Standards verify the credibility of new products & markets n Standards fuel the development and implementation of technologies that influence the way we live, work and communicate. Cindy Orser Ph. D

+ 4 Quality Assurance Tests for Cannabis n Residual n Potency: n Residual n Heavy Moisture Cannabinoids & Terpenoids Pesticides Metals n Residual Solvents n Microbials n Mycotoxins Cindy Orser Ph. D

+ Cindy Orser Ph. D 5

+ 6 Confounding Issues n Marijuana is a Schedule 1 drug and not recognized as a useable commodity, food, or drug at the Federal level n States that allow marijuana must therefore devise their own regulations governing cannabis production, quality assurance n Environmental impacts associated with growing practices are mostly not addressed n Synthetic Cindy Orser Ph. D cannabinoids

+ 7 Pesticide Testing n 12 states require random samples of cannabis batches for pesticide residue n 2 states require testing only after a complaint n 2 states are not explicit in requiring testing n 3 states have adopted the most stringent acceptable standard for a pesticide residue on any food crop from 40 CFR 180 n Oregon arbitrarily deems a cut off at 0. 1 ppm n Nevada last week adopted 17 pesticides from Crop Group 19 Cindy Orser Ph. D

+ 8 Uniform Testing & Sampling for Cannabis Products n Flower gets all the attention for quality assurance testing n Concentrates should also be tested for pesticide residues as some pesticides concentrate along with the cannabinoids n Standardize n Create Cindy Orser Ph. D sampling parameters mechanism for validating assays

+ 9 Food Safety & Modernization Act (FSMA) n Enacted by President Obama in 2011 and enforced in 2015 n Allergic Foods n Prepared Foods n Medicinal Foods n Focus has now shifted from responding to contamination to preventing it n FDA is responsible under the Federal Food, Drug, and Cosmetic Act for enforcing tolerances established by the EPA for amounts of pesticide residues that may legally remain on food Cindy Orser Ph. D

+ 10 In Summary n The public and environment require uniform protections and quality assurances n Medical and recreational marijuana should both be subjected to the same quality assurance standards; only the dosing and packaging should vary. n It is time to have a national discussion to move toward a more unified approach to cannabis production, safety and quality assurance testing Cindy Orser Ph. D