Medical M Marijuan ana T Testing g Ad Adviso sory Cou y Counci cil December 10, 2019
Council’s Charge
A.R.S. §36-2821(B) The MMJ Testing Advisory Council shall make recommendations…regarding: • Establishing a required testing program • Testing and potency standards • Procedural requirements for collection, storing, and testing • Reporting results to patients and the Department • Remediation and disposal requirements • Additional items as necessary
Discussion/recommendations of testing and potency standards
NOTE: The following slides are intended as a starting point for Council discussion based on information presented at the initial Council meeting on 9/26/19 and updated based subsequent meetings and recommedations by Council members.
Heavy Metals
50 State Review Heavy Metals
Member Submission of Colorado’s Current Limits: Heavy Metals
ADHS Note: Consider MI Member chromium limits, USP limits for Recommendations: all other elements and differing limits for inhalables vs. other These mirror Colorado’s prior limits and MD current limits based on ICH products Guideline Q3D on Elemental Impurities Metal Limit (ppm) Inhalable Other Metal Limit (ppm) Arsenic 0.2 1.5 Arsenic ≤0.4 Cadmium ≤0.4 Cadmium 0.2 0.5 Lead ≤1.0 Lead 0.5 0.5 Mercury ≤0.2 Mercury 0.1 3.0 Chromium 0.6 2.0 Heavy Metals
Method Considerations ● Metals testing can be conducted using any national, international or in-house method that is validated by AOAC Appendix K or other federal or international standards that can meet the method criteria from the EPA methods Heavy Metals
Pesticides, Fungicides, Herbicides, Growth Regulators
Available at https://www.oregon.gov/oha/ph/Pr eventionWellness/marijuana/Docu ments/oha- 8964 -technical-report- marijuana-contaminant-testing.pdf Pesticides, Fungicides, Herbicides, Growth Regulators
Pesticides, Fungicides, Herbicides, Growth Regulators
Oregon List and Limits Pesticides, Fungicides, Herbicides, Growth Regulators
Pesticide Analysis and Proposal – Jennifer Corso See accompanying document: Arizona Proposed Pesticides Pesticides, Fungicides, Herbicides, Growth Regulators
Member Feedback Reported as difficult to test: Acequinocyl: Half life when in contact with H2O is about 24 ● hrs. Not really a bad responder, it just disappears in the QC as the sequence is running Carbaryl: Another low responder ● Chlorfenapyr : Very low responder. Really hard to see at lower ● levels. Daminozide: Same as above. Not really a pesticide but more of a ● preservative. Fipronil: A little tricky at lower levels. ● Imazalil: Another low responder. ● Methyl Parathion: Another low responder. ● Phosmet : Similar to Acequinocyl but half life is about 1/3 longer. ● Pyrethrins: Tough to pick out of baseline at lower levels. ● Pesticides, Fungicides, Herbicides, Growth Regulators
Member Recommendations ● Implement the Oregon list ● Implement the Colorado approved pesticide list o Rationale – Arizona Department of Agriculture has adapted this state’s list for the Hemp program. (ADHS Note: Colorado list does not have growth regulator or herbicide – Colorado recommended to ADHS not adopting their list because they believe it is inadequate. Colorado has had to use Executive Orders and Emergency Rule making to make up for the short list) Pesticides, Fungicides, Herbicides, Growth Regulators
Method Considerations ● Testing can be conducted using any national, international or in-house method that is validated by AOAC Appendix K or other federal or international standards that can meet the method criteria from the EPA methods Pesticides, Fungicides, Herbicides, Growth Regulators
Aflatoxins
Member Information: Aflatoxins
Microbiological Safety Testing of Cannabis Aflatoxins
Cannabis Safety Institute – May 2015 Aflatoxins
Other Parameters – Member Recommendations No testing for aflatoxins. These would be at least partly degraded by the heat of smoking or decarboxylation, if present. Seedless cannabis plants are not capable of supporting aflatoxin production, because they lack the high oil content necessary for A. flavus replication. Aflatoxins
Other Testing Potency
Terpenes – Member Recommendation ● Any terpene claims made by a product's label, must be verified by terpene analysis ● Data must be present on certification of analysis (COA) and handed out to every patient at time of purchase Other Testing
Water Activity – Member Recommendation ● Test for water activity o In dried flower harvest-batch sample o In concentrates o In infused products ● Limits o Water activity ≤0.65 Aw passes o Water activity >0.65 Aw fails must be remediated Rationale Water activity vs. moisture content: While moisture content simply defines the amount of water in bud, concentrates, food and ingredients, water activity defines how the water in your food will react with microorganisms. The higher the water activity, the faster microorganisms like bacteria, yeast, and mold will be able to grow. Other Testing
Filth and Foreign Material – Member Recommendation ● Use CA § 5325 for definition of “filth and foreign material” Includes but not limited to hair, insects, feces, packaging contaminants, and manufacturing waste and by-products. ● Sample passage levels: ○ Mold or foreign material – Average of ≤5%, by weight ○ Mammalian excreta – Average of ≤1mg per pound Other Testing
Presentation/Discussion: • Sample Collection & Storage • Reporting Results • Remediation • Disposal
Potency Sample Collection and Storage
A.R.S. § 36-2803 E. “Beginning November 1, 2020, before selling or dispensing marijuana or marijuana products to registered designated caregivers, nonprofit medical dispensaries shall test marijuana and marijuana products for medical use to determine unsafe levels of microbial contamination, heavy metals, pesticides, herbicides, fungicides, growth regulators and residual solvents and confirm the potency of the marijuana to be dispensed.” Potency Sample Collection and Storage
Sample Collection • ARS 36-2803(E) requires testing finished products only. • The dispensary should have a Sampling Plan SOP. • The dispensary sampler should collect a representative random sample from each batch or lot of the final, ready-for-sale product that is adequate to perform the required testing (e.g. at least 5g/lb. of flower). • 5% of samples submitted by the dispensary should be collected in duplicate rotating the type of sample over time to include all sold products. • Appropriate sample information should be documented into the dispensary’s inventory control system and on the trip plan. Potency Sample Collection and Storage
Sample Collection – Member Recommendation Base sampling plan on Colorado regulations: ● Unless a greater amount is required to comply with these rules, each test batch of regulated marijuana must be comprised of at least the following number of separately taken samples, which must be submitted for testing in all required testing categories: Sample Collection and Storage
Sample Collection – Member Recommendation Samples for test batches of regulated marijuana: ● For Harvest Batches weighing up to 10 pounds, a minimum of eight separate 0.5 gram Samples must be combined into one 4 gram Sample and submitted as one Test Batch. ● For Harvest Batches weighing more than 10 pounds but less than 20 pounds, a minimum of 12 separate 0.5 gram Samples must be combined into one 6 gram Sample and submitted as one Test Batch. ● For Harvest Batches weighing 20 pounds or more but less than 30 pounds, a minimum of 15 separate 0.5 gram Samples must be combined into one 7.5 gram Sample and submitted as one Test Batch. ● For Harvest Batches weighing 30 pounds or more but less than 40 pounds, a minimum of 18 separate 0.5 gram Samples must be combined into one 9 gram Sample and submitted as one Test Batch. ● For Harvest Batches or weighing 40 pounds or more but less than 100 pounds, a minimum of 23 separate 0.5 gram Samples must be combined into one 11.5 gram Sample and submitted as one Test Batch. ● For Harvest Batches weighing 100 pounds or more, a minimum of 29 separate 0.5 gram Samples must be combined into one 14.5 gram Sample and submitted as one Test Batch. Sample Collection and Storage
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