Me Medica cal Ma Marijuana Te Testing Advisor Advisory Council Council October 24, 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
Review of timeline and steps for lab certification
Lab Certification Process ● Administrative Review (30 days) ○ NOD or Notification of Admin Complete ■ Lab has 90 days to respond to an NOD ● Substantive Review (60 days) ○ RFI ■ Lab has 10 days to respond to an RFI ○ Inspection ■ SOD and POC
Review of current lab testing practices – Tabitha Hauer
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.
Key Discussion Points ● What parameters should be tested for within each category? ● What is the safety level before a product must be remediated or disposed? ● What test method options should be used?
Considerations for Discussion ● Statutory intent is to detect “unsafe levels” and confirm potency ● What framework should guide setting action levels? Variable? Protective for children? For immunocompromised? ● Consider requiring existing methods OR in- house developed methods meeting method criteria of previously validated methods
Microbial Contamination
E. coli Considerations Microbial Contamination
Aspergillus Considerations ● Option: Test for Aspergillus flavuus, fumigatus, niger, terreus ○ If positive, product cannot be sold OR ○ If positive, product cannot be sold in an inhalable form ● Option: Do not test; label inhalables with a warning that they may contain Aspergillus Microbial Contamination
Methods ● Use Bacteriological Analytical Manual (FDA 2013a) and validated by AOAC Appendix J Microbial Contamination
Additional Discussion ● Any other parameters for testing? ● Any other method options for testing? Microbial Contamination
Heavy Metals
Considerations ● Varying limits based on method of consumption ○ Inhalable ○ Other ● Any FDA/USP or in-house developed method that is validated by AOAC Appendix K and can meet the method criteria from the EPA methods Heavy Metals
Metal Limit (ppm) Method Inhalable Other Arsenic 0.2 1.5 Any FDA/USP or in-house developed Cadmium 0.5 0.5 method that is validated by Lead 0.5 0.5 AOAC Appendix K Mercury 0.1 3.0 and can meet the method criteria from the Chromium 0.6 2.0 EPA methods Heavy Metals
Additional Discussion ● Any other parameters for testing? ● Any other method options for testing? Heavy Metals
Pesticides, Fungicides, Herbicides, Growth Regulators
Considerations ● Utilize Oregon’s list of parameters plus at least one herbicide. ● Utilize Oregon’s safety limits and the USP limits for herbicides. ● Utilize any AOAC or in-house developed method that is validated by AOAC Appendix K and can meet the method criteria from the EPA methods. Pesticides, Fungicides, Herbicides, Growth Regulators
Oregon List and Limits Pesticides, Fungicides, Herbicides, Growth Regulators
Additional Discussion ● Any other parameters for testing? ● Any other method options for testing? Pesticides, Fungicides, Herbicides, Growth Regulators
Residual Solvents
Considerations ● Utilize Oregon’s list of parameters ● Utilize Oregon’s safety limits ● Any EPA, AOAC, or in-house developed method that is validated by AOAC Appendix K and can meet the method criteria from the EPA methods Residual Solvents
Oregon List and Limits Residual Solvents
Additional Discussion ● Any other parameters for testing? ● Any other method options for testing? Residual Solvents
Potency Potency
Considerations ● Create an Arizona cannabinoid list that includes the acid forms: THCa, CBDa, CBCa ● Test the cannabinoid list by AHP or in-house methods that are validated by AOAC Appendix K and can meet the method criteria from the EPA methods Potency
Additional Discussion ● Set limits for THC, CBD, and/or CBC levels? ● Any other method options for testing? Potency
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