Me Medica cal Ma Marijuana Te Testing Advisor Advisory Council - - PowerPoint PPT Presentation

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Oct 21, 2023 564 likes •883 views

Me Medica cal Ma Marijuana Te Testing Advisor Advisory Council Council October 24, 2019 Councils Charge A.R.S. 36 2821(B) The MMJ Testing Advisory Council shall make recommendationsregarding: Establishing a required testing

SLIDE 1

Me Medica cal Ma Marijuana Te Testing Advisor Advisory Council Council

October 24, 2019

SLIDE 2

Council’s Charge

SLIDE 3

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

SLIDE 4

Review of timeline and steps for lab certification

SLIDE 5

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

SLIDE 6

Review of current lab testing practices – Tabitha Hauer

SLIDE 7

Discussion/recommendations of testing and potency standards

SLIDE 8

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.

SLIDE 9

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?

SLIDE 10

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

SLIDE 11

Microbial Contamination

SLIDE 12

E. coli Considerations

Microbial Contamination

SLIDE 13

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

SLIDE 14

Methods

Use Bacteriological Analytical Manual (FDA

2013a) and validated by AOAC Appendix J

Microbial Contamination

SLIDE 15

Additional Discussion Microbial Contamination

Any other parameters for testing?
Any other method options for testing?

SLIDE 16

Heavy Metals

SLIDE 17

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

SLIDE 18

Metal Limit (ppm) Method Inhalable Other Arsenic 0.2 1.5

Any FDA/USP

r in-house

developed method that is validated by AOAC Appendix K and can meet the method criteria from the EPA methods

Cadmium 0.5 0.5 Lead 0.5 0.5 Mercury 0.1 3.0 Chromium 0.6 2.0

Heavy Metals

SLIDE 19

Additional Discussion

Any other parameters for testing?
Any other method options for testing?

Heavy Metals

SLIDE 20

Pesticides, Fungicides, Herbicides, Growth Regulators

SLIDE 21

Considerations

Utilize Oregon’s list of parameters plus at least
ne 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

SLIDE 22

Oregon List and Limits

Pesticides, Fungicides, Herbicides, Growth Regulators

SLIDE 23

Additional Discussion

Any other parameters for testing?
Any other method options for testing?

Pesticides, Fungicides, Herbicides, Growth Regulators

SLIDE 24

Residual Solvents

SLIDE 25

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

SLIDE 26

Oregon List and Limits Residual Solvents

SLIDE 27

Additional Discussion

Any other parameters for testing?
Any other method options for testing?

Residual Solvents

SLIDE 28

Potency Potency

SLIDE 29

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

SLIDE 30

Additional Discussion

Set limits for THC, CBD, and/or CBC levels?
Any other method options for testing?