Medical M Marijuan ana T Testing g Ad Adviso sory Cou y - - PowerPoint PPT Presentation

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

Heavy Metals

50 State Review

Heavy Metals

Member Submission of Colorado’s Current Limits:

Member Recommendations:

Heavy Metals

Metal Limit (ppm) Inhalable Other Arsenic 0.2 1.5 Cadmium 0.2 0.5 Lead 0.5 0.5 Mercury 0.1 3.0 Chromium 0.6 2.0

ADHS Note: Consider MI chromium limits, USP limits for all other elements and differing limits for inhalables vs. other products

These mirror Colorado’s prior limits and MD current limits based on ICH Guideline Q3D on Elemental Impurities Metal Limit (ppm) Arsenic ≤0.4 Cadmium ≤0.4 Lead ≤1.0 Mercury ≤0.2

Heavy Metals

• 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

Method Considerations

Pesticides, Fungicides, Herbicides, Growth Regulators

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

Oregon List and Limits

Pesticides, Fungicides, Herbicides, Growth Regulators

Pesticide Analysis and Proposal – Jennifer Corso

Pesticides, Fungicides, Herbicides, Growth Regulators See accompanying document: Arizona Proposed Pesticides

Member Feedback

Pesticides, Fungicides, Herbicides, Growth Regulators

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.

Member Recommendations

• Implement the Oregon list
• Implement the Colorado approved pesticide list
• 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

• r international standards that can meet the

method criteria from the EPA methods

Pesticides, Fungicides, Herbicides, Growth Regulators

Aflatoxins

Aflatoxins Member Information:

Aflatoxins

Microbiological Safety Testing of Cannabis

Aflatoxins

Cannabis Safety Institute – May 2015

Other Parameters –

Member Recommendations

Aflatoxins

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.

Potency Other Testing

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
• In dried flower harvest-batch sample
• In concentrates
• In infused products
• Limits
• Water activity ≤0.65 Aw passes
• 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

Potency Sample Collection and Storage

A.R.S. § 36-2803

• E. “Beginning November 1, 2020, before selling
• r 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

• 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.

Sample Collection

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
• f 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
• f 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

Sample Collection – Member Recommendation

Samples for test batches of regulated marijuana concentrate:

• A Licensee shall submit Samples of Regulated Marijuana Concentrate that has completed

all required steps and is in its final form. This includes the addition of all Ingredients and Additives.

• For Production Batches weighing up to one pound, a minimum of eight separate 0.25 gram

Samples must be combined into one 2 gram Sample and submitted as one Test Batch.

• For Production Batches weighing more than one pound and less than two pounds, a

minimum of 12 separate 0.25 gram Samples must be combined into one 3 gram Sample and submitted as one Test Batch.

• For Production Batches weighing two pounds or more but less than three pounds, a

minimum of 15 separate 0.25 gram Samples must be combined into one 3.75 gram Sample and submitted as one Test Batch.

• For Production Batches weighing three pounds or more but less than four pounds, a

minimum of 18 separate 0.25 gram Samples must be combined into one 4.5 gram Sample and submitted as one Test Batch.

• For Production Batches weighing four pounds or more but less than 10 pounds, a minimum
• f 23 separate 0.25 gram Samples must be combined into one 5.75 gram Sample and

submitted as one Test Batch.

• For Production Batches weighing 10 pounds or more, a minimum of 29 separate 0.25 gram

Samples must be combined into one 7.25 gram Sample and submitted as one Test Batch.

Sample Collection and Storage

Potency Sample Collection and Storage

• The samples should be transported under proper

chain of custody to the laboratory in a manner to prevent tampering, protect the samples from contamination and to maintain the samples in the same storage and temperature condition (e.g. frozen products) that the products are sold.

• The laboratory should document the sample’s integrity

upon receipt. This may include a photo of each sample to document sample condition upon receipt and for use in reporting.

• A unique laboratory number should be assigned to

each sample.

Sample Collection and Storage Considerations

Potency Sample Collection and Storage

Sample Collection and Storage Considerations

• The samples should be stored in the laboratory:
• Under proper security pursuant to ADHS

requirements to prevent tampering and theft;

• In a manner to protect the samples from

contamination pursuant to R9-17-409;

• From degradation (e.g. temperature condition

with frozen products) before testing in the condition products are sold; and

• After the samples have been opened for testing

they should be stored in zip top bags or other sealed containers to protect the opened samples.

Potency Sample Collection and Storage

• Ensure homogeneity of cannabinoids in edibles
• Methods to reduce latency in testing to

accommodate products with a short shelf life

Sampling Discussion - Other Identified Topics

Potency Reporting Results

Potency Reporting Results

• The laboratory should produce two distinct

reports:

• Technical Report
• Certificate of Analysis
• The laboratory’s technical report should also be

available from the dispensary for the patient upon request.

Reporting Results – ADHS Considerations

Potency Reporting Results

Example Certificate of Analysis

Potency Remediation

Potency Remediation

Testing Failures – Product Remediation by State

States Micro Solvents Metals Pesticides

Plant Material Concentrates & Extracts Plant Material Concentrates & Extracts Plant Material Concentrates & Extracts Plant Material Concentrates & Extracts

CO

X

MA

X1 X X X

MI

X X X X

OR

X1 X X X2 X3

1 Remediated material may only be used to derive other finished marijuana products (concentrates, resins, etc.) 2 Only for the analytes piperonyl butoxide or pyrethrins and only with approval from the regulatory body. 3 Only if the plant material used to process the finished product passed pesticide testing.

Potency Remediation

Summary of State Remediation Requirements

• MD, CA, and WA allow remediation but their rules are

unclear as to which contaminants/products may be remediated.

• OR sets timeframes for when remediation must take

place (i.e. within 30 days after approval for remediation has been granted).

• CA and MI do not allow contaminant remediation for

edibles and non-edible marijuana-infused products.

• All remediated products must be retested.

Potency Remediation

Remediation Considerations

• Any product that exceeds safety limits should be

quarantined while awaiting retesting and/or remediation results and clearly labeled by the dispensary.

• Remediated product should be treated as a new lot

but traceable by records to the original lot.

• All remediated products must be retested.

Potency Remediation

Remediation – Member Recommendation

Failed Analysis Product Type Action needed for retest Pesticides Flower, Extract/Concentrate Instruct initial lab to send portion of sample tested to 2 other labs for retest, inform labs of retest Or, Have 2 other labs resample and retest new samples, inform labs of retest Solvents Extract/Concentrate Re-process using procedures to reduce solvent concentrations Schedule resample and retest

• f remediated batch, inform

lab of retest Water Activity Flower Use flower to make extracts or concentrates Continue to dry or cure Schedule resample and retest

• f remediated batch, inform

lab of retest Microbiological Contaminant Flower Use flower to make extracts or concentrates, must use sterilization method Further process in a manner that effectively sterilizes the batch Schedule resample and retest

• f remediated batch, inform

lab of retest

Potency Retesting

Potency Retesting

Summary of State Retesting Requirements

• CA – Retesting in not allowed
• MA – One retest is allowed
• CO, MI – Two retests are required. MI prohibits

retesting if the product is in a final package.

• MD – Two retests by two different labs are required
• OR – If first retest passes, a second retest by a

different lab is required

• WA – Retesting for contaminant failures may be

authorized by the regulatory body. Potency retesting generally not authorized.

Potency Retesting

• If after a failed test a registrant wishes to have a sample reanalyzed:
• The registrant must request a reanalysis within 7 calendar days from the date

the laboratory sent notice of the failed test.

• The reanalysis must be completed by the laboratory within 30 days from the

date the reanalysis was requested.

• If a registrant requested a reanalysis and the sample passes:
• The registrant has 7 calendar days from the date the laboratory sent notice of

the passed test to request that another laboratory resample the batch and confirm the passing test result.

• The retesting must be completed by the second laboratory within 30 days from

the date the retesting was requested.

• The registrant needs to follow DHS instructions for reporting reanalysis and

subsequent testing results.

Retesting – Member Recommendation

(adapted from OR regulation – OAR 333-007-0450)

Potency Disposal

Potency Disposal

Disposal Considerations

• All medical marijuana waste generated during testing

should be stored in a secured and locked location prior to destruction or collection by a waste hauler in accordance with all applicable federal, state and local statutes, regulations, ordinances or other requirements.

• Proper documentation should be maintained for all

marijuana waste and marijuana waste removal.

• Labs should keep records for at least three years.

Potency Disposal

Disposal Considerations

Marijuana Waste not designated as hazardous should generally meet these requirements:

• Be removed from packaging and rendered “unusable

and unrecognizable.”

• Be incorporated with non-medical marijuana waste

such as non-consumable solid wastes

• Resulting mixture should be at least 50% non-

marijuana waste and should be placed in a secured waste receptacle

**Adapted from 2019 ESD/MWRA Solid Waste Technical Conference

Discussion:

• Additional items as necessary

Potency Other Items

Mile Markers, Testing Rollout, Patient Communication – Member Recommendation

• Create a “checklist” of necessary objectives (one for dispensaries and one for

testing labs) resulting from the recommendations made by the council, and the checklists should be accompanied by resources and a “help” number.

• For each upcoming deadline (accreditation, beginning of testing regulations,

when edible companies should begin testing products, etc.) ADHS should send communication detailing the upcoming deadline, how to achieve the desired

• bjective, and offering a “help call line” with an ADHS representative prepared to

walk dispensaries and testing laboratories through the process.

• Outreach/communication to medical marijuana patients from ADHS that details

the council’s recommendations, what ADHS is doing to meet those objectives, and any necessary contact information for patients if they have questions.

• Question - Should patients be warned about potential “gaps” in the process?

If so, we should be concerned about unnecessarily alarming patients.

• Any other necessary suggestions to successfully operationalize the council’s

recommendations with an emphasis on the patient communication?

Final Meeting: December 17, 2019

Adjourn