Bulletin | Recommendations for Consideration: Testing of Marijuana and Marijuana Products Protocol

Massachusetts Cannabis Control Commission Testing Protocol Recommendations – Package 1

The below recommendations from the Testing Department within the Investigations and Enforcement Division remain subject to change as the agency’s review process proceeds.

Focus Area 1: Microbial Testing Technique Standardization

Recommendation 1: Independent Testing Laboratories (“ITL”) to follow most recently published manufacturer’s protocols.

Require ITLs to follow validated manufacturer protocols for microbial tests. ITLs must obtain a sufficient amount of Marijuana test sample material to conduct analysis as stated per the manufacturer’s analytical testing methodologies and procedures.

All method development for product testing must include a documented validation and suitability determination process that aligns with and is according to the recommendations set forth in USP chapters 1223 and 1227.

Recommendation 2: ITLs to report species inclusivity/exclusivity lists for methods used to the Commission.

Require all ITLs to provide the Commission with a validated species inclusivity/exclusivity list for the methodologies ITLs propose.

Focus Area 2: Recalls

Recommendation 3: Recommendation regarding lab supply manufacturer recalls & protocol updates (recalls initiated by third party manufacturers).

In the event of a manufacturer recall, ITLs shall discontinue use of any recalled materials and/or implement the recommended process by the manufacturer. The ITL shall immediately initiate a recall response process. The ITL shall notify the Commission within 72 hours (3 business days) of an ITL’s receipt of notification from the manufacturer related to a recall.

Recommendation 4: Enhance regulations regarding Marijuana and Marijuana Product recalls initiated by the Commission.

Require all Licensees to maintain written policies and procedures for initiating, managing, and documenting voluntary and mandatory recalls of Marijuana and Marijuana Products.

Specify that those policies and procedures must address, at minimum, the following:

• Identification of responsible party for each step of the procedure;
• Process for notifying the Commission immediately, and consumers, patients and the public expeditiously;
• Success monitoring protocol;
• Process for identification of impacted products with Metrc tags;
• Process for identifying date ranges when impacted products were sold;
• Process for identifying original product manufacturer; and
• Process to remove defective products from inventory.

Focus Area 3: Reporting Standardization

Recommendation 5: Too Numerous to Count Result Handling

Upon an ITL determination that a test result is “too numerous to count” (“TNTC”), the ITL shall follow the producers’/manufacturers’ protocols (i.e., diluting the sample) in order to obtain a reportable value.

Recommendation 6: ‘Not detected’ Result Reporting

Upon determination that a test result is “Not Detected” (“ND”), ITLs shall report “0” in the “Result” field in the Commission’s seed-to-sale system of record (“SOR”), Metrc, in addition to a required and standardized note in the Metrc “Note” field stating “ND, LOD = X” with the X being the method’s Limit of Detection (“LOD”), for each test.

Recommendation 7: ‘Below quantifiable limit’ Result Reporting

Upon determination that a test result is “below quantification limit” (“BQL”), ITLs shall report “0” in the “Result” field of the Commission’s seed-to-sale SOR, Metrc, in addition to a required and standardized note in the Metrc “Note” field stating “BQL, LOQ = X” with the X being the method’s Limit of Quantification (“LOQ”) for each test.

Focus Area 4: Sampling & Analysis Updates

Recommendation 8: Sub-sampling representativeness.

Specify that sub-samples used for tests must be representative of the entire test sample received. Require all test samples received by an ITL to be homogenized prior to sub-sample creation as applicable, unless otherwise specified by the manufacturer.

Recommendation 9: Clarification of retest criteria.

Conditions for Re-testing:

Scenario #1 (Quality Control Issue): Specify that ITLs may only perform reanalysis or retesting as a result of a documented quality control issue (e.g., process and handling error, method deviation, or non-conforming work). The internal retest(s) must be performed using the same standard operational procedure as the initial test. The recorded documentation of the issue or event must be made available to the Commission upon request.

Scenario #2 (Post-Failure): Specify that a new Marijuana test sample submitted by a Licensee for testing due to failure of the initial sample must be reanalyzed using the same technique as the first sample that was tested. Specify that the same technique is to be used by both the ITL that initially failed the product and the ITL that performs the second confirmatory screen.

Recommendation 10: Immediate data upload.

Require initial reportable test results to be uploaded in the Commission’s seed-to-sale SOR, Metrc immediately, but no later than 48 hours (2 business days), by an ITL.

ITLs shall not communicate test results to Licensees until those results have been uploaded to the Commissions SOR.

Recommendation 11: The Commission may require additional testing.

Highlight that the Commission has the authority to require additional tests.

Highlight that the Commission reserves the right to require root cause analysis for repeat failures, at the Commission’s discretion.

Recommendation 12: Final form testing for raw pre-rolls.

Require final form testing to be completed for raw Marijuana pre-rolls.

Recommendation 13: Incorporate language from Administrative Order #4.

Incorporate the requirements of Administrative Order #4 (“AO#4”) into the Testing Protocol for clarity and efficiency.

Focus Area 5: Pesticides

Recommendation 14: Update the Pesticides section for clarity and consistency with MDAR

Incorporate updates to the Pesticides Section of the Testing Protocol for clarity and consistency with MDAR’s statutory authority.