FAQ | Administrative Order No. 4 | March 25, 2025

Administrative Order No. 4 was issued by the Cannabis Control Commission (Commission) on December 17, 2024 to ensure proper testing of Marijuana and Marijuana Products for patients and consumers, in accordance with the applicable Adult-use and Medical-use regulations.

Effective: April 1, 2025, this order will remain in effect until it is amended or rescinded by the Commission.

Guidance for Marijuana Establishments

Pursuant to this Order, Licensees can no longer submit multiple test samples to multiple Independent Testing Laboratories (ITLs), nor can Licensees split the tests for compliance panels amongst multiple ITLs. As of the effective date, one representative test sample will be submitted to one ITL for a complete compliance panel.

Guidance for ITLs

Originating ITLs may only accept one test sample package for every production batch and must complete all required compliance testing. In the event of a documented hardship, ITLs who seek to continue compliance testing during said hardship must request temporary approval from the Commission to subcontract compliance testing to another ITL. A single final COA will be generated by the originating ITL for each test sample, including test data and or results reported by the subcontracted ITL. At all times throughout the subcontracting period, the originating ITL is accountable for all reported results and is responsible for generating the final COA.

While the Metrc process for MEs remains unchanged, the Metrc guidance for ITLs has been updated to include step-by-step instructions in the Massachusetts Testing Facility User Guide on subcontracting functionality. This guidance is issued directly to ITLs by Metrc.

If approved to subcontract due to a hardship, Licensees must notify the Commission within five (5) business days of any substantial change in the documentation related to this request pursuant to 935 CMR 500.104(5) and 935 CMR 501.104(5). The Commission may rescind a hardship approval if there is a material change in the circumstances of the hardship request, or as necessitated by a change in the ITLs’ ability to compliantly perform testing under the subcontracting agreement(s) or for other reasons as determined by the Commission.

Frequently Asked Questions (FAQ)

1. What is hardship subcontracting?
   In cases of justified hardship, the originating ITL can request and receive approval from the Commission to subcontract one or more parts of compliance testing to another ITL.
2. How do ITLs request approval to subcontract?
   Licensees should email the Hardship Subcontracting Request Form to Testing@CCCMass.com and cc the ITL Lead. The subject line of the email should include ‘Hardship Subcontracting Request Form – [ITL’s name and License #]’. Additionally, all supporting documentation must be submitted in a single PDF file.
3. What conditions must be met for the Commission to approve an ITLs subcontracting request?
   1. The original ITL must notify the Commission and obtain approval by submitting a hardship subcontracting request form.
   2. The original ITL must provide an explanation and supporting documentation to substantiate the request. The Commission may request additional information it deems necessary to make a determination.
4. What are acceptable criteria for an ITL to subcontract?
   The Commission may approve subcontracting agreement requests when the Originating ITL is incapable of performing certain required tests due to a hardship relative to categories below:
   1. Facility hardships may include, but are not limited to:
      1. Natural disasters, fire, hazardous conditions, environmental factors (i.e., contamination risk, temperature controls).
   2. Instrumentation hardships may include, but are not limited to:
      1. ITL does not possess required equipment to perform specific test, Instrumentation break down, technical faults, calibration issues, outdated technology that does not meet the necessary requirements.
   3. Personnel hardships may include, but are not limited to:
      1. Insufficient staffing, lack of staff expertise/knowledge, incomplete training or certifications.
   4. Consumable Materials hardships may include, but are not limited to:
      1. Supply chain shortages, quality of materials available.
   5. Conflict of interest hardships may include, but are not limited to:
      1. Financial interests, consulting agreements, contractual agreements or legal disputes.
5. What conditions must be met before subcontracting can be approved?
   The originating ITL must submit a hardship Subcontracting Request Form and meet one or more conditions identified in question #4. In the ITL’s hardship Subcontracting Request Form, the ITL must adequately detail the circumstances leading to the hardship, state the specific corrective step(s) to be taken to resolve the hardship, a timetable for such steps, and the estimated date by which full testing capabilities will be restored. The timetable and the dates must be in the most expeditious manner possible and include measures to mitigate future hardships.
6. Can the Originating ITL subcontract R&D tests?
   The administrative order is applicable to compliance testing requirements. All test samples received during or held at the origination of the hardship period must be tested by the subcontracting ITL for the test(s) the originating ITL is incapable of performing.
7. Does this Administrative Order impact Retesting?
   No, retesting will follow the same process as defined in 935 CMR 500.160(13) and 935 CMR 501.160(12).
8. If the product fails at the subcontracting ITL, are Licensees permitted to retest the product?
   Yes, the Licensee must create a new test sample and resubmit the test sample to the originating ITL. The originating ITL must use the same subcontracting ITL that conducted the initial panel for retests if the subcontracting agreement is still in place. In the event the retesting occurs after the subcontracting period, the test sample must be submitted to the originating ITL to complete the retest panel. The second confirmatory test cannot be performed by either the originating ITL or the subcontracted ITL, in accordance with 935 CMR 500.160(13) and 935 CMR 501.160(12).
9. Can the originating ITL subcontract to multiple ITLs for testing services?
   No, the originating ITL can only subcontract with one other ITL at a time during each approved hardship period. However, the originating ITL does not have to use the same subcontracted ITL for future approved hardships.
10. Can Licensees submit additional test sample material if requested by either the originating or subcontracted ITL?
    The ITL should not accept any test sample packages that lack sufficient test material for a complete test panel. If such a package is received, the ITL should reject it and request that the ME resubmit the necessary amount of test material. If additional test material is needed, the ME must notify the ITL lead Lab or Testing@CCCMass.com before creating a new test sample package.
11. Can Licensees create multiple test sample packages from the same Marijuana or Marijuana Product source package?
    No, Licensees cannot create multiple test sample packages from the same source package for compliance testing requirements.
12. Which ITL can a Licensee use to test their sample?
    Any Commission-licensed ITL can be used for compliance testing.
13. Are Licensees required to use one ITL for all compliance testing?
    All compliance testing for each test sample must be performed by one ITL. For example, a Licensee may choose to engage with one ITL for all compliance testing for flower products and another ITL for all edibles.

    Please note that all restrictions relative to subcontracting discussed above apply if the ITL has an approved subcontracting agreement.

14. How does the originating ITL transfer test samples to the subcontracting ITL?
    The originating ITL will create and submit a subset test sample and any relevant documentation to the subcontracted ITL after Commission approval. The original ITL will generate a transfer manifest and facilitate the transfer of test samples to the subcontracted ITL.
15. What are acceptable forms of supporting documentation when submitting a Subcontract Request Form?
    An ITL should submit any documentation necessary to support its request.
16. Can subcontracted testing be used for individual assays within each category of contaminant tests?
    No, subcontracted testing must be completed on all contaminant types per category (e.g., Heavy Metals category consist of 4 contaminant types- cadmium, arsenic, lead and mercury).