Current through Register 1536, December 6, 2024
Section 501.160 - Testing of Marijuana and Marijuana Products(1) No Marijuana Product, including Marijuana, may be sold or otherwise marketed for medical use that is not capable of being tested by Independent Testing Laboratories, except as allowed under 935 CMR 501.000. Testing of Marijuana Products shall be performed by an Independent Testing Laboratory in compliance with a protocol(s) established in accordance with M.G.L. c. 94G, § 15 and in a form and manner determined by the Commission including, but not limited to, the Protocol for Sampling and Analysis of Finished Marijuana and Marijuana Products for Marijuana Establishments, Medical Marijuana Treatment Centers and Colocated Marijuana Operations. Testing of environmental media (e.g., soils, solid growing media, and water) shall be performed in compliance with the Protocol for Sampling and Analysis of Environmental Media for Massachusetts Registered Medical Marijuana Dispensaries published by the Commission.(2) Marijuana and Marijuana Products shall be tested for the Cannabinoid profile and for contaminants as specified by the Commission including, but not limited to, mold, mildew, heavy metals, plant growth regulators, and the presence of Pesticides. The Commission may require additional testing. In addition to these contaminant tests, final ready-to-sell Marijuana Vaporizer Products shall be screened for heavy metals and Vitamin E Acetate (VEA) in accordance with the Protocol for Sampling and Analysis of Finished Marijuana and Marijuana Products for Marijuana Establishments, Medical Marijuana Treatment Centers and Colocated Marijuana Operations issued by the Commission.(3) The Commission may, at its discretion, require additional testing where necessitated to safeguard public health or safety and so identified by the Commission.(4) An MTC shall have a written policy for responding to laboratory results that indicate contaminant levels are above acceptable limits established in the protocols identified in 935 CMR 501.160(1). Such policy shall be available to Registered Qualifying Patients and Personal Caregivers. (a) Any such policy shall include: 1. Notifying the Commission within 72 hours of any laboratory testing results indicating that the contamination cannot be remediated and disposing of the Production Batch submission of any information regarding contamination immediately upon request by the Commission; and2. Notifying the Commission of any information regarding contamination as specified by the Commission or immediately upon request by the Commission.(b) The notification shall be from both the MTC and the Independent Testing Laboratory, separately and directly.(c) The notification from the MTC shall describe a proposed plan of action for both the destruction of the contaminated product and the assessment of the source of contamination.(5) An MTC shall maintain the results of all testing for no less than one year. Testing results shall be valid for a period of one year. Marijuana and Marijuana Products with testing dates in excess of one year shall be deemed expired and may not be dispensed, sold, Transferred or otherwise conveyed until retested.(6) The sale of seeds is not subject to these testing provisions.(7) Clones are subject to these testing provisions, but are exempt from testing for metals.(8) All transportation of Marijuana and Marijuana Products to and from Independent Testing Laboratories providing Marijuana testing services shall comply with 935 CMR 501.105(13).(9) All storage of Marijuana and Marijuana Products at a laboratory providing Marijuana testing services shall comply with 935 CMR 501.105(11).(10) All excess Marijuana and Marijuana Products shall be disposed of in compliance with 935 CMR 501.105(12), either by the Independent Testing Laboratory returning excess Marijuana or Marijuana Products to the source MTC for disposal or by the Independent Testing Laboratory disposing of it directly;(11) No Marijuana or Marijuana Product shall be sold or otherwise marketed for adult use that has not first been tested by an Independent Testing Laboratory and deemed to comply with the standards required under 935 CMR 501.160; and(12) A Licensee that receives notice that Marijuana or a Marijuana Product it has submitted for testing has failed any test for contaminants shall either reanalyze the Marijuana or Marijuana Product without remediation, take steps to remediate the identified contaminants or dispose of the Marijuana or Marijuana Product. (a)Reanalysis by a Second ITL. If the Licensee chooses to reanalyze the sample, a sample from the same batch shall be submitted for reanalysis at the ITL that provided the initial failed result. If the sample passes all previously failed tests at the initial ITL, a sample from the same batch previously tested shall be submitted to a second ITL other than the original ITL for a Second Confirmatory Test. To be considered passing and therefore safe for sale, the sample shall have passed the Second Confirmatory Test at a second ITL. Any Marijuana and Marijuana product that fails the Second Confirmatory Test may not be sold, transferred or otherwise dispensed to Consumers, Patients or Licensees without first being remediated. Otherwise, the MTC shall dispose of any such product.(b)Remediation. If the Licensee chooses to remediate, a new test sample shall be submitted to any licensed ITL, which may include the initial ITL, for a full-panel test. Any failing Marijuana or Marijuana product may be remediated a maximum of two times. Any Marijuana or Marijuana product that fails any test after the second remediation attempt may not be sold, transferred or otherwise dispensed to Consumers, Patients or Licensees. The MTC shall dispose of any such product.(c) If the Licensee chooses to dispose of the Marijuana or Marijuana Products, it shall do so in compliance with 935 CMR 501.105(12).Adopted by Mass Register Issue 1403, eff. 11/1/2019.Amended by Mass Register Issue 1434, eff. 1/8/2021.Amended by Mass Register Issue 1436, eff. 1/8/2021.Amended by Mass Register Issue 1441, eff. 1/8/2021.Amended by Mass Register Issue 1507, eff. 10/27/2023.