935 CMR, § 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;
and
2. 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).
Notes
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