Connecticut Administrative Code › Title 21a - Consumer Protection › 408 - Palliative Use of Marijuana › Section 21a-408-60 - Laboratory testing

Current through July 10, 2024
(a) Immediately
			 prior to manufacturing any marijuana product or packaging raw marijuana for
			 sale to a dispensary, a producer shall segregate all harvested marijuana into
			 homogenized batches.
(b) A producer
			 shall make available each such batch at the production facility for a
			 laboratory employee to select a random sample. The laboratory shall test each
			 sample for microbiological contaminants, mycotoxins, heavy metals and pesticide
			 chemical residue, and for purposes of conducting an active ingredient
			 analysis.
(c) From the time that a
			 batch of marijuana has been homogenized for sample testing and eventual
			 packaging and sale to a dispensary facility, until the laboratory provides the
			 results from its tests and analysis, the producer shall segregate and withhold
			 from use the entire batch of marijuana, except the samples that have been
			 removed by the laboratory for testing. During this period of segregation, the
			 producer shall maintain the marijuana batch in a secure, cool and dry location
			 so as to prevent the marijuana from becoming contaminated or losing its
			 efficacy. Under no circumstances shall a producer include marijuana in a
			 marijuana product or sell it to a dispensary facility prior to the time that
			 the laboratory has completed its testing and analysis and provided those
			 results, in writing, to the producer or other designated production facility
			 employee.
(d) A laboratory shall
			 immediately return or dispose of any marijuana upon the completion of any
			 testing, use, or research. If a laboratory disposes of marijuana, the
			 laboratory shall comply with section 21a-408-66 of the Regulations of
			 Connecticut State Agencies.
(e) If
			 a sample of marijuana does not pass the microbiological, mycotoxin, heavy metal
			 or pesticide chemical residue test, based on the standards set forth in this
			 subsection, the producer shall dispose of the entire batch from which the
			 sample was taken in accordance with section 21a-408-66 of the Regulations of
			 Connecticut State Agencies.
(1) For the
			 purposes of the microbiological test, a marijuana sample of not less than one
			 gram shall be tested using a molecular method that is certified for identifying
			 microbiological DNA and approved by the Association of Official Analytical
			 Collaboration (AOAC) International and includes quantitative polymerase chain
			 reaction (qPCR), or an alternative method approved by the department. For the
			 purposes of the microbiological test, such samples shall be deemed satisfactory
			 if (A) E. coli, shiga toxin producing E. coli, L. monocytogenes, and salmonella
			 spp. are not detected, (B) the total aerobic microbial count and total combined
			 yeast and mold count are each equal to or less than
			 105 cfu/g or ml, and (C) the pathogenic
Aspergillus
species
A. fumigatus, A. flavus, A.
			 niger,
and
A. terreus
are not detected. Laboratories
			 designated as medical marijuana laboratories as of July 1, 2021 shall have one
			 hundred eighty days from
{insert effective date of this
			 section}
to obtain the necessary equipment and accreditation to comply
			 with the qPCR testing method but shall otherwise meet the standard set forth in
			 this subdivision.
(2) For the
			 purposes of the mycotoxin test, a marijuana sample shall be deemed satisfactory
			 if not less than one half of one gram is tested using a liquid
			 chromatography-mass spectrometry (LC-MS) or an enzyme-linked immunosorbent
			 assay (ELISA) method approved by the Association of Official Analytical
			 Collaboration (AOAC) International, Federal Food and Drug Association or United
			 States Pharmacopeia, or an alternative method approved by the department, and
			 such sample contains less than 20 micrograms per kilogram of each of the
			 following mycotoxins: aflatoxin B1, aflatoxin B2, aflatoxin G1, aflatoxin G2,
			 and ochratoxin A.
(3) For the
			 purposes of the heavy metal test, a marijuana sample shall be deemed to have
			 passed if it meets the following standards:
Metal
Natural Health Products Acceptable limits uG/KG
							 BW/Day
Arsenic
<0.14
Cadmium
<0.09
Lead
<0.29
Mercury
<0.29
(4)
			 For the purposes of the pesticide chemical residue test, a marijuana sample
			 shall be deemed to have passed if it satisfies the most stringent acceptable
			 standard for a pesticide chemical residue in any food item as set forth in
			 Subpart C of the federal Environmental Protection Agency's regulations for
			 Tolerances and Exemptions for Pesticide Chemical Residues in Food,  40 CFR 180.