Section 21a-408-60 - Laboratory testing(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.(f) If a sample of marijuana passes the microbiological, mycotoxin, heavy metal and pesticide chemical residue test, the laboratory shall release the entire batch for immediate manufacturing, packaging and labeling for sale to a dispensary facility.(g) The laboratory shall file with the department an electronic copy of each laboratory test result for any batch that does not pass the microbiological, mycotoxin, heavy metal or pesticide chemical residue test, at the same time that it transmits those results to the producer. In addition, the laboratory shall maintain the laboratory test results and make them available in accordance with section 21a-408-72 of the Regulations of Connecticut State Agencies.(h) A producer shall provide to a dispensary facility the laboratory test results for each batch of marijuana used in a product purchased by the dispensary facility. Each dispensary facility shall have such laboratory results available upon request to qualifying patients, caregivers and physicians or APRNs who have certified qualifying patients.Conn. Agencies Regs. § 21a-408-60
Effective September 6, 2013; amended 8/28/2018; amended 6/13/2022