R.C.S.A. § 21a-408-58
Packaging and labeling by producer
Cite as Conn. Agencies Regs. § 21a-408-58
(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 21a-408-64 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-408-64 of the Regulations of Connecticut State Agencies.
(1) For purposes of the microbiological test, a marijuana sample shall be deemed to have
passed if it satisfies the standards set forth in Section 1111 of the United States
Pharmacopeia, which can be obtained at http://www.usp.org.
(2) For purposes of the mycotoxin test, a marijuana sample shall be deemed to have passed
if it meets the following standards:
Test
Specification
Alfatoxin B1
<20 uG/KG of Substance
Alfatoxin B2
<20 uG/KG of Substance
Alfatoxin O1
<20 uG/KG of Substance
Alfatoxin O2
<20 uG/KG of Substance
Ochratoxin A
<20 uG/KG of Substance
(3) For 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 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-408-70 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, primary caregivers and physicians who have certified qualifying patients.