1000.510 Laboratory Testing
a) Immediately prior
to manufacturing or natural processing of any cannabis or cannabis-infused
product or packaging cannabis for sale to a dispensary, each batch shall be made
available at the cultivation center for an employee of an approved laboratory to
select a random sample, which shall be tested by the approved laboratory for:
1) microbiological contaminants;
3) pesticide active ingredients;
4) residual solvent; and
5) purposes of conducting an active ingredient analysis.
b) The Department may
select a random sample that shall, for the purposes of conducting an active
ingredient analysis, be tested by the Department for verification of label
c) A laboratory shall
immediately return or dispose of any cannabis upon the completion of any
testing, use or research. If cannabis is disposed of, it shall be done in
compliance with Section 1000.460.
d) If a sample of
cannabis does not pass the microbiological, mycotoxin, pesticide chemical
residue or solvent residue test, based on the standards set forth in this
Section, the following shall apply:
1) If the sample
failed the pesticide chemical residue test, the entire batch from which the
sample was taken shall, if applicable, be recalled as provided for in Section
1000.410(c)(1) and disposed of in accordance with Section 1000.460.
2) If the sample
failed any other test, the batch may be used to make a CO2 or solvent based extract. After
processing, the CO2 or solvent based extract must still pass all
Test: For purposes of the microbiological test, a cannabis sample shall be deemed to have
passed if it satisfies the recommended microbial and fungal limits for cannabis
products in colony forming units per gram (CFU/g) set out in the American
Herbal Pharmocopoeia Monograph Table as follows:
viable aerobic bacteria
yeast and mold
(pathogenic strains) and Salmonella spp.
and solvent based extracts
detected in 1 g
Unprocessed materials include minimally processed crude cannabis
preparations such as inflorescences, accumulated resin glands (kief), and
compressed resin glands (hashish). Processed materials include various solid or
liquid infused edible preparations, oils, topical preparations, and
water-processed resin glands (bubble hash).
f) Mycotoxin Test:
For purposes of the mycotoxin test, a cannabis sample shall be deemed to have
passed if it meets the following standards:
Aflatoxin B1 <20 μg/kg of substance
Aflatoxin B2 <20 μg/kg of substance
Aflatoxin G1 <20 μg/kg of substance
Aflatoxin G2 <20 μg/kg of substance
Ochratoxin A <20 μg//kg of substance
g) Pesticide Chemical Residue Test: For
purposes of the pesticide chemical residue test, a cannabis 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 USEPA's
regulations for Tolerances and Exemptions for Pesticide Chemical Residues in
Food (40 CFR 180 (2014)).
h) Residue Solvent Test: For purposes
of the residue solvent test, a cannabis sample shall be below 10 ppm.
i) 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, or pesticide chemical residue
test, at the same time that it transmits those results to the cultivation
center. In addition, the laboratory shall maintain the laboratory test results
for at least five years and make them available at the Department's request.
j) A cultivation center shall provide
to a dispensary organization the laboratory test results for each batch of
cannabis product purchased by the dispensary organization, if sampled. Each
dispensary organization shall have that laboratory results available upon
request to qualifying patients, designated caregivers and a physician who has
certified a qualifying patient.