Ill. Admin. Code tit. 8 § 1000.510

Current through Register Vol. 48, No. 49, December 6, 2024

Section 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;

2) mycotoxins;

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 information.

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 required tests

e) Microbiological 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:

Total viable aerobic bacteria	Total yeast and mold	Total coliforms	Bile-tolerant gram-negative bacteria	E. coli (pathogenic strains) and Salmonella spp.
CO₂and solvent based extracts	10⁴	10³	10²	10²	Not 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:

TestSpecification

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.

Ill. Admin. Code tit. 8, § 1000.510

Adopted at 38 Ill. Reg. 16731, effective 7/25/2014.