Pursuant to Subsection 4-41-204(2), this rule establishes the standards for industrial hemp cannabinoid product potency testing and sets limits for foreign matter, microbial life, pesticides, residual solvents, heavy metals, and mycotoxins.R66-31-2. Definitions.
(1) "Analyte" means a substance or chemical component that is undergoing analysis.
(2) "Batch or lot" means a quantity of:
(a) cannabinoid concentrate produced on a particular date and time, following clean up until the next clean up during which the same lots of industrial hemp are used; or
(b) cannabinoid product produced on a particular date and time, following clean up until the next clean up during which industrial hemp concentrate is used.
(3) "Cannabinoid" means any:
(a) naturally occurring derivative of Cannabigerolic acid (CAS 25555-57-1); or
(b) any chemical compound that is both structurally and chemically similar to a derivative of Cannabigerolic acid.
(4) "Cannabinoid concentrate" means:
(a) the product of any chemical or physical process applied to naturally occurring biomass that concentrates or isolates the cannabinoids contained in the biomass; and
(b) any amount of a natural, derivative, or synthetic cannabinoid in the synthetic cannabinoid's purified state.
(5) "Certificate of analysis" (COA) means a document produced by a testing laboratory listing the results for which that testing was performed.
(6) "Final product" means a reasonably homogenous cannabinoid product in its final packaged form created using the same standard operating procedures and the same formulation.
(7) "Foreign matter" means:
(a) any matter that is present in a cannabis lot that is not a part of the cannabis plant; or
(b) any matter that is present in a cannabis or cannabinoid product that is not listed as an ingredient.
(8) "Pesticide" means any:
(a) substance or mixture of substances, including a living organism, that is intended to prevent, destroy, control, repel, attract, or mitigate any insect, rodent, nematode, snail, slug, fungus, weed, or other forms of plant or animal life that are normally considered to be a pest or that the commissioner declares to be a pest;
(b) any substance or mixture of substances intended to be used as a plant regulator, defoliant, or desiccant; and
(c) any spray adjuvant, such as a wetting agent, spreading agent, deposit builder, adhesive, or emulsifying agent with deflocculating properties of its own used with a pesticide to aid in the application or effect of a pesticide.
(9) "THCA" means delta-9-tetrahydrocannabinolic acid (CAS 23978-85-0).
(10) "Unknown Cannabinoid" means any component of a cannabis plant product, cannabis concentrate, or cannabis product that a laboratory determines is likely to be a cannabinoid by comparison of physical properties, including molecular weight, retention time, and absorption spectra but is not delta-9-THC, THCA, or any of the cannabinoids listed in Subsection 4-41-102(22)(b).
(11) "Unit" means each individual portion of an individually packaged product.
R66-31-3. Required Cannabinoid Product Tests.
(1) A cannabinoid processor may not register or sell a cannabinoid product until a representative sample has been tested by: (a) the department's analytical laboratory to determine the amount of any THC analogs present in the sample; and
(b) the department's analytical laboratory or a third party testing laboratory to determine the presence of adulterants in the sample.
(2) Each batch of cannabinoid product shall include a COA in accordance with this rule.
(3) If multiple laboratories perform the required tests, all laboratories shall test the same batch.
R66-31-4. Foreign Matter Standards.
A sample and related batch of cannabinoid product fails quality assurance testing if:
(1) the sample contains foreign matter visible to the unaided human eye;
(2) the sample is found to contain microscopic foreign matter considered to be harmful or estimated to comprise greater than 3% of the mass of the representative sample as determined by the testing laboratory; or
(3) foreign matter is found that is suspected to have been intentionally added to the sample to increase its visual appeal or market value.
R66-31-5. Potency Testing and Standards.
(1) A batch of cannabinoid product shall have the following determined and listed on the COA:
(a) quantity of any cannabinoid it is known to contain, including any THC analog; and
(b) the cannabinoid profile by percentage of mass.
(2) Cannabinoid products may not exceed the cannabinoid product THC level.
(3) A lot or batch of cannabis plant product, cannabis concentrate, or cannabis product fails quality assurance testing for cannabinoid content if:
(a) any of the artificially derived cannabinoids listed in Table 1 are found to be present; or
(b) greater than 10% of the total cannabinoid peak area is comprised of unknown cannabinoids after peaks smaller than 1% of the total peak area have been excluded as determined by high-performance liquid chromatography with a diode array detector (HPLC-DAD); or
(c) a newly identified cannabinoid approved by the department is present in a quantity greater than 2% by mass.
(4)(a) The department recognizes the following as newly identified cannabinoids:
(b) Cannabicitran (CBTC), CAS 31508-71-1.
TABLE 1
Artificially Derived Cannabinoids
