Agency head or
designee and title:
Kelly Pehrson, Commissioner
R66. Agriculture and Food, Specialized Products.
R66-52. Kratom Product Testing.
R66-52-1. Authority and Purpose.
Pursuant to Section 4-45-107, this rule establishes the standards for kratom product potency testing and sets limits for foreign matter, microbial life, pesticides,[ residual solvents,] heavy metals, and mycotoxins[, and other additives]. R66-52-2. Definitions.
(1) "7-OH level" means the concentration of 7-OH divided by the combined concentration of total kratom alkaloids.
(2) "Adulterant" means any poisonous or deleterious substance in a quantity that may be injurious to health, including:
[(a) prohibited additives outlined in Section R66-52-11;] (3) "Alkaloid" means any class of nitrogenous organic compounds of plant origin which have pronounced physiological actions on humans. (4) "Analyte" means a substance or chemical component undergoing analysis.
(5) "Certificate of Analysis (COA)" means a certificate from a laboratory describing the results of the laboratory's analytical testing of a sample.
(a) the product of any chemical or physical process applied to naturally occurring biomass that concentrates or isolates the alkaloid contained in the biomass; and (b) any amount of a natural, derivative, or synthetic alkaloid in the synthetic alkaloid's purified state.] ([7]6) "Foreign matter" means any matter that is present in a kratom: (a) lot that is not a part of the kratom plant; or
(b) product that is not listed as an ingredient.
[(8) "Kratom manufacturer" means an entity that holds, stores, packages, or labels a kratom product.] ([9]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.
[(10) "Total alkaloid" means the sum of the determined amount of alkaloids from Mitragyna speciosa.] R66-52-3. Required Kratom Product Tests.
(1) Testing shall be performed on finished products identified with a lot or batch number.
(2) A kratom [manufacturer]processor may not register or sell a kratom product unless a third-party ISO/IEC 17025:2017 accredited testing laboratory has tested a representative sample of the kratom product to determine: (a) the amount of any alkaloids present in the sample; and
(b) the presence of adulterants in the sample.
(3) Each batch or lot of kratom product shall include a [certificate of analysis]COA, in accordance with Section R66-51-5. R66-52-4. Foreign Matter Standards.
A sample and related batch of kratom product fail 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.
R66-52-5. Potency Testing and Standards.
(1) At a minimum, the [certificate of analysis]COA for each batch of kratom product shall include the following test results, when applicable: (a) the [contents ]level of mitragynine and 7-hydroxymitragynine in the kratom product certifying compliance with this rule and [Subsection 4-45-104(1)]Title 4, Chapter 45, Kratom Regulation Act; (i) the department may require testing of alkaloid content of a kratom product by the department lab for verification, at the cost of the registrant.
(b) the level of microbials in the kratom product that does not exceed the amounts listed in Table 1 when one gram or greater sample is tested;
(c) the levels of heavy metals in the kratom product that do not exceed the amounts listed in Table 2;
(d) the levels of pesticides in the kratom product do not exceed the amounts listed in Table 3; and [(e) the levels of residual solvents in the kratom product that do not exceed the amounts listed in Table 4; and] ([f]e) if required by the department, mycotoxin levels that are compliant with Table 4 listed in Section R66-52-[10]9. 
