37.107.204 PRODUCING MARIJUANA-INFUSED PRODUCTS, CONCENTRATES, AND EXTRACTS
(1) To produce marijuana-infused products or engage in chemical manufacturing, a licensee must:
(a) ensure the registered premises and equipment are maintained in a clean and sanitary condition for product preparation purposes;
(b) use equipment, counters, and surfaces for processing that are food grade, do not react adversely with any solvent being used, reduce the potential for development of microbials, molds and fungi, and can be easily cleaned;
(c) maintain detailed instructions for making each infused product, concentrate, or extract;
(d) conduct necessary safety checks prior to commencing processing; and
(e) create written detailed operating procedures for:
(i) cleaning all equipment, counters, and surfaces thoroughly;
(ii) proper handling and storage of any solvent, gas, or other chemical used in processing or on the registered premises;
(iii) proper disposal of any waste produced during processing;
(iv) training licensee employees on how to use the system and handle and store the solvents and gases safely; and
(v) any other written procedures required by the department.
(2) A licensee with a chemical manufacturing endorsement must:
(a) only use hydrocarbon-based solvents that are at least 99 percent pure, except when using solvents outlined in (3);
(b) only use nonhydrocarbon-based solvents that are food grade;
(c) work in an environment with proper ventilation, controlling all sources of ignition where a flammable atmosphere is or may be present;
(d) use only potable water and ice made from potable water in processing;
(e) process in a fully enclosed room;
(f) use a professional grade closed loop extraction system designed to recover the solvents;
(g) have equipment and facilities used in processing approved for use by the local fire code official;
(h) have an emergency eye-wash station in any room in which chemical manufacturing is occurring;
(i) have all applicable material safety data sheets readily available; and
(j) establish written emergency procedures to be followed in case of a fire, chemical spill, or other emergencies at all registered premises.
(3) A licensee with a chemical manufacturing endorsement may use:
(a) a mechanical extraction process;
(b) a chemical extraction process using a nonhydrocarbon-based or other solvent, such as water, vegetable glycerin, vegetable oils, animal fats, isopropyl alcohol or ethanol; or
(c) a chemical extraction process using the solvent carbon dioxide, provided that the process:
(i) does not involve the use of heat over 180 degrees Fahrenheit; and
(ii) uses a professional grade closed-loop carbon dioxide gas extraction system where every vessel is rated to a minimum of six hundred pounds per square inch.
(4) A licensee with a chemical manufacturing endorsement may not use:
(a) class I solvents;
(b) pressurized canned flammable fuel intended for use in camp stoves, handheld torch devices, refillable cigarette lighters, and similar products; or
(c) denatured alcohol.
(5) A licensee may not treat or otherwise alter a marijuana item with any noncannabinoid additive that would increase potency, toxicity, or addictive potential that would create an unsafe combination with other psychoactive substances.
(6) All licensees using solvent-based or solvent-free extraction processes authorized under this rule must obtain a chemical manufacturing endorsement.
History: 50-46-344, MCA; IMP, 50-46-303, 50-46-308, 50-46-312, 50-46-328, 50-46-329, 50-46-330, MCA; NEW, 2018 MAR p. 321, Eff. 4/10/18.