Or. Admin. R. 333-008-1800 - Medical Marijuana Processors: Cannabinoid Concentrate and Extract Processor Requirements

Current through Register Vol. 61, No. 4, April 1, 2022

(1) Cannabinoid Concentrates or Extracts. A processing site endorsed to make cannabinoid concentrates or extracts:
(a) May not use Class I solvents as those are classified in the Federal Drug Administration Guidance, Table I, published in the Federal Register on December 24, 1997 (62 FR 67377).
(b) Must:
(A) Only use a hydrocarbon-based solvent that is at least 99 percent purity.
(B) Only use a non-hydrocarbon-based solvent that is 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) If making a concentrate or extract that will be used in a cannabinoid edible, be endorsed as a cannabinoid edible processor.
(2) Cannabinoid Extracts. A processing site endorsed to make cannabinoid extracts:
(a) May not use pressurized canned flammable fuel, including but not limited to butane and other fuels intended for use in camp stoves, handheld torch devices, refillable cigarette lighters and similar consumer products
(b) Must:
(A) Process in a:
(i) Fully enclosed room clearly designated on the current diagram of the registered premises.
(ii) Room and with equipment, including all electrical installations, that meet the requirements of the Oregon Structural Specialty Code, related Oregon Specialty Codes and the Oregon Fire Code.
(B) Use a commercially manufactured professional grade closed loop extraction system designed to recover the solvents and built to recognized and generally accepted good engineering standards, such as those of:
(i) American National Standards Institute (ANSI);
(ii) Underwriters Laboratories (UL); or
(iii) The American Society for Testing and Materials (ASTM).
(C) If using carbon dioxide in processing, use a professional grade closed loop carbon dioxide gas extraction system where every vessel is rated to a minimum of 600 pounds per square inch.
(D) For extraction system engineering services, including but not limited to consultation on and design of extraction systems or components of extraction systems, use the services of a professional engineer registered with the Oregon State Board of Examiners for Engineering and Land Surveying, unless an exemption under ORS 672.060 applies;
(E) Have an emergency eye-wash station in any room in which cannabinoid extract is being processed.
(F) Have all applicable material safety data sheets readily available to personnel working for the processor.
(3) Cannabinoid Concentrates. A processing site endorsed to make cannabinoid concentrates:
(a) May not:
(A) Use denatured alcohol.
(B) If using carbon dioxide, apply high heat or pressure.
(b) Must only use or store dry ice in a well ventilated room to prevent against the accumulation of dangerous levels of carbon dioxide.
(c) 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 hydrocarbon-based solvent carbon dioxide, provided that the process does not involve the use heat over 180 degrees or pressure.

Notes

Or. Admin. R. 333-008-1800
PH 9-2016, f. 2-26-16, cert. ef. 3/1/2016; PH 21-2016, f. 6-24-16, cert. ef. 6/28/2016; PH 180-2018, minor correction filed 04/30/2018, effective 4/30/2018; PH 225-2018, minor correction filed 05/17/2018, effective 5/17/2018

Statutory/Other Authority: ORS 475B.840 & 475B.849

Statutes/Other Implemented: ORS 475B.840 & 475B.849

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