OAR 845-026-0410: Adult Use Cannabinoid Concentration Level for Industrial Hemp Commodities or Products Constituting Marijuana Items: Definitions, Purpose, Scope and Effective Date

(1) Applicability. (a) Except as provided in subsection (b) of this section, this rule applies to industrial hemp commodities or products that: (A) Contain cannabinoids and are intended for consumption or use by humans or animals; and (B) Are offered for sale or transfer to a consumer in Oregon or imported into Oregon for delivery to a consumer. (b) Hemp items, as that term is defined in OAR 845-025-1015, subject to the concentration and serving size limits in OAR 845-025-2760 must also comply with the requirements in OAR 845-025-2760. (2) An industrial hemp commodity or product does not exceed the concentration limits established under this rule if: (a) The total delta-9-THC as calculated in accordance with OAR 333-064-0100(4) does not exceed the maximum amount of THC permitted by more than 10 percent; (b) The total delta-9-THC as calculated in accordance with OAR 333-064-0100(4) does not exceed the maximum concentration of THC permitted by more than 10 percent; and (c) The testing done in accordance with ORS 571.330 or 571.339 was performed using a method with a LOQ sufficient to demonstrate that the total delta-9-THC does not exceed the maximum amount of THC permitted in a container by more than 10 percent. (3) Table 4, incorporated by reference, establishes the maximum concentration and amount of total delta-9-THC for a container and the maximum concentration or amount of total delta-9-THC for a serving. (4) An industrial hemp commodity or product may contain an adult use cannabinoid that is an artificially derived cannabinoid only if: (a) Until July 1, 2025: (A) The only artificially derived cannabinoid the industrial hemp product contains is cannabinol (CBN); (B) The product is not intended for human inhalation; and (C) The CBN: (i) Is not a controlled substance under OAR chapter 855, division 80; (ii) Was manufactured in compliance with applicable laws relating to food safety; and (D) The manufacturer of the CBN: (i) Has taken substantial steps towards meeting the requirements described in subsection (1)(c) of this rule, including but not limited to initiating or contracting to initiate safety studies; (ii) Has conducted a hazard analysis as described in 21 CFR 117.130 to identify foreseeable hazards in the process of manufacturing the CBN; and (iii) Has documented any preventative controls, as described in 21 CFR 117.135 that minimize or prevent any hazards requiring preventive control; or (b) At any time: (A) The artificially derived cannabinoid: (i) Is not a controlled substance under OAR chapter 855, division 80; (ii) Was manufactured in compliance with applicable laws relating to food safety; (iii) In the Commission’s judgment, is not impairing or intoxicating at the intended concentration in the product; and (iv) Has been reported as a naturally-occurring component of the plant Cannabis family Cannabaceae in at least three peer-reviewed publications. (B) The product is not intended for human inhalation; and (C) The manufacturer of the artificially derived cannabinoid: (i) Has made a “Generally Recognized as Safe” (GRAS) determination for the artificial cannabinoid; (ii) Has received a Food and Drug Administration (FDA) letter responding to a “Generally Recognized as Safe” (GRAS) notice for the artificially derived cannabinoid manufactured by the same method that the manufacturer uses, affirming that FDA has no questions about the notice; or (iii) Has received an FDA letter of acknowledgement with no objections in response to a New Dietary Ingredient notification for the artificially derived cannabinoid manufactured by the same method that the manufacturer uses. (5) Serving size is as determined by the manufacturer and must comply with applicable serving size limits. (6) An industrial hemp commodity or product that does not fall within a category in Table 4 must meet the concentration and serving size limits applicable to a cannabinoid edible in Table 4. (7) Civil Penalties. The Commission may impose a civil penalty of no more than $10,000 for each violation of ORS 475C.257 against a person other than a commission-licensed marijuana retailer for selling an industrial hemp commodity or product to a consumer that exceeds the concentration and serving size limits in this rule. [ED. NOTE: To view attachments referenced in rule text, click here to view rule.]