OAR 845-026-0400: Maximum Concentration and Serving Size Limits for Industrial Hemp Products: Definitions, Purpose, Scope and Effective Date

(1) Applicability. (a) Except as provided in subsection (b) of this section, this rule applies to industrial hemp products that: (A) Contain cannabinoids and are intended for human consumption or intended for human use; and (B) Are offered for sale, transfer, or delivery to a consumer in Oregon or imported into Oregon for delivery to a consumer. (b) This rule does not apply to hemp items, as that term is defined in OAR 845-025-1015, that are subject to the concentration and serving size limits in OAR 845-025-2760. (2) An industrial hemp product meets the concentration limits permitted 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) The maximum concentration and amount of total delta-9-THC permitted in a container and the maximum concentration or amount of total delta-9-THC permitted in a serving is listed in Table 3, incorporated by reference. (4) An industrial hemp product may only contain an artificially derived cannabinoid 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 product that does not fall within a category in Table 3 must meet the concentration and serving size limits applicable to a cannabinoid edible in Table 3. [ED. NOTE: To view attachments referenced in rule text, click here to view rule.]