Current through Register Vol. 64, No. 3, March 1, 2025
(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 January 2,
2025:
(A) The industrial hemp product contains
only artificially derived cannabinoid 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.
To view attachments referenced in rule text,
click here to view
rule.
Statutory/Other Authority: ORS
475C.017, ORS
475C.257 & 2024 OL Ch. 16
Sec. 9
Statutes/Other Implemented: ORS
475C.257 & 2024 OL Ch. 16
Sec. 9
