333-007-0300
Cannabis Testing: Purpose

(1) The purpose of these rules is to establish the minimum compliance testing standards for marijuana items and industrial hemp-derived vapor items. These rules are applicable to persons who process, sell, or transfer marijuana items or industrial hemp-derived vapor items except as exempted in section (2) of this rule.

(2) The testing requirements do not apply to:

(a) A grower if the person is transferring usable marijuana or an immature marijuana plant to:

(A) A patient who designated the grower to grow marijuana for the patient; or

(B) A designated primary caregiver or an organization or facility caregiver of the patient who designated the grower to grow marijuana for the patient; or

(b) A designated primary caregiver or an organization or facility caregiver of a patient if the caregiver is transferring a marijuana item to a patient of the designated primary caregiver or organization or facility caregiver.

(c) Immature plants or seeds.

(3) A person registered with the Authority under ORS 475C.770 to 475C.803 who is subject to these rules may not:

(a) Transfer a marijuana item that is not sampled and tested in accordance with these rules; or

(b) Accept the transfer of a marijuana item that is not sampled and tested in accordance with these rules.

(4) A person licensed by the Commission must comply with these rules at all times.

(5) If a registrant, who is exempt from the testing requirements, chooses to have a marijuana item tested for pesticides, the requirements of OAR 333-007-0450 and 333-007-0500 still apply.

Statutory/Other Authority: ORS 475C.544 & ORS 475C.540
Statutes/Other Implemented: ORS 475C.544 & ORS 475C.540
History:
PH 29-2022, minor correction filed 04/26/2022, effective 04/26/2022
PH 95-2021, amend filed 12/29/2021, effective 01/01/2022
PH 89-2020, amend filed 12/30/2020, effective 01/01/2021
PH 282-2018, amend filed 12/20/2018, effective 01/01/2019
PH 105-2018, minor correction filed 04/27/2018, effective 04/27/2018
PH 9-2017, f. 5-26-17, cert. ef. 5-31-17
PH 33-2016, f. & cert. ef. 11-28-16
PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16

333-007-0310
Definitions

For purposes of OAR 333-007-0300 through 333-007-0500:

(1) "Added substance" means any component or ingredient added to usable marijuana, cannabinoid concentrate or cannabinoid extract during or after processing that is present in the finished cannabinoid product, including but not limited to flavors, non-marijuana derived terpenes, and any substances used to change the viscosity or consistency of the cannabinoid product.

(2) "Adult use cannabinoid" includes, but is not limited to, tetrahydrocannabinols, tetrahydrocannabinolic acids that are artificially or naturally derived, delta-8-tetrahydrocannabinol, delta-9-tetrahydrocannabinol, the optical isomers of delta-8-tetrahydrocannabinol or delta-9-tetrahydrocannabinol and any artificially derived cannabinoid that is reasonably determined to have an intoxicating effect.

(3)(a) "Artificially derived cannabinoid" means a chemical substance that is created by a chemical reaction that changes the molecular structure of any chemical substance derived from the plant Cannabis family Cannabaceae.

(b) "Artificially derived cannabinoid" does not include:

(A) A naturally occurring chemical substance that is separated from the plant Cannabis family Cannabaceae by a chemical or mechanical extraction process;

(B) Cannabinoids that are produced by decarboxylation from a naturally occurring cannabinoid acid without the use of a chemical catalyst; or

(C) Any other chemical substance identified by the Commission, in consultation with the Authority and the Department of Agriculture, by rule.

(4) "Authority" means the Oregon Health Authority.

(5) "Batch" means:

(a) A quantity of marijuana or usable marijuana from a harvest lot; or

(b) A quantity of cannabinoid concentrate or extract or cannabinoid product from a process lot.

(6) "Cannabinoid" means any of the chemical compounds that are the active constituents of marijuana.

(7) "Cannabinoid capsule":

(a) Means a small soluble pill, tablet, or container that contains liquid or powdered cannabinoid product, concentrate, or extract and is intended for human ingestion.

(b) Does not mean a cannabinoid suppository.

(8) "Cannabinoid concentrate or extract" means a substance obtained by separating cannabinoids from marijuana by a mechanical, chemical or other process.

(9) "Cannabinoid edible" means food or potable liquid into which a cannabinoid concentrate or extract or the dried leaves or flowers of marijuana have been incorporated.

(10)(a) "Cannabinoid product" means a cannabinoid edible or any other product intended for human consumption or use, including a product intended to be applied to a person’s skin or hair, that contains cannabinoids or the dried leaves or flowers of marijuana; or

(b) Usable marijuana, cannabinoid extracts and cannabinoid concentrates that have been combined with an added substance.

(c) "Cannabinoid product" does not include:

(A) Usable marijuana by itself;

(B) A cannabinoid concentrate or extract by itself.; or

(C) Industrial hemp.

(11) "Cannabinoid suppository" means a small soluble container designed to melt at body temperature within a body cavity other than the mouth, especially the rectum or vagina, containing a cannabinoid product, concentrate or extract.

(12) "Cannabinoid tincture" means a liquid cannabinoid product packaged in a container of four fluid ounces or less that consists of either:

(a) A non-potable solution consisting of at least 25 percent non-denatured alcohol, in addition to cannabinoid concentrate, extract or usable marijuana, and perhaps other ingredients intended for human consumption or ingestion that is exempt from the Liquor Control Act under ORS 471.035; or

(b) A non-potable solution comprised of glycerin, plant-based oil, or concentrated syrup; cannabinoid concentrate, extract or usable marijuana; and perhaps other ingredients that does not contain any added sweeteners and is intended for human consumption or ingestion.

(13) "Cannabinoid topical" means a cannabinoid product intended to be applied to skin or hair and for purposes of testing includes a cannabinoid transdermal patch.

(14) "Cannabinoid transdermal patch" means an adhesive substance applied to human skin that contains a cannabinoid product, concentrate or extract for absorption into the bloodstream.

(15) "Cannabis" means the plant species Cannabis sativa and in these rules refers to all forms of the plant regardless of total delta-9-THC content and may also be used to refer to processed products that contain marijuana or industrial hemp.

(16) “Cannabis reference laboratory” means the Oregon Department of Agriculture cannabis testing laboratory.

(17) "Cannabis Tracking System" or "CTS" means the Oregon Liquor and Cannabis Commission’s system for tracking the transfer of marijuana items or industrial hemp-derived vapor item and other information as authorized by ORS 475C.177.

(18) "CBD" means cannabidiol, Chemical Abstracts Service Number 13956-29-1.

(19) "CBDA" means cannabidiolic acid, Chemical Abstracts Service Number 1244-58-2.

(20) "Commission" means the Oregon Liquor and Cannabis Commission.

(21) "Compliance test" means a laboratory test required by these rules in order to allow the transfer or sale of a marijuana item or industrial hemp-derived vapor item.

(22) "Consumer" has the meaning given that term in ORS 475C.009 and does not include a patient, designated primary caregiver or organization or facility caregiver.

(23) "Cured" means a process of removing moisture from marijuana under controlled environmental conditions so the moisture content is 15 percent or less.

(24) "Delta-8-tetrahydrocannabinol" or "delta-8-THC" means (6aR, 10aR)-6,6,9-trimethyl-3-pentyl6a,7,10,10a-tetrahydro-6H-benzo[c]chromen-1-ol, Chemical Abstracts Service Number 5957-75-5.

(25) "Delta-9-tetrahydrocannabinol" or "delta-9-THC" means (6aR,10aR)-6,6,9-trimethyl-3-pentyl-6a,7,8,10a-tetrahydro-6H- benzo[c]chromen-1-ol., Chemical Abstracts Service Number 1972-08-3.

(26) "Delta-9-tetrahydrocannabinolic acid" or "delta-9-THCA" means (6aR,10aR)-1-hydroxy-6,6,9-trimethyl-3-pentyl-6a,7,8,10a-tetrahydro-6H-benzo[c]chromene-2- carboxylic acid, Chemical Abstracts Service Number 23978-85-0.

(27)(a) "Designated primary caregiver" means an individual 18 years of age or older who has significant responsibility for managing the well-being of a person who has been diagnosed with a debilitating medical condition, who is designated as such on that person's application for a registry identification card or in other written notification to the Authority, and who has been issued an identification card by the Authority under ORS 475C.783(5)(b).

(b) "Designated primary caregiver" does not include the person's attending physician.

(28) "Duplicate sample" means sample increments taken in an identical manner to sample increments taken for the primary sample and representative of the same marijuana item or industrial hemp-derived vapor item being sampled that is prepared and analyzed separately from the primary sample.

(29) "Finished cannabinoid concentrate or extract" means a cannabinoid concentrate or extract that is in its final form ready for packaging for sale or transfer to a patient, designated primary caregiver or consumer.

(30) "Finished cannabinoid product" means a cannabinoid product that is in its final form ready for packaging for sale or transfer to a patient, designated primary caregiver or consumer, and includes all ingredients whether or not the ingredients contain cannabinoids.

(31) "Finished inhalable cannabinoid product" means a cannabinoid product that is intended for human use via inhalation, is in its final form ready for packaging for sale or transfer to a patient, designated primary caregiver or consumer, and includes all ingredients whether or not the ingredients contain cannabinoids.

(32) "Food" means a raw, cooked, or processed edible substance, or ingredient used or intended for use or for sale in whole or in part for human consumption, chewing gum and includes beverages.

(33) "Grow site" means a specific location registered by the Authority and used by the grower to produce marijuana for medical use by a specific patient under ORS 475C.792.

(34) "Grower" has the same meaning as "person responsible for a marijuana grow site."

(35) "Harvest lot" means a specifically identified quantity of marijuana that is cultivated utilizing the same growing practices, harvested within a seven calendar-day period at the same location and cured under uniform conditions.

(36) "Homogeneous" means a cannabinoid product, concentrate or extract has uniform composition and properties throughout each process lot.

(37) "Human consumption or human ingestion" means to ingest, generally through the mouth, food, drink or other substances such that the substance enters the human body but does not include inhalation.

(38) "Human use" includes human consumption or human ingestion, inhalation, topical application or any other use that allows a cannabinoid to enter the human body.

(39) "Industrial hemp" has the meaning given that term in ORS 571.269.

(40) "Industrial hemp-derived vapor item" means an industrial hemp concentrate or industrial hemp extract, as those terms are defined in ORS 571.269, whether alone or combined with other substances, that is intended for use in an inhalant delivery system.

(41) "Inhalant delivery system" has the meaning given that term in ORS 431A.175.

(42) "Laboratory" means a laboratory that is accredited under ORS 438.605 to 438.620 to sample or conduct tests on marijuana items and licensed by the Oregon Liquor and Cannabis Commission under ORS 475C.548.

(43) "Licensee" has the meaning given that term in ORS 475C.009.

(44)(a) "Marijuana" means the plant Cannabis family Cannabaceae, any part of the plant Cannabis family Cannabaceae and the seeds of the plant Cannabis family Cannabaceae.

(b) "Marijuana" does not include industrial hemp.

(45) "Marijuana item" means marijuana, usable marijuana, a cannabinoid product or a cannabinoid concentrate or extract.

(46) "Marijuana processing site" means a marijuana processing site registered under ORS 475C.815.

(47) "Medical marijuana dispensary" or "dispensary" means a medical marijuana dispensary registered under ORS 475C.833.

(48) "ORELAP" means the Oregon Environmental Laboratory Accreditation Program administered by the Authority pursuant to ORS 438.605 to 438.620.

(49) "Organization or facility caregiver" means:

(a) An organization that provides hospice, palliative or home health care services that:

(A) Is licensed under ORS 443.014 to 443.105, 443.305 to 443.355, or 443.850 to 443.869;

(B) Has significant responsibility for managing the well-being of a patient; and

(C) Is designated by the Authority as an additional caregiver for a patient; or

(b) A residential facility as defined in ORS 443.400 that:

(A) Is licensed under ORS 443.400 to 443.455;

(B) Has significant responsibility for managing the well-being of a patient: and

(C) Is designated by the Authority as an additional caregiver for a patient.

(50) "Patient" has the same meaning as "registry identification cardholder."

(51) "Person responsible for a marijuana grow site" has the same meaning as "grower" and means a person who has been selected by a patient to produce medical marijuana for the patient and who has been registered by the Authority for this purpose under ORS 475C.792.

(52) "Process lot" means:

(a) Any amount of cannabinoid concentrate or extract or industrial hemp-derived vapor item of the same type that is homogeneous and processed using the same extraction methods, standard operating procedures and batches from the same or a different harvest lot; or

(b) Any amount of a cannabinoid product of the same type and processed using the same ingredients, standard operating procedures and batches from the same or a different harvest lot or process lot of cannabinoid concentrate or extract.

(53) "Processing" means:

(a) The compounding or conversion of marijuana into cannabinoid products, or cannabinoid concentrates or extracts.

(b) The compounding or conversion of industrial hemp into industrial hemp concentrates or industrial hemp extracts.

(54) "Processing site" means a processor registered with Authority under ORS 475C.815.

(55) "Processor" means a marijuana processor, as that term is defined in ORS 475C.009, that holds a license issued under ORS 475C.085.

(56) "Producer" has the meaning given that term in OAR 845-025-1015.

(57) "Registrant" means a grower, marijuana processing site, or a medical marijuana dispensary registered with the Authority under ORS 475C.792, 475C.815 or 475C.833.

(58) "Registry identification cardholder" means a person who has been diagnosed by an attending physician with a debilitating medical condition and for whom the use of medical marijuana may mitigate the symptoms or effects of the person's debilitating medical condition, and who has been issued a registry identification card by the Authority under ORS 475C.783(5)(a).

(59) "Relative percentage difference" or "RPD" means the comparison of two quantities while taking into account the size of what is being compared as calculated under OAR 333-064-0100.

(60) "Relative standard deviation" or "RSD" means the standard deviation expressed as a percentage of the mean recovery as calculated under OAR 333-064-0100.

(61) "Remediation":

(a) Means a process or technique applied to a marijuana item or industrial hemp-derived vapor item to remove, destroy, or eliminate heavy metals, pesticides, microbiological contaminants, or solvents.

(b) Does not include dilution.

(62) "Replicate sample" means a sample in addition to the primary and duplicate samples that consists of the same number of increments taken in the same manner as the primary and duplicate samples.

(63) "Sample" means an amount of a marijuana item or industrial hemp-derived vapor item collected by laboratory personnel from a registrant or licensee and provided to a laboratory for testing.

(64) "Sample increment" means an amount of a marijuana item or industrial hemp-derived vapor item collected by laboratory personnel from a registrant or licensee that may be combined into a sample for purposes of testing.

(65) "Standard operating procedure" means:

(a) A written set of instructions or procedures using the same ingredients, methods and steps to create a single type of marijuana item or industrial hemp-derived vapor item.

(b) For the purposes of producing kief includes but is not limited to procedures for creating the kief, purging unwanted components from the kief, thoroughly cleaning all equipment, counters and surfaces used to produce the kief, and appropriate use of any necessary safety or sanitary equipment.

(66) "Sterilization" means the removal, destruction, or elimination of all microorganisms and other pathogens from a marijuana item or industrial hemp-derived vapor item by treating it with approved chemicals, subjecting it to a temperature exceeding 180 degrees Fahrenheit, or other process.

(67) "Test batch" means a group of samples from a batch submitted collectively to a laboratory for testing purposes.

(68) "Texture" means the feel, appearance, or consistency of a marijuana item or industrial hemp-derived vapor item.

(69) "These rules" means OAR 333-007-0300 through 333-007-0500.

(70) "Total CBD" means the sum of the concentration or mass of CBDA multiplied by 0.877 plus the concentration or mass of CBD.

(71) "Total delta-9-THC" means the sum of the concentration or mass of delta-9-THCA multiplied by 0.877 plus the concentration or mass of delta-9-THC.

(72) "Unit of sale" means an amount of a marijuana item or industrial hemp-derived vapor item commonly packaged for transfer or sale to a consumer, patient, designated primary caregiver or organization or facility caregiver, or capable of being packaged for transfer or sale to a consumer, patient, designated primary caregiver or organization or facility caregiver.

(73) "Usable marijuana":

(a) Means the dried leaves and flowers of marijuana.

(b) Includes, for purposes of these rules, pre-rolled marijuana as long as the pre-roll consists of only dried marijuana leaves and flowers, an unflavored rolling paper and a filter or tip.

(c) Does not include:

(A) The seeds, stalks and roots of marijuana; or

(B) Waste material that is a by-product of producing or processing marijuana.

Statutory/Other Authority: ORS 475C.544 & ORS 475C.540
Statutes/Other Implemented: ORS 475C.544 & ORS 475C.540
History:
PH 6-2024, amend filed 03/20/2024, effective 04/01/2024
PH 25-2022, amend filed 04/07/2022, effective 04/07/2022
PH 24-2022, amend filed 03/15/2022, effective 03/31/2022
PH 95-2021, amend filed 12/29/2021, effective 01/01/2022
PH 89-2020, amend filed 12/30/2020, effective 01/01/2021
PH 282-2018, amend filed 12/20/2018, effective 01/01/2019
PH 106-2018, minor correction filed 04/27/2018, effective 04/27/2018
PH 9-2017, f. 5-26-17, cert. ef. 5-31-17
PH 35-2016(Temp), f. & cert. ef. 12-2-16 thru 5-30-17
PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16

333-007-0315
Ordering Tests

(1) To request a compliance test a requestor must provide a laboratory, prior to laboratory taking samples, with at a minimum, the following information as applicable:

(a) The registrant or licensee’s registrant or license number.

(b) The name, address and contact information of the registrant or licensee.

(c) If a registrant, whether the registrant is subject to tracking in CTS, under OAR chapter 333, division 8.

(d) Type of marijuana item or industrial hemp-derived vapor item.

(e) Harvest lot number that is associated with the batch numbers, if applicable.

(f) Process lot number that is associated with the batch numbers, if applicable.

(g) Batch numbers to be sampled.

(h) Total mass or volume of each batch to be sampled.

(i) For cannabinoid products, all intended units of sale.

(j) Identification of the test or tests the laboratory is being requested to conduct.

(k) Whether the test or tests being requested are compliance tests.

(l) Whether the test or tests being requested are for quality control, research and development, or any other purpose other than a compliance test.

(m) Whether a batch is being re-sampled because of a failed test, the date the failed test result was received by the registrant or licensee and laboratory identification number of the laboratory that conducted the initial test.

(n) Whether the marijuana item or industrial hemp-derived vapor item was remediated if remediation is permitted under OAR 333-007-0450.

(o) If a wholesaler is requesting a test on behalf of another registrant or licensee, the wholesaler must provide in addition to their own license number and name, the registration or license number and name of that registrant or licensee.

(2) If the registrant or licensee informs a laboratory that a marijuana item or industrial hemp-derived vapor item is being re-sampled after a failed test, the registrant or licensee must provide the laboratory with documentation of the failed test as applicable.

(3) It is the responsibility of the registrant or the licensee to order the tests necessary to comply with these rules.

(4) A registrant or licensee may only order a compliance test for a marijuana item that the registrant or licensee has produced or processed, as applicable, except a wholesaler who may order a compliance test.

(5) More than one compliance test for the same marijuana item or industrial hemp-derived vapor item may not be ordered.

(6) It is a violation of these rules for a registrant or licensee to:

(a) Fail to provide the information required in these rules to the laboratory; or

(b) Submit false or misleading information to a laboratory or a directed agent to submit false or misleading information to a laboratory.

(7) Once a test order has been submitted to a laboratory by a registrant or licensee and at least one test has already been performed, the order may not be canceled unless written permission is given by the Oregon Liquor and Cannabis Commission, the Oregon Health Authority or the Department of Agriculture.

Statutory/Other Authority: ORS 475C.544
Statutes/Other Implemented: ORS 475C.544
History:
PH 6-2024, amend filed 03/20/2024, effective 04/01/2024
PH 24-2022, amend filed 03/15/2022, effective 03/31/2022
PH 95-2021, amend filed 12/29/2021, effective 01/01/2022
PH 282-2018, amend filed 12/20/2018, effective 01/01/2019
PH 29-2017, amend filed 12/22/2017, effective 01/01/2018
PH 9-2017, f. 5-26-17, cert. ef. 5-31-17
PH 35-2016(Temp), f. & cert. ef. 12-2-16 thru 5-30-17
PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16

333-007-0320
Compliance Testing Requirements for Marijuana or Usable Marijuana

(1) A producer or grower must test every batch from a harvest lot of marijuana or usable marijuana intended for use by a consumer or patient prior to selling or transferring the marijuana or usable marijuana for the following:

(a) Pesticides in accordance with OAR 333-007-0400.

(b) Water activity and moisture content in accordance with OAR 333-007-0420.

(c) Adult use cannabinoid and CBD concentration in accordance with OAR 333-007-0430.

(d) Heavy metals in accordance with OAR 333-007-0415 if the marijuana or usable marijuana is or was harvested on or after March 1, 2023.

(e) Mycotoxins in accordance with OAR 333-007-0425 if the marijuana or usable marijuana is or was harvested on or after July 1, 2022.

(f) Microbiological contaminants in accordance with OAR 333-007-0390 if the marijuana or usable marijuana is or was harvested on or after March 1, 2023.

(2) A producer or grower must test every batch from a harvest lot of marijuana or usable marijuana harvested before March 1, 2023, intended for use by a processor or processing site in making a cannabinoid concentrate, extract, or finished inhalable cannabinoid product for water activity and moisture content in accordance with OAR 333-007-0420 unless the processor or processing site uses a method of processing that results in effective sterilization.

(3) A producer or grower must test every batch from a harvest lot of marijuana or usable marijuana intended for use by a processor or processing site in making a cannabinoid product, except for a finished inhalable cannabinoid product, for the following:

(a) Pesticides in accordance with OAR 333-007-0400.

(b) Water activity and moisture content in accordance with OAR 333-007-0420 unless the processor or processing site uses a method of processing that results in effective sterilization.

(c) Heavy metals in accordance with OAR 333-007-0415 if the marijuana or usable marijuana is or was harvested on or after March 1, 2023.

(d) Mycotoxins in accordance with OAR 333-007-0425 if the marijuana or usable marijuana is or was harvested on or after July 1, 2022.

(e) Microbiological contaminants in accordance with OAR 333-007-0390 if the marijuana or usable marijuana is or was harvested on or after March 1, 2023.

(4) In lieu of ordering and arranging for the sampling and testing required in this rule a producer may transport batches of marijuana or usable marijuana to a wholesaler licensed by the Commission under ORS 475C.093 and the wholesaler may order and arrange for the sampling and testing of the batches, in accordance with rules established by the Commission.

(5) A marijuana producer must test every batch from a harvest lot of marijuana or usable marijuana harvested before March 1, 2023 intended to produce kief for water activity prior to producing the kief unless the producer tests the kief for water activity per OAR 333-007-0420.

Statutory/Other Authority: ORS 475C.544
Statutes/Other Implemented: ORS 475C.544
History:
PH 24-2022, amend filed 03/15/2022, effective 03/31/2022
PH 95-2021, amend filed 12/29/2021, effective 01/01/2022
PH 89-2020, amend filed 12/30/2020, effective 01/01/2021
PH 9-2017, f. 5-26-17, cert. ef. 5-31-17
PH 38-2016(Temp), f. 12-13-16, cert. ef. 12-15-16 thru 5-30-17
PH 35-2016(Temp), f. & cert. ef. 12-2-16 thru 5-30-17
PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16

333-007-0330
Compliance Testing Requirements for Cannabinoid Concentrates and Extracts

(1) A processor or processing site must test every process lot of a finished cannabinoid concentrate or extract for use by a consumer or patient prior to selling or transferring the cannabinoid concentrate or extract for the following:

(a) Pesticides in accordance with OAR 333-007-0400.

(b) Solvents in accordance with OAR 333-007-0410.

(c) Adult use cannabinoid and CBD concentration in accordance with OAR 333-007-0430.

(d) Heavy metals in accordance with OAR 333-007-0415 if the cannabinoid concentrate or extract is or was manufactured on or after March 1, 2023.

(e) Mycotoxins in accordance with OAR 333-007-0425 if the cannabinoid concentrate or extract is or was manufactured on or after July 1, 2022.

(f) Microbiological contaminants in accordance with OAR 333-007-0390 if the cannabinoid concentrate or extract is or was manufactured on or after March 1, 2023.

(2) A processor or processing site must test every process lot of a cannabinoid concentrate or extract intended for use by a processor or processing site to make a cannabinoid product, other than a finished inhalable cannabinoid product, for the following, except for a cannabinoid concentrate that meets the criteria in section (5) of this rule:

(a) Pesticides in accordance with OAR 333-007-0400.

(b) Solvents in accordance with OAR 333-007-0410.

(c) Heavy metals in accordance with OAR 333-007-0415 if the cannabinoid concentrate or extract is or was manufactured on or after March 1, 2023.

(d) Mycotoxins in accordance with OAR 333-007-0425 if the cannabinoid concentrate or extract is or was manufactured on or after July 1, 2022.

(e) Microbiological contaminants in accordance with OAR 333-007-0390 if the cannabinoid concentrate or extract is or was manufactured on or after March 1, 2023.

(3) A processor or processing site is exempt from testing for solvents under this rule if the processor or processing site:

(a) Did not use any solvent listed in OAR 333-007-0410, Table 4; and

(b) Only used a mechanical extraction process to separate cannabinoids from the marijuana; or

(c) Used only water, animal fat or vegetable oil as a solvent to separate the cannabinoids from the marijuana.

(4) In lieu of ordering and arranging for the sampling and testing required in this rule a processor may transport batches of cannabinoid concentrates or extracts to a wholesaler licensed by the Commission under ORS 475C.093 and the wholesaler may order and arrange for the sampling and testing of the batches, in accordance with rules established by the Commission.

(5) A process lot of a cannabinoid concentrate that is made only using food grade animal fat or food grade plant-based oil is not required to be tested for pesticides, heavy metals starting March 1, 2023, mycotoxins starting July 1, 2022, or microbiological contaminants starting March 1, 2023 if:

(a) All marijuana or usable marijuana used to make the concentrate was tested for and passed:

(A) Pesticide testing in accordance with OAR 333-007-0400.

(B) Heavy metal testing in accordance with OAR 333-007-0415 on or after March 1, 2023.

(C) Mycotoxin testing in accordance with OAR 333-007-0425 on or after July 1, 2022.

(D) Microbiological contaminants in accordance with OAR 333-007-0390 on or after March 1, 2023.

(b) The concentrate itself is only used to make a cannabinoid product intended for human consumption or use but not intended for inhalation and the concentrate is not sold directly to consumers or patients.

(6) Marijuana producers producing kief as permitted under OAR 845-025-2020:

(a) Must test every process lot for use by a consumer or patient prior to selling or transferring the kief for the following:

(A) Pesticides in accordance with OAR 333-007-0400.

(B) Water activity in accordance with OAR 333-007-0420 for kief manufactured before March 1, 2023.

(C) Adult use cannabinoid and CBD concentration in accordance with OAR 333-007-0430.

(D) Heavy metals in accordance with OAR 333-007-0415 if the kief is or was manufactured on or after March 1, 2023.

(E) Mycotoxins in accordance with OAR 333-007-0425 if the kief is or was manufactured on or after July 1, 2022.

(F) Microbiological contaminants in accordance with OAR 333-007-0390 if the kief is or was manufactured on or after March 1, 2023.

(b) Must test every process lot intended for use by a processor in making a cannabinoid product, other than a finished inhalable cannabinoid product, for the following:

(A) Pesticides in accordance with OAR 333-007-0400.

(B) Water activity in accordance with OAR 333-007-0420 for kief manufactured before March 1, 2023.

(C) Heavy metals in accordance with OAR 333-007-0415 if the kief is or was manufactured on or after March 1, 2023.

(D) Mycotoxins in accordance with OAR 333-007-0425 if the kief is or was manufactured on or after July 1, 2022.

(E) Microbiological contaminants in accordance with OAR 333-007-0390 if the kief is or was manufactured on or after March 1, 2023.

Statutory/Other Authority: ORS 475C.544
Statutes/Other Implemented: ORS 475C.544
History:
PH 24-2022, amend filed 03/15/2022, effective 03/31/2022
PH 95-2021, amend filed 12/29/2021, effective 01/01/2022
PH 89-2020, amend filed 12/30/2020, effective 01/01/2021
PH 282-2018, amend filed 12/20/2018, effective 01/01/2019
PH 9-2017, f. 5-26-17, cert. ef. 5-31-17
PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16

333-007-0340
Compliance Testing Requirements for Cannabinoid Products

(1) A processor or processing site must test every process lot of a finished cannabinoid product intended for human consumption, use or ingestion for use by a consumer or patient prior to selling or transferring the cannabinoid product for adult use cannabinoid and CBD concentration in accordance with OAR 333-007-0430.

(2) A processor or processing site must test a process lot of a finished cannabinoid product intended for human consumption, use or ingestion for microbiological contaminants in accordance with OAR 333-007-0390, upon written request by the Authority or the Commission.

(3) In lieu of ordering and arranging for the sampling and testing required in this rule a processor may transport batches of cannabinoid products referenced in section (1) of this rule to a wholesaler licensed by the Commission under ORS 475C.093 and the wholesaler may order and arrange for the sampling and testing of the batches, in accordance with rules established by the Commission.

Statutory/Other Authority: ORS 475C.544
Statutes/Other Implemented: ORS 475C.544
History:
PH 30-2022, minor correction filed 04/26/2022, effective 04/26/2022
PH 95-2021, amend filed 12/29/2021, effective 01/01/2022
PH 282-2018, amend filed 12/20/2018, effective 01/01/2019
PH 9-2017, f. 5-26-17, cert. ef. 5-31-17
PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16

333-007-0341
Compliance Testing Requirements for Finished Inhalable Cannabinoid Products

(1) A processor or processing site must test every process lot of a finished inhalable Cannabinoid product prior to selling or transferring the product for the following:

(a) Pesticides in accordance with OAR 333-007-0400.

(b) Solvents in accordance with OAR 333-007-0410.

(c) Adult use cannabinoid and CBD concentration in accordance with OAR 333-007-0430.

(d) Heavy metals in accordance with OAR 333-007-0415 if the finished inhalable cannabinoid product is or was manufactured on or after March 1, 2023.

(e) Mycotoxins in accordance with OAR 333-007-0425 finished inhalable cannabinoid product is or was manufactured on or after July 1, 2022.

(f) Microbiological contaminants in accordance with OAR 333-007-0390 finished inhalable cannabinoid product is or was manufactured on or after March 1, 2023.

(2) In lieu of ordering and arranging for the sampling and testing required in this rule a processor may transport batches of finished inhalable Cannabinoid products to a wholesaler licensed by the Commission under ORS 475C.093 and the wholesaler may order and arrange for the sampling and testing of the batches, in accordance with rules established by the Commission.

(3) To the extent that the testing required under this rule is also required under OAR 333-007-0340, a processor or processing site is only required to comply with the testing under this rule.

Statutory/Other Authority: ORS 475C.544
Statutes/Other Implemented: ORS 475C.544
History:
PH 24-2022, adopt filed 03/15/2022, effective 03/31/2022

333-007-0342
Compliance Testing Requirements for Industrial Hemp-Derived Vapor Items

(1) Every process lot of an industrial hemp-derived vapor item for use by a consumer or patient prior to selling or transferring the item must be tested for the following:

(a) Pesticides in accordance with OAR 333-007-0400.

(b) Solvents in accordance with OAR 333-007-0410.

(c) Adult use cannabinoid and CBD concentration in accordance with OAR 333-007-0430.

(d) Heavy metals in accordance with OAR 333-007-0415 if the industrial hemp-derived vapor item is or was manufactured on or after March 1, 2023.

(e) Mycotoxins in accordance with OAR 333-007-0425 if the industrial hemp-derived vapor item is or was manufactured on or after July 1, 2022.

(f) Microbiological contaminants in accordance with OAR 333-007-0390 if the industrial hemp-derived vapor item is or was manufactured on or after March 1, 2023.

(2) In lieu of ordering and arranging for the sampling and testing required in this rule a processor may transport batches of industrial hemp-derived vapor items that the processor manufactured to a wholesaler licensed by the Commission under ORS 475C.093 and the wholesaler may order and arrange for the sampling and testing of the batches, in accordance with rules established by the Commission.

Statutory/Other Authority: ORS 475C.544
Statutes/Other Implemented: ORS 475C.544
History:
PH 24-2022, amend filed 03/15/2022, effective 03/31/2022
PH 95-2021, adopt filed 12/29/2021, effective 01/01/2022

333-007-0350
Batch Requirements for Compliance Testing

(1) Marijuana or usable marijuana.

(a) A producer or grower must separate each harvest lot of marijuana or usable marijuana harvested before July 1, 2022, into no larger than 15 pound batches.

(b) A producer or grower must separate each harvest lot of marijuana or usable marijuana harvested on or after July 1, 2022, into no larger than 50.0-pound batches.

(2) Cannabinoid concentrates and extracts.

(a) A process lot of a cannabinoid concentrate or extract is considered a batch.

(b) A batch of a cannabinoid concentrate or extract must be produced using a standard operating procedure and result in one finished cannabinoid concentrate or extract that is uniform in texture and form.

(3) Cannabinoid products.

(a) A processor or processing site must separate process lots into not larger than 35,000 unit of sale batches.

(b) A batch of a cannabinoid product must be produced using a standard operating procedure and result in a finished cannabinoid product that is uniform in potency, texture, and weight. A standard operating procedure may use different flavors or colors in a batch if the different flavors or colors:

(A) Are substituted for one another at a 1:1 ratio; and

(B) Do not affect the potency, texture, or weight of the finished cannabinoid product.

(c) If a cannabinoid product is or may be sold in different quantities in a unit of sale, then the process lot shall be sampled based on the smallest unit of sale for the purposes of sampling and testing. All proposed units of sales must meet the Commission’s concentration limit rules found in chapter 845, division 26.

(4) Industrial hemp-derived vapor items.

(a) A process lot of an industrial hemp-derived vapor item is considered a batch.

(b) A batch of an industrial hemp-derived vapor item must be made from a standard operating procedure and result in one final industrial hemp-derived vapor item that is uniform in flavor, texture, and form.

(5) Finished inhalable cannabinoid products.

(a) A process lot of a finished inhalable cannabinoid product is considered a batch.

(b) A batch of a finished inhalable cannabinoid product must be made from a standard operating procedure and result in one finished inhalable cannabinoid product that is uniform in flavor, texture, and form.

(6) A grower and processing site must assign each batch a unique batch number and that unique batch number must be:

(a) Documented and maintained in the grower and processing site records for at least two years and available to the Authority upon request;

(b) Provided to the individual responsible for taking samples; and

(c) Included on the batch label as required in OAR 333-007-0380.

(7) A grower and processing site may not reuse a unique batch number.

(8) For the purposes of this rule, "flavor" means:

(a) The essential oil or essence which contains the flavoring constituents derived from a spice, fruit, fruit juice, vegetable, vegetable juice, herb, root, leaf, or similar plant material.

(b) Any substance, the function of which is to impart flavor, which is not derived from a spice, fruit, fruit juice, vegetable, vegetable juice, herb, root, leaf, or similar plan material.

(c) Flavor does not include flavoring constituents derived from the cannabis plant.

Statutory/Other Authority: ORS 475C.544
Statutes/Other Implemented: ORS 475C.544
History:
PH 24-2022, amend filed 03/15/2022, effective 03/31/2022
PH 95-2021, amend filed 12/29/2021, effective 01/01/2022
PH 282-2018, amend filed 12/20/2018, effective 01/01/2019
PH 9-2017, f. 5-26-17, cert. ef. 5-31-17
PH 38-2016(Temp), f. 12-13-16, cert. ef. 12-15-16 thru 5-30-17
PH 35-2016(Temp), f. & cert. ef. 12-2-16 thru 5-30-17
PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16

333-007-0360
Sampling and Sample Size Requirements for Compliance Testing

(1) Marijuana or usable marijuana.

(a) Usable marijuana may only be sampled after it is cured, unless the usable marijuana is intended for sale or transfer to a processor or processing site to make a cannabinoid concentrate or extract.

(b) Sample increments taken must in total represent a minimum of 0.5 percent of the batch, consistent with the laboratory’s accredited sampling policies and procedures, described in OAR 333-064-0100(2).

(c) A portion of homogenized samples taken from multiple batches of usable marijuana from the same harvest lot as described in OAR 333-064-0100(2)(f) may be combined into one sample for purposes of testing for adult use cannabinoids and CBD if the batches are the same strain and appear to be substantially similar in appearance and quality, regardless of the size of the multiple batches. Sampling must be performed in accordance with ORELAP-SOP-001 Rev 4.0 and on or after July 1, 2022, ORELAP-SOP-001 Rev 4.1.

(d) The whole batch of marijuana or usable marijuana must be made available for sampling and placed in containers that holds no more than 15 pounds of marijuana or usable marijuana.

(2) Cannabinoid concentrates, extracts, products, and finished inhalable cannabinoid products.

(a) The whole batch of finished cannabinoid concentrates, extracts, products, or finished inhalable cannabinoid products must be available for sampling.

(b) Samples of cannabinoid concentrates, extracts, products, and finished inhalable cannabinoid products intended for human consumption, use or ingestion for use by a consumer or patient must be taken from the finished cannabinoid concentrate, extract, product, or finished inhalable cannabinoid product as those terms are defined in OAR 333-007-0310, except for as outlined in subsection (2)(f) of this rule.

(c) For a cannabinoid concentrate, extract or finished inhalable cannabinoid product, the minimum number of sample increments that must be taken are established in Exhibit B, Table 7, incorporated by reference. The sample increments shall be combined as described in Exhibit B, Table 7, OAR 333-064-0100, and ORELAP-SOP-002 Rev. 4.3. The primary sample, the duplicate sample and any required replicate samples must be prepared and analyzed separately.

(d) For a cannabinoid product, a minimum of one unit of sale chosen at random, is required for the primary sample and one unit of sale chosen at random, is required for the duplicate sample for testing in accordance with OAR 333-007-0440, OAR 333-064-0100(2), and ORELAP-SOP-002 Rev. 4.3. The primary sample and the duplicate sample must be prepared and analyzed separately.

(e) A sufficient sample size must be taken for analysis of all requested tests and the quality control performed by the testing laboratory for these tests.

(f) If baking of a cannabinoid edible is the final step to create a finished cannabinoid product, the processor or processing site may leave the production batch unbaked and only bake the samples chosen by the testing laboratory for sampling. Prior to sampling, the processor or processing site must ensure that the entire batch is available to the laboratory and in a form where the only remaining step to complete the edible is baking. If anything is added to the edible after baking, the entire batch must be baked and finished prior to sampling. Baking means to subject the item to dry heat, typically by an oven.

(3) Industrial hemp-derived vapor items.

(a) The whole finished batch of industrial hemp-derived vapor items must be available for sampling.

(b) Samples of industrial hemp-derived vapor items must be taken in its final form ready for packaging for sale or transfer to a patient, designated primary caregiver or consumer.

(c) The minimum number of sample increments that must be taken are established in Exhibit B, Table 7, incorporated by reference. The sample increments shall be combined into a primary sample and a duplicate sample as described in OAR 333-064-0100, ORELAP-SOP-002 Rev. 4.3. The primary sample, the duplicate sample and any required replicate sample must be prepared and analyzed separately.

(d) A sufficient sample size must be taken for analysis of all requested tests and the quality control performed by the testing laboratory for these tests.

(4) Sufficient sample increments must be taken for analysis of all required tests and the quality control performed by the testing laboratory for these tests.

NOTE: ORELAP SOPs are available under OAR 333-064-0100

[ED. NOTE: To view attachments referenced in rule text, click here to view rule.]

Statutory/Other Authority: ORS 475C.544
Statutes/Other Implemented: ORS 475C.544
History:
PH 24-2022, amend filed 03/15/2022, effective 03/31/2022
PH 95-2021, amend filed 12/29/2021, effective 01/01/2022
PH 89-2020, amend filed 12/30/2020, effective 01/01/2021
PH 282-2018, amend filed 12/20/2018, effective 01/01/2019
PH 9-2017, f. 5-26-17, cert. ef. 5-31-17
PH 38-2016(Temp), f. 12-13-16, cert. ef. 12-15-16 thru 5-30-17
PH 35-2016(Temp), f. & cert. ef. 12-2-16 thru 5-30-17
PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16

333-007-0370
Sampling Personnel Requirements; Sampling Recordkeeping

(1) Only individuals employed by a laboratory with an ORELAP accredited scope item for sampling under these rules may take samples.

(2) Sampling may only be conducted at a licensee’s or registrant’s premises or the licensee or registrant may transport the entire batch to a laboratory with an ORELAP accredited scope item for sampling under these rules.

Statutory/Other Authority: ORS 475C.544
Statutes/Other Implemented: ORS 475C.544
History:
PH 6-2024, amend filed 03/20/2024, effective 04/01/2024
PH 31-2022, minor correction filed 04/26/2022, effective 04/26/2022
PH 9-2017, f. 5-26-17, cert. ef. 5-31-17
PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16

333-007-0380
Grower and Processing Site Requirements for Labeling, Storing, and Securing Pre-Tested Marijuana Items; Recordkeeping

(1) Following samples being taken from a harvest or process lot batch a grower or processing site must:

(a) Label the batch with the following information:

(A) The registrant’s registration number;

(B) The harvest or process lot unique identification number;

(C) The name and accreditation number of the laboratory that took samples and the name and accreditation number of the laboratory responsible for the testing, if different;

(D) The test batch or sample unique identification numbers supplied by the laboratory personnel;

(E) The date the samples were taken; and

(F) In bold, capital letters, no smaller than 12 point font, "PRODUCT NOT TESTED."

(b) Store and secure the batch in a manner that prevents the product from being tampered with or transferred prior to test results being reported.

(c) Be able to easily locate a batch stored and secured under section (1)(b) of this rule and provide that location to the Authority or a laboratory upon request.

(2) If the samples pass testing the product may be sold or transferred in accordance with the applicable Authority rules.

(3) If the samples do not pass testing the grower or processing site must comply with OAR 333-007-0450.

Statutory/Other Authority: ORS 475C.544
Statutes/Other Implemented: ORS 475C.544
History:
PH 32-2022, minor correction filed 04/26/2022, effective 04/26/2022
PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16

333-007-0390
Standards for Microbiological Contaminants Compliance Testing

(1) A marijuana item or industrial hemp-derived vapor item required to be tested for microbiological contaminants under OAR 333-007-0320 to 333-007-0342 must be sampled using appropriate aseptic technique and tested by a laboratory for Shiga toxin-producing Escherichia coli and Salmonella species.

(2) A batch fails microbiological contaminants testing if, during an initial test where no reanalysis is requested or upon reanalysis as described in OAR 333-007-0450(1) the laboratory detects:

(a) Shiga toxin-producing Escherichia coli in one gram; or

(b) Salmonella spp. in one gram.

(3) Marijuana items and industrial hemp-derived vapor items tested for Aspergillus on or before August 25, 2023, in accordance with the rules that were in effect at the time, that have a laboratory test report indicating the samples contained pathogenic Aspergillus flavus, A. fumigatus, A. niger or A. terreus that were remediated or were attempted to be remediated must be resampled and retested in accordance with OAR 333-007-0450(6)(c) but are not required to be tested for pathogenic Aspergillus flavus, A. fumigatus, A. niger or A. terreus.

(4) A marijuana item or industrial hemp-derived vapor item tested for Aspergillus on or before August 25, 2023, in accordance with the rules that were in effect at the time, that have a laboratory test report indicating the samples contained pathogenic Aspergillus flavus, A. fumigatus, A. niger or A. terreus, is not considered to have failed a compliance test for the purposes of OAR 333-007-0450.

Statutory/Other Authority: ORS 475C.544
Statutes/Other Implemented: ORS 475C.544
History:
PH 53-2023, amend filed 12/12/2023, effective 12/20/2023
PH 43-2023, temporary amend filed 09/15/2023, effective 09/15/2023 through 03/12/2024
PH 24-2022, amend filed 03/15/2022, effective 03/31/2022
PH 95-2021, amend filed 12/29/2021, effective 01/01/2022
PH 258-2018, minor correction filed 11/28/2018, effective 11/28/2018
PH 9-2017, f. 5-26-17, cert. ef. 5-31-17
PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16

333-007-0400
Standards for Pesticides Compliance Testing

(1) A marijuana item or industrial hemp-derived vapor item required to be tested for pesticides must be tested by a laboratory for all the analytes listed in Exhibit A, Table 3, incorporated by reference.

(2) A batch fails pesticide testing if a laboratory detects the presence of a pesticide above the action levels listed in Exhibit A, Table 3 in any sample, including a duplicate:

(a) During an initial test where no reanalysis is requested; or

(b) Upon reanalysis as described in OAR 333-007-0450(1).

(3) The Authority will review and update, if necessary, the analytes listed in Exhibit A, Table 3, at least every two years.

[ED. NOTE: To view attachments referenced in rule text, click here to view rule.]

Statutory/Other Authority: ORS 475C.544
Statutes/Other Implemented: ORS 475C.544
History:
PH 24-2022, amend filed 03/15/2022, effective 03/31/2022
PH 95-2021, amend filed 12/29/2021, effective 01/01/2022
PH 282-2018, amend filed 12/20/2018, effective 01/01/2019
PH 9-2017, f. 5-26-17, cert. ef. 5-31-17
PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16

333-007-0410
Standards for Solvents Compliance Testing

(1) A marijuana item or industrial hemp-derived vapor item required to be tested for solvents must be tested by a laboratory for all the analytes listed in Exhibit A, Table 4 incorporated by reference.

(2) A batch fails solvent testing if a laboratory, during an initial test where no reanalysis is requested or upon reanalysis as described in OAR 333-007-0450(1):

(a) Detects the presence of a solvent above the action level listed in Exhibit A, Table 4 in a sample;

(b) Calculates a RPD of more than 10 percent between the primary result and the duplicate result if the mean result is greater than half the action level for any analyte listed in Exhibit A, Table 4; or

(c) Calculates a RSD of more than 10 percent between the primary result, the duplicate result and any replicate result if the mean result is greater than half the action level for any analyte listed in Exhibit A, Table 4.

(3) The Authority will review and update, if necessary, the analytes listed in Exhibit A, Table 4, at least every two years.

[ED. NOTE: To view attachments referenced in rule text, click here to view rule.]

Statutory/Other Authority: ORS 475C.544
Statutes/Other Implemented: ORS 475C.544
History:
PH 24-2022, amend filed 03/15/2022, effective 03/31/2022
PH 95-2021, amend filed 12/29/2021, effective 01/01/2022
PH 282-2018, amend filed 12/20/2018, effective 01/01/2019
PH 9-2017, f. 5-26-17, cert. ef. 5-31-17
PH 35-2016(Temp), f. & cert. ef. 12-2-16 thru 5-30-17
PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16

333-007-0415
Standards for Heavy Metal Compliance Testing

(1) A marijuana item or industrial hemp-derived vapor item required to be tested for heavy metals must be tested by a laboratory for the analytes listed in Exhibit A, Table 8 incorporated by reference.

(2) A batch fails heavy metal testing if a laboratory detects the presence of a heavy metal above the action levels listed in Exhibit A, Table 8 in any sample, including a duplicate:

(a) During an initial test where no reanalysis is requested; or

(b) Upon reanalysis as described in OAR 333-007-0450(1).

[ED. NOTE: To view attachments referenced in rule text, click here to view rule.]

Statutory/Other Authority: ORS 475C.544
Statutes/Other Implemented: ORS 475C.544
History:
PH 24-2022, adopt filed 03/15/2022, effective 03/31/2022

333-007-0420
Standards for Testing Water Activity and Moisture Content

(1) Usable marijuana must be tested by a laboratory for:

(a) Water activity; and

(b) Moisture content.

(2) Kief manufactured before March 1, 2023, must be tested by a laboratory for water activity unless the marijuana or usable marijuana used to produce the kief has already passed testing for water activity prior to producing the kief in accordance with OAR 333-007-0320(6).

(3) If a sample has a water activity rate of more than 0.65 Aw the sample fails.

(4) If a sample has a moisture content of more than 15 percent the sample fails.

Statutory/Other Authority: ORS 475C.544
Statutes/Other Implemented: ORS 475C.544
History:
PH 24-2022, amend filed 03/15/2022, effective 03/31/2022
PH 89-2020, amend filed 12/30/2020, effective 01/01/2021
PH 282-2018, amend filed 12/20/2018, effective 01/01/2019
PH 9-2017, f. 5-26-17, cert. ef. 5-31-17
PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16

333-007-0425
Standards for Mycotoxin Contaminants Compliance Testing

(1) A marijuana item or industrial hemp-derived vapor item required to be tested for mycotoxin must be tested by a laboratory for:

(a) Aflatoxins B1, B2, G1, G2; and

(b) Ochratoxin A.

(2) A batch fails mycotoxin testing if, during an initial test where no reanalysis is requested or upon reanalysis as described in OAR 333-007-0450(1), the laboratory detects levels above the action levels listed in Exhibit A, Table 9 in any sample.

[ED. NOTE: To view attachments referenced in rule text, click here to view rule.]

Statutory/Other Authority: ORS 475C.544
Statutes/Other Implemented: ORS 475C.544
History:
PH 24-2022, adopt filed 03/15/2022, effective 03/31/2022

333-007-0430
Standards for Adult Use Cannabinoid and CBD Compliance Testing

(1) A laboratory must test for all of the following analytes when testing a marijuana item or industrial hemp-derived vapor item for potency:

(a) Delta-9-THC.

(b) Delta-9-THCA.

(c) Delta-8-THC.

(c) CBD.

(d) CBDA.

(2) A process lot of a cannabinoid concentrate, extract, product, finished inhalable cannabinoid product, or industrial hemp-derived vapor item fails potency testing if, based on an initial test where no reanalysis is requested or upon reanalysis as described in OAR 333-007-0450(1):

(a) The amount of delta-8-THC, total delta-9-THC or total CBD, as calculated pursuant to OAR 333-064-0100, between the primary sample and the duplicate sample exceeds 10 percent RPD or between the primary sample, duplicate sample and any replicate samples exceeds 10 percent RSD; or

(b) The amount or percentage of delta-8-THC, total delta-9-THC, as calculated pursuant to OAR 333-064-0100, exceeds the maximum concentration limits permitted in a package by over 10 percent as specified in the Oregon Liquor and Cannabis Commission’s concentration limit rules in OAR chapter 845, division 26, as applicable.

(3) Notwithstanding subsection (2)(a) of this rule:

(a) A cannabinoid product that has less than 5 mg of total delta-9-THC per unit of sale as calculated pursuant to OAR 333-064-0100 does not fail potency testing based on exceedance of the RPD or RSD as described in subsection (2)(a) of this rule.

(b) A cannabinoid product that has less than 10 mg of total CBD per unit of sale as calculated pursuant to OAR 333-064-0100 does not fail potency testing based on exceedance of the RPD or RSD as described in subsection (2)(a) of this rule.

(c) A cannabinoid product that has less than 5 mg of delta-8-THC per unit of sale as calculated pursuant to OAR 333-064-0100 does not fail potency testing based on exceedance of the RPD or RSD as described in subsection (2)(a) of this rule.

(d) A cannabinoid concentrate, extract, finished inhalable cannabinoid product, or industrial hemp-derived vapor item that has less than 5 mg total delta-9-THC per gram as calculated pursuant to OAR 333-064-0100 does not fail potency testing based on exceedance of the RPD or RSD as described in subsection (2)(a) of this rule.

(e) A cannabinoid concentrate, extract, finished inhalable cannabinoid product, or industrial hemp-derived vapor item that has less than 10 mg total CBD per gram as calculated pursuant to OAR 333-064-0100 does not fail potency testing based on exceedance of the RPD or RSD as described in subsection (2)(a) of this rule.

(f) A cannabinoid concentrate, extract, finished inhalable cannabinoid product, or industrial hemp-derived vapor item that has less than 5 mg delta-8-THC per gram as calculated pursuant to OAR 333-064-0100 does not fail potency testing based on exceedance of the RPD or RSD as described in subsection (2)(a) of this rule.

Statutory/Other Authority: ORS 475C.544
Statutes/Other Implemented: ORS 475C.544
History:
PH 6-2024, amend filed 03/20/2024, effective 04/01/2024
PH 24-2022, amend filed 03/15/2022, effective 03/31/2022
PH 95-2021, amend filed 12/29/2021, effective 01/01/2022
PH 89-2020, amend filed 12/30/2020, effective 01/01/2021
PH 282-2018, amend filed 12/20/2018, effective 01/01/2019
PH 9-2017, f. 5-26-17, cert. ef. 5-31-17
PH 35-2016(Temp), f. & cert. ef. 12-2-16 thru 5-30-17
PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16

333-007-0450
Failed Test Samples

(1) If a sample or a duplicate sample (collectively referred to as "sample" for purposes of this rule) fails any initial test the laboratory that did the testing may reanalyze the sample. The laboratory that did the initial test may not subcontract the reanalysis. If a primary sample or a duplicate sample fails, both must be reanalyzed. If the sample passes, another laboratory must resample the batch and confirm that result in order for the batch to pass testing.

(a) If a registrant or licensee requests to have a sample reanalyzed, the registrant or licensee must request a reanalysis within seven calendar days from the date the laboratory sent notice of the failed test to the registrant or licensee. The reanalysis must be completed by the laboratory within 30 days from the date the reanalysis was requested.

(b) If a registrant or licensee has requested a reanalysis in accordance with subsection (1)(a) of this rule and the sample passes, the registrant or licensee has seven calendar days from the date the laboratory sent notice of the passed test to request that another laboratory resample the batch and confirm the passed test result. The retesting must be completed by the second laboratory within 30 days from the date the retesting was requested. The second laboratory performing the retesting:

(A) May not be performed at a laboratory under the same ownership as the original laboratory that performed the testing.

(B) May not be done by a laboratory that was subcontracted to do the original testing.

(C) May only conduct retesting for the compliance test that initially failed.

(c) If reanalysis in accordance with subsection (1)(a) or retesting in accordance with subsection (1)(b) is ordered, then the batch must remain in its original quantity as it was initially submitted to the laboratory for testing and may not be subdivided.

(d) A registrant must inform the Oregon Health Authority (Authority) immediately, of the following, in a manner prescribed by the Authority:

(A) A request for reanalysis of a sample;

(B) The testing results of the reanalysis;

(C) A request for retesting; and

(D) The results of retesting.

(2) If a sample fails a test or a reanalysis under section (1) of this rule the batch:

(a) May be remediated or sterilized in accordance with this rule.

(b) Must be destroyed in a manner specified by the Authority or the Oregon Liquor and Cannabis Commission (Commission) if it is not or cannot be remediated or sterilized under this rule.

(c) May not be combined with other batches as part of remediation or further processing.

(3) If a registrant is permitted to remediate or sterilize under this rule, the registrant must provide notice to the Authority of the registrant’s intent to remediate or sterilize.

(4) Except as otherwise permitted under this rule, a cannabinoid concentrate, extract, finished inhalable cannabinoid product, or industrial hemp-derived vapor item that is permitted to undergo remediation cannot be further processed into a cannabinoid product during the remediation process.

(5) If a licensee or registrant is permitted under this rule to sell or transfer a batch that has failed a test, the licensee or registrant must notify the licensee or registrant to whom the batch is sold or transferred of the failed test.

(6) Failed microbiological contaminant testing.

(a) If a sample from a batch of marijuana or usable marijuana fails microbiological contaminant testing the batch may either:

(A) Be remediated using a sterilization process; or

(B) Be used to make a cannabinoid concentrate or extract if the processing method effectively sterilizes the batch, such as a method using a hydrocarbon-based solvent or a CO2 closed loop system.

(b) If a sample from a batch of a cannabinoid concentrate, extract, finished inhalable cannabinoid product, or industrial hemp-derived vapor item fails microbiological contaminant testing the batch may be further processed if the processing method effectively sterilizes the batch, such as a method using a hydrocarbon-based solvent or a CO2 closed loop system.

(c) A batch that is remediated through a sterilization process in accordance with subsection (a) or (b) of this section must be sampled in accordance with OAR 333-007-0360 and must be tested for:

(A) Microbiological contaminants;

(B) Solvents if required per OAR 333-007-0410;

(C) Pesticides;

(D) Water activity and moisture content if required per OAR 333-007-0420;

(E) Potency in accordance with OAR 333-007-0430(1);

(F) Heavy metals if the marijuana item or industrial hemp-derived vapor item was harvested or manufactured on or after March 1, 2023; and

(G) Mycotoxins if the marijuana item or industrial hemp-derived vapor item was harvested or manufactured on or after July 1, 2022.

(d) A batch that fails microbiological contaminant testing after undergoing remediation through a sterilization process in accordance with paragraph (a)(A) of this section must be destroyed in a manner specified by the Authority or the Commission, or may be further processed as described in paragraph (a)(B) of this section.

(7) Failed solvent testing.

(a) If a sample from a batch fails solvent testing the batch may be remediated using procedures that would reduce the concentration of solvents to less than the action level.

(b) A batch that is remediated in accordance with subsection (a) of this section must be re-sampled in accordance with OAR 333-007-0360 and must be re-tested for:

(A) Solvents;

(B) Pesticides;

(C) Potency in accordance with OAR 333-007-0430(1);

(D) Heavy metals if the marijuana item or industrial hemp-derived vapor item was manufactured on or after March 1, 2023;

(E) Mycotoxins if the marijuana item or industrial hemp-derived vapor item was manufactured on or after July 1, 2022; and

(F) Microbiological contaminants if the marijuana item or industrial hemp-derived vapor item was manufactured on and after March 1, 2023.

(c) A batch that fails solvent testing that is not remediated must be destroyed in a manner specified by the Authority or the Commission.

(8) Failed water activity or moisture content testing.

(a) If a sample from a batch of marijuana or usable marijuana fails for water activity or moisture content the batch from which the sample was taken may:

(A) Be used to make a cannabinoid concentrate or extract if the processing method effectively sterilizes the batch; or

(B) Continue to dry or cure.

(b) A batch that undergoes additional drying or curing as described in paragraph (a)(B) of this section must be re-sampled in accordance with OAR 333-007-0360 and re-tested for:

(A) Pesticides;

(B) Water activity and moisture content;

(C) Potency in accordance with OAR 333-007-0430(1);

(D) Heavy metals if the marijuana or usable marijuana was harvested on or after March 1, 2023;

(E) Mycotoxins if the marijuana or usable marijuana was harvested on or after July 1, 2022; and

(F) Microbiological contaminants if the marijuana or usable marijuana was harvested on and after March 1, 2023.

(9) Failed pesticide testing.

(a) If a sample from a batch of marijuana or usable marijuana fails pesticide testing the batch may not be remediated and must be destroyed as ordered by the Authority or the Commission, except as permitted under subsection (c) of this section. A batch may not be destroyed without obtaining permission from the Authority or the Commission.

(b) The Authority must report to the Oregon Department of Agriculture all test results that show that a sample of usable marijuana failed a pesticide test.

(c) If a sample from a batch of marijuana or usable marijuana fails pesticide testing but only for the analytes piperonyl butoxide or pyrethrins, and the Oregon Department of Agriculture determines that the products used were listed on the Department’s Guide List for Pesticides and Cannabis and the product was applied in accordance with the label, the Authority or the Commission may permit the producer or grower to remediate the usable marijuana using procedures that would reduce the concentration of pesticides to less than the action level. A batch of usable marijuana that is permitted to be remediated must be re-sampled in accordance with OAR 333-007-0360 and re-tested for:

(A) Pesticides;

(B) Water activity and moisture content;

(C) Potency in accordance with OAR 333-007-0430(1);

(D) Microbiological contaminates if the marijuana item was harvested on or after March 1, 2023;

(E) Heavy metals if the marijuana item was harvested on or after March 1, 2023; and

(F) Mycotoxins if the marijuana item was harvested on or after July 1, 2022.

(d) If a processor or a processing site is only processing with marijuana or usable marijuana that has passed pesticide testing in accordance with OAR 333-007-0400 and a sample from a batch of a cannabinoid concentrate or extract fails pesticide testing the batch may be remediated using procedures that would reduce the concentration of pesticides to less than the action level.

(e) If a batch of industrial hemp-derived vapor item fails pesticides testing, it may only be remediated using procedures that would reduce the concentration of pesticides to less than the action level if the input material used to make the industrial hemp-derived vapor item passed pesticide testing in accordance with OAR 333-007-0400.

(f) A batch that is remediated in accordance with subsection (d) or (e) of this section must be re-sampled in accordance with OAR 333-007-0360 and re-tested for:

(A) Pesticides;

(B) Potency in accordance with OAR 333-007-0430(1);

(C) Solvent testing if required per OAR 333-007-0410;

(D) Heavy metals;

(E) Mycotoxins; and

(F) Microbiological contaminants.

(g) If a sample from a batch of finished inhalable cannabinoid products fails pesticide testing, the batch may not be remediated and must be destroyed in a manner specified by the Authority or the Commission.

(h) A batch that is remediated but after being re-sampled and re-tested fails pesticide testing must be destroyed as ordered by the Authority or the Commission.

(10) Failed potency testing.

(a) A marijuana item or industrial hemp-derived vapor item that fails potency testing under OAR 333-007-0430(2)(b) may be repackaged in a manner that enables the item to meet the concentration limit standards in the Commission’s concentration limit rules in OAR chapter 845, division 26, as applicable. A marijuana item or industrial hemp-derived vapor item that is repackaged in accordance with this subsection must be re-sampled and re-tested in accordance with these rules.

(b) A marijuana item or industrial hemp-derived vapor item that fails potency testing under OAR 333-007-0430(2)(a) may be re-mixed to meet the standards in OAR 333-007-0430(2)(a). A marijuana item or industrial hemp-derived vapor item that is re-mixed must be re-sampled in accordance with OAR 333-007-0360 and re-tested in accordance with these rules for the marijuana item or industrial hemp-derived vapor item for:

(A) Pesticides;

(B) Potency in accordance with OAR 333-007-0430(1);

(C) Solvent testing if required per OAR 333-007-0410;

(D) Heavy metals if the marijuana item or industrial hemp-derived vapor item is or was manufactured on or after March 1, 2023;

(E) Mycotoxins if the marijuana item or industrial hemp-derived vapor item is or was manufactured on or after July 1, 2022; and

(F) Microbiological contaminants if the marijuana item or industrial hemp-derived vapor item is or was manufactured on and after March 1, 2023.

(11) Failed heavy metal testing.

(a) If a sample from a batch of marijuana or usable marijuana fails heavy metal testing, the batch may be remediated by processing into a cannabinoid concentrate or extract if the processing method reduces the concentration of heavy metals to less than the action levels.

(b) If a sample from a cannabinoid concentrate or extract fails heavy metal testing, the batch may be remediated using procedures that would reduce the concentration of heavy metals to less than the action level.

(c) If a sample from a batch of finished inhalable cannabinoid product or industrial hemp-derived vapor item fails for heavy metals, the batch may not be remediated and must be destroyed in a manner specified by the Authority or Commission.

(d) A batch that is remediated in accordance with subsection (a) or (b) of this section must be re-sampled in accordance with OAR 333-007-0360 and re-tested for:

(A) Pesticides;

(B) Solvents if required under OAR 333-007-0410;

(C) Potency in accordance with OAR 333-007-0430(1);

(D) Heavy metals;

(E) Mycotoxins; and.

(F) Microbiological contaminants.

(e) A batch that fails heavy metal testing that is not remediated must be destroyed in a manner specified by the Authority, Commission, or the Department of Agriculture.

(12) Failed mycotoxin testing. If a sample from a batch of a marijuana item or industrial hemp-derived vapor item fails mycotoxin testing the batch may not be remediated and must be destroyed in a manner specified by the Authority, Commission, or the Department of Agriculture.

(13) A registrant must inform a laboratory prior to samples being taken that the batch has failed a test and is being retested after undergoing remediation or sterilization.

(14) A registrant must, as applicable:

(a) Have detailed procedures for sterilization processes to remove microbiological contaminants and for reducing the concentration of solvents.

(b) Document all sampling, testing, sterilization, remediation and destruction that are a result of failing a test under these rules.

(15) If a batch fails a test under these rules a registrant:

(a) Must store and segregate the batch in a secure area and label the batch clearly to indicate it has failed a test and the label must include a test batch number.

(b) May not remove the batch from the registered premises without permission from the Authority.

Statutory/Other Authority: ORS 475C.544
Statutes/Other Implemented: ORS 475C.544
History:
PH 6-2024, amend filed 03/20/2024, effective 04/01/2024
PH 24-2022, amend filed 03/15/2022, effective 03/31/2022
PH 95-2021, amend filed 12/29/2021, effective 01/01/2022
PH 89-2020, amend filed 12/30/2020, effective 01/01/2021
PH 282-2018, amend filed 12/20/2018, effective 01/01/2019
PH 29-2017, amend filed 12/22/2017, effective 01/01/2018
PH 9-2017, f. 5-26-17, cert. ef. 5-31-17
PH 35-2016(Temp), f. & cert. ef. 12-2-16 thru 5-30-17
PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16

333-007-0470
Tentative Identification of Compounds

(1) Tentatively Identified Compounds (TICs) are compounds detected in a sample using gas chromatography mass spectrometry that are not among the target analytes for the residual solvent analysis.

(2) The Authority or Commission may initiate an investigation of a registrant or licensee for TICS and may require a registrant or licensee to submit samples for additional testing, including testing for analytes that are not required by these rules, at the registrant’s or licensee’s expense.

Statutory/Other Authority: ORS 475C.544
Statutes/Other Implemented: ORS 475C.544
History:
PH 33-2022, minor correction filed 04/26/2022, effective 04/26/2022
PH 95-2021, amend filed 12/29/2021, effective 01/01/2022
PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16

333-007-0480
Audit and Random Testing

(1) The Oregon Health Authority (Authority) may require a registrant to submit samples identified by the Authority to a laboratory of the Authority's choosing or the cannabis reference laboratory to be tested in order to determine whether a registrant is in compliance with OAR 333-007-0300 through 333-007-0600 or any other rule of the Authority.

(2) A laboratory doing audit testing under section (1) of this rule must comply with these rules unless otherwise authorized by the Authority.

(3) The Authority may, at any time, require a registrant to permit the sampling of or submit a sample of a marijuana item to the Authority for testing. Such testing may include testing for:

(a) Any microbiological contaminant.

(b) Heavy metals;

(c) Solvents;

(d) Pesticides;

(e) Mycotoxins;

(f) Adulterants, additives, or other contaminants that may pose a risk to public health or safety, or is prohibited by law.

(4) The Authority may require any testing ordered under sections (1) and (3) of this rule to be paid for by the registrant.

(5) The Authority may obtain a marijuana item from a registrant at any time and have it tested to ensure compliance with these rules and OAR chapter 333, division 8, or to protect the public health and safety.

Statutory/Other Authority: ORS 475C.544
Statutes/Other Implemented: ORS 475C.544
History:
PH 6-2024, amend filed 03/20/2024, effective 04/01/2024
PH 24-2022, amend filed 03/15/2022, effective 03/31/2022
PH 89-2020, amend filed 12/30/2020, effective 01/01/2021
PH 21-2019, temporary amend filed 10/11/2019, effective 10/15/2019 through 04/11/2020
PH 9-2017, f. 5-26-17, cert. ef. 5-31-17
PH 35-2016(Temp), f. & cert. ef. 12-2-16 thru 5-30-17
PH 21-2016, f. 6-24-16, cert. ef. 6-28-16
PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16

333-007-0500
Quality Control and Research and Development Testing

(1) A registrant or a licensee may request that a laboratory conduct testing for the purpose of assuring quality control or for research and development, except as provided in section (2) of this rule.

(a) A quality control test result, research and development test result, or test results from testing for any purpose other than compliance testing must be tracked and entered into CTS.

(b) A registrant, licensee, or other requestor must ensure that relevant information regarding the registrant, licensee, or manufacturer of the item is provided to the laboratory conducting the testing in accordance with OAR 333-007-0315.

(2) A registrant or a licensee may not request that a laboratory conduct pesticide testing on marijuana or usable marijuana for the purpose of quality control, research and development or any purpose other than compliance testing. A pesticide test on marijuana or usable marijuana is considered by the Authority and the Commission to be a compliance test.

(3) A marijuana item or industrial hemp-derived vapor item submitted for quality control or research and development testing is not subject to OAR 333-007-0320 to 333-007-0470.

(4) A laboratory result from a quality control or research and development test cannot be used as a compliance test result and a marijuana item or an industrial hemp-derived vapor item that has only undergone a quality control or research and development test may not be transferred or sold, unless the marijuana item is not required to have a compliance test before being transferred or sold.

(5) The certificate of analysis must clearly indicate that the testing performed was for quality control or research and development testing and is not considered a compliance test.

(6) Registrants and licensees must maintain and retain all quality control and research and development test results for at least two years and provide copies of such results upon request to the Authority or the Commission.

Statutory/Other Authority: ORS 475C.544
Statutes/Other Implemented: ORS 475C.544
History:
PH 24-2022, amend filed 03/15/2022, effective 03/31/2022
PH 95-2021, amend filed 12/29/2021, effective 01/01/2022
PH 32-2021, amend filed 07/27/2021, effective 07/27/2021
PH 10-2021, temporary amend filed 03/03/2021, effective 03/03/2021 through 08/29/2021
PH 89-2020, amend filed 12/30/2020, effective 01/01/2021
PH 282-2018, amend filed 12/20/2018, effective 01/01/2019
PH 29-2017, amend filed 12/22/2017, effective 01/01/2018
PH 9-2017, f. 5-26-17, cert. ef. 5-31-17

333-007-0600
Cannabis Reference Laboratory

(1) The Oregon Health Authority (Authority) may request that the cannabis reference laboratory conduct any of the following:

(a) Audit testing as described in OAR 333-007-0480; or

(b) Testing if the Authority has reason to believe the marijuana item, industrial hemp or hemp item is not in compliance with ORS 475C.544 or these rules.

(2) The Authority may consider a test conducted by the cannabis reference laboratory to be a compliance test.

(3) If a test conducted by the cannabis reference laboratory indicates a sample fails to comply with concentration limits in OAR chapter 845, division 26 or an action level in OAR chapter 333, division 7, the Authority may invalidate the results of the test conducted by the original laboratory. If the Authority invalidates a compliance test result:

(a) The Authority must notify the registrant who ordered the compliance test.

(b) The registrant must follow the applicable procedures under OAR 333-007-0450 regarding failed test samples.

(c) Subject to any reanalysis conducted pursuant to OAR 333-007-0450, the Authority may require the recall of any marijuana items, industrial hemp or hemp items associated with a failed sample that have been sold or transferred. The recall must be conducted in accordance with instructions provided by the Authority. The registrant must either:

(A) Destroy the affected marijuana items, industrial hemp, or hemp items; or

(B) Remediate the affected marijuana items, industrial hemp, or hemp items in accordance with OAR 333-007-0450.

(4) The Authority may request or require a recall based on the cannabis reference laboratory audit testing.

Statutory/Other Authority: ORS 475C.523
Statutes/Other Implemented: ORS 475C.523
History:
PH 6-2024, adopt filed 03/20/2024, effective 04/01/2024