The Oregon Health Authority (OHA) adopted new marijuana testing rules that went into effect on March 31, 2022. OHA released a bulletin explaining the rule changes, but the agency stresses that licensees should not rely on the bulletin solely and should themselves review all applicable rule changes. The new rules are significant and change batching and sampling requirements, control studies, and quality and control testing. This blog focuses on the new types of testing applicable to cannabis products.
Marijuana items and industrial hemp-derived vapor items harvested or manufactured on or after July 1, 2022, must be tested for mycotoxin contamination pursuant to OAR 333-007-0425 if the product is intended for use by a consumer or will be transferred to a processor to make a cannabinoid product (except for inhalable cannabinoid products).
A batch fails mycotoxins testing if the test detects the presence of mycotoxins above “action levels” listed in Exhibit A, Table 9 of the new rules. The set action levels for all mycotoxins are set at 0.02 ug/g, and the testing will look for aflatoxin B1, B2, G1, G2, and ochratoxin A. Mycotoxin testing was added to the list of random testing OHA can require of marijuana items pursuant to OAR 333-007-0480.
Heavy Metals Testing
Beginning March 1, 2023, marijuana items and industrial hemp-derived vapor items must be tested for heavy metals testing pursuant to OAR 333-007-0415. Just like mycotoxins testing, only products intended for use by a consumer or transfer to a processor to make a cannabinoid product (again, excluding inhalable cannabinoid products) must go through this new testing.
Batches fail if they exceed the action levels set out in Exhibit A (Table 8) of the new rules. The exhibit sets the action levels at 0.2 ug/g for arsenic and cadmium, 0.5 ug/g for lead, and 0.1 ug/g for mercury. Notably, the new rules allow for remediation of products that fail heavy metals testing.
Microbiological Testing Requirements
The March 1, 2023, harvest date also attaches new requirements for microbiological contaminant testing pursuant to OAR 333-007-0390. Previously, microbiological contaminant testing looked specially for the presence of E. Coli and batches failed if samples showed a detection of E. Coli at 100 colony forming units per gram. Under the new rules, microbiological testing looks specifically for pathogenic Aspergillus flavus, A. fumigatus, A. niger and A. terreus, Shiga toxin-producing Escherichia coli and Salmonella species. The failure level is set at a uniform cut off point of one gram per sample.
Compliance Testing Requirements for Finished Inhalable Cannabinoid Products
The updated rules create a newly defined class of products called “Finished Inhalable Cannabinoid Products,” which include any “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.” OHA’s bulletin provides examples of these products to include “infused pre-rolls or inhalable cannabinoid products with non-cannabis additives.”
Under OAR 333-007-0341, these products must undergo testing for pesticides, solvents, adult use cannabinoid and CBD concentration, mycotoxins testing if manufactured on or after July 1, 2022, and heavy metals and the updated microbiological contamination testing if manufactured on or after March 1, 2023.
Repeal of “Control Study” Rule
OLCC’s eliminated control studies, which were previously required pursuant OAR 333-007-0440. The purpose of the now repealed rule was to ensure processors use standard operating procedures (SOP) that result in homogenous finished products. The tracked changed copy of the new regulations explains that control studies are repealed because of changes in “how sampling and testing will occur with the adoption of additional testing for heavy metals, mycotoxins and microbiological contaminants.”
The control study requirement for cannabinoid products is partially replaced by new SOP requirements under OAR 333-007-0350. For cannabinoid products a batch “must be produced using a standard operating procedure and result in a finished cannabinoid product that is uniform in potency, texture, and weight.” Similarly, Industrial hemp-derived vapor items and finished inhalable cannabinoid products “must be made from a standard operating procedure and result in one finished inhalable cannabinoid product that is uniform in flavor, texture, and form.”
Outgoing Water Activity and Moisture Content Testing
Beginning March 1, 2023, water activity and moisture content testing is not required for batches of harvested marijuana or usable marijuana intended for use by a processor in making cannabinoid concentrates, extracts, or finished inhalable cannabinoid products. The outgoing water activity testing requirement also applies to marijuana harvested with the intent of producing kief if the marijuana is harvested after March 1, 2023. Water activity and moisture content testing will remain a requirement for marijuana intended for transfer to a consumer or transfer to a processor with the intent of making cannabinoid products (except for finished inhalable cannabinoid products).