Oregon Psilocybin Advisory Board Draft Testing Rules; To Discuss Tomorrow (2/24)
The Oregon Psilocybin Advisory Board (the “Board”) has released a set of draft rules covering proposed testing, production, and training requirements for psilocybin service providers. Last week we discussed the draft production and training rules ahead of the Rules Advisory Committee (“RAC”) meetings discussing those draft rules.
In preparation of the RAC’s meeting tomorrow, February 24th from 9:00 am – 12:00 pm, to discuss the draft psilocybin testing rules, let’s take a look at some of the highlights in the first draft of the psilocybin testing rules. As I’ve stated previously, while the draft rules are likely to change substantially prior to their enactment they give us nice peek into our future and what Oregon’s psilocybin program may look like come January of 2023.
Zoom links and call-in information for tomorrow’s RAC meeting, and Friday’s meeting wherein the RAC will discuss the draft training rules for the second time, can be found here.
Testing, Testing, 1-2-3
The draft rules set out a number of tests psilocybin products will have to pass before they can be brought to market.
Speciation Testing: Every harvest lot of psilocybin must pass the speciation test. To pass the speciation test, psilocybin from each harvest lot must test as 100% Psilocybe cubensis (the draft products rules only authorize this species), demonstrating that the fungi does not contain any other fungi species. I guess variety is not the spice of life after all…
Potency Testing: Manufacturers must test every batch of finished psilocybin product from a harvest lot to determine the concentration of psilocybin and psilocin in the product. The potency levels of psilocybin and psilocin in each sample tested in a batch cannot deviate more than 20% from one another. No word on remediation.
Solvent Testing: Manufacturers using methanol to manufacture psilocybin extract must order tests for methanol for every process lot of extract. Extract samples cannot contain more than 3000 μg/g of methanol. The draft rules do allow for remediation for those samples that fail solvency testing.
Pesticide Testing: Psilocybin manufacturers will only have to test their psilocybin product for pesticides upon the written request of the Oregon Health Authority (the “Authority”). If so requested by the Authority, every harvest or process lot of psilocybin tested must pass tests indicating that the lot does not contain amounts of pesticides in excess of the amounts authorized by the rules. Remediation is not authorized for psilocybin that fails pesticide testing and failed batches must be destroyed.
Microbiological Contaminant Testing: Upon the written request of the Authority, a manufacturer must submit a batch from their psilocybin harvest lot for microbiological contaminant testing. Psilocybin samples that contain E. Coli at more than 100 colony forming units per gram will fail testing and, thankfully, cannot be remediated.
Heavy Metals Testing: While heavy metal may be king🤘—heavy metals in psilocybin are not. Similar to pesticide testing, psilocybin manufacturers will only be required to complete heavy metals testing upon the written request of the Authority. If so requested, labs will test harvest or process lot psilocybin batches for lead, cadmium, mercury, and arsenic. A batch fails heavy metals testing if it includes levels of any one of the aforementioned metals in excess of the amounts authorized by the rules. Remediation is not authorized for psilocybin that fails heavy metals testing and failed batches must be destroyed.
For more information on ordering tests, batch requirements, product sampling requirements, requirements for pre-tested psilocybin products, what happens to failed test samples, and quality control and R&D testing take a look at the draft rules.
Stay tuned for more updates as Oregon’s psilocybin program progresses. For questions about Oregon’s psilocybin program please contact Gleam Law.