Measure 109 covered psilocybin testing standards in some detail. It also directed the Oregon Health Authority (OHA) to adopt rules on this topic. I’ll cover the unreleased, first draft of those rules today. They begin at OAR 333-333-7010.
As I wrote in parts one and two of this series (training; products) it’s important to remember that because these rules are nonfinal, things could change between now and May– or whenever the final versions of the product rules are released. Still, these draft rules give a strong indication of the thinking and direction of OHA psilocybin program architecture.
The nature of psilocybin testing labs
Before I get into the nitty gritty here, I should note that an early testing bottleneck for Oregon psilocybin – similar to what we saw with cannabis – would not surprise me.
It is an open question whether OHA licensed, ORELAP certified cannabis labs will bulk up and “pivot” to the psilocybin space. It would be challenging to make cannabis testing equipment work for psilocybin in most cases. Psilocybin is water soluble (see, “mushroom tea”) whereas cannabis is fat soluble (see, “CBD gummy”). The labs that currently test cannabis in Oregon typically extract through CO2, hydrocarbon, butane or ethanol.
Because of this fundamental incompatibility, we may instead see new labs come online. Or, we may see legacy labs move over from traditional fields like water testing. An issue for many there would be fear of expansion into a controlled substances space, due to federal funding and liability issues.
The psilocybin testing chain of custody
The draft testing rules are clear that a licensee “may not transfer, accept or provide a psilocybin product unless it has been sampled and tested according to these rules.” The actual testing protocol involves OHA licensed, ORELAP accredited laboratories, which will take custody of psilocybin products created by licensed, psilocybin manufacturers.
There are certain labeling and custody requirements for “pre-tested” products. If the lab results clear, these products may then be transferred to service centers for client consumption. If the products fail, re-testing is permitted in some cases but not others (see below section on “failed test samples”).
Automatic psilocybin testing requirements
- Speciation – Each harvest lot must be tested to ensure that only psilocybe cubensis is present. No other species are allowed.
- Potency – This is a test of concentration. In the event that a process lot of homogenized fungi, psilocybin extract or edible psilocybin exceeds “20 percent relative standard deviation”, it would fail.
- Solvents – This testing is required in all cases where methanol is used to manufacture a psilocybin extract. A batch will fail if methanol above 3000 μg/g is detected in any sample.
Psilocybin testing required only upon OHA written request
- Pesticides – A failed test would detect the presence of a pesticide above specified “action levels” in any sample.
- Microbiological Contaminants – Each harvest lot would be tested for total coliform count. If coliforms are detected, the relevant sample would be assessed for E. Coli. In the event of the presence of E. Coli at more than 100 colony forming units per gram, the test would fail.
- Heavy Metals – This one tests for lead above 3.0 μg/g; cadmium above .2 μg/g; arsenic above .2 μg/g; and mercury above .1 μg/g.
Psilocybin batch requirements
The batch requirements differ for whole fungi and other products.
For whole fungi, a licensed psilocybin manufacturer must separate each “harvest lot” of dried into batches no larger than five pounds prior to testing. “Harvest lot” is defined elsewhere in the rules as a:
“specifically identified quantity of fungi that are cultivated and derived under the same conditions and harvested within a 12-hour period at the same location, within the licensed premises.”
And “batch” is defined as “a quantity of whole fungi from a harvest lot, or a quantity of psilocybin product from a process lot.”
With respect to homogenized fungi, psilocybin extracts or edible psilocybin, the five-pound rule does not apply, and each “process lot” is considered a batch. For the sake of completion, “process lot” is defined elsewhere in the rules as:
“homogenized fungi, psylocibin extract or edible psilocybin product of the same type that was processed at the same time using the same processing method, ingredients, and standard operating procedures.”
Finally, batch numbers are assigned and testing follows from there.
Psilocybin product sampling requirements
As with batch requirements, the rules here distinguish between whole fungi and other product types. Interestingly, sampling may be conducted at a manufacturer’s licensed premises, or the accredited laboratory.
For whole fungi, the rules are simple: it “may only be sampled after it is dried, regardless of whether the whole fungi will be processed into another product type.” Additionally, sample increments must be taken from at least 2% of the batch.
For other product types, anything intended for use by a client must be taken from the finished product. There is no “2% rule” but “sufficient sample increments from a batch must be taken to determine whether the batch is homogenous.” The sample also must be sizable enough for all relevant tests to be performed.
Failed psilocybin test samples
The rules contain a lengthy section on failed test samples. Highlights include:
- The lab that performed the first test may not subcontract the reanalysis;
- Any reanalysis must be requested by a manufacturer within 7 days, and reanalyzed within 30 days after that;
- Upon a successful reanalysis, the manufacturer has 7 days to have the batch resampled at another lab, to confirm the test result within another 30 days;
- All requests for reanalysis must also be reported by the manufacturer to OHA, along with ensuing developments; and
- Certain failed samples cannot be remediated and must be destroyed. These include samples that fail heavy metal testing, pesticide testing, and microbiological contaminant testing.
Quality control and R&D testing
The rules contain an interesting section on what amounts to optional testing. Here, manufacturers can test for quality control or for research and development purposes.
These tests cannot be used as compliance test results, and the products tested may not be transferred or sold. Manufacturers must retain these test results for at least two years and provide them to OHA upon request.