Oregon would only allow the use of one mushroom species in its new psilocybin system and would ban chemically synthesized psilocybin.
These are just two details in a release of new draft rules expected Tuesday from the Oregon Health Authority. The rules, crafted by an advisory board of doctors and other public health experts, will be used to create Oregon’s ground-breaking system for allowing the use of psilocybin, the hallucinogenic substance produced by many mushrooms.
The rules cover three basic areas: how the mushrooms will be produced; how they will be tested; and what kind of training will be required of people assisting clients taking the drug.
“It is kind of a landmark moment because Oregon is the very first state to have created such a system of regulation,” said Mason Marks, a member of Oregon’s psilocybin advisory board and a senior fellow on the Project on Psychedelics Law and Regulation at Harvard Law School. “These are the very first draft rules that we’re seeing, so it really is a kind of pivotal event.”
Oregonians voted to set up a system that would allow the use of psilocybin in some therapies back in 2020 by passing ballot Measure 109. And it’s been a year since Oregon set up an advisory board to recommend how to roll out a safe and equitable system. It will be almost another year until all the rules are set and the system can start receiving applications from those seeking to work in the industry.
But this is the first time Oregonians have been allowed to see some of the nuts and bolts of what some predict could grow into a billion-dollar industry nationally, according to Data Bridge Market Research.
For example, under the draft rules, manufacturers can only cultivate one mushroom species: Psilocybe cubensis. Experts say there are up to 200 different types of mushrooms that contain psilocybin. Marks said some people on Oregon’s psilocybin board have expressed concern that only using one species is too drastic.
“Some people have expressed concern that by limiting the species, you’re also limiting potential benefits because it is believed that different species promote different types of experiences,” Marks said.
Psilocybe cubensis was chosen because it’s one of the most popular mushrooms consumed and one of the most studied. Advisory board members also thought that it would be best to start simple, with one mushroom. Other species might be introduced later.
There’s also concern about a rare condition known as wood lover’s paralysis, a condition that produces muscle weakness a few hours after hallucinogenic mushrooms are consumed. Scientists don’t know why this condition occurs, but it isn’t believed to happen with Psilocybe cubensis.
Preventing wood lover’s paralysis is also one reason why the new draft rules would ban psilocybin mushrooms grown in wood. The rules would also bar mushrooms grown in dung, for fear of spreading E. coli and other potentially dangerous bacteria, though many grocery store mushrooms are grown in dung. Instead, manufacturers will have to grow using things like rice bran or popcorn.
The draft rules also show the state is taking the significant step of prohibiting the chemical synthesis of psilocybin. In practical terms, that means it may be harder for large pharmaceutical companies to come into Oregon with a cheap pill and potentially dominate the market.
Board members hope the ban will allow lots of small farmers to set up grow operations. Measure 109 called on the state to only license people who have been Oregon residents for at least two years, until 2025.
Marks said there are other reasons for the ban on synthesized psilocybin. For example, synthesis requires the use of toxic chemicals, which must then be removed so there’s no residue in the final product.
“That’s a huge undertaking,” Marks said. “There was some sentiment that that might be maybe unrealistic or overly burdensome, at least initially to expect people to have that level of expertise or equipment in order to do that.”
The new draft rules dictate the manufacturing process in fine detail. For example, manufacturers have to use clean, food-grade equipment in an area that can be locked. Production can’t be in a restaurant. Manufacturers also can’t make psilocybin products that may appeal to minors, say in the shape of animals or cartoon characters.
Manufacturers will have to obtain a state license. They can’t add alcohol, cannabis, or anything that might alter the potency or make psilocybin potentially addictive. The psilocybin can only be taken orally – not via an inhaler, a suppository or an injection.
The draft rules share some similarities with Oregon’s cannabis rules. For example, every batch of mushrooms must be numbered and tested to determine factors such as potency, pesticide concentration and the presence of heavy metals like lead or mercury.
There are also draft rules on how facilitators will be trained to sit with people taking psilocybin to ensure safety. For example, instructors must have sufficient experience to teach, they must keep records of who is attending the class; and facilitators must have at least 120 hours of instruction covering everything from the historical use of psilocybin to safety.
Anne Marie Backstrom, who worked on Measure 109, serves on the equity subcommittee of the psilocybin advisory board. She said classes will pay particular attention to diversity, cultural equity and racial justice.
“This is really important because our facilitators are going to be working with various diverse communities and communities that have experienced historical inequities and generational traumas,” she said. “We really want to make sure that all of our facilitators go into this work with that lens of racial justice.”
Students will learn about the federal Controlled Substances Act and its impact on psilocybin research. They should also get the opportunity to facilitate and observe what the rules call “non-ordinary states of consciousness.”
These draft rules still need to be discussed and adopted by regulators with the Oregon Health Authority. Other rules are still pending, such as how psilocybin research should be conducted, and who will be screened out of the system and for which medical conditions.
Other more complicated issues still need to be decided. For example, there’s a desire among some people to microdose psilocybin, that is taking very small amounts every few days. Proponents say the practice can boost creativity and focus, or help with depression. But the OHA has not yet drafted rules or taken a position.
Backstrom said the advisory board also recommended the OHA reevaluate its rules every year.
“They have a couple of pieces that they need to report back on in relation to safety, social impact, review of any new or ongoing clinical trials,” Backstrom said. “Just to be sure that … they are still safe and applicable.”
The state has set up public comment sessions, it’s also running a survey, to find out how many people plan to sign up for psilocybin services, and other issues.
Oregon’s new psilocybin system is scheduled to begin in January 2023.
Correction: An earlier version of this story misstated Anne Marie Backstrom’s work on Measure 109 and the new advisory board. OPB regrets the error.