Oregon’s Psilocybin Mushroom Testing and Training Rules Are Out

By Masha Belinson
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‍In this post:

• Psilocybin Services Act
• Oregon's psilocybin testing standards
• Psilocybin facilitator requirements
• Allowable psychedelic mushroom products
• Bottom Line

Oregon’s Division 333 “Psilocybin,” rules are out, and we couldn’t be more excited. Yesterday the state’s Health Authority issued standards for the nation’s first sanctioned psilocybin mushroom program.

The rules cover magic mushroom sales, testing, and training, inevitably setting a precedent for the country. Specifically, Oregon outlined how to train psilocybin facilitators, which product types it will allow, and how laboratories must test mushrooms to guarantee safety and quality.

Here we review Oregon’s first set of final psilocybin rules as we look toward the future of regulated plant experiences.

Oregon’s  Psilocybin Services Act

Passed in November 2020, the Psilocybin Services Act (PSA) established a program that allows Oregon adults (21 and older) to purchase, possess, and consume psilocybin at designated centers. The PSA is not a medical program. It does not require people to have pre-existing mental or physical health conditions.

However, the Act says all individuals must participate in a preparation session and sit with a trained facilitator during the experience. Before implementing the program, Oregon required its Health Authority to establish a framework.

So, after two years, a public comment period, and several expert testimonies, the Health Authority’s first adopted psilocybin rules mean the state can start accepting facilitator applications in June!

Oregon’s Psilocybin Testing Standards

Oregon’s proposed psilocybin testing standards establish rules to “protect consumer health and safety” by ensuring that psilocybin products are properly tested for psilocybin content, speciation, and contaminants.

• Speciation: Oregon mandated that producers can only cultivate Psilocybin Cubensis species to avoid potential poison risks posed by other species.
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  ◊ That means cultivators must submit their first recorded harvest lot for testing to ensure it consists only of the Cubensis family. Additionally, growers must submit every new psychedelic mushroom batch monthly for speciation testing.
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• Contaminants:  Like cannabis, psilocybin compliance may include solvents, pesticides, heavy metals, and microbial testing, as requested by the Health Authority.
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  ◊ For example, producers that use methanol or acetic acid to manufacture psilocybin extract must test for these residual solvents.
  ◊ A failure is indicated by levels above 3000 μg/g or acetic acid above 5000 μg/g in any sample.
  ◊ Failed batches may be remediated and re-tested.
  ◊ Other contaminants, like pesticides, bacteria, heavy metals, microbial, or mycotoxins, are not required unless formally requested.
  ◊ Psychedelic mushroom products that fail these tests cannot be remediated and must be destroyed.
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• Potency: Manufacturers must test every batch of finished product from a harvest or processing lot to determine the potency of its psychoactive components, psilocybin, and psilocin. According to the rules, “if the amount of psilocybin or psilocin between samples taken from the batch exceeds 20 percent relative standard deviation between sample increments,” then the product fails to meet compliance requirements. The rules do not specify remediation options in this case.
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• Sampling & Testing Requirements: The rules state manufacturers are responsible for ordering compliance tests to meet state standards and can only submit one test per harvest lot, process lot, or psilocybin product.
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  ◊ All tests expire after one year. Laboratories must re-test expired psychedelic mushroom products before manufacturers can sell them to clients.
  ◊ Manufacturers must separate each harvest lot of whole dried fungi into batches no larger than one kilogram. A process lot for extracts, homogenized fungi, or edible products is considered a batch.
  ◊ Whole Fungi can only be sampled and tested after they’re dried, regardless of whether they will be processed later into another product.
  ◊ Only people employed by a laboratory with an ORELAP accredited scope can take psilocybin samples for testing.
  ◊ All samples must be labeled with the harvest or process lot number and include the laboratory's name, among other requirements.
  ◊ Manufacturers may also request R&D tests for quality-control purposes only.

Oregon’s Psilocybin Facilitator Requirements

Below are a few of Oregon’s core psilocybin facilitator mandates:

• Applicants must submit a $500 curriculum approval fee. If approved, the license covers a five-year term.
• Applicants must demonstrate that their training program’s course modules, instruction hours, and practicum meets the state’s core requirements.
• Training must occur in the U.S, and course instructors must have sufficient experience, knowledge, and skills.
• Training must be at least 120 hours and include a course on end-of-life care.
• Of the 120 hours, applicants must complete 40 hours of “practicum” training, which requires observing and/or co-facilitating psilocybin sessions.
• Facilitators must work with clients at a certified psilocybin facility. They can’t conduct at-home services.
• A facilitator license does not distinguish between clinicians and non-clinicians. Oregon specifies that facilitation is “nondirective,” which means clients don’t have to be diagnosed with a medical condition to receive psilocybin services.

Oregon’s Psychedelic Mushroom Product Rules

Oregon specified several rules relating to psilocybin production, manufacturing, and product types, including:

• Psilocybin products must be consumable, like drinks, edibles, or raw dried plants. No transdermal, nasal sprays, inhalers, injections, or suppositories are allowed.
• Allowable products are limited to whole dried fungi, mycelium, and homogenized fungi products.
• Producers cannot create psilocybin using GMOs or through chemical synthesis.
• Cultivators are also prohibited from using wood chips as a growing medium.
• Finally, producers may not utilize pesticides or manure during cultivation.
• Manufacturers must maintain a food-grade facility to minimize the chances of contamination.
• Licensees can't add any substances to the psilocybin products that would affect potency, like MAOIs, alcohol, or cannabis.
• Extractors can only use approved solvents, including water, vegetable glycerin, acetic acid, ethanol, and methanol,
• Manufacturers cannot produce or sell products that appeal to minors, including “products in the shape of an animal, vehicle, person, or character.”
• An entity must receive an Oregon Health Authority endorsement before cultivating, extracting, or producing psilocybin products. Additionally, the Authority will only endorse entities in one of the three areas.

Bottom Line

Oregon is blazing the trail for the country at large, and we’re thrilled to be at the forefront. As we continue monitoring the situation, we hope to be one of the first laboratories to ride the wave of regulated psychedelic mushroom journeying.