On Tuesday, February 8, 2022, the Oregon Health Authority (OHA) released proposed rules regarding the production process, testing, and training requirements for psilocybin. Oregon legalized psilocybin services via Measure 109 in 2020, and these draft rules were influenced by recommendations from the Oregon Psilocybin Advisory Board, which is made up of doctors and public health experts. The rules are subject to change after a public comment session extending from April 1 to April 21, 2022 and must still be discussed and adopted by the OHA before they are binding.
Rulemaking for training will take place on February 15 and 25. Products is scheduled for February 17, and testing is scheduled for February 24. This blog post previews the most significant rules and policy considerations surrounding products, testing, and training that will be considered as the Rule Advisory Committees work on promulgating final rules.
Fungi cultivators may produce whole fungi, mycelium (the fungal thread of psilocybe cubensis), and homogenized fungi. Extraction processors may produce edible products. All products must be designed to be consumed orally, meaning psilocybin products will not be offered as patches, inhalers, nasal spray, suppositories, or injections.
Only one mushroom species, psilocybe cubensis, may be cultivated or possessed for use in psilocybin services. Although up to 200 different types of mushrooms exist that contain psilocybin, this species was chosen because it is the most studied species to date. Despite this current limitation, Advisory Board members indicated that other species may be introduced as the program progresses.
In line with Oregon’s cannabis rules, all products must be stored in a locked area, including refrigerated products, each process lot must receive a unique identification number to be used in the Psilocybin Tracking System, and manufacturers are prohibited from producing, transferring, or selling a product that appeals to minors.
The proposed rules also place general restrictions on production activity, prohibiting using dung in cultivation and production, using wood chips in cultivation and production for fear of wood lover’s paralysis, using GMOs, and producing psilocybin via chemical synthesis.
Manufacturers must receive OHA endorsement before they can produce and sell products and may choose from three endorsement types: 1) fungi cultivation, 2) psilocybin extraction, and 3) edible psilocybin production. An individual manufacturer may hold multiple endorsements and can request to add or remove an endorsement at any time following licensure.
Edible product processing may not occur in a location operating as any form of restaurant, commissary, mobile unit, bed and breakfast, or warehouse, nor can the food establishment be shared with any other person or entity. Additionally, processing may only involve food that contains psilocybin and is intended for commercial sale.
Processors must have records indicating instructions/ingredients for making each product and explicit procedures for making each lot homogenous. Additionally, manufacturers cultivating mycelium must maintain a material safety data sheet (MSDA), an original label of or a copy of a label, and a log of all pesticides, fertilizers, and other agricultural chemicals used in production. These records must be kept for at least two years.
Manufacturers, under the proposed rules, must order testing for every harvest lot to ensure their product consists of only psilocybe cubensis and meets concentration standards. The process for ordering tests is somewhat analogous to cannabis. Manufacturers must inform the laboratory of the type of product being tested, the batch numbers being sampled, and the harvest lot or process lot number associated with the batch.
Producers who manufacture psilocybin extract using methanol must order special solvent testing. Batches will fail solvent testing if there is a presence of methanol above 3000 μg/g in any sample. Failed batches could be remediated using procedures that would reduce the concentration of solvents. Remediated batches would require further testing to ensure compliance.
All products, regardless of manufacturing process or product type, must pass pesticide testing, microbiological contaminant testing, and heavy metals testing. Batches that fail any of these tests can be reanalyzed but cannot be remediated and must be destroyed.
Psilocybin facilitator curriculum and training requirements reflect the Advisory Board’s recommendations. Psilocybin facilitator training would require at least 120 hours of core training with at least 25% of those core training hours taking place in-person. The in-person training requirement, however, can be waived by OHA anytime the Governor declares a public health emergency. Oregon’s current COIVD-19 emergency declaration is scheduled to last until June 30 of this year, so it remains to be seen whether OHA will waive the in-person training requirement when training programs first open.
The training curriculum focuses on providing a “nondirective facilitation approach” to psilocybin service administration. The nondirective approach, which is a common theme amongst other psilocybin legalization bills, calls on facilitators to avoid giving a client direct advice or interpretations of the client’s statement or behaviors during administration. Centering treatment in the nondirective approach raises interesting questions regarding the extent to which service centers can ethically or legally provide psilocybin in tandem with guided psychotherapeutic or religious services.
Practicum (hands on) training is also a major focus in facilitator training, with the proposed rules requiring 30 hours of direct practice and 10 hours of consultation training to review the student’s direct practice. Training programs that develop practicum training sites would allow students to observe a psilocybin service session and develop practical skills under the supervision of a practicum site supervisor. Programs without a practicum site can meet the practicum requirement by providing alternative training that reasonably approximates on-site practicum training.
Individuals interested in starting a training program will need to complete an application and pay a $500 non-refundable application evaluation fee to OHA. The agency would deny any application that fails to offer all training and curriculum requirements discussed above. Requiring training centers to offer a full curriculum is an interesting development, as there was extensive discussion in Oregon Psilocybin Advisory Board meetings about offering partial training programs.