Oregon’s Measure 109 left much to do with “psilocybin products” to the administrative rulemaking process. Measure 109 defined “psilocybin products” as: “(A) psilocybin-producing fungi and (B) mixtures of substances containing a detectable amount of psilocybin.” Pretty simple. Beyond that, the measure directed the Oregon Health Authority to “establish a regulatory framework concerning psilocybin products.” This blog post will look at unpublished draft rules to that effect.
As I wrote in part one of this series (training), 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. Today let’s start from the top, with “definitions.”
Definitions for psilocybin products; problematic restrictions on consumption
Scientists, medical professionals, traditional mushroom growers and others will find many of the definitions included in the draft rules interesting. These start at OAR 333-333-1010 and cover everything from “chemical synthesis” to “adulterant” to “dung” to “wood chips.” One term they do not define is “consume.” That may sound silly but it is actually very important here—especially because a later section of the rules provide that “all psilocybin products must be designed to be consumed by a client orally” (my emphasis.) The rules expressly prohibit “transdermal patches, inhalers, nasal sprays, suppositories and injections.”
Why am I pointing this out? Well, studies have shown that psilocybin therapy is effective in relieving emotional and existential distress at the end of life for 65-85% of terminally ill people in clinical trials, when administered properly. Many terminal patients cannot swallow. These individuals are forced to take food and medicine sublingually or intravenously. (Access to psilocybin drugs for terminal patients is what AIMS v DEA is about.) If OHA sticks to this “oral only” stricture in the final rules — based on a restrictive reading of Measure 109 or for any other reason — you can expect some controversy and perhaps even legislative intervention.
Psilocybin production protocols
Prospective “manufacturer” (mushroom grower) licensees will be interested to note that the draft rules prohibit use of the aforementioned dung and wood chips in cultivation and production of psilocybin products. These media are traditionally often used. Further prohibitions include producing psilocybin using genetically modified organisms, and producing synthetic psilocybin. This final prohibition cuts against the FDA and big pharma psilocybin model, which is synthetic all the way.
The draft rules contain further, common sense provisions related to sanitation (food grade equipment, counters and surfaces would be required), as well as rules around security and storage. They also contain restrictions on marketing and sales to minors which are straightforward and pulled directly from Measure 109.
Psilocybin product manufacturer “endorsements”
The rules clearly break out manufacturer endorsements which is something 109 left open, but directed OHA to create. The endorsement types on offer are: (a) fungi cultivation (for whole fungi, mycelium and homogenized fungi); (b) psilocybin extraction (extract) and (c) edible psilocybin production (edible products). Per Measure 109, a manufacturer could have any or all of these endorsements at once, and manufacturers would be able to add or remove endorsements at any time following licensure. This mirrors Oregon’s cannabis model.
Psilocybin pesticides, fertilizers, adulterants and solvents
The rules on pesticides and fertilizers appear to be much simpler than with marijuana. Permitted pesticide use must be in accordance with ORS 634, and the related Department of Agriculture (ODA) rules at OAR 603, Division 57. I say pesticides for psilocybin will be simpler than marijuana because unlike with the latter controlled substance, OHA is simply adopting Oregon pesticide rules applicable to other crops and organic matter. In other words, this is not a dynamic where ODA is creating a psilocybin-approved pesticide list out of nothing.
The rules on adulterants are pretty tight. I want to quote that provision verbatim here:
A licensee may not add to psilocybin products any chemical, drug, plant, or substance that has the effect of altering potency, intoxicating effect, duration of effect, toxicity or potential for addiction, including but not limited to monoamine oxidase inhibitors (MAOI’s), beverage alcohol or cannabis. A psilocybin product that has added chemicals, drugs, plants or substances that alter the potency, intoxicating effect, duration of effect, toxicity or addictiveness is considered adulterated.
As far as extraction goes, water, vegetable glycerin, acetic acids, ethanol and methanol would all be permitted solvents. Nothing else would be kosher, including denatured alcohol. Key safety-related limitations include: a) a prohibition on pressure or heat over 140 degrees Fahrenheit; b) compliance requirements for Fire Code and other safety codes where ethanol or methanol are used; and c) ventilation and training program requirements. As with cannabis, any manufacturer making edible products will be required to operate in an ODA licensed food establishment (a “commercial kitchen” basically).
Psilocybin manufacturer location and SOPs
For edibles makers specifically, mobile locations are out, as are restaurants of all sorts and “food service facilities” as defined at ORS 624. Shared space arrangements, like those that licensed marijuana processors may use, are also prohibited here. Finally, a section exists on “records” which is really just an enumerated list of standard policies and procedures a manufacturer must implement. These cover everything from procedures for cleaning, waste disposal and safety checks, to emergency procedures in the case of fire, chemical spill or other emergency.
Stay tuned for tomorrow’s final post in this series, when I will cover the draft rules on testing.