On Friday, April 1, 2022 the Oregon Health Authority (OHA) released revised proposed Oregon Administrative Rules (OARs) for psilocybin products, testing, and training programs. This post will focus on the rules related to products. Readers of this blog will recall we reviewed an early draft of these administrative rules back in February.
Unsurprisingly, the rules related to products are primarily geared toward safety. The rules cover everything from growing mushrooms safely to the types of products containing psilocybin. There will be public hearings on these rules on April 18 and April 21, 2022.
This post will summarize the rules by referencing each rule by number, but can see the exact text of each rule here.
The rules begin with prohibited cultivation methods and media. First, psilocybin manufacturers may not use manure. The definition section defines “manure” as:
“[A]nimal excreta, alone or in combinations with litter, such as straw and feathers used for animal bedding, for use as a soil amendment or substrate. Manure does not include stabilized compost produced through a controlled composting process.”
The FDA has assessed the safety of using manure in the past few years because it “has the potential to contain foodborne pathogens,” including E. coli and Salmonella. Prohibiting manure as a growing medium will prevent unnecessary contamination in psilocybin mushroom products.
Second, psilocybin manufacturers may not use wood chips as a growing medium. The associated hazards are not as obvious as with manure; yet, wood chips can produce bacteria dangerous for human consumption. Depending on the source, wood chips may contain pesticides which contaminate produce. Further, wood materials are generally restricted by food sanitation rules.
Finally, psilocybin manufacturers are prohibited from producing psilocybin using genetically modified organisms (GMOs) or by chemical synthesis. Although producing psilocybin by chemical synthesis is gaining attention in the medical community, the OHA will not allow products of chemical synthesis at this time.
Here, OHA expands on requirements for manufacturers, focusing on sanitation, storage, tracking, and minors.
Psilocybin manufacturers will have to adhere to general sanitary requirements similar to other industries. All equipment, counters and surfaces must be “food-grade,” and must be easily cleaned. Further, the whole premise must be kept safe and sanitary.
Psilocybin is similar to chemicals used in pharmaceuticals and other controlled substances. It is imperative that psilocybin is stored in a manner that prevents theft or misplacement. Relatedly, any psilocybin produced should be identifiable to limit misplacement, or alert third parties if a harvest is contaminated. Thus, manufacturers will be required to store all psilocybin products in a locked area, assign psilocybin harvests identification numbers and report those numbers in a Psilocybin Tracking System.
Finally, manufacturers are prohibited from making any products that appeal to minors. It is easy to see why this rule is necessary, given the nature of psilocybin in pop culture; psilocybin mushrooms are referred to as “magic mushrooms,” and are often associated with Alice in Wonderland, magical elves, and fairy tales. Yet, Measure 109 strictly prohibits people under 21 years of age from consuming psilocybin under the OHA regime.
Thus, products in the shape of animals, cartoon characters, vehicles, or modeled after non-psilocybin products are prohibited.
This rule introduces possible endorsements for manufacturers. “Endorsements” are additions to licenses granted by government agencies, allowing a licensed person or entity to engage in a certain activity in that profession. For instance, the Oregon Construction Contractors Board gives endorsements for licensed contractors to work in residential areas, provide locksmith services, provide home inspection services, etc.
Here, the OHA has outlined three endorsements for licensed psilocybin manufacturers:
- Fungi Cultivation
- Psilocybin Extraction
- Edible Psilocybin Production
When a manufacturer applies for a psilocybin license, it must choose at least one of these endorsements, but may apply for all three. Once licensed, the manufacturer can add or remove endorsements at a later time. The specifics for endorsements are outlined in rules below.
This rule bluntly states manufacturers are prohibited from applying pesticides to either the psilocybin mushrooms themselves, or the growing media for the mushrooms.
Manufacturers are prohibited adulterating products with substances that alter potency or duration of the psilocybin’s effect on a client.
A product is considered “adulterated” if a manufacturer adds chemicals, drugs, plants or substances like monoamine oxidase inhibitors (MAOI’s), liquor, alcohol, or cannabis. Further, a product can be considered adulterated if it has any substance hazardous for human consumption, the manufacturing premises is unsanitary, or flaws are concealed. However, if a product is meant for research and not for consumption, it may be stored in an adulterated manner.
OAR 333-333-2060 & OAR 333-333-2070
Back to endorsements, these rules provide requirements for the Psilocybin Extraction endorsement, and related safety procedures.
To extract the psilocybin chemical from the mushroom, manufacturers may only use water, vegetable glycerin, acetic acids, ethanol, and methanol. All other solvents are prohibited.
Further, denatured alcohol, pressure, or heat over 140 degrees Fahrenheit are all prohibited in extraction. Ethanol and methanol extractions must adhere to the Oregon Specialty Code and Fire Code. Additionally, if the psilocybin will be used for edibles, the manufacture must be licensed by the Oregon Department of Agriculture as a “food establishment.”
The premises must have proper ventilation, potable water, emergency eye-wash stations, an emergency rinse kits, and emergency showers. Employees must use protective equipment and have comprehensive safety training.
Next are requirements for Edible Psilocybin Production endorsements. For this endorsement, manufactures must operate in a “food establishment” licensed by the Oregon Department of Agriculture, complying with OAR 603 division 21, 24, 25, and 28. Further, these manufacturers may only use psilocybin that was processed in a “food establishment” licensed by the Oregon Department of Agriculture (See OAR 333-333-2060).
As discussed under OAR 333-333-2020, identification and tracking is crucial for manufacturing psilocybin safely. This rule specifically lays out record keeping requirements for Psilocybin Extraction and Edible Psilocybin Production endorsements.
Such manufacturers must standardize policies for products, such as recipe instructions, ingredients, recipe procedures, safety checks, sanitization, storage, waste disposal and emergency procedures. Standardizing such policies will ensure products are predictable, homogenous, trackable and safe.
The OHA is limiting the variety of psilocybin products, promulgating a list of three allowable product types corresponding to the three types of manufacturer endorsements.
- Fungi Cultivation products, including dry whole fungi, mycelium, and homogenized fungi
- Psilocybin Extract
- Psilocybin Edibles
All other products are prohibited. Though this may seem limited, there is still much room for variation and creativity within each of these categories.
Finally, the last rule related to psilocybin products governs “product delivery,” meaning the method in which psilocybin is administered to a client.
All psilocybin products must be made for oral consumption, or some other enteral method. All other methods are prohibited, including patches, inhalers, nasal sprays etc.
Invitation for public comment
Do you have an opinion about any of these rules? The above rules are open for public comment from April 1, to April 22, 2022. You can find more information on how to comment here.
Look out for Part II, where we will discuss psilocybin testing rules, and Part III, where we will cover rules for training programs.
The post Oregon Psilocybin Draft Rules: Products appeared first on Harris Bricken Sliwoski LLP.