Regulated use programs may use various mechanisms to engage in the aforementioned activities. Licenses, permits, and certifications have distinct purposes within these programs. A license is an official authorization or legal permission granted by a governing body to an individual or entity to engage in a specific activity that is regulated by law. This grants the holder the right to operate or engage in a particular activity or business (e.g., business license, manufacturing license, etc.). A permit is an official document that grants permission to carry out a specific activity or action and is issued for a particular task that might not require a long-term license (e.g., building permit, health permit, etc.). A certification is awarded after completing specific training or meeting professional standards but does not grant authority to perform a regulated activity (e.g., certified facilitator). Each of these has different purposes, limitations, and advantages and can be applied in various ways depending on the goals of the scheme.
In general, MAPS supports structures that increase the choices available to service providers and seekers alike. While licensing and certification create additional barriers to entry into the legal market, we recognize that the state’s responsibility is to balance public health and safety, equity and access, and oversight and management of participants in the system. Many legislators and agency staff are rightfully cautious about what responsible access looks like, and safety is often a top concern, given psychedelics’ reputation and current hype. However, we believe that more realistic approaches — even if they at times seem counterintuitive — are the best way to ensure as much safety as possible. With that in mind, we reserve our most critical eye for unnecessary hurdles that disincentivize participation in the regulated system and push people toward unregulated environments, which naturally have fewer points of accountability.
Any regulated program should balance safety concerns with a realistic understanding of actual behavior to prioritize harm reduction and public health. We can draw from lessons of past and existing cannabis regulation and underground psychedelic markets, where we can see examples of issues to watch out for:
- Unreasonable financial or logistical barriers make obtaining a facilitation, cultivation, or other license commercially unreasonable for people with low incomes. This keeps some facilitators or services underground and out of visibility due to their lack of ability to pay additional overhead, creating a de facto income threshold for those who do and do not legally participate.
- Requiring a dual or secondary license for all permitted activities and not offering multiple tiers of services prevents people without medical or psychological licenses from offering non-medical services like peer support or integration. While it may seem apparent to some people that requiring more, not less, licensing is in the interest of safety, it misses the reality that not all care requires medical oversight, and not all medical or psychological professionals are good fit for therapeutic or other guided care. Over-cautious regulations here could result in an environment where services that don’t require the highest-touch care have no place in a regulated system, resulting in no oversight whatsoever on casual, social, or community use settings where even basic regulations like quality control on products could be beneficial without being burdensome.[34]
- Mismatching incentives to encourage participation in regulated programs. If regulated individuals or businesses were permitted additional privileges like insurance coverage and limited promotions, while unregulated individuals or services were more restricted in their claims and branding, the difference between each system may be enough for an individual to decide where they want to land. They may opt for the smaller and more limited contexts where unregulated use is permitted, or the more visible industry marketplace available by participating in the regulated system.
Case Studies: Oregon Measure 109 & Colorado Proposition 122
The licensing frameworks for both Oregon Measure 109[35] and Colorado Proposition 122[36] establish regulatory systems for the use of psychedelics for therapeutic purposes, but there are differences in how the licensing structures are organized, who is eligible to operate within the systems, and the overall scope of regulation. Oregon’s program licenses growers who provide products to psilocybin service centers where licensed psilocybin facilitators guide clients through therapy sessions. Facilitators undergo a state-approved training program, set up by the Oregon Health Authority. In Colorado, the Department of Regulatory Agencies (DORA), through the Office of Natural Medicine, approves training for healing guides who facilitate at licensed healing centers, and have access to a broader range of psychedelic medicines including DMT, mescaline (excluding peyote), and ibogaine. Manufacturers are also permitted to produce psychedelic substances for therapeutic use in this state. Psilocybin remains illegal for adult-use in Oregon and is strictly confined to therapeutic use in a regulated setting, while Proposition 122 decriminalizes the possession, cultivation, and use of natural psychedelics for adults 21 and older in Colorado.
- Transportation/Delivery
The Oregon Health Authority has powers to regulate transportation and delivery of psilocybin products, and has the duty to prevent diversion. Under OHA rules[37], producers and service centers must implement tracking systems to monitor chain of custody for secure, properly labeled and packaged psilocybin products as they move securely from the production facility to the service centers. Only authorized transporters are allowed to deliver products to licensed service centers. The OHA is responsible for monitoring compliance, inspecting facilities, and enforcing regulations to ensure safe transportation and delivery of psilocybin products.
Similarly, under Colorado’s rules the psychedelic product must be tested, packaged in a child-resistant container, and labeled adequately before transportation.[38] Transport of up to 750 mg of psilocin can only be done by licensed parties, and must be between licensed facilities or directly to a licensed facilitator. The rules require detailed reporting, and cultivation licensees must implement a tracking system.
- Location Requirements & Restrictions (including Zoning)
Service centers in Oregon are subject to local zoning ordinances and land use regulations, and must be located in areas where commercial or business activities are permitted. They may not be a residence, located on state or federally owned land, be mobile, or overlap with any site registered under a cannabis or health care facility license. Licensed premises cannot contain unlicensed areas within the boundaries of the licensed premises. Centers cannot be located within 1,000 feet of a public or private primary or secondary school, and may be subject to additional proximity restrictions to sensitive locations like daycare centers, parks, or community centers. Localities also have the authority to restrict or ban psilocybin service centers within their jurisdiction, including time and manner restrictions.
Colorado’s rules also defer to local jurisdictions: an applicant must own the proposed licensed premises, and must present documentation “demonstrating that the address for the proposed licensed premise is permitted under the local jurisdiction’s applicable zoning laws for the cultivation, manufacturing, testing, storage, distribution, transfer, or dispensation of Regulated Natural Medicine and Regulated Natural Medicine Product” (1 CCR 213-1). A proposed Healing Center must not be within 1,000 feet from a licensed child care center, preschool, elementary, middle, junior, or high school, or a residential child care facility. With certain limitations, a Healing Center may be co-located with another natural medicine business: a cultivation facility, products manufacturer, another Healing Center, or a health-care facility (Part 3, Section 3105).
- Manufacture/Cultivation
Psilocybin production in Oregon must adhere to strict safety, health, and environmental standards. Genetically modified organisms, chemical synthesis, and manure/wood chips in cultivation are prohibited. Under this license, cultivators may only grow the mushroom species psilocybe cubensis. Manufacturers must comply with specific composting, sanitation, solvent, pesticide, and adulterant rules, and there are particular requirements for extraction, edible psilocybin production (can only be processed in a food establishment), and in the maintaining of detailed records. (Sections 333-333-2010 to 333-333-2110).
Colorado rules also prohibit synthetics and synthetic analogs of Natural Medicine (Section 3005). Clear guidelines are provided for manufacturers and cultivators to implement and manage security, sanitary requirements, and waste disposal (Sections 3110 to 3305). Psilocybin products are limited to the psilocybe cubensis strain, and all cultivated products must be tested for active compounds and contaminants before transfer to a manufacturer (if transfer is necessary). Specifically for cultivation, a licensee may only possess up to the maximum amount of Natural Medicine permitted by their cultivation tier, designated as either a micro-cultivation tier (to store up to 750 grams of dried fruiting bodies) or a standard cultivation (to store up to 5,000 kilograms of dried fruiting bodies at any one time) (Section 5005 and 5015).
- Creative Licensing
One option deserving of special mention that touches on the range of possible size and scope of all the above activities is the “micro-tier” license. These are licenses that permit a limited size or number of activities compared to regular licenses, which allow for a more “mom-and-pop” or farmer’s market style approach, or that simplify and reduce the cost of the process for people seeking more than one role in the regulated system.
- California’s cannabis licensing agency, the Department of Cannabis Control (DCC) uses a “microbusiness” license for businesses engaging in at least three of the following activities at one location: cultivation, manufacturing, distribution, and/or retail. California places no limit on profits or employees but does restrict size — microtier licensees may not cultivate over 10,000 square feet. This approach allows businesses to apply for a single license, which is slightly less costly than the combination of licenses that would otherwise be required.
- New Jersey took a more restrictive approach with its cannabis regulations by, among other requirements, limiting cultivation to a total square footage of 2,500 feet, preventing businesses from having more than ten employees, limiting possession to no more than 1,000 mature plants per month, etc. By law, at least 25% of licenses granted in NJ must go to microbusinesses, with fees being at least half of what they would be for a non-microbusiness.
- In Colorado, rules were proliferated that allow healing centers to register as “Micro-Healing Centers” where a “restricted area” for medicine cultivation, testing, and storage is not required. Additionally, an applicant for a cultivation facility license may choose between the “micro-cultivation tier” or the “standard cultivation tier” for purposes of production and inventory management, and there is flexibility to change tiers (1 CCR 213-1).
Endnotes
Colorado Prop 122: 12-170-174; see also, Considering Complexities with Measure 109 Implementation
↑Measure 109 passed in Oregon in November 2020 , representing the first state-level program in the U.S. to establish a legal, regulated psychedelic therapy program. It created a legal framework for adults 21 and older to access psilocybin - the active compound in psychedelic mushrooms - for therapeutic purposes under the supervision of licensed professionals.
↑Proposition 122, also known as the Natural Medicine Health Act, was approved by Colorado voters two years later. Unlike Measure 109, this measure legalized a broader range of natural psychedelics, including psilocybin mushrooms, psilocin, DMT, mescaline (excluding peyote), and ibogaine for adults 21 years and older.
↑Oregon Health Authority, Public Health Division, Chapter 333 Division 333: Psilocybin
↑Department of Revenue, Natural Medicine Division, Colorado Regulated Natural Medicine Rules, 1 CCR 213-1.
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