PORTLAND, Ore. (KOIN) – The Oregon Health Authority is asking for the public’s input on its latest draft of rules related to psilocybin services in the state. It will hold public hearings Tuesday, Wednesday and Thursday and hopes to receive valuable feedback.
On Nov. 1, the Oregon Health Authority released a 70-page document of its proposed rules for the implementation of its psilocybin program, which is set to begin in 2023.
These rules have been revised from a previous draft and the public has until 5 p.m. on Nov. 21, 2022, to share their thoughts on the current proposed rules.
Oregonians can submit their comments or take part in public hearings on the draft rules. The hearings will take place Tuesday from 6 p.m. to 8 p.m., Wednesday from 12 p.m. to 2 p.m. and Thursday from 10 a.m. to 12 p.m.
“This will be kind of our last iteration and will really take a look at all the feedback coming in from the public and make those final decisions and those rules will become final and we’ll start training,” Angie Allbee, section manager for the Oregon Psilocybin Services Section, told KOIN 6 News in early November.
The rules will be finalized by Dec. 31, 2022, and the Oregon Health Authority plans to start accepting applications for psilocybin services or manufacturing licenses on Jan. 2, 2023.
The latest draft rules cover everything from the species of fungi that are allowed for psilocybin services to how the products must be labeled. They provide specific language for the “Client Bill of Rights” and even explain the maximum amount of time a psilocybin facilitator is allowed to leave a client alone for a restroom break.
Allbee said the Oregon Psilocybin Advisory Committee has done an incredible job compiling useful information from Oregon’s cannabis rules, indigenous communities and other people who have been practicing psilocybin services around the world to craft these rules.
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The committee has spoken with medical, psychological and academic institutions that have been studying psilocybin and its potential to treat certain mental illnesses. Research suggests psilocybin is effective at addressing depression, anxiety, trauma and addiction.
“We really wanted to take all of that information and try to… create a minimal requirement that upheld client safety,” Allbee said. “This really has been a culmination of lots of feedback from lots of different partners, the members of the public board members, and of course, our team working hard to try to understand the complexities of regulating this work.”
The Basic Rules
OHA’s draft rules state that no one under the age of 21 is allowed to receive psilocybin services, work in psilocybin services or step foot on property where licensed psilocybin business is taking place
They say that a psilocybin administrator must be present with a client at all times during an administration session and that they must work with a client to establish a transportation plan. Clients should not operate motor vehicles, bicycles or other forms of self-operated transportation immediately after their administration session. The transportation plan is to help ensure they have a safe way to leave a facility after their session.
A licensed service center or representative cannot allow a client to consume more than a total of 50 mg of psilocybin analyte during an administration session. Clients can consume a secondary dose of psilocybin during a session, but the total dosage cannot exceed 50 mg, according to the draft rules.
Licensed service centers must exercise client confidentiality, the rules state, and may not share a client’s records with anyone unless the client gives them permission to do so.
Psilocybin Administration Sessions
Unlike recreational marijuana, customers cannot purchase psilocybin products and remove them from licensed facilities. The services are only allowed to be provided on site at licensed facilities and a licensed facilitator must be present during the administration process.
According to OHA’s draft rules, an administration session must be conducted by a facilitator and the facilitator must continuously monitor any client participating in a session. This means they must maintain visual and audio contact with clients and must monitor them for signs of physical or emotional distress.
A facilitator is only allowed to leave a client alone for 5 minutes if they need to use the restroom.
Before a client can attend an administration session, the rules say a facilitator must complete an initial preparation session with every client. During a preparation session, a psilocybin facilitator may decide they can’t serve a client or may instead refer them to another facilitator.
Administration sessions may be conducted outdoors, but the space must be free of falling hazards, drowning hazards and other safety risks, the rules state. The boundaries of an outdoor administration area must be clearly marked.
Service centers may operate between the hours of 6 a.m. and 11:59 p.m.
Every client who attends an administration session must be provided with a copy of the “Client Bill of Rights,” which details what rights they have as a person receiving psilocybin services.
The draft rules say that a facilitator must try to contact every client within 72 hours of the end of their administration session to offer the client information on integration sessions and other services, including peer support groups and community resources that support a client’s ongoing integration needs.
Security
In addition to protecting clients’ privacy, the draft rules state that psilocybin service centers must keep a daily log of all employees and permitted visitors who perform work at the site.
They must provide “adequate safeguards against theft or diversion of psilocybin products.”
As they’re written, the rules say a service center, manufacturer or laboratory must have a fully operational security alarm system on the premises that is activated at all times outside business hours. The alarm system must be able to detect any unauthorized attempts to enter the premises and should notify the licensee if someone tries to enter.
A licensed service center, manufacturer or laboratory must have cameras that continuously record 24 hours a day in all areas where psilocybin products are produced or stored, at all points of entry or exit, all indoor areas on the premises, and areas where there might be psilocybin waste.
A service center is not allowed to install video surveillance equipment in areas where psilocybin is administered, the rules state. However, servicers can record an administration session if they receive written consent from a client.
Who can’t receive psilocybin?
Before a psilocybin administration session, OHA suggests facilitators ask clients a series of questions to determine if they are eligible for treatment. One of those questions asks if a client has taken the prescription drug Lithium in the last 30 days.
According to the Mayo Clinic, Lithium is a drug used to treat mania that is part of bipolar disorder. If a client answers yes to this question, they cannot participate in an administration session.
If a client says they’ve had an allergic reaction to mushrooms or other fungi in the past, the facilitator should encourage the client to consume an alternative psilocybin product rather than whole fungi, according to the rules.
If a client arrives at a psilocybin administration session and they are visibly intoxicated, the draft rules say licensed employees are not allowed to sell or give them any psilocybin products.
Fees and Taxes
The Oregon Health Authority plans to charge an application fee of $150 to anyone interested in becoming a licensed facilitator. Every applicant must take an exam and must get 75 percent of the questions correct to receive a license.
If OHA approves an initial license application, it will require manufacturers to pay $10,000 in fees, service centers to pay $10,000, facilitators to pay $2,000 and laboratories to pay $10,000.
If the applicant is a non-profit, OHA’s draft rules say the fees will be reduced. A manufacturer must pay $5,000 and a service center must pay $5,000.
OHA is planning to reduce the fees for individuals who receive Social Security benefits, who are enrolled in the Oregon Health Plan, who receive food stamp benefits, and who are enrolled in the U.S. armed forces.
The OHA draft rules say service centers must collect a tax on psilocybin products from clients and must pay the taxes to the Oregon Department of Revenue.
These are several examples of the rules detailed in OHA’s draft rules pertaining to psilocybin services. The full document of draft rules is available for the public to read online.
Anyone interested in providing feedback on the rules can email publichealth.rules@odhsoha.oregon.gov. More information about the public hearings is available on the Oregon Health Authority’s website.