Or. Admin. Code § 333-333-1010

Current through Register Vol. 63, No. 12, December 1, 2024

Section 333-333-1010 - [Effective until 1/1/2025] Definitions

For purposes of chapter 333, division 333, in addition to the definitions in ORS 475A.220, the following definitions apply:

(1)

(a) "Adulterant" means:

(A) Chemicals, drugs, plants or substances that alter the potency, intoxicating effect, duration of effect, toxicity or potential for excessive use when added to psilocybin products.

(B) Any additives that are intended to manipulate the ratio of any analyte or to manipulate the ratio of compound relative to another analyte or compound present in the fungi used in extraction or processing.

(b) Adulterant does not mean naturally occurring substances contained in food items such as, but not limited to chocolate.

(2) "Adverse reaction" means an adverse behavioral or medical reaction that occurred during an administration session and does not require transport to a hospital.

(3) "Adverse behavioral reaction" means a client's behavioral reaction to consuming psilocybin products that required contacting emergency services or receiving care from a medical care provider that occurred during an administration session.

(4) "Adverse medical reaction" means a client's medical reaction to consuming psilocybin products that required contacting emergency services or receiving care from a medical care provider that occurred during an administration session.

(5) "Advertising" means publicizing the trade name of a licensee together with words or symbols referring to psilocybin or publicizing the brand name of a psilocybin product.

(6) "Aggregate," for the purpose of reporting 303 service center data and 303 client data, means to combine and categorize quantitative data in a manner that prevents a client or an individual from whom the data was collected, from being identified, taking into consideration how the data could be used in combination with other data sources.

(7) "Applicant" means an individual who applies for a facilitator license and an individual or legal entity who:

(a) Holds or controls an interest of more than 20 percent in the entity proposed to be licensed;

(b) Is entitled to receive 20 percent or more of revenue, profits or proceeds from the entity proposed to be licensed; or

(c) Is entitled to exercise control over the entity proposed to be licensed.

(8) "Attractive to minors" means:

(a) Cartoons;

(b) A design, brand or name that resembles a non-psilocybin consumer product of the type that is typically marketed to minors;

(c) Symbols or celebrities that are commonly used to market products to minors;

(d) Images of minors; or

(e) Words that refer to products that are commonly associated with minors or marketed by minors.

(9) "Authority" means the Oregon Health Authority.

(10) "Authorized Authority representative" means an employee of the Authority who is authorized to conduct inspections or investigations and otherwise enforce ORS chapter 475A and any rules adopted thereunder.

(11) "Batch" means a quantity of whole fungi from a harvest lot, or a quantity of psilocybin product from a process lot.

(12) "Billboard" means a large outdoor advertising structure.

(13) "Capsule" means a small soluble pill, tablet or container that contains psilocybin extract or homogenized fungi and is intended for human consumption.

(14) "Cartoon" means any drawing or other depiction of an object, person, animal, creature or any similar caricature which may exhibit any of the following:

(a) The use of comically exaggerated features;

(b) The attribution of human characteristics to animals, plants or other objects, or the similar use of anthropomorphic technique; or

(c) The attribution of unnatural or extra-human abilities, such as imperviousness to pain or injury, X-ray vision, tunneling at very high speeds or transformation.

(15) "Chemical synthesis" means a method of producing psilocybin products using precursor ingredients rather than cultivation of fruiting bodies and mycelium, or a method of producing psilocybin products that results in psilocybin products that contain analytes or compounds that were not present in the source fruiting bodies, mycelium and other ingredients.

(16) "Client administration area" means any area within the licensed premises of a service center where:

(a) Psilocybin products may be transferred to a client.

(b) Psilocybin products may be consumed by a client.

(c) Administration sessions may take place.

(17) "Client information form" means the form required by ORS 475A.350.

(18) "Client packaging" means packaging containing psilocybin products intended to be sold to clients.

(19) "Client records" means information held or known by a service center or facilitator that may be used to identify a client or prospective client, including any communication made by a client or prospective client and any information related to providing psilocybin services or selling psilocybin products to a client.

(20) "Client support person" means a person who will be present during a client's administration session for any purposes described in OAR 333-333-5050(5)(d), (f), (g) or (m).

(21) "Control over the entity" includes but is not limited to the authority to bind the entity to contracts, obligations or debt and does not include a licensee representative acting under the direction of a licensee.

(22) "Cultivation batch" means a quantity of unharvested fruiting body or mycelium that is grown together under the same conditions, that may contain fungi that originates from diverse spores or mycelial tissue of psilocybe cubensis.

(23) "Cultural equity" means values, policies, and practices that ensure all people, especially those who have been historically marginalized based on race, ethnicity, religion, language, disability, age, gender, gender identity, sexual orientation, social class, intersections among these communities or identities, or other socially determined circumstances are considered in the development of social pathways to health equity.

(24) "Curriculum" means the topics, subjects, and activities that make up courses taught by a training program.

(25) "De-identified data" means data that cannot be reasonably used to infer information about, or otherwise be linked to, an identified or identifiable client, or to a device that identifies, is linked to or is reasonably linkable to a client.

(26) "Direct owner" means an individual, legal entity or partnership that holds an ownership interest in a business proposed to be licensed directly rather than holding that interest through ownership of or affiliation with another legal entity or partnership.

(27) "Disciplinary actions," for the purpose of Oregon Laws 2023, chapter 150, means any final order issued under ORS chapter 183 finding a licensee violated ORS chapter 475A or these rules.

(28) "Edible psilocybin product" means psilocybin extract or homogenized fungi that has been incorporated into a food product or potable beverage.

(29) "Elementary school":

(a) Means a learning institution containing any combination of grades kindergarten through 8.

(b) Does not mean a learning institution that includes only pre-kindergarten, only kindergarten, or only a combination of pre-kindergarten and kindergarten.

(30) "Extraction" means:

(a) The process of separating psilocybin from fungi by using a solvent; and

(b) Manufacturing psilocybin extracts.

(31) "Facilitation" means the provision of services to a client by a licensed facilitator during a preparation, administration, or integration session.

(32) "Financial interest":

(a) Means entitlement to receive a portion of revenue, proceeds or profits from a licensed entity or an entity proposed to be licensed; or

(b) A membership interest, partnership interest or other ownership interest in a licensed entity or an entity proposed to be licensed.

(c) Includes any individual person or legal entity that qualifies as an applicant under OAR 333-333-1010 or 333-333-4030.

(d) Does not include an investment interest that the investor does not control in nature, amount or timing.

(33) "Fruiting bodies" means the spore producing organs of the fungi Psilocybe cubensis.

(34) "Fungi" means the fruiting bodies or mycelium of the fungi Psilocybe cubensis.

(35) "Harvest" means the act of removing mycelium or fruiting bodies from a production environment for drying or processing.

(36) "Harvest lot" means a specifically identified quantity of fungi that is cultivated and dried under the same conditions and harvested within a seven calendar-day period at the same location within the licensed premises, that may be partially harvested, and may use the substrate material for multiple harvests.

(37) "Health equity" means the opportunity for all people to reach their full health potential and well-being without being disadvantaged by their race, ethnicity, religion, language, disability, age, gender, gender identity, sexual orientation, social class, intersections among these communities or identities or other socially determined circumstances.

(38) "Homogenized fungi" means dried fruiting bodies or mycelium that have been mixed by powdering or other techniques which uniformly distribute psilocybin throughout the product. Homogenized fungi may be packaged in capsules and may contain inactive ingredients such as binders, dilutants and carrying agents.

(39) "Intervention" means taking proactive steps to respond to the client's behavior, experience, or condition during an administration session.

(40) "Intoxicant" means any substance that has intoxicating effects, and includes alcohol, prescription drugs, non-prescription drugs and any other controlled substances. Intoxicant does not include caffeine or nicotine.

(41) "Laboratory" means a laboratory licensed under ORS 475A.594.

(42) "Lead educator" means a person affiliated with a training program who is responsible for tracking the progress of students throughout the program.

(43) "Licensee representative":

(a) Means an owner, director, officer, manager, employee, agent or other representative of a manufacturer, service center, or laboratory licensee.

(b) Does not mean a facilitator who provides services at a service center unless that facilitator is also an owner, director, officer, manager, employee, agent or other representative of the service center.

(c) Includes an independent contractor of a manufacturer, service center, or laboratory licensee who acts in a representative capacity.

(44) "Licensed premises":

(a) Means the area of a location that is licensed under ORS chapter 475A, including:

(A) All public and private enclosed areas at the location that are used in the licensee's operations at the location;

(B) All areas outside a building that are used in the licensee's operations at a location for which the Authority has issued a license for a manufacturer or service center; and

(C) For a location that the Authority has specifically issued a license for the operation of a psilocybin service center, any outdoor area of the location used to operate the psilocybin service center and provide psilocybin services to clients.

(b) Cannot include a residence.

(c) Cannot contain unlicensed areas within the boundaries of the licensed premises.

(45) "Licensee" means any person who holds a license issued under ORS chapter 475A and includes each individual and legal entity identified as an applicant on an application that the Authority has approved and each individual or legal entity who is added to the license as described in OAR 333-333-4200.

(46) "Limited access area" means any area of a licensed premises where psilocybin products or psilocybin waste are stored or produced.

(47) "Manufacturer" means a manufacturer licensed under ORS 475A.290.

(48) "Manure" means animal 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.

(49) "Marijuana" has the meaning given that term in ORS 475C.009.

(50) "Mycelium" means the fungal threads or hyphae of Psilocybe cubensis.

(51) "Nondirective facilitation" means a client-centered approach to facilitation in which the client makes decisions related to their participation in psilocybin services and the facilitator maintains a consistent disposition with a client, while avoiding giving the client direct advice or offering an interpretation of a client's statements, behaviors or needs unless appropriate for health and safety reasons. Nondirective facilitation does not prohibit a facilitator from offering options, resources, referrals or providing health and safety support to clients within their scope of practice.

(52) "Non-profit entity" means a nonprofit corporation organized under ORS chapter 65, registered with the Secretary of State as a nonprofit organization, and registered with the Oregon Department of Justice as a charitable organization, if applicable.

(53) "Operational name" means an individual, legal entity or business name listed on an application and license certificate of a service center, manufacturer or laboratory license that the licensee(s) will use for purposes of advertising and doing business with the public.

(54) "Oregon Psilocybin Services Act" means ORS 475A.210 to ORS 475A.722.

(55) "Pesticide" means any substance or mixture of substances included in ORS 634.006(8).

(56) "Permittee" means a person who holds a permit issued under ORS 475A.480.

(57) "Practicum site" means a designated service center that provides practicum training.

(58) "Practicum site supervisor" means an onsite practicum supervisor of assigned trainees, affiliated with a practicum site.

(59) "Pre-production process" means cultivation environments that are used to facilitate growth of mycelial tissue prior to that tissue being transferred to production growth medium. Examples include but are not limited to agar dishes and grain spawn.

(60) "Process lot" means homogenized fungi, psylocibin extract or edible psilocybin product of the same type that was processed at the same time using the same processing method, ingredients, and standard operating procedures.

(61) "Production process" means cultivation environments from which fruiting bodies or usable mycelium are harvested, including but not limited to substrates used in the production of fruiting bodies.

(62) "Psilocybin" has the meaning described in ORS 475A.220.

(63) "Psilocybin analyte" has the meaning described in OAR 333-064-0025. As used in these rules psilocybin analyte refers to content of psilocybin analyte as measured by potency tests required by OAR 333-333-7040.

(64) "Psilocybin extract" means:

(a) A substance consisting entirely of solid or liquid psilocybin and may include other compounds which were simultaneously extracted from fruiting bodies or mycelium of Psilocybe cubensis; and

(b) A substance consisting of solid or liquid psilocybin and may include other compounds which were simultaneously extracted from fruiting bodies or mycelium of Psilocybe cubensis and inactive ingredients that are used to form capsules, tinctures and other oral preparations.

(65) "Product tracking system" or "PTS" means the system for tracking psilocybin products required by ORS 475A.400.

(66) "Psilocybin product" means psilocybin-producing fungi, mycelium and mixtures or substances containing a detectable amount of psilocybin, including whole fungi, homogenized fungi, psilocybin extract and edible psilocybin products.

(67) "Psilocybin waste" means:

(a) Waste material that is a byproduct of manufacturing psilocybin products that contains a detectable amount of psilocybin.

(b) Partially consumed psilocybin products, excluding client packaging.

(c) Psilocybin products that a manufacturer, service center or laboratory disposes.

(d) Any psilocybin product that is required to be designated as waste by these rules.

(68) "Radio" means a system for transmitting sound without visual images, and includes broadcast, cable, on-demand, satellite, or internet programming. Radio includes any audio programming downloaded or streamed via the internet.

(69) "Residence" means real property inhabited by an owner, renter or tenant, including but not limited to manufactured homes and vehicles used as domiciles, and attached garages or other structures that may be directly accessed from any ingress or egress of a residence.

(70) "Responsible referral and support" means supporting the personal needs, growth, and wellbeing of others, particularly those going through temporal crises such as houselessness, illness or marginalization.

(71) "Safe" means a fireproof metal cabinet with a mechanical or electronic combination lock that is capable of storing psilocybin products and weighs at least 375 pounds.

(72) "Scope of practice" means practice boundaries related to psilocybin facilitation and avoiding the unlicensed practice of other disciplines including but not limited to medicine or psychotherapy.

(73) "Secondary school" means a learning institution containing any combination of grades 9 through 12 and includes junior high schools that have 9th grade.

(74) "Service center" means a premises licensed under ORS 475A.305.

(75) "Severe adverse reaction" means an adverse behavioral or medical reaction that requires a client to be transported to a hospital.

(76) "Stabilized compost" means any organic material that has undergone the process to further reduce pathogens and has reached a stage of reduced biological activity as indicated by a lower temperature and a rate of respiration below that of active compost.

(77) "Sublet" means to sublease or otherwise allow a person who is not a licensee representative to exercise privileges that require a manufacturer, service center, facilitator or laboratory license on the licensed premises. Sublet does not include a facilitator providing psilocybin services at a service center.

(78) "Synchronous learning" means that students learn from their instructor at the same time as their fellow students.

(79) "Television" means a system for transmitting visual images and sound that are reproduced on screens, and includes broadcast, cable, on-demand, satellite, or internet programming. Television includes any video programming downloaded or streamed via the internet.

(80) "These rules" means OAR 333-333-1010 through 333-333-8250.

(81) "Tincture" means a liquid containing psilocybin that consists of either:

(a) A non-potable solution of at least 25 percent non-denatured alcohol, that is exempt from the Liquor Control Act under ORS 471.035; or

(b) A non-potable solution comprised of glycerin, plant-based oil, syrup and other ingredients.

(82) "Training, Licensing and Compliance System" means the online training, license and compliance portal maintained by the Authority to receive applications, communicate with applicants, licensees, permittees and training programs, and track compliance actions.

(83) "Training program" means a program that has been approved to offer training to psilocybin facilitators as described in ORS 475A.380.

(84) "Training program applicant" means a program that has applied to offer training to psilocybin facilitators as described in ORS 475A.380.

(85) "Unique identification number" means a unique number generated by the product tracking system for the purpose of tracking psilocybin products within the product tracking system.

(86) "Whole fungi" means dried fruiting bodies of Psilocybe cubensis, or portions thereof, that have not been homogenized.

(87) "Wood chips" mean substrates consisting primarily of wood products that have not been composted.

(88) "Worker permit" means a permit required by ORS 475A.480.

(89) "303 client data" means information that OAR 333-333-4900 requires service centers to collect from clients, store and maintain.

(90) "303 service center data" means information that OAR 333-333-4910(3) and (4) require service centers to compile, aggregate, compute and report to the Authority.

Or. Admin. Code § 333-333-1010

PH 74-2022, adopt filed 05/19/2022, effective 5/20/2022; PH 206-2022, amend filed 12/27/2022, effective 12/27/2022; PH 58-2023, amend filed 12/21/2023, effective 1/1/2024

Statutory/Other Authority: ORS 475A.235 & OL 2023, ch. 150

Statutes/Other Implemented: ORS 475A.235 & OL 2023, ch. 150