justicedao/ipfs_state_laws huggingface dataset:
333-333-6210 Licensee Responsibility (1) A licensee is responsible for: (a) The violation of any of these rules and any provision of ORS 475A.210 to 475A.722. (b) Any act or omission of a licensee representative in violation of these rules or of ORS 475A.210 to 475A.722. (2) If a facilitator is a licensee representative of a service center, a service center shall be responsible for any violation of these rules or ORS 475A.210 to 475A.722 that occurs on the service center’s licensed premises that is related to the facilitator’s acts or omissions. (3) If a facilitator is not a licensee representative of a service center, a service center shall be responsible for any violations of these rules or ORS 475A.210 to 475A.722 that is related to the facilitator’s acts or omissions if: (a) The violation occurs on the licensed premises; and (b) The service center fails to take reasonable steps to prevent the violation. (4) Sections (1), (2) and (3) of this rule apply to every individual and legal entity identified as a licensee on a license issued by the Authority. (5) Violation of any of these rules or any provision of ORS 475A.210 to 475A.722 shall be attributed to every individual and legal entity identified as a licensee on a license issued by the Authority for the purpose of considering the individual or legal entities record of compliance under 475A.250(2)(h). Statutory/Other Authority: ORS 475A.235 & ORS 475A.420 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.420 History: PH 206-2022, adopt filed 12/27/2022, effective 12/27/2022
333-333-6220 Suspended Licenses: Posting of Suspension Notice Sign, Activities Allowed During Suspension (1) Before 6:00 AM on the date a license suspension goes into effect, and until the suspension is completed, Authority staff must ensure that a suspension notice sign is posted on each outside entrance or door to the licensed premises of a service center, manufacturer or laboratory. (2) The suspension notice sign must be posted in a way that allows any person entering the licensed premises to read it. Licensees must use the suspension notice sign provided by the Authority. The sign will state that the license has been suspended by order of the Authority. If there are multiple licenses at the location, the sign will specify which license privileges have been suspended. (3) During the period of license suspension, the licensee is responsible for ensuring: (a) Compliance with all applicable laws and rules. (b) That the suspension notice sign is not removed, altered, or covered. (4) A service center licensee or licensee representative may not allow sale, delivery to or from, or receipt of psilocybin products at the licensed premises, or provision of psilocybin services at licensed premises, during the period that the license is under suspension, except as otherwise permitted by the Authority in the order of suspension. During the period that the license is under suspension, a licensee may operate the licensed entity only in compliance with this rule. (5) A manufacturer licensee or licensee representative may not allow sale, delivery to or from, or receipt of psilocybin products at the licensed premises, harvesting or drying of fungi, processing of psilocybin product during the period that the license is under suspension, except as otherwise permitted by the Authority in the order of suspension. During the period that a license is suspended, a licensee may operate the licensed entity only in compliance with this rule. (6) A facilitator licensee may not provide psilocybin services during the period that the license is under suspension, except as otherwise permitted by the Authority in the order of suspension. (7) A laboratory licensee or licensee representative may not allow delivery to or from, or receipt of psilocybin products at the licensed premises or testing of psilocybin products during the period that the license is under suspension, except as otherwise permitted by the Authority in the order of suspension. During the period that the license is under suspension, a licensee may operate the licensed entity only in compliance with this rule. (8) A permittee may not perform any of the activities described in OAR 333-333-4700 during the period that their worker permit is under suspension, except as otherwise permitted by the Authority in the order of suspension. Statutory/Other Authority: ORS 475A.235 & ORS 475A.420 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.420 History: PH 206-2022, adopt filed 12/27/2022, effective 12/27/2022
333-333-7010 Psilocybin Testing: Purpose (1) The purpose of OAR 333-333-7010 to OAR 333-333-7150 is to establish minimum compliance testing standards for psilocybin products. (2) A person licensed under ORS 475A.290 or 475A.305may not transfer, accept or provide a psilocybin product unless it has been sampled and tested in accordance with OAR 333-333-7010 to OAR 333-333-7150. Statutory/Other Authority: ORS 475A.235 & ORS 475A.590 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.590 History: PH 82-2024, amend filed 11/22/2024, effective 01/01/2025 PH 74-2022, adopt filed 05/19/2022, effective 05/20/2022
333-333-7020 Ordering Tests (1) A manufacturer must provide to a laboratory, prior to the laboratory taking samples, the following information: (a) The manufacturer’s license number and endorsement type; (b) The manufacturer’s name, address and contact information; (c) Type of psilocybin product; (d) Unique identification numbers assigned to products that will be sampled; (e) Total mass or volume of each batch to be sampled; and (f) Identification of tests requested pursuant to OAR 333-333-7030, OAR 333-333-7040, OAR 333-333-7050, OAR 333-333-7060, OAR 333-333-7070, OAR 333-333-7080 and OAR 333-333-7150. (2) If the manufacturer informs a laboratory that a psilocybin product is being re-sampled after a failed test, the manufacturer must provide the laboratory with documentation of the failed test. (3) A manufacturer is responsible for ordering the compliance tests necessary to comply with OAR 333-333-7010 to OAR 333-333-7150. (4) A manufacturer may not order more than one compliance test for the same harvest lot, process lot or psilocybin product except as allowed under OAR 333-333-7120. (5) A manufacturer violates these rules if they: (a) Fail to provide information required in these rules to a laboratory. (b) Submit false or misleading information to a laboratory. (6) Tests ordered under these rules expire after one year. If a test has expired, the psilocybin product must be tested again before it can be sold to a client, transferred to another licensee, or converted to another product type. (7) Manufacturers may only order tests for the purposes described in OAR 333-333-7010 to OAR 333-333-7150. Statutory/Other Authority: ORS 475A.235 & ORS 475A.590 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.590 History: PH 82-2024, amend filed 11/22/2024, effective 01/01/2025 PH 58-2023, amend filed 12/21/2023, effective 01/01/2024 PH 74-2022, adopt filed 05/19/2022, effective 05/20/2022
333-333-7030 Speciation Testing (1) A manufacturer must order a test for a batch taken from the first harvest lot recorded in a calendar year to ensure that the lot contains Psilocybe cubensis. This test must be performed prior to transferring the harvest lot to another licensee or converting the harvest lot to a psilocybin extract or edible psilocybin product. (2) Following the test described in section (1) of this rule, a manufacturer must order tests for the first batch harvested in each calendar month that a harvest lot is recorded to ensure that the lot contains Psilocybe cubensis. (3) A batch fails speciation testing if the test demonstrates that the batch does not contain Psilocybe cubensis. (4) If a batch fails speciation testing, a manufacturer must order tests for every harvest lot for a period of 12 months following the failed test to ensure that batches contain Psilocybe cubensis. This test must be performed prior to transferring the harvest lot to another licensee or converting the harvest lot to a psilocybin extract or edible psilocybin product. (5) In addition to the requirements of section (1) of this rule, a manufacturer must submit one or more batches from a harvest lot or process lot for speciation testing upon written request by the Oregon Health Authority. Statutory/Other Authority: ORS 475A.235 & ORS 475A.590 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.590 History: PH 58-2023, amend filed 12/21/2023, effective 01/01/2024 PH 74-2022, adopt filed 05/19/2022, effective 05/20/2022
333-333-7040 Potency Testing (1) A manufacturer must order tests for every batch of finished psilocybin product from a harvest lot or process lot to determine the concentration (potency) of psilocybin and psilocin in the product. (2) A process lot of homogenized fungi, psilocybin extract or edible psilocybin product fails potency testing if the amount of psilocybin or psilocin between primary and duplicate samples taken from the batch exceeds 20 percent relative percent difference between samples. (3) In addition to the requirements of section (1) of this rule, a manufacturer must submit one or more batches from a harvest lot or process lot for potency testing upon written request by the Oregon Health Authority. Statutory/Other Authority: ORS 475A.235 & ORS 475A.590 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.590 History: PH 58-2023, amend filed 12/21/2023, effective 01/01/2024 PH 74-2022, adopt filed 05/19/2022, effective 05/20/2022
333-333-7050 Solvent Testing (1) If methanol or acetic acid are used to manufacture psilocybin extract, a manufacturer must order tests for methanol or acetic acid for every process lot of psilocybin extract prior to selling or transferring the psilocybin extract or converting to another product type. (2) A batch fails solvent testing if a laboratory detects the presence of methanol above 3000 μg/g or acetic acid above 5000 μg/g in any sample. (3) If a sample from a batch fails solvent testing, the batch may be remediated using procedures that would reduce the concentration of solvents to less than the action level. (4) A batch that is remediated in accordance with section (3) of this rule, must be re-sampled and re-tested for solvents in accordance with these rules. (5) In addition to the requirements of section (1) of this rule, a manufacturer must submit one or more batches from a process lot for solvent testing upon written request by the Authority. Statutory/Other Authority: ORS 475A.235 & ORS 475A.590 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.590 History: PH 74-2022, adopt filed 05/19/2022, effective 05/20/2022
333-333-7060 Pesticide Testing (1) A licensee must submit one or more batches from a harvest lot or process lot for pesticide testing upon written request by the Oregon Health Authority. (2) A batch fails pesticide testing if the test detects the presence of a pesticide above action levels in any sample, including a field duplicate: (a) During an initial test where no reanalysis is requested; or (b) Upon reanalysis as described in OAR 333-333-7120. (3) If a sample from a harvest lot or process lot fails pesticide testing, the batch may not be remediated and must be destroyed. Statutory/Other Authority: ORS 475A.235 & ORS 475A.590 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.590 History: PH 58-2023, amend filed 12/21/2023, effective 01/01/2024 PH 74-2022, adopt filed 05/19/2022, effective 05/20/2022
333-333-7070 Contaminant Testing (1) A licensee must submit one or more batches from a harvest lot or process lot for contaminant testing upon written request by the Oregon Health Authority. (2) A psilocybin product required to be tested for contaminants under these rules must be sampled using appropriate aseptic technique and tested for total coliform count. (3) If the presence of any fecal coliforms is detected the sample must be assessed for Escherichia coli (E. Coli) (4) A batch fails microbial contaminant testing if the presence of E. Coli at more than 100 colony forming units per gram is detected in a sample. (5) A psilocybin product required to be tested for contaminants may also be tested for aflatoxins and other harmful mycotoxins. (6) A psilocybin product fails testing for aflatoxins and other harmful mycotoxins if the tests detect mycotoxins at levels that are unsafe for human consumption. (7) If a sample from a batch of psilocybin product fails contaminant testing, the batch may not be remediated and must be destroyed. Statutory/Other Authority: ORS 475A.235 & ORS 475A.590 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.590 History: PH 58-2023, amend filed 12/21/2023, effective 01/01/2024 PH 74-2022, adopt filed 05/19/2022, effective 05/20/2022
333-333-7080 Heavy Metals Testing (1) A licensee must submit one or more batches from a harvest lot or process lot for heavy metal testing upon written request by the Oregon Health Authority. (2) A harvest lot or process lot required to be tested for heavy metals may be tested for lead, cadmium, mercury and arsenic. (3) A batch fails heavy metal testing if the presence of metals above the limits in section (4) of this rule are detected in any sample, including a field duplicate: (a) During an initial test where no reanalysis is requested; or (b) Upon reanalysis as described in OAR 333-333-7120. (4) The limits for heavy metal testing are: (a) Lead (Pb) above .5 μg/g. (b) Cadmium (Cd) above .2 μg/g. (c) Arsenic (As) above .2 μg/g. (d) Mercury (Hg) above .1 μg/g. (5) If a sample from a batch of psilocybin product fails heavy metal testing, the batch may not be remediated and must be destroyed. Statutory/Other Authority: ORS 475A.235 & ORS 475A.590 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.590 History: PH 58-2023, amend filed 12/21/2023, effective 01/01/2024 PH 74-2022, adopt filed 05/19/2022, effective 05/20/2022
333-333-7090 Psilocybin Batch Requirements (1) A manufacturer must separate each harvest lot of dried whole fungi into batches no larger than one kilogram. (2) A process lot for psilocybin extracts, homogenized fungi or edible psilocybin products is considered a batch. (3) A manufacturer must associate each batch with a unique identification number and that unique identification number must be: (a) Provided to the individual responsible for taking samples; and (b) Included in the batch labels required by OAR 333-333-7110. Statutory/Other Authority: ORS 475A.235 & ORS 475A.590 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.590 History: PH 58-2023, amend filed 12/21/2023, effective 01/01/2024 PH 74-2022, adopt filed 05/19/2022, effective 05/20/2022
333-333-7100 Psilocybin Product Sampling Requirements (1) Whole fungi. (a) Whole fungi may only be sampled after it is dried, regardless of whether the whole fungi will be processed into another product type. (b) Sufficient sample increments must be taken to perform required tests and samples must be taken in a manner consistent with the laboratory’s sampling policies and procedures. (2) Other product types. (a) Samples of psilocybin extracts, homogenized fungi, and edible psilocybin products intended for use by a client must be taken from the finished product. (b) Sufficient sample increments from a batch must be taken to determine whether the batch is homogenous and must be taken in a manner consistent with the laboratory’s sampling policies and procedures. (c) A sufficient sample size must be taken for analysis of all requested tests and the quality control performed by the testing laboratory for these tests. (3) Only individuals employed by a laboratory with an Oregon Environmental Laboratory Accreditation Program (ORELAP) accredited scope item for sampling under these rules may take samples. (4) Sampling may be conducted at a manufacturer’s licensed premises, or the manufacturer may transport the batch to a laboratory with an ORELAP accredited scope item for sampling under these rules. (5) After entering test results into the product tracking system (PTS) of all compliance testing that was completed as required by OAR 333-333-7030, OAR 333-333-7040, OAR 333-333-7050, OAR 333-333-7060, OAR 333-333-7070, OAR 333-333-7080, a laboratory licensee must retain the remaining sample material for a minimum of 30 additional calendar days. Statutory/Other Authority: ORS 475A.235 & ORS 475A.590 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.590 History: PH 82-2024, amend filed 11/22/2024, effective 01/01/2025 PH 74-2022, adopt filed 05/19/2022, effective 05/20/2022
333-333-7110 Requirements for Pre-Tested Psilocybin Products (1) Following samples being taken from a harvest or process lot a manufacturer must: (a) Label the batch with the following information: (A) The harvest or process lot unique identification number; (B) The name of the laboratory that took samples and the name of the laboratory responsible for testing, if different; (C) The test batch or sample unique identification numbers supplied by the laboratory; (D) The date the samples were taken: and (E) In bold, capital letters, no smaller than 12-point font, "PRODUCT NOT TESTED." (b) Store and secure the batch in a manner that prevents the product from being tampered with or transferred prior to test results being reported; and (c) Be able to easily locate a batch stored and secured under subsection (1)(b) of this rule and provide that location to the Authority or a laboratory upon request. (2) If the samples pass testing, the product may be sold or transferred in accordance with applicable rules. (3) If the samples do not pass testing, the manufacturer must comply with OAR 333-333-7120. Statutory/Other Authority: ORS 475A.235 & ORS 475A.590 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.590 History: PH 74-2022, adopt filed 05/19/2022, effective 05/20/2022
333-333-7150 Quality Control Testing (1) A manufacturer may request that a laboratory conduct testing for the purpose of assuring quality control for psilocybin products that are manufactured in compliance with these rules, except as provided in section (2) of this rule. (2) A manufacturer may not request that a laboratory conduct pesticide testing on psilocybin products for the purpose of quality control. A pesticide test is always a compliance test. (3) A manufacturer that submits a psilocybin product for quality control testing is not subject to OAR 333-333-7010 to OAR 333-333-7120. (4) A laboratory result from a quality control test cannot be used as a compliance test result and may not be displayed on client packaging or labels. A psilocybin product that has undergone a quality control test may not be transferred or sold without undergoing required compliance tests. (5) Manufacturers must retain all quality control test results for at least two years and provide copies of such results upon request to the Oregon Health Authority. Statutory/Other Authority: ORS 475A.235 & ORS 475A.590 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.590 History: PH 82-2024, amend filed 11/22/2024, effective 01/01/2025 PH 58-2023, amend filed 12/21/2023, effective 01/01/2024 PH 74-2022, adopt filed 05/19/2022, effective 05/20/2022
333-333-8210 Product Tracking - Reconciliation of Inventory (1) Each service center, manufacturer and laboratory licensee must: (a) Use the product tracking system for all inventory tracking activities, as required by these rules. (b) By 11:59 AM local time of the next calendar day, reconcile all psilocybin product inventory in the product tracking system to reflect the prior day’s activity. (c) For psilocybin products that have completed potency testing, use the product tracking system to record the total amount of psilocybin analyte contained in psilocybin products by weight, measured in grams or milligrams. (2) The requirements of subsection (1)(b) of this rule do not apply: (a) To psilocybin spores or mycelium that are in a preproduction process at a manufacturer’s licensed premises. (b) During the first 15 days following the harvest of fruiting bodies or mycelium, daily reconciliation by a manufacturer of the weight of moisture lost to evaporation is not required. The weight of moisture loss must be reconciled by a manufacturer prior to transferring, processing, selling, or packaging the fungi and no later than 15 days after the harvest, whichever comes first. (c) To psilocybin products held by a laboratory licensee that are undergoing analytical testing required by these rules so long as the psilocybin products do not leave the laboratory’s licensed premises and are reconciled on the same day that the analytical testing concludes. (3) In addition to the requirements in section (1) of this rule, service centers must record each individual sale or transfer of a psilocybin product to a client as a sales transaction and record the price before tax and amount of each individual item sold and the date of each transaction in the product tracking system for each individual transaction. Statutory/Other Authority: ORS 475A.235 & ORS 475A.400 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.400 History: PH 82-2024, amend filed 11/22/2024, effective 01/01/2025 PH 58-2023, amend filed 12/21/2023, effective 01/01/2024 PH 206-2022, adopt filed 12/27/2022, effective 12/27/2022
333-333-8220 Product Tracking - Unique Identification Numbers (1) A service center, manufacturer or laboratory licensee must use unique identification numbers generated by the product tracking system for inventory tracking activities required by these rules. (2) A manufacturer licensee must: (a) Assign and affix a unique identification number to each separated area containing a cultivation batch of mycelium or fruiting bodies as described in OAR 333-333-8230. (b) After harvest, assign and affix a unique identification number to all psilocybin products or receptacles containing psilocybin products. (c) Assign and affix unique identification numbers in a manner that: (A) Establishes an accurate record of cultivation, harvest and drying of fungi, including documentation of harvest lots and batches as described in OAR 333-333-2020 and OAR 333-333-7090. (B) Establishes an accurate record when one psilocybin product is converted to another product type. (C) Uses a new unique identification number each time a psilocybin product is added to a quantity of psilocybin products grouped together under a pre-existing unique identification number. (d) Affix unique identification numbers in a position that can be clearly read by an individual standing next to the item. (3) To allow for a drying period, the requirements of subsection (2)(c) of this rule do not apply to harvested mycelium or fruiting bodies in the first 15 days after harvest. (4) The requirements of section (2) of this rule do not apply to psilocybin spores or mycelium that are in a preproduction process at a manufacturer’s licensed premises. (5) A manufacturer licensee may not combine psilocybin products of different package or serving size, potency, or type under a single unique identification number, except for mixed lots of homogenized fungi or psilocybin extracts that will undergo further processing. (6) A service center, manufacturer or laboratory licensee may not reuse unique identification numbers. Statutory/Other Authority: ORS 475A.235 & ORS 475A.400 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.400 History: PH 58-2023, amend filed 12/21/2023, effective 01/01/2024 PH 206-2022, adopt filed 12/27/2022, effective 12/27/2022