333-333-2010 Psilocybin Production (1) A manufacturer is prohibited from: (a) Using manure in cultivation or production of psilocybin products. (b) Using wood chips as a growing medium in cultivation or production of psilocybin products. (c) Producing psilocybin by using genetically modified organisms such as bacteria. (d) Producing psilocybin by chemical synthesis. (e) Promoting unregulated cultivation and processing of psilocybin products by offering for sale spores, mycelium or materials used to cultivate and process psilocybin products, except for sales to other licensed parties as allowed by ORS chapter 475A and these rules. (2) Manufacturers who produce their own compost in cultivation must comply with the following requirements: (a) Compost shall not exceed the maximum acceptable pathogen concentrations described in subsection (2)(b) of this rule. Compost that contains any pathogens in amounts that exceed these pathogen reduction requirements shall be designated for additional processing, disposal, or other use as approved by local or state agencies having appropriate jurisdiction. (b) Manufacturers that produce their own compost shall ensure that: (A) The density of fecal coliform in compost, that is or has at one time been active compost, shall be less than 1,000 Most Probable Number per gram of total solids (dry weight basis), and the density of Salmonella sp. bacteria in compost shall be less than three Most Probable Number per four grams of total solids (dry weight basis). (B) If using a vessel composting process, active compost is maintained at a temperature of 55 degrees Celsius or higher for a pathogen reduction period of three days. (C) If using a windrow composting process, active compost is maintained under aerobic conditions at a temperature of 55 degrees Celsius higher for a pathogen reduction period of 15 days or longer. During the period when the compost is maintained at 55 degrees Celsius or higher, there shall be a minimum of five turnings of the windrow. (D) If using an aerated static pile composting process, all active compost is covered with 6 to 12 inches thickness of insulating material, and the active compost shall be maintained at a temperature of 55 degrees Celsius or higher for a pathogen reduction period of three days. (c) Manufacturers that utilize a windrow composting process or an aerated static pile composting process shall monitor as follows to ensure that the standards in subsection (2)(b) of this rule are met: (A) Each day during the pathogen reduction period, at least one temperature reading shall be taken per every 150 feet of windrow, or fraction thereof, or for every 200 cubic yards of active compost, or fraction thereof. (B) Temperature measurements for pathogen reduction are measured as follows: (i) Windrow composting processes and agitated bays shall be monitored 12 to 24 inches below the pile surface. (ii) Aerated static pile composting processes shall be monitored 12 to 18 inches from the point where the insulation cover meets the active compost. (d) Alternative methods of compliance to meet the pathogen reduction requirements of this section may be approved by the Oregon Health Authority (Authority) if the Authority determines that the alternative method will provide equivalent pathogen reduction. Statutory/Other Authority: ORS 475A.235 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.290 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