Or. Admin. Code § 333-333-8000

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

Section 333-333-8000 - [Effective 1/1/2025] Waste Management

(1) A manufacturer, service center or laboratory licensee must store, manage and dispose of solid and liquid wastes generated during production and processing of psilocybin products in accordance with applicable state and local laws and regulations which may include but are not limited to:

(a) Solid waste requirements in ORS chapter 459 and OAR chapter 340, divisions 93 to 96.

(b) Hazardous waste requirements in ORS chapter 466 and OAR chapter 340, divisions 100 to 106.

(c) Wastewater requirements in ORS chapter 468B and OAR chapter 340, divisions 41 to 42, 44 to 45, 53, 55 and 73.

(2) Psilocybin waste consisting of psilocybin products that have not been rendered unfit for human consumption must be securely stored and disposed of on the licensed premises or transferred to another licensee for disposal. Licensees must store psilocybin waste in either a limited access area or a locked waste receptacle located on the licensed premises until it is disposed.

(3) Psilocybin waste consisting of psilocybin products that have been rendered unfit for consumption may be stored prior to final disposal in a locked dumpster or other locked receptable outside of the licensed premises or may be stored pursuant to section (2) of this rule. Psilocybin products may be rendered unusable by composting, mixing with inactive ingredients, or any other method which renders the product unfit for consumption but does not pose a safety risk for accidental consumption.

(4) Manufacturers may dispose of waste that is a byproduct of cultivation or processing by composting that waste in a secured area on the licensed premises subject to the requirements of OAR 333-333-2010.

(5) If a licensee generates psilocybin waste after a harvest or process lot has been recorded, or if psilocybin waste was previously designated as a finished psilocybin product, the licensee must document:

(a) A reason for the waste in the product tracking system.

(b) The exact time and method of destruction in the product tracking system.

(6) All psilocybin waste must be disposed of in a manner that effectively prevents spontaneous growth of fruiting bodies or mycelium containing psilocybin. For example, through a controlled composting process or by placing waste in a sealed container.

(7) Material that has been designated as psilocybin waste must be disposed of pursuant to this rule and may not be used in the production of psilocybin products.

Or. Admin. Code § 333-333-8000

PH 206-2022, adopt filed 12/27/2022, effective 12/27/2022; PH 58-2023, amend filed 12/21/2023, effective 1/1/2024; PH 82-2024, amend filed 11/22/2024, effective 1/1/2025

Statutory/Other Authority: ORS 475A.235

Statutes/Other Implemented: ORS 475A.235