1. (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. (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. (3) If the presence of any fecal coliforms is detected the sample must be assessed for Escherichia coli (E. Coli)
4. (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. (5) A psilocybin product required to be tested for contaminants may also be tested for aflatoxins and other harmful mycotoxins.
6. (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. (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