Or. Admin. Code § 333-333-7070

Current through Register Vol. 63, No. 11, November 1, 2024

Section 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.

Or. Admin. Code § 333-333-7070

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

Statutory/Other Authority: ORS 475A.235 & ORS 475A.590

Statutes/Other Implemented: ORS 475A.235 & ORS 475A.590