Or. Admin. R. 333-007-0390 - [Effective 3/12/2024] Standards for Microbiological Contaminants Compliance Testing

(1) A marijuana item or industrial hemp-derived vapor item required to be tested for microbiological contaminants under OAR 333-007-0320 to 333-007-0342 must be sampled using appropriate aseptic technique and tested by a laboratory for pathogenic Aspergillus flavus, A. fumigatus, A. niger and A. terreus, Shiga toxin-producing Escherichia coli and Salmonella species.
(2) A batch fails microbiological contaminants testing if, during an initial test where no reanalysis is requested or upon reanalysis as described in OAR 333-007-0450(1) the laboratory detects:
(a) The presence of any of the following species of pathogenic molds in one gram of sample: Aspergillus flavus, A. fumigatus, A. niger and A. terreus;
(b) Shiga toxin-producing Escherichia coli in one gram; or
(c) Salmonella spp. in one gram.
(3) Aspergillus speciation testing as required in section (1) of this rule shall be performed using a qPCR analysis or other DNA-based method that has been certified by an independent scientific body.
(a) The certified method shall show equivalency in terms of fractional recovery with no statistically significant difference between the method and a reference method requiring enrichment such as plate culture.
(b) Laboratories shall follow the protocol or product instructions provided by the manufacturer, including any enrichment steps. If enrichment is recommended but not required, the enrichment shall be performed.

Notes

Or. Admin. R. 333-007-0390
PH 22-2015(Temp), f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16; PH 21-2016, f. 6-24-16, cert. ef. 6/28/2016; PH 9-2017, f. 5-26-17, cert. ef. 5/31/2017; PH 258-2018, minor correction filed 11/28/2018, effective 11/28/2018; PH 95-2021, amend filed 12/29/2021, effective 1/1/2022; PH 24-2022, amend filed 03/15/2022, effective 3/31/2022; PH 43-2023, temporary amend filed 09/15/2023, effective 9/15/2023 through 3/12/2024

Statutory/Other Authority: ORS 475C.544

Statutes/Other Implemented: ORS 475C.544

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