1. (1) For purposes of this rule the definitions in OAR 333-333-1010 apply unless the context indicates otherwise.

2. (2) A test report must clearly identify for the manufacturer:

   1. (a) Whether a sample has exceeded an action limit for an analyte in OAR 333-333-7050, or has otherwise failed a test as described in OAR 333-333-7030 and 333-333-7040.
   2. (b) The batch unique identification number required under OAR 333-333-7090 and the test batch number associated with the samples tested, as required by OAR 333-333-7110.
   3. (c) Identification of the test as a compliance test or a quality control or research and development test. If the test is not for compliance, the report shall indicate clearly on the first page the testing was for quality control or research and development.
   4. (d) If applicable, a statement that the test was done on a sample from a remediated psilocybin product.
3. (3) Within 24 hours of completion of the laboratory’s data review and approval procedures a laboratory must report all failed tests for testing required under OAR 333-333-7030, 333-333-7040, and 333-333-7050, whether or not the laboratory is reanalyzing the sample under OAR 333-333-7120, into PTS if performing testing for a manufacturer who is subject to PTS tracking under OAR chapter 333, division 333.
4. (4) If the laboratory discovers that an error has occurred after reporting a result to a manufacturer or into PTS, an amended report shall be generated and communicated to the manufacturer. The laboratory shall ensure that results entered into the PTS are accurate and updated if necessary to reflect the amended report. The laboratory shall ensure that the amended report, communication, and updates to PTS as described in this rule are completed within 48 hours of learning of the error.
5. (5) The laboratory must report all test results required under OAR 333-333-7030, 333-333-7040, and 333-333-7050 that have not been reported under section (3) of this rule into PTS if performing testing for a manufacturer who is subject to PTS tracking under OAR chapter 333, division 333.

6. (6) Each potency testing report shall include the results for psilocybin analyte and psilocin analyte expressed in mg/g as well as Total Potential Psilocin in accordance with OAR-333-333-7040.

   1. (a) Total Potential Psilocin must be calculated as follows:

      mg/g Total Potential Psilocin = mg/g psilocin analyte + 0.719 * mg/g psilocybin analyte.

   2. (b) Potency results for whole fungi shall be reported as the calculated values for psilocybin analyte, psilocin analyte, and Total Potential Psilocin as determined in the composite sample.
   3. (c) Potency results for homogenized fungi, psilocybin extract, or edibles shall be reported as the calculated values for psilocybin analyte, psilocin analyte, and Total Potential Psilocin as determined in the primary composite sample.
7. (7) Each solvent testing report shall include the results for the solvent used by the manufacturer in accordance with OAR 333-333-7050.
8. (8) Each speciation testing report shall indicate if the batch was positively identified as Psilocybe cubensis.
9. (9) A laboratory must determine and include on each test report its limit of quantitation (LOQ) and action level for each analyte listed in OAR 333-333-7040 and 333-333-7050.

10. (10) A laboratory must include in a test report the results of all associated batch quality control samples, with the date of analysis of the quality control samples and the acceptance limits used to determine acceptability.

    1. (a) Batch quality control samples are the method blank and laboratory control sample and the positive and negative controls in speciation testing.
    2. (b) The report must clearly show the association to the client samples in the report by listing the batch identification numbers.
11. (11) A laboratory that is reporting failed test results to the Authority in accordance with section (3) of this rule must report the failed test at the same time or before reporting to the manufacturer.
12. (12) If requested by the Authority, a laboratory must report sampling and testing information to the Authority, in a manner prescribed by the Authority.

13. (13) If a laboratory’s calculated potency result exceeds 100 percent or 1000mg/g and the difference between the result and 100 percent or 1000mg/g is within the laboratory’s calculated analytical uncertainty, the laboratory may report the result as 100 percent or 1000mg/g with a qualifying statement on the certificate of analysis or the laboratory may report the calculated result with or without a qualifying statement. If the difference between the result and 100 percent or 1000mg/g is outside the calculated analytical uncertainty, the calculated result shall be reported without correction.

    1. (a) The qualifying statement on the certificate of analysis must clearly state the calculated value and the laboratory’s analytical uncertainty.
    2. (b) For the purposes of calculating RPD or RSD, a laboratory must use the calculated result and not the adjusted result described in this rule.

14. (14) A primary accredited laboratory may subcontract with accredited laboratories to perform required compliance testing. The primary accredited laboratory must issue the final report.

    1. (a) Accredited, subcontracted laboratories must validate the results of any sample analysis and report that analysis to their client laboratory within 24 hours of completing the analytical run if the analysis results in a failed compliance test.
    2. (b) The accredited laboratory that issues the final test report must validate and report the results of any failed sample analysis as described in section (3) of this rule.

Statutory/Other Authority

ORS 438.605, 438.610, 438.615, 438.620, 475A.590 & 475A.606

Statutes/Other Implemented

ORS 438.605, 438.610, 438.615, 438.620, 475A.590 & 475A.606

History

PH 207-2022, adopt filed 12/27/2022, effective 12/27/2022