Or. Admin. R. 333-007-0450

Current through Register Vol. 63, No. 6, June 1, 2024

Section 333-007-0450 - Failed Test Samples

(1) If a sample or a duplicate sample (collectively referred to as "sample" for purposes of this rule) fails any initial test the laboratory that did the testing may reanalyze the sample. The laboratory that did the initial test may not subcontract the reanalysis. If a primary sample or a duplicate sample fails, both must be reanalyzed. If the sample passes, another laboratory must resample the batch and confirm that result in order for the batch to pass testing.

(a) If a registrant or licensee requests to have a sample reanalyzed, the registrant or licensee must request a reanalysis within seven calendar days from the date the laboratory sent notice of the failed test to the registrant or licensee. The reanalysis must be completed by the laboratory within 30 days from the date the reanalysis was requested.

(b) If a registrant or licensee has requested a reanalysis in accordance with subsection (1)(a) of this rule and the sample passes, the registrant or licensee has seven calendar days from the date the laboratory sent notice of the passed test to request that another laboratory resample the batch and confirm the passed test result. The retesting must be completed by the second laboratory within 30 days from the date the retesting was requested. The second laboratory performing the retesting:

(A) May not be performed at a laboratory under the same ownership as the original laboratory that performed the testing.

(B) May not be done by a laboratory that was subcontracted to do the original testing.

(C) May only conduct retesting for the compliance test that initially failed.

(c) If reanalysis in accordance with subsection (1)(a) or retesting in accordance with subsection (1)(b) is ordered, then the batch must remain in its original quantity as it was initially submitted to the laboratory for testing and may not be subdivided.

(d) A registrant must inform the Oregon Health Authority (Authority) immediately, of the following, in a manner prescribed by the Authority:

(A) A request for reanalysis of a sample;

(B) The testing results of the reanalysis;

(C) A request for retesting; and

(D) The results of retesting.

(2) If a sample fails a test or a reanalysis under section (1) of this rule the batch:

(a) May be remediated or sterilized in accordance with this rule.

(b) Must be destroyed in a manner specified by the Authority or the Oregon Liquor and Cannabis Commission (Commission) if it is not or cannot be remediated or sterilized under this rule.

(c) May not be combined with other batches as part of remediation or further processing.

(3) If a registrant is permitted to remediate or sterilize under this rule, the registrant must provide notice to the Authority of the registrant's intent to remediate or sterilize.

(4) Except as otherwise permitted under this rule, a cannabinoid concentrate, extract, finished inhalable cannabinoid product, or industrial hemp-derived vapor item that is permitted to undergo remediation cannot be further processed into a cannabinoid product during the remediation process.

(5) If a licensee or registrant is permitted under this rule to sell or transfer a batch that has failed a test, the licensee or registrant must notify the licensee or registrant to whom the batch is sold or transferred of the failed test.

(6) Failed microbiological contaminant testing.

(a) If a sample from a batch of marijuana or usable marijuana fails microbiological contaminant testing the batch may either:

(A) Be remediated using a sterilization process; or

(B) Be used to make a cannabinoid concentrate or extract if the processing method effectively sterilizes the batch, such as a method using a hydrocarbon-based solvent or a CO2 closed loop system.

(b) If a sample from a batch of a cannabinoid concentrate, extract, finished inhalable cannabinoid product, or industrial hemp-derived vapor item fails microbiological contaminant testing the batch may be further processed if the processing method effectively sterilizes the batch, such as a method using a hydrocarbon-based solvent or a CO2 closed loop system.

(c) A batch that is remediated through a sterilization process in accordance with subsection (a) or (b) of this section must be sampled in accordance with OAR 333-007-0360 and must be tested for:

(A) Microbiological contaminants;

(B) Solvents if required per OAR 333-007-0410;

(C) Pesticides;

(D) Water activity and moisture content if required per OAR 333-007-0420;

(E) Potency in accordance with OAR 333-007-0430(1);

(F) Heavy metals if the marijuana item or industrial hemp-derived vapor item was harvested or manufactured on or after March 1, 2023; and

(G) Mycotoxins if the marijuana item or industrial hemp-derived vapor item was harvested or manufactured on or after July 1, 2022.

(d) A batch that fails microbiological contaminant testing after undergoing remediation through a sterilization process in accordance with paragraph (a)(A) of this section must be destroyed in a manner specified by the Authority or the Commission, or may be further processed as described in paragraph (a)(B) of this section.

(7) Failed solvent testing.

(a) If a sample from a batch fails solvent testing the batch may be remediated using procedures that would reduce the concentration of solvents to less than the action level.

(b) A batch that is remediated in accordance with subsection (a) of this section must be re-sampled in accordance with OAR 333-007-0360 and must be re-tested for:

(A) Solvents;

(B) Pesticides;

(C) Potency in accordance with OAR 333-007-0430(1);

(D) Heavy metals if the marijuana item or industrial hemp-derived vapor item was manufactured on or after March 1, 2023;

(E) Mycotoxins if the marijuana item or industrial hemp-derived vapor item was manufactured on or after July 1, 2022; and

(F) Microbiological contaminants if the marijuana item or industrial hemp-derived vapor item was manufactured on and after March 1, 2023.

(c) A batch that fails solvent testing that is not remediated must be destroyed in a manner specified by the Authority or the Commission.

(8) Failed water activity or moisture content testing.

(a) If a sample from a batch of marijuana or usable marijuana fails for water activity or moisture content the batch from which the sample was taken may:

(A) Be used to make a cannabinoid concentrate or extract if the processing method effectively sterilizes the batch; or

(B) Continue to dry or cure.

(b) A batch that undergoes additional drying or curing as described in paragraph (a)(B) of this section must be re-sampled in accordance with OAR 333-007-0360 and re-tested for:

(A) Pesticides;

(B) Water activity and moisture content;

(C) Potency in accordance with OAR 333-007-0430(1);

(D) Heavy metals if the marijuana or usable marijuana was harvested on or after March 1, 2023;

(E) Mycotoxins if the marijuana or usable marijuana was harvested on or after July 1, 2022; and

(F) Microbiological contaminants if the marijuana or usable marijuana was harvested on and after March 1, 2023.

(9) Failed pesticide testing.

(a) If a sample from a batch of marijuana or usable marijuana fails pesticide testing the batch may not be remediated and must be destroyed as ordered by the Authority or the Commission, except as permitted under subsection (c) of this section. A batch may not be destroyed without obtaining permission from the Authority or the Commission.

(b) The Authority must report to the Oregon Department of Agriculture all test results that show that a sample of usable marijuana failed a pesticide test.

(c) If a sample from a batch of marijuana or usable marijuana fails pesticide testing but only for the analytes piperonyl butoxide or pyrethrins, and the Oregon Department of Agriculture determines that the products used were listed on the Department's Guide List for Pesticides and Cannabis and the product was applied in accordance with the label, the Authority or the Commission may permit the producer or grower to remediate the usable marijuana using procedures that would reduce the concentration of pesticides to less than the action level. A batch of usable marijuana that is permitted to be remediated must be re-sampled in accordance with OAR 333-007-0360 and re-tested for:

(A) Pesticides;

(B) Water activity and moisture content;

(C) Potency in accordance with OAR 333-007-0430(1);

(D) Microbiological contaminates if the marijuana item was harvested on or after March 1, 2023;

(E) Heavy metals if the marijuana item was harvested on or after March 1, 2023; and

(F) Mycotoxins if the marijuana item was harvested on or after July 1, 2022.

(d) If a processor or a processing site is only processing with marijuana or usable marijuana that has passed pesticide testing in accordance with OAR 333-007-0400 and a sample from a batch of a cannabinoid concentrate or extract fails pesticide testing the batch may be remediated using procedures that would reduce the concentration of pesticides to less than the action level.

(e) If a batch of industrial hemp-derived vapor item fails pesticides testing, it may only be remediated using procedures that would reduce the concentration of pesticides to less than the action level if the input material used to make the industrial hemp-derived vapor item passed pesticide testing in accordance with OAR 333-007-0400.

(f) A batch that is remediated in accordance with subsection (d) or (e) of this section must be re-sampled in accordance with OAR 333-007-0360 and re-tested for:

(A) Pesticides;

(B) Potency in accordance with OAR 333-007-0430(1);

(C) Solvent testing if required per OAR 333-007-0410;

(D) Heavy metals;

(E) Mycotoxins; and

(F) Microbiological contaminants.

(g) If a sample from a batch of finished inhalable cannabinoid products fails pesticide testing, the batch may not be remediated and must be destroyed in a manner specified by the Authority or the Commission.

(h) A batch that is remediated but after being re-sampled and re-tested fails pesticide testing must be destroyed as ordered by the Authority or the Commission.

(10) Failed potency testing.

(a) A marijuana item or industrial hemp-derived vapor item that fails potency testing under OAR 333-007-0430(2)(b) may be repackaged in a manner that enables the item to meet the concentration limit standards in the Commission's concentration limit rules in OAR chapter 845, division 26, as applicable. A marijuana item or industrial hemp-derived vapor item that is repackaged in accordance with this subsection must be re-sampled and re-tested in accordance with these rules.

(b) A marijuana item or industrial hemp-derived vapor item that fails potency testing under OAR 333-007-0430(2)(a) may be re-mixed to meet the standards in OAR 333-007-0430(2)(a). A marijuana item or industrial hemp-derived vapor item that is re-mixed must be re-sampled in accordance with OAR 333-007-0360 and re-tested in accordance with these rules for the marijuana item or industrial hemp-derived vapor item for:

(A) Pesticides;

(B) Potency in accordance with OAR 333-007-0430(1);

(C) Solvent testing if required per OAR 333-007-0410;

(D) Heavy metals if the marijuana item or industrial hemp-derived vapor item is or was manufactured on or after March 1, 2023;

(E) Mycotoxins if the marijuana item or industrial hemp-derived vapor item is or was manufactured on or after July 1, 2022; and

(F) Microbiological contaminants if the marijuana item or industrial hemp-derived vapor item is or was manufactured on and after March 1, 2023.

(11) Failed heavy metal testing.

(a) If a sample from a batch of marijuana or usable marijuana fails heavy metal testing, the batch may be remediated by processing into a cannabinoid concentrate or extract if the processing method reduces the concentration of heavy metals to less than the action levels.

(b) If a sample from a cannabinoid concentrate or extract fails heavy metal testing, the batch may be remediated using procedures that would reduce the concentration of heavy metals to less than the action level.

(c) If a sample from a batch of finished inhalable cannabinoid product or industrial hemp-derived vapor item fails for heavy metals, the batch may not be remediated and must be destroyed in a manner specified by the Authority or Commission.

(d) A batch that is remediated in accordance with subsection (a) or (b) of this section must be re-sampled in accordance with OAR 333-007-0360 and re-tested for:

(A) Pesticides;

(B) Solvents if required under OAR 333-007-0410;

(C) Potency in accordance with OAR 333-007-0430(1);

(D) Heavy metals;

(E) Mycotoxins; and.

(F) Microbiological contaminants.

(e) A batch that fails heavy metal testing that is not remediated must be destroyed in a manner specified by the Authority, Commission, or the Department of Agriculture.

(12) Failed mycotoxin testing. If a sample from a batch of a marijuana item or industrial hemp-derived vapor item fails mycotoxin testing the batch may not be remediated and must be destroyed in a manner specified by the Authority, Commission, or the Department of Agriculture.

(13) A registrant must inform a laboratory prior to samples being taken that the batch has failed a test and is being retested after undergoing remediation or sterilization.

(14) A registrant must, as applicable:

(a) Have detailed procedures for sterilization processes to remove microbiological contaminants and for reducing the concentration of solvents.

(b) Document all sampling, testing, sterilization, remediation and destruction that are a result of failing a test under these rules.

(15) If a batch fails a test under these rules a registrant:

(a) Must store and segregate the batch in a secure area and label the batch clearly to indicate it has failed a test and the label must include a test batch number.

(b) May not remove the batch from the registered premises without permission from the Authority.

Or. Admin. R. 333-007-0450

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 35-2016(Temp), f. & cert. ef. 12-2-16 thru 5-30-17; PH 9-2017, f. 5-26-17, cert. ef. 5/31/2017; PH 29-2017, amend filed 12/22/2017, effective 1/1/2018; PH 282-2018, amend filed 12/20/2018, effective 1/1/2019; PH 89-2020, amend filed 12/30/2020, effective 1/1/2021; 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 6-2024, amend filed 03/20/2024, effective 4/1/2024

Statutory/Other Authority: ORS 475C.544

Statutes/Other Implemented: ORS 475C.544