Or. Admin. Code § 845-025-5850

Current through Register Vol. 63, No. 12, December 1, 2024

Section 845-025-5850 - Failed Test Samples for Industrial Hemp and Hemp Items

(1) Additional potency testing failures. In addition to the criteria for a failed test described in OAR 333-007-0430:

(a) A hemp item that a processor intends to transfer to an unlicensed person in accordance with OAR 845-025-3320 fails potency testing if, based on an initial test where no reanalysis is requested or upon reanalysis as described in OAR 333-007-0450(1), the percentage of total delta-9 THC, as calculated pursuant to OAR 333-064-0100, exceeds 0.3 percent. A laboratory licensee shall record a failed test described in this subsection in CTS.

(b) A batch of harvested industrial hemp or usable hemp or a process lot an industrial hemp concentrate, industrial hemp extract, or finished hemp cannabinoid product that is not subject to subsection (a) of this section fails potency testing if, based on an initial test where no reanalysis is requested or upon reanalysis as described in OAR 333-007- 0450(1), the amount or percentage of total delta-9 THC, as calculated pursuant to OAR 333-064-0100, exceeds the maximum quantity or concentration limits in OAR 845-025-2760 by over 10 percent. A laboratory licensee shall record a failed test described in this section in CTS.

(2) If a sample or a duplicate sample (collectively referred to as "sample" for purposes of this rule) fails any initial test the laboratory licensee that did the testing may reanalyze the sample. The laboratory licensee 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 licensee must resample the batch and confirm that result in order for the batch to pass testing.

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

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

(c) A licensee or certificate holder must inform the Commission immediately of the following, in a manner prescribed by the Commission:

(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.

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

(a) May be remediated or sterilized in accordance with OAR 333-007-0450; or

(b) If it is not or cannot be remediated or sterilized under OAR 333-007-0450, must be destroyed in a manner specified by the Commission.

(4) Except as otherwise permitted under this OAR 333-007-0450, an industrial hemp concentrate, industrial hemp extract, or finished inhalable hemp cannabinoid product that is permitted to undergo remediation cannot be further processed into a cannabinoid product during the remediation process.

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

(6) If the batch fails under section (1) of this rule, the certificate holder must:

(a) Store and segregate the batch in a secure area;

(b) Label the batch clearly to indicate it has failed a test and the label must include a test batch number; and

(c) For each batch of industrial hemp or hemp items that fails potency testing, resolve the failure in one of the following ways:

(A) If the certificate holder is a Commission-certified hemp handler, process the batch into a hemp item that does not exceed the THC limits specified in OAR 845-025-2760 in accordance with OAR 333-007-0450(10);

(B) Transfer the batch to a Commission-certified hemp handler for the purposes of processing the industrial hemp or hemp item into a hemp item that does not exceed the THC limits specified in OAR 845-025-2760;

(C) Remove the industrial hemp or hemp item from their inventory tracked in CTS and use or transfer the industrial hemp or hemp item in accordance with state law and the privileges of their hemp license issued under ORS 571.281; or

(D) Destroy the batch in a manner specified by the Commission.

Or. Admin. Code § 845-025-5850

OLCC 202-2022, adopt filed 11/21/2022, effective 1/1/2023

Statutory/Other Authority: ORS 475C.017, ORS 571.336, 571.337

Statutes/Other Implemented: ORS 571.336, 571.337