§ 990.25 - Standards of performance for detecting total delta-9 tetrahydrocannabinol (THC) concentration levels.  


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  • § 990.25 Standards of performance for detecting total delta-9 tetrahydrocannabinol (THC) concentration levels.

    (a)

    Analytical testing for purposes of

    detecting the concentration levels of delta-9 tetrahydrocannabinol (THC) in the flower material of the cannabis plant shall meet the following standard: (1

    determining total THC in cannabis plants shall meet the standards in this section.

    (a) Laboratory quality assurance must ensure the validity and reliability of test results

    ;

    .

    (

    2

    b) Analytical method selection, validation, and verification must ensure that the testing method used is appropriate (fit for purpose), and that the laboratory can successfully perform the testing

    ;

    .

    (

    3

    c) The demonstration of testing validity must ensure consistent, accurate analytical performance

    ; and

    .

    (

    4

    d) Method performance specifications must ensure analytical tests are sufficiently sensitive for the purposes of the detectability requirements of this part.

    (

    b)

    e) Laboratory must have an effective disposal procedure for non-compliant samples that do not meet the requirements of this part.

    (f) Measurement of uncertainty (MU) must be estimated and reported with test results. Laboratories shall use appropriate, validated methods and procedures for all testing activities and evaluate measurement of uncertainty.

    (g) At a minimum, analytical testing of samples for

    delta-9 tetrahydrocannabinol concentration levels

    total THC must use post-decarboxylation or other similarly reliable methods approved by the Secretary. The testing methodology must consider the potential conversion of

    delta-9 tetrahydrocannabinolic acid (

    THCA

    )

    in hemp into

    delta-9 tetrahydrocannabinol (

    THC

    )

    and the test result must reflect the total available THC derived from the sum of the THC and

    THC-A

    THCA content. Testing methodologies meeting the requirements of this paragraph (

    b

    g) include, but are not limited to, gas or liquid chromatography with detection.

    (

    c

    1) The total

    delta-9 tetrahydrocannabinol concentration level

    THC shall be determined and reported on a dry weight basis. Additionally, measurement of uncertainty (MU) must be estimated and reported with test results. Laboratories shall use appropriate, validated methods and procedures for all testing activities and evaluate measurement of uncertainty.

    (

    d

    2) Any sample test result exceeding the acceptable hemp THC level shall be conclusive evidence that the lot represented by the sample is not in compliance with this part.

    (3) After December 31, 2022, USDA licensees may only use laboratories registered with the DEA to conduct testing under this section.