Section R66-32-4 - Industrial Hemp Testing Laboratory Requirements(1) On or after January 1, 2022, an industrial hemp testing laboratory shall be registered with the DEA in accordance with the Controlled Substances Act, 21 USC 823 (f), 21 CFR 1301.13, and 7 CFR 990.(2) An industrial hemp testing laboratory shall:(a) establish written standard operating procedures (SOPs) for each test being conducted;(b) establish an internal SOP that shall address testing and retesting industrial hemp material;(c) ensure that any SOPs are consistent with Cannabis Inflorescence: Standards of Identity, Analysis, and Quality Control, 2014 Revisions, published by the American Herbal Pharmacopoeia;(d) establish quality assurance protocols that:(i) ensure the validity and reliability of test results;(ii) ensure consistent, accurate, analytical performance; and(iii) include an effective disposal procedure, in accordance with state and federal laws for noncompliant samples;(e) require grinding of any pre- or post-harvest testing sample to ensure homogeneity of plant material before testing;(f) ensure that: (i) pre-harvest testing measures the total THC concentration in a sample submitted for analysis;(ii) the laboratory performs chemical analysis on the sample using post-decarboxylation or other similarly reliable methods where total THC concentration level considers the potential to convert delta-9-tetrahydrocannabinolic acid (THCA) into THC;(ii) test results reflect the total available THC derived from the sum of the THC and THCA content; and(iii) testing of final products measures total composite tetrahydrocannabinol, and that the total delta-9 tetrahydrocannabinol concentration level is determined and reported on a dry weight basis;(h) calculate and include the measurement of uncertainty when THC concentration test results are reported and that:(i) the method used to calculate the measurement of uncertainty may include one listed in the AOAC Standard Method Performance Requirements 2019.003 found at https://www.aoac.org/resources/smpr-2019003/, or any equivalent method approved by the department;(ii) the measurement of uncertainty is estimated and reported with test results;(iii) each industrial hemp testing laboratory uses appropriate, validated methods and procedures for testing activities and evaluating the measurement of uncertainty; and(iv) the range of the measurement of uncertainty is reported as a +/- value and uses the same unit as the hemp THC threshold, such as +/- 0.05, following best practices for significant figures and rounding;(i) follow validated analytical methods, such as those published by AOAC, American Herbal Pharmacopoeia, the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), or another reputable scientific organization, or notify the department of an alternative scientifically valid testing methodology the lab is following for each required test:(i) an industrial hemp testing laboratory may not use an alternative testing method without prior review from the department;(ii) an alternative testing protocol shall only be considered if it is comparable to the baseline mandated in the 2018 Farm Bill and established under the United States Department of Agriculture (USDA) Final Rule establishing a Domestic Hemp Production Program published at 7 CFR Part 990 ;(iii) alternative procedures shall be validated by the USDA in writing;(iv) the department shall review any monograph or analytical method followed by an industrial hemp testing laboratory to ensure the methodology produces scientifically accurate results before the use of an alternative testing methods to conduct the required tests; and(v) method performance specifications shall ensure analytical tests are sufficiently sensitive for the purposes of the detectability requirements of this rule;(j) provide the department with documentation showing that the industrial hemp testing laboratory has obtained and maintained the International Organization for Standardization (ISO) 17025:2017 accreditation. An industrial hemp testing laboratory may be permitted before ISO 17025:2017 accreditation provided the industrial hemp testing laboratory: (i) adopts and follows minimum good laboratory practices which satisfy the OECD Principles of Good Laboratory Practice and Compliance Monitoring published by the Organization for Economic Co-operation and development; and(ii) becomes ISO 17025:2017 accredited within 18 months.(3) The department incorporates the following materials by reference: (a) Cannabis Inflorescence: Standards of Identity, Analysis, and Quality Control, 2014 Revisions, published by the American Herbal Pharmacopoeia; and(b) OECD Principles of Good Laboratory Practice and Compliance Monitoring, 1997 version, published by the Organization for Economic Co-operation and Development.Utah Admin. Code R66-32-4
Adopted by Utah State Bulletin Number 2024-10, effective 5/13/2024