R9-18-408. Method Criteria and References for Laboratory Analyses

A. In addition to the definitions in A.R.S. § 36-2850 and R9-18- 101, the definitions in A.A.C. R9-17-404.03(A) apply in this Section unless otherwise stated. B. A technical laboratory director shall ensure that the marijuana testing facility complies with the requirements in A.A.C. R9- 17-404.03(B) through (O) when using chemical analytical methods for any of the analytes in Table 3.1. C. A technical laboratory director may release testing results that are scientifically valid and defensible from analyses using chemical analytical methods, according to R9-18-410(B)(3) and (C), with the following data qualifier notations if: 1. The target analyte detected in the calibration blank required in A.A.C. R9-17-404.03(F)(1)(c) or the method blank specified in A.A.C. R9-17-404.03(K)(1) is at or above the limit of quantitation, but the sample result: a. For potency testing, is below the limit of quantitation – B1; or b. When testing for pesticides, fungicides, growth regulators, mycotoxins, heavy metals, or residual solvents, is below the maximum allowable concentration in Table 3.1 for the analyte – B2; 2. The limit of quantitation and the sample results were adjusted to reflect sample dilution - D1; 3. The relative intensity of a characteristic ion in a sample analyte exceeded the acceptance criteria in A.A.C. R9- 17-404.03(L)(1) with respect to the reference spectra, indicating interference – I1; 4. When testing for pesticides, fungicides, growth regulators, mycotoxins, heavy metals, or residual solvents, the percent recovery of a laboratory control sample is greater than the acceptance limits in A.A.C. R9-17- 404.03(K)(2)(d), but the sample’s target analytes were not detected above the maximum allowable concentrations in Table 3.1 for the analytes in the sample – L1; 5. The recovery from the matrix spike in A.A.C. R9-17- 404.03(K)(4) was: a. High, but the recovery from the laboratory control sample in A.A.C. R9-17-404.03(K)(2) was within acceptance criteria – M1, b. Low, but the recovery from the laboratory control sample in A.A.C. R9-17-404.03(K)(2) was within acceptance criteria – M2, or c. Unusable because the analyte concentration was disproportionate to the spike level, but the recovery from the laboratory control sample in A.A.C. R9-17- 404.03(K)(2) was within acceptance criteria – M3; 6. The analysis of a spiked sample required a dilution such that the spike recovery calculation does not provide useful information, but the recovery from the associated laboratory control sample in A.A.C. R9-17-404.03(K)(2) was within acceptance criteria – M4; 7. The analyte concentration was determined by the method of standard addition, in which the standard is added directly to the aliquots of the analyzed sample – M5; 8. A description of the variance is described in the final report of testing according to R9-18-410(B)(3) and (C) – N1; 9. The relative percent difference for the laboratory control sample and duplicate exceeded the limit in A.A.C. R9- 17-404.03(K)(3), but the recovery in A.A.C. R9-17- 404.03(K)(2)(d) was within acceptance criteria – R1; 10. The relative percent difference for a sample and duplicate exceeded the limit in A.A.C. R9-17-404.03(O) – R2; or 11. The recovery from continuing initial calibration verification standards or continuing calibration verification standards is greater than the acceptance limits in A.A.C. R9- 17-404.03(H)(2) or (J)(1)(b) as applicable, but the sample’s target analytes were not detected above the maximum allowable concentrations in Table 3.1 for the analytes in the sample – V1. D. A technical laboratory director shall include in the final report of testing from analyses using chemical analytical methods, according to R9-18-410(B)(3) and (C), the following data qualifier notations if: 1. Sample integrity was not maintained – Q1; 2. The sample is heterogeneous, and sample homogeneity could not be readily achieved using routine laboratory practices – Q2; or 3. Testing result is for informational purposes only and cannot be used to satisfy marijuana establishment testing requirements in R9-18-311(A) or labeling requirements in R9-18-310 – Q3. E. For batch analysis of samples to determine potency, a technical laboratory director may check precision by using either a duplicate laboratory control sample or a duplicate sample prepared from the marijuana or marijuana product being tested, according to requirements in A.A.C. R9-17-404.03(K)(2) and (3). F. A technical laboratory director shall ensure that the reporting units for: 1. Pesticides, fungicides, growth regulators, heavy metals, or residual solvents is in parts per million (ppm); and 2. Mycotoxins are according to A.A.C. R9-17-404.04(I)(4); and 3. Potency are: a. In either: i. Percent (w/w) relative to the bulk plant material or marijuana product, as applicable; or ii. Number of milligrams per designated unit; and b. For: i. Total tetrahydrocannabinol, the sum of tetrahydrocannabinolic acid (THC-A), multiplied by 0.877, and delta-9-tetrahydrocannabinol (Δ9- THC); and ii. Total cannabidiol, the sum of cannabidiolic acid (CBD-A), multiplied by 0.877, and cannabidiol (CBD). G. To perform testing for the microbial contaminants in Table 3.1, a marijuana testing facility shall: 1. Use an applicable method described in A.A.C. R9-17- 404.04(A)(1) and validated according to A.A.C. R9-17- 404.04(A)(2), and 2. Comply with A.A.C. R9-17-404.04(A)(3) and (4), as applicable. H. A technical laboratory director shall ensure that the marijuana testing facility complies with the requirements in A.A.C. R9- 17-404.04(B) through (G) when performing testing for the microbial contaminants in Table 3.1. I. A technical laboratory director shall include in the final report of testing for the microbial contaminants in Table 3.1, according to R9-18-410(B)(3) and (C), the following data qualifier notations if: 1. The limit of quantitation and the sample results were adjusted to reflect sample dilution - D1; 2. A description of the variance is described in the final report of testing according to A.A.C. R9-17-410(B)(3) and (C) – N1; 3. Sample integrity was not maintained – Q1; 4. The sample is heterogeneous, and sample homogeneity could not be readily achieved using routine laboratory practices – Q2; or 5. Testing result is for informational purposes only and cannot be used to satisfy marijuana establishment testing requirements R9-18-311(A) or labeling requirements in R9-18-310 – Q3. J. A technical laboratory director shall ensure that: 1. The reporting units for Escherichia coli are colony forming units per gram (CFU/g); 2. Reporting for Salmonella is “Detected” or “Not detected” in one gram; 3. Reporting for Aspergillus is “Detected” or “Not detected” in one gram; and 4. Reporting for mycotoxins includes: a. Total aflatoxins in units of micrograms per kilogram (µg/kg), and b. Ochratoxin A in units of micrograms per kilogram (µg/kg).