Ariz. Admin. Code § 9-18-408

Current through Register Vol. 30, No. 50, December 13, 2024

Section 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 ([DELTA]9-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).

Ariz. Admin. Code § R9-18-408

Adopted by exempt rulemaking at 27 A.A.R. 697, effective 5/1/2021. Amended by exempt rulemaking at 29 A.A.R. 2453, effective 10/1/2023. Amended by exempt rulemaking at 30 A.A.R. 3451, effective 11/1/2024.