Ariz. Admin. Code § 9-17-404.04

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

Section R9-17-404.04 - Method Criteria and References for Analyses for Microbial Contaminants

A. To perform laboratory testing for the microbial contaminants in Table 3.1, a laboratory shall use an applicable method:

1. Described in:

a. The Bacteriological Analytical Manual (BAM), 2019, which is incorporated by reference, includes no future editions or amendments, and is available at https://www.fda.gov/food/laboratory-methods-food/bacteriological-analytical-manual-bam; or

b. AOAC Official Methods of Analysis, 21st Edition, 2019, which is incorporated by reference, includes no future editions or amendments, and is available at https://www.aoac.org/official-methods-of-analysis-21st-edition-2019;

2. Validated according to, as applicable:

a. AOAC - Appendix J: Guidelines for Validation of Microbiological Methods for Food and Environmental Surfaces, 2012, which is incorporated by reference, includes no future editions or amendments, and is available at http://www.eoma.aoac.org/app_j.pdf;

b. AOAC - Appendix K: Guidelines for Dietary Supplements and Botanicals, 2013, which is incorporated by reference, includes no future editions or amendments, and is available at http://www.eoma.aoac.org/app_k.pdf;

c. ICH - Validation of Analytical Procedures: Text and Methodology Q2(R1) 2005, which is incorporated by reference, includes no future editions or amendments, and is available at https://database.ich.org/sites/default/files/Q2_R1__Guide-line.pdf or https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q2-r1-validation-analytical-procedures-text-and-methodology;

d. AOAC SMPR® 2019.001 - Standard Method Performance Requirements (SMPRs®) for Detection of Aspergillus in Can-nabis and Cannabis Products, which is incorporated by reference, includes no future editions or amendments, and is available at https://www.aoac.org/wp-content/uploads/2020/11/SMPR202019_001.pdf; or

e. AOAC SMPR® 2020.002 - Standard Method Performance Requirements (SMPRs®) for Detection of Salmonella species in Cannabis and Cannabis Products, which is incorporated by reference, includes no future editions or amendments, and is available at https://www.aoac.org/wp-content/uploads/2020/07/SMPR-2020_002.pdf;

3. For Escherichia coli testing, having a limit of quantitation of at least 10 colony forming units per gram; and

4. If applicable, meeting the requirements in subsection (I)(2) or (3).

B. A technical laboratory director shall ensure that all instruments and equipment used for testing medical marijuana or a marijuana product for microbial contaminants are:

1. Set up, calibrated, and verified according to:

a. Manufacturer's acceptance criteria; and

b. Requirements for the specific method, as specified in subsection (A)(1)(a) or (b), as applicable;

2. Monitored and maintained according to AOAC - Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals, 6.3: Facilities and Environmental Conditions, 6.4: Equipment, 7.7: Ensuring the Validity of Results, and Appendix A: Equipment, August 2018, which is incorporated by reference, includes no future editions or amendments, and is available at https://www.aoac.org/aoac-accreditation-guidelines-for-laboratories-alacc; and

3. Applicable for the analytes to be tested.

C. A technical laboratory director shall ensure that:

1. The organisms required as controls are checked, as appropriate for their application:

a. To ensure there is no contamination with other organisms,

b. For verification of biochemical or other biological characteristics, and

c. To ascertain the number of organisms; and

2. Documentation is maintained of the:

a. Checking required in subsection (C)(1), and

b. Traceability of the organisms in subsection (C)(1) from date of possession.

D. A technical laboratory director shall ensure that for an initial demonstration of capability:

1. Before implementing a method, at least four replicate reference samples for each analyte are:

a. Spiked with control organisms at an amount allowing for quantitation, and

b. Taken through the entire sample preparation and analysis process;

2. Whenever a significant change to instrumentation or to a standard operating procedure occurs, the laboratory demonstrates, as specified in subsection (D)(1), that acceptable precision and bias can still be obtained by the changed conditions; and

3. Whenever a new laboratory agent who will be performing testing on medical marijuana or marijuana products is being trained, the laboratory agent demonstrates, as specified in subsection (D)(1), acceptable precision and bias.

E. A technical laboratory director shall ensure that each batch of media or reagent:

1. Is examined to ensure it is suitable for use;

2. If externally prepared, has a certificate of meeting quality control standards, issued by the manufacturer, before the batch of media or reagent is used;

3. If internally prepared, has documentation of:

a. Instructions for preparation;

b. Traceability to dehydrated media or reagent concentrate;

c. Sterility, including, as applicable:

i. Autoclave records showing the date, run number, autoclave identifier, nature of the material being autoclaved, time at desired temperature, and name of the laboratory agent starting the autoclave; and

ii. For another sterilization method, records showing the date, type of sterilization method, nature of the material being sterilized, confirmation of the sterilization as applicable to the method, and name of the laboratory agent initiating the sterilization method;

d. Checking for the following, as applicable, including the name of the laboratory agent who performed the check and date of the check:

i. pH,

ii. Appearance,

iii. Fill volumes,

iv. Batch size, and

v. Quantity; and

4. Undergoes quality control verification, as applicable, including the name of the laboratory agent who performed the verification and date of verification, for:

a. The ability of media to sustain growth of the organism for which the media will be used;

b. If applicable, the ability of media to select for specific organisms or characteristics of an organism;

c. The ability of a reagent to function as intended; and

d. Sterility of the media or reagent before use.

F. If test kits or other identification systems are used for laboratory testing, a technical laboratory director shall ensure that:

1. Each lot of test kits or other identification systems undergoes quality control verification before use, including the name of the laboratory agent who performed the verification and date of verification, for:

a. Having a certificate of meeting quality control standards, issued by the manufacturer; and

b. Passing a visual inspection of physical characteristics;

2. If an identification system is intended to speciate organisms, the identification system is tested with at least one control organism appropriate for the identification system to confirm acceptability; and

3. For testing using ELISA:

a. The ELISA testing calibration curve has at least four standards;

b. The standards in subsection (F)(3)(a) bracket the maximum allowable contaminants in Table 3.1 for the analyte; and

c. For linear and non-linear calibration models, the coefficient of determination (r²) is greater than or equal to 0.990 with no rounding.

G. A technical laboratory director shall ensure that:

1. For testing for Aspergillus with a plating method:

a. One of the following plating media is used:

i. Malt extract agar, BAM Media M182;

ii. Dichloran rose bengal chloramphenicol agar, BAM Media M183: or

iii. Potato dextrose agar with rose bengal and chloramphenicol; and

b. Petrifilm^TM, Simplate^TM, or another pre-made plate that is unsuitable for growing spreading molds is not used;

2. For testing for mycotoxins by any method, at least a 0.5 g sample is tested;

3. For testing for Aspergillus or Salmonella, the samples are enriched using a validated AOAC method; and

4. For samples that test "Detected" for Aspergillus or Salmonella:

a. A log is maintained identifying the samples, and

b. A sample is only retested when quality control standards have failed or when recommended by the instrument manufacturer.

H. A technical laboratory director shall include in the final report of testing, according to R9-17-404.06(B)(3)(d)(iii), 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 R9-17-404.06(B)(3)(d)(ii) - 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 dispensary testing requirements in R9-17-317.01(A) or labeling requirements in R9-17-317 - Q3.

I. 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 § R9-17-404.04

Adopted by final exempt rulemaking at 26 A.A.R. 734, effective 4/2/2020. Amended by final exempt rulemaking at 27 A.A.R. 111, effective 1/15/2021. Amended by final rulemaking at 29 A.A.R. 2396, effective 10/1/2023.