Arizona Administrative Code
Title 9 - HEALTH SERVICES
Chapter 18 - DEPARTMENT OF HEALTH SERVICES ADULT-USE MARIJUANA PROGRAM
Article 3 - MARIJUANA ESTABLISHMENTS
Section R9-18-311 - Analysis of Marijuana or a Marijuana Product

Universal Citation: AZ Admin Code R 9-18-311

Current through Register Vol. 30, No. 38, September 20, 2024

A. Before offering a batch of marijuana or of a marijuana product for sale or otherwise transferring marijuana or a marijuana product to a consumer, a marijuana establishment shall ensure that:

1. Except as provided in subsection (A)(2) or (3), each batch of marijuana is tested in compliance with requirements in R9-18-408 and Table 3.1;

2. Each batch of a marijuana product is tested according to requirements in R9-18-408 and Table 3.1 for, as applicable:
a. At least potency and microbial contaminants other than mycotoxins if the marijuana product was prepared from another marijuana product, such as a marijuana concentrate or tincture, that is in compliance with requirements in R9-18-408 and Table 3.1, using none of the following:
i. A temperature above which any analyte could chemically decompose or react with a component of the marijuana product;

ii. A pressure above which any analyte could chemically decompose or react with a component of the marijuana product;

iii. A process by which any analyte in the marijuana product that is in compliance with requirements in R9-18-408 and Table 3.1 may be further concentrated; or

iv. A solvent other than water; or

b. All analytes except:
i. Ethanol if the marijuana product is intended to contain ethanol; or

ii. For a marijuana product intended for topical application, isopropanol if the marijuana product is intended to contain isopropanol; and

3. If the results of testing of the marijuana establishment's marijuana and marijuana products for heavy metals, according to R9-18-408, indicate that the marijuana and marijuana products are in compliance with Table 3.1 for a period of at least six consecutive months:
a. Each batch of marijuana or a marijuana product is tested according to requirements in R9-18-408 and Table 3.1 for all analytes except heavy metals; and

b. At least once every three months, each batch of marijuana or a marijuana product is tested according to requirements in R9-17-408 and Table 3.1 for heavy metals.

B. A marijuana establishment shall ensure that:

1. Until testing of the marijuana or marijuana product has been completed and testing results received by the marijuana establishment that comply with requirements in R9-18-408 and Table 3.1, a batch of marijuana or of a marijuana product is stored in a location away from marijuana and marijuana products offered for sale or transfer;

2. Except as provided in subsection (D), only one sample of each batch of marijuana or marijuana product is collected according to ANSI/ASQ Standard Z1.4 (2018), General Inspection Level II, incorporated by reference, including no future editions, and available at https://asq.org/quality-resources/z14-z19, including:
a. Use, as applicable, of one of the following sampling methods:
i. Top, middle, and bottom sampling using a sample thief, a device consisting of two nested tubes with one or more aligned slots through which a sample may be collected and then sealed into the inner tube by rotating the outer tube;

ii. Star pattern sampling from the top, middle, and bottom of each storage container;

iii. Collecting discrete incremental units of a batch, such as every 10th unit or every 20th drop; or

iv. Quartering until the sample reaches the size specified in subsection (B)(3); and

b. For sampling methods specified in subsections (B)(2)(a)(i) through (iii), quartering the volume of the aggregated portions collected to obtain the sample size specified in subsection (B)(3);

3. The size of the sample provided to a marijuana testing facility is sufficient for testing and, if necessary, retesting;

4. Each sample in subsection (B)(3) is packaged in a container made of:
a. The same material that would be used for sale or transfer, or

b. Another material that will not react with or leach into the sample;

5. Each packaged sample is labeled with:
a. The marijuana establishment's license number;

b. The amount, strain, and batch number of the marijuana or marijuana product;

c. The analytes for which testing is being requested;

d. The storage temperature for the marijuana or marijuana product; and

e. The date of sampling;

6. A packaged sample in subsection (B)(4) is submitted to a marijuana testing facility that:
a. Has a marijuana testing facility license issued by the Department, and

b. Is approved for testing by the Department for each analyte for which testing is being requested;

7. Except as specified in subsections (A)(2) and (3) and (C)(1), as applicable, the samples in subsection (B)(4) are tested for each analyte specified in Table 3.1 by a marijuana testing facility that is approved by the Department for testing the analyte;

8. Only batches of marijuana or marijuana products for which testing results in subsection (B)(7) are in compliance with the requirements in R9-18-408 and Table 3.1 are offered for sale or transfer; and

9. Except as provided in subsection (C), any batch of marijuana or marijuana product that does not comply with the requirements in R9-18-408 and Table 3.1 is remediated, if applicable, or destroyed according to policies and procedures.

C. If a marijuana establishment receives a final report of testing, specified in R9-18-410(B)(3), from a marijuana testing facility that indicates that a batch of marijuana or marijuana product does not comply with the requirements in R9-18-408 and Table 3.1, the marijuana establishment:

1. Within seven days after receiving the final report of testing, may request retesting of the remaining portion of the sample in subsection (B)(4) for all analytes that do not comply with the requirements in R9-18-408 and Table 3.1 by no more than two other marijuana testing facilities that are independent of a marijuana testing facility conducting a test included in the final report of testing and that are approved by the Department for testing the analytes;

2. If the final report of testing conducted according to subsection (C)(1) from another, independent marijuana testing facility indicates that any analyte tested for according to subsection (C)(1) does not comply with the requirements in R9-18-408 and Table 3.1, shall remediate, if applicable, or destroy the batch of marijuana or marijuana product according to policies and procedures; and

3. If the final report of testing from each of the two other independent marijuana testing facilities, allowed according to subsection (C)(1), indicates that all analytes tested for according to subsection (C)(1) comply with the requirements in R9-18-408 and Table 3.1

may offer the batch of marijuana or marijuana product for sale or transfer

.

D. A marijuana establishment may request retesting of a batch of marijuana or marijuana product using a second sample if:

1. The batch of marijuana or marijuana product is still in the possession of the marijuana establishment;

2. The marijuana establishment receives notification from the Department, another marijuana establishment, or a dispensary that indicates that the final report of testing from a marijuana testing facility, specified in R9-18-410(B)(3), or laboratory, specified in A.A.C. R9-17-404.06(B)(3), for the batch of marijuana or marijuana product may be inaccurate;

3. The marijuana establishment:
a. If the notification in subsection (D)(2) is from another marijuana establishment or a dispensary, informs the Department that the final report of testing may be inaccurate;

b. Collects the second sample according to subsections (B)(2) and (3);

c. Packages and labels the sample according to subsections (B)(4) and (5); and

d. Submits the sample to a second, independent marijuana testing facility that is approved by the Department for testing the analytes; and

4. The marijuana establishment follows the requirements in subsections (C)(1) through (3) in determining whether the batch of marijuana or marijuana product:
a. May be offered for sale or transfer; or

b. Is required to be remediated, if applicable, or destroyed.

E. A marijuana establishment shall ensure that remediation of a batch of marijuana or of a marijuana product that has undergone testing and does not comply with the requirements in R9-18-408 and Table 3.1:

1. Is performed according to policies and procedures,

2. Uses a method that is appropriate to address an analyte not in compliance with Table 3.1, and

3. Does not introduce or produce a substance in a concentration that is known to be harmful to humans.

F. If a batch of marijuana or a marijuana product is remediated, a marijuana establishment shall submit samples from the remediated batch for testing according to subsection (B).

G. A marijuana establishment shall provide to the Department upon request a sample of the marijuana establishment's inventory of marijuana or a marijuana product of sufficient quantity to enable the Department to conduct an analysis of the marijuana or marijuana product.

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