Ariz. Admin. Code § 9-18-410

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

Section R9-18-410 - Operations

A. A technical laboratory director shall ensure that:

1. A sample of marijuana or a marijuana product accepted at the technical laboratory director's marijuana testing facility is analyzed:

a. Either:

i. At the marijuana testing facility with methods approved by the Department; or

ii. For testing of parameters or analytes that the marijuana testing facility is not approved by the Department to conduct, at another marijuana testing facility with an approval for testing issued by the Department;

b. As received; and

c. Within 10 calendar days after receipt;

2. If an instrument or equipment used for testing marijuana or a marijuana product has a mechanism to track any changes made to testing results, the tracking mechanism is installed and activated;

3. The facility and utilities required to operate equipment and perform testing of marijuana or marijuana products are maintained;

4. Environmental controls are maintained within the marijuana testing facility to ensure that marijuana testing facility environmental conditions do not affect analytical results beyond quality control limits established for the methods performed at the marijuana testing facility;

5. Storage, handling, and disposal of hazardous materials at the marijuana testing facility are in accordance with all state and federal regulations;

6. The marijuana testing facility complies with all applicable federal, state, and local occupational safety and health regulations; and

7. The following information is maintained for all marijuana facility agents providing supervisory, quality assurance, or analytical functions related to testing of marijuana or a marijuana product:

a. A summary of each marijuana facility agent's education and professional experience;

b. Documentation of each marijuana facility agent's applicable certifications and specialized training;

c. Information related to the marijuana facility agent's license;

d. Documentation of each marijuana facility agent's review of the quality assurance plan required under R9-18-409(B) and the methods and standard operating procedures for all testing of marijuana or marijuana products performed by the marijuana facility agent or for which the marijuana testing facility agent has supervisory or quality assurance responsibility;

e. Documentation of each marijuana facility agent's completion of training on the use of equipment and of proper laboratory technique, including the name of the marijuana facility agent, the name of the instructor, the duration of the training, and the date of completion of the training;

f. Documentation of each marijuana facility agent's completion of training classes, continuing education courses, seminars, and conferences that relate to the testing procedures used by the marijuana facility agent for testing of marijuana or marijuana products;

g. Documentation of each marijuana facility agent's completion of initial demonstration of capability, as required according to R9-18-408, for each approved method performed by the marijuana facility agent;

h. Documentation of each marijuana facility agent's performance of proficiency testing; and

i. Documentation of each marijuana facility agent's completion of training related to instrument calibration that includes:

i. Instruction on each calibration model that the marijuana facility agent will use or for which the marijuana facility agent will review data;

ii. For each calibration model in subsection (A)(7)(i)(i), description of the specific aspects of the calibration model that might compromise the data quality, such as detector saturation, lack of detector sensitivity, the calibration model's not accurately reflecting the calibration points, inappropriate extension of the calibration range, weighting factors, and dropping of mid-level calibration points without justification; and

iii. Instruction that a calibration model shall not be used or changed to avoid necessary instrument maintenance.

B. A technical laboratory director shall ensure that:

1. A testing record for marijuana or marijuana products contains:

a. Sample information, including the following:

i. A unique sample identification assigned at the marijuana testing facility;

ii. A description of the marijuana or marijuana product from which the submitted sample was taken, including the amount, strain, and batch number;

iii. The sample collection date and time;

iv. The type of testing to be performed, including whether the testing is to satisfy the requirement in R9-18-311(A) or for a marijuana establishment's information only; and

v. The analytes to be tested for, as specified by the marijuana establishment or individual submitting the sample to the marijuana testing facility according to subsection (B)(1)(c);

b. A color picture of the sample as submitted;

c. The name and one of the following, as applicable, for the marijuana establishment or individual submitting the sample to the marijuana testing facility:

i. The marijuana establishment license number, or

ii. The number on the document used to identify the individual;

d. If applicable, name and the marijuana facility agent license number of the marijuana facility agent submitting the sample to the marijuana testing facility on behalf of a marijuana establishment;

e. The date and time of receipt of the sample at the marijuana testing facility;

f. The name and registry identification number of the marijuana facility agent who received the sample at the marijuana testing facility;

g. The dates and times of testing, including the date and time of each critical step;

h. Whether testing results related to a sample were changed;

i. If testing results related to a sample were changed, what was changed, the name of the marijuana facility agent who changed the testing results, the time and date the data were changed, and why the testing results were changed;

j. If testing results were changed due to retesting:

i. What was used or done to the sample, and

ii. The original and changed testing results;

k. The actual results of testing, including all raw data, work sheets, and calculations performed;

l. The actual results of quality control data validating the testing results, including the calibration and calculations performed;

m. The name of each marijuana facility agent who performed the testing; and

n. A copy of the final report;

2. A testing result for marijuana or a marijuana product that is known to be inaccurate is not reported; and

3. Except as specified in subsection (C) or (D) as applicable, a final report of testing of marijuana or marijuana products contains:

a. The name, address, and telephone number of the marijuana testing facility;

b. The marijuana testing facility license number issued by the Department;

c. Actual scientifically valid and defensible results of testing of a sample of marijuana or a marijuana product in appropriate units of measure, obtained in accordance with R9-18-408, and the quality assurance plan;

d. As applicable:

i. A statement that testing results were obtained according to requirements in the quality assurance plan in R9-18-409(B), in the applicable standard operating procedure, and in R9-18-408;

ii. A description of any variances from the requirements in the quality assurance plan in R9-18-409(B), the applicable standard operating procedure, or R9-18-408 made to ensure scientifically valid and defensible testing results, and the reason for the variance; or

iii. A qualifier, according to R9-18-408(C), (D), or (I), as applicable, located adjacent to the name of the analyte or testing result to which the qualifier pertains;

e. A list of each method used to obtain the reported results;

f. Sample information, including the following:

i. The unique sample identification assigned at the marijuana testing facility;

ii. A color picture of the sample as submitted;

iii. A description of the marijuana or marijuana product from which the submitted sample was taken, including the strain and batch number;

iv. The sample collection date and time;

v. The name and identifying number recorded for the marijuana establishment or individual submitting the sample to the marijuana testing facility according to subsection (B)(1)(c); and

vi. Any changes made to the information recorded according to subsection (B)(1)(a) since sample submission;

g. The date of testing for each parameter reported;

h. The date of the final report; and

i. The technical laboratory director's or designee's signature.

C. If a sample of marijuana or a marijuana product accepted at a marijuana testing facility is analyzed at another marijuana testing facility, as allowed according to subsection (A)(1)(a)(ii), a technical laboratory director shall ensure that the final report of testing required in subsection (B)(3) includes a copy of the final report of testing from each marijuana testing facility to which the marijuana testing facility accepting the sample from a marijuana establishment sent a portion of the sample for testing of parameters or analytes that the marijuana testing facility is not approved by the Department to conduct.

D. If a final report of testing issued according to subsection (B)(3) needs to be changed, amended, or reissued, a technical laboratory director shall ensure that a changed, amended, or reissued report of testing is generated by the marijuana testing facility and includes:

1. The date of the changed, amended, or reissued report of testing;

2. A statement that the changed, amended, or reissued report is an amendment to the original final report of testing, including any unique number or other designator given by the marijuana testing facility to the original final report of testing;

3. If it is necessary to issue a completely new final report of testing, the information required in subsection (B)(3); and

4. The change to the information provided in the original final report of testing and, where appropriate, the reason for the change, located either:

a. Adjacent to the testing result to which the change pertains, or

b. On the same page of the final report of testing with an indicator located adjacent to the testing result to which the change pertains.

E. For a sample of marijuana or a marijuana product accepted at the technical laboratory director's marijuana testing facility, a technical laboratory director shall ensure that the final report of testing in subsection (B)(3):

1. For a sample received from a marijuana establishment, is sent to the marijuana establishment within 10 calendar days after receipt of the sample;

2. For a sample received from a marijuana testing facility according to subsection (A)(1)(a)(ii), is sent to the marijuana testing facility from which the sample was sent within seven calendar days after receipt of the sample;

3. For a sample received from a marijuana testing facility according to R9-18-311(C), to the marijuana establishment within seven calendar days after receipt of the sample; and

4. For a sample received from an individual as recorded according to subsection (B)(1)(c), is sent to the individual within 10 calendar days after receipt of the sample.

Ariz. Admin. Code § R9-18-410

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.