Ariz. Admin. Code § 9-18-405

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

Section R9-18-405 - Administration

An owner of a marijuana testing facility shall:

1. Comply with the:

a. Quality assurance requirements in R9-18-409,

b. Operation requirements in R9-18-410, and

c. Laboratory records and reports requirements in R9-18-410(B) and (C);

2. Maintain accreditation for each approved parameter and analyte;

3. Designate in writing a technical laboratory director who:

a. Has knowledge and experience in overseeing a marijuana testing facility as documented by:

i. A doctoral degree in chemistry, biochemistry, microbiology, or a similar laboratory science;

ii. A master's degree in chemistry, biochemistry, microbiology, or a similar laboratory science and at least two years of experience working in a laboratory and providing testing; or

iii. A bachelor's degree in chemistry, biochemistry, microbiology, or a similar laboratory science and at least four years of experience working in a laboratory and providing testing; and

b. Is responsible for:

i. Ensuring that all services and tests provided by the marijuana testing facility are performed in compliance with the requirements in this Article;

ii. Directing and supervising services and tests provided by the marijuana testing facility;

iii. Overseeing the work of all personnel in the marijuana testing facility;

iv. Providing ongoing training to marijuana facility agents, as applicable to the functions performed by a marijuana facility agent; and

v. Ensuring safety and hazardous substance control in the marijuana testing facility;

4. Notify the Department in writing within 20 business working days after any change in the technical laboratory director, providing the name and contact information for the new technical laboratory director;

5. Develop, document, and implement policies and procedures regarding:

a. Job descriptions and employment contracts, including:

i. Personnel duties, authority, responsibilities, and qualifications;

ii. Personnel supervision;

iii. Ongoing training, applicable to the functions performed by a marijuana facility agent;

iv. Training in and adherence to confidentiality requirements;

v. Periodic performance evaluations, including proficiency testing on a rotating basis among all marijuana facility agent performing similar functions; and

vi. Disciplinary actions;

b. Business records, such as manual or computerized records of assets and liabilities, monetary transactions, journals, ledgers, and supporting documents, including agreements, checks, invoices, and vouchers;

c. Inventory control, including:

i. Tracking;

ii. Accepting marijuana or marijuana products for testing;

iii. Transferring a portion of a sample prepared or selected according to subsection (5)(e)(v) to another marijuana testing facility for testing of parameters or analytes that the marijuana testing facility is not approved by the Department to conduct;

iv. Testing marijuana and marijuana products;

v. Providing a representative portion of the sample of tested marijuana or a marijuana product , which had been prepared or selected according to subsection (5)(e)(v), to up to two other marijuana testing facilities, with an approval for testing issued by the Department, at the request of a marijuana establishment according to R9-18-311(C);

vi. Retaining the residual portion of a sample accepted for testing from a marijuana establishment for at least 14 days after sending the final report of testing required in R9-18-410(B)(3) to the marijuana establishment; and

vii. Disposing of marijuana or a marijuana product such that the marijuana or marijuana product is unrecognizable or cannot otherwise be used and documenting:

(1) The method of disposal;

(2) Whether the marijuana or marijuana product was tested;

(3) If not tested, the reason for not testing;

(4) The marijuana facility agent overseeing the disposal; and

(5) The date of disposal;

d. Standard operating procedures, including:

i. The review and updating of standard operating procedures;

ii. Requirements for a marijuana facility agent to review current, new, or updated standard operating procedures applicable to the functions performed by the marijuana facility agent; and

iii. Documenting the review of standard operating procedures by applicable marijuana facility agents;

e. Marijuana testing facility records, including:

i. Maintenance and monitoring of instruments and equipment;

ii. Acceptance of marijuana and marijuana products for testing, including the specification of the analytes to be tested for;

iii. The chain of custody and applicable trip plan, according to R9-18-413, for a sample accepted by the marijuana testing facility for testing;

iv. The storage of a submitted sample prior to testing to maintain the integrity of the sample and analyte;

v. The process for ensuring that a homogeneous portion of a submitted sample is prepared or selected for testing, including:

(1) The aseptic removal of a homogeneous portion of the sample for testing according to R9-18-408; and

(2) Further preparation of a homogeneous portion of the sample, if necessary, for testing according to R9-18-408;

vi. Ensuring testing results are accurate, precise, and scientifically valid before reporting the results;

vii. Reporting of testing results, including:

(1) Testing results obtained from another marijuana testing facility for testing of parameters or analytes that the marijuana testing facility is not approved by the Department to conduct, or

(2) Testing results provided to another marijuana testing facility from which the marijuana testing facility had received a portion of a sample for testing of parameters or analytes that the other marijuana testing facility is not approved by the Department to conduct;

viii. If applicable, transfer of a portion of a sample, according to subsection (5)(c)(v), to another marijuana testing facility with an approval for testing issued by the Department for testing of parameters or analytes that the marijuana testing facility is not approved by the Department to conduct, including:

(1) The name and marijuana establishment license number of the marijuana establishment from which the sample was obtained,

(2) The name and marijuana testing facility license number of the marijuana testing facility to which the portion of the sample is being transferred,

(3) The date of the transfer,

(4) The amount of sample being transferred,

(5) The name and marijuana facility agent license number of the marijuana facility agent receiving the marijuana or marijuana products on behalf of the other marijuana testing facility;

(6) The parameters or analytes being tested by the other marijuana testing facility, and

(7) The testing results obtained from the other marijuana testing facility;

ix. If applicable, transfer of the portion of a sample remaining after testing, according to subsection (5)(c)(v), to no more than two other marijuana testing facilities with an applicable approval for testing issued by the Department at the request of a marijuana establishment according to R9-18-311(C), including:

(1) The name and marijuana establishment license number of the marijuana establishment,

(2) The name and marijuana facility agent license number of the marijuana facility agent requesting the transfer on behalf of the marijuana establishment,

(3) The date of the request,

(4) The amount of sample being transferred,

(5) The name and marijuana testing facility license number of each other marijuana testing facility, and

(6) The name and marijuana facility agent license number of the marijuana facility agent receiving the marijuana or marijuana products on behalf of each receiving marijuana testing facility;

x. Confidentiality; and

xi. Sample retention;

f. A quality assurance program and standards;

g. A records retention process; and

h. Security;

6. Review and document the review of marijuana testing facility policies and procedures at least once every 12 months after the issue date of the marijuana testing facility license and update as needed;

7. Ensure that each marijuana facility agent has the marijuana facility agent's license in the marijuana facility agent's immediate possession when the marijuana facility agent is working or providing volunteer services related to marijuana or marijuana products testing at the marijuana testing facility;

8. Ensure that a marijuana facility agent accompanies any individual other than another marijuana facility agent associated with the marijuana testing facility when the individual is present in the area of the marijuana testing facility where marijuana or marijuana products are being tested or stored for testing;

9. Not allow an individual who does not possess a marijuana facility agent license to:

a. Serve as an owner for the marijuana testing facility,

b. Be employed by the marijuana testing facility, or

c. Provide volunteer services at or on behalf of the marijuana testing facility;

10. Provide written notice to the Department, including the date of the event, within 10 working days after the date, when a marijuana facility agent no longer:

a. Serves as an owner for the marijuana testing facility,

b. Is employed by the marijuana testing facility, or

c. Provides volunteer services at or on behalf of the marijuana testing facility; and

11. Unless otherwise specified, maintain copies of any documentation required in this Chapter for at least two years after the date on the documentation and provide copies of the documentation to the Department for review upon request.

Ariz. Admin. Code § R9-18-405

Adopted by exempt rulemaking at 27 A.A.R. 696, effective 5/1/2021. Amended by exempt rulemaking at 29 A.A.R. 2453, effective 10/1/2023.