Ariz. Admin. Code § R9-17-402 - Applying for a Laboratory Registration Certificate

A. To apply for a laboratory registration certificate, an applicant shall submit to the Department the following:

1. An application in a Department-provided format that includes:

a. The physical address of the laboratory;

b. The distance to the closest private school or public school from the laboratory;

c. The following information for the laboratory applying:

i. The legal name of the laboratory,

ii. Type of business organization,

iii. Mailing address,

iv. Telephone number, and

v. E-mail address;

d. The name of the owner designated to submit laboratory agent registry identification card applications on behalf of the laboratory;

e. The name, residence address, and date of birth of each owner;

f. The identifying number on the applicable card or document in subsection (A)(4)(d)(i) through (v);

g. The name, residence address, and date of birth of the technical laboratory director designated according to R9-17-404(3) ;

h. The name, residence address, and date of birth of each laboratory agent other than an owner or the technical laboratory director, if applicable;

i. Whether the laboratory agrees to allow the Department to submit supplemental requests for information;

j. A statement that, if the applicant is issued a laboratory registration certificate, the laboratory will not begin testing marijuana pursuant to R9-17-317.01 until the laboratory has been inspected and issued an approval for testing by the Department;

j.k. An attestation that the information provided to the Department to apply for a laboratory registration certificate is true and correct; and

k.l. The signatures of the owner of the laboratory, according to R9-17-401(A), and the technical laboratory director and the date each signed;

2. Policies and procedures that comply with the requirements in this Chapter that contain:

a. Inventory control;

b. A chain of custody and sample requirement process;

c. A records retention process;

d. A secure method to transfer the portion of a sample remaining after testing to another laboratory with an approval for testing issued by the Department:

i. For testing of parameters or analytes that the laboratory receiving the sample from a dispensary is not approved by the Department to conduct, or

ii. For retesting at the request of a dispensary according to R9-17-317.01(C) ;

e. Security;

f. A process to ensure marijuana or marijuana products testing results are accurate, precise, and scientifically valid before reporting the results; and

g.f. A process for disposal of marijuana or marijuana products that are submitted to the laboratory for testing;

3. If the applicant is one of the business organizations in R9-17-401(A)(2) through (7), a copy of the business organization's articles of incorporation, articles of organization, or partnership or joint venture documents that include:

a. The name of the business organization,

b. The type of business organization, and

c. The names and titles of the individuals in R9-17-401(A) ;

4. For each owner:

a. An attestation signed and dated by the owner that the owner has not been convicted of an excluded felony offense as defined in A.R.S. § 36-2801;

b. An attestation signed and dated by the owner that the owner does not have a direct or indirect familial or financial relationship with or interest in a dispensary, marijuana establishment, or related medical marijuana business entity\ or management company;

c. An attestation signed and dated by the owner that the laboratory will not test marijuana or marijuana products for a designated caregiver who the owner has a direct or indirect familial or financial relationship with;

d. An attestation signed and dated by the owner pledging not to divert marijuana to any individual who or entity that is not allowed to possess marijuana pursuant to A.R.S. Title 36, Chapter 28.1;

e. A copy the owner's:

i. Arizona driver's license issued on or after October 1, 1996;

ii. Arizona identification card issued on or after October 1, 1996;

iii. Arizona registry identification card;

iv. Photograph page in the owner's U.S. passport or a U.S. passport card; or

v. Arizona driver's license or identification card issued before October 1, 1996 and one of the following for the owner:

(1) Birth certificate verifying U.S. citizenship,

(2) U. S. Certificate of Naturalization, or

(3) U. S. Certificate of Citizenship; and

f. For the Department's criminal records check authorized in A.R.S. §§ 36-2804.01 and 36-2804.07:

i. The owner's fingerprints on a fingerprint card that includes:

(1) The owner's first name; middle initial, if applicable; and last name;

(2) The owner's signature;

(3) If different from the owner, the signature of the individual physically rolling the owner's fingerprints;

(4) The owner's residence address;

(5) If applicable, the owner's surname before marriage and any names previously used by the owner;

(6) The owner's date of birth;

(7) The owner's Social Security number;

(8) The owner's citizenship status;

(9) The owner's gender;

(10) The owner's race;

(11) The owner's height;

(12) The owner's weight;

(13) The owner's hair color;

(14) The owner's eye color; and

(15) The owner's place of birth; or

ii. If the fingerprints and information required in subsection (A)(4)(f)(i) were submitted to the Department as part of an application for a designated caregiver registry identification card, dispensary agent registry identification card, or laboratory agent registry identification card within the previous six months, the registry identification number on the registry identification card issued to the owner as a result of the application;

5. If zoning restrictions have been enacted, a statement, in a Department-provided format, signed and dated within 60 calendar days before the date of the application by a representative of the local jurisdiction:

a. Certifying that the laboratory is in compliance with any local zoning restrictions; and

b. Including:

i. Information identifying the local jurisdiction and the local jurisdiction's representative,

ii. The legal name of the laboratory, and

iii. The physical address of the laboratory as specified according to subsection (A)(1)(a);

6. A copy of documentation issued by the local jurisdiction to the laboratory authorizing occupancy of the building as a laboratory, such as a certificate of occupancy, a special use permit, or a conditional use permit;

7. A site plan drawn to scale of the laboratory location showing streets, property lines of the contiguous premises, buildings, parking areas, outdoor areas if applicable, fences, security features, fire hydrants if applicable, and access to water mains;

8. A building plan drawn to scale of the building where the laboratory is located showing the:

a. Layout and dimensions of each room;

b. Name and function of each room;

c. Fire ratings of the materials used for ceilings, walls, doors, and floors of rooms used to store flammable substances;

d. Location of each fire protection device;

e. Layout of heating, air conditioning, exhaust, and ventilation systems;

f. Location and layout of refrigerated rooms or freezer rooms;

g. Location of each sink, safety shower, other water supply, or plumbing fixture;

h. Location of fixed or movable equipment and instruments that require dedicated electrical, water, vacuum, gas, or other building systems;

i. Location of security measures or equipment to protect from diversion of marijuana or marijuana products; and

j. Means of egress;

9. Documentation of accreditation of the location specified according to subsection (A)(1)(a) for which the applicant is applying for a laboratory registration certificate;

10. The laboratory's Transaction Privilege Tax Number issued by the Arizona Department of Revenue, if applicable; and

11. The applicable fee in R9-17-102 for applying for a laboratory registration certificate.

B. Within 72 hours after an owner receives a laboratory registration certificate pursuant to an application submitted according to subsection (A), the owner shall apply for a laboratory agent registry identification card, according to R9-17-405, for each laboratory agent, including a technical laboratory director.

C. A change in location of the laboratory's physical address or ownership requires a new application to be submitted according to subsection (A).

D. A separate laboratory registration certificate is required for each noncontiguous portion of a laboratory.

Notes

Ariz. Admin. Code § R9-17-402

Adopted by final exempt rulemaking at 25 A.A.R. 2421, effective 8/27/2019. Amended by final exempt rulemaking at 26 A.A.R. 734, effective 4/2/2020. Amended by exempt rulemaking at 26 A.A.R. 968, effective 4/20/2020. Amended by final rulemaking at 29 A.A.R. 2396, effective 10/1/2023.