R66. Agriculture and Food, Specialized Products.

R66-4. Independent Cannabis Testing Laboratory.

R66-4-1. Authority and Purpose.

Pursuant to Subsections 4-41a-103(5), 4-41a-302(3)(b)(ii), 4-41a-701(1), 4-41a-801(1), and 4-2-103(1)(i), this rule establishes the application process, qualifications, and requirements to obtain and maintain an independent cannabis testing laboratory license.

R66-4-2. Definitions.

(1) "Applicant" means any person or business entity who applies for an independent cannabis testing laboratory license.

(2) "Lot" means the quantity of:

(a) flower produced on a particular date and time, following clean up until the next clean up during which the same materials are used; or

(b) trim, leaves, or other plant matter from cannabis plants produced on a particular date and time, following clean up until the next clean up.

R66-4-3. Independent Testing Laboratory License.

(1) An independent testing laboratory license allows the licensee to receive cannabis from a licensed cannabis cultivation facility to conduct testing as required by Section 4-41a-701 and Rule R66-3.

(2) An independent testing laboratory license allows the licensee to receive cannabis from a licensed cannabis processing facility to conduct testing as required by Section 4-41a-701 and Rule R66-3.

(3) An independent testing laboratory license allows the licensee to receive cannabis from a licensed cannabis cultivation facility and a cannabis processing facility to conduct the additional test as requested.

(4) The license shall expire 12 months from the date on which the license is issued.

R66-4-4. Independent Cannabis Testing Laboratory Requirements.

(1) An independent testing laboratory shall employ a scientific director responsible for:

(a) ensuring that the laboratory achievement and maintenance of quality standards of practice; and

(b) supervising laboratory staff.

(2) The scientific director for an independent laboratory shall have:

(a) a doctorate in chemical or biological sciences from an accredited college or university, and have at least 2 years of post-degree laboratory experience;

(b) a master's degree in chemical or biological sciences from an accredited college or university, and have at least 4 years of post-degree laboratory experience; or

(c) a bachelor's degree in chemical or biological sciences from an accredited college or university, and have at least 6 years of post-degree laboratory experience.

(3) An independent cannabis testing laboratory shall follow validated analytical methods, such as those published by the Association of Official Agricultural Chemists (AOAC), American Herbal Pharmacopoeia, EPA, FDA, or other reputable scientific organizations or notify the department of alternative scientifically valid testing methodology the lab is following for each required test.

(4) An independent cannabis testing laboratory may not use an alternative testing method without earlier review from the department.

(5) The department shall review any monograph or analytical method followed by an independent cannabis testing laboratory to ensure the methodology produces scientifically accurate results before the use of alternative testing methods to conduct the required tests.

(6) An independent cannabis testing laboratory shall establish written standard operating procedures for each test being conducted.

(7) An independent cannabis testing laboratory shall maintain an average testing turnaround time below ten business days within any three- month period.

(8) An independent cannabis testing laboratory shall obtain and keep the International Organization for Standardization (ISO) 17025:2017 accreditation.

(9) An independent cannabis testing laboratory may be licensed before ISO 17025:2017 accreditation, provided the independent cannabis testing laboratory:

(a) adopt and follow minimum good laboratory practices which satisfy the OECD Principles of Good Laboratory Practice and Compliance Monitoring published by the Organization for Economic Co-operation and Development; and

(b) becomes ISO 17025:2017 accredited within 24 months.

(10) The department incorporates the following materials by reference:

(a) Cannabis Inflorescence: Standards of Identity, Analysis, and Quality Control (2014 Revisions) published by the American Herbal Pharmacopoeia; and

(b) OECD Principles of Good Laboratory Practice and Compliance Monitoring (1997) published by the Organization for Economic Co-operation and Development.

R66-4-5. Security Requirements.

(1) At a minimum, a licensed independent cannabis testing laboratory shall have a complete video surveillance system:

(a) with minimum camera resolution of 640 x 470 pixels or pixel equivalent for analog; and

(b) allows for the clear and certain identification of any person and activity.

(2) Any visitors to an independent cannabis testing laboratory shall be required to have a properly displayed identification badge issued by the facility at all times while on the premises of the facility.

(3) Any visitors shall be escorted by an independent cannabis facility agent at all times while in the facility.

(4) An independent cannabis testing laboratory shall keep and maintain a visitor's log showing:

(a) the full name of each visitor entering the facility;

(b) the badge number issued;

(c) the time of arrival;

(d) the time of departure; and

(e) the purpose of the visit.

(5) The independent cannabis testing laboratory shall keep the visitors log for a minimum of a year.

(6) The independent cannabis testing laboratory shall make the visitor log available to the department upon request.

R66-4-6. Inventory Control.

(1) Each test sample shall have a unique identification number in the inventory control system.

(2) Each test sample shall be traceable to the lot or batch used as the base material from the cannabis production establishment.

(3) Unique identification numbers may not be reused.

(4) Each test sample that has been issued a unique identification number shall have a physical tag placed on it with:

(a) the unique identification number;

(b) the license number and name of the lab receiving the test sample;

(c) the license number and name of the cannabis production establishment name;

(d) the date the test sample was collected; and

(e) the weight of the sample.

(5) The tag shall be legible and placed in a position that can be clearly read and shall be kept free from dirt and debris.

(6) An independent cannabis testing laboratory shall document in the inventory tracking system any test samples received, and any difference between the quantity specified in the transport and the quantity received.

R66-4-7. Independent Cannabis Testing Laboratory Agents.

(1) An independent cannabis testing laboratory is responsible to ensure that each agent has received any task-specific training as outlined in the operating plan submitted to the department.

(2) An independent cannabis testing agent shall have a properly displayed identification badge which has been issued by the department while on the facility premises or while engaged in the transportation of cannabis.

(3) Cannabis testing laboratory agents shall have their state-issued identification card in their possession to certify that the information on their badge is correct.

R66-4-8. Cannabis Waste Disposal.

(1) Solid and liquid wastes generated during cannabis testing shall be stored, managed, and disposed of in accordance with applicable state law.

(2) Waste water generated during cannabis testing shall be disposed of in compliance with applicable state law.

(3) An independent cannabis testing laboratory may transfer cannabis waste material to a cannabis testing laboratory operated by the department for use by a medical cannabis research licensee if:

(a) the laboratory operated by the department agrees to accept the material;

(b) the licensee that submitted the material to the laboratory for testing allows the use of their material for medical cannabis research;

(c) the material passed all required tests or is clearly labeled "not for human consumption" and is accompanied by a list of known contaminants; and

(d) the material has met the sample retention requirements of the laboratory.

(4) The cannabis testing laboratory operated by the department may transfer any cannabis waste material to a medical cannabis research licensee if:

(a) the licensee that submitted the material to the laboratory for testing agrees to the use of their material for medical cannabis research;

(b) the material passed all required tests or is clearly labeled "not for human consumption" and is accompanied by a list of known contaminants; and

(c) the material has met the sample retention requirements of the laboratory.

R66-4-9. Change in Operation Plans.

(1) An independent cannabis testing laboratory shall submit a notice, on a form provided by the department, before making any changes to:

(a) ownership or financial backing of the facility;

(b) the facility's name;

(c) a change in location;

(d) change in testing methods, equipment, remodeling, expansion, reduction or physical, non-cosmetic alteration of the lab; or

(e) change in written operating procedures.

(2) An independent cannabis testing laboratory may not implement changes to the approved operation plan without department approval.

(3) The department shall approve the requested changes unless approval would lead to a violation of the applicable laws and rules of the state.

(4) The department shall specify the reason for the denial of approval for a change to the operation plan.

R66-4-10. Renewals.

(1) An independent cannabis testing laboratory shall submit a notice of intent to renew and the licensing fee to the department by their license expiration date.

(2) If the licensing fee and intent to renew are not submitted on or before the license expiration date, the licensee may not continue to operate.

(3) The department shall renew a license unless renewal would lead to a violation of the applicable laws and rules of the state.

R66-4-11. Additional Testing.

(1) The department may establish a testing program for conducting a study.

(2) Each independent cannabis testing laboratory shall participate in the study as determined by the department.

R66-4-13. Violation Categories.

(1) Public Safety Violations: $3,000- $5,000 per violation. This category is for violations which present a direct threat to public health or safety, including:

(a) cannabis sent to an unapproved source;

(b) cannabis received from an unapproved source;

(c) refusal to allow inspection;

(d) refusal to participate in proficiency testing;

(e) failure to comply with testing requirements;

(f) failure to report testing results;

(g) unauthorized personnel on the premises;

(h) permitting criminal conduct on the premises;

(i) engaging in or permitting a violation of the Title 4, Chapter 41a, Cannabis Production Establishments, that amounts to a public safety violation as described in this subsection.

(2) Regulatory Violations: $1,000-$5,000 per violation. This category is for violations involving this rule and other applicable state rules including:

(a) failure to maintain alarm and security systems;

(b) failure to keep and maintain records for at least two years;

(c) failure to maintain traceability;

(d) failure to follow transportation requirements;

(e) failure to follow the waste and disposal requirements; or

(f) engaging in or permitting a violation of Title 4, Chapter 41a, Cannabis Production Establishments or this rule that amounts to a regulatory violation as described in this subsection.

(3) Licensing Violations: $500- $5,000 per violation. This category is for violations involving licensing requirements, including:

(a) an unauthorized change to the operating plan;

(b) failure to notify the department of changes to the operating plan;

(c) failure to notify the department of changes to financial or voting interests of greater than 2%;

(d) failure to follow the operating plan as approved by the department;

(e) engaging in or permitting a violation of this rule or Title 4, Chapter 41, Cannabis Production Establishments, that amounts to a licensing violation as described in this subsection; or

(f) failure to respond to violations.

(4) The department shall calculate penalties based on the level of violation and the adverse effect or potential adverse effect at the time of the incidents giving rise to the violation.

KEY: cannabis laboratory, cannabis testing, inventory control system, cannabis waste disposal, agents, security requirements, operation plans

Date of Last Change: August 21, 2025

Authorizing, and Implemented or Interpreted Law: 4-41a-701(1); 4-41a-103(5)