Ariz. Admin. Code § 3-4-1008

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

Section R3-4-1008 - Compliance; Recordkeeping; Audits

A. General compliance requirements.

1. All licensees are subject to audits to ensure compliance with the recordkeeping requirements in R3-4-1008(B);

2. An authorized Department inspector shall be allowed access to all growing, storage, and processing locations of a licensee's industrial hemp crop, hemp seed, propagative material, harvested material, handling and processing equipment to conduct a visual inspection and determine if a violation of this Article may exist.

B. Recordkeeping. All licensees may be audited to ensure compliance with all recordkeeping requirements. A licensee shall comply with the recordkeeping requirements in this subsection at a minimum. Additional recordkeeping requirements may be established as set by policy and updated annually.

1. All records documenting the geospatial location, growth, propagation, harvesting, storage, agronomic data, shipping, receiving, transportation, distribution, processing, sale, purchase, third party analysis or research of all plants, seeds and materials shall be kept within the state of Arizona and made available for inspection on request.

2. An in-state agent must be maintained for receipt and storage of records.

3. All records shall be maintained for not less than five years.

C. Sampling and testing. All licensees are subject to the collection of a representative sample of any Cannabis plant, hemp crop or harvested hemp in possession of the licensee or licensee's agent to determine the total concentration of delta-9 THC as reported by a certified laboratory to ensure compliance with this Article and any state or federal law, rule or order regulating Cannabis as an agricultural commodity. Unless otherwise specified in an alternative performance-based sampling policy, crops shall be sampled within 30 days prior to the intended date of harvest and samples must be collected from mature flowering plants. All sampling agents must have undergone official sampling training by an authorized representative of the Department for the collection of cannabis samples for determination of compliance with the program. A licensed grower shall not harvest an industrial hemp crop prior to the collection of an official sample for compliance purposes.

1. Sampling method. The Department shall publish a policy on the procedures used by the Department to sample a Cannabis plant or crop ; and may publish a policy or policies for alternative, performance-based methods that have the potential to ensure, at a 95% level of confidence, that the Cannabis plant or crop will not test above the acceptable hemp total delta-9 THC level, such policy or policies may be updated annually as dictated by changing circumstances.

2. Only an authorized Department inspector , or other authorized sampling agent, may collect an official sample to determine compliance with this Article.

3. When collecting an official sample, an authorized Department inspector , or other authorized sampling agent, shall:

a. Ensure the licensee or authorized representative of the licensee is present during the collection of the official sample;

b. Collect a representative sample of the crop, plants or harvested crop;

c. Split the official sample as follows:

i. One-third for retention by the Department or to provide to a certified laboratory for compliance with this Article;

ii. One-third for confirmation of analytical results if required; and

iii. One-third that is provided to the licensee for retention or to utilize for additional analysis by a third party laboratory. Any results provided to the licensee by a third party laboratory do not supersede official results.

d. Label all official samples with an official sample number, sample date, collector name, location ID, and grower license ID number;

e. Apply official custody seals to all official samples; and

f. Complete an official chain of custody form that is signed and dated by the inspector and licensee or the licensee's representative.

4. Sample transport and submission. The Department shall not be liable for samples that are detained by any federal, state or local law enforcement agency.

a. If a certified laboratory receives a sample with a broken custody seal or incomplete or missing chain of custody, that sample shall be null and void;

b. All official samples retained by the Department are the property of the Department; and

c. The Department is not liable to reimburse the licensee for official samples collected.

5. Laboratory Standards. Certified laboratories conducting testing of hemp must conduct analytical testing for purposes of detecting the total calculable amount of delta-9 THC and shall meet the following standards:

a. Laboratory quality assurance must ensure the validity and reliability of test results;

b. Analytical method selection, validation, and verification must ensure that the testing method used is appropriate and that the laboratory can successfully perform the testing;

c. The demonstration of testing validity must ensure consistent and accurate analytical performance; and

d. Method performance specifications must ensure analytical tests are sufficiently sensitive for the purposes of the detectability requirements of this Article.

e. At a minimum, analytical testing of samples for total calculable amount of delta-9 THC levels must use post-decarboxylation or other similarly reliable methods approved by the U.S. Secretary of Agriculture. The testing methodology must consider the potential conversion of delta-9 tetrahydrocannabinolic acid (THCA) in hemp into delta-9 tetrahydrocannabinol (THC). The test result must reflect the total calculable amount of delta-9 THC. Testing methodologies meeting these requirements include, but are not limited to, gas chromatography and high-performance liquid chromatography.

f. The total delta-9 tetrahydrocannabinol concentration level shall be determined and reported on a dry weight basis.

g. Certified laboratories must report the measurement of uncertainty (MU) of the methodology, in reference to the U.S. Department of Agriculture's Laboratory Testing Guidelines, U.S. Hemp Production Program, published on January 15, 2021, or its successor document in reference to the AOAC International (Association of Official Agricultural Chemists), Standard Method Performance Requirements (SMPRs®) for Quantitation of Cannabinoids in Plant Materials of Hemp (Low THC Varieties Cannabis sp.) SMPR 2019.003 found at the website: https://www.aoac.org/resources/smpr-2019003/ . Certified laboratories must also report the MU as a ± value and report the total delta-9 value in the same unit of measure used to report the MU.

h. Any sample test result showing with at least 95% confidence that the total delta 9 THC content of the sample is higher than the acceptable hemp THC level shall be conclusive evidence that the lot represented by the sample is not in compliance with this Article.

6. DEA Registration. Certified laboratories must also be registered with DEA to handle controlled substances under the Controlled Substances Act (CSA), 21 CFR part 1301.13 no later than December 31, 2022.

7. Sample results. A copy of any result produced by a certified laboratory shall be provided to the licensee, but such result is the property of the state.

D. Crop compliance.

1. Compliant crops. When a crop is found to be compliant with the regulations governing the production of industrial hemp, a grower will be provided documentation authorizing the movement of the harvest lot. Upon receiving authorization from the Department the licensed grower shall not comingle the harvest lot with any other compliant or non-compliant harvest lot. The grower shall:

a. Harvest the compliant harvest lot within 30 business days;

b. Notify the Department if there is a delay in the 30 business day harvest window due to inclement weather or other natural causes; and

c. Notify the Department prior to shipping or transporting the harvest lot as provided in section R3-4-1011(D).

2. Non-compliant crops. Non-compliant crops with a total delta-9 THC concentration greater than 0.3% shall not be allowed into the stream of commerce. When a crop is found to be non-compliant with the regulations governing the production of industrial hemp, a grower will be required, within 15 business days of notification of non-compliance, to either voluntarily dispose of the crop by a method prescribed in R3-4-1013(F) and submit a notice of destruction R3-4-1011(E), together with supporting evidence of disposal. Alternatively the grower may submit a corrective action plan under R3-4-1013(D) to remediate the crop to achieve compliance with the regulations governing the production of industrial hemp. A corrective action plan may be issued by the Department, or if submitted by the grower, must be approved by the Department. A corrective action plan will only be approved if the total delta-9 THC concentration is greater than 0.3% and less than 1.0%. Failure to dispose of the crop or comply with approved corrective action plan may result in a notice of violation under R3-4-1012. Upon receiving a notification of noncompliance from the Department, the licensed grower shall not move or transport the non-compliant crop from the hemp site, unless otherwise permitted by the Department to remediate the crop. Non-compliant crops shall not be comingled with any other compliant or non-compliant harvest lot. Harvest lots with a total delta-9 THC concentration greater than 1.0% constitutes a violation and must be disposed of by method indicated in section R3-4-1013(F).

E. Volunteer hemp plants. It shall be the responsibility of the licensee to monitor and destroy volunteer hemp plants.

Ariz. Admin. Code § R3-4-1008

Adopted by exempt rulemaking at 25 A.A.R. 1447, effective 5/31/2019. Amended by final rulemaking at 27 A.A.R. 1570, effective 9/16/2021.