Section 15-22-5.3 - Sample Size, Handling, Storage and Disposal5.3.1 An employee of a licensed testing facility will obtain and analyze test samples only from usable medical cannabis. Cannabis products shall be sampled and tested in final form in accordance with the rules in this Part.
5.3.2 Sampling shall be conducted on-site at the cannabis cultivation or processing entity. Testing entity personnel shall have access to the entire batch for the purposes of sampling.5.3.3 Sampling Requirements for Mandatory Testing.A. All samples must be collected, stored, and transported in a way that mitigates contamination and degradation.B. Sampling of each harvest batch or production batch shall be conducted with representative samples such that there is assurance that all harvest or process lots are adequately assessed for contaminants and that the cannabinoid profile is consistent throughout.C. For mandatory harvest/production batch sampling, the total batch weight or count to be sampled shall be verified by the testing licensee. A testing licensee shall not pull samples for mandatory testing if there is reasonable belief the full batch is not present for sampling.D. A representative sample shall be taken from each container or area holding the harvest/production batch, from the top, middle, and bottom of the total contents.E. The sampling shall be video-recorded, with the batch number stated verbally or in writing on the video at the beginning of the video and a visible time and date indication on the video recording footage. A facility employee must be present but not involved nor assisting with the sampling. The video recordings shall be maintained for 90 calendar days.5.3.4 The maximum harvest batch package is twenty-five pounds (25 lbs). For harvest batch sampling a licensed testing entity shall take a minimum of fifteen (15) sample increments of half a gram (0.5 g) each. Additional increments may be collected to ensure that the samples obtained are representative and sufficient to perform required testing.5.3.5 The production batch for infused cannabis products (edible, non-edible liquids, non-edible solids) shall not contain more than 150,000 units. For infused and edible cannabis products, the test sample collected by a licensed testing entity for product testing shall comply with the minimum number of units set forth below based upon the production batch size. Additional increments may be collected to ensure that the samples obtained are representative. A. 3 units for a production batch of up to 100 units.B. 6 units for a production batch of 101 to 500 units.C. 9 units for a production batch of 501 to 1000 units.D. 12 units for a production batch of 1001 to 5000 units.E. 15 units for a production batch of 5001 to 10,000 units.F. 20 units for a production batch 10,001 to 35,000 units.G. 30 units for a production batch of 35,001 to 100,000 units.H. 50 units for a production batch of 100,001 to 150,000 units.5.3.6 For a cannabis concentrate, each sample increment taken by a licensed testing entity for product testing shall be one-quarter gram (0.25 g). The test sample collected by a licensed testing entity for product testing shall comply with the minimum number of increments set forth below based upon the production batch size. Additional increments may be collected to ensure that the samples obtained are representative. A. 12 increments for a production batch of 1 to 2 pounds.B. 15 increments for a production batch of 2.01 to 3 pounds.C. 18 increments for a production batch of 3.01 to 4 pounds.D. 23 increments for a production batch of 4.01 to 10 pounds.E. 30 increments for a production batch greater than 10 pounds.5.3.7 A production batch of raw or infused pre-rolls shall contain no more than 150,000 units. The test sample collected by a licensed testing entity for product testing shall comply with the minimum number of increments relative to the batch size as set forth below. Additional increments may be collected at the discretion of the licensed testing entity to ensure that the samples obtained are representative. Each sample increment consists of one packaged unit.A. 2 units for a production batch of up to 50 units.B. 3 units for a production batch of 51 to 100 units.C. 4 units for a production batch of 101 to 500 units.D. 8 units for a production batch of 501 to 1500 units.E. 12 units for a production batch of 1501 to 3000 units.F. 20 units for a production batch of 3001 to 10,000 units.G. 30 units for a production batch of 10,001 units- 35,000 units.H. 50 units for a production batch of 35,001 units - 150,000 units.5.3.8 A production batch of inhalable concentrate products shall contain no more than 150,000 units. The test sample collected by a licensed testing entity for product testing shall comply with the minimum number of increments relative to the batch size as set forth below. Additional increments may be collected at the discretion of the licensed testing entity to ensure that the samples obtained are representative. Each sample increment consists of one packaged unit. A. 2 units for a production batch of up to 50 units.B. 3 units for a production batch of 51 to 100 units.C. 4 units for a production batch of 101 to 500 units.D. 8 units for a production batch of 501 to 1500 units.E. 12 units for a production batch of 1501 to 3000 units.F. 20 units for a production batch of 3001 to 10,000 units.G. 30 units for a production batch of 10,001 units- 35,000 units.H. 50 units for a production batch of 35,001 units - 150,000 units.5.3.9 A licensed testing entity shall not do any of the following:B. Test compliance samples without homogenization where required by the rules in this Part; orC. Select only the most desirable material from a batch or sample for testing; orD. Manipulate samples in any way that would alter the sample integrity or homogeneity of the sample. All sample increments must have the same genesis.5.3.10 Only qualified employees/representatives of a licensed testing entity may collect and transport test samples and shall follow the testing entity's accredited sampling and transportation policies and procedure when collecting samples for testing.A. A licensed testing entity shall prepare medical cannabis sampling policies and procedures that contain all of the information necessary for collecting and transporting samples from usable medical cannabis in a manner that does not endanger the integrity of the sample for any analysis required by this rule. These policies and procedures shall be appropriate to the matrix being sampled.B. Care shall be taken to avoid contamination of the non-sampled material. Sample containers shall be free of analytes of interest and appropriate for the analyses requested.C. A sufficient sample size shall be taken for analysis of all requested tests and the quality control performed by the testing laboratory for these tests.D. A licensed testing entity shall comply with any recording requirements for samples and subsamples in the policies and procedures and at a minimum:1. Record the location of each sample and subsample taken.2. Subsamples collected from the same batch shall be combined into a single sample by a laboratory prior to testing.3. Subsamples and samples collected from different batches may not be combined.4. Field duplicates may not be combined with the primary samples.5. Assign a field identification number for each sample, subsample and field duplicate that have an unequivocal link to the laboratory identification number.6. Assign a unique identification number for each test batch.7. Have a documented system for uniquely identifying the samples to be tested to ensure there can be no confusion regarding the identity of such samples at any time. This system shall include identification for all samples, subsamples, preservations, sample containers, tests, and subsequent extracts or digestates.8. Place the licensed testing entity identification code as a durable mark on each sample container.9. Enter a unique sample identification number into the laboratory records. This number shall be the link that associates the sample with related laboratory activities such as sample preparation. In cases where the sample collector and analyst are the same individual, or the laboratory pre-assigns numbers to sample containers, the unique identification number may be the same as the field identification code.E. The test sample(s) shall be transported in one or more sealed containers and not be accessible while in transit.F. The vehicle a testing facility employee uses to transport medical cannabis test samples shall not bear markings or other indication that it is carrying cannabis or a cannabis product.G. All test samples shall be transported by a qualified employee of a licensed testing facility and shall not be transported in the same vehicle as other products.H. An employee of the medical cannabis establishment from which a test sample is being collected shall be physically present to observe the testing facility employee collect the test sample and ensure that the sample increments are taken from throughout the batch.I. No employee of the medical cannabis establishment from which a test sample is being collected shall assist the testing facility employee nor touch the harvest and/or production batch package or sampling equipment while the testing facility employee is obtaining the test sample.J. After test samples have been selected, both the employee of the medical cannabis establishment having the test samples collected and the employee of the testing facility shall sign and date the chain of custody form, attesting to the following sample information: 3. All products and test samples are correctly identified in the statewide seed-to-sale system; and,4. If the test sample is obtained for a retest, the testing facility confirms that it is not accepting a test sample that is prohibited from being retested.K. The medical cannabis establishment from which the test sample is collected shall enter in the statewide seed-to-sale system the test sample that is collected by a licensed testing facility, including the date and time the test sample is collected and transferred.L. When a test sample is collected from a medical cannabis establishment for testing, that licensee shall quarantine the product that is undergoing the testing from any other product at the facility. The quarantined product may not be packaged, transferred, or sold until passing test results are entered into the statewide monitoring system.M. Any cannabis or cannabis product collected for testing shall not be transferred or sold to any person or entity other than the licensee from whom the sample was collected. This provision does not apply to a testing facility that engages another testing facility to perform certain safety tests on a subcontracted basis.N. A testing facility may collect additional sample material from the same licensee from which the original sample was collected for the purposes of completing the required safety tests as long as the requirements of this Rule are met.5.3.11 An approved testing entity shall store each test sample under the appropriate conditions to protect the physical and chemical integrity of the sample. A. Analyzed test samples consisting of cannabis or cannabis-derived product shall be appropriately segregated, controlled, and held in a controlled access area pending destruction or other disposal.B. Any portion of a cannabis or cannabis-derived test sample that is not destroyed during analysis shall be:1. Returned to the licensed producer who provided the sample under chain of custody; or2. Destroyed in accordance with the disposal requirements of this Part.5.3.12 A testing entity shall maintain the documentation required in these rules for at least five years and shall provide that information to the Department upon request.