1 CCR 212-3-4-105 - Regulated Marijuana Testing Program: Mandatory Testing

Basis and Purpose - 4-105

The statutory authority for this rule includes but is not limited to sections 44-10-202(1)(c), 44-10-203(1)(a), 44-10-203(1)(c), 44-10-203(1)(g), 44-10-203(1)(k), 44-10-203(2)(d), 44-10-203(2)(f), 44-10-203(3)(d), 44-10-203(3)(e), 44-10-501(6), 44-10-502(3), 44-10-503(8), 44-10-504(1)(b), 44-10-504(2), 44-10-601(4), 44-10-602(4), 44-10-603(6), 44-10-604(1)(b), and 44-10-604(2), C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(VII). The purpose of this rule is to protect the public health and safety by establishing the mandatory testing portion of the Division's Regulated Marijuana sampling and testing program. This Rule 4-105 was previously Rules M and R 1502, 1 CCR 212-1 and 1 CCR 212-2.

A. Required Test Batch Submission. A Regulated Marijuana Business may be required by the Division to submit a Test Batch(es) of Regulated Marijuana it possesses to a Medical Marijuana Testing Facility or a Retail Marijuana Testing Facility at any time regardless of whether it has achieved a Reduced Testing Allowance and without notice.

1. Test Batches collected pursuant to this Rule may be tested for potency or contaminants which may include, but is not be limited to, Pesticide, microbials, mycotoxin, molds, elemental impurities, residual solvents, biological contaminants, and chemical contaminants.

2. When a Test Batch(es) is required to be submitted for testing, the Regulated Marijuana Business may not Transfer or process into a Medical Marijuana Concentrate or Medical Marijuana Product any Medical Marijuana, Medical Marijuana Concentrate, or Medical Marijuana Product, or Transfer or process into a Retail Marijuana Concentrate or Retail Marijuana Product any Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product, from the Inventory Tracking System package, Harvest Batch or Production Batch from which the Test Batch was taken, until it passes all required testing.

B. Methods for Determining Required Testing.

1. Random Testing. The Division may require Test Batches to be submitted for testing through any one or more of the following processes: random process, risk-based process, or other internally developed process, regardless of whether a Regulated Marijuana Business has achieved a Reduced Testing Allowance.

2. Inspection or Enforcement Tests. In addition, the Division may require a Regulated Marijuana Business to submit a Sample for testing if the Division has reasonable grounds to believe that:

a. Regulated Marijuana is contaminated or mislabeled;

b. A Regulated Marijuana Business is in violation of any product safety, health or sanitary statute, rule or regulation; or

c. The results of a test would further an investigation by the Division into a violation of any statute, rule, or regulation.

3. Beta Testing. The Division may require a Regulated Marijuana Business to submit Test Batches from certain randomly selected Harvest Batches or Production Batches for potency or contaminant testing prior to implementing mandatory testing.

C. Minimum Testing Standards. The testing requirements contained in this 4-100 Series are the minimum required testing standards. Regulated Marijuana Businesses are responsible for ensuring adequate testing on any Regulated Marijuana they produce or Transfer to ensure safety for human consumption.

D. Additional Test Batch Types. The Division may also require a Regulated Marijuana Business to submit Test Batches comprised of items other than Regulated Marijuana to be tested for contaminants which may include, but may not be limited to, Pesticide, microbials, molds, elemental impurities, residual solvents, biological contaminants, and chemical contaminants. The following is a non-exhaustive list of the types of Test Batches that may be required to be submitted for contaminant testing:

1. Specific Regulated Marijuana plant(s) or any portion of a Regulated Marijuana plant(s);

2. Any growing medium, water, or other substance used in the cultivation process;

3. Any water, solvent, or other substance used in the processing of a Regulated Marijuana Concentrate;

4. Any Ingredient or substance used in the manufacturing of a Regulated Marijuana Product; or

5. Swab of any equipment or surface.

E. R&D Testing.

1. R&D Tests. A Regulated Marijuana Business may submit Test Batches from a Harvest Batch (including a Manicure Batch) or Production Batch for R&D testing. R&D testing may be performed for any test required by these 4-100 Series Rules or any other test.

a. Harvest Batches or Production Batches that are Designated in the Inventory Tracking System as an R&D batch.

i. The Regulated Marijuana from these batches shall not be Transferred to other Regulated Marijuana Businesses except for Regulated Marijuana Testing Facilities.

ii. Failing R&D test results do not require compliance with failed test procedures and are not considered a failing result for the purposes of achieving or maintaining Reduced Testing Allowance.

b. Harvest Batches or Production Batches that are Intended to be Transferred to other Regulated Marijuana Businesses.

i. Passing R&D Test Results. If a Harvest or Production Batch passes an R&D test it shall not constitute a pass for the purposes of compliance with required contaminant or potency testing. If a Harvest or Production Batch passes an R&D test it shall not constitute a pass for purposes of achieving or maintaining a Reduced Testing Allowance. See Rules 4-120 and 4-125.

ii. Failed R&D Test Results. If a Harvest or Production Batch fails an R&D test:

A. It does not require compliance with failed test procedures. See Rule 4-135.

B. If a Test Batch fails an R&D test that is a test type required by these Rules, the Licensee must submit a Test Batch from the same Harvest or Production Batch for compliance testing and obtain passing results for that test type prior to Transferring that Harvest or Production Batch to a Regulated Marijuana Business.

C. If the Test Batch submitted pursuant to paragraph (1)(b) fails testing, compliance with the failed test procedures in Rule 4-135 is required.

D. Licensees shall not Transfer Regulated Marijuana that they have reason to believe would not pass testing required by Rule 4-120 and 4-125, unless otherwise authorized in these rules.

c. Repealed.

F. Violation Affecting Public Safety. Failure to comply with this Rule may constitute a license violation affecting public safety.

Notes

1 CCR 212-3-4-105

42 CR 23, December 10, 2019, effective 1/1/2020 43 CR 21, November 10, 2020, effective 1/1/2021 44 CR 07, April 10, 2021, effective 5/1/2021 44 CR 13, July 10, 2021, effective 8/1/2021 44 CR 23, December 10, 2021, effective 1/1/2022 45 CR 21, November 10, 2022, effective 12/1/2022 46 CR 23, December 10, 2023, effective 1/8/2024