1 CCR 212-3-4-205 - Regulated Marijuana Testing Program: Mandatory Testing

Basis and Purpose - 4-205

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 4-205 was previously Rules 4-105, 4-115, and 4-130, 1 CCR 212-3, and Rules M and R 1502, 1 CCR 212-1 and 1 CCR 212-2.

A. Required Test Batch Submission. The Division may require a Regulated Marijuana Business to submit a Test Batch(es) of Regulated Marijuana it possesses to a Regulated 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 are not limited to, Pesticides, 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 Test Batch 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. Additional Division-Directed 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 4-200 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, Pesticides, 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. Division Authority. The Division may require that a Test Batch be submitted to a specific Regulated Marijuana Testing Facility for testing to verify compliance, perform investigations, compile data or address a public health and safety concern.

1. Independent Third-Party Review. The Division may require Regulated Marijuana to undergo an independent third-party review to verify that the Regulated Marijuana does not pose a threat to public health and safety when the Division, in consultation with the Colorado Department of Public Health and Environment, has objective and reasonable grounds to believe and finds, upon a full investigation, one of the following:

a. The Regulated Marijuana contains one or more substances known to cause harm; or

b. The Regulated Marijuana contains one or more substances that could be toxic as consumed or applied in accordance with the intended use.

2. The fact that Regulated Marijuana contains marijuana shall not constitute grounds to require an independent third-party review. Ingredients Generally Recognized as Safe by the U.S. Food & Drug Administration or that are regulated by the U.S. Food & Drug Administration under the Dietary Supplement Health and Education Act of 1994 that are included in Edible Medical Marijuana Product or Edible Retail Marijuana Product shall not constitute grounds to require an independent third-party review.

3. Quarantine. In addition to any other remedies provided by law, the Division may immediately quarantine Regulated Marijuana pursuant to Rule 4-240(A) in any one of the following circumstances:

a. The Division has objective and reasonable grounds to believe and finds, upon a full investigation, that a Regulated Marijuana Business has been guilty of deliberate and willful violations of these rules;

b. The Regulated Marijuana or Alternative Use Product poses a potential threat to public health and safety;

c. The Division has received one or more reports of an Adverse Health Event related to Regulated Marijuana or Alternative Use Product;

d. The Division determines the independent third-party audit submitted pursuant to Rules 5-325(B) or 6-325(B) does not meet the requirements of Rules 5-325 or 6-325; or

e. The Regulated Marijuana Products Manufacturer has violated or is not in compliance with all of the requirements in Rules 5-325 or 6-325.

4. Any quarantine pursuant to subparagraph (E)(3) above shall remain in effect unless the Regulated Marijuana undergoes an independent third-party review to verify the Regulated Marijuana does not pose a risk to public health and safety.

5. For the purpose of this Rule, full investigation means a reasonable ascertainment of the underlying facts on which the agency action is based.

F. The cost for all sampling and tests conducted pursuant to these rules shall be the financial responsibility of the Regulated Marijuana Business that is required to submit the Test Batch for testing.

G. Testing Regulated Marijuana Ready for Transfer.

1. All tests must occur at the time the Regulated Marijuana is ready for Transfer to another Regulated Marijuana Business, according to the required steps outlined in the Standard Operating Procedures of the Licensee submitting the Test Batch.

2. Licensees shall not Transfer Regulated Marijuana that they have reason to believe would not pass testing required by Rules 4-210 and 4-215, unless otherwise permitted in these Rules.

Notes

1 CCR 212-3-4-205

47 CR 21, November 10, 2024, effective 12/4/2024