Basis and Purpose
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)(j), 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 Sample Submission
A Regulated Marijuana Business may be required by the Division to submit a Sample(s) of Regulated Marijuana it possesses to a Medical Marijuana Testing Facility or a Retail Marijuana Testing Facility at any time regardless of whether its process has been validated and without notice.
- Samples 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, metals, residual solvents, biological contaminants, and chemical contaminants.
- When a Sample(s) 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 Sample was taken, unless or until it passes all required testing.
B. Methods for Determining Required Testing
The Division may require Samples 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’s process has been validated.
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:
- Regulated Marijuana is contaminated or mislabeled;
- A Regulated Marijuana Business is in violation of any product safety, health or sanitary statute, rule or regulation; or
- The results of a test would further an investigation by the Division into a violation of any statute, rule, or regulation.
The Division may require a Regulated Marijuana Business to submit Samples 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 Sample Types
The Division may also require a Regulated Marijuana Business to submit Samples comprised of items other than Regulated Marijuana to be tested for contaminants which may include, but may not be limited to, Pesticide, microbials, molds, metals, residual solvents, biological contaminants, and chemical contaminants. The following is a nonexhaustive list of the types of Samples that may be required to be submitted for contaminant testing:
- Specific Regulated Marijuana plant(s) or any portion of a Regulated Marijuana plant(s);
- Any growing medium, water, or other substance used in the cultivation process;
- Any water, solvent, or other substance used in the processing of a Regulated Marijuana Concentrate;
- Any Ingredient or substance used in the manufacturing of a Regulated Marijuana Product; or
- 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 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. 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 obtaining or maintaining process validation. See Rules 4-120 and 4-125.
b. Failing R&D Test Results
If a Harvest or Production Batch fails an R&D test that is a contaminant or potency test required by these rules, it does not require compliance with failed test procedures. See Rule 4-135. A Licensee cannot obtain process validation if a Harvest or Production Batch fails an R&D test that is required by contaminant and potency testing rules. See Rules 4-120 and 4- 125. If a Licensee is process validated, and fails an R&D test that is required by contaminant and potency testing rules, the Licensee must comply with Rules 4- 120(F)(2) and 4-125(H)(2).
F. Violation Affecting Public Safety
Failure to comply with this Rule may constitute a license violation affecting public safety.
The above information provided as a courtesy to assist Medical and Retail Marijuana Business Licensees in complying with the Marijuana Rules, 1 CCR 212-3. These links are provided only as a courtesy, and therefore neither these documents nor the information contained therein shall be represented, relied upon, or referenced, in any manner, as an official legal source. Official Rules are available on the Colorado Secretary of State’s Code of Regulations available on their Administrative Rules of State Agencies webpage.