1. Home
  2. Colorado Regulations
  3. 4-115 – Sampling and Testing Program

4-115 – Sampling and Testing Program

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 establish the portion of the Division’s mandatory testing and sampling program that is applicable to Regulated Marijuana Businesses, and specifically Medical Marijuana Testing Facilities and Retail Marijuana Testing Facilities. While the Marijuana Code requires the State Licensing Authority to establish acceptable limits of potential contaminants, it also requires the State Licensing Authority to enact a plus or minus 15 percent potency variance, which is also included in this rule. This Rule 4-115 was previously Rules M and R 712, 1 CCR 212-1 and 1 CCR 212-2.

A. Division Authority

The Division may require that a Test Batch be submitted to a specific Medical Marijuana Testing Facility or Retail 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:
    • The Regulated Marijuana contains one or more substances known to cause harm; or
    • 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 4-135(A) in any one of the following circumstances:
    • 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;
    • The Regulated Marijuana or Alternative Use Product poses a potential threat to public health and safety;
    • The Division has received one or more reports of an adverse event related to Regulated Marijuana or Alternative Use Product. For purpose of this Rule, adverse event means any untoward medical occurrence associated with the use of Regulated Marijuana or Alternative Use Product—this could include any unfavorable and unintended sign (including hospitalization, emergency department visit, doctor’s visit, abnormal laboratory finding), symptom, or disease temporally associated with the use of a Regulated Marijuana or Alternative Use Product;
    • 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
    • The Medical Marijuana Products Manufacturer or Retail 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 (A)(3) above shall remain in effect unless and until 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.

B. Test Batches

  1. Regulated Marijuana and Regulated Marijuana Concentrate. A Medical Marijuana Testing Facility must establish a standard minimum weight of Medical Marijuana and Medical Marijuana Concentrate, and a Retail Marijuana Testing Facility must establish a standard minimum weight of Retail Marijuana and Retail Marijuana Concentrate that must be included in a Test Batch for every type of test that it conducts.
  2. Regulated Marijuana Product. Medical Marijuana Testing Facilities and Retail Marijuana Testing Facilities must establish a standard number of Samples required to be included in each Test Batch of Medical Marijuana Product or Retail Marijuana Product for every type of test that it conducts. See Rule 4-110 – Regulated Marijuana Testing Program – Sampling Procedures.

C. Rejection of Test Batches

  1. A Medical Marijuana Testing Facility or Retail Marijuana Testing Facility may not accept a Test Batch that is smaller than its standard minimum amount.
  2. A Medical Marijuana Testing Facility or Retail Marijuana Testing Facility may not accept a Test Batch that it knows was not taken in accordance with these rules, unless otherwise permitted by Rule 4-105(E), and except a Medical Marijuana Testing Facility or Retail Marijuana Testing Facility may accept a Test Batch that was collected by Division representatives or that was collected by a Licensee pursuant to Division direction.

D. Permissible Levels of Contaminants

If Regulated Marijuana is found to have a contaminant in levels exceeding those established as permissible under this Rule, then it shall be considered to have failed contaminant testing. Notwithstanding the permissible levels established in this Rule, the Division reserves the right to determine, upon good cause and reasonable grounds, that a particular Test Batch presents a risk to the public health or safety and therefore shall be considered to have failed a contaminant test.

1. Microbials (Bacteria, Fungus)

*The Medical Marijuana Testing Facility or Retail Marijuana Testing Facility shall contact the Colorado Department of Public Health and Environment when STEC and Salmonella are detected beyond the acceptable limits.

2. Mycotoxins

3. Residual Solvents

** Note: These solvents are not approved for use. Due to their possible presence in the solvents approved for use per Rule R 605, limits have been listed here accordingly.

*** Note: Solvent-Based Medical Marijuana Concentrate and Solvent-Based Retail Marijuana Concentrate that exceeds the acceptable limit for ethanol may only be used in Medical Marijuana Concentrate or Medical Marijuana Product, or Retail Marijuana Concentrate or Retail Marijuana Product, which intended use is oral consumption, skin and body products, a vaporizer delivery device, pressurized metered dose inhaler, or Audited Product .

4. Metals

5. Pesticides

6. Other Contaminants

7. Division Notification

A Medical Marijuana Testing Facility or Retail Marijuana Testing Facility must notify the Division by timely input in the Inventory Tracking System if a Test Batch is found to contain levels of a contaminant not listed within this Rule that could be injurious to human health if consumed. See Rule 3-825.

E. Potency Testing

1. Cannabinoid Potency Profiles

A Medical Marijuana Testing Facility or Retail Marijuana Testing Facility may test and report results for any Cannabinoid provided the test is conducted in accordance with the Division’s Medical Marijuana Testing Facility’s or Retail Marijuana Testing Facility’s standard operating procedure.

2. Reporting of Results

  • For potency tests on Regulated Marijuana and Regulated Marijuana Concentrate, results must be reported by listing a single percentage concentration for each Cannabinoid that represents an average of all Samples within the Test Batch. This includes reporting the Total THC in addition to each Cannabinoid required in Rule 4-125.
  • For potency tests conducted on Regulated Marijuana Product, whether conducted on each individual Production Batch or via process validation per Rule 4-125, results must be reported by listing the total number of milligrams contained within a single Regulated Marijuana Product unit for sale for each Cannabinoid and stating whether the THC content is homogenous as defined in Paragraph (4)(b) of this Rule.

3. Failed Potency Tests for Medical Marijuana Product

  • If the Cannabinoid content of Medical Marijuana Product is determined not to be homogeneous, then it shall be considered to have failed potency testing. A Production Batch of Medical Marijuana Product shall be considered homogeneous if a minimum of a total of four servings from two packaged units of a Test Batch has a relative standard deviation of less than 10 percent for each Cannabinoid listed on the label. A Production Batch of Medical Marijuana Product shall be considered homogenous if a minimum of a total of four servings from four individual single serve packaged units of a Test Batch has a relative standard deviation of less than 10 percent for each Cannabinoid listed on the label.
    • The four servings must also test within plus or minus15 percent of the Target Potency.
    • Any Cannabinoid that makes up less than 10 percent of the total amount of Cannabinoids in the Medical Marijuana Product shall not be subject to the requirements set forth in this subparagraph (F)(3).
  • If an individually packaged Edible Medical Marijuana Product is determined to have more than the total milligrams of THC stated on the Container, or less than the total milligrams of THC stated on the Container, then the Test Batch shall be considered to have failed potency testing. Except that the potency variance provided for in subparagraph (F)(5) of this Rule 4-115 shall apply to potency testing.

4. Failed Potency Tests for Retail Marijuana Product.

  1. If the Cannabinoid content of Retail Marijuana Product is determined not to be homogeneous, then it shall be considered to have failed potency testing. A Production Batch of Retail Marijuana Product shall be considered homogeneous if a minimum of a total of four servings from two packaged units of a Test Batch has a relative standard deviation of less than 10 percent for each Cannabinoid listed on the label. A Production Batch of Retail Marijuana Product shall be considered homogenous if a minimum of a total of four servings from four individual single serve packaged units of a Test Batch has a relative standard deviation of less than 10 percent for each Cannabinoid listed on the label.
    • The four servings must also test within plus or minus 15 percent of the Target Potency.
    • Any Cannabinoid that makes up less than 10 percent of the total amount of Cannabinoids in the Retail Marijuana Product shall not be subject to the requirements set forth in this subparagraph (F)(4).
  2. If an individually packaged Edible Retail Marijuana Product is determined to have more than 100 milligrams of THC within it, then the Test Batch shall be considered to have failed potency testing. If an individually packaged Edible Retail Marijuana Product is determined to have more than the total milligrams of THC stated on the Container, or less than the total milligrams of THC stated on the Container, then the Test Batch shall be considered to have failed potency testing. If a single serving in an individually packaged Edible Retail Marijuana Product is determined to have more than 10 milligrams of THC, or less than 10 milligrams of THC, then the Test Batch shall be considered to have failed potency testing. Except that the potency variance provided for in subparagraph (F)(5) of this Rule 4-115 shall apply to potency testing.

5. Potency Variance

Regulated Marijuana Product shall differ no more than plus or minus 15 percent from the Target Potency provided to the Medical Marijuana Testing Facility or Retail Marijuana Testing Facility. If Regulated Marijuana is submitted to a Medical Marijuana Testing Facility or Retail Marijuana Testing Facility making a potency claim, the potency shall differ no more than plus or minus 15 percent.

F. Testing Regulated Marijuana Ready for Transfer

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.


*LEGAL DISCLAIMER* 

The above links are 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.

Updated on May 26, 2020

Was this article helpful?

Related Articles