R 1501 – Contaminant Testing

Basis and Purpose

The statutory authority for this rule includes but is not limited to sections 44-12-202(2)(b), 44-12- 202(3)(a)(IV), 44-12-202(3)(a)(VII), 44-12-202(3)(a)(VIII), 44-12-202(3)(a)(X), 44-12-202(3)(a)(XI), 44-12- 202(3)(a)(XII), 44-12-202(3)(c)(III), 44-12-202(3)(c)(VIII), 44-12-202(3)(d)(VI), 44-12-402(4), 44-12-403(4), 44-12-404(3), and 44-12-404(6), 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 contaminant testing and related process validation portion of the Division’s Retail Marijuana sampling and testing program.

Contaminant Testing

A. Contaminant Testing Required. 

Unless a Retail Marijuana Cultivation Facility’s or a Retail Marijuana Product Manufacturing Facility’s cultivation or production process has achieved process validation under this rule, it shall not Transfer, or process into a Retail Marijuana Concentrate or Retail Marijuana Product any Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product unless Samples from each Harvest Batch or Production Batch from which that Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product was derived has been tested by a Retail Marijuana Testing Facility for contaminants and passed all contaminant tests required by Paragraph (C) of this rule

B. Process Validation and Ongoing Testing

  1. Retail Marijuana. A Retail Marijuana Cultivation Facility’s cultivation process shall be deemed validated for Contaminant testing if every Harvest Batch that it produced during at least a six-week period but no longer than a 12-week period passed all contaminant tests required by Paragraph (C) of this Rule. This must include at least six Test Batches. A Retail Marijuana Cultivation Facility can obtain process validation for all contaminants listed in paragraph (C) of this Rule at the same time or separately for each contaminant.
  2. Retail Marijuana Concentrate or Retail Marijuana Product. A Retail Marijuana Cultivation Facility’s or a Retail Marijuana Products Manufacturing Facility’s production process shall be deemed validated for contaminant testing if every Production Batch that it produced during at least a four-week period but no longer than an eight-week period passed all contaminant tests required by Paragraph (C) of this Rule. This must include Test Batches from at least four Production Batches.
  3. Process Validation is Effective for One Year. Once a Retail Marijuana Cultivation Facility and Retail Marijuana Products Manufacturing Facility has successfully obtained process validation for each of the contaminants listed in paragraph (C) f this Rule, the process validation shall be effective for one year from the date of the last passing test required to satisfy the process validation requirements.

C. Required Contaminant Tests

  1. Microbial Contaminant Testing. Harvest Batches of Retail Marijuana and Production Batches of Water, Heat/Pressure-, or Food-Based Retail Marijuana Concentrate, Retail Marijuana Product, and Audited Product must be tested for microbial contamination by a Retail Marijuana Testing Facility at the frequency established by Paragraphs (A) and (B) of this Rule. The microbial contamination test must include, but need not be limited to, testing to determine the presence of and amounts present of microbial contaminants listed in Rule R 712(E)(1).
  2. Repealed
  3. Repealed
  4. Residual Solvent Contaminant Testing. Production Batches of Solvent-Based Retail Marijuana Concentrate and Audited Product that contains any Solvent-Based Retail Marijuana Concentrate produced by a Retail Marijuana Products Manufacturing Facility must be tested by a Retail Marijuana Testing Facility for residual solvent contamination at the frequency established by Paragraphs (A) and (B) of this Rule. The residual solvent contamination test must include, but need not be limited to, testing to determine the presence of, and amounts present of acetone,, butane, ethanol, heptanes, isopropyl alcohol, propane, benzene*, toluene*, pentane, hexane*, and total xylenes* (m, p, o –
    xylenes).
    * Note: These solvents are not approved for use. Testing is required for these solvents due to their possible presence in the solvents approved for use per Rule R 605.
  5. Mycotoxin Contaminant Testing. As part of Remediation, each Production Batch of Solvent-Based Retail Marijuana Concentrate produced by a Retail Marijuana Products Manufacturing Facility from Retail Marijuana that failed microbial contaminant testing produced must be tested by a Retail Marijuana Testing Facility for mycotoxin contamination. The mycotoxin contaminant test must include, but need not be limited to, testing to determine the presence of, and amounts present of, aflatoxins (B1, B2, G1, and G2) and ochratoxin A. This is in addition to all other contaminant testing required by this Paragraph (C).
  6. Pesticide Contaminant Testing. Harvest Batches of Retail Marijuana must be tested for Pesticide contamination by a Retail Marijuana Testing Facility at the frequency established by this Rule R 1501(A) and (B). The Pesticide contamination test must include, but need not be limited to, testing to determine the presence of, and amounts present of, the Pesticides listed in Rule R 712(E)(5).
  7. Metals Contaminant Testing. Each Harvest Batch and Production Batch of Retail Marijuana must be tested for metals contamination by a Retail Marijuana Testing Facility at the frequency established in paragraphs (A) and (B) of this Rule. The metals contamination test must include, but need not be limited to, testing to determine the presence of, and amounts present of, arsenic, cadmium, lead, and mercury.

D. Additional Required Tests.

The Division may require additional tests to be conducted on a Harvest Batch or Production Batch prior to a Retail Marijuana Cultivation Facility or a Retail
Marijuana Product Manufacturing Facility Transferring or processing into a Retail Marijuana Concentrate or Retail Marijuana Product any Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product from that Harvest Batch or Production Batch. Additional tests may include, but need not be limited to, screening for Pesticide, chemical contaminants, biological contaminants, or other types of microbials, molds, metals, or residual solvents.

E. Exemptions

  1. Retail Marijuana Concentrate. A Production Batch of Retail Marijuana Concentrate shall be considered exempt from this Rule if the Retail Marijuana Products Manufacturing Facility that produced it does not Transfer any portion of the Production Batch and uses the entire Production Batch to manufacture Retail Marijuana Product, except that a Solvent-Based Retail Marijuana Concentrate must still be submitted for residual solvent contaminant testing. The manufactured Retail Marijuana Product shall be subject to testing under this Rule.

F. Required Re-Validation – Contaminants.

  1. Material Change Re-Validation. If a Retail Marijuana Cultivation Facility or a Retail Marijuana Product Manufacturing Facility makes a Material Change to its cultivation or production process or its standard operating procedure manual, then it must have the first five Harvest Batches or Production Batches produced using the new procedures tested for all of the contaminants required by Paragraph (C) of this Rule regardless of whether its process has been previously validated regarding contaminants. If any of those tests fail, then the Retail Marijuana Establishment’s process must be re-validated.

    1. Pesticide. It shall be considered a Material Change if a Retail Marijuana Cultivation Facility begins using a new or different Pesticide during its cultivation process.
    2. Solvents. It shall be considered a Material Change if a Retail Marijuana Products Manufacturing Facility begins using a new or different solvent or combination of solvents or changes any parameters for equipment related to the solvent purging process, including but not limited to, time, temperature, or pressure.
    3. Cultivation. It shall be considered a Material Change if a Retail Marijuana Cultivation Facility begins using a new or different method for any material part of >the cultivation process, including, but not limited to, changing from one growing medium to another.
    4. Notification. A Retail Marijuana Cultivation Facility or a Retail Marijuana Product Manufacturing Facility must notify the Retail Marijuana Testing Facility of the Material Change.
    5. Testing Required Prior to Transfer or Processing. When a Harvest Batch or Production Batch is required to be submitted for testing pursuant to this rule, the Retail Marijuana Cultivation Facility or a Retail Marijuana Product Manufacturing Facility that produced it may not Transfer or process into a Retail Marijuana Concentrate or Retail Marijuana Product any of the Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product from that Harvest Batch or Production Batch unless and until the Harvest Batch or Production Batch passes all required testing.
  2. Failed Contaminant Testing and Re-Validation. Failed contaminant testing may constitute a violation of these rules. Additionally, if a Sample the Division requires to be tested fails contaminant testing, the Retail Marijuana Cultivation Facility or Retail Marijuana Products Manufacturing Facility shall follow the procedures in Rule R 1507(B) for any Inventory Tracking System package, Harvest Batch, or Production Batch from which the failed Sample was taken. The Retail Marijuana Cultivation Facility or Retail Marijuana Products Manufacturing Facility shall also submit three additional Test Batches of the Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Product for contaminant testing by a Retail Marijuana Testing Facility within no more than 30 days. If any one of the three submitted Test Batches fails contaminant testing, the Retail Marijuana Cultivation Facility or Retail Marijuana Products Manufacturing Facility shall re-validate its process for contaminants.
  3. Repealed.

G. Violation Affecting Public Safety. 

Failure to comply with this rule may constitute a license violation affecting public safety.

Updated on July 22, 2019

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