1 CCR 212-3-4-240 - Regulated Marijuana Testing Program: Contaminated Product and Failed Test Results and Procedures

Basis and Purpose - 4-240

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 rules governing the quarantining of potentially contaminated product and the destruction of product that failed contaminant or potency testing for Division's Regulated Marijuana Sampling and Testing Program. This Rule 4-240 was previously Rules 4-115, 4-125, and 4-135, 1 CCR 212-3, Rules M and R 1507, 1 CCR 212-1 and 1 CCR 212-2.

A. Quarantining of Product.

1. If the Division has reasonable grounds to believe that a particular Harvest Batch, Production Batch, or Inventory Tracking System package of Regulated Marijuana is contaminated or presents a risk to public safety, then the Division may require a Regulated Marijuana Business to quarantine it until the completion of the Division's investigation, which may include, but is not limited to, the receipt of any test results.

2. If a Regulated Marijuana Business is notified by any local or state agency, or by a Regulated Marijuana Testing Facility that a Test Batch failed a contaminant or potency testing, then the Regulated Marijuana Business shall quarantine any Regulated Marijuana from any Inventory Tracking System package, Harvest Batch or Production Batch associated with that failed Test Batch and must follow the procedures established pursuant to this Rule.

3. Except as provided by this Rule, Regulated Marijuana that has been quarantined pursuant to this Rule must be physically separated from all other inventory and the Licensee may not Transfer or further process the Regulated Marijuana.

4. In addition to any other method authorized by law, the Division may implement the quarantine through the Inventory Tracking System by (a) indicating failed test results and (b) limiting the Licensee's ability to Transfer the quarantined Regulated Marijuana unless otherwise permitted by these rules

B. Failed Pesticide Contaminant Testing and Failed Elemental Impurities Testing of Regulated Marijuana Flower, Wet Whole Plant, or Trim. If a Regulated Marijuana Business is notified by the Division or a Regulated Marijuana Testing Facility that a Test Batch failed Pesticide testing of any product type or elemental impurities testing of Regulated Marijuana flower, wet whole plant, or trim, then for each Inventory Tracking System package, Harvest Batch, or Production Batch associated with that failed Test Batch the Regulated Marijuana Business may request that the Regulated Marijuana Testing Facility that reported the original fail conduct two additional analyses of the original Test Batch submitted in accordance with Rule 4-225.

1. If both retesting analyses pass the required Pesticide testing, then the Inventory Tracking System package, Harvest Batch, or Production Batch of Regulated Marijuana, Regulated Marijuana Concentrate, Regulated Marijuana Product, Pre-Rolled Marijuana or Infused Pre-Rolled Marijuana may be Transferred or processed into a Regulated Marijuana Concentrate or Regulated Marijuana Product.

2. If one or both of the retesting analyses do not pass testing, then the Regulated Marijuana Business must destroy and document the destruction of the Inventory Tracking System package, Harvest Batch, or Production Batch pursuant to Rule 3-230 - Waste Disposal.

a. Solely for in the case of elemental impurities, if one or both of the retesting analyses do not pass testing, then the Licensee may remediate the batch following the rules in subparagraph (C)(3) outlined below.

C. Failed Contaminant Testing. If a Regulated Marijuana Business is notified by the Division or a Regulated Marijuana Testing Facility that a Test Batch failed contaminant testing, then for each Inventory Tracking System package, Harvest Batch, or Production Batch associated with that failed Test Batch the Regulated Marijuana Business must destroy, Decontaminate or Remediate the Batch, as described by this Rule 4-240:

1. Destroy. Destroy and document the destruction of the Inventory Tracking System package, Harvest Batch or Production Batch pursuant to Rule 3-230 - Waste Disposal;

2. Decontamination. In some special circumstances outlined below, batches may be Decontaminated instead of being destroyed. In those circumstances, a Licensee may Decontaminate the batch themselves or may Transfer the Inventory Tracking System package, Harvest Batch, or Production Batch that failed contaminant testing to another Regulated Marijuana Products Manufacturer, Regulated Marijuana Cultivation Facility (except failed Solvent-Based Regulated Marijuana Concentrate, Heat/Pressure-Based Regulated Marijuana Concentrate, and Regulated Marijuana Product) or an Accelerator Manufacturer for Decontamination.

a. For all types of Decontamination, after Decontamination has been performed on Regulated Marijuana, Regulated Marijuana Concentrate, or Regulated Marijuana Product, the Licensee must do the following: Create two new Test Batches, each containing the requisite number of Sample Increments, and have those Test Batches tested for the required contaminant test that failed. Such testing must comport with the sampling procedures under Rule 4-225. A Licensee shall (1) submit both new Test Batches to the same Regulated Marijuana Testing Facility that reported the original failed test result, or (2) submit the new Test Batches to two different Medical Marijuana Testing Facilities or Retail Marijuana Testing Facilities.

i. If both retesting analyses pass the required contaminant testing, then the Inventory Tracking System package or Harvest Batch may be Transferred or processed into a Regulated Marijuana Concentrate or Regulated Marijuana Product;

ii. If one or both of the retesting analyses do not pass contaminant testing, then the Regulated Marijuana Business must either destroy and document the destruction of the Inventory Tracking System package or Harvest Batch pursuant to Rule 3-230 - Waste Disposal, or Remediate the Inventory Tracking System package or Harvest Batch pursuant to Paragraph (3).

b. Nothing in this Rule eliminates or alters the responsibility of the Regulated Marijuana Business Transferring the Regulated Marijuana that failed contaminant testing from complying with the requirement to pay excise tax pursuant to article 28.8 of Title 39, C.R.S.

c. The types of contaminants and batches that may be decontaminated are outlined below along with any additional stipulations besides those in subparagraph (C)(2) of this Rule. If a contaminant and batch type are not listed below, then the batch may not be decontaminated.

i. Failed Microbial Testing of Physical Separation-Based, Heat/Pressure-Based, Food-Based Retail Marijuana Concentrate, Physical Separation-Based, Heat/Pressure-Based, Food-Based Medical Marijuana Concentrate, Vaporizer Delivery Device, and Regulated Marijuana Product.

ii. Failed Microbial Testing of Regulated Marijuana Flower, Wet Whole Plant, Trim, Pre-Rolled Marijuana, and Infused Pre-Rolled Marijuana.

A. If the Inventory Tracking System package, Harvest Batch, or Production Batch has undergone Decontamination, then it must also pass a mycotoxin and water activity test prior to Transfer. The mycotoxin and water activity testing must occur after the final Decontamination attempt, but is not required to occur until after the Inventory Tracking System package, Harvest Batch, or Production Batch has passed microbial testing. If a Test Batch fails mycotoxin or water activity testing the Regulated Marijuana Business must follow the failed contaminant testing procedures pursuant to subparagraphs (B) and (C) of this Rule. Pursuant to Rule 4-245(B), wet whole plant is exempt from water activity testing.

iii. Failed Water Activity Testing.

A. If the Inventory Tracking System package, Harvest Batch, or Production Batch has undergone Decontamination, then it must also pass a microbial contaminant test prior to Transfer. The microbial contaminant test is not required to occur until after the Inventory Tracking System package, Harvest Batch, or Production Batch has passed water activity testing. If a Test Batch fails microbial contaminant testing, the Regulated Marijuana Business must follow the failed contaminant testing procedures pursuant to subparagraph (C) above.

B. Pursuant to Rule 4-245(B), wet whole plant is exempt from water activity testing.

iv. Failed Residual Solvent Testing of Solvent-Based Regulated Marijuana Concentrate.

d. Third-Party Decontamination Testing Responsibility. If the Regulated Marijuana Business receiving the Regulated Marijuana for Decontamination will Transfer the Regulated Marijuana back to the originating Regulated Marijuana Business following the Decontamination procedures, then the originating Regulated Marijuana Business is responsible for all required testing. If the Regulated Marijuana Business receiving the Regulated Marijuana for Decontamination will Transfer the Regulated Marijuana to a different Regulated Marijuana Business or further processes the Regulated Marijuana following Decontamination, then the receiving Regulated Marijuana Business that performed the Decontamination is responsible for all required testing following the procedures in subparagraph (C)(2) of this Rule.

3. Remediation. In lieu of destroying or Decontaminating the Batch pursuant to Paragraph (C)(2) above, in the specific circumstances outlined below, the Regulated Marijuana Business may Remediate the batch themselves or Transfer all Regulated Marijuana from the Inventory Tracking System packages, Harvest Batches, and Production Batches associated with that failed Test Batch to a Regulated Marijuana Products Manufacturer for Remediation pursuant to the following types of Regulated Marijuana listed in subparagraph (3)(c) of this Rule.

a. For all types of permitted Remediation, after Remediation procedures for the failing contaminant have been completed, the Licensee must do the following: Create two new Test Batches, each containing the requisite number of Sample Increments, and have those Test Batches tested for the required contaminant test that failed. Such testing must comport with the sampling procedures under Rule 4-225.

i. If both retesting analyses pass the required contaminant testing, then the Inventory Tracking System package or Harvest Batch may be Transferred or processed into a Regulated Marijuana Concentrate or Regulated Marijuana Product.

ii. If one or both of the retesting analyses do not pass contaminant testing, then the Regulated Marijuana Business must either destroy and document the destruction of the Inventory Tracking System package or Harvest Batch pursuant to Rule 3-230 - Waste Disposal.

iii. If a batch that has undergone Remediation fails contaminant testing other than the tests performed pursuant to Rule 4-240(C) (3)(a)(i) and (ii), the Regulated Marijuana Business shall destroy and document the destruction of the Inventory Tracking System package(s) or Production Batch(es) of Regulated Marijuana Concentrate pursuant to Rule 3-230 - Waste Disposal or Decontaminate the Inventory Tracking System package(s) pursuant to this Rule 4-240.

b. Nothing in this Rule eliminates or alters the responsibility of the Retail Marijuana Business Transferring the Retail Marijuana that failed contaminant testing from complying with the requirement to pay excise tax pursuant to article 28.8 of Title 39, C.R.S.

c. The types of contaminants and batches that may be Remediated are outlined below along with any additional stipulations besides those in subparagraph (C)(3) of this Rule. If a contaminant and batch type are not listed below, then the batch may not be Remediated.

i. Failed Microbial Testing of Regulated Marijuana Flower, Wet Whole Plant, Trim, Pre-Rolled Marijuana, and Infused Pre-Rolled Marijuana. The new Test Batches are required to be re-tested for microbial, mycotoxin, and water activity contaminant testing. Such testing must comport with sampling procedures under Rule 4-225.

ii. Failed Microbial Testing of Physical Separation-Based and Heat/Pressure-Based Retail Marijuana Concentrate, Physical Separation-Based and Heat/Pressure-Based Medical Marijuana Concentrate and Vaporizer Delivery Device. The new Test Batches are required to be re-tested for microbial and mycotoxin contaminant testing. Such testing must comport with sampling procedures under Rule 4-225.

iii. Failed Water Activity Testing of Regulated Marijuana Flower, Wet Whole Plant, Trim, Pre-Rolled Marijuana, and Infused Pre-Rolled Marijuana. The new Test Batches are required to be re-tested for microbial, mycotoxin, and water activity contaminant testing. Such testing must comport with sampling procedures under Rule 4-225.

iv. Failed Contaminant Testing: Elemental Impurities Testing of Regulated Marijuana Flower, Wet Whole Plant, Physical Separation-Based and Heat/Pressure-Based Regulated Marijuana Concentrate, and Vaporizer Delivery Device.

A. If the failed Test Batch is not deemed hazardous waste per the Resource Conservation and Recovery Act or other applicable federal, state, or local regulations, then the Regulated Marijuana Business may Transfer all Regulated Marijuana from the Inventory Tracking System packages, Harvest Batch, or Production Batch associated with that failed Test Batch to a Regulated Marijuana Products Manufacturer for Remediation.

B. The Retail Marijuana Business that Transfers the Retail Marijuana that failed elemental impurities testing must comply with the requirement to pay excise tax pursuant to article 28.8 of Title 39, C.R.S.

C. The Regulated Marijuana Products Manufacturer may Remediate the Inventory Tracking System package or Harvest Batch associated with the failed Test Batch by processing it into a Regulated Marijuana Concentrate. The Regulated Marijuana Products Manufacturer is prohibited from adding any other Regulated Marijuana to the Regulated Marijuana Concentrate it manufactures until the Regulated Marijuana Concentrate Production Batch passes all required testing pursuant to this Rule.

D. In addition to all applicable regulations, the Regulated Marijuana Products Manufacturer must comply with 3-230(C)(1), 5-315(D)(9), and 6-315(D)(9).

E. The Regulated Marijuana Concentrate that was manufactured pursuant to subparagraph (C)(3)(c)(v)(C) of this Rule shall undergo all required contaminant testing pursuant to Rule 4-215 - Regulated Marijuana Testing Program: Contaminant Testing, potency testing pursuant to Rule 4-210 - Regulated Marijuana Testing Program: Potency Testing, and any other testing required or allowed by the Marijuana Code or these Rules, including but not limited to elemental impurities testing. Such testing must comport with the sampling procedures under Rule 4-225.

F. For elemental impurities testing, the Regulated Marijuana Business must create two new Test Batches from the Remediated Production Batch, each containing the requisite number of Sample Increments, and have those Test Batches tested. Such testing must comport with the sampling procedures under Rule 4-225.

G. A Licensee must either (1) submit both new Test Batches to the same Marijuana Testing Facility that reported the original failed test result, or (2) submit the new Test Batches to two different Marijuana Testing Facilities.

H. If both Test Batches pass the required elemental impurities testing, then the Inventory Tracking System package or Harvest Batch associated with each Test Batch may be Transferred or processed into a Regulated Marijuana Concentrate or Regulated Marijuana Product.

I. If one or both of the Test Batches do not pass elemental impurities testing, then the Regulated Marijuana Business must destroy and document the destruction of the Inventory Tracking System package or Harvest Batch pursuant to Rule 3-230 - Waste Disposal.

J. All Production Batches undergoing Remediation for elemental impurities must be tested and are not eligible for a Reduced Testing Allowance or otherwise exempt from required testing.

d. Third-Party Remediation Testing Responsibility. If the Regulated Marijuana Business receiving the Regulated Marijuana for Remediation will Transfer the Regulated Marijuana back to the originating Regulated Marijuana Business following the Remediation procedures, then the originating Regulated Marijuana Business is responsible for all required testing. If the Regulated Marijuana Business receiving the Regulated Marijuana for Remediation will Transfer the Regulated Marijuana to a different Regulated Marijuana Business or further processes the Regulated Marijuana following Remediation, then the receiving Regulated Marijuana Business that performed the Remediation is responsible for all required testing following the procedures in subparagraph (C)(3) of this Rule.

Notes

1 CCR 212-3-4-240

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