1 Colo. Code Regs. § 212-3-3-320

Current through Register Vol. 47, No. 7, April 10, 2024

Section 1 CCR 212-3-3-320 - Contaminated Product: Approved Microbial Decontamination and Microbial Control Step Methods

Basis and Purpose - 3-320

The statutory authority for this rule includes but is not limited to sections 44-10-203(1)(c), 44-10-203(1)(k), 44-10-203(2)(d), 44-10-203(2)(g), 44-10-203(2)(h), 44-10-203(2)(dd)(X), and 44-10-203(3)(c), C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(VII). This rule prohibits a Regulated Marijuana Business from Transferring any contaminated Regulated Marijuana or Regulated Marijuana Product to any Person or another Regulated Marijuana Business. Additionally, this rule provides permitted Microbial Decontamination or Microbial Control Step methods that a Licensee may utilize in the course of their business. These provisions outline the minimum requirements a Licensee must comply with to utilize approved Microbial Decontamination or Microbial Control Step methods and do not reflect an endorsement of these methods.

A. A Regulated Marijuana Business shall not accept or Transfer to any Person any Regulated Marijuana that has failed required testing pursuant to Rule 4-120 or Rule 4-125, unless otherwise permitted in these rules. See Rule 4-135. If, despite the prohibitions in these rules, another Regulated Marijuana Business Transfers any Regulated Marijuana that has failed or subsequently fails required testing pursuant to Rule 4-120 or Rule 4-125, the receiving Regulated Marijuana Business shall ensure that all Regulated Marijuana that failed required testing are safely disposed of in accordance with Rule 3-230.

B.Approved Microbial Decontamination and Microbial Control Step Methods. Licensees are permitted to use only the following Microbial Decontamination or Microbial Control Step techniques to treat an entire Harvest Batch or Production Batch and are not approved for use on plants that have not been harvested. Licensees must not use a technique to treat a Test Batch alone. Inclusion of a technique in this Rule does not imply that a substance or a device is compliant with other requirements or regulations. Regulated Marijuana Businesses must comply with any applicable state and federal requirements regarding the use of any substance or device used for Microbial Decontamination or Microbial Control Step. Any substance or device used for Microbial Decontamination or Microbial Control Step must be registered in accordance with state and federal requirements. Any substance that would be considered a pesticide must meet all criteria at 8 CCR 1203-2 Part 17.

1.Ozone treatment.

a.Equipment requirements: Non-enclosed ozone generating device. A Licensee who seeks to use a non-enclosed ozone generating device for Decontamination, or Microbial Control Step must comply with the following safety requirements, which must be documented in a standard operating procedure:

i. Sufficient air filtration and/or handling systems to protect worker safety, meet manufacturer safety recommendations, and comply with any federal, state, or local regulations; and

ii. Review by an Industrial Hygienist that includes, at a minimum:

A. Consideration of volume and storage of chemicals;

B. Fire safety considerations;

C. Ambient levels of chemicals (e.g. ozone, flammable liquids); and

D. Environmental monitoring.

iii. Any Material Change in the Licensee's standard operating procedures or processes requires subsequent Industrial Hygienist review and approval.

b.Equipment requirements: Sealed enclosure ozone generating device. A Licensee who seeks to use a sealed enclosure ozone generating device for Decontamination or Microbial Control Steps must comply with the following safety requirements, which must be documented in a standard operating procedure:

i. Sufficient air filtration and/or handling systems to protect worker safety, meet manufacturer safety recommendations, and comply with any federal, state, or local regulations; and

ii. To be considered a sealed enclosure ozone generating device, the ozone must be contained in an enclosed space not intended for human occupancy and capture the ozone or reactive oxygen species generated by the device and degrade it into molecular oxygen (O₂) or other components that are safe for human exposure.

2.X-ray irradiation in a sealed enclosure device. A Licensee who uses x-ray irradiation in a sealed enclosure device for Decontamination or Microbial Control Steps must require the use of personal protective equipment and safety procedures to prevent human exposure to UV radiation and to comply with the following safety requirements, which must be documented in a standard operating procedure:

a. Radiation survey and dosimeter badges for operators; and

b. Inspection by a Colorado registered qualified inspector and certification by the Colorado Department of Public Health and Environment X-ray Certification Unit.

3.Ultraviolet light (UV) irradiation. A Licensee who seeks to use UV light irradiation for Decontamination or Microbial Control Steps must require the use of personal protective equipment and safety procedures to prevent human exposure to UV radiation.

4.Microwave Irradiation. A Licensee who seeks to use microwave irradiation for Decontamination or Microbial Control Steps must only use a microwave device that is constructed, inside and outside, in a manner that it may be adequately cleaned.

5.Vaporized hydrogen peroxide in a sealed enclosure device.

a. A Licensee who seeks to use vaporized hydrogen peroxide in a sealed enclosure device for Decontamination or Microbial Control Steps must have sufficient air filtration and/or handling systems to protect worker safety, meet manufacturer safety recommendations, and comply with all federal, state or local regulations, which must be documented in a standard operating procedure.

b. To be considered a sealed enclosure device, the vaporized hydrogen peroxide and any reactive oxygen species must be contained in an enclosed space not intended for human occupancy and capture the hydrogen peroxide or reactive oxygen species generated by the device and degrade it into molecular oxygen (O₂), water, or other components that are safe for human exposure.

6.Pasteurization. A Licensee who seeks to use pasteurization must have sufficient air filtration and/or handling systems to protect worker safety, meet manufacturer safety recommendations, and comply with all federal, state, or local regulations.

C.Required Safety Measures. A Licensee who conducts Decontamination or seeks to use any of the above approved Microbial Control Step methods must:

1. Ensure proper training of personnel operating the equipment or working in the vicinity of the equipment;

2. Ensure proper use of appropriate personal protective equipment (PPE) and requiring that PPE be worn by anyone working in the vicinity of the Decontamination or Microbial Control Step equipment;

3. Comply with all manufacturer safety recommendations;

4. Comply with any additional safety mitigation measures recommended by the manufacturer.

5. Include signage clearly indicating areas where Decontamination or Microbial Control Steps are taking place;

6. If compressed gasses or other simple asphyxiants are present, a device must be used that monitors oxygen levels and alarms if an oxygen deficient environment exists; and

7. Document all training, safety, and other operating processes in standard operating procedures.

D. The Microbial Decontamination method must be accurately documented in the Inventory Tracking System for packages that have been Decontaminated.

1. Uniform treatment of Harvest Batches prior to Sample Increment Collection is required. Storage of Test Batches after collection and prior to Transfer to a Licensed Marijuana Testing Facility shall be consistent with storage conditions of the Harvest Batch that they were pulled from, including but not limited to temperature, airflow, and humidity. Equipment used for Decontamination or Microbial Control Steps shall be located in a Limited Access Area of the Licensed Premises.

2. Equipment used for Decontamination or Microbial Control Steps shall be used exclusively for the purpose of Decontamination or Microbial Control Steps.

3. No other activity is permitted to be used with the equipment including, but not limited to preparing food.

E.Microbial Decontamination and Microbial Control Step Methods Approval Process. A Licensee may submit a request to the Division to consider approval of a Decontamination or Microbial Control Step method not permitted under this Rule. The request must include scientific data and evidence on the principles and efficacy of the method and detail all aspects of the Decontamination or Microbial Control Step method including associated safety risks and appropriate safety mitigation steps including training requirements, use of personal protective equipment (PPE), and the appropriate occupational, environmental, and product/consumer safety precautions, including any safety-related manufacturer recommendations.

1 CCR 212-3-3-320

42 CR 23, December 10, 2019, effective 1/1/2020

43 CR 21, November 10, 2020, effective 1/1/2021

44 CR 07, April 10, 2021, effective 5/1/2021

44 CR 13, July 10, 2021, effective 8/1/2021

44 CR 23, December 10, 2021, effective 1/1/2022

45 CR 21, November 10, 2022, effective 12/1/2022

46 CR 23, December 10, 2023, effective 1/8/2024