1 Colo. Code Regs. § 212-3-3-330

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

Section 1 CCR 212-3-3-330 - Cultivation of Regulated Marijuana: Specific Health and Safety Requirements

Basis and Purpose - 3-330

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)(i), 44-10-203(3)(c), 44-10-203(3)(e), and 44-10-1001, C.R.S. The purpose of this rule is to clarify the minimum health and safety requirements imposed on a Medical or Retail Marijuana Cultivation Facility. The State Licensing Authority has determined the cultivation of Medical or Retail Marijuana requires the application of processes and procedures, and the use of materials, chemicals, and pesticides which, if improperly used, may be potentially harmful to employees and consumers. Therefore, the cultivation of Medical or Retail Marijuana must be performed in a manner that reduces the likelihood of exposure to such materials, chemicals and pesticides, or other microbials or molds. The State Licensing Authority intends for this rule to reduce any product contamination, which will benefit both the Licensees and consumers. The State Licensing Authority modeled this rule after those adopted by the Colorado Department Revenue for Medical Marijuana and those adopted by the Colorado Department of Public Health and Environment. Overall, the State Licensing Authority intends this rule to help maintain the integrity of Colorado's Retail Marijuana businesses and the safety of the public.

A.Additional Sanitary Requirements. In addition to the general sanitary requirements in Rule 3-310, a Regulated Marijuana Cultivation Facility shall take all reasonable measure and precautions to ensure the following:

1. That all contact surfaces, including utensils and equipment used for the preparation of Regulated Marijuana, Physical Separation-Based Medical Marijuana Concentrate, or Physical Separation-Based Retail Marijuana Concentrate, Pre-Rolled Marijuana, and Infused Pre-Rolled Marijuana shall be cleaned and sanitized as frequently as necessary to protect against contamination. Equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable and shall be properly maintained. Only sanitizers and disinfectants registered with the Environmental Protection Agency shall be used in a Regulated Marijuana Cultivation Facility;

2. That the water supply shall be sufficient for the operations intended and shall be derived from a source that is a regulated water system. Private water supplies shall be derived from a water source that is capable of providing a safe, potable, and adequate supply of water to meet the Licensed Premises' needs. Reclaimed water may also be used only for the cultivation of Regulated Marijuana to the extent authorized under the Reclaimed Water Control Regulations (5 CCR 1002-84), and subject to approval of the Water Quality Control Division of the Colorado Department of Public Health and Environment and the local water provider;

3. That plumbing shall be of adequate size and design and adequately installed and maintained to carry sufficient quantities of water to required locations throughout the plant and that shall properly convey sewage and liquid disposable waste from the Licensed Premises. There shall be no cross-connections between the potable water, reclaimed water, and waste water lines; and

4. That any room used for the cultivation of Regulated Marijuana has measures to prevent the accumulation of dangerous levels of CO₂.

B.Pesticide Application. A Regulated Marijuana Cultivation Facility may only use Pesticide in accordance with the "Pesticide Act" sections 35-9-101 et seq., C.R.S., the "Pesticides Applicators' Act," sections 35-10-101 et seq., C.R.S., and all other applicable federal, state, and local laws, statutes, rules and regulations. This includes, but shall not be limited to, the prohibition on detaching, altering, defacing or destroying, in whole or in part, any label on any Pesticide. The Colorado Department of Agriculture's determination that the Licensee used any quantity of a Pesticide that would constitute a violation of the Pesticide Act or the Pesticide Applicators' Act shall constitute prima facie evidence of a violation of this Rule.

C.Application of Other Agricultural Chemicals. A Regulated Marijuana Cultivation Facility may only use agricultural chemicals, other than a Pesticide, in accordance with all applicable federal, state, and local laws, statutes, rules, and regulations.

D.Required Documentation.

1.Standard Operating Procedures. A Regulated Marijuana Cultivation Facility must establish written standard operating procedures for the cultivation, harvesting, drying, curing, trimming, packaging, storing, and sampling for testing of Regulated Marijuana, and the processing, packaging, storing, and sampling for testing of Regulated Marijuana Concentrate, and the processing, rolling, filling or similar process, packaging, storing and sampling for testing of Pre-Rolled Marijuana and Infused Pre-Rolled Marijuana made from Physical Separation-Based Concentrate. A copy of all standard operating procedures must be maintained on the Licensed Premises of the Regulated Marijuana Cultivation Facility.

a. The standard operating procedures must include when, and the manner in which, all Pesticides and other agricultural chemicals are to be applied during its cultivation process.

b. The standard operating procedures of the Licensee conducting Microbial Decontamination or Microbial Control Steps must also include any methods and processes related to Decontamination or Microbial Control Steps of Harvest Batches.

i. The standard operating procedures must also include detailed descriptions of any methods and processes related to Decontamination or Microbial Control Steps of Harvest Batches including steps to meet safety mitigation requirements associated with the Decontamination or Microbial Control Step method in use. This documentation must demonstrate that appropriate occupational, environmental, and product / consumer safety procedures are in place, including any safety-related manufacturer recommendations. Standard operating procedures must also document steps to ensure uniformity of treatment of the entire Harvest Batch or Production Batch during the Decontamination or Microbial Control Steps process.

ii. Use of Decontamination and Remediation techniques must be accurately documented in the Inventory Tracking System.

iii. For Licensees sending Harvest Batches for Decontamination to a third party to conduct Decontamination procedures, standard operating procedures must include detailed descriptions of methods and processes related to handling Harvest Batches in such a manner as to ensure uniformity of treatment of the entire Harvest Batch or Production Batch prior to and after the completion of the Decontamination process conducted by a third party.

c. If a Regulated Marijuana Cultivation Facility produces Pre-Rolled Marijuana or Infused Pre-Rolled Marijuana made from Physical Separation-Based Concentrate, the standard operating procedures must include all methods and processes related to the creation of each type of Pre-Rolled Marijuana or Infused Pre-Rolled Marijuana product, including but not limited to, the strains used, where strains are sourced, which parts of Harvest Batches are used (e.g. flower, shake, trim), the size of the product (e.g. 1 gram pre-rolls), and how much and what type of Regulated Marijuana Concentrate is added (if applicable) for each type of Pre-Rolled Marijuana or Infused Pre-Rolled Marijuana it produces.

d. Provide adequate training to every Owner Licensee and Employee Licensee who performs a task or set of tasks that are referenced in the standard operating procedures. Adequate training must include, but need not be limited to, providing a copy of the standard operating procedures for that Licensed Premises detailing at least all of the topics required to be included in the standard operating procedures.

e. A Regulated Marijuana Cultivation Facility seeking to achieve and maintain Reduced Testing Allowance for microbial contamination on Regulated Marijuana flower, shake, trim, Pre-Rolled Marijuana, and Infused Pre-Rolled Marijuana, the Licensee's standard operating procedures must include:

i.Cleaning Records. Cleaning records must include cleaning methods, frequency specifications for cleaning, and record keeping requirements of cleaning occurrence for areas that contain Regulated Marijuana and surfaces that contact Regulated Marijuana. Specifications shall be reasonable and adequate to control microbial contaminants. Licensees must verify cleaning records at least every seven days, and a Licensee may choose to verify cleaning records more frequently.

ii.Maintenance Records. Maintenance record keeping must include requirements for facility maintenance occurrence logs that affect areas containing Regulated Marijuana and surfaces that contact Regulated Marijuana stating what maintenance was performed, what affects the maintenance had on areas containing Regulated Marijuana and surfaces that contact Regulated Marijuana, what measures were taken to avoid contamination of the Regulated Marijuana, and record keeping requirements of these logs. Specifications must be reasonable and adequate to control microbial contaminants. Licensees must verify maintenance records at least every 30 days, and a Licensee may choose to verify maintenance records more frequently.

2.Material Change. If a Regulated Marijuana Cultivation Facility makes a Material Change to its cultivation procedures, it must document the change and revise its standard operating procedures accordingly. Records detailing the Material Change must be maintained on the relevant Licensed Premises.

3.Safety Data Sheet. A Regulated Marijuana Cultivation Facility must obtain a safety data sheet for any Pesticide or other agricultural chemical used or stored on its Licensed Premises. A Regulated Marijuana Cultivation Facility must maintain a current copy of the safety data sheet for any Pesticide or other agricultural chemical on the Licensed Premises where the product is used or stored.

4.Labels of Pesticide and Other Agricultural Chemicals. A Regulated Marijuana Cultivation Facility must have the original label or a copy thereof at its Licensed Premises for all Pesticide and other agricultural chemicals used during its cultivation process.

5.Pesticide Application Documentation. A Regulated Marijuana Cultivation Facility that applies any Pesticide to any portion of a Regulated Marijuana plant during cultivation or generally within the Licensed Premises must document, and maintain a record on its Licensed Premises of, the following information:

a. The name, signature, and Employee License number of the individual who applied the Pesticide;

b. Applicator certification number if the applicator is licensed through the Department of Agriculture in accordance with the "Pesticides Applicators' Act," sections 35-10-101 et seq., C.R.S.;

c. The date and time of the application;

d. The EPA registration number of the Pesticide applied;

e. Any of the active ingredients of the Pesticide applied;

f. Brand name and product name of the Pesticide applied;

g. The restricted entry interval from the product label of any Pesticide applied;

h. The Inventory Tracking System tag number of the Regulated Marijuana plant(s) that the Pesticide was applied to or if applied to all plants, a statement to that effect; and

i. The total amount of each Pesticide applied.

E.Adulterants. A Regulated Marijuana Cultivation Facility may not treat or otherwise adulterate Regulated Marijuana with any chemical or other compound whatsoever to alter its color, appearance, weight, or smell.

1 CCR 212-3-3-330

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