1 Colo. Code Regs. § 212-3-5-5020

Current through Register Vol. 47, No. 20, October 25, 2024

Section 1 CCR 212-3-5-5020 - Cultivation Procedures

Basis and Purpose - 5020

The statutory authority for this rule includes but is not limited to sections 44-50-202(1)(b), 44-50-203(1)(b), 44-50-203(1)(g), 44-50-203(1)(j), 44-50-203(2)(e), 44-50-203(2)(g), 44-50-203(2)(h), 44-50-203(2)(i), 44-50-203(2)(j), 44-50-203(2)(k), 44-50-203(2)(p), C.R.S. The purpose of this rule is to establish health and sanitation requirements for Natural Medicine Cultivation Facilities and the equipment used at Natural Medicine Cultivation Facilities, record requirements, waste and destruction requirements for contaminated Natural Medicine, and storage, packaging and labeling requirements.

A. Regulated Natural Medicine must be produced in a sanitary environment, where all surfaces are maintained and kept in a clean manner.

1. Filters for air conditioning, ventilation, and air filtration systems must be cleaned and replaced regularly. Overhead light fixtures must be reasonably free of dust and insects.

2. Water must be potable. If well water is used, wells must be maintained to protect them from contamination. Floors must drain adequately, and there shall not be standing water on the floor of the Licensed Premises.

B.Cultivation Activities - Premises and Safety Requirements.

1. Toxic cleaning compounds, sanitizing agents, and other chemicals shall be identified, held, stored, and disposed of in a manner that protects against contamination of Regulated Natural Medicine, and in accordance with any applicable local, state, or federal law, rule, regulation, or ordinance. The use of any of the above compounds must be tracked in the safety data sheet, which must be kept in accordance with Rule 3010.

2. Ambient oxygen and CO₂ monitors with alarms for elevated CO₂ levels (>1000 ppm) must be used in any fruiting rooms. CO₂ monitors should be placed at eye level.

3. All individuals working in direct contact with Regulated Natural Medicine in open-air cultivation rooms must have access to appropriate respiratory protection equipment to prevent mushroom worker's lung.

4. The movement of employees between growing areas and substrate production areas must be controlled to prevent contamination.

5. Any receiving areas for raw materials or substrate must be located away from areas where harvest containers, packaging materials, spores, and other sanitary supplies are received. This includes where Regulated Natural Medicine is located.

C.Equipment. Equipment must be maintained to prevent contamination.

1. Equipment must be maintained to ensure it is in proper working order and does not contribute to contamination. All lubricants used on machinery with direct or indirect food contact and all processing aids must be food grade.

2. Suppliers of baskets, lugs, trays, tills and boxes must provide documentation that the material purchased is approved by the FDA for food contact surfaces.

a. Harvest baskets, lugs, and trays must be cleaned and sanitized before use or stored, and maintained to prevent splinters or shards. Containers with Regulated Natural Medicine must be clearly marked for this purpose and not be used for any other purpose

3. Temperature probes and supporting hardware to monitor growing conditions must be monitored and calibrated on a regular basis. Only non-mercury thermometers are allowed.

4.Cultivation Equipment. All harvesting equipment must be cleaned and sanitized prior to harvesting, and on a scheduled basis.

a. Baskets, lugs, trays and boxes used for harvesting must not contact the floor. Any filled harvest containers must be moved from growing rooms to staging areas in order to not contact the floor. If any Regulated Natural Medicine comes in contact with the floor, it must be discarded.

b. Once Regulated Natural Medicine is harvested, it must be placed in a container that is protected from materials that could fall into it.

D.Cultivation materials.

1. Cultivation materials, ingredients, and Regulated Natural Medicine that can support the rapid growth of undesirable microorganisms must be stored in a manner that prevents the growth of these microorganisms.

2.Substrate Preparation. Any unpasteurized substrate and storage areas must be adequately separated from areas where pasteurized substrate is stored to prevent cross-contamination.

a. Appropriate measures must be in place to prevent any seepage or runoff from the unpasteurized substrate preparation area by collecting or diverting it from the pasteurized substrate area.

E.Records. All records must be kept on file in accordance with Rule 3010.

1. If a Natural Medicine Cultivation Facility uses raw materials in the production of Regulated Natural Medicine, the Licensee must obtain and maintain documentation of the substrate, compost or other cultivation materials purchased, including the date of purchase.

2.Standard Operating Procedures (SOP). A Natural Medicine Cultivation Facility must have standard operating procedures for each method of cultivation on file, and available upon request for inspection by the Division. The SOP must include:

a. A documented Regulated Natural Medicine safety plan, including worker training on proper Regulated Natural Medicine handling, hand washing, hair restraint, and use of gloves.

b.Handling of Chemicals. Written procedures must document how workers are trained on the proper use of chemicals, and containers used to store chemical solutions are clearly marked with the common name of the chemical, and instructions for proper use, and non-food containers are used to prepare and hold all chemical solutions.

c.Pest Control. Written procedures must document pest control strategies. All pest control devices must be located away from products so as to avoid contamination. At least one pest control device should be within 10 feet of each side of an outside entrance. If used, poison bait stations are used exclusively on the outside of the building. If used, all live traps are placed a maximum of 30 feet apart and at entrances. If pest lights are used, they must be placed so as to not attract pests into the building. All pest control devices are located on a map.

d.Cultivation Materials and Procedures. Written documentation of materials used to cultivate Regulated Natural Medicine, including any equipment, ingredients, substrate, raw materials, spore type, and any additives.

e.Instructions for Cultivation and Sampling. Specific instructions detailing each step in the cultivation process, including the expected yield of the cultivation. Written sampling procedures including Sample collection and test submission steps.

3.Corrective Action Preventative Action. A Natural Medicine Cultivation Facility shall establish and maintain written procedures for implementing corrective action and preventive action (CAPA). The written procedures shall include the requirements listed below as determined by the Licensee. All activities required under this Rule, and their results, shall be documented and kept as business records. The written procedures shall include requirements, as appropriate, for:

a. What constitutes a Nonconformance in the Licensee's business operation;

b. Analyzing processes, work operations, reports, records, service records, complaints, returned product, and/or other sources of data to identify existing and potential root causes of Nonconformances or other quality problems;

c. Investigating the root cause of Nonconformances relating to product, processes, and the quality system;

d. Identifying the action(s) needed to correct and prevent recurrence of Nonconformance and other quality problems;

e. Verifying the CAPA to ensure that such action is effective and does not adversely affect finished products;

f. Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems;

g. Ensuring the information related to quality problems or Nonconformances is disseminated to those directly responsible for assuring the quality of products or the prevention of such problems; and

h. Submitting relevant information on identified quality problems and CAPA documentation, and confirming the result of the evaluation, for management review.

4. Any Adverse Health Events required to be reported in Rule 3015.

5.Certificates of Analysis. All certificates of analysis provided to the Natural Medicine Cultivation Facility by a Natural Medicine Testing Facility for any Samples submitted for testing shall be maintained on the Licensed Premises in accordance with Rule 3010.

F.Contaminated Regulated Natural Medicine.

1. If a Sample that was submitted for testing is contaminated or adulterated, the Harvest Lot must be disposed of according to Rule 3120.

2. If any Regulated Natural Medicine is exposed to blood or bodily fluids or is found to contain filth or foreign matter, it must be disposed of according to Rule 3120.

G.Directed Testing. A Natural Medicine Cultivation Facility Licensee shall, upon the Division's direction, submit a sufficient quantity of Regulated Natural Medicine to a Natural Medicine Testing Facility for laboratory or chemical analysis in accordance with Rule 4020. The Division will notify the Licensee of the results of the analysis.

H.Storage, Packaging, and Labeling.

1.Storage. After cultivation, Regulated Natural Medicine should follow best practices for storage prior to packaging. Current best practices for the storage of psilocybin-containing products are to store them at room temperature in darkness and away from moisture or with devices to absorb moisture to improve the stability of the active ingredients in the products.

2.Packaging. All Regulated Natural Medicine must be packaged in accordance with Rule 3305.

3.Labeling. All Regulated Natural Medicine must be labeled in accordance with Rule 3305.

a. A Natural Medicine Cultivation Facility may establish an expiration date upon which the Regulated Natural Medicine's Total Psilocin will differ by an amount greater than +/- fifteen percent from the original test results.

b. The Licensee shall determine the expiration date by conducting the required testing pursuant to Rule 4010 on the Regulated Natural Medicine to ensure the Regulated Natural Medicine can pass tryptamine content and contaminant testing through the established expiration date.

c. When determining the expiration date pursuant to this Rule, the Licensee shall also consider the ideal storage conditions for the Regulated Natural Medicine.

d. Expiration date determinations, along with any data used to establish the expiration date, such as test results, shall be documented and maintained in the Licensee's records pursuant to these Part 5 Rules and Rule 3010.

I.Internal Audit. Natural Medicine Cultivation Facilities must conduct an annual internal audit to assess that they are in substantial compliance with the requirements of this Rule 5020. A copy of the internal audit shall be retained as business records for one year.

1 CCR 212-3-5-5020

47 CR 17, September 10, 2024, effective 10/1/2024