1 Colo. Code Regs. § 212-3-4-4010

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

Section 1 CCR 212-3-4-4010 - Natural Medicine Cultivation Facility - Required Regulated Natural Medicine Testing

Basis and Purpose - 4010

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)(f), 44-50-203(1)(n), 44-50-203(2)(d), 44-50-203(2)(g), and 44-50-404(2), C.R.S. The purpose of this rule is to establish the required testing and sampling procedures for Regulated Natural Medicine that a Natural Medicine Cultivation Facility must complete prior to transferring Regulated Natural Medicine.

These testing rules reflect initial rules that attempt to balance the costs to Natural Medicine Businesses and protect public health and safety. These rules are based on limited available data and prior experience with other similar programs due to the nascent nature of the Regulated Natural Medicine program. The State Licensing Authority will monitor testing data and Participant experiences and may revise testing requirements to require more or less frequent testing, testing for additional or different contaminants, additional testing requirements if additional routes of administration are permitted and other testing updates. Further, if additional Natural Medicines are permitted in the Regulated Natural Medicine program, those may also require additional testing requirements.

A. Regulated Natural Medicine must pass all required testing conducted by a Natural Medicine Testing Facility prior to transfer to a Natural Medicine Products Manufacturer, Healing Center, or Facilitator.

B.Sampling Procedures.

1.Harvest Lot Sampling. Whole fungi must be fully dried to be submitted to a Natural Medicine Testing Facility. The Sample must be a mixture of parts of the Fruiting Bodies, including caps and stems of different Fruiting Bodies.

a. Samples collected from a Harvest Lot shall be a minimum of 2.5 grams and contain a minimum of 5 Sample Increments.

b. Sample Increments collected from a Harvest Lot shall be a minimum of 0.5 grams.

2.Sampling Procedure Training. A Natural Medicine Cultivation Facility must provide standard operating procedures and training to any Natural Medicine Handler Licensee or Owner Licensee who will collect Samples for required testing.

a. The standard operating procedures and training must include at least the following topics:

i. These Part 4 Rules - Regulated Natural Medicine Testing Program;

ii. Sampling procedures or guidance established by the Division, as available;

iii. Cross contamination as it relates to Sample collection;

iv. Sample collection documentation and record keeping requirements; and

v. Use of and disinfection of Sample collection equipment.

C.Required Testing - Harvest Lot Testing. Prior to transferring any Regulated Natural Medicine to a Natural Medicine Product Manufacturer, Healing Center, or Facilitator, a Natural Medicine Cultivation Facility must comply with required testing and that testing must be completed with a Sample submitted that is representative of the Harvest Lot it came from.

1.Tryptamine Content Analysis Testing.

a. Each Harvest Lot of Regulated Natural Medicine must be submitted for tryptamine content analysis. The results of the tryptamine content analysis required in this Rule must be accurately documented in the Licensee's inventory tracking records and on the label prior to transfer to a Facilitator, Natural Medicine Products Manufacturer, or Healing Center. The tryptamine content analysis shall test for:

i. Psilocybin;

ii. Psilocin;

iii. Baeocystin;

iv. Aeruginascin; and

v. Norbaeocystin.

b. Each Sample of Regulated Natural Medicine must also be tested for the presence of 4-acetoxy-N,N-Dimethyltryptamine (4-AcO DMT). The presence of any amount of 4-AcO-DMT is considered a failing test.

c.Failed Testing. The detection of a synthetic tryptamine or synthetic analog of a tryptamine, including a derivative of naturally occurring compounds of psilocybin or psilocin that is produced using chemical synthesis, chemical modification, or chemical conversion shall constitute a failed tryptamine content analysis test.

d. Tryptamine content analysis shall be conducted every nine months from the date of the original test or most recent retest. When retesting indicates a significant deviation of Total Psilocin, more than 15% higher or lower than the previous Total Psilocin, the Regulated Natural Medicine must be relabeled with the new tryptamine content.

2.Contaminant Testing - Microbial Panel. A Natural Medicine Cultivation Facility shall subject at least one Harvest Lot to the following microbial contaminant testing once every 30-day period following the Sample submission of the last Sample. If during any 30-day period the Natural Medicine Cultivation Facility does not possess a Harvest Lot that is ready for testing, the Natural Medicine Cultivation Facility must subject its first Harvest Lot that is ready for testing to the required contaminant testing prior to transfer to a Facilitator, Healing Center, or Natural Medicine Products Manufacturer.

a. Each Sample of Regulated Natural Medicine must be submitted for the following microbial contaminant tests:

i.Salmonella. Salmonella must be absent from the Sample.

ii. Shiga toxin producing Escherichia coli (STEC). STEC must be absent from the Sample.

1 CCR 212-3-4-4010

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