1 Colo. Code Regs. § 212-3-4-4020

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

Section 1 CCR 212-3-4-4020 - Division Directed Testing

Basis and Purpose - 4020

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)(j), 44-50-203(2)(d), 44-50-203(2)(g), 44-50-203(2)(r), and 44-50-404(2), C.R.S. The purpose of this rule is to establish the Natural Medicine Division's authority to request testing at any time and to require the Licensee to submit Samples for any required tests to a Natural Medicine Testing Facility.

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. Upon direction by the Division or the State Licensing Authority, a Natural Medicine Business must submit one or more Samples of Regulated Natural Medicine or Regulated Natural Medicine Product for any tests required under this Rule and other tests as may be necessary for investigation. If the Division directs a test, the results will be shared with the Natural Medicine Business.

B. Samples collected pursuant to this Rule may be tested for tryptamine content, Total Psilocin, or contaminants which may include, but is not limited to, pesticides, microbial contaminants, mycotoxins, elemental impurities, residual solvents, or other chemical contaminants.

C. A Licensee must submit a Sample(s) to a Natural Medicine Testing Facility within 48 hours of receiving a Division directive for additional testing, unless otherwise noted in the directive.

D. The Division may elect, at its sole direction, to assign Division representatives to collect Samples.

E. The Division may issue a Notice of Embargo or Notice of Destruction pursuant to Rule 3210 based on test results that pose a risk to public health, safety, or welfare.

1 CCR 212-3-4-4020

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