Basis and Purpose - 7030
The statutory authority for this rule includes but is not limited to sections 25-2.5-120, 44-50-202(1)(b), 44-50-203(1)(f), 44-50-203(1)(g), 44-50-203(2)(g), 44-50-203(2)(k), and 44-50-404(2), C.R.S. The purpose of this rule is to establish the notification requirements for a Natural Medicine Testing Facility in the event of a failed test or detection of contaminants.
A. If Regulated Natural Medicine or Regulated Natural Medicine Product fails a contaminant test, then the Natural Medicine Testing Facility must immediately: 1. Notify the Natural Medicine Business that submitted the Sample for testing; and2. Report the failure to the Division and track the failure in accordance with Rule 7035.B.Other Contaminants. If any Sample is found to contain levels of any microorganism, chemical, elemental impurity, or pesticides that could be toxic if consumed or present, then the Natural Medicine Testing Facility must notify the Natural Medicine Business and the Division. The Natural Medicine Business that was notified must initiate their CAPA plan in accordance with Rule 5020(E)(3) or 6015(E)(3).47 CR 17, September 10, 2024, effective 10/1/2024