Basis and Purpose - 4-235
The statutory authority for this rule includes but is not limited to sections 44-10-202(1)(c), 44-10-203(1)(a), 44-10-203(1)(c), 44-10-203(1)(g), 44-10-203(1)(k), 44-10-203(2)(d), 44-10-203(2)(f), 44-10-203(3)(d), 44-10-203(3)(e), 44-10-501(6), 44-10-502(3), 44-10-503(8), 44-10-504(1)(b), 44-10-504(2), 44-10-601(4), 44-10-602(4), 44-10-603(6), 44-10-604(1)(b), and 44-10-604(2), C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a) (VII). The purpose of this rule is to protect the public health and safety by establishing the potency testing and related Reduced Testing Allowance portion of the Division's Regulated Marijuana sampling and testing program. This Rule 4-235 was previously Rules 4-120, 4-121, 4-125, and 4-135, 1 CCR 212-3, Rules M and R 1503, 1 CCR 212-1 and 1 CCR 212-2.
A.Failed Potency Testing. If a Regulated Marijuana Business is notified by the Division or a Regulated Marijuana Testing Facility that a Test Batch of Regulated Marijuana Product failed potency testing, then for each Inventory Tracking System package or Production Batch associated with that failed Test Batch the Regulated Marijuana Business must either: 1. Destroy and document the destruction of the Inventory Tracking System package or Production Batch pursuant to Rule 3-230 - Waste Disposal; or2. Attempt corrective measures, if possible, and create two new Test Batches each containing the requisite number of Sample Increments and have those Test Batches tested for the required potency test that failed. Such testing must comport with the sampling procedures under Rule 4-225. a. A Licensee must either (1) submit both new Test Batches to the same Regulated Marijuana Testing Facility that reported the original failed test result, or (2) submit the new Test Batches to two different Regulated Marijuana Testing Facilities.b. If both new Test Batches pass potency testing, then the Inventory Tracking System package or Production Batch associated with each Test Batch may be Transferred.c. If one or both of the Test Batches do not pass potency testing, then the Regulated Marijuana Products Manufacturer must destroy and document the destruction of Inventory Tracking System package or Production Batch pursuant to Rule 3-230 - Waste Disposal.B.Failed Potency Testing and Reduced Testing Allowance. Failed potency testing may constitute a violation of these Rules.1. If a Test Batch is required to be tested by these Rules or required to be tested by the Division pursuant to Rule 4-205(E) and fails potency testing, the Regulated Marijuana Products Manufacturer shall follow the procedures in subparagraph (B) of this Rule for any Inventory Tracking System package or Production Batch associated with the failed Test Batch.2. If the Regulated Marijuana Products Manufacturer has achieved a Reduced Testing Allowance, they shall also submit Test Batches from three new Production Batches of the Regulated Marijuana Product for potency testing by a Regulated Marijuana Testing Facility within no more than 30 days from the Production Batch date. If any one of the three submitted Test Batches fails potency testing, the Regulated Marijuana Products Manufacturer shall achieve a new Reduced Testing Allowance.47 CR 21, November 10, 2024, effective 12/4/2024