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; or
2.
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.
