Basis and Purpose - 4-245
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 rules governing the quarantining of
potentially contaminated product and the destruction of product that failed
contaminant or potency testing for Division's Regulated Marijuana Sampling and
Testing Program. This Rule 4-245 was previously Rule 4-115, 4-125, and 4-135, 1
CCR 212-3, Rules M and R 1507,
1 CCR
212-1 and
1 CCR
212-2.
A.
Exemptions.
1.
Medical Marijuana Concentrate.
a. A Medical Marijuana Products Manufacturer
who combines multiple Production Batches of Solvent-Based Medical Marijuana
Concentrate into a Production Batch of Solvent-Based Medical Marijuana
Concentrate shall be considered exempt from residual solvent testing pursuant
to this Rule only if all original Production Batches passed residual solvent
testing. This does not apply if a solvent, Additive, or any other Ingredient
was introduced during the combination of the Production Batches.
b. A Production Batch of Medical Marijuana
Concentrate shall be considered exempt from contaminant testing requirements
pursuant to this Rule if the Medical Marijuana Products Manufacturer that
produced it does not Transfer any portion of the Production Batch and uses the
entire Production Batch to manufacture Medical Marijuana Product, except that a
Solvent-Based Medical Marijuana Concentrate must still be submitted for
residual solvent contaminant testing and Medical Marijuana Concentrate must
still be submitted for pesticide contaminant testing. The manufactured Medical
Marijuana Product shall be subject to mandatory testing under this
Rule.
2.
Retail Marijuana Concentrate.
a. A Retail Marijuana Products Manufacturer
or Accelerator Manufacturer who combines multiple Production Batches of
Solvent-Based Retail Marijuana Concentrate into a Production Batch of
Solvent-Based Retail Marijuana Concentrate shall be considered exempt from
residual solvent testing pursuant to this Rule only if all original Production
Batches passed residual solvent testing. This does not apply if a solvent,
Additive or any other Ingredient was introduced during the combination of the
Production Batches.
b. A Production
Batch of Retail Marijuana Concentrate shall be considered exempt from
contaminant testing requirements pursuant to this Rule if the Retail Marijuana
Products Manufacturer that produced it does not Transfer any portion of the
Production Batch and uses the entire Production Batch to manufacture Retail
Marijuana Product, except that a Solvent-Based Retail Marijuana Concentrate
must still be submitted for residual solvent contaminant testing and Retail
Marijuana Concentrate must still be submitted for pesticide contaminant
testing. The manufactured Retail Marijuana Product shall be subject to testing
under this Rule.
3.
Regulated Marijuana Product. A Regulated Marijuana
Business that produces Regulated Marijuana Products with intended use for oral
consumption or skin and body products, is exempt from aspergillus testing as
required by these 4-200 Series Rules.
B.
Testing Exemptions for Wet
Whole Plant.
1. Harvest Batches
of Regulated Marijuana wet whole plant are exempt from required water activity
testing.
2. Harvest Batches of
Regulated Marijuana wet whole plant are exempt from required microbial
contaminant testing if a Regulated Marijuana Cultivation Facility Transfers the
Regulated Marijuana wet whole plant for the purposes of extraction to a
Regulated Marijuana Business with at least one identical Controlling Beneficial
Owner and in accordance with this Rule. If a Regulated Marijuana wet whole
plant Harvest Batch is not tested for microbial contamination, each resulting
Regulated Marijuana Concentrate Production Batch shall be tested for microbial
contamination pursuant to Rule 4-215.
C.
Pre-Rolled Marijuana Potency
Exemption. A Regulated Marijuana Business shall be considered
exempt from potency testing if the Pre-Rolled Marijuana Production Batch uses a
single strain and uses all parts of the Harvest Batch that were included in the
potency testing of the Harvest Batch prior to creating the Pre-Rolled Marijuana
Production Batches. In this case, the potency test results of the Harvest Batch
shall be used for the Pre-Rolled Marijuana Production Batch.
D.
Pre-Rolled Marijuana and
Infused Pre-Rolled Marijuana Homogeneity Exemption. Production
Batches of Pre-Rolled Marijuana and Infused Pre-Rolled Marijuana are exempt
from homogeneity testing.
E.
Potency Testing Exemption for Marijuana Allocated for
Extraction. Any Regulated Marijuana that will be allocated for
extraction in the Inventory Tracking System shall be considered exempt from
potency testing pursuant to this Rule.
