Basis and Purpose - 4-225
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 sampling procedures and rules for the
Division's Regulated Marijuana sampling and testing program. This Rule 4-225
was previously Rules 4-110 and 4-125, 1 CCR 212-3, Rules M and R 1504,
1 CCR
212-1 and
1 CCR
212-2.
A.
Collection of Test Batches.
1.
Sample Increment
Collection. All Test Batches submitted for testing pursuant to
this Rule must be collected by Division representatives or in accordance with
the Division's sampling policy reflected in the marijuana laboratory testing
reference library available at the Colorado Department of Public Health and
Environment's website. This reference library may be continuously updated as
new materials become available in accordance with section
25-1.5-106 (3.5)(d),
C.R.S.
2.
Sample
Increment Selection. The Division may elect, at its sole
direction, to assign Division representatives to collect Sample Increments, or
may otherwise direct Sample Increment selection, including, but not limited to,
through Division designation of a Harvest Batch or Production Batch in the
Inventory Tracking System from which a Regulated Marijuana Business shall
select Test Batches for testing. A Regulated Marijuana Business, its
Controlling Beneficial Owners, Passive Beneficial Owners, and employees shall
not attempt to influence the Sample Increments selected by Division
representatives. If the Division does not select the Harvest Batch or
Production Batch to be tested, a Regulated Marijuana Business must collect and
submit Sample Increments that are representative of the Harvest Batch or
Production Batch being tested.
3.
Adulteration or Alteration Prohibited. Pursuant to
section 44-10-701(3)(b) and
(9), C.R.S., it is unlawful for a Licensee or
its agent to knowingly adulterate or alter, or attempt to adulterate or alter,
any Sample Increments or Test Batches of Regulated Marijuana. The Sample
Increments collected and submitted for testing must be representative of the
Harvest Batch or Production Batch being tested. A person who commits
adulteration or alteration of Sample Increments or Test Batches commits a class
2 misdemeanor and may be punished as provided in section
18-1.3-501,
C.R.S.
B.
Timing of Sample Increments for Harvest Batches and Production
Batches. A Licensee shall not collect Sample Increments or submit
Test Batches for testing until the Harvest or Production Batch that is
represented by the Test Batch has completed all required steps and is in its
final form as outlined in the Standard Operating Procedures of the Licensee
submitting the Test Batch, with the exception of packaging and labeling
requirements which shall comply with Rule 3-1025.
1. The following examples illustrate various
methods, which are not limited to those listed herein, that a Licensee's
Standard Operating Procedures may include to verify a Test Batch completed all
required steps and is in its final form pursuant to this Rule:
a. The Licensee's Standard Operating
Procedures may include procedures that ensure the addition of all Ingredients
or Additives has occurred and that the Harvest Batch or Production Batch
associated with the Test Batch is completely ready to be packaged pending
results of testing required by these Rules. This also includes creating
Pre-Rolled Marijuana and Infused Pre-Rolled Marijuana;
b. For a Production Batch of Concentrate, the
Licensee's Standard Operating Procedure may include procedures that ensure the
entire Production Batch associated with the Test Batch has completed all
sifting, extracting, purging, winterizing, and steps to remove plant pigments
and ensuring the addition of all Ingredients and Additives has
occurred.
c. For a Production Batch
of Regulated Marijuana Product, the Licensee's Standard Operating Procedure may
include procedures that ensure the addition of all Ingredients and Additives
has occurred and the Production Batch associated with the Test Batch is
completely ready to be packaged pending results of testing required by these
Rules.
2. A Test Batch
from a Harvest Batch or Production Batch shall be packaged and labeled
according to Series 3-1025 prior to Transfer to a Regulated Marijuana Testing
Facility.
3. This Rule 4-225(B)
does not apply for the submission of Test Batches submitted for R&D
testing.
4.
Vaporizer
Delivery Device. Retail Marijuana Concentrate that has been placed
into a Vaporizer Delivery Device must be sampled and tested using a methodology
that allows the laboratory to analyze the emission of the contents of the
Vaporizer Delivery Device.
C.
Potency Testing -
General.
1.
Test
Batches. A Test Batch submitted for potency testing may only be
comprised of Sample Increments that are of the same strain of Medical Marijuana
or Retail Marijuana or from the same Production Batch of Medical Marijuana
Concentrate or Medical Marijuana Product, or from the same Production Batch of
Retail Marijuana Concentrate or Retail Marijuana Product, or from the same
Production Batch of Pre-Rolled Marijuana or Infused Pre-Rolled
Marijuana.
D.
Designated Test Batch Collector Training, Documentation, and
Designation.
1.
Required Sample Increment Collection Training. To
become a Designated Test Batch Collector an Owner Licensee or Employee Licensee
involved in the Sample Increment Collection of Regulated Marijuana must be
designated by a manager or Owner Licensee as such and must also complete either
in-house training provided by the Regulated Marijuana Business or training from
a third-party vendor including all of the topics set forth in subparagraph (2)
of this Rule. Nothing in this rule requires a Designated Test Batch Collector
to be employed by the Regulated Marijuana Business making the designation.
2.
Designated Test
Batch Collection Training Required Topics. The training required
to become a Designated Test Batch Collector must include at least the following
topics:
a. Part 4-200 Series Rules - Regulated
Marijuana Testing Program;
b. The
Regulated Marijuana Business's Standard Operating Procedures on creating a
Sampling Plan and Test Batches, and the CDPHE's Sampling Procedures.
c. "Guidance on Marijuana Sampling
Procedures" Training Video or an equivalent training covering the following
subjects:
i. Introduction to Sample Increment
Collection:
A. Cross contamination as it
relates to Sample Increment Collection;
B. Sample Increment Collection and how it
works;
C. Sample Increment
Collection documentation and record keeping requirements;
D. Penalties for Sample Increment or Test
Batch adulteration or alteration;
E. Use of and disinfection of the Designated
Test Batch Collection Area; and
F.
Use of the Sample Plan.
3.
Documentation of Designated
Test Batch Collector Training. Any individual receiving the
Designated Test Batch Collector training must sign and date a document which
shall be maintained by the Regulated Marijuana Business as a business record
pursuant to Rule 3-905. The document must acknowledge the following:
a. The identity of the Person that created
the training, such as the Regulated Marijuana Business or a third-party vendor;
and
b. That all required topics of
the training identified in this Rule have been reviewed and understood by the
Owner Licensee or Employee Licensee.
E.
Test Batch Collection
Requirements.
1.
Required Minimum of Two Test Batch Collectors. At a
minimum, two Designated Test Batch Collectors shall be involved in the
collection of Sample Increments such that at least one Designated Test Batch
Collector is responsible for collecting the Sample Increments and another
Designated Test Batch Collector is responsible for reviewing documentation
associated with the collection of Sample Increments in a timely manner and
prior to any Transfer of the Production Batch or Harvest Batch from which
Sample Increments were collected. This review can be completed in person or may
be completed remotely by reviewing image(s) of the Test Batch and associated
documentation. All Designated Test Batch Collectors must be identified as such
in the Inventory Tracking System account associated with the Regulated
Marijuana Business.
2.
Sample Plan Required. A Designated Test Batch
Collector must establish a Sample Plan consistent with the Regulated Marijuana
Business's Standard Operating Procedure for Sample Increment Collection. At a
minimum, a Sample Plan must include the following:
a. The date, amount or weight, and specific
location for each Sample Increment collected;
b. Identification of and acknowledgements
from all Designated Test Batch Collectors involved in the Sample Increment
Collection; and
c. If applicable,
the strain name(s) for each Harvest Batch from which Sample Increments are
collected.
F.
Minimum Number of Sample Increments Per Test Batch
Submission. These sampling rules shall apply until such time as
the State Licensing Authority revises these rules to implement a statistical
sampling model. Unless a greater amount is required to comply with these rules
or is required by a Regulated Marijuana Testing Facility to perform all
requested testing, each Test Batch of Regulated Marijuana must contain at least
the number of Sample Increments prescribed by this Section.
1. A Test Batch of Regulated Marijuana must
be packaged and labeled according to Rule 3-1025.
2. The minimum number of Sample Increments
required to be collected for each Test Batch from a Harvest Batch of Retail
Marijuana or Medical Marijuana shall be determined as directed in subparagraphs
(F)(4)(c)(i) - (iv) of this Rule.
3. The minimum number of Sample Increments
required to be collected for each Test Batch from a Production Batch of
Regulated Marijuana Product, Pre-Rolled Marijuana, Infused Pre-Rolled
Marijuana, Audited Product and Alternative Use Product shall be determined as
directed in subparagraphs (F)(4)(c)(i) - (iv) of this Rule.
a. The Retail Marijuana Products Manufacturer
or Medical Marijuana Products Manufacturer shall determine what constitutes a
"Serving" and thus how many Servings are contained in a Production Batch of
Regulated Marijuana Product, except that no serving of Edible Retail Marijuana
Product can contain more than 10mg of active THC
b. Because all Test Batches of Regulated
Marijuana Product, Pre-Rolled Marijuana and Infused Pre-Rolled Marijuana are
required to be submitted for testing in their final form, in the event the
required number of Sample Increments does not match up within a finished
package, the manufacturer must increase the number of Sample Increments
collected for the Test Batch such that only finished packages of Regulated
Marijuana Products, Pre-Rolled Marijuana and Infused Pre-Rolled Marijuana are
submitted for testing. For example, if a Production Batch of 4000 chocolate
bars is manufactured, with each bar containing 100 mg THC and 10 servings per
bar, the Production Batch would contain 40,000 Sample Increments which would
require collection of at least 33 Sample Increments per Test Batch. But in this
case, the manufacturer would have to collect 40 Sample Increments for testing
(4 complete chocolate bars in final form).
c. No matter how small the Production Batch
of Regulated Marijuana Product, Pre-Rolled Marijuana, and Infused Pre-Rolled
Marijuana a minimum of two finished packages in final form must be submitted
for a Test Batch.
4. The
minimum number of Sample Increments required to be collected for each Test
Batch from a Production Batch of Retail Marijuana Concentrate or Medical
Marijuana Concentrate shall be determined as directed in subparagraphs (F)(4)
(c)(i) - (iv) of this Rule.
a. Because all
Test Batches of Retail Marijuana Concentrate and Medical Marijuana Concentrate
are required to be submitted for testing in their final form, in the event the
required number of Sample Increments does not match up with the number of
Sample Increments in a finished package, the manufacturer must increase the
number of Sample Increments collected for the Test Batch such that only
finished packages of Marijuana Concentrate are submitted for testing. For
example, if a Production Batch of 4,000 Vaporizer Delivery Devices is
manufactured, with each Vaporizer Delivery Device containing 500 milligrams of
Marijuana Concentrate, the Production Batch would contain 2,000 grams of
Marijuana Concentrate, which would require collection of at least 15 Sample
Increments per Test Batch. But in this case, the manufacturer would have to
collect 16 Sample Increments for testing (8 vaporizer Delivery Devices in final
form).
b. No matter how small the
Production Batch of Retail Marijuana Concentrate or Medical Marijuana
Concentrate, a minimum of two finished packages must be submitted for a Test
Batch.
c.
Determining
minimum number of Sample Increments.
i. The following table represents Regulated
Marijuana Sample Increments of 0.5 grams:
4-225(F)(4)(c)(i) 1
|
Minimum Number of Sample Increments
Required to be Collected per Test Batch
|
Total Weight of Harvest Batch
(lbs)
|
Total Weight of Harvest Batch
(grams)
|
Minimum Weight of Test Batch
(grams)
|
|
5
|
0.000 - 0.999
|
0.0 - 453.5
|
2.50
|
|
8
|
1.00 - 9.999
|
453.6 - 4535.9
|
4.00
|
|
15
|
10.000 - 19.999
|
4536.0 - 9071.8
|
7.50
|
|
22
|
20.000 - 39.999
|
9071.9 - 18143.6
|
11.00
|
|
33
|
40.000 - 99.999
|
18143.7 - 45359.2
|
16.50
|
|
43
|
100.000 - 199.999
|
45359.3 - 90718.4
|
21.50
|
|
53
|
200.000 - 499.999
|
90718.5 - 226796.1
|
26.50
|
|
80
|
500 or more
|
226796.2 or more
|
40.00
|
ii.
The following table represents Regulated Marijuana Concentrate Sample
Increments of 0.25 grams:
4-225(F)(4)(c)(ii) 1
|
Minimum Number of Sample Increments
Required to be Collected per Test Batch
|
Total Weight of Production Batch
(lbs)
|
Total Weight of Production Batch
(grams)
|
Minimum Weight of Test Batch
(grams)
|
|
5
|
0.000 - 0.999
|
0.0-453.5
|
1.25
|
|
8
|
1.00 - 1.999
|
453.6-907.1
|
2.00
|
|
15
|
2.00 - 4.999
|
907.2-2267.9
|
3.75
|
|
22
|
5.000 - 14.999
|
2268.0-6803.8
|
5.50
|
|
33
|
15.000 - 49.999
|
6803.9-22679.6
|
8.25
|
|
43
|
50.000 - 99.999
|
22679.7-45359.2
|
10.75
|
|
53
|
100.000 - 249.999
|
45359.3-113398.0
|
13.25
|
|
80
|
250 or more
|
113398.1 or more
|
20.00
|
iii. The following table represents Regulated
Marijuana Products Sample Increments of 1 Serving:
4-225(F)(4)(c)(iii) 1
|
Minimum Number of Sample Increments
Required to be Collected per Test Batch
|
Number of Servings within Production
Batch
|
Minimum Number of Units for a Test Batch
for a 5-Serving Unit*
|
Minimum Number of Units for a Test Batch
for a 10-Serving Unit*
|
Minimum Number of Units for a Test Batch
for a 20-Serving Unit*
|
Minimum Number of Units for a Test Batch
for a 100-Serving Unit*
|
|
5
|
0 - 99
|
2
|
2
|
2
|
2
|
|
8
|
100 - 999
|
2
|
2
|
2
|
2
|
|
15
|
1000 - 4999
|
3
|
2
|
2
|
2
|
|
22
|
5000 - 9999
|
5
|
3
|
2
|
2
|
|
33
|
10000 - 49999
|
7
|
4
|
2
|
2
|
|
43
|
50000 - 99999
|
9
|
5
|
3
|
3
|
|
53
|
100000 - 249999
|
11
|
6
|
3
|
3
|
|
80
|
250000 or more
|
16
|
8
|
4
|
4
|
*Other serving amounts per unit are acceptable. These are
provided as examples.
iv.
Pre-Rolled Marijuana and Infused Pre-Rolled Marijuana.
The following table represents the minimum number of Pre-Rolls for a Test Batch
based on the minimum number of Sample Increments required to be collected per
Test Batch, the number of Pre-Rolls within the Production Batch, and the weight
of each Pre-Roll.
4-225(F)(4)(c)(iv) 1
|
|
Pre-Roll Weight
< or = 0.39 g
|
Pre-Roll Weight
0.40g to 0.50g
|
Pre-Roll Weight
0.51g to 0.75g
|
Pre-Roll Weight
0.76g to 1.00g
|
Pre-Roll Weight
1.01g to 2.00g
|
Pre-Roll Weight
2.01g to 3.00g
|
Pre-Roll Weight
3.01g +
|
|
Minimum Number of Sample Increments
Required to be Collected per Test Batch
|
Number of Pre-Rolls within the Production
Batch
|
Minimum Number of Pre-Rolls for a Test
Batch
|
Minimum Number of Pre-Rolls for a Test
Batch
|
Minimum Number of Pre-Rolls for a Test
Batch
|
Minimum Number of Pre-Rolls for a Test
Batch
|
Minimum Number of Pre-Rolls for a Test
Batch
|
Minimum Number of Pre-Rolls for a Test
Batch
|
Minimum Number of Pre-Rolls for a Test
Batch
|
|
5
|
0 - 99
|
5
|
4
|
3
|
2
|
2
|
2
|
2
|
|
8
|
100 - 999
|
8
|
5
|
4
|
3
|
2
|
2
|
2
|
|
15
|
1000 - 4999
|
15
|
10
|
8
|
5
|
4
|
2
|
2
|
|
22
|
5000 - 9999
|
22
|
14
|
11
|
8
|
6
|
3
|
2
|
|
33
|
10000 - 49999
|
33
|
21
|
17
|
11
|
9
|
5
|
3
|
|
43
|
50000 - 99999
|
43
|
27
|
22
|
15
|
11
|
6
|
4
|
|
53
|
100000 - 249999
|
53
|
34
|
26
|
18
|
14
|
7
|
5
|
|
80
|
250000 or more
|
80
|
50
|
40
|
27
|
20
|
10
|
7
|
G.
Regulated Marijuana Testing
Facility Selection. Unless otherwise restricted or prohibited by
these Rules or ordered by the State Licensing Authority, a Regulated Marijuana
Business may select which Medical Marijuana Testing Facility or Retail
Marijuana Testing Facility will test a Test Batch made up of Sample Increments
collected pursuant to this Rule. However, the Division may elect, at its sole
discretion, to assign a Regulated Marijuana Testing Facility to which a
Regulated Marijuana Business must submit for testing any Test Batch made up of
Sample Increments collected pursuant to this Rule.
H.
Hemp Product Sampling
Procedures. Absent sampling and testing standards established by
the Colorado Department of Public Health and Environment for the sampling and
testing of Hemp Product, a Person Transferring a Hemp Product to a Licensee
pursuant to the Marijuana Code and these Rules shall comply with the sampling
and testing standards set forth in these 4-200 Series Rules - Regulated
Marijuana Testing Program and as required by these Rules.
