Basis and Purpose - 4-135
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 4-135 was previously Rules M and R 1507,
1 CCR
212-1 and
1 CCR
212-2.
A.
Quarantining of Product.
1. If the Division has reasonable grounds to
believe that a particular Harvest Batch, Production Batch, or Inventory
Tracking System package of Regulated Marijuana is contaminated or presents a
risk to public safety, then the Division may require a Regulated Marijuana
Business to quarantine it until the completion of the Division's investigation,
which may include, but is not limited to, the receipt of any test
results.
2. If a Regulated
Marijuana Business is notified by any local or state agency, or by a Regulated
Marijuana Testing Facility that a Test Batch failed a contaminant or potency
testing, then the Regulated Marijuana Business shall quarantine any Regulated
Marijuana from any Inventory Tracking System package, Harvest Batch or
Production Batch associated with that failed Test Batch and must follow the
procedures established pursuant to this Rule.
3. Except as provided by this Rule, Regulated
Marijuana that has been quarantined pursuant to this Rule must be physically
separated from all other inventory and the Licensee may not Transfer or further
process the Regulated Marijuana.
4.
In addition to any other method authorized by law, the Division may implement
the quarantine through the Inventory Tracking System by (a) indicating failed
test results and (b) limiting the Licensee's ability to Transfer the
quarantined Regulated Marijuana unless otherwise permitted by these
rules.
B.
Failed Contaminant Testing: All Contaminant Testing Except
Microbial and Water Activity Testing of Regulated Marijuana Flower, Wet Whole
Plant, Trim, Pre-Rolled Marijuana, Infused Pre-Rolled Marijuana, Pesticide
Testing, and Elemental Impurities Testing of Regulated Marijuana Flower or
Trim. If a Regulated Marijuana Business is notified by the
Division or a Regulated Marijuana Testing Facility that a Test Batch failed
contaminant testing (except microbial and water activity testing of Regulated
Marijuana flower or trim, Pre-Rolled Marijuana and Infused Pre-Rolled
Marijuana, Pesticide testing, and elemental impurities testing of Regulated
Marijuana flower or trim), then for each Inventory Tracking System package,
Harvest Batch, 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,
Harvest Batch or Production Batch pursuant to Rule 3-230 - Waste
Disposal;
2. Decontaminate the
Inventory Tracking System package, Harvest Batch, or Production Batch, and
create two new Test Batches, each containing the requisite number of Sample
Increments, and have those Test Batches tested for the required contaminant
test that failed. Such testing must comport with the sampling procedures under
Rule 4-110.
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 Medical Marijuana Testing Facilities or Retail
Marijuana Testing Facilities;
b. If
both new Test Batches pass the required contaminant testing, then the Inventory
Tracking System package, Harvest Batch, or Production Batch of Regulated
Marijuana or Regulated Marijuana Product associated with each Test Batch may be
Transferred or processed into a Medical Marijuana Concentrate, Retail Marijuana
Concentrate, Medical Marijuana Product, or Retail Marijuana Product;
c. If one or both of the Test Batches do not
pass contaminant testing, then the Regulated Marijuana Business must destroy
and document the destruction of the Inventory Tracking System package, Harvest
Batch, or Production Batch included in that Test Batch pursuant to Rule 3-230 -
Waste Disposal.
3. The
Regulated Marijuana Business may Transfer the Inventory Tracking System
package, Harvest Batch, or Production Batch that failed contaminant testing to
another Medical Marijuana Products Manufacturer, Retail Marijuana Products
Manufacturer, or an Accelerator Manufacturer for Decontamination, and create
two new Test Batches after Decontamination has occurred, each containing the
requisite number of Sample Increments, and have those Test Batches tested for
the required contaminant test that failed. Such testing must comport with the
sampling procedures under Rule 4-110.
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 Medical Marijuana Testing
Facilities or Retail Marijuana Testing Facilities;
b. If both new Test Batches pass the required
contaminant testing, then the Inventory Tracking System package, Harvest Batch,
or Production Batch of Regulated Marijuana or Regulated Marijuana Product
associated with each Test Batch may be Transferred or processed into a Medical
Marijuana Concentrate, Retail Marijuana Concentrate, Medical Marijuana Product,
or Retail Marijuana Product;
c. If
one or both of the Test Batches do not pass contaminant testing, then the
Regulated Marijuana Business must destroy and document the destruction of the
Inventory Tracking System package, Harvest Batch, or Production Batch included
in that Test Batch pursuant to Rule 3-230 - Waste Disposal.
C.
Failed
Contaminant Testing: Microbial Testing of Regulated Marijuana Flower, Wet Whole
Plant, Trim, Pre-Rolled Marijuana, and Infused Pre-Rolled
Marijuana. If a Regulated Marijuana Business is notified by the
Division or a Regulated Marijuana Testing Facility that a Test Batch of
Regulated Marijuana flower, wet whole plant, trim, Pre-Rolled Marijuana or
Infused Pre-Rolled Marijuana failed microbial testing, then for each Inventory
Tracking System package, Harvest Batch, 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, Harvest Batch, or Production Batch
pursuant to Rule 2-230 - Waste Disposal;
2. Decontaminate the Inventory Tracking
System package, Harvest Batch, or Production Batch, and create two new Test
Batches, each containing the requisite number of Sample Increments, and submit
those Test Batches for microbial contaminant testing. Such testing must comply
with the sampling procedures under Rule 4-110. If the Inventory Tracking System
package, Harvest Batch, or Production Batch has undergone Decontamination, then
it must also pass a mycotoxin and water activity test prior to Transfer. The
mycotoxin and water activity testing must occur after the final Decontamination
attempt but is not required to occur until after the Inventory Tracking System
package, Harvest Batch, or Production Batch has passed microbial testing. If a
Test Batch fails mycotoxin or water activity testing the Regulated Marijuana
Business must follow the failed contaminant testing procedures pursuant to
Paragraphs (B) and (C.5.) of this Rule. Pursuant to Rule 4-120(C), wet whole
plant is exempt from water activity testing.
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 Test Batches pass the required
microbial testing, then the Inventory Tracking System package, Harvest Batch,
or Production Batch associated with each Test Batch may be Transferred or
processed into a Regulated Marijuana Concentrate or Regulated Marijuana
Product.
c. If one or both of the
Test Batches do not pass microbial testing, then the Regulated Marijuana
Business must:
i. Destroy and document the
destruction of the Inventory Tracking System package, Harvest Batch, or
Production Batch pursuant to Rule 3-230 - Waste Disposal;
ii. Decontaminate and re-test in accordance
with this Paragraph (C)(2); or
iii.
Transfer the Inventory Tracking System package, Harvest Batch, or Production
Batch for Decontamination or Remediation pursuant to Paragraph (C)(3)(b)
below.
3. In
lieu of Decontamination pursuant to Paragraph (C)(2) above, the Regulated
Marijuana Business may Transfer all Regulated Marijuana from the Inventory
Tracking System packages, Harvest Batches, and Production Batches associated
with that failed Test Batch to a Regulated Marijuana Cultivation Facility for
Decontamination, or may Transfer such Regulated Marijuana to a Regulated
Marijuana Products Manufacturer for Decontamination and/or Remediation. If the
Regulated Marijuana Business receiving the Regulated Marijuana for
Decontamination will Transfer the Regulated Marijuana back to the originating
Regulated Marijuana Business following the Decontamination procedures, then the
originating Regulated Marijuana Business is responsible for all required
testing. If the Regulated Marijuana Business receiving the Regulated Marijuana
for Decontamination will Transfer the Regulated Marijuana to a different
Regulated Marijuana Business or further processes the Regulated Marijuana
following Decontamination, then the receiving Regulated Marijuana Business that
performed the Decontamination is responsible for all required testing.
a.
Decontamination.
The Regulated Marijuana Business may Decontaminate the Inventory Tracking
System package, Harvest Batch, or Production Batch, and create two new Test
Batches, each containing the requisite number of Sample Increments, and submit
those Test Batches for microbial contaminant testing. Such testing must comply
with the sampling procedures under Rule 4-110. If the Inventory Tracking System
package, Harvest Batch, or Production Batch has undergone Decontamination, then
it must also pass a mycotoxin and water activity test prior to Transfer. The
mycotoxin and water activity testing must occur after the final Decontamination
attempt but is not required to occur until after the Inventory Tracking System
package, Harvest Batch, or Production Batch has passed microbial testing. If a
Test Batch fails mycotoxin or water activity testing the Regulated Marijuana
Business must follow the failed contaminant testing procedures pursuant to
Paragraphs (B) and (C.5.) of this Rule. Pursuant to Rule 4-120(C), wet whole
plant is exempt from water activity testing.
i. 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 Medical Marijuana Testing Facilities or Retail Marijuana Testing
Facilities
ii. If both Test Batches
pass the required microbial testing, then the Inventory Tracking System
packages, Harvest Batch, or Production Batch associated with each Test Batch
may be Transferred or processed into a Regulated Marijuana Concentrate or
Regulated Marijuana Product.
iii.
If one or both of the Test Batches that were created from Harvest Batches or
Production Batches pursuant to Paragraph (C)(3)(a) do not pass microbial
testing, the Regulated Marijuana Business must either:
A. Destroy and document the destruction of
the Inventory Tracking System package, Harvest Batch, or Production Batch
pursuant to Rule 3-230 Waste Disposal;
B. Decontaminate and re-test in accordance
with this paragraph;
C. Attempt
Remediation pursuant to Paragraph (C)(3)(b), except for Production Batches of
Infused Pre-Rolled Marijuana; or
D.
Transfer the Inventory Tracking System package, Harvest Batch, or Production
Batch of Pre-Rolled Marijuana and Infused Pre-Rolled Marijuana for
Decontamination or Transfer the Inventory Tracking System package, Harvest
Batch, or Production Batch of Pre-Rolled Marijuana for Remediation pursuant to
Paragraph (C)(3)(b).
b.
Remediation. The
Regulated Marijuana Products Manufacturer may Remediate the Inventory Tracking
System package, Harvest Batch, or Production Batch of Pre-Rolled Marijuana, if
possible, and create two new Test Batches, each containing the requisite number
of Sample Increments. The new Test Batches are required to be re-tested for
Microbial, Mycotoxin, and Water Activity contaminant testing. Such testing must
comport with sampling procedures under Rule 4-110.
i. For Remediation, the Regulated Marijuana
Business shall process the Inventory Tracking System package, Harvest Batch, or
Production Batch of Pre-Rolled Marijuana associated with the failed Test Batch
into a Solvent-Based Medical Marijuana Concentrate or Solvent-Based Retail
Marijuana Concentrate.
ii. The
Solvent-Based Medical Marijuana Concentrate or Solvent-Based Retail Marijuana
Concentrate that was manufactured pursuant to Paragraph (C)(3)(b) shall undergo
all required contaminant testing pursuant to Rule 4-120(C) - Regulated
Marijuana Testing Program - Contaminant Testing, potency testing pursuant to
Rule 4-125 - Regulated Marijuana Testing Program - Potency Testing, and any
other testing required or allowed by the Marijuana Code or these rules,
including but not limited to microbial and mycotoxins contamination. Such
testing must comport with the sampling procedures under Rule 4-110.
iii. If the Solvent-Based Medical Marijuana
Concentrate or Solvent-Based Retail Marijuana Concentrate that was manufactured
pursuant to Paragraph (C)(3)(b) fails contaminant testing, the Regulated
Marijuana Business shall destroy and document the destruction of the Inventory
Tracking System package(s) or Production Batch(es) of Solvent-Based Medical
Marijuana Concentrate or Solvent-Based Retail Marijuana Concentrate pursuant to
Rule 3-230 - Waste Disposal.
4. Nothing in this Rule removes or alters the
responsibility of the Retail Marijuana Business Transferring the Retail
Marijuana that failed microbial testing from complying with the requirement to
pay excise tax pursuant to article 28.8 of title 39, C.R.S.
C.5.
Failed Contaminant Testing:
Water Activity Testing. If a Regulated Marijuana Business is
notified by the Division or a Regulated Marijuana Testing Facility that a Test
Batch of Regulated Marijuana flower, trim, Pre-Rolled Marijuana or Infused
Pre-Rolled Marijuana failed water activity testing, then for each Inventory
Tracking System package, Harvest Batch, 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, Harvest Batch, or Production Batch
pursuant to Rule 2-230 - Waste Disposal; or
2. Decontaminate the Inventory Tracking
System package, Harvest Batch, or Production Batch, and create two new Test
Batches, each containing the requisite number of Sample Increments, and submit
those Test Batches for water activity testing. Such testing must comply with
the sampling procedures under Rule 4-110. If the Inventory Tracking System
package, Harvest Batch, or Production Batch has undergone Decontamination, then
it must also pass a microbial contaminant test prior to Transfer. The microbial
contaminant test is not required to occur until after the Inventory Tracking
System package, Harvest Batch, or Production Batch has passed water activity
testing. If a Test Batch fails microbial contaminant testing the Regulated
Marijuana Business must follow the failed contaminant testing procedures
pursuant to Paragraph (C) above. Pursuant to Rule 4-120(E), wet whole plant is
exempt from water activity testing.
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 Test Batches
pass the required water activity testing, then the Inventory Tracking System
package, Harvest Batch, or Production Batch associated with each Test Batch may
be Transferred or processed into a Regulated Marijuana Concentrate or Regulated
Marijuana Product.
c. If one or
both of the Test Batches do not pass water activity testing, then the Regulated
Marijuana Business must:
i. Destroy and
document the destruction of the Inventory Tracking System package, Harvest
Batch, or Production Batch pursuant to Rule 3-230 - Waste Disposal;
ii. Decontaminate and re-test in accordance
with this Paragraph (C.5)(2); or
iii. Transfer the Inventory Tracking System
package, Harvest Batch, or Production Batch for Decontamination or Remediation
pursuant to Paragraph (C)(3)(b) below.
3. In lieu of Decontamination pursuant to
Paragraph (C.5)(2) above, the Regulated Marijuana Business may Transfer all
Regulated Marijuana from the Inventory Tracking System packages, Harvest
Batches, or Production Batches associated with that failed Test Batch to a
Regulated Marijuana Cultivation Facility for Decontamination, or may Transfer
such Regulated Marijuana to a Regulated Marijuana Products Manufacturer for
Decontamination and/or Remediation. If the Regulated Marijuana Business
receiving the Regulated Marijuana for Decontamination will Transfer the
Regulated Marijuana back to the originating Regulated Marijuana Business
following the Decontamination procedures, then the originating Regulated
Marijuana Business is responsible for all required testing. If the Regulated
Marijuana Business receiving the Regulated Marijuana for Decontamination will
Transfer the Regulated Marijuana to a different Regulated Marijuana Business or
further process the Regulated Marijuana following Decontamination, then the
receiving Regulated Marijuana Business that performed the Decontamination is
responsible for all required testing.
a.
Decontamination. The Regulated Marijuana Business may
Decontaminate the Inventory Tracking System package, Harvest Batch, or
Production Batch, and create two new Test Batches, each containing the
requisite number of Sample Increments, and submit those Test Batches for water
activity testing. Such testing must comply with the sampling procedures under
Rule 4-110. If the Inventory Tracking System package, Harvest Batch, or
Production Batch has undergone Decontamination, then it must also pass a
microbial contaminant test prior to Transfer. The microbial contaminant testing
is not required to occur until after the Inventory Tracking System package,
Harvest Batch, or Production Batch has passed water activity testing. If a Test
Batch fails microbial contaminant testing the Regulated Marijuana Business must
follow the failed contaminant testing procedures pursuant to Paragraph (C)
above. Pursuant to Rule 4-120(C), wet whole plant is exempt from water activity
testing.
i. 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 Medical Marijuana Testing Facilities or Retail Marijuana Testing
Facilities
ii. If both Test Batches
pass the required testing, then the Inventory Tracking System packages, Harvest
Batch, or Production Batch associated with each Test Batch may be Transferred
or processed into a Regulated Marijuana Concentrate or Regulated Marijuana
Product.
iii. If one or both of the
Test Batches that were created from Harvest Batches or Production Batches
pursuant to Paragraph (C.5)(3)(a) do not pass water activity testing, the
Regulated Marijuana Business must either:
A.
Destroy and document the destruction of the Inventory Tracking System package,
Harvest Batch, or Production Batch pursuant to Rule 3-230 Waste
Disposal;
B. Decontaminate and
re-test in accordance with this paragraph;
C. Attempt Remediation pursuant to Paragraph
(C.5)(3)(b), except for Production Batches of Infused Pre-Rolled Marijuana;
or
D. Transfer the Inventory
Tracking System package, Harvest Batch, or Production Batch of Pre-Rolled
Marijuana and Infused Pre-Rolled Marijuana for Decontamination or Transfer the
Inventory Tracking System package, Harvest Batch, or Production Batch of
Pre-Rolled Marijuana for Remediation pursuant to Paragraph
(C.5)(3)(b).
b.
Remediation. The Regulated Marijuana Products
Manufacturer may Remediate the Inventory Tracking System package, Harvest
Batch, or Production Batch of Pre-Rolled Marijuana, if possible, and create two
new Test Batches, each containing the requisite number of Sample Increments.
The new Test Batches are required to be re-tested for Microbial, Mycotoxin, and
Water Activity contaminant testing. Such testing must comport with sampling
procedures under Rule 4-110.
i. For
Remediation, the Regulated Marijuana Business shall process the Inventory
Tracking System package, Harvest Batch, or Production Batch of Pre-Rolled
Marijuana associated with the failed Test Batch into a Solvent-Based Medical
Marijuana Concentrate or Solvent-Based Retail Marijuana Concentrate.
ii. The Solvent-Based Medical Marijuana
Concentrate or Solvent-Based Retail Marijuana Concentrate that was manufactured
pursuant to Paragraph (C)(3)(b) shall undergo all required contaminant testing
pursuant to Rule 4-120(C) - Regulated Marijuana Testing Program - Contaminant
Testing, potency testing pursuant to Rule 4-125 - Regulated Marijuana Testing
Program - Potency Testing, and any other testing required or allowed by the
Marijuana Code or these rules, including but not limited to microbial and
mycotoxins contamination. Such testing must comport with the sampling
procedures under Rule 4-110.
iii.
If the Solvent-Based Medical Marijuana Concentrate or Solvent-Based Retail
Marijuana Concentrate that was manufactured pursuant to Paragraph (C.5)(3)(b)
fails contaminant testing, the Regulated Marijuana Business shall destroy and
document the destruction of the Inventory Tracking System package(s) or
Production Batch(es) of Solvent-Based Medical Marijuana Concentrate or
Solvent-Based Retail Marijuana Concentrate pursuant to Rule 3-230 - Waste
Disposal.
4.
Nothing in this Rule removes or alters the responsibility of the Retail
Marijuana Business Transferring the Retail Marijuana that failed microbial
testing from complying with the requirement to pay excise tax pursuant to
article 28.8 of title 39, C.R.S.
D.
Failed Contaminant Testing:
Pesticide Testing. If a Regulated Marijuana Business is notified
by the Division or a Regulated Marijuana Testing Facility that a Test Batch
failed Pesticide testing, then for each Inventory Tracking System package,
Harvest Batch, 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,
Harvest Batch, or Production Batch pursuant to Rule 3-230 - Waste Disposal;
or
2. Request that the Regulated
Marijuana Testing Facility that reported the original fail conduct two
additional analyses of the original Test Batch submitted in accordance with
Rule 4-110.
a. If both retesting analyses
pass the required Pesticide testing, then the Inventory Tracking System
package, Harvest Batch, or Production Batch of Regulated Marijuana, Regulated
Marijuana Concentrate, Regulated Marijuana Product, Pre-Rolled Marijuana or
Infused Pre-Rolled Marijuana may be Transferred or processed into a Regulated
Marijuana Concentrate or Regulated Marijuana Product.
b. If one or both of the retesting analyses
do not pass Pesticide testing, then the Regulated Marijuana Business must
destroy and document the destruction of the Inventory Tracking System package,
Harvest Batch, or Production Batch pursuant to Rule 3-230 - Waste
Disposal.
D.1.
Failed Contaminant Testing: Elemental Impurities Testing of
Regulated Marijuana Flower, Wet Whole Plant, and Trim. If a
Regulated Marijuana Business is notified by the Division or a Testing Facility
that a Test Batch of Regulated Marijuana flower, wet whole plant, or trim
failed elemental impurities testing, then for each Inventory Tracking System
package or Harvest 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
Harvest Batch pursuant to Rule 3-230 Waste Disposal.
2. Request that the Regulated Marijuana
Testing Facility that reported the original fail conduct two additional
analyses of the original Test Batch submitted in accordance with Rule 4-110.
a. If both retesting analyses pass the
required elemental impurities testing, then the Inventory Tracking System
package or Harvest Batch may be Transferred or processed into a Regulated
Marijuana Concentrate or Regulated Marijuana Product.
b. If one or both of the retesting analyses
do not pass elemental impurities testing, then the Regulated Marijuana Business
must either destroy and document the destruction of the Inventory Tracking
System package or Harvest Batch pursuant to Rule 3-230 - Waste Disposal or
Remediate the Inventory Tracking System package or Harvest Batch pursuant to
Paragraph (3).
3. If the
failed Test Batch is not deemed hazardous waste per the Resource Conservation
and Recovery Act or other applicable federal, state, or local regulations, then
the Regulated Marijuana Business may Transfer all Regulated Marijuana from the
Inventory Tracking System packages or Harvest Batch associated with that failed
Test Batch to a Regulated Marijuana Products Manufacturer for Remediation.
a. The Regulated Marijuana Business that
Transfers the Retail Marijuana that failed elemental impurities testing must
comply with the requirement to pay excise tax pursuant to article 28.8 of title
39, C.R.S.
b. The Regulated
Marijuana Products Manufacturer may Remediate the Inventory Tracking System
package or Harvest Batch associated with the failed Test Batch by processing it
into a Regulated Marijuana Concentrate. The Regulated Marijuana Products
Manufacturer is prohibited from adding any other Regulated Marijuana to the
Regulated Marijuana Concentrate it manufactures pursuant to this
Rule.
c. In addition to all
applicable regulations, the Regulated Marijuana Products Manufacturer must
comply with 3-230 (C)(1), 5-315(D)(9), and 6-315 (D)(9).
d. The Regulated Marijuana Concentrate that
was manufactured pursuant to Paragraph (D.1)(3)(b) shall undergo all required
contaminant testing pursuant to Rule 4-120(C) Regulated Marijuana Testing
Program Contaminant Testing, potency testing pursuant to Rule 4-125 - Regulated
Marijuana Testing Program - Potency Testing, and any other testing required or
allowed by the Marijuana Code or these rules, including but not limited to
elemental impurities testing. Such testing must comport with the sampling
procedures under Rule 4- 110.
e.
For elemental impurities testing, the Regulated Marijuana Business must create
two new Test Batches from the Remediated Production Batch, each containing the
requisite number of Sample Increments, and have those Test Batches tested. Such
testing must comport with the sampling procedures under Rule 4-110.
i. A Licensee must either (1) submit both new
Test Batches to the same Marijuana Testing Facility that reported the original
failed test result, or (2) submit the new Test Batches to two different
Marijuana Testing Facilities.
ii.
If both Test Batches pass the required elemental impurities testing, then the
Inventory Tracking System package or Harvest Batch associated with each Test
Batch may be Transferred or processed into a Regulated Marijuana Concentrate or
Regulated Marijuana Product.
iii.
If one or both of the Test Batches do not pass elemental impurities testing,
then the Regulated Marijuana Business must destroy and document the destruction
of the Inventory Tracking System package or Harvest Batch pursuant to Rule
3-230 - Waste Disposal.
f. All Production Batches undergoing
Remediation for elemental impurities must be tested and are not eligible for a
Reduced Testing Allowance or otherwise exempt from required
testing.
4. Nothing in
this Rule eliminates or alters the responsibility of the Retail Marijuana
Business Transferring the Retail Marijuana that failed elemental impurities
testing from complying with the requirement to pay excise tax pursuant to
article 28.8 of Title 39, C.R.S.
E.
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 4-110.
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.
F.
Violation Affecting
Public Safety. Failure to comply with this Rule may constitute a
license violation affecting public safety.
Notes
1
CCR 212-3-4-135
42
CR 23, December 10, 2019, effective
1/1/2020
43
CR 21, November 10, 2020, effective
1/1/2021
44
CR 07, April 10, 2021, effective
5/1/2021
44
CR 13, July 10, 2021, effective
8/1/2021
44
CR 23, December 10, 2021, effective
1/1/2022
45
CR 21, November 10, 2022, effective
12/1/2022
46
CR 23, December 10, 2023, effective
1/8/2024