1 CCR 212-3-4-120 - Regulated Marijuana Testing Program: Contaminant Testing
Basis and Purpose - 4-120
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 contaminant testing and related Reduced Testing Allowance portion of the Division's Regulated Marijuana sampling and testing program. This Rule 4-120 was previously Rules M and R 1501, 1 CCR 212-1 and 1 CCR 212-2.
A.
Contaminant Testing Required.
1. A Regulated Marijuana Business shall not
Transfer or process Regulated Marijuana, Pre-Rolled Marijuana, Infused
Pre-Rolled Marijuana, Regulated Marijuana Concentrate or Regulated Marijuana
Product unless Test Batches from each Harvest Batch or Production Batch from
which that Regulated Marijuana was derived has been tested by a Regulated
Marijuana Testing Facility for contaminants and passed all contaminant tests
required by this Rule, except as permitted in Rule 5-205(C), 6-205(C), or the
cultivation or production process has achieved a Reduced Testing Allowance
under this Rule.
B.
Reduced Testing Allowance and Ongoing Testing - Contaminant
Testing.
1.
Regulated Marijuana. A Regulated Marijuana Cultivation
Facility's cultivation process may achieve a Reduced Testing Allowance for
contaminant testing if every Harvest Batch that it produced during at least a
six-week period (minimum 42 days) but no longer than a 12-week period (maximum
84 days) passed all contaminant tests required by Paragraph (C) of this Rule.
This must include at least six Test Batches. The period begins from the date of
the creation of the first Harvest Batch that passed reduced testing allowance
testing. A Medical Marijuana Cultivation Facility, a Retail Marijuana
Cultivation Facility, or an Accelerator Cultivator can achieve a Reduced
Testing Allowance for all contaminants listed in paragraph (C) of this Rule at
the same time or separately for each contaminant. A Regulated Marijuana
Cultivation Facility must cultivate and process all Harvest Batches the same
way, including the same growing media, lighting, pesticides, and drying,
trimming, and packaging procedures to be eligible to obtain and maintain a
Reduced Testing Allowance.
a.
Visual Microbial Growth. If a Regulated Marijuana
Cultivation Facility is aware that a Harvest Batch contains visual microbial
contamination, the Regulated Marijuana Cultivation Facility shall subject the
Harvest Batch to microbial contaminant testing pursuant to Rule 4-120(C)(1). If
the Test Batch fails testing, then the Harvest Batch shall be subject to the
requirements in Rule 4-135(C). The Licensees must also follow Rule
4-120(F)(2).
b. Effective July 1,
2024, a Regulated Marijuana Cultivation Facility may achieve a Reduced Testing
Allowance for microbial contaminant testing pursuant to this Rule 4-120 if the
Licensee has a Hazard Analysis and Critical Control Point (HACCP) System
containing elements defined in ASTM D8250-19: "Standard Practice for Applying a
Hazard Analysis Critical Control Points (HACCP) System for Cannabis Consumable
Products" that addresses each product type to receive Reduced Testing Allowance
for microbial contaminant testing. The materials incorporated by reference
shall be those effective as of January 8, 2024. This Rule does not include any
later amendments or editions to this ASTM Standard. The Division maintains a
copy of ASTM D8250-19 at 1697 Cole Boulevard, Suite 200, Lakewood, Colorado,
80401, which is available to the public for inspection during the Division's
regular business hours. The pre-requisite programs requirements by the standard
will be considered to have been met if the Regulated Marijuana Cultivation
Facility includes documentation on how the sanitary and health requirements
from Rules 3-310 and 3-330 are implemented to ensure the hygienic and safe
processing of consumable marijuana. This HACCP System must address biological
hazards at a minimum, and may also address additional hazards such as chemical
hazards and physical hazards.
i. If a
Critical Control Point (CCP) is found to be outside of the Critical Limits
(CLs) established in the HACCP plan during the production of a Harvest
Batch(es) then this Harvest Batch(es) shall be submitted for microbial
contaminant testing. For purposes of this Rule, Critical Control Point (CCP)
means a step in the processing of Regulated Marijuana at which control can be
applied and is essential to prevent or eliminate a safety hazard or reduce it
to an acceptable level and shall have the same meaning as defined and used in
ASTM Standard D8250-19, which the Division has maintained a copy and is
available to the public for inspection.
A. If
the Harvest Batch passes microbial contaminant testing, then there is no effect
on the Reduced Testing Allowance and the Harvest Batch may be
Transferred.
B. If the Harvest
Batch fails microbial contaminant testing, then the Licensee shall follow Rule
4-120(F)(2) to reauthorize the Reduced Testing Allowance for microbial
contaminants.
ii. The
HACCP System shall be documented as per ASTM D8250-19.6.1.12. The following
records must be kept during the time that a Regulated Marijuana Cultivation
Facility qualifies for and maintains a Reduced Testing Allowance for microbial
contaminants and for one year after the Reduced Testing Allowance expires for
any reason:
A. List of the HACCP team,
including relevant experience;
B.
Product description and intended use for each product type receiving a Reduced
Testing Allowance for microbial contaminants;
C. Verified Process Flow Diagram, including
Critical Control Points (CCPs);
D.
Hazard Analysis;
E. List of CCPs
and reasoning as to how they were identified;
F. List of Critical Limits (CLs) and
reasoning as to how they were selected;
G. List of Monitoring Procedures for
CCPs;
H. List of pre-planned
Corrective Actions in case of deviations;
I. List of verification procedures;
J. HACCP system summary page that includes:
1. CCPs;
2. Critical Limits (CLs);
3. Monitoring Procedures;
4. Corrective Actions related to specific
CCPs;
5. Verification procedures;
and
6. Record Titles associated
with the CCP activities (i.e. The Water Activity Monitoring Logbook,
etc.);
K. Support
documentation of the CCP validation (i.e. microbial contaminants testing
results for Reduced Testing Allowance qualification and maintenance periods);
and
L. Documents generated during
operational activities related to the HACCP system, including at minimum:
Verified Monitoring Logs for CCPs, Corrective and Preventive Actions
documentation related to CCPs, and Material Changes related to HACCP
system.
c.
Effective July 1, 2024, to achieve a Reduced Testing Allowance for microbial
contaminants, a Regulated Marijuana Cultivation Facility must conduct an
internal audit to assess that they are in substantial compliance with the
requirements of Rules 3-310, 3-330, 3-336, 4-110, 4-120, 6-210(D), and 6-210(E)
by achieving a passing score. This internal audit will be performed and scored
per the rubric listed in Rule 4-120(B)(1)(b)(i). A copy of this internal audit
shall be retained as business records for one year. Internal Audit Scoring
Rubric. The internal audit will be scored as follows:
i. Scoring System: 0% - 100%
ii. Passing Score: 80% - 100%
iii. Non-Conformance Finding Deductions:
A. Minor: -1%
B. Major: -5%
C. Critical: -100%
iv. Definition of Non-Conformances:
A. Minor: A deficiency in the compliance to
Rule that reasonably could lead to a risk in product safety.
B. Major: A deficiency in compliance to Rule
that carries a highly likely-to-definite risk to product safety.
C. Critical: A clear deficiency in compliance
to Rule that could lead to serious injury or death; or if any falsification of
records is found.
d. Effective July 1, 2024, Attestation of
Substantial Compliance with Rules. To achieve a Reduced Testing Allowance for
Microbial Contaminants, an authorized representative of the Regulated Marijuana
Cultivation Facility must sign an attestation that they are, to the best of
their knowledge, in substantial compliance with Rules 3-330 and 4-120 by
achieving a passing score. A copy of this Attestation shall be retained as
business records for one year.
2.
Regulated Marijuana
Concentrate, Regulated Marijuana Product, Pre-Rolled Marijuana or Infused
Pre-Rolled Marijuana. A Regulated Marijuana Business's production
process may achieve a Reduced Testing Allowance for contaminant testing if for
a particular type of Regulated Marijuana Concentrate, Regulated Marijuana
Product, or Pre-Rolled Marijuana or Infused Pre-Rolled Marijuana every
Production Batch that it produced during at least a four-week period (minimum
28 days) but no longer than an eight-week period (maximum 56 days) passed all
contaminant tests required by Paragraph (C) of this Rule. This must include
Test Batches from at least four Production Batches. This period begins from the
date of the creation of the first Production Batch that passed reduced testing
allowance testing. If a Regulated Marijuana Concentrate or Regulated Marijuana
Product is manufactured using a different extraction process or infusion
process or using any different Additives or Botanically Derived Compounds, it
will be considered a different type of Regulated Marijuana Concentrate or
Regulated Marijuana Product and therefore must separately achieve a Reduced
Testing Allowance. If Pre-Rolled Marijuana or Infused Pre-Rolled Marijuana is
produced using different input materials, such as a different marijuana
category (e.g. flower or trim), different wrapper materials, different
processes, or different equipment, they must achieve separate Reduced Testing
Allowances.
3.
Reduced
Testing Allowances are Effective for One Year. Once a Regulated
Marijuana Business has successfully achieved a Reduced Testing Allowance for
each of the contaminants listed in paragraph (C) of this Rule, the Reduced
Testing Allowance is effective for one year (365 days inclusive, or 366 days
inclusive during a leap year) from the date of the first passing harvest date
or production date required to satisfy the Reduced Testing Allowance
requirements.
4.
Regulated Marijuana Ongoing Contaminant Testing. After
successfully achieving a Reduced Testing Allowance, a Regulated Marijuana
Business shall subject at least one Harvest Batch to all contaminant testing
required by Paragraph (C) of this Rule once every 30-day period following the
test submission date of the last Test Batch used to achieve the Reduced Testing
Allowance. If during any 30-day period the Regulated Marijuana Business does
not possess a Harvest Batch that is ready for testing, The Regulated Marijuana
Business must subject its first Harvest Batch that is ready for testing to the
required contaminant testing prior to Transfer or processing of the Regulated
Marijuana. If a Harvest Batch subject to ongoing contaminant testing fails
contaminant testing, the Regulated Marijuana Business shall follow the
procedure in Paragraph (F)(2) of this Rule. Ongoing contaminant testing
pursuant to this Rule 4-120 shall be subject to the requirements in Rule 4-110.
See Rule 4-110(A) - Collection of Test Batches.
a. The Division may reduce the frequency of
ongoing contaminant testing required if the Division has reasonable grounds to
believe Medical Marijuana Testing Facilities and Retail Marijuana Testing
Facilities have reached maximum capacity to perform testing required by this
Rule. The Division will provide notification of any reduction to the frequency
of ongoing contaminant testing to the Licensee's last electronic mailing
address provided to the Division.
b. If the Licensee fails to comply with
paragraph (B)(4) of this Rule, the Regulated Marijuana Business is no longer
authorized a Reduced Testing Allowance.
5.
Regulated Marijuana
Concentrate, Regulated Marijuana Product, Pre-Rolled Marijuana, and Infused
Pre-Rolled Marijuana Ongoing Contaminant Testing. After
successfully achieving a Reduced Testing Allowance, once every 30 days the
Regulated Marijuana Business shall subject at least one Production Batch of
each particular type of Regulated Marijuana Concentrate, Regulated Marijuana
Product, Pre-Rolled Marijuana, or Infused Pre-Rolled Marijuana for which it has
achieved a Reduced Testing Allowance to all contaminant testing required by
Paragraph (C) of this Rule. If during any 30-day period the Regulated Marijuana
Business does not possess a Production Batch that is ready for testing, the
Regulated Marijuana Business must subject its first Production Batch that is
ready for testing to the required contaminant testing prior to Transfer or
processing of the Regulated Marijuana. If a Production Batch submitted for
ongoing contaminant testing fails contaminant testing, the Regulated Marijuana
Business shall follow the procedure in Paragraph (F)(2) of this Rule.
a. The Division may reduce the frequency of
ongoing contaminant testing required if the Division has reasonable grounds to
believe Medical Marijuana Testing Facilities and Retail Marijuana Testing
Facilities have reached maximum capacity to perform testing required by this
Rule. The Division will provide notification of any reduction to the frequency
of ongoing contaminant testing to the Licensee's last electronic mailing
address provided to the Division.
b. If the Licensee fails to comply with
paragraph (B)(5) of this Rule, the Regulated Marijuana Business is no longer
authorized under a Reduced Testing Allowance.
6.
Reduced Testing Allowance
Certification Fee. Effective January 8, 2024, a Licensee seeking
to obtain Reduced Testing Allowance must first pay the fee in Rule 2-205.
a. A Licensee who chooses to pay the Reduced
Testing Allowance fee must also submit an attestation form that at a minimum
requires the Licensee attest they understand these testing Rules and
requirements.
b. Upon the
Division's receipt of payment of the fee and submission of the attestation
form, a Licensee may exercise the privileges of Reduced Testing Allowance for a
12-month period.
c. If a Licensee
is required, under these Rules, to reauthorize the Reduced Testing Allowance
within the 12-month period, the Licensee is not required to pay a new
fee.
d. Reduced Testing Allowance
Certification can be renewed annually.
C.
Required Contaminant
Tests.
1.
Microbial
Contaminant Testing. Harvest Batches of Regulated Marijuana,
flower, shake, and trim, re-testing of Regulated Marijuana flower, shake,
and/or trim that has undergone Decontamination, Production Batches of Physical
Separation-, Heat/Pressure-, or Food-Based Medical Marijuana Concentrate,
Production Batches of Physical Separation-, Heat/Pressure-, or Food-Based
Retail Marijuana Concentrate, Solvent-Based Medical Marijuana Concentrate
produced through Remediation, Solvent-Based Retail Marijuana Concentrate
produced through Remediation, Regulated Marijuana Product, Pre-Rolled
Marijuana, Infused Pre-Rolled Marijuana, Hemp Products, Pressurized Metered
Dose Inhalers, Vaporizer Delivery Devices, and Audited Product must be tested
for microbial contamination by a Regulated Marijuana Testing Facility at the
frequency established by Paragraphs (A) and (B) of this Rule. The microbial
contamination test must include, but need not be limited to, testing to
determine the presence of and/or amounts present of microbial contaminants
listed in Rule 4-115(D)(1): Shiga-toxin producing Escherichia coli (STEC)*-
Bacteria, Aspergillus (A. fumigatus, A. flavus, A. niger, A.
terreus), Salmonella species* - Bacteria, Total Yeast and Mold, Total
aerobic microbial count, Staphylococcus Aureus, Pseudomonas aeruginosa,
Bile tolerant gram negative bacteria and Candida albicans.
a.
Effective Date for Required
Aspergillus Testing. Requirements for
Aspergillus testing pursuant to this rule shall take effect on
July 1, 2022.
1.5
Water Activity Testing. Harvest Batches of Regulated
Marijuana, flower, shake, and trim (other than wet whole plant), re-testing of
Regulated Marijuana flower, shake, and/or trim that has undergone
Decontamination, Pre-Rolled Marijuana, and Infused Pre-Rolled Marijuana at the
frequency established by Paragraphs (A) and (B) of this Rule.
2.
Residual Solvent Contaminant
Testing. Production Batches of Solvent-Based Medical Marijuana
Concentrate, Solvent-Based Retail Marijuana Concentrate, and Audited Product
that contains any Solvent-Based Medical Marijuana Concentrate or Solvent-Based
Retail Marijuana Concentrate produced by a Regulated Marijuana Products
Manufacturer must be tested by a Regulated Marijuana Testing Facility for
residual solvent contamination at the frequency established by Paragraphs (A)
and (B) of this Rule. The residual solvent contamination test must include, but
need not be limited to, testing to determine the presence of, and amounts
present of acetone, butane, ethanol, heptanes, isopropyl alcohol, propane,
benzene*, toluene*, pentane, hexane*, methanol*, ethyl acetate, and total
xylenes* (m, p, o - xylenes).
* Note: These solvents are not approved for use. Testing is required for these solvents due to their possible presence in the solvents approved for use per Rule 5-315 and 6-315.
3.
Mycotoxin Contaminant
Testing. As part of Remediation, each Production Batch of
Solvent-Based Medical Marijuana Concentrate produced by a Medical Marijuana
Products Manufacturer or Solvent-Based Retail Marijuana Concentrate produced by
a Regulated Marijuana Products Manufacturer from Regulated Marijuana that
failed microbial contaminant testing produced must be tested by a Regulated
Marijuana Testing Facility for mycotoxin contamination. Each failed Harvest
Batch of Regulated Marijuana flower, shake, and/or trim and each failed
Production Batch of Pre-Rolled Marijuana or Infused Pre-Rolled Marijuana that
has undergone Decontamination must be tested by a Regulated Marijuana Testing
Facility for mycotoxin contamination. Each Production Batch of Regulated
Marijuana Concentrate produced from wet whole plant that was not tested for
microbial contamination must be tested for mycotoxin contamination. The
mycotoxin contaminant test must include, but need not be limited to, testing to
determine the presence of, and amounts present of, aflatoxins (B1, B2, G1, and
G2) and ochratoxin A. This is in addition to all other contaminant testing
required by this Paragraph (C). This contaminant test cannot be exempt from
testing by a Reduced Testing Allowance in accordance with subparagraph (B)(2)
of this Rule, except Regulated Marijuana Concentrate produced from wet whole
plant that was not tested for microbial contamination pursuant to Rule
4-121.
4.
Pesticide
Contaminant Testing. Harvest Batches of Regulated Marijuana,
Production Batches of Regulated Marijuana Concentrate, Production Batches of
Pre-Rolled Marijuana, and Production Batches of Infused Pre-Rolled Marijuana
must be tested for Pesticide contamination by a Regulated Marijuana Testing
Facility at the frequency established by this Rule 4-120(A) and (B). The
Pesticide contamination test must include, but need not be limited to, testing
to determine the presence of, and amounts present of, the Pesticides listed in
Rule 4-115(D)(5).
a.
Effective
Date for Required Pesticide Contaminant Testing for Production Batches of
Regulated Marijuana Concentrate: Requirements for Pesticide
contaminant testing for Production Batches of Regulated Marijuana Concentrate
pursuant to this rule shall take effect on July 1, 2021.
5.
Elemental Impurities
Testing.
a. Each Harvest Batch
and Production Batch of Regulated Marijuana must be tested for elemental
impurities by a Regulated Marijuana Testing Facility at the frequency
established in paragraphs (A) and (B) of this Rule. The elemental impurities
test must include, but need not be limited to, testing to determine the
presence of, and amounts present of, arsenic, cadmium, lead, and
mercury.
b.
Emissions
Testing. This subsection (C)(5)(b) is effective January 1, 2022.
Each Harvest Batch and Production Batch of Regulated Marijuana Concentrate in a
Vaporized Delivery Device must be tested for elemental impurities via emissions
testing by a Regulated Marijuana Testing Facility at the frequency established
in subparagraphs (A) and (B) of this Rule. The elemental impurities test must
include, but need not be limited to, testing to determine the presence and
amounts of arsenic, cadmium, lead, and mercury.
D.
Additional Required
Tests. The Division may require additional tests to be conducted
on a Harvest Batch or Production Batch prior to a Regulated Marijuana
Cultivation Facility or Regulated Marijuana Products Manufacturer Transferring
or processing any Regulated Marijuana from that Harvest Batch or Production
into a Regulated Marijuana Concentrate or Regulated Marijuana Product.
Additional tests may include, but need not be limited to, screening for
Pesticides, chemical contaminants, biological contaminants, or other types of
microbials, molds, elemental impurities, or residual solvents.
E.
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 4-100 Series
Rules.
F.
Events Requiring Re-Authorization for a Reduced Testing Allowance -
Contaminants.
1.
Material Change. If a Licensee makes a Material Change
to its cultivation or production process or its standard operating procedures,
then it must have the first five Harvest Batches or Production Batches produced
using the new procedures tested for all of the contaminants required by
Paragraph (C) of this Rule regardless of whether its process has previously
achieved a Reduced Testing Allowance regarding contaminants. If any of those
tests fail, then the Regulated Marijuana Business's process must achieve a new
Reduced Testing Allowance.
a.
Pesticide or other Agricultural Substances. It is a
Material Change if a Regulated Marijuana Cultivation Facility begins using a
new or different Pesticide or other agricultural substances (e.g. nutrients,
fertilizers) during its cultivation process.
b.
Solvents. It is a
Material Change if a Regulated Marijuana Products Manufacturer begins using a
new or different solvent or combination of solvents or changes any parameters
for equipment related to the solvent purging process, including but not limited
to, time, temperature, or pressure.
c.
Cultivation. It
is a Material Change if a Regulated Marijuana Cultivation Facility begins using
a new or different method for any material part of the cultivation process,
including, but not limited to, changing from one growing medium to
another.
d.
Environmental Conditions. It is a Material Change if a
Regulated Marijuana Cultivation Facility changes parameters associated with
environmental conditions, including temperature, humidity, or
lighting.
e.
Cleaning
and Sanitation. It is a Material Change if a Regulated Marijuana
Cultivation Facility makes changes to cleaning or sanitation
processes.
f.
Inputs
and Contact Surfaces. It is a Material Change if a Regulated
Marijuana Cultivation Facility changes materials that have direct contact with
product components, including but not limited to, ingredients, additives, or
hardware such as Vaporizer Delivery Devices.
g.
Testing Required Prior to
Transfer or Processing. When a Harvest Batch or Production Batch
is required to be submitted for testing pursuant to this Rule, the Licensee
that produced it may not Transfer or process Regulated Marijuana, Pre-Rolled
Marijuana, Infused Pre-Rolled Marijuana, Regulated Marijuana Concentrate or
Regulated Marijuana Product unless the Harvest Batch or Production Batch passes
all required testing.
2.
Failed Contaminant Testing and Reduced Testing
Allowance. Failed contaminant testing may constitute a violation
of these rules.
a. If a Test Batch is
required to be tested by these Rules or required to be tested by the Division
pursuant to Rule 4-120(A) and fails contaminant testing, the Licensee shall
follow the procedures in Rule 4-135 for any Inventory Tracking System package,
Harvest Batch, or Production Batch from which the failed Sample was
taken.
b. The Licensee shall also
submit Test Batches from three new Harvest Batches or Production Batches of the
Regulated Marijuana for contaminant testing by a Regulated Marijuana Testing
Facility within no more than 30 days. If any one of the three submitted Test
Batches fails contaminant testing, the Licensee shall achieve a new Reduced
Testing Allowance for contaminants.
3.
Failed Internal Audit or a
Failed MED Inspection for Compliance with Rule 4-120(B)(1)(b). If
a Regulated Marijuana Cultivation Facility fails an internal audit or a
Division inspection evaluating compliance with the requirements referenced in
Rule 4-120(B)(1)(b), then the Licensee must:
a. Correct the identified deficiencies. These
activities to correct such deficiencies must follow Corrective Action
Preventive Action procedures listed in Rule 6-120(D).
b. Complete a new internal audit to the Rules
listed in Rule 4-120(B)(1)(b) and scored according to Rule
4-120(B)(1)(c).
c. Complete a new
attestation of substantial compliance to the Rules referenced in Rule
4-120(B)(1)(d) signed by an authorized representative of the Regulated
Marijuana Cultivation Facility.
d.
Follow Re-Authorization procedures listed in paragraph (F)(2) of this Rule
after paragraphs (a) - (c) have been addressed.
In addition, regardless of completion of the steps above, the Regulated Marijuana Cultivation Facility may be required to submit additional Sample(s) or Test Batches pursuant to Rule 4-105 to address concerns from the failed internal audit or Division inspection.
G.
Violation
Affecting Public Safety. Failure to comply with this Rule may
constitute a license violation affecting public safety.
Notes
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