1 Colo. Code Regs. § 212-3-4-120

Current through Register Vol. 47, No. 20, October 25, 2024

Section 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.

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.

1.5Water 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.

1 CCR 212-3-4-120

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