1 CCR 212-3-4-230 - Regulated Marijuana Testing Program: Reduced Testing Allowance Procedures

Basis and Purpose - 4-230

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 contaminant testing and related Reduced Testing Allowance procedures and rules for the Division's Regulated Marijuana sampling and testing program. This Rule 4-230 was previously Rules 4-120, 4-121, and 4-125, 1 CCR 212-3, Rules M and R 1504, 1 CCR 212-1 and 1 CCR 212-2.

A. Achieving a Reduced Testing Allowance.

4-230(A) 1

Product Class	Minimum time for testing all batches of product to qualify for RTA	Maximum time for testing all batches of product to qualify for RTA	Minimum number of Test Batches for product to qualify for RTA	Scope of products that must be tested to qualify for RTA	Test Types eligible for RTA (Note: All Test Types are individual RTAs)
Regulated Marijuana	6 weeks (42 days)	12 weeks (84 days)	6 Test Batches	All Regulated Marijuana produced in a given Cultivation Facility	Pesticides, Elemental Impurities, Microbial Contaminants
Regulated Marijuana Product	4 weeks (28 days)	8 weeks (56 days)	4 Test Batches	A specific type of Regulated Marijuana Product (Rule 4-230(B)(2))	Pesticides, Elemental Impurities, Microbial Contaminants, Residual Solvents Potency, Homogeneity
Wet Whole Plant	3 weeks (21 days)	12 weeks (84 days)	6 Test Batches	All Wet Whole Plant produced in a given Cultivation Facility	Microbial Contaminants

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 Rule 4-215(E). 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 Rule 4-215(E) 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.

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 Rule 4-215(E). 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.

C. Wet Whole Plant. A Regulated Marijuana Cultivation Facility's cultivation process for wet whole plant shall be deemed acceptable for a Reduced Testing Allowance for microbial contaminant testing if every Harvest Batch of wet whole plant that it produced during at least a three-week (minimum 21 days) period but no longer than a 12-week (maximum 84 days) period passed all microbial contaminant tests required by this Rule. This must include at least six Test Batches. A Medical Marijuana Cultivation Facility, a Retail Marijuana Cultivation Facility, or an Accelerator Cultivator can achieve a Reduced Testing Allowance for contaminants listed in this Rule 4-230.

D. Reduced Testing Allowance - Potency and Homogeneity.

1. A Retail Marijuana Products Manufacturer or Accelerator Manufacturer may achieve a Reduced Testing Allowance for potency and homogeneity for each type of Retail Marijuana Product it manufactures.

a. For Edible Retail Marijuana Products a potency test result that is within 15 percent of the target potency will count towards a Reduced Testing Allowance.

i. For Edible Retail Marijuana Products that contain 2.5 milligrams of THC or less per serving, a potency test result that is within the greater of plus or minus 0.5 milligrams or 40 percent per serving will count towards a Reduced Testing Allowance.

2. A Medical Marijuana Products Manufacturer may achieve a Reduced Testing Allowance for potency and homogeneity for each type of non-Edible Medical Marijuana Product and each type of Edible Medical Marijuana Product that it manufactures.

a. For Edible Medical Marijuana Products that contain 100 milligrams of THC or less per Container, a potency test result that is within 15 percent of the target potency will count towards a Reduced Testing Allowance.

i. For Edible Medical Marijuana Products that contain 2.5 milligrams of THC or less per serving and 100 milligrams of THC or less per Container, a potency test result that is within the greater of plus or minus 0.5 milligrams or 40 percent per serving will count towards a Reduced Testing Allowance.

b. For Edible Medical Marijuana Products that contain between 101 and 500 milligrams of THC per Container, a potency test result that is within 10 percent of the target potency will count towards a Reduced Testing Allowance.

c. For Edible Medical Marijuana Products that contain 501 milligrams of THC or more per Container, a potency test result that is within 5 percent of the target potency will count towards a Reduced Testing Allowance.

3. A Regulated Marijuana Products Manufacturer's production process for a particular type of Regulated Marijuana Product shall be deemed acceptable for a Reduced Testing Allowance for potency and homogeneity testing if every Production Batch that it produces for that particular type of Regulated Marijuana Product during at least a four-week period but no longer than an eight-week period passes all potency and homogeneity tests required by Rule 4-210. This must include at least four Test Batches.

E. Expiration of a Reduced Testing Allowance. Once a Regulated Marijuana Business has successfully achieved Reduced Testing Allowance for any contaminants listed in Rule 4-215 or Potency as required by 4-210(E), Reduced Testing Allowance is effective for one year from the date of the first passing Harvest Batch or Production Batch. One year is equal to 365 days inclusive, or 366 days inclusive during a leap year. When the Reduced Testing Allowance expires, the Regulated Marijuana Business shall achieve new Reduced Testing Allowance or Perform all testing Required by 4-210 and 4-215.

F. Reduced Testing Allowance Certification Fee. A Licensee seeking to obtain Reduced Testing Allowance must first pay the fee in Rule 2-140(A).

1. 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.

2. 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.

3. 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.

4. Reduced Testing Allowance Certification can be renewed annually.

G. Maintaining a Reduced Testing Allowance.

4-230(G) 1

Product Class	Frequency for Submitting Required Ongoing Contaminant Tests for Maintaining RTA	Frequency for Submitting Required Ongoing Potency & Homogeneity Tests for Maintaining RTA
Regulated Marijuana, Regulated Marijuana Concentrate, Pre-Rolled Marijuana, Infused Pre-Rolled Marijuana	1 Test Batch every 30 days	N/A
Wet Whole Plant	1 Test Batch every 30 days (Microbial Only)	N/A
Regulated Marijuana Product	1 Test Batch every 30 days	1 Test Batch every quarter (90 days)

Note: If during any period of ongoing testing specified in the table above the Regulated Marijuana Business does not possess a Harvest Batch or Production Batch that is ready for testing, the Regulated Marijuana Business must subject its first Harvest Batch or Production Batch that is ready for testing to the required contaminant testing prior to Transfer or processing of the Regulated Marijuana, Regulated Marijuana Product, Pre-Rolled Marijuana, and Infused Pre-Rolled Marijuana.

H. 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 Rule 4-215(E) 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 subparagraph (K)(2) of this Rule. Ongoing contaminant testing pursuant to this Rule 4-230 shall be subject to the requirements in Rule 4-225. See Rule 4-225(A) - Collection of Test Batches.

1. 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.

2. If the Licensee fails to comply with subparagraph (H) of this Rule, the Regulated Marijuana Business is no longer authorized a Reduced Testing Allowance.

3. Visual Microbial Growth - Regulated Marijuana. 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 4-215(E). If the Test Batch fails testing, then the Harvest Batch shall be subject to the requirements in Rule 4-240(C). The Licensees must also follow subparagraph (K)(2) of this Rule.

I. Regulated Marijuana Ongoing Contaminant Testing - Wet Whole Plant. After successfully achieving a Reduced Testing Allowance, once every 30 days a Regulated Marijuana Cultivation Facility shall subject at least one Harvest Batch of wet whole plant to microbial contaminant testing. If during any 30-day period a Regulated Marijuana Cultivation Facility does not possess a Harvest Batch of wet whole plant that is ready for testing, the Regulated Marijuana Cultivation Facility must subject its first Harvest Batch of wet whole plant that is ready for testing to microbial contaminant testing prior to Transfer or processing of the Regulated Marijuana wet whole plant. If a Harvest Batch of wet whole plant subject to ongoing contaminant testing fails contaminant testing, the Regulated Marijuana Cultivation Facility shall follow the procedure in subparagraph (K)(2) of this Rule. Ongoing contaminant testing pursuant to this Rule shall be subject to the requirements in Rule 4-225. See Rule 4-225(A) - Collection of Test Batches.

1. 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.

2. If the Licensee fails to comply with subparagraph (H) of this Rule, the Regulated Marijuana Cultivation Facility is no longer authorized a Reduced Testing Allowance.

J. Regulated Marijuana Product Ongoing Potency and Homogeneity Testing. After successfully achieving a Reduced Testing Allowance, once per quarter a Regulated Marijuana Products Manufacturer shall subject at least one Production Batch of each type of Medical Marijuana Product or Retail Marijuana Product that it produces to potency and homogeneity testing required by subparagraph (D) of this Rule. If during any quarter the Regulated Marijuana Products Manufacturer does not possess a Production Batch that is ready for testing, the Licensee must subject its first Production Batch that is ready for testing to the required potency and homogeneity testing prior to Transfer or processing of the Regulated Marijuana. If a Test Batch submitted for ongoing potency and homogeneity testing fails potency and homogeneity testing, the Licensee shall follow the procedure in subparagraph (K) of this Rule. Ongoing potency and homogeneity testing pursuant to this Rule 4-210 shall be subject to the requirements in Rule 4-225. See Rule 4-225(A) - Collection of Test Batches.

1. The Division may reduce the frequency of ongoing potency and homogeneity 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 potency and homogeneity testing to the Licensee's last electronic mailing address provided to the Division.

2. If the Licensee fails to comply with subparagraph (J) of this Rule, the Regulated Marijuana Cultivation Facility is no longer authorized for a Reduced Testing Allowance.

K. Events Requiring Reauthorization for a Reduced Testing Allowance. A Regulated Marijuana Cultivation Facility must follow subparagraph (L) of this Rule for any events that would require a reauthorization for a Reduced Testing Allowance. That may include a failed test or a Material Change described in subparagraph (K)(1) of this Rule. The Licensee must act in accordance with Rule 4-230(K)(2) if either scenario occurs.

1. Material Change. If a Licensee makes a Material Change to its cultivation or production process or its Standard Operating Procedures, then it shall follow Reduced Testing Allowance Reauthorization Procedures in Rule 4-230(L).

a. New Equipment. It is a Material Change if the Regulated Marijuana Products Manufacturer begins using new or different equipment for any material part of the production process.

b. 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.

c. 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.

d. 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.

e. Environmental Conditions. It is a Material Change if a Regulated Marijuana Cultivation Facility changes parameters associated with environmental conditions, including temperature, humidity, or lighting.

f. Cleaning and Sanitation. It is a Material Change if a Regulated Marijuana Cultivation Facility makes changes to cleaning or sanitation processes.

g. Inputs and Contact Surfaces. It is a Material Change if a Regulated Marijuana Products Manufacturer changes materials that have direct contact with product components, including but not limited to, ingredients, additives, or hardware such as a Vaporizer Delivery Devices.

h. 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 Required Testing and Reduced Testing Allowance. Failed required 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 4-215(A) and fails contaminant testing, the Licensee shall follow the procedures in Rule 4-240 for any Inventory Tracking System package, Harvest Batch, or Production Batch from which the failed Test Batch was taken.

b. The Licensee will not be considered qualified for a Reduced Testing Allowance for the required test type(s) that failed required testing. To qualify for the Reduced Testing Allowance again, the Licensee shall follow subparagraph (L) of this Rule.

3. Failed Internal Audit or a Failed Division Inspection for Compliance with Rule 4-230(M)(1).

a. If a Regulated Marijuana Cultivation Facility fails an internal audit or a Division inspection evaluating compliance with the requirements referenced in subparagraph (M)(1) of this Rule, then the Licensee must:

i. Correct the identified deficiencies. These activities to correct such deficiencies must follow Corrective Action Preventive Action procedures listed in Rules 5-210(D) and 6-210(D).

ii. Complete a new internal audit to the Rules listed in subparagraph (M)(1) of this Rule and scored according to Rule 4-230(M)(2)(a) - (d).

iii. Complete a new attestation of substantial compliance to the Rules referenced in subparagraph (M)(3) of this Rule, signed by an authorized representative of the Regulated Marijuana Cultivation Facility.

iv. Follow re-authorization procedures listed in subparagraph (L) of this Rule after subparagraphs (K)(3)(a)(i) - (iii) of this Rule have been addressed.

b. In addition, regardless of completion of the steps above, the Regulated Marijuana Cultivation Facility may be required to submit additional Test Batches pursuant to Rule 4-205 to address concerns from the failed internal audit or Division inspection.

L. Reauthorization of a Reduced Testing Allowance.

1. Material Change. If a Licensee is required by these Rules to reauthorize a Reduced Testing Allowance for a Material Change pursuant to Rule 4-230(K)(1), the Licensee shall submit Test Batches pursuant to Rule 4-225(B) from the next five (5) Harvest Batches or Production Batches of the same product type for all required testing.

2. Failed Required Testing. If a Licensee is required by these Rules to reauthorize a Reduced Testing Allowance for a failed test pursuant to Rule 4-230(K)(2) the Licensee shall submit Test Batches pursuant to Rule 4-225(B) for the test type that failed from the next five (5) Harvest Batches or Production Batches of the same product type.

3. Failed Internal Audit or a Failed Division Inspection for Compliance. If a Licensee is required by these Rules to reauthorize a Reduced Testing Allowance pursuant to Rule 4-230(K)(3), the Licensee shall submit Test Batches pursuant to Rule 4-225(B) for microbial contaminant testing from the next five (5) Harvest Batches it produces.

4. If all five (5) of the Test Batches pass required testing pursuant to Rule 4-230(L)(1) - (3), the Licensee will have reauthorized the Reduced Testing Allowance for the required test. The reauthorization tests will satisfy ongoing testing requirements for the Reduced Testing Allowance during the 30-day period that reauthorization testes were submitted.

5. If any of the five (5) submitted Test Batches fails testing pursuant to Rule 4-230(L)(1) - (3), the Licensee will no longer have a Reduced Testing Allowance for the required test type(s), and the Licensee must follow the procedures in this Rule 4-230(A).

M. Special Cases Pertaining to Reduced Testing Allowance. The following are specific additional considerations for Reduced Testing Allowance requirements.

1. A Regulated Marijuana Cultivation Facility may achieve a Reduced Testing Allowance for microbial contaminant testing pursuant to this Rule 4-230 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.

a. 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 the 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.

i. 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.

ii. If the Harvest Batch fails microbial contaminant testing, then the Licensee shall follow subparagraph (K)(2) of this Rule to reauthorize the Reduced Testing Allowance for microbial contaminants.

b. 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:

i. List of the HACCP team, including relevant experience;

ii. Product description and intended use for each product type receiving a Reduced Testing Allowance for microbial contaminants;

iii. Verified Process Flow Diagram, including Critical Control Points (CCPs);

iv. Hazard Analysis;

v. List of CCPs and reasoning as to how they were identified;

vi. List of Critical Limits (CLs) and reasoning as to how they were selected;

vii. List of Monitoring Procedures for CCPs;

viii. List of pre-planned Corrective Actions in case of deviations;

ix. List of verification procedures;

x. HACCP system summary page that includes:

A. CCPs;

B. Critical Limits (CLs);

C. Monitoring Procedures;

D. Corrective Actions related to specific CCPs;

E. Verification procedures; and

F. Record Titles associated with the CCP activities (i.e. The Water Activity Monitoring Logbook, etc.);

xi. Support documentation of the CCP validation (i.e. microbial contaminants testing results for Reduced Testing Allowance qualification and maintenance periods); and

xii. 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.

2. 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, 4-225, 4-230, 5-210(D), 5-210(E), 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 4-230(M)(2)(a-d). 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:

a. Scoring System: 0% - 100%

b. Passing Score: 80% - 100%

c. Non-Conformance Finding Deductions:

i. Minor: -1%

ii. Major: -5%

iii. Critical: -100%

d. Definition of Non-Conformances:

i. Minor: A deficiency in the compliance to Rule that reasonably could lead to a risk in product safety.

ii. Major: A deficiency in compliance to Rule that carries a highly likely-to-definite risk to product safety.

iii. Critical: A clear deficiency in compliance to Rule that could lead to serious injury or death; or if any falsification of records is found.

3. 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 3-310, 3-330, 3-336, 4-230, 5-210, and 6-210 by achieving a passing score. A copy of this attestation shall be retained as business records for one year.

N. Regulated Marijuana Concentrate Produced from Wet Whole Plant Not Tested for Microbial Contamination. A Regulated Marijuana Business that produces Regulated Marijuana Concentrate may achieve a Reduced Testing Allowance for a Regulated Marijuana Concentrate produced from wet whole plant that was not tested for microbial contamination, subject to the following requirements:

1. Qualification Form. The Regulated Marijuana Business that produces Regulated Marijuana Concentrate from wet whole plant not tested for microbial contamination shall obtain a completed qualification form from the Regulated Marijuana Business that cultivated the wet whole plant. The qualification form must detail the following information related to the cultivation of the wet whole plant:

a. Implemented quality management systems;

b. Record keeping;

c. Notification of Material Change;

d. Notification of a wet whole plant microbial Test Batch failure;

e. Cultivation and post-harvest procedures;

f. Cleaning; and

g. Corrective action and preventative action.

2. Completion Required. The Regulated Marijuana Business that wishes to Transfer the wet whole plant that was not tested for microbial contamination must provide a completed qualification form detailing the information listed above.

3. Approval. The Regulated Marijuana Business that receives a Transfer of wet whole plant is responsible for ensuring it conforms with specified approval requirements, which shall include, but is not limited to the following:

a. The receiving Regulated Marijuana Business has confirmed it has not received notification by the Regulated Marijuana Cultivation Facility of a Material Change to its cultivation process;

b. The receiving Regulated Marijuana Business has inspected the wet whole plant Harvest Batch for visual microbial contamination. If visual microbial contamination is identified in the Harvest Batch of wet whole plant, the Licensee shall subject the Harvest Batch to microbial contaminant testing pursuant to Rule 4-215. If the Test Batch fails testing, then the Harvest Batch shall be subject to the requirements in Rule 4-240(C); and

c. The receiving Regulated Marijuana Business has obtained evidence of compliance with testing requirements for the wet whole plant and proof of any Reduced Testing Allowances, if applicable.

4. Origin Verification. Verification of the Regulated Marijuana Business that cultivated the wet whole plant used to manufacture the Regulated Marijuana Concentrate.

O. Recordkeeping Requirements. A Regulated Marijuana Business shall maintain copies of documents and other records evidencing compliance with this Rule as part of its business books and records. See Rule 3-905 - Business Records Required.

Notes

1 CCR 212-3-4-230

47 CR 21, November 10, 2024, effective 12/4/2024