1 Colo. Code Regs. § 212-3-4-115

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

Section 1 CCR 212-3-4-115 - Regulated Marijuana Testing Program: Sampling and Testing Program

Basis and Purpose - 4-115

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 establish the portion of the Division's mandatory testing and sampling program that is applicable to Regulated Marijuana Businesses, and specifically Medical Marijuana Testing Facilities and Retail Marijuana Testing Facilities. While the Marijuana Code requires the State Licensing Authority to establish acceptable limits of potential contaminants, it also requires the State Licensing Authority to enact a plus or minus 15 percent potency variance, which is also included in this rule. This Rule 4-115 was previously Rules M and R 712, 1 CCR 212-1 and 1 CCR 212-2.

A.Division Authority. The Division may require that a Test Batch be submitted to a specific Regulated Marijuana Testing Facility for testing to verify compliance, perform investigations, compile data or address a public health and safety concern.

1.Independent Third Party Review. The Division may require Regulated Marijuana to undergo an independent third-party review to verify that the Regulated Marijuana does not pose a threat to public health and safety when the Division, in consultation with the Colorado Department of Public Health and Environment, has objective and reasonable grounds to believe and finds, upon a full investigation, one of the following:

a. The Regulated Marijuana contains one or more substances known to cause harm; or

b. The Regulated Marijuana contains one or more substances that could be toxic as consumed or applied in accordance with the intended use.

2. The fact that Regulated Marijuana contains marijuana shall not constitute grounds to require an independent third-party review. Ingredients Generally Recognized as Safe by the U.S. Food & Drug Administration or that are regulated by the U.S. Food & Drug Administration under the Dietary Supplement Health and Education Act of 1994 that are included in Edible Medical Marijuana Product or Edible Retail Marijuana Product shall not constitute grounds to require an independent third-party review.

3.Quarantine. In addition to any other remedies provided by law, the Division may immediately quarantine Regulated Marijuana pursuant to Rule 4-135(A) in any one of the following circumstances:

a. The Division has objective and reasonable grounds to believe and finds, upon a full investigation, that a Regulated Marijuana Business has been guilty of deliberate and willful violations of these rules;

b. The Regulated Marijuana or Alternative Use Product poses a potential threat to public health and safety;

c. The Division has received one or more reports of an adverse event related to Regulated Marijuana or Alternative Use Product. For purpose of this Rule, adverse event means any untoward medical occurrence associated with the use of Regulated Marijuana or Alternative Use Product-this could include any unfavorable and unintended sign (including hospitalization, emergency department visit, doctor's visit, abnormal laboratory finding), symptom, or disease temporally associated with the use of a Regulated Marijuana or Alternative Use Product;

d. The Division determines the independent third-party audit submitted pursuant to Rules 5-325(B) or 6-325(B) does not meet the requirements of Rules 5-325 or 6-325; or

e. The Regulated Marijuana Products Manufacturer has violated or is not in compliance with all of the requirements in Rules 5-325 or 6-325.

4. Any quarantine pursuant to subparagraph (A)(3) above shall remain in effect unless the Regulated Marijuana undergoes an independent third-party review to verify the Regulated Marijuana does not pose a risk to public health and safety.

5. For the purpose of this Rule, full investigation means a reasonable ascertainment of the underlying facts on which the agency action is based.

B.Standard Minimum Weight of Test Batches and Photo Documentation.

1.Standard Minimum Weight of Test Batches.

a.Regulated Marijuana and Regulated Marijuana Concentrate. A Medical Marijuana Testing Facility must establish a standard minimum weight of Medical Marijuana and Medical Marijuana Concentrate, and a Retail Marijuana Testing Facility must establish a standard minimum weight of Retail Marijuana and Retail Marijuana Concentrate that must be included in a Test Batch for every type of test that it conducts.

b.Regulated Marijuana Product, Pre-Rolled Marijuana, and Infused Pre-Rolled Marijuana. Regulated Marijuana Testing Facilities must establish a standard number of Sample Increments required to be included in each Test Batch of Regulated Marijuana Product, Pre-Rolled Marijuana, and Infused Pre-Rolled Marijuana for every type of test that it conducts. See Rule 4-110 - Regulated Marijuana Testing Program - Sampling Procedures.

2.Photo Documentation of Test Batches.

a. A Regulated Marijuana Testing Facility shall digitally photograph each Test Batch it receives to document the Sample Increments collected, condition of the Test Batch, and compliance with these rules.

b. The Regulated Marijuana Testing Facility must maintain the digital photographs of each Test Batch as business records. See Rule 3-905 - Required Business Records.

c. Upon request by the Division, a Regulated Marijuana Testing Facility must provide copies of the digital photographs of Test Batches within seven days of the request unless a different deadline is agreed to.

C.Rejection of Test Batches.

1. A Regulated Marijuana Testing Facility shall not accept a Test Batch that is smaller than its standard minimum amount.

2. A Regulated Marijuana Testing Facility shall not accept a Test Batch that does not contain the minimum number and weight of Sample Increments, or the Regulated Marijuana Testing Facility has reason to believe it was not collected in accordance with Test Batch collection requirements in Rule 4-110.

3. Effective July 1, 2023, if a Regulated Marijuana Testing Facility suspects or has reason to suspect a Sample Increment or Test Batch has been adulterated, the Regulated Marijuana Testing Facility must:

a. Notify the Division; and

b. Quarantine the Sample Increment or Test Batch for a minimum of 48 hours from the time of notification to the Division before proceeding with any testing.

D.Permissible Levels of Contaminants. If Regulated Marijuana is found to have a contaminant in levels exceeding those established as permissible under this Rule, then it shall be considered to have failed contaminant testing. Notwithstanding the permissible levels established in this Rule, the Division reserves the right to determine, upon good cause and reasonable grounds, that a particular Test Batch presents a risk to the public health or safety and therefore shall be considered to have failed a contaminant test.

1.Microbials (Bacteria, Fungus)

Substance	Acceptable Limits	Product to be Tested
-Shiga-toxin producing Escherichia coli (STEC)*- Bacteria	Absent in 1 g	* Regulated Marijuana flower, shake, and trim (other than wet whole plant allocated for extraction); * Regulated Marijuana Products (other than Audited Product); * Pre-Rolled Marijuana; * Infused Pre-Rolled Marijuana; Physical Separation-Based, Heat/Pressure-Based, and Food-Based Medical Marijuana Concentrate; * Physical Separation-Based, Heat/Pressure-Based, and Food-Based Retail Marijuana Concentrate; * Hemp Products; * Pressurized Metered Dose Inhalers; * Vaporizer Delivery Device; * Solvent-Based Medical Marijuana Concentrate produced through Remediation; * Solvent-Based Retail Marijuana Concentrate produced through Remediation; * Solvent-Based Medical Marijuana Concentrate produced from Regulated Marijuana wet whole plant that was not tested for microbials; * Solvent-Based Retail Marijuana Concentrate produced from Regulated Marijuana wet whole plant that was not tested for microbials; * Re-testing of Regulated Marijuana flower, shake, and trim that has undergone Decontamination.
Salmonella species* - Bacteria	Absent in 1 g
Aspergillus (A. fumigatus, A. flavus, A. niger, A. terreus)**	Absent in 1 g
Total Yeast and Mold	< 1.0 x 104 Colony Forming Unit (CFU) per 1 ml or 1 g
	< 1.0 x 101 CFU/ml or < 1.0 x 101 CFU/g	Audited Product: administration by metered dose nasal spray or vaginal administration
	< 1.0 x 102 CFU/ml or < 1.0 x 102 CFU/g	Audited Product: rectal administration
Total aerobic microbial count	< 1.0 x 102 CFU/ml or < 1.0 x 102 CFU/g	Audited Product: administration by metered dose nasal spray or vaginal administration
	< 1.0 x 103 CFU/ml or < 1.0 x 103 CFU/g	Audited Product: rectal administration
Staphylococcus aureus	Absent in 1 ml or 1 g	Audited Product: administration by metered dose nasal spray or vaginal administration
Pseudomonas aeruginosa	Absent in 1 ml or 1 g	Audited Product: administration by metered dose nasal spray or vaginal administration
Bile tolerant gram negative bacteria	Absent in 1 ml or 1 g	Audited Product: administration by metered dose nasal spray
Candida albicans	Absent in 1 ml or 1 g	Audited Product: vaginal administration

*The Regulated Marijuana Testing Facility shall contact the Colorado Department of Public Health and Environment when STEC and Salmonella are detected beyond the acceptable limits.

** Regulated Marijuana Products with intended use for oral consumption or skin and body products are exempt from required aspergillus testing.

1.5 Water Activity

Substance	Acceptable Limits	Product to be Tested
Water Activity	0.65 aW	* Regulated Marijuana flower shake, and trim (other than wet whole plant); * Retesting of Regulated Marijuana flower, shake, and trim that has undergone Decontamination; * Pre-Rolled Marijuana; * Infused Pre-Rolled Marijuana.

2.Mycotoxins

Substance	Acceptable Limits	Product to be Tested
Aflatoxins (B1, B2, G1, and G2)	< 20 Parts Per Billion (PPB) (total of B1 + B2 + G1 + G2)	* Solvent-Based Medical Marijuana Concentrate manufactured from Medical Marijuana flower or trim that failed microbial testing; * Solvent-Based Retail Marijuana Concentrate manufactured from Retail Marijuana flower or trim that failed microbial testing; * Solvent-Based Medical Marijuana Concentrate produced from Regulated Marijuana wet whole plant that was not tested for microbials; * Solvent-Based Retail Marijuana Concentrate produced from Regulated Marijuana wet whole plant that was not tested for microbials; * Regulated Marijuana flower, shake, and trim that has undergone Decontamination.
Ochratoxin A	< 20 PPB

3.Residual Solvents

Substance	Acceptable Limits	Product to be Tested
Acetone	< 1,000 Parts Per Million (PPM)	* Solvent-Based Medical Marijuana Concentrate; * Solvent-Based Retail Marijuana Concentrate; * Hemp Product (if a solvent was used)
Butanes	< 1,000 PPM
Ethanol***	< 1,000 PPM
Heptanes	< 1,000 PPM
Isopropyl Alcohol	< 1,000 PPM
Propane	< 1,000 PPM
Benzene**	< 2 PPM
Toluene**	< 180 PPM
Pentane	< 1,000 PPM
Hexane**	< 60 PPM
Total Xylenes (m,p, o-xylenes)**	< 430 PPM
Methanol**	< 600 PPM
Ethyl Acetate	< 1000 PPM
Any other solvent not permitted for use pursuant to Rules 5-315 and 6-315.	None Detected

** Note: These solvents are not approved for use. Due to their possible presence in the solvents approved for use per Rule 6-315, limits have been listed here accordingly.

***Note: Solvent-Based Medical Marijuana Concentrate and Solvent-Based Retail Marijuana Concentrate that exceeds the acceptable limit for ethanol may only be used in Medical Marijuana Concentrate or Medical Marijuana Product, or Retail Marijuana Concentrate or Retail Marijuana Product, which intended use is oral consumption, skin and body products, a vaporizer delivery device, pressurized metered dose inhaler, or Audited Product.

4.Elemental Impurities

Substance	Acceptable Limits Based on Intended Use	Product to be Tested
Elemental Impurities (Arsenic, Cadmium, Lead and Mercury)	Inhaled Product or Audited Product: administration by metered dose nasal spray Lead - Max Limit: < .5 PPM Arsenic - Max Limit: < 0.2 PPM Cadmium - Max Limit: < 0.2 PPM Mercury - Max Limit: < 0.1 PPM	* Regulated Marijuana flower, shake, trim, and wet whole plant; * Physical Separation-Based, Food-Based, Heat/Pressure-Based, and Solvent-Based Medical Marijuana Concentrate; * Physical Separation-Based, Food-Based, Heat/Pressure-Based and Solvent Based Retail Marijuana Concentrate; * Regulated Marijuana Product; * Pre-Rolled Marijuana; * Infused Pre-Rolled Marijuana; * Pressurized Metered Dose Inhaler; * Vaporizer Delivery Device; * Audited Product; * Hemp Product
	Topical and/or Transdermal Lead - Max Limit: < 10 PPM Arsenic - Max Limit: < 3 PPM Cadmium - Max Limit: < 3 PPM Mercury - Max Limit: < 1 PPM
	Oral Consumption or Audited Product: rectal or vaginal administration Lead - Max Limit: < 1 PPM Arsenic - Max Limit: < 1.5 PPM Cadmium - Max Limit: < 0.5 PPM Mercury - Max Limit: < 1.5 PPM

5.Pesticides.

a. Effective January 1, 2023, the following pesticides are currently subject to required testing, at the associated action limits:

Substance	Action Limit	Product to be Tested
Abamectin (Avermectins: B1a & B1b)	< 0.1 PPM	* Regulated Marijuana flower, shake, trim, and wet whole plant; * Physical Separation-Based, Food-Based, Heat/Pressure-Based, and Solvent-Based Medical Marijuana Concentrate; * Physical Separation-Based, Food-Based, Heat/Pressure-Based, and Solvent-Based Retail Marijuana Concentrate; * Pre-Rolled Marijuana; * Infused Pre-Rolled Marijuana. * Hemp Product
Azoxystrobin	< 0.02 PPM
Bifenazate	< 0.02 PPM
Etoxazole	< 0.02 PPM
Imazalil	< 0.05 PPM
Imidacloprid	< 0.02 PPM
Malathion	< 0.02 PPM
Myclobutanil	< 0.02 PPM
Permethrin (mix of isomers)	< 0.5 PPM
Spinosad (Mixture of A and D)	< 0.1 PPM
Spiromesifen	< 3.0 PPM
Spirotetramat	< 0.02 PPM
Tebuconazole	< 0.05 PPM

b. Effective July 1, 2023, the following pesticides will be subject to required testing, at the associated action limits:

Substance	Action Limit	Product To Be Tested
Abamectin (Avermectins B1a & B1b)	< 0.1 PPM	* Regulated Marijuana flower, shake, trim, and wet whole plant; * Physical Separation-Based, Food-Based, Heat/Pressure-Based, and Solvent-Based Medical Marijuana Concentrate; * Physical Separation-Based, Food-Based, Heat/Pressure-Based, and Solvent-Based Retail Marijuana Concentrate; * Pre-Rolled Marijuana; * Infused Pre-Rolled Marijuana. * Hemp Product
Azoxystrobin	< 0.02 PPM
Bifenthrin	< 1.0 PPM
Bifenazate	< 0.02 PPM
Boscalid	< 0.02 PPM
Carbaryl	< 0.05 PPM
Chlorpyrifos	< 0.04 PPM
Clothianidin	< 0.05 PPM
Cyhalothrin lambda	< 0.25 PPM
Dichlorvos	< 0.1 PPM
Dimethoate	< 0.02 PPM
Dinotefuran	< 0.1 PPM
Diuron	< 0.125 PPM
Etoxazole	< 0.02 PPM
Imazalil	< 0.05 PPM
Imidacloprid	< 0.02 PPM
Malathion	< 0.02 PPM
Metalaxyl	< 0.02 PPM
Myclobutanil	< 0.02 PPM
Permethrins	< 0.5 PPM
Propiconazole	< 0.1 PPM
Pyriproxyfen	< 0.01 PPM
Spinosad	< 0.1 PPM
Spiromesifen	< 3.0 PPM
Spirotetramat	< 0.02 PPM
Tebuconazole	< 0.05 PPM
Thiabendazole	< 0.02 PPM
Thiamethoxam	< 0.02 PPM

c. Effective July 1, 2024, the following pesticides will be subject to required testing, at the associated action limits:

Substance	Action Limit	Product To Be Tested
Abamectin (Avermectins B1a & B1b)	< 0.1 PPM	* Regulated Marijuana flower, shake, trim, and wet whole plant; * Physical Separation-Based, Food-Based, Heat/Pressure-Based, and Solvent-Based Medical Marijuana Concentrate; * Physical Separation-Based, Food-Based, Heat/Pressure-Based, and Solvent-Based Retail Marijuana Concentrate; * Pre-Rolled Marijuana; * Infused Pre-Rolled Marijuana. * Hemp Product
Acephate	< 0.02 PPM
Acequinocyl	< 0.03 PPM
Acetamiprid	< 0.1 PPM
Aldicarb	< 1.0 PPM
Allethrin	< 0.2 PPM
Atrazine	< 0.025 PPM
Azoxystrobin	< 0.02 PPM
Benzovindiflupyr	< 0.02 PPM
Bifenazate	< 0.02 PPM
Bifenthrin	< 1.0 PPM
Boscalid	< 0.02 PPM
Buprofezin	< 0.02 PPM
Carbaryl	< 0.05 PPM
Carbofuran	< 0.02 PPM
Chlorantraniliprole	< 0.02 PPM
Chlorphenapyr	< 0.05 PPM
Chlorpyrifos	< 0.04 PPM
Clofentezine	< 0.02 PPM
Clothianidin	< 0.05 PPM
Coumaphos	< 0.02 PPM
Cyantraniliprole	< 0.02 PPM
Cyfluthrin	< 0.2 PPM
Cyhalothrin lambda	< 0.25 PPM
Cypermethrin	< 0.3 PPM
Cyprodinil	< 0.25 PPM
Daminozide	< 0.1 PPM
Deltamethrin	< 0.5 PPM
Diazinon	< 0.02 PPM
Dichlorvos	<0.1 PPM
Dimethoate	< 0.02 PPM
Dimethomorph	< 0.05 PPM
Dinotefuran	< 0.1 PPM
Diuron	< 0.125 PPM
Dodemorph	< 0.05 PPM
Endosulfan sulfate	< 0.05 PPM
Endosulfan-alpha	< 0.2 PPM
Endosulfan-beta	< 0.05 PPM
Ethoprophos	< 0.02 PPM
Etofenprox	< 0.05 PPM
Etoxazole	< 0.02 PPM
Etridiazole	< 0.03 PPM
Fenhexamid	< 0.125 PPM
Fenoxycarb	< 0.02 PPM
Fenpyroximate	< 0.02 PPM
Fensulfothion	< 0.02 PPM
Fenthion	< 0.02 PPM
Fenvalerate	< 0.1 PPM
Fipronil	< 0.06 PPM
Flonicamid	< 0.05 PPM
Fludioxonil	< 0.02 PPM
Fluopyram	< 0.02 PPM
Hexythiazox	< 0.01 PPM
Imazalil	< 0.05 PPM
Imidacloprid	< 0.02 PPM
Iprodione	< 1.0 PPM
Kinoprene	< 0.5 PPM
Krosoxim-methyl	< 0.02 PPM
Malathion	< 0.02 PPM
Metalaxyl	< 0.02 PPM
Methiocarb	< 0.02 PPM
Methomyl	< 0.05 PPM
Methoprene	< 2.0 PPM
Mevinphos	< 0.05 PPM
MGK-264	< 0.05 PPM
Myclobutanil	< 0.02 PPM
Naled	< 0.1 PPM
Novaluron	< 0.05 PPM
Oxamyl	< 3.0 PPM
Paclobutrazol	< 0.02 PPM
Parathion-methyl	< 0.05 PPM
Permethrins	< 0.5 PPM
Phenothrin	< 0.05 PPM
Phosmet	< 0.02 PPM
Pirimicarb	< 0.02 PPM
Prallethrin	< 0.05 PPM
Propiconazole	< 0.1 PPM
Propoxur	< 0.02 PPM
Pyraclostrobin	< 0.02 PPM
Pyridaben	< 0.05 PPM
Pyriproxyfen	< 0.01 PPM
Quintozene	< 0.02 PPM
Resmethrin	< 0.1 PPM
Spinetoram	< 0.02 PPM
Spinosad	< 0.1 PPM
Spirodiclofen	< 0.25 PPM
Spiromesifen	< 3.0 PPM
Spirotetramat	< 0.02 PPM
Spiroxamine	< 0.1 PPM
Tebuconazole	< 0.05 PPM
Tebuenozide	< 0.02 PPM
Teflubenzuron	< 0.05 PPM
Tetrachlorvinphos	< 0.02 PPM
Tetramethrin	< 0.1 PPM
Thiabendazole	< 0.02 PPM
Thiacloprid	< 0.02 PPM
Thiamethoxam	< 0.02 PPM
Thiophanate-methyl	< 0.05 PPM
Trifloxystrobin	< 0.02 PPM

6.Other Contaminants. If any Test Batch is found to contain levels of any microorganism, chemical, elemental impurity, or pesticides that could be toxic if consumed or present, then the Regulated Marijuana Testing Facility must notify the Regulated Marijuana Business and the Division, in accordance with subparagraph (7) of this Rule, and initiate corrective actions with all parties.

7.Division Notification. A Regulated Marijuana Testing Facility must notify the Division by timely input in the Inventory Tracking System if a Test Batch is found to contain levels of a contaminant not listed within this Rule that could be injurious to human health if consumed. See Rule 3-825.

E.Potency Testing.

1.Cannabinoids Potency Profiles. A Regulated Marijuana Testing Facility may test and report results for any Cannabinoid provided the test is conducted in accordance with the Regulated Marijuana Testing Facility's standard operating procedure.

2.Reporting of Results.

a. For potency tests on Regulated Marijuana, Regulated Marijuana Concentrate, Pre-Rolled Marijuana, and Infused Pre-Rolled Marijuana, results must be reported by listing a single percentage concentration for each Cannabinoid that represents an average of all Sample Increments within the Test Batch. This includes reporting the Total THC in addition to each Cannabinoid required in Rule 4-125.

b. For potency tests conducted on Regulated Marijuana Product, whether conducted on each individual Production Batch or via a Reduced Testing Allowance per Rule 4-125, results must be reported by listing the total number of milligrams contained within a single Regulated Marijuana Product unit for sale for each Cannabinoid and stating whether the THC content is homogenous as defined in Paragraphs 3 and 4 of this subparagraph E.

c.Effective Date for Reporting D8-THC, D10-THC, and Exo-THC. Requirements for reporting potency test results for D8-THC, D10-THC, and Exo-THC shall take effect on July 1, 2022.

3.Failed Potency Tests for Medical Marijuana Product.

a. If the Cannabinoid content of Medical Marijuana Product is determined not to be homogeneous, then it shall be considered to have failed potency testing. A Production Batch of Medical Marijuana Product shall be considered homogeneous if a minimum of a total of four servings from two packaged units of a Test Batch has a relative standard deviation of less than 10 percent for each Cannabinoid listed on the label. A Production Batch of Medical Marijuana Product shall be considered homogenous if a minimum of a total of four servings from four individual single serve packaged units of a Test Batch has a relative standard deviation of less than 10 percent for each Cannabinoid listed on the label.

i. The four servings must also test within the allowed potency variance set forth in subparagraph E(5) of this Rule 4-115.

ii. Any Cannabinoid that makes up less than 10 percent of the total amount of Cannabinoids in the Medical Marijuana Product shall not be subject to the requirements set forth in this subparagraph (E)(3).

b. If an individually packaged Edible Medical Marijuana Product is determined to have more than the total milligrams of THC stated on the Container, or less than the total milligrams of THC stated on the Container, then the Test Batch shall be considered to have failed potency testing. Except that the potency variance provided for in subparagraph (E)(5) of this Rule 4-115 shall apply to potency testing.

4.Failed Potency Tests for Retail Marijuana Product.

a. If the Cannabinoid content of Retail Marijuana Product is determined not to be homogeneous, then it shall be considered to have failed potency testing. A Production Batch of Retail Marijuana Product shall be considered homogeneous if a minimum of a total of four servings from two packaged units of a Test Batch has a relative standard deviation of less than 10 percent for each Cannabinoid listed on the label. A Production Batch of Retail Marijuana Product shall be considered homogenous if a minimum of a total of four servings from four individual single serve packaged units of a Test Batch has a relative standard deviation of less than 10 percent for each Cannabinoid listed on the label.

i. The four servings must also test within the allowed potency variance set forth in subparagraph E(5) of this Rule 4-115.

ii. Any Cannabinoid that makes up less than 10 percent of the total amount of Cannabinoids in the Retail Marijuana Product shall not be subject to the requirements set forth in this subparagraph (E)(4).

b. If an individually packaged Edible Retail Marijuana Product is determined to have more than 100 milligrams of THC within it, then the Test Batch shall be considered to have failed potency testing. If an individually packaged Edible Retail Marijuana Product is determined to have more than the total milligrams of THC stated on the Container, or less than the total milligrams of THC stated on the Container, then the Test Batch shall be considered to have failed potency testing. If a single serving in an individually packaged Edible Retail Marijuana Product is determined to have more than 10 milligrams of THC then the Test Batch shall be considered to have failed potency testing. Except that the potency variance provided for in subparagraph (E)(5) of this Rule 4-115 shall apply to potency testing.

5.Potency Variance. Regulated Marijuana Product provided to the Regulated Marijuana Testing Facility must comply with the following potency variance:

a. For Regulated Marijuana Product with a Target Potency or making a potency claim for any cannabinoid of more than 2.5 milligrams per serving the potency variance shall differ no more than plus or minus 15 percent.

b. For Regulated Marijuana Product with a Target Potency or making a potency claim for any cannabinoid of 2.5 milligrams or less per serving the potency variance shall differ no more than the greater of plus or minus 0.5 mg or 40 percent per serving.

F.Testing Regulated Marijuana Ready for Transfer. All tests must occur at the time the Regulated Marijuana is ready for Transfer to another Regulated Marijuana Business, according to the required steps outlined in the standard operating procedures of the Licensee submitting the Test Batch.

F.5. Licensees shall not Transfer Regulated Marijuana that they have reason to believe would not pass testing required by Rules 4-120 and 4-125, unless otherwise permitted in these rules.

G.Violation Affecting Public Safety. Failure to comply with this Rule may constitute a license violation affecting public safety.

1 CCR 212-3-4-115

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