retail mandatory testing and random sampling draft language

8/14/2019 Retail Mandatory Testing and Random Sampling Draft Language

1/27

Basis and Purpose R 103

The statutory authority for this rule is found at subsection 12-43.4-202(2)(b), C.R.S. The purpose of this ruleis to provide necessary definitions of terms used throughout the rules. Defined terms are capitalized wherethey appear in the rules, to let the reader know to refer back to these definitions. When a term is used in aconventional sense, and not intended to be a defined term, it is not capitalized.

With regard to the definition of Child-Resistant, the State Licensing Authority relied extensively upon writtencommentary provided by a public health agency within a Colorado hospital, which had conducted a healthimpact assessment of packaging regulations, looking at accidental ingestion of medical marijuana. Theassessment was supported by others in the public, including industry representatives and a physicianspecializing in medical toxicology.

With regard to the definition of Restricted Access Area, the State Licensing Authority relied extensively uponwritten commentary provided by a consumer advocate.

R 103 Defini tions

Definitions. The following definitions of terms, in addition to those set forth in section 12-43.4-103, C.R.S.,shall apply to all rules promulgated pursuant to the Retail Code, unless the context requires otherwise:

Advertising means the act of providing consideration for the publication, dissemination,solicitation, or circulation, visual, oral, or written, to induce directly or indirectly any Person topatronize a particular a Retail Marijuana Establishment, or to purchase particular Retail Marijuanaor a Retail Marijuana Product. Advertising includes marketing, but does not include packagingand labeling. Advertising proposes a commercial transaction or otherwise constitutes commercialspeech.

Alarm Installation Company means a Person engaged in the business of selling, providing,

maintaining, servicing, repairing, altering, replacing, moving or installing a Security Alarm Systemin a Licensed Premises.

Applicant means a Person that has submitted an application pursuant to these rules that wasaccepted by the Division for review but has not been approved or denied by the State LicensingAuthority.

Batch Number means any distinct group of numbers, letters, or symbols, or any combinationthereof, assigned by a Retail Marijuana Cultivation Facility or Retail Marijuana ProductsManufacturer to a specific Harvest Batch or Production Batch of Retail Marijuana.

"Cannabinoid" means any of the chemical compounds that are the active principles of marijuana.

Child-Resistant means special packaging that is:

a. Designed or constructed to be significantly difficult for children under five years of age toopen and not difficult for normal adults to use properly as defined by 16 C.F.R. 1700.20(1995) and ASTM classification standard D3475-12,http://www.astm.org/Standards/D3475.htm. Note that this rule does not include any lateramendments or editions to the Code of Federal Regulations or the ASTM classification


2/27

standards. The Division has maintained a copy of the applicable federal regulation andASTM classification standard, which are available to the public.

b. Opaque so that the product cannot be seen from outside the packaging;

c. Closable for any product intended for more than a single use or containing multipleservings, and

d. Labeled properly as required by the R 1000 Series.

"Container" means the sealed package in which Retail Marijuana or a Retail Marijuana Product isplaced for sale to a consumer and that has been labeled according to the requirements set forth inRules R 1002et.seq.

"Denied Applicant" means any Person whose application for licensure pursuant to the Retail Codehas been denied.

Department means the Colorado Department of Revenue.

"Director" means the Director of the Marijuana Enforcement Division.

"Division" means the Marijuana Enforcement Division.

"Edible Retail Marijuana Product" means any Retail Marijuana Product which is intended to beconsumed orally, including but not limited to, any type of food, drink, or pill.

Executive Director means the Executive Director of the Department of Revenue.

"Exit Package" means a sealed Container or package provided at the retail point of sale, in whichany Retail Marijuana or Retail Marijuana Product already within a Container are placed.

Final Agency Order means an Order of the State Licensing Authority issued in accordance withthe Retail Code and the State Administrative Procedure Act. The State Licensing Authority willissue a Final Agency Order following review of the Initial Decision and any exceptions filed theretoor at the conclusion of the declaratory order process. A Final Agency Order is subject to judicialreview.

Flower means the gametophytic or reproductive state of Cannabisin which the plant in in a lightcycle intended to produce flowers, trichromes, and cannabinoids characteristic of marijuana.

Good Cause for purposes of denial of an initial, renewal, or reinstatement of a license application,means:

a. The Licensee or Applicant has violated, does not meet, or has failed to comply with any ofthe terms, conditions, or provisions of the Retail Code, any rules promulgated pursuant toit, or any supplemental relevant state or local law, rule, or regulation;


3/27

b. The Licensee or Applicant has failed to comply with any special terms or conditions thatwere placed upon the license pursuant to an order of the State Licensing Authority or therelevant local jurisdiction; or

c. The Licensees Licensed Premises have been operated in a manner that adverselyaffects the public health or welfare or the safety of the immediate neighborhood in which

the establishment is located.

Good Moral Character means an individual with a personal history demonstrating honesty,fairness, and respect for the rights of others and for the law.

Harvest Batch means a specifically identified quantity of processed Retail Marijuana that isuniform in strain, cultivated utilizing the same herbicides, pesticides, and fungicides, and harvestedat the same time.

Identity Statement means the name of the business as it is commonly known and used in anyAdvertising.

"Immature plant means a nonflowering Retail Marijuana or Medical Marijuana plant that is no tallerthan eight inches and no wider than eight inches produced from a cutting, clipping, or seedling andthat is in a growing/cultivating container that is no larger than two inches wide and two inches tallthat is sealed on the sides and bottom.

Initial Decision means a decision of a hearing officer in the Department following a licensing,disciplinary, or other administrative hearing. Either party may file exceptions to the Initial Decision.The State Licensing Authority will review the Initial Decision and any exceptions filed thereto, andwill issue a Final Agency Order.

"Licensed Premises means the premises specified in an application for a license pursuant to the

Retail Code that are owned or in possession of the Licensee and within which the Licensee isauthorized to cultivate, manufacture, distribute, sell, or test Retail Marijuana in accordance with theprovisions of the Retail Code and these rules.

"Licensee" means any Person licensed pursuant to the Retail Code or, in the case of anOccupational License Licensee, any individual licensed pursuant to the Retail Code or MedicalCode.

"Limited Access Area" means a building, room, or other contiguous area upon the LicensedPremises where Retail Marijuana is grown, cultivated, stored, weighed, packaged, sold, orprocessed for sale, under control of the Licensee.

Limit of Detection or LOD means the lowest quantity of a substance that can be distinguishedfrom the absence of that substance (a blank value) within a stated confidence limit (generally 1%).[

Limit of Quantitation or LOQ means the lowest concentration at which the analyte can not onlybe reliably detected but at which some predefined goals for bias and imprecision are met.

MITS means Marijuana Inventory Tracking Solution.


4/27

MITS Trained Administrator means an Owner or an occupationally licensed employee of a RetailMarijuana Establishment who has attended and successfully completed MITS training and who hascompleted any additional training required by the Division.

MITS User means an Owner or occupationally licensed Retail Marijuana Establishment employeewho is granted MITS User account access for the purposes of conducting inventory tracking

functions in the MITS system and who has been successfully trained by a MITS TrainedAdministrator in the proper and lawful use of MITS.

Medical Code means the Colorado Medical Marijuana Code found at sections 12-43.3-101 et.seq., C.R.S.

Medical Marijuana means Medical Marijuana means marijuana that is grown and sold pursuantto the Medical Code and includes seeds and Immature Plants.

"Medical Marijuana Business" means a Medical Marijuana Center, a Medical Marijuana-InfusedProduct Manufacturing Business, or an Optional Premises Cultivation Operation.

"Medical Marijuana Center" means a Person licensed pursuant to the Medical Code to operate abusiness as described in section 12-43.3-402, C.R.S., and sells medical marijuana to registeredpatients or primary caregivers as defined in Article XVIII, Section 14 of the Colorado Constitution,but is not a primary caregiver.

Medical Marijuana-Infused Product means a product infused with Medical Marijuana that is

intended for use or consumption other than by smoking, including but not limited to edible product,

ointments, and tinctures. Such products shall not be considered a food or drug for purposes of the

Colorado Food and Drug Act, part 4 of Article 5 of Title 25, C.R.S.

"Medical Marijuana-Infused Products Manufacturing Business" means a Person licensed pursuantto the Medical Code to operate a business as described in section 12-43.3-404, C.R.S.

"Monitoring means the continuous and uninterrupted attention to potential alarm signals that couldbe transmitted from a Security Alarm System located at a Retail Marijuana Establishment LicensedPremises, for the purpose of summoning a law enforcement officer to the premises during alarmconditions.

"Monitoring Company means a person in the business of providing security system Monitoringservices for the Licensed Premises of a Retail Marijuana Establishment.

"Notice of Denial" means a written statement from the State Licensing Authority, articulating the

reasons or basis for denial of a license application.

Occupational License means a license granted to an individual by the State Licensing Authority

pursuant to section 12-43.3-401 or 12-43.4-401, C.R.S.

"Optional Premises Cultivation Operation" means a Person licensed pursuant to the Medical Codeto operate a business as described in section 12-43.3-403, C.R.S.


5/27

"Order to Show Cause" means a document from the State Licensing Authority alleging the groundsfor imposing discipline against a Licensees license.

Owner means the Person or Persons whose beneficial interest in the license is such that theybear risk of loss other than as an insurer, have an opportunity to gain profit from the operation orsale of the establishment, and have a controlling interest in a Retail Marijuana Establishment

license, and includes any other Person that qualifies as an Owner pursuant to Rule R 204.

Person means a natural person, partnership, association, company, corporation, limited liabilitycompany, or organization, or a manager, agent, owner, director, servant, officer, or employeethereof; except that Person does not include any governmental organization.

"Pesticide" means any substance or mixture of substances intended for preventing, destroying,repelling, or mitigating any pest or any substance or mixture of substances intended for use as aplant regulator, defoliant, or desiccant; except that the term "pesticide" shall not include any articlethat is a "new animal drug" as designated by the United States food and drug administration."

Production Batch means a group of Retail Marijuana Product created from a production run ofmarijuana product.

Proficiency Testing Samples means performing the same analyses on the same samples andcomparing results to ensure the Samples are homogenous and stable, and also that the set ofsamples analyzed are appropriate to test and display similarities and differences in results.

Propagation means the reproduction of Retail Marijuana plants by seeds, cuttings or grafting.

RFID means Radio Frequency Identification.

Residual Solvents means the classification of volatile organic compounds (VOC) with a low

boiling point or other solvents used in the manufacturing process of Retail Marijuana Concentrateproducts. The authorized solvents permissible for used include: N-Butane, Iso-Butane, Propane,Heptane, 2-Proponyl (Isopropyl Alcohol), Ethanol, Propylene Glycol, Glycerin and CO2 to excludetypical cooking fats.

Respondent means a Person who has filed a petition for declaratory order that the StateLicensing Authority has determined needs a hearing or legal argument or a Licensee who issubject to an Order to Show Cause.

Restricted Access Area means a designated and secure area within a Licensed Premises in aRetail Marijuana Store where Retail Marijuana and Retail Marijuana Product are sold, possessedfor sale, and displayed for sale, and where no one under the age of 21 is permitted.

"Retail Code" means the Colorado Retail Marijuana Code found at sections 12-43.4-101 et.seq.,C.R.S.

"Retail Marijuana means all parts of the plant of the genus cannabis whether growing or not, theseeds thereof, the resin extracted from any part of the plant, and every compound, manufacture,salt, derivative, mixture, or preparation of the plant, its seeds, or its resin, including marijuanaconcentrate, that is cultivated, manufactured, distributed, or sold by a licensed Retail Marijuana


6/27

Establishment. "Retail Marijuana" does not include industrial hemp, nor does it include fiberproduced from stalks, oil, or cake made from the seeds of the plant, sterilized seed of the plantwhich is incapable of germination, or the weight of any other ingredient combined with marijuana toprepare topical or oral administrations, food, drink, or other product.

"Retail Marijuana Cultivation Facility" means an entity licensed to cultivate, prepare, and package

Retail Marijuana and sell Retail Marijuana to Retail Marijuana Establishments, but not toconsumers.

"Retail Marijuana Establishment" means a Retail Marijuana Store, a Retail Marijuana CultivationFacility, a Retail Marijuana Products Manufacturing Facility, or a Retail Marijuana Testing Facility.

"Retail Marijuana Product" means concentrated Retail Marijuana and Retail Marijuana Product thatare comprised of Retail Marijuana and other ingredients and are intended for use or consumption,such as, but not limited to, edible product, ointments, and tinctures.

Retail Marijuana Products Manufacturing Facility means an entity licensed to purchase Retail

Marijuana; manufacture, prepare, and package Retail Marijuana Product; and sell Retail Marijuanaand Retail Marijuana Product only to other Retail Marijuana Products Manufacturing Facilities andRetail Marijuana Stores.

Retail Marijuana Store means an entity licensed to purchase Retail Marijuana from a RetailMarijuana Cultivation Facility and to purchase Retail Marijuana Product from a Retail MarijuanaProducts Manufacturing Facility and to sell Retail Marijuana and Retail Marijuana Product toconsumers.

Retail Marijuana Testing Facility means an entity licensed and certified to analyze and certify thesafety and potency of Retail Marijuana.

Sample means any Retail Marijuana, Retail Marijuana Product, Medical Marijuana, or MedicalMarijuana-Infused Product provided for testing or research purposes to a Retail Marijuana TestingFacility by a Retail Marijuana Establishment or Medical Marijuana Business.

"Security Alarm System means a device or series of devices, intended to summon lawenforcement personnel during, or as a result of, an alarm condition. Devices may include hard-wired systems and systems interconnected with a radio frequency method such as cellular orprivate radio signals that emit or transmit a remote or local audible, visual, or electronic signal;motion detectors, pressure switches, duress alarms (a silent system signal generated by the entryof a designated code into the arming station to indicate that the user is disarming under duress);panic alarms (an audible system signal to indicate an emergency situation); and hold-up alarms (asilent system signal to indicate that a robbery is in progress).

Shipping Container means any container or wrapping used solely for the transport of RetailMarijuana or Retail Marijuana Product in bulk, or in a quantity for other Retail MarijuanaEstablishments.

"Standardized Graphic Symbol" means a graphic image or small design adopted by a Licensee toidentify its business.


7/27

"State Licensing Authority" means the authority created for the purpose of regulating andcontrolling the licensing of the cultivation, manufacture, distribution, and sale of Medical Marijuanaand Retail Marijuana in Colorado, pursuant to section 12-43.3-201, C.R.S.

"THC" means tetrahydrocannabinol.

"THCA" means tetrahydrocannabinolic acid.

Test Batch means a Sample that is comprised of Retail Marijuana from more than one HarvestBatch or Retail Marijuana Concentrate or Retail Marijuana Product from more than one ProductionBatch.

"Universal Symbol" means the image established by the Division and made available to Licenseesthrough the Divisions website indicating Retail Marijuana or a Retail Marijuana Product is within aContainer.

Unrecognizable means marijuana orCannabisplant material rendered indistinguishable from any

other plant material.

Vegetation means the sporophytic state of the Cannabis plant that is a form of asexualreproduction in plants during which plants do not produce resin or flowers and are bulking up to adesired production size for Flowering.


8/27


The statutory authority for this rule is found at subsections 12-43.4-202(2)(b) and 12-43.4-403(5), C.R.S.The purpose of this rule is to establish the portion of the Divisions Mandatory Testing and RandomSampling program that is applicable to Retail Marijuana Stores.

R 407 Retail Marijuana Stores: Mandatory Testing and Random Sampling Program

A. Random Sampling.

1. A Retail Marijuana Store may be required by the Division to submit a random Sample ofRetail Marijuana or Retail Marijuana Product it posses to a Retail Marijuana TestingFacility to be tested for potency or contaminants at any time and without notice. Samplescollected pursuant to this rule may be tested for contaminants which may include, but maynot be limited, pesticides, microbials, molds, filth, residual solvents, harmful chemicals,and potency.

2. The cost for all tests conducted pursuant to this rule shall be the financial responsibility ofthe Retail Marijuana Store.

B. Failed Contaminant Tests.

1. If a Retail Marijuana Store is notified by the Division or a Retail Marijuana Testing Facilitythat a Harvest Batch failed contaminant testing, then the Retail Marijuana Store shalldestroy any Retail Marijuana it possesses from the Harvest Batch that failed contaminanttesting.

2. If a Retail Marijuana Store is notified by the Division or a Retail Marijuana Testing Facilitythat a Production Batch failed contaminant testing, then the Retail Marijuana Store shall

destroy any Retail Marijuana Concentrate or Retail Marijuana Product it possesses fromthe Harvest Batch that failed contaminant testing.

3. A violation of this rule may constitute a violation against public safety.


9/27


The statutory authority for this rule is found at subsections 12-43.4-202(2)(b) and 12-43.4-403(5), C.R.S.The purpose of this rule is to establish that Retail Marijuana Cultivation Facilities may provide Samples fortesting and research purposes. The purpose of this rule is to establish the portion of the DivisionsMandatory Testing and Random Sampling program that is applicable to Retail Marijuana Flowers cultivatedor possessed by a Retail Marijuana Cultivation Facility.

R 505 Retail Marijuana Cultivation Facilities: Testing Requirements Retail Marijuana CultivationFacility: Mandatory Testing and Random Sampling Program for Retail Marijuana Flowers

A. Samples on Demand. A Retail Marijuana Cultivation Facility shall, upon request of the Division,submit a sufficient quantity of Retail Marijuana to a Retail Marijuana Testing Facility to enablelaboratory or chemical analysis thereof. The Division will notify the Licensee of the results of theanalysis.

B. Samples Provided for Testing. A Retail Marijuana Cultivation Facility may provide Samples of its

Retail Marijuana to a Retail Marijuana Testing Facility for testing and research purposes. TheRetail Marijuana Cultivation Facility shall maintain the testing results as part of its business books

and records. See Rule R 901 Business Records Required.

A. Pesticide Disclosures.

1. A Retail Marijuana Cultivation Facility must provide the Division with a complete list of allPesticides, Herbicides, Fertilizers or other chemicals used during its cultivation process.This disclosure must occur prior to the use of any previously undisclosed Pesticide by theRetail Marijuana Cultivation Facility.

2. If a Retail Marijuana Cultivation Facility uses the same process for all strains it cultivates,then it may provide the Division with a single, universal list. If a Retail MarijuanaCultivation Facility utilizes a different process for any of the strains it cultivates, then itmust supply the Division with a list for each strain.


B. Mandatory Contaminant Testing.

1. A Retail Marijuana Cultivation Facility shall not wholesale, transfer, or process into aRetail Marijuana Concentrate any Retail Marijuana unless the Harvest Batch from whichthat Retail Marijuana was derived was tested by a Retail Marijuana Testing Facility andpassed all contaminant tests required by this rule.

a. Pesticide Contaminant Testing. Each Harvest Batch of Retail Marijuanaproduced by a Retail Marijuana Cultivation Facility must be tested for Pesticides,Herbicides, Fertilizers or other chemical contamination by a Retail MarijuanaTesting Facility. The contaminant testing must include, but need to be limited to,


10/27

testing to determine the presence of and residual amounts of every Pesticide,Herbicide, Fertilizer or other chemicals disclosed to the Division.

b. Microbial Contaminant Testing. Each Harvest Batch of Retail Marijuanaproduced by a Retail Marijuana Cultivation Facility must be tested for microbialcontamination by a Retail Marijuana Testing Facility. The microbial

contamination test must include, but need to be limited to, testing to determinethe presence of and amounts present of Salmonella sp., Ecoli sp. and totalcoliforms.

c. Mold Contaminant Testing. Each Harvest Batch of Retail Marijuana produced bya Retail Marijuana Cultivation Facility must be tested for mold contamination by aRetail Marijuana Testing Facility. The mold contamination test must include, butneed to be limited to, testing to determine presence and the level of Aspergillussp., Mucor sp., Penicillium sp., thermophilic Actinomycetes sp.

d. Filth Contaminant Testing. Each Harvest Batch of Retail Marijuana produced bya Retail Marijuana Cultivation Facility must be tested for filth contamination by aRetail Marijuana Testing Facility. The filth contamination test must include, butneed to be limited to, the detection, separation, quantification, identification andinterpretation of extraneous materials (including insects, rodent droppings andother contaminants) in Retail Marijuana flowers and trim.

2. Test Batches. A Retail Marijuana Cultivation Facility may comply with this provision bycombining any number of Harvest Batches cultivated within a 7 day period into a singleTest Batch. A Test Batch must consist of at least one half of a gram of flower and onegram of trim from every Harvest Batch combined into that Test Batch. If a Test Batch failsa contaminant test then each Harvest Batch that was combined into that Test Batch mustbe separately tested for contaminants or all Harvest Batches combined into that TestBatch must be destroyed and its destruction clearly documented.

C. Process Certification.

1. A Retail Marijuana Cultivation Facilitys cultivation process shall be deemed certified bythe Division if every Harvest Batch that it produced during a 12 week period passed allcontaminant tests required by Rule R505 (B).

2. If a Retail Marijuana Cultivation Facilitys cultivation process has been certified by theDivision, then it shall be considered exempt from the requirements of Rule R505 (B). ARetail Marijuana Cultivation Facility that has had its cultivation process certified by theDivision shall be required to submit two Harvest Batches per year, at six month intervals,

for contaminant testing that must include all tests required by Rule R 505 (B).

3. Nothing within this rule shall exempt a Retail Marijuana Cultivation Facility from theDivisions random sampling program set forth in Rule R 505 (E).

4. A Retail Marijuana Cultivation Facility shall be required to notify the Division within 30-days when any change to the production process occurs and its process must berecertified according to the procedures set forth in subparagraph (1).


11/27

D. Potency Testing. A Retail Marijuana Cultivation Facility shall have potency tests conducted by aRetail Marijuana Testing Facility on three separate Harvest Batches separated by a minimum of 4weeks for each strain of Retail Marijuana that it produces. After the initial three Harvest Batchtests, a Retail Marijuana Cultivation Facility shall have each strain of Retail Marijuana that itcultivates tested for potency at least once per year.

E. Random Sampling.

1. A Retail Marijuana Cultivation Facility may be required by the Division to submit a randomSample of Retail Marijuana it posses to a Retail Marijuana Testing Facility to be tested forpotency or contaminants at any time and without notice. Testing on samples collectedpursuant to this rule may include, but may not be limited to, Pesticides, Herbicides,Fertilizers or other chemicals, microbials, molds, filth, harmful chemicals, and potency.

2. The Division, at its own discretion, may elect to have MED personnel or a divisionauthorized sample collection entity collect the random Samples for testing at a RetailMarijuana Testing Facility.

3. The cost for all tests conducted pursuant to this rule shall be the financial responsibility ofthe Retail Marijuana Cultivation Facility.

F. Failed Contaminant Tests. If a Retail Marijuana Cultivation Facility is notified by the Division or aRetail Marijuana Testing Facility that a Harvest Batch failed contaminant testing, then the RetailMarijuana Cultivation Facility may not process, transfer, or wholesale any part of the RetailMarijuana it possesses from the Harvest Batch that failed contaminant testing and must either;

1. Destroy and document the destruction of the entire portion of the Harvest Batch that itpossesses; or

2. Decontaminate the portion of the Harvest Batch it possesses prior to having twoindependent samples re-collected and re-tested for the identified contaminant. If bothSamples pass the contaminant re-test(s), then any Retail Marijuana from that HarvestBatch may be processed, wholesaled, or transferred. If one or both of the Samples do notpass the contaminant re-test(s), then the Retail Marijuana Cultivation Facility must destroyand document the destruction of the entire portion of the Harvest Batch that it possesses.



12/27


The statutory authority for this rule is found at subsections 12-43.4-202(2)(b) and 12-43.4-403(5), C.R.S.The purpose of this rule is to establish the portion of the Divisions Mandatory Testing and RandomSampling program that is applicable to Water-Based Retail Marijuana Concentrates produced or possessedby a Retail Marijuana Cultivation Facility.

R 506 Retail Marijuana Cultivation Facility: Mandatory Testing and Random Sampling Program forWater-Based Retail Marijuana Concent rates

A. A Retail Marijuana Cultivation Facility may only produce Water-Based Retail MarijuanaConcentrates. See Rule R 507 -Retail Marijuana Cultivation Facilities: Retail MarijuanaConcentrate Production.

B. Mandatory Contaminant Testing.

1. A Retail Marijuana Cultivation Facility shall not wholesale or transfer a Retail Marijuana

Concentrate unless the Production Batch from which that Retail Marijuana Concentratewas derived was tested by a Retail Marijuana Testing Facility and passed all contaminanttests required by this rule.

a. Microbial Contaminant Testing. Each Production Batch of Retail MarijuanaConcentrate produced by a Retail Marijuana Cultivation Facility must betested for microbial contamination by a Retail Marijuana Testing Facility.The microbial contamination test must include, but need to be limited to,testing to determine the presence of and amounts present of Salmonella sp.,Ecoli sp. and total coliforms.

b) Mold Contaminant Testing. Each Production Batch of Retail Marijuana

Concentrate produced by a Retail Marijuana Cultivation Facility in themandatory testing program must be tested for mold contamination by aRetail Marijuana Testing Facility. The mold contamination test must include,but need to be limited to, testing to determine the presence and level ofAspergillus sp., Mucor sp., Penicillium sp., thermophilic Actinomycetes sp.

2. Test Batches. A Retail Marijuana Cultivation Facility may comply with this provision bycombining any number of Production Batches produced within a 7 day period into a singleTest Batch. A Test Batch must consist of at least one half of a gram of every ProductionBatch combined into that Test Batch. If a Test Batch fails a contaminant test then eachProduction Batch that was combined into that Test Batch must be separately tested forcontaminants or all Production Batches combined into that Test Batch must be destroyed

and its destruction clearly documented.

C. Process Certification.

1. A Retail Marijuana Cultivation Facilitys Water-Based Retail Marijuana Concentrateproduction process shall be deemed certified by the Division if every Production Batch ofWater-Based Retail Marijuana Concentrate that it produced during a 4 week periodpassed all contaminant tests required by Rule R506 (B).


13/27

2. If a Retail Marijuana Cultivation Facilitys Water-Based Retail Marijuana Concentrateproduction process has been certified by the Division, then it shall be considered exemptfrom the requirements of Rule R506 (B). A Retail Marijuana Cultivation Facility that hashad its Water-Based Retail Marijuana Concentrate production process certified by theDivision shall be required to submit four Production Batches of Water-Based RetailMarijuana Concentrate per year, at three month intervals, for contaminant testing that

must include all tests required by Rule R 506 (B).

3. Nothing within this rule shall exempt a Retail Marijuana Cultivation Facility from theDivisions random sampling program set forth in Rule R 506 (E).

4. A Retail Marijuana Cultivation Facility shall be required to notify the Division within 30-days when any change to its Water-Based Retail Marijuana Concentrate productionprocess occurs and its process must be recertified according to the procedures set forth insubparagraph (1).

D. Potency Testing. A Retail Marijuana Cultivation Facility shall not wholesale or transfer a RetailMarijuana Concentrate unless the Production Batch from which that Retail Marijuana Concentratewas derived was tested by a Retail Marijuana Testing Facility for potency.

E. Random Sampling.

1. A Retail Marijuana Cultivation Facility may be required by the Division to submit a randomSample of Retail Marijuana it posses to a Retail Marijuana Testing Facility to be tested forpotency or contaminants at any time and without notice. Testing on samples collectedpursuant to this rule may include, but may not be limited to, Pesticides, Herbicides,Fertilizers or other chemicals, microbials, molds, filth, harmful chemicals, and potency.

2. The Division, at its own discretion, may elect to have MED personnel or a division

authorized sample collection entity collect the random samples for testing at a RetailMarijuana Testing Facility.

3. The cost for all tests conducted pursuant to this rule shall be the financial responsibility ofthe Retail Marijuana Cultivation Facility.

G. Failed Contaminant Tests. If a Retail Marijuana Cultivation Facility is notified by the Division or aRetail Marijuana Testing Facility that a Production Batch failed contaminant testing, then the RetailMarijuana Cultivation Facility may not wholesale or transfer any of the Retail MarijuanaConcentrate it possesses from that Production Batch that failed contaminant testing and musteither;

1. Destroy and document the destruction of the entire portion of the Production Batch that itpossesses; or

2. Decontaminate the portion of the Production Batch it possesses prior to having twoindependent samples re-collected and re-tested for the identified contaminant. If bothSamples pass the contaminant re-test(s), then any Retail Marijuana Concentrate from thatProduction Batch may be wholesaled or transferred. If one or both of the Samples do notpass the contaminant re-test(s), then the Retail Marijuana Cultivation Facility must destroy


14/27

and document the destruction of the entire portion of the Production Batch that itpossesses.



15/27


The statutory authority for this rule is found at subsections 12-43.4-202(2)(b) and 12-43.4-403(5), C.R.S.The purpose of this rule is to establish the portion of the Divisions Mandatory Testing and RandomSampling program that is applicable to Retail Marijuana Concentrates produced or possessed by a RetailMarijuana Products Manufacturing Facility.

R 606 Retail Marijuana Products Manufacturing Facility: Mandatory Testing and Random SamplingProgram for Retail Marijuana Concentrates

A. Mandatory Testing for Water-Based Retail Marijuana Concentrates.

1. Mandatory Contaminant Testing.

a. A Retail Marijuana Products Manufacturing Facility shall not wholesale, transferor infuse into a Retail Marijuana Product a Water-Based Retail MarijuanaConcentrate unless the Production Batch from which that Water-Based Retail

Marijuana Concentrate derived was tested by a Retail Marijuana Testing Facilityand passed all contaminant tests required by this rule.

i. Microbial Contaminant Testing. Each Production Batch of RetailMarijuana Concentrate produced by a Retail Marijuana CultivationFacility must be tested for microbial contamination by a RetailMarijuana Testing Facility. The microbial contamination test mustinclude, but need to be limited to, testing to determine the presenceof and amounts present of Salmonella sp., Ecoli sp. and totalcoliforms.

ii. Mold Contaminant Testing. Each Production Batch of Water-Based

Retail Marijuana Concentrate produced by a Retail MarijuanaProducts Manufacturing Facility must be tested for moldcontamination by a Retail Marijuana Testing Facility. The moldcontamination test must include, but need to be limited to, testing todetermine the presence and level of Aspergillus sp., Mucor sp.,Penicillium sp., thermophilic Actinomycetes sp.

b. Test Batches. A Retail Marijuana Products Manufacturing Facility may complywith this provision by combining any number of Production Batches of Water-Based Retail Marijuana Concentrate produced within a 7 day period into a singleTest Batch. A Test Batch must consist of at least one half of a gram of everyProduction Batch combined into that Test Batch. If a Test Batch fails a

contaminant test then each Production Batch that was combined into that TestBatch must be separately tested for contaminants or all Production Batchescombined into that Test Batch must be destroyed and its destruction clearlydocumented.

2. Process Certification.


16/27

a. A Retail Marijuana Products Manufacturing Facilitys Water-Based RetailMarijuana Concentrate production process shall be deemed certified by theDivision if every Production Batch of Water-Based Retail Marijuana Concentratethat it produced during a 4 week period passed all contaminant tests required byRule R606 (A) (1).

b. If a Retail Marijuana Products Manufacturing Facilitys Water-Based RetailMarijuana Concentrate production process has been certified by the Division,then it shall be considered exempt from the requirements of Rule R606 (A). ARetail Marijuana Products Manufacturing Facility that has had its Water-BasedRetail Marijuana Concentrate production process certified by the Division shallbe required to submit four Production Batches of Water-Based Retail MarijuanaConcentrate per year, at three month intervals, for contaminant testing that mustinclude all tests required by Rule R 606 (A).

c. Nothing within this rule shall exempt a Retail Marijuana Products ManufacturingFacility from the Divisions random sampling program set forth in Rule R 606 (E).

d. A Retail Marijuana Products Manufacturing Facility shall be required to notify theDivision within 30-days when any change to its Water-Based Retail MarijuanaConcentrate production process occurs and its process must be recertifiedaccording to the procedures set forth in subparagraph (a).

3. Potency Testing. A Retail Marijuana Products Manufacturing Facility shall not wholesaleor transfer a Retail Marijuana Concentrate unless the Production Batch from which thatRetail Marijuana was derived was tested by a Retail Marijuana Testing Facility forpotency.

B. Mandatory Testing for Fat-Based Retail Marijuana Concentrates.


a. A Retail Marijuana Products Manufacturing Facility shall not wholesale, transferor process into a Retail Marijuana Product a Fat-Based Retail MarijuanaConcentrate unless the Production Batch from which that Fat-Based RetailMarijuana Concentrate was derived was tested by a Retail Marijuana TestingFacility and passed all contaminant tests required by this rule.

i. Microbial Contaminant Testing. Each Production Batch of RetailMarijuana Concentrate produced by a Retail Marijuana CultivationFacility must be tested for microbial contamination by a Retail Marijuana

Testing Facility. The microbial contamination test must include, butneed to be limited to, testing to determine the presence of and amountspresent of Salmonella sp., Ecoli sp. and total coliforms.

ii. Mold Contaminant Testing. Each Production Batch of Fat-Based RetailMarijuana Concentrate produced by a Retail Marijuana ProductsManufacturing Facility must be tested for mold contamination by aRetail Marijuana Testing Facility. The mold contamination test mustinclude, but need to be limited to, testing to determine the presence and


17/27

level of Aspergillus sp., Mucor sp., Penicillium sp., thermophilicActinomycetes sp.

b. Test Batches. A Retail Marijuana Products Manufacturing Facility may complywith this provision by combining any number of Fat-Based Retail MarijuanaConcentrate Production Batches produced within a 7 day period into a single

Test Batch. A Test Batch must consist of at least one half of a gram of everyProduction Batch combined into that Test Batch. If a Test Batch fails acontaminant test then each Production Batch that was combined into that TestBatch must be separately tested for contaminants or all Production Batchescombined into that Test Batch must be destroyed and its destruction clearlydocumented.


a. A Retail Marijuana Products Manufacturing Facilitys Fat-Based Retail MarijuanaConcentrate production process shall be deemed certified by the Division if fiveconsecutively produced Production Batches of Fat-Based Retail MarijuanaConcentrate pass all contaminant tests required by Rule R606 (B) (1).

b. If a Retail Marijuana Products Manufacturing Facilitys Fat-Based RetailMarijuana Concentrate production process has been certified by the Division,then it shall be considered exempt from the requirements of Rule R606 (B) (1).A Retail Marijuana Products Manufacturing Facility that has had its Fat-BasedRetail Marijuana Concentrate production process certified by the Division shallbe required to submit two Production Batches of Fat-Based Retail MarijuanaConcentrate per year, at six month intervals, for contaminant testing that mustinclude all tests required by Rule R 606 (B) (1).


d. A Retail Marijuana Products Manufacturing Facility shall be required to notify theDivision within 30-days when any change to its Fat-Based Retail MarijuanaConcentrate production process occurs and its process must be recertifiedaccording to the procedures set forth in subparagraph (a).

3. Potency Testing. A Retail Marijuana Cultivation Facility shall not wholesale or transfer aRetail Marijuana Concentrate unless the Production Batch from which that RetailMarijuana was derived was tested by a Retail Marijuana Testing Facility for potency.

4. Exemption. If a Retail Marijuana Products Manufacturing Facility does not wholesale ortransfer any of portion of a Fat-Based Retail Marijuana Concentrate from a ProductionRun and instead uses all of it produce Retail Marijuana Product, then that ProductionBatch shall be considered exempt from Rule R 60? (B).

C. Mandatory Testing for Solvent-Based Retail Marijuana Concentrate.



18/27

a. A Retail Marijuana Products Manufacturing Facility shall not wholesale, transferor process into a Retail Marijuana Product a Solvent-Based Retail MarijuanaConcentrate unless the Production Batch from which that Solvent-Based RetailMarijuana Concentrate was derived was tested by a Retail Marijuana TestingFacility and passed all contaminant tests required by this rule.

i. Residual Solvent Contaminant Testing. Each Production Batch ofSolvent-Based Retail Marijuana Concentrate produced by a RetailMarijuana Products Manufacturing Facility must be tested for residualsolvent contamination by a Retail Marijuana Testing Facility. Theresidual solvent contamination test must include, but need to be limitedto, testing to determine the presence and level of the solvent or solventsused during the extraction process.

ii. Microbial Contaminant Testing. Each Production Batch of RetailMarijuana Concentrate produced by a Retail Marijuana CultivationFacility must be tested for microbial contamination by a Retail MarijuanaTesting Facility. The microbial contamination test must include, but

need to be limited to, testing to determine the presence of and amountspresent of Salmonella sp., Ecoli sp. and total coliforms.

iii. Mold Contaminant Testing. Each Production Batch of Solvent-BasedRetail Marijuana Concentrate produced by a Retail Marijuana ProductsManufacturing Facility must be tested for mold contamination by aRetail Marijuana Testing Facility. The mold contamination test mustinclude, but need to be limited to, testing to determine the presence andlevel of Aspergillus sp., Mucor sp., Penicillium sp., thermophilicActinomycetes sp.

b. Test Batches. A Retail Marijuana Products Manufacturing Facility may complywith this provision by combining any number of Solvent-Based Retail MarijuanaConcentrate Production Batches produced within a 7 day period into a singleTest Batch. A Test Batch must consist of at least one half of a gram of everyProduction Batch combined into that Test Batch. If a Test Batch fails acontaminant test then each Production Batch that was combined into that TestBatch must be separately tested for contaminants or all Production Batchescombined into that Test Batch must be destroyed and its destruction clearlydocumented.


a. A Retail Marijuana Products Manufacturing Facilitys Solvent-Based RetailMarijuana Concentrate production process shall be deemed certified by theDivision if every Production Batch of Solvent-Based Retail MarijuanaConcentrate that it produced during a 4 week period passed all contaminant testsrequired by Rule R606 (C) (1).

b. If a Retail Marijuana Products Manufacturing Facilitys Solvent-Based RetailMarijuana Concentrate production process has been certified by the Division,then it shall be considered exempt from the requirements of Rule R606 (C) (1).


19/27

A Retail Marijuana Products Manufacturing Facility that has had its Solvent-Based Retail Marijuana Concentrate production process certified by the Divisionshall be required to submit twelve Production Batches of Solvent-Based RetailMarijuana Concentrate per year, at one month intervals, for contaminant testingthat must include all tests required by Rule R 606 (C) (1).


d. A Retail Marijuana Products Manufacturing Facility shall be required to notify theDivision within 30-days when any change to its Solvent-Based Retail MarijuanaConcentrate production process occurs and its process must be recertifiedaccording to the procedures set forth in subparagraph (a).

3. Potency Testing. A Retail Marijuana Products Manufacturing Facility shall not wholesaleor transfer a Solvent-Based Retail Marijuana Concentrate unless the Production Batchfrom which that Solvent-Based Retail Marijuana Concentrate was derived was tested by aRetail Marijuana Testing Facility for potency.

4. Exemption. If a Retail Marijuana Products Manufacturing Facility does not wholesale ortransfer any of portion of a Solvent-Based Retail Marijuana Concentrate within aProduction Run and instead uses all of it produce Retail Marijuana Product, then thatProduction Batch shall be considered exempt from Rule R 606 (C), except that residualsolvent contamination testing shall still be required.

D. Mandatory Testing for Critical Fluid Extraction Retail Marijuana Concentrate.


a. A Retail Marijuana Products Manufacturing Facility shall not wholesale, transferor process into a Retail Marijuana Product a Critical Fluid Extraction RetailMarijuana Concentrate unless the Production Batch from which that Critical FluidExtraction Retail Marijuana Concentrate was derived was tested by a RetailMarijuana Testing Facility and passed all contaminant tests required by this rule.

i. Residual Solvent Contaminant Testing. Each Production Batch ofCritical Fluid Extraction Retail Marijuana Concentrate produced by aRetail Marijuana Products Manufacturing Facility must be tested forresidual solvent contamination by a Retail Marijuana Testing Facility.The residual solvent contamination test must include, but need to belimited to, testing to determine the presence and level of the solvent or

solvents used during the extraction process.

ii. Microbial Contaminant Testing. Each Production Batch of RetailMarijuana Concentrate produced by a Retail Marijuana CultivationFacility must be tested for microbial contamination by a Retail MarijuanaTesting Facility. The microbial contamination test must include, butneed to be limited to, testing to determine the presence of and amountspresent of Salmonella sp., Ecoli sp., and total coliforms.


20/27

iii. Mold Contaminant Testing. Each Production Batch of Critical FluidExtraction Retail Marijuana Concentrate produced by a Retail MarijuanaProducts Manufacturing Facility must be tested for mold contaminationby a Retail Marijuana Testing Facility. The mold contamination testmust include, but need to be limited to, testing to determine thepresence and level of Aspergillus sp., Mucor sp., Penicillium sp.,

thermophilic Actinomycetes sp.

b. Test Batches. A Retail Marijuana Products Manufacturing Facility may complywith this provision by combining any number of Critical Fluid Extraction RetailMarijuana Concentrate Production Batches produced within a 7 day period into asingle Test Batch. A Test Batch must consist of at least one half of a gram ofevery Production Batch combined into that Test Batch. If a Test Batch fails acontaminant test then each Production Batch that was combined into that TestBatch must be separately tested for contaminants or all Production Batchescombined into that Test Batch must be destroyed and its destruction clearlydocumented.


a. A Retail Marijuana Products Manufacturing Facilitys Critical Fluid ExtractionRetail Marijuana Concentrate production process shall be deemed certified bythe Division if every Production Batch of Critical Fluid Extraction Retail MarijuanaConcentrate that it produced during a 4 week period passed all contaminant testsrequired by Rule R606 (D) (1).

b. If a Retail Marijuana Products Manufacturing Facilitys Critical Fluid ExtractionRetail Marijuana Concentrate production process has been certified by theDivision, then it shall be considered exempt from the requirements of Rule R606(D) (1). A Retail Marijuana Products Manufacturing Facility that has had itsCritical Fluid Extraction Retail Marijuana Concentrate production processcertified by the Division shall be required to submit twelve Production Batches ofCritical Fluid Extraction Retail Marijuana Concentrate per year, at one monthintervals, for contaminant testing that must include all tests required by Rule R606 (D) (1).


d. A Retail Marijuana Products Manufacturing Facility shall be required to notify theDivision within 30-days when any change to its Critical Fluid Extraction Retail

Marijuana Concentrate production process occurs and its process must berecertified according to the procedures set forth in subparagraph (a).

3. Potency Testing. A Retail Marijuana Products Manufacturing Facility shall not wholesaleor transfer a Critical Fluid Extraction Retail Marijuana Concentrate unless the ProductionBatch from which that Critical Fluid Extraction Retail Marijuana Concentrate was derivedwas tested by a Retail Marijuana Testing Facility for potency.

4. Exemption.


21/27

a. A Retail Marijuana Products Manufacturer shall not be required to conductresidual solvent tests on the Product Batches of a Critical Fluid Extraction RetailMarijuana Concentrate if only CO2 was used during the extraction process.

b. If a Retail Marijuana Products Manufacturing Facility does not wholesale ortransfer any of portion of a Critical Fluid Extraction Retail Marijuana Concentrate

within a Production Run and instead uses all of it produce Retail MarijuanaProduct, then that Production Batch shall be considered exempt from Rule R 606(D), except that residual solvent contamination testing shall still be required.

E. Random Sampling.

1. A Retail Marijuana Products Manufacturing Facility may be required by the Division tosubmit a random Sample of any Retail Marijuana Product it posses to a RetailMarijuana Testing Facility to be tested for potency or contaminants at any time andwithout notice. Testing on samples collected pursuant to this rule may include, butmay not be limited to, Pesticides, Herbicides, Fertilizers or other chemicals,microbials, molds, filth, harmful chemicals, and potency.

2. The Division, at its own discretion, may elect to have MED personnel or a divisionauthorized sample collection entity collect the random samples for testing at a RetailMarijuana Testing Facility.

3. The cost for all tests conducted pursuant to this rule shall be the financialresponsibility of the Retail Marijuana Products Manufacturing Facility.

H. Failed Contaminant Tests. If a Retail Marijuana Products Manufacturing Facility is notified by theDivision or a Retail Marijuana Testing Facility that a Production Batch failed contaminant testing,then the Retail Marijuana Products Manufacturing Facility may not process, wholesale or transfer

any of the Retail Marijuana Concentrate it possesses from that Production Batch that failedcontaminant testing and must either;

1. Destroy and document the destruction of the entire portion of the Production Batchthat it possesses; or

2. Decontaminate the portion of the Production Batch it possesses prior to having twoindependent samples re-collected and re-tested for the identified contaminant. If bothSamples pass the contaminant re-test(s), then any Retail Marijuana Concentrate fromthat Production Batch may be processed, wholesaled, or transferred. If one or bothof the Samples do not pass the contaminant re-test(s), then the Retail MarijuanaProducts Manufacturing Facility must destroy and document the destruction of the

entire portion of the Production Batch that it possesses.



22/27


The statutory authority for this rule is found at subsections 12-43.4-202(2)(b) and 12-43.4-403(5), C.R.S.The purpose of this rule is to establish the portion of the Divisions Mandatory Testing and RandomSampling program that is applicable to Retail Marijuana Product produced or possessed by a RetailMarijuana Products Manufacturing Facility.

R 607 Retail Marijuana Products Manufacturing Facility: Mandatory Testing and Random SamplingProgram for Retail Marijuana Product

A. Mandatory Contaminant Testing. A Retail Marijuana Products Manufacturing Facility shall notwholesale or transfer a Retail Marijuana Product unless the Production Batch from which thatRetail Marijuana derived was tested by a Retail Marijuana Testing Facility and passed allcontaminant tests required by this rule.

1. Microbial Contaminant Testing. Each Production Batch of Retail Marijuana Concentrateproduced by a Retail Marijuana Cultivation Facility must be tested for microbial

contamination by a Retail Marijuana Testing Facility. The microbial contamination testmust include, but need to be limited to, testing to determine the presence of and amountspresent of Salmonella sp., Ecoli sp. and total coliforms.

2. Mold Contaminant Testing. Each Production Batch of Retail Marijuana Product producedby a Retail Marijuana Products Manufacturing Facility must be tested for moldcontamination by a Retail Marijuana Testing Facility. The mold contamination test mustinclude, but need to be limited to, testing to determine the presence and level ofAspergillus sp., Mucor sp., Penicillium sp., thermophilic Actinomycetes sp.

B. Process Certification.

1. A Retail Marijuana Products Manufacturing Facilitys Retail Marijuana Product productionprocess shall be deemed certified by the Division if every Production Batch of RetailMarijuana Product that it produced during a 4 week period passed all contaminant testsrequired by Rule R607 (A).

2. If a Retail Marijuana Products Manufacturing Facilitys Retail Marijuana Productproduction process has been certified by the Division, then it shall be considered exemptfrom the requirements of Rule R60? (A). A Retail Marijuana Products ManufacturingFacility that has had its Retail Marijuana Product production process certified by theDivision shall be required to submit twelve Production Batches of Retail MarijuanaProduct per year, at one month intervals, for contaminant testing that must include alltests required by Rule R 607 (A).

3. Nothing within this rule shall exempt a Retail Marijuana Products Manufacturing Facilityfrom the Divisions random sampling program set forth in Rule R 607 (A).

4. A Retail Marijuana Products Manufacturing Facility shall be required to notify the Divisionwithin 30-days when any change to its Retail Marijuana Product production processoccurs and its process must be recertified according to the procedures set forth insubparagraph (a).


23/27

C. Potency Testing. A Retail Marijuana Products Manufacturing Facility shall not wholesale ortransfer a Retail Marijuana Product unless the Production Batch from which that Retail Marijuanawas derived was tested by a Retail Marijuana Testing Facility for potency.

D. Random Sampling.

1. A Retail Marijuana Products Manufacturing Facility may be required by the Division tosubmit a random Sample of any Retail Marijuana Product it posses to a Retail MarijuanaTesting Facility to be tested for potency or contaminants at any time and without notice.Testing on samples collected pursuant to this rule may include, but may not be limited to,Pesticides, Herbicides, Fertilizers or other Chemicals, residual solvents, microbials,molds, filth, harmful chemicals, and potency.

2. The Division, at its own discretion, may elect to have MED personnel or a divisionauthorized sample collection entity collect the random samples for testing at a RetailMarijuana Testing Facility.

3. The cost for all tests conducted pursuant to this rule shall be the financial responsibility ofthe Retail Marijuana Products Manufacturing Facility.

E. Failed Contaminant Tests. If a Retail Marijuana Products Manufacturing Facility is notified by theDivision or a Retail Marijuana Testing Facility that a Production Batch failed contaminant testing,then the Retail Marijuana Products Manufacturing Facility may not process, wholesale or transferany of the Retail Marijuana Product it possesses from that Production Batch that failed contaminanttesting and must either;

1. Destroy and document the destruction of the entire portion of the Production Batch that itpossesses; or

2. Decontaminate the portion of the Production Batch it possesses prior to having twoindependent samples re-collected and re-tested for the identified contaminant. If bothSamples pass the contaminant re-test(s), then any Retail Marijuana Product from thatProduction Batch may be wholesaled, or transferred. If one or both of the Samples do notpass the contaminant re-test(s), then the Retail Marijuana Products Manufacturing Facilitymust destroy and document the destruction of the entire portion of the Production Batchthat it possesses.



24/27


The statutory authority for this rule is found at subsections 12-43.4-202(2)(b) and 12-43.4-403(5), C.R.S.The purpose of this rule is to establish the portion of the Divisions Mandatory Testing and RandomSampling program that is applicable to Retail Marijuana Testing Facilities.

R 712 Retail Marijuana Testing Facility: Mandatory Testing and Random Sampling Program

A. Permissible Levels of Contaminants.

1. Microbials (Bacteria, Molds, Mildew, Fungus, Filth)

Escherichia coli - Bacteria Negative - No growth present

Salmonella species - Bacteria Negative No growth present

Total Coliform - Bacteria Less than 10,000 colony forming units per

microliter.

Aspergillus sp. Molds, Fungus Negative No growth present

Mucor sp. Molds, Fungus Negative No growth present

Penicillium sp. Molds, Fungus Negative No growth present

Thermophilic Actinomycetes sp. Molds,Fungus

Negative No growth present

Filth Analysis Levels TBD FDA references needed.

2. Residual Solvents

N-Butane < 5.0 Parts Per Million (PPM)

Iso-Butane < 5.0 Parts Per Million (PPM)

Propane < 5.0 Parts Per Million (PPM)

Heptane < 5.0 Parts Per Million (PPM)

2-propanol (isopropyl alcohol) < 5.0 Parts Per Million (PPM)

Ethanol < 5.0 Parts Per Million (PPM)


25/27

Propylene Glycol < 5.0 Parts Per Million (PPM)

Glycerin < 5.0 Parts Per Million (PPM)

B. Permissible THC Potency Variance.

1. THC Potency Variance for Types of Retail Marijuana.

a. Retail Marijuana Flower THC potency variance shall not exceed 20% from thereported and labeled value.

b. Retail Marijuana Concentrate THC potency variance shall not exceed 10% fromthe reported and labeled value.

c. Retail Marijuana Product THC potency variance shall not exceed 10% from the

reported and labeled value. Additionally, the potency must be homogenousthroughout the entire Retail Marijuana Product, meaning that 10% of any RetailMarijuana Product may contain more than 15% of the total THC contained withinentire Retail Marijuana Product.

2. Procedures for Retail Marijuana, Retail Marijuana Concentrates and Retail MarijuanaProducts That Exceed Permissible THC Potency Variances.

a. Variances exceeding the defined amounts listed in this rule require retesting ofthe Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Productto verify the potency. If the verification testing results confirm a potencyexceeding acceptable THC potency variance, then all reporting and labeling

must immediately be adjusted to accurately reflect that potency.

b. A Retail Marijuana Testing Facility must notify the Division within 30-days when aTHC potency test results falls outside of the acceptable variances established bythis rule.

C. Retesting of Retail Marijuana and Retail Marijuana Product.

1. If Retail Marijuana or Retail Marijuana Product failed a mandatory contaminant test, thenthe Retail Marijuana Testing Facility must immediately notify the Retail MarijuanaEstablishment that submitted the sample for testing. The Retail Marijuana Establish must

meet the retesting requirements found in Rule R 505, R506, R606, or R607 depending onthe source and type of Retail Marijuana. The Retail Marijuana Establishment may requestthat the Retail Marijuana Testing Facility that conducted the first test or another RetailMarijuana Testing Facility perform the secondary testing on the affected Harvest Batch orProduction Batch. The Retail Marijuana Establishment must report the all initial andsecondary test failure in accordance with all MITS procedures.

2. If Retail Marijuana or Retail Marijuana Product fails a mandatory contaminant test butsubsequently passes secondary contaminant tests, then the Division shall consider the


26/27

results of only the secondary testing when making a determination regarding anyexemption from mandatory testing.

D. Cost to Other Licensees. A Retail Marijuana Testing Facility must change the same price for alltests conducted pursuant to the Mandatory Testing Program established in Rules R 505, R506,R606, and R607 that it charges for any other similar test.


27/27


The statutory authority for this rule is found at subsections 12-43.4-202(2)(b) and 12-43.4-403(5), C.R.S.The purpose of this rule is to establish the portion of the Divisions Mandatory Testing and RandomSampling program that is applicable to Retail Marijuana Testing Facilities.

R 713 Retail Marijuana Testing Facility: Random Sampling Procedures

A. Sampling Procedures.

1. All Samples of Retail Marijuana must be taken by Division personnel or an individualcertified Division to collect a Retail Marijuana Sample.

2. All Samples of Retail Marijuana must be collected using industry best standards forcollection that ensure consistency, homogeneity and an accurate representative sample isobtained for testing by the Retail Marijuana Testing Facility.

B. Third-Party Samplers. If an individual certified by the Division to collect a Retail Marijuana Samplecollects the Sample, then that individual may not be employed by the Retail MarijuanaEstablishment submitting the Sample or by the Retail Marijuana Testing Facility testing theSample.

retail mandatory testing and random sampling draft language

Documents