Basis and Purpose – M 103

The statutory authority for this rule is found at subsection 12-43.3-202(1)(b)(I), C.R.S. The purpose of this rule is to provide necessary definitions of terms used throughout the rules. Defined terms are capitalized where they appear in the rules, to let the reader know to refer back to these definitions. . When a term is used in a conventional 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 written commentary provided by a public health agency within a Colorado hospital, which had conducted a health impact assessment of packaging regulations, looking at accidental ingestion of medical marijuana. The assessment was supported by others in the public, including industry representatives and a physician specializing in medical toxicology.

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

M 103 – Definitions

Definitions. The following definitions of terms, in addition to those set forth in section 12-43.3-104, C.R.S., shall apply to all rules promulgated pursuant to the Medical 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 to patronize a particular a Medical Marijuana Business, or to purchase particular Medical Marijuana or a Medical Marijuana-Infused Product. “Advertising” includes marketing, but does not include packaging and labeling. “Advertising” proposes a commercial transaction or otherwise constitutes commercial speech.

“Alarm Installation Company” means a Person engaged in the business of selling, providing, maintaining, servicing, repairing, altering, replacing, moving or installing a Security Alarm System in a Licensed Premises.

“Applicant” means a Person that has submitted an application pursuant to these rules that was accepted by the Division for review but has not been approved or denied by the State Licensing Authority.

“Associated Key License” means an Occupational License for an individual who is an Owner of the Medical Marijuana Business.

“Batch Number” means any distinct group of numbers, letters, or symbols, or any combination thereof, assigned by a Medical Marijuana Optional Premises Cultivation Operation or Medical Marijuana-Infused Products Manufacturer to a specific Harvest Batch or Production Batch of Retail Marijuana.

“Child-Resistant” means special packaging that is:

a.	Designed or constructed to be significantly difficult for children under five years of age to open 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 later amendments or editions to the Code of Federal Regulations or the ASTM classification standards. The Division has maintained a copy of the applicable federal regulation and ASTM 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 multiple servings, and

d.	Labeled properly as required by the M 1000 series.

"Container" means the sealed package in which Medical Marijuana or a Medical Marijuana-Infused Product is placed for sale to a patient and that has been labeled according to the requirements set forth in Rules M 1002 et. seq.

“CRITICAL FLUID EXTRACTION MEDICAL MARIJUANA CONCENTRATE” MEANS A MEDICAL MARIJUANA CONCENTRATE THAT WAS PRODUCED BY EXTRACTING CANNBINIODS FROM MEDICAL MARIJUANA THROUGH THE USE OF A HYDRO-CARBON SOLVENT, SUCH AS BUTANE OR PROPANE, OR CO2.

"Denied Applicant" means any Person whose application for licensure pursuant to the Medical Code has 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 Medical Marijuana-Infused Product" means any Medical Marijuana-Infused Product that is intended to be consumed 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 which any Medical Marijuana or Medical Marijuana-Infused Product already within a Container  are placed.

“FAT-BASED MEDICAL MARIJUANA CONCENTRATE” MEANS A MEDICAL MARIJUANA CONCENTRATE THAT WAS PRODUCED BY EXTRACTING CANNABINOIDS FROM MEDICAL MARIJUANA THROUGH THE USE OF BUTTER, OLIVE OIL OR OTHER TYPICAL COOKING FATS AS A SOLVENT.

“Final Agency Order” means an Order of the State Licensing Authority issued in accordance with the Medical Code and the State Administrative Procedure Act. The State Licensing Authority will issue a Final Agency Order following review of the Initial Decision and any exceptions filed thereto

or at the conclusion of the declaratory order process. A Final Agency Order is subject to judicial review.

“Flower” means the gametophytic or reproductive state of Cannabis in which the plant is in a light cycle intended to produce flowers, trichromes, and cannabinoids characteristic of marijuana.

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

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

b.	The Licensee or Applicant has failed to comply with any special terms or conditions that were placed upon the license pursuant to an order of the State Licensing Authority or the relevant local licensing authority; or

c.	The Licensee’s or the Applicant’s Licensed Premises have been operated in a manner that adversely affects 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 Medical Marijuana that is uniform in strain, cultivated using the same herbicides, pesticides, and fungicides, and harvested at the same time.

“Identity Statement” means the name of the business as it is commonly known and used in any Advertising materials.

"Immature plant” means a nonflowering Medical Marijuana plant that is no taller than eight inches and no wider than eight inches produced from a cutting, clipping, or seedling and that is in a growing/cultivating container that is no larger than two inches wide and two inches tall that 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.

“Key License” means an Occupational License for an individual who performs duties that are key to the Medical Marijuana Business’ operation and have the highest level of responsibility. Examples of individuals who need this type of license include, but are not limited to, managers and bookkeepers but do not include an Owner.

"Licensed Premises” means the premises specified in an application for a license pursuant to the Medical Code that are owned or in possession of the Licensee and within which the Licensee is

authorized to cultivate, manufacture, distribute, sell, or test Medical Marijuana in accordance with the provisions of the Medical Code and these rules.

"Licensee" means any Person licensed or registered pursuant to the Medical Code, including an Occupational Licensee.

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

“Limit of Detection” or “LOD” means the lowest quantity of a substance that can be distinguished from 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 only be reliably detected but at which some predefined goals for bias and imprecision are met.

“MITS” means Marijuana Inventory Tracking Solution.

“MITS Trained Administrator” means an Owner or an Occupational Licensed Licensee of a Medical Marijuana Business who has attended and successfully completed MITS training and who has completed any additional training required by the Division.

“MITS User” means an Owner or an occupationally licensed Medical Marijuana Business employee who is granted MITS User account access for the purposes of conducting inventory tracking functions in the MITS system, who has been successfully trained by MITS Trained Administrator(s) in the proper and lawful use MITS, and who has completed any additional training required by the Division.

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

“Medical Marijuana” means marijuana that is grown and sold pursuant to the Medical Code and includes seeds and Immature Plants.

"Medical Marijuana Business" means a licensed Medical Marijuana Center, a Medical Marijuana- Infused Products Manufacturer, or an Optional Premises Cultivation Operation.

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

“MEDICAL MARIJUANA  CONCENTRATE” MEANS SPECIFIC SUBSET OF MEDICAL MARIJUANA THAT WAS PRODUCED BY EXTRACTING CANNABINOIDS FROM MEDICAL MARIJUANA. TYPES OF MEDICAL MARIJUANA CONCENTRATES INCLUDE WATER-BASED MEDICAL MARIJUANA CONCENTRATES, SOLVENT-BASED MEDICAL MARIJUANA CONCENTRATES, CRITICAL FLUID EXTRACTION MEDICAL MARIJUANA CONCENTRATES AND FAT-BASED MEDICAL MARIJUANA CONCENTRATES.

“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 products, 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 Manufacturer" means a Person licensed pursuant to 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 could be transmitted from a Security Alarm System located at a Medical Marijuana Business Licensed Premises, for the purpose of summoning a law enforcement officer to the premises during alarm conditions.

"Monitoring Company” means a Person in the business of providing Monitoring services for a Medical Marijuana Business.

"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, C.R.S. An Occupational License may be an Associated Key License, a Key License or a Support License.

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

"Order to Show Cause" means a document from the State Licensing Authority alleging the grounds for imposing discipline against a Licensee’s license.

“Owner” means the Person or Persons whose beneficial interest in the license is such that they bear risk of loss other than as an insurer, and have an opportunity to gain profit from the operation or sale of the establishment. Each individual Owner must have an Associated Key License. Owner includes any other Person that qualifies as an Owner pursuant to Rule M 204.

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

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

“Production Batch” means a group of Medical Marijuana-Infused Product created from a production run of marijuana product.

“Propagation” means the reproduction of Medical Marijuana plants by seeds, cuttings or grafting. “RFID” means Radio Frequency Identification.

“Respondent’ means a person who has filed a petition for declaratory order that the State Licensing Authority has determined needs a hearing or legal argument or a Licensee who is subject to an Order to Show Cause.

“Restricted Access Area” means a designated and secure area within a Licensed Premises in a Medical Marijuana Center where Medical Marijuana and Medical Marijuana-Infused Product are sold, possessed for sale, and displayed for sale, and where no one without a valid patient registry card 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, the seeds 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 marijuana concentrate that is cultivated, manufactured, distributed, or sold by a licensed Retail Marijuana Establishment. "Retail Marijuana" does not include industrial hemp, nor does it include fiber produced from stalks, oil, or cake made from the seeds of the plant, sterilized seed of the plant which is incapable of germination, or the weight of any other ingredient combined with marijuana to prepare 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 Retail Marijuana Establishments, but not to consumers.

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

"Retail Marijuana Product" means concentrated Retail Marijuana Product and Retail Marijuana Product that are comprised of Retail Marijuana and other ingredients and are intended for use or consumption, such as, but not limited to, edible products, 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 Marijuana and Retail Marijuana Product to other Retail Marijuana Products Manufacturing Facilities and to Retail Marijuana Stores, but not to consumers.

“Retail Marijuana Store” means an entity licensed to purchase Retail Marijuana from a Retail Marijuana Cultivation Facility and to purchase Retail Marijuana Product from a Retail Marijuana Products Manufacturing Facility and to sell Retail Marijuana and Retail Marijuana  Product  to consumers.

“Retail Marijuana Testing Facility” means an entity licensed and certified to analyze and certify the safety and potency of Retail Marijuana.

“Sample” means any Medical Marijuana or Medical Marijuana-Infused Product provided for testing or research purposes to a Retail Marijuana Testing Facility with a vendor registration and Occupational License in accordance with Rule M 701 – Vendor Registration and Occupational License for Medical Marijuana Testing and Research.

"Security Alarm System” means a device or series of devices, intended to summon law enforcement 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 or private 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 entry of 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 (a silent system signal to indicate that a robbery is in progress).

“Shipping Container” means any container or wrapping used solely for the transport of Medical Marijuana or Medical Marijuana-Infused Product in bulk, or in a quantity for other Medical Marijuana Businesses.

“SOLVENT-BASED MEDICAL MARIJUANA CONCENTRATE” MEANS A MEDICAL MARIJUANA CONCENTRATE THAT WAS PRODUCED BY EXTRACTING CANNBINIODS FROM MEDICAL MARIJUANA THROUGH THE USE OF GLYCERIN, ISOPROPYL ALCOHOL, ETHANOL, OR PROPYLENE GLYCOL AS A SOLVENT.

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

“Support License” means a license for an individual who performs duties that support the Medical Marijuana Business’ operations. While a Support Licensee must conduct himself or herself professionally, he or she has limited decision making authority and always fall under the supervision of an Associated Key Licensee. Examples of individuals who need this type of license include, but are not limited to, sales clerks or cooks.

"THC" means tetrahydrocannabinol.

“Unrecognizable” means marijuana or Cannabis plant material rendered indistinguishable from any other plant material.

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

“WATER-BASED MEDICAL MARIJUANA CONCENTRATE” MEANS A MEDICAL MARIJUANA CONCENTRATE THAT WAS PRODUCED BY EXTRACTING CANNABINOIDS FROM MEDICAL MARIJUANA THROUGH THE USE OF ONLY WATER OR ICE.

M 504 – Optional Premises Cultivation Operation: Health and Safety Regulations

A.	Local Safety Inspections. An Optional Premises Cultivation Operation may be subject to inspection of its Licensed Premises by the local fire department, building inspector, or code enforcement officer to confirm that no health or safety concerns are present. The inspection could result in additional specific standards to meet local licensing authority restrictions related to Medical Marijuana or other local businesses. An annual fire safety inspection may result in the required installation of fire suppression devices, or other means necessary for adequate fire safety.

B.	General  Sanitary  Requirements.	An Optional Premises Cultivation Operation shall take all reasonable measures and precautions to ensure the following:

1.	That any person who, by medical examination or supervisory observation, is shown to have, or appears to have, an illness, open lesion, including boils, sores, or infected wounds, or any other abnormal source of microbial contamination for whom there is a reasonable possibility of  contact with Medical Marijuana shall be  excluded  from  any operations which may be expected to result in such contamination until the condition is corrected;

2.	That all persons working in direct contact with Medical Marijuana shall conform to hygienic practices while on duty, including but not limited to:

a.	Maintaining adequate personal cleanliness;

b.	Washing hands thoroughly in an adequate hand-washing area(s) before starting work and at any other time when the hands may have become soiled or contaminated;

c.	Hand-washing facilities shall be adequate and convenient and be furnished with running water at a suitable temperature. Hand-washing facilities shall be located in the Licensed Premises and where good sanitary practices require employees to  wash and/or sanitize their hands, and provide effective hand-cleaning and sanitizing preparations and sanitary towel service or suitable drying devices; and

d.	Refraining from having direct contact with Medical Marijuana if the person has or may have an illness, open lesion, including boils, sores, or infected wounds, or any other abnormal source of microbial contamination, until such condition is corrected.

3.	That litter and waste are properly removed and the operating systems for waste disposal are maintained in an adequate manner so that they do not constitute a source of contamination in areas where Medical Marijuana is exposed;

4.	That floors, walls, and ceilings are constructed in such a manner that they may be adequately cleaned and kept clean and kept in good repair;

5.	That there is adequate lighting in all areas where Medical Marijuana is stored and where equipment or utensils are cleaned;
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6.	That the Licensee provides adequate screening or other protection against the entry of pests. Rubbish shall be disposed of so as to minimize the development of odor and minimize the potential for the waste becoming an attractant, harborage, or breeding place for pests;

7.	That any buildings, fixtures, and other facilities are maintained in a sanitary condition;

8.	That toxic cleaning compounds, sanitizing agents, solvents used in the production of Medical Marijuana concentrates, and pesticide chemicals shall be identified, held, and stored in a manner that protects against contamination of Medical Marijuana, and in a manner that is in accordance with any applicable local, state, or federal law, rule, regulation, or ordinance;

9.	That all contact surfaces, including utensils and equipment used for the preparation of Retail Marijuana or Retail Marijuana Product, shall be cleaned and sanitized as frequently as necessary to protect against contamination. Equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained. Only sanitizing agents registered with the Environmental Protection Agency shall be used in Retail Marijuana Products Manufacturing Facilities and used in accordance with labeled instructions;

10.	That the water supply shall be sufficient for the operations intended and shall be derived from a source that is a regulated water system. Private water supplies shall be derived from a water source that is capable of providing a safe, potable, and adequate supply of water to meet the facility’s needs;

11.	That plumbing shall be of adequate size and design and adequately installed and maintained to carry sufficient quantities of water to required locations throughout the plant and that shall properly convey sewage and liquid disposable waste from the facility. There shall be no cross-connections between the potable and waste water lines;

12.	That all operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of Retail Marijuana or Retail Marijuana Product shall be conducted in accordance with adequate sanitation principles;

13.	That each Optional Premises Cultivation Operation shall provide its employees with adequate and readily accessible toilet facilities that are maintained in a sanitary condition and good repair; and

14.	That Medical Marijuana that can support the rapid growth of undesirable microorganisms shall be held in a manner that prevents the growth of these microorganisms.

C.	Sanitary Requirements for Concentrate Production. If an Optional Premises Cultivation Operation produces Medical Marijuana concentrates, all areas in which those concentrates are produced shall be subject to all of sanitary requirements for a Medical Marijuana Infused-Products Manufacturer. See Rule M 605 – Sanitary Requirements: Medical Marijuana-Infused Products Manufacturers.
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D.	Prohibited Chemicals. The following chemicals shall not be used in Medical Marijuana cultivation.
Possession of chemicals and/or containers from these chemicals upon the Licensed Premises shall be a violation of this rule. Prohibited chemicals are:

Chemical Name

CAS	Registry	Number	(or	EDF Substance ID)

ALDRIN 309-00-2

ARSENIC OXIDE (3) 1327-53-3

ASBESTOS (FRIABLE) 1332-21-4

AZODRIN 6923-22-4

1,4-BENZOQUINONE, 2,3,5,6-TETRACHLORO-
118-75-2

BINAPACRYL 485-31-4

2,3,4,5-BIS (2-BUTENYLENE) TETRAHYDROFURFURAL
126-15-8

BROMOXYNIL BUTYRATE EDF-186

CADMIUM COMPOUNDS CAE750

CALCIUM ARSENATE [2ASH3O4.2CA] 7778-44-1

CAMPHECHLOR 8001-35-2

CAPTAFOL 2425-06-1

CARBOFURAN 1563-66-2

CARBON TETRACHLORIDE

CHLORDANE 57-74-9

CHLORDECONE (KEPONE)

143-50-0

CHLORDIMEFORM 6164-98-3

CHLOROBENZILATE 510-15-6

CHLOROMETHOXYPROPYLMERCURIC	ACETATE [CPMA] EDF-183

COPPER ARSENATE 10103-61-4

2,4-D, ISOOCTYL ESTER
25168-26-7

DAMINOZIDE 1596-84-5

DDD 72-54-8

DDT
50-29-3

DI(PHENYLMERCURY)DODECENYLSUCCINATE [PMDS] EDF- 187

1,2-DIBROMO-3-CHLOROPROPANE   (DBCP)
96-12-8

1,2-DIBROMOETHANE
106-93-4

1,2-DICHLOROETHANE
107-06-2

DIELDRIN 60-57-1

4,6-DINITRO-O-CRESOL

DINITROBUTYL PHENOL 88-85-7

ENDRIN 72-20-8

EPN 2104-64-5

ETHYLENE OXIDE 75-21-8

FLUOROACETAMIDE 640-19-7

GAMMA-LINDANE 58-89-9

HEPTACHLOR 76-44-8

HEXACHLOROBENZENE 118-74-1

1,2,3,4,5,6-HEXACHLOROCYCLOHEXANE (MIXTURE OF ISOMERS)
608-73-1

1,3-HEXANEDIOL, 2-ETHYL-
94-96-2

LEAD ARSENATE 7784-40-9

LEPTOPHOS 21609-90-5

MERCURY 7439-97-6

METHAMIDOPHOS 10265-92-6

METHYL PARATHION 298-00-0

MEVINPHOS 7786-34-7

MIREX

NITROFEN 1836-75-5

OCTAMETHYLDIPHOSPHORAMIDE 152-16-9

PARATHION 56-38-2

PENTACHLOROPHENOL 87-86-5

PHENYLMERCURIC OLEATE [PMO] EDF-185

PHOSPHAMIDON 13171-21-6

PYRIMINIL 53558-25-1

SAFROLE 94-59-7

SODIUM ARSENATE 13464-38-5

SODIUM ARSENITE 7784-46-5

2,4,5-T
93-76-5

TERPENE POLYCHLORINATES (STROBANE6) 8001-50-1

THALLIUM(I) SULFATE 7446-18-6

2,4,5-TP ACID (SILVEX)
93-72-1

TRIBUTYLTIN COMPOUNDS EDF-184

2,4,5-TRICHLOROPHENOL

VINYL CHLORIDE 75-01-4

E.	The use of Dimethylsulfoxide (DMSO) in the production of Medical Marijuana shall be prohibited and possession of DMSO upon the Licensed Premises is prohibited.

F.	That all sanitary requirements shall also apply to any Occupational Licensee making Medical Marijuana concentrates on the Licensed Premises.

G.	Medical Marijuana Optional Premises Cultivation  Operations  may  only  produce  water  based Medical Marijuana concentrates on its Licensed Premises and only in an area so designated clearly on the current diagram of the Licensed Premises. See Rule M 901- Business Records Required. A Medical Marijuana Optional Premises Cultivation Operation  is  prohibited  from engaging in any other method of extraction.
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BASIS AND PURPOSE – M 506

THE STATUTORY AUTHORITY FOR THIS RULE IS FOUND AT SUBSECTIONS 12-43.3-202(2)(B), C.R.S. THE PURPOSE OF THIS RULE IS TO ESTABLISH THE TYPES OF MEDICAL MARIJUANA CONCENTRATES THAT MAY BE PRODUCED AT AN OPTIONAL PREMISES CULTIVATION OPERATION AND STANDARDS FOR THE PRODUCTION OF THOSE CONCENTRATES.

M 506 – OPTIONAL PREMISES CULTIVATION OPERATION: MEDICAL MARIJUANA CONCENTRATE PRODUCTION

A.	PERMISSIBLE TYPES OF CONCENTRATE PRODUCTION. AN OPTIONAL PREMISES CULTIVATION OPERATION MAY ONLY PRODUCE WATER-BASED MEDICAL MARIJUANA CONCENTRATES ON ITS LICENSED PREMISES AND ONLY IN AN AREA CLEARLY DESIGNATED FOR CONCENTRATE PRODUCTION ON THE CURRENT DIAGRAM OF THE LICENSED PREMISES. SEE RULE M 901- BUSINESS RECORDS REQUIRED. NO OTHER METHOD OF PRODUCTION OR EXTRACTION FOR MEDICAL MARIJUANA CONCENTRATES MAY BE CONDUCTED WITHIN THE LICENSED PREMISE OF AN OPTIONAL PREMISES CULTIVATION OPERATION.

B.	SAFETY AND SANITARY REQUIREMENTS FOR CONCENTRATE PRODUCTION. IF AN OPTIONAL PREMISES CULTIVATION OPERATION PRODUCES WATER-BASED MEDICAL MARIJUANA CONCENTRATES, ALL AREAS IN WHICH THOSE CONCENTRATES ARE PRODUCED AND ALL OWNERS AND OCCUPATIONAL LICENSEES ENGAGED IN THE PRODUCTION OF THOSE CONCENTRATES SHALL BE SUBJECT TO ALL  OF REQUIREMENTS IMPOSED UPON  A MEDICAL MARIJUANA-INFUSED PRODUCTS	MANUFACTURER	THAT	PRODUCES	WATER-BASED	MEDICAL	MARIJUANA CONCENTRATES. SEE RULE M 604 – MEDICAL MARIJUANA-INFUSED PRODUCTS MANUFACTURER: HEALTH AND SAFETY REGULATIONS AND RULE M 605 MEDICAL MARIJUANA-INFUSED PRODUCTS MANUFACTURER: MEDICAL MARIJUANA CONCENTRATE PRODUCTION.
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Basis and Purpose – M 604

The statutory authority for this rule is found at subsections 12-43.3-202(1)(b)(I) and 12-43.3-202(2)(a)(XX), and section 12-43.3-404, C.R.S. The purpose of this rule is to  establish  minimum  health  and safety regulations for Medical Marijuana-Infused Products Manufacturers. IT REQUIRES ALL OWNERS AND OCCUPATIONAL  LICENSEES  TO  ATTEND  A  FOOD  HANDLER  TRAINING  COURSE  PRIOR  TO  MANUFACTURING  ANY
EDIBLE MARIJUANA PRODUCT. It sets forth general standards and basic sanitary requirements for Medical Marijuana-Infused Products Manufacturers. It covers the physical premises where the products are made as well as the individuals handling the products. The State Licensing Authority modeled this rule after those adopted by the Colorado Department of Public Health and Environment.   The State Licensing Authority
intends this rule to help maintain the integrity of Colorado’s Medical Marijuana Businesses and the safety of the public.

M 604 – Medical Marijuana-Infused Products Manufacturer: Health and Safety Regulations

A.	Training. All Owners and Occupational Licensees must attend a ServeSafe Food Handler course conducted by the National Restaurant Association and successful complete online assessment or print exam with a score sufficient to receive the ServeSafe Food Handler Certificate prior to engaging in the manufacture of any Edible Retail Marijuana Product.

B.	General Standards

1.	A Medical Marijuana-Infused Products Manufacturer may be subject to inspection by the local fire department, building inspector, or code enforcement officer to confirm that no health or safety concerns are present. The inspection could result in additional specific standards to meet local jurisdiction restrictions related to Medical Marijuana. An annual fire safety inspection may result in the required installation of fire suppression devices, or other means necessary for adequate fire safety.

2.	A Medical Marijuana-Infused Products Manufacturer that manufacturers Edible Medical Marijuana-Infused Product shall comply with all kitchen-related health  and  safety standards of the relevant local licensing authority and, to the extent applicable, with all Colorado Department of Public Health and Environment health and safety regulations applicable to retail food establishments, as set forth in 6 CCR 1010-2.

C.	General Sanitary Requirements. The Licensee shall take all reasonable measures and precautions to ensure the following:

1.	That any person who, by medical examination or supervisory observation, is shown to have, or appears to have, an illness, open lesion, including boils, sores, or infected wounds, or any other abnormal source of microbial contamination for whom there is a reasonable possibility of contact with preparation surfaces for Medical Marijuana or Medical Marijuana-Infused Product shall be excluded from any operations which may be expected to result in such contamination until the condition is corrected;

2.	That hand-washing facilities shall be adequate and convenient and be furnished with running water at a suitable temperature. Hand-washing facilities shall be located in the facility and/or in Medical Marijuana-Infused Product preparation areas and where good sanitary practices require employees to wash and/or sanitize their hands, and provide
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effective hand-cleaning and sanitizing preparations and sanitary towel service or suitable drying devices;

3.	That all persons working in direct contact with preparation of Medical Marijuana  or Medical Marijuana-Infused Product shall conform to hygienic practices while on duty, including but not limited to:

a.	Maintaining adequate personal cleanliness;

b.	Washing hands thoroughly in an adequate hand-washing area(s) before starting work and at any other time when the hands may have become soiled or contaminated; and

c.	Refraining from having direct contact with preparation of Medical Marijuana or Medical Marijuana-Infused Product if the person has or may have an illness, open lesion, including boils, sores, or infected wounds, or any other abnormal source of microbial contamination, until such condition is corrected.

4.	That there is sufficient space for placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations for production of Medical Marijuana or Medical Marijuana-Infused Product;

5.	That litter and waste are properly removed and the operating systems for waste disposal are maintained in an adequate manner so that they do not constitute a source of contamination in areas where Medical Marijuana or Medical Marijuana-Infused Product are exposed;

6.	That floors, walls, and ceilings are constructed in such a manner that they may be adequately cleaned and kept clean and kept in good repair;

7.	That there is adequate safety-type lighting in all areas where Medical Marijuana  or Medical Marijuana-Infused Product are processed or stored and where equipment or utensils are cleaned;

8.	That the facility provides adequate screening or other protection against the entry of pests. Rubbish shall be disposed of so as to minimize the development of odor and minimize the potential for the waste becoming an attractant, harborage, or breeding place for pests;

9.	That any buildings, fixtures, and other facilities are maintained in a sanitary condition;

10.	That all contact surfaces, including utensils and equipment used for the preparation of Medical Marijuana or Medical Marijuana-Infused Product, shall be cleaned and sanitized as frequently as necessary to protect against contamination. Equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained. Only sanitizing agents registered with the Environmental Protection Agency shall be used in Medical Marijuana-Infused Products Manufacturer and used in accordance with labeled instructions;
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11.	That toxic cleaning compounds, sanitizing agents, solvents used in the production of Medical Marijuana concentrates, and pesticide chemicals shall be identified, held, and stored in a manner that protects against contamination of Medical Marijuana or Medical Marijuana-Infused Product, and in a manner that is in accordance with any applicable local, state, or federal law, rule, regulation or ordinance;

12.	That the water supply shall be sufficient for the operations intended and shall be derived from a source that is a regulated water system. Private water supplies shall be derived from a water source that is capable of providing a safe, potable, and adequate supply of water to meet the facility’s needs;

13.	That plumbing shall be of adequate size and design and adequately installed and maintained to carry sufficient quantities of water to required locations throughout the plant and that shall properly convey sewage and liquid disposable waste from the facility. There shall be no cross-connections between the potable and waste water lines;

14.	That each Medical Marijuana-Infused Products Manufacturer shall provide its employees with adequate and readily accessible toilet facilities that are maintained in a sanitary condition and good repair;

15.	That all operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of Medical Marijuana or Medical Marijuana-Infused Product shall be conducted in accordance with adequate sanitation principles;

16.	That Medical Marijuana or Medical Marijuana-Infused Product that can support the rapid growth of undesirable microorganisms shall be held in a manner that prevents the growth of these microorganisms; and

17.	That storage and transport of finished Medical Marijuana-Infused Product shall be under conditions that will protect products against physical, chemical, and microbial contamination as well as against deterioration of any container.
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BASIS AND PURPOSE – M 605

THE STATUTORY AUTHORITY FOR THIS RULE IS FOUND AT SUBSECTIONS 12-43.3-202(2)(B). THE PURPOSE OF THIS RULE IS TO ESTABLISH THE TYPES OF MEDICAL MARIJUANA CONCENTRATES THAT MAY BE PRODUCED AT A MEDICAL MARIJUANA-INFUSED PRODUCTS MANUFACTURER AND ESTABLISH STANDARDS FOR THE PRODUCTION OF THOSE CONCENTRATES.

M 605 – MEDICAL  MARIJUANA-INFUSED  PRODUCTS  MANUFACTURER: MEDICAL  MARIJUANA  CONCENTRATE PRODUCTION

A.	PERMISSIBLE TYPES OF CONCENTRATE PRODUCTION.

1.	A MEDICAL MARIJUANA-INFUSED PRODUCTS MANUFACTURER MAY PRODUCE WATER-BASED MEDICAL MARIJUANA CONCENTRATES, FAT-BASED MEDICAL MARIJUANA CONCENTRATES AND SOLVENT-BASED MEDICAL MARIJUANA CONCENTRATE. A MEDICAL MARIJUANA-INFUSED PRODUCTS MANUFACTURER MAY ALSO PRODUCE CRITICAL FLUID EXTRACTION MEDICAL MARIJUANA CONCENTRATES, PROVIDED THE  VOC SOLVENTS USED IN THE PROCESS ONLY INCLUDE: N-BUTANE, ISO-BUTANE, PROPANE, HEPTANE, OR CO2. THE USE OF ANY OTHER SOLVENT IS EXPRESSLY PROHIBITED UNLESS AND UNTIL IT IS APPROVED BY THE DIVISION.

2.	A MEDICAL MARIJUANA-INFUSED PRODUCTS MANUFACTURER MAY APPLY TO THE DIVISION FOR APPROVAL OF ADDITIONAL TYPES OF SOLVENTS OR PRODUCTION METHODS.

B.	GENERAL APPLICABILITY. A MEDICAL MARIJUANA-INFUSED PRODUCTS MANUFACTURER THAT ENGAGES IN THE PRODUCTION OF MEDICAL MARIJUANA CONCENTRATES, REGARDLESS OF THE METHOD OF EXTRACTION OR TYPE OF CONCENTRATE BEING PRODUCED, MUST:

1.	ENSURE THAT THE SPACE IN WHICH ANY MEDICAL MARIJUANA CONCENTRATE IS TO BE PRODUCED IS A FULLY ENCLOSED ROOM AND CLEARLY DESIGNATED ON THE CURRENT DIAGRAM OF THE LICENSED PREMISES. SEE RULE M 901- BUSINESS RECORDS REQUIRED.

2.	ESTABLISH A STANDARD OPERATING PROCEDURE FOR EACH METHOD USED TO PRODUCE A MEDICAL MARIJUANA CONCENTRATE ON ITS LICENSED PREMISE.

3.	ESTABLISH  WRITTEN  AND  DOCUMENTABLE  QUALITY  CONTROL  PROCEDURES  DESIGNED  TO MINIMIZE ANY POTENTIAL RISKS TO EMPLOYEES OR CONTAMINATION OF PRODUCTS.

4.	HAVE A COMPREHENSIVE TRAINING MANUAL THAT PROVIDES STEP-BY-STEP INSTRUCTIONS FOR EACH METHOD USED TO PRODUCE A MEDICAL MARIJUANA CONCENTRATE ON ITS LICENSED PREMISE. THE TRAINING MANUAL MUST INCLUDE, BUT NEED NOT BE LIMITED TO, ALL STANDARD OPERATING PROCEDURES, QUALITY CONTROL PROCEDURES AND SAFETY PROCEDURES FOR EACH METHOD OF PRODUCTION, INSTRUCTIONS ON THE APPROPRIATE USE AND MAINTENANCE OF ALL EQUIPMENT INVOLVED IN EACH PROCESS, AND ANY CLEANING REQUIRED TO COMPLY WITH ALL APPLICABLE SANITARY RULES.

5.	PROVIDE ADEQUATE TRAINING TO EVERY OWNER OR OCCUPATIONAL LICENSEE PRIOR TO THAT INDIVIDUAL ENGAGING THE PRODUCTION OF A MEDICAL MARIJUANA CONCENTRATE. ADEQUATE TRAINING MUST INCLUDE, BUT NEED NOT BE LIMITED TO, PROVIDING THE OWNER OR OCCUPATIONAL LICENSEE WITH THE  TRAINING  MANUAL FOR  THAT  LICENSED PREMISE AND
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LIVE, IN-PERSON INSTRUCTION DETAILING SAFETY PROCEDURES FOR EACH METHOD OF PRODUCTION, INSTRUCTIONS ON THE APPROPRIATE USE AND MAINTENANCE OF ALL EQUIPMENT INVOLVED IN THE PROCESS, AND ANY CLEANING REQUIRED TO MAINTAIN COMPLIANCE WITH ALL APPLICABLE SANITARY RULES.

6.	MAINTAIN CLEAR AND COMPREHENSIVE RECORDS THAT DOCUMENT EVERY PHASE OF EACH PRODUCTION RUN OF MEDICAL MARIJUANA CONCENTRATE, WHICH MUST INCLUDE THE NAME AND LICENSE NUMBER OF EVERY OWNER OR OCCUPATIONAL LICENSEE THAT WORKED ON THE PRODUCTION OF THAT MEDICAL MARIJUANA CONCENTRATE.

C.	WATER-BASED	MEDICAL	MARIJUANA	CONCENTRATES,    FAT-BASED	MEDICAL	MARIJUANA CONCENTRATES AND SOLVENT-BASED MEDICAL MARIJUANA CONCENTRATES. A MEDICAL MARIJUANA- INFUSED PRODUCTS MANUFACTURER THAT ENGAGES IN THE PRODUCTION OF A WATER-BASED MEDICAL MARIJUANA CONCENTRATE, A FAT-BASED MEDICAL MARIJUANA CONCENTRATE, OR A SOLVENT-BASED MEDICAL MARIJUANA CONCENTRATE MUST:

1.	ESTABLISH A STANDARD OPERATING PROCEDURE FOR EACH TYPE OF WATER-BASED MEDICAL MARIJUANA CONCENTRATE, FAT-BASED MEDICAL MARIJUANA CONCENTRATE OR A SOLVENT- BASED MEDICAL MARIJUANA CONCENTRATE TO BE PRODUCED AT THAT LICENSED PREMISE THAT IS DESIGNED TO MINIMIZE THE POTENTIAL FOR THE DEVELOPMENT OF MICROBIALS AND MOLD AND PRESENCE OF RESIDUAL SOLVENTS (WHEN NECESSARY).

2.	REQUIRE EACH OWNER OR OCCUPATIONAL LICENSEE TO THOROUGHLY WASH HIS OR HER HANDS PRIOR TO ENGAGING IN ANY ACTIVITY RELATED TO THE PRODUCTION OF A WATER- BASED MEDICAL MARIJUANA CONCENTRATE, FAT-BASED MEDICAL MARIJUANA CONCENTRATE OR A SOLVENT-BASED MEDICAL MARIJUANA CONCENTRATE.

3.	ENSURE THAT ALL EQUIPMENT USED IN THE PRODUCTION OF A WATER-BASED MEDICAL MARIJUANA CONCENTRATE, FAT-BASED MEDICAL MARIJUANA CONCENTRATE OR A SOLVENT- BASED MEDICAL MARIJUANA CONCENTRATE IS FOOD-GRADE, INCLUDING ENSURING THAT ALL
COUNTERS AND SURFACE AREAS WERE CONSTRUCTED IN SUCH A MANNER THAT IT REDUCES THE POTENTIAL FOR THE DEVELOPMENT OF MICROBIALS AND MOLD AND CAN BE EASILY CLEANED.

4.	ENSURE THAT ALL EQUIPMENT, COUNTERS, AND SURFACES USED IN THE PRODUCTION OF A WATER-BASED MEDICAL MARIJUANA CONCENTRATE, FAT-BASED MEDICAL MARIJUANA CONCENTRATE OR A SOLVENT-BASED MEDICAL MARIJUANA CONCENTRATE IS THOROUGHLY CLEANED AFTER THE COMPLETION OF EACH PRODUCTION BATCH.

D.	CRITICAL FLUID EXTRACTION MEDICAL MARIJUANA CONCENTRATES. A MEDICAL MARIJUANA-INFUSED PRODUCTS MANUFACTURER THAT ENGAGES IN THE PRODUCTION  OF  CRITICAL  FLUID  EXTRACTION MEDICAL MARIJUANA CONCENTRATES MUST:

1.	ENSURE THAT THE FACILITY AND ALL EQUIPMENT USED IN PRODUCTION OF THE CRITICAL FLUID EXTRACTION MEDICAL MARIJUANA CONCENTRATE MEETS THE FOLLOWING REQUIREMENTS:

a.	A   PROFESSIONAL   GRADE,   CLOSED-LOOP   EXTRACTION   SYSTEM   CAPABLE   OF RECOVERING THE SOLVENT USED;
a.	
b.	IF A PRESSURIZED EXTRACTION SYSTEM IS UTILIZED, THEN EVERY VESSEL IN THE SYSTEM MUST BE RATED TO A MINIMUM OF NINE HUNDRED POUNDS PER SQUARE INCH;

c.	A SUFFICIENT FUME HOOD  AND  EXHAUST  SYSTEM  IS  INSTALLED  IN  THE  ROOM  IN WHICH A CRITICAL FLUID EXTRACTION MEDICAL MARIJUANA CONCENTRATE SHALL BE PRODUCED AND THAT THE SYSTEM IS FULLY FUNCTIONING PRIOR TO THE PRODUCTION A CRITICAL FLUID EXTRACTION MEDICAL MARIJUANA CONCENTRATE;

d.	ALL FLAMMABLE MATERIAL USED IN THE PRODUCTION OF A CRITICAL FLUID EXTRACTION MEDICAL MARIJUANA CONCENTRATE ARE STORED IN A STORAGE-TANK DESIGNED TO HOLD FLAMMABLE MATERIAL AND IS OUTSIDE OF THE ROOM IN WHICH THE CONCENTRATES ARE TO BE PRODUCED;

e.	A SUFFICIENT FIRE-SUPPRESSION SYSTEM IS INSTALLED IN THE ROOM IN WHICH A CRITICAL FLUID EXTRACTION MEDICAL MARIJUANA CONCENTRATE SHALL BE PRODUCED AND THAT THE SYSTEM IS FULLY FUNCTIONING PRIOR TO THE PRODUCTION A CRITICAL FLUID EXTRACTION MEDICAL MARIJUANA CONCENTRATE;

f.	ALL EQUIPMENT USED IN THE PRODUCTION OF A  CRITICAL  FLUID  EXTRACTION MEDICAL MARIJUANA CONCENTRATE IS FOOD-GRADE AND ALL COUNTERS  AND SURFACE AREAS ARE CONSTRUCTED IN SUCH A MANNER THAT IT REDUCES  THE POTENTIAL FOR THE DEVELOPMENT OF MICROBIALS AND MOLD AND CAN BE EASILY CLEANED;

g.	A HYDRO-CARBON GAS MONITORING SYSTEM, A CO2 GAS MONITORING SYSTEM OR BOTH, DEPENDING ON THE TYPE OF MEDICAL MARIJUANA CONCENTRATE TO BE PRODUCED, WITH EMERGENCY SHUTDOWN RELAYS IS INSTALLED IN THE ROOM IN WHICH A CRITICAL FLUID EXTRACTION MEDICAL MARIJUANA CONCENTRATE SHALL BE PRODUCED AND THAT THE SYSTEM IS FULLY FUNCTIONING PRIOR TO THE PRODUCTION
A CRITICAL FLUID EXTRACTION MEDICAL MARIJUANA CONCENTRATE;

h.	THE ROOM IN WHICH A CRITICAL FLUID EXTRACTION MEDICAL MARIJUANA CONCENTRATE SHALL BE PRODUCED IS A SPARK-FREE ENVIRONMENT, WHICH SHALL INCLUDE THE USE OF NEC CLASS 1 DIVISION 2 OUTLETS, LIGHTS AND JUNCTION BOXES, THE GROUNDING OF ALL OUTLETS AND THE PLACEMENT OF GROUNDING MATS ALONG THE FLOOR AND ON WORK SURFACES. THIS REQUIREMENT SHALL NOT APPLY TO A MEDICAL MARIJUANA-INFUSED PRODUCTS MANUFACTURER THAT ONLY USES CO2 TO PRODUCE CRITICAL FLUID EXTRACTION MEDICAL MARIJUANA CONCENTRATE
AND

i.	THE ROOM IN WHICH A CRITICAL FLUID EXTRACTION MEDICAL MARIJUANA CONCENTRATE SHALL BE PRODUCED CONTAINS AN EMERGENCY SHOWER. THIS REQUIREMENT SHALL NOT APPLY TO A MEDICAL MARIJUANA-INFUSED PRODUCTS MANUFACTURER THAT ONLY USES CO2 TO PRODUCE CRITICAL FLUID EXTRACTION MEDICAL MARIJUANA CONCENTRATE.

2.	ENSURE THAT ALL FLUIDS USED IN THE EXTRACTION PROCESS ARE FOOD-GRADE AND 99% PURE BY OBTAINING A MATERIAL SAFETY DATA SHEET FROM THE FLUIDS MANUFACTURER OR DISTRIBUTOR. A MEDICAL MARIJUANA-INFUSED PRODUCTS MANUFACTURER MUST MAINTAIN A
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COPY OF THE MATERIAL SAFETY DATA SHEET AND A RECEIPT OF PURCHASE FOR ALL FLUIDS USED OR TO BE USED IN AN EXTRACTION PROCESS.

3.	ESTABLISH A STANDARD OPERATING PROCEDURE FOR EACH TYPE OF CRITICAL FLUID EXTRACTION MEDICAL MARIJUANA CONCENTRATE TO BE PRODUCED AT THAT LICENSED PREMISE THAT IS DESIGNED TO MAXIMIZE EMPLOYEE SAFETY AND MINIMIZE POTENTIAL CONTAMINATION OF PRODUCTS WITH RESIDUAL SOLVENTS OR MICROBIALS AND MOLD.

4.	REQUIRE EACH OWNER OR OCCUPATIONAL LICENSEE TO THOROUGHLY WASH HIS OR HER HANDS PRIOR TO ENGAGING IN ANY ACTIVITY RELATED TO THE PRODUCTION OF A CRITICAL FLUID EXTRACTION MEDICAL MARIJUANA CONCENTRATE.

5.	OBTAIN A REPORT FROM AN INDUSTRIAL HYGIENIST CERTIFIED BY THE AMERICAN BOARD OF INDUSTRIAL HYGIENE AND PROFESSIONAL ENGINEER THAT VERIFIES THAT THE FACILITY AND STANDARD OPERATING PROCEDURES COMPLY WITH ALL APPLICABLE LOCAL AND STATE LAWS AND ADEQUATELY PROTECT THE FACILITY AND PERSONS WITHIN THE FACILITY AND ADJACENT PROPERTIES FROM HARM.