9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 1 of 201 R 100 Series – General Applicability Basis and Purpose – R 101 The statutory authority for this rule includes but is not limited to subsections 12-43.4-102(2), 12-43.4202(2)(b), and 12-43.4-901(2)(a), C.R.S. Unless such activity is authorized by the Colorado Constitution, article XVIII, Section 14 or Section 16, the Retail Marijuana Code, section 25-1.5-106.5, C.R.S., or these rules, any Person who buys, Transfers or acquires Retail Marijuana outside the requirements of the Retail Code is engaging in illegal activity pursuant to Colorado law. This rule clarifies that those engaged in the business of possessing, cultivating, dispensing, Transferring, transporting, testing, or researching Retail Marijuana must be properly licensed to be in compliance with Colorado law. R 101 – Engaging in Business Except as authorized by the Colorado Constitution, article XVIII, Subsection 16(3), the Retail Marijuana Code, or section 25-1.5-106.5, C.R.S., no person shall possess, cultivate, dispense, Transfer, transport, offer to sell, manufacture, test, or research Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product unless said Person is duly licensed by the State Licensing Authority and approved by the relevant local jurisdiction(s) and/or licensed by the relevant local licensing authority(-ies). Basis a Purpose – R 102 The statutory authority for this rule is found at subsection 12-43.4-202(2)(b), C.R.S. The purpose of this rule is to clarify that each rule is independent of the others, so that if one is found to be invalid, the remainder will stay in effect. This will give the regulated community confidence in the rules even if one is challenged. R 102 – Severability If any portion of the rules is found to be invalid, the remaining portion of the rules shall remain in force and effect. Basis and Purpose – R 103 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b) and 12-43.4-202(3)(b)(IX), C.R.S., section 12-43.4-103, and all of the Retail Code. 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. R 103 – Definitions 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, of visual, oral, or written communication, to induce directly or indirectly any Person to patronize a particular Retail Marijuana Establishment, or to purchase particular Retail Marijuana or a Retail Marijuana Product. “Advertising” includes marketing, but does not include packaging and labeling. “Advertising” proposes a commercial transaction or otherwise constitutes commercial speech. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 1 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 2 of 201 “Additive” means any substance added to Retail Marijuana Product that is not a common baking or cooking item. “Affiliated Interest” means any Business Interest related to a Retail Marijuana Establishment that does not rise to the level of a Financial Interest in a Retail Marijuana Establishment license. An Affiliated Interest may include, but shall not be limited to, an Indirect Beneficial Interest Owner that is not a Financial Interest, an indirect financial interest, a lease agreement, secured or unsecured loan, or security interest in fixtures or equipment with a direct nexus to the cultivation, manufacture, saleTransfer, transportation, or testing or researching of Retail Marijuana or Retail Marijuana Products. Except as otherwise provided by these rules, an Affiliated Interest holder shall neither exercise control of nor be positioned so as to enable the exercise of control over the Retail Marijuana Establishment or its operations. A Retail Marijuana Establishment shall report each of its Affiliated Interests to the Division with each application for initial licensure, renewal, change of ownership or change of corporate structure. “Agreement” means any unsecured convertible debt option, option agreement, warrant, or at the Division’s discretion, other document that establishes a right for a person to obtain a Permitted Economic Interest that might convert to an ownership interest in a Retail Marijuana Establishment or Medical Marijuana Business. “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 for licensure or registration, or for renewal of licensure or registration, 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 a Direct Beneficial Interest Owner of the Retail Marijuana Establishment, other than a Qualified Limited Passive Investor, and any Person who controls or is positioned so as to enable the exercise of control over a Retail Marijuana Establishment. Each shareholder, officer, director, member, or partner of a Closely Held Business Entity that is a Direct Beneficial Interest Owner and any Person who controls or is positioned so as to enable the exercise of control over a Retail Marijuana Establishment must hold an Associated Key License. “Batch Number” means any distinct group of numbers, letters, or symbols, or any combination thereof, assigned by a Retail Marijuana Cultivation Facility or Retail Marijuana Products Manufacturer to a specific Harvest Batch or Production Batch of Retail Marijuana. “Business Interest” means any Person that holds a Financial Interest or an Affiliated Interest in a Retail Marijuana Establishment. “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 to open and not difficult for normal adults to use properly as defined by 116 C.F.R. 1700.15 (1995) and 16 C.F.R. 1700.20 (1995). Note that this rule does not include any later amendments or editions to the Code of Federal Regulations. The Division has maintained a copy of the applicable federal regulations, which is available to the public. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 2 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 3 of 201 b. Opaque so that the packaging does not allow the product to be seen without opening the packaging material; c. Resealable for any product intended for more than a single use or containing multiple servings. “Closely Held Business Entity” means an “entity” as defined in section 7-90-102, C.R.S., that has no more than fifteen shareholders, officers, directors, members, partners or owners, each of whom are natural persons, each of whom holds an Associated Key License, and each of whom is a United States citizen prior to the date of application. There must be no publicly traded market for interests in the entity. A Closely Held Business Entity and each of the natural persons who are its shareholders, officers, directors, members, partners or owners, are Direct Beneficial Interest Owners. A Closely Held Business Entity is an associated business of the Retail Marijuana Establishment for which it is a Direct Beneficial Interest Owner. “Commercially Reasonable Royalty” means a right to compensation in the form of a royalty payment for the use of product-specific intellectual property with a direct nexus to the cultivation, manufacture, Transfer or testing of Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product. A Commercially Reasonable Royalty must be limited to a specific intellectual property the Commercially Reasonable Royalty Interest Holder owns or is otherwise authorized to license or to a product or line of products. product or line of products and provide compensation to the Commercially Reasonable Royalty Holder as a percentage of gross revenue or gross profit generated from sales of the particular product or line of products. A Commercially Reasonable Royalty will not be approved where it could cause reasonable consumer confusion or violate any federal copyright, trademark or patent law or regulation. The Commercially Reasonably Royalty shall provide for compensation to the Commercially Reasonable Royalty Holder as a percentage of gross revenue or gross profit. The royalty payment must be at a reasonable percentage rate. To determine whether the percentage rate is reasonable, the Division will consider the totality of the circumstances, including but not limited to the following factors: a. The percentage of royalties received by the recipient for the licensing of the intellectual property. b. The rates paid by the Licensee for the use of other intellectual property. c. The nature and scope of the license, as exclusive or non-exclusive; or as restricted or non-restricted in terms of territory or with respect to whom the manufactured product may be sold. d. The licensor’s established policy and marketing program to maintain his intellectual property monopoly by not licensing others or by granting licenses under special conditions designed to preserve that monopoly. e. The commercial relationship between the recipient and Licensee, such as, whether they are competitors in the same territory in the same line of business. f. The effect of selling the intellectual property in promoting sales of other products of the Licensee; the existing value of the intellectual property to the recipient as a generator of sales of his non-intellectual property items; and the extent of such derivative sales. g. The duration of the term of the license for use of the intellectual property. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 3 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 4 of 201 h. The established or projected profitability of the product made using the intellectual property; its commercial success; and its current popularity. i. The utility and advantages of the intellectual property over products or businesses without the intellectual property. j. The nature of the intellectual property; the character of the commercial embodiment of it as owned and produced by the licensor; and the benefits to those who have used the intellectual property. k. The portion of the profit or of the selling price that may be customary in the particular business or in comparable businesses to allow for the use of the intellectual property. l. The portion of the realizable profit that should be credited to the intellectual property as distinguished from non-intellectual property elements, the manufacturing process, business risks, or significant features or improvements added by the Licensee. “Commercially Reasonable Royalty Interest Holder” means a Person that receives a Commercially Reasonable Royalty in exchange for a Licensee’s use of the Commercially Reasonable Royalty Interest Holder’s intellectual property. A Commercially Reasonable Royalty Interest Holder is an Indirect Beneficial Interest Owner. “Container” means the Child-Resistant receptacle directly containing Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product that is labeled according to the requirements in Rules R 1001 et. seq. or Rules R 1001-1 et. seq. “Container” means the sealed package in which Retail Marijuana or a Retail Marijuana Product is placed for sale to a consumer and that has been labeled according to the requirements set forth in Rules R 1002 et. seq. “Denied Applicant” means any Person whose application for licensure pursuant to the Retail Code has been denied. “Department” means the Colorado Department of Revenue. “Direct Beneficial Interest Owner” means a natural person or a Closely Held Business entity that owns a share or shares of stock in a licensed Retail Marijuana Establishment, including the officers, directors, members, or partners of the licensed Retail Marijuana Establishment or Closely Held Business Entity, or a Qualified Limited Passive Investor. Each natural person that is a Direct Beneficial Interest Owner must hold an Associated Key License. Except that a Qualified Limited Passive Investor need not hold an Associated Key License and shall not engage in activities for which an Occupational License is required. “Director” means the Director of the Marijuana Enforcement Division. “Division” means the Marijuana Enforcement Division. “Edible Retail Marijuana Product” means any Retail Marijuana Product for which the intended use is oral consumptionwhich is intended to be consumed orally, including but not limited to, any type of food, drink, or pill. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 4 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 5 of 201 “Executive Director” means the Executive Director of the Department of Revenue. “Exit Package” means an Opaque bag or sealed Container other similar Opaque covering package or package provided at the retail point of sale, in which any Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product already within a Container is are placed. The Exit Package is not required to be labeled in accordance with Rules R 1001 et. seq. or Rules R 1001.1 et. seq. but may include the Retail Marijuana Store’s Identity Statement and/or Standardized Graphic Symbol. “Final Agency Order” means an Order of the State Licensing Authority issued in accordance with the Retail 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. “Financial Interest” means any Direct Beneficial Interest Owner, a Commercially Reasonable Royalty Interest Holder who receives more than 30 percent of the gross revenue or gross profit from sales of the product subject to the royalty, a Permitted Economic Interest holder, and any other Person who controls or is positioned so as to enable the exercise of control over the Retail Marijuana Establishment. “Flammable Solvent” means a liquid that has a flash point below 100 degrees Fahrenheit. “Flowering” means the reproductive state of the Cannabis plant in which there are physical signs of flower budding out of the nodes in the stem. in which the plant is in a light cycle intended to stimulate production of flowers, trichromes, and cannabinoids characteristic of marijuana. “Food-Based Retail Marijuana Concentrate” means a Retail Marijuana Concentrate that was produced by extracting cCannabinoids from Retail Marijuana through the use of propylene glycol, glycerin, butter, olive oil or other typical cooking fats. “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 of the terms, conditions, or provisions of the Retail Code, any rules promulgated pursuant to 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 jurisdiction; or c. The Licensee’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 having a personal history that demonstrates 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 is uniform in strain, cultivated utilizing the same Pesticide and other agricultural chemicals and harvested at the same time. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 5 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 6 of 201 “Harvested Marijuana” means post-Flowering Retail Marijuana not including trim, concentrate or waste that remains on the premises of the Retail Marijuana Cultivation Facility or its off-premises storage location beyond 60 days from harvest. “Heat/Pressure Based Retail Marijuana Concentrate” means a Retail Marijuana Concentrate that was produced by extracting Cannabinoids from Retail Marijuana through the use of heat and/or pressure. This method of extraction may be used by only a Retail Marijuana Products Manufacturing Facility and can be used alone or on a Production Batch that also includes WaterBased Retail Marijuana Concentrate or Solvent-Based Retail Marijuana Concentrate. “Identity Statement” means the name of the business as it is commonly known and used in any Advertising. “Immature plant” means a nonflowering Retail Marijuana plant that is no taller than eight inches and no wider than eight inches produced from a cutting, clipping or seedling and is in a cultivating container. Plants meeting these requirements are not attributable to a Licensee’s maximum allowable plant count, but must be fully accounted for in the Inventory Tracking System. “Indirect Beneficial Interest Owner” means a holder of a Permitted Economic Interest, a recipient of a Commercially Reasonable Royalty associated with the use of intellectual property by a Licensee, a Profit-Sharing Plan Employee, a Qualified Institutional Investor, or another similarly situated Person as determined by the State Licensing Authority. An Indirect Beneficial Interest Owner is not a Licensee. The Licensee must obtain Division approval for an Indirect Beneficial Interest Owner that constitutes a Financial Interest before such Indirect Beneficial Interest Owner may exercise any of the privileges of the ownership or interest with respect to the Licensee. “Industrial Hemp” means a plant of the genus Cannabis and any part of the plant, whether growing or not, containing a delta-9 tetrahydrocannabinol (THC) concentration of no more than three-tenths of one percent (0.3%) on a dry weight basis. “Industrial Hygienist” means an individual who has obtained a baccalaureate or graduate degree in industrial hygiene, biology, chemistry, engineering, physics, or a closely related physical or biological science from and accredited college or university. a. b. The special studies and training of such individuals shall be sufficient in the cognate sciences to provide the ability and competency to: 1. Anticipate and recognize the environmental factors and stresses associated with work and work operations and to understand their effects on individuals and their well-being; 2. Evaluate on the basis of training and experience and with the aid of quantitative measurement techniques the magnitude of such environmental factors and stresses in terms of their ability to impair human health and well-being; 3. Prescribe methods to prevent, eliminate, control, or reduce such factors and stresses and their effects. Any individual who has practiced within the scope of the meaning of industrial hygiene for a period of not less than five years immediately prior to July 1, 1997, is exempt from the degree requirements set forth in the definition above. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 6 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 c. RETAIL - Page 7 of 201 Any individual who has a two-year associate of applied science degree in environmental science from an accredited college or university and in addition not less than four years practice immediately prior to July 1, 1997, within the scope of the meaning of industrial hygiene is exempt from the degree requirements set forth in the definition above. “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, and will issue a Final Agency Order. “Inventory Tracking System” means the required seed-to-sale tracking system that tracks Retail Marijuana from either the seed or immature plant stage until the Retail Marijuana or Retail Marijuana Product is sold to a customer at a Retail Marijuana Store, Transferred to a Medical Research Facility, Transferred to a Pesticide Manufacturer, or is destroyed. “Inventory Tracking System Trained Administrator” means an Associated Key Licensee of a Retail Marijuana Establishment or an occupationally licensed employee of a Retail Marijuana Establishment, each of whom has attended and successfully completed Inventory Tracking System training and has completed any additional training required by the Division. “Inventory Tracking System User” means an Associated Key Licensee of a Retail Marijuana Establishment or an occupationally licensed Retail Marijuana Establishment employee, who is granted Inventory Tracking System User account access for the purposes of performing inventory tracking functions in the Inventory Tracking System. Each Inventory Tracking System User must have been successfully trained by an Inventory Tracking System Trained Administrator in the proper and lawful use of Inventory Tracking System. “Key License” means an Occupational License for an individual who performs duties that are central key to the Retail Marijuana Establishment’s operation. A Key Licensee has the highest level of responsibility but is not an Owner. An example of a Key Licensee includes and have the highest level of responsibility. Examples of individuals who need this type of license include, but is 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 Retail Code that are owned or in possession of the Licensee and within which the Licensee is authorized to cultivate, manufacture, distribute, sell, store, transport, or test, or research Retail Marijuana in accordance with the provisions of the Retail Code and these rules. “Licensed Research Business” means a Marijuana Research and Development Facility or a Marijuana Research and Development Cultivation. “Licensee” means any Person licensed or registered pursuant to the Retail Code or, in the case of an Occupational License Licensee, any individual licensed pursuant to the Retail Code or Medical Code. “Limited Access Area” means a building, room, or other contiguous area upon the Licensed Premises where Retail Marijuana is grown, cultivated, stored, weighed, packaged, soldTransferred, or processed for saleTransfer, 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%). 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 7 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 8 of 201 “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. “Liquid Edible Retail Marijuana Product” means an Edible Retail Marijuana Product that is a liquid beverage or food-based product for which the intended use is oral consumptionand intended to be consumed orally, such as a soft drink or cooking sauce. “Marijuana-Based Workforce Development Training Program” means a program designed to train individuals to work in the legal Medical or Retail Marijuana industry operated by an entity licensed under the Medical Code and/or the Retail Code or by a school that is authorized by the Division of Private Occupational Schools. “Marketing Layer” means packaging in addition to the Container that is the outermost layer visible to the consumer at the point of sale. The Marketing Layer is optional, but if used by a Licensee in addition to the required Container, it must be labeled according to the requirements in Rules R 1001 et. seq. or Rules R 1001.1 et.seq. “Marijuana Research and Development Cultivation” means a Person that is licensed pursuant to the Medical Code to grow, cultivate, possess, and Transfer Medical Marijuana to a Marijuana Research and Development Facility for limited research purposes authorized pursuant to section 12-43.3-407, C.R.S. A Marijuana Research and Development Cultivation is a Licensed Research Business. “Marijuana Research and Development Facility” means a Person that is licensed pursuant to the Medical Code to possess Medical Marijuana for limited research purposes authorized pursuant to section 12-43.3-407, C.R.S. A Marijuana Research and Development Facility is a Licensed Research Business. “Material Change” means any change that would require a substantive revision to a Retail Marijuana Establishment’s standard operating procedures for the cultivation of Retail Marijuana or the production of a Retail Marijuana Concentrate or Retail Marijuana Product. “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. Unless the context otherwise requires, Medical Marijuana Concentrate is considered Medical Marijuana and is included in the term “Medical Marijuana” as used in these rules. “Medical Marijuana Business” means a Medical Marijuana Center, a Medical Marijuana-Infused Product Manufacturer, an Optional Premises Cultivation Operation, a Medical Marijuana Testing Facility, a Medical Marijuana Business Operator, or a Medical Marijuana Transporter, a Marijuana Research and Development Facility, or a Marijuana Research and Development Cultivation. “Medical Marijuana Business Operator” means an entity that holds a registration or license from the State Licensing Authority to provide professional operational services to one or more Medical Marijuana Businesses, other than Licensed Research Businesses, for direct remuneration from the Medical Marijuana Business(es), which may include compensation based upon a percentage of the profits of the Medical Marijuana Business(es) being operated. A Medical Marijuana Business Operator may contract with Medical Marijuana Business(es) to provide operational services. A Medical Marijuana Business Operator’s contract with a Medical Marijuana Business does not in and of itself constitute ownership. The Medical Code and rules apply to all Medical 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 8 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 9 of 201 Marijuana Business Operators regardless of whether such operator holds a registration or license. Any reference to “license” or “licensee” shall mean “registration” or “registrant” when applied to a Medical Marijuana Business Operator that holds a registration issued by the State Licensing Authority. “Medical Marijuana Center” means a Person licensed pursuant to the Medical Code to operate a business as described in section 12-43.3-402, C.R.S., and 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 a specific subset of Medical Marijuana that was produced by extracting cCannabinoids from Medical Marijuana. Categories of Medical Marijuana Concentrate include Water-Based Medical Marijuana Concentrate, Food-Based Medical Marijuana Concentrate, and Solvent-Based Medical Marijuana Concentrate and Heat/Pressure Based Medical Marijuana Concentrate. “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 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. “Medical Marijuana Testing Facility” means a public or private laboratory licensed and certified, or approved by the Division, to conduct research and analyze Medical Marijuana, Medical Marijuana-Infused Products, and Medical Marijuana Concentrate for contaminants and potency. “Medical Marijuana Transporter” means a Person that is licensed to transport Medical Marijuana and Medical Marijuana-Infused Products from one Medical Marijuana Business to another Medical Marijuana Business or to a Medical Research Facility or Pesticide Manufacturer, and to temporarily store the transported Medical Marijuana and Medical Marijuana-Infused Products at its licensed premises, but is not authorized to sell, give away, buy, or receive complimentary Medical Marijuana or Medical Marijuana-Infused Products under any circumstances. A Medical Marijuana Transporter does not include a Licensee that transports its own Medical Marijuana or Medical Marijuana-Infused Products. “Medical Research Facility” means a Person approved and grant-funded by the State Board of Health pursuant to section 25-1.5-106.5, C.R.S., to conduct Medical Marijuana research. A Medical Research Facility is neither a Medical Marijuana Business, a Retail Marijuana Establishment, nor a Licensee. “Monitoring” means the continuous and uninterrupted attention to potential alarm signals that could be transmitted from a Security Alarm System located at a Retail Marijuana Establishment 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 security system Monitoring services for the Licensed Premises of a Retail Marijuana Establishment. “Multiple-Serving Edible Retail Marijuana Product” means an Edible Retail Marijuana Product unit for sale to consumers containing more than 10mg of active THC and no more than 100mg of active THC. If the overall Edible Retail Marijuana Product unit for sale to the consumer consists of 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 9 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 10 of 201 multiple pieces where each individual piece may contain less than 10mg active THC, yet in total all pieces combined within the unit for sale contain more than 10mg of active THC, then the Edible Retail Marijuana Product shall be considered a Multiple-Serving Edible Retail Marijuana Product. “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. An Occupational License may be an Associated Key License, a Key License or a Support License. “Opaque” means that the packaging does not allow the product to be seen without opening the packaging material. “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, except where the context otherwise requires, a Direct Beneficial Interest Owner. “Permitted Economic Interest” means an Agreement to obtain an ownership interest in a Retail Marijuana Establishment or Medical Marijuana Business when the holder of such interest is a natural person who is a lawful United States resident and whose right to convert into an ownership interest is contingent on the holder qualifying and obtaining a license as a Direct Beneficial Interest Ownern owner under the Retail Code or Medical Code. A Permitted Economic Interest holder is an Indirect Beneficial Interest Owner. “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. “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 a plant regulator, defoliant or desiccant; except that the term “pesticide” shall not include any article that is a “new animal drug” as designated by the United States Food and Drug Administration. “Pesticide Manufacturer” means a Person who (1) manufactures, prepares, compounds, propagates, or processes any Pesticide or device or active ingredient used in producing a Pesticide; (2) who possesses an establishment registration number with the U.S. Environmental Protection Agency pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. § 136 et seq.; (3) who conducts research to establish safe and effective protocols, including but not limited to establishing efficacy and toxicity, for the use of Pesticides on Medical Marijuana; (4) who has applied for and received any necessary license, registration, certifications, or permits from the Colorado Department of Agriculture pursuant to the Pesticide Act, sections 35-9-101 et seq., C.R.S. and/or the Pesticide Applicators’ Act, sections 35-10-101 et seq., C.R.S.; (5) who is authorized to conduct business in the State of Colorado; and (6) who has physical possession of the location in the State of Colorado where its research activities occur. A Pesticide Manufacturer is neither a Medical Marijuana Business, a Retail Marijuana Establishment, nor a Licensee. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 10 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 11 of 201 “Production Batch” means (a) any amount of Retail Marijuana Concentrate of the same category and produced using the same extraction methods, standard operating procedures and an identical group of Harvest Batch(es) of Retail Marijuana; or (b) any amount of Retail Marijuana Product of the same exact type, produced using the same ingredients, standard operating procedures and the same Production Batch(es) of Retail Marijuana Concentrate. “Professional Engineer” means an individual who is licensed by the State of Colorado as a professional engineer pursuant to 12-25-101 et. seq., C.R.S. “Proficiency Testing Samples” means an assessment of the performance of a Retail Marijuana Testing Facility’s methodo logy and processes. Proficiency Testing is also known as interlaboratory comparison. The goal of Proficiency Testing is to ensure results are accurate, reproducible, and consistent.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. “Profit-Sharing Plan” means a profit-sharing plan that is qualified pursuant to 26 U.S.C. § 401 of the Internal Revenue Code and subject to the Employee Retirement Income Security Act, and which provides for employer contributions in the form of cash, but not in the form of stock or other equity interests in a Retail Marijuana Establishment. “Profit-Sharing Plan Employee” means an employee holding an Occupational License who receives a share of a Retail Marijuana Establishment’s profits through a Profit-Sharing Plan. A Profit-Sharing Plan Employee is an Indirect Beneficial Interest Owner. “Propagation” means the reproduction of Retail Marijuana plants by seeds, cuttings or grafting. “Public Institution” means any entity established or controlled by the federal government, a state government, or a local government or municipality, including but not limited to institutions of higher education or a public higher education research institution. “Public Money” means any funds or money obtained by the holder from any governmental entity, including but not limited to research grants. “Qualified Institutional Investor” means: a. A bank as defined in Section 3(a) (6) of the Federal Securities Exchange Act of 1934, as amended; b. An insurance company as defined in Section 2(a) (17) of the Investment Company Act of 1940, as amended; c. An investment company registered under Section 8 of the Investment Company Act of 1940, as amended; d. An investment adviser registered under Section 203 of the Investment Advisers Act of 1940, as amended; e. Collective trust funds as defined in Section 3(c) (11) of the Investment Company Act of 1940, as amended; f. An employee benefit plan or pension fund that is subject to the Employee Retirement Income Security Act of 1974, as amended, excluding an employee 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 11 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 12 of 201 benefit plan or pension fund sponsored by a licensed or an intermediary or holding company licensee which directly or indirectly owns five percent or more of a licensee; g. A state or federal government pension plan; or h. A group comprised entirely of persons specified in (a) through (g) of this definition. A Qualified Institutional Investor is an Indirect Beneficial Interest Owner. “Qualified Limited Passive Investor” means a natural person who is a United States citizen and is a passive investor who owns less than a five percent share or shares of stock in a licensed Retail Marijuana Establishment. A Qualified Limited Passive Investor is a Direct Beneficial Interest Owner. “RFID” means Radio Frequency Identification. “Remediation” means the process by which Retail Marijuana flower or trim, which has failed microbial testing, is processed into a Solvent-Based Retail Marijuana Concentrate and retested as required by these rules. “Resealable” means that the Container package maintains its Child-Resistant effectiveness for multiple openings. “Research Project” means a discrete scientific endeavor to answer a research question or a set of research questions. A Research Project must include a description of a defined protocol, clearly articulated goal(s), defined methods and outputs, and a defined start and end date. The description must demonstrate that the Research Project will comply with all requirements in the M 1900 Series – Licensed Research Businesses. All research and development conducted by a Licensed Research Business must be conducted in furtherance of an approved Research Project. “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 Retail Marijuana Store where Retail Marijuana and Retail Marijuana Product are sold, possessed for 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, 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 but not limited to Retail mMarijuana cConcentrate, 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. Unless the context otherwise requires, Retail Marijuana Concentrate is considered Retail Marijuana and is included in the term “Retail Marijuana” as used in these rules. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 12 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 13 of 201 “Retail Marijuana Concentrate” means a specific subset of Retail Marijuana that was produced by extracting cCannabinoids from Retail Marijuana. Categories of Retail Marijuana Concentrate include Water-Based Retail Marijuana Concentrate, Food-Based Retail Marijuana Concentrate, and Solvent-Based Retail Marijuana Concentrate and Heat/Pressure Based Retail Marijuana Concentrate. “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 to consumers. “Retail Marijuana Establishment” means a Retail Marijuana Store, a Retail Marijuana Cultivation Facility, a Retail Marijuana Products Manufacturing Facility, a Retail Marijuana Testing Facility, a Retail Marijuana Establishment Operator or a Retail Marijuana Transporter. “Retail Marijuana Establishment Operator” means an entity that holds a license from the State Licensing Authority to provide professional operational services to one or more Retail Marijuana Establishments for direct remuneration from the Retail Marijuana Establishment(s), which may include compensation based upon a percentage of the profits of the Retail Marijuana Establishment(s) being operated. A Retail Marijuana Establishment Operator contracts with Retail Marijuana Establishment(s) to provide operational services. A Retail Marijuana Business Establishment Operator’s contract with a Retail Marijuana Establishment does not in and of itself constitute ownership. “Retail Marijuana Product” means a product that is comprised of Retail Marijuana and other ingredients and is 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 Marijuana and Retail Marijuana Product only to other Retail Marijuana Products Manufacturing Facilities and Retail Marijuana Stores. “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 a public or private laboratory licensed and certified, or approved by the Division, to conduct research and analyze Retail Marijuana, Retail Marijuana Products and Retail Marijuana Concentrate for contaminants and potency. “Retail Marijuana Transporter” means a Person that is licensed to transport Retail Marijuana and Retail Marijuana Products from one Retail Marijuana Establishment to another Retail Marijuana Establishment and to temporarily store the transported Retail Marijuana and Retail Marijuana Products at its licensed premises, but is not authorized to sell, give away, buy, or receive complimentary Retail Marijuana or Retail Marijuana Products under any circumstances. A Retail Marijuana Transporter does not include a Licensee that transports and distributes its own Retail Marijuana or Retail Marijuana Products. “Sample” means any item thing collected from a Retail Marijuana Establishment or Medical Marijuana Business that is and provided to a Retail Marijuana Testing Facility for testing. The following is a non-exhaustive list of types of Samples: Retail Marijuana, Retail Marijuana Product, 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 13 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 14 of 201 Retail Marijuana Concentrate, Medical Marijuana, Medical Marijuana-Infused Product, Medical Marijuana Concentrate, soil, growing medium, water, solvent or swab of a counter or equipment. “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 hardwired 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 a hard-sided container with a lid or other enclosure that can be secured in place that , and the container is used solely for the transport of Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product in bulk, or in a quantity forbetween other Retail Marijuana Establishments. “Single-Serving Edible Retail Marijuana Product” means an Edible Retail Marijuana Product unit for sale to consumers containing no more than 10mg of active THC. “Solvent-Based Retail Marijuana Concentrate” means a Retail Marijuana Concentrate that was produced by extracting cCannabinoids from Retail Marijuana through the use of a solvent approved by the Division pursuant to Rule R 605. “Standardized Graphic Symbol” means a graphic image or small design adopted by a Licensee to identify its business. “Standardized Serving Of Marijuana” means a standardized single serving of active THC. The size of a Standardized Serving Of Marijuana shall be no more than 10mg of active THC. “State Licensing Authority” means the authority created for the purpose of regulating and controlling the licensing of the cultivation, manufacture, distribution, and sale Transfer 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 Retail Marijuana Establishment’s operations. A Support Licensee is a person with less decision making authority than a Key Licensee and who is reasonably supervised by a Key Licensee or 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. “THCA” means tetrahydrocannabinolic acid. “Test Batch” means a group of Samples that are that are derived from a single Harvest Batch or Production Batch and that are collectively submitted to a Retail Marijuana Testing Facility for testing purposes. A Test Batch may not be a combination of any two or three of the following: Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product. “Total THC” means the sum of the percentage by weight of THCA multiplied by 0.87 plus the percentage by weight of THC i.e., Total THC = (%THCA x 0.877) + %THC. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 14 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 15 of 201 “Transfer(s)(ed)(ing)” means to grant, convey, hand over, assign, sell, exchange, donate, or barter, in any manner or by any means, with or without consideration, any Retail Marijuana or Retail Marijuana Product from one licensee to another licensee or to a consumer. A Transfer includes the movement of Retail Marijuana or Retail Marijuana Product from one licensed premises to another, even if both premises are contiguous, and even if both premises are owned by a single entity or individual or group of individuals and also includes a virtual transfer that is reflected on the Inventory Tracking System, even if no physical movement of the Retail Marijuana or Retail Marijuana Product occurs. “Universal Symbol” means the image established by the Division and made available to Licensees through the Division’s website indicating the Retail Marijuana or Retail Marijuana Product contains marijuana. “Unrecognizable” means marijuana or Cannabis plant material rendered indistinguishable from any other plant material. “Vegetative” means the state of the Cannabis plant during which plants do not produce resin or flowers and are bulking up to a desired production size for Flowering. “Water-Based Retail Marijuana Concentrate” means a Retail Marijuana Concentrate that was produced by extracting cCannabinoids from Retail Marijuana through the use of only water or, ice or dry ice. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 15 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 16 of 201 R 200 Series – Licensing and Interests Basis and Purpose – R 201 The statutory authority for this rule is found at subsections 12-43.4-104(2)(a), 12-43.4-202(2)(b), 12-43.4202(3)(a)(I), 12-43.4-202(3)(a)(III), 12-43.4-202(3)(a)(XX), 12-43.4-202(3)(b)(IX),and 12-43.4-304(1), and sections 12-43.4-103, 12-43.4-306.5, 12-43.4-309, 12-43.4-312, 12-43.4-401, and 24-76.5-101, et seq., C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(III). The purpose of this rule is to establish that only materially complete applications for licenses, accompanied by all required fees, will be accepted and processed by the Division. The purpose of the rule is also to clarify that when an initial application is materially complete and accepted, but the Division determines further information is required before the application can be fully processed, the Applicant must provide the additional requested information within the time frame provided by the Division. Otherwise, the Division cannot act on the application in a timely manner, and the application may be denied. R 201 – Application Process A. General Requirements 1. All applications for licenses authorized pursuant to subsections 12-43.4-401(1)(a)-(g), C.R.S., shall be made upon current forms prescribed by the Division. 2. A license issued to a Retail Marijuana Establishment or an individual constitutes a revocable privilege. The burden of proving an Applicant’s qualifications for licensure rests at all times with the Applicant. 3. Each application shall identify the relevant local jurisdiction. 4. Applicants must submit a complete application to the Division before it will be accepted or considered. a. All applications must be complete and accurate in every material detail. b. All applications must include all attachments or supplemental information required by the current forms supplied by the Division. c. All applications must be accompanied by a full remittance of the application and relevant license fees for each applicant and each premise. See Rules R 207 Schedule of Application Fees: Retail Marijuana Establishments, R 208 Schedule of Business License Fees: Retail Marijuana Establishments, R 209 – Schedule of Business License Renewal Fees: Retail Marijuana Establishments, R 234 – Schedule of License Fees: Individuals, and R 235 – Schedule of Renewal Fees: Individuals. d. All applications must include all information required by the Division related to the Applicant’s proposed Direct Beneficial Interest Owners, Indirect Beneficial Interest Owners and Qualified Limited Passive Investors, and all other direct and indirect financial interests in the Applicant. e. At a minimum, each Applicant for a new license shall provide, at the time of application, the following information: 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 16 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 17 of 201 i. For each Associated Key License Applicant, evidence of proof of lawful presence, citizenship, if applicable, residence, if applicable, and Good Moral Character as required by the current forms prescribed by the Division; ii. For each Retail Marijuana Establishment Applicant and each Associated Key License Applicant, all requested information concerning financial and management associations and interests of other Persons in the business; iii. If the Applicant for any license pursuant to the Retail Code is a Closely Held Business Entity it shall submit with the application: A. The Associated Key License applications for all of its shareholders, members, partners, officers and directors who do not already hold an Associated Key License; B. If the Closely Held Business Entity is a corporation, a copy of its articles of incorporation or articles of organization; evidence of authorization from the Colorado Secretary of State to do business within this State, for each shareholder: his or her name, mailing address, state of residence and certification of Colorado residency for at least one officer and all officers with day-to-day operational control over the business; C. If the Closely Held Business Entity is a limited liability company, a copy of its articles of organizationincorporation and its operating agreement; evidence of authorization from the Colorado Secretary of State to do business within this State, for each member: his or her name, mailing address, state of residence and certification of Colorado residency for at least one officer and all officers with day-to-day operational control over the business; D. If the Closely Held Business Entity is a general partnership, limited partnership, limited liability partnership, or limited liability limited partnership, a copy of the partnership agreement and, for each partner, his or her name, mailing address and state of residency and certification of Colorado residency for at least one officer and all officers with day-to-day operational control over the business. iv. For each Retail Marijuana Establishment Applicant and each Associated Key License Applicant, documentation establishing compliant return filing and payment of taxes related to any Medical Marijuana Business or Retail Marijuana Establishment in which such Applicant is, or was, required to file and pay taxes; v. For each Retail Marijuana Establishment Applicant and each Associated Key License Applicant, documentation verifying and confirming the funds used to start and/or sustain the operation of the mMedical Marijuana Business or rRetail mMarijuana Establishment business were lawfully earned or obtained. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 17 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 B. RETAIL - Page 18 of 201 vi. Accurate floor plans for the premises to be licensed; and viii. The deed, lease, sublease, contract, or other document(s) governing the terms and conditions of occupancy of the premises to be licensed. 5. All applications to reinstate a license will be deemed applications for new licenses. This includes, but is not limited to, Associated Key licenses that have expired, Retail Marijuana Establishment licenses that have been expired for more than 90 days, licenses that have been voluntarily surrendered, licenses for which local licensing approval was not obtained within 12 months, and licenses that have been revoked. 6. The Division may refuse to accept or consider an incomplete application. Additional Information May Be Required 1. Upon request by the Division, an Applicant shall provide any additional information required to process and fully investigate the application. The additional information must be provided to the Division no later than seven days after the request is made unless otherwise specified by the Division. 2. An Applicant’s failure to provide the requested information by the Division deadline may be grounds for denial of the application. C. Information Must Be Provided Truthfully. All Applicants shall submit information to the Division in a full, faithful, truthful, and fair manner. The Division may recommend denial of an application where the Applicant made misstatements, omissions, misrepresentations or untruths in the application or in connection with the Applicant’s background investigation. This type of conduct may be considered as the basis for additional administrative action against the Applicant and it may also be the basis for criminal charges against the Applicant. D. Application Forms Accessible. All application forms supplied by the Division and filed by an Applicant for a license, including attachments and any other documents associated with the investigation, may be used for a purpose authorized by the Medical Code, the Retail Code or for any other state or local law enforcement purpose or as otherwise required by law. E. Division Application Management and Local Licensure. 1. The Division will either approve or deny a complete application between 45 days and 90 days of its receipt. 2. For each application for a new Retail Marijuana Establishment, the Applicant shall submit the original application and one identical copy. The Division will retain the original application for a new Retail Marijuana Establishment and will send the copy and half the application fee to the relevant local jurisdiction within seven days of receiving the application. 3. If the Division grants a license before the relevant local jurisdiction approves the application or grants a local license, the license will be conditioned upon local approval. Such a condition will not be viewed as a denial pursuant to the Administrative Procedure Act. If the local jurisdiction denies the application, the state license will be revoked. 4. The Applicant has one year from the date of licensing by the State Licensing Authority to obtain approval or licensing through the relevant local jurisdiction. Should the Applicant 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 18 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 19 of 201 fail to obtain local jurisdiction approval or licensing within the specified period, the state license shall expire and may not be renewed. 5. An Applicant is prohibited from operating a Retail Marijuana Establishment prior to obtaining all necessary licenses or approvals from both the State Licensing Authority and the relevant local jurisdiction. 6. Each Financial Interest is void and of no effect unless and until approved by the Division. A Financial Interest shall not exercise any privilege associated with the proposed interest until approved by the Division. Any violation of this requirement may be considered a license violation affecting public safety. Basis and Purpose – R 202.1 The statutory authority for this rule is found at subsections, 12-43.4-104(2)(a), 12-43.4-202(2)(a), 12-43.4202(2)(b), 12-43.4-202(3)(a)(I), 12-43.4-202(3)(a)(III), 12-43.4-202(3)(a)(XX), 12-43.4-202(3)(b)(IX), 1243.4-306.5, and 12-43.4-309(2), and sections 12-43.4-103 and 12-43.4-312, C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(III). The purpose of this rule is to clarify the process to be followed when a Retail Marijuana Establishment applies to obtain financing or otherwise have a relationship with an Indirect Beneficial Interest Owner. The rule establishes that only materially complete Retail Marijuana Establishment applications for Indirect Beneficial Interest Owners, accompanied by all required fees, will be accepted and processed by the Division. The rule also clarifies that when an initial application is materially complete and accepted, but the Division determines further information is required before the application can be fully processed, the Retail Marijuana Establishment Applicant must provide the additional requested information within the time frame provided by the Division. Otherwise, the Division cannot act on the application in a timely manner, and the Retail Marijuana Establishment’s application may be denied. The rule sets forth requirements for the contents of the contract or Agreement between Retail Marijuana Establishments and Indirect Beneficial Interest Owners, which reflect basic legal requirements surrounding the relationship between the parties. R 202.1 – Applications, Agreements, Contracts and Certifications Required for Indirect Beneficial Interest Owners: Retail Marijuana Establishments A. Retail Marijuana Establishment Initiates Process. The Retail Marijuana Establishment seeking to obtain financing or otherwise establish any type of relationship with an Indirect Beneficial Interest Owner, including a Permitted Economic Interest, a Commercially Reasonable Royalty Interest Holder, a Profit-Sharing Plan Employee, or a Qualified Institutional Investor, must file all required documents with the Division, including any supplemental documents requested by the Division in the course of its review of the application. B. General Requirements. The Retail Marijuana Establishment seeking approval of an Indirect Beneficial Interest Owner must meet the following requirements: 1. All applications for approval of an Indirect Beneficial Interest Owner shall be made upon current forms prescribed by the Division. 2. The burden of proving that a proposed Indirect Beneficial Interest Owner is qualified to hold such an interest rests at all times with the Retail Marijuana Establishment submitting the application. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 19 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 20 of 201 3. The Retail Marijuana Establishment applying for approval of any type of Indirect Beneficial Interest Owner must submit a complete application to the Division before it will be accepted or considered. 4. All applications must be complete and accurate in every material detail. 5. All applications must include all attachments or supplemental information required by the current forms supplied by the Division. 6. All applications must be accompanied by a full remittance of the required fees. 7. The Division may refuse to accept an incomplete application. 8. The proposed holder of the Indirect Beneficial Interest is not a publicly traded company. 9. Additional Information May Be Required a. Upon request by the Division, a Retail Marijuana Establishment applying to have any type of Indirect Beneficial Interest Owner shall provide any additional information required to process and fully investigate the application. The additional information must be provided to the Division no later than seven days after the request is made unless otherwise specified by the Division. b. Failure to provide the requested information by the Division’s deadline may be grounds for denial of the application. C. Information Must Be Provided Truthfully. A Retail Marijuana Establishment applying for approval of any type of Indirect Beneficial Interest Owner shall submit information to the Division in a full, faithful, truthful, and fair manner. The Division may recommend denial of an application where any party made misstatements, omissions, misrepresentations or untruths in the application or in connection with the background investigation of the proposed Indirect Beneficial Interest Owner. This type of conduct may be considered as the basis for additional administrative action against the Retail Marijuana Establishment and it may also be the basis for criminal charges against either the Retail Marijuana Establishment Applicant or the Indirect Beneficial Interest Owner. D. Application Forms Accessible. All application forms supplied by the Division and filed by an Applicant for a license, including attachments and any other documents associated with the investigation, may be used for a purpose authorized by the Medical Code, the Retail Code or for any other state or local law enforcement purpose or as otherwise required by law. E. Approval of Financial Interest. Each Financial Interest in a Retail Marijuana Establishment is void and of no effect unless and until approved by the Division. Any amendment of a Financial Interest is also void and of no effect unless and until approved by the Division. F. Ongoing Qualification and Violation Affecting Public Safety. If at any time the Division finds any Indirect Beneficial Interest Owner is not qualified, or is no longer qualified, the Division may require the Retail Marijuana Establishment to terminate its relationship with and financial ties to the Indirect Beneficial Interest Owner within a specified time period. Failure to terminate such relationship and financial ties within the specified time period may constitute a violation affecting public safety and be a basis for administrative action against the Retail Marijuana Establishment. G. Permitted Economic Interest Holder Requirements. At the time of application, a Retail Marijuana Establishment seeking to obtain approval of a Permitted Economic Interest shall provide evidence 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 20 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 21 of 201 to establish that the natural person seeking to become a Permitted Economic Interest holder is a lawful resident of the United States and shall provide documentation verifying and confirming the funds used for the Permitted Economic Interest were lawfully earned or obtained. H. Permitted Economic Interest Agreement Requirements. The Retail Marijuana Establishment Applicant seeking to obtain financing from a Permitted Economic Interest must submit a copy of the Agreement between the Retail Marijuana Establishment and the person seeking to hold a Permitted Economic Interest. The following requirements apply to all Agreements: 1. The Agreement must be complete, and must fully incorporate all terms and conditions. 2. The following provisions must be included in the Agreement: a. Any interest in a Retail Marijuana Establishment, whether held by a Permitted Economic Interest or any other person, must be acquired in accordance with the provisions of the Medical Code and/or Retail Code, as applicable, and the rules promulgated thereunder. The issuance of any Agreement or other interest in violation thereof shall be void. The Permitted Economic Interest holder shall not provide funding to the Retail Marijuana Establishment until the Permitted Economic Interest is approved by the Division. b. No Agreement or other interest issued by the Retail Marijuana Establishment and no claim or charge therein or thereto shall be transferred except in accordance with the provisions of the Medical Code and/or Retail Code as applicable, and the rules promulgated thereunder. Any transfer in violation thereof shall be void. c. The Retail Marijuana Establishment and the Permitted Economic Interest holder must sign an affirmation of passive investment on a form approved by the Division. d. The Retail Marijuana Establishment must initiate any process to convert a Permitted Economic Interest to a Direct Beneficial Interest Owner and the process to convert the Permitted Economic Interest into a Direct Beneficial Interest Owner must be completed prior to the expiration or termination of the Agreement. The holder of the Permitted Economic Interest must meet all qualifications for licensure and ownership pursuant to the Medical Code and/or Retail Code and any rules promulgated thereunder prior to conversion of the Permitted Economic Interest to a Direct Beneficial Interest Owner. e. At the election of the Retail Marijuana Establishment, if the holder of the Permitted Economic Interest is not qualified for licensure as a Direct Beneficial Interest Owner but is qualified as a holder of the Permitted Economic Interest, and the Permitted Economic Interest is also approved by the Division then the Permitted Economic Interest may remain in force and effect for as long as it remains approved by the Division under the Medical Code and/or Retail Code as applicable, and any rules promulgated thereunder. f. The Permitted Economic Interest holder shall disclose in writing to the Division and to the Retail Marijuana Establishment any and all disqualifying events, within ten days after occurrence of the event, that could lead to a finding that the holder no longer qualifies to hold the Permitted Economic Interest and/or that could lead to a denial of licensure pursuant to the Medical Code and/or Retail Code and any rules promulgated thereunder. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 21 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 22 of 201 g. The Retail Marijuana Establishment shall disclose in writing to the Division any and all disqualifying events, within ten days after receiving notice of the event, which could lead to a finding that the holder is no longer qualified to hold the Permitted Economic Interest and/or that could lead to a denial of licensure pursuant to the Medical Code and/or Retail Code as applicable, and any rules promulgated thereunder. h. A Permitted Economic Interest holder’s or a Retail Marijuana Establishment’s failure to make required disclosures may be grounds for administrative action including but not limited to denial of a subsequent request to convert the Permitted Economic Interest into an ownership interest in the Retail Marijuana Establishment. Failure to make required disclosures may lead to a finding that the Permitted Economic Interest is no longer approved, and a requirement that the Retail Marijuana Establishment terminate its relationship with the Permitted Economic Interest holder. i. The Permitted Economic Interest holder agrees and acknowledges that it has no entitlement or expectation of being able to invest in, or have a relationship with, the Retail Marijuana Establishment unless and until the Division determines the Permitted Economic Interest is approved. The Permitted Economic Interest holder agrees and acknowledges that its relationship with the Retail Marijuana Establishment is contingent upon Division approval. The Permitted Economic Interest holder understands and acknowledges that approval by the Division is wholly discretionary and the Division may, at any time, deny approval of the Permitted Economic Interest or find that the Permitted Economic Interest is no longer qualified. The Permitted Economic Interest Holder agrees and acknowledges it has no entitlement to or expectation of the Division approving the Permitted Economic Interest. The Permitted Economic Interest holder further agrees that any administrative or judicial review of a determination by the Division regarding the qualification or approval of the Permitted Economic Interest will only occur through licensing or enforcement proceedings involving the Retail Marijuana Establishment. The Permitted Economic Interest holder further agrees and acknowledges that the Permitted Economic Interest holder shall only be entitled to notice of a denial or administrative action concerning the Retail Marijuana Establishment if the denial or administrative action is based upon, or directly related to, the qualifications or actions of the Permitted Economic Interest holder. The Permitted Economic Interest holder also agrees and acknowledges that the Permitted Economic Interest holder may only request leave to intervene in an administrative proceeding against the Retail Marijuana Establishment, pursuant to subsection 24-4-105(2)(c), C.R.S., if the administrative proceeding is based upon, or directly related to, the qualifications or actions of the Permitted Economic Interest holder. Furthermore, the Permitted Economic Interest holder agrees and acknowledges that the Permitted Economic Interest holder may only seek judicial review of an action against the Retail Marijuana Establishment, pursuant to subsection 24-4106(4), C.R.S., if the administrative action is based upon, or directly related to, the qualifications or actions of the Permitted Economic Interest Holder. THE PERMITTED ECONOMIC INTEREST HOLDER KNOWINGLY, FREELY, AND VOLUNTARILY WAIVES ANY RIGHT OR CLAIM TO SEEK ANY INDEPENDENT REVIEW OF APPROVAL OR 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 22 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 23 of 201 DENIAL OF THE PERMITTED ECONOMIC INTEREST BY THE DIVISION, OR OF AN ADMINISTRATIVE ACTION AGAINST THE RETAIL MARIJUANA ESTABLISHMENT, THAT IS BASED UPON, OR DIRECTLY RELATED TO, THE QUALIFICATIONS OR ACTIONS OF THE PERMITTED ECONOMIC INTEREST, AND EXPRESSLY AGREES THAT THE ONLY ADMINISTRATIVE OR JUDICIAL REVIEW OF SUCH A DETERMINATION OR ACTION WILL OCCUR THROUGH A LICENSING OR ENFORCEMENT PROCEEDING FOR THE RETAIL MARIJUANA ESTABLISHMENT. I. Commercially Reasonable Royalty Interest Contract Requirements. A Retail Marijuana Establishment seeking to utilize the intellectual property of a Commercially Reasonable Royalty Interest Holder must submit a copy of the contract between the Retail Marijuana Establishment and the Person seeking to hold a Commercially Reasonable Royalty Interest. The following requirements apply to all such contracts: 1. The contract must be complete, and must fully incorporate all terms and conditions. 2. The following provisions must be included in the contract: a. Any interest in a Retail Marijuana Establishment, whether held by a Commercially Reasonable Royalty Interest Holder or any other person, must be acquired in accordance with the provisions of the Medical Code and/or Retail Code, as applicable, and the rules promulgated thereunder. The issuance of any contract or other interest in violation thereof shall be void. b. No contract, royalty or other interest issued by the Retail Marijuana Establishment and no claim or charge therein or thereto shall be transferred except in accordance with the provisions of the Medical Code and/or Retail Code as applicable, and the rules promulgated thereunder. Any transfer in violation thereof shall be void. c. The Retail Marijuana Establishment and the Commercially Reasonable Royalty Interest Holder must sign an affirmation of passive investment on a form approved by the Division. d. The Commercially Reasonable Royalty Interest Holder shall disclose in writing to the Division and to the Retail Marijuana Establishment any and all disqualifying events, within ten days after occurrence of the event, that could lead to a finding that the Commercially Reasonable Royalty Interest Holder is not qualified to hold the Commercially Reasonable Royalty Interest. e. The Retail Marijuana Establishment shall disclose in writing to the Division any and all disqualifying events, within ten days after receiving notice of the event, which would lead to a finding that the Commercially Reasonable Royalty Interest Holder is not qualified to hold the Commercially Reasonable Royalty Interest. f. A Commercially Reasonable Royalty Interest Holder’s or a Retail Marijuana Establishment’s failure to make required disclosures may lead to a finding that the Commercially Reasonable Royalty Interest is not approved, or is no longer approved, and may lead to a requirement that the Retail Marijuana Establishment terminate its relationship with the Commercially Reasonable Royalty Interest Holder. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 23 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 24 of 201 g. The Commercially Reasonable Royalty Interest Holder agrees and acknowledges that its relationship with the Retail Marijuana Establishment is contingent upon Division approval throughout the entire term of its relationship with the Retail Marijuana Establishment. The Commercially Reasonable Royalty Interest Holder understands and acknowledges that approval by the Division is wholly discretionary and the Division may, at any time, find that the Commercially Reasonable Royalty Interest Holder does not qualify or no longer qualifies. The Commercially Reasonable Royalty Interest Holder agrees and acknowledges it has no entitlement to or expectation to approval of the Commercially Reasonable Royalty Interest. h. The Commercially Reasonable Royalty Interest Holder further agrees that any administrative or judicial review of a determination by the Division approving or denying the Commercially Reasonable Royalty will only occur through licensing or enforcement proceedings involving the Retail Marijuana Establishment. The Commercially Reasonable Royalty Interest Holder further agrees and acknowledges that the Commercially Reasonable Royalty Interest Holder shall only be entitled to notice of a denial or administrative action concerning the Retail Marijuana Establishment if the denial or administrative action is based upon, or directly related to, the qualifications or actions of the Commercially Reasonable Royalty Interest Holder. The Commercially Reasonable Royalty Interest Holder also agrees and acknowledges that the Commercially Reasonable Royalty Interest Holder may only request leave to intervene in an administrative proceeding against the Retail Marijuana Establishment, pursuant to subsection 24-4-105(2)(c), C.R.S., if the administrative proceeding is based upon, or directly related to, the qualifications or actions of the Commercially Reasonable Royalty Interest Holder. Furthermore, the Commercially Reasonable Royalty Interest Holder agrees and acknowledges that the Commercially Reasonable Royalty Interest Holder may only seek judicial review of an action against the Retail Marijuana Establishment, pursuant to subsection 24-4-106(4), C.R.S., if the administrative action is based upon, or directly related to, the qualifications or actions of the Commercially Reasonable Royalty Interest Holder. THE COMMERCIALLY REASONABLE ROYALTY INTEREST HOLDER KNOWINGLY, FREELY, AND VOLUNTARILY WAIVES ANY RIGHT OR CLAIM TO SEEK ANY INDEPENDENT REVIEW OF APPROVAL OR DENIAL OF THE COMMERCIALLY REASONABLE ROYALTY INTEREST BY THE DIVISION, OR OF AN ADMINISTRATIVE ACTION AGAINST THE RETAIL MARIJUANA ESTABLISHMENT, THAT IS BASED UPON, OR DIRECTLY RELATED TO, THE QUALIFICATIONS OR ACTIONS OF THE COMMERCIALLY REASONABLE ROYALTY INTEREST HOLDER, AND EXPRESSLY AGREES THAT THE ONLY ADMINISTRATIVE OR JUDICIAL REVIEW OF SUCH A DETERMINATION OR ACTION WILL OCCUR THROUGH A LICENSING OR ENFORCEMENT PROCEEDING FOR THE RETAIL MARIJUANA ESTABLISHMENT. i. If the Division determines the Commercially Reasonable Royalty Interest Holder is not in compliance with the Retail Code, the Medical Code or these rules, then the recipient shall discontinue use of such Commercially Reasonable Royalty Interest Holder’s intellectual property sales of any product or line of products containing any of that Commercially Reasonable Royalty Interest Holder’s intellectual property within thirty (30) days of the Division finding. The recipient shall not pay any remuneration to a Commercially Reasonable Royalty Interest Holder that does not qualify under the Retail Code and these rules, including but not limited to Rule R 231.2(B). 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 24 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 j. J. RETAIL - Page 25 of 201 The Commercially Reasonable Royalty Interest Holder shall neither exercise control over nor be positioned so as to enable the exercise of control over the Retail Marijuana Establishment. Notwithstanding the foregoing, a Commercially Reasonable Royalty Interest Holder may influence the marketing, advertising, labeling and display of any the product or line of products for which the Commercially Reasonably Royalty Interest exists so long as such influence is not inconsistent with the Retail Code, the Medical Code or these rules. Profit-Sharing Plan Documents. A Retail Marijuana Establishment offering licensed employees a share of the profits through a Profit-Sharing Plan must submit a list of all proposed participants in the Profit-Sharing Plan along with their names, addresses and occupational license numbers and submit a copy of all documentation regarding the Profit-Sharing Plan in connection with the Retail Marijuana Establishment’s application: 1. The documents establishing the Profit-Sharing Plan must be complete and must fully incorporate all terms and conditions. 2. The following provisions must be included in the documents establishing the ProfitSharing Plan: a. Any interest in a Retail Marijuana Establishment, whether held by a ProfitSharing Plan Employee or any other person, must be acquired in accordance with the provisions of the Medical Code and/or Retail Code, as applicable, and the rules promulgated thereunder. The issuance of any contract or other interest in violation thereof shall be void. b. No contract or other interest issued by the Retail Marijuana Establishment and no claim or charge therein or thereto shall be transferred except in accordance with the provisions of the Medical Code and/or Retail Code as applicable, and the rules promulgated thereunder. Any transfer in violation thereof shall be void. Any distributions from a Profit-Sharing Plan must be made in cash, not in the form of stock or other equity interests in the Retail Marijuana Establishment. c. The Retail Marijuana Establishment shall disclose in writing to the Division any and all disqualifying events, within ten days after receiving notice of the event, which would lead to a finding that any Profit-Sharing Plan Employee does not qualify under the Retail Code and these rules, including but not limited to Rule R 231.6(B), to participate in the Profit-Sharing Plan. d. A Profit-Sharing Plan Employee shall disclose in writing to the Division and to the Retail Marijuana Establishment any and all disqualifying events, within ten days after occurrence of the event that could lead to a finding that the Profit-Sharing Plan Employee does not qualify or no longer qualifies under the Retail Code and these rules, including but not limited to Rule R 231.2(B), to participate in the Profit-Sharing Plan. e. A Retail Marijuana Establishment’s or a Profit-Sharing Plan Employee’s failure to make required disclosures may lead to a finding that the Profit-Sharing Plan is not approved, and may lead to a requirement that the Retail Marijuana Establishment terminate or modify the Profit-Sharing Plan. f. The Profit-Sharing Plan Employee agrees and acknowledges that its relationship with the Retail Marijuana Establishment is contingent upon Division approval 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 25 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 26 of 201 throughout the entire term of its relationship with the Retail Marijuana Establishment. The Profit-Sharing Plan Employee understands and acknowledges that approval by the Division is wholly discretionary and the Division may, at any time, deny approval of the Profit-Sharing Plan. The ProfitSharing Plan Employee agrees and acknowledges he or she has no entitlement to or expectation to Division approval of the Profit-Sharing Plan or the ProfitSharing Plan Employee’s participation in the plan. The Profit-Sharing Plan Employee further agrees that any administrative or judicial review of a determination by the Division approving or denying the Profit-Sharing Plan or the Profit-Sharing Plan Employee will only occur through licensing or enforcement proceedings involving the Retail Marijuana Establishment. Each Profit-Sharing Plan Employee further agrees and acknowledges that the Profit-Sharing Plan Employee shall only be entitled to notice of a denial or administrative action concerning the Retail Marijuana Establishment if the denial or administrative action is based upon, or directly related to, the qualifications or actions of the Profit-Sharing Plan Employee. The Profit-Sharing Plan Employee also agrees and acknowledges that the Profit-Sharing Plan Employee may only request leave to intervene in an administrative proceeding against the Retail Marijuana Establishment, pursuant to subsection 24-4-105(2)(c), C.R.S., if the administrative proceeding is based upon, or directly related to, the qualifications or actions of the Profit-Sharing Plan Employee. Furthermore, the Profit Sharing Plan Employee agrees and acknowledges that the Profit-Sharing Plan Employee may only seek judicial review of an action against the Retail Marijuana Establishment, pursuant to subsection 24-4-106(4), C.R.S., if the administrative action is based upon, or directly related to, the qualifications or actions of the Profit-Sharing Plan Employee. THE PROFIT-SHARING PLAN EMPLOYEE KNOWINGLY, FREELY, AND VOLUNTARILY WAIVES ANY RIGHT OR CLAIM TO SEEK ANY INDEPENDENT REVIEW OF APPROVAL OR DENIAL OF THE PROFIT-SHARING PLAN OR THE PROFIT-SHARING PLAN EMPLOYEE BY THE DIVISION, OR OF AN ADMINISTRATIVE ACTION AGAINST THE RETAIL MARIJUANA ESTABLISHMENT, THAT IS BASED UPON, OR DIRECTLY RELATED TO, THE PROFIT-SHARING PLAN OR THE PROFIT-SHARING PLAN EMPLOYEE’S QUALIFICATIONS OR ACTIONS OF THE PROFITSHARING PLAN EMPLOYEE, AND EXPRESSLY AGREES THAT THE ONLY ADMINISTRATIVE OR JUDICIAL REVIEW OF SUCH A DETERMINATION OR ACTION WILL OCCUR THROUGH A LICENSING OR ENFORCEMENT PROCEEDING FOR THE RETAIL MARIJUANA ESTABLISHMENT. K. Qualified Institutional Investor Requirements. Before a Retail Marijuana Establishment may permit a Qualified Institutional Investor to own any portion of the Retail Marijuana Establishment, the Retail Marijuana Establishment must submit the following documentation to the Division in connection with the Retail Marijuana Establishment’s application: 1. A description of the Qualified Institutional Investor's business and a statement as to why the Qualified Institutional Investor meets the definition of Qualified Institutional Investor in Rule R 103 and subsection 12-43.4-306.5(7), C.R.S. 2. A certification made under oath and the penalty of perjury by the Qualified Institutional Investor: a. That the ownership interests were acquired and are held for investment purposes only and were acquired and are held in the ordinary course of business as a Qualified Institutional Investor and not for the purposes of causing, directly or 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 26 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 27 of 201 indirectly, the election of a majority of the board of directors, any change in the corporate charter, bylaws, management, policies, or operations of a Retail Marijuana Establishment. b. That the Qualified Institutional Investor is bound by and shall comply with the Retail Code and the rules adopted pursuant thereto, is subject to the jurisdiction of the courts of Colorado, and consents to Colorado as the choice of forum in the event any dispute, question, or controversy arises regarding the Qualified Institutional Investor’s relationship with the Retail Marijuana Establishment or activities pursuant to the Retail Code and rules adopted pursuant thereto. c. The Qualified Institutional Investor agrees and acknowledges that its relationship with the Retail Marijuana Establishment is contingent upon Division approval throughout the entire term of its relationship with the Retail Marijuana Establishment. The Qualified Institutional Investor understands and acknowledges that approval by the Division is wholly discretionary and the Division may, at any time, deny approval of the Qualified Institutional Investor. The Qualified Institutional Investor agrees and acknowledges it has no entitlement to or expectation to Division approval of the Qualified Institutional Investor. The Qualified Institutional Investor further agrees that any administrative or judicial review of a determination by the Division approving or denying the Qualified Institutional Investor will only occur through licensing or enforcement proceedings involving the Retail Marijuana Establishment. The Qualified Institutional Investor further agrees and acknowledges that the Qualified Institutional Investor shall only be entitled to notice of a denial or administrative action concerning the Retail Marijuana Establishment if the denial or administrative action is based upon, or directly related to, the qualifications or actions of the Qualified Institutional Investor. The Qualified Institutional Investor also agrees and acknowledges that the Qualified Institutional Investor may only request leave to intervene in an administrative proceeding against the Retail Marijuana Establishment, pursuant to subsection 24-4-105(2)(c), C.R.S., if the administrative proceeding is based upon, or directly related to, the qualifications or actions of the Qualified Institutional Investor. Furthermore, the Qualified Institutional Investor agrees and acknowledges that the Qualified Institutional Investor may only seek judicial review of an action against the Retail Marijuana Establishment, pursuant to subsection 24-4-106(4), C.R.S., if the administrative action is based upon, or directly related to, the qualifications or actions of the Qualified Institutional Investor. THE QUALIFIED INSTITUTIONAL INVESTOR KNOWINGLY, FREELY, AND VOLUNTARILY WAIVES ANY RIGHT OR CLAIM TO SEEK ANY INDEPENDENT REVIEW OF APPROVAL OR DENIAL OF THE QUALIFIED INSTITUTIONAL INVESTOR BY THE DIVISION, OR OF AN ADMINISTRATIVE ACTION AGAINST THE RETAIL MARIJUANA ESTABLISHMENT, THAT IS BASED UPON, OR DIRECTLY RELATED TO, THE QUALIFICATIONS OR ACTIONS OF THE QUALIFIED INSTITUTIONAL INVESTOR, AND EXPRESSLY AGREES THAT THE ONLY ADMINISTRATIVE OR JUDICIAL REVIEW OF SUCH A DETERMINATION OR ACTION WILL OCCUR THROUGH A LICENSING OR ENFORCEMENT PROCEEDING FOR THE RETAIL MARIJUANA ESTABLISHMENT. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 27 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 d. RETAIL - Page 28 of 201 An explanation of the basis of the signatory’s authority to sign the certification and to bind the Qualified Institutional Investor to its terms. 3. The name, address, telephone number and any other information requested by the Division as required on its approved forms for the officers and directors, or their equivalent, of the Qualified Institutional Investor as well as those Persons that have direct control over the Qualified Institutional Investor's ownership interest in the Retail Marijuana Establishment. 4. The name, address, telephone number and any other information requested by the Division as required on its approved forms for each Person who has the power to direct or control the Qualified Institutional Investor's voting of its shares in the Retail Marijuana Establishment. 5. The name of each Person that beneficially owns 5 percent or more of the Qualified Institutional Investor's voting securities or other equivalent. 6. A list of the Qualified Institutional Investor's affiliates. 7. A list of all regulatory agencies with which the Qualified Institutional Investor files periodic reports, and the name, address, and telephone number of the individual, if known, to contact at each agency regarding the Qualified Institutional Investor. 8. A disclosure of all criminal or regulatory sanctions imposed during the preceding 10 years and of any administrative or court proceedings filed by any regulatory agency during the preceding 5 years against the Qualified Institutional Investor, its affiliates, any current officer or director, or any former officer or director whose tenure ended within the preceding 12 months. As to a former officer or director, such information need be provided only to the extent that it relates to actions arising out of or during such person's tenure with the Qualified Institutional Investor or its affiliates. 9. A copy of any filing made under 16 U.S.C § 18a with respect to the acquisition or proposed acquisition of an ownership interest in the Retail Marijuana Establishment. 10. Any additional information requested by the Division. Basis and Purpose – R 204 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(a)(I), 1243.4-202(3)(a)(IX), 12-43.4-202(3)(a)(XV), and 12-43.4-202(3)(a)(XX), 12-43.4-202(3)(b)(IX), and 1243.4-601(1) and sections 12-43.4-103, 12-43.4-306.5, 12-43.4-309, and 12-43.4-312, and 12-43.4-901, C.R.S. The purpose of this rule is to provide clarity regarding the nature of a Direct Beneficial Interest Owner and an Indirect Beneficial Interest Owner, and to clarify what factors the State Licensing Authority generally considers regarding the same. The Division will review all relevant information to determine ownership of a Retail Marijuana Establishment. R 204 – Ownership Interests of a License: Retail Marijuana Establishments A. Licenses Held By Direct Beneficial Interest Owners. Each Retail Marijuana Establishment License must be held by its Direct Beneficial Interest Owner(s). Each natural person other than a Qualified Limited Passive Investor must hold an Associated Key license. A Direct Beneficial Interest Owner shall not be a publicly traded company. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 28 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 B. RETAIL - Page 29 of 201 100% Ownership. 1. The sum of the percentages of ownership of all Direct Beneficial Interest Owners of a Retail Marijuana Establishment and Qualified Institutional Investors must equal 100%. a. Qualified Institutional Investors may hold ownership interests, in the aggregate, of 30% or less in the Retail Marijuana Establishment. b. A Qualified Limited Passive Investor must be a natural person who is a United States citizen and may hold an ownership interest of less than five percent in the Retail Marijuana Establishment. c. Each Direct Beneficial Interest Owner, including but not limited to each officer, director, managing member, or partner of a Retail Marijuana Establishment, must hold a current and valid Associated Key License. See Rule R 233 – Retail Code or Medical Code Occupational Licenses Required. Except that this requirement shall not apply to Qualified Limited Passive Investors. d. With the exception of Qualified Institutional Investors, only Direct Beneficial Interest Owners may hold a partnership interest, limited or general, a joint venture interest, or ownership of a share or shares in a corporation or a limited liability company which is licensed. e. In the event of the death, disability, disqualification, divestment, termination, or revocation of the license of a Direct Beneficial Interest Owner or of approval of a Qualified Institutional Investor, a Retail Marijuana Establishment shall have 45 days to submit a change of ownership application to the Division detailing the Licensee’s plan for redistribution of ownership among the remaining Direct Beneficial Interest Owners and Qualified Institutional Investors. Such plan is subject to approval by the Division. If a change of ownership application is not timely submitted, the Retail Marijuana Establishment and its Associated Key Licensee(s) may be subject to administrative action. C. At Least One Associated Key License Required. No Retail Marijuana Establishment may operate or be licensed unless it has at least one Associated Key Licensee that is a Direct Beneficial Interest Owner who has been a Colorado resident for at least one year prior to application. Any violation of this requirement may be considered a license violation affecting public safety. D. Loss Of Occupational License As An Owner Of Multiple Businesses. If an Associated Key License is suspended or revoked as to one Retail Marijuana Establishment or Medical Marijuana Business, that Associated Key License, shall be suspended or revoked as to any other Retail Marijuana Establishment or Medical Marijuana Business in which that Person possesses an ownership interest. See Rule R 233 – Retail Code or Medical Code Occupational Licenses Required. E. Management Companies. Any Person contracted to manage the overall operation of a Licensed Premises must hold a Retail Marijuana Operator license. F. Role of Managers. Associated Key Licensees may hire managers, and managers may be compensated on the basis of profits made, gross or net. A Retail Marijuana Establishment license may not be held in the name of a manager who is not a Direct Beneficial Interest Owner. A manager who does not hold an Associated Key License as a Direct Beneficial Interest Owner of the Retail Marijuana Establishment, must hold a Key License as an employee of the Retail 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 29 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 30 of 201 Marijuana Establishment. Any change in manager must be reported to the Division within seven (7) days of the change. Additionally, a Retail Marijuana Operator may include management services as part of the operational services provided to a Retail Marijuana Establishment. A Retail Marijuana Establishment and its Direct Beneficial Interest Owners may be subject to license denial or administrative action including, but not limited to, fine, suspension or revocation of their license(s) based on the acts or omissions of any manager, Retail Marijuana Establishment Operator, or agents and employees thereof engaged in the operations of the Retail Marijuana Establishment. G. Prohibited Third-Party Acts. No Licensee may employ, contract with, hire, or otherwise engage any Person, including but not limited to an employee, agent, or independent contractor, to perform any act or conduct on the Licensee’s behalf or for the Licensee’s benefit if the Licensee is prohibited by law or these rules from engaging in such conduct itself. 1. A Licensee is responsible for all actions and omissions of any Person the Licensee employs, contracts with, hires, or otherwise engages, including but not limited to an employee, agent, or independent contractor, to perform any act or conduct on the Licensee’s behalf or for the Licensee’s benefit. 2. A Licensee may be subject to license denial or administrative action, including but not limited to fine, suspension or revocation of its license(s), based on the acts and/or omissions of any Person the Licensee employs, contracts with, hires, or otherwise engages, including but not limited to an employee, agent, or independent contractor, to perform any act or conduct on the Licensee’s behalf or for the Licensee’s benefit. Basis and Purpose – R 204.5 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(a)(I), 1243.3-202(3)(a)(III), 12-43.4-202(3)(a)(XIV.5), 12-43.4-202(3)(a)(XX), 12-43.4-202(3)(b)(V), 12-43.4202(3)(b)(VI), 12-43.4-202(3)(b)(VIII), 12-43.4-202(3)(b)(IX), and sections 12-43.4-103, 12-43.4-304, 1243.4-306, 12-43.4-306.5, 12-43.4-308, 12-43.4-309, and 12-43.4-312, C.R.S. The purpose of this rule is to clarify the application, review and approval process for various types of Business Interests. The Division will review all relevant information to determine ownership of, interests in, and control of a Retail Marijuana Establishment. R 204.5 – Disclosure, Approval and Review of Business Interests A. Business Interests. A Retail Marijuana Establishment shall disclose all Business Interests at the time of initial application and at the time of each renewal application. Business Interests include Financial Interests and Affiliated Interests. Any Financial Interest must be pre-approved by the Division. It shall be unlawful to fail to completely report all Business Interests in each license issued. It shall be unlawful for a person other than a Financial Interest holding an Associated Key License to exercise control over a Retail Marijuana Establishment or to be positioned so as to enable the exercise of control over a Retail Marijuana Establishment. Except that a Qualified Institutional Investor and a Qualified Limited Passive Investor may vote his, her or its shares in the Retail Marijuana Establishment. B. Financial Interests. A Retail Marijuana Establishment shall not permit any Person to hold or exercise a Financial Interest in the Retail Marijuana Establishment unless and until such Person’s Financial Interest has been approved by the Division. If a Retail Marijuana Establishment wishes to permit a Person to hold or exercise a Financial Interest, and that Person has not been previously approved in connection with an application for the Retail Marijuana Establishment, the 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 30 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 31 of 201 Retail Marijuana Establishment shall submit a change of ownership or financial interest form approved by the Division. A Financial Interest shall include: 1. Any Direct Beneficial Interest Owner; 2. The following types of Indirect Beneficial Interest Owners: 3. C. a. A Commercially Reasonable Royalty Interest Holder who receives a royalty of more than 30 percent of the gross revenue or gross profit from sales of the product or line of products subject to the royalty; and b. A Permitted Economic Interest holder. Control. Any other Person who exercises control or is positioned so as to enable the exercise of control over the Retail Marijuana Establishment must hold an Associated Key License. A natural person who exercises control or is positioned so as to enable the exercise of control over a Retail Marijuana Establishment shall include but shall not be limited to a natural person who: a. Bears the risk of loss and opportunity for profit; b. Has final decision making authority over any material aspect of the operation of the Retail Marijuana Establishment; c. Manages the overall operations of a Retail Marijuana Establishment or its Licensed Premises, or who manages a material portion of the Retail Marijuana Establishment or its Licensed Premises; d. Guarantees the Retail Marijuana Establishment’s debts or production levels; e. Is a beneficiary of the Retail Marijuana Establishment’s insurance policies; f. Receives the majority of the Retail Marijuana Establishment’s profits as compared to other recipients of the Retail Marijuana Establishment’s profits; or g. Acknowledges liability for the Retail Marijuana Establishment’s federal, state or local taxes. Affiliated Interests. A Retail Marijuana Establishment shall disclose all Affiliated Interests in connection with each application for licensure, renewal or reinstatement of the Retail Marijuana Establishment. The Division may conduct such background investigation as it deems appropriate regarding Affiliated Interests. An Affiliated Interest shall include any Person who does not hold a Financial Interest in the Retail Marijuana Establishment and who has any of the following relationships with the Retail Marijuana Establishment: 1. The following Indirect Beneficial Interest Owners: a. A Commercially Reasonable Royalty Interest Holder who receives, in the a royalty of 30 percent or less, in the aggregate, of the gross revenue or gross profit from sales of the product or line of products subject to the royalty; b. A Profit-Sharing Plan Employee; and 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 31 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 c. D. RETAIL - Page 32 of 201 A Qualified Institutional Investor. 2. Any other Person who holds any other disclosable interest in the Retail Marijuana Establishment other than a Financial Interest. Such disclosable interests shall include but shall not be limited to an indirect financial interest, a lease agreement, a secured or unsecured loan, or security interest in fixtures or equipment with a direct nexus to the cultivation, manufacture, Transfersale, transportation, or testing of Retail Marijuana or Retail Marijuana Products. 3. If the Division determines any Person disclosed as an Affiliated Interest should have been pre-approved as a Financial Interest, approval and further background investigation may be required. Additionally, the failure to seek pre-approval of a Financial Interest holder may form the basis for license denial or administrative action against the Retail Marijuana Establishment. Secured Interest In Marijuana Prohibited. No Person shall at any time hold a secured interest in Retail Marijuana or Retail Marijuana Products Basis and Purpose – R 205 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(a)(III), 1243.4-202(3)(a)(XIV.5), 12-43.4-304, 12-43.4-306, 12-43.4-309(2), and sections 12-43.4-103, 12-43.4-308, 12-43.4-406, 12-43.4-407 and 24-76.5-101, et. seq., C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(I). The purpose of this rule is to establish protocol for ownership transfers. In addition, the rule clarifies that a business cannot use the transfer of ownership process in order to circumvent the administrative disciplinary process and that an ongoing investigation or disciplinary action may: (1) constitute grounds to deny a transfer of ownership request; (2) constitute grounds to delay a transfer of ownership request, or (3) mandate that the new business owner is responsible for any imposed sanction. R 205 – Transfer of Ownership and Changes in Business Structure: Retail Marijuana Establishments A. General Requirements 1. All applications for transfers of Direct Beneficial Interest Owners or changes in corporate structure by licensed Retail Marijuana Establishments authorized pursuant to section 1243.4-401, C.R.S., shall be made upon current forms prescribed by the Division. Each application shall identify the relevant local jurisdiction. 2. All applications for transfers of ownership and changes in Retail Marijuana Establishments must include application fees, be complete in every material detail, and be filled out truthfully. 3. All applications for transfers of ownership and changes in licensed entities by Retail Marijuana Establishments must be reported to the State Licensing Authority or its designee and relevant local jurisdiction at least 30 days prior to any requested transfer or change. 4. Each Applicant for a transfer of ownership shall provide suitable evidence as required by the Division, in accordance with these rules and the Retail Code, of each natural person’s proof of lawful presence, citizenship, residence, good character and reputation and verification that funds used to invest in or finance the retail marijuana business were 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 32 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 33 of 201 lawfully earned or obtained. Each Applicant shall also provide all requested information concerning financial and management associations and interests of other Persons in the business, Department of Revenue tax payment information, the deed, lease, contract, or other document governing the terms and conditions of occupancy of the Licensed Premises. Nothing in this section is intended to limit the Division’s ability to request additional information it deems necessary to determining an Applicant’s suitability for licensure. 5. Failure to provide such additional information by the deadline specified by the Division may result in denial of the application. 6. The Applicant shall provide the original and one copy of an application for transfer of ownership to the Division. The Division will retain the original application and send the copy to the relevant local jurisdiction within seven days of receiving the application. See Rule R 1401 - Instructions for Local Jurisdictions and Law Enforcement Officers. 7. The Division will not approve a transfer of ownership application without first receiving written notification that the Applicant disclosed the transfer of ownership to the relevant local jurisdiction. If a local jurisdiction elects not to approve or deny a transfer of ownership application, the local jurisdiction must provide written notification acknowledging receipt of the application and the State Licensing Authority shall revoke the state-issued license. 8. The Applicant(s), or proposed transferee(s), for any license shall not operate the Retail Marijuana Establishment identified in the transfer of ownership application until the transfer of ownership request is approved in writing by the State Licensing Authority or its designee. A violation of this requirement shall constitute grounds to deny the transfer of ownership request, may be a violation affecting public safety, and may result in disciplinary action against the Applicant’s existing license(s), if applicable. 9. All current Direct Beneficial Interest Owner(s), or proposed transferor(s), of the license(s) at issue retain full responsibility for the Retail Marijuana Establishment identified in the transfer of ownership application until the transfer of ownership request is approved in writing by the Division. A violation of this requirement shall constitute grounds to deny the transfer of ownership request, may be a violation affecting public safety, and may result in disciplinary action against the license(s) of the current Direct Beneficial Interest Owners and/or the Retail Marijuana Establishment. 10. If a Retail Marijuana Establishment or any of its Direct Beneficial Interest Owners applies to transfer ownership and is involved in an administrative investigation or administrative disciplinary action, the following may apply: 11. a. The transfer of ownership may be delayed or denied until the administrative action is resolved; or b. If the transfer of ownership request is approved in writing by the Division, the transferee may be responsible for the actions of the Retail Marijuana Establishment and its prior Direct Beneficial Interest Owners, and subject to discipline based upon the same. Licensee Initiates Change of Ownership for Permitted Economic Interests. All individuals holding a Permitted Economic Interest who seek to convert to become a Direct Beneficial Interest Owner are subject to this Rule R 205. The Retail Marijuana Establishment must 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 33 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 34 of 201 initiate the change of ownership process for an individual holding a Permitted Economic Interest who seeks to convert its interest to become a Direct Beneficial Interest Owner. Permitted Economic Interest holders who are not qualified to become a Direct Beneficial Interest Owner shall not be allowed to convert. 12. B. Retail Marijuana Transporters Not Eligible. Retail Marijuana Transporters are not eligible to apply for change of ownership. As It Relates to Corporations and Limited Liability Companies 1. If the Applicant is a corporation or limited liability company, it shall submit with the application the names, mailing addresses, and background forms of all of its officers, directors, and Direct and Indirect Beneficial Interest Owners; a copy of its articles of incorporation or articles of organization; and evidence of its authorization to do business within this State. In addition, each Applicant shall submit the names, mailing addresses, and, where applicable, certifications of residency or citizenship for all Persons owning any of the outstanding or issued capital stock or holding a membership interest. No publicly traded company may be identified as the proposed recipient of any ownership interest in a Retail Marijuana Establishment. 2. Any proposed transfer of capital stock, regardless of the number of shares of capital stock transferred, shall be reported and approved by the State Licensing Authority or its designee and the relevant local jurisdiction at least 30 days prior to such transfer or change. If a local jurisdiction elects not to approve or deny this activity, the local jurisdiction must provide written notification acknowledging receipt of the application. C. As It Relates to Partnerships. If the Applicant is a general partnership, limited partnership, limited liability partnership, or limited liability limited partnership, it shall submit with the application the names, mailing addresses, background forms and, where applicable, certification of residency or citizenship for all of its partners and a copy of its partnership agreement. D. As It Relates to Entity Conversions. Any Licensee that qualifies for an entity conversion pursuant to sections 7-90-201, C.R.S., et. seq., shall not be required to file a transfer of ownership application pursuant to section 12-43.4-308, C.R.S., upon statutory conversion, but shall submit a report containing suitable evidence of its intent to convert at least 30 days prior to such conversion. Such evidence shall include, but not be limited to, any conversion documents or agreements for conversion at least ten days prior to the date of recognition of conversion by the Colorado Secretary of State. The Licensee shall submit to the Division the names and mailing addresses of any officers, directors, general or managing partners, and all Direct and Indirect Beneficial Owners. E. Approval Required. It may be considered a license violation affecting public safety if a Licensee engages in any transfer of ownership without prior approval from the Division and the relevant local jurisdiction. F. Applications for Reinstatement Deemed New Applications. The Division will not accept an application for transfer of ownership if the license to be transferred is expired for more than 90 days, is voluntarily surrendered, or is revoked. See Rule R 202 - Process for Issuing a New License: Retail Marijuana Establishments. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 34 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 35 of 201 Basis and Purpose – R 206 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(2)(e), and 1243.4-202(3)(a)(I), 12-43.4-309(6), 12-43.4-309(12) and section 12-43.4-304, C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(I). The purpose of this rule is to clarify the application process for changing location of a Licensed Premises. R 206 – Changing Location of Licensed Premises: Retail Marijuana Establishments A. B. Application Required to Change Location of Licensed Premises 1. A Direct Beneficial Interest Owner or other authorized representative of a Retail Marijuana Establishment must make application to the Division for permission to change location of its Licensed Premise. 2. Such application shall: a. Be made upon current forms prescribed by the Division; b. Be complete in every material detail and include remittance of all applicable fees; c. Be submitted at least 30 days prior to the proposed change; d. Explain the reason for requesting such change; e. Be supported by evidence that the application complies with the relevant local jurisdiction requirements; and f. Contain a report of the relevant local jurisdiction(s) in which the Retail Marijuana Establishment is to be situated, which report shall demonstrate the approval of the local jurisdiction(s) with respect to the new location. If the relevant local jurisdiction elects not to approve or deny a change of location of Licensed Premises application, the local jurisdiction must provide written notification acknowledging receipt of the application. Permit Required Before Changing Location 1. No change of location shall be permitted until after the Division considers the application, and such additional information as it may require, and issues to the Applicant a permit for such change. 2. The permit shall be effective on the date of issuance, and the Licensee shall, within 120 days, change the location of its business to the place specified therein and at the same time cease to operate a Retail Marijuana Establishment at the former location. At no time may a Retail Marijuana Establishment operate or exercise any of the privileges granted pursuant to the license in both locations. For good cause shown, the 120 day deadline may be extended for an additional 90120 days. If the Licensee does not change the location of its business within the time period granted by the Division, including any extension, the Licensee shall submit a new application, pay the requisite fees and receive a new permit prior to completing any change of the location of the business. 3. The permit shall be conspicuously displayed at the new location, immediately adjacent to the license to which it pertains. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 35 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 C. RETAIL - Page 36 of 201 General Requirements 1. An application for change of location to a different local jurisdiction shall follow the same procedures as an application for a new Retail Marijuana Establishment license, except that licensing fees will not be assessed until the license is renewed. See Rule R 202 Process for Issuing a New License: Retail Marijuana Establishments. 2. An Applicant for change of location within the same local jurisdiction shall file a change of location application with the Division and pay the requisite change of location fee. See Rule R 207 - Schedule of Application Fees: Retail Marijuana Establishments. Basis and Purpose – R 207 The statutory authority for this rule is found at subsections 12-43.4-202(2)(a), 12-43.4-202(2)(b), 12-43.4104(1)(a)(I), 12-43.4-202(3)(a)(II), 12-43.4-202(3)(a)(XIV.5), 12-43.4-306.5(5)(a)-(b), and 12-43.4401(1)(a)-(g), and sections 12-43.4-103, 12-43.4-401, 12-43.3-501, 12-43.3-502 and 12-43.4-501, C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(II). The purpose of this rule is to clarify the schedules of application fees for new retail business Licensees. R 207 – Schedule of Application Fees: Retail Marijuana Establishments A. Base Retail Marijuana Application Fees 1. Application Fee for Existing Medical Marijuana Licensees in Good Standing and Qualified Applications. a. B. A Person licensed pursuant to the Medical Code, section 12-43.3-401, and that meets the requirements of 12-43.4-104, C.R.S., shall pay a $500 application fee, for each application submitted, to operate a Retail Marijuana Establishment if the following are met: i. The Licensee is operating; and ii. The Licensee’s license is in good standing. A license in good standing has complied consistently with the provisions of the Medical Code and the regulations adopted pursuant thereto and is not subject to a disciplinary action at the time of the application. 2. Application Fee for New Applicants - Retail Marijuana Store, Cultivation Facility, or Product Manufacturer. Applicants that do not meet the criteria in Part A. of this rule are required to pay a $5000 application fee that must be submitted with each application before it will be considered. 3. Retail Marijuana Testing Facility Application Fee - $1,000.00 4. Retail Marijuana Transporter Application Fee - $1,000.00 5. Retail Marijuana Establishment Operator License Application Fee - $1,000.00 Retail Marijuana Establishment Application Fees for Indirect Beneficial Interest Owners, Qualified Limited Passive Investors and Other Affiliated Interests 1. Affiliated Interest that is not an Indirect Beneficial Interest Owner - $200.00 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 36 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 2. Commercially Reasonable Royalty Interest Holder receiving a royalty of more than 30 percent of the gross revenue profit from the sales of the product or lines of products subject to the royalty - $400.00 3. Commercially Reasonable Royalty Interest Holder receiving, in the aggregate, a royalty of 30 percent or lessless than or equal to 30 percent of the gross revenue or gross profit from the sales of the product or lines of product subject to the royalty - $200.00 4. Permitted Economic Interest - $400.00 5. Employee Profit Sharing Plan - $200.00 6. Qualified Limited Passive Investor 7. C. RETAIL - Page 37 of 201 a. Standard limited initial background check - $75.00 b. Full background check for reasonable cause - $125.00 Qualified Institutional Investor - $200.00 When Application Fees Are Due. All application fees are due at the time a Retail Marijuana Establishment submits an application and/or at the time a Retail Marijuana Establishment submits an application for a new Financial Interest. An Applicant must follow Division policies regarding payment to local jurisdictions. Basis and Purpose – R 210 The statutory authority for this rule is found at subsections 12-43.4-202(2)(a), 12-43.3-1101, 12-43.31102, 12-43.4-202(2)(b), 12-43.4-202(3)(a)(II), and12-43.4-304(1), and sections 12-43.4-103, 12-43.4401,12-43.3-501, 12-43.3-502 and 12-43.4-501, C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(II). The purpose of this rule is to establish basic requirements for all Division applications and help the regulated community understand procedural licensing requirements. R 210 – Schedule of Other Application Fees: All Licensees A. Other Application Fees. The following application fees apply: 1. Transfer of Ownership - New Owners - $1,600.00 2. Transfer of Ownership - Reallocation of Ownership - $1,000.00 3. Change of Corporation or LLC Structure - $800.00/Person 4. Change of Trade Name - $50.00 5. Change of Location Application Fee - Same Local Jurisdiction Only - $500.00 6. Modification of Licensed Premises - $100.00 7. Duplicate Business License - $20.00 8. Duplicate Occupational License - $20.00 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 37 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 38 of 201 9. Off Premises Storage Permit - $1,500.00 10. Retail Marijuana Transporter Off Premises Storage Permit - $2,200.00 11. Responsible Vendor Program Provider Application Fee: $850.00 12. Responsible Vendor Program Provider Renewal Fee: $350.00 13. Responsible Vendor Program Provider Duplicate Certificate Fee: $50.00 B. When Other Application Fees Are Due. All other application fees are due at the time the application and/or request is submitted. C. Subpoena Fee – See Rule MR 106 – Subpoena Fees Basis and Purpose - R 211 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(a)(I) and (II), 12-43.4-202(3)(b)(IX), and 12-43.4-202(4)(a) and (b) and sections 12-43.4-103, 12-43.4-104, and 1243.4-501, C.R.S. The purpose of this rule is to clarify that, with the exception of Medical Marijuana Testing Facilities, Medical Marijuana Business Operators and Medical Marijuana Business Transporters, an existing Medical Marijuana Business may apply to convert a Medical Marijuana Business License to a Retail Marijuana Establishment License or may apply to obtain one additional license to operate a Retail Marijuana Establishment. It is important to note that the State Licensing Authority considers each license issued as separate and distinct. Each license, whether it is in the same location or not, is fully responsible to maintain compliance with all statutes and rules promulgated regardless of whether or not they are located in a shared address. A Medical Marijuana Business may only obtain one Retail Marijuana Establishment License, whether it converts the Medical Business License or obtains a Retail Marijuana Establishment License, for each Medical Marijuana Business License it holds. In order to ensure all Retail Marijuana and Retail Marijuana Product are tracked in the Inventory Tracking System and as a condition of licensure, a Medical Marijuana Business must declare in the Inventory Tracking System all Medical Marijuana and Medical Marijuana Infused-Product that are converted for Transfer sale as Retail Marijuana or Retail Marijuana Product prior to initiating or allowing any Transferssales. This declaration may be made only once, in part, due to the excise tax issues that may be implicated if a Licensee makes multiple conversions from Medical Marijuana or Medical Marijuana-Infused Product to Retail Marijuana or Retail Marijuana Product. Beginning July 1, 2016, the only allowed tTransfer of marijuana between a Medical Marijuana Business and Retail Marijuana Establishment is the tTransfer of Medical Marijuana and Medical Marijuana Concentrate that was produced at the Optional Premises Cultivation Operation, from the Optional Premises Cultivation Operation to a Retail Marijuana Cultivation Facility. The marijuana subject to the one-time transfer is subject to the excise tax upon the first tTransfer from the Retail Marijuana Cultivation Facility to another Retail Marijuana Establishment. The State Licensing Authority received several comments from stakeholders who requested lower fees for Medical Marijuana Businesses that were either converting a Medical Marijuana Business license to a Retail Marijuana Establishment license or obtaining an additional Retail Marijuana Establishment license while retaining the existing Medical Marijuana Business license. The adopted permanent regulations reflect changes to address this concern. Under the rules as adopted Medical Marijuana Businesses that apply to convert to a Retail Marijuana Establishment license will be required to pay an application fee, but no license fees will be charged until such time as the renewal fees would have been due under the Medical Marijuana Business license term. The Retail Marijuana Establishment license, if approved, would 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 38 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 39 of 201 assume the balance of the license term from the Medical Marijuana Business license and have the same expiration date. This rule also informs existing and prospective licensees of production management conditions. The State Licensing Authority intends to replace or revise this rule’s production management provisions as early as January 2017 by transitioning to an output-based production management model. Existing and prospective licensees should be on notice that the new or revised regulations may impact the production limits provided for in this rule. Additionally, throughout the rulemaking process stakeholders expressed concern over ensuring an adequate amount of licensed Retail Marijuana Stores exist to Transfersell the amount of Retail Marijuana being produced at licensed Retail Marijuana Cultivation Facilities. Scaling the number of interests a person may hold in Retail Marijuana Cultivation Facility licenses relative to the number of controlling interests the person has in Retail Marijuana Store(s) has been incorporated in the production management rules as a means to address this production management concern. R 211 – Conversion - Medical Marijuana Business to Retail Marijuana Establishment Pursuant to 12-43.4-104(1)(a)(I), C.R.S. A. Medical Marijuana Business Applying for a Retail Marijuana Establishment License. Except for a Medical Marijuana Testing Facility, a Medical Marijuana Business Operator or a Medical Marijuana Business Transporter, a Medical Marijuana Business in good standing or who had a pending application as of December 10, 2012 that has not yet been denied, and who has paid all applicable fees may apply for a Retail Marijuana Establishment license in accordance with the Retail Code and these rules on or after October 1, 2013. A Medical Marijuana Business meeting these conditions may apply to convert a Medical Marijuana Business license to a Retail Marijuana Establishment license or may apply for a single Retail Marijuana Establishment of the requisite class of license in the Medical Marijuana Code for each Medical Marijuana Business License not converted. B. Retail Marijuana Establishment Expiration Date. C. 1. A Medical Marijuana Business converting its license to a Retail Marijuana Establishment license shall not be required to pay a license fee at the time of application for conversion. 2. If a Medical Marijuana Business licensee is scheduled to renew its license during the processing of its conversion to a Retail Marijuana Establishment license, the Medical Marijuana Business must complete all renewal applications and pay the requisite renewal licensing fees. 3. A Retail Marijuana Establishment license that was fully converted from a Medical Marijuana Business license will assume the balance of licensing term previously held by the surrendered Medical Marijuana Business license. Retail Marijuana Establishment Licenses Conditioned 1. It shall be unlawful for a Retail Marijuana Establishment to operate without being issued a Retail Marijuana Establishment license by the State Licensing Authority and receiving all relevant local jurisdiction approvals. Each Retail Marijuana Establishment license issued shall be conditioned on the Licensee’s receipt of all required local jurisdiction approvals and licensing, if required. 2. Each Retail Marijuana Establishment license issued shall be conditioned on the Medical Marijuana Business’ declaration of the amount of Medical Marijuana or Medical Marijuana-Infused Product it intends to tTransfer from the requisite Medical Marijuana 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 39 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 40 of 201 Business for sale as Retail Marijuana or Retail Marijuana Product. A Licensee that converts to a Retail Marijuana Establishment shall not exercise any of the rights or privileges of a Retail Marijuana Establishment until such time as all such Medical Marijuana and Medical Marijuana-Infused Product are fully tTransferred and declared in the Inventory Tracking System as Retail Marijuana and Retail Marijuana Product. See also, Rule R 309 –Inventory Tracking System. Beginning July 1, 2016, the only allowed tTransfer of marijuana between a Medical Marijuana Business and Retail Marijuana Establishment is the tTransfer of Medical Marijuana and Medical Marijuana Concentrate that was produced at the Optional Premises Cultivation Operation, from the Optional Premises Cultivation Operation to a Retail Marijuana Cultivation Facility. D. E. F. One-Time Transfer 1. This rule R 211(D)(1) is repealed effective July 1, 2016. Prior to July 1, 2016, once a Retail Marijuana Establishment has declared Medical Marijuana and Medical MarijuanaInfused Product as Retail Marijuana or Retail Marijuana Product in the Inventory Tracking System and begun exercising the rights and privileges of the license, no additional Medical Marijuana or Medical Marijuana-Infused Product can be tTransferred from the Medical Marijuana Business to the relevant Retail Marijuana Establishment at any time. 1.5. Beginning July 1, 2016, the only allowed tTransfer of marijuana between a Medical Marijuana Business and a Retail Marijuana Establishment is the tTransfer of Medical Marijuana and Medical Marijuana Concentrate that was produced at the Optional Premises Cultivation Operation, from the Optional Premises Cultivation Operation to a Retail Marijuana Cultivation Facility. All other tTransfers are prohibited, including but not limited to tTransfers from a Medical Marijuana Center or Medical Marijuana-Infused Products Manufacturer to any Retail Marijuana Establishment. Once a Retail Marijuana Establishment has declared Medical Marijuana and Medical Marijuana Concentrate as Retail Marijuana or Retail Marijuana Concentrate in the Inventory Tracking System and begun exercising the rights and privileges of the license, no additional Medical Marijuana or Medical Marijuana Concentrate can be tTransferred from the Medical Marijuana Business to the relevant Retail Marijuana Establishment at any time. Additional Application Disclosures. 1. At the time of application for a Retail Marijuana Store license an Applicant must designate the Medical Marijuana Center license intended to be used to obtain the Retail Marijuana Store license, whether or not that license will be converted, by providing its business license number. 2. At the time of application for a Retail Marijuana Products Manufacturing Facility license an Applicant must designate the Medical Marijuana Infused-Products Manufacturing Business license intended to be used to obtain the Retail Marijuana Products Manufacturing license, whether or not that license will be converted, by providing its business license number. 3. At the time of application for a Retail Marijuana Cultivation Facility license an Applicant must designate the Optional Premises Cultivation Operation license intended to be used to obtain the Retail Marijuana Cultivation Facility license, whether or not that license will be converted, by providing its business license number. One Retail Cultivation License per Licensed Premises. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 40 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 G. RETAIL - Page 41 of 201 1. Only one Retail Marijuana Cultivation Facility License shall be permitted at each licensed premises. Each licensed premises must be located at a distinct address recognized by the local jurisdiction. Each licensed premise must have its own public entrance and be securely and physically separated from any other address located within the same structure. 2. Existing Retail Marijuana Cultivation Facilities that have Multiple Cultivation Licenses at the Licensed Premises. Upon the first renewal at the Retail Marijuana Cultivation Facility, all of the Retail Marijuana Cultivation Facility’s licenses will be collapsed into one surviving license, and fees shall be prorated for the non-expiring licenses. The maximum authorized plant count shall also collapse into the surviving license. See rule R 506 – Retail Marijuana Cultivation Facility: Production Management. Authorized Plant Count and Associated Fees. 1. All Retail Marijuana Cultivation Facility licenses granted on or after November 30, 2015 shall be authorized to cultivate no more than 1,800 plants at any given time and are subject to the production management requirements of rule R 506 – Retail Marijuana Cultivation Facility: Production Management. See rule R 506 – Retail Marijuana Cultivation Facility: Production Management. 2. All Retail Marijuana Cultivation Facility licenses granted before November 30, 2015 are subject to the production management requirements of rule R 506 – Retail Marijuana Cultivation Facility: Production Management. 3. As of November 30, 2015, a Retail Marijuana Cultivation Facility license that was associated with a Retail Marijuana Products Manufacturing Facility shall be authorized to cultivate no more than 1,800 plants at any given time. If such a Retail Marijuana Cultivation Facility licensee submitted a plant count waiver application prior to August 31, 2015 and it was subsequently approved, the license shall be authorized to cultivate the maximum number of plants at any given time in the corresponding production management tier pursuant to rule R 506 – Retail Marijuana Cultivation Facility: Production Management. 4. Upon demonstrating certain conditions, the Direct Beneficial Interest Owner/s of an existing Retail Marijuana Cultivation Facility license may apply to the Division for a production management tier increase to be authorized to cultivate the number of plants in the next highest production management tier. See rule R 506 – Retail Marijuana Cultivation Facility: Production Management. If the application is approved, the Licensee shall pay the applicable expanded production management tier fee prior to cultivating the additional authorized plants. See rule R 208 – Schedule of Business License Fees: Retail Marijuana Establishments. 5. At renewal, a Licensee that is authorized to cultivate more than 1,800 plants shall pay the requisite Retail Marijuana Cultivation Facility licensee fee and the applicable expanded production management tier fee. See rule R 209 – Schedule of Business License Renewal Fees: Retail Marijuana Establishments. 6. At renewal, the Division will review a Licensee’s maximum authorized plant count and may reduce it pursuant to the requirements of rule R 506. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 41 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 7. H. RETAIL - Page 42 of 201 The State Licensing Authority, in its sole discretion, may adjust any of the plant limits described in this rule on an industry-wide aggregate basis for all Retail Marijuana Cultivation Facility Licensees subject to that limitation. Maximum Allowed Retail Marijuana Cultivation Facility Licenses. 1. A Person with an Interest in Three or More Retail Marijuana Cultivation Facility Licenses. For every multiple of three Retail Marijuana Cultivation Facility licenses a person has an interest in, the person must have a controlling interest in at least one Retail Marijuana Store. For example: (1) a person with an interest in three, four, or five Retail Marijuana Cultivation Facility licenses also must have a controlling interest in at least one Retail Marijuana Store; (2) a person with an interest in six, seven, or eight Retail Marijuana Cultivation Facility licenses also must have a controlling interest in at least two Retail Marijuana Stores; (3) a person with an interest in nine, ten, or eleven Retail Marijuana Cultivation Facility licenses also must have a controlling interest in at least three Retail Marijuana Stores; etc. 2. A Person with an Interest in Less than Three Retail Marijuana Cultivation Facility Licenses. The person shall not be required to have an interest in a Retail Marijuana Store. Basis and Purpose – R 212 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(a)(I-II), 1243.4-202(3)(b)(IX), and 12-43.4-202(4)(a) and (b); and sections 12-43.4-103, 12-43.4-104, and 12-43.4501, C.R.S. This rule also informs existing and prospective licensees licensed pursuant to 12-43.4104(1)(b)(II), C.R.S. of licensing and production management conditions. The State Licensing Authority intends to replace or revise this rule’s production management provisions as early as January 2017 by transitioning to an output-based production management model. Existing and prospective licensees should be on notice that the new or revised regulations may impact the production limits provided for in this rule. Additionally, throughout the rulemaking process stakeholders expressed concern over ensuring an adequate amount of licensed Retail Marijuana Stores exist to Transfersell the amount of Retail Marijuana being produced at licensed Retail Marijuana Cultivation Facilities. Scaling the number of interests a person may hold in Retail Marijuana Cultivation Facility licenses relative to the number of controlling interests the person has in Retail Marijuana Store(s) has been incorporated in the production management rules as a means to address this production management concern. Rule R 212 – New Applicant Retail Marijuana Cultivation Facilities Licensed Pursuant To 12-43.4104(1)(b)(II), C.R.S. A. Applicability. This rule R 212 shall apply to all new applicant Retail Marijuana Cultivation Facility Licenses granted after September 30, 2014 pursuant to 12-43.4-104(1)(b)(II), C.R.S. B. One Retail Cultivation License per Licensed Premises. 1. Only one Retail Marijuana Cultivation Facility License shall be permitted at each licensed premises. Each licensed premises must be located at a distinct address recognized by the local jurisdiction. Each licensed premise must have its own public entrance and be securely and physically separated from any other address located within the same structure. 2. Existing Retail Marijuana Cultivation Facilities that have Multiple Cultivation Licenses at the Licensed Premises. Upon the first renewal at the Retail Marijuana Cultivation Facility, 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 42 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 43 of 201 all of the Retail Marijuana Cultivation Facility’s licenses will be collapsed into one surviving license, and fees shall be prorated for the non-expiring licenses. The maximum authorized plant count shall also collapse into the surviving license. See rule R 506 – Retail Marijuana Cultivation Facility: Production Management. C. D. Authorized Plant Count and Associated Fees. 1. All Retail Marijuana Cultivation Facility licenses granted on or after November 30, 2015 shall be authorized to cultivate no more than 1,800 plants at any given time and are subject to the production management requirements of rule R 506 – Retail Marijuana Cultivation Facility: Production Management. 2. All Retail Marijuana Cultivation Facility licenses granted before November 30, 2015 are subject to the production management requirements of rule R 506 – Retail Marijuana Cultivation Facility: Production Management. 3. As of November 30, 2015, a Retail Marijuana Cultivation Facility license that was associated with a Retail Marijuana Products Manufacturing Facility shall be authorized to cultivate no more than 1,800 plants at any given time. If such a Retail Marijuana Cultivation Facility licensee submitted a plant count waiver application prior to August 31, 2015 and it was subsequently approved, the license shall be authorized to cultivate the maximum number of plants at any given time in the corresponding production management tier pursuant to rule R 506 – Retail Marijuana Cultivation Facility: Production Management. 4. Upon demonstrating certain conditions, the Direct Beneficial Interest Owner/s of an existing Retail Marijuana Cultivation Facility license may apply to the Division for a production management tier increase to be authorized to cultivate the number of plants in the next highest production management tier. See rule R 506 – Retail Marijuana Cultivation Facility: Production Management. If the application is approved, the Licensee shall pay the applicable expanded production management tier fee prior to cultivating the additional authorized plants. See rule R 208 – Schedule of Business License Fees: Retail Marijuana Establishments. 5. At renewal, a Licensee that is authorized to cultivate more than 1,800 plants shall pay the requisite Retail Marijuana Cultivation Facility licensee fee and the applicable expanded production management tier fee. See rule R 209 – Schedule of Business License Renewal Fees: Retail Marijuana Establishments. 6. At renewal, the Division will review a Licensee’s maximum authorized plant count and may reduce it pursuant to the requirements of rule R 506. 7. The State Licensing Authority, at its sole discretion, may adjust any of the plant limits described in this rule on an industry-wide aggregate basis for all Retail Marijuana Cultivation Facility Licensees subject to that limitation. Maximum Allowed Retail Marijuana Cultivation Facility Licenses. 1. A Person with an Interest in Three or More Retail Marijuana Cultivation Facility Licenses. For every multiple of three Retail Marijuana Cultivation Facility licenses a person has an interest in, the person must have a controlling interest in at least one Retail Marijuana Store. For example: (1) a person with an interest in three, four, or five Retail Marijuana Cultivation Facility licenses also must have a controlling interest in at least one Retail 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 43 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 44 of 201 Marijuana Store; (2) a person with an interest in six, seven, or eight Retail Marijuana Cultivation Facility licenses also must have a controlling interest in at least two Retail Marijuana Stores; (3) a person with an interest in nine, ten, or eleven Retail Marijuana Cultivation Facility licenses also must have a controlling interest in at least three Retail Marijuana Stores; etc. 2. A Person with an Interest in Less than Three Retail Marijuana Cultivation Facility Licenses. The person shall not be required to have an interest in a Retail Marijuana Store. Basis and Purpose – R 231 The statutory authority for this rule is found at subsections 12-43.3-201(4), 12-43.4-202(2)(b), 12-43.4202(3)(a)(III), and 24-18-105(3), and sections 12-43.4-103, 12-43.4-305, 12-43.4-306 12-43.3-306.5, and 24-76.5-101, et. seq., C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(III). The purpose of this rule is to clarify the qualifications for licensure, including, but not limited to, background investigations forDirect Beneficial Interest Owners, Indirect Beneficial Interest Owners, contractors, employees, and other support staff of licensed entities. R 231 – Qualifications for Licensure and Residency A. Any Applicant may be required to establish his or her identity and age by any document required for a determination of Colorado residency, United States citizenship or lawful presence. B. Maintaining Ongoing Licensing Qualification: Duty to Report Offenses. An Applicant or Licensee shall notify the Division in writing of any felony criminal charge and felony conviction against such person within ten days of such person’s arrest or felony summons, and within ten days of the disposition of any arrest or summons. Failure to make proper notification to the Division may be grounds for disciplinary action. Applicants and Licensees shall notify the Division within ten days of any other event that renders the Applicant or Licensee no longer qualified under these rules. Licensees shall cooperate in any investigation conducted by the Division. This duty to report includes, but is not limited to, deferred sentences or judgments that are not sealed. If the Division lawfully finds a disqualifying event and an Applicant asserts that the record was sealed, the Division may require the Applicant to provide proof from a court evidencing the sealing of the case. C. Application Forms Accessible to Law Enforcement and Licensing Authorities. All application forms supplied by the Division and filed by an Applicant for licensure shall be accessible by the State Licensing Authority, local jurisdictions, and any state or local law enforcement agent. D. Associated Key Licenses. Each Direct Beneficial Interest Owner who is a natural person, including but not limited to each officer, director, member or partner of a Closely Held Business Entity, must apply for and hold at all times a valid Associated Key License. Except that these criteria shall not apply to Qualified Limited Passive Investors, who are not required to hold Associated Key Licenses. Each such Direct Beneficial Interest Owner must establish that he or she meets the following criteria before receiving an Associated Key License: 1. The Applicant has paid the annual application and licensing fees; 2. The Applicant’s criminal history indicates that he or she is of Good Moral Character; 3. The Applicant is not employing, or financed in whole or in part, by any other Person whose criminal history indicates that he or she is not of Good Moral Character; 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 44 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 4. The Applicant is at least 21 years of age; 5. The Applicant has paid all taxes, interest, or penalties due the Department of Revenue relating to a Retail Marijuana Establishment or Medical Marijuana Business, if applicable; 6. The Applicant is not currently subject to and has not discharged a sentence for a conviction of a felony in the five years immediately preceding his or her application date; 7. The Applicant meets qualifications for licensure that directly and demonstrably relate to the operation of a Retail Marijuana Establishment;. 8. The Applicant is not currently subject to or has not discharged a sentence for a conviction of a felony pursuant to any state or federal law regarding the possession, distribution, manufacturing, cultivation, or use of a controlled substance in the ten years immediately preceding his or her application date or five years from May 28, 2013, whichever is longer, except that the State Licensing Authority may grant a license to a Person if the Person has a state felony conviction based on possession or use of marijuana or marijuana concentrate that would not be a felony if the Person were convicted of the offense on the date he or she applied for a license; 9. The Applicant does not employ another person who does not have a valid Occupational License issued pursuant to either the Retail Code or the Medical Code. 10. The Applicant is not a sheriff, deputy sheriff, police officer, or prosecuting officer, or an officer or employee of the State Licensing Authority or a local licensing authority; 11. The Applicant has not been a State Licensing Authority employee with regulatory oversight responsibilities for individuals, Retail Marijuana Establishments and/or Medical Marijuana Businesses licensed by the State Licensing Authority in the six months immediately preceding the date of the Applicant’s application; 12. The premises that the Applicant proposes to be licensed is not currently licensed as a retail food establishment or wholesale food registrant; 13. The Applicant either: 14. E. RETAIL - Page 45 of 201 a. Has been a resident of Colorado for at least one year prior to the date of the application, or b. Has been a United States citizen since a date prior to the date of the application and has received a Finding of Suitability from the Division prior to filing the application. See Rule R 231.1 – Finding of Suitability, Residency and Requirements for Direct Beneficial Interest Owners; Rule R 232 – Factors Considered When Determining Residency and Citizenship: Individuals. For Associated Key Licensees who are owners of a Closely Held Business Entity, the Applicant is a United States citizen. Occupational Licenses. An Occupational License Applicant who is not applying for an Associated Key License must establish that he or she meets the following criteria before receiving an Occupational License: 1. The Applicant has paid the annual application and licensing fees; 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 45 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 F. RETAIL - Page 46 of 201 2. The Applicant’s criminal history indicates that he or she is of Good Moral Character; 3. The Applicant is at least 21 years of age; 4. The Applicant is currently a resident of Colorado. See Rule R 232 – Factors Considered When Determining Residency and Citizenship: Individuals;. 5. The Applicant has paid all taxes, interest, or penalties due the Department of Revenue relating to a Medical Marijuana Business or Retail Marijuana Establishment; 6. The Applicant is not currently subject to and has not discharged a sentence for a conviction of a felony in the five years immediately preceding his or her application date; 7. The Applicant is not currently subject to and has not discharged a sentence for a conviction of a felony pursuant to any state or federal law regarding the possession, distribution, manufacturing, cultivation, or use of a controlled substance in the ten years immediately preceding his or her application date or five years from May 28, 2013, whichever is longer, except that the State Licensing Authority may grant a license to a person if the person has a state felony conviction based on possession or use of marijuana or marijuana concentrate that would not be a felony if the person were convicted of the offense on the date he or she applied for a license; 8. The Applicant is not a sheriff, deputy sheriff, police officer, or prosecuting officer, or an officer or employee of the State Licensing Authority or a local jurisdiction; and 9. The Applicant has not been a State Licensing Authority employee with regulatory oversight responsibilities for occupational licensees, Retail Marijuana Establishments and/or Medical Marijuana Businesses licensed by the State Licensing Authority in the six months immediately preceding the date of the Applicant’s application. Current Medical Marijuana Occupational Licensees. 1. An individual who holds a current, valid Occupational License issued pursuant to the Medical Code may also work in a Retail Marijuana Establishment; no separate Occupational License is required. 2. An individual who holds a current, valid Occupational License issued pursuant to the Retail Code and these rules shall only work at licensed premises that are exclusively a Retail Marijuana Establishment and shall not work at a Medical Marijuana Business unless he or she also holds a current, valid Occupational License issued pursuant to the Medical Code. G. Associated Key License Privileges. A person who holds an Associated Key License must associate that license separately with each Retail Marijuana Establishment or Medical Marijuana Business with which the person is associated by submitting a form approved by the Division. A person who holds an Associated Key License may exercise the privileges of a licensed employee in any licensed Retail Marijuana Establishment or Medical Marijuana Business in which they are not an owner so long as the person does not exercise privileges of ownership. H. Qualified Limited Passive Investor. An Applicant who wishes to be a Qualified Limited Passive Investor and hold an interest in a Retail Marijuana Establishment as a Direct Beneficial Interest Owner must establish that he or she meets the following criteria before the ownership interest will be approved: 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 46 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 I. RETAIL - Page 47 of 201 1. He or she is a natural person; 2. The Applicant qualifies under Rule R 231.2(B); 3. He or she has been a United States citizen since a date prior to the date of the application, and 4. He or she has signed an affirmation of passive investment. Workforce Training or Development Residency Exempt License. An Applicant who wishes to obtain a workforce development or training exemption to the license residency requirement may only apply for a Support License or a Key License and must: 1. Submit a complete application on the Division’s approved forms; 2. Establish he or she meets the licensing criteria of Rule R 231(E)(1)-(3) and 231(E)(5)-(9) for Occupational Licensees; 3. Establish that he or she is a United States citizen prior to the date of the application; and 4. Provide a complete Workforce Training or Development Affirmation form executed under penalty of perjury. Basis and Purpose – R 231.1 The statutory authority for this rule is found at subsections 12-43.3-201(4), 12-43.4-202(2)(b), 12-43.4202(3)(a)(III)) and 24-18-105(3), 12-43.4-202(3)(a)(XX), and sections 12-43.4-103, 12-43.4-304, 12-43.4305, 12-43.4-306.5 and 24-76.5-101, et. seq., C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(III). The purpose of this rule is to clarify the qualifications for Direct Beneficial Interest Owners. R 231.1 – Finding of Suitability, Residency and Reporting Requirements for Direct Beneficial Interest Owners A. Finding of Suitability – Non-Resident Direct Beneficial Interest Owners. A natural person, owner, shareholder, director, officer, member or partner of an entity that intends to apply to become a Direct Beneficial Interest Owner who has not been a resident of Colorado for at least one year prior to the application shall first submit a request to the State Licensing Authority for a finding of suitability to become a Direct Beneficial Interest Owner as follows: 1. A request for a finding of suitability for a non-resident natural person shall be submitted on the forms prescribed by the Division. 2. A natural person or all owners, shareholders, directors, officers, members or partners of an entity who have not been a resident of Colorado for at least one year shall obtain a finding of suitability prior to submitting an application to become a Direct Beneficial Interest Owner to the State Licensing Authority. A non-Colorado resident’s failure to obtain a finding of suitability prior to submitting an application to become a Direct Beneficial Interest Owner to the State Licensing Authority shall be grounds for denial of the application. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 47 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 B. RETAIL - Page 48 of 201 3. A finding of suitability is valid for one year from the date it is issued by the Division. If more than one year has passed since the Division first issued a finding of suitability to a natural person, owner, shareholder, director, officer, member or partner of an entity that intends to apply to become a Direct Beneficial Interest Owner who has not been a resident of Colorado for at least one year prior to the application, then such applicant shall submit a new request for finding of suitability to the State Licensing Authority and obtain a new finding of suitability before submitting any application to become a Direct Beneficial Interest Owner to the State Licensing Authority. All recipients of a finding of suitability shall disclose in writing to the Division any and all disqualifying events within ten days after occurrence of the event that could lead to a finding that the recipient no longer qualifies to become a Direct Beneficial Interest Owner. 4. The failure of a non-Colorado resident, who is not already a Direct Beneficial Interest Owner, to obtain a finding of suitability within the year prior to submission of an application to become a Direct Beneficial Interest Owner to the State Licensing Authority shall be grounds for denial of the application. Number of Permitted Direct Beneficial Interest Owners. 1. A Retail Marijuana Establishment may be comprised of an unlimited number of Direct Beneficial Interest Owners that have been residents of Colorado for at least one year prior to the date of the application. 2. On and after January 1, 2017, a Retail Marijuana Establishment that is comprised of one or more Direct Beneficial Interest Owners who have not been Colorado residents for at least one year is limited to no more than fifteen Direct Beneficial Interest Owners, each of whom is a natural person. Further, a Retail Marijuana Establishment that is comprised of one or more Direct Beneficial Interest Owners who have not been Colorado residents for at least one year shall have at least one officer who is a Colorado resident. All officers with day-to-day operational control over a Retail Marijuana Establishment must be Colorado residents for at least one year, must maintain their Colorado residency during the period while they have day-to-day operational control over the Retail Marijuana Establishment and shall be licensed as required by the Retail Code. Rule 231 – Qualifications for Licensure and Residency: Individuals. C. Notification of Change of Residency. A Retail Marijuana Establishment with more than fifteen Direct Beneficial Interest Owners shall provide thirty days prior notice to the Division of any Direct Beneficial Interest Owners’ intent to change their residency to a residency outside Colorado. A Retail Marijuana Establishment with no more than fifteen Direct Beneficial Interest Owners shall notify the Division of the change of residency of any Direct Beneficial Interest Owner at the time of its license renewal. Failure to provide timely notice pursuant to this rule may lead to administrative action against the Retail Marijuana Establishment and its Direct Beneficial Interest Owners. D. A Direct Beneficial Interest Owner shall not be a publicly traded company. Basis and Purpose – R 231.2 The statutory authority for this rule is found at subsections 12-43.3-201(4), 12-43.4-202(2)(b), 12-43.4202(3)(a)(III), 24-18-105(3) and 12-43.4-202(3)(a)(XX), and sections 12-43.4-103, 12-43.4-304, 12-43.4305, 12-43.4-306.5 and 24-76.5-101, et. seq., C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(III). The purpose of this rule is to clarify the qualifications for an Indirect Beneficial Interest Owner other than a Permitted Economic Interest. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 48 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 49 of 201 R 231.2 – Qualifications for Indirect Beneficial Interest Owners and Qualified Limited Passive Investors A. B. General Requirements 1. An Applicant applying to become a Commercially Reasonable Royalty Interest holder who receives a royalty of more than 30 percent of the gross revenue or gross profit from sales of the product or line of products or the holder of a Permitted Economic Interest must be pre-approved by the Division. 2. An Applicant applying to become an Indirect Beneficial Interest Owner or Qualified Limited Passive Investor shall submit information to the Division in a full, faithful, truthful, and fair manner. The Division may recommend denial of an application where the Applicant made misstatements, omissions, misrepresentations, or untruths in the application. This type of conduct may be considered as the basis of additional administrative action against the Applicant and the Retail Marijuana Establishment. 3. The Division may deny the application when the Applicant fails to provide any requested information by the Division’s deadline. 4. The Division’s determination that an Indirect Beneficial Interest Owner or Qualified Limited Passive Investor is qualified constitutes a revocable privilege held by the Retail Marijuana Establishment. The burden of proving the Indirect Beneficial Interest Owner or Qualified Limited Passive Investor is qualified rests at all times with the Retail Marijuana Establishment Applicant. Indirect Beneficial Interest Owners and Qualified Limited Passive Investors are not separately licensed by the Division. Any administrative action regarding an Indirect Beneficial Interest Owner or Qualified Limited Passive Investor may be taken directly against the Retail Marijuana Establishment. 5. Permitted Economic Interest Fingerprints Required. Any individual applying to hold his or her first Permitted Economic Interest shall be fingerprinted for a criminal history record check. In the Division’s discretion, an individual may be required to be fingerprinted again for additional criminal history record checks. 6. No publicly traded company can be an Indirect Beneficial Interest Owner or Qualified Limited Passive Investor. Qualification. The Division may consider the following non-exhaustive list of factors to determine whether an Indirect Beneficial Interest Owner or Qualified Limited Passive Investor is qualified: 1. The Applicant’s criminal history indicates that he or she is of Good Moral Character; 2. The Applicant is at least 21 years of age; 3. The Applicant has paid all taxes, interest, or penalties due the Department of Revenue relating to a Retail Marijuana Establishment or Medical Marijuana Business, if applicable; 4. The Applicant is not currently subject to and has not discharged a sentence for a conviction of a felony in the five years immediately preceding his or her application date; 5. The Applicant is not currently subject to and has not discharged a sentence for a conviction of a felony pursuant to any state or federal law regarding the possession, distribution, manufacturing, cultivation, or use of a controlled substance in the ten years 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 49 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 50 of 201 immediately preceding his or her application date or five years from May 28, 2013, whichever is longer, except, in the Division’s discretion, a state felony conviction based on possession or use of marijuana or marijuana concentrate that would not be a felony if the Person were convicted of the offense on the date he or she applied may not disqualify an Indirect Beneficial Interest Owner or Qualified Limited Passive Investor; C. D. 6. The Applicant is not a sheriff, deputy sheriff, police officer, or prosecuting officer, or an officer or employee of the State Licensing Authority or a local jurisdiction; 7. The Applicant has not been a State Licensing Authority employee with regulatory oversight responsibilities for individuals, Retail Marijuana Establishments and/or Medical Marijuana Businesses licensed by the State Licensing Authority in the six months immediately preceding the date of the Applicant’s application. 8. The Applicant has provided all documentation requested by the Division to establish qualification to be an Indirect Beneficial Interest Owner. Maintaining Qualification: 1. An Indirect Beneficial Interest Owner or Qualified Limited Passive Investor shall notify the Division in writing of any felony criminal charge and felony conviction against such person within ten days of such person’s arrest or felony summons, and within ten days of the disposition of any arrest or summons. Failure to make proper notification to the Division may be grounds for disciplinary action. This duty to report includes, but is not limited to, deferred sentences, prosecutions, or judgments that are not sealed. If the Division lawfully finds a disqualifying event and the individual asserts that the record was sealed, the Division may require the individual to provide proof from a court evidencing the sealing of the case. 2. An Indirect Beneficial Interest Owner, Qualified Limited Passive Investor and Retail Marijuana Establishment shall cooperate in any investigation into whether an Indirect Beneficial Interest Owner or Qualified Limited Passive Investor continues to be qualified that may be conducted by the Division. Divestiture of Indirect Beneficial Interest Owner or Qualified Limited Passive Investor. If the Division determines an Indirect Beneficial Interest Owner or Qualified Limited Passive Investor is not permitted to hold their interest, the Retail Marijuana Establishment shall have 60 days from such determination to divest the Indirect Beneficial Interest Owner or Qualified Limited Passive Investor. The Division may extend the 60-day deadline for good cause shown. Failure to timely divest any Indirect Beneficial Interest Owner or Qualified Limited Passive Investor the Division determines is not qualified, or is no longer qualified, may constitute grounds for denial of license or administrative action against the Retail Marijuana Establishment and/or its Associated Key Licensee(s). Basis and Purpose – R 233 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-309(5) and 1243.4-401(1)(e), C.R.S. The purpose of this rule is to clarify when an individual must be licensed or registered with the Division before commencing any work activity at a licensed Retail Marijuana Establishment. The rule also sets forth the process for obtaining a license or registration and explains what information may be required before obtaining such license or registration. R 233 – Retail Code or Medical Code Occupational Licenses Required 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 50 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 A. RETAIL - Page 51 of 201 Retail Code or Medical Code Occupational Licenses and Identification Badges 1. Any person who possesses, cultivates, manufactures, tests, dispenses, Transferssells, serves, transports or delivers Retail Marijuana or Retail Marijuana Product as permitted by privileges granted under a Retail Marijuana Establishment license must have a valid Occupational License. 2. Any person who has the authority to access or input data into the Inventory Tracking System or a Retail Marijuana Establishment point of sale system must have a valid Occupational License. 3. Any person within a Restricted Access Area or Limited Access Area that does not have a valid Occupational License shall be considered a visitor and must be escorted at all times by a person who holds a valid Associated Key License or other Occupational License. Failure by a Retail Marijuana Establishment to continuously escort a person who does not have a valid Occupational License within a Limited Access Area may be considered a license violation affecting the public safety. See Rule R 1307 – Penalties; see also Rule R 301 – Limited Access Areas. Nothing in this provision alters or eliminates a Retail Marijuana Establishment’s obligation to comply with the Occupational License requirements of paragraph (A) of this rule R 233. Trade craftspeople not normally engaged in the business of cultivating, processing, or Transferringselling Retail Marijuana do not need to be accompanied at all times, and instead only reasonably monitored. B. Occupational License Required to Commence or Continue Employment. Any person required to be licensed pursuant to these rules shall obtain all required approvals and obtain a Divisionissued identification badge before commencing activities permitted by his or her Retail Code or Medical Code Occupational License. See Rules R 231 – Qualifications for Licensure and Residency; Rule R 204 – Ownership Interests of a License: Retail Marijuana Establishments; and R 301 – Limited Access Areas. C. Identification Badges Are Property of State Licensing Authority. All identification badges shall remain the property of the State Licensing Authority, and all identification badges shall be returned to the Division upon demand of the State Licensing Authority or the Division. The Licensee shall not alter, obscure, damage, or deface the badge in any manner. Basis and Purpose – R 251 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(a)(XV), 1243.4-202(3)(a)(XVI), and 12-43.4-305, and sections 24-4-104 and 24-4-105, C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsections 16(5)(a)(I). The purpose of this rule is to establish what factors the State Licensing Authority will consider when denying an application for licensure. R 251 – Application Denial and Voluntary Withdrawal: All Licensees A. Applicant Bears Burden of Proving It Meets Licensing Requirements 1. At all times during the application process, an Applicant must be capable of establishing that it is qualified to hold a license. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 51 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 2. B. C. D. E. RETAIL - Page 52 of 201 An Applicant that does not cooperate with the Division during the application phase may be denied as a result. For example, if the Division requests additional evidence of qualification and the Applicant does not furnish such evidence by the date requested, the Applicant’s application may be denied. Applicants Must Provide Accurate Information 1. An Applicant must provide accurate information to the Division during the entire Application process. 2. If an Applicant provides inaccurate information to the Division, the Applicant’s application may be denied. Grounds for Denial 1. The State Licensing Authority will deny an application from an Applicant that forms a business including but not limited to a sole proprietorship, corporation, or other business enterprise, with the purpose or intent, in whole or in part, of transporting, cultivating, processing, tTransferring, or distributing Retail Marijuana or Retail Marijuana Product without receiving prior approval from all relevant local jurisdictions. 2. The State Licensing Authority will deny an application for Good Cause, as defined in subsection 12-43.4-305(1), C.R.S., of the Retail Code. 3. The State Licensing Authority will deny an Applicant’s application that is statutorily disqualified from holding a license. Voluntary Withdrawal of Application 1. The Division and Applicant may mutually agree to allow the voluntary withdrawal of an application in lieu of a denial proceeding. 2. Applicants must first submit a notice to the Division requesting the voluntary withdrawal of the application. In such instances, an Applicant waives his or her right to a hearing in the matter once the voluntary withdrawal is approved. 3. The Division will consider the request along with any circumstances at issue with the application in making a decision to accept the voluntary withdrawal. The Division may at its discretion grant the request with or without prejudice or deny the request. 4. The Division will notify the Applicant and relevant local jurisdiction of its acceptance of the voluntary withdrawal and the terms thereof. 5. If the Applicant agrees to a voluntary withdrawal granted with prejudice, then the Applicant is not eligible to apply again for licensing or approval until after expiration of one year from the date of such voluntary withdrawal. An Applicant May Appeal a Denial 1. An Applicant may appeal an application denial pursuant to the Administrative Procedure Act. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 52 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 2. RETAIL - Page 53 of 201 See also Rules R 1304 – Administrative Hearings, R 1305 – Administrative Subpoenas, and R 1306 – Administrative Hearing Appeals. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 53 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 54 of 201 R 300 Series – The Licensed Premises Basis and Purpose – R 301 The statutory authority for this rule is found at subsection 12-43.4-103(1), 12-43.4-103(1.3), 12-43.4202(2)(b), 12-43.4-202(3)(a)(V), 12-43.4-202(3)(a)(X), and 12-43.4-202(3)(b)((IX) and section 12-43.4105, C.R.S. The purpose of this rule is to establish Limited Access Areas for Licensed Premises under the control of the Licensee to only individuals licensed by the State Licensing Authority. In addition, this rule clarifies that businesses and individuals cannot use the visitor system as a means to employ an individual who does not possess a valid and current Occupational License. R 301 – Limited Access Areas A. Proper Display of License Badge. All persons in a Limited Access Area as provided for in section 12-43.4-105, C.R.S., shall be required to hold and properly display a current license badge issued by the Division at all times. Proper display of the license badge shall consist of wearing the badge in a plainly visible manner, at or above the waist, and with the photo of the Licensee visible. B. Visitors in Limited Access Areas 1. Prior to entering a Limited Access Area, all visitors, including outside vendors, contractors or others, must obtain a visitor identification badge from management personnel of the Licensee that shall remain visible while in the Limited Access Area. 2. Visitors shall be escorted by the Retail Marijuana Establishment’s licensed personnel at all times. No more than five visitors may be escorted by a single employee. Except that trade craftspeople not normally engaged in the business of cultivating, processing or selling Retail Marijuana need not be accompanied on a full-time basis, but only reasonably monitored. 2.1 A Retail Marijuana Establishment and a Licensee employed by the Retail Marijuana Establishment shall report any discovered plan of or other action or omission by any visitor or other Person (1) to commit theft, burglary, underage sales, diversion of Retail Marijuana or Retail Marijuana Product, or other crime related to the operation of the subject Retail Marijuana Establishment; (2) to compromise the integrity of the Inventory Tracking System; or (3) that results in injury to any Person on the Licensed Premises of the Retail Marijuana Establishment or otherwise creates a risk to public health and safety. Such discovered plan or other action shall be reported to the Division in accordance with Rule R 904 – Retail Marijuana Establishment Reporting Requirements. 3. The Licensee shall maintain a log of all visitor activity, for any purpose, within the Limited Access Area and shall make such logs available for inspection by the Division or relevant local jurisdiction. 4. All visitors must provide proof of age and must be at least 21 years of age. See Rule R 404 – Acceptable Forms of Identification. 5. The Licensee shall check the identification for all visitors to verify that the name on the identification matches the name in the visitor log. See Rule R 404 – Acceptable Forms of Identification. 6. A Licensee may not receive consideration or compensation for permitting a visitor to enter a Limited Access Area. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 54 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 7. RETAIL - Page 55 of 201 Use of a visitor badge to circumvent the Occupational License requirements of rule R 233 - Retail Code or Medical Code Occupational Licenses Required is prohibited and may constitute a license violation affecting public safety. C. Required Signage. All areas of ingress and egress to Limited Access Areas on the Licensed Premises shall be clearly identified by the posting of a sign which shall be not less than 12 inches wide and 12 inches long, composed of letters not less than a half inch in height, which shall state, “Do Not Enter - Limited Access Area – Access Limited to Licensed Personnel and Escorted Visitors.” D. Diagram for Licensed Premises. All Limited Access Areas shall be clearly identified to the Division or relevant local jurisdiction and described in a diagram of the Licensed Premises reflecting walls, partitions, counters and all areas of ingress and egress. The diagram shall also reflect all Propagation, cultivation, manufacturing, and retail sales areas. See Rule R 901 – Business Records Required. E. Modification of Limited Access Area. A Licensee’s proposed modification of designated Limited Access Areas must be approved by the Division and, if required, the relevant local jurisdiction prior to any modifications being made. See Rule R 303 – Changing, Altering, or Modifying Licensed Premises. F. Law Enforcement Personnel Authorized. Notwithstanding the requirements of subsection A of this rule, nothing shall prohibit investigators and employees of the Division, authorities from relevant local jurisdiction or state or local law enforcement, for a purpose authorized by the Retail Code or for any other state or local law enforcement purpose, from entering a Limited Access Area upon presentation of official credentials identifying them as such. R 304 [REPEALED] Basis and Purpose – R 304.1 The statutory authority for this rule is found at subsections 12-43.3-202(1)(b)(I), 12-43.3-202(2)(a)(XX), 12-43.3-202(2.5)(a)(I)(A)-(F), 12-43.4-104(1)(a)(V), 12-43.4-202(2)(b), 12-43.4-401(2), and 12-43.4404(2), C.R.S. and sections 12-43.3-406, 12-43.4-405 and 12-43.4-406, C.R.S. The purpose of this rule is to establish guidelines for the manner in which a Medical Marijuana Business may share its existing Licensed Premises with a Licensed Retail Marijuana Establishment, and to ensure the proper separation of a Medical Marijuana Business operation from Retail Marijuana Establishment operation. M 304.1 – Medical Marijuana Business and Retail Marijuana Establishment – Shared Licensed Premises and Operational Separation A. Co-Located Medical Marijuana Centers and Retail Marijuana Stores 1. Medical Marijuana Center that authorizes only patients that are over the age of 21. A Medical Marijuana Center that authorizes only Medical Marijuana patients who are over the age of 21 years from being on the Licensed Premises may also hold a Retail Marijuana Store license and operate at the same location under the following circumstances: a. The relevant local licensing authority and local jurisdiction permit a dual operation at the same location; 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 55 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 2. RETAIL - Page 56 of 201 b. The Medical Marijuana Center and Retail Marijuana Store are commonly owned; c. The Medical Marijuana Center and Retail Marijuana Store shall maintain physical or virtual separation between (i) Medical Marijuana, Medical Marijuana-Infused Products and other inventory and (ii) Retail Marijuana, Retail Marijuana Products and other inventory; d. The Medical Marijuana Center and Retail Marijuana Store shall maintain separate displays between (i) Medical Marijuana, Medical Marijuana-Infused Products and other inventory and (ii) Retail Marijuana, Retail Marijuana Products and other inventory, but the displays may be on the same sale floor. e. Record-keeping, inventory tracking, packaging and labeling for the Medical Marijuana Center and Retail Marijuana Store shall enable the Division and local licensing authority to clearly distinguish the inventories and business transactions of the Medical Marijuana Center from the inventories and business transactions of the Retail Marijuana Store.; and f. The Medical Marijuana Center shall post and maintain signage that clearly conveys that persons under the age of 21 years may not enter.; Medical Marijuana Center that authorizess patients under the age of 21. A Medical Marijuana Center that authorizes Medical Marijuana patients under the age of 21 years to be on the premises may operate in the same location with a Retail Marijuana Store under the following conditions: a. The relevant local licensing authority and local jurisdiction permit a dual operation at the same location; b. The Medical Marijuana Center and the Retail Marijuana Store are commonly owned; c. The Medical Marijuana Center and the Retail Marijuana Store maintain physical separation, including separate entrances and exits, between all portions of the Licensed Premises where sales occur; d. No point of sale operations occur at any time outside the physically separated Licensed Premises; e. All Medical Marijuana and Medical Marijuana-Infused Product in a Restricted Access Area must be physically separated from all Retail Marijuana and Retail Marijuana Product in a Restricted Access Area, and such physical separation must include separate entrances and exits; f. Any display shall be located in the physically separated sales The Medical Marijuana Center and Retail Marijuana Store must occur in portions of the Licensed Premises where sales occur; g. In addition to the physically separated sales and display areas, the Medical Marijuana Center and Retail Marijuana Store shall maintain physical or virtual separation for storage of Medical Marijuana, Medical Marijuana-Infused Products and other inventory from storage of Retail Marijuana, Retail Marijuana Products and other inventory; and 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 56 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 h. B. C. RETAIL - Page 57 of 201 Record-keeping, inventory tracking, packaging and labeling for the Medical Marijuana Center and Retail Marijuana Store shall enable the Division and local licensing authority to clearly distinguish the inventories and business transactions of the Medical Marijuana Center from the inventories and business transactions of the Retail Marijuana Store. Co-located Optional Premises Cultivation Operation and Retail Marijuana Cultivation Facility. An Optional Premises Cultivation Operation and a Retail Marijuana Cultivation Facility may share a single Licensed Premises and operate at the same location under the following circumstances: 1. The relevant local licensing authority and local jurisdiction permit a dual operation at the same location; 2. The Optional Premises Cultivation Operation and the Retail Marijuana Cultivation Facility are commonly owned; 3. The co-located Optional Premises Cultivation Operation and Retail Marijuana Cultivation Facility shall maintain either physical or virtual separation between Medical Marijuana and Retail Marijuana; and 4. Record keeping, inventory tracking, packaging and labeling for the Optional Premises Cultivation Operation and Retail Marijuana Cultivation Facility must enable the Division and relevant local licensing authority to clearly distinguish the inventories and business transactions of the Optional Premises Cultivation Operation from the Retail Marijuana Cultivation Facility. Co-located Medical Marijuana-Infused Products Manufacturer and Retail Marijuana Products Manufacturer. A Medical Marijuana-Infused Products Manufacturer and a Retail Marijuana Products Manufacturing Facility may share a single Licensed Premises and operate at the same location under the following circumstances: 1. The relevant local licensing authority and local jurisdiction permit a dual operation at the same location; 2. The Medical Marijuana-Infused Products Manufacturer and the Retail Marijuana Products Manufacturing Facility are commonly owned; 3. The Medical Marijuana-Infused Products Manufacturer and Retail Marijuana Products Manufacturing Facility shall maintain either physical or virtual separation between (i) Medical Marijuana, Medical Marijuana-Infused Products and other inventory and (ii) Retail Marijuana, Retail Marijuana Products and other inventory; except that nothing in this rule prohibits a co-located Retail Marijuana Establishment and Medical Marijuana Business from sharing raw ingredients in bulk, for example flour or sugar, except that Retail Marijuana and Medical Marijuana may not be shared under any circumstances; and 4. Record keeping, inventory tracking, packaging and labeling for the Medical MarijuanaInfused Products Manufacturer and Retail Marijuana Products Manufacturing Facility must enable the Division and local licensing authority to clearly distinguish the inventories and business transactions of the Medical Marijuana-Infused Product Manufacturer from the Retail Marijuana Product Manufacturing Facility. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 57 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 D. E. F. RETAIL - Page 58 of 201 Co-located Medical Marijuana Testing Facility and Retail Marijuana Testing Facility. A Medical Marijuana Testing Facility and a Retail Marijuana Testing Facility may share a single Licensed Premises and operate at the same location under the following circumstances: 1. The relevant local licensing authority and local licensing jurisdiction permit dual operation at the same location; 2. The Medical Marijuana Testing Facility and Retail Marijuana Products Manufacturer are identically owned; 3. The Medical Marijuana Testing Facility and Retail Marijuana Testing Facility shall maintain either physical or virtual separation between (i) Medical Marijuana, Medical Marijuana-Infused Products and other inventory and (ii) Retail Marijuana, Retail Marijuana Products and other inventory; and 4. Record keeping, inventory tracking, packaging and labeling for the Medical Marijuana Testing Facility and Retail Marijuana Testing Facility must enable the Division and local licensing authority to clearly distinguish the inventories and business transactions of the Medical Marijuana Testing Facility from the Retail Marijuana Testing Facility. Co-Located Medical Marijuana Transporter and Retail Marijuana Transporter. A Medical Marijuana Transporter and a Retail Marijuana Transporter may share a single Licensed Premises and operate dual transporting, logistics, and temporary storage business operation at the same location under the following circumstances: 1. The relevant local licensing authority and local licensing jurisdiction permit dual operation at the same location; 2. The Medical Marijuana Transporter and Retail Marijuana Transporter are identically owned; 3. The Medical Marijuana Transporter and Retail Marijuana Transporter shall maintain either physical or virtual separation between (i) Medical Marijuana, Medical MarijuanaInfused Products and other inventory and (ii) Retail Marijuana, Retail Marijuana Products and other inventory; and 4. Record keeping, inventory tracking, packaging and labeling for the Medical Marijuana Transporter and Retail Marijuana Transporter must enable the Division and local licensing authority to clearly distinguish the inventories and business transactions of the Medical Marijuana Transporter from the Retail Marijuana Transporter. Violation of this rule may be considered a license violation affecting public safety. Basis and Purpose – R 304 The statutory authority for this rule is found at subsections 12-43.3-202(1)(b), 12-43.4-104(1)(a)(V), 1243.4-202(2)(b), 12-43.3-202(2.5)(a)(I)(A)-(F), 12-43.4-401(2), and 12-43.4-404(2), and sections 12-43.3406, 12-43.4-405, and 12-43.4-406, C.R.S. The purpose of this rule is to establish guidelines for the manner in which a Medical Marijuana Licensee may share its existing Licensed Premises with a Licensed Retail Marijuana Establishment, and to ensure the proper separation of a medical marijuana operation from Retail Marijuana Establishment operation. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 58 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 59 of 201 R 304 – Medical Marijuana Business and Retail Marijuana Establishment – Shared Licensed Premises and Operational Separation A. B. Licensed Premises – General Requirements 1. A Medical Marijuana Center that prohibits patients under the age of 21 years to be on the Licensed Premises may also hold a Retail Marijuana Store license and operate a dual retail business operation on the same Licensed Premises if the relevant local jurisdiction permits a dual operation at the same location and the two are commonly owned. 2. A Medical Marijuana Center that authorizes medical marijuana patients under the age of 21 years to be on the premises is prohibited from sharing its Licensed Premises with a Retail Marijuana Establishment. Even when the two are commonly owned, the two shall maintain distinctly separate Licensed Premises; including, but not limited to, separate sales and storage areas, separate entrances and exits, separate inventories, separate point-of-sale operations, and separate record-keeping. 3. An Optional Premises Cultivation Operation and a Retail Marijuana Cultivation Facility may share a single Licensed Premises in order to operate a dual cultivation business operation if the relevant local jurisdiction permits a dual operation at the same location and the two are commonly owned. 4. A Medical Marijuana-Infused Products Manufacturer may also apply to also hold a Retail Marijuana Products Manufacturing Facility License and operate a dual manufacturing business on the same Licensed Premises, if the relevant local jurisdiction permits a dual operation at the same location and the two are commonly owned. 5. A Medical Marijuana Testing Facility Licensee and a Retail Marijuana Testing Facility Licensee may share a single Licensed Premises to operate a dual testing business operation at the same location if the relevant local jurisdiction permits dual operation at the same location and the two are identically owned. 6. A Medical Marijuana Transporter Licensee and a Retail Marijuana Transporter Licensee may share a single Licensed Premises to operate a dual transporting, logistics, and temporary storage business operation at the same location if the relevant local jurisdiction permits dual operation at the same location and the two are identically owned. Separation of Co-located Licensed Operations 1. Cultivation Operations. A Licensee that operates an Optional Premises Cultivation Operation and a Retail Marijuana Cultivation Facility shall maintain either physical or virtual separation of the facilities, marijuana plants, and marijuana inventory. Recordkeeping for the business operations and labeling of product must enable the Division and relevant local jurisdictions to clearly distinguish the inventories and business transactions of the Medical Marijuana Business from the Retail Marijuana Establishment. 2. Manufacturing Operations. A Licensee that operates a Medical Marijuana-Infused Products Manufacturer and Retail Marijuana Products Manufacturing Facility shall maintain either physical or virtual separation of the facilities, product ingredients, product manufacturing, and final product inventory. Record-keeping for the business operations and labeling of products must enable the Division and Local Jurisdictions/Local Licensing Authorities to clearly distinguish the inventories and business transactions of Medical Marijuana-Infused Product from Retail Marijuana Product. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 59 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 60 of 201 3. Raw Ingredients May Be Shared. Nothing in this rule prohibits a co-located Retail Marijuana Establishment and Medical Marijuana Business from sharing raw ingredients in bulk, for example flour or sugar, except that Retail Marijuana and Medical Marijuana may not be shared under any circumstances. 4. Retail Store and Medical Center Operations: No Patients Under The Age of 21 Years. Persons operating a Medical Marijuana Center that prohibits the admittance of patients under the age of 21 years and a Retail Marijuana Store may share their Licensed Premises. Such a Medical Marijuana Center Licensee must post signage that clearly conveys that persons under the age of 21 years may not enter. Under these circumstances, and upon approval of the State Licensing Authority, the Medical Marijuana Center and the Retail Marijuana Store may share the same entrances and exits. Also under these circumstances, Medical Marijuana and Retail Marijuana and Medical Marijuana-Infused Product and Retail Marijuana Product must be separately displayed on the same sale floor. Record-keeping for the business operations of both must enable the Division and relevant local jurisdictions to clearly distinguish the inventories and business transactions of Medical Marijuana and Medical MarijuanaInfused Products from Retail Marijuana and Retail Marijuana Product. Violation of the restrictions in this rule by co-located Medical Marijuana Centers and Retail Marijuana Stores may be considered a license violation affecting public safety. 5. Retail Stores and Medical Marijuana Centers: Patients Under The Age of 21 Years. A colocated Medical Marijuana Center and Retail Marijuana Store shall maintain separate Licensed Premises, including entrances and exits, inventory, point of sale operations, and record keeping if the Medical Marijuana Center serves patients under the age of 21 years or permits admission of patients under the age of 21 years on its Licensed Premises. 6. Testing Facilities. A co-located Medical Marijuana Testing Facility and Retail Marijuana Testing Facility shall maintain either physical or virtual separation of the facilities and marijuana and products being tested. Record keeping for the business operations and labeling of products must enable the Division and local licensing authority to clearly distinguish the inventories and business transactions of Medical Marijuana and Medical Marijuana-Infused Product and Retail Marijuana and Retail Marijuana Product. 6.1. Transporters. A co-located Medical Marijuana Transporter and Retail Marijuana Transporter shall maintain either physical or virtual separation of the facilities and Medical Marijuana, Medical Marijuana-Infused Products, Retail Marijuana, and Retail Marijuana Products being transported and stored. Record keeping for the business operations and storage of products must enable the Division and local licensing authority to clearly distinguish the inventories and business transactions of Medical Marijuana and Medical Marijuana-Infused Product and Retail Marijuana and Retail Marijuana Product. 7. Clear Separation of Inventory. A Licensee that operates both a Medical Marijuana Business and Retail Marijuana Establishment within one location is required to maintain separate and distinct inventory tracking processes for Medical Marijuana and Retail Marijuana inventories. The inventories must be clearly tagged or labeled so that the product can be reconciled to a particular Medical Marijuana Business or a Retail Marijuana Establishment. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 60 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 61 of 201 Basis and Purpose – R 305 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b) and 12-43.4-202(3)(a)(V), C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(IV). The purpose of this rule is to ensure adequate control of the Licensed Premises and Retail Marijuana and Retail Marijuana Product contained therein. This rule also establishes the minimum guidelines for security requirements for alarm systems and commercial locking mechanisms for maintaining adequate security. R 305 – Security Alarm Systems and Lock Standards A. Security Alarm Systems – Minimum Requirements. The following Security Alarm Systems and lock standards apply to all Retail Marijuana Establishments. 1. Each Licensed Premises shall have a Security Alarm System, installed by an Alarm Installation Company, on all perimeter entry points and perimeter windows. 2. Each Licensee must ensure that all of its Licensed Premises are continuously monitored. Licensees may engage the services of a Monitoring Company to fulfill this requirement. 3. A Licensee shall maintain up-to-date and current records and existing contracts on the Licensed Premises that describe the location and operation of each Security Alarm System, a schematic of security zones, the name of the Alarm Installation Company, and the name of any Monitoring Company. See Rule R 901 – Business Records Required. 4. Upon request, Licensees shall make available to agents of the Division or relevant local jurisdiction or state or local law enforcement agency, for a purpose authorized by the Retail Code or for any other state or local law enforcement purpose, all information related to Security Alarm Systems, Monitoring, and alarm activity. 5. Any outdoor or greenhouse Retail Marijuana Cultivation Facility, or greenhouse cultivation, is a Limited Access Area and must meet all of the requirements for Security Alarm Systems described in this rule. An outdoor or greenhouse Retail Marijuana Cultivation Facility must provide sufficient security measures to demonstrate that outdoor areas are not readily accessible by unauthorized individuals. This shall include, at a minimum, perimeter fencing designed to prevent the general public from entering the Limited Access Areas. It shall be the responsibility of the Licensee to maintain physical security in a manner similar to a Retail Marijuana Cultivation Facility located in an indoor Licensed Premises so it can be fully secured and alarmed. The fencing requirements shall include, at a minimum, perimeter fencing designed to prevent the general public from entering the Limited Access Areas that meets at least the following minimum requirements: a. b. c. The entire Limited Access Area shall be surrounded by a fence that measures at least eigt feet from the ground to the top of the fence and is constructed of at least six gauge or higher metal chain link fence or another similarly secure material but may not be wood. All support postslls shall be steel and securely anchored. All entry gates shall measure at least eight feet from the ground to the top of the entry gate and shall be constructed of six gauge or higher metal chain link fence or a similarly secure material but may not be wood. The fence shall obscure the Limited Access Area so that it is not easily viewed from outside the fence. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 61 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 B. RETAIL - Page 62 of 201 d. The perimeter of the fence shall be surrounded with lights illuminating all sides of the fence for at least 20 feet from the fence. The required lights may be, but are not required to be, motion sensing. e. A Licensee may, in writing, request that the Division waive one or more of the security requirements described in this subsection (a) through (d) above, by submitting on a form prescribed by the Division a security waiver request for Division approval. The Division may, in its discretion and on a case by case basis, approve the security waiver if it finds that the alternative safeguard proposed by the Licensee meets the goals of the above security requirements. Approved security waivers expire at the same time as the underlying License. The Licensee’s request for a waiver shall include: i. The specific rules and subsections of a rule that is requested to be waived; ii. The reason for the waiver; iii. A description of an alternative safeguard the licensee can implement in lieu of the requirement that is the subject of the waiver; and iv. An explanation of how and why the alternative safeguard accomplishes the goals of the security rules, specifically public safety, prevention of diversion, accountability, and prohibiting access to minors. Lock Standards – Minimum Requirement 1. At all points of ingress and egress, the Licensee shall ensure the use of a commercialgrade, non-residential door locks. 2. Any outdoor or greenhouse Retail Marijuana Cultivation Facility, or greenhouse cultivation, must meet all of the requirements for the lock standards described in this rule. Basis and Purpose – R 307 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), and 12-43.4-202(3)(a)(X), 12-43.4-202(3)(a)(XI), 12-43.4-202(3)(a)(XII), and 12-43.4-202(3)(b)(IX), C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(VII). The purpose of this rule is to establish waste disposal requirements for Retail Marijuana Establishments. The State Licensing Authority modeled this rule after its Medical Marijuana rules. R 307 – Waste Disposal A. All Applicable Laws Apply. Retail Marijuana and Retail Marijuana Product waste must be stored, secured, locked, and managed in accordance with all applicable federal, state, and local statutes, regulations, ordinances, or other requirements. B. Liquid Waste. Liquid waste from Retail Marijuana Establishments shall be disposed of in compliance with all applicable federal, state and local laws, regulations, rules and other requirements. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 62 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 63 of 201 C. Chemical, Dangerous and Hazardous Waste. Disposal of chemical, dangerous or hazardous waste must be conducted in a manner consistent with federal, state and local laws, regulations, rules and other requirements. This may include, but is not limited to, the disposal of all Pesticide or other agricultural chemicals, certain solvents or other chemicals used in the production of Retail Marijuana Concentrate or any Retail Marijuana soaked in a Flammable Solvent for purposes of producing a Retail Marijuana Concentrate. D. Waste Must Be Made Unusable and Unrecognizable. Retail Marijuana and Retail Marijuana Product waste must be made unusable and Unrecognizable prior to leaving the Licensed Premises. E. Methods to Make Waste Unusable and Unrecognizable. Retail Marijuana and Retail Marijuana Product waste shall be rendered unusable and Unrecognizable through one of the following methods: 1. F. Grinding or compacting and incorporating the marijuana waste with non-consumable, solid wastes listed below such that the resulting mixture is at least 50 percent nonmarijuana waste: a. Paper waste; b. Plastic waste; c. Cardboard waste; d. Food waste; e. Grease or other compostable oil waste; f. Bokashi or other compost activators; g. Soil; h. Sawdust; i. Other wastes approved by the Division that will render the Retail Marijuana waste unusable and Unrecognizable; and h. Soil. After Waste is Made Unusable and Unrecognizable. Licensees shall not dispose of Retail Marijuana waste in an unsecured waste receptacle not in possession and control of the Licensee. After the Retail Marijuana waste is made unusable and Unrecognizable, then the rendered waste shall be: 1. Disposed of at a solid waste site and disposal facility that has a Certificate of Designation from the local governing body; 2. Deposited at a compost facility that has a Certificate of Designation from the Department of Public Health and Environment, if required; or 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 63 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 3. RETAIL - Page 64 of 201 Composted on-site at a facility owned by the generator of the waste and operated in compliance with the Regulations Pertaining to Solid Waste Sites and Facilities (6 CCR 1007-2, Part 1) in the Department of Public Health and Environment. G. Proper Disposal of Waste. A Licensee shall not dispose of Retail Marijuana and Retail Marijuana Product waste in an unsecured waste receptacle not in possession and control of the Licensee. H. Inventory Tracking Requirements 1. In addition to all other tracking requirements set forth in these rules, a Licensee shall utilize the Inventory Tracking System to ensure its post-harvest waste materials are identified, weighed and tracked while on the Licensed Premises until disposed of. 2. All Retail Marijuana waste must be weighed before leaving any Retail Marijuana Establishment. A scale used to weigh Retail Marijuana waste prior to entry into the Inventory Tracking System shall be tested and approved in accordance with 35-14-127, C.R.S. See Rule R 309 – Retail Marijuana Establishments: Inventory Tracking Systemolution. 3. A Licensee is required to maintain accurate and comprehensive records regarding waste material that accounts for, reconciles, and evidences all waste activity related to the disposal of Marijuana. See Rule R 901 – Business Records Required. 4. A Licensee is required to maintain accurate and comprehensive records regarding any waste material produced through the trimming or pruning of a Retail Marijuana plant prior to harvest, which must include weighing and documenting all waste. Unless required by an Inventory Tracking System procedure, records of waste produced prior to harvest must be maintained on the Licensed Premises. All waste, whether produced prior or subsequent to harvest, must be disposed of in accordance with this rule and be made unusable and unrecognizable. Basis and Purpose – R 309 The statutory authority for this rule is found at subsections 12-43.4-104(1)(a)(III)12-43.4-201(1), 12-43.4202(2)(b), 12-43.4-402(1)(e), 12-43.4-402(4), 12-43.4-403(2)(d), and 12-43.4-404(1)(b), C.R.S. The purpose of this rule is to establish a system that will allow the State Licensing Authority and the industry to jointly track Retail Marijuana and Retail Marijuana Product from either seed or immature plant stage until the Retail Marijuana or Retail Marijuana Product is sold to the customer or destroyed. The Inventory Tracking System is a web-based tool coupled with RFID technology that allows both the Inventory Tracking System user and the State Licensing Authority the ability to identify and account for all Retail Marijuana or Retail Marijuana Product. Through the use of RFID technology, a Retail Marijuana Cultivation Facility will tag either the seed or immature plant with an individualized number, which will follow the Retail Marijuana through all phases of production and final sale to a consumer. This will allow the State Licensing Authority and the Inventory Tracking System user the ability to monitor and track Retail Marijuana and Retail Marijuana Product inventory. The Inventory Tracking System will also provide a platform for the State Licensing Authority to exchange information and provide compliance notifications to the industry. The State Licensing Authority finds it essential to regulate, monitor, and track all Retail Marijuana to eliminate diversion, inside and outside of the state, and to ensure that all marijuana grown, processed, sold and disposed of in the Retail Marijuana market is transparently accounted for. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 64 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 65 of 201 The State Licensing Authority will engage the industry and provide training opportunities and continue to evaluate the Inventory Tracking System to promote an effective means for this industry to account for and monitor its Retail Marijuana inventory. R 309 – Retail Marijuana Establishments: Inventory Tracking Systemolution A. Inventory Tracking System Required. A Retail Marijuana Establishment is required to use the Inventory Tracking System as the primary inventory tracking system of record. A Retail Marijuana Establishment must have an Inventory Tracking System account activated and functional prior to operating or exercising any privileges of a license. Medical Marijuana Businesses converting to or adding a Retail Marijuana Establishment must follow the inventory transfer guidelines detailed in Rule R 309(C) below. B. Inventory Tracking System Access - Inventory Tracking System Administrator C. 1. Inventory Tracking System Administrator Required. A Retail Marijuana Establishment must have at least one individual Owner who is an Inventory Tracking System Administrator. A Retail Marijuana Establishment may also designate additional Owners and occupationally licensed employees to obtain Inventory Tracking System Administrator accounts. 2. Training for Inventory Tracking System Administrator Account. In order to obtain a Inventory Tracking System Administrator account, a person must attend and successfully complete all required Inventory Tracking System training. The Division may also require additional ongoing, continuing education for an individual to retain his or her Inventory Tracking System Administrator account. 3. Inventory Tracking System Access - Inventory Tracking System User Accounts. A Retail Marijuana Establishment may designate licensed Owners and employees who hold valid Occupational Licenses as Inventory Tracking System Users. A Retail Marijuana Establishment shall ensure that all Owners and Occupational License Licensees who are granted Inventory Tracking System User account access for the purposes of conducting inventory tracking functions in the system are trained by Inventory Tracking System Administrators in the proper and lawful use of Inventory Tracking System. Medical Marijuana Business License Conversions - Declaring Inventory Prior to Exercising Licensed Privileges as a Retail Marijuana Establishment 1. Medical Marijuana Inventory Transfer to Retail Marijuana Establishments. a. This rule R 309(C)(1)(a) is repealed effective July 1, 2016. Prior to July 1, 2016, each Medical Marijuana Business that is either converting to or adding a Retail Marijuana Establishment license must create a Retail Marijuana Inventory Tracking System account for each license it is converting or adding. A Medical Marijuana Business must transfer all relevant Medical Marijuana inventory into the Retail Marijuana Establishment’s Inventory Tracking System accounts and affirmatively declare those items as Retail Marijuana and Retail Marijuana Product. b. Beginning July 1, 2016: i. The the only allowed transfer of marijuana between a Medical Marijuana Business and Retail Marijuana Establishment is Medical Marijuana and 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 65 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 66 of 201 Medical Marijuana Concentrate that was produced at the Optional Premises Cultivation Operation, from the Optional Premises Cultivation Operation to a Retail Marijuana Cultivation Facility. 2. D. E. ii. Each Optional Premises Cultivation Operation that is either converting to or adding a Retail Marijuana Cultivation Facility license must create a Retail Marijuana Inventory Tracking System account for each license it is converting or adding. iii. An Optional Premises Cultivation Operation must transfer all relevant Medical Marijuana and Medical Marijuana Concentrate into the Retail Marijuana Cultivation Facility’s Inventory Tracking System account and affirmatively declare those items as Retail Marijuana or Retail Marijuana Concentrate as appropriate. iv. The marijuana subject to the one-time transfer is subject to the excise tax upon the first transfer from the Retail Marijuana Cultivation Facility to another Retail Marijuana Establishment. v. All other transfers are prohibited, including but not limited to transfers from a Medical Marijuana Center or Medical Marijuana-Infused Products Manufacturer to any Retail Marijuana Establishment. No Further Transfer Allowed. Once a Licensee has declared any portion of its Medical Marijuana inventory as Retail Marijuana, no further transfers of inventory from Medical Marijuana to Retail Marijuana shall be allowed. RFID Tags Required 1. Authorized Tags Required and Costs. Licensees are required to use RFID tags issued by a Division-approved vendor that is authorized to provision RFID tags for the Inventory Tracking System. Each licensee is responsible for the cost of all RFID tags and any associated vendor fees. 2. Use of RFID Tags Required. A Licensee is responsible to ensure its inventories are properly tagged where the Inventory Tracking System requires RFID tag use. A Retail Marijuana Establishment must ensure it has an adequate supply of RFID tags to properly tag Retail Marijuana and Retail Marijuana Product as required by the Inventory Tracking System. An RFID tag must be physically attached to every plant being cultivated that is greater than four inches tall or four inches wide. An RFID tag must be assigned to all Harvested Marijuana, Retail Marijuana Concentrate and Retail Marijuana Product. See also R 801(G.5) – Required RFID Tags; R 1007-1(H) – Shipping Containers. 3. Reuse of RFID Tags Prohibited. A Licensee shall not reuse any RFID tag that has already been affixed or assigned to any Harvested Marijuana, Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product. General Inventory Tracking System Use 1. Reconciliation with Inventory. All inventory tracking activities at a Retail Marijuana Establishment must be tracked through use of the Inventory Tracking System. A Licensee must reconcile all on-premises and in-transit Retail Marijuana and Retail 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 66 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 67 of 201 Marijuana Product inventories each day in the Inventory Tracking System at the close of business. 2. 3. 4. Common Weights and Measures. a. A Retail Marijuana Establishment must utilize a standard of measurement that is supported by the Inventory Tracking System to track all Retail Marijuana and Retail Marijuana Product. b. A scale used to weigh product prior to entry into the Inventory Tracking System system shall be tested and approved in accordance with 35-14-127, C.R.S. Inventory Tracking System Administrator and User Accounts – Security and Record a. A Retail Marijuana Establishment shall maintain an accurate and complete list of all Inventory Tracking System Administrators and Inventory Tracking System Users for each Licensed Premises. A Retail Marijuana Establishment shall update this list when a new Inventory Tracking System User is trained. A Retail Marijuana Establishment must train and authorize any new Inventory Tracking System Users before those Owners or employees may access Inventory Tracking System or input, modify, or delete any information in the Inventory Tracking System. b. A Retail Marijuana Establishment must cancel any Inventory Tracking System Administrators and Inventory Tracking System Users from their associated Inventory Tracking System accounts once any such individuals are no longer employed by the Licensee or at the Licensed Premises. c. A Retail Marijuana Establishment is accountable for all actions employees take while logged into the Inventory Tracking System or otherwise conducting Retail Marijuana or Retail Marijuana Product inventory tracking activities. d. Each individual user is also accountable for all of his or her actions while logged into the Inventory Tracking System or otherwise conducting Retail Marijuana or Retail Marijuana Product inventory tracking activities, and shall maintain compliance with all relevant laws. Secondary Software Systems Allowed a. Nothing in this rule prohibits a Retail Marijuana Establishment from using separate software applications to collect information to be used by the business including secondary inventory tracking or point of sale systems. b. A Licensee must ensure that all relevant Inventory Tracking System data is accurately transferred to and from the Inventory Tracking System for the purposes of reconciliations with any secondary systems. c. A Retail Marijuana establishment must preserve original Inventory Tracking System data when transferred to and from a secondary application(s). Secondary software applications must use the Inventory Tracking System data as the primary source of data and must be compatible with updating to the Inventory Tracking System. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 67 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 F. G. RETAIL - Page 68 of 201 Conduct While Using Inventory Tracking System 1. Misstatements or Omissions Prohibited. A Retail Marijuana Establishment and its designated Inventory Tracking System Administrator(s) and Inventory Tracking System User(s) shall enter data into the Inventory Tracking System that fully and transparently accounts for all inventory tracking activities. Both the Retail Marijuana Establishment and the individuals using the Inventory Tracking system are responsible for the accuracy of all information entered into the Inventory Tracking System. Any misstatements or omissions may be considered a license violation affecting public safety. 2. Use of Another User’s Login Prohibited. Individuals entering data into the Inventory Tracking System shall only use that individual’s Inventory Tracking System account. 3. Loss of System Access. If at any point a Retail Marijuana Establishment loses access to the Inventory Tracking System for any reason, the Retail Marijuana Establishment must keep and maintain comprehensive records detailing all Retail Marijuana and Retail Marijuana Product tracking inventory activities that were conducted during the loss of access. See Rule R 901 – Business Records Required. Once access is restored, all Retail Marijuana and Retail Marijuana Product inventory tracking activities that occurred during the loss of access must be entered into the Inventory Tracking System. A Retail Marijuana Establishment must document when access to the system was lost and when it was restored. A Retail Marijuana Establishment shall not transport any Retail Marijuana or Retail Marijuana Product to another Retail Marijuana Establishment until such time as access is restored and all information is recorded into the Inventory Tracking System. System Notifications 1. Compliance Notifications. A Retail Marijuana Establishment must monitor all compliance notifications from the Inventory Tracking System. The Licensee must resolve the issues detailed in the compliance notification in a timely fashion. Compliance notifications shall not be dismissed in the Inventory Tracking System until the Retail Marijuana Establishment resolves the compliance issues detailed in the notification. 2. Informational Notifications. A Retail Marijuana Establishment must take appropriate action in response to informational notifications received through the Inventory Tracking System, including but not limited to notifications related to RFID billing, enforcement alerts, and other pertinent information. H. Lawful Activity Required. Proper use of the Inventory Tracking System does not relieve a Licensee of its responsibility to maintain compliance with all laws, rules, and other requirements at all times. I. Inventory Tracking System Procedures Must Be Followed. A Retail Marijuana Establishment must utilize Inventory Tracking System in conformance with these rules and Inventory Tracking System procedures, including, but not limited to: 1. Properly indicating the creation of a Production Batch including the assigned Production Batch Number; 2. Accurately identifying the cultivation rooms and location of each plant within those rooms on the Licensed Premises; 3. Accurately identifying when inventory is no longer on the Licensed Premises; 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 68 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 69 of 201 4. Properly indicating that a Test Batch is being used as part of achieving process validation; 5. Accurately indicating the METRC category for all Medical Marijuana, Medical Marijuana Concentrate and Medical Marijuana-Infused Product; and 6. Accurately including a note explaining the reason for any destruction of plants or adjustment of weights to Inventory Tracking System packages. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 69 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 70 of 201 R 400 Series – Retail Marijuana Stores Basis and Purpose – R 401 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b),, 12-43.4-202(3)(b)(IX), 1243.4-309(7)(a), and 12-43.4-901(4)(f), and sections 12-43.4-402 and 12-43.4-406, C.R.S. The purpose of this rule is to establish that it is unlawful for a Retail Marijuana Store to exercise any privileges other than those granted by the State Licensing Authority, and to clarify the license privileges. R 401 – Retail Marijuana Store: License Privileges A. Privileges Granted. A Retail Marijuana Store shall only exercise those privileges granted to it by the State Licensing Authority. B. Licensed Premises. To the extent authorized by Rule R 304 – Medical Marijuana Business and Retail Marijuana Establishment – Shared Licensed Premises and Operational Separation, a Retail Marijuana Store may share a location with a commonly-owned Medical Marijuana Center. However, a separate license is required for each specific business or business entity, regardless of geographical location. C. Authorized Sources of Retail Marijuana. A Retail Marijuana Store may only sell Transfer Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product that was obtained from another Retail Marijuana Establishment that it has purchased from a Retail Marijuana Cultivation Facility or that the retailer has cultivated itself, after first obtaining a Retail Marijuana Cultivation Facility License. See Rule R 501 – Retail Marijuana Cultivation Facility: License Privileges. D. Authorized Sources of Retail Marijuana Product. A Retail Marijuana Store may only sell Retail Marijuana Product that it has purchased from a Retail Marijuana Products Manufacturing Facility, so long as such product is pre-packaged and labeled upon purchase from the manufacturer.Repealed. E. Samples Provided for Testing. A Retail Marijuana Store may provide samples of its products for testing and research purposes to a Retail Marijuana Testing Facility. The Retail Marijuana Store shall maintain the testing results as part of its business books and records. See Rule R 901 – Business Records Required. F. Authorized On-Premises Storage. A Retail Marijuana Store is authorized to store inventory on the Licensed Premises. All inventory stored on the Licensed Premises must be secured in a Limited Access Area or Restricted Access Area, and tracked consistently with the inventory tracking rules. G. Authorized Marijuana Transport. A Retail Marijuana Store is authorized to utilize a licensed Retail Marijuana Transporter for transportation of its Retail Marijuana and Retail Marijuana Product so long as the place where transportation orders are taken and delivered is a licensed Retail Marijuana Establishment. Nothing in this rRule prevents a Retail Marijuana Store from transporting its own Retail Marijuana and Retail Marijuana Product. Basis and Purpose – R 402 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(a)(VIII), 1243.4-202(3)(a)(IX), 12-43.4-202(3)(a)(X), 12-43.4-202(3)(a.5)(I), 12-43.4-202(3)(b)(IX), 12-43.4-401(4), 12-43.4-901(1), and 12-43.4-901(4)(c) and (g), and sections 12-43.4-105 and 12-43.4-402, C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsections 16(3)(a), 16(5)(a)(V) and 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 70 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 71 of 201 16(5)(a)(VIII). The purpose of this rule is to clarify those acts that are limited in some fashion, or prohibited, by a licensed Retail Marijuana Store. Regarding quantity limitations on sales, equivalencies for Retail Marijuana Concentrate and Retail Marijuana Product to Retail Marijuana flower have been included in this rule pursuant to the mandate of House Bill 14-1361. The equivalencies have been determined through utilizing findings of a study that the House Bill authorized. The study, “Marijuana Equivalency in Portion and Dosage,” was authored by the Marijuana Policy Group and is available on the Division’s website. The study was presented to a group of stakeholders during a public meeting as part of the rulemaking process. Although there was disagreement among stakeholders regarding what the equivalencies should be, the general consensus was that the equivalencies must be simple and straightforward, which would facilitate regulatory compliance and serve public safety. The establishment of equivalencies also provides information to stakeholders including Licensees, the general public, and law enforcement to aid in the enforcement of and compliance with the lawful personal possession limit of one ounce or less of marijuana. Setting these equivalencies provides Retail Marijuana Stores and their employees with necessary information to avoid being complicit in a patron acquiring more marijuana than is lawful to possess under the Colorado Constitution pursuant to Article XVIII, Subsection 16(3)(a). R 402 – Retail Marijuana Sales: General Limitations or Prohibited Acts A. Sales to Persons Under 21 Years. Licensees are prohibited from sellingTransferring, giving, or distributing Retail Marijuana or Retail Marijuana Product to persons under 21 years of age. B. Age Verification. Prior to initiating the sale Transfer of Retail Marijuana or Retail Marijuana Product, a Licensee must verify that the purchaser has a valid government-issued photo identification showing that the purchaser is 21 years of age or older. C. Quantity Limitations On Sales. 1. Repealed. 1.5. Repealed. 2. Repealed. 3. A Retail Marijuana Store and its employees are prohibited from selling Transferring more than one ounce of Retail Marijuana flower or its equivalent in Retail Marijuana Concentrate or Retail Marijuana Product in a single transaction to a consumer. A single transaction includes multiple Transfers to the same consumer during the same business day where the Retail Marijuana Store employee knows or reasonably should know that such Transfer would result in that consumer possessing more than one ounce of marijuana. 4. Equivalency. during a sales transaction to a consumer. Except that nNon-edible, nonpsychoactive Retail Marijuana Products including ointments, lotions, balms, and other non-transdermal topical products are exempt from the one-ounce quantity limitation on salesTransfers. For all other Retail Marijuana Products or Retail Marijuana Concentrate, the following equivalency applies for the one ounce quantity Transfer limit: a. One ounce of Retail Marijuana flower shall be equivalent to eight grams of Retail Marijuana Concentrate. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 71 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 b. RETAIL - Page 72 of 201 One ounce of Retail Marijuana flower shall be equivalent to 80 ten-milligram servings of THC in Retail Marijuana Product. D. Licensees May Refuse Sales. Nothing in these rules prohibits a Licensee from refusing to sell Transfer Retail Marijuana or Retail Marijuana Product to a customer. E. Sales over the Internet. A Licensee is prohibited from selling Retail Marijuana or Retail Marijuana Product over the internet. Anyll Transfer sales and transfers of possession of Retail Marijuana and Retail Marijuana Product must occur within the Retail Marijuana Store’s Licensed Premises. F. Purchases Only Within Restricted Access Area. A customer must be physically present within the Restricted Access Area of the Retail Marijuana Store’s Licensed Premises to purchase Retail Marijuana or Retail Marijuana Product. G. Evidence of Excise Tax Paid. A Retail Marijuana Store is prohibited from accepting Retail Marijuana from a Retail Marijuana Cultivation Facility or Retail Marijuana Manufacturing Facility unless the Retail Marijuana Store Licensee has received evidence that any applicable excise tax due pursuant to Article 28.8 of Title 39, C.R.S., was paid. H. Prohibited Items. A Retail Marijuana Store is prohibited from selling or giving away any consumable product that is not a Retail Marijuana Product including, but not limited to, cigarettes or tobacco products, alcohol beverages, and food products or non-alcohol beverages that are not Retail Marijuana Product. I. Free Product Prohibited. A Retail Marijuana Store may not give away Retail Marijuana or Retail Marijuana Product to a consumer for any reason. J. Nicotine or Alcohol Prohibited. A Retail Marijuana Store is prohibited from selling Transferring Retail Marijuana or Retail Marijuana Product that contain nicotine or alcohol, if the sale of the alcohol would require a license pursuant to Articles 46 or 47 of Title 12, C.R.S. K. Consumption Prohibited. A Licensee shall not permit the consumption of marijuana or marijuana product on the Licensed Premises. L. Storage and Display Limitations. M. 1. A Retail Marijuana Store shall not display Retail Marijuana and Retail Marijuana Product outside of a designated Restricted Access Area or in a manner in which Retail Marijuana or Retail Marijuana Product can be seen from outside the Licensed Premises. Storage of Retail Marijuana and Retail Marijuana Product shall otherwise be maintained in Limited Access Areas or Restricted Access Area. 2. Any Retail Marijuana Concentrate displayed in a Retail Marijuana Store must include the potency of the concentrate on a sign next to the name of the product. a. The font on the sign must be large enough for a consumer to reasonably see from the location where a consumer would usually view the concentrate. b. The potency displayed on the sign must be within plus or minus fifteen percent of the concentrate’s actual potency. Sale Transfer of Expired Product Prohibited. A Retail Marijuana Store shall not sell Transfer any expired Retail Marijuana Product. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 72 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 73 of 201 N. A Retail Marijuana Store shall not sell Transfer or give away Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product to a Retail Marijuana Transporter, and shall not buy or receive complimentary Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product from a Retail Marijuana Transporter. O. A Retail Marijuana Store shall not compensate its employees using performance-based sales incentives. Performance-based incentives that are not sales-based are acceptable. Examples of performance-based incentives that are not sales-based include recognition for providing quality information to consumers, or the duration of the employee’s employment with the Retail Marijuana Store. P. Edibles Prohibited that are Shaped like a Human, Animal, or Fruit. This paragraph (P) is effective beginning October 1, 2017. 1. Q. The sale of Edible Retail Marijuana Products in the following shapes is prohibited: a. The distinct shape of a human, animal, or fruit; or b. A shape that bears the likeness or contains characteristics of a realistic or fictional human, animal, or fruit, including artistic, caricature, or cartoon renderings. 2. The prohibition on human, animal, and fruit shapes does not apply to the logo of a licensed Retail Marijuana Establishment. Nothing in this subparagraph (P)(2) alters or eliminates a Licensee’s obligation to comply with the requirements of Rrule R 1001 – Labeling and Packaging Requirements: General Applicability or Rule R 1000-1 Series – Labeling, Packaging, and Product Safety. 3. Edible Retail Marijuana Products that are geometric shapes and simply fruit flavored are not considered fruit and are permissible; and 4. Edible Retail Marijuana Products that are manufactured in the shape of a marijuana leaf are permissible. Research Transfers Prohibited. A Retail Marijuana Store shall not Transfer any Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product to a Medical Research Facility, a Pesticide Manufacturer or a Research and Development Licensee. Basis and Purpose – R 404 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(2)(e), 12-43.4202(3)(b)(VII), 12-43.4-202(3)(b)(IX), and 12-43.4-402(3)(a), C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsections 16(5)(a)(V). The purpose of this rule is to establish guidelines for the acceptable forms of identification for verifying the lawful sale of Retail Marijuana or Retail Marijuana Product. R 404 – Acceptable Forms of Identification for Retail Sales A. Valid Identification to Verify Age Only. A Licensee shall refuse the sale Transfer of Retail Marijuana or Retail Marijuana Product to anyone, unless such person can produce a form of valid identification showing that the purchaser is 21 years of age or older. If the identification contains a 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 73 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 74 of 201 picture and date of birth, the kind and type of identification deemed adequate shall be limited to the following, so long as such identification is valid and not expired: 1. An operator's, chauffeur's or similar type driver's license, issued by any state within the United States, any U.S. Territory; 2. An identification card, issued by any state for the purpose of proof of age using requirements similar to those in sections 42-2-302 and 42-2- 303, C.R.S.; 3. A United States military identification card; 4. A passport; or 5. Enrollment card issued by the governing authority of a federally recognized Indian tribe located in the state of Colorado, if the enrollment card incorporates proof of age requirements similar to sections 42-2-302 and 42-2- 303, C.R.S. 6. Repealed. B. Affirmative Defense and Licensee’s Burden. It shall be an affirmative defense to any administrative action brought against a Licensee for alleged sale Transfer to a minor if the minor presented fraudulent identification of the type established in paragraph A above and the Licensee possessed an identification book issued within the past three years, which contained a sample of the specific kind of identification presented for compliance purposes. As an affirmative defense, the burden of proof is on the Licensee to establish by a preponderance of the evidence that the minor presented fraudulent identification. C. Repealed. Basis and Purpose – R 405 The statutory authority for this rule is found at subsections 12-43.4-202(1), 12-43.4-202(2)(b), and 1243.4-402(1)(e), C.R.S. The purpose of this rule is to establish a Retail Marijuana Store’s obligation to account for and track all inventories on the Licensed Premises from the point of Transferthey are transferred from a Retail Marijuana Cultivation Facility, Retail Marijuana Products Manufacturing Facility, or Retail Marijuana Transporter to the point of sale. R 405 – Retail Marijuana Store: Inventory Tracking System A. Minimum Tracking Requirement. A Retail Marijuana Store must use Inventory Tracking System to ensure its inventories are identified and tracked from the point ofthey are Ttransferred to or from another Retail Marijuana Establishment through the point- of -saleCultivation Facility, Retail Marijuana Products Manufacturing Facility, or Retail Marijuana Transporter through the point of sale, given to a Retail Marijuana Testing Facility, or otherwise disposed of. See also Rule R 309 – Retail Marijuana Establishment: Inventory Tracking System. The Retail Marijuana Store must have the ability to reconcile its inventory records with the Inventory Tracking System and the associated transaction history and sale receipts. See also Rule R 901 – Business Records Required. 1. A Retail Marijuana Store is prohibited from accepting any Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product from a Retail Marijuana Cultivation Facility, Retail Marijuana Products Manufacturing Facility, or Retail Marijuana Transporter 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 74 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 75 of 201 without receiving a valid transport manifest generated from the Inventory Tracking System. 2. A Retail Marijuana Store must immediately input all Retail Marijuana Marijuana , Retail Marijuana Concentrate and Retail Marijuana Product delivered to the its Licensed Premises, accounting for all RFID tags, into the Inventory Tracking System at the time of delivery to the Retail Marijuana Storefrom a Retail Marijuana Cultivation Facility, Retail Marijuana Products Manufacturing Facility, or Retail Marijuana Transporter. All delivered Retail Marijuana must be weighed and the scale used shall be tested and approved in accordance with measurement standards established in 35-14-127, C.R.S. A Retail Marijuana Store must account for all variances. 3. A Retail Marijuana Store must reconcile transactions from their point of sale processes and on-hand inventory to the Inventory Tracking System at the close of business each day. Basis and Purpose – R 406 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(a)(X), 1243.4-202(3)(a)(XI), 12-43.4-202(3)(a)(XII), and 12-43.4-202(3)(b)(IX), C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(VII). It sets forth general standards and basic sanitary requirements for Retail Marijuana Stores. It covers the physical premises where the products are made as well as the individuals handling the products. This rule also authorizes the State Licensing Authority to require an independent consultant to conduct a health and sanitary audit of a Retail Marijuana Store. This rule explains when an independent health and sanitary audit may be deemed necessary and sets forth possible consequences of a Retail Marijuana Establishment’s refusal to cooperate or pay for the audit. The State Licensing Authority intends for this rule to reduce any product contamination, which will benefit both the Licensees and consumers. The State Licensing Authority modeled this rule after those adopted by the Colorado Department Revenue for Medical Marijuana and those adopted by the Colorado Department of Public Health and Environment. Overall, the State Licensing Authority intends this rule to help maintain the integrity of Colorado’s Retail Marijuana businesses and the safety of the public. R 406 – Retail Marijuana Store: Health and Safety Regulations: A. Local Safety Inspections. A Retail Marijuana Store 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 Retail Marijuana. An annual fire safety inspection may result in the required installation of fire suppression devices, or other means necessary for adequate fire safety. B. Sanitary Conditions. A Retail Marijuana Store 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 Retail Marijuana and Retail Marijuana Product, shall be excluded from any operations which may be expected to result in such contamination until the condition is corrected; 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 75 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 76 of 201 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 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; 3. That all persons working in direct contact with Retail Marijuana or Retail Marijuana 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 Retail Marijuana or Retail Marijuana 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 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 Retail Marijuana or Retail Marijuana Product are exposed; 5. 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; 6. That there is adequate lighting in all areas where Retail Marijuana or Retail Marijuana Product are stored or sold, and where equipment or utensils are cleaned; 7. 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; 8. That any buildings, fixtures, and other facilities are maintained in a sanitary condition; 9. That toxic cleaning compounds, sanitizing agents, and other chemicals shall be identified, held, stored and disposed of in a manner that protects against contamination of Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product and in a manner that is in accordance with any applicable local, state or federal law, rule, regulation or ordinance; 10. 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; 11. That each employee is provided with adequate and readily accessible toilet facilities that are maintained in a sanitary condition and good repair; and 12. That Retail Marijuana or Retail Marijuana Product that can support the rapid growth of undesirable microorganisms shall be held in a manner that prevents the growth of these microorganisms. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 76 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 C. RETAIL - Page 77 of 201 Independent Health and Sanitary Audit 1. 2. State Licensing Authority May Require a Health and Sanitary Audit a. When the State Licensing Authority determines a health and sanitary audit by an independent consultant is necessary, it may require a Retail Marijuana Store to undergo such an audit. The scope of the audit may include, but need not be limited to, whether the Retail Marijuana Store is in compliance with the requirements set forth in this rRule and other applicable health, sanitary or food handling laws, rules and regulations. b. In such instances, the Division may attempt to mutually agree upon the selection of the independent consultant with a Retail Marijuana Store. However, the Division always retains the authority to select the independent consultant regardless of whether mutual agreement can be reached. c. The Retail Marijuana Store will be responsible for all costs associated with the independent health and sanitary audit. When Independent Health and Sanitary Audit Is Necessary. The State Licensing Authority has discretion to determine when an audit by an independent consultant is necessary. The following is a non-exhaustive list of examples that may justify an independent audit: a. The Division has reasonable grounds to believe that the Retail Marijuana Store is in violation of one or more of the requirements set forth in this rRule or other applicable public health or sanitary laws, rules or regulations; or b. The Division has reasonable grounds to believe that the Retail Marijuana Store was the cause or source of contamination of Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product. 3. Compliance Required. A Retail Marijuana Store must pay for and timely cooperate with the State Licensing Authority’s requirement that it undergo an independent health and sanitary audit in accordance with this Rrule. 4. Suspension of Operations a. If the State Licensing Authority has objective and reasonable grounds to believe and finds upon reasonable ascertainment of the underlying facts that the public health, safety or welfare imperatively requires emergency action and incorporates such findings into its order, it may order summary suspension of the Retail Marijuana Store’s license. See Rule R 1302 – Disciplinary Process: Summary Suspensions. b. Prior to or following the issuance of such an order, the Retail Marijuana Store may attempt to come to a mutual agreement with the Division to suspend its operations until the completion of the independent audit and the implementation of any required remedial measures. i. If an agreement cannot be reached or the State Licensing Authority, in its sole discretion, determines that such an agreement is not in the best 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 77 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 78 of 201 interests of the public health, safety or welfare, then the State Licensing Authority will promptly institute license suspension or revocation procedures. See Rule R 1302 – Disciplinary Process: Summary Suspensions. ii. If an agreement to suspend operations is reached, then the Retail Marijuana Store may continue to care for its inventory and conduct any necessary internal business operations but it may not sell Transfer any Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product to a consumer or to any other Retail Marijuana Establishment during the period of time specified in the agreement. D. Contaminated Product. A Retail Marijuana Store shall not accept or Transfer to any Person any Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product that has failed required testing pursuant to Rule R 1501 or Rule 1503, unless otherwise permitted in these rules. If, despite the prohibitions in these rules, another Retail Marijuana Establishment Transfers to the Retail Marijuana Store any Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product that has failed required testing pursuant to Rule R 1501 or Rule R 1503, the Retail Marijuana Store shall assure that all Retail Marijuana, Retail Marijuana Concentrate and Retail Marijuana Products that failed required testing are safely disposed of in accordance with Rule R 307. E. Violation Affecting Public Safety. Failure to comply with this Rrule may constitute a license violation affecting public safety. Basis and Purpose - R 407 The statutory authority for this rule is found at section 12-43.3-1101, 12-43.3-1102, and subsections, 1243.4-202(2)(b), 12-43.4-202(3)(a)(XII), 12-43.4-202(3)(b)(VII), and 12-43.4-202(3)(b)(IX), C.R.S. The purpose of this rule is to establish minimum standards for responsible vendor programs that provide training to personnel at Retail Marijuana Stores seeking designation as a “responsible vendor.” It sets forth general standards and basic requirements for responsible vendor programs. This rule also establishes the timeframe for new staff to complete a responsible vendor program and the requirements for recertification. The State Licensing Authority intends this rule to help maintain the integrity of Colorado’s Retail Marijuana Stores R 407 - Retail Marijuana Store: Responsible Vendor Program A. General Standards. 1. To be designated a “responsible vendor” of Retail Marijuana, Retail Marijuana Product and Retail Marijuana Concentrate at any licensed Retail Marijuana Store, a Retail Marijuana Store licensee shall comply with this rRule. 2. To be designated a “responsible vendor” all Owners, managers and employees involved in the handling and sale Transfer of Retail Marijuana, Retail Marijuana Product and Retail Marijuana Concentrate shall attend and successfully complete a responsible vendor program. 3. Once a licensee is designated a “responsible vendor,” all new employees involved in the handling and sale Transfer of Retail Marijuana, Retail Marijuana Product and Retail Marijuana Concentrate shall successfully complete the training described in this rRule within 90 days of hire. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 78 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 4. B. After initial successful completion of a responsible vendor program, each Owner, manager and employee of a Retail Marijuana Store shall successfully complete the program once every two years thereafter to maintain designation as a “responsible vendor.” Certification Training Program Standards. 1. No owner or employee of a responsible vendor program shall have an interest in a licensed Medical Marijuana Business or Retail Marijuana Establishment. 2. Program providers shall submit their programs to the division for approval as a responsible vendor program. 3. Program providers shall submit their programs for approval every two years in order to maintain designation as a responsible vendor program. 4. The program shall include at least two hours of instruction time. 5. The program shall be taught in a real-time, interactive classroom setting where the instructor is able to verify the identification of each individual attending the program and certify completion of the program by the individual identified. 6. The program provider shall maintain its training records at its principal place of business during the applicable year and for the following three years. The provider shall make the records available for inspection by the licensing authority upon request during normal business hours. 7. The program shall provide written documentation of attendance and successful passage of a test on the knowledge of the required curriculum for each attendee. 8. C. RETAIL - Page 79 of 201 a. Attendees who can speak and write English must successfully pass a written test with a score of 70% or better. b. Attendees who cannot speak or write English may be offered a verbal test, provided that the same questions are given as are on the written test and the results of the verbal test are documented with a passing score of 70% or better. Program providers shall solicit effectiveness evaluations from individuals who have completed their program. Certification Training Class Core Curriculum. 1. 2. Discussion concerning marijuana’s effect on the human body. Training shall include: a. Marijuana’s physical effects based on type of marijuana product; b. The amount of time to feel impairment; c. Visible signs of impairment; and d. Recognizing the signs of impairment. Sales Transfers to minors. Training shall cover all pertinent Colorado law provisions. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 79 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 3. 4. RETAIL - Page 80 of 201 Acceptable forms of Identification. Training shall include: a. How to check identification; b. Spotting false identification; c. Patient Registry Cards issued by the department of public health and environment and equivalent patient verification documents; d. Provisions for confiscating fraudulent identifications; and e. Common mistakes made in verification. Other key state laws and rules affecting owners, managers, and employees. Training shall include: a. Local and state licensing and enforcement; b. Compliance with all Inventory Tracking System regulations; c. Administrative and criminal liability; d. License sanctions and court sanctions; e. Waste disposal f. Health and safety standards g. Patrons prohibited from bringing marijuana onto licensed premises; h. Permitted hours of sale; i. Conduct of establishment; j. Permitting inspections by state and local licensing and enforcement authorities; k. Licensee responsible for activities occurring within licensed premises; l. Maintenance of records; m. Privacy issues; and n. Prohibited purchases. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 80 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 81 of 201 R 500 Series – Retail Marijuana Cultivation Facilities Basis and Purpose – R 501 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(b)(IX), and 12-43.4-401(4) , and sections 12-43.4-403 and 12-43.4-406, C.R.S. The purpose of this rule is to establish that it is unlawful for a Retail Marijuana Cultivation Facility to exercise any privileges other than those granted by the State Licensing Authority and to clarify the license privileges. R 501 – Retail Marijuana Cultivation Facility: License Privileges A. Privileges Granted. A Retail Marijuana Cultivation Facility shall only exercise those privileges granted to it by the State Licensing Authority. B. Licensed Premises. To the extent authorized by Rule R 304 – Medical Marijuana Business and Retail Marijuana Establishment – Shared Licensed Premises and Operational Separation, a Retail Marijuana Cultivation Facility may share a location with a commonly-owned Optional Premises Cultivation Operation. However, a separate license is required for each specific business or business entity, regardless of geographical location. C. Cultivation of Retail Marijuana Authorized. A Retail Marijuana Cultivation Facility may Propagate, cultivate, harvest, prepare, cure, package, store, and label Retail Marijuana, whether in concentrated form or otherwise. D. Authorized TransferSales. A Retail Marijuana Cultivation Facility may only Transfer sell Retail Marijuana and Water-Based Retail Marijuana Concentrate to another Retail Marijuana Establishment. a Retail Marijuana Store, Retail Marijuana Products Manufacturing Facility, and other Retail Marijuana Cultivation Facility(-ies). 1. A Retail Marijuana Cultivation Facility is also authorized to Transfer Retail Marijuana and Water-Based Retail Marijuana Concentrate to a Medical Research Facility pursuant to section 25-1.5-106.5, C.R.S., or Pesticide Manufacturer pursuant to section 12-43.3202(1)(h)(II), C.R.S. and these Rules. 2. An Retail Marijuana Cultivation Facility shall not Transfer Flowering plants or Vegetative plants to any Person except as authorized pursuant to Rule M 801. E. Authorized On-Premises Storage. A Retail Marijuana Cultivation Facility is authorized to store inventory on the Licensed Premises. All inventory stored on the Licensed Premise must be secured in a Limited Access Area and tracked consistently with the inventory tracking rules. F. 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. The Retail Marijuana Cultivation Facility shall maintain the testing results as part of its business books and records. See Rule R 901 – Business Records Required. G. Authorized Marijuana Transport. A Retail Marijuana Cultivation Facility is authorized to utilize a licensed Retail Marijuana Transporter for transportation of its Retail Marijuana so long as the place where transportation orders are taken and delivered is a licensed Retail Marijuana Establishment. Nothing in this Rrule prevents a Retail Marijuana Cultivation Facility from transporting its own Retail Marijuana. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 81 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 82 of 201 H. Performance Based Incentives. A Retail Marijuana Cultivation Facility may compensate its employees using performance-based incentives. I. Authorized Sources of Retail Marijuana Seeds and Immature Plants. A Retail Marijuana Cultivation Facility shall only obtain Retail Marijuana seeds or Immature Plants from its own Retail Marijuana or from another Retail Marijuana Establishment. Basis and Purpose – R 502 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(2)(e), 12-43.4202(3)(a)(VI), 12-43.4-202(3)(a)(VIII), 12-43.4-202(3)(a)(X), 12-43.4-202(3)(b)(IX), , and 12-43.4901(2)(a), 12-43.4-901(4)(c) and 12-43.4-901(4)(g), and sections 12-43.4-403 and 12-43.4-406, C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(V). The purpose of this rule is to clarify those acts that are limited in some fashion, or prohibited, by a Retail Marijuana Cultivation Facility. R 502 – Retail Marijuana Cultivation Facility: General Limitations or Prohibited Acts A. Temporary Limitations 1. Repealed. 2. Repealed B. Packaging and Labeling Standards Required. A Retail Marijuana Cultivation Facility is prohibited from selling Transferring Retail Marijuana that is not packaged and labeled in accordance with these rules. See Rules R 1001 – Packaging Requirements: General Requirements and R 1002 – Labeling Requirements: General Requirements or Rule 1000-1 Series – Labeling, Packaging, and Product Safety. C. Sale Transfer to Consumer Prohibited. A Retail Marijuana Cultivation Facility is prohibited from selling Transferring Retail Marijuana to a consumer. D. Consumption Prohibited. A Retail Marijuana Cultivation Facility shall not permit the consumption of marijuana or marijuana products on its Licensed Premises. E. Excise Tax Paid. A Retail Marijuana Cultivation Facility shall remit any applicable excise tax due pursuant to Article 28.8 of Title 39, C.R.S., and shall provide verification to purchasers of the Retail Marijuana that any required excise tax was, or will be, paid. F. Sales and Gifts to Transporters Prohibited. A Retail Marijuana Cultivation Facility shall not sell or give away Retail Marijuana or Retail Marijuana Product to a Retail Marijuana Transporter, and shall not buy or receive complimentary Retail Marijuana or Retail Marijuana Product from a Retail Marijuana Transporter. Basis and Purpose – R 503 The statutory authority for this rule is found at subsections 12-43.4-202(1), 12-43.4-202(2)(b), 12-43.4202(3)(b)(IX) and 12-43.4-403(4), C.R.S. The purpose of this rule is to establish a Retail Marijuana Cultivation Facility’s obligation to account for and track all inventories on the Licensed Premises from seed or cutting to transfer or saleTransfer to other Retail Marijuana Establishments. R 503 – Retail Marijuana Cultivation Facility: Inventory Tracking System 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 82 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 83 of 201 A. Minimum Tracking Requirement. A Retail Marijuana Cultivation Facility must use the Inventory Tracking System to ensure its inventories are identified and tracked from the point Retail Marijuana is Propagated from seed or cutting to the point when it is delivered to a Retail Marijuana Establishment. See also Rule R 309 –Inventory Tracking System. A Retail Marijuana Cultivation Facility must have the ability to reconcile its Retail Marijuana inventory with the Inventory Tracking System and the associated transaction history and sale receipts. See also Rule R 901 – Business Records Required. B. Transport of Retail Marijuana Without Transport Manifest Prohibited. A Retail Marijuana Cultivation Facility is prohibited from transporting any Retail Marijuana without a valid transport manifest generated by the Inventory Tracking System. C. Accepting Retail Marijuana Without Transport Manifest Prohibited. Retail Marijuana Cultivation Facility is prohibited from accepting any Retail Marijuana from another Retail Marijuana Establishment Cultivation Facility or Retail Marijuana Transporter without receiving a valid transport manifest generated from the Inventory Tracking System. D. Input Into Inventory Tracking System Required. A Retail Marijuana Cultivation Facility must immediately input all Retail Marijuana delivered to its Licensed Premises, accounting for all RFID tags, into the Inventory Tracking System at the time of delivery from anotherto the Retail Marijuana Cultivation Facility. E. Inventory Must Be Reconciled Daily. A Retail Marijuana Cultivation Facility must reconcile its transaction history and on-hand inventory to the Inventory Tracking System at the close of business each day. Basis and Purpose – R 504 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(a)(X), 1243.4-202(3)(a)(XI), 12-43.4-202(3)(a)(XII), and 12-43.4-202(3)(b)(IX), C.R.S. The purpose of this rule is to establish minimum health and safety regulation for Retail Marijuana Cultivation Facilities. The rule prohibits a Retail Marijuana Cultivation Facility from treating or otherwise adulterating Retail Marijuana with any chemical or other compound whatsoever to alter its color, appearance, weight or smell. This rule also authorizes the State Licensing Authority to require an independent consultant to conduct a health and sanitary audit of a Retail Marijuana Cultivation Facility. This rule explains when an independent health and sanitary audit may be deemed necessary and sets forth possible consequences of a Retail Marijuana Establishment’s refusal to cooperate or pay for the audit. R 504 – Retail Marijuana Cultivation Facility: Health and Safety Regulations A. Local Safety Inspections. A Retail Marijuana Cultivation Facility 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 jurisdiction restrictions related to Retail Marijuana. 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. A Retail Marijuana Cultivation Facility 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 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 83 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 84 of 201 reasonable possibility of contact with Retail 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 Retail 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, prior to engaging in the production of a Retail Marijuana Concentrate, 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 Retail 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 Retail 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 Retail Marijuana are stored or sold, and where equipment or utensils are cleaned; 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 and other chemicals shall be identified, held, stored and disposed of in a manner that protects against contamination of Retail Marijuana or Retail Marijuana Concentrate, and in a manner that is in accordance with any applicable local, state, or federal law, rule, regulation or ordinance. All Pesticide must be stored and disposed of in accordance with the information provided on the product’s label; 9. That all contact surfaces, including utensils and equipment used for the preparation of Retail Marijuana or Retail Marijuana Concentrate 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 sanitizers and disinfectants registered with the 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 84 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 85 of 201 Environmental Protection Agency shall be used in a Retail Marijuana Cultivation Facility 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 Licensed Premises needs. Reclaimed water may also be used subject to approval of the Water Quality Control Division of the Colorado Department of Public Health and Environment and the local water provider; 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 Licensed Premises. There shall be no cross-connections between the potable water, reclaimed water 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 Retail Marijuana Cultivation Facility shall provide its employees with adequate and readily accessible toilet facilities that are maintained in a sanitary condition and good repair; and 14. That Retail Marijuana that can support the rapid growth of undesirable microorganisms shall be held in a manner that prevents the growth of these microorganisms. C. Pesticide Application. A Retail Marijuana Cultivation Facility may only use Pesticide in accordance with the “Pesticide Act,” section 35-9-101 et seq., C.R.S., “Pesticides Applicators’ Act,” section 35-10-101 et seq., C.R.S., and all other applicable federal, state, and local laws, statutes, rules and regulations. This includes, but shall not be limited to, the prohibition on detaching, altering, defacing or destroying, in whole or in part, any label on any Pesticide. The Colorado Department of Agriculture’s determination that the Licensee used any quantity of a Pesticide that would constitute a violation of the Pesticide Act or the Pesticide Applicators’ Act shall constitute prima facie evidence of a violation of this Rrule. D. Application of Other Agricultural Chemicals. A Retail Marijuana Cultivation Facility may only use agricultural chemicals, other than Pesticide, in accordance with all applicable federal, state, and local laws, statutes, rules and regulations. E. Required Documentation 1. Standard Operating Procedures. A Retail Marijuana Cultivation Facility must establish written standard operating procedures for the cultivation, harvest, drying, curing, packaging, storing and sampling of Retail Marijuana. The standard operating procedures must also at a minimum include when, and the manner in which, all Pesticide and other agricultural chemicals are to be applied during its cultivation process. A copy of all standard operating procedures must be maintained on the Licensed Premises of the Retail Marijuana Cultivation Facility. 2. Material Change. If a Retail Marijuana Cultivation Facility makes a Material Change to its standard operating procedures, it must document the change and revise its standard 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 85 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 86 of 201 operating procedures accordingly. Records detailing the Material Change must be maintained on the Licensed Premises of the Retail Marijuana Cultivation Facility. F. 3. Material Safety Data Sheet. A Retail Marijuana Cultivation Facility must obtain a material safety data sheet for any Pesticide or other agricultural chemical used or stored on its Licensed Premises. A Retail Marijuana Cultivation Facility must maintain a current copy of the material safety data sheet for any Pesticide or other agricultural chemical on the Licensed Premises where the product is used or stored. 4. Labels of Pesticide and Other Agricultural Chemicals. A Retail Marijuana Cultivation Facility must have the original label or a copy thereof at its Licensed Premises for all Pesticide and other agricultural chemicals used during its cultivation process. 5. Pesticide Application Documentation. A Retail Marijuana Cultivation Facility that applies any Pesticide or other agricultural chemical to any portion of a Retail Marijuana plant, water or feed used during cultivation or generally within the Licensed Premises must document, and maintain a record on its Licensed Premises of, the following information: a. The name, signature and Occupational License number of the individual who applied the Pesticide or other agricultural chemical; b. Applicator certification number if the applicator is licensed through the Department of Agriculture in accordance with the “Pesticides Applicators’ Act,” section 35-10-101 et seq., C.R.S.; c. The date and time of the application; d. The EPA registration number of the Pesticide or CAS number of any other agricultural chemical(s) applied; e. Any of the active ingredients of the Pesticide or other agricultural chemical(s) applied; f. Brand name and product name of the Pesticide or other agricultural chemical(s) applied; g. The restricted entry interval from the product label of any Pesticide or other agricultural chemical(s) applied; h. The RFID tag number of the Retail Marijuana plant(s) to which the Pesticide or other agricultural chemical(s) were applied, or, if the Pesticide or other agricultural chemical(s) were applied to all plants throughout the Licensed Premises, a statement to that effect; and i. The total amount of each Pesticide or other agricultural chemical applied. Prohibited Chemicals. The following chemicals are prohibited and shall not be used in Retail Marijuana cultivation. Possession of chemicals and/or containers from these chemicals upon the Licensed Premises shall be a violation of this Rrule. Additionally, possession of Retail Marijuana or Retail Marijuana Concentrate on which any of the following chemicals is detected shall constitute a violation of this Rule. Prohibited chemicals are: 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 86 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 1. RETAIL - Page 87 of 201 Any Pesticide the use of which would constitute a violation of the Pesticide Act, section 35-9-101 et seq., C.R.S., the “Pesticides Applicators’ Act,” section 35-10-101 et seq., C.R.S., or the rules and regulations pursuant thereto. 2. Other chemicals (listed by Cchemical Nname and 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-TETRACHLORO118-75-2 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 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 87 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 88 of 201 2425-06-1 CARBOFURAN 1563-66-2 CARBON TETRACHLORIDE 56-23-5 CHLORDANE 57-74-9 CHLORDECONE (KEPONE) 143-50-0 CHLORDIMEFORM 6164-98-3 CHLOROBENZILATE 510-15-6 CHLOROMETHOXYPROPYLMERCURIC ACETATE [CPMA] EDF183 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- 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 88 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 89 of 201 187 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 534-52-1 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 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 89 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 90 of 201 118-74-1 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 2385-85-5 NITROFEN 1836-75-5 OCTAMETHYLDIPHOSPHORAMIDE 152-16-9 PARATHION 56-38-2 PENTACHLOROPHENOL 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 90 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 91 of 201 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 95-95-4 VINYL CHLORIDE 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 91 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 92 of 201 75-01-4 G. DMSO. The use of Dimethylsulfoxide (“DMSO”) in the production of Retail Marijuana shall be prohibited and possession of DMSO upon the Licensed Premises is prohibited. H. Adulterants. A Retail Marijuana Cultivation Facility may not treat or otherwise adulterate Retail Marijuana with any chemical or other compound whatsoever to alter its color, appearance, weight or smell. I. Independent Health and Sanitary Audit 1. 2. State Licensing Authority May Require A Health and Sanitary Audit a. When the State Licensing Authority determines a health and sanitary audit by an independent consultant is necessary, it may require a Retail Marijuana Cultivation Facility to undergo such an audit. The scope of the audit may include, but need not be limited to, whether the Retail Marijuana Cultivation Facility is in compliance with the requirements set forth in this rule and other applicable public health or sanitary laws and regulations. b. In such instances, the Division may attempt to mutually agree upon the selection of the independent consultant with a Retail Marijuana Cultivation Facility. However, the Division always retains the authority to select the independent consultant regardless of whether mutual agreement can be reached. c. The Retail Marijuana Cultivation Facility will be responsible for all costs associated with the independent health and sanitary audit. When Independent Health and Sanitary Audit Is Necessary. The State Licensing Authority has discretion to determine when an audit by an independent consultant is necessary. The following is a non-exhaustive list of examples that may justify an independent audit: a. A Retail Marijuana Cultivation Facility does not provide requested records related to the use of Pesticide or other agricultural chemicals during in the cultivation process; b. The Division has reasonable grounds to believe that the Retail Marijuana Cultivation Facility is in violation of one or more of the requirements set forth in this rule or other applicable public health or sanitary laws, rules or regulations; c. The Division has reasonable grounds to believe that the Retail Marijuana Cultivation Facility was the cause or source of contamination of Retail Marijuana or Retail Marijuana Concentrate; or d. Multiple Harvest Batches or Production Batches produced by the Retail Marijuana Cultivation Facility failed contaminant testing. 3. Compliance Required. A Retail Marijuana Cultivation Facility must pay for and timely cooperate with the State Licensing Authority’s requirement that it undergo an independent health and sanitary audit in accordance with this rRule. 4. Suspension of Operations 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 92 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 J. K. RETAIL - Page 93 of 201 a. If the State Licensing Authority has objective and reasonable grounds to believe and finds upon reasonable ascertainment of the underlying facts that the public health, safety or welfare imperatively requires emergency action and incorporates such findings into its order, it may order summary suspension of the Retail Marijuana Cultivation Facility’s license. See Rule R 1302 – Disciplinary Process: Summary Suspensions. b. Prior to or following the issuance of such an order, the Retail Marijuana Cultivation Facility may attempt to come to a mutual agreement with the Division to suspend its operations until the completion of the independent audit and the implementation of any required remedial measures. i. If an agreement cannot be reached or the State Licensing Authority, in its sole discretion, determines that such an agreement is not in the best interests of the public health, safety or welfare, then the State Licensing Authority will promptly institute license suspension or revocation procedures. See Rule R 1302 – Disciplinary Process: Summary Suspensions. ii. If an agreement to suspend operations is reached, then the Retail Marijuana Cultivation Facility may continue to care for its inventory and conduct any necessary internal business operations but it may not Transfersell, transfer or wholesale Retail Marijuana or Retail Marijuana Concentrate to any other Retail Marijuana Establishment during the period of time specified in the agreement. Contaminated Product. Unless otherwise permitted by these rules: 1. A Retail Marijuana Cultivation Facility shall not accept or Transfer to another Retail Marijuana Establishment or any other Person any Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product that has failed required testing pursuant to Rule R 1501 or Rule R 1503. 2. If a Retail Marijuana Cultivation Facility possesses any Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product that failed required testing pursuant to Rule R 1501 or Rule R 1503, the Retail Marijuana Products Manufacturing Facility shall assure that all Retail Marijuana, Retail Marijuana Concentrate and Retail Marijuana Product that failed required testing is destroyed safely in accordance with Rule R 307. Violation Affecting Public Safety. Failure to comply with this rule may constitute a license violation affecting public safety. Basis and Purpose – R 505 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(a)(VIII), 1243.4-202(3)(a)(XI), and 12-43.4-2-2(3)(b)(IX), and sections 12-43.4-403 and 12-43.4-405, C.R.S. The purpose of this rule is to establish the categories of Retail Marijuana Concentrate that may be produced at a Retail Marijuana Cultivation Facility and standards for the production of Retail Marijuana Concentrate. R 505 – Retail Marijuana Cultivation Facilities: Retail Marijuana Concentrate Production 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 93 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 94 of 201 A. Permitted Production of Certain Categories of Retail Marijuana Concentrate. A Retail Marijuana Cultivation Facility may only produce Water-Based Retail Marijuana Concentrate on its Licensed Premises and only in an area clearly designated for concentrate production on the current diagram of the Licensed Premises. See Rule R 901- Business Records Required. No other method of production or extraction for Retail Marijuana Concentrate may be conducted within the Licensed Premises of a Retail Marijuana Cultivation Facility unless the Owner(s) of the Retail Marijuana Cultivation Facility also has a valid Retail Marijuana Products Manufacturing Facility license and the room in which Retail Marijuana Concentrate is to be produced is physically separated from all cultivation areas and has clear signage identifying the room. B. Safety and Sanitary Requirements for Concentrate Production. If a Retail Marijuana Cultivation Facility produces Retail Marijuana Concentrate, then all areas in which the Retail Marijuana Concentrate are produced and all Owners and Occupational Licensees engaged in the production of the Retail Marijuana Concentrate shall be subject to all of the requirements imposed upon a Retail Marijuana Products Manufacturing Facility that produces Retail Marijuana Concentrate, including all general requirements. See Rule R 604– Health and Safety Regulations: Retail Marijuana Products Manufacturing Facility and Rule R 605 – Retail Marijuana Products Manufacturing Facility: Retail Marijuana Concentrate Production. C. Possession of Other Categories of Retail Marijuana Concentrate. 1. It shall be considered a violation of this rule if a Retail Marijuana Cultivation Facility possesses a Retail Marijuana Concentrate other than a Water-Based Retail Marijuana Concentrate on its Licensed Premises unless the Owner(s) of the Retail Marijuana Cultivation Facility also has a valid Retail Marijuana Products Manufacturing Facility license. 2. Notwithstanding subparagraph (C)(1) of this rule R 505, a Retail Marijuana Cultivation Facility shall be permitted to possess Solvent-Based Retail Marijuana Concentrate only when the possession is due to the tTransfer of Retail Marijuana flower or trim that failed microbial testing to a Retail Marijuana Products Manufacturing Facility for processing into a Solvent-Based Retail Marijuana Concentrate, and the Retail Marijuana Products Manufacturing Facility Ttransfers the resultant Solvent-Based Retail Marijuana Concentrate back to the originating Retail Marijuana Cultivation Facility. a. The Retail Marijuana Cultivation Facility shall comply with all requirements in rule R 1507(B.1) when having Solvent-Based Retail Marijuana Concentrate manufactured out of Retail Marijuana flower or trim that failed microbial testing. b. The Retail Marijuana Cultivation Facility is responsible for submitting the SolventBased Retail Marijuana Concentrate for all required testing for contaminants pursuant to rule R 1501 – Retail Marijuana Testing Program – Contaminant Testing, for potency pursuant to rule R 1503 – Retail Marijuana Testing Program – Potency Testing, and any other testing required or allowed by the Retail Marijuana Rules or Retail Marijuana Code. c. Nothing in this rule removes or alters the responsibility of the Retail Marijuana Cultivation Facility that Transferstransferring the Retail Marijuana that failed microbial testing from complying with the requirement to pay excise tax pursuant to rule R 502(E). 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 94 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 95 of 201 Basis and Purpose – R 506 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(a)(I-II), 1243.4-202(3)(b)(IX), and 12-43.4-202(4)(a) and (b) and sections 12-43.4-103, 12-43.4-104, and 12-43.4501, C.R.S. The rule establishes a means by which to manage the overall production of retail marijuana. The intent of this rule is to encourage responsible production to meet demand for retail marijuana, while also avoiding overproduction or underproduction. The establishment of production management is necessary to ensure there is not significant under or over production, either of which will increase incentives to engage in diversion and facilitate the continuation of the sale of illegal marijuana. The State Licensing Authority intends to replace or revise this rule’s production management provisions as early as January 2017 by transitioning to an output-based production management model. Existing and prospective licensees should be on notice that the new or revised regulations may impact the production limits provided for in this rule. Additionally, throughout the rulemaking process stakeholders expressed concern over ensuring an adequate amount of licensed Retail Marijuana Stores exist to sell the amount of Retail Marijuana being produced at licensed Retail Marijuana Cultivation Facilities. Scaling the number of interests a person may hold in Retail Marijuana Cultivation Facility licenses relative to the number of controlling interests the person has in Retail Marijuana Store(s) has been incorporated in the production management rules as a means to address this production management concern. R 506 – Retail Marijuana Cultivation Facility: Production Management A. Applicability. This rule is effective beginning November 30, 2015 and shall apply to all Retail Marijuana Cultivation Facility Licensees. B. One Retail Cultivation License per Licensed Premises. C. 1. Only one Retail Marijuana Cultivation Facility License shall be permitted at each licensed premises. Each licensed premises must be located at a distinct address recognized by the local jurisdiction. 2. Existing Retail Marijuana Cultivation Facilities that have Multiple Cultivation Licenses at the Licensed Premises. Upon the first renewal at the Retail Marijuana Cultivation Facility, all of the Retail Marijuana Cultivation Facility’s licenses will be collapsed into one surviving license, and fees shall be prorated for the non-expiring licenses. The maximum authorized plant count shall also collapse into the surviving license. Production Management. 1. Production Management Tiers. a. Tier 1: 1 - 1,800 plants b. Tier 2: 1,801 – 3,600 plants c. Tier 3: 3,601 – 6,000 plants d. Tier 4: 6,001 – 10,200 plants e. Tier 5: 10,201 – 13,800+ plants 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 95 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 D. RETAIL - Page 96 of 201 i. Tier 5 shall not have a cap on the maximum authorized plant count. ii. The maximum authorized plant count above 10,200 plants shall increase in one or two increments of 3,600 plants. A Retail Marijuana Cultivation Facility Licensee shall be allowed to increase its maximum authorized plant count one or two increments of 3,600 plants at a time upon application and approval by the Division pursuant to the requirements of paragraph (E) of this rRule R 506. 2. All Retail Marijuana Cultivation Facility licenses granted on or after November 30, 2015 shall be authorized to cultivate no more than 1,800 plants at any given time. 3. As of November 30, 2015, a Retail Marijuana Cultivation Facility license that was associated with a Retail Marijuana Products Manufacturing Facility shall be authorized to cultivate no more than 1,800 plants at any given time. If such a Retail Marijuana Cultivation Facility Licensee submitted a plant count waiver application prior to August 31, 2015 and it was subsequently approved, the license shall be authorized to cultivate the maximum number of plants at any given time in the corresponding production management tier pursuant to subparagraph (C)(1) of this Rrule R 506. 4. Each Retail Marijuana Cultivation Facility with a license(s) granted before November 30, 2015 shall be authorized to cultivate the same number of plants that it was authorized to cultivate prior to November 30, 2015. Pursuant to subparagraph (B)(2) of this Rrule R 506, for any Retail Marijuana Cultivation Facility that has multiple licenses, the total plant count authorized in sum across those licenses shall apply to the entire Retail Marijuana Cultivation Facility and shall be collapsed into one license upon renewal. 5. In connection with the license renewal process for Retail Marijuana Cultivation Facilities that are authorized to cultivate more than 1,800 plants, the Division will review the purchases, salesTransfers, and cultivated plant count of the Retail Marijuana Cultivation Facility Licensee during the preceding licensing term. The Division may reduce the Licensee’s maximum allowed plant count to a lower production management tier pursuant to subparagraph (C)(1) of this rRule if the Licensee sold less than 70% of what it produced during the six months prior to the application for renewal. When determining whether to reduce the maximum authorized plant count, the Division may consider the following factors including but not limited to: a. Cultivation and production history including whether the plants/inventory suffered a catastrophic event during the licensing period; b. Transfer, sales, and excise tax payment history; c. Existing inventory and inventory history; d. Sales contracts; and e. Any other factors relevant to ensuring responsible cultivation, production, and inventory management. Inventory Management. 1. Inventory Management for Retail Cultivation Facilities that have one or two harvest seasons once or twice a year. Beginning February 1, 2015, a Retail Marijuana Cultivation 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 96 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 97 of 201 Facility that has one or two harvests seasons once or twice a year may not accumulate Harvested Marijuana in excess of the total amount of inventory the Licensee produced that was tTransferred to another Retail Marijuana Establishment in the previous twentyfour monthsyear. 2. E. Inventory Management for Retail Cultivation Facilities that have more than two or more harvest seasons more than twice a year. Beginning February 1, 2015, a Retail Marijuana Cultivation Facility that has more than two harvests seasons more than twice a year may not accumulate Harvested Marijuana in excess of the total amount of inventory the Licensee produced that was was tTransferredTransferred to another Retail Marijuana Establishment in the previous six months. Application for Additional Plants. 1. 2. Retail Marijuana Cultivation Facilities that have one or two cultivation seasons per year. a. After accruing at least one harvest season two quarters of sales, a Retail Marijuana Cultivation Facility Licensee may apply to the Division for a production management tier increase to be authorized to cultivate the number of plants in the next highest production management tier. The Licensee shall provide documentation demonstrating that for during the previous cultivation season at least six consecutive months prior to the tier increase application, it has consistently cultivated an amount of plants that is at or near its maximum authorized plant count. The Licensee shall also provide documentation demonstration that for the previous twelve months it has , and has tTransferred at least 85% of the inventory it produced during that time period to another Retail Marijuana Establishment, and any other information requested to aid the Division in its evaluation of the tier increase application. b. If the Division approves the production management tier increase application, the Licensee shall pay the applicable expanded production management tier fee prior to cultivating the additional authorized plants. See See Rrule R 208 – Schedule of Business License Fees: Retail Marijuana Establishments. c. For a Licensee with an authorized plant count in Tier 2-5 to continue producing at its expanded authorized plant count, the Licensee shall pay the requisite Retail Marijuana Cultivation Facility license fee and the applicable expanded production management tier fee at license renewal. See Rrule R 209 – Schedule of Business License Renewal Fees: Retail Marijuana Establishments. d. A Retail Marijuana Cultivation Facility may apply to increase its authorized plant count by two increments of 3,600 plants (7,200 plants total) every twelve months once it reaches Tier 5. It is within the Division’s discretion to determine whether or not to grant the requested two 3,600 plant increase. In making its determination, the Division will consider documents submitted by the Retail Marijuana Cultivation. By way of example and not limitation, supporting documents may include documents establishing: 3. i. That the Retail Marijuana Cultivation has consistently cultivated an amount of plants that is at or near its maximum authorized plant count, 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 97 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 98 of 201 and has Transferred at least 90% of the inventory it produced during that time period to another Retail Marijuana Establishment; 2. ii. That the Retail Marijuana Cultivation currently has possession of sufficient space to grow the requested two 3,600 plant increments; ii. That the Retail Marijuana Cultivation is commonly owned with one or more Retail Marijuana Stores and in the preceding twelve months, notwithstanding that the Retail Marijuana Cultivation cultivated all, or nearly all, of its authorized plant count, the Retail Marijuana Cultivation and/or the Retail Marijuana Store obtained Retail Marijuana from one or more unrelated Retail Marijuana Cultivations; and iv. That the Retail Marijuana Cultivation has contracts for the sale of Retail Marijuana in the next twelve months supporting the requested two 3,600 plant increments. Retail Marijuana Cultivation Facilities that have more than two cultivation seasons per year. a. After accruing at least on harvest seasontwo quarters of sales, a Retail Marijuana Cultivation Facility Licensee may apply to the Division for a production management tier increase to be authorized to cultivate the number of plants in the next highest production management tier. The Licensee shall provide documentation demonstrating that for at least six consecutive months prior to the tier increase application, it has consistently cultivated an amount of plants that is at or near its maximum authorized plant count, and has Transferred at least 85% of the inventory it produced during that time period to another Retail Marijuana Establishment, and any other information requested to aid the Division in its evaluation of the tier increase application. b. If the Division approves the production management tier increase application, the Licensee shall pay the applicable expanded production management tier fee prior to cultivating the additional authorized plants. See Rrule R 208 – Schedule of Business License Fees: Retail Marijuana Establishments. c. For a Licensee with an authorized plant count in Tier 2-5 to continue producing at its expanded authorized plant count, the Licensee shall pay the requisite Retail Marijuana Cultivation Facility license fee and the applicable expanded production management tier fee at license renewal. See Rrule R 209 – Schedule of Business License Renewal Fees: Retail Marijuana Establishments. d. A Retail Marijuana Cultivation Facility may apply to increase its authorized plant count by two increments of 3,600 plants (7,200 plants total) every six months once it reaches Tier 5. It is within the Division’s discretion to determine whether or not to grant the requested two 3,600 plant increase. In making its determination, the Division will consider documents submitted by the Retail Marijuana Cultivation. By way of example and not limitation, supporting documents may include documents establishing: i. That the Retail Marijuana Cultivation has consistently cultivated an amount of plants that is at or near its maximum authorized plant count, 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 98 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 99 of 201 and has Transferred at least 90% of the inventory it produced during that time period to another Retail Marijuana Establishment; F. G. ii. That the Retail Marijuana Cultivation currently has possession of sufficient space to grow the requested two 3,600 plant increments; ii. That the Retail Marijuana Cultivation is commonly owned with one or more Retail Marijuana Stores and in the preceding six months, notwithstanding that the Retail Marijuana Cultivation cultivated all, or nearly all, of its authorized plant count, the Retail Marijuana Cultivation and/or the Retail Marijuana Store obtained Retail Marijuana from one or more unrelated Retail Marijuana Cultivations; and iv. That the Retail Marijuana Cultivation has contracts for the sale of Retail Marijuana in the next six months supporting the requested two 3,600 plant increments. Maximum Allowed Retail Marijuana Cultivation Facility Licenses. 1. A Person with an Interest in Three or More Retail Marijuana Cultivation Facility Licenses. For every multiple of three Retail Marijuana Cultivation Facility licenses a person has an interest in, the person must have a controlling interest in at least one Retail Marijuana Store. For example: (1) a person with an interest in three, four, or five Retail Marijuana Cultivation Facility licenses also must have a controlling interest in at least one Retail Marijuana Store; (2) a person with an interest in six, seven, or eight Retail Marijuana Cultivation Facility licenses also must have a controlling interest in at least two Retail Marijuana Stores; (3) a person with an interest in nine, ten, or eleven Retail Marijuana Cultivation Facility licenses also must have a controlling interest in at least three Retail Marijuana Stores; etc. 2. A Person with an Interest in Less than Three Retail Marijuana Cultivation Facility Licenses. The person shall not be required to have an interest in a Retail Marijuana Store. The State Licensing Authority, at its sole discretion, may adjust any of the plant limits described in this rRule on an industry-wide aggregate basis for all Retail Marijuana Cultivation Facility Licensees subject to that limitation. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 99 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 100 of 201 R 600 Series – Retail Marijuana Products Manufacturing Facilities Basis and Purpose – R 601 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-306(1)(j), 12-43.4309(7)(a), 12-43.4-404(1)(a), 12-43.4-404(1)(b), 12-43.4-404(6), 12-43.4-406(1)(c), and 12-43.4406(4)(b), C.R.S. The purpose of this rule is to establish that it is unlawful for a Retail Marijuana Products Manufacturing Facility to exercise any privileges other than those granted by the State Licensing Authority and to clarify the license privileges. R 601 – Retail Marijuana Products Manufacturing Facilities: License Privileges A. Privileges Granted. A Retail Marijuana Products Manufacturing Facility shall only exercise those privileges granted to it by the State Licensing Authority. B. Licensed Premises. A separate license is required for each specific business or business entity and geographical location. A Retail Marijuana Products Manufacturing Facility may share a location with a commonly owned Medical Marijuana-Infused Products Manufacturer. However, a separate license is required for each specific business or business entity, regardless of geographical location. C. Authorized TransfersSales Restricted. A Retail Marijuana Products Manufacturing Facility may only Transfersell Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product to Retail Marijuana Stores, and to other Retail Marijuana Products Manufacturing Facilities, Retail Marijuana Testing Facilities, Medical Research Facilities, and Pesticide Manufacturers. D. Manufacture of Retail Marijuana Product Authorized. A Retail Marijuana Products Manufacturing Facility may manufacture, prepare, package, store, and label Retail Marijuana Product, whether in concentrated form or that are comprised of marijuana and other ingredients intended for use or consumption, such as edible products, ointments, or tinctures. E. Location Prohibited. A Retail Marijuana Products Manufacturing Facility may not manufacture, prepare, package, store, or label Retail Marijuana Product in a location that is operating as a retail food establishment or a wholesale food registrant. F. Samples Provided for Testing. A Retail Marijuana Products Manufacturing Facility may provide samples of its Retail Marijuana Product to a Retail Marijuana Testing Facility for testing and research purposes. The Retail Marijuana Products Manufacturing Facility shall maintain the testing results as part of its business books and records. G. Authorized Marijuana Transport. A Retail Marijuana Products Manufacturing Facility is authorized to utilize a licensed Retail Marijuana Transporter for transportation of its Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product so long as the place where transportation orders are taken and delivered is a licensed Retail Marijuana Establishment and the transportation order is delivered to a Retail Marijuana Establishment, Medical Research Facility, or Pesticide Manufacturer. Nothing in this Rrule prevents a Retail Marijuana Products Manufacturing Facility from transporting its own Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product. H. Compensation. A Retail Marijuana Products Manufacturing Facility may compensate its employees using performance-based incentives. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 100 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 101 of 201 Basis and Purpose – R 602 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(a)(VI), 1243.4-202(3)(a)(VII)(K), 12-43.4-202(3)(a)(VIII), 12-43.4-202(3)(a)(X), 12-43.4-202(3)(a)(XVII), 12-43.4202(3)(c)(V), 12-43.4-309(7)(a), 12-43.4-404(1)(d), 12-43.4-404(1)(e)(I), 12-43.4-404(4), 12-43.4-404(5), 12-43.4-404(9), 12-43.4-406(1)(a) and 12-43.4-901(2)(a), C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(V). The purpose of this rule is to clarify those acts that are limited in some fashion or prohibited by a Retail Marijuana Products Manufacturing Facility. R 602 – Retail Marijuana Products Manufacturing Facility: General Limitations or Prohibited Acts A. Temporary Sales Limitation. From January 1, 2014 to September 30, 2014, a Retail Marijuana Products Manufacturing Facility shall not sell Transfer any of the Retail Marijuana that was cultivated in its commonly-owned Retail Marijuana Cultivation Facility to any other Retail Marijuana Establishment. Such Retail Marijuana shall be used solely in Retail Marijuana Product produced by the Retail Marijuana Products Manufacturing Facility. B. Packaging and Labeling Standards Required. A Retail Marijuana Products Manufacturing Facility is prohibited from selling Transferring Retail Marijuana Product that are not properly packaged and labeled. See R 1000 Series – Labeling, Packaging, and Product Safety and R 1000-1 Series – Labeling, Packaging, and Product Safety. C. THC Content Container Restriction. Each individually packaged Edible Retail Marijuana Product, even if comprised of multiple servings, may include no more than a total of 100 milligrams of active THC. See Rule R 1004 – Labeling Requirements: Specific Requirements, Edible Retail Marijuana Product and Rule R 1008-1 – Additional Packaging Requirements – Edible Retail Marijuana Products. D. Sale Transfer to Consumer Prohibited. A Retail Marijuana Products Manufacturing Facility is prohibited from selling Transferring Retail Marijuana or Retail Marijuana Product to a consumer. E. Consumption Prohibited. A Retail Marijuana Products Manufacturing Facility shall not permit the consumption of marijuana or marijuana products on its Licensed Premises. F. Evidence of Excise Tax Paid. A Retail Marijuana Products Manufacturing Facility is prohibited from accepting Retail Marijuana from a Retail Marijuana Cultivation Facility or Retail Marijuana Manufacturing Facility Licensee unless the manufacturer has received evidence that any applicable excise tax due pursuant to Article 28.8 of Title 39, C.R.S., was paid. G. Adequate Care of Perishable Product. A Retail Marijuana Products Manufacturing Facility must provide adequate refrigeration for perishable Retail Marijuana Product that will be consumed and shall utilize adequate storage facilities and transport methods. H. Homogeneity of Edible Retail Marijuana Product. A Retail Marijuana Products Manufacturing Facility must ensure that its manufacturing processes are designed so that the cannabinoid content of any Edible Retail Marijuana Product is homogenous. I. A Retail Marijuana Products Manufacturing Facility shall not sell or give awayTransfer Retail Marijuana or Retail Marijuana Product to a Retail Marijuana Transporter, and shall not buy or receive complimentary Retail Marijuana or Retail Marijuana Product. Basis and Purpose – R 603 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 101 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 102 of 201 The statutory authority for this rule is found at subsections 12-43.4-202(1), 12-43.4-202(2)(b), 12-43.4202(3)(a)(XVII), 12-43.4-404 (1)(b), and 12-43.4-406(3), C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(VII). The purpose of this rule is to require all Retail Marijuana Products Manufacturing Facilities to track all inventory from the point it is received from a Retail Marijuana Cultivation Facility, Retail Marijuana Products Manufacturing Facility, or Retail Marijuana Transporter through any manufacturing processes, to the point of sale or Ttransfer to another Retail Marijuana Establishment. R 603 – Retail Marijuana Products Manufacturing Facility: Inventory Tracking System A. Minimum Tracking Requirement. A Retail Marijuana Products Manufacturing Facility must use the Inventory Tracking System to ensure its inventories are identified and tracked from the point they are tTransferred from a Retail Marijuana Cultivation Facility, Retail Marijuana Products Manufacturing Facility, or Retail Marijuana Transporter, or another Retail Marijuana Products Manufacturing Facility through wholesale transaction or tTransfer. See also Rule R 309 – Inventory Tracking System. A Retail Marijuana Products Manufacturing Facility must have the ability to reconcile its inventory records with the Inventory Tracking System and the associated transaction history and sale receipts. See also Rule R 901 – Business Records Required. 1. A Retail Marijuana Products Manufacturing Facility is prohibited from accepting any Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product from a Retail Marijuana Cultivation Facility, Retail Marijuana Products Manufacturing Facility, or Retail Marijuana Transporter without receiving a valid transport manifest generated from the Inventory Tracking System. 2. A Retail Marijuana Products Manufacturing Facility must immediately input all Retail Marijuana, Retail Marijuana Concentrate and Retail Marijuana Product delivered to its Licensed Premises, accounting for all RFID tags, into the Inventory Tracking System at the time of delivery from a Retail Marijuana Cultivation Facility,to the Retail Marijuana Products Manufacturing Facility, or Retail Marijuana Transporter. 3. A Retail Marijuana Products Manufacturing Facility must reconcile transactions to the Inventory Tracking System at the close of business each day. Basis and Purpose – R 604 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(a)(IV)(A), 12-43.4-202(3)(a)(VI), 12-43.4-202(3)(a)(VII), 12-43.4-202(3)(a)(VIII), 12-43.4-202(3)(a)(XI), 12-43.4202(3)(a)(XII), 12-43.4-202(3)(b)(IX), 12-43.4-202(3)(c)(V), 12-43.4-202(3)(c)(VII), 12-43.4202(3)(c)(IX)(A)-(B), and 12-43.4-202(3)(c.5)(I), and section 12-43.4-404, C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(VII). The purpose of this rule is to establish minimum health and safety regulation for Retail Marijuana Products Manufacturing Facilities. It requires all Owners and Occupational Licensees to demonstrate an understanding of basic food handling safety practices or attend a food handler training course prior to manufacturing any Edible Retail Marijuana Product. It sets forth general standards and basic sanitary requirements for Retail Marijuana Products Manufacturing Facilities. It covers the physical premises where the products are made as well as the individuals handling the products. The State Licensing Authority intends for this rule to reduce any product contamination, which will benefit both the Licensees and consumers. The State Licensing Authority modeled this rule after those adopted by the Colorado Department of Public Health and Environment. This rule also authorizes the State Licensing Authority to require an independent consultant to conduct a health and sanitary audit of a Retail Marijuana Products Manufacturing Facility. This rule explains when a heath and sanitary audit may be deemed necessary and sets forth possible consequences of a Retail Marijuana Establishment’s refusal to cooperate or pay for the audit. This rule 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 102 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 103 of 201 also establishes requirements for each Edible Retail Marijuana Product manufactured by a Retail Marijuana Products Manufacturing Facility. Product safety requirements were adopted to aid in making Edible Retail Marijuana Products more readily identifiable to the general public outside of their packaging as containing marijuana. Overall, the State Licensing Authority intends this rule to help maintain the integrity of Colorado’s Retail Marijuana businesses and the safety of the public. R 604 – Retail Marijuana Products Manufacturing Facility: Health and Safety Regulations A. Training 1. 2. B. Prior to engaging in the manufacture of any Edible Retail Marijuana Product each Owner or Occupational Licensee must: a. Have a currently valid ServSafe Food Handler Certificate obtained through the successful completion of an online assessment or print exam; or b. Take a food safety course that includes basic food handling training and is comparable to, or is a course given by, the Colorado State University extension service or a state, county, or district public health agency, and must maintain a status of good standing in accordance with the course requirements, including attending any additional classes if necessary. Any course taken pursuant to this rRule must last at least two hours and cover the following subjects: i. Causes of foodborne illness, highly susceptible populations and worker illness; ii. Personal hygiene and food handling practices; iii. Approved sources of food; iv. Potentially hazardous foods and food temperatures; v. Sanitization and chemical use; and vi. Emergency procedures (fire, flood, sewer backup). A Retail Marijuana Products Manufacturing Facility must obtain documentation evidencing that each Owner and each Occupational Licensee has successfully completed the examination or course required by this rRule and is in good standing. A copy of the documentation must be kept on file at any Licensed Premises where that Owner or Occupational Licensee is engaged in the manufacturing of an Edible Retail Marijuana Product. General Standards 1. A Retail Marijuana Products Manufacturing Facility 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 Retail Marijuana. An annual fire safety inspection may result in the required installation of fire suppression devices, or other means necessary for adequate fire safety. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 103 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 2. C. RETAIL - Page 104 of 201 A Retail Marijuana Products Manufacturing Facility that manufacturers edible Retail Marijuana Product shall comply with all kitchen-related health and safety standards of the relevant local jurisdiction 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. Product Safety Paragraph C is repealed effective October 1, 2016. Licensees shall refer to paragraph (C.5) of this rRule for product safety requirements beginning October 1, 2016. C.5. 1. A Retail Marijuana Products Manufacturing Facility that manufactures Edible Retail Marijuana Product shall comply fully with paragraph C of this Rrule no later than February 1, 2015. 2. A Retail Marijuana Products Manufacturing Facility that manufactures Edible Retail Marijuana Product shall create and maintain standard production procedures and detailed manufacturing processes for each Edible Retail Marijuana Product it manufactures. These procedures and processes must be documented and made available on the licensed premises for inspection by the Marijuana Enforcement Division, the Colorado Department of Public Health & Environment, and local licensing authorities. 3. The size of a Standardized Serving Of Marijuana shall be no more than 10mg of active THC. A Retail Marijuana Products Manufacturing Facility that manufactures Edible Retail Marijuana Product shall determine the total number of Standardized Servings Of Marijuana for each product that it manufactures. No individual Edible Retail Marijuana Product unit for sale shall contain more than 100 milligrams of active THC. 4. The following information must be documented in the standard production procedures for each Edible Retail Marijuana Product: the amount in milligrams of Standardized Serving Of Marijuana, the total number of Standardized Servings Of Marijuana, and the total amount of active THC contained within the product. 5. Multiple-Serving Edible Retail Marijuana Product. A Retail Marijuana Products Manufacturing Facility must ensure that each single Standardized Serving Of Marijuana of a Multiple-Serving Edible Retail Marijuana Product is physically demarked in a way that enables a reasonable person to intuitively determine how much of the product constitutes a single serving of active THC. Each demarked Standardized Serving Of Marijuana must be easily separable in order to allow an average person 21 years of age and over to physically separate, with minimal effort, individual servings of the product. 6. If an Edible Retail Marijuana Product is of the type that is impracticable to clearly demark each Standardized Serving Of Marijuana or to make each Standardized Serving Of Marijuana easily separable, then the product must contain no more than 10 mg of active THC per unit forof sale, and the Retail Marijuana Products Manufacturing Facility must ensure that the product complies with subparagraph (B)(2)(a) of Rrule R 1004.5. Product Safety. Paragraph (C.5) is effective beginning October 1, 2016. 1. A Retail Marijuana Products Manufacturing Facility that manufactures Edible Retail Marijuana Product shall create and maintain standard production procedures and 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 104 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 105 of 201 detailed manufacturing processes for each Edible Retail Marijuana Product it manufactures. These procedures and processes must be documented and made available on the Licensed Premises for inspection by the Division, the Colorado Department of Public Health & Environment, and local licensing authorities. 2. The size of a Standardized Serving Of Marijuana shall be no more than 10mg of active THC. A Retail Marijuana Products Manufacturing Facility that manufactures Edible Retail Marijuana Product shall determine the total number of Standardized Servings Of Marijuana for each product that it manufactures. No individual Edible Retail Marijuana Product unit for sale shall contain more than 100 milligrams of active THC. 3. The following information must be documented in the standard production procedures for each Edible Retail Marijuana Product: the amount in milligrams of Standardized Serving Of Marijuana, the total number of Standardized Servings Of Marijuana, and the total amount of active THC contained within the product. 4. Each single Standardized Serving Of Marijuana shall be marked, stamped, or otherwise imprinted with the Universal Symbol directly on at least one side of the Edible Retail Marijuana Product in a manner to cause the Universal Symbol to be distinguishable and easily recognizable. The Universal Symbol marking shall: 5. 6. a. Be centered either horizontally or vertically on each Standardized Serving Of Marijuana; and b. If centered horizontally on a serving, the height and width of the Universal Symbol shall be of a size that is at least 25% of the serving’s width, but not less than ¼ inch by ¼ inch; or c. If centered vertically on a serving, the height and width of the Universal Symbol shall be of a size that is at least 25% of the serving’s height, but not less than ¼ inch by ¼ inch. Notwithstanding the requirement of subparagraph (C.5)(4), an Edible Retail Marijuana Product shall contain no more than 10 mg of active THC per ContainerChild-Resistant package and the Retail Marijuana Products Manufacturing Facility must ensure that the product complies with subparagraph (A)(2) of rRule R 1004 or subparagraphs (A)-(C) of Rule R 1008-1 when: a. The Edible Retail Marijuana Product is of the type that is impracticable to mark, stamp, or otherwise imprint with the Universal Symbol directly on the product in a manner to cause the Universal Symbol to be distinguishable and easily recognizable; or b. The Edible Retail Marijuana Product is of the type that is impracticable to clearly demark each Standardized Serving Of Marijuana or to make each Standardized Serving Of Marijuana easily separable. The following categories of Edible Retail Marijuana Product are considered to be per se practicable to mark with the Universal Symbol: a. Chocolate b. Soft confections 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 105 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 7. c. Hard confections or lozenges d. Consolidated baked goods (e.g. cookie, brownie, cupcake, granola bar) e. Pressed pills and capsules The following categories of Edible Retail Marijuana Product are considered to be per se impracticable to mark with the Universal Symbol: a. Repealed. b. Loose bulk goods (e.g. granola, cereals, popcorn) c. Powders 8. Repealed. 8.1. Liquid Edible Retail Marijuana Product. 9. RETAIL - Page 106 of 201 a. Pursuant to 12-43.4-404(4)(b), C.R.S., Liquid Edible Retail Marijuana Products are impracticable to mark with the Universal Symbol and are exempt from the provision in subparagraph (C.5)(5) of this Rrule R 604 that requires Edible Retail Marijuana Products that are impracticable to mark with the Universal Symbol to contain 10mg or less active THC per ContainerChild-Resistant package. b. This exemption permits the manufacture and sale Transfer of Multi-Serving Liquid Edible Retail Marijuana Products so long as the product is: i. Packaged in a structure that uses a single mechanism to achieve both Child-Resistant properties and accurate pouring measurement of each liquid serving in increments equal to or less than 10mg of active THC per serving, with no more than 100mg of active THC total per ContainerhildResistant package; and ii. The measurement component is within the Child-Resistant cap or closure of the bottle and is not a separate component. Multiple-Serving Edible Retail Marijuana Product. a. A Retail Marijuana Products Manufacturing Facility must ensure that each single Standardized Serving Of Marijuana of a Multiple-Serving Edible Retail Marijuana Product is physically demarked in a way that enables a reasonable person to intuitively determine how much of the product constitutes a single serving of active THC. b. Each demarked Standardized Serving Of Marijuana must be easily separable in order to allow an average person 21 years of age and over to physically separate, with minimal effort, individual servings of the product. c. Each single Standardized Serving Of Marijuana contained in a Multiple-Serving Edible Retail Marijuana Product shall be marked, stamped, or otherwise imprinted with the Universal Symbol directly on the product in a manner to cause the Universal Symbol to be distinguishable and easily recognizable. The 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 106 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 107 of 201 Universal Symbol marking shall comply with the requirements of subparagraph (C.5)(4) of this Rrule R 604. d. 10. A Multiple-Serving Edible Retail Marijuana Product that is a Liquid Edible Retail Marijuana Product shall comply with the requirements in subsubparagraph (C.5)(8.1)(b) of this rRule R 604 and is exempt from subsubparagraphs a-c of this subparagraph (C.5)(9). Remanufactured Products Prohibited. A Retail Marijuana Product Manufacturing Facility shall not utilize a commercially manufactured food product as its Edible Retail Marijuana Product. The following exceptions to this prohibition apply: a. A food product that was commercially manufactured specifically for use by the Retail Marijuana Product Manufacturing Facility Licensee to infuse with marijuana shall be allowed. The Licensee shall have a written agreement with the commercial food product manufacturer that declares the food product’s exclusive use by the Retail Marijuana Product Manufacturing Facility. b. Commercially manufactured food products may be used as ingredients in a Retail Marijuana Product Manufacturing Facility’s Edible Retail Marijuana product so long as: (1) they are used in a way that renders them unrecognizable as the commercial food product in the final Edible Retail Marijuana Product, and (2) the Retail Marijuana Product Manufacturing Facility does not state or advertise to the consumer that the final Edible Retail Marijuana Product contains the commercially manufactured food product. 11. Trademarked Food Products. Nothing in this Rrule alters or eliminates a Retail Marijuana Product Manufacturing Facility’s responsibility to comply with the trademarked food product provisions required by the Retail Code per 12-43.4-404(1)(e)(I-III), C.R.S. 12. Edibles Prohibited that are Shaped like a Human, Animal, or Fruit. This subparagraph (C.5)(12) is effective beginning October 1, 2017. a. The production and sale Transfer of Edible Retail Marijuana Products in the following shapes is prohibited: i. The distinct shape of a human, animal, or fruit; or ii. A shape that bears the likeness or contains characteristics of a realistic or fictional human, animal, or fruit, including artistic, caricature, or cartoon renderings. b. The prohibition on human, animal, and fruit shapes does not apply to the logo of a licensed Retail Marijuana Establishment. Nothing in this subsubparagraph (C.5)(12)(b) alters or eliminates a Licensee’s obligation to comply with the requirements of Rrule R 1001 – Labeling and Packaging Requirements: General Applicability or Rule R 1000-1 Series –Labeling, Packaging, and Product Safety. c. Edible Retail Marijuana Products that are geometric shapes and simply fruit flavored are not considered fruit and are permissible; and d. Edible Retail Marijuana Products that are manufactured in the shape of a marijuana leaf are permissible. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 107 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 D. RETAIL - Page 108 of 201 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 Retail Marijuana or Retail Marijuana 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 Licensed Premises and/or in Retail Marijuana Product preparation areas 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; 3. That all persons working in direct contact with preparation of Retail Marijuana or Retail Marijuana 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, prior to engaging in the production of a Retail Marijuana Concentrate or manufacture of a Retail Marijuana Product and at any other time when the hands may have become soiled or contaminated; and c. Refraining from having direct contact with preparation of Retail Marijuana or Retail Marijuana 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 Retail Marijuana or Retail Marijuana 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 Retail Marijuana or Retail Marijuana 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 Retail Marijuana or Retail Marijuana Product are processed or stored and where equipment or utensils are cleaned; 8. That the Licensed Premises 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; 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 108 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 E. RETAIL - Page 109 of 201 10. That all contact surfaces, including utensils and equipment used for the preparation of Retail Marijuana, Retail Marijuana Concentrate 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 sanitizers and disinfectants registered with the Environmental Protection Agency shall be used in a Retail Marijuana Products Manufacturing Facility and used in accordance with labeled instructions; 11. That toxic cleaning compounds, sanitizing agents, solvents used in the production of Retail Marijuana concentrate and other chemicals shall be identified, held, stored and disposed of in a manner that protects against contamination of Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana 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 Licensed Premises 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 Licensed Premises. There shall be no cross-connections between the potable and waste water lines; 14. That each Retail Marijuana Products Manufacturing Facility 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 Retail Marijuana or Retail Marijuana Product shall be conducted in accordance with adequate sanitation principles; 16. That Retail Marijuana or Retail Marijuana 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 Retail Marijuana Product shall be under conditions that will protect products against physical, chemical, and microbial contamination as well as against deterioration of any container. Standard Operating Procedures 1. A Retail Marijuana Products Manufacturing Facility must have written standard operating procedures for each category of Retail Marijuana Concentrate and type of Retail Marijuana Product that it produces. a. All standard operating procedures for the production of a Retail Marijuana Concentrate must follow the requirements in Rule R 605. b. A copy of all standard operating procedures must be maintained on the Licensed Premises of the Retail Marijuana Products Manufacturing Facility. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 109 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 2. RETAIL - Page 110 of 201 If a Retail Marijuana Products Manufacturing Facility makes a Material Change to its standard Retail Marijuana Concentrate or Retail Marijuana Product production process, it must document the change and revise its standard operating procedures accordingly. Records detailing the Material Change must be maintained on the relevant Licensed Premises. F. Additives. A Retail Marijuana Products Manufacturing Facility shall not include any Additive that is toxic within a Retail Marijuana Product; nor include any Additive for the purposes of making the product more addictive, appealing to children or misleading to consumers. G DMSO. The use of Dimethylsulfoxide (“DMSO”) in the production of Retail Marijuana Concentrate or Retail Marijuana Product shall be prohibited and possession of DMSO upon the Licensed Premises is prohibited. HG. Independent Health and Sanitary Audit 1. 2. State Licensing Authority May Require An Independent Health and Sanitary Audit a. When the State Licensing Authority determines a health and sanitary audit by an independent consultant is necessary, it may require a Retail Marijuana Products Manufacturing Facility to undergo such an audit. The scope of the audit may include, but need not be limited to, whether the Retail Marijuana Products Manufacturing Facility is in compliance with the requirements set forth in this Rrule or other applicable food handling laws, rules or regulations or compliance with the concentrate production rules in Rule R 605 or other applicable laws, rules and regulations. b. In such instances, the Division may attempt to mutually agree upon the selection of the independent consultant with a Retail Marijuana Products Manufacturing Facility. However, the Division always retains the authority to select the independent consultant regardless of whether mutual agreement can be reached. c. The Retail Marijuana Products Manufacturing Facility will be responsible for all costs associated with the independent health and sanitary audit. When Independent Health and Sanitary Audit Is Necessary. The State Licensing Authority has discretion to determine when an audit by an independent consultant is necessary. The following is a non-exhaustive list of examples that may justify an independent audit: a. A Retail Marijuana Products Manufacturing Facility does not provide requested records related to the food handling training required for Owners or Occupational Licensees engaged in the production of Edible Retail Marijuana Product to the Division; b. A Retail Marijuana Products Manufacturing Facility does not provide requested records related to the production of Retail Marijuana Concentrate, including but not limited to, certification of its Licensed Premises, equipment or standard operating procedures, training of Owners or Occupational Licensees, or Production Batch specific records; 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 110 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 I. RETAIL - Page 111 of 201 c. The Division has reasonable grounds to believe that the Retail Marijuana Products Manufacturing Facility is in violation of one or more of the requirements set forth in this rRule or Rule R 605; d. The Division has reasonable grounds to believe that the Retail Marijuana Products Manufacturing Facility was the cause or source of contamination of Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product; or e. Multiple Production Batches of Retail Marijuana Concentrate or Retail Marijuana Product produced by the Retail Marijuana Products Manufacturing Facility failed contaminant testing. 3. Compliance Required. A Retail Marijuana Products Manufacturing Facility must pay for and timely cooperate with the State Licensing Authority’s requirement that it undergo an independent health and sanitary audit in accordance with this Rrule. 4. Suspension of Operations a. If the State Licensing Authority has objective and reasonable grounds to believe and finds upon reasonable ascertainment of the underlying facts that the public health, safety or welfare imperatively requires emergency action and incorporates such findings into its order, it may order summary suspension of the Retail Marijuana Products Manufacturing Facility’s license. See Rule R 1302 – Disciplinary Process: Summary Suspensions. b. Prior to or following the issuance of such an order, the Retail Marijuana Products Manufacturing Facility may attempt to come to a mutual agreement with the Division to suspend its operations until the completion of the independent audit and the implementation of any required remedial measures. i. If an agreement cannot be reached or the State Licensing Authority, in its sole discretion, determines that such an agreement is not in the best interests of the public health, safety or welfare, then the State Licensing Authority will promptly institute license suspension or revocation procedures. See Rule R 1302 – Disciplinary Process: Summary Suspensions. ii. If an agreement to suspend operations is reached, then the Retail Marijuana Products Manufacturing Facility may continue to care for its inventory and conduct any necessary internal business operations but it may not sell, Ttransfer or wholesale Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product to another Retail Marijuana Establishment during the period of time specified in the agreement. Depending on the condition of the Retail Marijuana Products Manufacturing Facility and required remedial measures, the Division may permit a Retail Marijuana Products Manufacturing Facility to produce Retail Marijuana Concentrate or manufacture Retail Marijuana Product while operations have been suspended. Contaminated Product. Unless otherwise permitted by these rules: 1. A Retail Marijuana Products Manufacturing Facility shall not accept or Transfer to another Retail Marijuana Establishment or any other Person any Retail Marijuana, Retail 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 111 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 112 of 201 Marijuana Concentrate or Retail Marijuana Product that has failed required testing pursuant to Rule R 1501 or Rule R 1503. 2. J. If a Retail Marijuana Manufacturing Facility possesses Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Products that failed required testing pursuant to Rule R 1501 or Rule R 1503, the Retail Marijuana Products Manufacturing Facility shall assure that all Retail Marijuana, Retail Marijuana Concentrate and Retail Marijuana Products that failed required testing is safely destroyed in accordance with Rule R 307. Violation Affecting Public Safety. Failure to comply with this Rrule may constitute a license violation affecting public safety. Basis and Purpose – R 605 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(a)(VIII), 1243.4-202(3)(a)(XI), and 12-43.4-2-2(3)(b)(IX), C.R.S. The purpose of this rule is to establish the categories of Retail Marijuana Concentrate that may be produced at a Retail Marijuana Products Manufacturing Facility and establish standards for the production of Retail Marijuana Concentrate. Nothing in this rule authorizes the unlicensed practice of engineering under Article 25 of Title 12, C.R.S. R 605 –Retail Marijuana Products Manufacturing Facility: Retail Marijuana Concentrate Production. A. B. Permitted Categories of Retail Marijuana Concentrate Production 1. A Retail Marijuana Products Manufacturing Facility may produce Water-Based Retail Marijuana Concentrate, and Food-Based Retail Marijuana Concentrate and Heat/Pressure Based Retail Marijuana Concentrate. 2. A Retail Marijuana Products Manufacturing Facility may also produce Solvent-Based Retail Marijuana Concentrate using only the following solvents: butane, propane, CO2, ethanol, isopropanol, acetone, and heptane and pentane. The use of any other solvent is expressly prohibited unless and until it is approved by the Division. 3. Beginning on July 1, 2014, a Retail Marijuana Products Manufacturing Facility may submit a request to the Division to consider the approval of solvents not permitted for use under this Rrule during the next formal rulemaking. General Applicability. A Retail Marijuana Products Manufacturing Facility that engages in the production of Retail Marijuana Concentrate, regardless of the method of extraction or category of concentrate being produced, must: 1. Ensure that the space in which any Retail Marijuana Concentrate is to be produced is a fully enclosed room and clearly designated on the current diagram of the Licensed Premises. See Rule R 901- Business Records Required. 2. Ensure that all applicable sanitary rules are followed. See R 604. 3. Ensure that the standard operating procedure for each method used to produce a Retail Marijuana Concentrate on its Licensed Premises includes, but need not be limited to, step-by-step instructions on how to safely and appropriately: a. Conduct all necessary safety checks prior to commencing production; 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 112 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 113 of 201 b. Prepare Retail Marijuana for processing; c. Extract cannabinoids and other essential components of Retail Marijuana; d. Purge any solvent or other unwanted components from a Retail Marijuana Concentrate, e. Clean all equipment, counters and surfaces thoroughly; and f. Dispose of any waste produced during the processing of Retail Marijuana in accordance with all applicable local, state and federal laws, rules and regulations. See Rule R 307 – Waste Disposal. 4. Establish written and documentable quality control procedures designed to maximize safety for Owners and Occupational Licensees and minimize potential product contamination. 5. Establish written emergency procedures to be followed by Owners or Occupational Licensees in case of a fire, chemical spill or other emergency. 6. Have a comprehensive training manual that provides step-by-step instructions for each method used to produce a Retail Marijuana Concentrate on its Licensed Premises. The training manual must include, but need not be limited to, the following topics: 7. a. All standard operating procedures for each method of concentrate production used at that Licensed Premises; b. The Retail Marijuana Products Manufacturing Facility’s quality control procedures; c. The emergency procedures for that Licensed Premises; d. The appropriate use of any necessary safety or sanitary equipment; e. The hazards presented by all solvents used within the Licensed Premises as described in the material safety data sheet for each solvent; f. Clear instructions on the safe use of all equipment involved in each process and in accordance with manufacturer’s instructions, where applicable; and g. Any additional periodic cleaning required to comply with all applicable sanitary rules. Provide adequate training to every Owner or Occupational Licensee prior to that individual undertaking any step in the process of producing a Retail Marijuana Concentrate. a. Adequate training must include, but need not be limited to, providing a copy of the training manual for that Licensed Premises and live, in-person instruction detailing at least all of the topics required to be included in the training manual. b. The individual training an Owner or Occupational Licensee must sign and date a document attesting that all required aspects of training were conducted and that 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 113 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 114 of 201 he or she is confident that the Owner or Occupational Licensee can safely produce a Retail Marijuana Concentrate. See Rule R 901- Business Records Required. c. 8. C. The Owner or Occupational Licensee that received the training must sign and date a document attesting that he or she can safely implement all standard operating procedures, quality control procedures, and emergency procedures, operate all closed-loop extraction systems, use all safety, sanitary and other equipment and understands all hazards presented by the solvents to be used within the Licensed Premises and any additional period cleaning required to maintain compliance with all applicable sanitary rules. See Rule R 901- Business Records Required. Maintain clear and comprehensive records of the name, signature and Owner or Occupational License number of every individual who engaged in any step related to the creation of a Production Batch of Retail Marijuana Concentrate and the step that individual performed. See Rule R 901- Business Records Required. Water-Based Retail Marijuana Concentrate, and Food-Based Retail Marijuana Concentrate and Heat/Pressure Based Retail Marijuana Concentrate. A Retail Marijuana Products Manufacturing Facility that engages in the production of a Water-Based Retail Marijuana Concentrate, or a Food-Based Retail Marijuana Concentrate or a Heat/Pressure Based Retail Marijuana Concentrate must: 1. Ensure that all equipment, counters and surfaces used in the production of a WaterBased Retail Marijuana Concentrate, or a Food-Based Retail Marijuana Concentrate or a Heat/Pressure Based Retail 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, molds and fungi and can be easily cleaned. 2. Ensure that all equipment, counters, and surfaces used in the production of a WaterBased Retail Marijuana Concentrate, or a Food-Based Retail Marijuana Concentrate or a Heat/Pressure Based Retail Marijuana Concentrate are thoroughly cleaned after the completion of each Production Batch. 3. Ensure that any room in which dry ice is stored or used in processing Retail Marijuana into a Retail Marijuana Concentrate is well ventilated to prevent against the accumulation of dangerous levels of CO2. 4. Ensure that the appropriate safety or sanitary equipment, including personal protective equipment, is provided to, and appropriately used by, each Owner or Occupational Licensee engaged in the production of a Water-Based Retail Marijuana Concentrate, or Food-Based Retail Marijuana Concentrate or Heat/Pressure Based Retail Marijuana Concentrate. 5. Ensure that only finished drinking water and ice made from finished drinking water is used in the production of a Water-Based Retail Marijuana Concentrate. 6. Ensure that if propylene glycol or glycerin is used in the production of a Food-Based Retail Marijuana Concentrate, then the propylene glycol or glycerin to be used is foodgrade. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 114 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 7. D. RETAIL - Page 115 of 201 Follow all of the rules related to the production of a Solvent-Based Retail Marijuana Concentrate if a pressurized system is used in the production of a Water-Based Retail Marijuana Concentrate, or a Food-Based Retail Marijuana Concentrate or a Heat/Pressure Based Retail Marijuana Concentrate. Solvent-Based Retail Marijuana Concentrate. A Retail Marijuana Products Manufacturing Facility that engages in the production of Solvent-Based Retail Marijuana Concentrate must: 1. Obtain a report from an Industrial Hygienist or a Professional Engineer that certifies that the equipment, Licensed Premises and standard operating procedures comply with these rules and all applicable local and state building codes, fire codes, electrical codes and other laws. If a local jurisdiction has not adopted a local building code or fire code or if local regulations do not address a specific issue, then the Industrial Hygienist or Professional Engineer shall certify compliance with the International Building Code of 2012 (http://www.iccsafe.org), the International Fire Code of 2012 (http://www.iccsafe.org) or the National Electric Code of 2014 (http://www.nfpa.org), as appropriate. Note that this rRule does not include any later amendments or editions to each Code. The Division has maintained a copy of each code, each of which is available to the public; a. b. Flammable Solvent Determinations. If a Flammable Solvent is to be used in the processing of Retail Marijuana into a Retail Marijuana Concentrate, then the Industrial Hygienist or Professional Engineer must: i. Establish a maximum amount of Flammable Solvents and other flammable materials that may be stored within that Licensed Premises in accordance with applicable laws, rules and regulations; ii. Determine what type of electrical equipment, which may include but need not be limited to outlets, lights and junction boxes, must be installed within the room in which Retail Marijuana Concentrate is to be produced or Flammable Solvents are to be stored in accordance with applicable laws, rules and regulations; iii. Determine whether a gas monitoring system must be installed within the room in which Retail Marijuana Concentrate is to be produced or Flammable Solvents are to be stored, and if required the system’s specifications, in accordance with applicable laws, rules and regulations; and iv. Determine whether fire suppression system must be installed within the room in which Retail Marijuana Concentrate is to be produced or Flammable Solvents are to be stored, and if required the system’s specifications, in accordance with applicable laws, rules and regulations. CO2 Solvent Determination. If C02 is used as solvent at the Licensed Premises, then the Industrial Hygienist or Professional Engineer must determine whether a CO2 gas monitoring system must be installed within the room in which Retail Marijuana Concentrate is to be produced or CO2 is stored, and if required the system’s specifications, in accordance with applicable laws, rules and regulations. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 115 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 116 of 201 c. Exhaust System Determination. The Industrial Hygienist or Professional Engineer must determine whether a fume vent hood or exhaust system must be installed within the room in which Retail Marijuana Concentrate is to be produced, and if required the system’s specifications, in accordance with applicable laws, rules and regulations. d. Material Change. If a Retail Marijuana Products Manufacturing Facility makes a Material Change to its Licensed Premises, equipment or a concentrate production procedure, in addition to all other requirements, it must obtain a report from an Industrial Hygienist or Professional Engineer re-certifying its standard operating procedures and, if changed, its Licensed Premises and equipment as well. e. Manufacturer’s Instructions. The Industrial Hygienist or Professional Engineer may review and consider any information provided to the Retail Marijuana Products Manufacturing Facility by the designer or manufacturer of any equipment used in the processing of Retail Marijuana into a Retail Marijuana Concentrate. f. Records Retention. A Retail Marijuana Products Manufacturing Facility must maintain copy of all reports received from an Industrial Hygienist and Professional Engineer on its Licensed Premises. Notwithstanding any other law, rule or regulation, compliance with this rRule is not satisfied by storing these reports outside of the Licensed Premises. Instead the reports must be maintained on the Licensed Premises until the Licensee ceases production of Retail Marijuana Concentrate on the Licensed Premises. 2. Ensure that all equipment, counters and surfaces used in the production of a SolventBased Retail Marijuana Concentrate are food-grade and do not react adversely with any of the solvents to be used in the Licensed Premises. Additionally, all counters and surface areas must be constructed in a manner that reduces the potential development of microbials, molds and fungi and can be easily cleaned; 3. Ensure that the room in which Solvent-Based Retail Marijuana Concentrate shall be produced must contain an emergency eye-wash station; 4. Ensure that only a professional grade, closed-loop extraction system capable of recovering the solvent is used to produce Solvent-Based Retail Marijuana Concentrate; a. UL or ETL Listing. i. If the system is UL or ETL listed, then a Retail Marijuana Products Manufacturing Facility may use the system in accordance with the manufacturer’s instructions. ii. If the system is UL or ETL listed but the Retail Marijuana Products Manufacturing Facility intends to use a solvent in the system that is not listed in the manufacturer’s instructions for use in the system, then, prior to using the unlisted solvent within the system, the Retail Marijuana Products Manufacturing Facility must obtain written approval for use of the non-listed solvent in the system from either the system’s manufacturer or a Professional Engineer after the Professional Engineer has conducted a peer review of the system. In reviewing the system, the 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 116 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 117 of 201 Professional Engineer shall review and consider any information provided by the system’s designer or manufacturer. iii. b. 5. If the system is not UL or ETL listed, then there must a designer of record. If the designer of record is not a Professional Engineer, then the system must be peer reviewed by a Professional Engineer. In reviewing the system, the Professional Engineer shall review and consider any information provided by the system’s designer or manufacturer. Ethanol or Isopropanol. A Retail Marijuana Products Manufacturing Facility need not use a professional grade, closed-loop system extraction system capable of recovering the solvent for the production of a Solvent-Based Retail Marijuana Concentrate if ethanol or isopropanol are the only solvents being used in the production process. Ensure that all solvents used in the extraction process are food-grade or at least 99% pure; a. A Retail Marijuana Products Manufacturing Facility must obtain a material safety data sheet for each solvent used or stored on the Licensed Premises. A Retail Marijuana Products Manufacturing Facility must maintain a current copy of the material safety data sheet and a receipt of purchase for all solvents used or to be used in an extraction process. See Rule R 901- Business Records Required. b. A Retail Marijuana Products Manufacturing Facility is prohibited from using denatured alcohol to produce a Retail Marijuana Concentrate. 6. Ensure that all Flammable Solvents or other flammable materials, chemicals and waste are stored in accordance with all applicable laws, rules and regulations. At no time may a Retail Marijuana Products Manufacturing Facility store more Flammable Solvent on its Licensed Premises than the maximum amount established for that Licensed Premises by the Industrial Hygienist or Professional Engineer; 7. Ensure that the appropriate safety and sanitary equipment, including personal protective equipment, is provided to, and appropriately used by, each Owner or Occupational Licensee engaged in the production of a Solvent-Based Retail Marijuana Concentrate; and 8. Ensure that a trained Owner or Occupational Licensee is present at all times during the production of a Solvent-Based Retail Marijuana Concentrate whenever an extraction process requires the use of pressurized equipment. E. Ethanol and Isopropanol. If a Retail Marijuana Products Manufacturing Facility only produces Solvent-Based Retail Marijuana Concentrate using ethanol or isopropanol at its Licensed Premises and no other solvent, then it shall be considered exempt from paragraph D of this rRule and instead must follow the requirements in paragraph C of this rRule. Regardless of which rule is followed, the ethanol or isopropanol must be food grade or at least 99% pure and denatured alcohol cannot be used. The Retail Marijuana Products Manufacturing Facility shall comply with contaminant testing required in Rule R 1501(C)(4). F. Violation Affecting Public Safety. Failure to comply with this rRule may constitute a license violation affecting public safety. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 117 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 118 of 201 R 700 Series – Retail Marijuana Testing Facilities Basis and Purpose – R 701 The statutory authority for this rule is found at subsections12-43.4-202(2)(b), 12-43.4-202(3)(a)(IV), 1243.4-202(3)(a)(X), 12-43.4-202(3)(a)(XVII), 12-43.4-202(3)(b)(IX), 12-43.4-202(3)(c)(IV), 12-43.4309(7)(a), 12-43.4-402(4), 12-43.4-403(5), 12-43.4-404(6), 12-43.4-405, 35-61-104, and 35-61-105.5, C.R.S. The purpose of this rule is to establish that it is unlawful for a Retail Marijuana Testing Facility Licensee to exercise any privileges other than those granted by the State Licensing Authority and to clarify the license privileges. R 701 – Retail Marijuana Testing Facilities: License Privileges A. Privileges Granted. A Retail Marijuana Testing Facility shall only exercise those privileges granted to it by the State Licensing Authority. B. Licensed Premises. A separate License is required for each specific Retail Marijuana Testing Facility and only those privileges granted by the Retail Code and any rules promulgated pursuant to it may be exercised on the Licensed Premises. C. Testing of Retail Marijuana and Retail Marijuana Product Authorized. A Retail Marijuana Testing Facility may accept Samples of Retail Marijuana or Retail Marijuana Product from Retail Marijuana Establishments for testing and research purposes only, which purposes may include the provision of testing services for Samples submitted by a Retail Marijuana Establishment for the purpose of product development. The Division may require a Retail Marijuana Establishment to submit a sSample of Retail Marijuana or Retail Marijuana Product to a Retail Marijuana Testing Facility upon demand. D. Product Development Authorized. Repealed. A Retail Marijuana Testing Facility may develop Retail Marijuana Product, but is not authorized to engage in the manufacturing privileges described in section 12-43.4-404, C.R.S. and Rule R 601 – Retail Marijuana Manufacturing Facilities: License Privileges. E. Medical Marijuana Occupational License for Testing and Research. This paragraph is rRepealed effective July 1, 2016. Licensees shall refer to the M 700 Series – Medical Marijuana Testing Facilities, located in 1 CCR 212-1, for the testing and research of Medical Marijuana and Medical Marijuana-Infused Product beginning July 1, 2016. A Retail Marijuana Testing Facility that has applied for and obtained a Medical Marijuana Occupational License for Testing and Research may accept Samples of Medical Marijuana or Medical Marijuana-Infused Product from Medical Marijuana Businesses for testing and research purposes only. F. Sending Transferring Samples to Other Another Licensed and Certified Retail Marijuana Testing Facility. A Retail Marijuana Testing Facility may send Transfer Samples to another Retail Marijuana Testing Facility for testing. All laboratory reports provided to or by a Retail Marijuana Establishment must identify the Retail Marijuana Testing Facility that actually conducted the test. G. Testing of Registered and Tracked Industrial Hemp Authorized. 1. A Retail Marijuana Testing Facility may accept and test sSamples of Industrial Hemp as regulated by Article 61 of Title 35, C.R.S. The sSamples must be submitted by a registered cultivator and tracked through the radio frequency identification-based inventory tracking system approved by the Commissioner of the Colorado Department of Agriculture, pursuant to 35-61-105.5, C.R.S. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 118 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 H. RETAIL - Page 119 of 201 2. Only Retail Marijuana Testing Facilities that are certified to test in the category of THC and other Cannabinoid potency shall be permitted to test sSamples of Industrial Hemp as regulated by Article 61 of Title 35, C.R.S. 3. Nothing in these rules shall be construed to require a Retail Marijuana Testing Facility to accept and/or test sSamples of Industrial Hemp. Authorized Retail Marijuana Transport. A Retail Marijuana Testing Facility is authorized to utilize a licensed Retail Marijuana Transporter to transport Samples of Retail Marijuana and Retail Marijuana Product for testing, in accordance with the Retail Marijuana Code and Retail Marijuana Rules, between the originating Retail Marijuana Establishment requesting testing services and the destination Retail Marijuana Testing Facility performing testing services. Nothing in this rule requires a Retail Marijuana EstablishmentTesting Facility, Retail Marijuana Store, Retail Marijuana Cultivation Facility, or Retail Marijuana Products Manufacturing Facility to utilize a Retail Marijuana Transporter to transport Samples of Retail Marijuana or Retail Marijuana Product for testing. Basis and Purpose – R 702 The statutory authority for this rule is found at subsections 12-43.3-901(2), 12-43.4-105, 12-43.4-202(1), 12-43.4-202(2)(b), 12-43.4-202(3)(a)(IV), 12-43.4-202(3)(a)(X), 12-43.4-202(3)(a)(XII), 12-43.4202(3)(a)(XVII), 12-43.4-202(3)(b)(IX), 12-43.4-405, 12-43.4-901, 35-61-104, and 35-61-105.5, C.R.S. The purpose of this rule is to clarify those acts that are limited in some fashion, or prohibited, by a Retail Marijuana Testing Facility. R 702 – Retail Marijuana Testing Facilities: General Limitations or Prohibited Acts A. Prohibited Financial Interest. A Person who is a Direct Beneficial Interestn Owner or an Indirect Beneficial Interest Owner of a Retail Marijuana Cultivation Facility, Retail Marijuana Products Manufacturing Facility, Retail Marijuana Store, Medical Marijuana Center, Optional Premises Cultivation, or a Medical Marijuana Infused-Products Manufacturing Facility shall not be a Direct Beneficial Interest n Owner or an Indirect Beneficial Interest Owner of a Retail Marijuana Testing Facility. A.2. Conflicts of Interest. The Retail Marijuana Testing Facility shall establish policies to prevent the existence of or appearance of undue commercial, financial, or other influences that may diminish the competency, impartiality, and integrity of the Retail Marijuana Testing Facility’s testing processes or results, or that may diminish public confidence in the competency, impartiality and integrity of the Retail Marijuana Testing Facility’s testing processes or results. At a minimum, employees, owners or agents of a Retail Marijuana Testing Facility who participate in any aspect of the analysis and results of a Sample or Test Batch are prohibited from improperly influencing the testing process, improperly manipulating data, or improperly benefiting from any on-going financial, employment, personal or business relationship with the Retail Marijuana Establishment that provided the Sample. B. TransferSale of Retail Marijuana Prohibited. A Retail Marijuana Testing Facility shall not is prohibited from selling, distributing, or transferring Transfer Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product, Medical Marijuana, or Medical Marijuana-Infused Product to another Retail Marijuana Establishment, a Medical Marijuana Business, or a consumer, except that a Retail Marijuana Testing Facility may Ttransfer a Sample to another Retail Marijuana Testing Facility. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 119 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 120 of 201 C. Destruction of Received Retail MarijuanaSamples. A Retail Marijuana Testing Facility shall properly dispose of all Samples it receives, that are not Ttransferred to another Retail Marijuana Testing Facility, after all necessary tests have been conducted and any required period of storage. See Rule R 307 – Waste Disposal. D. Consumption Prohibited. A Retail Marijuana Testing Facility shall not permit the consumption of marijuana or marijuana products on its Licensed Premises. E. Sample Rejection. A Retail Marijuana Testing Facility shall reject any Sample where the condition of the Sample at receipt indicates that that the sSample may have been tampered with. F. Retail Marijuana Establishment Requirements Applicable. A Retail Marijuana Testing Facility shall be considered a Licensed Premises. A Retail Marijuana Testing Facility shall be subject to all requirements applicable to Retail Marijuana Establishments. G. Retail Marijuana Testing Facility – Inventory Tracking System Required. A Retail Marijuana Testing Facility must use the Inventory Tracking System to ensure its all Test Batches or Samples containing Retail Marijuana, Retail Marijuana Concentrate, Retail Marijuana Product or Industrial Hemp are identified and tracked from the point they are tTransferred from a Retail Marijuana Establishment or Medical Marijuana Business through the point of Transfer or destruction or disposal. The Inventory Tracking System reporting shall include the results of any tests that are conducted on Retail Marijuana, Retail Marijuana Concentrate, Retail MarijuanaInfused Product or Industrial Hemp. See also Rule R 309 – Retail Marijuana Establishment: Inventory Tracking System and Rule R 711 – Reporting and Inventory Tracking System. The Retail Marijuana Testing Facility must have the ability to reconcile its Sample records with the Inventory Tracking System and the associated transaction history. See also Rule R 901 – Business Records Required and Rule R 711. H. Testing of Unregistered or Untracked Industrial Hemp Prohibited. A Retail Marijuana Testing Facility is authorized to shall not accept or test sSamples of Industrial Hemp only if that are not(1) the entity providing the Samples of Industrial Hemp is regulated by Article 61 of Title 35, C.R.S., (2) the Samples of Industrial Hemp are submitted by an un registered cultivator, and (3)or the Samples of Industrial Hemp are not tracked through the radio frequency identification-based inventory tracking system approved by the Commissioner of the Colorado Department of Agriculture, pursuant to section 35-61-105.5, C.R.S. I. Transporter Restrictions. A Retail Marijuana Testing Facility shall not sell or give away Retail Marijuana or Retail Marijuana Product to a Retail Marijuana Transporter, and shall not buy, or receive complimentary Retail Marijuana or Retail Marijuana Product from a Retail Marijuana Transporter. Basis and Purpose – R 703 The statutory authority for this rule is found at subsection 12-43.4-202(2)(b), 12-43.4-202(3)(a)(III), 1243.4-202(3)(a)(IV), 12-43.4-202(3)(a)(V), 12-43.4-202(3)(a)(X), 12-43.4-202(3)(a)(XII), 12-43.4202(3)(b)(III), 12-43.4-202(3)(b)(IX), and section 12-43.4-405, C.R.S. The purpose of this rule is to establish a frame work for certification for Retail Marijuana Testing Facilities. R 703 – Retail Marijuana Testing Facilities: Certification Requirements A. Certification Types. If certification in a testing category is required by the Division, then the Retail Marijuana Testing Facility must be certified in the category in order to perform that type of testing. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 120 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 B. 1. Residual solvents; 2. Repealed. 3. Repealed. 4. Repealed. 5. Microbials 6. Repealed 17. Microbials;THC and other Cannabinoid potency. 28. Mycotoxins;Chemical Contaminants; and 39. Residual Solvents;Biological Contaminants. 4. Pesticides; and 56. THC and other Cannabinoid potency. RETAIL - Page 121 of 201 Certification Procedures. The Retail Marijuana Testing Facility certification program is contingent upon successful on-site inspection, successful participation in Pproficiency tTesting, and ongoing compliance with the applicable requirements in this rule. 1. Certification Inspection. A Retail Marijuana Testing Facility must be inspected prior to initial certification and annually thereafter by an inspector approved by the Division. 2. Standards for Certification. A Retail Marijuana Testing Facility must meet standards of performance, as established by these rules, in order to obtain and maintain certification. Standards of performance include but are not limited to: personnel qualifications, standard operating procedure manual, analytical processes, pProficiency tTesting, quality control, quality assurance, security, chain of custody, specimenSample retention, space, records, and results reporting. 3. Personnel Qualifications 4. a. Laboratory Director. A Retail Marijuana Testing Facility must employ, at a minimum, a laboratory director with sufficient education and experience in a regulated laboratory environment in order to obtain and maintain certification. See Rule R 704 – Retail Marijuana Testing Facilities: Personnel. b. Employee Competency. A Retail Marijuana Testing Facility must have a written and documented system to evaluate and document the competency in performing authorized tests for employees. Prior to independently analyzing sSamples, testing personnel must demonstrate acceptable performance on precision, accuracy, specificity, reportable ranges, blanks, and unknown challenge samples (proficiency samples or internally generated quality controls). Standard Operating Procedure Manual. A Retail Marijuana Testing Facility must have a written standard operating procedure manual meeting the minimum standards set forth in 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 121 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 122 of 201 these rules detailing the performance of all methods employed by the facility used to test the analytes it reports and made available for testing analysts to follow at all times. C. a. The current laboratory director must approve, sign and date each procedure. If any modifications are made to those procedures, the laboratory director must approve, sign and date the revised version prior to use. b. A Retail Marijuana Testing Facility must maintain a copy of all Sstandard Ooperating Pprocedures to include any revised copies for a minimum of three years. See Rule R 710 – Retail Marijuana Testing Facilities: Records Retention and Rule R 901 – Business Records Required. 5. Analytical Processes. A Retail Marijuana Testing Facility must maintain a listing of all analytical methods used and all analytes tested and reported. The Retail Marijuana Testing Facility must provide this listing to the Division upon request. 6. Proficiency Testing. A Retail Marijuana Testing Facility must successfully participate in a Division approved pProficiency tTesting program in order to obtain and maintain certification. 7. Quality Assurance and Quality Control. A Retail Marijuana Testing Facility must establish and follow a quality assurance and quality control program to ensure sufficient monitoring of laboratory processes and quality of results reported. 8. Security. A Retail Marijuana Testing Facility must be located in a secure setting as to prevent unauthorized persons from gaining access to the testing and storage areas of the laboratory. 9. Chain of Custody. A Retail Marijuana Testing Facility must establish a system to document the complete chain of custody for sSamples from receipt through disposal. 10. Space. A Retail Marijuana Testing Facility must be located in a fixed structure that provides adequate infrastructure to perform analysis in a safe and compliant manner consistent with federal, state and local requirements. 11. Records. A Retail Marijuana Testing Facility must establish a system to retain and maintain all required records for a period not less than three years. See Rules R 710 – Retail Marijuana Testing Facilities: - Records Retention and R 901 – Business Records Required. 12. Results Reporting. A Retail Marijuana Testing Facility must establish processes to ensure results are reported in a timely and accurate manner. See Rule R 711 – Reporting and Inventory Tracking System. 13. Conduct While Seeking Certification. A Retail Marijuana Testing Facility, and its agents and employees, shall provide all documents and information required or requested by the Colorado Department of Public Health and Environment and its employees, and the Division and its employees in a full, faithful, truthful, and fair manner. A violation of this rule may be considered a license violation affecting public safety. Basis and Purpose – R 704 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 122 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 123 of 201 The statutory authority for this rule is found at subsection 12-43.4-202(2)(b), 12-43.4-202(3)(a)(III), 1243.4-202(3)(a)(IV), 12-43.4-202(3)(b)(IX), and section 12-43.4-405, C.R.S. The purpose of this rule is to establish personnel standards for the operation of a Retail Marijuana Testing Facility. R 704 – Retail Marijuana Testing Facilities: Personnel A. Laboratory Director. The laboratory director is responsible for the overall analytical operation and quality of the results reported by the Retail Marijuana Testing Facility, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurately, and proficiently and for assuring compliance with the standards set forth in this rule. 1. The laboratory director may also serve as a supervisory analyst or testing analyst, or both, for a Retail Marijuana Testing Facility. 2. The laboratory director for a Retail Marijuana Testing Facility must meet one of the following qualification requirements: a. The laboratory director must be a Medical Doctor (M.D.) licensed to practice medicine in Colorado and have at least three years of full-time laboratory experience in a regulated laboratory environment performing analytical scientific testing in which the testing methods were recognized by an accrediting body; or b. The laboratory director must hold a doctoral degree in one of the natural sciences and have at least three years of full-time laboratory experience in a regulated laboratory environment performing analytical scientific testing in which the testing methods were recognized by an accrediting body; or c. The laboratory director must hold a master’s degree in one of the natural sciences and have at least five years of full-time laboratory experience in a regulated laboratory environment performing analytical scientific testing in which the testing methods were recognized by an accrediting body. B. What the Laboratory Director May Delegate. The laboratory director may delegate the responsibilities assigned under this rule to a qualified supervisory analyst, provided that such delegation is made in writing and a record of the delegation is maintained. See Rule R 901 – Business Records Required. Despite the designation of a responsibility, the laboratory director remains responsible for ensuring that all duties are properly performed. C. Responsibilities of the Laboratory Director. The laboratory director must: 1. Ensure that the Retail Marijuana Testing Facility has adequate space, equipment, materials, and controls available to perform the tests reported; 2. Establish and adhere to a written standard operating procedure used to perform the tests reported; 3. Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 123 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 124 of 201 4. Ensure that the physical location and environmental conditions of the laboratory are appropriate for the testing performed and provide a safe environment in which employees are protected from physical, chemical, and biological hazards; 5. Ensure that the test methodologies selected have the capability of providing the quality of results required for the level of testing the laboratory is certified to perform; 6. Ensure that validation and verification test methods used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; 7. Ensure that testing analysts perform the test methods as required for accurate and reliable results; 8. Ensure that the laboratory is enrolled in and successfully participates in a Division approved pProficiency tTesting program; 9. Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; 10. Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; 11. Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance specifications are identified, and that test results are reported only when the system is functioning properly; 12. Ensure that reports of test results include pertinent information required for interpretation; 13. Ensure that consultation is available to the laboratory's clients on matters relating to the quality of the test results reported and their interpretation of said results; 14. Employ a sufficient number of laboratory personnel who meet the qualification requirements and provide appropriate consultation, properly supervise, and ensure accurate performance of tests and reporting of test results; 15. Ensure that prior to testing any sSamples, all testing analysts receive the appropriate training for the type and complexity of tests performed, and have demonstrated and documented that they can perform all testing operations reliably to provide and report accurate results; 16. Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimenSamples, perform test procedures and report test results promptly and proficiently, avoid actual and apparent conflicts of interests and whenever necessary, identify needs for remedial training or continuing education to improve skills; 17. Ensure that an approved standard operating procedure manual is available to all personnel responsible for any aspect of the testing process; and 18. Specify, in writing, the responsibilities and duties of each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 124 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 125 of 201 which examinations and procedures each individual is authorized to perform, whether supervision is required for specimenSample processing, test performance or results reporting, and whether consultant or laboratory director review is required prior to reporting test results. C.5 Change in Laboratory Director. In the event that the laboratory director leaves employment at the Retail Marijuana Testing Facility, the Retail Marijuana Testing Facility shall: 1. Provide written notice to the Colorado Department of Public Health and Environment and the Marijuana Enforcement Division within seven days of the laboratory director’s departure; and 2. Designate an interim laboratory director within seven days of the laboratory director’s departure. At a minimum, the interim laboratory director must meet the qualifications of a supervisory analyst. 3. The Retail Marijuana Testing Facility must hire a permanent laboratory director within 60 days from the date of the previous laboratory director’s departure. 4. Notwithstanding the requirement of subparagraph (C.5)(3), the Retail Marijuana Testing Facility may submit a waiver request to the Division Director to receive an additional 60 days to hire a permanent laboratory director provided that the Retail Marijuana Testing Facility submits a detailed oversight plan along with the waiver request. D. Supervisory Analyst. Supervisory analysts must meet one of the qualifications for a laboratory director or have at least a bachelor’s degree in one of the natural sciences and three years of fulltime laboratory experience in a regulated laboratory environment performing analytical scientific testing in which the testing methods were recognized by an accrediting body. A combination of education and experience may substitute for the three years of full-time laboratory experience. E. Laboratory Testing Analyst 1. Educational Requirements. An individual designated as a testing analyst must meet one of the qualifications for a laboratory director or supervisory analyst or have at least a bachelor’s degree in one of the natural sciences and one year of full-time experience in laboratory testing. 2. Responsibilities. In order to independently perform any test for a Retail Marijuana Testing Facility, an individual must at least meet the educational requirements for a testing analyst. R 705 – Basis and Purpose The statutory authority for this rule is found at subsection 12-43.4-202(3)(a)(IV) and section 12-43.4-405, C.R.S. The purpose of this rule is to establish Sstandard Ooperating Pprocedure Mmanual standards for the operation of a Retail Marijuana Testing Facility. R 705 –Retail Marijuana Testing Facilities: Standard Operating Procedure Manual A. A standard operating procedure manual must include, but need not be limited to, procedures for: 1. SpecimenSample receiving; 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 125 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 126 of 201 2. SpecimenSample accessioning; 3. SpecimenSample storage; 4. Identifying and rejecting unacceptable specimenSamples; 5. Recording and reporting discrepancies; 6. Security of specimenSamples, aliquots and extracts and records; 7. Validating a new or revised method prior to testing specimenSamples to include: accuracy, precision, analytical sensitivity, analytical specificity (interferences), LOD, LOQ, and verification of the reportable range; 8. Aliquoting specimens Samples to avoid contamination and carry-over; 9. Sample retention to assure stability for 90 days; 10. Disposal of specimenSamples; 11. The theory and principles behind each assay; 12. Preparation and identification of reagents, standards, calibrators and controls and ensure all standards are traceable to National Institute of Standards of Technology (“NIST”); 13. Special requirements and safety precautions involved in performing assays; 14. Frequency and number of control and calibration materials; 15. Recording and reporting assay results; 16. Protocol and criteria for accepting or rejecting analytical Pprocedure to verify the accuracy of the final report; 17. Pertinent literature references for each method; 18. Current step-by-step instructions with sufficient detail to perform the assay to include equipment operation and any abbreviated versions used by a testing analyst; 19. Acceptability criteria for the results of calibration standards and controls as well as between two aliquots or columns; 20. A documented system for reviewing the results of testing calibrators, controls, standards, and subject tests results, as well as reviewing for clerical errors, analytical errors and any unusual analytical results? Are corrective actions implemented and documented, and does the laboratory contact the requesting entity; and 21. Policies and procedures to follow when Samplesspecimens are requested for referral and testing by another certified Retail Marijuana Testing Facility or an approved local or state agency’s laboratory. 22. Testing Industrial Hemp, if the Retail Marijuana Testing Facility tests Industrial Hemp. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 126 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 127 of 201 R 706 – Basis and Purpose The statutory authority for this rule is found at subsection 12-43.4-202(3)(a)(IV) and section 12-43.4-405, C.R.S. The purpose of this rule is to establish analytical processes standards for the operation of a Retail Marijuana Testing Facility. R 706 –Retail Marijuana Testing Facilities: Analytical Processes A. B. Gas Chromatography (“GC”). A Retail Marijuana Testing Facility using GC must: 1. Document the conditions of the gas chromatograph, including the detector response; 2. Perform and document preventive maintenance as required by the manufacturer; 3. Ensure that records are maintained and readily available to the staff operating the equipment; 4. Document the performance of new columns before use; 5. Use an internal standard for each qualitative and quantitative analysis that has similar chemical and physical properties to that of the compound identified; 6. Establish criteria of acceptability for variances between different aliquots and different columns; and 7. Document the monitoring of the response (area or peak height) of the internal standard to ensure consistency overtime of the analytical system. Gas Chromatography Mass Spectrometry (“GC/MS”). A Retail Marijuana Testing Facility using GC/MS must: 1. Perform and document preventive maintenance as required by the manufacturer; 2. Document the changes of septa as specified in the Sstandard Ooperating Pprocedure; 3. Document liners being cleaned or replaced as specified in the Sstandard Ooperating Pprocedure; 4. Ensure that records are maintained and readily available to the staff operating the equipment; 5. Maintain records of mass spectrometric tuning; 6. Establish written criteria for an acceptable mass-spectrometric tune; 7. Document corrective actions if a mass-spectrometric tune is unacceptable; 8. Monitor analytic analyses to check for contamination and carry-over; 9. Use selected ion monitoring within each run to assure that the laboratory compare ion ratios and retention times between calibrators, controls and specimens Samples for identification of an analyte; 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 127 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 C. D. RETAIL - Page 128 of 201 10. Use an internal standard for qualitative and quantitative analysis that has similar chemical and physical properties to that of the compound identified and is isotopically labeled when available or appropriate for the assay; 11. Document the monitoring of the response (area or peak height) for the internal standard to ensure consistency overtime of the analytical system; 12. Define the criteria for designating qualitative results as positive; 13. When a library is used to qualitatively match an analyte, the relative retention time and mass spectra from a known standard or control must be run on the same system before reporting the results; and 14. Evaluate the performance of the instrument after routine and preventive maintenance (e.g. clipping or replacing the column or cleaning the source) prior to analyzing subject sSamples. Immunoassays. A Retail Marijuana Testing Facility using Immunoassays must: 1. Perform and document preventive maintenance as required by the manufacturer; 2. Ensure that records are maintained and readily available to the staff operating the equipment; 3. Validate any changes or modifications to a manufacturer’s approved assays or testing methods when a sSample is not included within the types of sSamples approved by the manufacturer; and 4. Define acceptable separation or measurement units (absorbance intensity or counts per minute) for each assay, which must be consistent with manufacturer’s instructions. Thin Layer Chromatography (“TLC”). A Retail Marijuana Testing Facility using TLC must: 1. Apply unextracted standards to each thin layer chromatographic plate; 2. Include in their written procedure the preparation of mixed solvent systems, spray reagents and designation of lifetime; 3. Include in their written procedure the storage of unused thin layer chromatographic plates; 4. Evaluate, establish, and document acceptable performance for new thin layer chromatographic plates before placing them into service; 5. Verify that the spotting technique used precludes the possibility of contamination and carry-over; 6. Measure all appropriate RF values for qualitative identification purposes; 7. Use and record sequential color reactions, when applicable; 8. Maintain records of thin layer chromatographic plates; and 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 128 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 9. E. F. G. RETAIL - Page 129 of 201 Analyze an appropriate matrix blank with each batch of Samplesspecimens analyzed. High Performance Liquid Chromatography (“HPLC”). A Retail Marijuana Testing Facility using HPLC must: 1. Perform and document preventive maintenance as required by the manufacturer; 2. Ensure that records are maintained and readily available to the staff operating the equipment; 3. Monitor and document the performance of the HPLC instrument each day of testing; 4. Evaluate the performance of new columns before use; 5. Create written standards for acceptability when eluting solvents are recycled; 6. Use an internal standard for each qualitative and quantitative analysis that has similar chemical and physical properties to that of the compound identified when available or appropriate for the assay; and 7. Document the monitoring of the response (area or peak height) of the internal standard to ensure consistency overtime of the analytical system. Liquid Chromatography Mass Spectroscopy (“LC/MS”). A Retail Marijuana Testing Facility using LC/MS must: 1. Perform and document preventive maintenance as required by the manufacturer; 2. Ensure that records are maintained and readily available to the staff operating the equipment; 3. Maintain records of mass spectrometric tuning; 4. Document corrective actions if a mass-spectrometric tune is unacceptable; 5. Use an internal standard with each qualitative and quantitative analysis that has similar chemical and physical properties to that of the compound identified and is isotopically labeled when available or appropriate for the assay; 6. Document the monitoring of the response (area or peak height) of the internal standard to ensure consistency overtime of the analytical system; 7. Compare two transitions and retention times between calibrators, controls and Samplesspecimens within each run; 8. Document and maintain records when changes in source, source conditions, eluent, or column are made to the instrument; and 9. Evaluate the performance of the instrument when changes in: source, source conditions, eluent, or column are made prior to reporting test results. Other Analytical Methodology. A Retail Marijuana Testing Facility using other methodology or new methodology must: 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 129 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 1. RETAIL - Page 130 of 201 Implement a performance based measurement system for the selected methodology and validate the method following good laboratory practices prior to reporting results. Validation of other or new methodology must include when applicable, but is not limited to: a. Verification of Accuracy b. Verification of Precision c. Verification of Analytical Sensitivity d. Verification of Analytical Specificity e. Verification of the LOD f. Verification of the LOQ g. Verification of the Reportable Range h. Identification of Interfering Substances 2. Validation of the other or new methodology must be documented. 3. Prior to use, other or new methodology must have a standard operating procedure approved and signed by the laboratory director. 4. Testing analysts must have documentation of competency assessment prior to testing sSamples. 5. Any changes to the approved other or new methodology must be revalidated and documented prior to testing sSamples. R 707 – Basis and Purpose The statutory authority for this rule is found at subsection 12-43.4-202(3)(a)(IV) and section 12-43.4-405, C.R.S. The purpose of this rule is to establish a Pproficiency Ttesting program for Retail Marijuana Testing Facilities. R 707 – Retail Marijuana Testing Facilities: Proficiency Testing A. Proficiency Testing Required. A Retail Marijuana Testing Facility must participate in a Proficiency Testing program for each approved category in which it seeks certification under Rule R 703 – Retail Marijuana Testing Facilities: Certification Requirements. B. Participation in Designated Proficiency Testing Event. If required by the Division as part of certification, the Retail Marijuana Testing Facility must have successfully participated in a Proficiency Testing in the category for which it seeks certification, within the preceding 12 months. C. Continued Certification. To maintain continued certification, a Retail Marijuana Testing Facility must participate in the designated Proficiency Testing program with continued satisfactory performance as determined by the Division as part of certification. The Division may designate a local agency, state agency, or third-party to provide Proficiency Testing. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 130 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 131 of 201 D. Analyzing Proficiency Testing Samples. A Retail Marijuana Testing Facility must analyze Proficiency Testing Samples using the same procedures with the same number of replicate analyses, standards, testing analysts and equipment as used in its standard operationsfor product testing. E. Proficiency Testing Challenge Attestation. The laboratory director and all testing analysts who that participated in a Proficiency Testing event must sign corresponding attestation statements. F. Laboratory Director Must Review Results. The laboratory director must review and evaluate all Proficiency Testing results. G. When Remedial Action Required. A Retail Marijuana Testing Facility must take and document remedial action when a score of less than 100% is achieved on any test during a Proficiency Testing. Remedial action documentation must include a review of Samples tested and results reported since the last successful Proficiency Testing challenge event. A requirement to take remedial action does not necessarily indicate unsatisfactory participation in a Proficiency Testing event. H. What Constitutes Successful or Unsatisfactory Participation in a Proficiency Testing Event. Unless the Retail Marijuana Testing Facility positively identifies Successful participation is the positive identification of at least 80% of the target analytes tested, participation in the Proficiency Testing event will be considered unsatisfactory. A positive identification must include accurate quantitative and qualitative results as applicable. that the Retail Marijuana Testing Facility reports to include quantitative results when applicable. Any false positive results reported will be considered an unsatisfactory score for participation in the Proficiency Testing event. I. Consequence of Unsatisfactory Unsuccessful Participation in a Proficiency Testing Event. Unsuccessful Unsatisfactory participation in a Proficiency Testing event may result in limitation, suspension or revocation of Rule R 703 certification. R 708 – Basis and Purpose The statutory authority for this rule is found at subsection 12-43.4-202(3)(a)(IV) and section 12-43.4-405, C.R.S. The purpose of this rule is to establish quality assurance and quality assurance standards for a Retail Marijuana Testing Facility. R 708 – Retail Marijuana Testing Facilities: Quality Assurance and Quality Control A. Quality Assurance Program Required. A Retail Marijuana Testing Facility must establish, monitor, and document the ongoing review of a quality assurance program that is sufficient to identify problems in the laboratory preanalytic, analytic and postanalytic systems when they occur and must include, but is not limited to: 1. Review of instrument preventive maintenance, repair, troubleshooting and corrective actions documentation must be performed by the laboratory director or designated supervisory analyst on an ongoing basis to ensure the effectiveness of actions taken over time; 2. Review by the laboratory director or designated supervisory analyst of all ongoing quality assurance; and 3. Review of the performance of validated methods used by the Retail Marijuana Testing Facility to include calibration standards, controls and the Sstandard Ooperating 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 131 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 132 of 201 Pprocedures used for analysis on an ongoing basis to ensure quality improvements are made when problems are identified or as needed. B. Quality Control Measures Required. A Retail Marijuana Testing Facility must establish, monitor and document on an ongoing basis the quality control measures taken by the laboratory to ensure the proper functioning of equipment, validity of standard operating procedures and accuracy of results reported. Such quality control measures must include, but shall not be limited to: 1. Documentation of instrument preventive maintenance, repair, troubleshooting and corrective actions taken when performance does not meet established levels of quality; 2. Review and documentation of the accuracy of automatic and adjustable pipettes and other measuring devices when placed into service and annually thereafter; 3. Cleaning, maintaining and calibrating as needed the analytical balances and in addition, verifying the performance of the balance annually using certified weights to include three or more weights bracketing the ranges of measurement used by the laboratory; 4. Annually verifying and documenting the accuracy of thermometers using a NIST traceable reference thermometer; 5. Recording temperatures on all equipment when in use where temperature control is specified in the standard operating procedures manual, such as water baths, heating blocks, incubators, ovens, refrigerators, and freezers; 6. Properly labeling reagents as to the identity, the concentration, date of preparation, storage conditions, lot number tracking, expiration date and the identity of the preparer; 7. Avoiding mixing different lots of reagents in the same analytical run; 8. Performing and documenting a calibration curve with each analysis using at minimum three calibrators throughout the reporting range; 9. For qualitative analyses, analyzing, at minimum, a negative and a positive control with each batch of sSamples analyzed; 10. For quantitative analyses, analyzing, at minimum, a negative and two levels of controls that challenge the linearity of the entire curve; 11. Using a control material or materials that differ in either source or, lot number, or concentration from the calibration material used with each analytical run; 12. For multi-analyte assays, performing and documenting calibration curves and controls specific to each analyte, or at minimum, one with similar chemical properties as reported in the analytical run; 13. Analyzing an appropriate matrix blank and control with each analytical run, when available; 14. Analyzing calibrators and controls in the same manner as unknowns; 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 132 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 133 of 201 15. Documenting the performance of calibration standards and controls for each analytical run to ensure the acceptability criteria as defined in the Sstandard Ooperating Pprocedure is met; 16. Documenting all corrective actions taken when unacceptable calibration, control, and standard or instrument performance does not meet acceptability criteria as defined in the Sstandard Ooperating Pprocedure; 17. Maintaining records of validation data for any new or modified methods to include; accuracy, precision, analytical specificity (interferences), LOD, LOQ, and verification of the linear range; and 18. Performing testing analysts that follow the current Sstandard oOperating Porocedures mManual for the test or tests to be performed. R 709 – Basis and Purpose The statutory authority for this rule is found at subsection 12-43.4-202(3)(a)(IV) and section 12-43.4-405, C.R.S. The purpose of this rule is to establish chain of custody standards for a Retail Marijuana Testing Facility. In addition, it establishes the requirement that a Retail Marijuana Testing Facility follow an adequate chain of custody for Samples it maintains. R 709 –Retail Marijuana Testing Facilities: Chain of Custody General Requirements. A Retail Marijuana Testing Facility must establish an adequate chain of custody and Sample requirement instructions that must include, but not be limited to; 1. Issue instructions for the minimum Sample requirements and storage requirements; 2. Document the condition of the external package and integrity seals utilized to prevent contamination of, or tampering with, the Sample; 3. Document the condition and amount of Sample provided at the time of receipt; 4. Document all persons handling the original Samples, aliquots, and extracts; 5. Document all Ttransfers of Samples, aliquots, and extracts referred to another certified Retail Marijuana Testing Facility Licensee for additional testing or whenever requested by a client; 6. Maintain a current list of authorized personnel and restrict entry to the laboratory to only those authorized; 7. Secure the Laboratory during non-working hours; 8. Secure short and long-term storage areas when not in use; 9. Utilize a secured area to log-in and aliquot Samples; 10. Ensure Samples are stored appropriately; and 11. Document the disposal of Samples, aliquots, and extracts. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 133 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 134 of 201 Basis and Purpose – R 710 The statutory authority for this rule is found at subsection 12-43.4-202(3)(a)(IV) and section 12-43.4-405, C.R.S. The purpose of this rule is to establish records retention standards for a Retail Marijuana Testing Facility. R 710 –Retail Marijuana Testing Facilities: Records Retention A. General Requirement. A Retail Marijuana Testing Facility must maintain all required business records. See Rule R 901 - Business Records Required. B. Specific Business Records Required: Three YearRecord Retention. A Retail Marijuana Testing Facility must establish processes to preserve records in accordance with Rule R 901 for a minimum of three years that includes, but is not limited to; C. 1. Test Results,; including final and amended reports, and identification of analyst and date of analysis; 2. Quality Control and Quality Assurance Records,; including accession numbers, specimenSample type, and acceptable reference range parameters; 3. Standard Operating Procedures; 4. Personnel Records; 5. Chain of Custody Records; 6. Proficiency Testing Records; and 7. Analytical Data to include dataprintouts generated by the instrumentation., raw data of calibration standards and curves. Specific Business Records Required: Five Year Retention. A Retail Marijuana Testing Facility must establish processes to preserve records for a minimum of five years of testing to include, accession numbers, specimen type, raw data of calibration standards and curves, controls and subject results, final and amended reports, acceptable reference range parameters, and identification of analyst and date of analysis. Basis and Purpose – R 711 The statutory authority for this rule is found at subsection 12-43.4-202(3)(a)(IV) and section 12-43.4-405, C.R.S. The purpose of this rule is to establish reporting standards for a Retail Marijuana Testing Facility. R 711 – Reporting and Inventory Tracking System Required Procedures. A Retail Marijuana Testing Facility must establish procedures to ensure that results are accurate, precise and scientifically valid prior to reporting such results that include the following processes;. A. Reports. Every final report, whether submitted to the Division, to a Retail Marijuana Establishment or to any other Person authorized to receive the report, must include the following: 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 134 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 135 of 201 1. Report quantitative results that are only above the lowest concentration of calibrator or standard used in the analytical run; 2. Verify results that are below the lowest concentration of calibrator or standard and above the LOQ by using a blank and a standard that falls below the expected value of the analyte in the sSample in duplicate prior to reporting a quantitative result; 3. Qualitatively report results below the lowest concentration of calibrator or standard and above the LOD as either trace or using a non-specific numerical designation; 4. Adequately document the available external chain of custody information; 5. Ensure all final reports contain the name and location of the Retail Marijuana Testing Facility that performed the test Licensee, name and unique identifier of sSample, submitting client, sSample received date, date of report, type of specimenSample tested, test result, units of measure, and any other information or qualifiers needed for interpretation when applicable to the test method and results being reported, to include any identified and documented discrepancies; 6. Provide the final report to the Division, as well as the Retail Marijuana Establishment and/or the other Person authorized to receive the report submitting client in a timely manner; and. B. Inventory Tracking System. Each Retail Marijuana Testing Facility shall: 71. 2. C. Report Provide copies of final reports to all test results to the Division as part of daily reconciliation and in accordance with all Inventory Tracking System Procedures under Rule R 309 – Retail Marijuana Establishments: Inventory Tracking System. The requirement to report all test results includes: a. Both positive and negative test results; b. Results from both mandatory and voluntary testing; and c. For quantitative tests, a quantitative value. As part of Inventory Tracking System reporting, when results of tested sSamples exceed maximum levels of allowable potency or contamination, or otherwise result in failed potency, homogeneity, or contaminant testing, the Retail Marijuana Testing Facility shall, in the Inventory Tracking System, indicate failed test results for the Inventory Tracking System package associated with the failed Sample. This requirement only applies to testing of Samples that are comprised of Retail Marijuana, Retail Marijuana Concentrate, Retail Marijuana Product or Industrial Hemp. Violation affecting public safety. Violation of this rule may constitute a license violation affecting public safety. Basis and Purpose – R 712 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(a)(IV), 1243.4-202(3)(a)(VII), 12-43.4-202(3)(a)(VIII), 12-43.4-202(3)(a)(X), 12-43.4-202(3)(a)(XI), 12-43.4202(3)(a)(XII), 12-43.4-202(3)(b)(III), 12-43.4-202(3)(b)(IX), 12-43.4-202(3)(c)(V), 12-43.4-202(3)(c)(VI), 12-43.4-202(3)(c)(VII), and 12-43.4-405, C.R.S. Authority also exists in the Colorado Constitution at 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 135 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 136 of 201 Article XVIII, Subsection 16(5)(a)(VII). The purpose of this rule is to establish the portion of the Division’s Mandatory Testing and Random Sampling program that is applicable to Retail Marijuana Testing Facilities. The allowable plus or minus 15% potency variance has been included in the rule pursuant to the mandate of House Bill 15-1283, which modified 12-43.4-202(3)(a)(IV)(E), C.R.S. The bill established that the acceptable potency variance, which the Division must determine, must be at least plus or minus 15 percent. R 712 – Retail Marijuana Testing Facilities: Sampling and Testing Program A. Division Authority. The Division may elect to require that a Test Batch be submitted to a specific Retail Marijuana Testing Facility for testing to verify compliance, perform investigations, compile data or address a public health and safety concern. B. Test Batches C. 1. Retail Marijuana and Retail Marijuana Concentrate. A Retail Marijuana Testing Facility must establish a standard minimum weight of Retail Marijuana and Retail Marijuana Concentrate that must be included in a Test Batch for every type of test that it conducts. 2. Retail Marijuana Product. A Retail Marijuana Testing Facility must establish a standard number of Samplesfinished produc t(s) it requires to be included in each Test Batch of Retail Marijuana Product for every type of test that it conducts. See Rule R 1504(B)(3) Retail Marijuana Testing Program – Sampling Procedures. Rejection of Test Batches and Samples 1. A Retail Marijuana Testing Facility may not accept a Test Batch that is smaller than its standard minimum amount. 2. A Retail Marijuana Testing Facility may not accept a Test Batch or that it knows was not taken in accordance with these rules, or and any additional Division sampling procedures or was not except that a Retail Marijuana Testing Facility may accept a Test Batch that was collected by Division personnel or that was collected by a Licensee pursuant to Division direction. D. Notification of Retail Marijuana Establishment. If Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product failed a contaminant test, then the Retail Marijuana Testing Facility must immediately (1) notify the Retail Marijuana Establishment that submitted the sample Test Batch for testing and (2) report the failure in accordance with the all Inventory Tracking System procedures reporting requirements in Rule R 711(B). E. Permissible Levels of Contaminants. If Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product is found to have a contaminant in levels exceeding those established as permissible under this rule, then it shall be considered to have failed contaminant testing. Notwithstanding the permissible levels established in this rule, the Division reserves the right to determine, upon good cause and reasonable grounds, that a particular Test Batch presents a risk to the public health or safety and therefore shall be considered to have failed a contaminant test. 1. Substance Microbials (Bacteria, Fungus) Acceptable Limits Per Gram 9 October 2017 – Proposed Rules 1 CCR 212-2 Product to be Tested RETAIL - Page 136 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 137 of 201 –Shiga-toxin producing Escherichia coli (STEC)*- Bacteria < 1 Colony Forming Unit (CFU) Salmonella species* – Bacteria < 1 Colony Forming Unit (CFU) Total Yeast and Mold < 10 Colony Forming Unit (CFU) 4 Flower; Retail Marijuana Products; Water-Based, Heat/Pressure Based and Food-Based Retail Marijuana Concentrates *The Retail Marijuana Testing Facility shall facilities should contact the Colorado Department of Public Health and Environment when STEC and Salmonella are detected beyond the acceptable limits. 2. Mycotoxins Substance Acceptable Limits Per Gram Product to be Tested Aflatoxins (B1, B2, G1, and G2) < 20 parts per billion (PPB) Solvent-Based Retail Marijuana Concentrates manufactured from Retail Marijuana flower or trim that failed microbial testing (total of B1 + B2 + G1 + G2) Ochratoxin A 3. < 20 parts per billion (PPB) Residual Solvents Substance Acceptable Limits Per Gram Acetone < 1,000 Parts Per Million (PPM) Butanes < 1,000 Parts Per Million (PPM) Ethanol*** < 1,000 Parts Per Million (PPM) Heptanes < 1,000 Parts Per Million (PPM) Isopropyl Alcohol < 1,000 Parts Per Million (PPM) Propane < 1,000 Parts Per Million (PPM) Benzene** < 2 Parts Per Million (PPM) Toluene** < 180 Parts Per Million (PPM) Pentane < 1,000 Parts Per Million (PPM) Hexane** < 60 Parts Per Million (PPM) Total Xylenes (m,p, o-xylenes)** < 430 Parts Per Million (PPM) Any other solvent not permitted for use pursuant to Rule R 605. None Detected Substance Acceptable Limits Per Gram 9 October 2017 – Proposed Rules 1 CCR 212-2 Product to be Tested Solvent-Based Retail Marijuana Concentrate Product to be Tested RETAIL - Page 137 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 138 of 201 Butanes < 5,000 Parts Per Million (PPM) Heptanes < 5,000 Parts Per Million (PPM) Benzene** < 2 Parts Per Million (PPM) Toluene** < 890 Parts Per Million (PPM) Hexane** < 290 Parts Per Million (PPM) Total Xylenes (m,p, o-xylenes)** < 2,170 Parts Per Million (PPM) Any solvent not permitted for use pursuant to Rule R 605. None Detected Solvent-Based Concentrates ** Note: These solvents are not approved for use. Due to their possible presence in the solvents approved for use per Rule R 605, limits have been listed here accordingly. ***Note: If the Retail Marijuana Concentrate or Retail Marijuana Product intended use is oral consumption or skin and body products only, this Solvent-Based Retail Marijuana Concentrate limit for ethanol does not apply. If the Retail Marijuana Concentrate or Retail Marijuana Product intended use includes inhaled product, this Solvent-Based Retail Marijuana Concentrate limit for ethanol applies. 43. Metals Substance Acceptable Limits Per Gram Metals (Arsenic, Cadmium, Lead and Mercury) Lead – Max Limit: < 1.0 ppm Product to be Tested Arsenic – Max Limit: < 0.4 ppm Cadmium – Max Limit: < 0.4 ppm Flower; Water-Based, FoodBased, Heat/Pressure Based, and Solvent-Based Concentrates Mercury – Max Limit: < 0.2 ppm 554. Pesticides Substance Detectable Action Limits Per Gram Abamectin (Avermectins: B1a & B1b) < 0.07 Parts Per Million (PPM) Azoxystrobin < 0.02 Parts Per Million (PPM) Bifenazate < 0.02 Parts Per Million (PPM) Etoxazole < 0.01 Parts Per Million (PPM) Imazalil < 0.04 Parts Per Million (PPM) Imidacloprid < 0.02 Parts Per Million (PPM) Malathion < 0.05 Parts Per Million (PPM) 9 October 2017 – Proposed Rules 1 CCR 212-2 Product to be Tested Retail Marijuana Flower RETAIL - Page 138 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 Myclobutanil < 0.04 Parts Per Million (PPM) Permethrin (mix of isomers) < 0.04 Parts Per Million (PPM) Spinosad (Mixture of A and D) < 0.06 Parts Per Million (PPM) Spiromesifen < 0.03 Parts Per Million (PPM) Spirotetramat < 0.02 Parts Per Million (PPM) Tebuconazole < 0.01 Parts Per Million (PPM) RETAIL - Page 139 of 201 6. Other Contaminants Pesticide If the Test Batch is found to contain testing identifies the use of a banned Pesticide not listed in section 5 above, or a Pesticide that could be toxic if consumed or as appliedor the improper application of a permitted Pesticide, then that Test Batch shall be considered to have failed contaminant testing. Chemicals If the Test Batch is found to contain levels of any chemical that could be toxic if consumed or as applied, then the Division may determine that the Test Batch has failed contaminant testing. Microbials If the Test Batch is found to contain levels of any microbial that could be toxic if consumed or present, then the Division may determine that the Test Batch has failed contaminant testing. 75. F. Division Notification. A Retail Marijuana Testing Facility must notify the Division by timely input in the Inventory Tracking System if a Test Batch is found to contain levels of a contaminant not listed within this rule that could be injurious to human health if consumed. See Rule R 711 – Reporting and Inventory Tracking System. Potency Testing 1. Cannabinoids Potency Profiles. A Retail Marijuana Testing Facility may test and report results for any cCannabinoid provided the test is conducted in accordance with the Division’s Retail Marijuana Testing Facility’s standard operating procedureCertification Policy Statement. 2. Reporting of Results a. For potency tests on Retail Marijuana and Retail Marijuana Concentrate, results must be reported by listing a single percentage concentration for each cCannabinoid that represents an average of all sSamples within the Test Batch. This includes reporting of Total THC in addition to each cCannabinoid required in Rule R 1503. b. For potency tests conducted on Retail Marijuana Product, whether conducted on each individual pProduction bBatch or via Pprocess Vvalidation per rRule R 1503, results must be reported by listing the total number of milligrams contained within a single Retail Marijuana Product unit for sale for each cCannabinoid and affirming stating whether the THC content is homogenous as defined in paragraph (4)(b) of this rule. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 139 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 140 of 201 3. Testing Retail Marijuana Ready for TransferDried Flower Retail Marijuana. All potency tests conducted must occur at the time the on Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product has completed all steps required prior to Transfer to another Retail Marijuana Establishment as outlined in the Retail Marijuana Testing Facility’sEstablishment’s standard operating proceduresmust occur on dried and cured Retail Marijuana that is ready for sale. 4. Failed Potency Tests for Retail Marijuana Products 5. a. If an individually packaged Edible Retail Marijuana Product contained within a Test Batch is determined to have more than 100 mgs of THC within it, then the Test Batch shall be considered to have failed potency testing. If an individually packaged Edible Retail Marijuana Product is determined to have more than the total mgs of THC stated on the Container, then the Test Batch shall be considered to have failed potency testing. If a single serving in an individually packaged Edible Retail Marijuana Product is determined to have more than 10 mgs of THC, then the Test Batch shall be considered to have failed potency testing. Except that the potency variance provided for in subparagraph (F)(5) of this rule R 712 shall apply to potency testing. b. If the THC content of a Retail Marijuana Product is determined through testing to not to be homogenous, then it shall be considered to have failed potency testing. A Retail Marijuana Product shall be considered to not be homogenous if 10% of the infused portion of the Retail Marijuana Product contains more than 20% of the total THC contained within entire Retail Marijuana Product. Potency Variance. A potency variance of no more than plus or minus 15% is allowed. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 140 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 141 of 201 R 800 Series – Transport and Storage Basis and Purpose – R 801 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(a)(X),, 1243.4-202(3)(a)(XVII), 12-43.4-202(3)(c)(IV), 12-43.4-309(4), and 12-43.4-401(1), and section 12-43.4-406 C.R.S. The purpose of the rule is to provide clarity as to the requirements associated with the transport and delivery of Retail Marijuana and Retail Marijuana Product between Licensed Premises. It also prescribes the manner in which licensed entities will track inventory in the transport process to prevent diversionary practices. R 801 – Transport of Retail Marijuana, Retail Marijuana Vegetative Plants, and Retail Marijuana Product: All Retail Marijuana Establishments A. Persons Authorized to Transport. Except as provided in the Rule R 1600 Series, any individual who transports The only Persons authorized to transport Retail Marijuana, Retail Marijuana Vegetative plants, Retail Marijuana Concentrate, or Retail Marijuana Product on behalf of a Retail Marijuana Establishment must hold a valid Occupational License and must be an employee or Owner of the Retail Marijuana Establishment.are those licensed by the State Licensing Authority pursuant to sections 12-43.3-401 (when applicable) and 12-43.4-401, C.R.S.; including those holding Owner and Occupational Licenses. An individual who does not possess a current and valid Owner or Occupational License from the State Licensing Authority may not transport Retail Marijuana, Retail Marijuana Vegetative plants, Retail Marijuana Concentrate, or Retail Marijuana Product between Licensed Premises. B. Transport Between Licensed Premises. C. 1. Retail Marijuana and Retail Marijuana Product. Retail Marijuana and Retail Marijuana Product shall only be transported between Licensed Premises; and between Licensed Premises and a permitted off-premises storage facility; between Licensed Premises and a Medical Research Facility; and between Licensed Premises and a Pesticide Manufacturer. Licensees transporting Retail Marijuana and Retail Marijuana Product are responsible for ensuring that all Retail Marijuana and Retail Marijuana Product are secured at all times during transport. 2. Retail Marijuana Vegetative Plants. Only Retail Marijuana Vegetative plants shall onlymay be transported between Licensed Premises and such transport shall only be permitted due to an approved change of location pursuant to rule Rule R 206 – Changing Location of Licensed Premises: Retail Marijuana Establishments. Transportation of Vegetative plants to a permitted off-premises storage facility shall not be allowed. Transport of Retail Marijuana plants other than Vegetative Plants shall not be allowed. Inventory Tracking System-Generated Transport Manifest Required. A Licensee may only transport Retail Marijuana, Retail Marijuana Vegetative plants, Retail Marijuana Concentrate, or Retail Marijuana Product if he or she has a hard copy of an Inventory Tracking System generated transport manifest that contains all the information required by this rule and shall be in the format prepared by the State Licensing Authority. 1. Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product. A Licensee may transport Retail Marijuana or Retail Marijuana Product from an originating location to multiple destination locations so long as the transport manifest correctly reflects the specific inventory destined for specific licensed locations, Medical Research Facilities, and/or Pesticide Manufacturers. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 141 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 142 of 201 2. Retail Marijuana Vegetative Plants. A Licensee shall transport Retail Marijuana Vegetative plants only from the originating Licensed Premises to the destination Licensed Premises due to a change of location that has been approved by the Division pursuant to Rule R 206. 3. Manifest for Transfers to Medical Research Facilities and Pesticide Manufacturers. A Licensee may not transport or permit the transportation of Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Product to a Medical Research Facility or Pesticide Manufacturer unless an Inventory Tracking System-generated transport manifest has been generated. D. Motor Vehicle Required. Transport of Retail Marijuana, Retail Marijuana Vegetative plants, Retail Marijuana Concentrate, and/or Retail Marijuana Product shall be conducted by a motor vehicle that is properly registered in the state of Colorado pursuant to motor vehicle laws, but need not be registered in the name of the Licensee. Except that when a rental truck is required for transporting Retail Medical Marijuana Vegetative plants, Colorado motor vehicle registration is not required. E. Documents Required During Transport. Transport of Retail Marijuana, Retail Marijuana Vegetative plants, or Retail Marijuana Product shall be accompanied by a copy of the originating Retail Marijuana Establishment’s business license, the driver’s valid Owner or Occupational License, the driver’s valid motor vehicle operator’s license, and all required vehicle registration and insurance information. F. Use of Colorado Roadways. State law does not prohibit the transport of Retail Marijuana , Retail Marijuana Vegetative plants, Retail Marijuana Concentrate, and/or Retail Marijuana Product on any public road within the state of Colorado as authorized in this rule. However, nothing herein authorizes a Licensee to violate specific local ordinances or resolutions enacted by any city, town, city and county, or county related to the transport of Retail Marijuana, Retail Marijuana Vegetative plants, Retail Marijuana or Retail Marijuana Product. G. Preparation of Retail Marijuana and Retail Marijuana Product for Transport 1. Final Weighing and Packaging. A Retail Marijuana Establishment shall comply with the specific rules associated with the final weighing and packaging of Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product before such items are prepared for transport pursuant to this rule. The scale used to weigh product to be transported shall be tested and approved in accordance with measurement standards established in 35-14127, C.R.S. 2. Preparation in Limited Access Area. Retail Marijuana and Retail Marijuana Product shall be prepared for transport in a Limited Access Area, including the packing and labeling of Shipping Containers. 3. Shipping Containers. Sealed packages or Containers, multiple Containers, bulk Retail Marijuana flower and trim, and bulk Retail Marijuana Concentrate must be placed in a Shipping Containers prior to transport to another Retail Marijuana Establishment. The contents of Shipping Containers shall be easily accessible and may be inspected by the State Licensing Authority, local jurisdictions, and state and local law enforcement agency for a purpose authorized by the Retail Code or for any other state or local law enforcement purpose. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 142 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 G.5. H. RETAIL - Page 143 of 201 Required RFID Tags. 1. Licensees shall ensure that either the multiple Containers placed within a Shipping Container each have an RFID tag, or the Shipping Container itself must have an RFID tag. If the Licensee elects to place the RFID tag on the Shipping Container, the Shipping Container shall contain only one Harvest Batch, or Production Batch of Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Product. If a Shipping Container consists of more than one Harvest Batch or Production Batch, then each group of multiple Containers shall be affixed with an RFID tag. 2. for Retail Marijuana Vegetative Plants. Each Retail Marijuana Vegetative pPlant that is transported pursuant to this rule must have a RFID tag affixed to it prior to transport. Creation of Records and Inventory Tracking 1. Use of Inventory Tracking System -Generated Transport Manifest. a. Retail Marijuana, Retail Marijuana Concentrate and Retail Marijuana Product. Licensees who transport or permit the transportation of Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Product shall create an Inventory Tracking System-generated transport manifest to reflect inventory that leaves the Licensed Premises destined for other Licensed Premises, Medical Research Facilities, or Pesticide Manufacturersfor destinations to other licensed locations. The transport manifest may either reflect all deliveries for multiple locations within a single trip or separate transport manifests may reflect each single delivery. In either case, no inventory shall be transported without an Inventory Tracking System -generated transport manifest. a.1 Use of a Retail Marijuana Transporter. In addition to subsubparagraph (H)(1)(a), Licensees shall also follow the requirements of this subsubparagraph (H)(1)(a.1) when a Licensee utilizes the services of a Retail Marijuana Transporter. i. When a Retail Marijuana Store, Retail Marijuana Cultivation Facility, Retail Marijuana Products Manufacturing Facility, or Retail Marijuana Testing Facility utilizes a Retail Marijuana Transporter for transporting its Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Products, the originating Licensee shall input the requisite information on the Inventory Tracking System-generated transport manifest for the final destination Licensee, Medical Research Facility, or Pesticide Manufacturer who will be receiving the Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Products. ii. A Retail Marijuana Transporter is prohibited from being listed as the final destination Licensee. iii. A Retail Marijuana Transporter shall not alter the information of the final destination Licensee , Medical Research Facility, or Pesticide Manufacturer after the information has been entered on the Inventory Tracking System-generated transport manifest by the originating Retail Marijuana Store, Retail Marijuana Cultivation Facility, Retail Marijuana Products Manufacturing Facility, or Retail Marijuana Testing FacilityLicensee. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 143 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 iv. b. RETAIL - Page 144 of 201 If the Retail Marijuana Transporter is not delivering the originating Licensee’s Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Product directly to the final destination Licensee, the Retail Marijuana Transporter shall communicate to the originating Licensee which of the Retail Marijuana Transporter’s Licensed Premises or offpremises storage facilities will receive and temporarily store the Retail Marijuana or Retail Marijuana Product. The originating Licensee shall input the Retail Marijuana Transporter’s location address and license number on the Inventory Tracking System-generated transport manifest. Retail Marijuana Vegetative Plants. i. Licensees who transport Retail Marijuana Vegetative plants shall create an Inventory Tracking System-generated transport manifest to reflect inventory that leaves the originating Licensed Premises to be transported to the destination Licensed Premises due to a change of location approved by the Division pursuant to rule Rule R 206. ii. Retail Marijuana Transporters are permitted to transport Retail Marijuana Vegetative Pplants on behalf of other Licensees due to a change of location approved by the Division pursuant to rule Rule R 206. The Retail Marijuana Transporter shall transport the Retail Marijuana Vegetative Plants directly from the originating Licensed Premises to the final destination Licensed Premises without any stops in between. 2. Copy of Transport Manifest to ReceiverRecipient. A Licensee shall provide a copy of the transport manifest to each Retail Marijuana Establishment, Medical Research Facility, or Pesticide Manufacturer receiving the inventory described in the transport manifest. In order to maintain transaction confidentiality, the originating Licensee may prepare a separate Inventory Tracking System-generated transport manifest for each receiving recipient Retail Marijuana Establishment, Medical Research Facility, or Pesticide Manufacturer.. 3. The Inventory Tracking System-generated transport manifest shall include the following: a. Departure date and approximate time of departure; b. Name, location address, and license number of the originating Retail Marijuana Establishment; c. Name, location address, and license number of the destination Retail Marijuana Establishment(s), name and location address of the destination Medical Research Facility or name and location address of the destination Pesticide Manufacturer; c.1 Name, location address, and license number of the Retail Marijuana Transporter if applicable pursuant to R 801(H)(1)(a.1)(iv). d. Product name and quantities (by weight or unit) of each product to be delivered to each specific destination location(s); e. Arrival date and estimated time of arrival; 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 144 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 J. RETAIL - Page 145 of 201 f. Delivery vehicle make and model and license plate number; and g. Name, Occupational License number, and signature of the Licensee accompanying the transport. Inventory Tracking. In addition to all the other tracking requirements set forth in these rules, a Retail Marijuana Establishment shall be responsible for all the procedures associated with the tracking of inventory that is transported between Licensed Premises. See Rule R 901 – Business Records Required. 1. 2. Responsibilities of Originating Licensee. a. Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product. Prior to departure, the originating Retail Marijuana Establishment shall adjust its records to reflect the removal of Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Product. The scale used to weigh product to be transported shall be tested and approved in accordance with measurement standards established in 35-14-127, C.R.S. Entries to the records shall note the Inventory Tracking System-generated transport manifest and shall be easily reconciled, by product name and quantity, with the applicable transport manifest. b. Retail Marijuana Vegetative Plants. Prior to departure, the originating Retail Marijuana Cultivation Facility shall adjust its records to reflect the removal of Retail Marijuana Vegetative plants. Entries to the records shall note the Inventory Tracking System-generated transport manifest and shall be easily reconciled, by product name and quantity, with the applicable transport manifest. Responsibilities of Receiving LicenseeRecipient. a. Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product. Upon receipt, the receiving Licensee shall ensure that the Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Product received are as described in the transport manifest and shall immediately adjust its records to reflect the receipt of inventory. The scale used to weigh product being received shall be tested and approved in accordance with measurement standards established in 35-14-127, C.R.S. Entries to the inventory records shall note the Inventory Tracking System-generated transport manifest and shall be easily reconciled, by product name and quantity, with the applicable transport manifest. Retail Marijuana Transporters shall comply with all requirements of this subsubparagraph (J)(2)(a) except that they are not required to weigh Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Products. i. b. When a Retail Marijuana Establishment transfers Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Product to a Medical Research Facility or Pesticide Manufacturer, the originating Licensee is responsible for confirming delivery of the Retail Marijuana or Retail Marijuana Product in the Inventory Tracking System. Retail Marijuana Vegetative Plants. Upon receipt, the receiving Licensee shall ensure that the Retail Marijuana Vegetative plants received are as described in the transport manifest, accounting for all RFID tags and each associated plant, and shall immediately adjust its records to reflect the receipt of inventory. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 145 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 3. RETAIL - Page 146 of 201 Discrepancies. A receiving Licensee shall separately document any differences between the quantity specified in the transport manifest and the quantities received. Such documentation shall be made in the Inventory Tracking System and in any relevant business records. a. Licensees. A receiving Licensee shall separately document any differences between the quantity specified in the transport manifest and the quantities received. Such documentation shall be made in the Inventory Tracking System and in any relevant business records. b. Medical Research Facilities and Pesticide Manufacturers. In the event of a discrepancy between the quantity specified in a transport manifest and the quantity received by a Medical Research Facility or Pesticide Manufacturer, the originating Licensee shall document the discrepancy in the Inventory Tracking System and in any relevant business records, and account for the discrepancy. K. Adequate Care of Perishable Retail Marijuana Product. A Retail Marijuana Establishment must provide adequate refrigeration for perishable Retail Marijuana Product during transport. L. Failed Testing. In the event Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Product has failed required testing, has been contaminated, or otherwise presents a risk of crosscontamination to other Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Product, such Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Product may only be transported if it is physically segregated and contained in a sealed package that prevents cross-contamination. Basis and Purpose – R 802 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(a)(X), 1243.4-202(3)(a)(XVII), 12-43.4-406(2), 12-43.4-701(2), C.R.S. The purpose of this rule is to establish that Retail Marijuana or Retail Marijuana Product may not be stored outside of Licensed Premises unless the Licensee obtains an off-premises storage facility permit.. R 802 – Off-Premises Storage of Retail Marijuana and Retail Marijuana Product: All Retail Marijuana Establishments A. Off-Premises Storage Permit Authorized. A Retail Marijuana Store, Retail Marijuana Products Manufacturing Facility, and a Retail Marijuana Cultivation Facility, and a Retail Marijuana Testing Facility may only store Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Product in their Licensed Premises or in their one permitted off-premises storage facility. Retail Marijuana Transporters are allowed to have more than one permitted off-premises storage facility. B. Permitting. To obtain a permit for an off-premises storage facility, a Retail Marijuana Establishment must apply on current Division forms and pay any applicable fees. A Retail Marijuana Transporter may only apply for and hold an off-premises storage permit in a local jurisdiction that permits the operation of Retail Marijuana Stores. C. Extension of Licensed Premises. A permitted off-premises storage facility shall constitute an extension of the Retail Marijuana Establishment’s Licensed Premises, subject to all applicable Retail Marijuana regulations. D. Limitation on Inventory to be Stored. A Retail Marijuana Store, Retail Marijuana Products Manufacturing Facility, and a Retail Marijuana Cultivation Facility may only have upon the 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 146 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 147 of 201 permitted off-premises storage facility Retail Marijuana or Retail Marijuana Product that are part of the particular Retail Marijuana Establishment’s finished goods inventory. The aforementioned Licensees may not share the premises with, or store inventory belonging to, a Medical Marijuana Business or a Retail Marijuana Establishment that is not commonly-owned or a Medical Marijuana Business. E. Restrictions. The permitted off-premises storage facility may be utilized for storage only. A Retail Marijuana Establishment may not sellTransfer, cultivate, manufacture, process, test, or consume any Retail Marijuana or Retail Marijuana Product within the premises of the permitted offpremises storage facility. F. Display of Off-premises Storage Permit and License. The off-premises storage facility permit and a copy of the Retail Marijuana Establishment’s license must be displayed in a prominent place within the permitted off-premises storage facility. G. Local Jurisdiction Approval 1. Prior to submitting an application for an off-premises storage facility permit, the Retail Marijuana Establishment must obtain approval or acknowledgement from the relevant local jurisdiction. 2. A copy of the relevant local jurisdiction’s approval or acknowledgement must be submitted by the Retail Marijuana Establishment in conjunction with its application for an off-premises storage facility. 3. No Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Product may be stored within a permitted storage facility until the relevant local jurisdiction has been provided a copy of the off-premises storage facility permit. 4. Any off-premises storage permit issued by the Division shall be conditioned upon the Retail Marijuana Establishment’s receipt of all required local jurisdiction approvals or acknowledgments. H. Security in Storage Facility. A permitted off-premises storage facility must meet all video, security and lock requirements applicable to a Licensed Premises. See Rules R 305 – Security Alarm and Lock Standards and R 306 – Video Surveillance. I. Transport to and from a Permitted Off-Premises Storage Facility. A Licensee must comply with the provisions of Rule R 801 - Transport of Retail Marijuana and Retail Marijuana Product when transporting any Retail Marijuana or Retail Marijuana Product to and from a permitted offpremises storage facility. J. Inventory Tracking. In addition to all the other tracking requirements set forth in these rules, a Retail Marijuana Establishment shall utilize the Inventory Tracking System to track its inventories from the point of transfer to or from a permitted off-premises storage facility. See Rules R 309 – Retail Marijuana Establishment: Inventory Tracking System and R 901 – Business Records Required. K. Inventory Tracking System Access and Scale. Every permitted off-premises storage facility must have an Inventory Tracking System terminal and a scale tested and approved in accordance with measurement standards established in 35-14-127, C.R.S. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 147 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 148 of 201 L. Adequate Care of Perishable Retail Marijuana Product. A Retail Marijuana Establishment must provide adequate refrigeration for perishable Retail Marijuana Product and shall utilize adequate storage facilities and transport methods. M. Consumption Prohibited. A Retail Marijuana Establishment shall not permit the consumption of marijuana or marijuana product on the premises of its permitted off-premises storage facility. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 148 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 149 of 201 R 900 Series – Business Records Basis and Purpose – R 901 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(a)(XII), and 12-43.4-701(1), and section 12-43.4-310, C.R.S. This rule explains what business records a Licensee must maintain and clarifies that such records must be made available to the Division on demand. Rule R 901.B was added due to written commentary received from an industry representative. R 901 – Business Records Required A. General Requirements 1. A Retail Marijuana Establishment must maintain the information required in this rule in a format that is readily understood by a reasonably prudent business person. 2. Each Retail Marijuana Establishment shall retain all books and records necessary to fully account for the business transactions conducted under its license for the current year and three preceding calendar years. 3. a. On premises records: The Retail Marijuana Establishment’s books and records for the preceding six months (or complete copies of such records) must be maintained on the Licensed Premises at all times. b. On- or off-premises records: Books and records associated with older periods may be archived on or off of the Licensed Premises. The books and records must fully account for the transactions of the business and must include, but shall not be limited to: a. Current Employee List – This list must provide the full name and Occupational License number of each employee and all non-employee Owners, who work at a Retail Marijuana Establishment. i. Once the functionality is developed, Eeach Licensed Premises shall enter the full name and Occupational license number of every employee that works on the premises into the Inventory Tracking System. The Licensed Premises shall update its list of employees in the Inventory Tracking System within 10 days of an employee commencing or ceasing employment on the premises. b. Secure Facility Information – For its Licensed Premises and any associated permitted off-premises storage facility, a Retail Marijuana Establishment must maintain the business contact information for vendors that maintain video surveillance systems and Security Alarm Systems. c. Advertising Records - All records related to Advertising and marketing, including, but not limited to, audience composition data. d. Licensed Premises – Diagram of all approved Limited Access Areas and any permitted off-premises storage facilities. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 149 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 150 of 201 e. Visitor Log – List of all visitors entering Limited Access Areas or Restricted Access Areas. gf. Waste log – Comprehensive records regarding all waste material that accounts for, reconciles, and evidences all waste activity related to the disposal of marijuana. gf. Surveillance logs – Surveillance logs as required by Rule R 306. h,i. Every Licensee shall maintain a record of its Identity Statement and Standardized Graphic Symbol which shall be available upon request by the State Licensing Authority. A Licensee may elect to have its Identity Statement also serve as its Standardized Graphic Symbol for purposes of complying with this rule. i. All records normally retained for tax purposes. j. Testing Records – all testing records required by Rule R 710. k. All other records required by these Rules. B. Loss of Records and Data. Any loss of electronically-maintained records shall not be considered a mitigating factor for violations of this rule. Licensees are required to exercise due diligence in preserving and maintaining all required records. C. Violation Affecting Public Safety. Violation of this rule may constitute a license violation affecting public safety. D. Records Related to Inventory Tracking. A Retail Marijuana Establishment must maintain accurate and comprehensive inventory tracking records that account for, reconcile and evidence all inventory activity for Retail Marijuana from either seed or immature plant stage until the Retail Marijuana or Retail Marijuana Product is destroyed or sold to another Retail Marijuana Establishment or a consumer. E. Records Related to Transport. A Retail Marijuana Establishment must maintain adequate records for the transport of all Retail Marijuana and Retail Marijuana Product. See Rule R 801 – Transport of Retail Marijuana and Retail Marijuana Product. F. Provision of Any Requested Record to the Division. A Licensee must provide on-demand access to on-premises records following a request from the Division during normal business hours or hours of apparent operation, and must provide access to off-premises records within three business days following a request from the Division. Basis and Purpose – R 904 The statutory authority for this rule is found at subsections 12-43.3-201(5), 12-43.3-202(1)(d), 12-43.4202(2)(b), 12-43.4-202(1), 12-43.4-202(2)(d), 12-43.4-202(3)(b)(IX), 12-43.4-309(11), and 12-43.4901(2)(a), C.R.S. The State Licensing Authority must be able to immediately access information regarding a Retail Marijuana Establishment’s managing individual. Accordingly, this rule reiterates the statutory mandate that Licensees provide any management change to the Division within seven days of any change, and also clarifies that a Licensee must save a copy of any management change report to the Division, and clarifies that failure to follow this rule can result in discipline. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 150 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 151 of 201 The State Licensing Authority finds it essential to the stringent and comprehensive enforcement of the Retail Code to regulate, monitor, and track all Retail Marijuana in order to prevent diversion and to ensure that all Retail Marijuana grown, processed, sold, and disposed of in the Retail Marijuana market is accounted for transparently in accordance with the Retail Code. Requiring Licensees to report instances when the Retail Marijuana they cultivate, manufacture, distribute, sell, or dispose of is stolen, unlawfully tTransferred, or otherwise diverted from the regulated market, or when Licensees discover plans to divert the Retail Marijuana, emphasizes that Licensees are accountable for their Retail Marijuana at all times and contributes to the transparency of the regulated market. In addition to maintaining transparency in the regulated marijuana industry, the State Licensing Authority also must ensure the confidentiality of certain Licensee information and records, including information in the Inventory Tracking System. Requiring Licensees to report instances where the Inventory Tracking System was compromised or planned to be compromised through unlawful access, use for unlawful purposes, the deliberate alteration or deletion of data, or deliberately entering false data, contributes to ensuring the accuracy and transparency of the system and therefore the regulated market, and aids in maintaining the confidentiality of Licensee data. R 904 – Retail Marijuana Establishment Reporting Requirements A. B. Manager Change Must Be Reported. 1. When Required. A Retail Marijuana Establishment shall provide the Division a written report within seven days after any change in manager occurs. 2. Licensee Must Maintain Record of Reported Change. A Retail Marijuana Establishment must also maintain a copy of this written report with its business records. 3. Consequence of Failure to Report. Failure to report a change in a timely manner may result in discipline. Reporting of Crime on the Licensed Premises or Otherwise Related to a Retail Marijuana Establishment. A Retail Marijuana Establishment and all Licensees employed by the Retail Marijuana Establishment shall report to the Division any discovered plan or other action of any Person to (1) commit theft, burglary, underage sales, diversion of marijuana or marijuana product, or other crime related to the operation of the subject Retail Marijuana Establishment; or (2) compromise the integrity of the Inventory Tracking System. A report shall be made as soon as possible after the discovery of the action, but not later than 14 days. Nothing in this paragraph (B) alters or eliminates any obligation a Retail Marijuana Establishment or Licensee may have to report criminal activity to a local law enforcement agency. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 151 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 152 of 201 R 1000 Series – Labeling, Packaging, and Product Safety Effective Date. Compliance with this R 1000 Series is mandatory until January 1, 2018. During the period January 1, 2018, to June 30, 2018, Licensees have the option of complying with this Rule R 1000 Series or with the Rule R 1000-1 Series, but must be fully compliant with at least one of those two Labeling, Packaging, and Product Safety Series. Beginning July 1, 2018, this Rule R 1000 Series is repealed, and compliance with the R 1000-1 Series is mandatory. R 1000-1 Series – Labeling, Packaging, and Product Safety Effective Date. The revised Packaging, Labeling and Product Safety rules set forth in this Rule R 1000-1 Series are effective January 1, 2018, except that during the period January 1, 2018, to June 30, 2018, Licensees have the option of complying with the Rule R 1000 Series or with this Rule R 1000-1 Series, but must be fully compliant with at least one of those two Labeling, Packaging, and Product Safety Series. Beginning July 1, 2018, the Rule R 1000 Series is repealed, and compliance with this R 1000-1 Series is mandatory. On and after July 1, 2018, all Licensees are required to package and label all Retail Marijuana, Retail Marijuana Concentrate and Retail Marijuana Product according to the Packaging, Labeling, and Product Safety rules in this Rule R 1000-1 Series. Basis and Purpose – Rule R 1001-1 The statutory authority for this rule is found at subsections 12-43.4-202(1), 12-43.4-202(2)(b), 12-43.4202(3)(a)(IV), 12-43.4-202(3)(a)(VI), 12-43.4-202(3)(a)(VII), 12-43.4-202(3)(b)(IX), 12-43.4-202(3)(c)(I), 12-43.4-202(3)(c)(III), 12-43.4-202(3)(c)(V), 12-43.4-202(c)(VI), 12-43.4-202(c.5), 12-43.4-202(f), 12-43.4402(1)(e), 12-43.4-402(2)(a), 12-43.4-402(5), 12-43.4-403(4), 12-43.4-404(1)(b), 12-43.4-404(1)(e), 1243.4-404(4)(a), 12-43.4-404(7)-(9), and 12-43.4-901(4)(b), 25-4-1614(3)(a), C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(VI). The purpose of the rules in this series, is to ensure that all Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product is sold and delivered to lawful consumers in packaging that is not easily opened by children, and that provides consumers with the information necessary to make informed decisions. These rules are in the interest of the health of the people of Colorado and are necessary for the stringent and comprehensive administration of the Retail Code. Based upon written and oral comments received through numerous rulemaking processes over the years and multiple focus groups with various industry stakeholders, the State Licensing Authority finds that these rules provide necessary information to consumers, promote prevention of underage use, and assist in limiting exposure, accidental consumption by, and diversion to, minors. These rules also aim to reduce duplication and facilitate compliance by moving to an intended use model. The State Licensing Authority finds that use of proper packaging and labeling techniques for all Retail Marijuana, Retail Marijuana Concentrate and Retail Marijuana Product is a public health and safety concern. The purpose of this rule is to describe the packaging and labeling responsibility of Retail Marijuana Stores, Retail Marijuana Cultivation Facilities and Retail Marijuana Products Manufacturing Facilities. Packaging and labeling in conformance with the requirements of these rules is a public health and safety concern. It is paramount that all Retail Marijuana Cultivation Facilities, Retail Marijuana Products Manufacturing Facilities and Retail Marijuana Stores ensure accurate, compliant packaging and labeling of all Retail Marijuana, Retail Marijuana Concentrate and Retail Marijuana Products. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 152 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 153 of 201 Rule R 1001-1 - Packaging and Labeling Responsibility – All Intended Uses Except Immature Plants A. Retail Marijuana Cultivation Facility. Other than bulk Retail Marijuana flower or trim and bulk Retail Marijuana Concentrate packaged and labeled in accordance with Rule R 1007-1(E), a Retail Marijuana Cultivation Facility shall not Transfer any Retail Marijuana, or Retail Marijuana Concentrate to another Retail Marijuana Establishment unless it has been placed into a Container and labeled in accordance with this R 1000-1 Series so that it is ready for sale to the consumer, except that the Retail Marijuana Store shall affix its license number and the date of sale to the consumer to the Container or the Marketing Layer prior to sale to the consumer. Other than bulk packaged Retail Marijuana flower or trim packaged and labeled in accordance with Rule R 10071(E), a Retail Marijuana Cultivation Facility shall not Transfer any Retail Marijuana or Retail Marijuana Concentrate to a Medical Research Facility or a Pesticide Manufacturer unless it has been placed into a Container and labeled in accordance with this R 1000-1 Series. B. Retail Marijuana Products Manufacturing Facility. Other than bulk Retail Marijuana flower or trim and bulk Retail Marijuana Concentrate packaged and labeled in accordance with Rule R 10071(E), a Retail Marijuana Products Manufacturing Facility shall not Transfer any Retail Marijuana, Retail Marijuana Product or Retail Marijuana Concentrate to another Retail Marijuana Establishment unless it has been placed into a Container and labeled in accordance with these R 1000-1 Series rules so that it is ready for sale to the consumer, except that the Retail Marijuana Store shall affix its license number and date of sale to the consumer to the Container or the Marketing Layer prior to sale to the consumer. If a Retail Marijuana Products Manufacturing Facility Transfers Retail Marijuana Product to another Retail Marijuana Products Manufacturing Facility it is not required to meet the Child-Resistant requirements for the Container but must still comply with all other packaging and labeling requirements of these R 1000-1 Series Rules. A Retail Marijuana Products Manufacturing Facility shall not Transfer any Retail Marijuana, Retail Marijuana Product or Retail Marijuana Concentrate to a Medical Research Facility or a Pesticide Manufacturer unless it has been placed into a Container and labeled in accordance with these R 1000-1 Series rules. C. Retail Marijuana Store. 1. Packaging and Labeling Prior to Sale to a Consumer. A Retail Marijuana Store shall ensure that all Retail Marijuana, Retail Marijuana Concentrate and Retail Marijuana Product is placed directly into a Container prior to sale to a consumer and that a label is affixed to the Container directly containing the Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product and that any Marketing Layer is labeled in accordance with these rules; however, a Retail Marijuana Store is not required to open any tamper evident Marketing Layer received from a Retail Marijuana Cultivation Facility or a Retail Marijuana Products Manufacturing Facility to verify the Container is ChildResistant or labeled. 2. Packaging and Labeling of Bulk Retail Marijuana Flower and Trim or Bulk Retail Marijuana Concentrate. If a Retail Marijuana Store receives bulk Retail Marijuana flower or trim or Retail Marijuana Concentrate from a Retail Marijuana Cultivation Facility or Retail Marijuana Products Manufacturing Facility, the Retail Marijuana Store shall place the Retail Marijuana flower or trim or Retail Marijuana Concentrate into a Container that does not exceed the sales limit in Rule R 402(C) and affix a label to the Container directly containing the Retail Marijuana flower or trim or Retail Marijuana Concentrate that includes all information required by these R 1000-1 Series rules. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 153 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 154 of 201 3. Exit Package Permitted. A Retail Marijuana Store may, but is not required to, place a Container or Marketing Layer into an Opaque Exit Package at the point of sale to the consumer. The Exit Package is not required to be labeled but may include the Retail Marijuana Store’s Identity Statement and/or Standardized Graphic Symbol. 4. Research Transfers Prohibited. A Retail Marijuana Store shall not sell or Transfer any Retail Marijuana, Retail Marijuana Product or Retail Marijuana Concentrate to a Medical Research Facility, a Pesticide Manufacturer or a Research and Development Licensee. D. Prohibited Transfers – All Retail Marijuana Establishments. A Retail Marijuana Establishment shall not Transfer, and another Retail Marijuana Establishment shall not accept nor offer for sale, any Retail Marijuana, Retail Marijuana Product or Retail Marijuana Concentrate that is not packaged and labeled in conformance with the requirements of these rules. E. Violation Affecting Public Safety. Any violation of any rule in these R 1000-1 Series may be considered a license violation affecting public safety. Basis and Purpose – R 1002-1 The statutory authority for this rule is found at subsections 12-43.4-202(1), 12-43.4-202(2)(b), 12-43.4202(3)(a)(IV), 12-43.4-202(3)(a)(VI), 12-43.4-202(3)(a)(VII), 12-43.4-202(3)(b)(IX), 12-43.4-202(3)(c)(I), 12-43.4-202(3)(c)(III), 12-43.4-202(3)(c)(V), 12-43.4-202(c)(VI), 12-43.4-202(c.5), 12-43.4-202(f), 12-43.3402(2)(a), 12-43.4-404(1)(e), 12-43.4-404(4)(a), 12-43.4-404(7)-(9), and 12-43.4-901(4)(b), 25-41614(3)(a), C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(VI). The State Licensing Authority finds it essential to regulate and establish labeling requirements for Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product and that this is in the interest of the health and safety of the people of Colorado. This rule identifies information that is required on all labels to provide necessary information to consumers to make informed decisions and first responders in the event of accidental ingestion, over ingestion or allergic reaction. This rule also identifies information necessary for the Division to regulate the cultivation, production and sale of Retail Marijuana, Retail Marijuana Concentrate and Retail Marijuana Product. This rule also requires labels that: (1) prohibit health and benefit claims, (2) are truthful and accurate, (3) are easily accessible to consumers and first responders, and (4) are clear and noticeable. This rule also seeks to minimize, to the extent practicable, the burden of labeling compliance to Licensees. R 1002-1 – Labeling Requirements: All Intended Uses Except Seeds and Immature Plants A. Applicability. The labeling requirements in this Rule R 1002-1 apply to all Containers directly containing Retail Marijuana, Retail Marijuana Concentrate and Retail Marijuana Product regardless of intended use and any Marketing Layer except that this rule does not apply to seeds and Immature Plants. The labeling requirements based on intended use in Rules R 1003-1-10051 are in addition to, not in lieu of, the requirements of this Rule R 1002-1. See also Rule R 1006-1 – Labeling Requirements – Seeds and Immature Plants. B. Labels Required. Every Container that directly contains Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product and any Marketing Layer shall have a label. Any intermediary packaging between the Container and the Marketing Layer is not required to be labeled. Any Shipping Container(s) that will not be displayed to the consumer also is not required to be labeled. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 154 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 155 of 201 C. Labels Shall Not Be Designed to Appeal to Children. A Retail Marijuana Establishment shall not place any content on a Container or the Marketing Layer in a manner that reasonably appears to target individuals under the age of 21, including but not limited to, cartoon characters or similar images. D. False or Misleading Statements. The label(s) on the Container and any Marketing Layer shall not include any false or misleading statements. E. Trademark Infringement Prohibited. No Container or Marketing Layer shall be intentionally or knowingly labeled so as to cause a reasonable consumer confusion as to whether the Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product is a trademarked product or labeled in a manner that violates any federal trademark law or regulation. F. Health and Benefit Claims. The label(s) on the Container and any Marketing Layer shall not make any claims regarding health or physical benefits to the consumer. G. Font Size. Labeling text on the Container and any Marketing Layer must be no smaller than 1/16 of an inch. H. Use of English Language. Labeling text on the Container and any Marketing Layer must be clearly written or printed and in the English language. In addition to the required English label, Licensees may include an additional, accurate foreign language translation on the label that otherwise complies with these rules. I. Unobstructed and Conspicuous. Labeling text on the Container and any Marketing Layer must be unobstructed and conspicuous. A Licensee may affix multiple labels to the Container, provided that none of the information required by these rules is obstructed. For example and not by means of limitation, labels may be accordion, expandable, extendable or layered to permit labeling of small Containers. J. Use of the Word “Candy” and/or “Candies” Prohibited. K. 1. Licensees shall not use the word(s) “candy” and/or “candies” on the label of any Container holding Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product or any Marketing Layer. 2. Notwithstanding the requirements of subparagraph (J)(1), a licensed Retail Marijuana Establishment whose Identity Statement contains the word(s) “candy” and/or “candies” may place its Identity Statement on the label of the Container holding Retail Marijuana, Retail Marijuana Concentrate and/or Retail Marijuana Product or on any Marketing Layer. Information Required on Every Label Regardless of Intended Use (Except for Seeds and Immature Plants). Every Container directly containing Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product and any Marketing Layer must have a label that includes at least the following information: 1. Required License Number(s). The license number(s) for each of the following: i. The Retail Marijuana Cultivation Facility(ies) where the Retail Marijuana was grown; ii. If applicable, the Retail Marijuana Cultivation Facility(ies) that produced the Water-Based Retail Marijuana Concentrate; 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 155 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 156 of 201 iii. If applicable, the Retail Marijuana Products Manufacturing Facility that produced the Retail Marijuana Product or Retail Marijuana Concentrate; and iv. The Retail Marijuana Store that sold the Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product to the consumer, except that the Retail Marijuana Store may affix its license number to the Container or Marketing Layer at the time of sale to the consumer. 2. Batch Numbers. The Harvest Batch Number(s) assigned to the Retail Marijuana or the Production Batch Number(s) assigned to Retail Marijuana Concentrate or Retail Marijuana Product. 3. Statement of Net Contents. Every label must identify the net weight, volume or number of items, using a standard of measure compatible with the Inventory Tracking System, of the Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Product prior to placement in the Container directly containing the Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product; 4. Universal Symbol. The Universal Symbol on the front of the Container and any Marketing Layer, no smaller than ½ of an inch by ½ of an inch, with the following statement directly below the Universal Symbol: “Contains Marijuana. Keep out of the reach of children.” 5. Ingredient List Including Major Allergens. A list of all ingredients used to manufacture the Retail Marijuana Concentrate or Retail Marijuana Product including identification of any major allergens contained in the Retail Marijuana Concentrate or Retail Marijuana Product in accordance with the Food Allergen Labeling and Consumer Protection Act of 2004, 21 U.S.C. § 343 (2010). The Food Allergen Labeling and Consumer Protection Act of 2004, 21 U.S.C. § 343 (2010) requires disclosure of the following major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. i. 6. Note that this rule does not include any later amendments or editions to the United States Code. The Division maintains a copy of 21 U.S.C. § 343 (2010), which is available to the public for inspection and copying during the Division’s regular business hours. Required Potency Statement. Each Container shall be labeled with the potency of the Retail Marijuana or Retail Marijuana Concentrate’s Total THC and CBD expressed as a percentage or Retail Marijuana Product’s THC and CBD expressed in milligrams. The potency label shall be either: i. In a font that is bold, and enclosed within an outlined shape such as a circle or square; or ii. Highlighted with a bright color such as yellow. 7. Solvent List. A list of any solvent(s) used to produce any Solvent-Based Retail Marijuana Concentrate that is sold on its own or as a production input in any Retail Marijuana Product. 8. Date of Sale. The Retail Marijuana Store shall affix the date of sale to the Container or Marketing Layer at the time of sale to the consumer. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 156 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 9. RETAIL - Page 157 of 201 Statement of Intended Use. The Container and any Marketing Layer shall identify one or more intended use for Retail Marijuana, Retail Marijuana Product and Retail Marijuana Concentrate from the following list: i. Inhaled Product: a. Flower or Trim (including pre-rolled joint and kief); b. Solvent-Based Retail Marijuana Concentrate; c. Water-Based Retail Marijuana Concentrate; d. Heat/Pressure-Based Retail Marijuana Concentrate; e. Vaporizer cartridge. ii. For Oral Consumption (Edible Retail Marijuana Product): a. Food and drink infused with Retail Marijuana; b. Retail Marijuana Concentrate; c. Pills and capsules; d. Tinctures. iii. Skin and Body Products: a. Topical; b. Suppository; c. Transdermal. L. No Other Intended Use Permitted. No intended use other than those identified in Rule R 10021(K.9) shall be identified on any label without first obtaining formal, written approval from the Division for such additional or new intended use. Licensees shall accurately identify all intended use(s) on the label. Beginning January 1, 2018, a Licensee may submit a request to the Division to consider the approval of an intended use not expressly permitted under this rule during the next formal rulemaking. M. Multiple Intended Uses. Any Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product having more than one intended use shall identify every intended use on the label and shall comply with all labeling requirements for each intended use. If there is any conflict between the labeling requirements for multiple intended uses, the most restrictive labeling requirements shall be followed. Licensees shall not counsel or advise any consumer to use Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product other than in accordance with the intended use(s) identified on the label. N. Information Required on the Label on the Container or Marketing Layer Regardless of Intended Use. Either the Label on the Container or the Marketing Layer shall include the following information: 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 157 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 1. O. RETAIL - Page 158 of 201 Required Warning Statements: i. “This product was produced without regulatory oversight for health, safety, or efficacy.” ii. “This product complies with testing requirements.” iii. “There may be long term physical or mental health risks from use of marijuana including additional risks for women who are or may become pregnant or are breastfeeding. Use of marijuana may impair your ability to drive a car or operate machinery.” Permissive Information. 1. 2. Identity Statement. The label may include, but is not required to include, the Identity Statement and/or Standardized Graphic Symbol for: i. The Retail Marijuana Cultivation Facility(ies) where the Retail Marijuana was grown; ii. The Retail Marijuana Products Manufacturing Facility that manufactured the Retail Marijuana Product or Retail Marijuana Concentrate; and/or iii. The Retail Marijuana Store that sold the Retail Marijuana, Retail Marijuana Product or Retail Marijuana Concentrate. Other Permissive Information. The labeling requirements in these R 1000-1 Series provide only the minimum labeling requirements. Licensees may include additional information on the label(s) so long as such information is consistent with the requirements of these Rules. Basis and Purpose – R 1003-1 The statutory authority for this rule is found at subsections 12-43.4-202(1), 12-43.4-202(2)(b), 12-43.4202(3)(a)(IV)(D), 12-43.4-202(3)(a)(VII), 12-43.4-202(3)(b)(IX), 12-43.4-202(c)(VI), 12-43.4-202(f), 1243.3-402(2)(a), 12-43.4-404(4)(a), and 12-43.4-404(8), C.R.S. The purpose of this rule is to define additional labeling requirements for Retail Marijuana, Retail Marijuana Concentrate and/or Retail Marijuana Product whose intended use is inhalation, and in particular to address potency statement requirements. These labeling requirements are in addition to, not in lieu of, the general labeling requirements in Rule R 1002-1 which apply to all Retail Marijuana (except seeds and Immature plants), Retail Marijuana Concentrate and Retail Marijuana Products regardless of intended use. R 1003-1 – Additional Labeling Requirements – Inhaled Products In addition to the labeling requirements in Rule R 1002-1, the label(s) on all inhaled product intended use shall also include: A. The potency statement required by Rule R 1002-1(K.6) for: (1) flower (including prerolls and kief), (2) Solvent-Based Retail Marijuana Concentrate, (3) Water-Based Retail Marijuana Concentrate, and (4) Heat/Pressure Based Retail Marijuana Concentrate shall be stated as the number of milligrams and percentage of Total THC and CBD. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 158 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 B. RETAIL - Page 159 of 201 The potency statement required by Rule R 1002-1(K.6) for vaporizer cartridges shall be stated as the percentage of Total THC and CBD, and the number of milligrams of THC and CBD per cartridge. Basis and Purpose – R 1004-1 The statutory authority for this rule is found at subsections 12-43.4-202(1), 12-43.4-202(2)(b), 12-43.4202(3)(a)(IV), 12-43.4-202(3)(a)(VI), 12-43.4-202(3)(a)(VII), 12-43.4-202(3)(b)(IX), 12-43.4-202(3)(c)(I), 12-43.4-202(3)(c)(III), 12-43.4-202(3)(c)(V), 12-43.4-202(c)(VI), 12-43.4-202(c.5), 12-43.4-202(f), 12-43.3402(2)(a), 12-43.4-404(4)(a), 12-43.4-404(7)-(9), and 25-4-1614(3)(a), C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(VI). The purpose of this rule is to define additional labeling requirements applicable to Edible Retail Marijuana Products. These labeling requirements are in addition to, not in lieu of the general labeling requirements in Rule R 1002-1, which apply to all Retail Marijuana (except seeds and Immature plants), Retail Marijuana Concentrate and Retail Marijuana Products regardless of intended use. R 1004-1 – Additional Labeling Requirements – Edible Retail Marijuana Products A. In addition to the general labeling requirements in Rule R 1002-1, the label(s) on all Edible Retail Marijuana Products, including but not limited to candy, liquids, Retail Marijuana-infused food, pills, capsules and tinctures, shall also include: 1. The potency statement required by Rule R 1002-1(K.6) shall be stated as: (1) milligrams of THC and CBD per serving and (2) milligrams of THC and CBD per Container where the Container contains more than one serving. For example: “The serving size of Total THC in this product is X mg and the amount of Total THC in this Container is X mg. The serving size of CBD in this product is X mg and the total amount of CBD in this Container is X mg.” 2. Additional Warning Statement Required. The following additional warning statement shall be included on the label on the Container or Marketing Layer for all Edible Retail Marijuana Product: “The intoxicating effects of this product may be delayed by up to 4 hours.” 3. Expiration/Use-By Date. A product expiration date, upon which the Edible Retail Marijuana Product will no longer be fit for consumption, or a use-by-date, upon which the oral consumption product will no longer be optimally fresh. Once a label with an expiration or use-by date has been affixed to a Container containing an Edible Retail Marijuana Product and any Marketing Layer, a Licensee shall not alter that expiration or use-by date or affix a new label with a later expiration or use-by date. 4. Production Date. The date on which the Edible Retail Marijuana Product was produced which may be included in the Batch Number required by Rule R 1002-1(K.2). 5. Statement Regarding Refrigeration. If an Edible Retail Marijuana Product is perishable, a statement that the product must be refrigerated. B. Permissive Nutritional Fact Panel. The label also may include, but is not required to include, a nutritional fact panel or dietary supplement fact panel in substantial conformance with 21 CFR 101.9 (2016) or 21 C.F.R. 101.36 (2016) as follows: 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 159 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 160 of 201 1. For Edible Retail Marijuana Products other than pills, capsules and tinctures and FoodBased Retail Marijuana Concentrate the nutritional fact panel shall be in substantial conformance with the requirements of 21 C.F.R. 101.9(C) (2016) which provides the FDA’s nutritional labeling requirements for food; 2. For pills, capsules and tinctures, the dietary supplement fact panel shall be in substantial conformance with the requirements of 21 C.F.R. 101.36 (2016) which provides the FDA’s nutritional labeling requirements for dietary supplements. 3. Note that this Rule R 1004-1(B) does not include any later amendments or editions to the Code of Federal Regulations. The Division maintains copies of 21 C.F.R. 101.9(C) (2016) and 21 C.F.R. 101.36 (2016), which are available to the public for inspection and copying during the Division’s regular business hours. Basis and Purpose – R 1005-1 The statutory authority for this rule is found at subsections 12-43.4-202(1), 12-43.4-202(2)(b), 12-43.4202(3)(a)(IV), 12-43.4-202(3)(a)(VI), 12-43.4-202(3)(a)(VII), 12-43.4-202(3)(b)(IX), 12-43.4-202(3)(c)(I), 12-43.4-202(3)(c)(III), 12-43.4-202(3)(c)(V), 12-43.4-202(c)(VI), 12-43.4-202(f), 12-43.3-402(2)(a), 1243.4-404(4)(a), and 12-43.4-404(8)-(9), C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(VI). The purpose of this rule is to define the additional labeling requirements applicable to products for which the intended use is application to the skin or non-oral insertion in the body, including topical products, suppositories and transdermal products. These labeling requirements are in addition to, not in lieu of, the general labeling requirements in Rule R 1002-1 which apply to all Retail Marijuana (except seeds and Immature plants), Retail Marijuana Concentrate and Retail Marijuana Products regardless of intended use. R 1005-1 – Additional Labeling Requirements – Skin and Body Products (Topical, Suppositories and Transdermal) In addition to the general labeling requirements in Rule R 1002-1, the label(s) on all skin and body product shall also include: A. Topical Product Potency Statement. For topical product, the potency statement required by Rule R 1002-1(K.6) shall be stated as the number of milligrams of THC and CBD per Container and per milliliter. B. Suppository and Transdermal Product Potency Statement. For suppository and transdermal product, the potency statement required by Rule R 1002-1(K.6) shall be stated as the number of milligrams of THC and CBD per suppository or transdermal and the total number of milligrams of THC and CBD per Container. For example: “The serving size of Total THC in this product is X mg and the amount of Total THC in this Container is X mg. The serving size of CBD in this product is X mg and the total amount of CBD in this Container is X mg.” C. Expiration/Use-By Date. A product expiration or use-by date, after which the skin and body product will no longer be fit for use. Once a label with an expiration or use-by date has been affixed to any Container holding a skin and body product and any Marketing Layer, a Licensee shall not alter that expiration or use-by date or affix a new label with a later expiration or use-by date. D. Production Date. The date on which the skin and body product was produced which may be included in the Batch Number required by Rule R 1002-1(K.2). 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 160 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 161 of 201 Basis and Purpose – R 1006-1 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(a)(IV), 1243.4-202(3)(a)(VII), 12-43.4-202(3)(b)(IX), 12-43.4-202(3)(c)(I), 12-43.4-202(3)(c)(III), 12-43.4-202(c)(VI), 12-43.4-202(c.5), 12-43.4-202(f), and 12-43.4-901(4)(b), C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(VI). The purpose of this rule is to define the labeling requirements for seeds and Immature plants that are offered for sale to a consumer by a Retail Marijuana Store. These labeling requirements do not apply to seeds or Immature Plants that are sold or Transferred between Licensees but are never offered for retail sale to a consumer. R 1006-1 – Labeling Requirements – Seeds and Immature Plants A. Labels Required. Every Container holding seeds and any plant pot holding an Immature plant that is offered for sale to a consumer, shall have a label. B. False or Misleading Statements. The label(s) shall not include any false or misleading statements. C. Health and Benefit Claims. The label(s) shall not make any claims regarding health or physical benefits to the consumer. D. Font Size. Labeling text on the labels must be no smaller than 1/16 of an inch. E. Use of English Language. Labeling text must be clearly written or printed and in the English language. In addition to the required English label, Licensees may include an additional, accurate foreign language translation on the label that otherwise complies with these rules. F. Unobstructed and Conspicuous. Labeling text must be unobstructed and conspicuous. A Licensee may affix multiple labels to a Container and any Marketing Layer holding seeds or a plant pot holding an Immature plant, provided that none of the information required by these rules is obstructed. For example and not by means of limitation, labels may be accordion, expandable, extendable or layered. G. Required Information. All labels on seeds or Immature plants offered for sale to a consumer shall include the following required information: 1. Required License Number(s). The license number(s) for each of the following: i. The Retail Marijuana Cultivation Facility(ies) where the Retail Marijuana was grown; and ii. The Retail Marijuana Store that sold the Retail Marijuana, to the consumer. 2. Statement of Net Contents. Every label on a Container and any Marketing Layer holding seeds shall identify the number of seeds in the Container. 3. Universal Symbol. The Universal Symbol on the front of a Container and any Marketing Layer holding seeds and the front of a plant pot holding each Immature plant, no smaller than ½ of an inch by ½ of an inch, with the following statement directly below the Universal Symbol: “Contains Marijuana. Keep out of the reach of children.” 4. Required Warning Statements: 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 161 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 5. RETAIL - Page 162 of 201 i. “This product was produced without regulatory oversight for health, safety, or efficacy.” ii. “There may be long term physical or mental health risks from use of marijuana including additional risks for women who are or may become pregnant or are breastfeeding. Use of marijuana may impair your ability to drive a car or operate machinery.” No Statement of Intended Use. No intended use shall be identified on the label for seeds or Immature plant labeled according to this Rule. Basis and Purpose – R 1007-1 The statutory authority for this rule is found at subsections 12-43.4-202(1), 12-43.4-202(2)(b), 12-43.4202(3)(b)(IX), 12-43.4-202(3)(c)(I), 12-43.4-202(3)(c)(III), 12-43.4-202(f), 12-43.3-402(2)(a), 12-43.4402(5), 12-43.4-404(1)(e), 12-43.4-404(4)(a), and 12-43.4-404(8), C.R.S. The purpose of this rule is to define the packaging requirements for Retail Marijuana (except Immature plants), Retail Marijuana Concentrate and Retail Marijuana Product regardless of intended use. The State Licensing Authority believes based on written and oral comments it has received through the focus group and rulemaking process that requiring child-resistant packaging is of a state wide concern and would assist in limiting accidental ingestion. The State Licensing Authority wants to ensure the regulated community employs proper packaging techniques for all Retail Marijuana, Retail Marijuana Concentrate and Retail Marijuana Product as this is a public health and safety concern. R 1007-1 – Packaging Requirements – All Intended Uses Except Immature Plants A. General Applicability. These packaging requirements apply to all Retail Marijuana, Retail Marijuana Concentrate and Retail Marijuana Product regardless of intended use except Immature plants. See also Rule R 1009-1. B. Container Required. The Container (except for bulk Transfers of Retail Marijuana flower or trim and Retail Marijuana Concentrate) shall be Child-Resistant. All Retail Marijuana, Retail Marijuana Concentrate and Retail Marijuana Product (except for bulk Transfers of Retail Marijuana flower or trim and Retail Marijuana Concentrate) shall be placed into the required Container prior to Transfer to a Retail Marijuana Store. Bulk Retail Marijuana flower or trim and Retail Marijuana Concentrate shall be placed into a Container by the Retail Marijuana Store prior to sale to the consumer. 1. A sealed vaporize cartridge or disposable vaporize pen need not itself be Child-Resistant but must be placed into a Container prior to Transfer to a Retail Marijuana Store. C. Child Resistant Certificate(s). Licensee shall maintain a copy of the certificate that each Container into which the Licensee places Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product is Child-Resistant and complies with the requirements of 16 C.F.R. 1700.15 (1995) and 16 C.F.R. 1700.20 (1995) in accordance with the requirements of Rule R 901(A). 1. Note that this Rule does not include any later amendments or editions to the Code of Federal Regulations. The Division has maintained a copy of 16 C.F.R. 1700.15 (1995) and 16 C.F.R. 1700.20 (1995), which is available to the public for inspection and copying during the Division’s regular business hours. D. Containers and Marketing Layers. Container and any Marketing Layer shall have a label. Any intermediary packaging between the Container and the Marketing Layer is not required to be 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 162 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 163 of 201 labeled in accordance with these Rules R 1002-1 - 1005-1. Any Shipping Container(s) that will not be displayed to the consumer also is not required to be labeled according to these Rules R 1002-1 - 1005-1. E. Bulk Packaging. Only Retail Marijuana flower or trim and Retail Marijuana Concentrate may be packaged in bulk for Transfer to a Retail Marijuana Products Manufacturing Facility or a Retail Marijuana Store. Only Retail Marijuana flower or trim may be packaged in bulk for Transfer to a Medical Research Facility or a Pesticide Manufacturer. Retail Marijuana flower or trim bulk packages shall not exceed ten pounds of Retail Marijuana flower or trim. Retail Marijuana Concentrate bulk packages shall not exceed five pounds of Retail Marijuana Concentrate. All bulk packaging must include an RFID tag and a label containing all information necessary to permit a Retail Marijuana Store to affix a label to any Container into which bulk Retail Marijuana flower or trim or Retail Marijuana Concentrate is placed prior to sale to the consumer. Bulk packaging labels shall include at least the following information: 1. The license number of the Retail Marijuana Cultivation Facility where the Retail Marijuana was grown; 2. If applicable, the license number of the Retail Marijuana Cultivation Facility(ies) that produced the Water-Based Retail Marijuana Concentrate; 3. If applicable, the license number of the Retail Marijuana Products Manufacturing Facility where the Retail Marijuana Concentrate was produced; 4. The Harvest Batch Number(s) assigned to the Retail Marijuana or the Production Batch Number(s) assigned to the Retail Marijuana Concentrate; 5. The net contents, using a standard of measure compatible with the Inventory Tracking System, of the Retail Marijuana or Retail Marijuana Concentrate prior to its placement in the bulk package; and 6. Potency test results as required to permit the receiving Licensee to label Retail Marijuana flower or trim or Retail Marijuana Concentrate as required by these rules. F. All Other Bulk Packaging Prohibited. Other than Retail Marijuana flower or trim and Retail Marijuana Concentrate that is bulk packaged in accordance with subparagraph (E) above, no Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product shall be Transferred to a Retail Marijuana Store, a Medical Research Facility or a Pesticide Manufacturer until it is placed in a Container and labeled in accordance with these rules so that it is ready for sale to the consumer, except that the Retail Marijuana Store shall affixed its license number and date of sale to the consumer to the Container or the Marketing Layer prior to sale to the consumer. G. Trademark Infringement Prohibited. No Retail Marijuana Product shall be intentionally or knowingly packaged so as to cause a reasonable consumer confusion as to whether the Retail Marijuana Product is a trademarked food product or packaged in a manner that violates any federal trademark law or regulation. H. Shipping Containers. A Retail Marijuana Cultivation Facility or Retail Marijuana Products Manufacturing Facility may package multiple Containers of Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product prior to transport, provided the multiple Containers have an RFID tag affixed to it. Licensees shall ensure that either the multiple Containers placed within a Shipping Container each have an RFID tag, or the Shipping Container itself must have an RFID tag. If the Licensee elects to place the RFID tag on the Shipping Container, the Shipping 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 163 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 164 of 201 Container shall contain only one Harvest Batch, or Production Batch of Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Product. If a Shipping Container consists of more than one Harvest Batch or Production Batch, then each group of multiple Containers shall be affixed with an RFID tag. See Rule R 309 – Inventory Tracking System and Rule R 801 – Transport of Retail Marijuana, Retail Marijuana Vegetative Plants, and Retail Marijuana Product: All Retail Marijuana Establishments. Basis and Purpose – R 1008-1 The statutory authority for this rule is found at subsections 12-43.4-202(1), 12-43.4-202(2)(b), 12-43.4202(3)(b)(IX), 12-43.4-202(3)(c)(I), 12-43.4-202(3)(c)(III), 12-43.4-202(f), 12-43.3-402(2)(a), 12-43.4404(1)(e), 12-43.4-404(4)(a), 12-43.4-404(4)(b) and 12-43.4-404(8), C.R.S. The purpose of this rule is to define the additional packaging requirements applicable to Edible Retail Marijuana Products. These packaging requirements are in addition to, not in lieu of, the general packaging requirements in Rule R 1007-1, which applies to all Retail Marijuana (except Immature plants), Retail Marijuana Concentrate and Retail Marijuana Products regardless of intended use. R 1008-1 – Additional Packaging Requirements – Edible Retail Marijuana Products In addition to the general packaging requirements in Rule R 1007-1, any Container holding Edible Retail Marijuana Product shall meet the following requirements: A. Single-Serving Edible Retail Marijuana Product. Every Single-Serving Edible Retail Marijuana Product must be put into a Container prior to transport to another Retail Marijuana Establishment. B. Bundled Single-Serving Edible Retail Marijuana Product. Single-Serving Edible Retail Marijuana Products that are put into a Container may be bundled into a larger Marketing Layer so long as the total amount of active THC per Marketing Layer does not exceed 100 milligrams. C. Multiple-Serving Edible Retail Marijuana Product. Every Multiple-Serving Edible Retail Marijuana Product shall be put into a Container that maintains its Child-Resistant effectiveness for multiple openings and shall not exceed 100 milligrams of active THC per Container. D. Liquid Edible Retail Marijuana Product. 1. Each Liquid Edible Retail Marijuana Product that is a Single-Serving Edible Retail Marijuana Product must be packaged in a Container prior to transport to another Retail Marijuana Establishment. 2. Each Liquid Edible Retail Marijuana Product that is a Multiple-Serving Edible Retail Marijuana Product shall be: ii. Packaged in a structure that uses a single mechanism to achieve both ChildResistant properties and accurate pouring measurement of each liquid serving in increments equal to or less than 10 milligrams of active THC per serving, with no more than 100 milligrams of active THC total per Container; and iii. The measurement component is within the Child-Resistant cap or closure of the bottle and is not a separate component. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 164 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 165 of 201 Basis and Purpose – R 1009-1 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(b)(IX), 1243.4-202(3)(c)(III) and 12-43.4-202(f) C.R.S. The purpose of this rule is to define the packaging requirements and responsibility for Immature plants. R 1009-1 – Packaging Requirements and Responsibility– Immature Plants A. Packaging. An Immature plant intended for sale to a consumer need only be packaged in a plant pot that is labeled in accordance with the requirements of Rule R 1006-1 – Labeling Requirements – Seeds and Immature Plants. B. Retail Marijuana Cultivation Facility. A Retail Marijuana Cultivation Facility shall not Transfer any Immature plant to a Retail Marijuana Store, a Medical Research Facility or a Pesticide Manufacturer unless it is in plant pot and labeled in accordance with Rule R 1006-1 – Labeling Requirements – Seeds and Immature Plants. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 165 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 166 of 201 R 1200 Series – Enforcement Basis and Purpose – R 1201 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(b)(II), and 12-43.4-202(3)(b)(III), and section 12-43.4-602, C.R.S. This rule explains that Licensees must cooperate with Division employees when they are acting within the normal scope of their duties and that failure to do so may result in sanctions. It also explains the administrative hold process, the handling of inventory subject to administrative hold and under investigation and the process for voluntary surrender of Retail Marijuana and Retail Marijuana Product R 1201 – Duties of Employees of the State Licensing Authority A. B. Duties of Director 1. The State Licensing Authority may delegate an act required to be performed by the State Licensing Authority related to the day-to-day operation of the Division to the Director. 2. The Director may authorize Division employees to perform tasks delegated from the State Licensing Authority. Duties of Division Investigators. The State Licensing Authority, the Department’s Senior Director of Enforcement, the Director, and Division investigators shall have all the powers of any peace officer to: 1. Investigate violations or suspected violations of the Retail Code and any rules promulgated pursuant to it. Make arrests, with or without warrant, for any violation of the Retail Code, any rules promulgated pursuant to it, Article 18 of Title 18, C.R.S., any other laws or regulations pertaining to Retail Marijuana in this state, or any criminal law of this state, if, during an officer’s exercise of powers or performance of duties pursuant to the Retail Code, probable cause exists that a crime related to such laws has been or is being committed; 2. Serve all warrants, summonses, subpoenas, administrative citations, notices or other processes relating to the enforcement of laws regulating Retail Marijuana and Retail Marijuana Product; 3. Assist or aid any law enforcement officer in the performance of his or her duties upon such law enforcement officer’s request or the request of other local officials having jurisdiction; 4. Inspect, examine, or investigate any premises where the Licensee’s Retail Marijuana or Retail Marijuana Product are grown, stored, cultivated, manufactured, tested, distributed, or sold, and any books and records in any way connected with any licensed or unlicensed activity; 5. Require any Licensee, upon demand, to permit an inspection of Licensed Premises during business hours or at any time of apparent operation, marijuana equipment, and marijuana accessories, or books and records; and, to permit the testing of or examination of Retail Marijuana or Retail Marijuana Product; 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 166 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 C. RETAIL - Page 167 of 201 6. Require Applicants to submit complete and current applications and fees and other information the Division deems necessary to make licensing decisions and approve material changes made by the Applicant or Licensee; 7. Conduct investigations into the character, criminal history, and all other relevant factors related to suitability of all Licensees and Applicants for Retail Marijuana licenses and such other Persons with a direct or indirect interest in an Applicant or Licensee, as the State Licensing Authority may require; and 8. Exercise any other power or duty authorized by law. Duties of State Licensing Authority and Division Employees. 1. Employees shall maintain the confidentiality of State Licensing Authority and Division records and information. For confidentiality requirements of State Licensing Authority and Division employees who leave the employment of the State Licensing Authority, see rRule R 1308 - Confidential Information and Former State Licensing Authority Employees. 2. Pursuant to subsection 12-43.3-201(4), C.R.S., State Licensing Authority employees with regulatory oversight responsibilities for marijuana businesses licensed by the state licensing authority shall not work for, represent, or provide consulting services to or otherwise derive pecuniary gain from a marijuana business licensed by the State Licensing Authority or other business entity established for the primary purpose of providing services to the marijuana industry for a period of six months following his or her last day of employment with the State Licensing Authority. 3. Pursuant to subsection 12-43.3-201(5), C.R.S., disclosure of confidential records or information in violation of the provisions of the Medical Code (some of which also pertain to regulation of Retail Marijuana Establishments) constitutes a class 1 misdemeanor. Basis and Purpose – R 1202 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(b)(II), and 12-43.4-202(3)(b)(III), and section 12-43.4-602, C.R.S. This rule explains that Licensees must cooperate with Division employees when they are acting within the normal scope of their duties and that failure to do so may result in sanctions. It also explains the administrative hold process, the handling of inventory subject to administrative hold and under investigation and the process for voluntary surrender of Retail Marijuana and Retail Marijuana Product. R 1202 – Requirement for Inspections and Investigations, Searches, Administrative Holds, Voluntary Surrenders and Such Additional Activities as May Become Necessary from Time to Time A. Applicants and Licensees Shall Cooperate with Division Employees 1. Applicants and Licensees must cooperate with employees of the Division who are conducting inspections or investigations relevant to the enforcement of laws and regulations related to the Retail Code. 2. No Applicant or Licensee shall by any means interfere with, obstruct or impede the State Licensing Authority or any employee of the Division from exercising their duties pursuant 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 167 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 168 of 201 to the provisions of the Retail Code and all rules promulgated pursuant to it. This would include, but is not limited to: B. a. Threatening force or violence against an employee or investigator of the Division, or otherwise endeavoring to intimidate, obstruct, or impede employees or investigator of the Division, their supervisors, or any peace officers from exercising their duties. The term “threatening force” includes the threat of bodily harm to such individual or to a member of his or her family; b. Denying investigators of the Division access to premises where the licensee’s Retail Marijuana or Retail Marijuana Product are grown, stored, cultivated, manufactured, tested, distributed, or sold during business hours or times of apparent activity; c. Providing false or misleading statements; d. Providing false or misleading documents and records; e. Failing to timely produce requested books and records required to be maintained by the Licensee; or f. Failing to timely respond to any other request for information made by a Division employee or investigator in connection with an investigation of the qualifications, conduct or compliance of an Applicant or Licensee. Administrative Hold 1. To prevent destruction of evidence, diversion or other threats to public safety, while permitting a Licensee to retain its inventory pending further investigation, a Division investigator may order an administrative hold of Retail Marijuana and Retail Marijuana Product pursuant to the following procedure: a. If during an investigation or inspection of a Licensee, a Division investigator develops reasonable grounds to believe certain Retail Marijuana and Retail Marijuana Product constitute evidence of acts in violation of the Retail Code or rules promulgated pursuant to it, or constitute a threat to the public safety, the Division investigator may issue a notice of administrative hold of any such Retail Marijuana and Retail Marijuana Product. The notice of administrative hold shall provide a documented description of the Retail Marijuana or Retail Marijuana Product to be subject to the administrative hold and a concise statement that is promptly issued and approved by the Director or his or her designee regarding the reasons for issuing the administrative hold. b. Following the issuance of a notice of administrative hold, the Division will identify the Retail Marijuana and Retail Marijuana Product subject to the administrative hold in the Inventory Tracking System. The Licensee shall continue to comply with all tracking requirements. See Rule R 309 Retail Marijuana Establishments: Inventory Tracking System. c. The Licensee shall completely and physically segregate the Retail Marijuana and Retail Marijuana Product subject to the administrative hold in a Limited Access Area of the Licensed Premises under investigation, where it shall be safeguarded by the Licensee. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 168 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 C. RETAIL - Page 169 of 201 d. While the administrative hold is in effect, , the Licensee is prohibited from selling, giving away, tTransferring, transporting, or destroying the Retail Marijuana and Retail Marijuana Product subject to the administrative hold, except as otherwise authorized by these rules. e. While the administrative hold is in effect, the Licensee must safeguard the Retail Marijuana and Retail Product subject to the administrative hold and must fully comply with all security requirements including but not limited to surveillance, lock and alarm requirements set forth in the Retail Code and the rules of the State Licensing Authority. See Rule R 1309 Administrative Warrants. f. Nothing herein shall prevent a Licensee from voluntarily surrendering Retail Marijuana or Retail Marijuana Product that is subject to an administrative hold, except that the Licensee must follow the procedures set forth below for voluntary surrender of Retail Marijuana or Retail Marijuana Product. g. Nothing herein shall prevent a Licensee from the continued possession, cultivation or harvesting of the Retail Marijuana subject to the administrative hold. All Retail Marijuana and Retail Marijuana Product subject to an administrative hold must be put into separate Harvest Batches. h. At any time after the initiation of the administrative hold, the Division may lift the administrative hold, order the continuation of the administrative hold pending the administrative process, or seek other appropriate relief. Voluntary Surrender of Retail Marijuana and Retail Marijuana Product 1. A Licensee, prior to a Final Agency Order and upon mutual agreement with the Division, may elect to voluntarily surrender any Retail Marijuana and Retail Marijuana Product to the Division. a. Such voluntary surrender may require destruction of any Retail Marijuana and Retail Marijuana Product in the presence of a Division investigator and at the Licensee’s expense. b. The individual signing the Division’s voluntary surrender form on behalf of the Licensee must certify that the individual has authority to represent and bind the Licensee. 2. The voluntary surrender form may be utilized in connection with a stipulated agency order through which the Licensee waives the right to hearing and any associated rights. 3. The voluntary surrender form may be utilized even if the Licensee does not waive the right to hearing and any associated rights, with the understanding that the outcome of the hearing does not impact the validity of the voluntary surrender. 4. A Licensee, after a Final Agency Order and upon mutual agreement with the Division, may elect to voluntarily surrender any marijuana or marijuana product to the Division. a. The Licensee must complete and return the Division's voluntary surrender form within 15 calendar days of the date of the Final Agency Order. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 169 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 170 of 201 b. Such voluntary surrender may require destruction of any marijuana or marijuana product in the presence of a Division investigator and at the Licensee’s expense. c. The individual signing the Division’s voluntary surrender form on behalf of the Licensee must certify that the individual has authority to represent and bind the Licensee. Basis and Purpose – R 1203 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(b)(I), 1243.3-202(2)(b)(III), and 12-43.4-602, C.R.S. The purpose of this rule is to provide guidance following either an agency decision or under any circumstances where the Licensee is ordered to surrender and/or destroy unauthorized Retail Marijuana or unauthorized Retail Marijuana Product. This rule also provides guidance as to the need to preserve evidence during agency investigations or subject to agency order. R 1203 – Disposition of Unauthorized Retail Marijuana A. B. After a Final Agency Order Orders the Destruction of Marijuana. If the State Licensing Authority issues a Final Agency Order pursuant to section 12-43.4-602, C.R.S., that orders the destruction of some or all of the Licensee’s unauthorized Retail Marijuana or unauthorized Retail Marijuana Product, the Licensee may: 1. Voluntarily Surrender. The Licensee may voluntarily surrender to the Division all of its unauthorized Retail Marijuana and unauthorized Retail Marijuana Product that are described in the Final Agency Order in accordance with the provisions of Rule R 1202. 2. Seek A Stay. The Licensee may file a petition for a stay of the Final Agency Order with the Denver district court within 15 days of the date of the Final Agency Order. 3. Take No Action. If the Licensee does not either (1) voluntarily surrender its unauthorized Retail Marijuana or unauthorized Retail Marijuana Product as set forth in section A(1)(a) of this rule; or (2) properly seek a stay of the Final Agency Order as set forth in section A(2) of this rule, the Division will enter upon the Licensed Premises and seize and destroy the marijuana and/or marijuana products that are the subject of the Final Agency Order. General Requirements Applicable To All Licensees Following Final Agency Order To Destroy Unauthorized Retail Marijuana and Unauthorized Retail Marijuana Product. The following requirements apply regardless of whether the Licensee voluntarily surrenders its unauthorized Retail Marijuana or unauthorized Retail Marijuana Product seeks a stay of agency action, or takes no action: 1. The 15 day period set forth in section 12-43.3-602(5), C.R.S., and this rule shall include holidays and weekends. 2. During the period of time between the issuance of the Final Agency Order and the destruction of the unauthorized Retail Marijuana or unauthorized Retail Marijuana Product the Licensee shall not Transfersell, destroy, or otherwise let any unauthorized Retail Marijuana or unauthorized Retail Marijuana Product that are subject to the Final Agency Order leave the Licensed Premises, unless specifically authorized by the State Licensing Authority or Court order. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 170 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 171 of 201 3. During the period of time between the issuance of the Final Agency Order and the destruction of unauthorized Retail Marijuana or unauthorized Retail Marijuana Product, the Licensee must safeguard any unauthorized Retail Marijuana or unauthorized Retail Marijuana Product in its possession or control and must fully comply with all security requirements including but not limited to surveillance, lock and alarm requirements set forth in the Retail Code and the rules of the State Licensing Authority. 4. Unless the State Licensing Authority otherwise orders, the Licensee may cultivate, water, or otherwise care for any unauthorized Retail Marijuana or unauthorized Retail Marijuana Product that are subject to the Final Agency Order during the period of time between the issuance of the Final Agency order and the destruction of the unauthorized Retail Marijuana or unauthorized Retail Marijuana Product. 5. If a district attorney notifies the Division that some or all of the unauthorized Retail Marijuana or unauthorized Retail Marijuana Product is involved in an investigation, the Division shall not destroy the unauthorized Retail Marijuana or unauthorized Retail Marijuana Product until approved by the district attorney. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 171 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 172 of 201 R 1300 Series – Discipline Basis and Purpose – R 1303 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(2)(c), 12-43.4202(3)(a)(I), 12-43.4-202(3)(a)(XVI) 12-43.4-202(3)(b)(IX) and 24-4-104(4)(a), C.R.S., and sections 1243.3-601 and 24-4-105, C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(I). The State Licensing Authority recognizes that if Licensees are not able to care for their products during a period of active suspension, then their plants could die, their edible products could deteriorate, and their on-hand inventory may not be properly maintained. Accordingly, this rule was written to clarify that Licensees whose licenses are summarily suspended may care for on-hand inventory, manufactured products, and plants during the suspension (unless the State Licensing Authority does not allow such activity), provided the Licensed Premises and all Retail Marijuana and Retail Marijuana Product are adequately secured. In addition, the rule clarifies what activity is always prohibited during such suspension. R 1303 – Suspension Process: Regular and Summary Suspensions A. Signs Required During Suspension. Every Licensee whose license has been suspended, whether summarily or after an administrative hearing, shall post two notices in conspicuous places, one on the exterior and one on the interior of its premises, for the duration of the suspension. The notices shall be at least 17 inches in length and 11 inches in width containing lettering not less 1/2'’ in height. 1. For suspension following issuance of a Final Agency Order, the sign shall be in the following form: NOTICE OF SUSPENSION RETAIL MARIJUANA LICENSES ISSUED FOR THESE PREMISES HAVE BEEN SUSPENDED BY ORDER OF THE STATE LICENSING AUTHORITY FOR VIOLATION OF THE COLORADO RETAIL MARIJUANA CODE 2. For a summary suspension pending issuance of a Final Agency Order, the sign shall be in the following form: NOTICE OF SUSPENSION RETAIL MARIJUANA LICENSES ISSUED FOR THESE PREMISES HAVE BEEN SUSPENDED BY ORDER OF THE STATE LICENSING AUTHORITY FOR ALLEGED VIOLATION OF THE COLORADO RETAIL MARIJUANA CODE Any advertisement or posted signs that indicate that the premises have been closed or business suspended for any reason other than by the manner described in this rule shall be deemed a violation of these rules. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 172 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 B. C. D. RETAIL - Page 173 of 201 Prohibited Activity During Active Suspension 1. Unless otherwise ordered by the State Licensing Authority, during any period of active license suspension the Licensee shall not permit the selling, serving, giving away, distribution, manufacture, sampling, acquisition, purchase , tTransfer, or transport of Retail Marijuana or Retail Marijuana Product on the Licensed Premises, nor allow customers to enter the Licensed Premises. 2. Unless otherwise ordered by the State Licensing Authority, during any period of suspension the Licensee may continue to possess, maintain, cultivate or harvest Retail Marijuana or Retail Marijuana Product on the Licensed Premises. The Licensee must fully account for all such Retail Marijuana and Retail Marijuana Product in the Inventory Tracking System. The Licensee must safeguard any Retail Marijuana or Retail Marijuana Product in its possession or control. The Licensee must fully comply with all security requirements including but not limited to surveillance, lock and alarm requirements set forth in the Retail Code and the rules of the State Licensing Authority. Removal and Destruction of Marijuana and Marijuana Product. Retail Marijuana and Retail Marijuana Product shall not be removed from the Licensed Premises or destroyed unless and until: 1. The provisions described in section 12-43.4-602, C.R.S., related to the proper destruction of unauthorized marijuana are met, and the State Licensing Authority orders forfeiture and destruction. See also Rule R1203 – Disposition of Unauthorized Retail Marijuana; 2. The Licensee has voluntarily surrendered the Retail Marijuana or Retail Marijuana Product in accordance with Rule R 1202(C) – voluntary surrender; 3. The State Licensing Authority has seized the Retail Marijuana or Retail Marijuana Product pursuant to an Administrative Warrant. See Rule R 1309 – Administrative Warrant. Renewal. The issuance of a suspension or an Order of Summary Suspension does not relieve the Licensee of the obligation to timely comply with all license renewal requirements. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 173 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 174 of 201 R 1500 Series – Retail Marijuana Testing Program Basis and Purpose – R 1501 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(a)(IV), 1243.4-202(3)(a)(VII), 12-43.4-202(3)(a)(VIII), 12-43.4-202(3)(a)(X), 12-43.4-202(3)(a)(XI), 12-43.4202(3)(a)(XII), 12-43.4-202(3)(b)(III), 12-43.4-202(3)(b)(IX), 12-43.4-202(3)(c)(VII), 12-43.4-402(4), 1243.4-403(5), 12-43.4-404(3), and 12-43.4-404(6), C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(VII). The purpose of this rule is to protect the public health and safety by establishing the contaminant testing and related process validation portion of the Division’s Retail Marijuana sampling and testing program. R 1501 – Retail Marijuana Testing Program – Contaminant Testing A. Contaminant Testing Required. Until Unless a Retail Marijuana Cultivation Facility’s or a Retail Marijuana Product Manufacturing Facility’s cultivation or production process has achieved process validation been validated under this rule, it shall not wholesale, tTransfer, or process into a Retail Marijuana Concentrate or Retail Marijuana Product any Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product unless Samples from each Harvest Batch or Production Batch from which that Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product was derived has been was tested by a Retail Marijuana Testing Facility for contaminants and passed all contaminant tests required by Pparagraph (C) of this rule. B. Validation of Process Validation and Ongoing Testing– Contaminant Testing 1. Retail Marijuana. A Retail Marijuana Cultivation Facility’s cultivation process shall be deemed validated regarding for Ccontaminants testing if every Harvest Batch that it produced during at least a six-week period but no longer than a 12-week period passed all contaminant tests required by Pparagraph (C) of this rule. This must include at least six6 Test Batches that contain Samples from entirely different Harvest Batches. 2. Retail Marijuana Concentrate or Retail Marijuana Product. A Retail Marijuana Cultivation Facility’s or a Retail Marijuana Products Manufacturing Facility’s production process shall be deemed validated for regarding contaminants testing if every Production Batch that it produced during at least a four-week period but no longer than an eight-week period passed all contaminant tests required by Pparagraph (C) of this rule. This must include at least four Test Batches that contain Samples from entirely different Production Batches. 3. Expiration of Process Validation is Effective for One Year. Once aA Retail Marijuana Cultivation Facility andor Retail Marijuana Products Manufacturing Facility has shall be required to re-validate its process for contaminant testing every 12 months from the date process validation is achieved, after which point he process validation expires. If the process validation expires, the Retail Marijuana Cultivation Facility shall comply with the requirements of Paragraph (A) of this rule.successfully obtained process validation for contaminants, the process validation shall be effective for one year from the date of the last passing test required to satisfy the process validation requirements. Retail Marijuana Ongoing Contaminant Testing. After successfully obtaining process validation, a Retail Marijuana Cultivation Facility shall subject at least one Harvest Batch to all contaminant testing required by Paragraph (C) of this rule every 7 days. If a Retail Marijuana Cultivation Facility does not possess a Harvest Batch that is ready for testing during any 7-day period, the Retail Marijuana Cultivation Facility must subject its first Harvest Batch that is ready for testing to the required contaminant testing prior to 4. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 174 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 175 of 201 Transfer or processing of the Retail Marijuana. If a Harvest Batch subject to ongoing contaminant testing fails contaminant testing, the Retail Marijuana Cultivation Facility shall follow the procedure in Paragraph (F)(2) of this rule. a. 5. Retail Marijuana Concentrate or Retail Marijuana Product Ongoing Contaminant Testing. After successfully obtaining process validation, a Retail Marijuana Cultivation Facility or Retail Marijuana Products Manufacturing Facility shall subject at least one Production Batch to all contaminant testing required by Paragraph (C) of this rule every 7 days. If a Retail Marijuana Cultivation Facility or Retail Marijuana Products Manufacturing Facility does not possess a Production Batch that is ready for testing during any 7-day period, the Retail Marijuana Cultivation Facility or Retail Marijuana Products Manufacturing Facility must subject its first Production Batch that is ready for testing to the required contaminant testing prior to Transfer or processing of the Retail Marijuana. If a Production Batch submitted for ongoing contaminant testing fails contaminant testing, the Retail Marijuana Cultivation Facility or Retail Marijuana Products Manufacturing Facility shall follow the procedure in Paragraph (F)(2) of this rule. a. C. The Division may reduce the frequency of ongoing contaminant testing required by Retail Marijuana Cultivation Facilities if the Division has reasonable grounds to believe Retail Marijuana Testing Facilities have reached maximum capacity to perform testing required by this rule. The Division will provide notification of any reduction to the frequency of ongoing contaminant testing to the Licensee’s last electronic mailing address provided to the Division. The Division may reduce the frequency of ongoing contaminant testing required by Retail Marijuana Cultivation Facilities and Retail Marijuana Products Manufacturing Facilities if the Division has reasonable grounds to believe Retail Marijuana Testing Facilities have reached maximum capacity to perform testing required by this rule. The Division will provide notification of any reduction to the frequency of ongoing contaminant testing to the Licensee’s last electronic mailing address provided to the Division. Required Contaminant Tests 1. Microbial Contaminant Testing. Each Harvest Batches of Retail Marijuana and Production Batches of Water, Heat/Pressure or Food-Based Retail Marijuana Concentrate and Retail Marijuana Product must be tested for microbial contamination by a Retail Marijuana Testing Facility at the frequency established by Paragraphs (A) and (B) of this rule. The microbial contamination test must include, but need not be limited to, testing to determine the presence of Salmonella sp. and shiga-toxin producing Escherichia coli., and the amount of total yeast and mold. 2. Repealed 3. Repealed. 4. Residual Solvent Contaminant Testing. Each Production Batches of Solvent-Based Retail Marijuana Concentrate produced by a Retail Marijuana Products Manufacturing Facility must be tested by a Retail Marijuana Testing Facility for residual solvent contamination at the frequency established by Paragraphs (A) and (B) of this rule. The residual solvent 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 175 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 176 of 201 contamination test must include, but need not be limited to, testing to determine the presence of, and amounts present of, acetone butane, ethanol, heptanes, isopropyl alcohol, propane, benzene*, toluene*, pentane, hexane*, and total xylenes (m, p, o – xylenes)*. * Note: These solvents are not approved for use. Testing is required for these solvents due to their possible presence in the solvents approved for use per rule R 605. 5. Mycotoxin Contaminant Testing. As part of Remediation, each Production Batch of Solvent-Based Retail Marijuana Concentrate produced by a Retail Marijuana Products Manufacturing Facility from Retail Marijuana that failed microbial contaminant testing produced must be tested by a Retail Marijuana Testing Facility for mycotoxin contamination at the frequency established by Paragraphs (A) and (B) of this rule. The mycotoxin contaminant test must include, but need not be limited to, testing to determine the presence of, and amounts present of, aflatoxins (B1, B2, G1, and G2) and ochratoxin A. This is in addition to all other contaminant testing required by this paragraph C. 6. Pesticide Contaminant Testing. Harvest Batches of Retail Marijuana must be tested for Pesticide contamination by a Retail Marijuana Testing Facility. The Pesticide contamination test must include, but need not be limited to, testing to determine the presence of, and amounts present of, the Pesticides listed in Rule R 712(E)(5). D. Additional Required Tests. The Division may require additional tests to be conducted on a Harvest Batch or Production Batch prior to a Retail Marijuana Cultivation Facility or a Retail Marijuana Product Manufacturing Facility wholesaling, tTransferring, or processing into a Retail Marijuana Concentrate or Retail Marijuana Product any Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product from that Harvest Batch or Production Batch. Additional tests may include, but need not be limited to, screening for Pesticide, chemical contaminants, biological contaminants, or other types of microbials, molds, metals, or residual solvents. E. Exemptions 1. F. Retail Marijuana Concentrate. A Production Batch of Retail Marijuana Concentrate shall be considered exempt from this rule if the Retail Marijuana Products Manufacturing Facility that produced it does not wholesale or tTransfer any of portion of the Production Batch and uses the entire Production Batch to manufacture Retail Marijuana Product, except that a Solvent-Based Retail Marijuana Concentrate must still be submitted for residual solvent contaminant testing. The manufactured Retail Marijuana Product shall be subject to mandatory testing under this rule. Required Re-Validation - Contaminants. 1. Material Change Re-validation. If a Retail Marijuana Cultivation Facility or a Retail Marijuana Product Manufacturing Facility makes a Material Change to its cultivation or production process or its standard operating procedure manual, then it must have the first five Harvest Batches or Production Batches produced using the new standard operating procedures tested for all of the contaminants required by Pparagraph (C) of this rule regardless of whether its process has been previously validated regarding contaminants. If any of those tests fail, then the Retail Marijuana Establishment’s process must be revalidated. a. Pesticide. It shall be considered a Material Change if a Retail Marijuana Cultivation Facility begins using a new or different Pesticide during its cultivation 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 176 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 177 of 201 process. and the first five Harvest Batches produced using the new or different Pesticide must also be tested for Pesticide. 2. b. Solvents. It shall be considered a Material Change if a Retail Marijuana Products Manufacturing Facility begins using a new or different solvent or combination of solvents or changes any parameters for equipment related to the solvent purging process, including but not limited to, time, temperature, or pressure. c. Cultivation. It shall be considered a Material Change if a Retail Marijuana Cultivation Facility begins using a new or different method for any material part of the cultivation process, including, but not limited to, changing from one growing medium to another. dc. Notification. A Retail Marijuana Cultivation Facility or a Retail Marijuana Product Manufacturing Facility that makes a Material Change must notify the Retail Marijuana Testing Facility of the Material Change. that conducts contaminant testing on the first five Harvest Batches or Production Batches produced using the new standard operating procedures. ed. Testing Required Prior to Wholesale, Transfer or Processing. When a Harvest Batch or Production Batch is required to be submitted for testing pursuant to this rule, the Retail Marijuana Cultivation Facility or a Retail Marijuana Product Manufacturing Facility that produced it may not wholesale, tTransfer or process into a Retail Marijuana Concentrate or Retail Marijuana Product any of the Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product from that Harvest Batch or Production Batch. Failed Contaminant Testing and Re-Validation. Failed contaminant testing may constitute a violation of these rules. Additionally, iIf a Sample the Division requires to be tested fails contaminant testing, the Retail Marijuana Cultivation Facility or Retail Marijuana Products Manufacturing Facility shall follow the procedures in paragraph B of rRule R 1507(B) for any Inventory Tracking System package, Harvest Batch, or Production Batch from which the failed Sample was taken. The Retail Marijuana Cultivation Facility or Retail Marijuana Products Manufacturing Facility shall also submit three additional Test Batches of the Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product for contaminant testing by a Retail Marijuana Testing Facility within no more than 30 days. If any one of the three submitted Test Batches fails contaminant testing, the Retail Marijuana Cultivation Facility or Retail Marijuana Products Manufacturing Facility shall re-validate its process for contaminants. 3. G. Repealed. Expiration of Process Validation. A Retail Marijuana Cultivation Facility or Retail Marijuana Products Manufacturing Facility shall be required to re-validate its process once the one year of process validation expires, or the Retail Marijuana Establishment shall comply with the requirements of paragraph A of this rule R 1501. Violation Affecting Public Safety. Failure to comply with this rule may constitute a license violation affecting public safety. Basis and Purpose – R 1502 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(a)(IV), 1243.4-202(3)(a)(VII), 12-43.4-202(3)(a)(VIII), 12-43.4-202(3)(a)(X), 12-43.4-202(3)(a)(XI), 12-43.4- 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 177 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 178 of 201 202(3)(a)(XII), 12-43.4-202(3)(b)(III), 12-43.4-202(3)(b)(IX), 12-43.4-202(3)(c)(VII), 12-43.4-402(4), 1243.4-403(5), 12-43.4-404(3), and 12-43.4-404(6), C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(VII). The purpose of this rule is to protect the public health and safety by establishing the mandatory testing portion of the Division’s Retail Marijuana sampling and testing program. R 1502 – Retail Marijuana Testing Program – Mandatory Testing A. B. Required Sample Submission. A Retail Marijuana Establishment may be required by the Division to submit a Sample(s) of Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product it possesses to a Retail Marijuana Testing Facility at any time regardless of whether its process has been validated and without notice. 1. Samples collected pursuant to this rule may be tested for potency or contaminants which may include, but may not be limited to, Pesticide, microbials, mycotoxin, molds, metals, residual solvents, biological contaminants, and chemical contaminants.. 2. When a Sample(s) is required to be submitted for testing, the Retail Marijuana Establishment may not sell, wholesale, tTransfer or process into a Retail Marijuana Concentrate or Retail Marijuana Product any Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product from the Inventory Tracking System package, Harvest Batch or Production Batch from which the Sample was taken, unless or until it passes all required testing. Methods for Determining Required Testing 1. Random Testing. The Division may require Samples to be submitted for testing through any one or more of the following processes: random process, risk-based process or other internally developed process, regardless of whether a Retail Marijuana Establishment’s process has been validated. 2. Inspection or Enforcement Tests. The Division may require a Retail Marijuana Establishment to submit a Sample for testing if the Division has reasonable grounds to believe that: 3. C. a. Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product is contaminated or mislabeled; b. A Retail Marijuana Establishment is in violation of any product safety, health or sanitary lawstatute, rule or regulation; or c. The results of a test would further an investigation by the Division into a violation of any lawstatute, rule or regulation. Beta Testing. The Division may require a Retail Marijuana Establishment to submit Samples from certain randomly selected Harvest Batches or Production Batches for potency or contaminant testing prior to implementing mandatory testing. Minimum Testing Standards. The testing requirements contained in the R 1500 series are the minimum required testing standards. Retail Marijuana Establishments are responsible for receiving enough ensuring adequate testing on any Retail Marijuana, Retail Marijuana Concentrate, and/or Retail Marijuana Product they produce or Transfer to ensure the marijuana consumables are safe safety for human consumption. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 178 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 D. E. RETAIL - Page 179 of 201 Additional Sample Types. The Division may also require a Retail Marijuana Establishment to submit Samples comprised of items other than Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product to be tested for contaminants which may include, but may not be limited to, Pesticide, microbials, molds, metals, residual solvents, biological contaminants, and chemical contaminants.. The following is a non-exhaustive list of the types of Samples that may be required to be submitted for contaminant testing: 1. Specific Retail Marijuana plant(s) or any portion of a Retail Marijuana plant(s), 2. Any growing medium, water or other substance used in the cultivation process, 3. Any water, solvent or other substance used in the processing of a Retail Marijuana Concentrate, 4. Any ingredient or substance used in the manufacturing of a Retail Marijuana Product; or 5. Swab of any equipment or surface. Violation Affecting Public Safety. Failure to comply with this rule may constitute a license violation affecting public safety. Basis and Purpose – R 1503 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(a)(IV), 1243.4-202(3)(a)(VII), 12-43.4-202(3)(a)(X), 12-43.4-202(3)(a)(XII), 12-43.4-202(3)(b)(III), 12-43.4202(3)(b)(IX), 12-43.4-202(3)(c)(V), 12-43.4-202(3)(c)(VI), 12-43.4-202(3)(c)(VII), 12-43.4-402(4), 1243.4-403(5), and 12-43.4-404(6), C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(VII). The purpose of this rule is to protect the public health and safety by establishing the potency testing and related process validation portion of the Division’s Retail Marijuana sampling and testing program. R 1503 – Retail Marijuana Testing Program – Potency Testing A. Potency Testing – General 1. Test Batches. A Test Batch submitted for potency testing may only be comprised of Samples that are of the same strain of Retail Marijuana or from the same Production Batch of Retail Marijuana Concentrate or Retail Marijuana Product. 2. Cannabinoid Profile. A potency test conducted pursuant to this rule must at least determine the level of concentration of THC, THCA, CBD, CBDA and CBN. B. Potency Testing for Retail Marijuana. 1. Initial Potency Testing. A Retail Marijuana Cultivation Facility must have potency tests conducted by a Retail Marijuana Testing Facility on four Harvest Batches, created a minimum of one week apart, for each strain of Retail Marijuana that it cultivates. a. The first potency test must be conducted on each strain prior to the Retail Marijuana Cultivation Facility wholesaling, tTransferring or processing into a Retail Marijuana Concentrate any Retail Marijuana of that strain. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 179 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 b. 2. RETAIL - Page 180 of 201 All four potency tests must be conducted on each strain no later than December 1, 2014 or six months after the Retail Marijuana Cultivation Facility begins cultivating that strain, whichever is later. Ongoing Potency Testing. After the initial four potency tests, a Retail Marijuana Cultivation Facility shall have each strain of Retail Marijuana that it cultivates tested for potency at least once every six months. C. Potency Testing for Retail Marijuana Concentrate. A Retail Marijuana Cultivation Facility or Retail Marijuana Products Manufacturing Facility must have a potency test conducted by a Retail Marijuana Testing Facility on every Production Batch of Retail Marijuana Concentrate that it produces prior to wholesaling, tTransferring or processing into a Retail Marijuana Product any of the Retail Marijuana Concentrate from that Production Batch. D. Potency Testing for Retail Marijuana Product E. 1. Potency Testing Required for non-Edible Retail Marijuana Product. A Retail Marijuana Products Manufacturing Facility shall have potency tests conducted by a Retail Marijuana Testing Facility on every Production Batch of each type of Retail Marijuana Product that is not Edible Retail Marijuana Product that it produces prior to tTransferring or wholesaling any of the non-Edible Retail Marijuana Product from that Production Batch,. unless the Retail Marijuana Products Manufacturing Facility has successfully completed process validation for potency and homogeneity for the particular type of Retail Marijuana Product. 1.5 Potency Testing Required for Edible Retail Marijuana Product. A Retail Marijuana Products Manufacturing Facility shall have potency tests conducted by a Retail Marijuana Testing Facility on every Production Batch of each type of Edible Retail Marijuana Product that it produces prior to transferring or wholesaling any of the Edible Retail Marijuana Product from that Production Batch, unless the Retail Marijuana Products Manufacturing Facility has successfully completed process validation for potency and homogeneity for the particular type of Edible Retail Marijuana Product. 2. Required Tests. Potency and homogeneity tests conducted on Retail Marijuana Product must determine the level of concentration of the required cCannabinoids and whether or not THC is homogeneously distributed throughout the product. 3. Partially Infused Retail Marijuana Products. If only a portion of a Retail Marijuana Product is infused with Retail Marijuana, then the Retail Marijuana Products Manufacturing Facility must inform the Retail Marijuana Testing Facility of exactly which portions of the Retail Marijuana Product are infused and which portions are not infused. Validation of Process Process Validation- Potency and Homogeneity. 1. A Retail Marijuana Products Manufacturing Facility may process validate potency and homogeneity for each type of Edible Retail Marijuana Product it manufactures. 2. A Retail Marijuana Products Manufacturing Facility’s production process for a particular type of Edible Retail Marijuana Product shall be deemed valid regarding potency and homogeneity if every Production Batch that it produces for that particular type of Edible Retail Marijuana Product during at least a four-week period but no longer than an eightweek period passes all potency and homogeneity tests required by Pparagraph (D)(2) of 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 180 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 181 of 201 this rule R 1503(D)(2). This must include at least four Test Batches. that contain Samples from entirely different Production Batches. 3. Expiration of Process Validation is Effective for One Year. Once aA Retail Marijuana Products Manufacturing Facility shall be required to re-validate its process every 12 months from the date process validation is achieved, after which point the process validation expires. If the process validation expires, the Retail Marijuana Products Manufacturing Facility shall comply with the requirements of Paragraph (D)(1) of this rule. has successfully obtained process validation for potency and homogeneity for a particular type of Edible Retail Marijuana Product that it produces, the process validation shall be effective for one year from the date of the last passing test required to satisfy the process validation requirements. 4. Edible Retail Marijuana Product Ongoing Potency and Homogeneity Testing. After successfully obtaining process validation, a Retail Marijuana Products Manufacturing Facility shall subject at least one Production Batch to potency and homogeneity testing required by Paragraph (D) of this rule every 7 days. If a Retail Marijuana Products Manufacturing Facility does not possess a Production Batch that is ready for testing during any 7-day period, the Retail Marijuana Products Manufacturing Facility must subject its first Production Batch that is ready for testing to the required potency and homogeneity testing prior to Transfer or processing of the Retail Marijuana. If a Test Batch submitted for ongoing potency and homogeneity testing fails potency and homogeneity testing, the Retail Marijuana Products Manufacturing Facility shall follow the procedure in Paragraph (F)(2) of this rule. a. F. The Division may reduce the frequency of ongoing potency and homogeneity testing required by Retail Marijuana Products Manufacturing Facilities if the Division has reasonable grounds to believe Retail Marijuana Testing Facilities have reached maximum capacity to perform testing required by this rule. The Division will provide notification of any reduction to the frequency of ongoing potency and homogeneity testing to the Licensee’s last electronic mailing address provided to the Division. Required Re-Validation - Potency and Homogeneity - Edible Retail Marijuana Product. 1. Material Change Re-Validation. If a Retail Marijuana Products Manufacturing Facility elects to process validate any Edible Retail Marijuana Product for potency and homogeneity and it makes a Material Change to its production process for that particular type of Edible Retail Marijuana Product, then the Retail Marijuana Products Manufacturing Facility must re-validate the production process. a. New Equipment. It shall be considered a Material Change if the Retail Marijuana Products Manufacturing Facility begins using new or different equipment for any material part of the production process. b. Notification. A Retail Marijuana Product Manufacturing Facility that makes a Material Change to the production process of a validated Edible Retail Marijuana Product must notify the Retail Marijuana Testing Facility of a Material Change that conducts potency and homogeneity testing on the first four Production Batches produced using the new standard operating procedures. c. Testing Required Prior to Wholesale or Transfer. When a Production Batch is required to be submitted for testing pursuant to this rule, the Marijuana Product 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 181 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 182 of 201 Manufacturing Facility that produced it may not wholesale or tTransfer Retail Marijuana Product from that Production Batch unless or until it obtains a passing test. G. 2. Failed Potency Testing Re-Validation. If a Sample the Division requires to be tested fails potency testing, the Retail Marijuana Products Manufacturing Facility shall follow the procedures in paragraph C of Rrule R 1507(C) for any Inventory Tracking System package or Production Batch associated with the failed Sample. The Retail Marijuana Products Manufacturing Facility shall also submit three additional Test Batches of the Retail Marijuana Product for potency testing by a Retail Marijuana Testing Facility within no more than 30 days. If any one of the three submitted Test Batches fails potency testing, the Retail Marijuana Products Manufacturing Facility shall re-validate its process for potency. 3. Repealed. Expiration of Process Validation. A Retail Marijuana Products Manufacturing Facility shall be required to re-validate its process for each particular type of Edible Retail Marijuana Product it produces once the one year of process validation expires, or the Licensee shall comply with the requirements of the potency testing requirements found in rule R 1503(D)(1.5). Violation Affecting Public Safety. Failure to comply with this rule may constitute a license violation affecting public safety. Basis and Purpose – R 1504 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(a)(IV), 1243.4-202(3)(a)(VII), 12-43.4-202(3)(a)(VIII), 12-43.4-202(3)(a)(X), 12-43.4-202(3)(a)(XI), 12-43.4202(3)(a)(XII), 12-43.4-202(3)(b)(III), 12-43.4-202(3)(b)(IX), 12-43.4-202(3)(c)(V), 12-43.4-202(3)(c)(VI), 12-43.4-202(3)(c)(VII), 12-43.4-402(4), 12-43.4-403(5), 12-43.4-404(3), and 12-43.4-404(6), C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(VII). The purpose of this rule is to protect the public health and safety by establishing sampling procedures and rules for the Division’s Retail Marijuana sampling and testing program. R 1504 – Retail Marijuana Testing Program – Sampling Procedures A. Collection of Samples 1. Sample Collection. All Samples submitted for testing pursuant to this rule must be collected by Division personnel or in accordance with the Division’s sampling policy, which is found in the Colorado Department of Public Health and Environment Reference Library at https://tinyurl.com/y8p86vu3. This Reference Library may be continuously updated as new materials become available in accordance with section 25-1.5106(3.5)(d), C.R.S. 2. Sample Selection. The Division may elect, at its sole direction, to assign Division personnel to collect Samples. ANeither a Retail Marijuana Establishment, nor its Owners, and employees or agents shall not attempt to influence the any Samples selected by Division personnel. 3. Adulteration or Alteration Prohibited. A Licensee or its agent shall not adulterate or alter, or attempt to adulterate or alter, any Samples of Retail Marijuana or Retail Marijuana Product for the purpose of circumventing contaminant testing detection limits or potency testing requirements. The Sample(s) collected and submitted for testing must be 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 182 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 183 of 201 representative of the Harvest Batch or Production Batch being tested. A violation of this sub-pParagraph (A)(3) shall be considered a license violation affecting public safety. B. Samples for Test Batches of Retail Marijuana and Retail Marijuana Concentrate. Minimum Number of Samples. These sampling rules shall apply until such time as the State Licensing Authority revises these rules to implement a statistical sampling model. Each Test Batch of Retail Marijuana, or Retail Marijuana Concentrate, or Retail Marijuana Product submitted for testing must be comprised of a representative selection of Samples. Unless a greater amount is required to comply with these rules, each Test Batch of Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Product must be comprised of at least the following number of separately taken Samples: 1. Minimum Number of Samples. At a minimum, each Test Batch of Retail Marijuana or Retail Marijuana Concentrate must be comprised of at least the following number of separately taken Samples:Samples for Test Batches of Retail Marijuana: a. For Test Batches comprised of Harvest Batches or Production Batches weighing up to 10 pounds, a minimum of eight separate 0.5 gram Samples must be taken and combined into submitted as one Test Batch per testing category. b. For Test Batches comprised of Harvest Batches or Production Batches weighing more than 10 pounds but less than 20 pounds, a minimum of 12 separate 0.5 gram Samples must be taken and combined into submitted as one Test Batch per testing category. c. For Test Batches comprised of Harvest Batches or Production Batches weighing 20 pounds or more but less than 30 pounds, a minimum of 15 separate 0.5 gram Samples must be taken and combined into submitted as one Test Batch per testing category. d. For Test Batches comprised of Harvest Batches or Production Batches weighing 30 pound or more but less than 40 pounds, a minimum of 18 separate 0.5 gram Samples must be taken and combined into submitted as one Test Batch per testing category. e. For Test Batches comprised of Harvest Batches or Production Batches weighing 40 pounds or more but less than 100 pounds, a minimum of 23 separate 0.5 gram Samples must be taken and combined into submitted as one Test Batch per testing category. f. For Test Batches comprised of Harvest Batches or Production Batches weighing 100 pounds or more, a minimum of 29 separate 0.5 gram Samples must be taken and combined into submitted as one Test Batch per testing category. 2. Multiple Harvest Batches or Production Batches. If more than one Harvest Batch or Production Batch is combined into a single Test Batch, then that Test Batch must include at least one Sample from each Harvest Batch or Production Batch. 2. Samples for Test Batches of Retail Marijuana Concentrate: a. For Production Batches weighing up to one pound, a minimum of eight separate 0.5 gram Samples must be submitted as one Test Batch per testing category. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 183 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 C. 3. 2. D. RETAIL - Page 184 of 201 b. For Production Batches weighing more than one pound and less than two pounds, a minimum of 12 separate 0.5 gram Samples must be submitted as one Test Batch per testing category. c. For Production Batches weighing two pounds or more but less than three pounds, a minimum of 15 separate 0.5 gram Samples must be submitted as one Test Batch per testing category. d. For Production Batches weighing three pounds or more but less than four pounds, a minimum of 18 separate 0.5 gram Samples must be submitted as one Test Batch per testing category. e. For Production Batches weighing four pounds or more but less than 10 pounds, a minimum of 23 separate 0.5 gram Samples must be submitted as one Test Batch per testing category. f. For Production Batches weighing 10 pounds or more, a minimum of 29 separate 0.5 gram Samples must be submitted as one Test Batch per testing category. Samples for Test Batches of Retail Marijuana Product: 1.a. Finished Product. Test Batches of A Sample of Retail Marijuana Product must be comprised of finished product that is packaged for sale prior to Transfer to a Retail Marijuana Testing Facility. Each such package of Retail Marijuana Product shall constitute one Sample. b. For Production Batches of up to 100 Samples, a minimum of two separate Samples must be submitted as one Test Batch per testing category. c. For Production Batches of up to 500 Samples, a minimum of four separate Samples must be submitted as one Test Batch per testing category. d. For Production Batches of up to 1000 Samples, a minimum of six separate Samples must be submitted as one Test Batch per testing category. e. For Production Batches of up to 5000 Samples, a minimum of eight separate Samples must be submitted as one Test Batch per testing category. f. For Production Batches of up to 10,000 Samples, a minimum of 10 Samples must be submitted as one Test Batch per testing category. g. For Production Batches of more than 10,000 Samples, a minimum 12 Samples must submitted as one Test Batch per testing category. Multiple Production Batches. If more than one Production Batch of Retail Marijuana Product is combined into a single Test Batch, then that Test Batch must include at least one finished product that is packaged for sale from each Production Batch combined into that Test Batch. Retail Marijuana Testing Facility Selection. The Division will generally permit a Retail Marijuana Establishment to select which Retail Marijuana Testing Facility will test a Sample collected pursuant to this rule. However, the Division may elect, at is sole discretion, to assign a Retail Marijuana Testing Facility to test the Sample. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 184 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 E. RETAIL - Page 185 of 201 Violation Affecting Public Safety. Failure to comply with this rule may constitute a license violation affecting public safety. Basis and Purpose – R 1505 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(a)(IV), 1243.4-202(3)(a)(VII), 12-43.4-202(3)(b)(III), 12-43.4-202(3)(b)(IX), 12-43.4-202(3)(c)(V), 12-43.4202(3)(c)(VI), 12-43.4-202(3)(c)(VII), 12-43.4-402(4), 12-43.4-403(5), and 12-43.4-404(6), C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(VII). The purpose of this rule is to protect the public health and safety by establishing rules governing Test Batches for the Division’s Retail Marijuana Sampling and Testing Program. R 1505 – Retail Marijuana Testing Program – Test Batches – Repealed. This rule shall be effective on May 1, 2014. A. No Combination of Product Types. A Test Batch may not be a combination of any two or three of the following: Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product. B. Combining Samples C. 1. Harvest Batches and Production Batches. The Division will generally permit a Retail Marijuana Cultivation Facility or Retail Marijuana Products Manufacturing Facility to combine Samples from any number of Harvest Batches or Production Batches created within a 7 day period into a single Test Batch for any contaminant testing required by rule. However, the Division may elect, at is sole discretion, to require a Test Batch to be comprised of Samples from only one Harvest Batch, Production Batch or a specifically identified quantity of Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Production. 2. Packages. The Division will generally permit a Retail Marijuana Establishment to combine Samples from any number of packages of Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product into a single Test Batch for any contaminant testing required by rule. However, the Division may elect, at is sole discretion, to require a Test Batch to be comprised of Samples from only one package or a specifically identified quantity of Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Production. Same Processes 1. General Applicability. All Harvest Batches or Production Batches combined into a single Test Batch must be cultivated or produced using the same standard operating procedure. 2. Retail Marijuana. All Harvest Batches of Retail Marijuana combined into a single Test Batch must be cultivated using the same Pesticide and other agricultural chemicals. If a Retail Marijuana Cultivation Facility applies a Pesticide or other agriculture chemical to only a specific set of plants, then Samples from those plants must be placed within a separate Test Batch. 3. Retail Marijuana Concentrate. All Production Batches of Retail Marijuana Concentrate combined into a single Test Batch must be of the same category and produced using the same extraction methods and combination of solvents. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 185 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 4. RETAIL - Page 186 of 201 Retail Marijuana Product. All Production Batches of Retail Marijuana Product combined into a single Test Batch must be of the exact same product type and made using the same ingredients. D. Failed Contaminant Testing. If a Test Batch fails a contaminant test, then each Harvest Batch or Production Batch that was combined into that Test Batch shall be considered to have failed contaminant testing. See Rule R 1507. E. Violation Affecting Public Safety. Failure to comply with this rule may constitute a license violation affecting public safety. Basis and Purpose – R 1506 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(a)(IV), 1243.4-402(4), 12-43.4-403(5), and 12-43.4-404(6), C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(VII). The purpose of this rule is to protect the public health and safety by establishing rules requiring Retail Marijuana Establishments to cover certain costs associated with the Division’s Retail Marijuana Sampling and Testing Program. R 1506 – Retail Marijuana Testing Program – Costs This rule shall be effective on May 1, 2014. Costs. The cost for all sampling and tests conducted pursuant to these rules shall be the financial responsibility of the Retail Marijuana Establishment that is required to submit the Sample for testing. Basis and Purpose – R 1507 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(a)(IV), 1243.4-202(3)(a)(VII), 12-43.4-202(3)(a)(VIII), 12-43.4-202(3)(a)(X), 12-43.4-202(3)(a)(XI), 12-43.4202(3)(a)(XII), 12-43.4-202(3)(b)(III), 12-43.4-202(3)(b)(IX), 12-43.4-202(3)(c)(V), 12-43.4-202(3)(c)(VII), 12-43.4-402(4), 12-43.4-403(5), 12-43.4-404(3), and 12-43.4-404(6), C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a)(VII). The purpose of this rule is to protect the public health and safety by establishing rules governing the quarantining of potentially contaminated product and the destruction of product that failed contaminant or potency testing for Division’s Retail Marijuana Sampling and Testing Program. R 1507 – Retail Marijuana Testing Program – Contaminated Product and Failed Test Results A. Quarantining of Product 1. If the Division has reasonable grounds to believe that a particular Harvest Batch, Production Batch, Inventory Tracking System package or quantity of Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product is contaminated or presents a risk to public safety, then the Division may require a Retail Marijuana Establishment to quarantine all or part of it until the completion of the Division’s investigation, which may include, but is not limited to the receipt of any test results. 2. If a Retail Marijuana Establishment is notified by the Division or any local or state agency, or by a Retail Marijuana Testing Facility that a Test Batch failed a contaminant or potency testing, then the Retail Marijuana Establishment shall quarantine any Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product from any Inventory Tracking System package, Harvest Batch, or Production Batch combined into that associated with 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 186 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 187 of 201 that failed Test Batch and must follow the procedures established pursuant to paragraph B of this rule. If permitted by the Division, the quarantine may include part of the Harvest Batch, Production Batch or Inventory Tracking System. B. B.1. 3. Except as provided by this rule, Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product that has been quarantined pursuant to this rule must be physically separated from all other inventory and the Licensee may not Transfer or further process be sold, wholesaled, transferred or processed into a the Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product. 4. In addition to any other method authorized by law, the Division may implement the quarantine through the Inventory Tracking System by (a) indicating failed test results and (b) limiting the Licensee’s ability to Transfer the quarantined Retail Marijuana, Retail Marijuana or Retail Marijuana Concentrate unless otherwise permitted by these rules. Failed Contaminant Testing: All Contaminant Testing Except Microbial Testing of Retail Marijuana Flower or Trim and Pesticide Testing. If a Retail Marijuana Establishment is notified by the Division or a Retail Marijuana Testing Facility that a Test Batch failed contaminant testing, then for each Inventory Tracking System package, Harvest Batch or Production Batch combined into associated with that failed Test Batch the Retail Marijuana Establishment must either: 1. Destroy and document the destruction of the Inventory Tracking System package, Harvest Batch or Production Batch pursuant to that it possesses, See Rule R 307 – Waste Disposal; or 2. Decontaminate the portion of the Inventory Tracking System package, Harvest Batch or Production Batch that it possesses, if possible, and create two new Test Batches, each containing the requisite number of Samples, and have those Test Batches tested for the required identified contaminant test that failed. by the same or different Retail Marijuana Testing Facility. Unless at least one of the two retests is conducted by the same Retail Marijuana Testing Facility that reported the original failed test result, the two retests must be performed by two different Retail Marijuana Testing Facilities. Such testing must comport with the sampling procedures under Rule R 1504. a. If both new Test Batches pass the required contaminant testing, then any the Inventory Tracking System package, Harvest Batch or Production Batch of Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product from any package, Harvest Batch or Production Batch included inassociated with that each Test Batch may be sold, wholesaled, tTransferred or processed into a Retail Marijuana Concentrate or Retail Marijuana Product. b. If one or both of the Test Batches do not pass contaminant testing, then the Retail Marijuana Establishment must destroy and document the destruction of the entire portion of the Inventory Tracking package, Harvest Batch or Production Batch pursuant to included in that Test Batch that it possesses. See Rule R 307 – Waste Disposal. Failed Contaminant Testing: Microbial Testing of Retail Marijuana Flower or Trim. If a Retail Marijuana Cultivation Facility is notified by the Division or a Retail Marijuana Testing Facility that a Test Batch of Retail Marijuana flower or trim failed microbial testing, then for each Inventory Tracking System package or Harvest Batch combined intoassociated with that failed Test Batch the Retail Marijuana Cultivation Facility must: either 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 187 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 188 of 201 1. Destroy and document the destruction of the Inventory Tracking System package or Harvest Batch pursuant to, See Rule R 307 – Waste Disposal; or 2. Decontaminate the Inventory Tracking System package or Harvest Batch of Retail Marijuana flower or trim, if possible, and create two new Test Batches, each containing the requisite number of Samples, and have those Test Batches tested for the required microbial test that failed. Unless at least one of the two retests is conducted by the same Retail Marijuana Testing Facility that reported the original failed test result, the two retests must be performed by two different Retail Marijuana Testing Facilities. Such testing must comport with the sampling procedures under Rule R 1504. 3. a. If both Test Batches pass the required microbial testing, then the Inventory Tracking System package or Harvest Batch of Retail Marijuana flower or trim associated with each Test Batch may be Transferred or processed into a Retail Marijuana Concentrate or Retail Marijuana Product. b. If one or both of the Test Batches do not pass microbial testing, then the Retail Marijuana Establishment must either (i) destroy and document the destruction of the Inventory Tracking System package or Harvest Batch pursuant to Rule R 307 – Waste Disposal; or (ii) Transfer the Inventory Tracking System package or Harvest Batch for Remediation pursuant to Paragraph B.1(3)(b) below. In lieu of decontamination by the Retail Marijuana Cultivation Facility, Tthe Retail Marijuana Cultivation Facility may tTransfer all the Inventory Tracking System packages or Harvest Batches associated with thate failed Test Batch to a Retail Marijuana Products Manufacturing Facility for decontamination and/or Remediation by the Retail Marijuana Products Manufacturing Facility.processing the particular Retail Marijuana into a SolventBased Retail Marijuana Concentrate. a. Decontamination. Only if the Retail Marijuana Cultivation Facility has not already attempted to decontaminate pursuant to Paragraph B.1(2) above, the Retail Marijuana Products Manufacturing Facility may decontaminate the Inventory Tracking System package or, Harvest Batch of Retail Marijuana flower or trim, if possible, and create two new Test Batches, each containing the requisite number of Samples, and have those Test Batches tested for the required microbal test that failed. Unless at least one of the two retests is conducted by the same Retail Marijuana Testing Facility that reported the original failed test result, the two retests must be performed by two different Retail Marijuana Testing Facilities. Such testing must comport with the sampling procedures under Rule R 1504. i. If both Test Batches pass the required microbial testing, then the Inventory Tracking System package or Harvest Batch of Retail Marijuana flower or trim associated with each Test Batch may be Transferred or processed into a Retail Marijuana Concentrate or Retail Marijuana Product. ii. If one or both of the Test Batches do not pass microbial testing, then the Retail Marijuana Establishment must either (i) destroy and document the destruction of the Inventory Tracking System package or Harvest Batch pursuant to Rule R 307 – Waste Disposal; or (ii) attempt Remediation of the Inventory Tracking System package or Harvest Batch for Remediation pursuant to Paragraph B.1(3)(b) below. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 188 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 b. c. 43. B.2. RETAIL - Page 189 of 201 Remediation. i. For Remediation, the Retail Marijuana Cultivation Facility shall process the Inventory Tracking System package or Harvest Batch of The SolventBased Retail Marijuana Concentrate shall be manufactured entirely from the Retail Marijuana flower or trim associated with the failed Test Batchthat failed microbial testing into a Solvent Based Retail Marijuana Concentrate. No other Retail Marijuana shall be included in the SolventBased Retail Marijuana Concentrate manufactured pursuant to subparagraph (B.1)(23) of this rule R 1507. ii.b. The Solvent-Based Retail Marijuana Concentrate that was manufactured pursuant to Paragraph B.1(3)(b)out of the Retail Marijuana flower or trim that failed microbial testing shall undergo all required contaminant testing for contaminants pursuant to rule R 1501(C) – Retail Marijuana Testing Program – Contaminant Testing, for potency testing pursuant to rule R 1503 – Retail Marijuana Testing Program – Potency Testing, and any other testing required or allowed by the Retail Marijuana Rules or Retail Marijuana Code or these rules, including but not limited to mycotoxins. Such testing must comport with the sampling procedures under Rule R 1504. iii. If the Solvent-Based Retail Marijuana Concentrate that was manufactured pursuant to Paragraph B.1(3)(b) out of the Retail Marijuana flower or trim that failed microbial testing fails contaminant testing, the Retail Marijuana Cultivation Facility shall destroy and document the destruction of the entire portion of the Inventory Tracking System package(s) or Production Batch(es) associated with theof Solvent-Based Retail Marijuana Concentrate that failed contaminant testingpursuant to, See Rule R 307 – Waste Disposal. Nothing in this rule removes or alters the responsibility of the Retail Marijuana Cultivation Facility tTransferring the Retail Marijuana that failed microbial testing from complying with the requirement to pay excise tax pursuant to rule R 502(E) and article 28.8 of title 39, C.R.S. Failed Contaminant Testing: Pesticide Testing. If a Retail Marijuana Establishment is notified by the Division or a Retail Marijuana Testing Facility that a Test Batch failed Pesticide testing, then for each Inventory Tracking System package, Harvest Batch or Production Batch associated with that failed Test Batch the Retail Marijuana Establishment must either: 1. Destroy and document the destruction of the Inventory Tracking System package, Harvest Batch or Production Batch pursuant to Rule R 307 – Waste Disposal; or 2. Request that the Retail Marijuana Testing Facility that reported the original fail conduct two additional analyses of the original Test Batch submitted in accordance with Rule R 1504. a. If both retesting analyses pass the required Pesticide testing, then the Inventory Tracking System package, Harvest Batch or Production Batch of Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product may be Transferred or processed into a Retail Marijuana Concentrate or Retail Marijuana Product. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 189 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 b. C. D. RETAIL - Page 190 of 201 If one or both of the retesting analyses do not pass Pesticide testing, then the Retail Marijuana Establishment must destroy and document the destruction of the Inventory Tracking System package, Harvest Batch or Production Batch pursuant to Rule R 307 – Waste Disposal. Failed Potency Testing. If a Retail Marijuana Establishment is notified by the Division or a Retail Marijuana Testing Facility that a Test Batch of Retail Marijuana Product failed potency testing, then for theeach Inventory Tracking System package or Production Batch associated with that failed from which that Test Batch was produced the Retail Marijuana Establishment must either: 1. Destroy and document the destruction of the entire portion of the Inventory Tracking System package or Production Batch that it possesses, See pursuant to Rule R 307 – Waste Disposal; or 2. Attempt corrective measures, if possible, and create two new Test Batches, each containing the requisite number of Samples, and have those Test Batches tested for the required potency test that failed. Unless at least one of the two retests is conducted by the same Retail Marijuana Testing Facility that reported the original failed test result, the two retests must be performed by two different Retail Marijuana Testing Facilities. Such testing must comport with the sampling procedures under Rule R 1504.create two new Test Batches and have those Test Batches tested for potency by the same or different Retail Marijuana Testing Facility. a. If both new Test Batches pass potency testing, then any the Inventory Tracking System package or Production Batch of Retail Marijuana Concentrate or Retail Marijuana Product from the Production Batch included in the associated with each Test Batch may be sold, wholesaled or tTransferred. b. If one or both of the Test Batches do not pass fail potency testing, then the Retail Marijuana Products Manufacturing Facility must destroy and document the destruction of the entire portion of the Inventory Tracking System package or Production Batch pursuant to that it possesses. See Rule R 307 – Waste Disposal. Violation Affecting Public Safety. Failure to comply with this rule may constitute a license violation affecting public safety. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 190 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 191 of 201 R 1600 Series – Retail Marijuana Transporters Basis and Purpose – R 1602 The statutory authority for this rule is found at subsections 12-43.4-202(2)(b), 12-43.4-202(3)(a)(X), 1243.4-202(3)(a)(XVII), 12-43.4-202(3)(b)(IX), and 12-43.4-406, C.R.S. The purpose of this rule is to clarify those acts that are limited in some fashion or prohibited by a Retail Marijuana Transporter. R 1602 – Retail Marijuana Transporter: General Limitations or Prohibited Acts A. Sales, Liens, and Secured Interests Prohibited. A Retail Marijuana Transporter is prohibited from buying, selling, or giving away Retail Marijuana or Retail Marijuana Product, or from receiving complimentary Retail Marijuana or Retail Marijuana Product. A Retail Marijuana Transporter shall not place or hold a lien or secured interest on Retail Marijuana or Retail Marijuana Product. B. Licensed Premises Permitted Required. A Retail Marijuana Transporter shall maintain a Licensed Premises if it: (1) temporarily stores any Retail Marijuana or Retail Marijuana Product, or (2) modifies any information in the Inventory Tracking System generated transport manifest. The Licensed Premises shall be in a local jurisdiction that authorizes the operation of Retail Marijuana Stores. If a Retail Marijuana Transporter Licensed Premises is co-located with a Medical Marijuana Transporter Licensed Premises, then the combined Licensed Premises shall be in a local jurisdiction that authorizes the operation of both Retail Marijuana Stores and Medical Marijuana Centers. C. Off-Premises Storage Permit. A Retail Marijuana Transporter may maintain one or more permitted off-premises storage facilities. See rule R 802 – Off-Premises Storage of Retail Marijuana and Retail Marijuana Product: All Retail Marijuana Establishments. D. Storage Duration. A Retail Marijuana Transporter shall not store Retail Marijuana or Retail Marijuana Product for longer than 7 days from receiving it at its Licensed Premises or offpremises storage facility. The total allowable 7 day storage duration begins and applies regardless of which of the Retail Marijuana Transporter’s premises receives the Retail Marijuana or Retail Marijuana Product first, ie. the Retail Marijuana Transporter’s Licensed Premises, or any of its off-premises storage facilities. E. Control of Retail Marijuana and Retail Marijuana Product. A Retail Marijuana Transporter is responsible for the Retail Marijuana and Retail Marijuana Product once it takes control of the Retail Marijuana and Retail Marijuana Product and until the Retail Marijuana Transporter delivers it to the receiving Retail Marijuana Establishment, Medical Research Facility or Pesticide Manufacturer. For purposes of this rule, taking control of the Retail Marijuana and Retail Marijuana Product means removing it from the originating Retail Marijuana Establishment’s Licensed Premises and placing the Retail Marijuana and Retail Marijuana Product in the transport vehicle. F. Location of Orders Taken and Delivered. A Retail Marijuana Transporter is permitted to take orders on the Licensed Premises of any Retail Marijuana Establishment to transport Retail Marijuana and Retail Marijuana Product. The Retail Marijuana Transporter shall deliver the Retail Marijuana and Retail Marijuana Product to the Licensed Premises of a licensed Retail Marijuana Establishment, a Medical Research Facility, or a Pesticide Manufacturer. G. Consumption Prohibited. A Licensee shall not permit the consumption of marijuana or marijuana product on the Licensed Premises or in transport vehicles. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 191 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 192 of 201 H. A Retail Marijuana Transporter shall receive Retail Marijuana and Retail Marijuana Product from the originating Licensee packaged in the way that it is intended to be delivered to the final destination Licensee, Medical Research Facility, or Pesticide Manufacturer. The Retail Marijuana Transporter shall deliver the Retail Marijuana and Retail Marijuana Product in the same, unaltered packaging to the final destination Licensee. I. Opening of Sealed Packages orBulk Packages or Containers and Re-Packaging Prohibited. A Retail Marijuana Transporter shall not open bulk packages of Retail Marijuana or Retail Marijuana Concentratesealed packages or Containers of Retail Marijuana or Retail Marijuana Product. Retail Marijuana Transporters are prohibited from re-packaging Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product. J. Temperature-Controlled Transport Vehicles. A Retail Marijuana Transporter shall utilize temperature-controlled transport vehicles when necessary to prevent spoilage of the transported Retail Marijuana and Retail Marijuana Product. K. Damaged or Refused Product. Any damaged Retail Marijuana or Retail Marijuana Product that is undeliverable to the final destination Retail Marijuana Establishment, Medical Research Facility or Pesticide Manufacturer, or any Retail Marijuana or Retail Marijuana Product that is refused by the final destination Retail Marijuana Establishment, Medical Research Facility or Pesticide Manufacturer shall be transported back to the originating Retail Marijuana Establishment. L. Transport of Retail Marijuana Vegetative Plants Authorized. Only Retail Marijuana Vegetative plants may be transported between Licensed Premises and such transport shall only be permitted due to an approved change of location pursuant to Rule R 206. Transportation of Vegetative plants to a permitted off-premises storage facility shall not be allowed. Basis and Purpose – R 1603 The statutory authority for this rule is found at subsections 12-43.4-202(1), 12-43.4-202(2)(b), 12-43.4202(3)(a)(X), 12-43.4-202(3)(a)(XII), 12-43.4-202(3)(a)(XVII), 12-43.4-202(3)(b)(IX), and 12-43.4-406(3) C.R.S. The purpose of this rule is to establish a Retail Marijuana Transporter’s obligation to account for and track all Retail Marijuana and Retail Marijuana Product on the Licensed Premises from the point they are transferred from the originating Retail Marijuana Establishment to the destination Retail Marijuana Establishment. R 1603 – Retail Marijuana Transporter: Inventory Tracking System A. Minimum Tracking Requirement. A Retail Marijuana Transporter must use the Inventory Tracking System to ensure its transported Retail Marijuana and Retail Marijuana Product are identified and tracked from the point they are transferred from a Retail Marijuana Establishment when the Retail Marijuana Transporter takes control of the Retail Marijuana and Retail Marijuana Product by removing it from the originating Retail Marijuana Establishment’s Licensed Premises and placing the Retail Marijuana and Retail Marijuana Product in the Retail Marijuana Transporter’s transport vehicle, through delivery to the destination Retail Marijuana Establishment, Medical Research Facility or Pesticide Manufacturer. See also Rule R 309 –Inventory Tracking System. A Retail Marijuana Transporter must have the ability to reconcile its transported Retail Marijuana and Retail Marijuana Product with the Inventory Tracking System and the associated transaction history and transportation order receipts. See also Rule R 901 – Business Records Required. 1. A Retail Marijuana Transporter is prohibited from accepting any Retail Marijuana or Retail Marijuana Product from another Retail Marijuana Establishment without receiving a valid transport manifest generated from the Inventory Tracking System. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 192 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 193 of 201 2. A Retail Marijuana Transporter must immediately input all Retail Marijuana and Retail Marijuana Product received at its Licensed Premises or off-premises storage facility, accounting for all RFID tags, into the Inventory Tracking System at the time of receiving the Retail Marijuana or Retail Marijuana Product. 3. A Retail Marijuana Transporter must reconcile transactions to the Inventory Tracking System at the close of business each day. 4. All information on the Inventory Tracking System generated transport manifests must be accurate. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 193 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 194 of 201 R 1800 Series – Retail Marijuana Transfers to Unlicensed Medical Research Facilities and Pesticide Manufacturers R 1801 – Basis and Purpose The statutory authority for this rule includes but is not limited to subsections 12-43.4-202(1)(a), 12-43.4202(2)(b) and subsection 25-1.5-106.5(5)(b), C.R.S. The purpose of this rule is to establish requirements associated with the Transfer of Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product to Medical Research Facilities, including requirements for the possession and disposition of Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product by Medical Research Facilities. Rule R 1801 – Medical Research Facilities A. B. Transfers to Medical Research Facilities. A Retail Marijuana Cultivation Facility may Transfer Retail Marijuana to a Medical Research Facility. A Retail Marijuana Products Manufacturing Facility may Transfer Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product to a Medical Research Facility. 1. A Retail Marijuana Cultivation Facility is authorized to Transfer by donation Retail Marijuana to a Medical Research Facility pursuant to Rule R 501. 2. A Retail Marijuana Products Manufacturing Facility is authorized to Transfer by donation Retail Marijuana Concentrate and Retail Marijuana Product to a Medical Research Facility pursuant to Rule R 601. 3. Upon Transfer of the Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product to the Medical Research Facility, such Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Product shall be deemed Medical Marijuana, Medical Marijuana Concentrate or Medical Marijuana-Infused Product. Agreement with Medical Research Facility. A Retail Marijuana Cultivation Facility or Retail Marijuana Products Manufacturing Facility that Transfers Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Product to a Medical Research Facility shall enter into a written agreement with the Medical Research Facility prior to Transferring any Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Product to the Medical Research Facility. The written agreement shall constitute a business record. See Rule R 901 – Business Records Required. The written agreement shall include the following information: 1. The identity of the Medical Research Facility; 2. The quantity of Retail Marijuana, Retail Marijuana Concentrate and/or Retail Marijuana Product that will be Transferred to the Medical Research Facility; 3. An affirmation by the Medical Research Facility that it (a) has received approval and funding from the State Board of Health for the research to be conducted on the marijuana; and (b) remains authorized to receive the quantity of Retail Marijuana, Retail Marijuana Concentrate and/or Retail Marijuana Product that will be Transferred to the Medical Research Facility; 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 194 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 C. D. RETAIL - Page 195 of 201 4. An affirmation by the Licensee that the Medical Research Facility has provided it with written proof of the State Board of Health’s approval and funding of the Medical Research Facility’s research; 5. The date(s) upon which Transfer of the Retail Marijuana, Retail Marijuana Concentrate, and/or Retail Marijuana Product will occur; and 6. An acknowledgement that, pursuant to these rules, upon Transfer of the Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product to the Medical Research Facility, such Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Product shall be deemed Medical Marijuana, Medical Marijuana Concentrate or Medical Marijuana-Infused Product. State Board of Health Approval. A Retail Marijuana Cultivation Facility or Retail Marijuana Products Manufacturing Facility shall not Transfer Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product unless and until the State Board of Health approves and funds the Medical Research Facility’s research pursuant to section 25-1.5-106.5, C.R.S. 1. A Retail Marijuana Cultivation Facility or Retail Marijuana Products Manufacturing Facility shall not Transfer any Retail Marijuana, Retail Marijuana Concentrate and/or Retail Marijuana Product until the Retail Marijuana Cultivation Facility or Retail Marijuana Products Manufacturing Facility receives written proof of the State Board of Health’s approval and funding of the Medical Research Facility’s research. The written proof of the State Board of Health’s approval and funding of the Medical Research Facility’s research shall constitute a business record. See Rule R 901 – Business Records Required. 2. Transferring Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Concentrate, or Retail Marijuana Product to a Medical Research Facility before the Medical Research Facility receives approval and funding from the State Board of Health shall be considered a violation affecting public safety. Inventory Tracking Requirements. A Retail Marijuana Cultivation Facility or Retail Marijuana Products Manufacturing Facility shall track all Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product in the Inventory Tracking System until it is delivered to a Medical Research Facility. 1. Transport Manifest. A Licensee shall not deliver or permit the delivery of Retail Marijuana, Retail Marijuana Concentrate or Retail Marijuana Product unless a manifest is generated from the Inventory Tracking System. See Rule R 801(C)- Transport of Retail Marijuana, Retail Marijuana Vegetative Plants, and Retail Marijuana Product: All Retail Marijuana Establishments. 2. Complete Manifest. A Licensee shall not relinquish possession or control of Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Product to a Medical Research Facility until a natural person authorized by the Medical Research Facility acknowledges receipt of the Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Concentrate, or Retail Marijuana Product by signing the transport manifest. See Rule R 801(I). 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 195 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 196 of 201 3. No Inventory Tracking Following Delivery. Once Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Product has been Transferred by a Licensee to a Medical Research Facility, no further inventory tracking is required. 4. Licensee Delivery Responsibility. The originating Licensee is responsible for confirming delivery of the Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Product in the Inventory Tracking System. See Rule R 801(I). E. Packaging, Labeling, and Testing. A Retail Marijuana Cultivation Facility or Retail Marijuana Products Manufacturing Facility that Transfers Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Product to a Medical Research Facility shall package, label, and test all Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product in conformance with the Retail Marijuana Rules, 1 CCR 212-2, prior to Transferring the Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Product. F. Business Records. A Retail Marijuana Cultivation Facility or Retail Marijuana Products Manufacturing Facility that Transfers Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Product to a Medical Research Facility shall keep all documents concerning the relationship and Transfer of any Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product in accordance with Rules R 801 and 901. G. Quantity Limitations for Medical Research Facilities. A Medical Research Facility shall only obtain Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product for the medical research approved pursuant to section 25-1.5-106.5, C.R.S. A Medical Research Facility shall not possess at any time a quantity of Transferred Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Product greater than the quantity approved by the research grant awarded to the Medical Research Facility by the State Board of Health. In no event shall the Medical Research Facility possess an excess of 12 Retail Marijuana Plants, four pounds of Retail Marijuana, 512 grams of Retail Marijuana Concentrate or 5,120 ten-milligram servings of Retail Marijuana Product at any given time. H. Colorado Department of Public Health and Environment and State Board of Health Administration. The Colorado Department of Public Health and Environment and the State Board of Health are the state agencies with the authority to approve or deny research grant proposals pursuant to section 25-1.5-106.5, C.R.S. The Colorado Department of Public Health and Environment is responsible for the administration of grants to Medical Research Facilities pursuant to section 24-1.5-106.5(2), C.R.S. I. Disposal of Medical Marijuana. A Medical Research Facility shall destroy all Transferred Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product following completion of research activities as required by subsection 25-1.5-106.5(5)(b), C.R.S. J. No Transfer to Licensees. Under no circumstance may a Licensee receive or obtain for any purposes any Transferred Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product or Medical Marijuana or Medical Marijuana-Infused Product from a Medical Research Facility. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 196 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 197 of 201 R 1802 – Basis and Purpose The statutory authority for this rule includes but is not limited to subsections 12-43.4-202(1)(b) and 1243.4-202(2)(b), C.R.S. The purpose of this rule is to establish requirements associated with the Transfer of Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product to Pesticide Manufacturers, including requirements for the possession and disposition of Medical Marijuana, Medical Marijuana Concentrate, and Medical Marijuana-Infused Products by Pesticide Manufacturers. Rule R 1802 – Pesticide Manufacturers A. B. Transfers to Pesticide Manufacturers. A Retail Marijuana Cultivation Facility may Transfer Retail Marijuana and Retail Marijuana Concentrate to a Pesticide Manufacturer solely for the purpose of conducting research to establish safe and effective protocols, including but not limited to establishing efficacy and toxicity, for the use of Pesticides on Medical Marijuana. A Retail Marijuana Products Manufacturing Facility may Transfer Retail Marijuana Concentrate and Retail Marijuana Product to a Pesticide Manufacturer solely for the purpose of research to establish safe and effective protocols, including but not limited to establishing efficacy and toxicity, for the use of Pesticides on Medical Marijuana. 1. A Retail Marijuana Cultivation Facility is authorized to Transfer by donation Retail Marijuana to a Pesticide Manufacturer pursuant to Rule R 501. 2. A Retail Marijuana Products Manufacturing Facility is authorized to Transfer by donation Medical Marijuana-Infused Products and Medical Marijuana Concentrate to a Pesticide Manufacturer pursuant to Rule R 601. Written Documentation Required. A Licensee shall require, and shall not Transfer Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product prior to receiving, written proof under oath, as evidenced by an affidavit entered into by an authorized person on behalf of the Pesticide Manufacturer, that the Pesticide Manufacturer: 1. Possesses an establishment registration number with the U.S. Environmental Protection Agency pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act, §§ 7 U.S.C. § 136 et seq.; 2. Is authorized to do business in Colorado; 3. Is in physical possession of the location in the State of Colorado where its research activities will occur; 4. Has applied for and received any necessary license, registration, certification, or permit from the Colorado Department of Agriculture pursuant to the Pesticide Act, sections 35-9101 et seq., C.R.S. and/or the Colorado Pesticide Applicators’ Act, sections 35-10-101 et seq., C.R.S.; and, 5. Will conduct pesticide research on Medical Marijuana to establish safe and effective protocols for the use of pesticides on Medical Marijuana, which protocols may include but not be limited to establishing efficacy and toxicity. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 197 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 198 of 201 This documentation shall constitute a business record under Rule R 901 – Business Records Required C. D. Agreement with Pesticide Manufacturer. A Retail Marijuana Cultivation Facility or Retail Marijuana Products Manufacturing Facility that Transfers Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product to a Pesticide Manufacturer shall enter into a written agreement with the Pesticide Manufacturer prior to Transferring any Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product to the Pesticide Manufacturer. The written agreement, which shall constitute a business record under Rule R 901, shall include: 1. The identity of the Pesticide Manufacturer; 2. The quantity of Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product that will be Transferred to the Pesticide Manufacturer; 3. The date(s) upon which Transfer of the Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product will occur; 4. An affirmation by the Pesticide Manufacturer that it (a) is registered with the U.S. Environmental Protection Agency pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act, §§ 7 U.S.C. § 136 et seq., (b) is authorized to do business in Colorado; (c) is in possession of a physical location in the State of Colorado; (d) will conduct its pesticide research in Colorado; (e) has applied for and received any necessary license, registration, certification, or permit from the Colorado Department of Agriculture pursuant to the Pesticide Act, sections 35-9-101 et seq., C.R.S. and/or the Colorado Pesticide Applicators’ Act, sections 35-10-101 et seq., C.R.S.; (f) remains authorized to receive the quantity of Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product that will be Transferred to the Pesticide Manufacturer; and (g) the Pesticide Manufacturer will only use the Transferred Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product for the purpose of research to establish safe and effective protocols for the use of pesticides on Medical Marijuana, which protocols may include but not be limited to establishing efficacy and toxicity; and, 5. An affirmation by the Licensee that it has received written proof the Pesticide Manufacturer (a) possesses an establishment registration number with the U.S. Environmental Protection Agency pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act, §§ 7 U.S.C. § 136 et seq.; (b) is authorized to do business in Colorado; (c) is in possession of a physical location in the State of Colorado; (d) will conduct its pesticide research in Colorado; (e) has applied for and received any necessary license, registration, certification, or permit from.the Colorado Department of Agriculture pursuant to the Pesticide Act, sections 35-9-101 et seq., and/or the Colorado Pesticide Applicators’ Act, sections 35-10-101 et seq., C.R.S.; and (f) remains authorized to receive the quantity of Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product that will be Transferred to the Pesticide Manufacturer. Inventory Tracking Requirements. A Retail Marijuana Cultivation Facility and Retail Marijuana Products Manufacturing Facility shall track all Retail Marijuana, Retail Marijuana Concentrate, 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 198 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 199 of 201 and Retail Marijuana Product in the Inventory Tracking System until it is delivered to a Pesticide Manufacturer. 1. Transport Manifest. A Licensee shall not deliver or permit the delivery of Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product unless a manifest is generated from the Inventory Tracking System. 2. Complete Manifest. A Licensee shall not relinquish possession or control of Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product to a Pesticide Manufacturer until a natural person authorized by the Pesticide Manufacturer acknowledges receipt of the Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product by signing the transport manifest. 3. No Inventory Tracking Following Delivery. Once Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product has been Transferred by a Licensee to a Pesticide Manufacturer, no further inventory tracking is required. 4. Licensee Delivery Responsibility. The originating Licensee is responsible for confirming delivery of the Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product in the Inventory Tracking System. E. Packaging, Labeling, and Testing. A Retail Marijuana Cultivation Facility or Retail Marijuana Products Manufacturing Facility that sells or Transfers Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product to a Pesticide Manufacturer shall package, label, and test all Retail Marijuana, Retail Marijuana Concentrate, or Retail Marijuana Product in conformance with the Retail Marijuana Rules, 1 CCR 212-2, prior to Transferring the Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product. F. Business Records. A Retail Marijuana Cultivation Facility or Retail Marijuana Products Manufacturing Facility that Transfers Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product to a Pesticide Manufacturer shall keep all documents concerning the relationship and Transfer of any Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product in accordance with Rules R 801 and R 901. G. Pesticide Manufacturer Authorized Activities. A Pesticide Manufacturer is only authorized to possess Medical Marijuana and/or Medical Marijuana-Infused Product in order to conduct research to establish safe and effective protocols, including but not limited to establishing efficacy and toxicity, for the use of Pesticides on Medical Marijuana. H. Quantity Limitations for Pesticide Manufacturer. 1. Plants. A Pesticide Manufacturer shall not possess in excess of 12 Transferred Retail Marijuana Plants. 2. Transferred Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product. A Pesticide Manufacturer shall not obtain or possess an amount of Transferred Retail Marijuana, Retail Marijuana Product, Retail Marijuana Concentrate, Medical Marijuana or Medical Marijuana-Infused Product in excess of four pounds of Retail 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 199 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 200 of 201 Marijuana, 512 grams of Retail Marijuana Concentrate or 5,120 ten-milligram servings of Retail Marijuana Product at any given time. I. Disposition of Transferred Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product. A Pesticide Manufacturer shall destroy all Transferred Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product received from a Licensee following completion of research activities. 1. A Pesticide Manufacturer shall destroy Transferred Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product in conformance with Rule R 307 – Waste Disposal. 2. A Pesticide Manufacturer shall document the destruction of Transferred Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product, which documentation shall include: 3. J. Whether the destroyed material was Transferred Retail Marijuana, Retail Marijuana Concentrate, and/or Retail Marijuana Product; ii. The date of destruction; iii. The location of the destruction; iv. The manner in which the Transferred Retail Marijuana, Retail Marijuana Concentrate, and/or Retail Marijuana Product was rendered unusable and unrecognizable; v. The method of final disposition pursuant to Rule R 307; and, vi. The identity(ies) and contact information of all Person(s) involved in the destruction. A Pesticide Manufacturer shall keep all documentation regarding destruction of Transferred Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product for the current year and three preceding calendar years. No Pesticide on Licensed Premises. Under no circumstance may a Pesticide Manufacturer apply Pesticide(s) for research purposes on the Licensed Premises of a Retail Marijuana Establishment. 1. L. i. Licensees Shall Not Permit Pesticide on Licensed Premises. Under no circumstance may a Licensee allow or permit the application of Pesticide(s) by a Pesticide Manufacturer for research purposes on the Licensed Premises of a Retail Marijuana Establishment. A violation of this prohibition shall be considered a violation affecting public safety. No Human or Animal Subjects. Under no circumstance shall a Pesticide Manufacturer receiving Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product from a Licensee engage in research involving human subjects. Additionally, under no circumstance shall a Pesticide Manufacturer receiving Retail Marijuana, Retail Marijuana Concentrate, and Retail 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 200 of 201 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 201 of 201 Marijuana Product from a Licensee engage in research involving animal subjects, as defined in the Animal Welfare Act, 7 U.S.C. § 2132(g). 1. L. Licensees Shall Not Permit Human or Animal Subject Research. If a Licensee knows or should know that a Pesticide Manufacturer intends to engage in or has engaged in marijuana-related research involving human and/or animal subjects, the Licensee shall not Transfer any Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product to the Pesticide Manufacturer. A violation of this prohibition shall be considered a violation affecting public safety. No Transfer to Licensees Under no circumstance may a Licensee receive or obtain for any purposes any Transferred Retail Marijuana, Retail Marijuana Concentrate, and Retail Marijuana Product or Medical Marijuana or Medical Marijuana-Infused Product from a Pesticide Manufacturer. 9 October 2017 – Proposed Rules 1 CCR 212-2 RETAIL - Page 201 of 201